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## Protocol Section
### Identification Module
**NCT ID:** NCT06434155
**Acronym:** OCT
**Brief Title:** Social History and Glaucoma Progression
**Official Title:** Social History and Glaucoma Progression: The Effect of Body Mass Index, Tobacco, and Alcohol Consumption on the Rates of Structural Change in Patients With Open Angle Glaucoma
#### Organization Study ID Info
**ID:** 17200545
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2022-07-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-07-01
**Type:** ACTUAL
#### Start Date
**Date:** 2022-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Khaled Abdelazeem
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The objective of this study is to predict of glaucoma progression. By imaging of the retinal nerve fiber layer RNFL, optic nerve head (ONH) and macular measurements using spectral-domain OCT (SD-OCT) instruments
**Detailed Description:** Glaucoma is a multifactorial optic neuropathy characterized by structural damage of retinal ganglion cells (RGCs) and their axons that is associated with vision loss and may lead to irreversible blindness. Because glaucomatous damage is irreversible and effective treatment is available to halt further damage, glaucoma management should be optimized with precise micrometer-scale quantifications of ocular structures that improve detection of the disease and its progression. The introduction of OCT technology more than 20 years ago provided in vivo detailed visualization of the optic nerve head (ONH) and retina and enabled the quantitative evaluation of these tructures. Circumpapillary retinal nerve fiber layer (RNFL) thickness is a common OCT measurement that provides comprehensive evaluation of all RGCs in an eye as they converge into the ONH.
When measured with spectral-domain OCT, the RNFL has been shown to differentiate between healthy and glaucomatous eyes. The steady evolution of OCT technology has led to imaging with better resolution, higher scanning speeds, and advanced imaging patterns that has improved the reliability of OCT measurements and allowed for detection of minute changes that can improve the sensitivity of progression detection. Assessment of glaucoma progression usually is based on event or trend analysis. Event-based progression determines when a measurement exceeds a pre-established threshold for change from baseline. Trend-based analysis quantifies the rate of a parameter's progression over time.
### Conditions Module
**Conditions:**
- Glaucoma Open-Angle
**Keywords:**
- Glaucoma
- OCT
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 1584
**Type:** ACTUAL
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 6 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** 1. Patients older than 18 years of age with primary open-angle glaucoma (POAG)
2. POAG diagnosed on the basis of IOP measurements more than 21 mmHg, Open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width), glaucomatous visual field defects consistent with glaucomatous optic disc changes.
3. Eyes with baseline macular and ONH OCT images and ONH photographs of adequate quality and r performed within 6 months of each other were selected
**Label:** Primary Open Angle Glaucoma
### Outcomes Module
#### Primary Outcomes
**Description:** RNFL in (um), ONH in (um), as well as the inner macula thickness (in um) using spectral domain OCT
**Measure:** OCT structural parameters
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* IOP measurements more than 21 mmHg
* Open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width)
* Glaucomatous visual field defects consistent with glaucomatous optic disc changes.
* Eyes with baseline macular and ONH OCT images and ONH photograps
Exclusion Criteria:
* Participants with significant retinal disease.
* non-glaucomatous optic neuropathy.
* anomalous discs
* any retinal pathology.
* history of cataract or glaucoma surgery will not be exclusion criteria.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients older than 18 years of age with primary open-angle glaucoma (OAG)
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Assiut
**Country:** Egypt
**Facility:** Faculty of Medicine
**Zip:** 71515
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009798
- Term: Ocular Hypertension
- ID: D000005128
- Term: Eye Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M20559
- Name: Disease Progression
- Relevance: LOW
- As Found: Unknown
- ID: M3774
- Name: Alcohol Drinking
- Relevance: LOW
- As Found: Unknown
- ID: M9013
- Name: Glaucoma
- Relevance: HIGH
- As Found: Glaucoma
- ID: M9014
- Name: Glaucoma, Open-Angle
- Relevance: HIGH
- As Found: Glaucoma Open-Angle
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M12731
- Name: Ocular Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005901
- Term: Glaucoma
- ID: D000005902
- Term: Glaucoma, Open-Angle
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434142
**Brief Title:** Wear Assessment of Novel PEEK Telescopic Attachment for Overdenture
**Official Title:** Wear Assessment of Novel PEEK Telescopic Attachment for Implant Retained Mandibular Overdenture
#### Organization Study ID Info
**ID:** 751/306
#### Organization
**Class:** OTHER
**Full Name:** Al-Azhar University
### Status Module
#### Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-20
**Type:** ACTUAL
#### Start Date
**Date:** 2024-02-11
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hamada Zaki Mahross Atia
#### Responsible Party
**Investigator Affiliation:** Al-Azhar University
**Investigator Full Name:** Hamada Zaki Mahross Atia
**Investigator Title:** Assistant Professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To assess the wear of Zirconia-PEEK versus cobalt-chromium-PEEK telescopic attachments for implant retained complete mandibular overdenture. The wear of Zirconia-PEEK telescopic attachments can affect the retention of implant retained complete mandibular overdenture.
**Detailed Description:** Twelve completely edentulous patients were randomly chosen for implant retained telescopic overdentures construction and divided into two groups, where group I was a patient with zirconia copy, and group II was with cobalt chromium CoCr copy. The PEEK was constructed for both groups as a secondary coping telescopic attachment for the denture. The wear measurements of PEEK were performed optically by using a USB digital microscope with a built-in camera connected to a compatible personal computer at different intervals of baseline, 3, 6, and 9 months. The data was statistically analyzed and compared using student t-test, ANOVA, and Post Hoc Test.
### Conditions Module
**Conditions:**
- Attachment Disorder
- Stress Disorder
**Keywords:**
- Telescopic attachment
- Attachment Wear
- Zirconia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Group I (study group) was the group of patients with zirconia as a primary copings that attach to the abutment and PEEK as a secondary coping telescopic attachment that attaches to the fitting surface of the denture.
**Intervention Names:**
- Procedure: implant overdenture
**Label:** patient with zirconia copy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Group II (control group) was the group of patients with cobalt chromium (CoCr) as primary copings attached to the abutment and PEEK as a secondary coping's telescopic attachment attached to the fitting surface of the denture.
**Intervention Names:**
- Procedure: implant overdenture
**Label:** patients with cobalt chromium (CoCr) as primary copings
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- patient with zirconia copy
- patients with cobalt chromium (CoCr) as primary copings
**Description:** Following the two-stage surgical protocol, two dental implant fixtures with a length of 10 mm and a diameter of 3.7 mm were inserted at the canine area of the mandibular alveolar ridge.
**Name:** implant overdenture
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** measurement of the mean of wear between two test groups
**Measure:** the mean wear values
**Time Frame:** at baseline
**Description:** measurement of the mean of wear between two test groups
**Measure:** the mean wear values
**Time Frame:** after 3 months interval
**Description:** measurement of the mean of wear between two test groups
**Measure:** the mean wear values
**Time Frame:** after 6 months interval
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* completely edentulous
* free from any dental or systemic diseases
Exclusion Criteria:
* medically ill fit patient
* female patient
**Healthy Volunteers:** True
**Maximum Age:** 70 Years
**Minimum Age:** 50 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Hamada Zaki Mahross
**Zip:** 11884
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000068099
- Term: Trauma and Stressor Related Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M24916
- Name: Stress Disorders, Traumatic
- Relevance: HIGH
- As Found: Stress Disorder
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M222
- Name: Trauma and Stressor Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000040921
- Term: Stress Disorders, Traumatic
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M6097
- Name: Chromium
- Relevance: LOW
- As Found: Unknown
- ID: M6265
- Name: Cobalt
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434129
**Brief Title:** Role of Diffusion Tensor-magnetic Resonance Imaging in Investigating Sensorineural Hearing Loss
**Official Title:** Role of Diffusion Tensor-magnetic Resonance Imaging in Investigating Sensorineural Hearing Loss
#### Organization Study ID Info
**ID:** 1a
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2026-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-10-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Mahmoud Mohammad Aly
**Investigator Title:** Assistant lecturer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** DTI and auditory tractography can be incorporated into the diagnostic toolkit for patients who are scheduled to undergo cochlear implantation and whose standard assessments have been unable to determine the functional integrity of the auditory pathway. These techniques aid in decision-making processes regarding potential outcomes, determining the optimal side for implantation, providing counseling regarding the possibility of limited benefits from surgery, and considering alternative forms of rehabilitation. The investigators including patients with varying degrees of hearing loss, as well as patients with normal radiological findings who are scheduled for cochlear implantation. The ultimate goal is to create a comprehensive map across the entire hearing spectrum and validate the findings of this study..
**Detailed Description:** Hearing is a complex process in which many parts of the ear contribute to transmit signals to the brain. The auditory system consists of both peripheral structures (external, middle, and inner ear)as well as central regions (cochlear nuclei in the medulla oblongata, superior olivary nuclei and lateral lemniscus in the pons, inferior colliculus in the midbrain, medial geniculate nuclei in the thalamus, and auditory cortex in the superior temporal Heschl gyrus). Most of auditory fibres undergo a contralateral decussation to the opposite superior olive in the region known as the trapezoid body.
The broad term "sensorineural hearing loss" (SNHL) It accounts for a substantial proportion of hearing impairment cases globally, affecting individuals of various age groups. It has been used by clinicians to refer to either malfunctioning inner ear or a retrocochlear problem affecting the canalicular vestibule-chochlear (VIII) cranial nerve and cerebellopontine angle or that involves the higher (central) auditory nuclei and neural tracts. Identifying the etiology of hearing loss is valuable to establish a treatment strategy that can help to prevent or slow down complete loss of auditory function.
The central auditory structures are involved in various processes that may occur in isolation from those involving peripheral receptors .SNHL can be a consequence of different conditions, including viral infection, tumor, ischemia, multiple sclerosis, or congenital malformations.
Despite continuous efforts to delineate the pathophysiological attributes of SNHL, the aetiology remains mostly unclear with nearly 90% of cases being idiopathic. Therefore, finding a method to accurately predict microstructural changes of the auditory circuit is extremely important.
Conventional imaging modalities, including computed tomography (CT) and magnetic resonance imaging (MRI), have offered invaluable insights into the macroscopic changes associated with SNHL, such as cochlear morphology and structural abnormalities. However, these techniques lack the sensitivity to discern subtle alterations occurring at the microstructural level, impeding a comprehensive understanding of the underlying pathophysiological processes.
DTI-MRI's ability to capture subtle changes in tissue microstructure makes it an ideal candidate for probing the intricate auditory pathways affected by SNHL. By quantifying the diffusion of water molecules along axonal pathways, DTI-MRI can uncover alterations in the integrity of auditory neural connections, which are often missed by conventional imaging methods. Furthermore, DTI-derived metrics, such as fractional anisotropy (FA), axial diffusivity (AD), radial diffusivity (RD), and mean diffusivity (MD), offer quantitative measures to characterize the white matter integrity and myelination in auditory pathways.
### Conditions Module
**Conditions:**
- Sensorineural Hearing Loss
**Keywords:**
- DTI
- Sensorineural hearing loss
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 72
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** cases with SNHL
**Intervention Names:**
- Diagnostic Test: DTI
**Label:** Cases
#### Arm Group 2
**Description:** Normal people
**Intervention Names:**
- Diagnostic Test: DTI
**Label:** Controls
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cases
- Controls
**Description:** Diffusion MRI imaging
**Name:** DTI
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Assess the integrity of auditory pathway via measuring DTI metrics ( Fractional anisotropy and mean diffusivity)
**Measure:** Assessment of role of DTI in SNHL
**Time Frame:** one year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with audiometrically proven SNHL
Exclusion Criteria:
* Neurologically or psychiatric conditions affecting patient stability during MRI examination.
* Cochlear implants.
* Contraindications for MRI.
**Healthy Volunteers:** True
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Assiut university hospital patients
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mahmoud Aly, Master
**Phone:** 00201011367958
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Assiut
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mahmoud Aly, Master
- **Phone:** 00201011367958
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Faculty of Medicine of Assuit
**Status:** RECRUITING
**Zip:** 71515
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006311
- Term: Hearing Disorders
- ID: D000004427
- Term: Ear Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
- ID: D000012678
- Term: Sensation Disorders
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M24420
- Name: Hearing Loss
- Relevance: HIGH
- As Found: Hearing Loss
- ID: M6840
- Name: Deafness
- Relevance: HIGH
- As Found: Hearing Loss
- ID: M9407
- Name: Hearing Loss, Sensorineural
- Relevance: HIGH
- As Found: Sensorineural Hearing Loss
- ID: M9400
- Name: Hearing Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7601
- Name: Ear Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15490
- Name: Sensation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000034381
- Term: Hearing Loss
- ID: D000003638
- Term: Deafness
- ID: D000006319
- Term: Hearing Loss, Sensorineural
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434116
**Acronym:** RVI-ERS
**Brief Title:** Benefits of Immersive Virtual Reality on Dyspnoea During a Weaning Test in the Intensive Care Unit.
**Official Title:** Benefits of Immersive Virtual Reality on Dyspnoea During a Weaning Test in the Intensive Care Unit
#### Organization Study ID Info
**ID:** APHP240431
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
### Status Module
#### Completion Date
**Date:** 2025-06-25
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-25
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### 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:** A weaning trial is a test that simulates physiological respiratory conditions after extubation in order to assess the patient's ability to breathe without the assistance of a ventilator.
This test is highly susceptible to induce dyspnea, with 62% of patients reporting a dyspnea score on VAS greater than 3.
Similarly, the prevalence of anxiety is high during weaning trials. 60% of patients treated in a respiratory weaning unit report psychological symptoms.
Dyspnea can be a traumatic experience for patients. In intensive care, up to half of patients suffer from dyspnea, which is described by patients as one of the worst memories of their stay in intensive care.
The virtual reality headset is a device that simulates a realistic, three-dimensional environment, allowing the patient to be totally immersed, so that they feel as if they are really present in a virtual world. This environment can be combined with hypnotic verbal support.
The research hypothesis is that virtual reality during a spontaneous breathing trial would relieve the respiratory discomfort induced by the weaning trial.
The secondary hypotheses are that virtual reality could reduce the anxiety associated with spontaneous breathing trials. These benefits could be associated to a reduction in ventilatory drive.
To assess dyspnea a VAS scale will be used, as the MV-RDOS scale, and the amplitude of EMG activity of inspiratory muscles.
**Detailed Description:** A weaning trial is a test that simulates physiological respiratory conditions after extubation in order to assess the patient's ability to breathe without the assistance of a ventilator.
This test is highly susceptible to induce dyspnea, with 62% of patients reporting a dyspnea score on VAS greater than 3.
Similarly, the prevalence of anxiety is high during weaning trials. 60% of patients treated in a respiratory weaning unit report psychological symptoms.
Dyspnea can be a traumatic experience for patients. In intensive care, up to half of patients suffer from dyspnea, which is described by patients as one of the worst memories of their stay in intensive care.
Dyspnea exposes patients to the risk of neuropsychological sequel, in particular the occurrence of post-traumatic stress.
Dyspnea is define by the ATS as "a subjective experience of breathing discomfort that consists of qualitatively distinct sensations that vary in intensity " . It represents a conscious and distressing sensation of breathing difficulty. It is characterized by its multidimensional aspect with a sensory and affective dimension.
To assess dyspnea a VAS scale will be used, the MV-RDOS scale, which is a recently developed tool for the hetero-assessment of dyspnea in intubated patients. The amplitude of EMG activity of the extradiaphragmatic inspiratory muscles is proportional to the intensity of dyspnea and reflects the intensity of ventilatory command. The activity of the parasternal and scalene muscles can be collected using surface electrodes.
The virtual reality headset is a device that simulates a realistic, three-dimensional environment, allowing the patient to be totally immersed, so that they feel as if they are really present in a virtual world. This environment can be combined with hypnotic verbal support.
Several studies have shown that medical hypnosis can improve the sensory and affective components of pain, and also appears to have a beneficial effect on the management of dyspnea and anxiety.
Numerous studies have shown that the use of virtual reality reduces the intensity of acute and chronic pain. Several studies have also shown that immersive virtual reality helps to reduce anxiety associated with medical procedures. A study has also found that the use of virtual reality in patients hospitalized with acute SARS-CoV-2 infection improves dyspnea, anxiety, well-being and fatigue.
The research hypothesis is that virtual reality during a spontaneous breathing trial would relieve the respiratory discomfort induced by the trial.
The secondary hypotheses are that virtual reality could reduce the anxiety associated with spontaneous breathing trials.
This will be an open label, monocentric, randomized controlled study in the intensive care unit of PItié-Salpêtrière hospital. Patient will be recruited if they are undergoing a spontaneous breathing trial as part of their usual care.
The main objective is to measure the effect of virtual reality during a ventilatory weaning trial in comparison with current practice on respiratory discomfort. Respiratory discomfort will be assessed using a visual analogue scale at the end of the ventilatory weaning trial.
The secondary objectives are to evaluate the effect of virtual reality on the intensity of anxiety, to evaluate the effect of virtual reality on respiratory discomfort assessed by the MV-RDOS score, to evaluate the effect of virtual reality on ventilatory drive assessed by the P 0.1 and EMG of scalene and parasternal muscle , to describe the effect of virtual reality on respiratory rate and heart rate, and to evaluate tolerance of virtual reality.
The study will be conducted as follows:
Once included in the study, the patient will undergo a 15-minute session of mechanical ventilation followed by a 15-minute weaning trial without intervention (control period).
A respiratory discomfort VAS is performed following the spontaneous breathing trial. If the VAS is ≥ 3 cm, the patient is randomised between the intervention group (immersive virtual reality) and the control group (standard care).
The spontaneous breathing trial will be continued for a further 15 minutes in accordance with usual care, with one of the two interventions according to randomisation.
Patients with a VAS \<3 cm after the first weaning trial will not be randomised. In line with standard care, a second weaning test lasting a further 15 minutes will also be performed without intervention.
Throughout the study, the investigator will record clinical and functional data. EMG monitoring of the paraspinal and scalene muscles will be carried out throughout the test. Similarly, P 0.1 will be monitored at the beginning and end of the weaning test. The respiratory discomfort VAS, the MV-RDOS and the anxiety VAS will be assessed at the end of the weaning trial.
Completion of the sickness simulator questionnaire after the use of virtual reality in order to assess tolerance.
Virtual reality will be achieved using a virtual reality headset (GAMIDA®, Pico G2 4K, France) and audio headphones with noise reduction (Bose® Quiet Comfort 35 II, France). A tablet (Samsung® Galaxy Tab A 2019, 4G / Lenovo M8, France) equipped with Healthy Mind software will enable patients to enjoy a 360° visual and auditory 3D experience via a Bluetooth connection."
### Conditions Module
**Conditions:**
- Spontaneous Breathing Trial in ICU
**Keywords:**
- Spontaneous breathing trial
- dyspnea
- virtual reality
- anxiety
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Once included in the study, the patient will undergo a 15-minute session of mechanical ventilation followed by a 15-minute weaning trial without intervention (control period).
A respiratory discomfort VAS is performed following the spontaneous breathing trial. If the VAS is ≥ 3 cm, the patient is randomised between the intervention group (immersive virtual reality) and the control group (standard care).
The spontaneous breathing trial will be continued for a further 15 minutes in accordance with usual management, with one of the two interventions according to randomisation.
**Intervention Names:**
- Device: Immersive virtual reality
**Label:** Immersive virtual reality in patient with VAS dyspnea ≥ 3
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Once included in the study, the patient will undergo a 15-minute session of mechanical ventilation followed by a 15-minute weaning trial without intervention (control period).
A respiratory discomfort VAS is performed following the spontaneous breathing trial. If the VAS is ≥ 3 cm, the patient is randomised between the intervention group (immersive virtual reality) and the control group (standard care).
The spontaneous breathing trial will be continued for a further 15 minutes in accordance with usual management, with one of the two interventions according to randomisation.
**Intervention Names:**
- Device: Immersive virtual reality
**Label:** Control in patient with VAS dyspnea ≥ 3
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control in patient with VAS dyspnea ≥ 3
- Immersive virtual reality in patient with VAS dyspnea ≥ 3
**Description:** The virtual reality headset is a device that simulates a realistic, three-dimensional environment, allowing the patient to be totally immersed, so that they feel as if they are really present in a virtual world. This environment can be combined with hypnotic verbal support.
Virtual reality will be achieved using a virtual reality headset (GAMIDA®, Pico G2 4K, France) and audio headphones with noise reduction (Bose® Quiet Comfort 35 II, France). A tablet (Samsung® Galaxy Tab A 2019, 4G / Lenovo M8, France) equipped with Healthy Mind software will enable patients to enjoy a 360° visual and auditory 3D experience via a Bluetooth connection.
**Name:** Immersive virtual reality
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The primary endpoint is the comparison of the respiratory discomfort VAS between the intervention group (VR) and the control group (standard care) at the end of the ventilatory weaning test.
Scale values:0-10, higher scores mean a worse outcome.
**Measure:** Respiratory discomfort VAS
**Time Frame:** At inclusion (day1)
#### Secondary Outcomes
**Description:** Comparison of the VAS anxiety at the end of the weaning trial between the VR group and the control group Scale values:0-10, higher scores mean a worse outcome.
**Measure:** Effect of IVR on anxiety intensity at the end of the withdrawal test
**Time Frame:** At inclusion (day1)
**Description:** Comparison of the MV-RDOS scale between the VR group and the control group (Clinically important dyspenea is defined by MV-RDOS value ≥ 2.6)
**Measure:** Evaluation of the effect of virtual reality on respiratory discomfort assessed by the MV-RDOS (Mechanical Ventilation-Respiratory Distress Observation) score
**Time Frame:** At inclusion (day1)
**Description:** Evolution of physiological measurements (RMS of the parasternal and scalene EMG, P 0.1) between the VR group and the control group
**Measure:** Evaluation of the effect of virtual reality on respiratory drive assessed by the P 0.1, and EMG of scalene and parasternal muscle
**Time Frame:** At inclusion (day1)
**Description:** Evolution of physiological measurements (respiratory rate, heart rate) between the VR group and the control group
**Measure:** Description of the effect of virtual reality on respiratory rate and heart rate
**Time Frame:** At inclusion (day1)
**Description:** Measurement of tolerance by the simulator sickness questionnaire in the VR group.
**Measure:** Evaluation of the tolerance of virtual reality.
**Time Frame:** At inclusion (day1)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥ 18 years
2. Patients intubated and on mechanical ventilation for more than 24 hours
3. Patients eligible for a weaning trial (resolution of acute phase of pathology, low bronchial congestion, effective cough, SpO2 \> 90% with Fio2 \< 40%, PEEP \< 8 cmH20, respiratory rate \< 40/min, haemodynamically stable)
4. Decision by the doctor in charge to initiate a respiratory weaning trial as part of treatment
5. RASS score between -1 and +1
6. Patient able to answer questionnaires
7. Informed of the study and whose free and informed written consent has been obtained
8. Beneficiary of a social security plan (excluding AME)
Exclusion Criteria:
1. Non french speaker
2. Acute confusion or cognitive disorders
3. No reliable assessment of dyspnea
4. Acrophobia
5. Claustrophobia
6. Photophobia
7. Hearing loss
8. Visual impairment
9. Subject under guardianship or curatorship
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Capucine MORELOT-PANZINI, MD,PHD
**Phone:** +33 1 42 16 78 59
**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
- ID: D000010335
- Term: Pathologic Processes
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M27137
- Name: Respiratory Aspiration
- Relevance: HIGH
- As Found: Breathing
- ID: M7591
- Name: Dyspnea
- Relevance: HIGH
- As Found: Dyspnea
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000053120
- Term: Respiratory Aspiration
- ID: D000004417
- Term: Dyspnea
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434103
**Brief Title:** Clinical Study of SHR-A1921 Combined With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC
**Official Title:** An Open, Multicenter Phase I/II Trial of SHR-A1921 in Combination With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC
#### Organization Study ID Info
**ID:** SHR-A1921-205
#### Organization
**Class:** INDUSTRY
**Full Name:** Suzhou Suncadia Biopharmaceuticals Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2027-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Suzhou Suncadia Biopharmaceuticals Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** A trial to evaluate the tolerability and efficacy of SHR-A1921 in combination with adbelizumab and SHR-8068 with or without carboplatin in patients with advanced non-small cell lung cancer
### Conditions Module
**Conditions:**
- Advanced 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:** 124
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: SHR-A1921；Adebrelimab；SHR-8068；carboplatin
**Label:** SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin
**Description:** SHR-A1921:Specified dose on specified days. SHR-8068: Specified dose on specified days. Adebrelimab: Specified dose on specified days. Carboplatin:Specified dose on specified days.
**Name:** SHR-A1921；Adebrelimab；SHR-8068；carboplatin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** DLT
**Time Frame:** 21 days after the first dose
**Measure:** ORR based on RECIST v1.1 assessment.
**Time Frame:** All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years
#### Secondary Outcomes
**Measure:** Adverse event
**Time Frame:** All informed subjects signed informed consent from the beginning to the end of the safety follow-up period， up to 2 years
**Measure:** DCR based on RECIST v1.1 assessment
**Time Frame:** All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
2. Aged 18-75 at the time of signing the informed consent;
3. Histologically or cytologically confirmed patients with locally advanced or metastatic non-cellular lung cancer who are not eligible for surgical resection or radical concurrent chemoradiotherapy;
4. At least one measurable lesion consistent with RECIST v1.1;
5. ECOG PS score: 0-1;
6. The organ function level is good;
Exclusion Criteria:
1. Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
2. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
3. Previous or co-existing malignant neoplasms;
4. The presence of any active or known autoimmune disease;
5. Have clinical symptoms or diseases of the heart that are not well controlled;
6. People with past or current interstitial pneumonia/interstitial lung disease;
7. Known allergic reactions to any component of SHR-A1921, Adebrelimab, or severe allergic reactions to other monoclonal antibodies;
8. Have previously received topoisomerase I inhibitors (including but not limited to irinotecan, Topotecan), TROP-2ADC, or ADC drugs containing topoisomerase I inhibitors; Previously received anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody treatment;
**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:** Mengbo Zhao
**Phone:** 0518-82342973
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ze Zhang
**Phone:** 0518-82342973
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002283
- Term: Carcinoma, Bronchogenic
- ID: D000001984
- Term: Bronchial Neoplasms
- ID: D000008175
- Term: Lung Neoplasms
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M11172
- Name: Lung Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: HIGH
- As Found: Non-Small Cell Lung Cancer
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M5540
- Name: Carcinoma, Bronchogenic
- Relevance: LOW
- As Found: Unknown
- ID: M5260
- Name: Bronchial Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002289
- Term: Carcinoma, Non-Small-Cell Lung
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M18650
- Name: Carboplatin
- Relevance: HIGH
- As Found: System
### Intervention Browse Module - Meshes
- ID: D000016190
- Term: Carboplatin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434090
**Brief Title:** Liposomal Irinotecan Plus Bevacizumab in Irinotecan-refractory Metastatic Colorectal Cancer
**Official Title:** Liposomal Irinotecan Plus Bevacizumab in Irinotecan-refractory Metastatic Colorectal Cancer:a Multicenter, Phase I/II Trial.
#### Organization Study ID Info
**ID:** CSPC-DEY-CRC-K06
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sun Yat-sen University
#### Responsible Party
**Investigator Affiliation:** Sun Yat-sen University
**Investigator Full Name:** Yanhong Deng
**Investigator Title:** Director of Medical Oncology, Clinical Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To evaluate the efficacy and safety of liposomal irinotecan plus bevacizumab in irinotecan-refractory metastatic colorectal cancer
**Detailed Description:** The standard treatment regimen based on irinotecan with or without bevacizumab is commonly used in metastatic colorectal cancer. With administration of traditional irinotecan, the parent drug and active metabolite SN-38 exist in the form of active lactone and carboxylate, and the lactone ring structure is unstable in neutral and alkaline solutions. In physiological pH conditions, the active lactone rapidly hydrolyzes to the inactive carboxylate, thereby reducing the efficacy, so there is certain limitation in clinical application.
Liposomes Irinotecan load the active substance irinotecan into liposomes, so that it can be slowly released in the body and achieve the effect of reducing toxicity and increasing efficacy.After being rationally designed, irinotecan liposomes can also take advantage of the high permeability and retention effect (EPR) to specifically target the tumor area, increase the amount of drug taken up by cancer cells, reduce the dosage, improve efficacy, and reduce side effects.
We are currently conducting an Phase I/II study in mCRC patients who have previously received irinotecan. After determining the maximum tolerable dose (MTD) of irinotecan liposomes in the combined regimen of irinotecan liposomes and bevacizumab, we will further explore the safety and initial efficacy of irinotecan liposomes combined with bevacizumab.
### Conditions Module
**Conditions:**
- Colorectal Cancer
**Keywords:**
- Liposomal irinotecan
- bevacizumab
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 74
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients received Liposomal irinotecan (a '3+3' design was adopted in the experimental arm, with 3 dose levels of 70mg/m2, 80mg/m2, and 90mg/m2 for dose exploration) every 2 weeks (Q2W).
bevacizumab, 5mg/m2, every 2 weeks The two-drug combination therapy was continued every 2 weeks in a cycle until patients developed disease progression or met other criteria for termination of study treatment specified in the protocol.
**Intervention Names:**
- Drug: Liposomal irinotecan
- Drug: Bevacizumab
**Label:** Liposomal irinotecan plus bevacizumab
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Liposomal irinotecan plus bevacizumab
**Description:** Liposomal irinotecan will be given biweekly at a dose from 70mg/m2 to 90mg/m2.
**Name:** Liposomal irinotecan
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Liposomal irinotecan plus bevacizumab
**Description:** bevacizumab will be given biweekly at a dose of 5mg/m2
**Name:** Bevacizumab
**Other Names:**
- avastin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Defined as the highest dose of DLT in\<33% of subjects .
**Measure:** Maximum tolerated dose (MTD) of liposomal irinotecan
**Time Frame:** 1 months
**Description:** Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
**Measure:** Objective Response Rate
**Time Frame:** 5 months
#### Secondary Outcomes
**Description:** Defined as adverse events that occur during the DLT observation period and are related to the study drug .
**Measure:** Dose-Limiting Toxicities (DLT) of liposomal irinotecan
**Time Frame:** 1 months
**Description:** Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1.
**Measure:** Disease Control Rate
**Time Frame:** 5 months
**Description:** Defined as the time from response(when CR or PR is first diagnosed) to disease progression or death due to any cause.
**Measure:** Duration of Response
**Time Frame:** 5 months
**Description:** Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause.
**Measure:** Progression free Survival
**Time Frame:** 1 years
**Description:** Defined as the time between signing the informed consent form to death due to various causes.
**Measure:** Overall survival
**Time Frame:** 1 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age: ≥18 years old；
2. Histopathologically and/or cytologically confirmed unresectable metastatic colorectal adenocarcinoma；
3. Previous treatment with irinotecan , and have progression of disease during treatment or within three months thereafter；
4. At least one measurable lesion (according to RECIST v1.1)；
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 \~ 1；
6. The expected survival time ≥3 months；
7. Adequate bone marrow function : no blood transfusion and/or use of increasing leukocyte drugs (excluding oral medication) within 14 days prior to enrollment Absolute neutrophil count (ANC) ≥1.5×109/L Platelet count ≥100×109/L Hemoglobin (Hgb) ≥90 g/L；
8. Adequate hepatic function as evidenced by:
Total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, ≤5 × ULN if liver metastases are present.
Serum albumin ≥30 g/L； (9Adequate renal function as evidenced by: serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL/min. proteinuria\<2+（those with proteinuria ≥2+ at baseline had to demonstrate ≤1 g protein per 24 hours）； (10)Coagulation function: International normalised ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5 × ULN； (11)Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening；
Exclusion Criteria:
1. Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc；
2. Patients with the primary lesion located in the left colon and RAS/BRAF wild-type who did not use cetuximab on the first-line；
3. Patients with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR)；
4. Massive pleural effusion or ascites requiring intervention；
5. Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment；
6. Active HIV infection；
7. Combined with uncontrollable systemic diseases within 6 months before the first administration；
8. Presence of severe gastrointestinal disease；
9. History of major surgery (such as laparotomy, thoracotomy or intestinal resection) within 28 days before the first administration,or plan to undergo major surgery during the study period；
10. Presence of interstitial pneumonia or pulmonary fibrosis；
11. History of allergy or hypersensitivity to drug or any of their excipients；
12. History of pulmonary hemorrhage/hemoptysis ≥Grade 2 (defined as bright red blood of at least 2.5mL) within one month before the first administration；
13. Presence of arterial embolism, severe bleeding (excluding bleeding caused by surgery) or tendency for existing embolism or severe bleeding within 6 months before the first administration；
14. Combined symptomatic brain metastasis, meningeal metastasis, spinal cord tumor invasion, and spinal cord compression syndrome；
15. Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1 within 14 days before the first administration；
16. Participate in other study and use study drug within 1 month or within 5 half-lives of the drug (whichever comes first) before the first administration；
17. Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception；
18. Patients who are not suitable to participate in this trial for any reason judged by the investigator；
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yanhong Deng, PhD
**Phone:** 020-38379762
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yanghong Deng, Phd
- **Phone:** 02038379762
- **Role:** CONTACT
**Country:** China
**Facility:** The Sixth Affiliated Hospital of Sun Yat-sen University
**State:** Guangdong
**Zip:** 510655
#### Overall Officials
**Official 1:**
**Affiliation:** Sixth Affiliated Hospital, Sun Yat-sen University
**Name:** Yanhong Deng, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000020533
- Term: Angiogenesis Inhibitors
- ID: D000043924
- Term: Angiogenesis Modulating Agents
- ID: D000006133
- Term: Growth Substances
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000006131
- Term: Growth Inhibitors
- ID: D000059004
- Term: Topoisomerase I Inhibitors
- ID: D000059003
- Term: Topoisomerase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M246
- Name: Bevacizumab
- Relevance: HIGH
- As Found: Non-
- ID: M1671
- Name: Irinotecan
- Relevance: HIGH
- As Found: Infection
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- ID: M22318
- Name: Angiogenesis Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M9231
- Name: Growth Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M29349
- Name: Topoisomerase I Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000068258
- Term: Bevacizumab
- ID: D000077146
- Term: Irinotecan
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434077
**Brief Title:** Clinical Trial Protocol: Randomized Placebo-Controlled Pilot Study of GcMAF (Soloways TM) in Patients With Metastatic Breast Cancer
**Official Title:** Clinical Trial Protocol: Randomized Placebo-Controlled Pilot Study of GcMAF (Soloways TM) in Patients With Metastatic Breast Cancer
#### Organization Study ID Info
**ID:** SW011
#### Organization
**Class:** OTHER
**Full Name:** S.LAB (SOLOWAYS)
### Status Module
#### Completion Date
**Date:** 2025-10-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Center of New Medical Technologies
#### Lead Sponsor
**Class:** OTHER
**Name:** S.LAB (SOLOWAYS)
#### 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 randomized, double-blind, placebo-controlled pilot study aims to evaluate the efficacy and safety of GcMAF in reducing nagalase levels and improving clinical outcomes in female patients with metastatic breast cancer over six months. Sixty patients will be randomized into two groups receiving either weekly GcMAF or placebo injections. The primary endpoint is the change in serum nagalase levels from baseline to six months. Secondary endpoints include clinical status, quality of life, adverse effects, and markers of inflammation and immune activity. Tumor response will be assessed using RECIST criteria, and quality of life will be measured with the EORTC QLQ-C30 questionnaire. Immune and inflammation markers will be evaluated using flow cytometry and ELISA. Adverse events will be monitored and categorized according to severity. Inclusion criteria include confirmed metastatic breast cancer, completion of one line of systemic therapy, adequate organ function, and elevated serum nagalase levels. The study will involve baseline measurements, monthly assessments, and final evaluations to compare changes in nagalase levels and other clinical outcomes between the GcMAF and placebo groups.
**Detailed Description:** This randomized, double-blind, placebo-controlled pilot study aims to evaluate the efficacy and safety of GcMAF (Gc Macrophage Activating Factor) in female patients with metastatic breast cancer. The primary objective is to assess the reduction in serum nagalase levels, an enzyme associated with tumor activity, over a six-month period, and to evaluate improvements in clinical outcomes. The study involves 60 patients who will be divided into two groups: one receiving weekly injections of GcMAF and the other receiving a placebo.
Patients eligible for the study must have histologically or cytologically confirmed metastatic breast cancer, completed at least one line of systemic therapy, and have elevated serum nagalase levels. Additional inclusion criteria include female patients aged 18 to 70 years, ECOG performance status of 0 to 2, adequate bone marrow, liver, and renal function, and an estimated life expectancy of at least six months. Patients must also agree to use effective contraception and provide informed consent.
The primary endpoint is the change in serum nagalase levels from baseline to six months. Measurements will be taken at baseline, monthly, and at the end of the study using standardized enzymatic assays. Secondary endpoints include clinical status, assessed through objective tumor response using RECIST criteria and performance status using the ECOG scale, quality of life evaluated through EORTC QLQ-C30 questionnaires, immune activity measured by flow cytometry for various immune cell subsets, and inflammation markers such as CRP, interleukins, and TNF-alpha measured by ELISA. Adverse effects will be monitored weekly and categorized according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
The study procedures include initial screening to measure baseline nagalase levels and assess eligibility, followed by randomization into the GcMAF or placebo groups. Patients will receive weekly injections for six months, with monthly assessments of nagalase levels, clinical status, quality of life, and blood samples for immune and inflammation markers. Interim assessments will occur at three months, with final assessments and data analysis at six months.
Exclusion criteria include the presence of other active malignancies, severe uncontrolled illnesses, pregnancy or breastfeeding, previous treatment with GcMAF, and known hypersensitivity to the study drug components. The study timeline consists of patient recruitment and baseline measurements in the first month, followed by six months of treatment and monitoring, with interim and final assessments and subsequent data analysis.
This study aims to determine if GcMAF can significantly reduce serum nagalase levels and improve clinical outcomes, including tumor response, performance status, quality of life, and immune and inflammation markers, in patients with metastatic breast cancer. The results will provide insight into the potential therapeutic benefits of GcMAF for this patient population.
### Conditions Module
**Conditions:**
- Breast Cancer
**Keywords:**
- Metastatic Breast Cancer
- GcMAF (Gc Macrophage Activating Factor)
- Nagalase
- Inflammation Markers
- Response Evaluation Criteria in Solid Tumors
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** GcMAF injections (100 ng)
**Intervention Names:**
- Biological: GcMAF injections (100 ng)
**Label:** CGMAF group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** placebo injections (100 ng)
**Intervention Names:**
- Other: placebo
**Label:** placebo group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CGMAF group
**Description:** The GcMAF 100 ng (Gc protein macrophage-activating factor) will be injected subcutaneously.
**Name:** GcMAF injections (100 ng)
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- placebo group
**Description:** the placebo solution will be injected subcutaneously 100 ng.
**Name:** placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Change in Serum Nagalase Levels
**Time Frame:** 6 months
#### Secondary Outcomes
**Measure:** Change in RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
**Time Frame:** 6 months
**Measure:** MRI changes in cancer volume
**Time Frame:** 6 months
**Description:** one of 4 categories Complete Response (CR), Partial Response (PR), Stable Disease (SD),Progressive Disease (PD)
**Measure:** Tumor response
**Time Frame:** 6 months
**Measure:** Eastern Cooperative Oncology Group (ECOG) performance status change
**Time Frame:** 6 months
**Description:** (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
**Measure:** EORTC QLQ-C30 change
**Time Frame:** 6 months
**Measure:** CD4+T cells percentage
**Time Frame:** 6 months
**Measure:** CD8+T cells percentage
**Time Frame:** 6 months
**Measure:** NK cells percentage
**Time Frame:** 6 months
**Measure:** CRP percentage
**Time Frame:** 6 months
**Measure:** IL-6 percentage
**Time Frame:** 6 months
**Measure:** IL-10 percentage
**Time Frame:** 6 months
**Measure:** tumor necrosis factor-alpha (TNF-α) necrosis factor-alpha (TNF-α)
**Time Frame:** 6 months
**Description:** any adverse events will be reported
**Measure:** Adverse events
**Time Frame:** 6 months
**Measure:** rank of adverse event severity in numbers
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosis:
* Histologically or cytologically confirmed metastatic breast cancer.
* Evidence of metastatic disease, confirmed by imaging studies (CT, MRI, or PET scans) and/or biopsy. 2. Prior Treatment:
* Patients must have completed at least one line of systemic therapy (e.g., chemotherapy, hormone therapy, targeted therapy) for metastatic breast cancer.
* A minimum of 4 weeks must have elapsed since the last chemotherapy, targeted therapy, or radiotherapy before starting the study treatment. 3. Age:
* Female patients aged 18 to 70 years. 4. Performance Status:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Life Expectancy:
* Estimated life expectancy of at least 6 months. 6. Laboratory Values:
* Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, platelets ≥ 100 x 10\^9/L, and hemoglobin ≥ 9 g/dL.
* Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver metastases).
* Adequate renal function: Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min/1.73 m\^2 (calculated using the Cockcroft-Gault formula). 7. Contraception:
* Women of childbearing potential must agree to use effective contraception (e.g., hormonal contraceptives, intrauterine device, barrier methods, or abstinence) during the study and for at least 6 months after the last dose of study treatment. 8. Informed Consent:
* Ability to understand and willingness to sign a written informed consent document.
9. Compliance:
* Willingness and ability to comply with the study protocol, including scheduled visits, treatment plans, laboratory tests, and other study procedures. 10. Nagalase Levels: • Elevated serum nagalase levels above the normal range, indicating active tumor burden.
Exclusion Criteria:
* Concurrent Malignancies:
* Presence of other active malignancies (excluding adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix). 2. Severe Comorbid Conditions:
* Severe uncontrolled concurrent illness, such as significant cardiovascular disease (e.g., uncontrolled hypertension, recent myocardial infarction), severe pulmonary conditions (e.g., uncontrolled asthma, chronic obstructive pulmonary disease), or active infections requiring systemic therapy. 3. Pregnancy and Lactation:
* Pregnant or breastfeeding women. 4. Previous GcMAF Treatment:
* Previous treatment with GcMAF. 5. Allergies and Sensitivities:
* Known hypersensitivity to any component of the study drug or its formulation.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Novosibirsk
**Country:** Russian Federation
**Facility:** Center of New Medical Technologies
**State:** Novosibisk Region
**Zip:** 630090
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434064
**Brief Title:** Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer
**Official Title:** A Pilot, Single-Arm, Phase II Trial of Tamoxifen Plus Pegylated Liposomal Doxorubicin in Patients With Metastatic Triple Negative Breast Cancer
#### Organization Study ID Info
**ID:** I-3671523
#### Organization
**Class:** OTHER
**Full Name:** Roswell Park Cancer Institute
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2024-03909
**Type:** REGISTRY
**Domain:** Roswell Park Cancer Institute
**ID:** I-3671523
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Roswell Park Cancer Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This phase II trial tests how well tamoxifen and pegylated liposomal doxorubicin works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that has spread to nearby tissue or lymph nodes (locally advanced) and is unable to be operated on (inoperable). Tamoxifen works by blocking the effects of estrogen in the breast. This may help stop the growth of tumor cells that need estrogen to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Giving tamoxifen and pegylated liposomal doxorubicin together may work better in treating patients with metastatic or inoperable, locally advanced triple negative breast cancer than giving either of these drugs alone.
**Detailed Description:** PRIMARY OBJECTIVE:
I. To determine the efficacy of the combination of tamoxifen and pegylated liposomal doxorubicin in patients with metastatic or inoperable locally advanced triple negative breast cancer (TNBC) (estrogen receptor \[ER\] \< 10%) as assessed by overall response rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of pegylated liposomal doxorubicin given in combination with tamoxifen.
II. To determine clinical benefit including overall and progression free survival (overall survival \[OS\] and progression free survival \[PFS\]) as defined by RECIST v1.1.
III. To determine the duration of response.
EXPLORATORY OBJECTIVES:
I. To analyze changes in circulating tumor deoxyribonucleic acid (ctDNA) from longitudinal liquid biopsy to follow therapeutic response.
II. To determine estrogen receptor beta (ERβ)-mutant p53 interaction in tumors with in situ proximity ligation assay (PLA).
III. To analyze changes in gene expression by global ribonucleic acid (RNA)-sequencing (seq).
IV. To determine changes in the tumor microenvironment (TME) of tumors in response to treatment by analyzing tumor infiltrating lymphocytes (TILS) selected markers in the tumor and stromal tissues combined with CYBERSORT analysis of the transcriptome data.
V. Analyze changes in immune cell populations and circulating protein biomarkers as detectable from blood.
OUTLINE:
Patients receive tamoxifen orally (PO) once daily (QD) on days 1-28 of each cycle and pegylated liposomal doxorubicin intravenously (IV) on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography, computed tomography (CT) scan or magnetic resonance imaging (MRI), tumor biopsy and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days and every 6 months for up to 2 years.
### Conditions Module
**Conditions:**
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IV Breast Cancer AJCC v8
- Locally Advanced Unresectable Triple-Negative Breast Carcinoma
- Metastatic Triple-Negative Breast Carcinoma
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 31
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients receive tamoxifen PO QD on days 1-28 of each cycle and pegylated liposomal doxorubicin IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography, CT scan or MRI, tumor biopsy, and blood sample collection throughout the study.
**Intervention Names:**
- Procedure: Biopsy
- Procedure: Biospecimen Collection
- Procedure: Computed Tomography
- Procedure: Echocardiography
- Procedure: Magnetic Resonance Imaging
- Drug: Pegylated Liposomal Doxorubicin Hydrochloride
- Drug: Tamoxifen
**Label:** Treatment (tamoxifen, pegylated liposomal doxorubicin)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment (tamoxifen, pegylated liposomal doxorubicin)
**Description:** Undergo tumor biopsy
**Name:** Biopsy
**Other Names:**
- BIOPSY_TYPE
- Bx
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Treatment (tamoxifen, pegylated liposomal doxorubicin)
**Description:** Undergo blood sample collection
**Name:** Biospecimen Collection
**Other Names:**
- Biological Sample Collection
- Biospecimen Collected
- Specimen Collection
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Treatment (tamoxifen, pegylated liposomal doxorubicin)
**Description:** Undergo CT scan
**Name:** Computed Tomography
**Other Names:**
- CAT
- CAT Scan
- Computed Axial Tomography
- Computerized Axial Tomography
- Computerized axial tomography (procedure)
- Computerized Tomography
- Computerized Tomography (CT) scan
- CT
- CT Scan
- tomography
**Type:** PROCEDURE
#### Intervention 4
**Arm Group Labels:**
- Treatment (tamoxifen, pegylated liposomal doxorubicin)
**Description:** Undergo echocardiography
**Name:** Echocardiography
**Other Names:**
- EC
**Type:** PROCEDURE
#### Intervention 5
**Arm Group Labels:**
- Treatment (tamoxifen, pegylated liposomal doxorubicin)
**Description:** Undergo MRI
**Name:** Magnetic Resonance Imaging
**Other Names:**
- Magnetic Resonance
- Magnetic Resonance Imaging (MRI)
- Magnetic resonance imaging (procedure)
- Magnetic Resonance Imaging Scan
- Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
- MR
- MR Imaging
- MRI
- MRI Scan
- MRIs
- NMR Imaging
- NMRI
- Nuclear Magnetic Resonance Imaging
- sMRI
- Structural MRI
**Type:** PROCEDURE
#### Intervention 6
**Arm Group Labels:**
- Treatment (tamoxifen, pegylated liposomal doxorubicin)
**Description:** Given IV
**Name:** Pegylated Liposomal Doxorubicin Hydrochloride
**Other Names:**
- ATI-0918
- Caelyx
- Dox-SL
- Doxil
- Doxilen
- Doxorubicin HCl Liposomal
- Doxorubicin HCl Liposome
- Doxorubicin Hydrochloride Liposome
- Duomeisu
- Evacet
- LipoDox
- Lipodox 50
- Liposomal Adriamycin
- Liposomal Doxorubicin Hydrochloride
- Liposomal-Encapsulated Doxorubicin
- Pegylated Doxorubicin HCl Liposome
- Pegylated Liposomal Doxorubicin
- S-Liposomal Doxorubicin
- Stealth Liposomal Doxorubicin
- TLC D-99
**Type:** DRUG
#### Intervention 7
**Arm Group Labels:**
- Treatment (tamoxifen, pegylated liposomal doxorubicin)
**Description:** Given PO
**Name:** Tamoxifen
**Other Names:**
- TMX
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be summarized using frequencies and relative frequencies.
**Measure:** Overall response rate
**Time Frame:** Up to 4 years
#### Secondary Outcomes
**Description:** Per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 will be summarized by attribution and grade using frequencies and relative frequencies.
**Measure:** Incidence of adverse events
**Time Frame:** Until progression or end of treatment, up to 4 years
**Description:** Will be summarized using standard Kaplan-Meier methods, where the median times will be estimated with 90% confidence intervals.
**Measure:** Duration of response
**Time Frame:** From initial response to disease progression (per RECIST version1.1) up to 4 years
**Description:** Will be summarized using standard Kaplan-Meier methods, where the median times will be estimated with 90% confidence intervals.
**Measure:** Overall survival
**Time Frame:** From treatment initiation until death due to any cause, up to 4 years
**Description:** Will be summarized using standard Kaplan-Meier methods, where the median times will be estimated with 90% confidence intervals.
**Measure:** Progression free survival
**Time Frame:** From treatment initiation until disease progression or death due to any cause, up to 4 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with pathologically confirmed metastatic triple negative breast cancer (ER ≤ 10%) that have been previously treated with at least 2 lines of therapy in the metastatic setting
* Patients must have ERα (estrogen receptor alpha) and PgR (progesterone receptor) status assessed using current American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines. Patients are eligible if the tumor staining is ERα low/negative (ER ≤ 10%) and PgR negative by ASCO/CAP guidelines
* The tumor must be HER-2 negative by immunochemistry (IHC) 0-1+ or IHC 2 + and fluorescence in situ hybridization (FISH) negative
* Patients must be ≥ 18 years of age
* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Absolute neutrophil count (ANC) ≥ 1500/ μL
* Hemoglobulin (hb) ≥ 9 g/dL
* Platelet count ≥ 100,000/ μL
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 x ULN
* Creatinine clearance \> 60 mL/min (Cockroft-Gault Equation)
* Left ventricular ejection fraction (LVEF) assessment must be performed within 30 days prior to enrollment. (LVEF assessment performed by 2-D echocardiogram is preferred; however, multigated acquisition scan \[MUGA\] scan may be substituted based on institutional preferences). The LVEF must be ≥ 50% regardless of the cardiac imaging facility's lower limit of normal
* Patients must be able to swallow oral medications
* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
* Patients must not have any known contraindications to endocrine therapy, in the opinion of the treating investigator
* Participants who have had chemotherapy, hormonal/endocrine therapy, immunotherapy, biologics or radiotherapy (as well as any other investigational agents/devices) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Have a known history of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to tamoxifen or any of its excipients
* Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, transient ischemic attack (TIA), or pulmonary embolism
* Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness
* Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimen. This includes angina pectoris, arrhythmias except for benign premature ventricular contractions, a history of myocardial infarction, documented congestive heart failure (CHF) or cardiomyopathy
* Patients with cirrhosis or severe hepatic impairment
* Patients must not have a condition or an uncontrolled intercurrent illness including, but not limited to any of the following: ongoing or active infection requiring systemic treatment, except uncomplicated urinary tract infection (UTI), or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or nursing female participants
* Unwilling or unable to follow protocol requirements
* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Buffalo
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sheheryar Kabraji
- **Phone:** 716-845-3429
- **Role:** CONTACT
***Contact 2:***
- **Name:** Sheheryar Kabraji
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Roswell Park Cancer Institute
**State:** New York
**Zip:** 14263
#### Overall Officials
**Official 1:**
**Affiliation:** Roswell Park Cancer Institute
**Name:** Sheheryar Kabraji
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M30373
- Name: Triple Negative Breast Neoplasms
- Relevance: HIGH
- As Found: Triple Negative Breast Cancer
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000001943
- Term: Breast Neoplasms
- ID: D000064726
- Term: Triple Negative Breast Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000000903
- Term: Antibiotics, Antineoplastic
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000059005
- Term: Topoisomerase II Inhibitors
- ID: D000059003
- Term: Topoisomerase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000004965
- Term: Estrogen Antagonists
- ID: D000006727
- Term: Hormone Antagonists
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018931
- Term: Antineoplastic Agents, Hormonal
- ID: D000020845
- Term: Selective Estrogen Receptor Modulators
- ID: D000020847
- Term: Estrogen Receptor Modulators
- ID: D000050071
- Term: Bone Density Conservation Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M7492
- Name: Doxorubicin
- Relevance: HIGH
- As Found: Cognitive
- ID: M16403
- Name: Tamoxifen
- Relevance: HIGH
- As Found: Less than
- ID: M227339
- Name: Liposomal doxorubicin
- Relevance: HIGH
- As Found: Recipients
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M8116
- Name: Estrogens
- Relevance: LOW
- As Found: Unknown
- ID: M8114
- Name: Estrogen Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M30483
- Name: Estrogen Receptor Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20966
- Name: Antineoplastic Agents, Hormonal
- Relevance: LOW
- As Found: Unknown
- ID: M22597
- Name: Selective Estrogen Receptor Modulators
- Relevance: LOW
- As Found: Unknown
- ID: M22599
- Name: Estrogen Receptor Modulators
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000013629
- Term: Tamoxifen
- ID: D000004317
- Term: Doxorubicin
- ID: C000506643
- Term: Liposomal doxorubicin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434051
**Brief Title:** The Effect of Traditional Chinese Cervical Manipulation for Cervicogenic Headache: a Pilot Randomized, Single-blind, Placebo-controlled Trial
**Official Title:** The Effect of Traditional Chinese Cervical Manipulation for Cervicogenic Headache: a Pilot Randomized, Single-blind, Placebo-controlled Trial
#### Organization Study ID Info
**ID:** Manipulation CGH
#### Organization
**Class:** OTHER
**Full Name:** Hong Kong Baptist University
### Status Module
#### Completion Date
**Date:** 2026-03-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hong Kong Baptist University
#### Responsible Party
**Investigator Affiliation:** Hong Kong Baptist University
**Investigator Full Name:** CHOW Chi Ho
**Investigator Title:** Associate Professor of Practice
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Background Cervical spondylosis is a prevalent condition. Studies has shown that it is a leading cause for headache, which is termed cervicogenic headache (CGH). The prevlance of CGH among severe headache is 17.5%. While conventional treatments, such as physical therapy and surgery, is effective in controlling symptoms, the effect was found to be short-lasting. There is existing clinical evidence supporting traditional Chinese cervical manipulation (CCM) as a viable treatment for CGH.
Objective To preliminarily assess the feasibility, safety, and effectiveness of CCM on patients with CGH, and to optimize parameters for a future large-scale trial.
Method This study is a pilot randomized, controlled, single-blind trial. 84 participants will be randomized evenly to receive either CCM or sham manipulation for 4 weeks. Outcome measurements will be conducted at baseline, week 2, week 4 and week 8 on cervical functional disability, cervical range of motion, and data on headache onset and painkiller assumption. Adverse events will be recorded using the Common Terminology Criteria for Adverse Events (CTCAE).
### Conditions Module
**Conditions:**
- Cervicogenic Headache
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This intervention involves cervical mobilization that constitutes elements of cervical rotation and traction.
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 84
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The CMP will first palpate the transverse processes of C1 and C2. The transverse process with apparent tenderness will be regarded as the pain side. The right side will be the painful side for the following example). During the manipulation, the CMP will use his left hand to support the lower jaw and passively rotate the neck to the left side by 70-75 degrees (or to the maximum angle without discomfort). The physician's right-hand fingers will support the left-side transverse processes of C1 and C2, and the thumb and thenar muscle will be placed on the spinous process and occipital area. While maintaining a passive left neck rotation, the physician will increase the rotation angle by 5-10 degrees with both hands under a sudden pulling force. The above procedure will be repeated on the right side (pain side).
**Intervention Names:**
- Other: Traditional Chinese cervical manipulation
**Label:** Traditional Chinese cervical manipulation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The posture and position of the participant and the practitioner and the procedure are the same as the CCM technique. The right side will be regarded as the pain side once again. When performing the sham technique, the CMP uses the left hand to support the lower jaw position and passively rotates the neck to the left side by 70-75 degrees or to the maximum angle. The right hand presses the upper inner corner of the right scapula. While maintaining the passive left rotation of the neck, the right hand slowly exerts force downwards and outwards on the inner side of the scapula. The left hand only maintains the left rotation of the neck without any pulling force. After completion, repeat the above actions on the right side. After the technique is completed, participants can get up after resting for 5-10 minutes.
**Intervention Names:**
- Other: Sham manipulation
**Label:** Sham manipulation
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Traditional Chinese cervical manipulation
**Description:** The CMP will first palpate the transverse processes of C1 and C2. The transverse process with apparent tenderness will be regarded as the pain side. The right side will be the painful side for the following example). During the manipulation, the CMP will use his left hand to support the lower jaw and passively rotate the neck to the left side by 70-75 degrees (or to the maximum angle without discomfort). The physician's right-hand fingers will support the left-side transverse processes of C1 and C2, and the thumb and thenar muscle will be placed on the spinous process and occipital area. While maintaining a passive left neck rotation, the physician will increase the rotation angle by 5-10 degrees with both hands under a sudden pulling force. The above procedure will be repeated on the right side (pain side).
**Name:** Traditional Chinese cervical manipulation
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Sham manipulation
**Description:** The posture and position of the participant and the practitioner and the procedure are the same as the CCM technique. The right side will be regarded as the pain side once again. When performing the sham technique, the CMP uses the left hand to support the lower jaw position and passively rotates the neck to the left side by 70-75 degrees or to the maximum angle. The right hand presses the upper inner corner of the right scapula. While maintaining the passive left rotation of the neck, the right hand slowly exerts force downwards and outwards on the inner side of the scapula. The left hand only maintains the left rotation of the neck without any pulling force. After completion, repeat the above actions on the right side. After the technique is completed, participants can get up after resting for 5-10 minutes.
**Name:** Sham manipulation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** It is used to evaluate cervical functional disability It has good reliability and validity, reflecting the degree of limitation on living ability and the impact on quality of life. The higher the score, the more severe the symptoms.
**Measure:** Neck Disability Index (NDI) scoring
**Time Frame:** Baseline, week 2, week 4 and week 8
#### Secondary Outcomes
**Description:** to evaluate the range neck flexion, extension, left and right lateral flexion, left and right rotation. The measuring instrument will be the cervical goniometer.
**Measure:** Active cervical range of motion
**Time Frame:** Baseline, week 2, week 4 and week 8
**Description:** All participants are required to complete an online headache diary daily. It will include the following items: the time of headache onset, duration, pain intensity, and the type and frequency of painkillers taken
**Measure:** Online headache diary:
**Time Frame:** Baseline, week 2, week 4 and week 8
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. The diagnostic criteria of cervical spondylosis according to "The expert consensus on the classification, diagnosis, and non-surgical treatment of cervical spondylosis (2018)" are as follows:
1. Patients must have a chief complaint of abnormal sensations such as pain in the occipital, neck, or shoulder area, and can be accompanied by related localized pain and tenderness
2. X-ray imaging shows degenerative changes in the cervical spine
3. Other conditions that could cause symptoms of the neck are excluded
2. The diagnostic criteria of CGH as listed by ICHD-3:
a. Any headache fulfilling criterion C b. Clinical and/or imaging evidence of a disorder or lesion within the cervical spine or soft tissues of the neck, known to be able to cause headache c. Evidence of causation demonstrated by at least two of the following: i. headache has developed in temporal relation to the onset of the cervical disorder or appearance of the lesion ii. headache has significantly improved or resolved in parallel with improvement in or resolution of the cervical disorder or lesion iii. cervical range of motion is reduced and headache is made significantly worse by provocative manoeuvre iv. headache is abolished following diagnostic blockade of a cervical structure or its nerve supply v. Not better accounted for by another ICHD-3 diagnosis
3. Of age between 18 to 65 years old
4. Headache recurs for at least three months
5. The frequency of headaches in the past three months is at least once a week
6. The frequency, dosage, and type of painkillers have remained stable over the past 6 weeks
7. Score at least 10 points on the Neck Disability Index -
Exclusion Criteria:
1. Presented with red flag presentations of headache listed in the SNNOOP10 list (systemic symptoms/signs and disease, neurologic symptoms or signs, onset sudden or onset after the age of 40 years, and change of headache pattern), including fever, vascular and non-vascular intracranial diseases, history of brain tumor, brain neurological dysfunction or disorder, etc.
2. With suspected cervical spinal stenosis, cervical spinal cord lesions, cervical vascular disease, cervical nerve root disease, cervical instability, or cervical fracture
3. Has suffered from a whiplash injury within the past 6 weeks
4. Had surgery on the neck or head
5. Currently pregnant or breastfeeding
**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:** Chi Ho Chow, Phd
**Phone:** 34118728
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hong Kong
**Country:** Hong Kong
**Facility:** Hong Kong Baptist University
**Location 2:**
**City:** Hong Kong
**Country:** Hong Kong
**Facility:** Lui Seng Chun,119 Lai Chi Kok Road, Mong Kok
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000051271
- Term: Headache Disorders, Secondary
- ID: D000020773
- Term: Headache Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC04
- Name: Neoplasms
### Condition Browse Module - Browse Leaves
- ID: M9351
- Name: Headache
- Relevance: HIGH
- As Found: Headache
- ID: M26669
- Name: Post-Traumatic Headache
- Relevance: HIGH
- As Found: Cervicogenic Headache
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M22529
- Name: Headache Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: LOW
- As Found: Unknown
- ID: M26658
- Name: Headache Disorders, Secondary
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000051298
- Term: Post-Traumatic Headache
- ID: D000006261
- Term: Headache
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434038
**Acronym:** INI-CSF-MA
**Brief Title:** Measurement of Insulin Levels in the Cerebrospinal Fluid of Healthy Adults After a Single Intranasal Dose - Middle Age
**Official Title:** Measurement of Insulin Levels in the Cerebrospinal Fluid (CSF) of Healthy Adults After a Single Intranasal Dose - Middle Age
#### Organization Study ID Info
**ID:** A22-210
#### Organization
**Class:** OTHER
**Full Name:** HealthPartners Institute
#### Secondary ID Infos
**Domain:** Department of Defense
**ID:** CDMRP-SC220220
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-02-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-02-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-10-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** FED
**Name:** Uniformed Services University of the Health Sciences
**Class:** FED
**Name:** United States Department of Defense
#### Lead Sponsor
**Class:** OTHER
**Name:** HealthPartners Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, reaches the brain and spinal cord when delivered as a nasal spray (intranasally). Intranasal insulin has been shown to improve memory and mood in patients with neurological diseases such as mild cognitive impairment and dementia, but more evidence is needed to support the ability to effectively target the brain through intranasal routes.
18 healthy middle-aged adults will be randomly assigned to receive a single intranasal dose of 40 units insulin ("low dose" group), 80 units insulin ("high dose" group), or saline (placebo, or control group). Participants will undergo an image-guided lumbar puncture (spinal tap) performed by a study clinician. Samples of cerebrospinal fluid (a fluid surrounding the brain and spinal cord) and blood will be collected at 5 timepoints during the lumbar puncture: once prior to the administration of intranasal insulin, and again at 10, 20, 30, and 40 minutes after the dose is given. Samples will be tested to determine the level of insulin detected in the cerebrospinal fluid and blood at each time point. Results of this study will provide essential information about the ability of insulin to reach the brain after intranasal administration.
### Conditions Module
**Conditions:**
- Healthy
**Keywords:**
- insulin
- intranasal
- Healthy Adults
- Middle Age
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Participants will be randomized into one of 3 groups: 40 IU insulin, 80 IU insulin, or saline control.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Single-blind
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 18
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** One dose of 40 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
**Intervention Names:**
- Drug: Low Dose Regular insulin
**Label:** Low dose intranasal insulin
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** One dose of 80 international units of regular insulin administered intranasally using the SipNose SP1N1C1 device.
**Intervention Names:**
- Drug: High Dose Regular insulin
**Label:** High dose Intranasal Insulin
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** One dose of 0.9% saline administered intranasally using the SipNose SP1N1C1 device
**Intervention Names:**
- Other: 0.9% Saline
**Label:** Placebo Control
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Low dose intranasal insulin
**Description:** Administered intranasally at 40 IU
**Name:** Low Dose Regular insulin
**Other Names:**
- Novolin-R
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- High dose Intranasal Insulin
**Description:** Administered Intranasally at 80 IU
**Name:** High Dose Regular insulin
**Other Names:**
- Novolin-R
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Placebo Control
**Description:** Placebo control
**Name:** 0.9% Saline
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Insulin concentration detected in cerebrospinal fluid at 5 time points (pre-insulin dose; and 10, 20, 30, 40 minutes after dose). Values will be reported as μIU/mL. Higher values indicate a greater concentration of insulin in the cerebrospinal fluid. Concentrations for each time point (overall and by dose) will be reported as a mean +/- standard error.
**Measure:** Concentration of insulin over Time - Cerebrospinal fluid
**Time Frame:** 0-40 minutes post-intranasal administration
**Description:** CSF insulin concentration will also be reported by Cmax (peak concentration)
**Measure:** Cmax of insulin concentration- Cerebrospinal Fluid
**Time Frame:** 0-40 minutes post- intranasal administration
**Description:** CSF insulin concentration will also be reported by Tmax (time of peak concentration)
**Measure:** Tmax of insulin concentration-Cerebrospinal FLuid
**Time Frame:** 0-40 minutes post-intranasal administration
**Description:** CSF insulin concentration will also be reported by AUC (area under the curve, measured as time x concentration)
**Measure:** AUC (area under the curve) of insulin concentration-Cerebrospinal Fluid
**Time Frame:** 0-40 minutes post-intranasal administration
#### Secondary Outcomes
**Description:** Insulin concentration detected in blood at 5 time points (pre-insulin dose; and 10, 20, 30, 40 minutes after dose). Values will be reported at μIU/mL. Higher values indicate a greater concentration of insulin in the blood. Concentrations for each time point (overall and by dose) will be reported as a mean +/- standard error.
**Measure:** Insulin Concentration Over Time- Serum
**Time Frame:** 0-40 minutes post-intranasal administration
**Description:** Serum insulin concentration will also be reported by Cmax (peak concentration)
**Measure:** Cmax of insulin concentration - Serum
**Time Frame:** 0-40 minutes post-intranasal adminitration
**Description:** Serum insulin concentration will also be reported by Tmax (time to peak concentration)
**Measure:** Tmax of insulin - Serum
**Time Frame:** 0-40 minutes post-intranasal administration
**Description:** Serum insulin concentration will also be reported by AUC (area under the curve, measured as time x concentration).
**Measure:** AUC (area under the curve) of insulin concentration - Serum
**Time Frame:** 0-40 minutes post-intranasal administration
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Subject is between ≥36 and ≤ 55 years of age
2. Subject's BMI is between \>=18.5 and \<=24.9, or can safely undergo a lumbar puncture at the discretion of the radiologist
3. MOCA score ≥26
4. Subject must be proficient in speaking English to comply with instructions and measures for the study
5. Subject can provide written informed consent
6. Female subjects must have either: (1) a negative pregnancy test at the screening visit and treatment visit OR (2) be at least 2 years post-menopausal / surgically sterile.
Exclusion Criteria:
1. Subject has medical history and/or clinically determined disorders: chronic sinusitis, previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies.
2. Subject has history of any of the following: active and significant central nervous system, psychiatric illness, pulmonary, or cardiovascular disorders or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator
3. Subject has participated in a clinical trial investigation within 3 months of this study.
4. Subject has an insulin allergy
5. Subject has Insulin-dependent diabetes
6. Subject is pregnant or breast feeding
7. Contraindication to spinal tap or other safety factors that preclude lumbar puncture in the investigator's opinion
8. Any other clinically relevant finding that would pose a safety risk to the subject as determined by the investigator
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 36 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Meghan E O'Brien
**Phone:** 651-495-6363
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Bethany K Crouse, PhD
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Saint Paul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Meghan E O'Brien
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Bethany K Crouse, PhD
- **Role:** CONTACT
***Contact 3:***
- **Name:** Leah R Hanson, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** HealthPartners Neuroscience Center
**State:** Minnesota
**Zip:** 55130
#### Overall Officials
**Official 1:**
**Affiliation:** HealthPartners Institute
**Name:** Leah R Hanson, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Uniformed Services University of the Health Sciences
**Name:** Kimberly Byrnes, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: HIGH
- As Found: Day 1
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: HIGH
- As Found: POC
- ID: M17768
- Name: Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000007328
- Term: Insulin
- ID: C000557859
- Term: Insulin, Globin Zinc
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434025
**Acronym:** COMBINED-HF
**Brief Title:** IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency
**Official Title:** Effect of Combination of Intravenous Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Patients With Heart Failure and Iron Deficiency.
#### Organization Study ID Info
**ID:** 78861724.0.0000.5327
#### Organization
**Class:** OTHER
**Full Name:** Hospital de Clinicas de Porto Alegre
#### Secondary ID Infos
**Domain:** AGH-Use HCPA
**ID:** 2023-0428
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-11-24
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-05-24
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-24
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Vifor Pharma
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospital de Clinicas de Porto Alegre
#### Responsible Party
**Investigator Affiliation:** Hospital de Clinicas de Porto Alegre
**Investigator Full Name:** Luis Beck Da Silva Neto
**Investigator Title:** Professor of Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Background. Treatment with intravenous iron has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. However, the mechanisms underlying these beneficial effects remain unknown. SGLT2i seem to alter hematocrit and other hematological markers or iron content.
This study aims to measure cardiac magnetic resonance changes in myocardial iron content and in left ventricular function after administration of intravenous iron with and without the concomitant use of SGLT2 inhibitor in patients with HFrEF and iron deficiency.
**Detailed Description:** Background. Treatment with intravenous iron has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. However, the mechanisms underlying these beneficial effects remain unknown. SGLT2i seem to alter hematocrit and other hematological markers or iron content. This study aims to measure cardiac magnetic resonance changes in myocardial iron content after administration of intravenous iron and to assess changes in left ventricular function in patients with HFrEF and iron deficiency.
Methods. Ninety-nine outpatient with symptomatic HFrEF, left ventricular ejection fraction (LVEF) \<40%, SGLT2i naive, and iron deficiency will be assigned, to receive intravenous iron + SGLT2i; or intravenous iron + placebo of SGLT2i; or placebo of both therapies for 30 days. Myocardial iron will be evaluated by T2-star (T2\*) cardiac magnetic resonance (CMR) sequencing before intravenous iron infusion. After 30 days, all patients will be reassessed by T2\* CMR sequencing. The primary endpoint will be changes in LVEF and myocardial iron content at 30 days. Secondary endpoints will include correlations of these changes with myocardial iron content, functional capacity, quality of life, and cardiac biomarkers.
Conclusions. This study will determine the effect of ferric carboxymaltose and its combination with SGLT2i on LVEF and its relationship with measures of myocardial iron content, functional capacity, and biomarkers in HFrEF and iron deficiency.
### Conditions Module
**Conditions:**
- Heart Failure, Systolic
- Iron Deficiencies
**Keywords:**
- heart failure
- iron deficiency
- SGLT2 inhibitor
- intravenous iron
- clinical trial
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** HFrEF, LVEF \<40%, SGLT2i naive, and iron deficiency. Assigned to receive:
1. intravenous iron + SGLT2i;
2. intravenous iron + placebo of SGLT2i;
3. placebo of both therapies.
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 99
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will receive 2 vials of ferric carboxymaltose 500 mg (Ferinject® 500 mg, Vifor-Pharma) IV, once; and Dapagliflozin 10 mg PO, once a day, for 30 days.
**Intervention Names:**
- Drug: Iron Carboxymaltose
- Drug: Dapagliflozin 10mg Tab
**Label:** ferric carboxymaltose + SGLT2 inhibitor
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients will receive 2 vials of ferric carboxymaltose 500 mg (Ferinject® 500 mg, Vifor-Pharma) IV, once; and placebo PO, once a day, for 30 days.
**Intervention Names:**
- Drug: Iron Carboxymaltose
- Drug: Placebo of Dapagliflozin
**Label:** ferric carboxymaltose + placebo of SGLT2 inhibitor
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Patients will receive 2 vials of placebo IV, once; and placebo PO, once a day, for 30 days.
**Intervention Names:**
- Drug: Placebo of Iron Carboxymaltose
- Drug: Placebo of Dapagliflozin
**Label:** Placebo of ferric carboxymaltose and placebo of SGLT2 inhibitor
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ferric carboxymaltose + SGLT2 inhibitor
- ferric carboxymaltose + placebo of SGLT2 inhibitor
**Description:** Iron Carboxymaltose 500 mg. 2 vials administered IV.
**Name:** Iron Carboxymaltose
**Other Names:**
- Ferinject
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- ferric carboxymaltose + SGLT2 inhibitor
**Description:** Dapagliflozin 10mg Tab, PO, onde a day.
**Name:** Dapagliflozin 10mg Tab
**Other Names:**
- Forxiga
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Placebo of ferric carboxymaltose and placebo of SGLT2 inhibitor
**Description:** Solution Sodium Chloride 0,9% 100 ml, IV, once.
**Name:** Placebo of Iron Carboxymaltose
**Other Names:**
- Saline
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Placebo of ferric carboxymaltose and placebo of SGLT2 inhibitor
- ferric carboxymaltose + placebo of SGLT2 inhibitor
**Description:** Equal shape and appearance tab as the tab containing Dapagliflozin 10 mg
**Name:** Placebo of Dapagliflozin
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** distance walked in six minute walk test
**Measure:** six minute walk test (6MWT)
**Time Frame:** 30 days
**Description:** NT-terminal pro-B-type natriuretic peptide (NT-proBNP) levels
**Measure:** NT-proBNP
**Time Frame:** 30 days
**Description:** Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire
**Measure:** MLHFQ
**Time Frame:** 30 days
**Description:** Serum Hepcidin levels
**Measure:** Hepcidin
**Time Frame:** 30 days
**Description:** Reticulocyte hemoglobin content
**Measure:** Reticulocyte hemoglobin content
**Time Frame:** 30 days
**Description:** Transferrin soluble receptors
**Measure:** Transferrin soluble receptors
**Time Frame:** 30 days
**Description:** Glomerular filtration rate
**Measure:** Glomerular filtration rate
**Time Frame:** 30 days
#### Primary Outcomes
**Description:** LVEF assessed by Cardiac Magnetic Resonance
**Measure:** left ventricular function assessed (LVEF) by CMR.
**Time Frame:** 30 days
#### Secondary Outcomes
**Description:** Myocardial iron content assessed by T2\* CMR
**Measure:** Myocardial iron content assessed by T2* CMR
**Time Frame:** 30 days
**Description:** myocardial strain assessed by T2\* CMR
**Measure:** myocardial strain assessed by T2* CMR
**Time Frame:** 30 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age 18 years or over;
2. Ejection fraction (EF) ≤40%, estimated by color Doppler echocardiography or CMR or radionuclide ventriculography;
3. Serum ferritin \<100 µg/L or serum ferritin between 100 and 299 µg/L and transferrin saturation \<20%;
4. Serum hemoglobin between 9.5 and 13.5 mg/dL;
5. Patients must be SGLT2 naive;
6. Informed consent form (ICF) signed.
Exclusion Criteria:
1. Kidney disease requiring dialysis or chronic kidney disease not requiring dialysis with an estimated glomerular filtration rate \<30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation;
2. Severe primary valve disease;
3. Acute coronary syndrome requiring cardiac surgery or coronary artery bypass surgery in the past 3 months;
4. Patients already being treated for some type of non-iron deficiency anemia;
5. Blood transfusion within 30 days prior to CMR examination;
6. Patients with a pacemaker, cardiac resynchronization therapy, or implantable defibrillator;
7. Diagnosis of hemochromatosis.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** LUIS BECK DA SILVA, MD ScD
**Phone:** 55 51 997330870
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Porto Alegre
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ana Paula Silveira, BMD
- **Phone:** 55 51 33596223
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Marcia Raymundo
- **Phone:** 55 51 33596224
- **Role:** CONTACT
**Country:** Brazil
**Facility:** Hospital de Clínicas de Porto Alegre
**State:** RS
**Zip:** 90450120
#### Overall Officials
**Official 1:**
**Affiliation:** Hospital de Clinicas de Porto Alegre
**Name:** LUIS BECK DA SILVA, MD ScD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000019189
- Term: Iron Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000000747
- Term: Anemia, Hypochromic
- ID: D000000740
- Term: Anemia
- ID: D000006402
- Term: Hematologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M20857
- Name: Anemia, Iron-Deficiency
- Relevance: HIGH
- As Found: Iron Deficiency
- ID: M2781
- Name: Iron Deficiencies
- Relevance: HIGH
- As Found: Iron Deficiency
- ID: M27579
- Name: Heart Failure, Systolic
- Relevance: HIGH
- As Found: Heart Failure, Systolic
- ID: M27583
- Name: Systolic Murmurs
- Relevance: LOW
- As Found: Unknown
- ID: M4070
- Name: Anemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21177
- Name: Iron Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4077
- Name: Anemia, Hypochromic
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
- ID: D000054143
- Term: Heart Failure, Systolic
- ID: D000018798
- Term: Anemia, Iron-Deficiency
- ID: D000090463
- Term: Iron Deficiencies
### Intervention Browse Module - Ancestors
- ID: D000014131
- Term: Trace Elements
- ID: D000018977
- Term: Micronutrients
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000077203
- Term: Sodium-Glucose Transporter 2 Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000006397
- Term: Hematinics
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: Hemat
- Name: Hematinics
### Intervention Browse Module - Browse Leaves
- ID: M348449
- Name: Dapagliflozin
- Relevance: HIGH
- As Found: 0.9
- ID: M1691
- Name: Sodium-Glucose Transporter 2 Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M10533
- Name: Iron
- Relevance: HIGH
- As Found: Gastric
- ID: M8425
- Name: Ferric Compounds
- Relevance: HIGH
- As Found: DNA test
- ID: M21009
- Name: Micronutrients
- Relevance: LOW
- As Found: Unknown
- ID: M16885
- Name: Trace Elements
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M9485
- Name: Hematinics
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000007501
- Term: Iron
- ID: C000529054
- Term: Dapagliflozin
- ID: D000005290
- Term: Ferric Compounds
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434012
**Brief Title:** Barts Endocarditis Research Registry
**Official Title:** Barts Endocarditis Research Registry
#### Organization Study ID Info
**ID:** 249740
#### Organization
**Class:** OTHER
**Full Name:** Queen Mary University of London
### Status Module
#### Completion Date
**Date:** 2029-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2029-04-24
**Type:** ESTIMATED
#### Start Date
**Date:** 2019-04-24
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Queen Mary University of London
#### Responsible Party
**Investigator Affiliation:** Queen Mary University of London
**Investigator Full Name:** Innocent Bvekerwa
**Investigator Title:** Mr
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The Barts Endocarditis Research Registry is being set up to give a unique opportunity to assess the characteristics of Infective Endocarditis (IE) in our population cohort, the current use of imaging techniques, as well as the implementation of the ESC guidelines and its consequence in terms of prognosis. All this will help improve the diagnosis and management of IE. The registry will also form the core of all our subsequent work, including interventional studies. The endocarditis research registry is to record the epidemiological, demographic, microbiological, surgical and outcome data in our cohort of endocarditis patients. This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment. We have a series of studies planned that we believe will influence the management of endocarditis (we are working up proposals for genomic and therapeutic trials that will subsequently be presented for ethical and hospital approval). The registry will be generic to all our planned studies, and will allow us to capture data to assess treatment effectiveness
**Detailed Description:** This research registry will give us the unique opportunity to assess the characteristics of IE in our population cohort, the current use of imaging techniques, as well as the implementation of the ESC guidelines and its consequence in terms of prognosis. All this will help improve the diagnosis and management of IE. The registry will also form the core of all our subsequent work, including interventional studies.
Infective endocarditis (IE) is a rare but serious disease, associated with high morbidity and in-hospital mortality. Despite improvements in diagnostic and therapeutic strategies the mortality remains at 15-30% in most published studies. The reasons for this persistent poor prognosis are numerous and include older patients with more severe disease, changes in the epidemiologic profiles and more patients with prosthetic or device related IE.
Following the formation of Barts Heart Centre (BHC) there was a sharp and noticeable increase in the number of patients with infective endocarditis (IE) referred to our centre. Recognising this change, the complexity of patients, and the coincident publication of the European Society of Cardiology Guidelines on Infective Endocarditis (2015), our Specialised Cardiology Directorate set up a new referral pathway, Standard Operating Procedure and Endocarditis Team meeting (MDT). The aim was to ensure focussed, consistent, and evidence-based care with joint medical and surgical input to this unique group of very unwell patients, with high inpatient mortality. In addition, the MDT would discuss and co-ordinate the care of all IE patients, with a weekly discussion of those on site, as well as at our referring hospitals. The MDT started in October 2015 and is composed of representatives from Cardiology (including imaging), Cardiac Surgery, Microbiology, Radiology/Nuclear Medicine and Pharmacy.
Since its inception, the MDT has discussed 367 patients at BHC and our wider referral centres (October 2015 - January 2018). Of those patients, 298 have been confirmed/probable as having IE: 144 surgically managed; 139 medically managed; 16 device extractions with intracardiac infection, all following international guidance. This does not include the grown-up congenital heart disease patients who are discussed and managed separately.
An audit database to track outcomes was started in January 2018, but there is a need to expand this work and make a registry that will form the foundation of all other research that we will undertake.
Mortality across the cohort has been at the lower end of international publications at 17.1% (51/298). Our current surgical mortality stands at 4.7% (14/298), which represents a significant reduction compared to pre-merger where combined mortality at the individual hospitals was 12.2%. In those patients who have died with medical management (37/51), the vast majority have had advanced life-limiting non-cardiac co-morbidities that preclude cardiac surgery (n=19) or on-going intravenous drug use after previous cardiac surgery for IE (n=6). Six patients have not been referred in time for surgery, having presented locally with septic shock and deteriorated rapidly, and this is an area of further education for our referring centres. Six patients have had operations without intra-operative evidence of infection. However, these patients had indications for surgery due to haemodynamically significant regurgitant valve disease.
Our morbidity and mortality reviews have allowed us to learn from all these cases, across all specialties and imaging modalities.
Not only has this approach led to improvements in patient care, but it has also raised the profile of BHC as a centre of special expertise. Our referring centres now include the DGH's of Barts Health NHS Trust (Whipps Cross University Hospital, Newham University Hospital, and The Royal London Hospital), plus many other district general hospitals in our locale.
### Conditions Module
**Conditions:**
- Infective Endocarditis
- Endocarditis
- Endocarditis, Bacterial
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 1000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** This is registry for Infective Endocarditis
**Name:** registry
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The primary goal of the endocarditis registry is to record the epidemiological, demographic, microbiological, surgical and outcome data in our cohort of endocarditis patients. This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment.
**Measure:** To define current mortality, morbidity, reinfection and relapse rates for patients treated at Barts Heart Centre
**Time Frame:** 10 years
#### Secondary Outcomes
**Description:** A secondary aim will be to use the registry to develop a series of observational studies, especially how the infecting organism interacts with the diagnostic indices in our labs and imaging protocols
**Measure:** To collect data regarding infecting organism, valve appearances and pathological markers and investigate their relationship to mortality, morbidity, reinfection and relapse rates
**Time Frame:** 10 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* • Patients aged 16 and over (Patients under 16 years of age are not admitted to Barts Heart Centre)
* Patients admitted to Barts Heart Centre with confirmed Endocarditis (see above)
* Patients attending outpatients with confirmed/suspected Endocarditis
* Patients with possible IE who complete treatment for endocarditis
* Patients with cardiac device related Endocarditis
* Patients with the ability to provide informed consent
Exclusion Criteria:
* • Patients with pacemaker pocket infection with no evidence of pacemaker lead or valve infection
* Patients who refuse consent to be included in the research database
* Patients with "rejected" endocarditis
**Minimum Age:** 16 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** There are approximately 150 cases of endocarditis each year treated within the trust and recruitment is expected to be rapid
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** London
**Country:** United Kingdom
**Facility:** St Bartholomews Hospital
#### Overall Officials
**Official 1:**
**Affiliation:** St Bartholomews Hospital
**Name:** Simon Woldman, MSc
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000001424
- Term: Bacterial Infections
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000007239
- Term: Infections
- ID: D000053821
- Term: Cardiovascular Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M7859
- Name: Endocarditis, Bacterial
- Relevance: HIGH
- As Found: Endocarditis, Bacterial
- ID: M7858
- Name: Endocarditis
- Relevance: HIGH
- As Found: Endocarditis
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4722
- Name: Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12136
- Name: Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M27489
- Name: Cardiovascular Infections
- Relevance: LOW
- As Found: Unknown
- ID: T3065
- Name: Infective Endocarditis
- Relevance: HIGH
- As Found: Infective Endocarditis
### Condition Browse Module - Meshes
- ID: D000004697
- Term: Endocarditis, Bacterial
- ID: D000004696
- Term: Endocarditis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433999
**Brief Title:** A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis
**Official Title:** A 12-Week Open-Label Pilot Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Skin-Predominant Dermatomyositis
#### Organization Study ID Info
**ID:** PVT-2201-202
#### Organization
**Class:** INDUSTRY
**Full Name:** Priovant Therapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2025-01
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Priovant Therapeutics, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a prospective, 12-week, open-label, single-arm study. The study population comprises individuals with refractory skin disease characteristic of dermatomyositis with no to minimal muscle involvement. After an up to 8-week Screening Period, eligible participants will receive brepocitinib 30 mg orally (PO) QD for 12 weeks.
### Conditions Module
**Conditions:**
- Dermatomyositis
- Dermatomyositis, Adult Type
**Keywords:**
- skin-predominant dermatomyositis
- dermatomyositis
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 5
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Brepocitinib 30 mg
**Label:** Arm 1
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Arm 1
**Description:** Oral Brepocitinib 30 mg PO QD
**Name:** Brepocitinib 30 mg
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** The primary endpoint is the change in CDASI-A score from baseline through Week 12
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies
* At least 2 of the following skin characteristics of dermatomyositis at screening;
* Gottron's papules;
* Gottron's sign;
* Heliotrope rash;
* Nailfold changes;
* Photo distributed violaceous erythema;
* History of positive dermatomyositis serology (e.g., transcriptional intermediary factor 1-lambda \[TIF1-λ\], nuclear matrix protein 2 \[NXP2\], nucleosome-remodelling deactylase complex, Mi2, melanoma differentiation antigen 5 \[MDA5\], small ubiquitin-like modifier activating enzyme 1/2, or anti-transfer ribonucleic acid \[tRNA\] synthetase).
* For participants with onset of dermatomyositis symptoms within 3 years prior to screening, have a documented CT (or PET-CT) scan with contrast of the chest, abdomen, and pelvis, taken after the onset of symptoms and within 1 year prior to screening, without findings suggestive of malignancy.
* Current therapy consisting of corticosteroid ≤ 20 mg/day (including a dose of 0 mg \[i.e., not taking corticosteroid\]) of prednisone or equivalent
* At most, one systemic non-steroid immunomodulatory/immunosuppressive therapy
* Adult subjects (18-75 years old)
* Weight \> 40 kg to \< 130 kg, and with a body mass index (BMI) \< 40 kg/m2.
Exclusion Criteria:
* Dermatomyositis with end-stage organ involvement
* Dermatomyositis with irreversible muscle involvement
History of:
* Any lymphoproliferative disorder
* Active malignancy;
* History of cancer within 5 years prior to randomization (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) Cancer-associated dermatomyositis
* Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome)
* Participants at a risk of thrombosis or cardiovascular disease
* Participants with a high risk for herpes zoster reactivation
* Participants with active or recent infections
**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:** Lindsey Rios, BS
**Phone:** (860) 307-5311
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Matt Cascino, MD
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Mayo Clinic
**Name:** Mangold, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000017285
- Term: Polymyositis
- ID: D000009220
- Term: Myositis
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000003240
- Term: Connective Tissue Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M7077
- Name: Dermatomyositis
- Relevance: HIGH
- As Found: Dermatomyositis
- ID: M19579
- Name: Polymyositis
- Relevance: LOW
- As Found: Unknown
- ID: M12172
- Name: Myositis
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1814
- Name: Dermatomyositis
- Relevance: HIGH
- As Found: Dermatomyositis
- ID: T4623
- Name: Polymyositis
- Relevance: LOW
- As Found: Unknown
- ID: T3001
- Name: Idiopathic Inflammatory Myopathy
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003882
- Term: Dermatomyositis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433986
**Brief Title:** MCAT Versus VISTA With Volume Stable Collagen Matrix in RT3 Gingival Recession
**Official Title:** Management of Isolated RT 3 Gingival Recession With Modified Coronally Advanced Tunnel Versus Vestibular Incision Subperiosteal Tunnel Access With Volume Stable Collagen Matrix: A RCT
#### Organization Study ID Info
**ID:** Rohan Goyal Perio 24/35
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Postgraduate Institute of Dental Sciences Rohtak
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study aims to compare MCAT technique (supraperiosteal approach with coronal advancement of flap) with VISTA technique(subperiosteal approach with coronal advancement of flap), Further, it may be hypothesized that supraperiosteal placement of graft material (in MCAT technique) may be better due to better blood supply, and MCAT technique utilizes a microsurgical concept, including microsurgical blades and suture material, which improves wound healing and establishes a better esthetic result and results in better outcome in terms of root coverage percentage compared to VISTA. Therefore, this study aims to compare minimally invasive technique MCAT and VISTA using VCMX as a graft in RT3 gingival recession in anterior teeth.
**Detailed Description:** Gingival recession is the migration of the gingiva to a point apical to the cement-enamel junction and is considered one of the most common periodontal problems.Besides aesthetic complaints, GR may also cause root hypersensitivity, risk for development of caries or non-carious cervical lesions, and difficulties to achieve optimal plaque control. In modified coronally advanced Tunnel (MCAT) technique partial-thickness flap is created on the entire buccal aspect, no parts of the alveolar bone are exposed, and resorption of bony structures, which occurs when using a full-thickness flap can be avoided, also,it minimizes trauma and ensure a better blood supply for the graft.
Zadeh H. in 2011 introduced a conservative modification in tunnel technique; vestibular incision subperiosteal tunnel access (VISTA) which preserve the papillary integrity and enhances patients compliance. Vista technique allows gingival tissue regeneration through subperiosteal undermining of soft tissues using a vestibular incision instead of elevating the whole flap.VISTA offers broader access and maximum esthetic outcome because of placement of incision in the frenum region.
### Conditions Module
**Conditions:**
- Gingival Recession
**Keywords:**
- gingival recession
- esthetics
- phenotype
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 34
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Scaling and root planing will be performed and after resolution of gingival inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using MCAT.
**Intervention Names:**
- Procedure: Modified Coronally Advanced Tunnel (MCAT)Technique
**Label:** Modified Coronally Advanced Tunnel (MCAT)Technique
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using VISTA.
**Intervention Names:**
- Procedure: Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique
**Label:** Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Modified Coronally Advanced Tunnel (MCAT)Technique
**Description:** Scaling and root planing will be performed and after resolution of gingival inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using MCAT.
**Name:** Modified Coronally Advanced Tunnel (MCAT)Technique
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique
**Description:** Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using VISTA.
**Name:** Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** percentage of root coverage will be calculated by using pre and post operative recession depth
**Measure:** Root coverage percentage
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** INCLUSION CRITERIA-
* Patients with RT 3 isolated recession defects present Labially in Anterior teeth region,with vestibular depth\>=6mm
* Systemically healthy individuals.
* Age \>18 years old.
* A full mouth plaque score (FMPS) and full mouth BOP (FMBOP) \< 20%
* Patient showing adequate compliance and willing to participate in the study.
EXCLUSION CRITERIA-
* Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
* Previous surgical attempt to correct gingival recession.
* Crowding of affected teeth and tooth without adjacent contact teeth.
* Patients with active periodontal disease.
* Smokers and tobacco users.
* Pregnant and lactating women.
* Involved tooth with trauma from occlusion
* Involved tooth with prosthesis.
* Endodontically treated tooth.
* Tooth with cervical abrasion/undetectable CEJ/ caries.
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** SHIKHA TEWARI, MDS
**Phone:** 9416514600
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rohtak
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dr. Shikha Tewari, MDS
- **Phone:** 09416514600
- **Role:** CONTACT
***Contact 2:***
- **Name:** ROHAN GOYAL
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** India
**Facility:** PGIDS
**State:** Haryana
**Zip:** 124001
#### Overall Officials
**Official 1:**
**Affiliation:** PGIDS, Rohtak
**Name:** ROHAN GOYAL, BDS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005882
- Term: Gingival Diseases
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000055093
- Term: Periodontal Atrophy
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M9001
- Name: Gingival Recession
- Relevance: HIGH
- As Found: Gingival Recession
- ID: M1112
- Name: Surgical Wound
- Relevance: LOW
- As Found: Unknown
- ID: M8994
- Name: Gingival Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13419
- Name: Periodontal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4589
- Name: Atrophy
- Relevance: LOW
- As Found: Unknown
- ID: M28025
- Name: Periodontal Atrophy
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005889
- Term: Gingival Recession
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433973
**Brief Title:** Chorion Membrane With Photobiostimulation ,Chorion Membrane & SCTG in Treating Isolated RT 2 Recession Defects
**Official Title:** Comparative Evaluation of Root Coverage Outcome by Using CM With Photobiostimulation ,CM & SCTG in Treating Isolated RT 2 Recession Defects Utilizing Minimally Invasive Technique: A RCT
#### Organization Study ID Info
**ID:** Anisha Kumari Perio 24/36
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Postgraduate Institute of Dental Sciences Rohtak
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Gingival recession (GR) is defined as apical displacement of the gingival margin relative to the cemento-enamel junction, with resultant oral exposure of the root.
Most of the recessions in periodontal patients involve the destruction of interproximal periodontal tissues, and these were classifed as Miller class III and IV or Cairo RT2 andRT3 gingival recessions (GRs).
Taking all this into account, numerous techniques have been attempted to achieve root coverage of single-rooted tooth, Connective tissue graft presently stands as the benchmark in periodontal plastic surgery, offering excellent predictability and enhanced long-term root coverage. However, its availability is limited and its use often leads to increased patient morbidity.Thus making placental allografts in dentistry a topic of growing interest and recent advancement.
It may be hypothesized that CM + LLLT or CM may be used an alternative to SCTG in minimally invasive technique in recession coverage. Hence, this study evaluates root coverage percentages in RT2 gingival defects using a CM with and without photobiostimulation, comparing them to each other and to SCTG- the gold standard control group.
**Detailed Description:** Most of the recessions in periodontal patients involve the destruction of interproximal periodontal tissues, therefore, these were classified as Miller class III and IV or Cairo RT2 and RT3 gingival recessions (GRs). The growing emphasis on aesthetics and the desire to minimize patient discomfort have led to the advancement of various mucogingival techniques aimed at covering exposed roots. numerous techniques have been attempted to achieve root coverage of single-rooted tooth. Connective tissue graft presently stands as the benchmark in periodontal plastic surgery, offering excellent predictability and enhanced long-term root coverage. However, its availability is limited and its use often leads to increased patient morbidity. Thus making placental allografts in dentistry a topic of growing interest and recent advancement. Other advantages like their capacity to self hydrate with blood. While these techniques have proven effective, the integration of devices capable of accelerating wound healing could enhance the outcomes of the latest graft techniques for root coverage, facilitating more predictable results.
Progress in low-level laser therapy (LLLT) within Periodontics has empowered periodontists to attain enhanced clinical outcomes. LLLT accelerates wound healing by enhancing the motility of human keratinocytes, stimulating early epithelialization, increasing fibroblast proliferation and matrix synthesis, and promoting neo vascularization.
.LLLT induces tissue surface sterilization, there by reducing the risk of bacteremia, and diminishing edema, swelling, and scarring .Additionally, it may provide greater tensile strength and stability to gingival margins, potentially preventing wound failure and reducing clinical recession. Besides all the advantages of LLLT and chorion membrane, there are very few studies which are published using theses two techniques in the recession defects. No prior research has examined the comparative efficacy of SCTG, CM + LLLT and CM for Miller's class III/RT2 recession defects. It may be hypothesized that CM + LLLT or CM may be used an alternative to SCTG in minimally invasive technique in recession coverage. Hence, this study evaluates root coverage percentages in RT2 gingival defects using a CM with and without photobiostimulation, comparing them to each other and to SCTG- the gold standard control group
### Conditions Module
**Conditions:**
- Gingival Recession
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 51
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. Photobiostimulation will be done using of diode laser.
**Intervention Names:**
- Procedure: Test group 1 - CM+LLLT+VISTA
**Label:** Test group 1 - CM+LLLT+VISTA
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique.
**Intervention Names:**
- Procedure: Test group 2 - CM+VISTA
**Label:** Test group 2 - CM+VISTA
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique.
**Intervention Names:**
- Procedure: Control group - SCTG+VISTA
**Label:** Control group - SCTG+VISTA
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Test group 1 - CM+LLLT+VISTA
**Description:** After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts.CM will be placed on the recession defect using minimally invasive technique. LLLT will be applied on the site for 10 sec.
**Name:** Test group 1 - CM+LLLT+VISTA
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Test group 2 - CM+VISTA
**Description:** After obtaining adequate LA exposed root surfaces of treated teeth are to be scaled with curettes to reduce root convexity and undercuts. Adequate size of CM will be trimmed and applied over the recession defect using minimally invasive technique and secured with sutures.
**Name:** Test group 2 - CM+VISTA
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Control group - SCTG+VISTA
**Description:** Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with CTG using minimally invasive access technique.
**Name:** Control group - SCTG+VISTA
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** ( Preoperative recession depth) - (Postoperative recession depth) × 100
Preoperative recession depth
**Measure:** Percentage root coverage
**Time Frame:** 6 months
**Description:** recorded in mm with a periodontal probe, from the crest of gingival margin to the mucogingival junction.
**Measure:** Keratinised tissue width
**Time Frame:** 6 months
**Description:** recorded in mm with a periodontal probe from the cemento enamel junction to the base of the pocket by inserting the periodontal probe at the interproximal region
**Measure:** interproximal Clinical attachment level (iCAL)
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** will be recorded as 1(present) if bleeding occurs within 15 seconds of probing and 0(absent) if no bleeding occurs. It will be calculated in percentage %. After adding all the scores, total score will be divided by the total number of surfaces accessed and multiplied by hundred. It will be designed as percentage sites with bleeding on probing
**Measure:** Bleeding on probing (BOP)
**Time Frame:** 6 months
**Description:** recorded in mm with a periodontal probe from the cemento enamel junction to the base of the pocket by inserting the periodontal probe at the mid-buccal region
**Measure:** Buccal Clinical attachment level
**Time Frame:** 6 months
**Description:** The GT will be assessed by probe transparency (TRAN) method
. Gingival thickness will be measured from the keratinized mucosa to the periosteum with a finger spreader and a silicon slider and digital calliper at a point lying in the centre of a line drawn from the gingival margin to mucogingival junction
**Measure:** change in Gingival thickness
**Time Frame:** 6 months
**Description:** recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at the mid-labial region.
**Measure:** Recession depth
**Time Frame:** 6 months
**Description:** recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction
**Measure:** Recession width
**Time Frame:** 6 months
**Description:** Measured in mm from the crest of the gingival margin to the base of the pocket at the mid-labial region
**Measure:** Pocket probing depth
**Time Frame:** 6 months
**Description:** The visual analogue scale (VAS) is considered to be one of the best methods available for the estimation of the intensity of pain. Postoperative pain using visual analog scale at treated site (VAS: a scale from 0-10 ; 0 means no pain/discomfort, 10 means maximum pain /discomfort )
**Measure:** Patient based evaluation of pain and hypersensitivity by visual analogue scale for pain(VAS)
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with Millers class3or RT2 isolated recession defects in labial mandibular anterior teeth region.
* Systemically healthy individuals.
* Absence of clinical tooth mobility.
* Age \>18 years old.
* A full mouth plaque index \< 20%
* Patient showing adequate compliance and willing to participate in the study.
Exclusion Criteria:
* Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy.
* patient with active periodontal disease
* smokers and tobacco users
* mal-alingned lower anteriors.
* patients who had already undergone root coverage procedure on the selected site.
* pregnant and lactating females
* Involved tooth with trauma from occlusion.
* Involved tooth with prosthesis.
* Endodontically involved/ RCT treated tooth
* Tooth with cervical abrasion / undetectable CEJ/ carious.
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Shikha Tewari, MDS
**Phone:** 8708249475
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rohtak
**Country:** India
**Facility:** PGIDS
**State:** Haryana
**Zip:** 124001
#### Overall Officials
**Official 1:**
**Affiliation:** PGIDS, Rohtak
**Name:** Anisha Kumari, BDS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005882
- Term: Gingival Diseases
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000055093
- Term: Periodontal Atrophy
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M9001
- Name: Gingival Recession
- Relevance: HIGH
- As Found: Gingival Recession
- ID: M8994
- Name: Gingival Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13419
- Name: Periodontal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4589
- Name: Atrophy
- Relevance: LOW
- As Found: Unknown
- ID: M28025
- Name: Periodontal Atrophy
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005889
- Term: Gingival Recession
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433960
**Brief Title:** Radial Artery Assessment in Surgical Coronary Revascularisation
**Official Title:** A Cross-Sectional Study and a Novel Screening Survey for Radial Artery Assessment in Surgical Coronary Revascularisation
#### Organization Study ID Info
**ID:** 24/SC/0076
#### Organization
**Class:** OTHER_GOV
**Full Name:** Papworth Hospital NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 2025-02-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-28
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Papworth Hospital NHS Foundation Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this observational study is to learn about how screening tests inform the radial artery (RA) suitability for harvesting and coronary bypass grafting in adults with ischaemic heart disease. The main question it aims to answer is:
• What factors influence the diagnostic accuracy of RA screening in patients undergoing surgical coronary revascularisation?
Participants will:
* Receive an assessment of their RA through routinely used techniques (Modified Allen Test +/- pulse-oximetry, Barbeau Test and Ultrasound examination)
* Answer a symptoms scale about their physical experience after surgery
**Detailed Description:** A multi-centre cross-sectional study design to investigate the validity of radial artery (RA) assessment techniques in adults with ischaemic heart disease undergoing surgical coronary revascularisation with their RA being selected as an autologous graft conduit.
Patients taking part in the study will receive an assessment of the arterial forearm circulation from their non-dominant upper extremity through multiple observations.
Pre-operative observations. Before surgery (in the ward environment after the patient is being admitted or whilst patient in the anaesthetic room) the forearm blood circulation is measured through a Modified Allen Test (MAT) (+/- pulse-oximetry), Barbeau Test and Ultrasonography examination. Assessment will be performed by experienced Surgical Care Practitioners/Advanced Nurse Practitioners/Cardiac Specialist Registrars. These assessments will inform the decision to surgically expose the RA.
Intra-operative observations. Oxygen saturation readings are taken prior to harvest the RA. Once the RA is surgically harvested a series of measures are taken through a validated structured questionnaire: the Radial Artery Quality Evaluation Survey (RAQES).
Observations at 4-6 weeks post operation. Patients finger movements, cold tolerance sensitivity and tactile/touch perception is measured through an ordinal symptoms scale (Follow-up Radial Artery Harvesting Scale) at post-operative day 2-5 and at follow-up appointment (3-6 weeks after surgery). Bilateral comparison between hands and forearms will be undertaken. A Surgical Care Practitioner will perform this assessment post-operatively.
Consecutive sampling will be used for the recruitment of study participants. The minimum required number of participants to test and verify research hypotheses is sixty-nine patients (N=69). An adaptive trial design will be implemented: at quarterly assessment points the statistical power is assessed and the remaining sample size required is updated accordingly.
Sample size calculation was undertaken using G\*Power software (version 3.1) using Chi-squared Test and adopting optimal effect size (w=0.4) and power (0.8).
Descriptive and inferential statistics will be used to perform quantitative analyses. Descriptive statistics (mode, median) will be implemented to analyse RAQES answers and ordinal symptoms scale findings and cross-tabulation used to record relationship between variables. Data analysis will also include measurement of sensitivity, specificity, positive and negative predictive values to investigate the validity of the RA assessment techniques. Correlational analysis will be implemented and Receiver Operating Characteristic curve analysis will be used to compare the diagnostic accuracy of the MAT, pulse-oximetry guided MAT and Barbeau Test with the ultrasonography examination.
### Conditions Module
**Conditions:**
- Coronary Artery Bypass Grafting
- Coronary Artery Disease
**Keywords:**
- Radial Artery
- Modified Allen Test
- Barbeau Test
- Ultrasonography
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 69
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Cardiac patients undergoing elective or urgent coronary artery bypass graft surgery and radial artery harvest in two Cardiothoracic hospitals.
**Intervention Names:**
- Diagnostic Test: Modified Allen Test
- Diagnostic Test: Pulse-oximetry guided Modified Allen Test
- Diagnostic Test: Barbeau Test
- Diagnostic Test: Ultrasound examination of the forearm arteries
- Diagnostic Test: Measurement of oxygen saturation
- Other: Radial Artery Quality Evaluation Survey
- Other: Follow-up Radial Artery Harvesting Scale
**Label:** Cardiovascular sample group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cardiovascular sample group
**Description:** Pre-operative intervention aimed at evaluating if forearm blood vessels (ulnar artery and collateral) would supply an adequate blood flow to the arm if the radial artery was harvested. Duration: 1 minute.
Instruct the patient to clench their wrist while the examiner occlude with three fingers the patients ulnar and radial arteries; instruct the patient to unclench their wrist; release the ulnar artery. The MAT result is negative or positive considering in how long the palm flushes:
≤5 seconds: negative MAT; good collateral hand circulation (suggesting harvestable radial artery).
greater than 5 seconds: positive MAT; poor collateral hand circulation (suggesting not-harvestable radial artery).
**Name:** Modified Allen Test
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- Cardiovascular sample group
**Description:** Pre-operative intervention aimed at evaluating if forearm blood vessels (ulnar artery and collateral) would supply an adequate blood flow to the arm if the radial artery was harvested. Duration: 1 minute.
A pulse-oximetry probe is positioned on the patients index finger; both radial and ulnar arteries are occluded by the examiner (with three fingers) until flattening of pulse waveform is obtained. Pressure on the ulnar artery is released and the result of the assessment is calculated considering in how long the pulse waveform returns to baseline:
≤5 seconds: negative result (suggesting harvestable radial artery). greater than 5 seconds: positive result (suggesting not harvestable radial artery).
(Busti and Kellogg, 2015)
**Name:** Pulse-oximetry guided Modified Allen Test
**Type:** DIAGNOSTIC_TEST
#### Intervention 3
**Arm Group Labels:**
- Cardiovascular sample group
**Description:** Pre-operative intervention aimed at evaluating if forearm blood vessels (ulnar artery and collateral) would supply an adequate blood flow to the arm if the radial artery was harvested. Duration: 2 minutes.
A pulse-oximetry probe is positioned on the patients thumb; the radial artery is then compressed by the examiner, and the pulse waveform is analysed for up to 120 seconds, providing four result patterns of ulno-palmar patency:
1. No damping of the pulse tracing immediately after compression (suggesting harvestable radial artery)
2. Damping of the pulse tracing (suggesting harvestable radial artery)
3. Loss of the pulse tracing, followed by recovery within 120 sec (suggesting harvestable radial artery)
4. Loss of the pulse tracing, without recovery within 120 sec (suggesting not harvestable radial artery).
(Zalocar et al., 2020)
**Name:** Barbeau Test
**Type:** DIAGNOSTIC_TEST
#### Intervention 4
**Arm Group Labels:**
- Cardiovascular sample group
**Description:** Pre-operative intervention aimed at evaluating morphological characteristics (diameter, presence of calcifications) of the radial and ulnar arteries. Duration: 5 minutes.
The radial artery is surgically exposed (negative result) when the following apply:
1. ulnar artery inner diameter ≥2 mm
2. radial artery inner diameter ≥2 mm
3. absence of radial artery intraluminal calcifications and plaques.
(Vukovic et al., 2017)
**Name:** Ultrasound examination of the forearm arteries
**Type:** DIAGNOSTIC_TEST
#### Intervention 5
**Arm Group Labels:**
- Cardiovascular sample group
**Description:** Intra-operative intervention aimed at evaluating the blood oxygen level in the hand if the radial artery was harvested. Duration: 1 minute.
The radial artery is surgically harvested when the oxygen saturation reading (SpO2) from the thumb through pulse-oximetry remains at 95% or above when an occlusive atraumatic clamp is applied on the mobilised radial artery.
**Name:** Measurement of oxygen saturation
**Type:** DIAGNOSTIC_TEST
#### Intervention 6
**Arm Group Labels:**
- Cardiovascular sample group
**Description:** Intra-operative intervention (validated structured questionnaire) aimed at evaluating anatomical and physiological characteristics of the radial artery and suitability for coronary graft implantation.
The radial artery is surgically harvested when its morphology and pathology (diameter, calcifications, presence of pulsatile flow), quality of harvesting technique and surgical accessibility are considered satisfactory, good or optimal.
The Radial Artery Quality Evaluation Survey is completed by surgical care practitioners.
**Name:** Radial Artery Quality Evaluation Survey
**Type:** OTHER
#### Intervention 7
**Arm Group Labels:**
- Cardiovascular sample group
**Description:** Postoperative intervention (ordinal symptoms scale) aimed at evaluating patients finger movements, cold tolerance sensitivity and tactile/touch perception at post-operative day 2 to 5 and at follow-up appointment (3-6 weeks after surgery). Bilateral comparison between hands and forearms is undertaken. Tactile perception is assessed through monofilaments (single touch). Cold sensitivity is assessed through the use of ice-pack.
The Follow-up Radial Artery Harvesting Scale was developed from a verbal rating scale (VRS) questionnaire documented in the literature. The VRS questionnaire was re-adapted to appreciate people postoperative experience with their finger movements, cold sensitivity and tactile/touch perception of their forearm.
**Name:** Follow-up Radial Artery Harvesting Scale
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Measure the sensitivity of the Modified Allen test (+/- pulse-oximetry), the Barbeau Test and ultrasonography examination.
**Measure:** Sensitivity of Radial Artery Assessment Techniques
**Time Frame:** From enrollment to the end of treatment at 12 weeks.
**Description:** Measure the specificity of the Modified Allen test (+/- pulse-oximetry), the Barbeau Test and ultrasonography examination.
**Measure:** Specificity of Radial Artery Assessment Techniques
**Time Frame:** From enrollment to the end of treatment at 12 weeks.
**Description:** Measure the negative and positive predictive values of the Modified Allen test (+/- pulse-oximetry), the Barbeau Test and ultrasonography examination.
**Measure:** Negative and Positive predictive values of Radial Artery Assessment Techniques
**Time Frame:** From enrollment to the end of treatment at 12 weeks.
#### Secondary Outcomes
**Description:** Measure the morphological and physiological quality of radial arteries through a validated structured questionnaire (Radial Artery Quality Evaluation Survey)
**Measure:** Radial Artery Quality Evaluation
**Time Frame:** From enrollment to surgical harvesting of the radial artery at day 1-2 after hospitalisation.
**Description:** Measure the patients' finger movements, cold tolerance sensitivity and tactile/touch perception through an ordinal symptoms scale (Follow-up Radial Artery Harvesting Scale).
**Measure:** Patients Physical Experience Evaluation
**Time Frame:** From day of surgery to the end of treatment at 12 weeks.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male and female adults patients undergoing elective or urgent coronary artery bypass graft (CABG) surgery and radial artery (RA) harvesting in two Cardiothoracic hospitals.
Exclusion Criteria:
* Paediatric patients and/or adult patients undergoing emergency CABG will not be considered within the participants of this cross-sectional study, as well as patients lacking capacity to consent and non-English speaking patients requiring use of interpreters. Patients not wishing to participate in the study will also not be recruited.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** People with ischaemic heart disease undergoing coronary bypass surgery and radial artery harvest at Royal Papworth and Royal Brompton hospitals will be invited to participate in this study.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Vincenzo De Franco, MSc SCP
**Phone:** +441223638000
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Naim Abdulmohdi, PhD
**Phone:** +441223695538
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cambridge
**Contacts:**
***Contact 1:***
- **Name:** Vincenzo De Franco
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** Royal Papworth Hospital
**State:** England/Cambridgeshire
**Zip:** CB20AY
**Location 2:**
**City:** London
**Contacts:**
***Contact 1:***
- **Name:** Vincenzo De Franco
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** Royal Brompton Hospital
**State:** England
**Zip:** SW3 6NP
#### Overall Officials
**Official 1:**
**Affiliation:** Royal Papworth Hospital NHS Foundation Trust
**Name:** Vincenzo De Franco, MSc SCP
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Researchers wishing to conduct a diagnostic accuracy analysis of the tests (interventions) under investigation car require copy of the anonymised IPD and supporting information to the principal investigator.
A proposal describing the planned analysis must be provided and a data sharing agreement form (requested to the sponsoring institution) must be signed.
Further instructions for obtaining access are available at the link below:
https://royalpapworth.nhs.uk/research-and-development or contacting: [email protected]
**Description:** All IPD that underlie results in a publication. Shared IPD will be presented in a de-identified (anonymised) format for each participant and will include information about interventions or tests received and outcomes observed.
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** Beginning 6 months and ending 3 years after the publication of results.
**URL:** https://royalpapworth.nhs.uk/research-and-development
### References Module
#### References
**Citation:** Zalocar LAD, Doroszuk G, Goland J. Transradial approach and its variations for neurointerventional procedures: Literature review. Surg Neurol Int. 2020 Aug 15;11:248. doi: 10.25259/SNI_366_2020. eCollection 2020.
**PMID:** 32905334
**Citation:** Vukovic P, Peric M, Radak S, Aleksic N, Unic-Stojanovic D, Micovic S, Stojanovic I, Milojevic P. Preoperative Insight Into the Quality of Radial Artery Grafts. Angiology. 2017 Oct;68(9):790-794. doi: 10.1177/0003319716686014. Epub 2017 Jan 5.
**PMID:** 28056520
#### See Also Links
**Label:** Busti, A.J. and Kellogg, D. (2015) Allens Test.
**URL:** https://www.ebmconsult.com/articles/physica-exam-allens-test
**Label:** Kinoue, T. and Arai, M. (2021) Comparison of Rating Scale Methods for Cold Sensation in Kampo Medicine, International Medical Journal, 28(1), pp.94-97.
**URL:** https://seronjihou.files.wordpress.com/2021/05/281094.pdf
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-04-09
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 408471
- Type Abbrev: Prot_SAP
- Upload Date: 2024-05-23T08:51
- Date: 2024-05-23
- Filename: ICF_002.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 122008
- Type Abbrev: ICF
- Upload Date: 2024-05-29T07:46
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003327
- Term: Coronary Disease
- ID: D000017202
- Term: Myocardial Ischemia
- 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
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: HIGH
- As Found: Coronary Artery Disease
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M6549
- Name: Coronary Disease
- Relevance: LOW
- As Found: Unknown
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4469
- Name: Arteriosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003324
- Term: Coronary Artery Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433947
**Brief Title:** Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
**Official Title:** A Phase 1b, Dose Escalation/Dose Expansion, Multicenter, Open-Label Study to Assess the Safety and Tolerability of OPN-6602 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma
#### Organization Study ID Info
**ID:** OPN6602-C01
#### Organization
**Class:** INDUSTRY
**Full Name:** Opna Bio LLC
### Status Module
#### Completion Date
**Date:** 2026-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Opna Bio LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Phase 1b, open-label study evaluating the safety, tolerability, pharmacokinetics, preliminary antitumor activity, and pharmacodynamics of OPN-6602 monotherapy and in combination with dexamethasone in subjects with relapsed and/or refractory MM.
### Conditions Module
**Conditions:**
- Relapsed Multiple Myeloma
- Refractory Multiple Myeloma
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 130
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: OPN-6602
**Label:** Dose escalation monotherapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: OPN-6602
- Drug: Dexamethasone
**Label:** Dose escalation in combo with dexamethasone
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Drug: OPN-6602
**Label:** Dose expansion
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dose escalation in combo with dexamethasone
- Dose escalation monotherapy
- Dose expansion
**Description:** orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily
**Name:** OPN-6602
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Dose escalation in combo with dexamethasone
**Description:** Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle
**Name:** Dexamethasone
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Number and type of dose-limiting toxicities (DLTs)
**Time Frame:** Through up to approximately 30 days following last dose of OPN-6602
**Measure:** Number and type of treatment-emergent adverse events (TEAEs)
**Time Frame:** Through up to approximately 30 days following last dose of OPN-6602
**Description:** Number of participants who experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and coagulation. Abnormalities considered are those Grade 3-4 events with a \>= 1 grade increase from baseline using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
**Measure:** Number of Participants With Clinical Laboratory Test Abnormalities
**Time Frame:** Through up to approximately 30 days following last dose of OPN-6602
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Confirmed diagnosis of multiple myeloma (MM)
* Relapsed or refractory to 3 or more different prior lines of therapy for MM that included immunomodulatory agents, proteosome inhibitors, and anti-CD38 antibody and not a candidate for or intolerant to established therapy known to provide clinical benefit
* Adequate hematologic, renal, liver, cardiac function
Exclusion Criteria:
* Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenström's macroglobulinemia, or IgM myeloma
* Active plasma cell leukemia
* Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS syndrome)
* Prior Stevens Johnson syndrome
* Localized radiation therapy to disease site(s) within 2 weeks of the first dose
* Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within \<90 days of the first dose of study drug
* Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of screening; subjects receiving immunosuppressive medication for active graft vs host disease will be excluded.
* Prior chemotherapy, targeted anticancer or radiation therapy within 2 weeks prior to first dose of study drug
* Concomitant high-dose corticosteroids (except subjects on chronic steroids given for disorders other than myeloma)
* Known central nervous system involvement by multiple myeloma
* Active known second malignancy with exception of adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer; adequately treated Stage 1 cancer from which the subject is currently in remission and has been in remission for ≥2 years; low-risk prostate cancer with a Gleason score \<7 and a PSA level \<10 ng/mL; any other cancer from which the subject has been disease-free for ≥3 years
* Ongoing systemic infection requiring parenteral treatment
* Poorly controlled Type 2 diabetes
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kerry Inokuchi
**Phone:** 650-204-4065
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Boston
**Country:** United States
**Facility:** Dana Farber Cancer Institute
**State:** Massachusetts
**Zip:** 02215
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000020141
- Term: Hemostatic Disorders
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010265
- Term: Paraproteinemias
- ID: D000001796
- Term: Blood Protein Disorders
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000006474
- Term: Hemorrhagic Disorders
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12058
- Name: Multiple Myeloma
- Relevance: HIGH
- As Found: Multiple Myeloma
- ID: M27588
- Name: Neoplasms, Plasma Cell
- Relevance: HIGH
- As Found: Multiple Myeloma
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M21977
- Name: Hemostatic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5059
- Name: Blood Coagulation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13178
- Name: Paraproteinemias
- Relevance: LOW
- As Found: Unknown
- ID: M5077
- Name: Blood Protein Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9560
- Name: Hemorrhagic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3947
- Name: Multiple Myeloma
- Relevance: HIGH
- As Found: Multiple Myeloma
### Condition Browse Module - Meshes
- ID: D000009101
- Term: Multiple Myeloma
- ID: D000054219
- Term: Neoplasms, Plasma Cell
### Intervention Browse Module - Ancestors
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000000932
- Term: Antiemetics
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000005765
- Term: Gastrointestinal Agents
- ID: D000005938
- Term: Glucocorticoids
- ID: D000006728
- Term: Hormones
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000018931
- Term: Antineoplastic Agents, Hormonal
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M7102
- Name: Dexamethasone
- Relevance: HIGH
- As Found: Children
- ID: M235549
- Name: Dexamethasone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M9047
- Name: Glucocorticoids
- Relevance: LOW
- As Found: Unknown
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4251
- Name: Antiemetics
- Relevance: LOW
- As Found: Unknown
- ID: M8881
- Name: Gastrointestinal Agents
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20966
- Name: Antineoplastic Agents, Hormonal
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000003907
- Term: Dexamethasone
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433934
**Brief Title:** Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery
**Official Title:** Comparison of the Oxymask and Oxy2mask on Supplemental Oxygen Delivery
#### Organization Study ID Info
**ID:** Oxymask
#### Organization
**Class:** OTHER
**Full Name:** Northwestern Medicine
### Status Module
#### Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Northwestern Medicine
#### Responsible Party
**Investigator Affiliation:** Northwestern Medicine
**Investigator Full Name:** Patti DeJuilio
**Investigator Title:** Director Respiratory Care and Diagnostic Services
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to determine if the performance of a newly released oxygen mask is the same, better, or worse than previous mask version. We will measure the flow rate necessary to maintain the same oxygen saturation in adult patients using each mask.
**Detailed Description:** Southmedic, Inc. has received approval to distribute a newly designed oxygen mask. The current design has been studied and the FiO2 delivered reported to be inconsistent. The purpose of this study is to determine if the performance is the same, better, or worse than current mask. We can evaluate performance by determining Liter flow required to maintain oxygen saturations that are within limits described in NM CDH oxygen protocol. We will measure the flow rate necessary to maintain the same saturation in adult patients using both the OxyMask and Oxy2Mask. The Oxymask has a flow device inside the mask that has been revised since implementation. The mask itself is otherwise unchanged. We intend to determine if the same amount of flow results in the same outcome.
This study will include adult patients that require supplemental oxygen and we do not believe the patients will report a difference between each mask. The only variance in care is mask version used, the oxygen protocol will remain the same.
### Conditions Module
**Conditions:**
- Hypoxia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Each patient will receive mask #1, then receive mask #2. The flowrate to maintain same desired oxygen saturations will be documented.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Change oxymask to oxy2mask
**Intervention Names:**
- Device: Oxy2mask
**Label:** Oxy2mask
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Oxy2mask
**Description:** Open design oxygen mask
**Name:** Oxy2mask
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Flow (LPM) required to maintain target oxygen saturation
**Measure:** Required Flowrate
**Time Frame:** 4 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants have oxygen device and are being titrated per NM CDH oxygen protocol (maintained between 90%-96%; or 88% - 92% if CO2 retainer)
* Participants to have period of stability; 2 hours at same liter flow on open design mask, 5-15 lpm 02.
* All adult patients (\> 18 years old) in med surge units (bed tower)
* Post-op patients requiring oxygen on Post-op Day 2.
* Patients currently on \>5 LPM via nasal cannula, clinician can recommend the change to OxyMask. If remains on \>5 LPM via OxyMask, patient can be included.
* Oxygen protocol will be followed per standards of care.
Exclusion Criteria:
* Patients receiving home oxygen therapy who do not require additional oxygen during hospital stay.
* Patients with a history of Bleomycin therapy.
* Patients with a history of Paraquat poisoning
* Patients that are pregnant
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Patti DeJuilio, MS
**Phone:** 6309332432
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Mary Henriksen, MS
**Phone:** 6309335875
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Winfield
**Country:** United States
**Facility:** Central DuPage Hospital
**State:** Illinois
**Zip:** 60190
#### Overall Officials
**Official 1:**
**Affiliation:** Northwestern Medicine IRB
**Name:** Megan Carney
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4185
- Name: Hypoxia
- Relevance: HIGH
- As Found: Hypoxia
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000860
- Term: Hypoxia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433921
**Brief Title:** A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
**Official Title:** A Phase 1, Randomized, 2-part, 7-way Cross-over (Part 1) and 7-way Cross-over (Part 2), Active Device Blinded, Single Dose Study in Mild Asthmatics Aged 18-65 to Assess the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a (Test) and HFA-134a (Reference) Via Methacholine Bronchoprovocation and Systemic Pharmacodynamic Effects
#### Organization Study ID Info
**ID:** 219729
#### Organization
**Class:** INDUSTRY
**Full Name:** GlaxoSmithKline
#### Secondary ID Infos
**Domain:** EU CT number
**ID:** 2024-511220-14-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-10-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-04
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** GlaxoSmithKline
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The primary objectives of the study are:
* Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) \[PC20\]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.
* Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.
### Conditions Module
**Conditions:**
- Asthma
- Mild Asthma
**Keywords:**
- salbutamol
- propellant HFA-152a
- propellant HFA-134a
- metered dose inhalers
- mild asthma
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** 2-part, 7-way cross-over (Part 1) and up to 7-way cross-over (Part 2).
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 91
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Part 1 will consist of a 7 treatment, 7 period cross-over evaluation with all participants receiving the following treatments once, randomized to varying pre-specified sequences of:
* Zero dose (placebo of both salbutamol HFA-134a and salbutamol HFA-152a)
* 100 μg salbutamol HFA-134a
* 200 μg salbutamol HFA-134a
* 400 μg salbutamol HFA-134a
* 100 μg salbutamol HFA-152a
* 200 μg salbutamol HFA-152a
* 400 μg salbutamol HFA-152a
A minimum of a 2-day and maximum of a 7-day methacholine washout will separate each treatment period.
**Intervention Names:**
- Drug: Salbutamol HFA-152a
- Drug: Salbutamol HFA-134a
- Drug: Placebo
**Label:** Part 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Part 2 is proposed to consist of up to a 7 treatment, 7-way cross-over pivotal evaluation with the following treatments given once, randomized to varying pre-specified sequences of:
* Zero dose (placebo of both salbutamol HFA-134a and salbutamol HFA-152a)
* 100 μg salbutamol HFA-134a
* 200 μg salbutamol HFA-134a
* 400 μg salbutamol HFA-134a
* 100 μg salbutamol HFA-152a
* 200 μg salbutamol HFA-152a
* 400 μg salbutamol HFA-152a
A minimum of a 2-day and maximum of a 7-day methacholine washout will separate each treatment period.
**Intervention Names:**
- Drug: Salbutamol HFA-152a
- Drug: Salbutamol HFA-134a
- Drug: Placebo
**Label:** Part 2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Part 1
- Part 2
**Description:** A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals.
**Name:** Salbutamol HFA-152a
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Part 1
- Part 2
**Description:** A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals.
**Name:** Salbutamol HFA-134a
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Part 1
- Part 2
**Description:** A single placebo HFA-152a suspension or placebo HFA-134a suspension dose, given as at 20 second intervals.
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** PC of methacholine causing at least a 20% fall in FEV1.
**Measure:** PC20
**Time Frame:** Up to 11 weeks
#### Secondary Outcomes
**Measure:** Peak QTc Interval
**Time Frame:** Up to 11 weeks
**Measure:** Peak Heart Rate (HR)
**Time Frame:** Up to 11 weeks
**Measure:** Minimum Serum Potassium
**Time Frame:** Up to 11 weeks
**Measure:** Maximum Observed Plasma Concentration (Cmax)
**Time Frame:** Up to 11 weeks
**Measure:** Time to Reach Cmax (Tmax)
**Time Frame:** Up to 11 weeks
**Measure:** Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])
**Time Frame:** Up to 11 weeks
**Measure:** Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Time Frame:** Up to 11 weeks
**Measure:** Absolute Values for 12-lead Electrocardiogram (ECG) Recording of HR
**Time Frame:** Up to 11 weeks
**Description:** Intervals recorded:
* PR
* QRS
* QT
* QTc
**Measure:** Absolute Values for 12-lead ECGs Recording of Intervals
**Time Frame:** Up to 11 weeks
**Description:** The 3 predose measures will be recorded and will be averaged for HR to derive 1 baseline value.
**Measure:** Change from Baseline for Post-dose 12-lead ECGs Recording of HR
**Time Frame:** Baseline and up to 11 weeks
**Description:** The 3 predose measures will be recorded and will be averaged for QTc interval to derive 1 baseline value.
Intervals recorded:
* PR
* QRS
* QT
* QTc
**Measure:** Change from Baseline for Post-dose 12-lead ECGs Recording of Intervals
**Time Frame:** Baseline and up to 11 weeks
**Measure:** Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
**Time Frame:** Up to 11 weeks
**Measure:** Absolute Values of Vital Signs (Systolic and Diastolic Blood Pressure)
**Time Frame:** Up to 11 weeks
**Measure:** Absolute Values of Vital Signs (Pulse Rate)
**Time Frame:** Up to 11 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
2. Participant must be 18 to 65 years of age inclusive, at the time of screening.
3. ≥50 kg, at the time of screening.
4. Documented history of asthma ≥ 6 months.
5. Receiving 1 of following asthma treatments, at a stable dose, for at least 12 weeks prior to the screening visit and is anticipated to remain stable for the duration of the study:
i. Short-acting beta-agonist (SABA) only. ii. Daily maintenance low-dose inhaled corticosteroids (ICS) (defined as 100-250 μg/day fluticasone propionate or equivalent plus or minus SABA which is anticipated to remain stable for the duration of the study.
iii. Daily maintenance low-dose ICS + Long-acting beta-2 agonist (LABA) therapy (low-dose ICS defined as 100-250 μg/day fluticasone propionate or equivalent as defined by GINA \[GINA, 2023\]) plus or minus SABA, which is anticipated to remain stable for the duration of the study.
6. No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening.
7. Pre-bronchodilator FEV1 ≥80% of predicted, at screening
8. PC20 to methacholine of ≤8 mg/mL, at screening.
9. A female participant is eligible to participate if she is not pregnant or breastfeeding, and Is a woman of woman of nonchildbearing potential (WONCBP) OR ii. Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective.
10. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
11. Non-smokers who have not used any tobacco containing-products within 12 months prior to study start, and with a total pack year history of ≤10 pack years.
Exclusion Criteria:
1. Medical Conditions
1. A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
2. A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other respiratory abnormalities other than asthma.
3. Asymptomatic gallstones.
4. History or current evidence of hematologic, neurologic, psychiatric, or other diseases that, in the opinion of the investigator, would put the participant at risk through study participation, or would affect the study analyses if the disease exacerbates during the study.
5. Recent eye surgery or any other condition in which raised intracranial pressure (caused by forceful exhalation) would be harmful.
6. Current use of cholinesterase inhibitor medication e.g., to treat myasthenia gravis.
2. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer.
3. Participants who are currently or in the last 15 days have worked nightshifts.
4. Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of \>21 units for males or \>14 units for females.
5. A positive test result for drugs of abuse (including tetrahydrocannabinol) at screening or Day -1.
6. Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to "vape" within 12 months prior to the start of the study.
**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:** US GSK Clinical Trials Call Center
**Phone:** 877-379-3718
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** EU GSK Clinical Trials Call Center
**Phone:** +44 (0) 20 89904466
**Role:** CONTACT
### IPD Sharing Statement Module
**Access Criteria:** Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
**Description:** Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
**IPD Sharing:** YES
**Time Frame:** Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
**URL:** https://www.gsk.com/en-gb/innovation/trials/data-transparency/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001982
- Term: Bronchial Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000008171
- Term: Lung Diseases
- ID: D000012130
- Term: Respiratory Hypersensitivity
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4556
- Name: Asthma
- Relevance: HIGH
- As Found: Asthma
- ID: M5258
- Name: Bronchial Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11170
- Name: Lung Diseases, Obstructive
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M14967
- Name: Respiratory Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001249
- Term: Asthma
### Intervention Browse Module - Ancestors
- ID: D000001993
- Term: Bronchodilator Agents
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018927
- Term: Anti-Asthmatic Agents
- ID: D000019141
- Term: Respiratory System Agents
- ID: D000015149
- Term: Tocolytic Agents
- ID: D000012102
- Term: Reproductive Control Agents
- ID: D000058666
- Term: Adrenergic beta-2 Receptor Agonists
- ID: D000000318
- Term: Adrenergic beta-Agonists
- ID: D000000322
- Term: Adrenergic Agonists
- ID: D000018663
- Term: Adrenergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000777
- Term: Anesthetics
- ID: D000002492
- Term: Central Nervous System Depressants
### Intervention Browse Module - Browse Branches
- Abbrev: Repr
- Name: Reproductive Control Agents
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
### Intervention Browse Module - Browse Leaves
- ID: M3767
- Name: Albuterol
- Relevance: HIGH
- As Found: Finger
- ID: M18666
- Name: Methacholine Chloride
- Relevance: LOW
- As Found: Unknown
- ID: M353106
- Name: Norflurane
- Relevance: HIGH
- As Found: C2D
- ID: M5269
- Name: Bronchodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20963
- Name: Anti-Asthmatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M21137
- Name: Respiratory System Agents
- Relevance: LOW
- As Found: Unknown
- ID: M17869
- Name: Tocolytic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20746
- Name: Adrenergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M3670
- Name: Adrenergic beta-Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M3673
- Name: Adrenergic Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000063006
- Term: Norflurane
- ID: D000000420
- Term: Albuterol
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433908
**Brief Title:** A Study to Compare the Pharmacokinetics (PK) of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152A (Test) or HFA-134A (Reference) in Healthy Participants Aged 18 to 55 Inclusive
**Official Title:** A Phase 1, Randomized, Open-label, Single Dose, 2-treatment Arm (200 μg and 800 μg), 4-way Crossover Study in Healthy Participants Aged 18 to 55 to Compare the Pharmacokinetics of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152A (Test) and HFA-134A (Reference)
#### Organization Study ID Info
**ID:** 219728
#### Organization
**Class:** INDUSTRY
**Full Name:** GlaxoSmithKline
#### Secondary ID Infos
**Domain:** EU CT number
**ID:** 2023-508279-36-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-09-27
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-13
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-27
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** GlaxoSmithKline
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The primary objective of the study is to characterize the PK of single doses of salbutamol in healthy participants delivered via an MDI containing propellant HFA-152a (test), and to compare with an MDI containing propellant HFA-134a (reference).
### Conditions Module
**Conditions:**
- Asthma
- Healthy Participants
**Keywords:**
- salbutamol
- propellant HFA-152a
- propellant HFA-134a
- metered dose inhalers
- healthy participants
- asthma
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** 4-way crossover study.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive single 200 μg doses given as 2x100 μg (ex-valve) at 20-second intervals. The intervention period will be 10 days with dosing with either HFA-152a or HFA-134a on Day 1, Day 4, Day 7, and Day 10.
**Intervention Names:**
- Drug: Salbutamol HFA-152a
- Drug: Salbutamol HFA-134a
**Label:** Cohort 1: Salbutamol 200 μg
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive single 800 μg doses given as 8x100 μg (ex-valve) at 20-second intervals. The intervention period will be 10 days with dosing with either HFA-152a or HFA-134a on Day 1, Day 4, Day 7, and Day 10.
**Intervention Names:**
- Drug: Salbutamol HFA-152a
- Drug: Salbutamol HFA-134a
**Label:** Cohort 2: Salbutamol 800 μg
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cohort 1: Salbutamol 200 μg
- Cohort 2: Salbutamol 800 μg
**Description:** 100 µg (ex-valve), given at 20-second intervals.
**Name:** Salbutamol HFA-152a
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Cohort 1: Salbutamol 200 μg
- Cohort 2: Salbutamol 800 μg
**Description:** 100 µg (ex-valve), given at 20-second intervals.
**Name:** Salbutamol HFA-134a
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Area Under the Plasma Concentration-time Curve up to 30 Minutes Post-dose (AUC[0-30min])
**Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, and 30 minutes post-dose
**Measure:** Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-∞])
**Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose
**Measure:** Maximum Observed Plasma Concentration (Cmax)
**Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose
#### Secondary Outcomes
**Measure:** Time to Reach Cmax (Tmax)
**Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose
**Measure:** Apparent Terminal Phase Half-life (t1/2)
**Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose
**Measure:** Area Under the Plasma Concentration-time Curve up to Last Time with Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])
**Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose
**Measure:** Intra-participant Variability of AUC(0-30min)
**Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, and 30 minutes post-dose
**Measure:** Intra-participant Variability of AUC(0-∞)
**Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose
**Measure:** Intra-participant Variability of AUC(0-last)
**Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose
**Measure:** Intra-participant Variability of Cmax
**Time Frame:** On each dosing day (Day 1, 4, 7, and 10) PK blood samples will be taken at pre-dose, at 3, 5, 10, 15, 20, 30, and 45 minutes post-dose; and at 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose
**Measure:** Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Time Frame:** Up to Day 18
**Measure:** Absolute Values for 12 Lead Electrocardiogram (ECGs) Recording of Heart Rate (HR)
**Time Frame:** At screening (Day -28 to -1), admission (Day -1), on each dosing day (Day 1, 4, 7, and 10) at pre-dose and at 30 minutes post-dose and at discharge (Day 11)
**Measure:** Absolute Values for 12 Lead ECGs Recording of QTc Intervals
**Time Frame:** At screening (Day -28 to -1), admission (Day -1), on each dosing day (Day 1, 4, 7, and 10) at pre-dose and at 30 minutes post-dose and at discharge (Day 11)
**Measure:** Change from Baseline for Post-dose 12 Lead ECGs Recording of HR
**Time Frame:** Baseline and on each dosing day (Day 1, 4, 7, and 10) at pre-dose and at 30 minutes post-dose and at discharge (Day 11)
**Measure:** Change from Baseline for Post-dose 12 Lead ECGs Recording of QTc Intervals
**Time Frame:** Baseline and on each dosing day (Day 1, 4, 7 and, 10) at pre-dose and at 30 minutes post-dose and at discharge (Day 11)
**Measure:** Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
**Time Frame:** Day-1 (admission) up to discharge (Day 11)
**Measure:** Absolute Values of Vital Signs (Systolic and Diastolic Blood Pressure)
**Time Frame:** At screening (Day -28 to -1), admission (Day -1), on each dosing day (Day 1, 4, 7, and 10) at pre-dose and at the following time points post-dose: 15, 30 minutes, 1, 2, 4 hours, and at discharge (Day 11)
**Measure:** Absolute Values of Vital Signs (Pulse Rate)
**Time Frame:** At screening (Day -28 to -1), admission (Day -1), on each dosing day (Day 1, 4, 7, and 10) at pre-dose and at the following time points post-dose: 15, 30 minutes, 1, 2, 4 hours, and at discharge (Day 11)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Sex: male or female; females may be of childbearing potential, of nonchild bearing potential, or postmenopausal.
2. Age: 18 to 55 years inclusive.
3. Weight: 45 to 110 kg inclusive
4. Status: healthy participants.
5. Females must not be pregnant or lactating.
6. All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research center based on investigator judgment. An exception is made for hormonal contraceptives, which may be used throughout the study.
7. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) must have been stopped at least 14 days prior to admission to the clinical research center based on investigator judgment. An exception is made for acetaminophen, which is allowed up to admission to the clinical research center.
8. Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening, and from 48 hours (2 days) prior to admission until discharge from the clinical research center.
9. Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to admission until discharge from the clinical research center.
10. Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the investigator.
11. Serum potassium and serum glucose levels within reference ranges of the clinical research center.
12. Willing and able to sign the informed consent form.
13. Spirometry at screening demonstrating forced expiratory volume ≥80% predicted.
Exclusion Criteria:
1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.
2. History or presence of any form of asthma, including childhood asthma and exercise induced asthma.
3. At screening, systolic blood pressure \<90 mmHg or \>140 mmHg, or diastolic blood pressure \<50 mmHg or \>90 mmHg.
4. History of pathological tachycardia, or a pulse rate \> 85 beats per minute (bpm) at screening or Day-1.
5. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
6. Breast cancer within the past 10 years.
7. A QTcF value of \>450 msec at screening based on a triplicate measurement taken at a single timepoint.
8. Vaccine(s) within 2 weeks prior to admission, or plans to receive such vaccines during the study.
9. Donation or loss of more than 450 mL of blood within 60 days prior to (the first) drug administration. Donation or loss of more than 1.5 L of blood (for male participants) or more than 1.0 L of blood (for female participants) in the 10 months prior to (the first) drug administration in the current study.
10. Participation in a drug study within 30 days prior to (the first) drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to (the first) drug administration in the current study.
11. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
12. Presence of hepatitis B surface antigen at screening or within 3 months prior to first dose of study intervention.
13. Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. NOTE: Participants with positive hepatitis C antibody test result due to prior resolved disease can be enrolled if a confirmatory negative hepatitis C RNA test is obtained.
14. Positive pre-study drug/alcohol screen, including tetrahydrocannabinol.
15. Positive HIV antibody test.
16. Cotinine levels indicative of smoking or history or use of tobacco- or nicotine containing products within 6 months prior to screening.
Assessment as ineligible by the investigator based on the results of the clinical laboratory tests or other assessments.
17. Average intake of more than 24 units of alcohol per week: 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits.
18. Regular use of known drugs of abuse, including tetrahydrocannabinol.
19. Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to "vape" within 6 months prior to screening.
20. Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc.).
21. Impairment which would prevent the correct and consistent use of an MDI, as determined by the investigator/delegate.
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** US GSK Clinical Trials Call Center
**Phone:** 877-379-3718
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** EU GSK Clinical Trials Call Center
**Phone:** +44 (0) 20 89904466
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Groningen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** US GSK Clinical Trials Call Center
- **Phone:** 877-379-3718
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** EU GSK Clinical Trials Call Centre
- **Phone:** +44 (0) 20 8990 4466
- **Role:** CONTACT
***Contact 3:***
- **Name:** Jeroen van de Wetering
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Netherlands
**Facility:** GSK Investigational Site
**Zip:** 9728
### IPD Sharing Statement Module
**Access Criteria:** Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
**Description:** Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
**IPD Sharing:** YES
**Time Frame:** Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
**URL:** https://www.gsk.com/en-gb/innovation/trials/data-transparency/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001982
- Term: Bronchial Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000008171
- Term: Lung Diseases
- ID: D000012130
- Term: Respiratory Hypersensitivity
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4556
- Name: Asthma
- Relevance: HIGH
- As Found: Asthma
- ID: M5258
- Name: Bronchial Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11170
- Name: Lung Diseases, Obstructive
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M14967
- Name: Respiratory Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001249
- Term: Asthma
### Intervention Browse Module - Ancestors
- ID: D000001993
- Term: Bronchodilator Agents
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018927
- Term: Anti-Asthmatic Agents
- ID: D000019141
- Term: Respiratory System Agents
- ID: D000015149
- Term: Tocolytic Agents
- ID: D000012102
- Term: Reproductive Control Agents
- ID: D000058666
- Term: Adrenergic beta-2 Receptor Agonists
- ID: D000000318
- Term: Adrenergic beta-Agonists
- ID: D000000322
- Term: Adrenergic Agonists
- ID: D000018663
- Term: Adrenergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000777
- Term: Anesthetics
- ID: D000002492
- Term: Central Nervous System Depressants
### Intervention Browse Module - Browse Branches
- Abbrev: Repr
- Name: Reproductive Control Agents
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: VaCoAg
- Name: Vasoconstrictor Agents
- Abbrev: CaAg
- Name: Cardiotonic Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
### Intervention Browse Module - Browse Leaves
- ID: M3767
- Name: Albuterol
- Relevance: HIGH
- As Found: Finger
- ID: M13031
- Name: Oxymetazoline
- Relevance: LOW
- As Found: Unknown
- ID: M13561
- Name: Phenylephrine
- Relevance: LOW
- As Found: Unknown
- ID: M353106
- Name: Norflurane
- Relevance: HIGH
- As Found: C2D
- ID: M5269
- Name: Bronchodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20963
- Name: Anti-Asthmatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M21137
- Name: Respiratory System Agents
- Relevance: LOW
- As Found: Unknown
- ID: M17869
- Name: Tocolytic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20746
- Name: Adrenergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M3670
- Name: Adrenergic beta-Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M3673
- Name: Adrenergic Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000063006
- Term: Norflurane
- ID: D000000420
- Term: Albuterol
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433895
**Brief Title:** Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus
**Official Title:** Efficacy of Manual Therapy in the Treatment of Somatic Tinnitus: A Randomised Controlled Trial
#### Organization Study ID Info
**ID:** E2-21-1003
#### Organization
**Class:** OTHER
**Full Name:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-25
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-25
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
**Investigator Full Name:** Tuğba Atan, MD
**Investigator Title:** Assoc. Prof.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Somatic tinnitus is an unpleasant perception of sound that occurs in the absence of any external acoustic stimulus. Despite the correct diagnosis of somatic tinnitus, there is currently no specific treatment. The hypothesis of this study is that the application of manual therapy to the cervical region will help to treat tinnitus in patients. This study aims to investigate the effectiveness of manual therapy in the treatment of somatic tinnitus of cervicogenic origin.
**Detailed Description:** Somatic tinnitus is an unpleasant perception of sound that occurs in the absence of any external acoustic stimulus. It results from complex interactions between the somatosensory and auditory systems, which involve the musculoskeletal system rather than the ear. The temporomandibular joint, craniocervical junction, cervical vertebrae and neck and shoulder muscles, in particular the sternocleidomastoid (SCM) muscle, upper trapezius and levator scapula, are anatomical regions that can cause somatic tinnitus.
Despite the correct diagnosis of somatic tinnitus, there is currently no specific treatment. The hypothesis of this study is that the application of manual therapy to the cervical region will help to treat tinnitus in patients. This study aims to investigate the effectiveness of manual therapy in the treatment of somatic tinnitus of cervicogenic origin.
### Conditions Module
**Conditions:**
- Tinnitus, Subjective
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Both groups will be instructed in the performance of isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation as a home programme for a six-week period. Additionally, patients in the manual therapy group will receive manual therapy on a weekly basis for a total of six sessions.
**Intervention Names:**
- Other: Manual Therapy
- Other: Exercise
**Label:** Manual therapy + Exercise group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Both groups will be instructed in the performance of isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation as a home programme for a six-week period.
**Intervention Names:**
- Other: Exercise
**Label:** Exercise group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Manual therapy + Exercise group
**Description:** Manual Therapy
**Name:** Manual Therapy
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Exercise group
- Manual therapy + Exercise group
**Description:** Isometric and strengthening exercises for the cervical region, which are provided to patients with cervical pain and limitation
**Name:** Exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The severity of tinnitus will be graded using a 10 cm visual analogue scale (VAS, 0-10 cm; 0 means no tinnitus, 10 means extremely severe tinnitus).
**Measure:** Visual Analogue Scale for Tinnitus (VAS-tinnitus)
**Time Frame:** baseline- 6 week
#### Secondary Outcomes
**Description:** Pain intensity will be assessed with the visual analogue scale (0-10mm), which has proven validity and reliability for measuring musculoskeletal pain.
**Measure:** Visual Analogue Scale for cervical pain (VAS-Cervical)
**Time Frame:** baseline- 6 week
**Description:** The THI contains a total of 25 items with functional (11 items), emotional (9 items) and catastrophic (5 items) subscales. Each item is rated 0 (not affected), 2 (sometimes affected) or 4 (always affected). The total score ranges from 0 to 100, with higher scores indicating higher levels of disability of perceived tinnitus.
**Measure:** Tinnitus Handicap Index (THI)
**Time Frame:** baseline- 6 week
**Description:** The NDI is designed to assess self-reported neck functional status. The questionnaire consists of 10 items related to pain, activities of daily living, weight lifting, reading, headache, concentration, working status, driving, sleep and recreation and is rated on a 6-point Likert scale ranging from 0 (no disability) to 50 (major disability). Higher scores represent greater disability. The NDI has been found to be reliable and valid for cervical disorders.
**Measure:** Neck disability index (NDI)
**Time Frame:** baseline- 6 week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Patients aged ≥ 18 and ≤ 65 years Patients fulfilling the clinical criteria4 defined for sevichogenic somatic tinnitus
1. Neck pain
2. Cervical joint range of motion limitation (especially rotation)
3. Modulation of tinnitus in relation to head and neck movements and posture
4. Tenderness in the cervico-occipital muscles Patients reporting cervical pain between \>2 and \<7 on a visual analogue scale (VAS) on most days of the last month Patients with stable medical and psychological status Patients willing to participate in the study
Exclusion Criteria:
Patients with objective tinnitus Patients with subjective tinnitus with hearing loss Patients with Meniere's disease Patients with a history of vertigo Patients with middle ear pathologies Patients with a history of intracranial pathology Patients with a history of whiplash injury Patients with a history of cervical spinal surgery Patients with a history of active infection, malignancy, inflammatory rheumatic disease or fibromyalgia Pregnancy Patients who have undergone any exercise or physiotherapy programme for the cervical region in the last 3 months
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ankara
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Tuğba Atan
- **Phone:** +90 312 2911000
- **Phone Ext:** 1414
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Gaziler Physical Medicine and Rehabilitation Educiation and Research Hospital
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006311
- Term: Hearing Disorders
- ID: D000004427
- Term: Ear Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
- ID: D000012678
- Term: Sensation Disorders
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M16769
- Name: Tinnitus
- Relevance: HIGH
- As Found: Tinnitus
- ID: M9400
- Name: Hearing Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7601
- Name: Ear Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15490
- Name: Sensation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000014012
- Term: Tinnitus
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433869
**Brief Title:** The Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis Factor(rmhTNF-NC) in the Treatment of Malignant Ascites
**Official Title:** Multi-arm, Phase II Clinical Study of Intraperitoneal Injection of Recombinant Human Tumor Necrosis Factor, Bevacizumab Monoclonal Antibody, and Serplulimab for the Treatment of Malignant Ascites Patients With Standard Therapy Failure
#### Organization Study ID Info
**ID:** HPPMS-001
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-12-14
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-23
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sun Yat-sen University
#### Responsible Party
**Investigator Affiliation:** Sun Yat-sen University
**Investigator Full Name:** Dong sheng Zhang
**Investigator Title:** Director
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** 1. More than half of peritoneal metastases are from digestive tract. Peritoneal metastasis has poor prognosis, poor treatment response and limited means.
2. rmhTNF-NC or bevacizumab are effective in the treatment of malignant pleuroabdominal effusion.
3, There is increasing evidence that PD-1/PD-L1 inhibitors in combination with vascular endothelial growth factor receptor (VEGFR) inhibitors have a complementary mechanism of action: VEGF pathway inhibitors normalize blood vessels in tumors and promote immune cell maturation and infiltration, thus playing a synergistic role with ICIs. The strategy of systemic immunotherapy combined with antivascular therapy has been confirmed by several large phase III clinical trials such as IMbrave-150. Basic studies have confirmed that uncontrolled tumor vessels in peritoneal metastasis and malignant ascites microenvironment also play an important role in promoting disease progression. Therefore, this project intends to explore the treatment of malignant abdominal effusion by local intraperitoneal injection of bevacizumab and PD-1 on the basis of rmhTNF-NC
**Detailed Description:** GROUP A: serplulimab(PD-1 inhibitor)+bevacizumab GROUP B: serplulimab+rmhTNF-NC GROUP C: serplulimab+bevacizumab+rmhTNF-NC
serplulimab(100mg,ip,D1、D15) bevacizumab(100mg,ip,D1、D15) rmhTNF-NC(300IU/time,ip,D1、D4、D7、D10)
### Conditions Module
**Conditions:**
- Malignant Ascites
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Treat the malignant ascites by local intraperitoneal injection of PD-1 inhibitor and bevacizumab
**Intervention Names:**
- Drug: serplulimab
- Drug: Bevacizumab
**Label:** Group A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Treat the malignant ascites by local intraperitoneal injection of PD-1 inhibitor and rmhTNF-NC
**Intervention Names:**
- Drug: serplulimab
- Drug: rmhTNF-NC
**Label:** Group B
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Treat the malignant ascites by local intraperitoneal injection of PD-1 inhibitor, rmhTNF-NC and bevacizumab
**Intervention Names:**
- Drug: serplulimab
- Drug: Bevacizumab
- Drug: rmhTNF-NC
**Label:** Group C
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A
- Group B
- Group C
**Description:** Additional intraperitoneal injection of bevacizumab or rmhTNF-NC is added to the PD-1 inhibitor.
**Name:** serplulimab
**Other Names:**
- PD-1 inhibitor
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Group A
- Group C
**Description:** Intraperitoneal injection of bevacizumab is added to PD-1 inhibitor or rmhTNF-NC.
**Name:** Bevacizumab
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Group B
- Group C
**Description:** Intraperitoneal injection of rmhTNF-NC is added to PD-1 inhibitor or bevacizumab.
**Name:** rmhTNF-NC
**Other Names:**
- recombinant human tumor necrosis factor
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Defined as the percentage of patients achieving CR or PR according to the WHO criteria detected by ultrasound.
**Measure:** Objective response rate of ascites
**Time Frame:** 2 months
#### Secondary Outcomes
**Description:** Time since first CR or PR to PD
**Measure:** Duration of ascites relief
**Time Frame:** 1 years
**Description:** percentage of patients achieving CR, PR and SD.
**Measure:** Ascites control rate
**Time Frame:** 2 months
**Description:** Adverse events according to the NCI CTCAE 5.0
**Measure:** Incidence of Treatment-Emergent Adverse Events
**Time Frame:** 2 months
**Description:** Measured by FACIT-AI,score range 1 to 5, higher scores mean a better
**Measure:** The score of chronic abdominal effusion function scale changed
**Time Frame:** 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥18 years old, gender unlimited;
* Malignant ascites confirmed by histology or cytology as originating from digestive system tumors (malignant confirmed by ascites cytology or clinically diagnosed as peritoneal metastases by imaging and symptoms);
* Patients with more than a moderate amount of abdominal fluid, who have failed initial treatment or have been treated with conventional chemotherapy drugs and/or biological response modulators intravenously. Moderate ascites is defined as:
* B ultrasound examination of ascites ≥3cm in lying position;
* Accompanied by clinical symptoms (chest tightness, shortness of breath, abdominal distension and discomfort, which were judged by researchers to be related to abdominal fluid accumulation);
* ECOG physical status is 0-2;
* Expected survival time \>3 months;
* Cardiopulmonary function is basically normal;
* For adequate organ function, subjects must meet the following laboratory criteria:
* Peripheral blood imaging: WBC≥4.0×109/L, PLT≥80×109/L, Hb≥90g/L;
* Renal function: serum creatinine ≤2×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥40 ml/min;
* Liver function: total bilirubin ≤1.5× upper limit of normal value (ULN); Or total bilirubin \>ULN but direct bilirubin ≤ ULN; Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN (ALT or AST ≤5×ULN in patients with liver metastasis);
* Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
* Thyroid stimulating hormone (TSH) ≤ULN; If abnormal, T3 and T4 levels and clinical manifestations should be investigated, and comprehensive assessment of non-acute activity can be included;
* Non-surgical sterilization or female patients of reproductive age who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for 6 months after the end of the study treatment period; Women of reproductive age who were not surgically sterilized had to be negative for serum or urine HCG within 7 days prior to study enrollment. And must be non-lactation period; For men whose partners are women of childbearing age, effective contraception should be used during the trial and within 6 months after the last administration of the study drug;
* Voluntarily enrolled in this study, with good compliance, signed written informed consent, and able to cooperate with follow-up observation.
Exclusion Criteria:
* History of allergy to tumor necrosis factor and its derivatives, bevacizumab analogues, and Serplulimab;
* Malignant diseases other than digestive tract neoplasms were diagnosed within 5 years prior to initial administration (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection);
* Received any other investigational drug therapy or participated in an interventional clinical investigator within 7 days prior to initial dosing; Or received anti-tumor drug treatment (including Chinese herbal medicine with anti-tumor indication) within 7 days prior to the first use of the study drug;
* Pregnant or lactating women, women of childbearing age who did not want to use contraception during the study period; Or the man is unwilling to use effective contraception during treatment and during the following 1 year;
* Significant damage to the function of important organs;
* Patients with obvious bleeding tendency;
* Clinically significant or uncontrolled heart disease, including unstable angina pectoris, acute myocardial infarction within 6 months prior to first dosing, New York Heart Association Class III/IV congestive heart failure, and uncontrolled arrhythmia (in subjects who are allowed to wear a pacemaker or have atrial fibrillation and have a well-controlled heart rate);
* Presence of ECG changes or medical history that investigators consider clinically significant; Screening QTcF interval \>480 ms, subjects with indoor block (QRS interval \>120 ms) can use JTc interval instead of QTc interval (if JTc is used instead of QTc, JTc must be ≤340 ms);
* Uncontrolled hypertension, systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy;
* Severe acute infection that is not under control; The patient is having fever (\> 38℃), or has suppurative and chronic infection, and the wound is prolonged and does not heal;
* Patients with encapsulated abdominal effusion confirmed by imaging; A definite diagnosis of abdominal infection;
* Persons infected with acute or chronic active hepatitis B or hepatitis C, hepatitis B virus (HBV) DNA\>2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV) RNA\> 103 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibodies were both positive. After nucleotide antiviral therapy, those who were lower than the above criteria could be included in the group. A known history of human immunodeficiency virus (HIV) infection or a confirmed positive immunotest result;
* Patients with obvious evidence of bleeding tendency or history within 3 months prior to enrollment (hemorrhage \>30 mL within 3 months, hematemesis, stool, and blood in the stool), hemoptysis (\>5 mL fresh blood within 4 weeks); People with a history of inherited or acquired bleeding or coagulation disorders. Have clinically significant bleeding symptoms or definite bleeding tendency within 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.; Arterial or venous thrombotic disease was present 6 weeks before enrollment;
* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
* Had a major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study therapy or expected to require major surgery during study therapy;
* Complications of toxicity and/or major surgery have not fully recovered before starting treatment;
* Women who are pregnant or nursing, or who are expected to become pregnant or give birth during the study period from screening visits to completion of safety follow-up visits (male subjects to 90 days after the last dosing);
* Radiotherapy was received within 4 weeks prior to the first administration of the study drug. Subjects must have fully recovered from radiation-related toxicities without the need for corticosteroid therapy, confirming the rule out of radiation pneumonia. For palliative radiotherapy for non-CNS disease, a 2-week washout period is allowed;
* Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, unable to cooperate with and describe the response to treatment; Patients with uncontrolled primary brain tumor or central nervous metastases, with obvious cranial hypertension or neuropsychiatric symptoms;
* There are other conditions that researchers consider inappropriate to participate in this experiment.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** dongsheng zhang, PHD
**Phone:** 020-87343533
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** yunxin LU, PHD
**Phone:** 020-87343533
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dongsheng Zhang, MD,PhD
- **Phone:** 86-2087343795
- **Role:** CONTACT
**Country:** China
**Facility:** Cancer center of SunYat-sen University
**State:** Guangdong
**Status:** RECRUITING
**Zip:** 510060
**Location 2:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Name:** LU YUNXIN
- **Role:** CONTACT
**Country:** China
**Facility:** Zhang Dongsheng
**Status:** RECRUITING
**Location 3:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Name:** ZHANG
- **Role:** CONTACT
**Country:** China
**Facility:** Zhang Dongsheng
**Status:** RECRUITING
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4509
- Name: Ascites
- Relevance: HIGH
- As Found: Ascites
- ID: M12284
- Name: Necrosis
- Relevance: HIGH
- As Found: Necrosis
### Condition Browse Module - Meshes
- ID: D000009336
- Term: Necrosis
- ID: D000001201
- Term: Ascites
### Intervention Browse Module - Ancestors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000020533
- Term: Angiogenesis Inhibitors
- ID: D000043924
- Term: Angiogenesis Modulating Agents
- ID: D000006133
- Term: Growth Substances
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000006131
- Term: Growth Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: LOW
- As Found: Unknown
- ID: M246
- Name: Bevacizumab
- Relevance: HIGH
- As Found: Non-
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M2342
- Name: Immune Checkpoint Inhibitors
- Relevance: HIGH
- As Found: Nitrate
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- ID: M22318
- Name: Angiogenesis Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M9231
- Name: Growth Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000068258
- Term: Bevacizumab
- ID: D000082082
- Term: Immune Checkpoint Inhibitors
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433856
**Brief Title:** Neuromuscular Responses to Recovery Techniques
**Official Title:** Effects of Cold Water Immersion and Percussive Gun Massage on Recovery Measures in Soccer Players
#### Organization Study ID Info
**ID:** Fisioterapia1705
#### Organization
**Class:** OTHER
**Full Name:** University of Trieste
### Status Module
#### Completion Date
**Date:** 2023-07-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-06-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Trieste
#### Responsible Party
**Investigator Affiliation:** University of Trieste
**Investigator Full Name:** Alex Buoite Stella
**Investigator Title:** RTD-A
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Cold water immersion (CWI) and percussive massage therapy (PMT) are commonly used re-covery techniques in team sports. In particular, despite its wide use, PMT has been scarcely investigated in the literature, especially regarding neuromuscular measures and in comparison with other techniques. This study aims to evaluate and compare the acute and short-term ef-fects (24 h) of CWI and PMT on muscle strength, contractile properties, and soreness after exercise. A randomized crossover study will be performed on sixteen male soccer players (22 y, 20-27) who participate in three experimental sessions involving high-intensity training and 12-min recovery including CWI (10 °C water), bilateral PMT on the anterior and posterior thigh, or passive resting. Outcomes will be assessed immediately after the exercise protocol, after the recovery intervention, and at 24 h. Isometric knee extension (IKE) and flexion (IKF), and tensiomyography (TMG) will be assessed.Muscle soreness and fatigue will be scored from 0 to 10.
**Detailed Description:** Participants will be invited to participate to a cross-over randomized trial, consisting in 3 experimental sessions at 7 days of distance one from another. During each experimental session, participants will be asked to train for about 45 min at a high-intensity protocol (High-Intensity Intermittent Running, plyometric jumps and isometric chair position). After the exercise, participants will be assessed for neuromuscular function (isometric strength and tensiomyography) as well as perceived soreness and fatigue. Then, in a randomized order, participants will receive three different recovery interventions: cold water immersion, percussive massage, or a passive control condition. After the recovery intervention, outcomes are assessed again, as well as at 24 h. Isometric strength is assessed with a dynamometer during knee extension and knee flexion. Tensiomyography is performed on the thigh muscles, and time to contraction and radial displacement are considered as outcomes. Soreness and fatigue are rated by the participant from 0 to 10.
### Conditions Module
**Conditions:**
- Muscle Soreness
**Keywords:**
- recovery
- team sport
- cryotherapy
- massage guns
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 16
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The CWI protocol consists of participants standing, with only their underwear and a t-shirt, in a portable tub for cold water therapy (Qryo, Italy), with the water to their hips being constantly maintained at 10±0.5 °C by a cooling system that pumped and stirred the water inside the tub and around the participant's lower limbs. Water temperature and the duration of the immersion, which is 12 minutes for all the participants considering they were characterized by similar anthropometrics and body composition, were based on previous literature
**Intervention Names:**
- Other: Cold Water Immersion
**Label:** CWI
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The PMT protocol is performed with the application of a percussive therapy gun (Theragun Elite, Therabody, USA). The participants rests with their underwear and a t-shirt on a treatment bed, and the percussive therapy gun with a "standard ball", 16 mm amplitude of percussions, and a frequency of 30 Hz, is applied to the thigh muscles of both lower limbs, 3 min on the anterior and 3 min on the posterior area of each thigh. The protocol is based on previous literature and adapted to the specific aims of this study.
**Intervention Names:**
- Device: Percussive Massage Therapy
**Label:** PMT
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** The control condition (PAS) consists of participants resting on a chair for 12 minutes in a quiet room at 25 °C.
**Label:** PAS
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CWI
**Description:** Cold water immersion consists in 12 min standing in 10 °C water
**Name:** Cold Water Immersion
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- PMT
**Description:** Percussive massage therapy is performed with a massage gun on the thigh muscles for 12 min
**Name:** Percussive Massage Therapy
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Subjective evalutation of muscle soreness from 0 to 10 with a numeric rating scale (NRS), where 0 is no soreness at all, and 10 is unbearable soreness
**Measure:** Muscle soreness
**Time Frame:** Within 10 min from exercise cessation (Post-Exercise); Within 10 min after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
**Description:** Subjective evaluation of muscle fatigue from 0 to 10 with a numeric rating scale (NRS), where 0 is no fatigue at all, and 10 is unbearable fatigue
**Measure:** Muscle fatigue
**Time Frame:** Within 10 min from exercise cessation (Post-Exercise); Within 10 min after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
#### Secondary Outcomes
**Description:** Isometric knee extension (IKE) and flexion (IKF) strength assessments performed on a treatment bed, with a digital handheld dynamometer
**Measure:** Isometric muscle strength
**Time Frame:** Within 10 min from exercise cessation (Post-Exercise); Within 10 min after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
**Description:** Tensiomyography (TMG) will be performed on anterior and posterior thigh muscles
**Measure:** Tensiomyography
**Time Frame:** Within 10 min from exercise cessation (Post-Exercise); Within 10 min after the intervention (Post-Intervention); 24 hours from the exercise (Post-24 hours)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* being healthy
* training in soccer for more than 3 years and with a training frequency \> 2 times/week
Exclusion Criteria:
* reported time-loss injuries
* using analgesics or other therapies affecting muscle function or pain
**Healthy Volunteers:** True
**Maximum Age:** 30 Years
**Minimum Age:** 16 Years
**Sex:** MALE
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Trieste
**Country:** Italy
**Facility:** CdL in Fisioterapia
**Zip:** 34100
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000059352
- Term: Musculoskeletal Pain
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M30156
- Name: Myalgia
- Relevance: HIGH
- As Found: Muscle Soreness
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M29444
- Name: Musculoskeletal Pain
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000063806
- Term: Myalgia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433843
**Brief Title:** FKBP5 Methylation and Childhood Emotional Abuse in Complex Posttraumatic Stress Disorder: Investigating the Relationship and Its Predictive Role in Therapy Outcome
**Official Title:** FKBP5 Methylation and Childhood Emotional Abuse in Complex Posttraumatic Stress Disorder: Investigating the Relationship and Its Predictive Role in Therapy Outcome
#### Organization Study ID Info
**ID:** 090/2015BO2
#### Organization
**Class:** OTHER
**Full Name:** University Hospital Tuebingen
### Status Module
#### Completion Date
**Date:** 2020-03
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-03
**Type:** ACTUAL
#### Start Date
**Date:** 2016-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital Tuebingen
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The aim of this study is to investigate the role FKBP5 DNA methylation levels in patients suffering from complex posttraumatic stress disorder, who participated in a 12-weeks disorder-specific DBT-PTSD inpatient treatment. DNA methylation levels were measured before and after completing DBT-PTSD.
**Detailed Description:** Epigenetic modifications in the FKBP5 gene, which is involved in regulating the stress response, have been found to be associated with trauma-related mental disorders like posttraumatic stress disorder (PTSD). Previous research has suggested that FKBP5 may also be a predictor of therapy outcomes. However, there is limited evidence regarding its relationship with complex PTSD (cPTSD). This pilot study aimed to investigate the association between cPTSD and FKBP5 DNA methylation, as well as its predictive role in therapy outcomes among patients undergoing Dialectical Behavior Therapy for PTSD (DBT-PTSD), a 12-week trauma-focused inpatient treatment program.
29 patients with cPTSD who participated in the DBT-PTSD program were enrolled. FKBP5 DNA methylation levels were measured at two CpG sites before treatment (n=25) and after completing DBT-PTSD (n=15). To assess the predictive value of FKBP5 DNA methylation, we categorized the sample into responders and non-responders based on therapy outcome.
### Conditions Module
**Conditions:**
- Borderline Personality Disorder
- Posttraumatic Stress Disorder
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 29
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The study consists of one arm including cPTSD patients, who participated in a 12-weeks dialectical behavioral therapy for the treatment of posttraumatic stress disorder (DBT-PTSD)
**Intervention Names:**
- Behavioral: Dialectical behavioral therapy for the treatment of posttraumatic stress disorder (DBT-PTSD)
**Label:** cPTSD patients participating in 12-weeks DBT-PTSD program
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- cPTSD patients participating in 12-weeks DBT-PTSD program
**Description:** 12 weeks inpatient disorder specific psychotherapy
**Name:** Dialectical behavioral therapy for the treatment of posttraumatic stress disorder (DBT-PTSD)
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** FK506 binding protein 5 (FKBP5), an immunoregulator modulating glucocorticoid receptor activity, plays a key role in stress reactivity
**Measure:** DNA methylation levels of FKBP5 before and following DBT-PTSD
**Time Frame:** After 12 weeks of DBT-PTSD treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
complex posttraumatic stress disorder with or wothout comorbid borderline personality disorder Age between 18 and 65 Years Participiation in 12 weeks DBT-PTSD inpatient treatment
Exclusion Criteria:
Acute suicidality
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Tuebingen
**Country:** Germany
**Facility:** University Hospital Tuebingen
**State:** Baden Württemberg
**Zip:** 72076
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000068099
- Term: Trauma and Stressor Related Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M13462
- Name: Personality Disorders
- Relevance: HIGH
- As Found: Personality Disorder
- ID: M5161
- Name: Borderline Personality Disorder
- Relevance: HIGH
- As Found: Borderline Personality Disorder
- ID: M16103
- Name: Stress Disorders, Post-Traumatic
- Relevance: HIGH
- As Found: Posttraumatic Stress Disorder
- ID: M24916
- Name: Stress Disorders, Traumatic
- Relevance: HIGH
- As Found: Stress Disorder
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M222
- Name: Trauma and Stressor Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000040921
- Term: Stress Disorders, Traumatic
- ID: D000013313
- Term: Stress Disorders, Post-Traumatic
- ID: D000010554
- Term: Personality Disorders
- ID: D000001883
- Term: Borderline Personality Disorder
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433830
**Brief Title:** Hetrombopag for the Thrombocytopenia Induced by Concurrent Chemoradiotherapy
**Official Title:** A Single-arm, Phase II Trial of Hetrombopag for the Treatment of Concurrent Chemoradiotherapy-induced Thrombocytopenia in Patients With Advanced Solid Tumors
#### Organization Study ID Info
**ID:** 20220125-10
#### Organization
**Class:** OTHER
**Full Name:** Sir Run Run Shaw Hospital
### Status Module
#### Completion Date
**Date:** 2025-07-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-05-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sir Run Run Shaw Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Thrombocytopenia represents one of the main toxicities of concurrent chemoradiotherapy, which may necessitate chemotherapy dose reductions, dose delays, or discontinuation, and even compromise survival. Hetrombopag, a thrombopoietin receptor agonist, has shown efficacy and safety in patients with chemotherapy-induced thrombocytopenia. However, the efficacy of hetrombopag in patients who received concurrent chemoradiotherapy is not clear yet. This study aimed to evaluate the efficacy and safety of hetrombopag in this patient population.
**Detailed Description:** Antitumor related therapy is one of the common causes of thrombocytopenia. Chemotherapy regimens based on drugs such as gemcitabine, platinum, anthracycline, and paclitaxel are high-risk options for thrombocytopenia. The degree of thrombocytopenia caused by external radiation therapy mainly depends on the irradiation dose, irradiation site, irradiation field size, and irradiation duration. The synchronous radiotherapy and chemotherapy regimen for head and neck tumors, esophageal cancer, rectal cancer, and other cancers often involves platinum drugs, and the irradiation site often involves flat and irregular bones. Therefore, the incidence of thrombocytopenia in patients during the treatment process is higher than that of chemotherapy or radiotherapy alone. In a phase III clinical study on the combination of carboplatin and paclitaxel in the treatment of esophageal cancer, the incidence of thrombocytopenia was as high as 54%. Once thrombocytopenia occurs, it may lead to a decrease in chemotherapy drug dosage, delay, and cessation of radiotherapy and chemotherapy, and may require platelet infusion. In follow-up studies of various cancer patients, it has been found that reducing the dosage of chemotherapy drugs or delaying the chemotherapy cycle will reduce treatment efficacy and lead to poor prognosis, including shortened disease-free survival (DFS) and overall survival (OS) time.
TPO-RA drugs are currently approved for indications in the fields of chronic primary immune thrombocytopenia (ITP), severe aplastic anemia (SAA), and chronic liver disease (CLD). There are also relevant data reports in the CIT field. A phase II clinical study using romiplostim for the treatment of CIT enrolled a total of 60 patients. After treatment with romiplostim, 85% of patients returned to normal platelet count within 3 weeks and resumed chemotherapy. In the subsequent prescribed chemotherapy cycle, only 6.8% of patients experienced a relapse due to another round of chemotherapy. The occurrence of CIT leads to a decrease or delay in chemotherapy dose; In another randomized placebo-controlled phase II study using eltrombopag for the prevention of solid tumor CIT, patients received gemcitabine monotherapy or gemcitabine combined with cisplatin/carboplatin regimen chemotherapy, and treated with eltrombopag or placebo 100mg before and 5 days after chemotherapy. In the 1-6 chemotherapy cycles, the average platelet count on the day before chemotherapy in the eltrombopag group was numerically higher than that in the placebo group, but did not reach statistically significant differences. The incidence of grade 3/4 thrombocytopenia in the eltrombopag group was lower than that in the placebo group. Among patients in the combination chemotherapy group, the average time required for eltrombopag group to recover from the lowest platelet count to normal was 8 days. The placebo group, on the other hand, requires 15 days, and the incidence of delayed/reduced chemotherapy dose or dose loss due to thrombocytopenia is lower in patients in the eltrombopag group, Therefore, in gemcitabine based chemotherapy, treatment with eltrombopag can shorten the time for platelet minimum recovery and reduce the delayed/reduced chemotherapy dose caused by thrombocytopenia. However, there is still a lack of stronger evidence-based medicine for the application of TPO-RA drugs in CIT, and there is no relevant data in the field of concurrent chemoradiotherapy induced thrombocytopenia.
### Conditions Module
**Conditions:**
- Thrombocytopenia
- Radiotherapy Side Effect
**Keywords:**
- hetrombopag
- thrombocytopenia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** patients receive oral hetrombopag at an initial dose of 7.5 mg QD
**Intervention Names:**
- Drug: Hetrombopag Olamine
**Label:** Hetrombopag
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Hetrombopag
**Description:** The administration of hetrombopag as a monotherapy and at an initial dose of 7.5 mg QD.The dose adjusted based on platelet count.
**Name:** Hetrombopag Olamine
**Other Names:**
- thrombopoietin receptor agonist
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The response rate is defined as the proportion of patients who receive treatment with hetrombopag until PLT≥100×10\^9/L
**Measure:** The proportion of patients with PLT ≥100×10^9/L
**Time Frame:** From admission to discharge, up to 6 weeks
#### Secondary Outcomes
**Description:** Use Kaplan Meier method to estimate median platelet recovery time.
**Measure:** The median time of PLT ≥100×10^9/L
**Time Frame:** From admission to discharge, up to 6 weeks
**Description:** The number of events in which radiotherapy and chemotherapy were suspended due to thrombocytopenia, as determined by researchers
**Measure:** Incidence of delayed radiotherapy cycles due to thrombocytopenia
**Time Frame:** From admission to discharge, up to 6 weeks
**Description:** Researchers determine the number of platelet transfusion events caused by thrombocytopenia
**Measure:** Number and percentage of patients receiving platelets transfusion for thrombocytopenia
**Time Frame:** From admission to discharge, up to 6 weeks
**Description:** Record the name and frequency of serious adverse events
**Measure:** Incidence of serious adverse events according to CTCAE 5.0 criteria
**Time Frame:** From admission to the end of the study, up to 9 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 years old, regardless of gender;
* Malignant tumor patients diagnosed through pathological or cytological examination, regardless of cancer type, may experience thrombocytopenia during radical synchronous radiotherapy and chemotherapy treatment;
* Platelet count of patients ≤ 75 × 10\^9/L on the day or 3 days prior to enrollment;
* Expected survival time ≥ 12 weeks;
* ECOG PS score for physical condition: 0-2 points;
* The laboratory inspection indicators meet the following requirements:
1. Renal function: Cr ≤ ULN (upper limit of normal value) x 1.5, endogenous creatinine clearance rate (Ccr) ≥ 55 ml/min;
2. Liver function: Total bilirubin ≤ ULN × 1.5; ALT and AST ≤ ULN × 3; (If it is intrahepatic cholangiocarcinoma or liver metastasis, total bilirubin should not exceed 3 times the normal upper limit, and transaminase should not exceed 5 times the normal upper limit);
* Women of childbearing age agree to use contraception during the study period and within 6 months after the end of the study; And not a lactating patient; Male patients who agree to contraception during the study period and within 6 months after the end of the study;
* Those who have not participated in clinical trials of other drugs within the 4 weeks prior to enrollment;
* It is expected that those with good compliance will be able to follow up on therapeutic effects and adverse reactions according to the protocol requirements;
* No serious complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal disorders Obstruction, non cancerous fever\>38 °C;
* The subjects are able to understand the situation of this study and voluntarily sign an informed consent form.
Exclusion Criteria:
* Screening for thrombocytopenia caused by non tumor treatment within the first 6 months, including but not limited to liver cirrhosis, splenic hyper function, infection, and bleeding;
* Suffering from other hematopoietic system diseases besides thrombocytopenia caused by concurrent radiotherapy and chemotherapy for malignant tumors, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;
* Combined bone marrow invasion or bone marrow metastasis;
* After treatment with infusion of red blood cells or erythropoietin (EPO), hemoglobin remains below 50g/L, or after treatment with granulocyte colony-stimulating factor (G-CSF), the absolute value of neutrophils remains below 1.0 × 10\^9/L;
* Have received pelvic and spinal radiation therapy, as well as bone field radiation, within the three months prior to screening;
* History of arterial or venous thrombosis within the first 6 months of screening;
* Clinical manifestations of severe bleeding (such as gastrointestinal bleeding) within the first two weeks of screening;
* Received platelet transfusion within 2 days prior to enrollment;
* Screening for patients with severe cardiovascular diseases (such as NYHA heart function score III-IV), known arrhythmias that increase the risk of thromboembolism, such as atrial fibrillation, coronary stent implantation, angioplasty, and coronary artery bypass grafting within the first 6 months;
* Received treatment with recombinant human thrombopoietin (rhTPO), recombinant human interleukin-11 (rhIL-11), or thrombopoietin receptor agonists (such as eltrombopag, avatrombopag) within 14 days prior to screening;
* Patients who are known or expected to be allergic or intolerant to the active ingredients or excipients of hetrombopag tablets (excipients include cellulose lactose, low substituted hydroxypropyl cellulose, magnesium stearate, and film coated premixes);
* Breastfeeding women;
* Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, etc;
* The researcher believes that the participants are not suitable for enrollment.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xiaonan Sun
**Phone:** (+86)-0571-86006783
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Weiwen Zhou
**Phone:** (+86)-0571-86006783
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xiaonan Sun
- **Phone:** (+86)-0571-86006783
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Weiwen Zhou
- **Phone:** (+86)-0571-86006783
- **Role:** CONTACT
**Country:** China
**Facility:** Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
**State:** Zhejiang
**Status:** RECRUITING
**Zip:** 310016
#### Overall Officials
**Official 1:**
**Affiliation:** Sir Run Run Shaw Hospital
**Name:** Xiaonan Sun
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Sir Run Run Shaw Hospital
**Name:** Weiwen Zhou
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001791
- Term: Blood Platelet Disorders
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000095542
- Term: Cytopenia
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M16680
- Name: Thrombocytopenia
- Relevance: HIGH
- As Found: Thrombocytopenia
- ID: M5072
- Name: Blood Platelet Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3170
- Name: Cytopenia
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013921
- Term: Thrombocytopenia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433817
**Brief Title:** Spectral CT in Radiotherapy for Cervical Cancer
**Official Title:** The Clinical Research of Spectral CT in Radiotherapy for Cervical Cancer
#### Organization Study ID Info
**ID:** SPRTCC-Trial
#### Organization
**Class:** OTHER
**Full Name:** Peking Union Medical College Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-05-22
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-22
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking Union Medical College Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The purpose of this study was to explore the potential application of spectral CT for radiotherapy in cervical cancer.
### Conditions Module
**Conditions:**
- Cervical Cancer
- Radiotherapy
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Spectral CT scans acquisition performed during the arterial phase and venous phase for cervical cancer
**Name:** Spectral computed tomography scan
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** To evaluate the tumor response of using quantitative parameters in spectral CT for cervical cancer patients according to RECIST 1.1
**Measure:** Comparison of spectral CT derived data with response evaluation in cervical cancer
**Time Frame:** through study completion, an average of 2 year
#### Secondary Outcomes
**Description:** To evaluate the diagnostic performances of using spectral CT for identifying metastatic lymph nodes in patients with cervical cancer
**Measure:** Identifying metastatic lymph nodes in cervical cancer with spectral CT
**Time Frame:** through study completion, an average of 2 year
**Description:** The ability to reduce metal artifact and assist in target delineation
**Measure:** Application of energy spectrum CT in brachytherapy of cervical cancer
**Time Frame:** through study completion, an average of 2 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. All patients were confirmed cervical cancer by pathology
2. patients were treated with concurrent chemoradiotherapy
3. Spectral CT scans acquisition performed during the arterial phase and venous phase
4. All the patients underwent a 18F-FDG PET/CT before treatment
Exclusion Criteria:
1. CT without spectral scans
2. History of allergy to intravenous contrast
3. Pregnant or potentially pregnant female subjects
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** adult patients with newly stablished diagnosis of cervical cancer complying with selection criteria for cervical cancer.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Fuquan Zhang, Porf
**Phone:** 86 01069154072
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zheng Zeng, MD.
- **Phone:** 86 01069154073
- **Role:** CONTACT
**Country:** China
**Facility:** Peking Union Medical College Hospital
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100010
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014594
- Term: Uterine Neoplasms
- ID: D000005833
- Term: Genital Neoplasms, Female
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000002577
- Term: Uterine Cervical Diseases
- ID: D000014591
- Term: Uterine Diseases
- ID: D000005831
- Term: Genital Diseases, Female
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000091662
- Term: Genital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5830
- Name: Uterine Cervical Neoplasms
- Relevance: HIGH
- As Found: Cervical Cancer
- ID: M17342
- Name: Uterine Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8945
- Name: Genital Neoplasms, Female
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5825
- Name: Uterine Cervical Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17339
- Name: Uterine Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002583
- Term: Uterine Cervical Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433804
**Brief Title:** Clinicopathological Parameters of HER2 Low Breast Cancers
**Official Title:** Exploring the Clinicopathological Parameters of HER2 Low Breast Cancers
#### Organization Study ID Info
**ID:** CC-229
#### Organization
**Class:** OTHER
**Full Name:** Vardhman Mahavir Medical College And Safdarjung Hospital
### Status Module
#### Completion Date
**Date:** 2024-02-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-01
**Type:** ACTUAL
#### Start Date
**Date:** 2022-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Vardhman Mahavir Medical College And Safdarjung Hospital
#### Responsible Party
**Investigator Affiliation:** Vardhman Mahavir Medical College And Safdarjung Hospital
**Investigator Full Name:** SANA AHUJA
**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:** This was a retrospective cohort study which included all histologically proven cases of breast cancer in the 2 years from January 2022- December 2023 at a tertiary care centre.
This study was performed in line with STROCSS criteria. The following clinicopathological data was retrieved from the histopathological records- age, tumor size, nodal involvement, lymphovascular/ perineural invasion, and Bloom Richardson grading.
Routine histopathological processing was done followed by immunohistochemical analysis for ER, PR, HER2, Ki67 and AR. All the cases were categorised into Luminal A, B, Her2 enriched and triple-negative breast cancer based on the surrogate molecular classification. Further, all the cases were categorised into HER2 negative (no staining or incomplete weak membrane staining in ≤10% tumor cells), HER2 3+ (complete membranous staining) and HER2 low (1-2+ staining without amplification on ISH) based on consensus of two pathology consultants. The present study aims to evaluate the clinicopathological parameters of the HER2 low breast cancers.
### Conditions Module
**Conditions:**
- HER2 Low Breast Cancers
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 70
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: HER2 IHC
**Label:** HER2 low
#### Arm Group 2
**Intervention Names:**
- Diagnostic Test: HER2 IHC
**Label:** HER2 negative
### Interventions
#### Intervention 1
**Arm Group Labels:**
- HER2 low
- HER2 negative
**Description:** Immunohistochemistry for HER2
**Name:** HER2 IHC
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** It will be measured for HER2 low breast cancer patients
**Measure:** Age (in years)
**Time Frame:** JANUARY 2022- DECEMBER 2023
**Description:** This denotes status of stage of tumor- T1, T2, T3, T4. It will be measured for HER2 low breast cancer patients
**Measure:** Tumor stage (categorised from T1-T4)
**Time Frame:** JANUARY 2022- DECEMBER 2023
**Description:** This denotes status of nodal involevement- N0, N1, N2 or N3. It will be measured for HER2 low breast cancer patients
**Measure:** N stage (categorised from N0-N3)
**Time Frame:** JANUARY 2022- DECEMBER 2023
**Description:** This denotes whether tumor is well, modeartely or porrly differentiated. It will be measured for HER2 low breast cancer patients.
**Measure:** Tumor grade (categorised from G1-G3)
**Time Frame:** JANUARY 2022- DECEMBER 2023
**Description:** This denoted the molecular classification of breast cancer based on ER, PR, Her2 expression.
**Measure:** Surrogate molecular classification (Categorised as luminal/ triple negative)
**Time Frame:** JANUARY 2022- DECEMBER 2023
**Description:** This denoted the immunohistochemical expression of androgen receptor which would be evaluted in all cases of HER2 low breast cancer
**Measure:** Androgen receptor expression (Denoted as present or absent)
**Time Frame:** JANUARY 2022- DECEMBER 2023
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All histologically proven cases of breast cancer in the 2 years from January 2022- December 2023
Exclusion Criteria:
* Benign breast tumors
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** All histologically proven cases of breast cancer in the 2 years from January 2022- December 2023
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** New Delhi
**Country:** India
**Facility:** VMMC SJH
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433791
**Brief Title:** Evaluation of Ascorbate-Meglumine Therapeutic for SRS
**Official Title:** Phase 1, Single-Center, Dose-Escalating, Open-Label, Safety Clinical Trial of Parenteral Ascorbate-Meglumine as a Novel Magnetic Resonance Imaging (MRI)-Guided Adjunctive Therapeutic for Stereotactic Radiosurgery (SRS)
**NCT ID Aliases:**
- NCT03927625
#### Organization Study ID Info
**ID:** LadeRX
#### Organization
**Class:** INDUSTRY
**Full Name:** LadeRx LLC
### Status Module
#### Completion Date
**Date:** 2025-06-17
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-03-17
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-17
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Duke Clinical Research Institute
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** LadeRx LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Phase 1, Single-Center, Dose-Escalating, Open-Label, Safety Clinical Trial of Parenteral Ascorbate-Meglumine as a Novel Magnetic Resonance Imaging (MRI)-guided Adjunctive Therapeutic for Stereotactic Radiosurgery (SRS)
**Detailed Description:** Phase 1, single-center, open-label study in subjects receiving Stereotactic Radiosurgery (SRS) for brain metastases. The study will consist of 4 principal cohorts (n=3 in each cohort). Each cohort will receive an escalating dose of ascorbate-meglumine as an Magnetic Resonance Imaging (MRI)-detectable adjunctive therapeutic to SRS.
Subjects will complete a planning MRI for SRS with gadolinium- diethylenetriamine penta-acetic acid (GD-DPTA) per standard of care for SRS. Forty-eight hours after the planning MRI, the subjects will complete the study MRI with ascorbate-meglumine contrast agent. Each cohort will receive an escalating dose of ascorbate-meglumine by intravenous administration over 1 hour during the MRI. The total dose of ascorbate-meglumine will escalate from the first cohort to the next cohort in a sequential manner. During ascorbate-meglumine infusion, MRI scans will be performed to evaluate the contrast effect and PK blood draws will occur at defined time points.
Patients will return for the SRS procedure within 1 week following the planning MRI per standard of care. During SRS, subjects will receive a second dose of ascorbate-meglumine as an adjunctive therapeutic.
Patients will enter into a follow up phase within 2 weeks after the SRS procedure per standard of care.
The primary endpoint is to evaluate the safety of parenteral ascorbate-meglumine as a MRI-detectable adjunctive therapeutic to SRS.
### Conditions Module
**Conditions:**
- Safety
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SEQUENTIAL
**Intervention Model Description:** dose escalation
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 12
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients receiving Stereotactic Radiosurgery (SRS) treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced Magnetic Resonance Imaging (MR) scan showing 1-3 brain metastases, including post-operative patients with 1-3 residual metastases. The first cohort of patients will receive ascorbate-meglumine at a dose administration rate of 0.16 g/min for 60 minutes.
Interventions:
Drug: Ascorbate-Meglumine
**Intervention Names:**
- Drug: Ascorbate-Meglumine
**Label:** Ascorbate Meglumine dose 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients receiving SRS treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced MRI scan showing 1-3 brain metastases, including post-operative patients with 1-3 residual metastases.The second cohort of patients will receive ascorbate-meglumine at a dose administration rate of 0.31 g/min for 60 minutes.
Interventions:
Drug: Ascorbate-Meglumine
**Intervention Names:**
- Drug: Ascorbate-Meglumine
**Label:** Ascorbate Meglumine dose 2
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Patients receiving SRS treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced MRI scan showing 1-3 brain metastases, includingpost-operative patients with 1-3 residual metastases. The third cohort of patients will receive ascorbate-meglumine at a dose administration rate of 0.63 g/min for 60 minutes.
Interventions:
Drug: Ascorbate-Meglumine
**Intervention Names:**
- Drug: Ascorbate-Meglumine
**Label:** Ascorbate Meglumine dose 3
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Patients receiving SRS treatment for cancer metastatic to the brain from an extracranial primary site with a contrast-enhanced MRI scan showing 1-3 brain metastases, includingpost-operative patients with 1-3 residual metastases. The fourth cohort of patients will receive ascorbate-meglumine at a dose administration rate of 1.25 g/min for 60 minutes.
Interventions:
Drug: Ascorbate-Meglumine
**Intervention Names:**
- Drug: Ascorbate-Meglumine
**Label:** Ascorbate Meglumine dose 4
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ascorbate Meglumine dose 1
- Ascorbate Meglumine dose 2
- Ascorbate Meglumine dose 3
- Ascorbate Meglumine dose 4
**Description:** Ascorbate, meglumine and sodium salt made by combining 375 mM sodium ascorbate,125 mM ascorbic acid and 125 mM meglumine in sterile water for injection
**Name:** Ascorbate-Meglumine
**Other Names:**
- Vitamin C
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Adverse events will be monitored in patients receiving ascorbate-meglumine during Stereotactic Radiosurgery (SRS)
**Measure:** Safety as measured by adverse events
**Time Frame:** 1 week after receiving study drug with SRS
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Primary cancer diagnosis with newly diagnosed brain metastases
* Diagnostic MRI demonstrates the presence of 1 to 3 intact (not previously irradiated or resected) brain metastases.
* Maximum tumor diameter ≤ 2.5 cm for the largest lesion determined during the planning MRI
* Plan of care must include Stereotactic Radiosurgery (SRS)
* SRS treatment plan must be delivered as a single RT fraction
* Age 18 years and older
* Life expectancy of at least 3 months
* GPA score 0.5 or greater
* Capable of providing written informed consent to participate in the study
Exclusion Criteria:
* Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma)
* Metastases in the brain stem, pons or medulla or within 3 mm of the optic apparatus (such that some portion of the optic nerve or chiasm would receive a radiation dose \> 10 Gy SRS in one single fraction)
* Previous whole-brain radiation (previous SRS to or resection of other brain lesions is permitted if more than 3 months prior to the date of enrollment on this protocol)
* Pregnancy
* History or manifestation of glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency
* History of oxalate kidney stones
* History of iron overload or hemochromatosis
* History of allergy to ascorbic acid
* Anuria, dehydration, serum albumin \<3.0 g/dL, severe pulmonary congestion or pulmonary edema or fixed low cardiac input since all are conditions for which osmotic diuresis are contraindicated .
* Subjects who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide.
* Subjects who are on strong inducers, inhibitors or substrates of CYP within 3 days of planned administration of study ascorbate-meglumine.
* Subjects for which MRI is contra-indicated (for example a pacemaker/recent surgery with orthopedic prosthesis)
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Christopher Lascola, MD
**Phone:** 9194752607
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Maureen Maughan, PhD
**Phone:** 9195979530
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Durham
**Country:** United States
**Facility:** Duke Health
**State:** North Carolina
**Zip:** 27709
#### Overall Officials
**Official 1:**
**Affiliation:** Duke Health
**Name:** John Kirkpatrick, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: M4513
- Name: Ascorbic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T437
- Name: Ascorbic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T477
- Name: Vitamin C
- Relevance: HIGH
- As Found: Adjusted
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433778
**Brief Title:** A Study on the Outcomes of Recombinant Von Willebrand Factor on Demand Treatment and Prevention and Treatment of Bleeding During and After Surgery in Adults With Inherited Von Willebrand Disease in the United Kingdom (UK)
**Official Title:** Vonicog Alfa (Recombinant Von Willebrand Factor) Treatment Outcomes in Von Willebrand Disease in the UK: a Retrospective Chart Review Study
#### Organization Study ID Info
**ID:** TAK-577-5001
#### Organization
**Class:** INDUSTRY
**Full Name:** Takeda
### Status Module
#### Completion Date
**Date:** 2023-10-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-10-30
**Type:** ACTUAL
#### Start Date
**Date:** 2021-12-16
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Takeda
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is a retrospective chart review study and will collect data on real world use of vonicog alfa (Recombinant Von Willebrand Factor \[rVWF\]). Von Willebrand disease (VWD) is the most common inherited bleeding disorder. rVWF is approved in Europe and UK to treat bleeding and to treat and prevent bleeding during surgeries in adults in 2018.
This study will review and collect information on the treatment and bleed prevention of adult persons with inherited VWD with rVWF in UK. These data were already collected as a part of the routine care.
The main aims of this study are to describe the use of rVWF in on-demand treatment of bleeding and the prevention of treatment and treatment of bleeding during surgeries. Other aims are to describe bleedings and their treatment as well as any surgeries before and after first treatment with rVWF and to gather information on the use of healthcare resources (such as hospital visits, emergency room visits, etc.).
### Conditions Module
**Conditions:**
- Von Willebrand Disease (VWD)
**Keywords:**
- Drug Therapy
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 34
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants who have been diagnosed with congenital VWD and prescribed rVWF within the index date range (defined as the first administration of rVWF and must fall between 1st October 2020 and 30th June 2022) will be assessed using data obtained from medical records to evaluate the treatment outcome of rVWF in real-world clinical practice.
**Intervention Names:**
- Other: No Intervention
**Label:** Participants diagnosed With Congenital VWD
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Participants diagnosed With Congenital VWD
**Description:** This is a non-interventional study.
**Name:** No Intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Bleeding episodes will be assessed based on categories of overall and annualized, type, severity, location, bleed frequency, bleed type/location and bleed severity.
**Measure:** Number of Participants With Bleeding Episodes Treated with rVWF Between the Index Date and Following 12 Months
**Time Frame:** From index date up to 12 months
**Description:** Surgical procedures included surgery type, severity, category (emergency or elective). Data on the participants use of rVWF in the pre-, intra- and post-operative setting during the period between the index date and the following 12 months, will be stratified by VWD type, surgery type, severity, location, or treatment rationale.
**Measure:** Number of Surgical Procedures Between the Index Date and Following 12 Months
**Time Frame:** From index date up to 12 months
**Description:** Surgery outcomes (success, failure, complications) will be reported.
**Measure:** Number of Participants with Surgery Outcomes (Success, Failure, Complications) Between the Index Date and Following 12 Months
**Time Frame:** From index date up to 12 months
#### Secondary Outcomes
**Description:** HRU will include bleeding-related hospitalization rates, outpatient visits, accident and emergency visits.
**Measure:** Number of Participants With VWD-Related Healthcare Resource Utilization (HRU)
**Time Frame:** Up to 24 months
**Description:** Surgery related costs by type will include length of stay in intensive care unit (ICU), rVWF consumption, factor VIII (FVIII) consumption, VWD treatment consumption, laboratory tests and examinations.
**Measure:** Number of Participants With Surgery Related Costs By Type
**Time Frame:** Up to 24 months
**Description:** Bleeding episodes will be reported based on type, severity, location, treatment, and outcomes, of all recorded bleeds within 12 months prior to and 12 months following the first administration of rVWF.
**Measure:** Number of Participants With Bleeding Episodes Treated With rVWF
**Time Frame:** Up to 24 months
**Description:** Surgical procedures will be reported based on surgery type (orthopaedic, gastro-intestinal, dental, etc), severity (major, minor), category (emergency or elective) treatment duration and outcomes, of all recorded surgeries within 12 months prior to and 12 months following the first administration of rVWF.
**Measure:** Number of Surgical Procedures
**Time Frame:** Up to 24 months
**Description:** Surgery outcomes (success, failure, complications) based on average number of post-operative bleeds will be reported.
**Measure:** Number of Participants with Surgery Outcomes (Success, Failure, Complications)
**Time Frame:** Up to 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
* Adults (aged 18 or over at time of first administration of rVWF) who have provided informed consent and used rVWF within its licensed indication.
* Participants who have been diagnosed with congenital von Willebrand disease.
* Confirmed instance of
* at least one bleed (either a new bleed or ongoing bleed treated under a treatment switch) treated on-demand with rVWF between 01-Oct-2020 and 30-Jun- 2022 and/or
* treatment to prevent and treat surgical bleeds with rVWF between 01-Oct-2020 and 30-Jun-2022
Exclusion criteria:
* Participants who were aged 17 years or less at the time of the first administration of rVWF.
* Participants who have been diagnosed with any other bleeding disorders or factor deficiencies including acquired von Willebrand disease.
* Participants with neutralising antibodies/inhibitors to VWF.
* Participants participation in a clinical trial of an investigational medical product during the study period.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Participants who have been diagnosed with congenital VWD and were prescribed rVWF in UK.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Birmingham
**Country:** United Kingdom
**Facility:** University Hospitals Birmingham
**Zip:** B15 2GW
**Location 2:**
**City:** Leeds
**Country:** United Kingdom
**Facility:** Leeds Teaching Hospital
**Zip:** LS9 7TF
**Location 3:**
**City:** Liverpool
**Country:** United Kingdom
**Facility:** Liverpool University Hospital
**Zip:** L7 8XP
**Location 4:**
**City:** London
**Country:** United Kingdom
**Facility:** Royal Free London
**Zip:** NW3 2QG
**Location 5:**
**City:** London
**Country:** United Kingdom
**Facility:** Imperial College Healthcare
**Zip:** W2 1NY
**Location 6:**
**City:** Manchester
**Country:** United Kingdom
**Facility:** Manchester University
**Zip:** M13 9WL
**Location 7:**
**City:** Oxford
**Country:** United Kingdom
**Facility:** Oxford University Hospital
**Zip:** OX3 9DU
#### Overall Officials
**Official 1:**
**Affiliation:** Takeda
**Name:** Study Director
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
**Description:** Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
**IPD Sharing:** YES
**URL:** https://vivli.org/ourmember/takeda/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000025861
- Term: Blood Coagulation Disorders, Inherited
- ID: D000001778
- Term: Blood Coagulation Disorders
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000020147
- Term: Coagulation Protein Disorders
- ID: D000001791
- Term: Blood Platelet Disorders
- ID: D000006474
- Term: Hemorrhagic Disorders
- ID: D000030342
- Term: Genetic Diseases, Inborn
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M9556
- Name: Hemorrhage
- Relevance: LOW
- As Found: Unknown
- ID: M17585
- Name: Von Willebrand Diseases
- Relevance: HIGH
- As Found: Von Willebrand Disease
- ID: M21977
- Name: Hemostatic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5059
- Name: Blood Coagulation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M23095
- Name: Blood Coagulation Disorders, Inherited
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21982
- Name: Coagulation Protein Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5072
- Name: Blood Platelet Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M9560
- Name: Hemorrhagic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000014842
- Term: Von Willebrand Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433765
**Brief Title:** A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
**Official Title:** BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®
#### Organization Study ID Info
**ID:** TG1101-RMS403
#### Organization
**Class:** INDUSTRY
**Full Name:** TG Therapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2030-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2030-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** TG Therapeutics, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.
### Conditions Module
**Conditions:**
- Multiple Sclerosis
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 728
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Pregnant participants with MS who are exposed to any dose of BRIUMVI® at any time during pregnancy (from conception to pregnancy outcome) or before pregnancy (within 6 months of the date of conception \[DOC\]).
**Intervention Names:**
- Other: No intervention
**Label:** BRIUMVI® Exposed Cohort
#### Arm Group 2
**Description:** Pregnant participants with MS who are not exposed to any dose of BRIUMVI® or other anti-CD20 monoclonal antibodies at any time during pregnancy but may be exposed to other products for the treatment of MS.
**Intervention Names:**
- Other: No intervention
**Label:** BRIUMVI® Unexposed Cohort
### Interventions
#### Intervention 1
**Arm Group Labels:**
- BRIUMVI® Exposed Cohort
- BRIUMVI® Unexposed Cohort
**Description:** No intervention
**Name:** No intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Percentage of Participants with Major Congenital Malformations (MCMs)
**Time Frame:** Up to 52 weeks post-delivery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI®.
2. For unexposed cohort: Participants not exposed to BRIUMVI® at any time during the pregnancy.
3. Diagnosis of MS.
4. Currently or recently (within 1 year of pregnancy outcome) pregnant.
5. Authorization from healthcare provider to provide data to registry.
Exclusion Criteria:
1. Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy.
2. Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).
3. Exposure to known teratogens and/or investigational medications during pregnancy.
**Gender Based:** True
**Maximum Age:** 50 Years
**Minimum Age:** 15 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
**Study Population:** The study population will include pregnant participants with MS who are either exposed or not exposed to BRIUMVI®.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
**Phone:** 1-877-411-4605
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** TG Therapeutics Clinical Support Team
**Phone:** 1-877-555-8489
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020278
- Term: Demyelinating Autoimmune Diseases, CNS
- ID: D000020274
- Term: Autoimmune Diseases of the Nervous System
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000003711
- Term: Demyelinating Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M12060
- Name: Multiple Sclerosis
- Relevance: HIGH
- As Found: Multiple Sclerosis
- ID: M15415
- Name: Sclerosis
- Relevance: HIGH
- As Found: Sclerosis
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22098
- Name: Demyelinating Autoimmune Diseases, CNS
- Relevance: LOW
- As Found: Unknown
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M6909
- Name: Demyelinating Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009103
- Term: Multiple Sclerosis
- ID: D000012598
- Term: Sclerosis
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: LOW
- As Found: Unknown
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433752
**Acronym:** ENABLE
**Brief Title:** A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
**Official Title:** REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)
#### Organization Study ID Info
**ID:** TG1101-RMS406
#### Organization
**Class:** INDUSTRY
**Full Name:** TG Therapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2027-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** TG Therapeutics, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting
### Conditions Module
**Conditions:**
- Relapsing Multiple Sclerosis
- Multiple Sclerosis
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 500
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive BRIUMVI® (Ublituximab-xiiy) intravenous (IV) infusion for the treatment of RMS.
**Intervention Names:**
- Other: No Intervention
**Label:** BRIUMVI® (Ublituximab-xiiy)
### Interventions
#### Intervention 1
**Arm Group Labels:**
- BRIUMVI® (Ublituximab-xiiy)
**Description:** No Intervention
**Name:** No Intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Annualized Relapse Rate (ARR)
**Time Frame:** Up to Week 96
#### Secondary Outcomes
**Measure:** Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
**Time Frame:** Up to Week 96
**Measure:** Number of Participants with Infusion Related Reaction (IRR) at Each Infusion
**Time Frame:** Up to Week 96
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Confirmed Multiple Sclerosis (MS) diagnosis.
2. Participants who have not received any BRIUMVI® (ublituximab-xiiy) infusion prior to study start. Participants who have been prescribed BRIUMVI® (ublituximab-xiiy) but have not yet received their first infusion on Day 1 of 150 milligrams (mg) can be included.
Exclusion Criteria:
1. Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 4 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration or any non-live vaccines within 2 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration.
2. Any active infection (e.g., active Hepatitis B virus \[HBV\])
3. Concurrent participation in any interventional MS trials, or planned concurrent treatment with other Multiple Sclerosis Disease Modifying Therapy (MS DMT) during the study period.
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study population will include participants with RMS who are receiving BRIUMVI® (ublituximab-xiiy).
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** TG Therapeutics Clinical Support Team
**Phone:** 1-877-555-8489
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020278
- Term: Demyelinating Autoimmune Diseases, CNS
- ID: D000020274
- Term: Autoimmune Diseases of the Nervous System
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000003711
- Term: Demyelinating Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M12060
- Name: Multiple Sclerosis
- Relevance: HIGH
- As Found: Multiple Sclerosis
- ID: M15415
- Name: Sclerosis
- Relevance: HIGH
- As Found: Sclerosis
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22098
- Name: Demyelinating Autoimmune Diseases, CNS
- Relevance: LOW
- As Found: Unknown
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M6909
- Name: Demyelinating Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009103
- Term: Multiple Sclerosis
- ID: D000012598
- Term: Sclerosis
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11982
- Name: Morphine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433739
**Acronym:** EACEC
**Brief Title:** Efficacy of a Clinical Algorithm for the Selection of Peripheral Venous Catheters
**Official Title:** Efficacy of a Clinical Algorithm for the Selection of Peripheral Venous Catheters to Reduce the Number of Catheter-Associated Complications in Hospitalized Patients: A Retrospective Cohort Study
#### Organization Study ID Info
**ID:** CSAPG-47
#### Organization
**Class:** OTHER
**Full Name:** Consorci Sanitari de l'Alt Penedès i Garraf
### Status Module
#### Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Consorci Sanitari de l'Alt Penedès i Garraf
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this observational study is to investigate the complications associated with peripheral venous catheterization based on whether a correct or incorrect catheter was used according to a clinical algorithm in patients admitted to an acute care unit. The main question it seeks to answer is:
• Are there fewer complications associated with catheterization when a correct catheter choice is made? Data from patients admitted to the acute care units of the sponsoring study center will be reviewed.
### Conditions Module
**Conditions:**
- Catheter Related Complication
**Keywords:**
- Catheterization, Peripheral
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 3314
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This group will include all peripheral venous catheterizations for which the appropriate catheter type selection according to the standardized algorithm has been performed
**Intervention Names:**
- Other: standardized algorithm
**Label:** appropriate catheter type selection
#### Arm Group 2
**Description:** This group will include all peripheral venous catheterizations for which an inappropriate catheter type selection according to the standardized algorithm has been performed
**Intervention Names:**
- Other: standardized algorithm
**Label:** inappropriate catheter type selection
### Interventions
#### Intervention 1
**Arm Group Labels:**
- appropriate catheter type selection
- inappropriate catheter type selection
**Description:** standardized algorithm for the correct selection of peripheral venous catheters
**Name:** standardized algorithm
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of catheters removed due to complications associated with the use of a peripheral venous catheter
**Measure:** Catheters removed due to complications associated with the use of a peripheral venous catheter
**Time Frame:** Through study completion, an average of 1 year
#### Secondary Outcomes
**Description:** Correct or incorrect selection of the catheter according to the clinical algorithm. The proportion of correctly selected catheters in relation to the total number of catheters will be calculated.
**Measure:** Selection of the peripheral venous catheter
**Time Frame:** Through study completion, an average of 1 year
**Description:** Number of complications associated with the use of a peripheral venous catheter depending on whether a correct or incorrect selection of the catheter was made according to the clinical algorithm.
**Measure:** Complications associated with the use of a peripheral venous catheter
**Time Frame:** Through study completion, an average of 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Admitted to acute care hospital wards.
* Carriers of a peripheral venous catheter.
* With the study evaluation criteria documented in their medical records.
Exclusion Criteria:
* Admitted to gynecology, obstetrics, and pediatrics wards.
* Admitted to the emergency department and intensive care units
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients admitted to some acute care unit requiring peripheral venous catheterization
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Esther Moreno
**Phone:** +34 938960025
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Noemí Casaponsa
**Phone:** +34 938960025
**Phone Ext:** 43197
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Sant Pere De Ribes
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Esther Moreno
- **Phone:** +34 938960025
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Noemí Casaponsa
- **Phone:** +34 938960025
- **Phone Ext:** 43197
- **Role:** CONTACT
***Contact 3:***
- **Name:** Esther Moreno
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Consorci Sanitari Alt Penedes i Garraf
**State:** Barcelona
**Zip:** 08810
#### Overall Officials
**Official 1:**
**Affiliation:** CSAPG
**Name:** Esther Moreno
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
**Description:** IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** After publication of main results of the study.
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433726
**Brief Title:** A Phase l Study of By101921, an Oral PARP7 Inhibitor, in Patients With Advanced Solid Tumors
**Official Title:** A Phase Ⅰ, Multi-center, Open-label, Dose-escalation, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activity of BY101921 Monotherapy in Patients With Advanced Solid Tumors
#### Organization Study ID Info
**ID:** BY1921-I-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Chengdu Baiyu Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-11
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Chengdu Baiyu Pharmaceutical Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** BY101921 is a novel small molecule, being developed as a PARP7 inhibitor which acts on the PARP7 catalytic subunit, for the treatment of solid tumors. PARP7 is a member of the monoPARP family and involved in various biological processes such as gene expression, protein degradation, and cellular stress response. The results of non-clinical studies showed BY101921 was a potent inhibitor of PARP7 and had good selectivity.
The primary objective is to assess the safety and tolerability and MTD of BY101921 in patients with refractory or metastatic solid tumors. This study will also evaluate pharmacokinetic (PK) profile, preliminary anti-tumor activity, major metabolites and biomarkers in patients with refractory or metastatic solid tumors.
### Conditions Module
**Conditions:**
- Solid Tumor, Adult
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Dose Escalation: Multiple doses of BY101921 for oral administration
**Intervention Names:**
- Drug: BY101921 tablets
**Label:** BY101921
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- BY101921
**Description:** An oral PARP7 Inhibitor
**Name:** BY101921 tablets
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Grade and frequency of adverse events and serious adverse events
**Measure:** To assess the safety and tolerability of BY101921 in patients with advanced solid tumors
**Time Frame:** through study completion (an average of 1.5 years)
**Description:** Incidence of Dose limiting Toxicities (DLTs)
**Measure:** To assess the maximum tolerated dose (MTD)
**Time Frame:** through study completion (an average of 1.5 years)
#### Secondary Outcomes
**Description:** ORR
**Measure:** To assess preliminary antitumor activity of BY101921 in patients with advanced solid tumors
**Time Frame:** through study completion (an average of 1.5 years)
**Description:** AUC
**Measure:** To assess pharmacokinetics (PK) parameters of BY101921 in patients with advanced solid tumors
**Time Frame:** through study completion (an average of 1.5 years)
**Description:** Cmax
**Measure:** To assess pharmacokinetics (PK) parameters of BY101921 in patients with advanced solid tumors
**Time Frame:** through study completion (an average of 1.5 years)
**Description:** T1/2
**Measure:** To assess pharmacokinetics (PK) parameters of BY101921 in patients with advanced solid tumors
**Time Frame:** through study completion (an average of 1.5 years)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Male or female patients ≥18 years and ≤75 years of age.
2. patients histologically or cytologically diagnosed advanced malignant solid tumors who have failed, cannot tolerate, or refuse prior standard treatment regimens. At least 1 measurable lesion per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
3. Have a projected life expectancy of at least 3 months.
4. Eastern Cooperative Oncology Group Performance Status 0 or 1.
5. Adequate organ and bone marrow function. Laboratory tests that meet the following criteria within 7 days prior to the first dose of study treatment (without blood transfusion, erythropoietin, recombinant human thrombopoietin or colony stimulating factor therapy, renal replacement therapy, etc., within 28 days prior to the screening examination):
Routine blood test:
Absolute neutrophil count (ANC) ≥ 1.5×109/L Platelets count (PLT) ≥ 100×109/L Hemoglobin (Hb) ≥ 90 g/L
Hepatic function:
Total bilirubin (TBIL) ≤ 1.5×ULN Aspartate aminotransferase (AST) ≤ 2.5×ULN Alanine aminotransferase (ALT) ≤ 2.5×ULN ALT and AST ≤ 5×ULN and TBIL ≤ 3×ULN for patients with primary liver cancer, liver metastases, or Gilbert 's syndrome.
Renal function:
Creatinine clearance ≥ 50 mL/min (calculated according to Cockcroft-Gault formula).
Coagulation function:
International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN
6. Females and males of childbearing potential must agree to use appropriate methods of contraception (hormonal/barrier method or abstinence) during the study and for 3 months after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to administration.
7. Understand and be willing to sign written informed consent and be able to follow the study protocol for treatment, visits, and other study procedures.
Exclusion Criteria:
1. Previously treated with PARP-7 inhibitors.
2. Treated with a potent CYP3A4 inhibitor or inducer within 2 weeks prior to the first dose of study treatment.
3. Previous any treatment with of the following:
1. Systemic chemotherapy, other antitumor agents (including endocrine therapy, macromolecular targeted therapy, immunotherapy, or biotherapy) within 4 weeks or 5 half-lives prior to the first dose of study treatment, or who need to continue receiving these agents during the study period;
2. Small molecule targeted therapy within 2 weeks or 5 half-lives prior to the first dose of study treatment;
3. Anti-tumor traditional Chinese medicine or proprietary Chinese medicine preparations prior to the first dose of study treatment;
4. Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment;
5. Palliative radiation therapy within 2 weeks prior to the first dose of study treatment;
6. Investigational drug within 4 weeks prior to the first dose of study treatment; g Radical radiation therapy within 4 weeks prior to the first dose of study treatment.
4. Major surgical intervention (excluding needle biopsy) within 28 days before study drug administration, surgical wound has not fully healed or surgery is scheduled during the study period.
5. Brain metastasis (except asymptomatic, stable for more than 4 weeks prior to the first dose and not requiring steroid therapy for at least 4 weeks prior to the first dose, no imaging findings of marked edema around the tumor lesion), presence of meningeal metastasis or brainstem metastasis, or presence of spinal cord compression.
6. History of other malignancy within the past 5 years, except skin basal cell carcinoma, skin squamous cell carcinoma, cervical carcinoma in situ, or other carcinomas in situ which have undergone curative treatment and have had no recurrence within 5 years after treatment.
7. Toxicities from prior antitumor therapy that have not recovered to CTCAE version 5.0 Grade 1 or less, except CTCAE (V5.0) Grade 2 peripheral neurotoxicity and alopecia of any grade.
8. Difficult-to-control pleural effusion, ascites, or pericardial effusion.etc, requiring repeated drainage and considered unsuitable for study enrollment by the investigator.
9. Serious or uncontrolled diseases as assessed by the investigator, including but not limited to:
Severe or uncontrolled diabetes, poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg under standardized antihypertensive regimens), epilepsy, chronic obstructive pulmonary disease, interstitial pneumonia, pulmonary interstitial fibrosis, Parkinson 's disease, active bleeding, uncontrolled infection.
Cognitive dysfunction, history of psychiatric disorders, other uncontrolled concomitant diseases, alcohol dependence, hormone dependence, or drug abuse.
History of immunodeficiency, including HIV antibody positive, other acquired or congenital immunodeficiency disease, or history of organ transplantation.
HBsAg or HBcAb positive, and peripheral blood HBV DNA titer test ≥ 200 IU/mL or ≥ 1000 copies/mL or above the upper limit of normal value at the study site; HCV antibody test positive, and HCV RNA test above the upper limit of normal value at the study site; treponema pallidum-specific antibody positive.
Clinically serious gastrointestinal dysfunction that may compromise drug intake, transport, or absorption. For example, inability to take oral medication, uncontrollable nausea or vomiting, history of massive gastrointestinal resection, history of gastrointestinal ulcer and gastrointestinal bleeding within 6 months prior to the first dose, untreated recurrent diarrhea, untreated stomach disease requiring long-term use of PPI acid suppressants, Crohn 's disease, ulcerative colitis, etc.
10. Cardiac dysfunction, including any of the following:
Myocardial infarction in past 6 months, heart failure classified as Class II/III/IV according to the New York Heart Association (NYHA) Functional Classification, unstable angina pectoris, and unstable arrhythmia.
Left ventricular ejection fraction LVEF \< 50% shown by echocardiography. QT interval corrected using Fridericia 's formula: QTcF \> 470 msec (females), QTcF \> 450 msec (males).
11. Pregnant (positive pregnancy test prior to dosing) or lactating.
12. History of serious hypersensitivity (e.g., anaphylactic shock) or hypersensitivity to excipients or other ingredients associated with the study drug.
13. Cannot follow the protocol to "avoid ingesting grapefruit , pomegranate, orange or green lemon (juice/sauce made from these fruits as well) within 7 days before study drug administration and throughout the BY101921 treatment period".
14. Other factors considered unsuitable for study enrollment by the investigator.
**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:** Jinming Yu
**Phone:** +8613806406293
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Jinan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jinming professor Yu, MD
- **Phone:** +8613806406293
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Yuping professor Sun, MD
- **Phone:** +86-531-67627158
- **Role:** CONTACT
***Contact 3:***
- **Name:** Jinming professor Yu, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Yuping professor Sun, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Cancer Hospital Affiliated to Shandong First Medical University / Shandong Cancer Research Institute / Shandong Cancer Hospital
**State:** Shandong
**Status:** RECRUITING
**Zip:** 250117
## Derived Section
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433713
**Brief Title:** Effect of Intraoperative Intravenous Lidocaine on Postoperative Pain and Return of Bowel Function After Cesarean Sections
**Official Title:** Effect of Intraoperative Intravenous Lidocaine on Postoperative Pain and Return of Bowel Function After Cesarean Sections, a Double-blinded Randomized Control Study
#### Organization Study ID Info
**ID:** MS-220
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-12-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-24
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cairo University
#### Responsible Party
**Investigator Affiliation:** Cairo University
**Investigator Full Name:** Amr Fathy Zaky
**Investigator Title:** Lecturer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Postoperative discomfort is a frequently seen adverse event after to caesarean operation. Early mobilization and bonding of the mother and her infant are typically impacted by this phenomenon.
Nevertheless, the current state of postoperative analgesia and recovery remains inadequate in clinical settings. In the context of major abdominal surgery, opioids are often regarded as the preferred postoperative analgesic. Nevertheless, they possess adverse side effects that might impact the process of recuperation after surgery. These symptoms include nausea and vomiting, decreased bowel movement, and shallow breathing.
One additional challenging consequence after surgery is the delayed restoration of bowel function, which has the potential to extend the duration of hospitalization and impede the initiation of oral feeding, resulting in gaseous colonic distension.
The administration of lidocaine infusion has been shown to possess analgesic, anti-hyperalgesic, and anti-inflammatory characteristics.
The use of intravenous lidocaine after surgery is postulated to have the dual effect of mitigating postoperative pain and expediting the resumption of bowel movements.
Recent studies have shown that the administration of intravenous lidocaine, either as a single dosage or by continuous infusion, may have potential advantages in maintaining gastrointestinal motility and exerting an impact on biochemical pain mechanisms.
However, the literature presents contradictory data about the effectiveness of lidocaine in providing sufficient postoperative pain relief and reducing postoperative ileus.
Consequently, this study was conducted and aimed to assess the effect of intravenous intraoperative lidocaine on postoperative pain and early return of bowel function following elective caesarean section.
This randomized clinical trial was conducted at Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University Hospitals from August till December 2023. A total of 60 pregnant women underwent elective caesarean section were enrolled and randomized into two groups; experimental group who received IV infusion of lidocaine starting with skin incision, which was maintained until skin closure and control group who received 0.9% normal saline at the same rate as that described in the experimental group. Both groups were compared as regard total operative time, medications given, start-stop time of the study drug infusion, and degree of pain using visual analogue scale, need for analgesics, time for first healing of normal intestinal sounds and time to first flatus and symptoms of lidocaine toxicity were recorded.
### Conditions Module
**Conditions:**
- Postoperative Pain
- Postoperative Return of Bowel Function
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Intravenous lidocaine infusion, 2 mg/kg/hour
**Intervention Names:**
- Drug: Lidocaine IV
**Label:** Lidocaine Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Normal saline infusion
**Intervention Names:**
- Drug: Placebo
**Label:** Control Group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Lidocaine Group
**Description:** They received IV infusion of 2 mg/kg per hour of lidocaine starting with skin incision, which was maintained until skin closure. This was done using a syringe pump with the calculated amount of lidocaine added to 50 ml of normal saline infused at a rate of 50 ml/hr.
**Name:** Lidocaine IV
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Control Group
**Description:** 0.9% normal saline infusion
**Name:** Placebo
**Other Names:**
- Normal saline
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The patients are asked to describe how much pain they feel in a scale from 0 to 10. Minimum score 0, maximum score 10 where 10 is worse and means more pain
**Measure:** Effect of intraoperative intravenous lidocaine on visual analogue scale pain scores among the two groups.
**Time Frame:** 12-24 hours
**Description:** Time to hearing of bowel sounds, passing of flatus \& passing of stool
**Measure:** Effect of intraoperative intravenous lidocaine on early return of bowel function assessed by the time to first hearing of bowel sounds and the time to first flatus passing.
**Time Frame:** 12-24 hours
#### Secondary Outcomes
**Description:** Nausea, perioral numbness, neurological symptoms or cardiac arrhythmia
**Measure:** Occurrence of lidocaine toxicity with the standard dose given.
**Time Frame:** 12-24 hours
**Measure:** Duration of hospital stay.
**Time Frame:** 12-24 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age \> 18 years.
2. American society of anesthesiology (ASA) class II (Normal pregnancy, well controlled gestational HTN, controlled preeclampsia without severe features, diet-controlled gestational DM).
3. Singleton term pregnancy.
4. Elective caesarean section.
5. Spinal anesthesia.
Exclusion Criteria:
1. Atypical postoperative care e.g. following caesarean hysterectomy.
2. Inflammatory bowel disease.
3. Prolonged surgery \>1.5 hours.
4. Medical disorders e.g. liver or renal affection
5. Previous bowel surgery.
6. History' of allergic reaction to lidocaine.
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Cairo University Kasr Al Aini School of Medicine
**Zip:** 11562
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## 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 - Ancestors
- ID: D000000779
- Term: Anesthetics, Local
- ID: D000000777
- Term: Anesthetics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000000889
- Term: Anti-Arrhythmia Agents
- ID: D000061567
- Term: Voltage-Gated Sodium Channel Blockers
- ID: D000026941
- Term: Sodium Channel Blockers
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11014
- Name: Lidocaine
- Relevance: HIGH
- As Found: Solution
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
- ID: M4213
- Name: Anti-Arrhythmia Agents
- Relevance: LOW
- As Found: Unknown
- ID: M23177
- Name: Sodium Channel Blockers
- Relevance: LOW
- As Found: Unknown
- ID: M30025
- Name: Diuretics, Potassium Sparing
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008012
- Term: Lidocaine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433700
**Brief Title:** Risk of Revision Following Knee Arthroplasty in Bariatric Surgery Patients
**Official Title:** Risk of Revision and Other Complications Following Knee Arthroplasty in Patients Previously Exposed to Bariatric Surgeries: A Nationwide, Register-based Study
#### Organization Study ID Info
**ID:** p-2023-14433
#### Organization
**Class:** OTHER
**Full Name:** Bispebjerg Hospital
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-07
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Bispebjerg Hospital
#### Responsible Party
**Investigator Affiliation:** Bispebjerg Hospital
**Investigator Full Name:** Saber Muthanna Saber
**Investigator Title:** Principal Investigator, PhD Fellow
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Previous studies have investigated the outcomes of Knee Arthroplasty (KA) following Bariatric Surgery (BAS), but with substantial limitations as not stratifying for Body Mass Index (BMI) at time of KA or not addressing the type of BAS (gastric bypass, banding or sleeve). Since BMI varies greatly in patients with previous BAS, it is likely that BMI affects outcomes after KA in BAS-operated patients.
The investigators believe that stratifying for BMI would explain the contradictions with the previous research in this patient group when it comes to the risk of revision after KA.
### Conditions Module
**Conditions:**
- Arthritis Knee
- Bariatric Surgery Candidate
- Prosthesis Failure
- Prosthesis Survival
- Prosthesis-Related Infections
**Keywords:**
- arthroplasty
- revision
- bariatric
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 90000
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 2 Years
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients who received bariatric surgery prior to their knee arthroplasty
**Intervention Names:**
- Other: BAS
**Label:** BAS group
#### Arm Group 2
**Description:** Patients who did not receive bariatric surgery prior to their knee arthroplasty
**Intervention Names:**
- Other: Non-BAS
**Label:** Non-BAS group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- BAS group
**Description:** NOMESCO (Nordic Medico-Statistical Committee) Classification of Surgical Procedures (KJDF10 \& KJDF11 \[gastric bypass\]; KJDF20 \& KJDF21 \[gastric banding\]; KJDF40, KJDF41, KJDF96 \& KJDF97 \[gastric sleeve\]).
**Name:** BAS
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Non-BAS group
**Description:** Patients without BAS codes
**Name:** Non-BAS
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Revision surgery is defined as surgery with debridement and/or exchange of at least one component
**Measure:** Hazard rate of Revision due to any cause
**Time Frame:** within 90 days and within 2 years
**Description:** Our definition of infection is adapted from the European Bone and Joint Infection Society (EBJIS) criteria as at least one of the following A. An indication of deep infection is reported to the Danish knee arthroplasty register (DKR) by the surgeon on revision surgery B. At least 2 deep-tissue samples of phenotypically indistinguishable bacteria isolated from at least 3 deep-tissue samples C. One or more positive intraoperative samples from a closed fluid aspirate AND a biopsy (fluid AND tissue) of phenotypically indistinguishable bacteria isolated.
**Measure:** Hazard rate of Revision due to infection
**Time Frame:** within 90 days and within 2 years
#### Secondary Outcomes
**Description:** the use of one of the following oral antibiotics: dicloxacillin, flucloxacillin, phenoxymethylpenicillin, amoxicillin, oral ciprofloxacin, roxithromycin, linezolid, cefuroxime and cefalexin
**Measure:** Hazard rate of Knee related antibiotic use within 30- and 90-days following KA
**Time Frame:** within 30- and 90-days following KA
**Description:** the use of one of oral antibiotics other than those that were mentioned in outcome 3.
**Measure:** Hazard rate of Antibiotic use due to other causes
**Time Frame:** within 30- and 90-days following KA
**Description:** Mortality registered in the Danish Civil Registration System (DCRS) by date
**Measure:** Mortality
**Time Frame:** 2 years postoperatively
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Primary knee arthroplasty due to osteoarthritis
Exclusion Criteria:
* Primary knee arthroplasty due to traumatic osteoarthritis.
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The investigators will include patients with primary/idiopathic or secondary (due to meniscus or cruciate ligament lesion) osteoarthritis (OA) who received primary KA in the period from 2011 and 2 years earlier to data-extraction date. Patients will be identified from the DKR. Patients are followed for 2 years, until first revision, death or migration, whichever comes first.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Saber M. Saber, MD
**Phone:** 004521299265
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Department of orthopedic surgery, Bispebjerg University Hospital, Denmark
**Name:** Søren Overgaard, MD,DMSc,Prof
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-05-27
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 236674
- Type Abbrev: Prot_SAP
- Upload Date: 2024-05-27T06:03
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007239
- Term: Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M4476
- Name: Arthritis
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M18866
- Name: Prosthesis-Related Infections
- Relevance: HIGH
- As Found: Prosthesis-Related Infections
- ID: M14338
- Name: Prosthesis Failure
- Relevance: HIGH
- As Found: Prosthesis Failure
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016459
- Term: Prosthesis-Related Infections
- ID: D000011475
- Term: Prosthesis Failure
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433687
**Acronym:** HekaHeart POC
**Brief Title:** HekaHeart Phase 1 Proof of Concept
**Official Title:** HeakHeart Phase 1 Study: Proof of Concept
#### Organization Study ID Info
**ID:** 2000037817
#### Organization
**Class:** OTHER
**Full Name:** Yale University
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Roivant Sciences (HekaHeart)
#### Lead Sponsor
**Class:** OTHER
**Name:** Yale University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This pilot study will test the feasibility of a novel digital health technology-enabled platform, HekaHeart, developed to facilitate comprehensive medical management, including medication initiation, titration, e-prescription eligibility, remote patient monitoring, and communication of care coordination activities, for patients with Heart Failure with Reduced Ejection Fraction (HFrEF) not currently on all four pillars of guideline-directed medical therapy (GDMT).
**Detailed Description:** Heart Failure (HF) is a major cause of morbidity, mortality, and healthcare expenditure in the United States (US). The 2022 AHA/ACC/HFSA Guideline for the management of HF strongly recommends quadruple therapy for all patients with HFrEF, which includes: beta-blockers (BB); renin-angiotensin-aldosterone-system (RAAS) inhibitors such as angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB) and angiotensin receptor-neprilysin inhibitors (ARNi); mineralocorticoid receptor antagonists (MRA); and sodium-glucose cotransporter-2 inhibitors (SGLT2i). Unfortunately, suboptimal adoption of GDMT persists despite mounting, unambiguous evidence of its substantial benefit on patient outcomes (including mortality) across numerous large-scale studies.
Further, following initial prescription of quadruple therapy, augmentation of each pillar to target or highest tolerated dosing is critical to achieve maximum benefit, as shown in a recent multinational randomized controlled trial (STRONG-HF) where rapid uptitration to optimal doses of GDMT reduced the risk of death and hospitalization just 180 days after an acute HF episode. Yet, multiple contemporary registry studies continue to reflect suboptimal uptake and dose escalation of GDMT for patients with HFrEF in real-world clinical practice due to both clinical and patient-based barriers.
The HekaHeart platform is a comprehensive remote care and monitoring-based method for GDMT titration and management. The platform uses a virtual team of clinicians with expertise in HF to manage GDMT prescription, dose escalation, and symptom monitoring for patients with HFrEF as a means to both provide personalized patient care and support while alleviating clinician burden. Once a patient is fully optimized with respect to GDMT, they are transitioned back to routine clinical care.
The present study will evaluate the usability of the HekaHeart platform to initiate, monitor, and manage GDMT for patients with HFrEF. The study will prospectively recruit eligible patients from ambulatory HF clinics affiliated with Yale New Haven Health System (YNHHS). Consented patients will be onboarded to the HekaHeart platform for GDMT management by HF disease management clinicians, which will include medication adjustment and remote patient monitoring to assess laboratory results, changes in body weight, blood pressure, and heart rate. Throughout the study, patients will engage in short message service (SMS), video and phone check-ins with clinicians, who will leverage standardized titration protocols to guide medication optimization, monitor patient progress and symptoms, and collect, analyze and respond to remote monitoring data. After 45 days, patients will be transitioned back to usual care.
The primary outcome is the Net Promoter Score (NPS), collected at study offboarding by each participant, and used to assess patient satisfaction with the HekaHeart platform and experience. The secondary outcome is the increase in proportion of HFrEF patients prescribed four pillars of GDMT. Other secondary endpoints include percent of patients successfully onboarded to the HekaHeart platform, proportion of patients whose GDMT is titrated toward target or maximally tolerated dosing, number scheduled visits attended, and percent of platform GDMT recommendations implemented.
### Conditions Module
**Conditions:**
- Heart Failure With Reduced Ejection Fraction
**Keywords:**
- Heart Failure
- Guideline-directed medical therapy
- Remote monitoring
- Medication optimization
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will onboard to the HekaHeart platform, which will recommend a GDMT management plan that has been validated by a Yale-based clinician, with consideration given to eligibility for GDMT, past medical history, and patient preference. Participants will also be provided with an at-home blood pressure cuff, weight scale, and heart rate monitor and be instructed to use these devices on a regular cadence. Measurements will be electronically transmitted in real-time to the HekaHeart platform and uploaded to a web-based portal for review. Weekly/bi-weekly scheduled remote check-ins will be used by clinicians to monitor patient progress with GDMT management, to evaluate whether additional medications or dose adjustments are necessary, monitor symptoms, identify issues, offer medical education, and provide continued assistance with remote patient monitoring (RPM) devices. A final patient offboarding visit will occur once the patient has been on the platform for 45 days.
**Intervention Names:**
- Device: HekaHeart platform medication management and remote monitoring
**Label:** HekaHeart-based medication optimization and remote monitoring
### Interventions
#### Intervention 1
**Arm Group Labels:**
- HekaHeart-based medication optimization and remote monitoring
**Description:** Onboarding to the HekaHeart platform which includes a personalized GDMT management plan along with remote monitoring kits including a scale, blood pressure cuff, and heart rate monitor. Patients engage in video and phone calls with clinicians who will use established standardized clinical protocols to guide medication and vital optimization. Once patients are determined to be maximally titrated on all GDMT, they are transitioned back to standard clinical care.
**Name:** HekaHeart platform medication management and remote monitoring
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** A metric used to gauge patient satisfaction with the HekaHeart platform. Patients are asked how likely they are to recommend the platform to a friend on a scale of 1 to 10 (with 1 being not likely to recommend, and 10 being highly likely to recommend).
**Measure:** Net Promoter Score
**Time Frame:** Assessed at time off patient offboarding (45 days after enrollment)
#### Secondary Outcomes
**Description:** Patients assessed for number of eligible classes of eligible GDMT medications prescribed.
**Measure:** Percent of patients on all eligible guideline-directed medical therapy (GDMT) classes
**Time Frame:** Assessed at time off patient offboarding (45 days after enrollment)
**Description:** Percent of patients who consented to the study who have successfully onboarded to the HekaHeart plan with an optimized medication management plan.
**Measure:** Percent of enrolled patients onboarded to HekaHeart
**Time Frame:** Assessed from time of enrollment to 45 days post-enrollment
**Description:** Percent of patients who have been prescribed a new medication within the HekaHeart platform after enrollment.
**Measure:** Percent of onboarded patients successfully prescribed a new medication
**Time Frame:** Assessed from time of enrollment to 45 days post-enrollment
**Description:** Percent of patients who attended a scheduled check-in (via SMS, text, email, or phone)
**Measure:** Percent of scheduled study check-ins attended by patients
**Time Frame:** Assessed from time of enrollment to 45 days post-enrollment
**Description:** Percent of HekaHeart-recommended medications prescribed
**Measure:** Percent of medication recommendations implemented
**Time Frame:** Assessed from time of enrollment to 45 days post-enrollment
**Description:** Time in days to optimal titration of all eligible classes of GDMT as determined by clinician judgement and expertise
**Measure:** Time to maximum titration
**Time Frame:** Assessed from time of enrollment to 45 days post-enrollment
**Description:** Time in days to first prescription made in HekaHeart platform
**Measure:** Time from patient enrollment to first remote prescription
**Time Frame:** Assessed from time of enrollment to 45 days post-enrollment
**Description:** Determined via qualitative survey assessment of clinicians which asks how well the HekaHeart platform integrates into existing systems and workflows
**Measure:** Ease of implementation of HekaHeart platform
**Time Frame:** Assessed up to one month post- study completion
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Documentation of HFrEF as evidenced by the presence of LVEF ≤40% reading at any time within the last 12 months,
1. with associated symptoms of HF
2. or an elevated NT-proBNP
3. or a hospitalization for HF within the preceding 12 months
* Currently receiving care at YNHHS
* Currently not on all 4 recommended classes of GDMT (BB, ACEi/ARB/ARNi, MRA, and SGLT2i)
Exclusion Criteria:
* Currently pregnant or breast feeding
* Received or listed for cardiac transplantation
* Planned or present durable left ventricular-assist device (LVAD)
* Goals of treatment are palliation
* Currently has a condition(s) that limit survival to \<1 year
* Unable to provide informed consent
* Unwilling to use remote monitoring devices
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study population will come from two outpatient Heart Failure clinics associated with Yale New Haven Hospital. The population will be adults ≥18 years with symptomatic HFrEF who are not on adequate GDMT.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Francis P Wilson, MD MSCE
**Phone:** 203 7371704
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guilford
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Marc Samsky, MD
- **Role:** CONTACT
**Country:** United States
**Facility:** Shoreline Medical Center- 111 Goose Lane location
**State:** Connecticut
**Zip:** 06437
**Location 2:**
**City:** New Haven
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Marc Samsky, MD
- **Role:** CONTACT
**Country:** United States
**Facility:** Yale Physicians Building- 800 Howard Ave location
**State:** Connecticut
**Zip:** 06519
#### Overall Officials
**Official 1:**
**Affiliation:** Yale University
**Name:** Francis P Wilson, MD MSCE
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** De-identified data for the primary and secondary outcomes will be made available upon publication.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
**IPD Sharing:** YES
**Time Frame:** Data will become available upon publication and indefinitely.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433674
**Brief Title:** Enteral Zinc Supplementation in Very Low Birth Weight Infants
**Official Title:** Enteral Zinc Supplementation in Very Low Birth Weight Infants
#### Organization Study ID Info
**ID:** 23-09580-FB
#### Organization
**Class:** OTHER
**Full Name:** University of Tennessee
### Status Module
#### Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Tennessee
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to observe for changes in rate of weight gain in the very low birth weight (VLBW) infants by adding an enteral Zinc supplement of 1 mg/kg/day of elemental zinc. The main question it aims to answer:
• Does an enteral Zinc supplement of 1 mg/kg/day increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups
* Once the participants have reached 100 ml/kg/day of enteral feeds. The participants will be randomized to one of two groups. The treatment group will receive \~1 mg/kg/day of elemental enteral Zinc, and the control group to receive similar amount of enteral sterile water put in a colored syringe. The Zinc Supplement would be Zinc Sulfate. The primary team would otherwise be managing the patient's feeding using our hospital's feeding protocol. As long as the patient is tolerating 100 ml/kg/day of enteral feeds, the Zinc Supplement will continue until 36 weeks postmenstrual age (PMA) or hospital discharge, whichever comes first.
* The participants will have three Zinc levels measured: once prior to Zinc Supplementation, once at around the four week mark, and once at the completion of therapy.
**Detailed Description:** This is a prospective, single center, randomized, double blinded, placebo controlled clinical trial. The goal of this clinical trial is to observe for changes in rate of weight gain in the VLBW infants by adding an enteral Zinc supplement of 1 mg/kg/day of elemental zinc. The main question it aims to answer:
• Does an enteral Zinc supplement of 1 mg/kg/day increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups
* Once the participants have reached 100 ml/kg/day of enteral feeds. The participants will be randomized using sealed envelopes. The subjects will be randomly selected to one of two groups. The treatment group will receive \~1 mg/kg/day of elemental enteral Zinc, and the control group to receive similar amount of enteral sterile water put in a colored syringe. The Zinc Supplement would be Zinc Sulfate. Only the pharmacy will know which patient is receiving the Zinc Sulfate and which patient is receiving the placebo. The primary team would otherwise be managing the patient's feeding using our hospital's feeding protocol. As long as the patient is tolerating 100 ml/kg/day of enteral feeds, the Zinc Supplement will continue until 36 weeks PMA or hospital discharge, whichever comes first.
* The participants will have three Zinc levels measured: once prior to Zinc Supplementation, once at around the four week mark, and once at the completion of therapy.
### Conditions Module
**Conditions:**
- Very Low Birth Weight Infant
- Nutritional Deficiency
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The intervention will be two parallel groups. one Group receiving Zinc Sulfate. The other group receiving Placebo
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The experimental group will receive \~1 mg/kg/day of elemental enteral Zinc
**Intervention Names:**
- Drug: Zinc Sulfate
**Label:** Zinc Sulfate
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The placebo group will receive a similar amount of sterile water in a colored syringe
**Intervention Names:**
- Other: Sterile Water
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Zinc Sulfate
**Description:** The pharmacy will be the one preparing the Zinc sulfate. The zinc sulfate comes in 220 mg tablets which are then mixed with 1 ml of Oral plus (a common suspending agent) as well as 9 ml of Sterile water. This then makes a Zinc Sulfate 22 mg/ml oral suspension which will be dispensed in an amber syringe.
**Name:** Zinc Sulfate
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** The placebo group with will receive a similar amount of sterile water in a colored syringe
**Name:** Sterile Water
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The primary outcome would be the rate of weight gain in grams/kg/day
**Measure:** Rate of weight gain
**Time Frame:** at hospital discharge or 36 weeks PMA whichever comes first.
#### Secondary Outcomes
**Description:** This secondary outcome would be the rate of length gain in cm/day
**Measure:** Length
**Time Frame:** at hospital discharge of 36 weeks PMA whichever comes first
**Description:** This secondary outcome would be the rate of head circumference gain in cm/day
**Measure:** Head Circumference
**Time Frame:** at hospital discharge of 36 weeks PMA whichever comes first
**Description:** This secondary outcome would be looking for a statically significant difference in zinc level
**Measure:** Zinc level
**Time Frame:** Comparing the initial zinc level to the four week zinc level as well as the zinc level at 36 weeks or discharge whichever comes first
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Birth weight \< 1500 grams
2. Infant is tolerating at least 100 ml/kg/day of enteral feeds
3. At least 25wks PMA.
Exclusion Criteria:
* Major congenital malformations especially anomaly of the GI tract
* Major congenital heart disease (i.e.: ductal dependent lesion)
* Previously diagnosed necrotizing enterocolitis (stage 2 or 3), bowel perforation, or bowel resection
* Infant who has tolerated ≥100 ml/kg/day prior to admission.
**Healthy Volunteers:** True
**Maximum Age:** 36 Weeks
**Minimum Age:** 25 Weeks
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Andrew C Mire, M.D.
**Phone:** 2255884831
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Mark Weems, M.D.
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** UTHSC
**Name:** Andrew C Mire, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Terrin G, Berni Canani R, Passariello A, Messina F, Conti MG, Caoci S, Smaldore A, Bertino E, De Curtis M. Zinc supplementation reduces morbidity and mortality in very-low-birth-weight preterm neonates: a hospital-based randomized, placebo-controlled trial in an industrialized country. Am J Clin Nutr. 2013 Dec;98(6):1468-74. doi: 10.3945/ajcn.112.054478. Epub 2013 Sep 11.
**PMID:** 24025633
**Citation:** Brion LP, Heyne R, Lair CS. Role of zinc in neonatal growth and brain growth: review and scoping review. Pediatr Res. 2021 May;89(7):1627-1640. doi: 10.1038/s41390-020-01181-z. Epub 2020 Oct 3. Erratum In: Pediatr Res. 2021 Mar 2;:
**PMID:** 33010794
**Citation:** Terrin G, Berni Canani R, Di Chiara M, Pietravalle A, Aleandri V, Conte F, De Curtis M. Zinc in Early Life: A Key Element in the Fetus and Preterm Neonate. Nutrients. 2015 Dec 11;7(12):10427-46. doi: 10.3390/nu7125542.
**PMID:** 26690476
**Citation:** Sinha B, Dudeja N, Chowdhury R, Choudhary TS, Upadhyay RP, Rongsen-Chandola T, Mazumder S, Taneja S, Bhandari N. Enteral Zinc Supplementation in Preterm or Low Birth Weight Infants: A Systematic Review and Meta-analysis. Pediatrics. 2022 Aug 1;150(Suppl 1):e2022057092J. doi: 10.1542/peds.2022-057092J.
**PMID:** 35921675
**Citation:** Shaikhkhalil AK, Curtiss J, Puthoff TD, Valentine CJ. Enteral zinc supplementation and growth in extremely-low-birth-weight infants with chronic lung disease. J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):183-7. doi: 10.1097/MPG.0000000000000145.
**PMID:** 24121149
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009748
- Term: Nutrition Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M5114
- Name: Body Weight
- Relevance: HIGH
- As Found: Weight
- ID: M25306
- Name: Malnutrition
- Relevance: HIGH
- As Found: Nutritional Deficiency
- ID: M5006
- Name: Birth Weight
- Relevance: HIGH
- As Found: Birth Weight
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000044342
- Term: Malnutrition
- ID: D000001835
- Term: Body Weight
- ID: D000001724
- Term: Birth Weight
### Intervention Browse Module - Ancestors
- ID: D000001252
- Term: Astringents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000003879
- Term: Dermatologic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
### Intervention Browse Module - Browse Leaves
- ID: M21269
- Name: Zinc Sulfate
- Relevance: HIGH
- As Found: Gastroesophageal Reflux
- ID: M17768
- Name: Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M4559
- Name: Astringents
- Relevance: LOW
- As Found: Unknown
- ID: M7074
- Name: Dermatologic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000019287
- Term: Zinc Sulfate
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433661
**Brief Title:** A Research Study of the Effect of Food on Etavopivat in Healthy Participants
**Official Title:** A Single-centre, Open-label, Randomised, Single-dose, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Etavopivat in Healthy Participants
#### Organization Study ID Info
**ID:** NN7535-7702
#### Organization
**Class:** INDUSTRY
**Full Name:** Novo Nordisk A/S
#### Secondary ID Infos
**Domain:** World Health Organization (WHO)
**ID:** U1111-1289-2544
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-07-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-28
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Novo Nordisk A/S
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to evaluate the effect of food on the amount of etavopivat in the bloodstream of healthy participants. Participants will take a single oral dose of etavopivat following a high-fat meal (i.e. fed) and on an empty stomach (i.e fasted) on two separate occasions.The study will last up to 50 days (including screening).
### Conditions Module
**Conditions:**
- Healthy Volunteers Sickle Cell Disease, Thalassemia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 16
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive a single dose of Etavopivat in fed condition in period 1 and a single dose of Etavopivat in fasted condition in period 2.
**Intervention Names:**
- Drug: Etavopivat
**Label:** Sequence 1: Etavopivat: fed-fasted
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive a single dose of Etavopivat in fasted condition in period 1 and a single dose of Etavopivat in fed condition in period 2.
**Intervention Names:**
- Drug: Etavopivat
**Label:** Sequence 2: Etavopivat: fasted-fed
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Sequence 1: Etavopivat: fed-fasted
- Sequence 2: Etavopivat: fasted-fed
**Description:** Participants will receive single dose of oral Etavopivat in each treatment period.
**Name:** Etavopivat
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Measured as hours nanograms per milliliter (h\*ng/mL).
**Measure:** AUC0-inf, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose
**Time Frame:** From 0 to 120 hours after IMP administration (V2/V6)
**Description:** Measured as nanograms per milliliter (ng/mL).
**Measure:** Cmax, etavopivat: Maximum observed etavopivat plasma concentration after a single dose
**Time Frame:** From 0 to 120 hours after IMP administration (V2/V6)
#### Secondary Outcomes
**Description:** Measured as hours nanograms per milliliter (h\*ng/ml).
**Measure:** AUC0-last, etavopivat: Area under the etavopivat plasma concentration-time curve from 0 hours to the time of last quantifiable concentration
**Time Frame:** From 0 to 120 hours after IMP administration (V2/V6)
**Description:** Measured as hours.
**Measure:** tmax, etavopivat: Time to maximum observed etavopivat plasma concentration after a single dose
**Time Frame:** From 0 to 120 hours after IMP administration (V2/V6)
**Description:** Measured as hours.
**Measure:** t1/2, etavopivat: Terminal half-life for etavopivat after a single dose
**Time Frame:** From 0 to 120 hours after IMP administration (V2/V6)
**Description:** Measured as liter per hours (L/h).
**Measure:** CL/Fetavopivat: Apparent plasma clearance of etavopivat after a single dose
**Time Frame:** From 0 to 120 hours after IMP administration (V2/V6)
**Description:** Measured as liters (L).
**Measure:** Vz/Fetavopivat: Apparent volume of distribution of etavopivat after a single dose based on plasma concentration values
**Time Frame:** From 0 to 120 hours after IMP administration (V2/V6)
**Description:** Measured as count of events.
**Measure:** Number of adverse events
**Time Frame:** From IMP administration on day 1 to completion of the end of study visit (V10)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male or female.
* Age 18-55 years (both inclusive) at the time of signing the informed consent.
* Body mass index (BMI) between 18.5 and 39.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening.
* Body weight greater than or equal to (≥) 40.0 kilogram (kg) at screening.
* Considered to be generally healthy based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion Criteria:
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods.
* Participation (i.e., signed informed consent) in any other interventional clinical study within 30 days or 5 times the half-life of the previous investigational medicinal product (IMP) (if known), whichever is longer before screening.
* Any disorder, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
* Use of tobacco and nicotine products, defined as any of the below:
* Has used any product containing tobacco or nicotine within 90 days prior to screening,
* Unable or unwilling to refrain from the use of any product containing tobacco or nicotine throughout the study,
* Positive nicotine test at screening.
* Participant is unable to refrain from or anticipates the use of any drug known to be a moderate or strong inhibitor or inducer of uridine 5'-diphospho-glucuronosyltransferase (UGT) enzymes, cytochrome P450 (CYP) 3A4, CYP2C9 or permeability glycoprotein (P-gp), including St. John's Wort, for 28 days prior to dosing and throughout the study.
* Participant is unable to refrain from or anticipate the use of any medications or substances prohibited in the study.
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Novo Nordisk
**Phone:** (+1) 866-867-7178
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Salt Lake City
**Country:** United States
**Facility:** ICON-Salt Lake City
**State:** Utah
**Zip:** 84124
#### Overall Officials
**Official 1:**
**Affiliation:** Novo Nordisk A/S
**Name:** Clinical Transparency (dept. 2834)
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
**IPD Sharing:** YES
**URL:** http://novonordisk-trials.com
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000000745
- Term: Anemia, Hemolytic, Congenital
- ID: D000000743
- Term: Anemia, Hemolytic
- ID: D000000740
- Term: Anemia
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000006453
- Term: Hemoglobinopathies
- ID: D000030342
- Term: Genetic Diseases, Inborn
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4085
- Name: Anemia, Sickle Cell
- Relevance: HIGH
- As Found: Sickle Cell Disease
- ID: M16557
- Name: Thalassemia
- Relevance: HIGH
- As Found: Thalassemia
- ID: M4070
- Name: Anemia
- Relevance: LOW
- As Found: Unknown
- ID: M9547
- Name: Hemolysis
- Relevance: LOW
- As Found: Unknown
- ID: M4073
- Name: Anemia, Hemolytic
- Relevance: LOW
- As Found: Unknown
- ID: M4075
- Name: Anemia, Hemolytic, Congenital
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9539
- Name: Hemoglobinopathies
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: T5229
- Name: Sickle Cell Anemia
- Relevance: LOW
- As Found: Unknown
- ID: T5622
- Name: Thalassemia
- Relevance: HIGH
- As Found: Thalassemia
### Condition Browse Module - Meshes
- ID: D000000755
- Term: Anemia, Sickle Cell
- ID: D000013789
- Term: Thalassemia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433648
**Brief Title:** Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait
**Official Title:** Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait
#### Organization Study ID Info
**ID:** STU00217960
#### Organization
**Class:** OTHER
**Full Name:** Shirley Ryan AbilityLab
### Status Module
#### Completion Date
**Date:** 2029-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2028-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shirley Ryan AbilityLab
#### Responsible Party
**Investigator Affiliation:** Shirley Ryan AbilityLab
**Investigator Full Name:** Levi Hargrove
**Investigator Title:** Scientific Chair, Center for Bionic Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this study is to understand how providing power at the knee or ankle individually, or providing power at both the knee and ankle, impacts ambulation for K2 level transfemoral amputees.
Aim 1: measure functional performance of K2 level ambulators when using a commercially available passive microprocessor knee prosthesis (Ottobock Cleg/Ottobock foot) or a powered knee and ankle prosthesis (SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle.
Aim 2: Participants will be evaluated on the contribution of adding power at the knee only or the ankle only.
Aim 3: The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis (SRALab Hybrid Knee and SRALab Polycentric Powered Ankle).
Our hypothesis is that providing powered componentry will improve function and that intensive training will magnify those improvements.
**Detailed Description:** Amputation of the lower limb causes profound disability, significantly limiting mobility, independence, and the ability to pursue employment or leisure activities. Nearly 90% of all lower limb amputations in the United States occur in older persons, mostly due to vascular disease, and this population is expected to triple by 2050. After lower limb loss, individuals walk more slowly and more asymmetrically are less stable, and expend more metabolic energy during walking than persons with intact limbs. Even when using state-of-the-art microprocessor-controlled prostheses (typically a microprocessor knee with a passive ankle), persons with transfemoral amputations expend approximately 60% more energy than able-bodied individuals during ambulation. In addition to the physical limitations caused by the amputation, the increased energy requirements affect performance of everyday activities, including getting up out of a chair or off the toilet, or stepping up or down a curb.
Most commercially available prosthetic legs are passive. The movement of a passive prosthetic joint relies on the properties of its mechanical components, such as hydraulic or pneumatic valves or sliding joints, together with compensatory adjustments made by the user. Since these computerized prostheses are passive, the user cannot efficiently negotiate stairs, an incline, or the numerous other functions that require net knee and/or ankle power.
Powered prostheses can actively generate joint torque, allowing easy and efficient performance of more demanding activities, such as ascending stairs and hills. Powered knees and ankles, may allow for better outcomes in both older and younger individuals with transfemoral amputation; this powered componentry may enable more energy efficient walking, allow users to stand up from a seated position with ease, and enable them to walk across more challenging terrains-such as up and down hills, ramps, and stairs-safely and with more normal and symmetric gait kinematics and kinetics.
This study will demonstrate the functional benefits of adding power at an individual joint. This knowledge will be critical for prioritizing future device development and will provide valuable information for clinicians and individuals on selecting appropriate componentry for transfemoral K2 amputees.
### Conditions Module
**Conditions:**
- Amputation
- Amputation, Traumatic
- Amputation of Knee
- Amputation; Traumatic, Limb
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** The goal of this study is to understand how providing power at the knee or ankle individually, or providing power at both the knee and ankle, impacts ambulation for transfemoral amputees with limited community mobility.
Aim 1: measure functional performance of transfemoral ambulators when using a commercially available passive microprocessor knee prosthesis (Ottobock Cleg/Ottobock foot) or a powered knee and ankle prosthesis (SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle.
Aim 2: Participants will be evaluated on the contribution of adding power at the knee only or the ankle only.
Aim 3: The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis (SRALab Hybrid Knee and SRALab Polycentric Powered Ankle).
##### 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:** Participant is fit with the commercially available device (Ottobock Cleg 4/Ottobock foot), they will receive standard of care clinical training for 3-4 sessions over 4 weeks, plus 1 session for outcome assessments.
Participant is then fit with the SRALAB Hybrid knee and SRALAB Polycentric Ankle prosthesis, they again will receive clinical training for 3-4 sessions over 4 weeks, plus 1 session for outcome assessments.
**Intervention Names:**
- Device: Ottobock CLeg4 + Ottobock foot
- Device: SRALAB Hybrid Knee + Polycentric Ankle
**Label:** Transfemoral Amputee participants: Ottobock Cleg4 + Ottobock foot; Hybrid Knee + Polycentric Ankle
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** For this arm, transfemoral amputees will participate in an AB/BA randomized crossover study.
Before each arm of the cross-over, baseline data will be taken with the Ottobock Cleg 4/Ottobock foot or their clinically prescribed microprocessor knee unit/foot.
Condition A is CLeg + Polycentric Ankle
Condition B is SRALab Hybrid knee + Passive Ankle
Subjects will participate in 2 sessions over 2 weeks, each lasting 2-3 hours to have the device tuned for the specific condition (A or B). On the third week, they will participate in 2 visits to complete functional outcome measures, biomechanical and metabolic assessments. They will then switch conditions, and repeat the protocol for the second condition.
There will not be a washout period between conditions, but subjects will complete outcome measures with the Ottobock Cleg 4/Ottobock foot or their clinically prescribed microprocessor knee unit/foot prior to each arm of the crossover to obtain baseline data.
**Intervention Names:**
- Device: SRALAB Hybrid Knee + Passive Ankle
- Device: Ottobock CLeg 4 + Polycentric Ankle
**Label:** Transfemoral Amputee participants: Ottobock CLeg4 + Polycentric Ankle, Hybrid Knee + Passive Ankle
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** During this arm, participants will receive intensive clinical training with the SRALAB Hybrid knee + Polycentric Ankle twice per week over 8 weeks, lasting 2-3 hours. Training will include patient-driven therapy to achieve participants' individual therapy goals, functional mobility and community skills.
At the end of the 8-week training period, subjects will complete the same set of functional outcome measures, biomechanical and metabolic assessments in previous arms.
To complete this arm, participants will again complete training and outcome measures with the Ottobock Cleg4/Ottobock or their clinically prescribed microprocessor knee unit/foot over 3 visits.
**Intervention Names:**
- Device: Ottobock CLeg4 + Ottobock foot
- Device: SRALAB Hybrid Knee + Polycentric Ankle
**Label:** Transfemoral Amputee participants: SRALAB Hybrid knee + Polycentric Ankle, Ottobock Cleg4 + OB foot
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Transfemoral Amputee participants: Ottobock Cleg4 + Ottobock foot; Hybrid Knee + Polycentric Ankle
- Transfemoral Amputee participants: SRALAB Hybrid knee + Polycentric Ankle, Ottobock Cleg4 + OB foot
**Description:** Commercially available Ottobock CLeg 4 microprocessor knee unit and Ottobock foot.
**Name:** Ottobock CLeg4 + Ottobock foot
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Transfemoral Amputee participants: Ottobock Cleg4 + Ottobock foot; Hybrid Knee + Polycentric Ankle
- Transfemoral Amputee participants: SRALAB Hybrid knee + Polycentric Ankle, Ottobock Cleg4 + OB foot
**Description:** Experimental powered prosthesis: SRALAB Hybrid Knee and powered polycentric ankle.
**Name:** SRALAB Hybrid Knee + Polycentric Ankle
**Type:** DEVICE
#### Intervention 3
**Arm Group Labels:**
- Transfemoral Amputee participants: Ottobock CLeg4 + Polycentric Ankle, Hybrid Knee + Passive Ankle
**Description:** Experimental powered prosthesis: SRALAB Hybrid Knee and passive ankle.
**Name:** SRALAB Hybrid Knee + Passive Ankle
**Type:** DEVICE
#### Intervention 4
**Arm Group Labels:**
- Transfemoral Amputee participants: Ottobock CLeg4 + Polycentric Ankle, Hybrid Knee + Passive Ankle
**Description:** Commercially available Ottobock CLeg 4 prosthetic knee and SRALAB powered polycentric ankle.
**Name:** Ottobock CLeg 4 + Polycentric Ankle
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The AMPRO measures the ambulatory potential of lower limb amputees. It is used to assess functional mobility through a standardized sequence of mobility tests while using a prosthesis. Individual tasks are scored and combined, resulting in a total assessment score out of a possible 47; the minimum score is zero. Higher scores indicate better mobility.
The AMPPRO is a reliable performance measure that has been validated for those with lower limb loss; it measures several functional mobility tasks that are needed during activities of daily living; it has been used to identify limitations in prosthetic mobility, including tasks that require both vertical mobility (sit/stand), horizontal mobility (walking), and balance. The AMPPRO scores have been shown to differentiate between Medicare K-levels and to provide information to guide therapeutic exercise techniques and document change after clinical instruction.
**Measure:** Amputee Mobility Predictor with Prosthesis (AMPRO) score
**Time Frame:** Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.
#### Secondary Outcomes
**Description:** The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
**Measure:** 6 Minute Walk Test (6MWT)
**Time Frame:** Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.
**Description:** The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults.
**Measure:** Timed Up and Go (TUG)
**Time Frame:** Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.
**Description:** A test of dynamic balance and coordination that clinically assesses the participant's ability to step over objects forward, sideways, and backwards.
**Measure:** Four Square Step Test (FSST)
**Time Frame:** Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38.
**Description:** Subjects will be instrumented with the COSMED® K5 system (COSMED, Rome, Italy). Baseline metabolic data prior to each walking bout will be recorded for 2 minutes of sitting and quiet rest. Metabolic data will then be collected during 6 minutes of walking at a constant self-selected walking velocity on a treadmill. After each walking bout, subjects will rest for 20 minutes to allow their heart rate to return to their baseline level.
**Measure:** Metabolic Testing
**Time Frame:** Completed at visit during week 5, week 10, week 11, week 14, week 15, week 18, week 35 and week 38
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Ages 18-95
* A unilateral transfemoral amputation
* At least 6 months since definitive prosthesis fitting
* Able to walk 50 meters (55 yards) with a prosthesis without the assistance of another person.
* Medically cleared by physician to participate in study
* English speaking
Exclusion Criteria:
* Weight greater than 250 pounds
* Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
* Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
* Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers.
**Maximum Age:** 95 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Suzanne Finucane, MS, PTA
**Phone:** 312-238-0937
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Levi Hargrove, PhD
**Phone:** 312-238-2080
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chicago
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Suzanne Finucane, MS, PTA
- **Phone:** 312-238-0937
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Levi Hargrove, PhD
- **Phone:** 312-238-2080
- **Role:** CONTACT
***Contact 3:***
- **Name:** Levi Hargrove, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Shirley Ryan AbilityLab
**State:** Illinois
**Status:** RECRUITING
**Zip:** 60611
### References Module
#### References
**Citation:** Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
**PMID:** 18295618
**Citation:** Gailey RS, Wenger MA, Raya M, Kirk N, Erbs K, Spyropoulos P, Nash MS. Energy expenditure of trans-tibial amputees during ambulation at self-selected pace. Prosthet Orthot Int. 1994 Aug;18(2):84-91. doi: 10.3109/03093649409164389.
**PMID:** 7991365
**Citation:** Hafner BJ, Sanders JE, Czerniecki J, Fergason J. Energy storage and return prostheses: does patient perception correlate with biomechanical analysis? Clin Biomech (Bristol, Avon). 2002 Jun;17(5):325-44. doi: 10.1016/s0268-0033(02)00020-7.
**PMID:** 12084537
**Citation:** Burger H, Marincek C. The life style of young persons after lower limb amputation caused by injury. Prosthet Orthot Int. 1997 Apr;21(1):35-9. doi: 10.3109/03093649709164528.
**PMID:** 9141124
**Citation:** Fey NP, Simon AM, Young AJ, Hargrove LJ. Controlling Knee Swing Initiation and Ankle Plantarflexion With an Active Prosthesis on Level and Inclined Surfaces at Variable Walking Speeds. IEEE J Transl Eng Health Med. 2014 Jul 25;2:2100412. doi: 10.1109/JTEHM.2014.2343228. eCollection 2014.
**PMID:** 27170878
**Citation:** Adamczyk PG, Kuo AD. Mechanisms of Gait Asymmetry Due to Push-Off Deficiency in Unilateral Amputees. IEEE Trans Neural Syst Rehabil Eng. 2015 Sep;23(5):776-85. doi: 10.1109/TNSRE.2014.2356722. Epub 2014 Sep 12.
**PMID:** 25222950
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4009
- Name: Amputation, Traumatic
- Relevance: HIGH
- As Found: Amputation, Traumatic
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000673
- Term: Amputation, Traumatic
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433635
**Acronym:** SMART-BD
**Brief Title:** Sequential Multiple Assignment Randomized Trial for Bipolar Depression
**Official Title:** Sequential Multiple Assignment Randomized Trial for Bipolar Depression
#### Organization Study ID Info
**ID:** 2024P000831
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts General Hospital
### Status Module
#### Completion Date
**Date:** 2030-02-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2030-02-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Patient-Centered Outcomes Research Institute
#### Lead Sponsor
**Class:** OTHER
**Name:** Massachusetts General Hospital
#### Responsible Party
**Investigator Affiliation:** Massachusetts General Hospital
**Investigator Full Name:** Andrew A. Nierenberg, MD
**Investigator Title:** Director, Dauten Family Center for Bipolar Treatment Innovation
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a sequential multiple assignment randomized trial for adults (ages \> 18) with a bipolar disorder type 1 diagnosis currently experiencing a depressive episode. It is a randomized pragmatic trial that will compare four commonly prescribed treatments for bipolar depression, which includes three FDA-approved medications (Cariprazine, Quetiapine and Lurasidone) and one antipsychotic/antidepressant combination (Aripiprazole/Escitalopram).
**Detailed Description:** This is a comparative effectiveness study to address the critical questions of how best to treat people with bipolar disorder who have a major depressive episode: how to get them well, provide second-line treatment when they don't initially get well, and keep them well after they get well. This is a multisite Sequential Multiple Assignment Randomized Trial (SMART) comparative effectiveness design. Investigators will recruit 2726 participants who have BD with a current major depressive episode. In Stage 1, investigators will compare four treatment arms, including three FDA approved monotherapies and the most widely used, but understudied, treatment for BD major depressive episode (i.e., a non-FDA approved combination of an antipsychotic and antidepressant). In Stage 2, participants who do not remit will be re-randomized to treatments not used in Stage 1. Investigators will follow all participants for a total of 52 weeks. This study will be conducted in two phases, a feasibility phase and a full study phase. In the feasibility phase, investigators will recruit at 8 of the 19 study sites based on readiness and interest, to ensure the efficacy of the study design before launching the full study phase.
Feasibility Aim 1: To ensure that 8 of the 19 selected sites can recruit, randomize, and retain participants. During the feasibility phase, the selected sites will recruit 133 participants, administer baseline assessments, randomize the participants (at baseline and again at 6-weeks for non-remitters), and conduct follow-up assessments at the end of Stage 1 (6-weeks) and the end of Stage 2 (12-weeks) and end of study (52 weeks or end of feasibility phase, whichever is sooner) and all other scheduled visits.
Feasibility Aim 2: To refine and finalize all study standard operating procedures for the full-scale study. After Aim 1 is complete, any changes in standard operating procedures will be made as needed to be implemented in the full study phase.
Full Scale Study Full-Scale Study Aim 1: To compare the effectiveness, tolerability, and safety of the four treatments for BD major depressive episodes.
Hypothesis 1a: There will be significant differences across the Stage 1 treatments in the proportion of remitters at week 6 (primary endpoint, effectiveness) and in the average adverse event burden and suicidal ideation/behavior at week 6 (secondary endpoints, tolerability and safety).
Hypothesis 1b: Among non-remitters of a given Stage 1 treatment (i.e., participants who do not remit by week 6), there will be significant differences across the three remaining Stage 2 treatments in the proportion of remitters at week 12 (primary endpoint, effectiveness) and the average side effect burden and suicidal ideation/behavior at week 12 (secondary endpoints, tolerability and safety).
Full-Scale Study Aim 2: To characterize the effectiveness, tolerability, and safety of the 12 adaptive interventions for BD major depressive episodes embedded within the SMART design.
Hypothesis 2: On average, there will be significant differences across the 12 embedded adaptive interventions in the proportion of remitters at week 12 (primary endpoint, effectiveness) and in the average side effect burden and suicidal ideation/behavior at week 12 (secondary endpoints, tolerability and safety).
Full-Scale Study Aim 3: To determine individual-level characteristics that predict heterogeneity of treatment effect (HTE) across the 12 adaptive interventions for BD major depressive episodes embedded within the SMART design.
Hypothesis 3a: Individual-level characteristics and symptoms assessed at baseline as well as symptom changes and side effect profiles at week 6 will predict HTE at weeks 12 and 52. Hypothesis 3b: Investigators hypothesize that an optimal personalized adaptive intervention will perform significantly better than the best aggregate embedded adaptive intervention identified in Aim 2 in terms of the proportion of remitters at week 12 (primary endpoint, effectiveness) and the side effect burden and suicidal ideation/behavior at week 12 (secondary endpoints, tolerability and safety).
### Conditions Module
**Conditions:**
- Bipolar I Disorder
- Depression
**Keywords:**
- Bipolar
- Depression
- Adults
- Medication
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 2726
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Cariprazine
**Label:** Cariprazine
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Aripiprazole/Escitalopram combination
**Label:** Aripiprazole /Escitalopram combination
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Drug: Quetiapine
**Label:** Quetiapine
**Type:** EXPERIMENTAL
#### Arm Group 4
**Intervention Names:**
- Drug: Lurasidone
**Label:** Lurasidone
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cariprazine
**Description:** 1. Cariprazine monotherapy outperformed placebo in improving depressive symptoms in most large randomized control trials (RCT). Pooled data showed higher remission rates (30.2%) with cariprazine (1.5 mg and 3 mg/day) compared to placebo (20.9%). Its efficacy extends to bipolar I depression, including mixed features and anxiety.
2. Common adverse effects include nausea (8%) and akathisia (7%). Somnolence and sedation were slightly more common with cariprazine than placebo.
3. Results from a large RCT evaluating cariprazine for bipolar disorder maintenance treatment (NCT03573297) are awaited. An open-label trial reported reduced manic symptoms over 16 weeks.
4. Cariprazine is a D3-preferring partial agonist for D3 and D2 receptors. It antagonizes 5-HT2A and 5-HT2B receptors and partially agonizes 5-HT1A receptors. Affinity for 5-HT1C and histamine 1 receptors is low to moderate.
**Name:** Cariprazine
**Other Names:**
- Vraylar
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Aripiprazole /Escitalopram combination
**Description:** 1. 40-70% of bipolar patients use antidepressants, often with antipsychotics or mood stabilizers. Aripiprazole lacks efficacy in bipolar depression but is used for mania. Escitalopram, studied alongside mood stabilizers, showed some efficacy.
2. Aripiprazole in bipolar depression trials led to higher rates of akathisia, insomnia, nausea, fatigue, and impulse control disorders. Escitalopram's is generally safe but adverse effects include nausea, diarrhea, insomnia, dry mouth, ejaculatory dysfunction and dizziness.
3. Aripiprazole monotherapy in bipolar I patients reduced relapse rates and delayed relapse time, but not for depressive episodes.
4. Aripiprazole acts as a partial agonist at D2, D3, 5-HT1A, and 5-HT2C receptors, with antagonistic effects on α1 and possibly H1 receptors. Escitalopram is highly selective for the serotonin transporter, with no significant activity at other receptors.
**Name:** Aripiprazole/Escitalopram combination
**Other Names:**
- Abilify/ Lexapro
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Quetiapine
**Description:** 1. Both immediate and extended-release quetiapine monotherapies showed superiority over placebo in acute BD depression across three 8-week randomized trials, confirmed by meta-analysis. Quetiapine exhibited significantly higher remission rates (52.8%) compared to placebo (34.7%) and improved various aspects of life, including quality of life, clinical global impression, sleep, functioning, and anxiety.
2. Common adverse events of quetiapine include sedation, hypotension, increased appetite, weight gain, dyslipidemia, and elevated glucose levels, particularly in a population already at risk.
3. Four studies examined quetiapine's maintenance effects in patients with manic, mixed, or depressive episodes. Overall, quetiapine prolonged the time to recurrence for both depressive and manic episodes.
**Name:** Quetiapine
**Other Names:**
- Seroquel
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Lurasidone
**Description:** 1. Lurasidone, either alone or with lithium/valproate, proved more effective than placebo for acute BD depression in two 6-week randomized trials. Remission rates were significantly higher with lurasidone monotherapy (40.9%) and in combination (50.3%) compared to placebo (24.7% and 35.4% respectively). Lurasidone also improved anxiety, quality of life, and disability.
2. Common mild adverse events included nausea, headache, akathisia, somnolence, sedation, dry mouth, and vomiting. Weight gain, dyslipidemia, and increased glucose levels were not observed.
3. In a 6-month double-blind discontinuation study post-acute treatment response, lurasidone combined with lithium/valproate prolonged time to depressive episode recurrence compared to placebo (hazard ratio: 0.68). Although not statistically significant due to low placebo recurrence and shorter follow-up, it hints at maintenance efficacy.
**Name:** Lurasidone
**Other Names:**
- Latuda
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** self-rating mania scale designed to assess the presence and/or severity of manic symptoms in children and adolescents
The range is from 5-25, higher scores reflect increased symptoms of of mania
**Measure:** Altman Self-Rating Mania Scale
**Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).
**Description:** A seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD).
The range is from 0-21, higher scores reflect increased symptoms of of anxiety
**Measure:** Generalized Anxiety Disorder Assessment
**Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).
**Description:** The MRTF generates the average number of necessary clinical adjustments per month, which provides a method to compare long-term outcomes in a pragmatic trial.
There is no range or scoring necessary for this assessment.
**Measure:** Medication Reconciliation Tracking Form
**Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).
**Description:** The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression
The range is from 0-27, higher scores reflect increased symptoms of of depression
**Measure:** Patient Health Questionnaire
**Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).
**Description:** Cognitive deficits will be assessed with the PROMIS- Cognitive Function-Short Form. This 8-item self-report questionnaire has good construct validity and psychometric properties and has been used as an outcome in multiple studies.
The range is from 8-40, increased scores are associated with a person's increased perception of cognitive function in areas such as concentration, memory, and mental acuity
**Measure:** PROMIS Item Bank v2.0 Cognitive Functioning- Short Form
**Time Frame:** Investigators will administer this measure at baseline (week 0), week 6, and week 12. Then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).
**Description:** This measure is an 8 item self-report questionnaire that assesses the individual's satisfaction with social roles and activities. The measure has clinical validity across a range of chronic conditions, including depression and responds to change in clinical state
The range is from 8-40 increased scores are associated with higher feelings of satisfaction with performing one's usual social roles and activities
**Measure:** PROMIS Item Bank v2.0 Satisfaction with Social Roles and Activities
**Time Frame:** Investigators will administer this measure at baseline (week 0), week 6, and week 12. Then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).
**Description:** The YMRS is a rating scale used to evaluate manic symptoms at baseline and over time in individuals with mania.
The range is from 0-60, higher scores reflect increased risk for Bipolar Disorder. If the participant scores 18 or above on the YMRS, they will be considered manic and not in remission even if they meet criteria for remission with the RDQ
**Measure:** Young Mania Rating Scale
**Time Frame:** Investigators can administer at any time between weeks 0 to 52. This assessment only applies if patients has a pseudo-remission from depression, indicated if the patient scores a 6 or higher on the self-rated Altman Scale for Rating Mania (ASRM)
**Description:** The QoL.BD93,94 measures 12 core domains (physical, sleep, mood, cognition, leisure, social, spirituality, finances, household, self-esteem, independence, identity) and 2 optional (work, education) domains
A brief 12-item version represents the core QoL domains and is scored on a five-point range (1: strongly disagree to 5: strongly agree). The range of scoring is 12-60 with higher scores reflecting a greater belief in ones quality of life.
**Measure:** Quality of Life Scale
**Time Frame:** Investigators will administer this measure at baseline (week 0), week 6, and week 12. Then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).
#### Primary Outcomes
**Description:** RDQ is a 41 items self report questionnaire used to assess the seven domains found in extensive previous research to be important to patients: depressive symptoms, anxiety, coping ability, positive mental health, functioning, life satisfaction and a general sense of well-being. Using a score of 27 as the cutoff, the RDQ scale has a sensitivity of 83.7% and specificity of 77.9% in predicting self-reported remission status. The RDQ has excellent internal consistency reliability (Cronbach's alpha of 0.97 for the total scale and above 0.80 for each of the 7 subscales with test-retest reliability of the total scale = 0.85 and \> 0.60 for each subscale). The primary outcome will be remission as defined by a RDQ score \< 27. This test will be administered in all assessment visits.
The RDQ scale ranges from 0-27 per domain, with higher scores indicating greater remission rates.
**Measure:** The Remission from Depression Questionnaire
**Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).
#### Secondary Outcomes
**Description:** CHRT is a 14 item self-report measure of suicidal ideation and behavior in individuals with mood disorders. The CHRT has excellent psychometric properties, with an internal consistency reliability (Cronbach's alpha) of 0.78 and a consistent factor structure with 3 independent factors (current suicidal thoughts and plans, perceived lack of social support, and hopelessness).
The range is from 14-70, higher scores reflect an increase in suicidality behaviors.
**Measure:** Safety: Concise Health Risk Tracking Scale
**Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).
**Description:** This subscale of the FIBSER scale is a reliable self-report measure of the intensity of side effects from medications in a population receiving treatment for depression. This scale measures the participants side effects intensity from the previous week and has them rate each on a scale from 0-6. The results will help the clinician determine the appropriate level of response.
The range is from 0-6, higher scores reflect an greater intensity in medication side effects.
**Measure:** Frequency and Intensity of Side Effects Ratings - Intensity
**Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).
**Description:** This subscale of the FIBSER scale is a reliable and valid self-report measure on the frequency of medication side effects in a population receiving treatment for depression. This scale measures the participants side effects frequency from the previous week and has them rate each on a scale from 0-6. The results will help the clinician determine the appropriate level of response.
The range is from 0-6, higher scores reflect an greater frequency in medication side effects.
**Measure:** Frequency and Intensity of Side Effects Ratings - Frequency
**Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).
**Description:** This subscale of the FIBSER scale is a reliable self-report measure of the side effects burden of medications in a population receiving treatment for depression. This scale measures the participants side effects burden from the previous week and has them rate each on a scale from 0-6. The results will help the clinician determine the appropriate level of response.
The range is from 0-6, higher scores reflect an greater burden in medication side effects.
**Measure:** Frequency and Intensity of Side Effects Ratings - Burden
**Time Frame:** Investigators will administer this measure every 2 weeks for the first 12 weeks (weeks:0,2,4,6,8,10,12), and then at each study visit during the follow up phase until they are discharged from the study (weeks:20,28,36,44,52 ).
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Aged between 18 years to 75 years
2. Meets criteria for DSM-V Bipolar I disorder with a history of manic episodes and current major depressive episode lasting at least 6 weeks
3. Can be managed as an outpatient and participate in the study
4. Willing to be randomized; able to perform study assessments
5. Women of childbearing potential must agree to use adequate contraception (e.g. oral contraceptives, intrauterine device, barrier methods, or total abstinence; Depo Provera is acceptable if it is started 3 months prior to enrollment), and inform staff of their plans to conceive.
Exclusion Criteria:
1. Meets current criteria for a manic episode, rapid cycling within the past year (history of 4 or more mood episodes per year)
2. History of schizophrenia or other nonaffective psychosis
3. Current substance use disorder that will interfere with participation in the study
4. Currently taking the study medications or a history of serious adverse events to any of the study medications, to the extent that as determined by site PI, another trial would not be clinically indicated
5. A history of non-response for depressive episodes, to any of the study medications, when given at adequate doses for at least 6 weeks
6. Current acute suicidal risk that requires inpatient treatment
7. Pregnancy or breastfeeding
**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:** Andrew Nierenberg, M.D
**Phone:** 617-724-0837
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Birmingham
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Samanta White
- **Role:** CONTACT
***Contact 2:***
- **Name:** Richard Shelton
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Matthew Macaluso
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Alabama Birmingham
**State:** Alabama
**Zip:** 35294
**Location 2:**
**City:** Baltimore
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Audrey Shoultz
- **Role:** CONTACT
***Contact 2:***
- **Name:** Scott Aaronson
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Sheppard Pratt Health System
**State:** Maryland
**Zip:** 21204
**Location 3:**
**City:** Baltimore
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Heather Klohr
- **Role:** CONTACT
***Contact 2:***
- **Name:** Fernando Goes
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** John Hopkins
**State:** Maryland
**Zip:** 21218
**Location 4:**
**City:** Belmont
**Contacts:**
***Contact 1:***
- **Name:** Jenny Clark
- **Role:** CONTACT
***Contact 2:***
- **Name:** Dost Ongur
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** McLean Hospital
**State:** Massachusetts
**Zip:** 02478
**Location 5:**
**City:** Boston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Khadija Tlaiti
- **Phone:** 617-584-3285
- **Role:** CONTACT
***Contact 2:***
- **Name:** Masoud Kamali
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Massachusetts General Hospital
**State:** Massachusetts
**Zip:** 02114
**Location 6:**
**City:** Ann Arbor
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jacqui Grisdale
- **Role:** CONTACT
***Contact 2:***
- **Name:** Sagar Parikh
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Melvin McInnis
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Michigan
**State:** Michigan
**Zip:** 48109
**Location 7:**
**City:** Rochester
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Michelle Skime
- **Role:** CONTACT
***Contact 2:***
- **Name:** Mark Frye
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Mayo Clinic
**State:** Minnesota
**Zip:** 55902
**Location 8:**
**City:** Albuquerque
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Josh Corb
- **Role:** CONTACT
***Contact 2:***
- **Name:** Mauricio Tohen
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of New Mexico Health Sciences Center Albuquerque
**State:** New Mexico
**Zip:** 87131-0001
**Location 9:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xiaotong Song
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Dan Iosifescu
- **Role:** CONTACT
***Contact 3:***
- **Name:** Dan Iosifescu
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** New York University Grossman School of Medicine NYU
**State:** New York
**Zip:** 10016
**Location 10:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jennifer Alexander
- **Role:** CONTACT
***Contact 2:***
- **Name:** Thomas Betzler
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Jonathan Alpert
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Montefiore Medical Center and Albert Einstein College of Medicine
**State:** New York
**Zip:** 10461
**Location 11:**
**City:** Chapel Hill
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Amanda Teer
- **Role:** CONTACT
***Contact 2:***
- **Name:** Bradley Gaynes
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of North Carolina at Chapel Hill
**State:** North Carolina
**Zip:** 27599
**Location 12:**
**City:** Cleveland
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Carla Conroy
- **Role:** CONTACT
***Contact 2:***
- **Name:** Keming Gao
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Case Western Reserve University
**State:** Ohio
**Zip:** 44106-1712
**Location 13:**
**City:** Philadelphia
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Anita Agarwal
- **Role:** CONTACT
***Contact 2:***
- **Name:** Michael Thase
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Pennsylvania
**State:** Pennsylvania
**Zip:** 19104
**Location 14:**
**City:** Pittsburgh
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Elizabeth Yute
- **Role:** CONTACT
***Contact 2:***
- **Name:** Holly Swartz
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Pittsburgh
**State:** Pennsylvania
**Zip:** 15260
**Location 15:**
**City:** Austin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lindsey Demeritt
- **Role:** CONTACT
***Contact 2:***
- **Name:** Jorge Almeida
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Texas at Austin
**State:** Texas
**Zip:** 78712
**Location 16:**
**City:** Dallas
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lezlie Britton
- **Role:** CONTACT
***Contact 2:***
- **Name:** Madhukar Trivedi
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Manish Jha
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Texas at Southwestern Medical Center
**State:** Texas
**Zip:** 75390-7208
**Location 17:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Chelsea Tran
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Courteny Vecera
- **Role:** CONTACT
***Contact 3:***
- **Name:** Giovana Zunta-Soares
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Jair Soares
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 5:***
- **Name:** Rodrigo MachadoVeira
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** UT Health Houston Texas
**State:** Texas
**Zip:** 77030
**Location 18:**
**City:** Vancouver
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Nazlin Walji
- **Role:** CONTACT
***Contact 2:***
- **Name:** Lakshmi Yatham
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Canada
**Facility:** University of British Columbia
**State:** British Columbia
**Zip:** V6T 1Z4
**Location 19:**
**City:** Toronto
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lee Phan
- **Role:** CONTACT
***Contact 2:***
- **Name:** Roger McIntyre
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Canada
**Facility:** University of Toronto
**State:** Ontario
**Zip:** M5R 0A3
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000019964
- Term: Mood Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000068105
- Term: Bipolar and Related Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: HIGH
- As Found: Depression
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M4996
- Name: Bipolar Disorder
- Relevance: HIGH
- As Found: Bipolar Depression
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M21835
- Name: Mood Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M226
- Name: Bipolar and Related Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003863
- Term: Depression
- ID: D000003866
- Term: Depressive Disorder
- ID: D000001714
- Term: Bipolar Disorder
### Intervention Browse Module - Ancestors
- ID: D000017367
- Term: Selective Serotonin Reuptake Inhibitors
- ID: D000014179
- Term: Neurotransmitter Uptake Inhibitors
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000018490
- Term: Serotonin Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000928
- Term: Antidepressive Agents
- ID: D000011619
- Term: Psychotropic Drugs
- ID: D000014150
- Term: Antipsychotic Agents
- ID: D000014149
- Term: Tranquilizing Agents
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000018491
- Term: Dopamine Agonists
- ID: D000015259
- Term: Dopamine Agents
- ID: D000058825
- Term: Serotonin 5-HT1 Receptor Agonists
- ID: D000017366
- Term: Serotonin Receptor Agonists
- ID: D000058830
- Term: Serotonin 5-HT2 Receptor Antagonists
- ID: D000012702
- Term: Serotonin Antagonists
- ID: D000065127
- Term: Dopamine D2 Receptor Antagonists
- ID: D000018492
- Term: Dopamine Antagonists
- ID: D000058669
- Term: Adrenergic alpha-2 Receptor Antagonists
- ID: D000000317
- Term: Adrenergic alpha-Antagonists
- ID: D000018674
- Term: Adrenergic Antagonists
- ID: D000018663
- Term: Adrenergic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AntiConv
- Name: Anticonvulsants
- Abbrev: AnDyAg
- Name: Anti-Dyskinesia Agents
- Abbrev: CaAg
- Name: Cardiotonic Agents
### Intervention Browse Module - Browse Leaves
- ID: M229
- Name: Aripiprazole
- Relevance: HIGH
- As Found: Safety and Tolerability
- ID: M399
- Name: Quetiapine Fumarate
- Relevance: HIGH
- As Found: Sugar
- ID: M293041
- Name: Cariprazine
- Relevance: HIGH
- As Found: Weekdays
- ID: M2732
- Name: Escitalopram
- Relevance: HIGH
- As Found: Enrollment
- ID: M19022
- Name: Lithium Carbonate
- Relevance: LOW
- As Found: Unknown
- ID: M17983
- Name: Citalopram
- Relevance: LOW
- As Found: Unknown
- ID: M9708
- Name: Histamine
- Relevance: LOW
- As Found: Unknown
- ID: M17383
- Name: Valproic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M4247
- Name: Antidepressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7104
- Name: Dexetimide
- Relevance: LOW
- As Found: Unknown
- ID: M16904
- Name: Antipsychotic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M15512
- Name: Serotonin
- Relevance: LOW
- As Found: Unknown
- ID: M212144
- Name: Histamine phosphate
- Relevance: LOW
- As Found: Unknown
- ID: M348
- Name: Lurasidone Hydrochloride
- Relevance: HIGH
- As Found: Cochlear Implant
- ID: M19649
- Name: Selective Serotonin Reuptake Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
- ID: M7473
- Name: Dopamine
- Relevance: LOW
- As Found: Unknown
- ID: M20595
- Name: Dopamine Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M17962
- Name: Dopamine Agents
- Relevance: LOW
- As Found: Unknown
- ID: M29240
- Name: Serotonin 5-HT1 Receptor Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M19648
- Name: Serotonin Receptor Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M20596
- Name: Dopamine Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20746
- Name: Adrenergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M29195
- Name: Adrenergic alpha-2 Receptor Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M3669
- Name: Adrenergic alpha-Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20755
- Name: Adrenergic Antagonists
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000068180
- Term: Aripiprazole
- ID: D000069348
- Term: Quetiapine Fumarate
- ID: D000069056
- Term: Lurasidone Hydrochloride
- ID: C000533287
- Term: Cariprazine
- ID: D000089983
- Term: Escitalopram
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433622
**Brief Title:** Platelet Transfusion and Repeat TEG-PM in Patients With Severe TBI on Antiplatelet Therapy (Repeat TEG-PM)
**Official Title:** Platelet Transfusion and Repeat Thromboelastography With Platelet Mapping in Patients With Severe Traumatic Brain Injuries on Antiplatelet Therapy
#### Organization Study ID Info
**ID:** 2023-47
#### Organization
**Class:** OTHER
**Full Name:** Lancaster General Hospital
### Status Module
#### Completion Date
**Date:** 2027-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-12-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Lancaster General Hospital
#### Responsible Party
**Investigator Affiliation:** Lancaster General Hospital
**Investigator Full Name:** Lindsey Perea
**Investigator Title:** Trauma and Acute Care Surgeon
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this study is to see if administering platelets (cells in our blood that stop or prevent bleeding) results in improved platelet function and slows/stops the progression of a head bleed for patients who have a traumatic head bleed and are on antiplatelet therapy (medications that stop blood cells from forming a blood clot) prior to admission.
**Detailed Description:** This study aims to determine if platelet function has improved following platelet transfusion by prospectively performing repeat thromboeleastography with platelet mapping (TEG-PM) assays on all patients consented and enrolled in the study. This study will also examine the rate of progression or stability of ICH on repeat head CT following platelet administration and will aid in the determination of a potential association between repeat CT head findings and the repeat TEG-PM results.
### Conditions Module
**Conditions:**
- Traumatic Intracranial Hemorrhage
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 225
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Will receive a repeat TEG-PM after platelet transfusion based on inclusion criteria.
**Intervention Names:**
- Diagnostic Test: Repeat Thromboelastography with Platelet Mapping
**Label:** Repeat TEG-PM
#### Arm Group 2
**Description:** Not eligible to be consented; will proceed with normal course of treatment.
**Label:** No Repeat TEG-PM
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Repeat TEG-PM
**Description:** Thromboelastography (TEG) is an assay used by many medical professionals to assess coagulopathy, predict outcomes, and guide treatment. Although TEG does not assess platelet function very well, a TEG with platelet mapping (TEG-PM) assay assesses platelet functioning by measuring the percent of arachidonic acid (AA) and adenosine diphosphate (ADP) that are inhibited in the patient's blood.
**Name:** Repeat Thromboelastography with Platelet Mapping
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Other Outcomes
**Description:** Determine the efficacy of platelet transfusion among this patient cohort by measuring mortality rate.
**Measure:** Mortality
**Time Frame:** During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an averge of 2 years.
#### Primary Outcomes
**Description:** Rate of reversed pathway inhibition on repeat thromboelastography with platelet mapping (TEG-PM) when platelets are administered to TICH patients who are on antiplatelet therapy prior to admission.
**Measure:** Repeat TEG
**Time Frame:** 1 hour after platelets given
**Description:** Number of patients with improved platelet function on repeat TEG-PM and stability of TICH on subsequent CT scan.
**Measure:** Repeat Head CT
**Time Frame:** From the time of interventional platelet administration until the time of patient discharge from their index admission, assessed up to 100 weeks.
#### Secondary Outcomes
**Description:** Determine the efficacy of platelet transfusion among this patient cohort by measuring need for neurosurgical intervention after second CT scan (ie: the failure of non-operative management)
**Measure:** Need for Neurosurgical Intervention
**Time Frame:** During index admission for traumatic intracranial hemorrhage (TICH), assessed through study completion, an average of 2 years.
**Description:** Determine the efficacy of platelet transfusion among this patient cohort by reviewing discharge status.
**Measure:** Discharge Status
**Time Frame:** From the time of interventional platelet administration until the time of patient discharge from their index admission assessed through study completion, an average of 2 years.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria for Interventional Portion of Study:
* Patients ≥ 18 years of age who present with isolated TICH meeting BIG 2 or 3 head bleed criteria
* Currently on antiplatelet medication on admission
* Must have taken this antiplatelet medication within the past 48 hours prior to presentation
* Patients who have AA and/or ADP inhibition of 70% or greater and MA \<50 will then receive a platelet transfusion and a repeat TEG-PM 1hr after transfusion
Exclusion Criteria for Interventional Portion of Study:
* Under 18 years of age
* Have a known bleeding diatheses
* Current therapeutic anticoagulation use
* Do not know the time of their last antiplatelet medication dose
* Patients or their proxy who are unable to provide consent
Inclusion Criteria for Retrospective Portion of Study:
• Patients with a TICH who are 18 years of age or older
Exclusion Criteria for Retrospective Portion of Study:
* AIS \>1 in body regions other than head
* Under 18 years of age
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The targeted population includes patients ≥ 18 years of age who present to Penn Medicine Lancaster General Health with isolated TICH. Selection of subjects is based on all adult patients presenting with isolated TICH that are admitted to Lancaster General Health Trauma Center.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lancaster
**Country:** United States
**Facility:** Penn Medicine Lancaster General Health
**State:** Pennsylvania
**Zip:** 17602
#### Overall Officials
**Official 1:**
**Affiliation:** Penn Medicine Lancaster General Health
**Name:** Lindsey Perea, DO
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Traumatic brain injury: time to end the silence. Lancet Neurol. 2010 Apr;9(4):331. doi: 10.1016/S1474-4422(10)70069-7. No abstract available.
**PMID:** 20298955
**Citation:** Li L, Geraghty OC, Mehta Z, Rothwell PM; Oxford Vascular Study. Age-specific risks, severity, time course, and outcome of bleeding on long-term antiplatelet treatment after vascular events: a population-based cohort study. Lancet. 2017 Jul 29;390(10093):490-499. doi: 10.1016/S0140-6736(17)30770-5. Epub 2017 Jun 13.
**PMID:** 28622955
**Citation:** Pace WD. Daily Low-Dose Aspirin, Diabetes, and Age-Still Looking for a Balance. JAMA Netw Open. 2021 Jun 1;4(6):e2112875. doi: 10.1001/jamanetworkopen.2021.12875. No abstract available.
**PMID:** 34152422
**Citation:** Alter SM, Mazer BA, Solano JJ, Shih RD, Hughes MJ, Clayton LM, Greaves SW, Trinh NQ, Hughes PG. Antiplatelet therapy is associated with a high rate of intracranial hemorrhage in patients with head injuries. Trauma Surg Acute Care Open. 2020 Nov 25;5(1):e000520. doi: 10.1136/tsaco-2020-000520. eCollection 2020.
**PMID:** 33294625
**Citation:** van den Brand CL, Tolido T, Rambach AH, Hunink MG, Patka P, Jellema K. Systematic Review and Meta-Analysis: Is Pre-Injury Antiplatelet Therapy Associated with Traumatic Intracranial Hemorrhage? J Neurotrauma. 2017 Jan 1;34(1):1-7. doi: 10.1089/neu.2015.4393. Epub 2016 May 9.
**PMID:** 26979949
**Citation:** Svedung Wettervik T, Lenell S, Enblad P, Lewen A. Pre-injury antithrombotic agents predict intracranial hemorrhagic progression, but not worse clinical outcome in severe traumatic brain injury. Acta Neurochir (Wien). 2021 May;163(5):1403-1413. doi: 10.1007/s00701-021-04816-0. Epub 2021 Mar 26.
**PMID:** 33770261
**Citation:** Peck KA, Calvo RY, Schechter MS, Sise CB, Kahl JE, Shackford MC, Shackford SR, Sise MJ, Blaskiewicz DJ. The impact of preinjury anticoagulants and prescription antiplatelet agents on outcomes in older patients with traumatic brain injury. J Trauma Acute Care Surg. 2014 Feb;76(2):431-6. doi: 10.1097/TA.0000000000000107.
**PMID:** 24458049
**Citation:** Fabbri A, Servadei F, Marchesini G, Bronzoni C, Montesi D, Arietta L; Societa Italiana di Medicina d'Emergenza Urgenza Study Group. Antiplatelet therapy and the outcome of subjects with intracranial injury: the Italian SIMEU study. Crit Care. 2013 Mar 21;17(2):R53. doi: 10.1186/cc12575.
**PMID:** 23514619
**Citation:** Joseph B, Pandit V, Aziz H, Kulvatunyou N, Hashmi A, Tang A, O'Keeffe T, Wynne J, Vercruysse G, Friese RS, Rhee P. Clinical outcomes in traumatic brain injury patients on preinjury clopidogrel: a prospective analysis. J Trauma Acute Care Surg. 2014 Mar;76(3):817-20. doi: 10.1097/TA.0b013e3182aafcf0.
**PMID:** 24553554
**Citation:** Van Ornam J, Pruitt P, Borczuk P. Is repeat head CT necessary in patients with mild traumatic intracranial hemorrhage. Am J Emerg Med. 2019 Sep;37(9):1694-1698. doi: 10.1016/j.ajem.2018.12.012. Epub 2018 Dec 10.
**PMID:** 30559018
**Citation:** Shammassian BH, Ronald A, Smith A, Sajatovic M, Mangat HS, Kelly ML. Viscoelastic Hemostatic Assays and Outcomes in Traumatic Brain Injury: A Systematic Literature Review. World Neurosurg. 2022 Mar;159:221-236.e4. doi: 10.1016/j.wneu.2021.10.180. Epub 2021 Nov 27.
**PMID:** 34844010
**Citation:** Fleming K, Redfern RE, March RL, Bobulski N, Kuehne M, Chen JT, Moront M. TEG-Directed Transfusion in Complex Cardiac Surgery: Impact on Blood Product Usage. J Extra Corpor Technol. 2017 Dec;49(4):283-290.
**PMID:** 29302119
**Citation:** Fan D, Ouyang Z, Ying Y, Huang S, Tao P, Pan X, Lu S, Pan Q. Thromboelastography for the Prevention of Perioperative Venous Thromboembolism in Orthopedics. Clin Appl Thromb Hemost. 2022 Jan-Dec;28:10760296221077975. doi: 10.1177/10760296221077975.
**PMID:** 35379018
**Citation:** Rao A, Lin A, Hilliard C, Fu R, Lennox T, Barbosa R, Schreiber M, Rowell S. The Utility of Thromboelastography for Predicting The Risk of Progression of Intracranial Hemorrhage in Traumatic Brain Injury Patients. Neurosurgery. 2017 Sep 1;64(CN_suppl_1):182-187. doi: 10.1093/neuros/nyx210. No abstract available.
**PMID:** 28899039
**Citation:** Kay AB, Morris DS, Collingridge DS, Majercik S. Platelet dysfunction on thromboelastogram is associated with severity of blunt traumatic brain injury. Am J Surg. 2019 Dec;218(6):1134-1137. doi: 10.1016/j.amjsurg.2019.09.024. Epub 2019 Sep 23.
**PMID:** 31575420
**Citation:** Davis PK, Musunuru H, Walsh M, Cassady R, Yount R, Losiniecki A, Moore EE, Wohlauer MV, Howard J, Ploplis VA, Castellino FJ, Thomas SG. Platelet dysfunction is an early marker for traumatic brain injury-induced coagulopathy. Neurocrit Care. 2013 Apr;18(2):201-8. doi: 10.1007/s12028-012-9745-6.
**PMID:** 22847397
**Citation:** Nekludov M, Bellander BM, Blomback M, Wallen HN. Platelet dysfunction in patients with severe traumatic brain injury. J Neurotrauma. 2007 Nov;24(11):1699-706. doi: 10.1089/neu.2007.0322.
**PMID:** 18001200
**Citation:** Daley MJ, Enright Z, Nguyen J, Ali S, Clark A, Aydelotte JD, Teixeira PG, Coopwood TB, Brown CV. Adenosine diphosphate platelet dysfunction on thromboelastogram is independently associated with increased morality in traumatic brain injury. Eur J Trauma Emerg Surg. 2017 Feb;43(1):105-111. doi: 10.1007/s00068-016-0643-z. Epub 2016 Feb 18.
**PMID:** 26888580
**Citation:** Cannon JW, Dias JD, Kumar MA, Walsh M, Thomas SG, Cotton BA, Schuster JM, Evans SL, Schreiber MA, Adam EH, Zacharowski K, Hartmann J, Schochl H, Kaplan LJ. Use of Thromboelastography in the Evaluation and Management of Patients With Traumatic Brain Injury: A Systematic Review and Meta-Analysis. Crit Care Explor. 2021 Sep 14;3(9):e0526. doi: 10.1097/CCE.0000000000000526. eCollection 2021 Sep.
**PMID:** 34549189
**Citation:** Lee J, Kim JK, Kim JH, Dunuu T, Park SH, Park SJ, Kang JY, Choi RK, Hyon MS. Recovery time of platelet function after aspirin withdrawal. Curr Ther Res Clin Exp. 2014 Mar 25;76:26-31. doi: 10.1016/j.curtheres.2014.02.002. eCollection 2014 Dec.
**PMID:** 25031665
**Citation:** Glass NE, Riccardi J, Horng H, Kacprzynski G, Sifri Z. Platelet dysfunction in patients with traumatic intracranial hemorrhage: Do desmopressin and platelet therapy help or harm? Am J Surg. 2022 Jan;223(1):131-136. doi: 10.1016/j.amjsurg.2021.07.050. Epub 2021 Aug 3.
**PMID:** 34446216
**Citation:** Wolff C, Muakkassa F, Marley R, El-Khatib A, Docherty C, Muakkassa L, Stephen H, Salvator A. Routine platelet transfusion in patients with traumatic intracranial hemorrhage taking antiplatelet medication: Is it warranted? Can J Surg. 2022 Mar 15;65(2):E206-E211. doi: 10.1503/cjs.018120. Print 2022 Mar-Apr.
**PMID:** 35292527
**Citation:** Miles MVP, Hicks RC, Parmer H, Brown C, Edwards A, Stewart K, Gao L, Maxwell R. Traumatic brain injury patients with platelet inhibition receiving platelet transfusion demonstrate decreased need for neurosurgical intervention and decreased mortality. J Trauma Acute Care Surg. 2022 Apr 1;92(4):701-707. doi: 10.1097/TA.0000000000003516.
**PMID:** 35320155
**Citation:** Jehan F, Zeeshan M, Kulvatunyou N, Khan M, O'Keeffe T, Tang A, Gries L, Joseph B. Is There a Need for Platelet Transfusion After Traumatic Brain Injury in Patients on P2Y12 Inhibitors? J Surg Res. 2019 Apr;236:224-229. doi: 10.1016/j.jss.2018.11.050. Epub 2018 Dec 20.
**PMID:** 30694760
**Citation:** Lokhandwala AM, Asmar S, Khurrum M, Chehab M, Bible L, Castanon L, Ditillo M, Joseph B. Platelet Transfusion After Traumatic Intracranial Hemorrhage in Patients on Antiplatelet Agents. J Surg Res. 2021 Jan;257:239-245. doi: 10.1016/j.jss.2020.07.076. Epub 2020 Aug 27.
**PMID:** 32862051
**Citation:** Spiess BD. Platelet transfusions: the science behind safety, risks and appropriate applications. Best Pract Res Clin Anaesthesiol. 2010 Mar;24(1):65-83. doi: 10.1016/j.bpa.2009.11.001.
**PMID:** 20402171
**Citation:** Joseph B, Pandit V, Sadoun M, Larkins CG, Kulvatunyou N, Tang A, Mino M, Friese RS, Rhee P. A prospective evaluation of platelet function in patients on antiplatelet therapy with traumatic intracranial hemorrhage. J Trauma Acute Care Surg. 2013 Dec;75(6):990-4. doi: 10.1097/TA.0b013e3182a96591.
**PMID:** 24256671
**Citation:** Holzmacher JL, Reynolds C, Patel M, Maluso P, Holland S, Gamsky N, Moore H, Acquista E, Carrick M, Amdur R, Hancock H, Metzler M, Dunn J, Sarani B. Platelet transfusion does not improve outcomes in patients with brain injury on antiplatelet therapy. Brain Inj. 2018;32(3):325-330. doi: 10.1080/02699052.2018.1425804. Epub 2018 Jan 17.
**PMID:** 29341793
#### See Also Links
**Label:** United Zion Retirement Community. Why Retire to Lititz in Lancaster County? Retirement Advice. February 11, 2019.
**URL:** http://www.uzrc.org/blog/retirement-advice/retire-to-lititz/
**Label:** Word Population Review. Lancaster County, Pennsylvania Population 2022. World Population Review. 2022.
**URL:** https://worldpopulationreview.com/us-counties/pa/lancaster-county-population
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000006259
- Term: Craniocerebral Trauma
- ID: D000020196
- Term: Trauma, Nervous System
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M5207
- Name: Brain Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M628
- Name: Brain Injuries, Traumatic
- Relevance: LOW
- As Found: Unknown
- ID: M9556
- Name: Hemorrhage
- Relevance: HIGH
- As Found: Hemorrhage
- ID: M22113
- Name: Intracranial Hemorrhages
- Relevance: HIGH
- As Found: Intracranial Hemorrhage
- ID: M22025
- Name: Intracranial Hemorrhage, Traumatic
- Relevance: HIGH
- As Found: Traumatic Intracranial Hemorrhage
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M9349
- Name: Craniocerebral Trauma
- Relevance: LOW
- As Found: Unknown
- ID: M22023
- Name: Trauma, Nervous System
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020300
- Term: Intracranial Hemorrhages
- ID: D000020198
- Term: Intracranial Hemorrhage, Traumatic
- ID: D000006470
- Term: Hemorrhage
### Intervention Browse Module - Browse Branches
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M3595
- Name: Adenosine
- Relevance: LOW
- As Found: Unknown
- ID: T362
- Name: Arachidonic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433609
**Brief Title:** Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer
**Official Title:** A Phase II Study of Antibody-Drug Conjugates (ADCs) Combined With Adebrelimab in HER2-negative Advanced Breast Cancer
#### Organization Study ID Info
**ID:** BJGBYY-IIT-LCYJ-2024-008
#### Organization
**Class:** OTHER
**Full Name:** Beijing GoBroad Hospital
#### Secondary ID Infos
**Domain:** Jiangsu Hengrui Pharmaceuticals Co., Ltd.
**ID:** BC-MUL-IIT-ADC-SHR1316
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Beijing GoBroad Hospital
#### Responsible Party
**Investigator Affiliation:** Beijing GoBroad Hospital
**Investigator Full Name:** Yang Ke
**Investigator Title:** Associate chief physician
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Our study is aimed to evaluate the efficacy and safety of novel ADCs named SHR-A1811 and SHR-A1921 combined with adebrelimab in HER2-negative advanced breast cancer.
### Conditions Module
**Conditions:**
- Advanced Breast Cancer
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 131
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: SHR-A1811
- Drug: Adebrelimab
**Label:** SHR-A1811+adebrelimab
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: SHR-A1921
- Drug: Adebrelimab
**Label:** SHR-A1921+adebrelimab
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SHR-A1811+adebrelimab
**Description:** Via intravenous infusion
**Name:** SHR-A1811
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- SHR-A1921+adebrelimab
**Description:** Via intravenous infusion
**Name:** SHR-A1921
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- SHR-A1811+adebrelimab
- SHR-A1921+adebrelimab
**Description:** Via intravenous infusion
**Name:** Adebrelimab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** ORR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1.
**Measure:** ORR (objective response rate) by investigator
**Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
#### Secondary Outcomes
**Description:** DCR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD (stable disease) per RECIST v1.1.
**Measure:** DCR (disease control rate) by investigator
**Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
**Description:** CBR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD lasting≥24 weeks (stable disease) per RECIST v1.1.
**Measure:** CBR (clinical benefit rate) by investigator
**Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
**Description:** DoR is the time from the date of first detection of objective response (which is subsequently confirmed) until the date of objective radiographic disease progression.
**Measure:** DoR (duration of response)
**Time Frame:** up to 3.5 years
**Description:** PFS is the time from the date of first dose until the date of objective radiographic disease progression or death (by any cause in the absence of progression).
**Measure:** PFS (progression-free survival)
**Time Frame:** From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
**Description:** OS is the time from the date of first dose until the date of death by any cause.
**Measure:** OS (overall survival)
**Time Frame:** up to 3.5 years
**Description:** An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Percentage of participants who experienced an adverse event and discontinued study drug due to an AE.
**Measure:** Safety as assessed by percentage of patients with any Adverse Event (AE)
**Time Frame:** up to 3.5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. 18 years to 75 years old (including boundary values), female patients with breast cancer;
2. ECOG PS Score: 0\~1;
3. Histologically or cytologically confirmed HER2-negative advanced breast cancer;
4. Disease progression after prior 1-2 lines of systemic therapy; if HR-positive, prior CDK4/6 inhibitor is necessary;
5. Based on RECIST v1.1, at least one measurable lesion;
6. Brain metastasis with no clinical symptoms, or treated, stable brain metastases are eligible;
7. No prior PD-(L)1 inhibitor;
8. Patients must have a life expectancy ≥ 6 months;
9. Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);
10. Patients of childbearing potential should have a negative urine or serum pregnancy, and must promise to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy or be celibate;
11. Available blood samples for ctDNA detection in the exploratory study;
12. Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.
Exclusion Criteria:
1. Has known active brain metastasis which needs local therapy immediately;
2. Prior anti-HER2 or anti-TROP-2 treatment;
3. Has received or been receiving PD-(L)1 inhibitors and/or ADC containing a topoisomerase inhibitor-like payload;
4. Existence of third space fluid that is not well controlled by effective methods, e.g. drainage;
5. Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy or immunological therapy within 4 weeks before first dose of study therapy; has received antitumor endocrine therapy within one week before first dose of study therapy;
6. Use of other antitumor systemic treatment during the study;
7. Has active autoimmune disease or a history of autoimmune disease;
8. Known history of immunodeficiency, including HIV-positive, other acquired or innate immunodeficient disease, or known history of organ transplantation;
9. Has active hepatitis B (HBsAg-positive and HBV DNA≥500 IU/mL), hepatitis C (positive for HCV antibody and HCV RNA above ULN) and hepatic cirrhosis;
10. Has an active infection requiring antibiotics, antiviral or antifungal treatment, or pyrexia \>38.5℃ of unknown origin during the screening period before first dose of study therapy (patients with pyrexia due to cancer could be enrolled determined by investigator);
11. Receiving immunosuppressive medication, or systemic corticosteroid therapy for the purpose of immunosuppression (prednisone at \>10mg/d or equivalent dose of other corticosteroids), and continuous use within 2 weeks before the first dose of study therapy;
12. Other malignancy within prior 5 years unless curatively treated with no evidence of disease for at least recent 3 years, except: curatively treated in situ cancer of the cervix, skin basal cell carcinoma or skin squamous cell carcinoma;
13. Hypersensitivity to study therapy or any of its excipients;
14. Has known clinically significant lung disease, including but not limited to: interstitial lung disease, pneumonitis, pulmonary fibrosis;
15. Known history of uncontrolled cardiovascular clinical symptom or disease that is not well controlled;
16. Has received a live vaccine within 4 weeks before first dose of study therapy, or potential to receive a live vaccine during the trial treatment;
17. Patients with a positive serum or urine pregnancy test or who are breastfeeding; patients of childbearing potential who are unwilling or not available to use an effective method of contraception;
18. Other conditions that might influence the study and analysis of results in the opinion of the investigator.
**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:** Yang Ke
**Phone:** +86-13592618724
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yang Ke
- **Phone:** +86-13592618724
- **Role:** CONTACT
***Contact 2:***
- **Name:** Yang Ke
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Beijing GoBroad Hospital
**State:** Beijing
**Zip:** 102200
#### Overall Officials
**Official 1:**
**Affiliation:** Beijing GoBroad Hospital
**Name:** Yang Ke
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433596
**Brief Title:** Autologous PRP and Focal Shock Waves for Erectile Dysfunction
**Official Title:** Effectiveness and Safety of Autologous Plasma Rich in Platelets and Focal Shock Waves for the Erectile Dysfunction Treatment
#### Organization Study ID Info
**ID:** PRP-SW-03
#### Organization
**Class:** OTHER
**Full Name:** Elexial Research Limited
#### Secondary ID Infos
**ID:** 2022-002985-34
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-06
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Boston Medical Group
#### Lead Sponsor
**Class:** OTHER
**Name:** Elexial Research Limited
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to learn if Platelet-rich plasma (PRP) combined with Shock-wave therapy (SWT) works to treat moderate or mild to moderate erectile dysfunction. It will also learn about the safety of this combined therapy.
The main questions it aims to answer are:
* Does Combined therapy PRP + SWT improve erection in men with moderate or mild to moderate erectile dysfunction?
* What medical problems do participants have when receiving Combined therapy PRP + SWT?
Researchers will compare Combined therapy PRP + SWT to placebo therapy (a look-alike substance that contains no PRP) to see if Combined therapy PRP + SWT works to treat moderate or mild to moderate erectile dysfunction.
Participants will:
* Take a lab test to evaluate their platelets
* Answer some questionnaires to assess your erectile function
* Receive Combined therapy PRP + SWT (3 sessions PRP + 6 sessions SWT) or placebo therapy for 9 weeks
* Visit the clinic one month, 3 months, and 6 months after finishing the treatment for checkups and tests
**Detailed Description:** The goal of this clinical trial is to evaluate the effectiveness of intracavernosal autologous platelet-rich plasma therapy, compared with placebo, for the treatment of moderate or mild to moderate erectile dysfunction, measured as improvement in the IIEF-EF questionnaire score.
Study design: Randomized, double-blind, placebo-controlled clinical trial, phase III. The study will include four groups:
* G1 - Autologous PRP: Autologous Platelet Rich Plasma (PRP) + placebo shock waves
* G2 - combined therapy: Autologous PRP + focal shock waves
* G3 - placebo control: Placebo PRP + placebo shock waves
* G4 - shock waves: PRP placebo + shock waves
116 subjects will be included, who will be randomized in a 1:1:1:1 ratio in the four groups described above.
The change in the International Index of Erectile Function - Erectile Function domain (IIEF-EF) score, the change in the Erection Hardness Score (EHS), and the adverse events will be evaluated at the end of treatment, and 1, 3, and 6 months of follow-up.
### Conditions Module
**Conditions:**
- Erectile Dysfunction
**Keywords:**
- Erectile dysfunction
- Platelet-rich plasma
- Shock wave therapy
- Randomized clinical trial
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 116
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 3 injections of 10 cc of autologous Platelet Rich Plasma (PRP) + 6 sessions of placebo shock waves
**Intervention Names:**
- Other: Platelet-rich plasma
- Other: Sham shock waves therapy
**Label:** Autologous PRP
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 3 injections of 10 cc of autologous PRP + 6 sessions of focal shock waves.
**Intervention Names:**
- Other: Platelet-rich plasma
- Other: Shock waves therapy
**Label:** Combined therapy
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** 3 injections of 10 cc of saline solution + 6 sessions of placebo shock waves
**Intervention Names:**
- Other: Placebo PRP
- Other: Sham shock waves therapy
**Label:** Placebo control
**Type:** PLACEBO_COMPARATOR
#### Arm Group 4
**Description:** 3 injections of 10 cc of saline solution + 6 sessions of waves of focal shock.
**Intervention Names:**
- Other: Shock waves therapy
- Other: Placebo PRP
**Label:** Shock waves
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Autologous PRP
- Combined therapy
**Description:** 3 injections of 10 cc of autologous Platelet Rich Plasma (PRP), weeks 1, 5 and 9
**Name:** Platelet-rich plasma
**Other Names:**
- PRP
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Combined therapy
- Shock waves
**Description:** 6 sessions of focal shock waves, 1 per week
**Name:** Shock waves therapy
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Placebo control
- Shock waves
**Description:** 3 injections of 10 cc of saline solution, weeks 1, 5 and 9
**Name:** Placebo PRP
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- Autologous PRP
- Placebo control
**Description:** 6 sessions of sham shock waves, 1 per week
**Name:** Sham shock waves therapy
**Other Names:**
- Placebo therapy
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Change in International Index of Erectile Function - Erectile Function domain (IIEF-EF) score between baseline and week 21 (3 months after completion of treatment)
**Measure:** Change in IIEF-EF score
**Time Frame:** From enrollment to the third month of follow-up at 21 weeks
#### Secondary Outcomes
**Description:** Change in International Index of Erectile Function - Erectile Function domain (IIEF-EF) score between baseline measurement and measurement at week 13
**Measure:** Change in IIEF-EF score 1- month follow-up
**Time Frame:** From enrollment to the first month of follow-up at 13 weeks
**Description:** Change in IIEF-EF score between baseline measurement and measurement at week 33
**Measure:** Change in IIEF-EF score 6 months follow-up
**Time Frame:** From enrollment to the sixth month of follow-up at 33 weeks
**Description:** Proportion of patients achieving the minimum clinically significant difference in the IIEF-EF score (5 points)
**Measure:** Minimum clinically significant difference
**Time Frame:** From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
**Description:** Change in EHS between baseline measurement and measurement at weeks 13, 21, and 33
**Measure:** Change in Erection Hardness Score (EHS)
**Time Frame:** From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
**Description:** Proportion of patients who accomplish to penetrate after treatment, evaluated by the change in the EHS from 1 or 2 at baseline to 3 or 4 in weeks 13, 21 and 33.
**Measure:** Ability to penetrate
**Time Frame:** From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
**Description:** Change in the score of the sexual quality of life questionnaire (SLQQ) between the baseline measurement and the measurement at weeks 13, 21 and 33.
**Measure:** Quality of sexual life
**Time Frame:** From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
**Description:** Change in the score of the global assessment questionnaire (GAQ) at weeks 13, 21 and 33.
**Measure:** Global assessment
**Time Frame:** From enrollment to the first, third and sixth month of follow-up at 13, 21, and 33 weeks
**Description:** Incidence of PRP-related adverse events during the study
**Measure:** Adverse events incidence
**Time Frame:** From the first intervention to end of follow-up at 33 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Men over 18 years of age.
2. Erectile dysfunction present for more than 3 months in more than 50% of intercourse.
3. Baseline score of the IIEF-EF questionnaire between 11 and 21.
4. Stable heterosexual relationship of at least 6 months.
5. Commitment to have at least 3 vaginal sexual relations per month after completing treatment.
6. Commitment not to use other natural, oral, or intracavernous pharmacological treatments during the treatment and up to 6 months after its completion.
7. A patient who agrees to voluntarily enter the study by signing an informed consent.
Exclusion Criteria:
1. Score of 4 on the EHS scale.
2. Patients with an international normalized ratio (INR) greater than 3.
3. Patients with sickle cell anemia.
4. Patients with clinical suspicion of hypogonadism (ADAM positive).
5. Acromegaly, gigantism, Addison disease, hyperprolactinemia, androgen deficiency.
6. Active bladder, prostate, or colon cancer.
7. Radical prostatectomy or other radical pelvic surgery.
8. History of pelvic radiotherapy.
9. Spinal cord injury or other neurological disease associated with erectile dysfunction.
10. Penile anatomical dysfunction, penile implant.
11. Platelet diseases or coagulation disorders.
12. Treatment with oral anticoagulants.
13. Platelet count outside the normal range (150 to 400 × 109/L).
14. Patients with active infections or lesions of the penis or pubic area.
15. Patients with erectile dysfunction secondary to drug treatment (antiandrogen therapy, Alpha-blockers for benign prostatic hyperplasia, use of corticosteroids, antiparkinsonian drugs, antipsychotics).
16. Patients with erectile dysfunction of psychological origin.
17. Abuse of psychoactive substances (including alcohol).
18. Cognitive or physical illness that prevents you from participating in the study, self-filling out the questionnaires, or attending therapies and controls.
19. Inability to attend therapies and controls.
**Gender Based:** True
**Gender Description:** The participant must be male by biological sex and their gender identity must be male
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Carolina Sandoval, Master
**Phone:** 0057 31339208916
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Héctor Corredor, MD
**Phone:** 0057 3174317162
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Madrid
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jose Benitez, MD
- **Phone:** 0034 607769225
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Mercedes Rodriguez, Coordinator
- **Phone:** 0034 610238191
- **Role:** CONTACT
***Contact 3:***
- **Name:** Jose Aramis Benitez, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** Boston Medical Group Spain S.L.U
**Status:** RECRUITING
**Zip:** 28046
#### Overall Officials
**Official 1:**
**Affiliation:** Boston Medical Group
**Name:** Jose Benitez, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** All individual participant data (IPD) collected throughout the trial, except personal identification data of the participants
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Beginning 1 month after publication with no end date
**URL:** https://www.elexialresearch.com/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000012735
- Term: Sexual Dysfunction, Physiological
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000020018
- Term: Sexual Dysfunctions, Psychological
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M15577
- Name: Shock
- Relevance: LOW
- As Found: Unknown
- ID: M10217
- Name: Erectile Dysfunction
- Relevance: HIGH
- As Found: Erectile Dysfunction
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15546
- Name: Sexual Dysfunction, Physiological
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21873
- Name: Sexual Dysfunctions, Psychological
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007172
- Term: Erectile Dysfunction
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433583
**Acronym:** NEUROMUTE
**Brief Title:** Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation in Adolescents
**Official Title:** Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation for the Prevention of Non-suicidal Self-injury Recurrence in Adolescents
#### Organization Study ID Info
**ID:** 2023-01-CHRMT
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Régional Metz-Thionville
### Status Module
#### Completion Date
**Date:** 2026-12-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Centre Hospitalier Régional Metz-Thionville
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Non-suicidal self-injury (NSSI) are acts defined by the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5) as intentional and deliberate, occurring outside a psychotic state and directly causing moderate injury.
Their international prevalence is between 13 and 17% in adolescents and young adults, and has recently increased with the COVID-19 health crisis, with the prevalence of NSSI rising to 40% in adolescents. Access to psychiatrists is declining. Drug solutions, meanwhile, lack scientific proof in this indication.
The autonomic nervous system and the hypothalamo-hypophyseal axis are involved in the human response to experimentally-induced pain, as well as in stress regulation, notably via control of cortisol secretion.
Abnormally low levels of the latter hormone have been detected in persons with NSSI disorder.
Transcutaneous neurostimulation of the atrial vagus nerve (taVNS) has been studied for some ten years. The afferent branches of the vagus nerve stimulate the hypothalamic-pituitary axis, leading to the production of cortisol by the adrenals.
The hypothesis of this research is that stimulation of the vagus nerve by taVNS would improve the functioning of the hypothalamic-pituitary axis in patients with NSSI, and thus reduce the frequency of acting out.
Although taVNS is an easy-to-access technique that patients can implement at home, the question of adherence to this treatment in adolescents has not yet been evaluated. The aim of this pilot study is to assess whether adolescents with NSSI will adhere to taVNS treatment.
### Conditions Module
**Conditions:**
- Psychiatric Disorder
**Keywords:**
- non-suicidal self-injury
- transcutaneous auricular vagal nerve stimulation
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 22
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Device: transcutaneous auricular vagal nerve stimulation
**Label:** transcutaneous auricular vagal nerve stimulation (taVNS) treatment
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- transcutaneous auricular vagal nerve stimulation (taVNS) treatment
**Description:** The use of TENS ECO PLUS and the vagus nerve ear electrode medical devices for transcutaneous auricular vagal nerve stimulation (taVNS) everyday for 10 minutes twice a day or 20 minutes for 8 successive weeks. Patients are included at week 0, use taVNS between week 2 and 10, and are followed up until week 22.
Patient adherence: percentage of patients performing 20 minutes of daily stimulation on at least 5 days a week for at least 6 cumulative weeks.
**Name:** transcutaneous auricular vagal nerve stimulation
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** percentage of patients performing 20 minutes of daily stimulation on at least 5 days a week for at least 6 weeks.
**Measure:** Patient adherence to treatment
**Time Frame:** 10 weeks after inclusion
#### Secondary Outcomes
**Description:** Cumulative daily duration of stimulation, number of daily taVNS sessions performed, number of days per week with at least one session, number of weeks with at least one session, number of premature study exists and reasons.
**Measure:** Other caracteristics for patient adherence to treatment
**Time Frame:** 10 weeks after inclusion
**Description:** Assessed by the patient on a Likert scale in a logbook.
**Measure:** Frequency of weekly non-suicidal self-injury (NSSI)
**Time Frame:** weekly, from 2 weeks before treatment and up to 20 weeks after treatment
**Description:** Using the Hospital Anxiety Depression (HAD) scale The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score.
Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case.
**Measure:** Anxiety and depression levels
**Time Frame:** at week 0, 2, 10 and 22 after inclusion
**Description:** assessed through patient logbook and consultations with psychiatrist during taVNS treatment
**Measure:** Adverse events
**Time Frame:** up to 22 weeks after inclusion
**Description:** Semi-structured questionnaire at the end of taVNS.
**Measure:** Patient's experience of taVNS
**Time Frame:** at week 10 after inclusion
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adolescents aged between 13 and 17 years old
* Patients with NSSI disorder as defined by DSM-5
* Patient affiliated to a social security scheme
* Patient who parents or guardians have signed a free and informed consent form
* Patient able to understand neurostimulation instructions
Exclusion Criteria:
* Contraindication to taVNS:
* Malformation, skin pathology of the external ear. (piercings in the area concerned must be removed during the neurostimulation session).
* Children with sleep apnea syndrome treated with NIV (non-invasive ventilation)
* Presence of epileptic seizures
* Proven cardiac pathology on the advice of the attending cardiologist
* History of venous or arterial thrombosis
* Adolescent with pacemaker or defibrillator
* Adolescent with an active implantable device
* Pregnancy (based on anamnestic criteria, checked by blood test if necessary)
* Patients with psychotic episodes, confusional states or severe neurodevelopmental disorders
* Patients with an allergic skin reaction to silicone (component of the ear electrode)
* Patients with a cochlear implant on the stimulation side
* Pregnant or breast-feeding women
* Minor under guardianship
* Minor under judicial measure or sanction
**Maximum Age:** 18 Years
**Minimum Age:** 13 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Justine GRIGORCEA, MD
**Phone:** 00333 82 88 15 03
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Thionville
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Arpiné EL NAR, PhD
- **Phone:** 0033387557766
- **Role:** CONTACT
***Contact 2:***
- **Name:** Dorin SINDILA, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Centre Médico-Psychologique adolescents - CHR Metz-Thionville
#### Overall Officials
**Official 1:**
**Affiliation:** CHR Metz Thionville
**Name:** Dorin SINDILA, MD
**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: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: HIGH
- As Found: Psychiatric Disorders
- ID: M19089
- Name: Self-Injurious Behavior
- Relevance: LOW
- As Found: Unknown
- ID: M85
- Name: Problem Behavior
- Relevance: HIGH
- As Found: Psychiatric Disorders
- 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: D000001523
- Term: Mental Disorders
- ID: D000066553
- Term: Problem Behavior
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10488
- Name: Iodine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433570
**Brief Title:** Detection of Krupple Like Factor -1(KLF1/ EKLF) DNA Mutations in Beta Thalassemia Patients
**Official Title:** Detection of Krupple Like Factor -1(KLF1/ EKLF) DNA Mutations in Beta Thalassemia Patients
#### Organization Study ID Info
**ID:** EKLFmutation in β thalassemia
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2027-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Mohamed Abd Elnasser Mahmoud
**Investigator Title:** Assiut
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** * Detection of KLF1 gene mutations in patients with beta thalassemia considering the alpha and beta molecular status of these patients.
* Study the relation between genotypic mutational status of KLF1 mutation with the level of Hb F and Hb A2 in the patients of beta thalassemia.
**Detailed Description:** Thalassemias are inherited abnormalities in globin chain synthesis of hemoglobin and one of the most common single gene disorders in the world.
β-Thalassemia is caused by reduced (β+) or absent (β0) synthesis of the β-globin chains of haemoglobin. Three clinical and hematological conditions of increasing severity are recognized: the β-thalassemia trait, thalassemia intermedia and thalassemia major.
The Erythroid Kruppel-like factor (EKLF or KLF1) is a master regulator of terminal erythroid differentiation, controlling expression of many key pathways and structures including cell division, the cell membrane and cytoskeleton, heme and globin synthesis.
The KLF1 works as a key regulator of γ-globin to β-globin switch by up-regulation of PUM1 that binds to fetal γ globin mRNA impairing its stability and translation and by Bcl11a expression that represses γ-globin expression.
Previous studies reported that KLF1 mutations have been identified in a variety of erythroid conditions like hereditary persistence of fetal hemoglobin, Congenital dyserythropoietic anemia and borderline HbA2.
An Indian study on KLF1 gene variations found a marginal significance in the thalassemia intermedia group (14%) as against the thalassemia major group (2.0%).
Also, a case report on a Chinese family with twin brothers, both of whom had the same genotype of β0/β0, reported that KLF1 mutations have a role in modulating the phenotypic severity of β-thalassemia.
In our study, where there is high incidence of beta thalassemia in Egypt, we try to detect KLF1 mutations and its relation to clinical phenotype of these patients.
### Conditions Module
**Conditions:**
- EKLF Mutations in Beta Thalassemia Patients
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Genetic: multiplex PCR
**Label:** 50 patients with beta thalassemia intermedia
#### Arm Group 2
**Intervention Names:**
- Genetic: multiplex PCR
**Label:** 50 patients with beta thalassemia major
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 50 patients with beta thalassemia intermedia
- 50 patients with beta thalassemia major
**Description:** Detection of Krupple Like Factor -1(KLF1/ EKLF) DNA Mutations in Beta Thalassemia Patients using multiplex PCR
**Name:** multiplex PCR
**Type:** GENETIC
### Outcomes Module
#### Primary Outcomes
**Description:** Study the relation between genotypic mutational status of KLF1 mutation with the level of Hb F and Hb A2 in the patients of beta thalassemia and with the clinical data (frequency of blood transfusions).
**Measure:** Detection of KLF1 gene mutations in patients with beta thalassemia considering the beta molecular status of these patients
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with β-thalassemia (intermedia and major) of both genders at any age
Exclusion Criteria:
* Patients with any other type of haemolytic anaemias.
* Patients on Hydroxyurea therapy
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** cross sectional study
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** mohamed mahmoud
**Phone:** 01113225644
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Somia Mohammed, prof
**Phone:** 01118279876
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Assiut University
**Name:** Reem Abd Elkhalek Mohamed, lecturer
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Assiut University
**Name:** Hebatallah Ahmed, lecturer
**Role:** STUDY_DIRECTOR
### References Module
#### References
**Citation:** Siatecka M, Bieker JJ. The multifunctional role of EKLF/KLF1 during erythropoiesis. Blood. 2011 Aug 25;118(8):2044-54. doi: 10.1182/blood-2011-03-331371. Epub 2011 May 25.
**PMID:** 21613252
**Citation:** Tallack MR, Perkins AC. Three fingers on the switch: Kruppel-like factor 1 regulation of gamma-globin to beta-globin gene switching. Curr Opin Hematol. 2013 May;20(3):193-200. doi: 10.1097/MOH.0b013e32835f59ba.
**PMID:** 23474875
**Citation:** Elagooz R, Dhara AR, Gott RM, Adams SE, White RA, Ghosh A, Ganguly S, Man Y, Owusu-Ansah A, Mian OY, Gurkan UA, Komar AA, Ramamoorthy M, Gnanapragasam MN. PUM1 mediates the posttranscriptional regulation of human fetal hemoglobin. Blood Adv. 2022 Dec 13;6(23):6016-6022. doi: 10.1182/bloodadvances.2021006730.
**PMID:** 35667093
**Citation:** Borg J, Papadopoulos P, Georgitsi M, Gutierrez L, Grech G, Fanis P, Phylactides M, Verkerk AJ, van der Spek PJ, Scerri CA, Cassar W, Galdies R, van Ijcken W, Ozgur Z, Gillemans N, Hou J, Bugeja M, Grosveld FG, von Lindern M, Felice AE, Patrinos GP, Philipsen S. Haploinsufficiency for the erythroid transcription factor KLF1 causes hereditary persistence of fetal hemoglobin. Nat Genet. 2010 Sep;42(9):801-5. doi: 10.1038/ng.630. Epub 2010 Aug 1.
**PMID:** 20676099
**Citation:** Srivorakun H, Thawinan W, Fucharoen G, Sanchaisuriya K, Fucharoen S. Thalassemia and erythroid transcription factor KLF1 mutations associated with borderline hemoglobin A2 in the Thai population. Arch Med Sci. 2020 Aug 11;18(1):112-120. doi: 10.5114/aoms.2020.93392. eCollection 2022.
**PMID:** 35154532
**Citation:** Waye JS, Eng B. Kruppel-like factor 1: hematologic phenotypes associated with KLF1 gene mutations. Int J Lab Hematol. 2015 May;37 Suppl 1:78-84. doi: 10.1111/ijlh.12356.
**PMID:** 25976964
**Citation:** Hariharan P, Colah R, Ghosh K, Nadkarni A. Differential role of Kruppel like factor 1 (KLF1) gene in red blood cell disorders. Genomics. 2019 Dec;111(6):1771-1776. doi: 10.1016/j.ygeno.2018.11.032. Epub 2018 Dec 5.
**PMID:** 30529538
**Citation:** Xie XM, Liu YN, Li J, Jiang F, Li DZ. A Kruppel-Like Factor 1 Gene Mutation Ameliorates the Severity of beta-Thalassemia: A Case Report. Hemoglobin. 2019 Mar;43(2):137-139. doi: 10.1080/03630269.2019.1607373. Epub 2019 May 21.
**PMID:** 31111750
**Citation:** El-Beshlawy A, Youssry I. Prevention of hemoglobinopathies in Egypt. Hemoglobin. 2009;33 Suppl 1:S14-20. doi: 10.3109/03630260903346395.
**PMID:** 20001619
**Citation:** Origa R. beta-Thalassemia. Genet Med. 2017 Jun;19(6):609-619. doi: 10.1038/gim.2016.173. Epub 2016 Nov 3.
**PMID:** 27811859
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000000745
- Term: Anemia, Hemolytic, Congenital
- ID: D000000743
- Term: Anemia, Hemolytic
- ID: D000000740
- Term: Anemia
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000006453
- Term: Hemoglobinopathies
- ID: D000030342
- Term: Genetic Diseases, Inborn
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16557
- Name: Thalassemia
- Relevance: HIGH
- As Found: Thalassemia
- ID: M19408
- Name: beta-Thalassemia
- Relevance: HIGH
- As Found: Beta Thalassemia
- ID: M4070
- Name: Anemia
- Relevance: LOW
- As Found: Unknown
- ID: M9547
- Name: Hemolysis
- Relevance: LOW
- As Found: Unknown
- ID: M4073
- Name: Anemia, Hemolytic
- Relevance: LOW
- As Found: Unknown
- ID: M4075
- Name: Anemia, Hemolytic, Congenital
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9539
- Name: Hemoglobinopathies
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: T5622
- Name: Thalassemia
- Relevance: HIGH
- As Found: Thalassemia
- ID: T737
- Name: Beta-thalassemia
- Relevance: HIGH
- As Found: Beta Thalassemia
### Condition Browse Module - Meshes
- ID: D000013789
- Term: Thalassemia
- ID: D000017086
- Term: beta-Thalassemia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433557
**Acronym:** COACH
**Brief Title:** A Phase 2 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of Navepegritide in Combination With Lonapegsomatropin in Children With Achondroplasia
**Official Title:** A Phase 2, Open-Label, Single-Arm, 156-week Trial to Investigate the Efficacy, Safety and Tolerability of Combined Once Weekly Navepegritide and Lonapegsomatropin in Children With Achondroplasia
#### Organization Study ID Info
**ID:** ASND0042
#### Organization
**Class:** INDUSTRY
**Full Name:** Ascendis Pharma A/S
### Status Module
#### Completion Date
**Date:** 2027-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Ascendis Pharma Growth Disorders A/S
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This proof-of-concept trial is being conducted to evaluate the efficacy, safety and tolerability of combination treatment with navepegritide and lonapegsomatropin administered as separate subcutaneous (SC) injections once weekly in children with achondroplasia (ACH) aged 2 to 11 years.
### Conditions Module
**Conditions:**
- Achondroplasia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 18
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Combination of Navepegritide and Lonapegsomatropin administered as two separate s.c. injections
**Label:** Combination of Navepegritide and Lonapegsomatropin
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Combination of Navepegritide and Lonapegsomatropin
**Description:** For navepegritide, a once weekly s.c. dose of 100 μg CNP/kg. For lonapegsomatropin, a once weekly s.c. dose of lonapegsomatropin 0.30 mg hGH/kg as starting dose. Treatment duration of up to 156 weeks.
**Name:** Combination of Navepegritide and Lonapegsomatropin administered as two separate s.c. injections
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** cm per year, compared to navepegritide alone
**Measure:** Annualized growth velocity
**Time Frame:** Week 52
**Description:** safety profile of navepegritide and lonapegsomatropin
**Measure:** Treatment-emergent adverse events (TEAEs).
**Time Frame:** Throughout the trial for 156 weeks
#### Secondary Outcomes
**Description:** cm per year
**Measure:** Annualized growth velocity
**Time Frame:** From start until 156 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Written, signed informed consent and/or assent (if applicable) by the parent(s) or legal representative(s) of the participant, and as required by the IRB/HREC/IEC.
2. Male or female between 2 to 11 years of age (inclusive) at the time of Visit 1.
3. Clinical diagnosis of ACH with genetic confirmation of heterozygote genotype present at Visit 1. Documentation of historic test results are acceptable for proof of diagnosis.
4. Able to stand without assistance.
5. Parent(s)/caregiver(s)/legal guardian(s) willing and able to administer weekly SC injections of IMP and comply with all protocol requirements.
6. At least 6 months of growth and disease history from TCC-NHS-01 or TCC-201 or comparable growth and disease history available from medical records.
7. No intracranial pathology as confirmed by brain MRI (historical MRI obtained within 2 years prior to screening allowable).
Exclusion Criteria:
1. Participation in any interventional clinical trial within three months prior to screening (except TCC-201 or ASND0039).
2. Closed epiphysis at screening.
3. History of or suspected hypersensitivity to the IMP or related products.
4. Findings on fundoscopy at screening consistent with intracranial hypertension, papilledema, or evidence of any other retinal disease for which GH therapy is contraindicated.
5. Have a growth disorder or medical condition other than ACH that results in short stature or abnormal growth such as severe ACH with developmental delay and acanthosis nigricans (SADDAN), hypochondroplasia, GHD, Turner syndrome, pseudoachondroplasia, inflammatory bowel disease, celiac disease, hypothyroidism, hyperthyroidism, pre-diabetes, or diabetes mellitus.
6. Have received any dose of prescription and/or investigational medications or device intended to affect stature, growth, or body proportionality at any time prior to screening.
7. Receiving concurrent treatment with any agent that might influence growth or interfere with GH secretion or action:
1. Inhaled corticosteroid therapy at a dose of \>400 µg/day of inhaled budesonide or equivalent for more than 28 consecutive days total over the course of 12 months prior to screening.
2. Require, or anticipated to require, chronic (\>4 weeks) or repeated treatment (more than twice/year and \>3 weeks/year) with systemic corticosteroids during participation in the trial.
3. Currently using or have used within 12 months prior to screening any sex steroids (for example estrogen), non-steroidal anabolic agents (for example, oxandrolone) or gonadotropin-releasing hormone (GnRH) analogues treatment.
4. Treatment for attention-deficit hyperactive disorder (ADHD) such as methylphenidate.
8. Known history or presence of injury or disease of the growth plate(s), other than ACH, that affects growth potential of long bones.
9. Known history of any bone-related surgery affecting growth potential of long bones, such as Orthopaedic reconstructive surgery for bone lengthening (procedures for leg bowing such as 8-plate are not exclusionary).
10. Cervicomedullary decompression surgery within 6 months prior to Screening or with anticipated need for repeat decompression surgery during the time of the trial.
11. Evidence at screening consistent with severe cervicomedullary junction compression based on clinical and/or radiologic findings that indicate immediate surgical intervention is required.
12. Ventriculoperitoneal shunt and laminectomy with full recovery within 6 months prior to Screening.
13. Salter-Harris fracture within 6 months prior to screening (within 2 months for fracture of digits and buckle fractures).
14. Clinically significant musculoskeletal disease, such as Salter-Harris fractures or clinical and/or radiographic evidence of severe hip pathology.
15. Planned or expected surgical intervention during trial participation that may significantly affect trial parameters (confounding of safety events) or would prevent the participant from performing trial procedures. Minimally invasive surgeries such as insertion of grommets, adenoidectomy, tonsillectomy, or myringotomy tube placement, are permitted during the trial.
16. Severe untreated sleep apnoea or newly initiated sleep apnoea treatment (e.g., Continuous Positive Airway Pressure \[CPAP\] in the previous 2 months prior to screening).
17. Clinically significant finding or arrhythmia as determined by the investigator that indicates abnormal cardiac function or conduction that includes, but is not exclusive to:
1. Repaired or unrepaired coarctation.
2. Moderate or greater complexity congenital heart disease including tetralogy of Fallot, Atrioventricular septal defects, truncus arteriosus, total anomalous pulmonary venous return, double outlet right ventricle, or single ventricle heart disease.
18. QT corrected using Fridericia's correction (QTcF) ≥ 450 msec at screening.
19. Known history or presence of condition that impacts haemodynamic stability (such as autonomic dysfunction and orthostatic intolerance).
20. Known history or presence at screening of the following:
1. Chronic anaemia (iron deficiency anaemia that is resolved or considered adequately treated in the Investigator's opinion is allowed).
2. Chronic renal insufficiency defined as estimated glomerular filtration rate (eGFR) according to the revised bedside Schwartz equation less than \<60 mL/min/1.73 m2 for \>3 months.
3. Chronic or recurrent illness that can affect hydration or volume status, including conditions associated with decreased nutritional intake or increased volume loss.
21. Known history or presence of malignant disease.
22. Hepatic transaminases (aspartate aminotransferase (AST) or alanine transferase (ALT)) greater than 3x upper limit of normal (ULN) at screening.
23. Serum 25-hydroxy-vitamin D (25OHD) level of \<30 nmol/L (\<12 ng/mL) at screening.
Participants with 25OHD levels between 30-50 nmol/L (12-20 ng/mL) may be enrolled provided treatment with Vitamin D supplementation is initiated.
24. Any disease or condition that, in the opinion of the Investigator, may make the participant unlikely to fully complete the trial, may confound interpretation of trial results, or may present undue risk from receiving trial treatment. This could include family situations, complications or manifestations, or medications that might impact safety or be considered confounding.
25. Sexually active male and female participants who are unwilling or unable to use a highly effective form of contraception for the entire trial period and for 90 days after last dose of trial treatment.
26. Female participants who are pregnant, lactating or breastfeeding.
**Maximum Age:** 11 Years
**Minimum Age:** 2 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Vibeke Breinholt
**Phone:** +4561242484
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Copenhagen
**Country:** Denmark
**Facility:** Ascendis Pharma Investigational Site
**Zip:** 2100
**Location 2:**
**City:** Dublin
**Country:** Ireland
**Facility:** Ascendis Pharma Investigational Site
**Zip:** D01 YC76
**Location 3:**
**City:** London
**Country:** United Kingdom
**Facility:** Ascendis Pharma Investigational Site
**Zip:** W1W 5AH
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004392
- Term: Dwarfism
- ID: D000001848
- Term: Bone Diseases, Developmental
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000010009
- Term: Osteochondrodysplasias
- ID: D000030342
- Term: Genetic Diseases, Inborn
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3494
- Name: Achondroplasia
- Relevance: HIGH
- As Found: Achondroplasia
- ID: M7566
- Name: Dwarfism
- Relevance: LOW
- As Found: Unknown
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5127
- Name: Bone Diseases, Developmental
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12932
- Name: Osteochondrodysplasias
- Relevance: LOW
- As Found: Unknown
- ID: M12043
- Name: Mucopolysaccharidosis IV
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: T102
- Name: Achondroplasia
- Relevance: HIGH
- As Found: Achondroplasia
- ID: T3909
- Name: Mucopolysaccharidosis Type IV
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000130
- Term: Achondroplasia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433544
**Brief Title:** Online Mindfulness Therapy for Pandemic Fatigue and Resilience in COVID-19 Nurses
**Official Title:** Evaluating the Effects of Online Mindfulness Therapy on Pandemic Fatigue and Resilience Among Nurses in COVID-19 Quarantine Wards
#### Organization Study ID Info
**ID:** 11112-001
#### Organization
**Class:** OTHER
**Full Name:** Chimei Medical Center
### Status Module
#### Completion Date
**Date:** 2023-05-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-05-31
**Type:** ACTUAL
#### Start Date
**Date:** 2022-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Chimei Medical Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study evaluates online mindfulness therapy's impact on pandemic fatigue and resilience in COVID-19 quarantine ward nurses. Sixty nurses were divided into experimental and control groups, with the experimental group receiving a 6-week online mindfulness course.
**Detailed Description:** This study evaluates the effectiveness of online mindfulness therapy on reducing pandemic fatigue and enhancing resilience among nurses in COVID-19 quarantine wards. Using a repeated-measures quasi-experimental design, 60 nurses were divided into experimental and control groups. The experimental group participated in a 6-week online mindfulness course. Outcomes were measured using pandemic fatigue and resilience questionnaires at the pre-test , three weeks and after six weeks.
### Conditions Module
**Conditions:**
- Mindfulness
- Nurses in COVID-19
- Pandemic Fatigue
- Resilience
**Keywords:**
- Online mindfulness
- COVID-19 quarantine ward nurses
- Pandemic fatigue
- Resilience
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 60
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The experimental group received a 6-week online mindfulness course, once a week for 90 minutes each session. Participants completed questionnaires before the course, at week 3, and at week 6.
**Intervention Names:**
- Other: 6-week online mindfulness course
**Label:** Experimental group will undergo a 6-week online mindfulness course
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** General routine care
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental group will undergo a 6-week online mindfulness course
**Description:** The experimental group received a 6-week online mindfulness course, once a week for 90 minutes each session.
**Name:** 6-week online mindfulness course
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Use Lockdown/Pandemic Fatigue Scale (LFS) measure pandemic fatigue. The scale with a total of 10 items measures pandemic fatigue. The range of total scores of the scale is 10-50. It shows that pandemic fatigue increases as total points of the scale increase.
**Measure:** Pandemic Fatigue
**Time Frame:** 6 weeks
#### Secondary Outcomes
**Description:** Use Connor-Davidson Resilience Scale (CD-RISC) measure individual resilience. The scale with a total of 25 items measures resilience. The range of total scores of the scale is 0-100. It shows that resilience increases as total points of the scale increase.
**Measure:** Resilience
**Time Frame:** 6 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Over 20 years old.
* Nurses of COVID-19 dedicated wards and dedicated intensive care units.
Exclusion Criteria:
* Difficulty in attending
* less than 80% of the total number of online mindfulness therapy sessions
**Gender Based:** True
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Tainan City
**Country:** Taiwan
**Facility:** Chi Mei Medical Center
**State:** 其他（非美國）
**Zip:** 71004
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Afshari D, Nourollahi-Darabad M, Chinisaz N. Demographic predictors of resilience among nurses during the COVID-19 pandemic. Work. 2021;68(2):297-303. doi: 10.3233/WOR-203376.
**PMID:** 33492260
**Citation:** Amutio A, Martinez-Taboada C, Delgado LC, Hermosilla D, Mozaz MJ. Acceptability and Effectiveness of a Long-Term Educational Intervention to Reduce Physicians' Stress-Related Conditions. J Contin Educ Health Prof. 2015 Fall;35(4):255-60. doi: 10.1097/CEH.0000000000000002.
**PMID:** 26953856
**Citation:** Asuero AM, Queralto JM, Pujol-Ribera E, Berenguera A, Rodriguez-Blanco T, Epstein RM. Effectiveness of a mindfulness education program in primary health care professionals: a pragmatic controlled trial. J Contin Educ Health Prof. 2014 Winter;34(1):4-12. doi: 10.1002/chp.21211.
**PMID:** 24648359
**Citation:** Barnett P, Barnett M, Borgueta E, Moreno JV, Watson J. COVID-19: An Organizational-theory-guided Holistic Self-caring and Resilience Project. J Holist Nurs. 2021 Dec;39(4):325-335. doi: 10.1177/08980101211007007. Epub 2021 Apr 16. Erratum In: J Holist Nurs. 2022 Sep;40(3):NP1-NP5.
**PMID:** 33861185
**Citation:** Barry KM, Woods M, Martin A, Stirling C, Warnecke E. A randomized controlled trial of the effects of mindfulness practice on doctoral candidate psychological status. J Am Coll Health. 2019 May-Jun;67(4):299-307. doi: 10.1080/07448481.2018.1515760. Epub 2018 Nov 2.
**PMID:** 30388950
**Citation:** Baskin RG, Bartlett R. Healthcare worker resilience during the COVID-19 pandemic: An integrative review. J Nurs Manag. 2021 Nov;29(8):2329-2342. doi: 10.1111/jonm.13395. Epub 2021 Jul 9.
**PMID:** 34182609
**Citation:** Bazarko D, Cate RA, Azocar F, Kreitzer MJ. The Impact of an Innovative Mindfulness-Based Stress Reduction Program on the Health and Well-Being of Nurses Employed in a Corporate Setting. J Workplace Behav Health. 2013 Apr;28(2):107-133. doi: 10.1080/15555240.2013.779518.
**PMID:** 23667348
**Citation:** Buleon C, Minehart RD, Fischer MO. Protecting healthcare providers from COVID-19 through a large simulation training programme. Br J Anaesth. 2020 Nov;125(5):e418-e420. doi: 10.1016/j.bja.2020.07.044. Epub 2020 Aug 5. No abstract available.
**PMID:** 32828493
**Citation:** Cai Z, Cui Q, Liu Z, Li J, Gong X, Liu J, Wan Z, Yuan X, Li X, Chen C, Wang G. Nurses endured high risks of psychological problems under the epidemic of COVID-19 in a longitudinal study in Wuhan China. J Psychiatr Res. 2020 Dec;131:132-137. doi: 10.1016/j.jpsychires.2020.09.007. Epub 2020 Sep 14.
**PMID:** 32971356
**Citation:** Catania G, Zanini M, Hayter M, Timmins F, Dasso N, Ottonello G, Aleo G, Sasso L, Bagnasco A. Lessons from Italian front-line nurses' experiences during the COVID-19 pandemic: A qualitative descriptive study. J Nurs Manag. 2021 Apr;29(3):404-411. doi: 10.1111/jonm.13194. Epub 2020 Nov 15.
**PMID:** 33107657
**Citation:** Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.
**PMID:** 12964174
**Citation:** Creswell JD, Lindsay EK, Villalba DK, Chin B. Mindfulness Training and Physical Health: Mechanisms and Outcomes. Psychosom Med. 2019 Apr;81(3):224-232. doi: 10.1097/PSY.0000000000000675.
**PMID:** 30806634
**Citation:** Croghan IT, Chesak SS, Adusumalli J, Fischer KM, Beck EW, Patel SR, Ghosh K, Schroeder DR, Bhagra A. Stress, Resilience, and Coping of Healthcare Workers during the COVID-19 Pandemic. J Prim Care Community Health. 2021 Jan-Dec;12:21501327211008448. doi: 10.1177/21501327211008448.
**PMID:** 33834900
**Citation:** Cuadrado E, Maldonado MA, Tabernero C, Arenas A, Castillo-Mayen R, Luque B. Construction and Validation of a Brief Pandemic Fatigue Scale in the Context of the Coronavirus-19 Public Health Crisis. Int J Public Health. 2021 Aug 30;66:1604260. doi: 10.3389/ijph.2021.1604260. eCollection 2021.
**PMID:** 34566554
**Citation:** de Vibe M, Solhaug I, Tyssen R, Friborg O, Rosenvinge JH, Sorlie T, Bjorndal A. Mindfulness training for stress management: a randomised controlled study of medical and psychology students. BMC Med Educ. 2013 Aug 13;13:107. doi: 10.1186/1472-6920-13-107.
**PMID:** 23941053
**Citation:** Dharra S, Kumar R. Promoting Mental Health of Nurses During the Coronavirus Pandemic: Will the Rapid Deployment of Nurses' Training Programs During COVID-19 Improve Self-Efficacy and Reduce Anxiety? Cureus. 2021 May 24;13(5):e15213. doi: 10.7759/cureus.15213.
**PMID:** 34178532
**Citation:** Dincer B, Inangil D. The effect of Emotional Freedom Techniques on nurses' stress, anxiety, and burnout levels during the COVID-19 pandemic: A randomized controlled trial. Explore (NY). 2021 Mar-Apr;17(2):109-114. doi: 10.1016/j.explore.2020.11.012. Epub 2020 Dec 3.
**PMID:** 33293201
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**PMID:** 27744228
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## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011024
- Term: Pneumonia, Viral
- ID: D000011014
- Term: Pneumonia
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000018352
- Term: Coronavirus Infections
- ID: D000003333
- Term: Coronaviridae Infections
- ID: D000030341
- Term: Nidovirales Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M2561
- Name: COVID-19
- Relevance: HIGH
- As Found: COVID-19
- ID: M8364
- Name: Fatigue
- Relevance: HIGH
- As Found: Fatigue
- ID: M13904
- Name: Pneumonia
- Relevance: LOW
- As Found: Unknown
- ID: M13914
- Name: Pneumonia, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20490
- Name: Coronavirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6555
- Name: Coronaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M23685
- Name: Nidovirales Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000086382
- Term: COVID-19
- ID: D000005221
- Term: Fatigue
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433531
**Brief Title:** A Clinical Study of TQH2929 Injection in Treatment With Generalized Pustular Psoriasis (GPP)
**Official Title:** Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Efficacy of TQH2929 in Healthy Adult Subjects and Psoriasis Subjects
#### Organization Study ID Info
**ID:** TQH2929-I-01 (Ib)
#### Organization
**Class:** INDUSTRY
**Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-02
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study is a multicenter, single-group, open-label study to evaluate the safety and tolerability of TQH2929 injection at a dose of 900mg in adult subjects with active Generalized Pustular Psoriasis (GPP), and to preliminarily evaluate the efficacy.
### Conditions Module
**Conditions:**
- Generalized Pustular Psoriasis
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** TQH2929 Injection is administered as a single dose.
**Intervention Names:**
- Drug: TQH2929 Injection
**Label:** TQH2929 Injection (900 mg)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- TQH2929 Injection (900 mg)
**Description:** TQH2929 injection is a humanized monoclonal antibody that interfering with the signal cascade.
**Name:** TQH2929 Injection
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The occurrence of all adverse events (AE).
**Measure:** Adverse events (AE)
**Time Frame:** From the first dose to 113 days after the last dose
**Description:** The occurrence of all serious adverse events (SAE).
**Measure:** Serious adverse events (SAE)
**Time Frame:** From the first dose to 113 days after the last dose
**Description:** The occurrence of all treatment-related adverse events(TRAE).
**Measure:** Treatment-related adverse events(TRAE)
**Time Frame:** From the first dose to 113 days after the last dose
**Description:** Incidence of participants with clinical laboratory abnormalities
**Measure:** Clinical laboratory abnormalities
**Time Frame:** From the first dose to 113 days after the last dose
#### Secondary Outcomes
**Description:** Time to reach maximum (peak) serum concentration following drug administration.
**Measure:** Time to reach maximum observed serum concentration (Tmax)
**Time Frame:** Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
**Description:** The Cmax is the maximum observed serum concentration of study drug.
**Measure:** Maximum serum concentration (Cmax)
**Time Frame:** Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
**Description:** Area under the concentration-time curve of the TQH2929 Injection in serum over the time interval from 0 extrapolated to infinity.
**Measure:** Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])
**Time Frame:** Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
**Description:** Area under the concentration-time curve of the TQH2929 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data point.
**Measure:** Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])
**Time Frame:** Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
**Description:** Apparent volume of distribution of the TQH2929 Injection in serum.
**Measure:** Apparent volume of distribution (Vd/F)
**Time Frame:** Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
**Description:** Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
**Measure:** Apparent clearance (CL/F)
**Time Frame:** Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
**Description:** Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.
**Measure:** Half-life (t1/2)
**Time Frame:** Single dose: within 1 hour (pre-dose), 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours post-dose
**Description:** A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.
**Measure:** Anti-drug antibodies (ADA)
**Time Frame:** Single dose: within 1 hour (pre-dose), Days 15, 57, 85, and 113 post-dose
**Description:** The Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) relies on clinical assessment of the Generalized Pustular Psoriasis (GPP) patient's skin presentation. The investigator (or qualified site personnel) scored the erythema, pustules, and scaling of all GPP lesions from 0 to 4. A lower GPPGA pustulation subscore indicates a better outcome. A GPPGA pustulation subscore of 0 means no visible pustules. The proportion of patients who achieved a GPPGA pustulation subscore of 0/1 at Week 1,2,4 is reported.
**Measure:** Proportion of patients with a generalized pustular psoriasis physician global assessment (GPPGA) pustulation subscore of 0/1 at Weeks 1,2,4
**Time Frame:** 1, 2 and 4 weeks post-dose
**Description:** GPPASI provides a numeric scoring for a patient's overall Generalized Pustular Psoriasis (GPP) disease state, ranging from 0 (no disease) to 72 (worse disease state). It is a linear combination of percent of surface area of skin affected by erythema, pustules, and scaling and the severity of erythema, pustules, and scaling (desquamation) over 4 body regions (head, trunk, upper limbs and lower limbs).
**Measure:** Percent change in generalized pustular psoriasis area and severity index (GPPASI) from baseline at weeks 1,2,4
**Time Frame:** Baseline and 1,2,4 weeks post-dose
**Description:** GPPGA relied on clinical assessment of the Generalized Pustular Psoriasis (GPP) patient's skin presentation. The GPPGA total score was calculated by taking the mean of the erythema subscore, pustules subscore and scaling/crusting subscore. The severity of each subscore was assessed using a 5 point scale score ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).
A lower GPPGA score indicates a better outcome, with 0 being clear and 1 being almost clear. The proportion of patients with a GPPGA score of 0 or 1 at Week 1,2,4 is reported.
**Measure:** Proportion of patients with a generalized pustular psoriasis physician global assessment (GPPGA) score of 0 or 1 at week 1
**Time Frame:** Baseline and 1,2,4 weeks post-dose
**Description:** Generalized Pustular Psoriasis Area and Severity Index (GPPASI) provides a numeric scoring for a patient's overall Generalized Pustular Psoriasis (GPP) disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin affected by erythema, pustules, and scaling and the severity of erythema, pustules, and scaling (desquamation) over 4 body regions (head, trunk, upper limbs and lower limbs). A higher score indicates a worse disease state, while a score of 0 indicates no disease.
**Measure:** Change in generalized pustular psoriasis area and severity index (GPPASI) from baseline at week 1,2,4.
**Time Frame:** Baseline and 1,2,4 weeks post-dose
**Description:** PSS is a 4-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms in moderate to severe psoriasis patients. The symptoms included are: pain, redness, itching, and burning. The symptom severity was assessed using a 5 point scale ranging from 0 to 4 where 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. The symptom scores are added to an unweighted total score (range: 0 to 16). A lower PSS score indicates a better outcome.
**Measure:** Change from baseline in psoriasis symptom scale (PSS) score at week 1,2,4
**Time Frame:** Baseline and 1,2,4 weeks post-dose
**Description:** PSS is a 4-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms in moderate to severe psoriasis patients. The symptoms included are: pain, redness, itching, and burning. The symptom severity was assessed using a 5 point scale ranging from 0 to 4 where 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
**Measure:** Proportion of patients with psoriasis symptom scale (PSS) score of 0 at week 1,2,4.
**Time Frame:** 1,2,4 weeks post-dose
**Description:** The DLQI is a 10-item questionnaire that asks participants to evaluate the degree that their skin problem has affected their quality of life in the last week in the following 6 aspects: symptoms and feelings, daily activities, leisure, work or school activities, personal relationships and treatment related feelings. Participants answer the 10 questions on a scale from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the scores of the 10 questions, resulting in a maximum of 30 and a minimum of 0 with higher scores indicating more impaired quality of life. A negative change from Baseline indicates improvement.
**Measure:** Change from baseline in dermatology life quality index (DLQI) score at weeks 1,2,4
**Time Frame:** Baseline and 1,2,4 weeks post-dose.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults aged between 18 and 75 years (inclusive)，both male and female；
* A known and documented history of Generalized Pustular Psoriasis diagnosed with European Rare and Severe Psoriasis Expert Network (ERASPEN) criteria in 2017；
* Presenting with a moderate-severe flare of Generalized Pustular Psoriasis (GPP)
* Body mass index (BMI) within 18\~36 kg/m2；
* Major organ function is good;
* Patients must be able to understand and sign a written informed consent document;
* Patients must be able to complete study-related procedures and questionnaires;
* Female and male subjects of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study; Female subjects need to serum pregnancy pregnancy test within 7 days before study enrollment.
Exclusion Criteria:
* Patients with primary plaque psoriasis vulgaris with pustules that are restricted to psoriatic plaques；
* Immediate life-threatening flare of Generalized Pustular Psoriasis or requiring intensive care treatment, according, to the judgment of the investigator；
* Computed Tomography of the chest shows active or occult tuberculosis or a history of contact with an open tuberculosis (TB) subject within the past 6 months. Subjects positive for tuber closes spot(T-SPOT) (or other tuberculosis diagnostic test) result;
* Active hepatitis during the screening period, or positive for hepatitis B surface antigen (HBsAg)；
* History of human immunodeficiency virus (HIV) infection, or positive HIV serological results at screening during screening；
* Positive antibodies to treponema pallidum during screening；
* History of serious infection leading to hospitalization or intravenous infusion of antibiotics or antiviral therapy within 3 months prior to baseline;
* Active systemic infections requiring systemic antibiotics or systemic antiviral therapy within 4 weeks prior to baseline;
* History of opportunistic infection and parasitic infection within 6 months prior to the screening period；
* History of herpes zoster infection within 2 months prior to baseline；
* Subject has known or suspected autoimmune disease;
* Receive major surgery within 4 weeks prior to the first dose;
* Subjects with any type of active malignancy or a history of malignancy (except cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma and papillary thyroid carcinoma) that has been cured for more than 5 years prior to the screening period;
* Subjects have history of significant drug allergies；
* Use of the following medications within the prescribed time:
1. Receive topical drugs for the treatment of skin diseases within 1 weeks prior to baseline;
2. Receive systemic therapy within 4 weeks prior to baseline;
3. Receive regular phototherapy within 4 weeks prior to baseline;
4. Within 12 weeks prior to baseline, receive live (attenuated) vaccine;
5. Receive antibiotics and antivirals within 4 weeks prior to baseline.
* People who are alcoholic, drug addicts, and known drug dependents;
* Pregnant or Breasting feeding subject;
* Received a blood transfusion within 4 weeks prior to the first dose;
* Subject is unable to tolerate intravenous infusion administration;
* During the period of participation in this study, participants had planned surgical procedures;
* Have participated in clinical trials of other drugs or medical devices within 4 weeks prior to baseline;
* In the judgment of the investigator or sponsoring medical auditor, it is believed that there are any medical or psychiatric symptoms that put the subject at risk, interfere with participation in the study, or interfere with the interpretation of the results of the study.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Hang Li, Doctor
**Phone:** 13693058190
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Xia Zhao, Master
**Phone:** 13621020878
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hang Li, Doctor
- **Phone:** 13693058190
- **Role:** CONTACT
**Country:** China
**Facility:** Peking University First Hospital
**State:** Beijing
**Zip:** 100871
**Location 2:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Bin Yang, Doctor
- **Phone:** 13922207231
- **Role:** CONTACT
**Country:** China
**Facility:** Dermatology Hospital of Southern Medical Universitye
**State:** Guangdong
**Zip:** 510091
**Location 3:**
**City:** Shijiazhuang
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Guoqiang Zhang, Doctor
- **Phone:** 18633888122
- **Role:** CONTACT
**Country:** China
**Facility:** The First Hospital of Hebei Medical University
**State:** Hebei
**Zip:** 050000
**Location 4:**
**City:** Shijiazhuang
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yanling Li, Doctor
- **Phone:** 15803212590
- **Role:** CONTACT
**Country:** China
**Facility:** The Second Hospital of Hebei Medical University
**State:** Hebei
**Zip:** 050000
**Location 5:**
**City:** Shenyang
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xinghua Gao, Doctor
- **Phone:** 13940152467
- **Role:** CONTACT
**Country:** China
**Facility:** The First Hospital of China Medical University
**State:** Liaoning
**Zip:** 110000
**Location 6:**
**City:** Chengdu
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Tao Chen, Doctor
- **Phone:** 13980427003
- **Role:** CONTACT
**Country:** China
**Facility:** Second People's Hospital of Chengdu
**State:** Sichuan
**Zip:** 610052
**Location 7:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xiaoyong Man, Doctor
- **Phone:** 13600516219
- **Role:** CONTACT
**Country:** China
**Facility:** The Second Affiliated Hospital Zhejiang University School of Medicine
**State:** Zhejiang
**Zip:** 310000
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000017444
- Term: Skin Diseases, Papulosquamous
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14422
- Name: Psoriasis
- Relevance: HIGH
- As Found: Psoriasis
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19713
- Name: Skin Diseases, Papulosquamous
- Relevance: LOW
- As Found: Unknown
- ID: T4835
- Name: Pustular Psoriasis
- Relevance: HIGH
- As Found: Pustular Psoriasis
- ID: T2462
- Name: Generalized Pustular Psoriasis
- Relevance: HIGH
- As Found: Generalized Pustular Psoriasis
### Condition Browse Module - Meshes
- ID: D000011565
- Term: Psoriasis
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: LOW
- As Found: Unknown
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433518
**Acronym:** BEST
**Brief Title:** BEst Size for Ovulation Triggering in Poseidon 4 Patients (BEST 4 Study)
**Official Title:** What Should Be The Optimal Ovulation Triggering Size in Poseidon Group 4 Patients Undergoing Ovarian Stimulation?
#### Organization Study ID Info
**ID:** 2024-3-1
#### Organization
**Class:** OTHER
**Full Name:** Centrum Clinic IVF Center
### Status Module
#### Completion Date
**Date:** 2024-11-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Centrum Clinic IVF Center
#### Responsible Party
**Investigator Affiliation:** Centrum Clinic IVF Center
**Investigator Full Name:** Emre Göksan Pabuçcu
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This observational clinical study aims to determine the optimal timing of ovulation triggering in women aged 35 and above with poor ovarian reserve.
For this purpose, cases undergoing ovarian stimulation for assisted reproductive treatment and planned final oocyte triggering will be evaluated in two separate groups:
1. \*\*Experimental Group\*\*: Final oocyte triggering will be performed when the follicle or follicles measure between 13-16 mm.
2. \*\*Control Group\*\*: Final oocyte triggering will be performed when the follicle or follicles measure greater than 17 mm.
All triggers will be administered uniformly with 6500 units of recombinant hCG and 0,2 mg triptorelin injections.
The primary outcome of the study will be the number of mature oocytes. Secondary outcomes will include fertilization rates, embryo counts, and implantation rates.
Primary and secondary outcomes will be compared between the two groups.
**Detailed Description:** The timing of final oocyte maturation in assisted reproductive techniques is critically important. If serum steroid hormone levels are appropriate during the late follicular phase, ovulation triggering can be performed using various agents. There are numerous comparative studies in the literature on this topic.
However, a key issue is determining the most optimal timing for this trigger. In standard practice, the final triggering is performed when the follicle size reaches 17 mm or more.
The purpose of this is to obtain mature eggs from these follicles during the oocyte aspiration process.
However, in some special cases, to maximize the desired yield, this size threshold may be adjusted.
A prime example of this is in older patients with poor ovarian reserve, as the expected egg yield may not be achieved with standard practices.
During the oocyte collection process, fewer mature oocytes (M2) may be retrieved, or no oocytes may be retrieved at all, despite proper ovarian stimulation. Therefore, the optimal follicle size for these cases has not been definitively established in the literature. Thus, there is a need to determine other follicular thresholds specifically for older women with poor ovarian reserves to enhance egg and mature egg yields.
For this purpose, cases undergoing ovarian stimulation for assisted reproductive treatment and planned final oocyte triggering will be evaluated in two separate groups:
1. \*\*Experimental Group\*\*: Final oocyte triggering will be performed when the follicle or follicles measure between 13-16 mm.
2. \*\*Control Group\*\*: Final oocyte triggering will be performed when the follicle or follicles measure greater than 17 mm.
All triggers will be administered uniformly with 6500 units of recombinant hCG and 0,2 mg triptorelin injections.
The primary outcome of the study will be the number of mature oocytes. Secondary outcomes will include fertilization rates, embryo counts, and implantation rates.
Primary and secondary outcomes will be compared between the two groups.
### Conditions Module
**Conditions:**
- Fertilization
- Fertilization in Vitro
**Keywords:**
- oocyte
- IVF
- poor responder
- ovarian stimulation
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 140
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 6 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** This group of women, who have low serum AMH levels and low antral follicle count obviusly reveal unfavorable ovarian stimulation and reproductive outcomes in daily practice. Since the most important outcome measure is the live birth rate in assisted reproduction, rates have been reportedly very low for this cohort. Depending from the reports, live birth rates particularly cumulative rates directly correlated with collected numbers of oocytes. Therefore, studies should focus on this entity.
**Intervention Names:**
- Drug: recombinant hCG
**Label:** Women defined as poor responders according to POSEIDON criteria group 4 undergoing IVF
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Women defined as poor responders according to POSEIDON criteria group 4 undergoing IVF
**Description:** Experimental Group: Final oocyte triggering will be performed when the follicle or follicles measure between 13-16 mm.
Control Group: Final oocyte triggering will be performed when the follicle or follicles measure greater than 17 mm.
All triggers will be administered uniformly with 6500 units of recombinant hCG and 0,2 mg triptorelin injections.
The primary outcome of the study will be the number of mature oocytes. Secondary outcomes will include fertilization rates, embryo counts, and implantation rates.
Primary and secondary outcomes will be compared between the two groups.
**Name:** recombinant hCG
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Mean numbers of oocytes, mature oocytes, fertilization rates, embryos and pregnancy rates will be compared between two different triggering sizes.
**Measure:** Change in the Mean Mature Oocytes between two triggering strategies
**Time Frame:** From enrollment to the end of treatment at 6-8 months.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Women age \>35 years Women with low serum AMH (\<1,2 ng/ml), low AFC (\<5) Undergoing assisted reproduction with Short antagonist protocol Max daily gonadotropin dose of 300 IU
Exclusion Criteria:
* women with uterine and/or endometrial abnormality, women with endometrioma(s), short or long GnRH-agonist ovarian stimulation protocols, severe male infertiliy, genetic conditions, with normal ovarian reserve markers, \<35 years old, women with prior ovarian surgeries, PGT-a cycles
**Gender Based:** True
**Gender Description:** Women with diminished ovarian reserve undergoing assisted reproduction.
**Maximum Age:** 44 Years
**Minimum Age:** 35 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** A group of women defined as Poseidon Group 4, who will apply to the infertility clinic to be scheduled for ovarian stimulation and assisted conception treatments during the study period.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Emre G Pabuccu, Professor
**Phone:** +90 532 4147844
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Recai Pabuccu, Professor
**Phone:** +90 532 6160086
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Ufuk University
**Name:** Emre Pabuccu, Prof.
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: Repr
- Name: Reproductive Control Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M19618
- Name: Triptorelin Pamoate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433505
**Brief Title:** A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants
**Official Title:** A Phase 1, Open-label, Two-Part Study to Evaluate the Pharmacokinetics, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants
#### Organization Study ID Info
**ID:** CA071-1005
#### Organization
**Class:** INDUSTRY
**Full Name:** Celgene
### Status Module
#### Completion Date
**Date:** 2024-09-23
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-23
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Celgene
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.
### Conditions Module
**Conditions:**
- Healthy Volunteers
**Keywords:**
- BMS-986365
- Pharmacokinetics
- Absolute Bioavailability
- Healthy Male Volunteers
- CC-94676
- ADME
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: BMS-986365
- Drug: [14C] BMS-986365
**Label:** Part A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: [14C] BMS-986409 + BMS-986410
**Label:** Part B - Arm 1
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Drug: [14C] BMS-986410 + BMS-986409
**Label:** Part B - Arm 2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Part A
**Description:** Specified dose on specified days
**Name:** BMS-986365
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Part A
**Description:** Specified dose on specified days.
**Name:** [14C] BMS-986365
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Part B - Arm 1
**Description:** Specified dose on specified days
**Name:** [14C] BMS-986409 + BMS-986410
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Part B - Arm 2
**Description:** Specified dose on specified days
**Name:** [14C] BMS-986410 + BMS-986409
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Part A and B
**Measure:** Maximum observed concentration (Cmax)
**Time Frame:** Up to Day 60
**Description:** Part A and B
**Measure:** Time of maximum observed concentration (Tmax)
**Time Frame:** Up to Day 60
**Description:** Part A and B
**Measure:** Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
**Time Frame:** Up to Day 60
**Description:** Part A and B
**Measure:** Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF))
**Time Frame:** Up to Day 60
**Description:** Part A and B
**Measure:** Apparent terminal plasma half-life (T-HALF)
**Time Frame:** Up to Day 60
**Description:** Part A
**Measure:** Total body clearance (CLT)
**Time Frame:** Up to Day 15
**Description:** Part A and B
**Measure:** Apparent total body clearance (CLT/F)
**Time Frame:** Up to Day 60
**Description:** Part A
**Measure:** Mean residence time (MRT)
**Time Frame:** Up to Day 15
**Description:** Part A
**Measure:** Apparent volume of distribution (Vz)
**Time Frame:** Up to Day 15
**Description:** Part A and B
**Measure:** Apparent volume of distribution (Vz/F)
**Time Frame:** Up to Day 60
**Description:** Part A
**Measure:** Absolute bioavailability (F)
**Time Frame:** Up to Day 15
#### Secondary Outcomes
**Description:** Part A and B
**Measure:** Number of participants with Adverse Events
**Time Frame:** Up to Day 60
**Description:** Part A and B
**Measure:** Number of participants with Serious Adverse Events
**Time Frame:** Up to Day 60
**Description:** Part A and B
**Measure:** Number of participants with AEs leading to discontinuation
**Time Frame:** Up to Day 60
**Description:** Part A and B
**Measure:** Number of participants with Vital sign abnormalities
**Time Frame:** Up to Day 60
**Description:** Part A and B
**Measure:** Number of participants with electrocardiogram (ECG) abnormalities
**Time Frame:** Up to Day 60
**Description:** Part A and B
**Measure:** Number of participants with physical examination abnormalities
**Time Frame:** Up to Day 60
**Description:** Part A and B
**Measure:** Number of participants with clinical laboratory abnormalities
**Time Frame:** Up to Day 60
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations, as determined by the investigator
* Participants will require a left ventricular ejection fraction of \> 50% at screening.
* Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening. Body mass index = weight(kg)/(height \[m\])2.
Exclusion Criteria:
* Any current or recent significant acute or chronic illness.
* Participants with a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QTcF interval (\> 450 ms) at screening.
* Current or recent (within 3 months of intervention administration) gastrointestinal disease that could affect the absorption of study drug including cholecystectomy. Mild gastroesophageal reflux (even if managed with avoidance of food triggers) is exclusionary.
* History of allergy to BMS-986365 or related compounds.
Other protocol-defined Inclusion/Exclusion criteria apply.
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** BMS Study Connect Contact Center www.BMSStudyConnect.com
**Phone:** 855-907-3286
**Role:** CONTACT
**Contact 2:**
**Name:** First line of the email MUST contain the NCT# and Site #.
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Madison
**Contacts:**
***Contact 1:***
- **Name:** Site 0001
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0001
**State:** Wisconsin
**Zip:** 53704
#### Overall Officials
**Official 1:**
**Affiliation:** Bristol-Myers Squibb
**Name:** Bristol-Myers Squibb
**Role:** STUDY_DIRECTOR
### References Module
#### See Also Links
**Label:** BMS Clinical Trial Information
**URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
**Label:** BMS Clinical Trial Patient Recruiting
**URL:** https://www.BMSStudyConnect.com
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433492
**Brief Title:** Safety and Efficacy of Viscosupplementation of Hyaluronic Acid With Addition of Lecithin in Patients With Mild or Moderate Osteoarthrosis of the Knee Joint.
**Official Title:** Safety and Efficacy of Viscosupplementation of Hyaluronic Acid With Addition of Liposomes in Patients With Mild or Moderate Osteoarthrosis of the Knee Joint.
#### Organization Study ID Info
**ID:** 2.0 06.10.2020
#### Organization
**Class:** INDUSTRY
**Full Name:** Biovico Sp. z o.o.
### Status Module
#### Completion Date
**Date:** 2022-12-21
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-12-21
**Type:** ACTUAL
#### Start Date
**Date:** 2020-12-30
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Biovico Sp. z o.o.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The main objective of this prospective, open-label clinical trial is to assess the effectiveness and safety of intra-articular liposomal gel therapy for knee OA symptoms.
### Conditions Module
**Conditions:**
- Osteoarthritis, Knee
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 50 patients age 38-70 with OA confirmed by ACR criteria and radiologically verified OA (Kellgren-Lawrence grade 2 or 3) suffering from knee joint pain for at least 3 months and VAS pain score minimum 4 in one knee, and \< 2 in the contralateral knee were subjected to the administration of Lipotris™. The product was administered as a course of three injections weekly.
**Intervention Names:**
- Device: Intra-articular injection
**Label:** Study group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Study group
**Description:** Three doses of intra-articular injection administered in weekely intervals.
**Name:** Intra-articular injection
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The visual analog scale (VAS) measures the severity of pain. The patient assesses the level of pain by marking a point on a line 10 cm long, where a value of 0 is assigned the complete absence of pain, and a value of 10 is assigned the most severe pain the patient can imagine.
**Measure:** The pain score of Visual Analog Scale (VAS) of target knee at 3 months post-treatment.
**Time Frame:** 3 months
#### Secondary Outcomes
**Description:** The pain score of VAS of target knee at baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment.
**Measure:** The pain score of VAS of target knee at baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment
**Time Frame:** baseline, 1 week, 2 weeks, 1 month, and 6 months post-treatment
**Description:** The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of hip and knee osteoarthritis. It is a self-administered questionnaire consisting of 24 items.The patient assesses his condition using a scale by marking one of 5 options (scoring 0 - 4, where 0 - no complaints, 1 - mild, 2 - moderate, 3 - severe, 4 - extreme). The scores for each subscale are summed up to give a total subscale score, with higher scores indicating greater severity of symptoms.
**Measure:** The score of WOMAC at baseline, 1 week, 2 weeks, 1 month, 3 months and 6 months post-treatment
**Time Frame:** baseline, 1 week, 2 weeks, 1 month, 3 months and 6 months post-treatment
**Description:** The TUG test measures the time it takes for a person to stand up from a chair, walk three meters, turn around, walk back to the chair, and sit down.
**Measure:** Functional status of knee joint according to time to perform the The Timed Up and Go Test.
**Time Frame:** baseline, 1 month, 3 months and 6 months post-treatment
**Description:** To perform "The Five Time Sit to Stand Test" (FTSST, 5xSTS), patient was asked to take a sitting position on a standard 45 cm high chair with arms crossed over the chest. At the command "START," the patient must stand up as quickly as possible five times and completely straighten up and sit back in the chair without supporting himself with his arms.
**Measure:** Functional status of knee joint according to time to perform the Five Time Sit to Stand Test.
**Time Frame:** baseline, 1 month, 3 months and 6 months post-treatment
**Description:** The 10 Meter Walk Test (10MWT) is a clinical assessment tool used to evaluate a patient's walking speed and mobility. The test involves measuring the time it takes for a patient to walk 10 meters (33 feet) at normal, self-selected pace.
**Measure:** Functional status of knee joint according to time to perform the to 10 Meter Walk Test.
**Time Frame:** baseline, 1 month, 3 months and 6 months post-treatment
**Description:** Maximal voluntary isometric contraction (MVIC) of extensor/flexor muscles of knee joint measurement was performed with Forcemeter FB 500 (AXIS, Gdansk, Poland). To measure the maximum isometric force of the knee joint extensors/flexors, a person sits on a bench with the belt around waist and legs placed freely beyond the table. The measuring belt is placed parallel to the floor just above the ankle joint with knee flexed to 90 degrees. The length of the measuring belt is specified 160 cm for extensors and 60 cm for flexors. The procedure starts with the measuring belt pretension, then the patient is asked to extend/flex the knee as hard as patient can and hold it for 6 s.
**Measure:** Maximum isometric force of flexor muscles of knee joint.
**Time Frame:** baseline, 1 month, 3 months and 6 months post-treatment
**Measure:** Maximum isometric force of extensor muscles of the knee joint.
**Time Frame:** baseline, 1 month, 3 months and 6 months post-treatment
**Description:** Number of patients with adverse events -type, duration and severity of every adverse event for each patient will be reported
**Measure:** Safety assesment
**Time Frame:** baseline, 1 month, 3 months and 6 months post-treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age between 38 and 70 years,
* OA diagnosed by the American College of Rheumatology (ACR) criteria,
* OA diagnosed by radiographic imaging (grade II - III according to the Kellgren-Lawrence scale),
* Pain in the knee joint for at least 3 months,
* Screening pain intensity in the target knee measured on VAS scale was required to be 4 for symptomatic knee and 2 for the contralateral knee.
Exclusion Criteria:
* Previous injections of hyaluronic acid or platelet-rich plasma within 6 months or corticosteroid injections within 3 months before the enrollment,
* Present joint infection,
* Previous knee arthroscopy up to 1 year prior to examination,
* Peripheral inflammatory and autoimmune diseases that progress with joint involvement (rheumatoid arthritis, spondyloarthropathies, systemic lupus erythematosus etc.),
* Total arthroplasty and osteotomy,
* Ankylosis of the study joint,
* Dermatitis or dermatological disease at the intended injection site,
* Known hypersensitivity to the components of the preparation,
* Coexistence of the degenerative changes in other limb joints (hip, foot),
* Cancer,
* Oral corticosteroid therapy,
* Use of medicines that affect blood clotting (heparins, oral anticoagulants, thrombolytic drugs),
* Pregnancy or breast-feeding.
* History of injury to the knee, a broken bone or dislocation of a joint, other musculoskeletal diseases that affect the study joint, neoplastic disease.
* Participation in other clinical trials.
**Maximum Age:** 70 Years
**Minimum Age:** 38 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Poznań
**Country:** Poland
**Facility:** Rehasport
**Zip:** 60-201
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001168
- Term: Arthritis
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M22168
- Name: Osteoarthritis, Knee
- Relevance: HIGH
- As Found: Osteoarthritis, Knee
- ID: M12926
- Name: Osteoarthritis
- Relevance: HIGH
- As Found: Osteoarthrosis
- ID: M4476
- Name: Arthritis
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010003
- Term: Osteoarthritis
- ID: D000020370
- Term: Osteoarthritis, Knee
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M9878
- Name: Hyaluronic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T404
- Name: Lecithin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433479
**Acronym:** DARE-AF
**Brief Title:** Efficacy of Dapagliflozin on Recurrence After Catheter Ablation for Atrial Fibrillation
**Official Title:** Efficacy of DApagliflozin on REcurrence After Catheter Ablation for Atrial Fibrillation
#### Organization Study ID Info
**ID:** 2024-4-20610
#### Organization
**Class:** OTHER
**Full Name:** Beijing Anzhen Hospital
### Status Module
#### Completion Date
**Date:** 2026-04-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Beijing Anzhen Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a single-center, parallel-group, randomized, open-label trial evaluating the effect of 3-month treatment with dapagliflozin 10mg once daily on the recurrence of atrial fibrillation after catheter ablation for atrial fibrillation in patients without diabetes, heart failure, or chronic kidney disease.
**Detailed Description:** Atrial fibrillation (AF) is one of the most common arrhythmias. Catheter ablation of atrial fibrillation, as the main means of rhythm control, can effectively maintain sinus rhythm, reduce the recurrence of AF burden, and improve the patient's quality of life and prognosis. However, AF recurrence still occurs in 30-50% of patients after atrial fibrillation catheter ablation, and there is currently no effective strategy to reduce the recurrence rate after atrial fibrillation ablation.
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a new class of diabetic drugs and large clinical trials have established their multiple cardiovascular benefits. Several studies demonstrated that SGLT2i might reduce AF/atrial flutter events among patients with diabetes. Our cohort study and meta-analysis demonstrated a lower risk of AF recurrence with the use of SGLT2i among patients with diabetes after AF ablation. However, the beneficial effects of SGLT2i in patients after AF catheter ablation without current indications for SGLT2i were uncertain.
In this study, we aim to evaluate the effect of dapagliflozin on AF burden. Patients with persistent AF undergoing initial catheter ablation without diabetes at high cardiovascular risk, heart failure, or chronic kidney disease will be enrolled. Patients will be randomly assigned to either the dapagliflozin group (10mg/d) for 3 months or the control group stratified according to body mass index (\<24, ≥24kg/m2) or left atrial diameter (\<45，≥45mm).
The primary outcome is atrial fibrillation burden calculated as the percentage of of all atrial arrhythmia episodes detected by 7-day single-lead ECG patches at 3 months after ablation. Quality of life and echocardiography changes of left atrial structure will also be evaluated at 3 months. Our central hypothesis is that SGLT2i will reduce the AF burden after catheter ablation.
### Conditions Module
**Conditions:**
- Atrial Fibrillation
**Keywords:**
- Catheter ablation
- Atrial fibrillation
- Recurrence
- Dapagliflozin
- AF Burden
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Dapagliflozin 10 mg per day for 3 months after initial catheter ablation
**Intervention Names:**
- Drug: Dapagliflozin 10 mg per day for 3 months after initial catheter ablation
**Label:** Dapagliflozin
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** No intervention
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dapagliflozin
**Description:** Dapagliflozin 10 mg per day for 3 months after initial catheter ablation
**Name:** Dapagliflozin 10 mg per day for 3 months after initial catheter ablation
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Atrial fibrillation burden is defined as the percent of time spent in atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) episodes detected by 7-day single-lead ECG patches at 3 months after ablation.
**Measure:** Atrial fibrillation burden at 3 months after ablation
**Time Frame:** 3 months
#### Secondary Outcomes
**Description:** Atrial fibrillation recurrence is defined as the recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting 30 seconds or longer detected by 7-day single-lead ECG patches at 3 months after ablation.
**Measure:** Atrial fibrillation recurrence at 3 months after ablation
**Time Frame:** 3 months
**Description:** Changes of quality of life from baseline to 3 months after ablation evaluated by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire.
**Measure:** Changes of quality of life at 3 months
**Time Frame:** 3 months
**Description:** Changes in the echocardiography parameter of anteroposterior atrial diameter from baseline to 3 months after ablation.
**Measure:** Echocardiography changes of left atrial structure at 3 months
**Time Frame:** 3 months
**Description:** Atrial fibrillation burden is defined as the percent of time spent in atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) episodes detected by 7-day single-lead ECG patches at 1 year after ablation.
**Measure:** Atrial fibrillation burden at 1 year after ablation
**Time Frame:** 1 year
**Description:** Atrial fibrillation recurrence is defined as the first recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting 30 seconds or longer detected by ECG during 1 year after ablation. In-person or telephonic follow-up visits will be scheduled at 3-, 6-, and 12-month post-procedure. At each time of follow-up, the following data will be collected: (1)7-day single-lead patch ECG and (2) symptom-triggered ECG since the last follow-up.
**Measure:** Atrial fibrillation recurrence during 1 year after ablation
**Time Frame:** 1 year
**Description:** The composite endpoint of cardiovascular death or cardiovascular hospitalization during 1-year follow-up.
**Measure:** Cardiovascular outcomes during 1-year follow-up
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. age between 18-80 years diagnosed with atrial fibrillation based on ECG or Holter
2. persistent atrial fibrillation
3. prepare to undergo initial catheter ablation for atrial fibrillation
4. agree to enrollment, randomization, treatment, and follow-up
Exclusion Criteria:
1. diagnosed with persistent atrial fibrillation longer than 5 years or left atrial anterior-posterior diameter ≥ 50mm
2. diagnosed with atrial fibrillation secondary to reversible causes (such as hyperthyroidism, acute infection, etc.)
3. severe structural heart disease (hypertrophic cardiomyopathy, rheumatic heart disease, dilated cardiomyopathy, etc.)
4. currently take sodium-glucose co-transporter 2 inhibitors
5. complicated with the following Class I indications for sodium-glucose co-transporter 2 inhibitors: i. patients with type 2 diabetes with atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD ii. patients with a history of heart failure (HF), including HF with reduced ejection fraction, mildly reduced ejection fraction, and preserved ejection fraction iii. patients with chronic kidney disease with eGFR=20-60 ml/min/1.73m2
6. complicated with the following contraindication of sodium-glucose co-transporter 2 inhibitors: i. with previous allergic reactions to dapagliflozin ii. with end-stage renal failure or dialysis
7. type 1 diabetes, or previous diabetic ketoacidosis
8. severe hypoglycemia or genitourinary infection in the past 12 months
9. hypovolemia or hypotension
10. currently enrolled in another clinical study.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Chao Jiang, MD
**Phone:** +86 (010) 84005361
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Chao Jiang
- **Phone:** 86+15001251357
- **Role:** CONTACT
***Contact 2:***
- **Name:** Zixu Zhao
- **Role:** SUB_INVESTIGATOR
***Contact 3:***
- **Name:** Zejun Yang
- **Role:** SUB_INVESTIGATOR
**Country:** China
**Facility:** Beijing Anzhen Hospital
**State:** Beijing
**Zip:** 100029
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001145
- Term: Arrhythmias, Cardiac
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020969
- Term: Disease Attributes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrence
- ID: M4586
- Name: Atrial Fibrillation
- Relevance: HIGH
- As Found: Atrial Fibrillation
- ID: M4453
- Name: Arrhythmias, Cardiac
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001281
- Term: Atrial Fibrillation
- ID: D000012008
- Term: Recurrence
### Intervention Browse Module - Ancestors
- ID: D000077203
- Term: Sodium-Glucose Transporter 2 Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M348449
- Name: Dapagliflozin
- Relevance: HIGH
- As Found: 0.9
- ID: M1691
- Name: Sodium-Glucose Transporter 2 Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000529054
- Term: Dapagliflozin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433466
**Brief Title:** Influencer Marketing: a Survey-based Experiment
**Official Title:** The Impact of Instagram and TikTok Influencer Marketing on Perceptions of E-cigarettes in Young Adults: a Survey-based Experiment
#### Organization Study ID Info
**ID:** unidentified
#### Organization
**Class:** OTHER
**Full Name:** University of Southern California
### Status Module
#### Completion Date
**Date:** 2023-06-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-06-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Southern California
#### Responsible Party
**Investigator Affiliation:** University of Southern California
**Investigator Full Name:** Jennifer Unger
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Young adults (N = 1,500) will participate in the online survey-based experiment. They will be randomly shown 10 videos, featuring influencers promoting e-cigarettes alongside healthy lifestyle activities (experimental group), or a healthy lifestyle activity alone (control). After watching each video, participants will rate perceptions of influencer credibility (i.e., honesty, trustworthiness, knowledge, attractiveness, intelligence, and popularity) on the scale of 0 (e.g., dishonest) to 100 (honest).
Among all participants, harm perceptions of e-cigarettes will be assessed. Susceptibility to use e-cigarettes will be assessed among never users. These outcomes will then be compared among participants who perceived influencers as credible and those who perceived influencers as non-credible.
**Detailed Description:** Young adults (18-24 years of age) living in California were recruited by YouGov marketing research panel to participate in a survey on tobacco-related attitudes and behaviors. YouGov, a research panel agency, has been used in prior research to survey young adults about their tobacco-related attitudes and behaviors. Respondents (N=1,500) were matched to a sampling frame based on gender, age, race, and education. The sampling frame was a politically representative modeled frame of United States (U.S.) adults based on the American Community Survey. The matched cases were weighted to the sampling frame using a propensity score matching procedure. Participants were provided with a survey URL link. After completing informed consent, participants completed the survey online. The study was approved by the University of Southern California Institutional Review Board (UP-21-00135). Respondents were randomly assigned to watch 10 10-second long TikTok videos in either experimental (influencers promoting e-cigarettes alongside healthy lifestyle activities ) or control group (influencers showing healthy lifestyle activity alone).
### Conditions Module
**Conditions:**
- Vaping
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** FACTORIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 1500
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Young adults were randomly shown 10 videos, featuring influencers promoting e-cigarettes alongside healthy lifestyle activities (experimental group).
**Intervention Names:**
- Other: Videos featuring influencers promoting e-cigarettes alongside healthy lifestyle activities
**Label:** Videos featuring influencers promoting e-cigarettes alongside healthy lifestyle activities
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Young adults were randomly shown 10 videos, featuring influencers promoting healthy lifestyle activity alone (control).
**Intervention Names:**
- Other: Videos featuring influencers promoting e-cigarettes alongside healthy lifestyle activities
**Label:** Videos featuring influencers showing healthy lifestyle activities
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Videos featuring influencers promoting e-cigarettes alongside healthy lifestyle activities
- Videos featuring influencers showing healthy lifestyle activities
**Description:** Young adults were randomly shown 10 videos, featuring influencers promoting e-cigarettes alongside healthy lifestyle activities (experimental group), or a healthy lifestyle activity alone (control).
**Name:** Videos featuring influencers promoting e-cigarettes alongside healthy lifestyle activities
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Responses to the question, "Do you think vaping e-cigarettes is harmful to your health?" were measured on a Likert scale, ranging from "definitely yes" (1), "probably yes" (2), to "probably not (3)," "definitely not (4)." The measure represents one validated item from the Population Assessment of Tobacco and Health (PATH).
**Measure:** harm perceptions of e-cigarettes
**Time Frame:** one-time assessment after the experimental exposure (immediately post-treatment)
**Description:** Susceptibility to use e-cigarettes was measured (among never-users of e-cigarettes), using the validated three-item scale adapted from PATH, and combined into one variable (α=0.93). Consistent with prior research, the measure was dichotomized with responses "definitely not" to all items being coded as "not susceptible" and responses "probably not," "probably yes", or "definitely yes" being coded as "susceptible."
**Measure:** Susceptibility to use e-cigarettes
**Time Frame:** one-time assessment after the experimental exposure (immediately post-treatment)
**Description:** Perceptions of influencer credibility (i.e., honesty, trustworthiness, knowledge, intelligence, attractiveness, and popularity) were assessed using a 0 (e.g., dishonest) -100 (e.g., honest) scale that has been validated in prior research.
**Measure:** Perceptions of influencer credibility
**Time Frame:** assessed 10 times after each video (during treatment, immediately after each video)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18-24 years of age,
* English fluency,
* Current California resident.
The survey was sampled to be representative by age group (18 to 24) and gender, and was weighted to be representative by age, gender, race, and educational attainment using propensity score weighting.
Exclusion Criteria:
Not meeting these criteria:
* 18-24 years of age,
* English fluency,
* Current California resident.
**Maximum Age:** 24 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Los Angeles
**Country:** United States
**Facility:** YouGov, online
**State:** California
**Zip:** 94102
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433453
**Brief Title:** Three Dimensional Ultrasonographic Detection of Human Ovulation
**Official Title:** Three Dimensional Ultrasonographic Detection of Human Ovulation and Anovulation
#### Organization Study ID Info
**ID:** Bio 2757
#### Organization
**Class:** OTHER
**Full Name:** University of Saskatchewan
### Status Module
#### Completion Date
**Date:** 2025-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Saskatchewan
#### Responsible Party
**Investigator Affiliation:** University of Saskatchewan
**Investigator Full Name:** Angela Baerwald
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The research aims to compare diagnosis of ovulation and anovulation in 2D and 3D ultrasonography.
**Detailed Description:** Thirty healthy participants will be enrolled. When their dominant ovarian follicle has a diameter of 16 mm or more, an anti-prostaglandin medication, indomethacin 30 mg, will be administered three times daily for 1-7 days. Anti-prostaglandins are known to cause anovulation. Daily 2D and 3D ultrasound scans, and urine and finger prick blood tests for reproductive hormonal assays will be performed. The medication will be discontinued once ultrasound features of anovulation are observed. These study procedures will also be carried out on days 1, 3 and 7 after anovulation.
A second cohort of 30 participants who had 2D and 3D ultrasound scans and hormonal assays in a natural cycle in a previous study (Bio 2080; NCT05531357) will also be evaluated.
These two groups represent the anovulatory and ovulatory groups, respectively, and their 2D and 3D ultrasound features will be compared. With 2D ultrasonography as a gold standard, the study aims to determine if 3D ultrasonography improves ovulation assessment and improves the recognition of anovulatory follicles in infertility treatment
### Conditions Module
**Conditions:**
- Ovulation Disorder
**Keywords:**
- ovulation
- 3D ultrasonography
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Oral indomethacin 50 mg three times daily for 1-7 days. The administration is terminated when signs of anovulation are observed.
**Intervention Names:**
- Drug: Indomethacin 50 MG
- Procedure: Transvaginal ultrasound scans
- Diagnostic Test: Finger prick blood test
- Diagnostic Test: Urine test
**Label:** Indomethacin
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Indomethacin
**Description:** The medication is commenced when a preovulatory follicle is observed. It will be administered for a minimum of one day, up to a maximum of 7 days. It will be discontinued when anovulation is observed.
**Name:** Indomethacin 50 MG
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Indomethacin
**Description:** Ultrasound scans done intermittently before and after an ovulatory or anovulatory event
**Name:** Transvaginal ultrasound scans
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Indomethacin
**Description:** Capillary blood extracted from a finger prick. Blood spots are collected on a specialized card, dried and frozen before reproductive hormones are assayed from them.
**Name:** Finger prick blood test
**Other Names:**
- Dried blood spots
**Type:** DIAGNOSTIC_TEST
#### Intervention 4
**Arm Group Labels:**
- Indomethacin
**Description:** Early morning urine tests to assay reproductive hormones
**Name:** Urine test
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Daily ultrasound scans to demonstrate the disappearance of a preovulatory follicle and replacement with a corpus luteum
**Measure:** Daily measures of follicle diameters in each ovary (mm)
**Time Frame:** 8-16 days
**Description:** Daily ultrasound scans to demonstrate the preovulatory follicle transforming into a corpus luteum vs anovulatory follicle
**Measure:** Presence of corpus luteum (Y/N)
**Time Frame:** 8-16 days
**Description:** FSH assay from dried blood spots and urine samples
**Measure:** Follicle stimulating hormone (FSH) level
**Time Frame:** 8-16 days
**Description:** LH assay from dried blood spots and urine samples
**Measure:** Luteinizing hormone (LH) level
**Time Frame:** 8-16 days
**Description:** Estradiol assay from dried blood spots and urine samples
**Measure:** Estradiol level
**Time Frame:** 8-16 days
**Description:** Progesterone assay from dried blood spots and urine samples
**Measure:** Progesterone level
**Time Frame:** 8-16 days
#### Secondary Outcomes
**Description:** A point system based on changes in follicle size, antrum size, follicle wall thickness, follicular vascularity, visualization of a rupture site, presence of irregular wall-antral borders, presence of internal echoes, visualization of a cumulus-oocyte complex, rise in serum LH, and rise in serum progesterone.
**Measure:** Ovulation score
**Time Frame:** 1 day
**Description:** Endometrial thickness and appearance to support the diagnosis of ovulation or ovulation failure.
**Measure:** Endometrial thickness
**Time Frame:** 8-16 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Healthy biological females
* Regular menstrual cycles (21-35 days)
Exclusion Criteria:
* BMI \<18 or \>30
* Pregnancy
* Breastfeeding mothers
* History of infertility
* History of hysterectomy or oophorectomy
* Reproductive health issues that can interfere with study outcomes
* Smoking
* Not on any hormonal medication that affects reproduction (including hormonal contraception)
* History of metabolic syndrome or untreated thyroid disease
* Contra-indication to non-steroidal anti-inflammatory drug (NSAID) use. These include:
* Gastric ulcers or gastro-intestinal bleeding
* History of myocardial infarction or a coronary artery bypass
* Cerebrovascular disease
* Hypertension
* Chronic or acute renal failure
* Severe liver disease
* Nasal polyp syndrome
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Angela R Baerwald, PhD,MD,CCFP
**Phone:** 306-555-4200
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Folasade A Bello, MBBS, FWACS
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Saskatoon
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Nike Bello, PhD Candidate
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Angela Baerwald, PhD MD
- **Role:** CONTACT
***Contact 3:***
- **Name:** Angela R Baerwald, PhD CCRP
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Nike Bello, MD MBBS MPH
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Roger PIERSON, PHD
- **Role:** SUB_INVESTIGATOR
**Country:** Canada
**Facility:** Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan
**State:** Saskatchewan
**Status:** RECRUITING
**Zip:** S7N0W8
#### Overall Officials
**Official 1:**
**Affiliation:** University of Saskatchewan
**Name:** Angela R Baerwald, PhD,MD,CCFP
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4184
- Name: Anovulation
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Ancestors
- ID: D000000894
- Term: Anti-Inflammatory Agents, Non-Steroidal
- ID: D000018712
- Term: Analgesics, Non-Narcotic
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000006074
- Term: Gout Suppressants
- ID: D000015149
- Term: Tocolytic Agents
- ID: D000012102
- Term: Reproductive Control Agents
- ID: D000016861
- Term: Cyclooxygenase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: Repr
- Name: Reproductive Control Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10257
- Name: Indomethacin
- Relevance: HIGH
- As Found: RAD
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4218
- Name: Anti-Inflammatory Agents, Non-Steroidal
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M20786
- Name: Analgesics, Non-Narcotic
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M17869
- Name: Tocolytic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M19209
- Name: Cyclooxygenase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000007213
- Term: Indomethacin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433440
**Brief Title:** Safety and Immunogenicity of Purified Verocell Rabies Vaccine PVRV Administered Intramuscularly and Intradermally
**Official Title:** An Open-label, Randomized Study Evaluating the Safety and Immunogenicity of the Purified Vero Cell Rabies Vaccine PVRV Administered Intradermally and Intramuscularly as Post-exposure Prophylaxis
#### Organization Study ID Info
**ID:** PVRV-ID
#### Organization
**Class:** OTHER
**Full Name:** University of Peshawar
### Status Module
#### Completion Date
**Date:** 2021-08-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-08-30
**Type:** ACTUAL
#### Start Date
**Date:** 2020-07-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Hayatabad Medical Complex
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Peshawar
#### Responsible Party
**Investigator Affiliation:** University of Peshawar
**Investigator Full Name:** Mohammad Ismail
**Investigator Title:** Dr. Mohammad Ismail Associate Professor of Clinical Pharmacy
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Rabies is fatal disease but preventable with rabies vaccines and immunoglobulins, conventionally involves intramuscular (IM) administration of the vaccine. However, switching the intradermal (ID) route offers potential advantages in dosing, time and cost without compromising efficacy and safety. Therefore, this study aims to compare the safety and immunogenicity of a short-term three-doses intradermal regimen (3D-ID) with a conventional five-doses intramuscular regimen (5D-IM) of the purified Vero cell rabies vaccine (PVRV), administered via both intramuscular (IM) and intradermal (ID) routes as post-exposure prophylaxis (PEP).
**Detailed Description:** Rabies vaccines can be used ID for PEP, according to a WHO Expert Committee recommendation. The administration of short-term PEP through ID (3-doses) offers a safe, immunogenic, dose-sparing, and cost-effective alternative to the conventional protocol (IM, 5-dose regimen) while reducing the volume by up to 60 to 80% and vaccination schedules by 3 weeks. This strategy has the potential to reduce the overall requirement and cost of such vaccines, along with minimizing the burden on healthcare professionals and facilities. Furthermore, this strategy is more likely to improve vaccination compliance compared to conventional protocol, and will certainly improve treatment outcomes.
### Conditions Module
**Conditions:**
- Rabies
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 100
**Type:** ACTUAL
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 0.2 ml of PVRV Intradermally (ID) on the following days: Day0, Day3, and Day7
Biological: PVRV
PEP regimen
**Intervention Names:**
- Biological: PVRV
**Label:** Group-1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 0.5 ml of PVRV Intramuscularly (IM) on the following days: Day0, Day3, and Day7, Day14 and Day28
Biological: PVRV
PEP regimen
**Intervention Names:**
- Biological: PVRV
**Label:** Group-2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group-1
- Group-2
**Description:** Group-1 will receive PVRV ID on on the following days: Day0, Day3, Day7, while group-2 will receive PVRV IM on Day0, Day3, Day7, Day14, and Day28.
**Name:** PVRV
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Patients were assigned into two groups each consisting of n=50 patients: Group-1 and Group-2. Group-1 were administered PVRV intradermally in a dose of 0.2ml on day 0, day 3, and day 7 as post exposure prophylaxis. While, patients in the group-2 received PVRV intramuscularly in a dose of 0.5ml on day 0, day 3, day 7, day 14 and day 28.
Efficacy of PVRV in both groups were measured by the presence of rabies virus neutralizing antibodies (RVNA). Patients with an RVNA titer of ≥ 0.5 IU/mL were considered immunized.
**Measure:** To evaluate the clinical efficacy of PVRV administered intradermally vs intramuscularly based on immune response.
**Time Frame:** 56 days
#### Secondary Outcomes
**Description:** Monitoring of both local and systemic adverse events occurring during the study period The safety of the PVRV was determined by reviewing ADEs obtained during physical examinations following vaccine administration and during follow-up visits in both the groups (group-1 and group-2). The ADEs were recorded after completion of the full vaccination schedule by following-up the patient until day 42. Adverse drug events were characterized in terms of local and systemic effects. A reaction was considered local when it occurred at the site of injection within a few hours of administration, while systemic effects were defined as those occurring in tissues distant from the site of contact between the body and vaccines.
**Measure:** To evaluate the safety of PVRV administered intradermally and intramuscularly based on the frequency of adverse drug events
**Time Frame:** 42 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants aged 2 year or older
* Both male and female
* Dog-bite cases only
* Informed consent form signed by the individual participant and/or their parents or guardian in case of minor age or major Trauma
Exclusion Criteria:
* Subject is participating in any other clinical trial.
* Pregnant and lactating women
* Have a plan to donate blood while participating in the study
* Received any other vaccine except rabies vaccines in last 6 months
**Maximum Age:** 76 Years
**Minimum Age:** 2 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Peshawar
**Country:** Pakistan
**Facility:** Mohammad Ismail
**State:** KPK
**Zip:** 25000
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Pharmacy, University of Peshawar
**Name:** Mohammad Ismail, PhD
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Department of Pharmacy University of Peshawar
**Name:** Waqar Ali, MPhil
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** Will be shared on reasonable request from the PI
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000018353
- Term: Rhabdoviridae Infections
- ID: D000018701
- Term: Mononegavirales Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000007239
- Term: Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14667
- Name: Rabies
- Relevance: HIGH
- As Found: Rabies
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20491
- Name: Rhabdoviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M20778
- Name: Mononegavirales Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: T4859
- Name: Rabies
- Relevance: HIGH
- As Found: Rabies
### Condition Browse Module - Meshes
- ID: D000011818
- Term: Rabies
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17360
- Name: Vaccines
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433427
**Acronym:** FRAMITO
**Brief Title:** Metabolic Dysregulation as Biomarker of Frailty: Role of the Mitochondrial Dysfunction
**Official Title:** Metabolic Dysregulation as Biomarker of Frailty: Role of the Mitochondrial Dysfunction
#### Organization Study ID Info
**ID:** 653/2023/Oss/AOUFe
#### Organization
**Class:** OTHER
**Full Name:** University Hospital of Ferrara
### Status Module
#### Completion Date
**Date:** 2026-02-22
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-29
**Type:** ESTIMATED
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-14
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Milano Bicocca
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital of Ferrara
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this observational study is to evaluate the presence of mitochondrial dysfunction related to oxidative stress and its possible role in frailty, with and without multimorbidity, and to identify possible frailty biomarkers correlated with mitochondrial dysfunction. The main questions it aims to answer are:
* What is the role of oxidative stress-related mitochondrial dysfunction in frailty, taking into account the interaction with multimorbidity.
* What could be the specific biomarkers associated with mitochondrial dysfunction in the assessment of frailty.
In order to reach the study goals, we will enroll three categories of older adults:
* Non-Frail without Multimorbidity (NFWoM);
* Frail with Multimorbidity (FWM);
* Frail without Multimorbidity (FWoM).
Each individual will undergo an assessment of frailty phenotype and multimorbidity, and the collection of blood samples to isolate Peripheral Blood Mononuclear Cells (PBMCs). The identification of frailty biomarkers in each group of participants will be performed by combining untargeted metabolomics-based approaches and functional studies on specific mitochondrial dysfunctions performed on PBMCs and their subpopulations. Multivariate statistical and machine learning techniques will characterize the three clinical phenotype groups based on molecular data.
**Detailed Description:** Study type: observational prospective study. Primary aim: is to evaluate the presence of mitochondrial dysfunction related to oxidative stress and its possible role in frailty, with and without multimorbidity.
Primary endpoint: mitochondrial dysfunction in frailty. Secondary aims: to combine untargeted metabolomics-based approaches and functional studies on specific mitochondrial dysfunctions performed on PBMCs and PBMC subpopulations (B lymphocytes, T lymphocytes and monocytes).
The research activities are organized in the following tasks:
* Task 1, Patient Enrollment: We will enroll individuals aged 65 years or older from geriatric outpatient clinics or geriatric wards. For each individual, we will perform an assessment of frailty and multimorbidity, and collect blood samples to isolate Peripheral Blood Mononuclear Cells (PBMCs). Three categories of individuals will be enrolled: 25 non-frail individuals without multimorbidity (NFWoM), 25 frail individuals with multimorbidity (FWM), and 25 frail individuals without multimorbidity (FWoM).
* Task 2, Separation of PBMC Subpopulations: T lymphocytes, B lymphocytes, and monocytes will be separated from frozen PBMCs using the Cell Sorting Facility for Fluorescence-Activated Cell Sorting (FACS) separation and the MoFlo Astrios cell sorter. The analyses on CD45+/CD3+/CD19-/CD14- T lymphocytes, CD45+/CD3-/CD19+/CD14- B lymphocytes, CD45+/CD3-/CD19-/CD14+ monocytes.
* Task 3, Mitochondrial Dysfunction Analysis on PBMCs and PBMC Subpopulations: For each individual, mitochondrial dysfunction will be evaluated by analyzing mtDNA damage (by Real-Time PCR), mitochondrial mass alteration (by Mitotracker staining), and intracellular and mitochondrial Reactive Oxygen Species (by DCF and MitoSOX staining). Moreover, we will evaluate alteration of glycolytic and mitochondrial metabolism using Agilent Seahorse Extracellular Flux Analyzer XFe96.
* Task 4, Untargeted Metabolomics on PBMCs and PBMC Subpopulations: To assess metabolic signature of PBMCs and subpopulations and highlight metabolic dysregulations linked to frailty, we will perform untargeted LC-MS-based metabolomics on PBMCs, T lymphocytes, B lymphocytes, and monocytes. The analysis on the polar metabolome will allow us to understand better the metabolic alterations associated with mitochondrial dysregulation.
* Task 5, Characterization of Biomarkers and Molecular Mechanism of Frailty: The potential biomarkers of frailty and the molecular mechanisms involved in mitochondrial dysfunction will be studied using statistical and machine learning techniques on molecular, metabolic and clinical data. This step will help characterize clinical phenotypes based on molecular measurements.
### Conditions Module
**Conditions:**
- Aging
- Frailty
- Mitochondrial Dysfunction
- Chronic Disease
**Keywords:**
- Metabolic dysregulation
### Design Module
#### Bio Spec
**Description:** The laboratory of Oncology and Molecular Pathology of the University of Milano Bicocca will perform DNA extraction and the mtDNA damage evaluation by Real Time PCR analysis on PBMCs and sorted T and B lymphocytes and monocytes, obtained from each participant.
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 75
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Day
### Arms Interventions Module
#### Arm Group 1
**Description:** Individuals aged 65 years or older without frailty and without multimorbidity. This group will serve as a reference for participants who are not frail and do not have multiple chronic conditions.
**Label:** Non-Frail without Multimorbidity (NFWoM)
#### Arm Group 2
**Description:** Frail individuals aged 65 years or older who have multimorbidity. This group will include participants who exhibit frailty and have two or more chronic diseases.
**Label:** Frail with Multimorbidity (FWM)
#### Arm Group 3
**Description:** Frail individuals aged 65 years or older without multimorbidity. This group will help assess frailty in the absence of multiple chronic conditions.
**Label:** Frail without Multimorbidity (FWoM)
### Outcomes Module
#### Primary Outcomes
**Description:** mtDNA copies isolated from total PBMCs and from T and B lymphocytes and monocytes, obtained from the participants, with JetQuick™ Blood and Cell Culture DNA Midiprep Kit (Invitrogen), and 10 ng of DNA will be used for analysis on QuantumStudio 7 Real Time PCR (Applied Biosystems). mtDNA copy number will be calculated by normalising the mitochondrial ND1 gene (mtND1) levels to nuclear Beta-2 microglobulin (B2M) levels.
The number mtDNA copies will be compared between individuals with frailty and multimorbidity vs individuals with frailty without multimorbidity. Frailty will be derived based on the presence of at least three criteria among: involuntary weight loss ≥ 4.5 kg, muscle weakness measured by handgrip, self-reported fatigue on ≥ 3 days per week, low physical activity (assessed with the IPAQ questionnaire), and reduced gait speed (measured by the 4-m walking test). Multimorbidity will be defined as the presence of at least two chronic diseases.
**Measure:** Difference in the mtDNA copy number between frail individuals with vs without multimorbidity
**Time Frame:** Baseline
**Description:** mtDNA copies isolated from total PBMCs and from T and B lymphocytes and monocytes, obtained from the participants, with JetQuick™ Blood and Cell Culture DNA Midiprep Kit (Invitrogen), and 10 ng of DNA will be used for analysis on QuantumStudio 7 Real Time PCR (Applied Biosystems). mtDNA copy number will be calculated by normalising the mitochondrial ND1 gene (mtND1) levels to nuclear Beta-2 microglobulin (B2M) levels.
The number mtDNA copies will be compared between individuals with frailty and multimorbidity vs individuals with frailty without multimorbidity. Frailty will be derived based on the presence of at least three criteria among: involuntary weight loss ≥ 4.5 kg, muscle weakness measured by handgrip, self-reported fatigue on ≥ 3 days per week, low physical activity (assessed with the IPAQ questionnaire), and reduced gait speed (measured by the 4-m walking test). Multimorbidity will be defined as the presence of at least two chronic diseases.
**Measure:** Difference in the mtDNA copy number between non-frail vs frail individuals without multimorbidity
**Time Frame:** Baseline
#### Secondary Outcomes
**Description:** 500,000 PBMCs obtained from the study participants will be stained with CD45, CD3, CD19 and CD14 antibodies and incubated with 100 nM Mitotracker Deep Red (Thermo Fisher Scientific) for 30 minutes at 30°C. Cells will be also labelled with Live/Dead dye and analyzed by flow cytometry with MoFLO Astrios cell sorter. Mitochondrial mass, evaluated as the median fluorescence intensity (MFI) of Mitotracker Deep Red, will be assessed in total PBMCs, T and B lymphocytes and monocytes. 40,000 events in each population gate will be acquired and offline analysis will be performed with Kaluza software.
**Measure:** Variation in the mean intensity of mitochondrial fluorescence between non-frail vs frail individuals without multimorbidity
**Time Frame:** Baseline
**Description:** 500,000 PBMCs obtained from the study participants will be stained with CD45, CD3, CD19 and CD14 antibodies and incubated with 100 nM Mitotracker Deep Red (Thermo Fisher Scientific) for 30 minutes at 30°C. Cells will be also labelled with Live/Dead dye and analyzed by flow cytometry with MoFLO Astrios cell sorter. Mitochondrial mass, evaluated as the median fluorescence intensity (MFI) of Mitotracker Deep Red, will be assessed in total PBMCs, T and B lymphocytes and monocytes. 40,000 events in each population gate will be acquired and offline analysis will be performed with Kaluza software.
**Measure:** Variation in the mean intensity of mitochondrial fluorescence between frail individuals with vs without multimorbidity
**Time Frame:** Baseline
**Description:** The fluorescent cell-permeable indicator 2',7'-dichlorofluorescin diacetate (DCFH-DA) will be used for detecting intracellular ROS. DCFH-DA is deacetylated by cellular esterases to a non-fluorescent compound, which is later oxidised by ROS into fluorescent 2',7'-dichlorofluorescein (DCF). The intensity of the generated fluorescent signal correlates with the intracellular level of ROS. 500,000 PBMCs obtained from 25 NFWoM, 25 FWM and 25 FWoM subjects will be stained with CD45, CD3, CD19 and CD14 antibodies and incubated with 10 μM 2',7'-dichlorofluorescin diacetate (DCFH-DA) at 37°C for 30 minutes. Cells will be also labelled with Live/Dead dye and analyzed by flow cytometry. Intracellular ROS, evaluated as the median fluorescence intensity (MFI) of DCF, will be assessed in total PBMCs, T and B lymphocytes and monocytes. 40,000 events in each population gate will be acquired and offline analysis will be performed with Kaluza software.
**Measure:** Difference of intracellular Reactive Oxygen Species (ROS) between non-frail vs frail individuals without multimorbidity
**Time Frame:** Baseline
**Description:** The fluorescent cell-permeable indicator 2',7'-dichlorofluorescin diacetate (DCFH-DA) will be used for detecting intracellular ROS. DCFH-DA is deacetylated by cellular esterases to a non-fluorescent compound, which is later oxidised by ROS into fluorescent 2',7'-dichlorofluorescein (DCF). The intensity of the generated fluorescent signal correlates with the intracellular level of ROS. 500,000 PBMCs obtained from 25 NFWoM, 25 FWM and 25 FWoM subjects will be stained with CD45, CD3, CD19 and CD14 antibodies and incubated with 10 μM 2',7'-dichlorofluorescin diacetate (DCFH-DA) at 37°C for 30 minutes. Cells will be also labelled with Live/Dead dye and analyzed by flow cytometry. Intracellular ROS, evaluated as the median fluorescence intensity (MFI) of DCF, will be assessed in total PBMCs, T and B lymphocytes and monocytes. 40,000 events in each population gate will be acquired and offline analysis will be performed with Kaluza software.
**Measure:** Difference of intracellular Reactive Oxygen Species (ROS) between frail individuals with vs without multimorbidity
**Time Frame:** Baseline
**Description:** Untargeted LC-MS-based metabolomics will be performed on PBMCs and on T and B lymphocytes and monocytes, obtained as described in Task 2. Cell samples will be quenched using cold methanol. After protein precipitation, metabolites will be extracted and analysed by liquid chromatography mass spectrometry (LC-MS). Hydrophilic interaction chromatography (HILIC) will be used to resolve the polar metabolome before MS detection using an Agilent 6546 lc/q-tof instrument (Agilent).The whole protein content will be quantified with NanoDrop™ (Thermofisher) and used to normalize the metabolic profile of each sample.
**Measure:** Qualitative difference in metabolomics profiles of PBMCs and PBMC subpopulations between non-frail vs frail individuals without multimorbidity
**Time Frame:** Baseline
**Description:** Untargeted LC-MS-based metabolomics will be performed on PBMCs and on T and B lymphocytes and monocytes, obtained as described in Task 2. Cell samples will be quenched using cold methanol. After protein precipitation, metabolites will be extracted and analysed by liquid chromatography mass spectrometry (LC-MS). Hydrophilic interaction chromatography (HILIC) will be used to resolve the polar metabolome before MS detection using an Agilent 6546 lc/q-tof instrument (Agilent).The whole protein content will be quantified with NanoDrop™ (Thermofisher) and used to normalize the metabolic profile of each sample.
**Measure:** Qualitative difference in metabolomics profiles of PBMCs and PBMC subpopulations between frail individuals with vs without multimorbidity
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 65 years
* Stable clinical conditions
* Willingness to participate in the study (provision of informed consent)
* Proficiency in the Italian language
Exclusion Criteria:
- Acute or unstable clinical conditions
**Healthy Volunteers:** True
**Minimum Age:** 65 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
**Study Population:** The study will enroll individuals aged 65 years or older. The enrollment will take place among patients accessing geriatric outpatient clinics or being discharged from geriatric wards in clinically stable conditions.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Caterina Trevisan, PhD
**Phone:** 00393896743650
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Università degli Studi di Ferrara
**Name:** Caterina Trevisan, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020969
- Term: Disease Attributes
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M1175
- Name: Frailty
- Relevance: HIGH
- As Found: Frailty
- ID: M6147
- Name: Chronic Disease
- Relevance: HIGH
- As Found: Chronic Disease
- ID: M23341
- Name: Mitochondrial Diseases
- Relevance: HIGH
- As Found: Mitochondrial Dysfunction
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000028361
- Term: Mitochondrial Diseases
- ID: D000073496
- Term: Frailty
- ID: D000002908
- Term: Chronic Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433414
**Acronym:** PAUSE
**Brief Title:** PAUSE: Sick Day Medication Management Mobile App Study
**Official Title:** Preventing Medication Complications During AcUte Illness Through Symptom Evaluation and Sick Day Guidance Mobile Application (PAUSE)
#### Organization Study ID Info
**ID:** Pro000140652
#### Organization
**Class:** OTHER
**Full Name:** University of Alberta
### Status Module
#### Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Calgary
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Alberta
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Diabetes, heart disease and kidney disease have high morbidity and costs of care. Medications used to treat these conditions are effective. Yet, some have the risk of preventable adverse events when people are sick with the flu or stomach bug. These events include low blood sugar and acute kidney injury which can lead to extended hospital stays or death. Sick day medication guidance (SDMG) recommends stopping these medications temporarily when sick and restarted after symptoms subside. Unfortunately, many patients are not aware of these recommendations or find them hard to follow.
The investigator's previous research has shown that there is a lack of SDMG education and patient resources. Research on the development, implementation, usability and efficacy of these resources is also limited. In developing a SDMG tool, the investigators surveyed patients who expressed interest in an electronic health (eHealth) tool. As a result, the PAUSE App provides a timely and innovative way to provide continuity of care to patients that is linked to each patients' unique pharmacy record.
In the present pilot randomized control trial, the investigators will examine the outcomes of the PAUSE Initiative consisting of the PAUSE App and a SDMG educational handout. Approximately 16 Loblaw/Shoppers Drug Mart pharmacies across Alberta will take part. Patients of these pharmacies who take high-risk medications will be invited to participate. Each pharmacy will be randomized to provide their patients usual care (i.e. SDMG handout) or the intervention (i.e., PAUSE App + handout). Approximately 320 participants (20 per pharmacy) are expected to be recruited. The expected trial length is 9 months from recruitment to analysis.
A simulated 'sick day' survey will be used to assess the fidelity and efficacy of the PAUSE Initiative. Feasibility of the study processes (i.e., recruitment, onboarding) will be assessed to inform a full-scale trial. The usability and acceptability of the PAUSE App will also be investigated. Pharmacists and participants will complete questionnaires and qualitative interviews to assess these outcomes. Additionally, PAUSE App user metrics will be collected. All participants will receive an honorarium for their time.
**Detailed Description:** Our previous research surveyed healthcare providers from Alberta on "factors affecting clinician's decision to provide sick day medication guidance to patients with diabetes and CKD to prevent adverse events." Our results identified 75% of primary health providers were aware of sick day medication guidance, but just 56% knew where to find guidelines and resources. An overwhelming majority of respondents (97%) were supportive of enrolling patients in a study evaluating alternative innovations for providing sick day medication guidance.
In a recent scoping review summarizing existing interventions, our research team found the majority of published SDMG documents were aimed towards healthcare providers, with few patient-targeted documents. These were mainly in the form of handouts, wallet-sized cards, webpages, or telephone support. There is limited primary research on the development, implementation, or evaluation of current SDMG interventions. Most were reported to be challenging to follow and identification of sick days or qualifying medication without error was low. This survey and review highlight the need to develop and to evaluate new solutions for providing SDMG to patients. Our previous work also found that seniors in Canada were receptive to the use of electronic means of communication and several patients have expressed interest in using electronic health (eHealth) tools for sick day self-management.
Participants receiving the intervention will receive access to the PAUSE App, a self-management tool for SDMG intended for patients to use during an acute illness. Users' Loblaw/Shoppers Drug Mart pharmacy records are electronically linked to the PAUSE App within the President's Choice (PC) Health app allowing for up-to-date recommendations based on current prescribed medications. The app asks users a series of questions regarding signs and symptoms that identify a qualifying sick day illness, and screens for 'red flags' that would require emergency, or healthcare provider or urgent care referral, and help patients identify which of their medications they should temporarily withhold or adjusted, tailored to a patients' current medication list. This aims to provide patients with interactive support for managing medication during a sick day event. As part of the intervention, patients will also receive a SDMG patient handout. The intervention addresses the previously identified challenges of identifying qualifying signs and symptoms that warrant SDMG and which medications qualify via an interactive and individualized electronic application designed to facilitate provision of SDMG. The usual care group will receive a SDMG patient handout which outlines SDMG and addresses which medications qualify for SDMG.
Based on preliminary data, the investigators assume an absolute difference of 30% (50% with the PAUSE app vs. 20% without the PAUSE app) in the proportion of participants who complete a simulated sick day without error. Using a two-sided alpha of 0.05, 80% power, and an interclass correlation coefficient of 0.1 between pharmacy clusters, a sample size of 280 participants will be required. To account for a 10% loss to follow-up, the investigators will aim to recruit a total of 320 participants in the trial. The investigators plan to recruit 16 pharmacies that will recruit 20 participants each.
Data Analysis Participant baseline data, including sociodemographics, comorbidities, and active prescriptions will be analyzed using descriptive statistics. Feasibility and fidelity outcomes will be reported using descriptive statistics with numbers and percentages. Comparisons of outcomes between groups (e.g., PAUSE App vs. usual care) will be reported using unadjusted and adjusted generalized estimating equations to determine mean differences and risk differences between groups. Descriptive statistics will be used as appropriate to evaluate group differences following the follow-up period. Associations between key variables and study outcomes will be analyzed using appropriate univariate, multivariate, and mixed model analyses. Exploratory analyses of Google Analytics data will be performed to report user behaviour insights. Analyses of routinely collected health data over a 5-year extended follow-up period will be used to determine the effect, if any, of the intervention on health outcomes.
The simulated sick day evaluations will be scored and analyzed according to predefined scorecards based on scenarios used by Doerfler et al. measuring correct usage of SDMG during acute illness. Log-binomial regression models will be used to directly estimate the risk ratios (RRs) and 95% confidence intervals for the outcome of error free completion of the simulated sick day, as well as for correct completion of each of the 3 individual components of the sick day simulation. Random effects will be used to account for clustering by pharmacies. Unadjusted and adjusted models will be fit, including fixed effects for individual participant characteristics including age, sex, demographics, diabetes, other comorbidities, number of qualifying medications and any other significant confounding variables from univariate analyses. Additionally, data collected from participants on the usefulness of the PAUSE App and/or SDMG patient handout in managing a simulated sick day and overall acceptability of the interventions will be used to further assess the fidelity of the intervention. All statistical analysis will be completed in R.
Selected participants (patients and pharmacists) will be invited to be interviewed following their simulated sick day scenario evaluation based on the purposive sampling strategy. One-on-one semi-structured interviews will be conducted with participants and pharmacists ranging from 30-60 minutes in duration. Interview questions and analysis will be iterative throughout the study to allow for emerging or irregular themes to be examined in later interviews. Qualitative interviews will be audio-recorded, transcribed verbatim and examined using multiple phases of inductive thematic analysis. Collected field notes and transcriptions from interviews will be analyzed using NVIVO qualitative analysis software. Analysis of data will begin immediately following the conclusion of the first participant interview. Data will be coded by two researchers independently and then codes will be compared after the first interview to draft the coding manual for subsequent interviews.
### Conditions Module
**Conditions:**
- Chronic Condition
- Adverse Event
**Keywords:**
- chronic condition
- medication safety
- sick day medication guidance
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Cluster randomized controlled trial
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 320
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants receiving usual care will only receive the SDMG patient handout from their community pharmacist. This handout has been adapted from the Diabetes Canada "How to Stay Safe When You Are Sick" SDMG patient resource as well as the results of a modified Delphi study conducted by the research team to achieve consensus among 25 international clinicians on recommendations for SDMG for people with diabetes, kidney, or cardiovascular disease. This handout will be reviewed and refined with input from people with lived experience with the chronic conditions of interest prior to the study and is intended to provide guidance on how to self-manage medications during a sick day event.
**Label:** Usual Care
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Participants will receive enhanced care through onboarding and accessing the PAUSE App via the PC Health app to provide continuity of care electronically through a personalized eHealth mobile application, as well as the SDMG patient resource handout. The PAUSE App provides the same guidance as the SDMG handout, but uses algorithms tailored to identify and provide guidance specific to users' symptoms and current medications.
**Intervention Names:**
- Other: PAUSE App
**Label:** PAUSE App Intervention
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- PAUSE App Intervention
**Description:** Participants receiving the intervention will receive access to the PAUSE App, a self-management tool for SDMG intended for patients to use during an acute illness. The app asks users a series of questions regarding signs and symptoms that identify a qualifying sick day illness, and screens for 'red flags' that would require emergency, or HCP or urgent care referral, and help patients identify which of their medications they should temporarily withhold or adjusted, tailored to a patients' current medication list. This aims to provide patients with interactive support for managing medication during a sick day event. As part of the intervention, patients will also receive a SDMG patient handout. The intervention addresses the previously identified challenges described above via an interactive and individualized electronic application designed to facilitate provision of SDMG.
**Name:** PAUSE App
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** Utilization of future health summary and administrative data to determine the difference, if any, of the intervention on all-cause health outcomes.
Proposed collected summary data may include:
* Increases in serum creatinine (mg/dl) based on the 2012 Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guidelines for AKI and AKD (i.e., \>/= 0.3 mg/dl increase or 1.5-1.9x baseline serum creatinine)
* Hospital admissions and emergency department data related to AKI and/or SDMG-related health outcomes
* Vital statistics (e.g., death records) summary data related to AKI
* Prescription medication history summary data related to AKI, worsening chronic conditions and/or SDMG
**Measure:** Exploration of future health outcomes summary data resultant of adverse drug-related events
**Time Frame:** Over an extended follow-up period of 5 years, or death (whichever comes first)
#### Primary Outcomes
**Description:** Two to three patient participants on average per pharmacy per week can be recruited (320 patients from 16 pharmacies over 8 weeks)
**Measure:** Recruitment rate
**Time Frame:** 3-month follow up
**Description:** ≥90% of study participants receive the intervention (SDMG handout, PAUSE App onboarding) to which they are randomized within 1 week of giving informed consent
**Measure:** Time to randomization
**Time Frame:** 3-month follow up
**Description:** ≥50% of study participants randomized to pharmacies using the PAUSE app follow SDMG error-free during the simulated sick day evaluation.
**Measure:** Adherence to SDMG
**Time Frame:** 3-month follow up
#### Secondary Outcomes
**Description:** Semi-structured participant interviews will be undertaken to explore themes related to study design elements, such as pharmacist onboarding and education, and barriers and facilitators to understanding and usability of the PAUSE App intervention/SDMG tools. Coded concepts will be synthesized into overall themes inductively to form a comprehensive description of the data.
**Measure:** Exploration of participant experiences of study design and intervention acceptability
**Time Frame:** 3-month follow-up
**Description:** Semi-structured pharmacist interviews will be undertaken to explore themes related to study design elements, such as onboarding procedures and education components, and experiences interacting with patients regarding the PAUSE App intervention and SDMG education. Coded concepts will be synthesized into overall themes inductively to form a comprehensive description of the data.
**Measure:** Exploration of pharmacist experiences of study design and intervention acceptability
**Time Frame:** 3-month follow-up
**Description:** Routinely collected, app-generated Google Analytics data will be captured over the data collection period to explore summary data trends, including but not limited to: total number of app visits, session duration, clicks on various pages within the app, time of day most frequently used, PDF (e.g., sick day guidance resources) downloads, and in-app engagement.
**Measure:** Exploration of PAUSE App-generated user behaviours and usage patterns
**Time Frame:** Throughout the 3-month data collection period
**Description:** Pre- and post-intervention evaluation of paraticipant medication self-management using a 13-item Self-efficacy for Appropriate Medication Use Scale (SEAMS-13) survey.
**Measure:** Exploration of the efficacy of the intervention in managing a simulated sick day event
**Time Frame:** At baseline and 3-month follow-up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* ≥18 years of age and able to provide informed consent
* be able to communicate (read, write, and speak) in English
* have access to a smartphone/tablet with an Internet connection
* be willing and able to download and use the PC Health app for the duration of the study
* currently be taking 2 or more medications from the following classes: renin-angiotensin-aldosterone system (RAAS) antagonists, diuretics, oral NSAIDs, metformin, or 1 or more medications from the following classes: insulin, sulfonylureas, meglitinides, SGLT2 inhibitors.
Exclusion Criteria:
* fail to meet the inclusion criteria
* have kidney failure requiring maintenance dialysis
* have had an organ transplant
* are pregnant
* receive qualifying medications in a blister pack or sachet
* do not primarily manage their own medications and condition (i.e., receive home care, in a rehabilitation or medical respite facility)
* cannot use the PC Health app independently
* previously participated in studies that led to the development of the PAUSE App (including the PAUSE study usability testing or needs assessment focus groups)
**Maximum Age:** 99 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Shania Liu, PhD
**Phone:** 825-965-3258
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Alberta
**Name:** Ross T Tsuyuki, PharmD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of Calgary
**Name:** David JT Campbell, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** IPD will not be shared with other researchers.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Watson KE, Dhaliwal K, McMurtry E, Donald T, Lamont N, Benterud E, Kung JY, Robertshaw S, Verdin N, Drall KM, Donald M, Campbell DJT, McBrien K, Tsuyuki RT, Pannu N, James MT. Sick Day Medication Guidance for People With Diabetes, Kidney Disease, or Cardiovascular Disease: A Systematic Scoping Review. Kidney Med. 2022 May 28;4(9):100491. doi: 10.1016/j.xkme.2022.100491. eCollection 2022 Sep.
**PMID:** 36046611
**Citation:** Watson KE, Dhaliwal K, Robertshaw S, Verdin N, Benterud E, Lamont N, Drall KM, McBrien K, Donald M, Tsuyuki RT, Campbell DJT, Pannu N, James MT; PAUSE (Preventing Medication Complications During Acute Illness Through Symptom Evaluation and Sick Day Guidance) Medication Safety Advisory Panel. Consensus Recommendations for Sick Day Medication Guidance for People With Diabetes, Kidney, or Cardiovascular Disease: A Modified Delphi Process. Am J Kidney Dis. 2023 May;81(5):564-574. doi: 10.1053/j.ajkd.2022.10.012. Epub 2022 Dec 5.
**PMID:** 36470530
**Citation:** Dhaliwal KK, Watson KE, Lamont NC, Drall KM, Donald M, James MT, Robertshaw S, Verdin N, Benterud E, McBrien K, Gil S, Tsuyuki RT, Pannu N, Campbell DJT. Managing 'sick days' in patients with chronic conditions: An exploration of patient and healthcare provider experiences. Health Expect. 2023 Aug;26(4):1746-1756. doi: 10.1111/hex.13789. Epub 2023 Jun 8.
**PMID:** 37291977
**Citation:** Watson KE, Dhaliwal K, Benterud E, Robertshaw S, Verdin N, McMurtry E, Lamont N, Drall KM, Gill S, Campbell DJT, McBrien K, Tsuyuki RT, Pannu N, James MT, Donald M. Managing Medications During "Sick Days" in Patients With Diabetes, Kidney, and Cardiovascular Conditions: A Theory-informed Approach to Intervention Design and Implementation. Can J Diabetes. 2024 Feb 21:S1499-2671(24)00045-5. doi: 10.1016/j.jcjd.2024.02.003. Online ahead of print.
**PMID:** 38395301
## 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
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M6147
- Name: Chronic Disease
- Relevance: HIGH
- As Found: Chronic Conditions
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002908
- Term: Chronic Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433401
**Brief Title:** The Effect of Structured Transition Care Model Applied to Adolescents With Congenital Heart Disease
**Official Title:** The Effect of Structured Transition Care Model Applied to Adolescents With Congenital Heart Disease on Transition Readiness, Self-Management Skills and Care Satisfaction
#### Organization Study ID Info
**ID:** AnkaraYBU-SBF-TKT-01
#### Organization
**Class:** OTHER
**Full Name:** Ankara Yildirim Beyazıt University
### Status Module
#### Completion Date
**Date:** 2025-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-17
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ankara Yildirim Beyazıt University
#### Responsible Party
**Investigator Affiliation:** Ankara Yildirim Beyazıt University
**Investigator Full Name:** tutkukırçı
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Congenital heart disease is one of the most common congenital defects with a high mortality and morbidity rate. Children with congenital heart disease step from pediatric care to adult care during adolescence. This situation has brought up transitional care, which is defined as "the purposeful and planned movement of adolescents and young adults with chronic physical and medical conditions from pediatric to adult-oriented health systems". Since adolescents with congenital heart disease are at high risk for complications in adulthood, it is very important to raise awareness, increase the level of readiness for adult care and gain self-management skills during the transition phase. This study was planned as a randomized controlled experimental study to evaluate the effect of the developmental transition care model applied to adolescents with congenital heart disease during the transition from pediatric care to adult care on the transition readiness level, self-management skills and care satisfaction of adolescents.
Studies have shown that both adolescents with congenital heart disease and their caregivers need professional support, appropriate transition education and care before transition to adult care in order to increase adaptation to adult care, to gain self-management skills and to reduce their concerns. Studies in which adolescents are followed up after transition to adult care show that when the transition process is not successfully completed, there is excessive time between the last pediatric control and the first adult control or there are losses in further follow-up. Although there are studies in our country in which transition care is applied, this study is planned because there is no intervention study in which developmental transition care model is applied to adolescents with congenital heart disease. It is thought that this study will increase the transition readiness levels, self-management skills and care satisfaction of adolescents with congenital heart disease and guide the nurses working with them.
**Detailed Description:** Congenital heart disease is one of the most common congenital defects with high mortality and morbidity rates. The American Heart Association reports that at least eight out of every 1000 babies born are born with heart disease. In Turkey, an average of 11,000-17,000 babies are born with congenital heart disease each year. Congenital heart diseases are a very large group of diseases and the level and prognosis of defects in this group vary. While severe defects result in neonatal and infant mortality, almost all children with mild defects survive. With the adolescent period, children step from pediatric care to adult care. While the transition to adulthood causes psychological and social changes for a healthy adolescent and his/her family, the need for additional care for adolescents with chronic diseases and the change in access to health services make the transition period even more challenging. This situation has brought transition care, defined as "the purposeful and planned movement of adolescents and young adults with chronic physical and medical conditions from pediatric health systems to adult-oriented health systems" to the agenda. Since adolescents with congenital heart disease are at high risk for complications in adulthood, raising awareness of the need for regular medical follow-up and preparing them for changes in the health care environment are very important for a successful transition.
The aim of transitional care is to maintain the control and well-being of the disease in adulthood and maximize its potential by providing the quality care practices needed by the adolescent without interruption. Studies have shown that both adolescents with congenital heart disease and their caregivers need professional support, appropriate transition education and care before transition to adult care in order to increase their adaptation to adult care, gain self-management skills and reduce their concerns. The American Academy of Pediatrics (APA) recommends that the transition process should begin with transition planning between the ages of 12-14. However, since physiological and psychological development and needs are not related to the chronological age of the individual, the essence of timing in the transition process is flexibility. The timing of transition varies depending on many individual and environmental variables such as age, gender, physical and psychological maturation, current medical condition, compliance and adherence to treatment, readiness of the adolescent for transition, finding an appropriate adult care provider, and insurance policies. In studies in which adolescents with congenital heart disease were followed up after transition to adult care, when the transition process was not successfully completed, there was a gap between the last pediatric control and the first adult control. In conclusion, there is no intervention study in our country in which the developmental transition care model was applied to adolescents with congenital heart disease and the results were evaluated. In addition, based on clinical experiences and observations, it was determined that adolescents and their parents had difficulties in the transition from pediatric care to adult care and this negatively affected self-management related to the disease. The aim of this study was to evaluate the effect of the developmental transition care model applied to adolescents with congenital heart disease during the transition from pediatric care to adult care on the transition readiness level, self-management skills and care satisfaction of adolescents.
### Conditions Module
**Conditions:**
- Congenital Heart Disease in Adolescence
**Keywords:**
- Congenital heart disease
- Adolescent
- Transition care
- Nurses
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The study included two groups, an intervention group and a control group. Intervention group receiving transitional care training and control group receiving routine care.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Participants will not know which group they are in. They will be assigned to groups by simple simple random randomization method. Since the researcher was the one who provided the training, researcher blinding could not be performed.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The transitional care group is a group that will receive a transitional care training consisting of a total of 3 modules in which the content is arranged for individualized needs with expert opinion from 10 faculty members working in the field of Child Health and Diseases Nursing.The education sessions will be conducted every 3 months in sessions of approximately 35-40 minutes face-to-face in the training room allocated to the individual researcher.
**Intervention Names:**
- Behavioral: Transitional care training with brochures, posters and slide training materials
**Label:** Transition care group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control group is the group receiving routine care that continues the normal follow-up of the clinic without any intervention. However, in terms of compliance with ethical principles, the same training will be given to them upon their request after the research is completely completed.
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Transition care group
**Description:** Education at 3 and 6 months after the first interview
**Name:** Transitional care training with brochures, posters and slide training materials
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** It addresses the readiness of adolescents/young adults with chronic diseases to transition from pediatric care to adult care with the sub-dimensions of management of treatment, management of appointments, monitoring of health status, communication with health personnel and management of daily activities. The Cronbach alpha internal consistency coefficient of the Turkish scale was .88. The readiness for transition assessment scale is a 5-point Likert-type self-assessment scale to assess the skills and behaviors required for disease management in five sub-dimensions. Each item is evaluated between 1 point (no, I do not know how to do it) and 5 points (yes, I can do it when I need to). Adolescents score a minimum of 20 and a maximum of 100 points. The higher the score obtained from the scale, the higher the level of readiness of the adolescent to transition from pediatric care to adult care.
**Measure:** Transition Readiness Assessment Scale
**Time Frame:** at certain intervals for 1 year
#### Secondary Outcomes
**Description:** This form was prepared by the researchers as a result of the literature review and will be used to obtain information on the age, gender, contact information, information on parents interested in health checks, initial diagnosis characteristics (date of diagnosis and complaints of hospital admission), degree of congenital heart disease, information on regularly used medication, body mass index, physical activity status, nutritional status, vital signs, cardiac examination and imaging information of adolescents.
**Measure:** Data Collection Form on Sociodemographic and Medical Characteristics
**Time Frame:** at certain intervals for 1 year
**Description:** This scale to determine the disease management skills of individuals with chronic diseases The scale consists of 21 items and 4 sub-dimensions. These sub-dimensions are self-stigmatization, coping with stigmatization, health care effectiveness and treatment compliance. It was stated that the scale is suitable for use in all individuals with chronic diseases. The scale score is calculated by arithmetic mean. Each item in the scale is scored between 1 and 5. Scores obtained from the scale indicate that self-management increases as it approaches 5, and self-management decreases as it decreases towards 1.
**Measure:** Chronic Disease Self-Management Scale
**Time Frame:** at certain intervals for 1 year
**Description:** The scale allows adolescents with chronic diseases to self-assess the care they receive and to determine their expectations; it is a scale that addresses the care provided with the dimensions of "Management of the Physical Environment (PME)", "Health Personnel Characteristics (HCP)" and "Care Process (CP)". The form of the scale used for adolescents consists of two separate questionnaires (ideal care/existing care) with 21 questions in which the adolescent's expected care and current care are evaluated. The scale forms are 7-point Likert-type with 1=strongly disagree and 7=strongly agree. Participants are asked to rate their current care based on the best care they expect for themselves. Scoring is based on the difference between the individual's expectations and what they actually perceive.
**Measure:** Transitional Care Satisfaction Rating Scale
**Time Frame:** at certain intervals for 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Voluntarily agree to participate in the research
* To be between the ages of 16-20,
* Having a diagnosis of congenital heart disease,
* Being followed up with a diagnosis of congenital heart disease for at least one year in the polyclinics where the study was conducted,
* To be able to communicate in Turkish,
* Not having any mental deficiency that may prevent communication
Exclusion Criteria:
* Refusing to participate in the research,
* Not being able to communicate in Turkish,
* Not showing up regularly for follow-ups,
* Having any mental disability that may prevent communication
**Maximum Age:** 20 Years
**Minimum Age:** 16 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Tutku KIRÇI TEMİZ, PhD s.
**Phone:** +905064278982
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Utku ARMAN ÖRÜN, Prof.Dr.
**Phone:** +905322933072
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ankara
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ankara Etlik City Hospital
- **Phone:** 0312 797 00 00
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Republic of Turkey Ministry of Health Ankara Etlik City Hospital
**State:** Ankara Yenimahalle
**Zip:** 06170
#### Overall Officials
**Official 1:**
**Affiliation:** Ankara Yildirim Beyazıt University
**Name:** Tutku KIRÇI TEMİZ, PhD s.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Ankara Yildirim Beyazıt University
**Name:** Evrim KIZILER, Asst.Prof.
**Role:** STUDY_DIRECTOR
**Official 3:**
**Affiliation:** Republic of Turkey Ministry of Health Ankara Etlik City Hospital
**Name:** Utku ARMAN ÖRÜN, Prof.Dr.
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000018376
- Term: Cardiovascular Abnormalities
- ID: D000000013
- Term: Congenital Abnormalities
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
### Condition Browse Module - Browse Leaves
- ID: M9419
- Name: Heart Diseases
- Relevance: HIGH
- As Found: Heart Disease
- ID: M9418
- Name: Heart Defects, Congenital
- Relevance: HIGH
- As Found: Congenital Heart Disease
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M20503
- Name: Cardiovascular Abnormalities
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006331
- Term: Heart Diseases
- ID: D000006330
- Term: Heart Defects, Congenital
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433388
**Brief Title:** Perirenal Fats of Chronic Kidney Disease in Patients With Fatty Liver Disease.
**Official Title:** Perirenal Fats of Chronic Kidney Disease in Patients With Fatty Liver Disease.
#### Organization Study ID Info
**ID:** perirenal fats of ckd
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-27
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Aml Ahmed Ramadan Mohamed
**Investigator Title:** Doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Exploring the association of perirenal fat thickness assessed by MRI in CKD patients with FLD.
**Detailed Description:** Fatty liver disease (FLD) is caused by an accumulation of excessive fat in the liver that leads to liver damage. It has been noticed that fatty liver disease affects not only liver diseases but also extra-hepatic organ systems such as the cardiovascular and renal systems. Increasing the prevalence of FLD has a great association with increasing the risk of cardiovascular diseases, chronic kidney diseases, and Type 2 diabetes mellitus. Hypertension, insulin resistance, and abdominal obesity are risk factors that are shared by FLD and CKD. Moreover, patients with CKD have a great prevalence of developing FLD, and CKD incidence is increased by the presence of FLD.
Obesity is one of the most comorbidities over the world, it is related and increase the risk of cardio metabolic disease, as well as it is a strong risk factor for chronic kidney disease (CKD), and the prevalence of both conditions is rising worldwide, Several recent epidemiologic studies have shown that obesity and the metabolic syndrome are independent predictors of CKD. The most common method for defining obesity is based on BMI(weight \[kilograms\] divided by the square of height \[meters\]).
previously abdominal fat distribution have been measured by BMI, waist to hip ratio (WHR), OR Waist circumference. Although waist circumference was noted to be a reliable predictor of visceral fat, many interfering factors may also reduce the reliability of WC in estimating abdominal fat deposition, as well as the associated risk for CKD like ageing and normal difference in fat distribution between the two genders. Based on these considerations, we presume that per renal fat thickness measurement by MRI may better reflect the risks commonly associated with increased visceral fat accumulation and particularly those related to renal function impairment.
Chronic kidney disease is defined as impairment or structural damage to kidney or kidney function. It manifested by reduction in estimated glomerular rate (eGFR) for at least 3 months. It presented with proteinuria or albuminuria, hematuria. The best diagnosis by biopsy showing renal impairment, or by imaging ultrasound. CKD associated with morbidity and mortality condition especially in developing countries, so it has been necessary to early detection to prevent CKD progression and associated complications, thus improving patient outcomes and reducing the impact of CKD on health-care resources.
FLD begins with liver lipid accumulation, and marked hepatic fat accumulation is a risk factor for disease progression. Liver biopsy is the golden for diagnosis and assessment of the severity of steatosis and grading of fibrosis, although being invasive and difficult method. Ultrasound and magnetic resonance imaging (MRI) biomarkers of liver fat Gives the advantage diagnose FLD as it is non-invasive imaging biomarkers to diagnose FLD, steatosis , and fibrosis.
Therefore the aim of this study is to determine the independent association of Perirenal fat assessment by MRI with the main markers of kidney function, such as estimated glomerular filtration rate (eGFR), albuminuria as well as with serum urate values on one side, and grading of fibrosis and steatosis in FLD patients on the other side.
### Conditions Module
**Conditions:**
- Chronic Kidney Diseases
- Fatty Liver
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Year
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Magnetic Resonance Imaging (MRI) is a non-invasive imaging technology that produces three dimensional detailed anatomical images. Patients will be subjected to MRI scans and imaging of the kidneys and liver
**Name:** MRI
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Association between perirenal fat thickness measured by MRI and PAUS and the main markers of kidney function, such as estimated glomerular filtration rate (eGFR), albuminuria and serum urate in CKD patient with FLD.
**Measure:** Perirenal fat thickness, as measured by MRI and PAUS and its relation to poor renal outcomes in chronic kidney diseased patient with Fatty liver disease.
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age more than 18 years old regardless of gender
Exclusion Criteria:
* Other causes of chronic liver diseases (HCV, HBV...).
* End stage renal diseases (GFR\<15 ml/min).
* A history of significant alcohol intake (\>20 g/day in females and 30 g/day in males).
* Those using medications that can cause fatty liver.
* Pregnant patients.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients will be recruited from the out-patient clinics of the Internal Medicine Department, Assiut university
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Aml Ahmed Ramadan, Master
**Phone:** +201024485855
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Samir Kamal Abdul_Hamid
**Phone:** +201062949199
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** professor
**Name:** Samir Kamal Abdul_Hamid, prof
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Targher G, Byrne CD. Non-alcoholic fatty liver disease: an emerging driving force in chronic kidney disease. Nat Rev Nephrol. 2017 May;13(5):297-310. doi: 10.1038/nrneph.2017.16. Epub 2017 Feb 20.
**PMID:** 28218263
**Citation:** Zhang QH, Xie LH, Zhang HN, Liu JH, Zhao Y, Chen LH, Ju Y, Chen AL, Wang N, Song QW, Xie LZ, Liu AL. Magnetic Resonance Imaging Assessment of Abdominal Ectopic Fat Deposition in Correlation With Cardiometabolic Risk Factors. Front Endocrinol (Lausanne). 2022 Mar 30;13:820023. doi: 10.3389/fendo.2022.820023. eCollection 2022.
**PMID:** 35432188
**Citation:** Wahba IM, Mak RH. Obesity and obesity-initiated metabolic syndrome: mechanistic links to chronic kidney disease. Clin J Am Soc Nephrol. 2007 May;2(3):550-62. doi: 10.2215/CJN.04071206. Epub 2007 Mar 14.
**PMID:** 17699463
**Citation:** Stenvinkel P, Zoccali C, Ikizler TA. Obesity in CKD--what should nephrologists know? J Am Soc Nephrol. 2013 Nov;24(11):1727-36. doi: 10.1681/ASN.2013040330. Epub 2013 Oct 10.
**PMID:** 24115475
**Citation:** Chen J, Muntner P, Hamm LL, Jones DW, Batuman V, Fonseca V, Whelton PK, He J. The metabolic syndrome and chronic kidney disease in U.S. adults. Ann Intern Med. 2004 Feb 3;140(3):167-74. doi: 10.7326/0003-4819-140-3-200402030-00007.
**PMID:** 14757614
**Citation:** Sanches FM, Avesani CM, Kamimura MA, Lemos MM, Axelsson J, Vasselai P, Draibe SA, Cuppari L. Waist circumference and visceral fat in CKD: a cross-sectional study. Am J Kidney Dis. 2008 Jul;52(1):66-73. doi: 10.1053/j.ajkd.2008.02.004. Epub 2008 Apr 28.
**PMID:** 18440683
**Citation:** Levin A, Stevens PE. Early detection of CKD: the benefits, limitations and effects on prognosis. Nat Rev Nephrol. 2011 Jun 28;7(8):446-57. doi: 10.1038/nrneph.2011.86.
**PMID:** 21712852
**Citation:** Tonelli M, Dickinson JA. Early Detection of CKD: Implications for Low-Income, Middle-Income, and High-Income Countries. J Am Soc Nephrol. 2020 Sep;31(9):1931-1940. doi: 10.1681/ASN.2020030277. Epub 2020 Aug 24.
**PMID:** 32839279
**Citation:** Ajmera V, Loomba R. Imaging biomarkers of NAFLD, NASH, and fibrosis. Mol Metab. 2021 Aug;50:101167. doi: 10.1016/j.molmet.2021.101167. Epub 2021 Jan 15.
**PMID:** 33460786
**Citation:** Byrne CD, Targher G. NAFLD: a multisystem disease. J Hepatol. 2015 Apr;62(1 Suppl):S47-64. doi: 10.1016/j.jhep.2014.12.012.
**PMID:** 25920090
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000051437
- Term: Renal Insufficiency
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Kidney Disease
- ID: M11107
- Name: Liver Diseases
- Relevance: HIGH
- As Found: Liver Disease
- ID: M8375
- Name: Fatty Liver
- Relevance: HIGH
- As Found: Fatty Liver
- ID: M26717
- Name: Renal Insufficiency, Chronic
- Relevance: HIGH
- As Found: Chronic Kidney Disease
- ID: M26718
- Name: Renal Insufficiency
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T5868
- Name: Visceral Steatosis
- Relevance: HIGH
- As Found: Fatty Liver
### Condition Browse Module - Meshes
- ID: D000008107
- Term: Liver Diseases
- ID: D000005234
- Term: Fatty Liver
- ID: D000007674
- Term: Kidney Diseases
- ID: D000051436
- Term: Renal Insufficiency, Chronic
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433375
**Brief Title:** Evaluation of the Efficacy of Growth Hormone on Healing of Periapical Pathosis
**Official Title:** Evaluation of the Efficacy of Growth Hormone and Non-Surgical Debulking of Periapical Tissues on Healing of Periapical Pathosis
#### Organization Study ID Info
**ID:** 27/4/2023
#### Organization
**Class:** OTHER
**Full Name:** Al-Azhar University
### Status Module
#### Completion Date
**Date:** 2025-04-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Al-Azhar University
#### Responsible Party
**Investigator Affiliation:** Al-Azhar University
**Investigator Full Name:** Mohamed Zakaria Abd El Aziz
**Investigator Title:** Principal investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aimed to evaluate the effect of growth hormone and non-surgical debulking of periapical tissues on healing of periapical pathosis
**Detailed Description:** Out of ninety patients, forty-eight healthy male patients aged 18 to 40 years old were selected from outpatients attending the Endodontic Clinic of the Faculty of Dental Medicine, Al-Azhar University Boys, Cairo, Egypt, to be included in this study. The selected patients have no medical contraindications for oral surgical procedures (Scores1-2) according to the classification of the American Society of Anesthesiologists (ASA)(8). Maxillary permanent incisor teeth were selected according to specific inclusion criteria based on preoperative assessment of the patients.
### Conditions Module
**Conditions:**
- Periapical Diseases
- Growth Hormone
- Non Surgical Debulking
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 48
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Teeth undergo non-surgical debulking of periapical tissues.
**Intervention Names:**
- Procedure: Non surgical debulking of periapical tissues
- Procedure: Non surgical debulking of periapical tissues with growth hormone application
**Label:** Non surgical debulking group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Teeth undergoes Growth Hormone application.
**Intervention Names:**
- Procedure: Growth hormone application
- Procedure: Non surgical debulking of periapical tissues with growth hormone application
**Label:** Growth hormone group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Teeth undergo non-surgical debulking of periapical tissues with Growth Hormone application.
**Intervention Names:**
- Procedure: Non surgical debulking of periapical tissues with growth hormone application
**Label:** Non surgical Debulking & Growth hormone group
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Teeth undergo conventional root canal treatment without any additional intervention
**Intervention Names:**
- Procedure: Root canal treatment
**Label:** Control group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Non surgical debulking group
**Description:** Non surgical debulking of periapical tissues
**Name:** Non surgical debulking of periapical tissues
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Growth hormone group
**Description:** Growth hormone application during non-surgical root canal treatment
**Name:** Growth hormone application
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Growth hormone group
- Non surgical Debulking & Growth hormone group
- Non surgical debulking group
**Description:** Non-surgical debulking of periapical tissues with growth hormone application during non-surgical root canal treatment
**Name:** Non surgical debulking of periapical tissues with growth hormone application
**Type:** PROCEDURE
#### Intervention 4
**Arm Group Labels:**
- Control group
**Description:** Teeth undergo conventional root canal treatment without any additional intervention
**Name:** Root canal treatment
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluation of non surgical root canal tratment healing according to CBCTPAI
**Measure:** Post operative CBCT scan
**Time Frame:** 6 months
**Description:** Evaluation of non surgical root canal tratment healing according to CBCTPAI
**Measure:** Post operative CBCT scan
**Time Frame:** 12 months
#### Secondary Outcomes
**Description:** The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).
**Measure:** Post operative pain assesment
**Time Frame:** 24 hours
**Description:** The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).
**Measure:** Post operative pain assesment
**Time Frame:** 48 hours
**Description:** The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).
**Measure:** Post operative pain assesment
**Time Frame:** 72 hours
**Description:** The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).
**Measure:** Post operative pain assesment
**Time Frame:** 96 hours
**Description:** The postoperative pain assessment was done after the second visit, using the modified verbal descriptor scale (VDS) as follow The VDS consist of a scoring system translated into an Arabic, describes a list of adjectives describing the different level of pain including, no pain (score 0 -1), mild pain (score 2-3), moderate pain (score 4 -5), strong pain (score 6 - 7), severe pain (score 8 - 9), worst pain (score 10).
**Measure:** Post operative pain assesment
**Time Frame:** 120 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:- Necrotic teeth with apical periodontitis.
* Teeth presented with normal pocket depth ranges from 1 to 3mm, up to grade II tooth mobility.
* Teeth with mature apices, root canal curvature between (0-10º) according to Schneider(9) and radii of curvature between 2 to 5 mm according to Pruett would be included in the study(10).
* Teeth with estimated working length of 20mm(±2mm) from the incisal edge as a reference point provided that the crown/root ratio was not compromised.
* Non-critical sized periapical lesion related only to one tooth of a 2 to 4mm diameter and score 3 when evaluated using the Cone Beam Computed Tomography Periapical Index Score (CBCTPAI)(11) , Table (1) presents the scoring scale of CBCT-PAI.
* Teeth located in anatomic areas in which enucleation of the periapical tissues may jeopardize nearby structures, such as the incisive foramen or nasal cavity should be at least 2 mm away from these structures.
Exclusion Criteria:
* Necrotic teeth with related periapical swelling or sinus tract.
* Teeth with previous root canal fillings and /or indirect coronal restoration.
* Teeth with abnormal root canal anatomy.
* Non-restorable teeth due to insufficient coronal tooth structure.
* Teeth with periodontal disease.
* Teeth with grade III mobility.
* Teeth with clinical evidence of a missing buccal bony plate over the periapical defect.
* Traumatized teeth with suspected root cracks, fractures, intrusive and extrusive injuries, previously avulsed or lateral luxation injuries.
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Al Azhar University
**State:** Nasr City
**Zip:** 4450113
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007571
- Term: Jaw Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
### Condition Browse Module - Browse Leaves
- ID: M13393
- Name: Periapical Diseases
- Relevance: HIGH
- As Found: Periapical Diseases
- ID: M10601
- Name: Jaw Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13419
- Name: Periodontal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010483
- Term: Periapical Diseases
### Intervention Browse Module - Ancestors
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M9789
- Name: Hormones
- Relevance: HIGH
- As Found: Loss
- ID: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000006728
- Term: Hormones
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433362
**Brief Title:** CMOEP in the Treatment of Untreated Peripheral T-cell Lymphoma
**Official Title:** A Single Arm, Open Label, Multi-center Study of Mitoxantrone Hydrochloride Liposome With Cyclophosphamide, Vincristine, Etoposide and Prednisone (CMOEP) in Treatment-Naive Patients With Peripheral T-Cell Lymphoma
#### Organization Study ID Info
**ID:** CSPC-DED-PTCL-K07
#### Organization
**Class:** OTHER
**Full Name:** Tianjin Medical University Cancer Institute and Hospital
### Status Module
#### Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Tianjin Medical University Cancer Institute and Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a prospective, single arm, multicenter study to evaluate the safety and efficacy of CMOEP in patients with untreated peripheral T-cell lymphoma.
**Detailed Description:** This is a single-arm, open label, multi-center clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with Cyclophosphamide, Vincristine, Etoposide and Prednisone(CMOEP) in patients with untreated Peripheral T-cell Lymphoma.Mitoxantrone hydrochloride liposome will be given on day 1 at dose of 18 mg/m2 and be combined with cyclophosphamide, vincristine, etoposide and prednisone.Each cycle consists of 21 days. A maximum of 6 cycles of therapy are planned.
### Conditions Module
**Conditions:**
- Peripheral T Cell Lymphoma
**Keywords:**
- Untreated Peripheral T-cell Lymphoma
- Mitoxantrone hydrochloride liposome
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 115
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Mitoxantrone Hydrochloride Liposome with Cyclophosphamide, Vincristine, Etoposide and Prednisone
**Intervention Names:**
- Drug: CMOEP
**Label:** CMOEP
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CMOEP
**Description:** Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (18 mg/m\^2) on day 1, every 3 weeks; Drug: Cyclophosphamide Cyclophosphamide(750 mg/m\^2) on day 1,every 3 weeks; Drug: Vincristine Vincristine (1.4mg/ m2，Max dose 2mg) will be administered by an intravenous injection on day 1(Or at the discretion of the investigator, use other vinblastine drugs with the same mechanism, such as vindesine 3 mg/m2, the maximum dose of 4mg),every 3 weeks; Drug: Etoposide Etoposide (60 mg/ m2) will be administered by an intravenous infusion on day 1-3,every 3 weeks;
**Name:** CMOEP
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Response is assessed according to the lugano criteria.
**Measure:** Complete Response Rate (CRR)
**Time Frame:** 2 year
#### Secondary Outcomes
**Description:** Response is assessed according to the lugano criteria.
**Measure:** Overall Response Rate (ORR)
**Time Frame:** 2 year
**Description:** From the date of the first dose of therapy is given until disease progression, death or last follow-up.
**Measure:** Progression-Free-Survival (PFS)
**Time Frame:** 2 year
**Description:** From the date of inclusion to date of death, irrespective of cause.
**Measure:** Overall survival (OS)
**Time Frame:** 2 year
**Description:** The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.Hematologic and non-hematologic toxicity.
**Measure:** Safety and Tolerability
**Time Frame:** From the first day of medication to 28 days after the last dose
**Description:** such as LVEF% change from baseline, cardiac injury indicators, etc.
**Measure:** Changes in cardiac safety indicators
**Time Frame:** 2 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1.Subjects fully understand and voluntarily participate in this study and sign informed consent.
2. Age ≥18, ≤70years(for 65-70 years old, researchers need to comprehensively evaluate the physical fitness and tolerance of patients), no gender limitation.
3. Expected survival ≥ 3 months. 4.Histologically confirmed diagnosis of Peripheral T-cell lymphoma： 1) Peripheral T-cell lymphoma unspecified (ptcl-NOS) 2) Angioimmunoblastic T-cell lymphoma (AITL) 3) Anaplastic large T-cell lymphoma (ALCL), ALK+ 4) Anaplastic large T-cell lymphoma (ALCL), ALK- 5) Other subtypes of PTCL that the investigator think can be included in the group.
5.No previous treatment for PTCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except for local radiotherapy to alleviate tumor related symptoms), surgical treatment.
6.Subjects must have at least one evaluable or measurable lesion per lugano2014 criteria: for lymph node lesions, the length and diameter should be \>1.5cm; For non-lymph node lesions, the length and diameter should be \>1.0cm.
7.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. 8.The following baseline laboratory criteria are required: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, Platelet count (PLT) ≥75×10\^9/L, Hemoglobin(HB)≥ 90 g/L(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) ≥1.0×10\^9/L, Platelet count (PLT) ≥50×10\^9/L, Hemoglobin(HB)≥ 75g/L).
9.Total Serum creatinine (Scr) ≤1.5X upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN(For patients with liver invasion ≤5X ULN), bilirubin (TBIL)≤1.5X ULN(For patients with liver invasion ≤3X ULN ).
Exclusion Criteria:
* 1.Subjects with a history of prior antitumor therapy. 2.Hypersensitivity to any study drug or its components. 3.Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.) 4.Heart function and disease meet one of the following conditions:1）Long QTc syndrome or QTc interval \>480 ms;2）Complete left bundle branch block, grade II or III atrioventricular block;3）Serious and uncontrolled arrhythmias requiring drug treatment;4）New York Heart Association grade ≥ II;5）Cardiac ejection fraction (LVEF)\<50%;6）A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment.
5.Hepatitis B and hepatitis C active infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than 1x10\^3 copy/mL; hepatitis C virus RNA high than 1x10\^3 copy/mL).
6.Human immunodeficiency virus (HIV) infection (HIV antibody positive). 7.Patients with other malignant tumors, except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ and other tumor during the past 5 years.
8.Patients with primary or secondary central nervous system (CNS) lymphoma or history of CNS lymphoma.
9.Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures.
10.Unsuitable subjects for this study determined by the investigator.
**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:** Jingwei Yu
**Phone:** 86-15022015208
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Tianjin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Huilai Zhang, MD
- **Phone:** +86-18622221228
- **Role:** CONTACT
**Country:** China
**Facility:** Tianjin Cancer Hospital
**Status:** RECRUITING
**Zip:** 300060
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital
**Name:** Huilai Zhang
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** The Second Affiliated Hospital of Harbin Medical University
**Name:** Qingyuan Zhang
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
- ID: D000008228
- Term: Lymphoma, Non-Hodgkin
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11220
- Name: Lymphoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: M18829
- Name: Lymphoma, T-Cell
- Relevance: HIGH
- As Found: T-cell Lymphoma
- ID: M18833
- Name: Lymphoma, T-Cell, Peripheral
- Relevance: HIGH
- As Found: Peripheral T-cell Lymphoma
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11222
- Name: Lymphoma, Non-Hodgkin
- Relevance: LOW
- As Found: Unknown
- ID: T3543
- Name: Lymphosarcoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: T4496
- Name: Peripheral T-cell Lymphoma
- Relevance: HIGH
- As Found: Peripheral T-cell Lymphoma
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
- ID: D000016399
- Term: Lymphoma, T-Cell
- ID: D000016411
- Term: Lymphoma, T-Cell, Peripheral
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
### Intervention Browse Module - Browse Leaves
- ID: M6727
- Name: Cyclophosphamide
- Relevance: LOW
- As Found: Unknown
- ID: M11908
- Name: Mitoxantrone
- Relevance: LOW
- As Found: Unknown
- ID: M14121
- Name: Prednisone
- Relevance: LOW
- As Found: Unknown
- ID: M8191
- Name: Etoposide
- Relevance: LOW
- As Found: Unknown
- ID: M17495
- Name: Vincristine
- Relevance: LOW
- As Found: Unknown
- ID: M341643
- Name: Etoposide phosphate
- Relevance: LOW
- As Found: Unknown
- ID: M17492
- Name: Vinblastine
- Relevance: LOW
- As Found: Unknown
- ID: M17496
- Name: Vindesine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433349
**Brief Title:** A Multi-center Investigation of Family Health.
**Official Title:** A Multi-center Investigation of Family Health, Needs, Perceived Support, Self-efficacy and Quality of Life During the Cancer Trajectory: A Longitudinal Mixed Methods Study Among Danish Cancer Patients and Their Caregivers
#### Organization Study ID Info
**ID:** FaCe Cancer
#### Organization
**Class:** OTHER
**Full Name:** Odense University Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-13
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-23
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Sygehus Lillebaelt
**Class:** OTHER
**Name:** Zealand University Hospital
**Class:** OTHER
**Name:** Rigshospitalet, Denmark
#### Lead Sponsor
**Class:** OTHER
**Name:** Odense University Hospital
#### Responsible Party
**Investigator Affiliation:** Odense University Hospital
**Investigator Full Name:** Laerke Kjaer Tolstrup
**Investigator Title:** Principal investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The current healthcare system is unable to identify burdened and vulnerable families affected by cancer, partly due to a lack of knowledge of how cancer affects family health during treatment and survivorship. Recent reviews have documented a general lack of cancer studies including both the patient and the family, and a particular deficiency in studies including more than the spouse.
The principal aim of this study is to investigate family health, needs and perceived support, quality of life, self-efficacy, depression, stress and resilience in both patients with cancer and their families across the cancer trajectory. Additionally, the study seeks to identify particularly burdened and vulnerable families and investigate contributing factors to their vulnerability.
**Detailed Description:** Background Around 45,000 Danes are diagnosed with cancer each year with an increasing incidence and more than 350,000 people are living with cancer. Depending on the specific diagnosis, the 5-year survival rates range between 67% for men and 69% for women. Approximately 15,000 die of cancer each year.
Receiving a cancer diagnosis not only affects patients; it also affects family members, making cancer disorders a family affair. However, adult cancer research rarely focuses on the well-being and health of the whole family, which is worrying as one-third of the Danish population gets a cancer diagnosis before the age of 75, suggesting that most Danes will become caregivers to a cancer patient at some time during their lives. Adding to this, the Danish Cancer Society recently documented that patients who receive support from caregivers perform better on all parameters, i.e. patients are more aware of signs of relapse and get more frequent help when needed. Thus, caregiver support is a significant component for getting well through the course of cancer without unnecessary discomfort.
In addition, there is an increasing political focus on the efficient utilization of resources, which has resulted in fast-track treatments (Danish: Kræftpakker) and an increasing number of patients in outpatient clinics. This change of treatment setting from hospital to outpatient settings or even hospitalization in the homes of patients directly involves family caregivers in the care of the individual patient, i.e. with treatment, physical care, or emotional support. Thus, the future healthcare system will increasingly depend on the patient´s family and social network when supporting patients with cancer, ensuring, and supporting the health of individuals and communities in multiple inter-connected ways. This evident shift in responsibility from the public to the private sphere has a direct and substantial effect on family function, with a greater burden on the family members involved, which may eventually lead to deteriorated overall family health. Adding to this, there is growing evidence that the health and well-being of family caregivers are affected by higher expectations of active involvement in the care of their ill family member. Families confronted with health problems are at risk of stress and disturbance of family functioning that could cause other health problems and additional harm within the family system. Similarly and highly concerning, is evidence suggesting caregivers have high rates (42%) of depression, a disorder that in itself is associated with multiple concerning outcomes including premature death, chronic disease courses, self-harm, and suicides.
The current healthcare system is unable to identify burdened and vulnerable families affected by cancer, partly due to a lack of knowledge of how cancer affects family health during treatment and survivorship. Recent reviews have documented a general lack of cancer studies including both the patient and the family, and a particular deficiency in studies including more than the spouse.
The principal aim of this study is to investigate family health, needs and perceived support, quality of life, self-efficacy, depression, stress and resilience in both patients with cancer and their families across the cancer trajectory. Additionally, the study seeks to identify particularly burdened and vulnerable families and investigate contributing factors to their vulnerability.
Methods and material
Setting The study will recruit patients and caregivers from six different Danish hospital departments.
Participants In total, 240 patients and their appointed caregivers will be included. Inclusion criteria: curative intended patients and their eventual appointed caregivers \>18 years affected by breast-, prostate-, colorectal cancer or lymphoma.
Exclusion criteria: Not able to understand or give written informed consent.
Design The Face Cancer study is a multi-center investigation of family health, needs, perceived support, self-efficacy, stress, resilience, and quality of life during the cancer trajectory among Danish cancer patients and their adult family caregivers. The study will use mixed methods including patient-reported outcomes in a longitudinal, prospective multicenter survey combined with family interviews conducted in a subset of participants included in the survey. A sequential explanatory design will be applied involving two phases, wherein the quantitative data collection (survey) and analysis will be followed by qualitative follow-up (interviews). Thus, the qualitative data from the family interviews will help to explain and interpret the context and depth of the mechanisms underlying the survey results. The rationale for applying a mixed-methods approach is to gain a deeper and more comprehensive understanding of the impact of cancer on patients and their families. For data presentation purposes, it will be depicted, by the use of a joint display, how the quantitative data is used to inform the qualitative data collection.
Quantitative data A prospective longitudinal multicenter survey including curatively intended cancer patients from the target group and their appointed adult family member(s) at entry of treatment (baseline), during treatment (3 months), and at 6, 12, and 18 months after baseline. The survey includes the following questionnaires. Family-reported outcomes will be assessed by the translated and validated Family Health Scale (Long-form) including family social and emotional health processes, family healthy lifestyle, family health resources, and family external social supports. Perceived support will be assessed by the ICE Family Perceived Support Questionnaires. HRQoL is assessed by the short generic EQ-5D-5L (EuroQol-5 dimensions). Self-efficacy is measured by the Danish version of the ten-item validated general self-efficacy scale (GSE) questionnaire to investigate the ability to act towards problems in everyday life. The GSE covers a broad range of the sense of personal competence to deal effectively with stressful situations. The scale has been found to have high validity and reliability in various populations across contexts and cultures To assess the degree of depression, the Patient Health Questionnaire-9 (PHQ-9) will be used. The Level of distress was measured with the Danish version of the National Comprehensive Cancer Network Distress thermometer (NCCN DT), and resilience was assessed with the Danish version of the 2-item Connor-Davidson-Resilience Scale (CD-RISC2). The survey will also assess real-time family needs \& preferences in free text.
In total, 240 patients (60 patients per patient group) plus appointed family members will be included based on a power calculation of SD applied sqrt(2)\*22 = 31 in the Family Health Scale. This would require 44 patients per patient group plus dropouts with 90% power to detect a minimal clinically important difference change two-time any pair of two-time points in the longitudinal design. Data are collected from six confirmed sites (Danish cancer departments) and questionnaires are distributed via the national mailbox e-Boks.
Qualitative data Family interviews will be conducted to illuminate how patients and caregivers experience (perceive) vulnerable situations, their family supportive care needs, and family support during and after cancer treatment. The groups (n=12-15) will consist of families (one patient and either one or two caregivers) identified in the survey. The interviews will take place longitudinally at two time points at three months (during treatment) and 12 months (during follow-up) after the completion of baseline questionnaires. The interviews can take place either at the hospital, in the patients´ homes or online depending on the preferences of patients and relatives, and are expected to last approximately one hour. We plan to use an integrated approach combining phenomenology with hermeneutics to gain a more complete understanding of the families' experiences, recognizing both their subjective perceptions and the broader cultural and social significance. We will try to carry out the interviews inductively, letting the respondents reflect on their own experiences without imposing preconceived notions. An interview guide will be prepared in alignment with this and the family systems theory. Purposive sampling will be used to ensure the inclusion of families with maximal variation in age, gender, and family life situation will be invited. Thematic analysis by Braun and Clarke is chosen to extract data, identify patterns, and analyze data and themes. NVivo will be used for coding interview data.
### Conditions Module
**Conditions:**
- Breast Cancer
- Prostate Cancer
- Colorectal Cancer
- Hematologic Neoplasms
- Caregivers
### Design Module
#### Design Info
**Observational Model:** FAMILY_BASED
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 240
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will complete the following questionnaires at baseline, 3, 6, 12, and 18 months:
Family Health Scale (Long-form), the ICE Family Perceived Support Questionnaires, EQ-5D-5L, The general self-efficacy scale (GSE), the Patient Health Questionnaire-9 (PHQ-9), the National Comprehensive Cancer Network Distress thermometer (NCCN DT) and resilience was assessed with the Danish version of the 2-item Connor-Davidson-Resilience Scale (CD-RISC2).
A subset of the patients will also participate in family interviews (n=12-15).
**Intervention Names:**
- Other: Survey and interviews
**Label:** Patients with breast-, prostate- colorectal cancer or lymphoma
#### Arm Group 2
**Description:** Caregivers will complete the following questionnaires at baseline, 3, 6, 12, and 18 months:
Family Health Scale (Long-form), the ICE Family Perceived Support Questionnaires, EQ-5D-5L, The general self-efficacy scale (GSE), the Patient Health Questionnaire-9 (PHQ-9), the National Comprehensive Cancer Network Distress thermometer (NCCN DT) and resilience was assessed with the Danish version of the 2-item Connor-Davidson-Resilience Scale (CD-RISC2).
A subset of the caregivers will also participate in family interviews (n=12-15).
**Intervention Names:**
- Other: Survey and interviews
**Label:** Caregivers to patients with breast-, prostate- colorectal cancer or lymphoma.
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Caregivers to patients with breast-, prostate- colorectal cancer or lymphoma.
- Patients with breast-, prostate- colorectal cancer or lymphoma
**Description:** Questionnaires and interviews
**Name:** Survey and interviews
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Family Health Scale: For each dimension, sum the scores to get a total score. Higher scores indicate better health. The ICE Family Perceived Support Questionnaires: Sum the scores for each item to get a total score. Higher scores indicate higher perceived support. The EQ-5D-5L: Digits for the five dimensions can be combined into a number that describes the patient's health from 11111 (full health) to 55555 (worst health). The General self-efficacy scale: Ranges between 10 and 40, a higher score indicating more self-efficacy. The Patient Health Questionnaire-9: Score ranges from 0 to 27 (5-9 are mild depression; 10-14 as moderate; 15-19 as moderately severe; ≥ 20 as severe). The National Comprehensive Cancer Network Distress thermometer, a single-item tool using a 0 (no distress) to 10 (extreme distress). The 2-item Connor-Davidson-Resilience Scale: Each item has a score between 0 and 4. Total scores are calculated by the two items. A higher score indicates higher resilience.
**Measure:** To investigate family health during the cancer trajectory.
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** To identify vulnerable families for the interviews, data from the survey will be used in accordance with the explanatory sequential design. To identify vulnerable patients and caregivers from the PRO-results, 10 items from the Family Health Scale long-form (items 4, 11, 16, 17, 18, 23, 26, 27, 31, 32), which corresponds to the Family Health short form, will be used. Each participant can have a final family health score between 0 and 10 points. Poor family health = 0-5 points; moderate family health = 6-8 points; excellent family health = 9-10 points \[30\]. If either the patient or the caregiver has a score indicating poor or moderate family health, the family will be considered a candidate for the interviews. Following this identification, interviews will be carried out to elucidate determinant factors for their vulnerability.
**Measure:** to identify vulnerable families and examine determinants for their vulnerability at identifying vulnerable families. To identify vulnerable families
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* curative intended patients and their eventual appointed caregivers \>18
* breast-, prostate- colorectal cancer or lymphoma.
Exclusion Criteria:
* Not able to understand or give written informed consent
* Not able to speak Danish or complete questionnaires in Danish
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with breast, prostate, colorectal cancer, or lymphoma and their appointed caregivers. The patients are to receive anti-neoplastic treatment with curative intent at one of the six hospitals included sites.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Odense C
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lærke K. Tolstrup, PhD
- **Phone:** +4540295129
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Karin B. Dieperink, Professor
- **Role:** CONTACT
**Country:** Denmark
**Facility:** Odense University Hospital
**Status:** RECRUITING
**Zip:** 5000
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Coyne E, Heynsbergh N, Dieperink KB. Acknowledging cancer as a family disease: A systematic review of family care in the cancer setting. Eur J Oncol Nurs. 2020 Dec;49:101841. doi: 10.1016/j.ejon.2020.101841. Epub 2020 Oct 14.
**PMID:** 33130424
**Citation:** Adashek JJ, Subbiah IM. Caring for the caregiver: a systematic review characterising the experience of caregivers of older adults with advanced cancers. ESMO Open. 2020 Sep;5(5):e000862. doi: 10.1136/esmoopen-2020-000862.
**PMID:** 32963088
**Citation:** Weiss-Laxer NS, Crandall A, Okano L, Riley AW. Building a Foundation for Family Health Measurement in National Surveys: A Modified Delphi Expert Process. Matern Child Health J. 2020 Mar;24(3):259-266. doi: 10.1007/s10995-019-02870-w.
**PMID:** 31912378
**Citation:** Jansen L, Dauphin S, van den Akker M, De Burghgraeve T, Schoenmakers B, Buntinx F. Prevalence and predictors of psychosocial problems in informal caregivers of older cancer survivors - A systematic review: Still major gaps in current research. Eur J Cancer Care (Engl). 2018 Nov;27(6):e12899. doi: 10.1111/ecc.12899. Epub 2018 Aug 31.
**PMID:** 30168877
**Citation:** Gray TF, Azizoddin DR, Nersesian PV. Loneliness among cancer caregivers: A narrative review. Palliat Support Care. 2020 Jun;18(3):359-367. doi: 10.1017/S1478951519000804.
**PMID:** 31581964
**Citation:** Ochoa CY, Buchanan Lunsford N, Lee Smith J. Impact of informal cancer caregiving across the cancer experience: A systematic literature review of quality of life. Palliat Support Care. 2020 Apr;18(2):220-240. doi: 10.1017/S1478951519000622.
**PMID:** 31588882
**Citation:** Cochrane A, Reid O, Woods S, Gallagher P, Dunne S. Variables associated with distress amongst informal caregivers of people with lung cancer: A systematic review of the literature. Psychooncology. 2021 Aug;30(8):1246-1261. doi: 10.1002/pon.5694. Epub 2021 May 4.
**PMID:** 33945184
**Citation:** Northouse L, Williams AL, Given B, McCorkle R. Psychosocial care for family caregivers of patients with cancer. J Clin Oncol. 2012 Apr 10;30(11):1227-34. doi: 10.1200/JCO.2011.39.5798. Epub 2012 Mar 12.
**PMID:** 22412124
**Citation:** Geng HM, Chuang DM, Yang F, Yang Y, Liu WM, Liu LH, Tian HM. Prevalence and determinants of depression in caregivers of cancer patients: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Sep;97(39):e11863. doi: 10.1097/MD.0000000000011863.
**PMID:** 30278483
**Citation:** GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9. Erratum In: Lancet. 2020 Nov 14;396(10262):1562.
**PMID:** 33069326
**Citation:** Konradsen H, Brodsgaard A, Ostergaard B, Svavarsdottir E, Dieperink KB, Imhof L, Luttik ML, Mahrer-Imhof R, Garcia-Vivar C. Health practices in Europe towards families of older patients with cancer: a scoping review. Scand J Caring Sci. 2021 Jun;35(2):375-389. doi: 10.1111/scs.12855. Epub 2020 Apr 14.
**PMID:** 32291782
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000006402
- Term: Hematologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M21314
- Name: Hematologic Neoplasms
- Relevance: HIGH
- As Found: Hematologic Neoplasms
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019337
- Term: Hematologic Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433336
**Acronym:** AF BP
**Brief Title:** Effect of Blood Pressure on Cardiovascular Outcomes and Recurrence After Catheter Ablation in Patients With Atrial Fibrillation
**Official Title:** Effect of Blood Pressure on Cardiovascular Outcomes and Recurrence After Catheter Ablation in Patients With Atrial Fibrillation
#### Organization Study ID Info
**ID:** lanzhou university second hosp
#### Organization
**Class:** OTHER
**Full Name:** The Second Hospital of Lanzhou University
#### Secondary ID Infos
**Domain:** lanzhou university second hospital
**ID:** lanzhou university
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-05-21
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-05-21
**Type:** ACTUAL
#### Start Date
**Date:** 2019-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The Second Hospital of Lanzhou University
#### Responsible Party
**Investigator Affiliation:** The Second Hospital of Lanzhou University
**Investigator Full Name:** Xiaowei Zhang
**Investigator Title:** lanzhou university second hospital
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Effect of blood pressure on cardiovascular outcomes and recurrence after catheter ablation in patients with atrial fibrillation
### Conditions Module
**Conditions:**
- Atrial Fibrillation, Persistent
- Blood Pressure
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 800
**Type:** ACTUAL
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Year
### Arms Interventions Module
#### Arm Group 1
**Description:** Atrial Fibrillation Recurrence Pulmonary Vein Isolation
**Label:** Effect of blood pressure on cardiovascular outcomes and recurrence after catheter ablation in patien
### Outcomes Module
#### Primary Outcomes
**Description:** death AMI stroke
**Measure:** cardiovascular events
**Time Frame:** 1 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
The inclusion criteria were age \>18 years and a diagnosis of AF by electrocardiogram during the preceding six months or on admission
Exclusion Criteria:
No follow-up
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Between February 2019 and December 2024, 800 consecutive patients who had been referred to lanzhou University second Hospital for treatment of AF and underwent successful ablation were assessed
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lanzhou
**Country:** China
**Facility:** Lanzhou University Second Hospital
**State:** Gansu
**Zip:** 730030
#### Overall Officials
**Official 1:**
**Affiliation:** The Second Hospital of Lanzhou University
**Name:** xiao wei xiaowei zhang, PHD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001145
- Term: Arrhythmias, Cardiac
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020969
- Term: Disease Attributes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrence
- ID: M4586
- Name: Atrial Fibrillation
- Relevance: HIGH
- As Found: Atrial Fibrillation
- ID: M4453
- Name: Arrhythmias, Cardiac
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001281
- Term: Atrial Fibrillation
- ID: D000012008
- Term: Recurrence
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433323
**Brief Title:** Biological Anti-aging Efficacy of a Cosmetic Night Cream
**Official Title:** Evaluation of Biological Anti-aging Efficacy of the Cosmetic Night Cream RV4983A- LA3365 in Women After 2 Months of Daily Use
#### Organization Study ID Info
**ID:** RV4983A20240122
#### Organization
**Class:** INDUSTRY
**Full Name:** Pierre Fabre Dermo Cosmetique
### Status Module
#### Completion Date
**Date:** 2024-07-26
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-19
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-23
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** SpinControl
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Pierre Fabre Dermo Cosmetique
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In a previous study, the cosmetic night cream RV4983A- LA3365 has proven a great efficacy in reducing the clinical signs of skin aging, as well as a great tolerance. The skin structure and composition greatly evolve over the time, and deciphering the biological mechanisms by which the cosmetic night cream RV4983A- LA3365 reduces the signs of skin aging is therefore of great interest to deepen our efficacy evaluation and knowledge on skin aging biology.
**Detailed Description:** An intra-individual, comparative study randomized will be conducted as monocentric trial in female adult
46 subjects are included
4 visits are planned:
* Visit 1 (D1): Inclusion and 1st product application
* Visit 2 (D28): Phone call follow-up
* Visit 3 (D57): End of application and biopsies
* Visit 4 (7 days after V3): Biopsies control and end-of-study
For a subject completing the study, the theoretical investigational product application will be 56 consecutive days up to 59 days maximum.
The maximal duration of participation for a subject is 68 days.
### Conditions Module
**Conditions:**
- Healthy
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 46
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: Anti-aging cosmetic care product
**Label:** Treated group : Healthy female adults
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treated group : Healthy female adults
**Description:** This is an intra-individual comparison study.
* frequency of application: Once a day (in the evening)
* modalities of application: Apply the cream on the tested area determined by the randomization
* duration of investigational product application: 56 days (a window of + 72 hours is allowed)
**Name:** Anti-aging cosmetic care product
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Will be determined from skin biopsies.
**Measure:** Biological efficacy assessed by the analysis of proteins expression related to aging.
**Time Frame:** Day 57
**Description:** The occurrence of Adverse Events will be determined by the subject's spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation.
**Measure:** General safety assessed by the occurence of Adverse Events.
**Time Frame:** Day 1 to Day 68
**Measure:** Compliance calculated from data reported by the subject in her diary.
**Time Frame:** Day 1 to Day 57
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subject with phototype I, II or III according to the Fitzpatrick scale
Non-inclusion Criteria:
* Criteria related to the subject's health / skin :
* Subject having any dermatologic condition or characteristics (like tattoo) on any of the target areas liable to interfere with the study assessments
* Subject having a dermatological condition, an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
* Subject having received on any of target areas artificial UV exposure, excessive or prolonged exposure to natural sunlight within 2 weeks before the inclusion visit or planning to be exposed to artificial UV, excessive or prolonged natural sunlight during the study and up to 3 months after completion of study participation
* Subject hirsute on the target areas
* Subject having contraindication to the local anaesthetic used for biopsies
* Subject with known immune deficiency
* Subject with a recognised addiction to alcohol or drug
* Subject with a scar pathology or pathology with consequences for healing such as diabetes
* Subject with known history of hepatitis B or C or known HIV positive status
* Subject with hereditary or acquired haemostasis disorder
* Smoker \> 10 cigarettes/day with nicotine (or equivalent in electronic cigarettes)
* Criteria related to treatments and/or products:
* Surgical, chemical or significant invasive treatment on any of the target areas within 6 months before the inclusion or planned during the study
* Techniques with aesthetic aim on any of the target areas (laser, pulsed flash lamp etc.) or injections of reshaping products (collagen, hyaluronic acid, botulinic toxin etc.) within 6 months before the inclusion or planned during the study
* Oral isotretinoin taken within 6 months before the inclusion or planned during the study
* Phototherapy treatment on any of the target areas within 2 months before the inclusion or planned during the study
* Systemic treatment likely to affect haemostasis (anticoagulants, platelet antiaggregants, etc.) taken within the weeks before the inclusion or planned during the study
* Systemic treatment may interfere with the healing process (non-steroidal anti-inflammatory drugs, corticosteroids, immunosuppressants) taken within the weeks before the inclusion or planned during the study
* Systemic treatment or topical treatment applied on any target areas likely to interfere with the local anesthetic (anti-arhythmic, beta blockers etc.) within the weeks before the inclusion or planned during the study
* Topical non-steroidal anti-inflammatory, dermocorticoids, immunomodulators applied on any of the target areas within the 2 weeks before the inclusion or planned during the study
* Topical skincare product (e.g. exfoliation, scrub, body mask) applied on any of the target areas within 7 days before the inclusion or planned during the study
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 40 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** Healthy female volunteers.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Adeline BACQUEY
**Phone:** +335.34.50.65.33
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Christophe CHAMARD
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** SpinControl
**Name:** Elisabeth GUITTON-OUDET, Dr
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433310
**Brief Title:** Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study
**Official Title:** Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study
#### Organization Study ID Info
**ID:** 23-09026469
#### Organization
**Class:** OTHER
**Full Name:** Weill Medical College of Cornell University
### Status Module
#### Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Weill Medical College of Cornell University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to explore how the dietary supplement L-Phenylalanine affects the production of the metabolite phenylpropionic acid (PPA) and changes in fungal populations in the gut microbiome.
**Detailed Description:** The human gastrointestinal tract hosts a diverse microbial community that has a role in influencing the host's pathophysiological responses. Although there is an abundance of metagenomic data available, the functional dynamics of the gut microbiota still need exploration in different conditions. The microbiota produces various metabolites from dietary products, impacting both host health and pathophysiological functions. The metabolites produced by different microbiota may selectively suppress or stimulate the growth of some components of the gut microbiome, ultimately influencing the dynamic of gut bacterial and fungal populations. Our lab is specifically interested in a metabolite, known as phenylpropionic acid (PPA) produced by a human gut resident bacteria known as Clostridium sporogenes. C.sporogenes produces PPA by metabolizing the amino acid, L-phenylalanine, which is sourced from human diet. Many studies have observed the antimicrobial and antifungal effects of PPA. Our lab determined the antifungal activity of PPA through decreased levels of Candida albicans in the mouse gut. We are interested in investigating how diversity in mycobiota populations, which focuses on the fungi species in the human gut, are related to changes in PPA levels.
Therefore, this study will assess whether additional oral supplementation of L-Phenylalanine has any effect on the way C. sporogenes metabolizes phenylalanine. Healthy subjects will receive a 14-day supply of L-phenylalanine supplements and will provide stool and blood samples to the study team.
### Conditions Module
**Conditions:**
- Gut Microbiome
- Gut Health
- Dietary Supplement
- L-Phenylalanine
- Phenylpropionic Acid
### 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:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive one bottle of L-Phenylalanine 500 mg Veg Capsule product on Day 0. All subjects will be asked to start taking the supplement on Day 1 continuing until Day 14. They will be asked to take 2x 500 mg capsules in the morning and 1x 500 mg capsule in the evening daily for 14 days.
**Intervention Names:**
- Dietary Supplement: L-Phenylalanine 500 mg Veg Capsule product
**Label:** Healthy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Healthy
**Description:** 500 mg Veg Capsule product
**Name:** L-Phenylalanine 500 mg Veg Capsule product
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Metabolite phenylpropionic acid levels will be measured using mass spectrometry before (baseline) and after intervention
**Measure:** Change in phenylpropionic acid levels from baseline in subject fecal material
**Time Frame:** Baseline, Week 2 (Day 14)
**Description:** Fungal populations, including Candida, will be measured using microbiota sequencing before (baseline) and after intervention. The most abundant fungal populations will be reported; however, the identity of those populations won't be known until sample analysis.
**Measure:** Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material
**Time Frame:** Baseline, Week 2 (Day 14)
**Description:** Blood will be processed through ELISA-based and in vitro restimulation assays to measure T cell reactivity to fungal antigens
**Measure:** Change in the number of T cells that react to fungal antigens from baseline in subject blood samples
**Time Frame:** Baseline, Week 2 (Day 14)
#### Secondary Outcomes
**Description:** Metabolite phenylpropionic acid levels will be measured using mass spectrometry before (baseline) and after intervention
**Measure:** Change in phenylpropionic acid levels from baseline in subject fecal material
**Time Frame:** Baseline, Week 4 (Day 28)
**Description:** Fungal populations, including Candida, will be measured using microbiota sequencing before (baseline) and after intervention. The most abundant fungal populations will be reported; however, the identity of those populations won't be known until sample analysis.
**Measure:** Change in fungal population levels, specifically gut Candida levels, from baseline in subject fecal material
**Time Frame:** Baseline, Week 4 (Day 28)
**Description:** Blood will be processed through ELISA-based and in vitro restimulation assays to measure T cell reactivity to fungal antigens
**Measure:** Change in the number of T cells that react to fungal antigens from baseline in subject blood samples
**Time Frame:** Baseline, Week 4 (Day 28)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male or female adults over the age of 18 years
Exclusion Criteria:
* History of a diagnosis of any gastrointestinal condition, such as inflammatory bowel syndrome or disease
* Antibiotic usage within the past two weeks
* Antifungal usage within the past month
* Allergy to L-Phenylalanine or individuals with phenylketonuria (PKU)
* Adults taking medications known to interact with L-phenylalanine supplements, such as Monoamine Oxidase Inhibitors (MOAI), L-DOPA, and some antipsychotic drugs (complete and extensive drug list will be provided to interested participants during screening)
* Pregnant or nursing women
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Tsering D Sherpa-Ngima, BSc
**Phone:** 929-328-9571
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Tsering D Sherpa-Ngima, BSc
- **Phone:** 929-328-9571
- **Role:** CONTACT
***Contact 2:***
- **Name:** Iliyan D Iliev, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Belfer Research Building
**State:** New York
**Zip:** 10022
#### Overall Officials
**Official 1:**
**Affiliation:** Weill Medical College of Cornell University
**Name:** Iliyan D Iliev, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: AA
- Name: Amino Acids
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T14
- Name: Phenylalanine
- Relevance: HIGH
- As Found: Sepsis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433297
**Brief Title:** Comparative Evaluation of Indirect vs. Direct Pulp Capping in Deep Carious Mandibular Molars
**Official Title:** Comparative Evaluation of Indirect and Direct Pulp Capping After Partial or Complete Caries Removal in Deeply Carious Mature Permanent Mandibular Molars With Moderate Pulpitis: A Randomized Clinical Trial
#### Organization Study ID Info
**ID:** Soma Chanakya
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2025-12-23
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-23
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-23
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Postgraduate Institute of Dental Sciences Rohtak
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Aim: To compare the outcome of indirect and direct pulp capping after partial or complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
Objectives:
1. To evaluate the clinical and radiographic success of indirect pulp capping after partial caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
2. To evaluate the clinical and radiographic success of direct pulp capping after complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
3. To evaluate pain incidence and severity after indirect and direct pulp capping after partial and complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
**Detailed Description:** Vital pulp therapy has been traditionally recommended only in teeth with reversible pulpitis with no periapical pathologies or in teeth with either mechanical pulp exposure or recent traumatic exposure. Clinical symptoms such as characteristics, severity and intensity of pre-operative pain do not accurately talk about the status of the pulp inflammation and the depth of involvement. It has been demonstrated that there is no precise correlation between clinical symptoms and the histopathological status of the pulp, mainly in case of irreversible pulpitis, that might lead to a wrong diagnosis. Vitality tests such as cold test or electric pulp tests reveal only whether the pulp is responsive to respective stimuli or not. According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which corresponds to irreversible pulpitis. Vital pulp therapy is suggested to be the choice of treatment for such cases. It has been suggested that infection is often a cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Partial caries removal, which involves complete removal of carious dentine from the surrounding cavity walls, followed by the partial removal of infected dentin at the pulpal wall which reduce chances of pulp exposure followed by placement of medicament for Indirect pulp capping. Whereas during Complete caries removal, caries is completely removed from surrounding walls as well as on pulpal wall which increase the chances of pulp exposure followed by placement of medicament for Direct pulp capping procedure. Based on this premise, IPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of direct pulp capping, partial pulpotomy or full pulpotomy in adults.
Research Question Does Indirect Pulp Capping have comparable outcome with Direct pulp capping after partial caries removal in deeply carious mature permanent molars with clinical signs indicative of moderate pulpitis? P (Population) - Deeply carious mature Permanent Mandibular molars with clinical signs indicative of moderate pulpitis I (Intervention) - Partial caries removal followed by Indirect pulp capping C (Comparison) - Complete caries removal followed by Direct pulp capping O (Outcome) - Assessment of clinical and radiographic success at 12 months follow up.
* To assess incidence and reduction in pain post operatively at every 24 hours till 1 week.
### Conditions Module
**Conditions:**
- Indirect Pulp Capping
- Reversible Pulpitis
**Keywords:**
- indirect pulp capping
- selective caries removal
- moderate pulpitis
- direct pulp capping
- deep caries
- complete caries removal
- mature permanent mandibular molars
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Considering the nature of intervention, masking of the operator will not be possible once he begins the caries removal. Patients will be unaware of the groups in which their allocation will take place. At the time of assessing data masking will be done by masking the entire crown of the tooth before evaluation by endodontist using Adobe Photoshop CS6.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 106
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Procedure: INDIRECT AND DIRECT PULP CAPPING AFTER PARTIAL OR COMPLETE CARIES REMOVAL IN DEEPLY CARIOUS MATURE PERMANENT MANDIBULAR MOLARS WITH MODERATE PULPITIS
**Label:** Partial caries removal followed by Indirect pulp capping.
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Procedure: INDIRECT AND DIRECT PULP CAPPING AFTER PARTIAL OR COMPLETE CARIES REMOVAL IN DEEPLY CARIOUS MATURE PERMANENT MANDIBULAR MOLARS WITH MODERATE PULPITIS
**Label:** Complete caries removal followed by Direct Pulp Capping
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Complete caries removal followed by Direct Pulp Capping
- Partial caries removal followed by Indirect pulp capping.
**Description:** After partial caries removal the cavity is disinfected, dried, and capped with a 2-3mm layer of MTA followed by a light-cured resin layer. The tooth is then definitively restored with composite.
Following complete caries removal, any bleeding pulp will be controlled with sodium hypochlorite for up to 5 minutes. Exposed pulp will then be directly capped with a 2-3mm layer of MTA, followed by a light-cured resin layer and definitive composite restoration using an etch-and-rinse technique.
**Name:** INDIRECT AND DIRECT PULP CAPPING AFTER PARTIAL OR COMPLETE CARIES REMOVAL IN DEEPLY CARIOUS MATURE PERMANENT MANDIBULAR MOLARS WITH MODERATE PULPITIS
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** No history of spontaneous pain or discomfort except for the initial days after treatment.
No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.
**Measure:** Clinical Success Rate
**Time Frame:** Base line to 12 months
**Description:** No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to Orstavic et al.
**Measure:** Radiographic success
**Time Frame:** Base line to 12 months
#### Secondary Outcomes
**Description:** Post operative pain To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to100 millimeter line.
**Measure:** Pain incidence and reduction
**Time Frame:** Baseline to seven days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. The patient should be ≥18 years of age.
2. Restorable mature permanent 1st and 2nd Mandibular molars with deep caries (reaching inner quarter of dentine)
3. Tooth should give positive response to pulp sensibility testing.
4. Clinical diagnosis of moderate pulpitis.
5. Radiographic finding of periapical index (PAI) score ≤2.
6. Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit).
7. Pulp exposure after complete caries excavation.
8. No pulp exposure after incomplete caries excavation
Exclusion Criteria:
1. Teeth with immature roots.
2. Pulp exposure after incomplete caries excavation.
3. No pulp exposure after complete caries excavation.
4. Bleeding could not be controlled in 5 minutes.
5. Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure.
6. History of analgesic intake in previous 1 week, or antibiotic intake in 1 month.
7. Internal/external resorption.
8. Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine)
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Dr. Vinay Kumar, MDS
**Phone:** 8901149107
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Dr. Soma Chanakya, MDS
**Phone:** 7396287866
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rohtak
**Country:** India
**Facility:** PGIDS, Rohtak
**State:** Haryana
#### Overall Officials
**Official 1:**
**Affiliation:** PGIDS, Rohtak, Haryana, 124001
**Name:** Dr, Sanjay Tewari, MDS
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003788
- Term: Dental Pulp Diseases
- ID: D000014076
- Term: Tooth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14525
- Name: Pulpitis
- Relevance: HIGH
- As Found: Pulpitis
- ID: M6984
- Name: Dental Pulp Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011671
- Term: Pulpitis
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M15775
- Name: Sodium Hypochlorite
- Relevance: LOW
- As Found: Unknown
- ID: M44557
- Name: Eusol
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433284
**Acronym:** MACROHOLE
**Brief Title:** Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes
**Official Title:** Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes (MACROHOLE): a Randomized-control Trial
#### Organization Study ID Info
**ID:** WU999
#### Organization
**Class:** OTHER
**Full Name:** Walailak University
### Status Module
#### Completion Date
**Date:** 2027-01-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-01
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-01-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-01-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Walailak University
#### Responsible Party
**Investigator Affiliation:** Walailak University
**Investigator Full Name:** Jakkrit Juhong
**Investigator Title:** Head of Vitreoretinal unit, Ophthalmology department, Walailak University
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The human amniotic membrane (hAM) patch, introduced by Rizzo et al. in 2018, showed a 100% anatomical success rate for large or failed macular holes over a 6-month follow-up. Despite its regenerative properties like promoting angiogenesis and having low immunogenicity, its clinical use is limited by challenges such as trimming to fit small holes and complications during insertion. To overcome these issues, decellularized amniotic membrane (dAM) has been processed into a hydrogel form, enhancing its applicability and allowing it to be used as an injectable hydrogel for minimally invasive therapies. While dAM hydrogels have been used in various medical fields, their application in intraocular surgery is new. This study proposes using dAM hydrogel for large macular hole closure, comparing its effectiveness to the inverted ILM flap technique in a randomized controlled trial.
**Detailed Description:** A macular hole (MH) is a neuroepithelial defect in the macular area of the retina. The estimation of macular hole incidence about 33 of every 10,000 person in individuals older than 55 years old1. The female-to-male ratio is 2 to 3:1. Idiopathic macular hole (IMH) is MHs occurring independently of primary ocular diseases such as trauma and vitreoretinopathy2 and represents the predominant subtype of MH, constituting approximately 83%1. There is a 5% to 15% risk of developing macular hole in the other eye if a macular hole develops in one eye.1 In 1988, Gass proposed a classification system for idiopathic macular holes, as well as a new hypothesis for its pathogenesis, which emphasizes the role of the vitreo-macular tangential traction in the formation of macular holes3. Macular hole closure can occurred spontaneously in approximately 5-10% cases in early stages. Pars plana vitrectomy with internal limiting membrane (ILM) peeling and gas tamponade has been the standard of care of small size macular hole treatment with success rate more than 90%4. However, in large macular hole more than 400 um, the success rate is lower. Previous study showed closure rate of large macular hole \> 400 μm is 56% with poor visual outcome.4,5 Several new techniques have been described to improve anatomical and functional outcomes in cases of large macular holes by inserting alternative tissues into the macular hole, such as the ILM flap, human amniotic membrane patch6, or retinal tissue implantation, to promote anatomical closure and improve visual acuity. The utilization of ILM flap coverage has emerged as an effective surgical approach for treating large, full-thickness idiopathic MH and myopic MH. This technique was initially introduced in 1999, showing promising results in enhancing macular hole closure rates through ILM peeling. Several subsequent studies 7-9 have further substantiated the efficacy of ILM flap coverage, making it the standard surgical treatment for large macular hole cases. However, this technique is often hindered by limitations related to the technical complexity of surgery and the risk of retinal trauma.
The human amniotic membrane (hAM) patch, proposed by Rizzo et al. in 20186, serves as another alternative technique for large or failed macular hole cases. The anatomical success rate was 100% during the 6 months follow-up. The exceptional biological properties of hAM, including its promote angiogenesis10, low immunogenicity11, and anti-inflammatory11,12, anti-fibrotic13, and antibacterial characteristics14, make it highly suitable for regenerative medicine and intraocular implantation. However, the clinical application of thin hAM sheets is limited by several challenges, such as the difficulty of trimming it to fit very small hole sizes (\< 0.2 cm), tissue loss after insertion into the PPV port, and complications during the insertion of the hAM patch into the hole. To address these limitations, processing decellularized amniotic membrane (dAM) tissue into a hydrogel form has enhanced its processability and applicability15. This transformation allows it to be used as an injectable hydrogel for minimally invasive therapies and facilitates its manipulation into the macular hole.
dAM hydrogels have been applied in various fields, including skin repair, cardiac treatment, cartilage regeneration, endometrial regeneration, vascular grafts, dental pulp regeneration, and as cell culture/carrier platforms. However, their use in intraocular surgery has not yet been established. Additionally, the benefits of dAM hydrogel over hAM tissue include lower immunogenicity due to the decellularization processs since the resident cells may cause intense host immunologic reactions after transplantation and transplant rejection and the homogeneous distribution of biochemical substances within the hydrogel structure.15 In this study, we will be the first to propose a new technique and invention for closing large macular holes using human amniotic membrane hydrogel filling in the hole after standard ILM peeling. We conducted a randomized controlled trial to compare the anatomical and visual outcomes of the inverted ILM flap technique (IFT) with the dHM hydrogel technique in idiopathic large macular holes with a minimum diameter (MD) greater than 400 μm.
### Conditions Module
**Conditions:**
- Macular Holes
**Keywords:**
- macular holes
- decellularized amniotic membrane
- human amniotic membrane hydrogel
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 26
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients who will undergo 25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade.
**Intervention Names:**
- Procedure: 25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade
**Label:** Inverted flap
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Patients who will undergo 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling, amniotic membrane hydrogel filling and SF6 tamponade.
**Intervention Names:**
- Procedure: 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling with amniotic membrane hydrogel filling and SF6 tamponade
**Label:** Amniotic membrane hydrogel
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Inverted flap
**Description:** Standard 3 port 25-gauge pars plana vitrectomy with inverted flap technique after brilliant blue dye staining and SF6 tamponade. "Flower petal" type of inverted flap will be performed - multiple small ILM flaps will be created around the macular hole and placed over the macular hole
**Name:** 25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Amniotic membrane hydrogel
**Description:** Standard 3 port 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling around the macular hole after brilliant blue dye staining then filling the hole with amniotic membrane hydrogel and sulfur hexafluoride (SF6) tamponade
**Name:** 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling with amniotic membrane hydrogel filling and SF6 tamponade
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Difference of best corrected visual acuity (BCVA) after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique
**Measure:** Best corrected visual acuity (BCVA)
**Time Frame:** 6 months
**Description:** Closure rate after primary vitrectomy for idiopathic full thickness macular holes with decellularized amniotic membrane hydrogel versus inverted flap technique
**Measure:** Closure rate
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* \>18 years old
* idiopathic full thickness macular hole \> 400 micron of diameter
* phakic or pseudophakic
* absence of systemic adverse conditions
Exclusion Criteria:
* idiopathic full thickness macular hole \> 1,500 micron of diameter
* traumatic macular holes
* myopic macular holes,
* concomitant retinal and other ocular disease
* previous ocular surgery except cataract surgery
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jakkrit Juhong, MD.
**Phone:** +66816773406
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** School of Medicine, Walailak university
**Name:** Jakkrit Juhong, MD.
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012164
- Term: Retinal Diseases
- ID: D000005128
- Term: Eye Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M15002
- Name: Retinal Perforations
- Relevance: HIGH
- As Found: Macular Hole
- ID: M14999
- Name: Retinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012167
- Term: Retinal Perforations
### Intervention Browse Module - Ancestors
- ID: D000006993
- Term: Hypnotics and Sedatives
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000014151
- Term: Anti-Anxiety Agents
- ID: D000014149
- Term: Tranquilizing Agents
- ID: D000011619
- Term: Psychotropic Drugs
- ID: D000018757
- Term: GABA Modulators
- ID: D000018682
- Term: GABA Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M16465
- Name: Temazepam
- Relevance: HIGH
- As Found: Transthoracic
- ID: M10043
- Name: Hypnotics and Sedatives
- Relevance: LOW
- As Found: Unknown
- ID: M16905
- Name: Anti-Anxiety Agents
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
- ID: M20827
- Name: GABA Modulators
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000013693
- Term: Temazepam
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433271
**Brief Title:** Transdiagnostic Behavior Therapy vs TAU for Adjustment Disorder Following Traumatic Event Exposure
**Official Title:** Comparative Effectiveness of Transdiagnostic Behavior Therapy vs TAU for Adjustment Disorder Following Traumatic Event Exposure
#### Organization Study ID Info
**ID:** Pro00134707
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Health Science Center, Houston
#### Secondary ID Infos
**Domain:** United States Army Medical Research and Development Command
**ID:** PR230007
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2029-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** FED
**Name:** Ralph H. Johnson VA Medical Center
**Class:** FED
**Name:** U.S. Army Medical Research and Development Command
#### Lead Sponsor
**Class:** OTHER
**Name:** The University of Texas Health Science Center, Houston
#### Responsible Party
**Investigator Affiliation:** The University of Texas Health Science Center, Houston
**Investigator Full Name:** Ronald E. Acierno
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Adjustment Disorder (AjD) is the most common mental health condition diagnosed in Active Duty personnel, and is diagnosed following an extreme stress event such as traumatic loss of a comrade, serious accident or injury, or other intense stress event. Despite its high prevalence, no evidence based treatment for AjD has been subjected to randomized controlled trials. This study seeks to build on the research team's pilot work across several disorders study to benefit service members and Veterans with AjD, a highly prevalent but frequently inadequately treated condition.
The investigators will compare the effects of Transdiagnostic Behavior Therapy (TBT) vs treatment as usual which is Moving Forward Problem Solving Therapy (TAU-PST) on AjD symptom outcomes. The investigators hypothesize that TBT will result in greater overall symptom reduction compared to TAU-PST.
**Detailed Description:** Adjustment Disorder (AjD) is the most common mental health condition diagnosed in Active Duty personnel, and is diagnosed following an extreme stress event such as traumatic loss of a comrade, serious accident or injury, or other intense stress event. Despite its high prevalence, no evidence based treatment for AjD has been subjected to randomized controlled trials.
Currently, the VA suggests a problem solving cognitive behavioral therapy, but this recommendation is not based on replicated, randomized controlled trials. Transdiagnostic Behavior Therapy (TBT), is based on key 'active components' of existing evidence based treatments such as Prolonged Exposure and Behavioral Activation, has been designed by this research team to be easily trained and inexpensively disseminated, and has been evaluated in a series of pilots with anxiety and depression disorders that, importantly, represent the key symptom classes of adjustment disorder.
Thus, the rationale for the proposed trial is that the research team has done preliminary efficacy testing of an easily exportable intervention that has impact on the key symptoms of adjustment disorder, and the standard of evidence demands replicated, randomized controlled trials to determine if initial signals of positive effect are sustained.
The study will use a 2 group repeated measures randomized controlled design to evaluate effectiveness of TBT for AjD compared to treatment as usual (TAU-PST). Participants will be randomly assigned in equal numbers (n = 75; N = 150) to one of two treatment arms: (1) TBT or (2) TAU-PST. Participants assigned to TBT will receive 10-14, 45-60-minute, manualized, individual therapy sessions. Participants assigned to TAU-PST will receive 10-14, 45-60-minute sessions of Problem-Solving Therapy. Dependent measures will include Department of Defense (DoD) specified common data elements and specific measures of AjD, PTSD, anxiety, depression, and functioning collected by blinded assessors at baseline, post-treatment, 3-month, and 6-month follow-up.
### Conditions Module
**Conditions:**
- Adjustment Disorders
- Mental Disorder
**Keywords:**
- Veterans
- Military Personnel
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive 10-14, 45-60-minute, manualized, individual therapy sessions.
**Intervention Names:**
- Behavioral: Transdiagnostic Behavior Therapy (TBT)
**Label:** Transdiagnostic Behavior Therapy (TBT)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive 10-14, 45-60-minute individual therapy sessions.
**Intervention Names:**
- Behavioral: Treatment as Usual-Problem Solving Therapy (TAU-PST)
**Label:** Active Comparator: Treatment as Usual-Problem Solving Therapy (TAU-PST)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Transdiagnostic Behavior Therapy (TBT)
**Description:** TBT manualized treatment incorporates daily exposure exercises from up to four categories of avoidance that are most characteristic of the emotional disorders (i.e., situational, interoceptive, imaginal, and positive emotional).
**Name:** Transdiagnostic Behavior Therapy (TBT)
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Active Comparator: Treatment as Usual-Problem Solving Therapy (TAU-PST)
**Description:** PST is an evidence- based psychotherapy implemented in VA Primary Care - Mental Health Integration (PC-MHI), with hundreds of VA providers trained in the intervention nationally. The primary aim of PST is to improve a patient's ability to cope with stressful events by adopting an adaptive perspective to stressors and using goal-focused, problem-solving behaviors to manage the problems associated with the stressors.
**Name:** Treatment as Usual-Problem Solving Therapy (TAU-PST)
**Other Names:**
- Moving Forward Problem Solving Therapy
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The Adjustment Disorder New Module (ADNM) is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with International Classification of Diseases 11th Revision (ICD-11) criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder.
**Measure:** Adjustment Disorder New Module Self Report
**Time Frame:** Baseline
**Description:** The ADNM is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with ICD-11 criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder.
**Measure:** Adjustment Disorder New Module Self Report
**Time Frame:** 1 week post treatment
**Description:** The ADNM is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with ICD-11 criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder.
**Measure:** Adjustment Disorder New Module Self Report
**Time Frame:** 3 months post treatment
**Description:** The ADNM is a 20-item self-report measure of AjD that first asks participants to select from a list of past year stressors and to identify which was the most prominent or distressing. The second section comprises 20 items, which form six subscales in accordance with ICD-11 criteria relating to pre-occupation, failure to adapt, avoidance, depressive mood, anxiety, and impulse disturbance (Lorenz et al., 2016). Participants rate on a 4-point Likert scale how often they have experienced particular symptoms during the past two weeks, and overall symptom severity is calculated as a sum of all item scores. Total score ranges from 20-80, with a higher score indicating a higher risk of developing adjustment disorder.
**Measure:** Adjustment Disorder New Module Self Report
**Time Frame:** 6 months post treatment
**Description:** The Post-traumatic stress disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (PCL-5) (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity.
**Measure:** PTSD Checklist-5
**Time Frame:** Baseline
**Description:** The PCL-5 (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity.
**Measure:** PTSD Checklist-5
**Time Frame:** 1 week post treatment
**Description:** The PCL-5 (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity.
**Measure:** PTSD Checklist-5
**Time Frame:** 3 months post treatment
**Description:** The PCL-5 (Weathers et al., 2013) is structured to correspond to the DSM-5 PTSD criteria. The 20-items are scored on a 0-4 Likert scale for each symptom corresponding to "Not at all" to "Extremely". Total score ranges from 0 to 80, with a higher score indicating greater PTSD symptom severity.
**Measure:** PTSD Checklist-5
**Time Frame:** 6 months post treatment
**Description:** The Patient Health Questionnaire-9 (PHQ-9) (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for major depressive disorder (MDD). This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).
**Measure:** Patient Health Questionnaire-9
**Time Frame:** Baseline
**Description:** The PHQ-9 (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).
**Measure:** Patient Health Questionnaire-9
**Time Frame:** 1 week post treatment
**Description:** The PHQ-9 (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).
**Measure:** Patient Health Questionnaire-9
**Time Frame:** 3 months post treatment
**Description:** The PHQ-9 (Kroenke et al., 2001) is a widely used, well-validated measure of depression severity with high internal consistency (alpha .83 to .92; Cameron et al, 2008) and is correlated strongly with other depression measures. Its nine items assess affective and somatic symptoms and correspond to diagnostic criteria for MDD. This measure will also be collected every other week during treatment. Total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).
**Measure:** Patient Health Questionnaire-9
**Time Frame:** 6 months post treatment
#### Secondary Outcomes
**Description:** The Insomnia Severity Index (ISI) self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.
**Measure:** Insomnia Severity Index
**Time Frame:** Baseline
**Description:** The ISI self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.
**Measure:** Insomnia Severity Index
**Time Frame:** 1 week post treatment
**Description:** The ISI self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.
**Measure:** Insomnia Severity Index
**Time Frame:** 3 months post treatment
**Description:** The ISI self-report measure captures a respondent's perception of his or her current insomnia. The ISI includes seven items that assess severity of sleep onset, sleep maintenance, and early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of sleep problems by others; and distress caused by the sleep difficulties. Each item is rated on a 4-point Likert scale and the total score ranges from 0 to 28. A higher score suggests more severe insomnia.
**Measure:** Insomnia Severity Index
**Time Frame:** 6 months post treatment
**Description:** The Short Form-36 (SF-36) (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status.
**Measure:** Medical Outcome Study Short Form-36 Health Survey
**Time Frame:** Baseline
**Description:** The SF-36 (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status.
**Measure:** Medical Outcome Study Short Form-36 Health Survey
**Time Frame:** 1 week post treatment
**Description:** The SF-36 (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status.
**Measure:** Medical Outcome Study Short Form-36 Health Survey
**Time Frame:** 3 months post treatment
**Description:** The SF-36 (Ware \& Sherbourne, 1992) is a 36-item questionnaire that measures health status, social support, and functioning over the past four weeks. Total score ranges from 0 to 100, with a higher score indicating better health status.
**Measure:** Medical Outcome Study Short Form-36 Health Survey
**Time Frame:** 6 months post treatment
**Description:** Number of treatment sessions completed.
**Measure:** Dose Received
**Time Frame:** 14 weeks after treatment starts
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult male or female over the age of 18 that has served, or is currently serving, in the military.
* Stable psychotropic medication for at least 4 weeks if applicable
* Current DSM-5 diagnosis of Adjustment Disorder
Exclusion Criteria:
* Active psychosis
* Suicidal ideation with clear intent
* Severe substance use
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Stephanie M Hart, MPH
**Phone:** 8435775011
**Phone Ext:** 205103
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Charleston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Stephanie M Hart, MPH
- **Phone:** 843-577-5011
- **Phone Ext:** 205103
- **Role:** CONTACT
***Contact 2:***
- **Name:** Ron Acierno, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Daniel Gros, PhD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Ralph H. Johnson VA Health Care System
**State:** South Carolina
**Zip:** 29401
#### Overall Officials
**Official 1:**
**Affiliation:** McGovern Medical School at UTHealth Houston
**Name:** Ron Acierno, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Gros DF. Development and initial evaluation of Transdiagnostic Behavior Therapy (TBT) for veterans with affective disorders. Psychiatry Res. 2014 Dec 15;220(1-2):275-82. doi: 10.1016/j.psychres.2014.08.018. Epub 2014 Aug 15.
**PMID:** 25193379
**Citation:** Gros DF, Allan NP. A randomized controlled trial comparing Transdiagnostic Behavior Therapy (TBT) and behavioral activation in veterans with affective disorders. Psychiatry Res. 2019 Nov;281:112541. doi: 10.1016/j.psychres.2019.112541. Epub 2019 Aug 29.
**PMID:** 31514043
**Citation:** Gros DF, Merrifield C, Rowa K, Szafranski DD, Young L, McCabe RE. A Naturalistic Comparison of Group Transdiagnostic Behaviour Therapy (TBT) and Disorder-Specific Cognitive Behavioural Therapy Groups for the Affective Disorders. Behav Cogn Psychother. 2019 Jan;47(1):39-51. doi: 10.1017/S1352465818000309. Epub 2018 May 29.
**PMID:** 29807553
**Citation:** Gros DF, Szafranski DD, Shead SD. A real world dissemination and implementation of Transdiagnostic Behavior Therapy (TBT) for veterans with affective disorders. J Anxiety Disord. 2017 Mar;46:72-77. doi: 10.1016/j.janxdis.2016.04.010. Epub 2016 Apr 27.
**PMID:** 27158076
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000068099
- Term: Trauma and Stressor Related Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M4815
- Name: Mental Disorders
- Relevance: HIGH
- As Found: Mental Disorders
- ID: M3627
- Name: Adjustment Disorders
- Relevance: HIGH
- As Found: Adjustment Disorders
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M222
- Name: Trauma and Stressor Related Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001523
- Term: Mental Disorders
- ID: D000000275
- Term: Adjustment Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433258
**Brief Title:** Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved and Rural Populations in South Texas
**Official Title:** Implementation and Evaluation of an Evidence-Based, Multilevel Lifestyle Intervention for Underserved and Rural Populations in South Texas: Tu Salud ¡Si Cuenta (TSSC)!
#### Organization Study ID Info
**ID:** HSC-SPH-23-1025
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Health Science Center, Houston
### Status Module
#### Completion Date
**Date:** 2025-03-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-03-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-03
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Cancer Prevention Research Institute of Texas
#### Lead Sponsor
**Class:** OTHER
**Name:** The University of Texas Health Science Center, Houston
#### Responsible Party
**Investigator Affiliation:** The University of Texas Health Science Center, Houston
**Investigator Full Name:** Belinda Reininger
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to enhance the current TSSC multilevel intervention delivered in Cameron and Hidalgo counties by adding additional components including an educational module on the risks of alcohol intake and its connection to cancer, as well as developing training and referral systems to address social determinants of health (SDOH) that negatively impact uptake of cancer prevention behaviors.
### Conditions Module
**Conditions:**
- Cancer Prevention
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 500
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: Enhanced TSSC curriculum
**Label:** Enhanced TSSC curriculum
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Behavioral: Original TSSC curriculum
**Label:** Original TSSC curriculum
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Enhanced TSSC curriculum
**Description:** In addition to the original TSSC curriculum participants will also be educated with the enhanced curriculum which includes components related to alcohol and social determinants of health needs) to promote cancer prevention through healthy lifestyles.
**Name:** Enhanced TSSC curriculum
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Original TSSC curriculum
**Description:** Participants will be educated with evidence-based modules focused on topics such as introduction to TSSC, physical activity, fruit and vegetable consumption, reduce sugar intake, diabetes, portion control, cancer, and high blood pressure.These modules are provided by community health workers who have been trained in the contents of the modules, as well as motivational interviewing techniques for delivering the modules.
**Name:** Original TSSC curriculum
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Measure:** Change in percentage of participants that show an increase in moderate and vigorous physical activity minutes as assessed by the Physical Activity Questionnaire
**Time Frame:** Baseline , 6 month follow up , 9 month month follow up
**Measure:** Change in percentage of participants that report increase in fruit and vegetable intake as assessed by the Nutritious Eating Questionnaire
**Time Frame:** Baseline , 6 month follow up , 9 month month follow up
**Measure:** Change in percentage of participants that report a reduced quantity of alcohol intake as assessed by a questionnaire
**Time Frame:** Baseline , 6 month follow up , 9 month month follow up
**Measure:** Change in percentage of participants that report a reduced frequency of alcohol intake as assessed by a questionnaire
**Time Frame:** Baseline , 6 month follow up , 9 month month follow up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* residents of partnering municipalities throughout Cameron and Hidalgo
Exclusion Criteria:
* participated in TSSC before
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Belinda Reininger, DrPH
**Phone:** (956) 755-0600
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Maria Zolezzi
**Phone:** (956) 755-0600
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Belinda Reininger, DrPH
- **Phone:** 956-755-0600
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Maria Zolezzi
- **Phone:** (956) 755-0600
- **Role:** CONTACT
**Country:** United States
**Facility:** The University of Texas Health Science Center at Houston
**State:** Texas
**Status:** RECRUITING
**Zip:** 77030
#### Overall Officials
**Official 1:**
**Affiliation:** The University of Texas Health Science Center, Houston
**Name:** Belinda Reininger, DrPH
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433245
**Brief Title:** Outcome Following Use of Different Concentrations of NaOCl as Wound Lavage and Hemostatic Agent in Partial Pulpotomy
**Official Title:** Outcome Following Use of Different Concentrations of Sodium Hypochlorite as Wound Lavage and Hemostatic Agent in Partial Pulpotomy: A Randomised Control Trial
#### Organization Study ID Info
**ID:** Ridhi Karwal
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2025-12-23
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-23
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-23
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Postgraduate Institute of Dental Sciences Rohtak
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this randomised control trial is to compare the effect of different concentrations of NaOCl on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
The main question it aims to answer are:
1. clinical and radiographic outcome of partial pulpotomy following use of 5% and 3% NaOCl in mature permanent teeth with clinical signs indicative of irreversible pulpitis.
2. OHRQoL and pain experience after use of 5% and 3% NaOCl during partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
**Detailed Description:** TITLE :- Outcome following use of different concentrations of NaOCl as wound lavage and hemostatic agent in partial pulpotomy: A Randomised control trial.
Question it aims to answer:
Does pulpal lavage using 3% and 5% sodium hypochlorite have comparable effect on outcome of partial pulpotomy in mature permanent teeth with clinical signs of irreversible pulpitis? P (Population) -Mature permanent mandibular molars with signs of irreversible pulpitis.
I (Intervention) - 5% NaOCl C (Comparison) - 3% NaOCl O (Outcome) - 1. Assessment of clinical and radiographic success at 12 months of follow up.
2. Assessment of OHRQoL and pain experience at baseline, post-operatively every 24 hours for 1 week and OHRQoL at 6 and 12 months.
In literature pertaining to vital pulp therapy procedures, there is often a focus on comparing various materials or treatment methodologies. However, the use of sodium hypochlorite, holds significant importance in ensuring the successful outcome of the procedure. The previous studies indicate that the use of NaOCl presents as a confounding factor, compounded by variations among operators in their choice of high and low concentrations of NaOCl.So, there is a pressing need for a direct comparative analysis to assess the influence of varying sodium hypochlorite concentrations on the overall efficacy and success rates of vital pulp therapy procedures.
### Conditions Module
**Conditions:**
- Irreversible Pulpitis
- Extremely Deep Caries
- Partial Pulpotomy
**Keywords:**
- partial pulpotomy
- sodium hypochlorite
- mature permanent mandibular molars
- hemostatic agent
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** The operator, patient and the outcome assessor will be masked to the group allocation
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 116
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** After partial pulpotomy procedure, pulp wound will be irrigated with 3% sodium hypochlorite and haemostasis will be achieved by placing the cotton pellet soaked with 3% sodium hypochlorite on the amputated pulp.
**Intervention Names:**
- Procedure: effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
**Label:** Control: 3% sodium hypochlorite
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** After partial pulpotomy procedure, pulp wound will be irrigated with 5% sodium hypochlorite and haemostasis will be achieved by placing the cotton pellet soaked with 5% sodium hypochlorite on the amputated pulp.
**Intervention Names:**
- Procedure: effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
**Label:** Test: 5% sodium hypochlorite
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control: 3% sodium hypochlorite
- Test: 5% sodium hypochlorite
**Description:** After caries removal and pulp exposure pulp tissue is amputated and hemostasis is achieved with 3% sodium hypochlorite in control group and 5% sodium hypochlorite in experimental group followed by capping with 2-3mm layer of MTA. A layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin.
**Name:** effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Clinical criteria of success:-
1. No pain or discomfort except for the first few days after treatment.
2. No tenderness to palpation or percussion and the tooth is functional.
3. Normal mobility and probing pocket depth.
4. Healthy soft tissues around teeth with no swelling, sinus tract.
**Measure:** Clinical success rate
**Time Frame:** baseline to 12 months
**Description:** Radiographic success criteria:-
1. No pathosis such as root resorption, furcal pathosis or new periapical pathosis evident on the radiograph.
2. Complete radiographic healing
**Measure:** Radiographic success rate
**Time Frame:** Baseline to 12 months
#### Secondary Outcomes
**Description:** To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score100 means maximum pain. To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain
**Measure:** Post Operative Pain
**Time Frame:** Baseline to 7 days
**Description:** OHIP-14 questionnare will be used to assess the quality of life.It consists of questionnaire in seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. It will be scored using a Lickert scale:
never=0; hardly ever=1; occasionally=2; fairly often=3; very often=4. Total score will be calculated ranging from 0-56, with higher score denoting the worst OHRQoL
**Measure:** OHRQoL assessment
**Time Frame:** baseline and at 24 h, 2, 3, 4, 5, 6 and 7 days after the treatment, and then at 6 and 12 months.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Mature permanent mandibular molars.
2. Teeth with clinical diagnosis of symptomatic irreversible pulpitis
3. Patients having normal periapical status with periapical index (PAI) score ≤ 2
4. Periodontally healthy teeth
5. Patients having physical status of class 1 or 2 according to ASA classification
6. Pulpal bleeding can be controlled within 6 minutes.
7. Presence of extremely deep carious lesion on radiograph -
Exclusion Criteria:
1) Non restorable teeth 2) Necrotic pulp evident upon exposure 3) Negative response to vitality test 4) Presence of sinus tract 5) Presence of soft tissue swelling 6) Radiographic signs of internal or external root resorption 7) Pregnant women
-
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 15 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Dr. Pankaj Sangwan, MDS
**Phone:** 9996112202
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ridhi Karwal, MDS
**Phone:** 9958430414
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rohtak
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** DR. Pankaj Sangwan, MDS
- **Phone:** 9996112202
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** : DR. Sanjay TewarI, MDS
- **Phone:** 9416259534
- **Role:** CONTACT
**Country:** India
**Facility:** PIGDS
**State:** Haryana
**Status:** RECRUITING
**Zip:** 124001
#### Overall Officials
**Official 1:**
**Affiliation:** PGIDS, Rohtak, Haryana 124001
**Name:** Dr. Sanjay Tewari, MDS
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003788
- Term: Dental Pulp Diseases
- ID: D000014076
- Term: Tooth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M14525
- Name: Pulpitis
- Relevance: HIGH
- As Found: Pulpitis
- ID: M6984
- Name: Dental Pulp Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011671
- Term: Pulpitis
### Intervention Browse Module - Ancestors
- ID: D000004202
- Term: Disinfectants
- ID: D000000890
- Term: Anti-Infective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Coag
- Name: Coagulants
### Intervention Browse Module - Browse Leaves
- ID: M15775
- Name: Sodium Hypochlorite
- Relevance: HIGH
- As Found: Postural Control
- ID: M44557
- Name: Eusol
- Relevance: HIGH
- As Found: Postural Control
- ID: M9576
- Name: Hemostatics
- Relevance: LOW
- As Found: Unknown
- ID: M7383
- Name: Disinfectants
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000012973
- Term: Sodium Hypochlorite
- ID: C000024611
- Term: Eusol
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433232
**Brief Title:** Effect of Endodontic Treatment on Inflammatory Markers, Disease Activity and Periapical Healing in Rheumatoid Arthritis Patients With Apical Periodontitis : A Prospective Interventional Study
**Official Title:** Effect of Endodontic Treatment on Inflammatory Markers, Disease Activity and Periapical Healing in Rheumatoid Arthritis Patients With Apical Periodontitis : A Prospective Interventional Study
#### Organization Study ID Info
**ID:** Bhavika Bansal
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2025-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Postgraduate Institute of Dental Sciences Rohtak
#### Responsible Party
**Investigator Affiliation:** Postgraduate Institute of Dental Sciences Rohtak
**Investigator Full Name:** Sanjay Tewari
**Investigator Title:** principal pgids
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** SUMMARY TITLE: "Effect of endodontic treatment on inflammatory markers, disease activity and periapical healing in rheumatoid arthritis patients with apical periodontitis"
RATIONALE: Chronic inflammation plays a pivotal role in rheumatoid arthritis as subjects present with elevated serum levels of numerous cytokines such as IL-1, IL-6, 1L-12, IL-17, tumour necrosis factor-alpha, RANK and RANK Ligand. Periodontal and pulpal inflammation are two major low grade chronic inflammatory diseases of the oral cavity. Apical periodontitis extends from the chronic inflammatory process that originated in the dental pulp to surround the apex of the tooth. Thus Rheumatoid arthritis and apical periodontitis converge upon common pathway of inflammation. The scientific literature has also shown to provide potential link between endodontic infection and rheumatoid arthritis. The evidence of increased prevalence of apical periodontitis in subjects of rheumatoid arthritis is provided mainly by cross-sectional and case control studies. Interventional studies have been performed in subjects with rheumatoid arthritis and periodontal disease, with results depicting beneficial effect of periodontal therapy in patients of rheumatoid arthritis. To best of our knowledge no interventional study has been performed to assess the healing pattern of apical periodontitis in subjects of rheumatoid arthritis and subsequently effect of endodontic intervention on inflammatory profile and disease burden in the same.
### Conditions Module
**Conditions:**
- Rheumatoid Arthritis AND Apical Periodontitis
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 76
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Rhuematoid arhtritis patients: Change in PAI, hsCRP, ESR, SDAI and quality of life using OHIP-14 will be assessed post root canal treatment
**Intervention Names:**
- Procedure: ROOT CANAL TREATMENT
**Label:** Rhuematoid arhtritis patients
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Systemically healthy patients: Change in PAI, hsCRP, ESR, and quality of life using OHIP-14 will be assessed post root canal treatment
**Intervention Names:**
- Procedure: ROOT CANAL TREATMENT
**Label:** Systemically healthy patients
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Rhuematoid arhtritis patients
- Systemically healthy patients
**Description:** ROOT CANAL TREATMENT
**Name:** ROOT CANAL TREATMENT
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Measure:** Change in levels of hsCRP
**Time Frame:** 12 MONTHS
#### Secondary Outcomes
**Measure:** Change in levels of ESR
**Time Frame:** 12 MONTHS
**Measure:** Change in SDAI
**Time Frame:** 12 MONTHS
**Measure:** Quality of life using OHIP-14
**Time Frame:** 12 MONTHS
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. Age of patients 30-65 years 2.Definite diagnosis of Rheumatoid arthritis based on ACR/EULAR 2010 criteria\[28\] i.e a score of 6 or greater out of 10 from the individual scores in four domains: number and site of involved joints (range 0-5), serological abnormality (range 0-3), elevated acute-phase response (range 0-1) and symptom duration (two levels; range 0-1) 3. The periapical index (PAI) will be used to evaluate the periapical status patients with PAI \>or=3 as given by Orstavik\[29\] will be included 4. Presence of total teeth \>/= 12
Exclusion Criteria:
1. Patients with periodontitis, pocket depth and CAL\>5mm (stage 3, 4) will be excluded.
2. Pregnancy; lactation \& contraceptives
3. Patients with any other systemic disease other than Rheumatoid arthritis i.e Diabetes, HIV, Chronic Liver Disease, Chronic Kidney disease and Cardiovascular disease
5. Conditions known to alter systemic inflammatory markers i.e orthopaedic trauma, surgery and viral infections 6. Patients with BMI \>/= 30 7. Medications (during last 3 months) known to affect systemic inflammatory markers (systemic steroids, immunosuppressants, hormone replacement therapy, contraceptives and systemic antibiotics) 8. Smoking
-
**Gender Based:** True
**Gender Description:** ender matched healthy control participants to the same gender rheumatoid arthritis individuals will be analyzed.
**Healthy Volunteers:** True
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** BHAVIKA BANSAL
**Phone:** 8288984027
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** MAYANK ARORA
**Phone:** 8295964200
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rohtak
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** mayank arora
- **Phone:** 8295964200
- **Role:** CONTACT
**Country:** India
**Facility:** Rheumatology clinic PGIMS ROHTAK
**Status:** RECRUITING
**Zip:** 124001
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
- ID: D000003240
- Term: Connective Tissue Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000010483
- Term: Periapical Diseases
- ID: D000007571
- Term: Jaw Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M13427
- Name: Periodontitis
- Relevance: HIGH
- As Found: Periodontitis
- ID: M13395
- Name: Periapical Periodontitis
- Relevance: HIGH
- As Found: Apical Periodontitis
- ID: M4476
- Name: Arthritis
- Relevance: HIGH
- As Found: Arthritis
- ID: M4480
- Name: Arthritis, Rheumatoid
- Relevance: HIGH
- As Found: Rheumatoid Arthritis
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: 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: M13393
- Name: Periapical Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10601
- Name: Jaw Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001168
- Term: Arthritis
- ID: D000001172
- Term: Arthritis, Rheumatoid
- ID: D000010518
- Term: Periodontitis
- ID: D000010485
- Term: Periapical Periodontitis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433219
**Brief Title:** Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)
**Official Title:** An Open-label, Multicenter, Randomized Phase 2 Study of the ATR Inhibitor Tuvusertib in Combination With the PARP Inhibitor Niraparib or the ATM Inhibitor Lartesertib in Participants With BRCA Mutant and/or Homologous Recombination deficiency (HRD)-Positive Epithelial Ovarian Cancer That Progressed on Prior PARP Inhibitor Therapy (DDRiver EOC 302)
#### Organization Study ID Info
**ID:** MS201924_0002
#### Organization
**Class:** INDUSTRY
**Full Name:** EMD Serono
#### Secondary ID Infos
**Domain:** EU trial number
**ID:** 2024-511202-23-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-01-25
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-01-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-26
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Merck KGaA, Darmstadt, Germany
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** EMD Serono Research & Development Institute, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of this study is to measure the effect and safety of treatment with tuvusertib combined with either niraparib or lartesertib in participants with epithelial ovarian cancer. The participants will previously have progressed while treated with a poly ADP ribose polymerase (PARP) inhibitor. The primary objective of the study is to assess the effect of the treatment in terms of overall response, i.e. whether the tumor disappears, shrinks, remains unchanged, or gets worse.
### Conditions Module
**Conditions:**
- Ovarian Cancer
**Keywords:**
- Ataxia telangiectasia mutated Rad3-related
- Ataxia telangiectasia mutated
- Poly-ADP ribose polymerase inhibitor resistance
- Homologous recombination deficiency
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Tuvusertib (M1774)
- Drug: Niraparib
**Label:** Tuvusertib with Niraparib
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Tuvusertib (M1774)
- Drug: Lartesertib (M4076)
**Label:** Tuvusertib with Lartesertib
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Tuvusertib with Lartesertib
- Tuvusertib with Niraparib
**Description:** Tuvusertib will be administered orally
**Name:** Tuvusertib (M1774)
**Other Names:**
- M1774, VXc-400, VRT-1363004, substance code MSC2584415A
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Tuvusertib with Niraparib
**Description:** Niraparib will be administered orally
**Name:** Niraparib
**Other Names:**
- GSK3985771, MK-4827
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Tuvusertib with Lartesertib
**Description:** Lartesertib will be administered orally
**Name:** Lartesertib (M4076)
**Other Names:**
- M4076, substance code MSC2585823A
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Confirmed Objective Response (OR) According to RECIST v1.1 as Assessed by Investigator
**Time Frame:** Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years.
**Measure:** Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs
**Time Frame:** Time from randomization to final assessment at end of safety follow-up visit, approximately up to 3.5 years.
#### Secondary Outcomes
**Measure:** Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator
**Time Frame:** Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years.
**Measure:** Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator
**Time Frame:** Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Histologically or cytologically confirmed high grade serous or high grade endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer that is recurrent.
* Participants whose tumor carries germline or somatic deleterious or suspected deleterious mutations in the genes BRCA1 (BReast CAncer gene 1) and BRCA2 (BReast CAncer gene 2), and/or tumors with positive HRD status. The presence of any of these mutations and/or the homologous recombination deficiency (HRD) status will be determined according to routinely used local standard of care tests. Results must be available before screening.
* Radiologically confirmed/documented disease progression while on Poly (ADP-ribose) polymerase (PARP) inhibitors therapy in either first or second-line maintenance setting (only 1 line of PARPi maintenance is allowed with or without bevacizumab). Note: Documentation of disease progression must be within 28 days of last PARPi dose taken. Surgical salvage intervention and/or focal ablative therapies are allowed, (further disease progression after these interventions must be documented), AND Clinically benefited from PARPi maintenance prior to documented progression, as defined by at least 6 months of treatment duration with no progressive disease observed, AND either, Progression on first-line maintenance PARPi: Participants are allowed maximum 1 additional line of platinum-based chemotherapy before study entry. (note: treatment-free interval on platinum rechallenge must be \>6 months, with documented disease progression prior to study entry).
OR Progression on second-line maintenance PARPi: Participants are not allowed any additional systemic anticancer treatments before study entry (i.e. PARPi is the last treatment before study entry)
* Measurable disease per RECIST v1.1, as assessed by Investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months.
* Other Protocol defined inclusion criteria.
Exclusion Criteria:
* Primary platinum-refractory disease defined as disease progression during primary platinum-based chemotherapy or platinum-resistant disease defined as disease progression within 6 months of the last platinum administration in the second-line setting.
* History of additional malignancy within 3 years before the date of enrollment.
* Known brain metastases, unless clinically stable, i.e. without evidence of progression by imaging for at least 4 weeks prior to the first dose of study intervention, no evidence of new brain metastases, and on a stable or decreasing dose of ≤ 10 mg of prednisone (or equivalent) or without corticosteroids for at least 14 days prior to study intervention administration.
* Active and/or uncontrolled infection.
* History of known hypersensitivity to the active substances or to any excipients (e.g. polysorbate 80) of the study interventions.
* Organ transplantation, including allogenic stem cell transplant.
* Other Protocol defined exclusion criteria.
**Gender Based:** True
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** US Medical Information
**Phone:** 888-275-7376
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Communication Center
**Phone:** +49 6151 72 5200
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rockland
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Please Contact U.S. Medical Information
- **Phone:** 888-275-7376
- **Role:** CONTACT
**Country:** United States
**Facility:** Please Contact U.S. Medical Information
**State:** Massachusetts
**Zip:** 02370
**Location 2:**
**City:** Darmstadt
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Please Contact the Communication Center
- **Phone:** +49 6151 72 5200
- **Role:** CONTACT
**Country:** Germany
**Facility:** Please Contact the Communication Center
**Zip:** 64293
#### Overall Officials
**Official 1:**
**Affiliation:** EMD Serono Research & Development Institute, Inc.
**Name:** Medical Responsible
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
**Description:** We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
**Info Types:**
- STUDY_PROTOCOL
- SAP
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
**URL:** http://bit.ly/IPD21
### References Module
#### See Also Links
**Label:** Trial Awareness and Transparency website
**URL:** https://clinicaltrials.emdgroup.com/en
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000010049
- Term: Ovarian Diseases
- ID: D000000291
- Term: Adnexal Diseases
- ID: D000005831
- Term: Genital Diseases, Female
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000005833
- Term: Genital Neoplasms, Female
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000091662
- Term: Genital Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000006058
- Term: Gonadal Disorders
- ID: D000002277
- Term: Carcinoma
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12974
- Name: Ovarian Neoplasms
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M4565
- Name: Ataxia
- Relevance: LOW
- As Found: Unknown
- ID: M5773
- Name: Cerebellar Ataxia
- Relevance: LOW
- As Found: Unknown
- ID: M1704
- Name: Carcinoma, Ovarian Epithelial
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M16456
- Name: Telangiectasis
- Relevance: LOW
- As Found: Unknown
- ID: M4566
- Name: Ataxia Telangiectasia
- Relevance: LOW
- As Found: Unknown
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12972
- Name: Ovarian Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3643
- Name: Adnexal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8945
- Name: Genital Neoplasms, Female
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9163
- Name: Gonadal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: T4352
- Name: Ovarian Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: T4354
- Name: Ovarian Epithelial Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: T519
- Name: Ataxia Telangiectasia
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010051
- Term: Ovarian Neoplasms
- ID: D000077216
- Term: Carcinoma, Ovarian Epithelial
### Intervention Browse Module - Ancestors
- ID: D000067856
- Term: Poly(ADP-ribose) Polymerase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M289466
- Name: Niraparib
- Relevance: HIGH
- As Found: Percutaneous Coronary Intervention
- ID: M205
- Name: Poly(ADP-ribose) Polymerase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000545685
- Term: Niraparib
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433206
**Brief Title:** Care Needs in Lung Cancer Patients Receiving Immunotherapy
**Official Title:** Quality of Life, Symptom Severity, and Care Needs in Lung Cancer Patients Receiving Immunotherapy
#### Organization Study ID Info
**ID:** 201911078RIND
#### Organization
**Class:** OTHER
**Full Name:** National Taiwan University Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-04-21
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** National Taiwan University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Lung cancer ranks as the leading cause of cancer-related deaths globally and is among the most common malignancies. In recent years, the advancements in immune checkpoint inhibitors have marked a significant breakthrough in the immunotherapy of lung cancer. However, immunotherapy is a relatively new treatment modality, and ongoing clinical trials continue to explore its efficacy. Due to a lack of knowledge about immunotherapy-related care, patients often experience uncertainty and anxiety regarding its effectiveness, resulting in associated care needs.
A total of 160 lung cancer patients were included in the study. The research findings revealed statistically significant correlations (p \< 0.05) between the severity of disease, symptomatology, overall health status, functional capacity, cognitive function, disease progression, mood, and general supportive care needs, as well as specific needs of lung cancer patients.
Regarding factors influencing care needs, it was found that general supportive care needs were significantly influenced by marital status, average personal monthly income, and disease progression. Additionally, age, surgical history, functional capacity, and cognitive function significantly influenced specific care needs. Based on these statistical findings, it is crucial for nursing staff to closely monitor changes in patients' symptoms and mood and provide timely care and support. Furthermore, future interventions should focus on addressing the heightened needs of lung cancer patients, thereby reducing their dissatisfaction along the cancer treatment journey.
**Detailed Description:** Background and Purpose: Lung cancer is a major health concern affecting the Taiwanese population. Immunotherapy represents a novel treatment approach which activates the immune system to combat tumor cells through a series of interactions. However, the side effects associated with immunotherapy can be significant, potentially causing uncertainty and anxiety in patients. Medical decision-making also involves numerous considerations, impacting their psychosocial well-being and subsequent health behaviors. Research in this area remains limited. Therefore, this study aims to (1) explore the quality of life, severity of symptoms, and care needs of lung cancer patients following immunotherapy; (2) investigate the correlations between quality of life, severity of symptoms, and care needs; and (3) identify predictive factors for the care needs of immunotherapy patients.
Research Method: This study adopts a cross-sectional research design, conducted at a medical center and a specialized cancer hospital in Taipei City. Recruitment takes place in hospital wards, treatment rooms, and outpatient clinics, utilizing consecutive sampling. Lung cancer patients who have undergone or are currently undergoing immunotherapy are selected. Structured questionnaires are employed, covering demographics, disease treatment characteristics, severity of symptoms, quality of life, functional disability, supportive care needs, fear of disease progression, and qualitative interviews. Quantitative data are analyzed using descriptive and inferential statistics in SPSS version 22.0. The study aims to enroll 180 participants.
Expected Results: The anticipated findings of this study are expected to provide valuable insights for clinical healthcare professionals. They can aid in understanding patients' needs, contribute to the development of post-immunotherapy care guidelines for lung cancer patients, and serve as essential references for healthcare reimbursement policies. These outcomes may help alleviate patient burden and enhance quality of life. It is expected that demographic characteristics, disease treatment characteristics, quality of life, severity of symptoms, and the extent of care needs will be positively correlated and serve as important predictors of care needs.
### Conditions Module
**Conditions:**
- Lung Cancer, Immunotherapy, Quality of Life, Symptom Severity, Care Needs
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 180
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Day
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** no intervention
**Name:** no intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Care Needs in Lung Cancer Patients Receiving Immunotherapy
**Time Frame:** 1year
#### Secondary Outcomes
**Measure:** Quality of Life in Lung Cancer Patients Receiving Immunotherapy
**Time Frame:** 1year
**Measure:** Symptom Severity in Lung Cancer Patients Receiving Immunotherapy
**Time Frame:** 1year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Individuals diagnosed with malignant lung tumors based on imaging or post-surgical histopathological examination results by specialized physicians.
2. Individuals who have received immunotherapy in the past or are currently undergoing immunotherapy.
3. Research participants who are conscious, aged 20 years or older, able to communicate in Mandarin or Taiwanese, capable of completing the questionnaire, willing to participate in the study, and have signed the research consent form.
Exclusion Criteria:
1. Individuals with significant cognitive impairments who are unable to complete the questionnaire.
2. Individuals who are unable to communicate in Mandarin or Taiwanese.
**Minimum Age:** 20 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Using consecutive sampling, lung cancer patients who have received or are currently undergoing immunotherapy will be selected from a medical center and a specialized cancer hospital in northern Taiwan.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Meng Ping Hsiao, master
**Phone:** +886 919865349
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Taipei
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Meng Ping Hsiao, Master
- **Phone:** +886 919865349
- **Role:** CONTACT
**Country:** Taiwan
**Facility:** National Taiwan University Cancer Center
**Status:** RECRUITING
**Zip:** 106
#### Overall Officials
**Official 1:**
**Affiliation:** NTUCC
**Name:** Meng Ping Hsiao, master
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M11172
- Name: Lung Neoplasms
- Relevance: HIGH
- As Found: Lung Cancer
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000008175
- Term: Lung Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433193
**Brief Title:** Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients
**Official Title:** Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients
#### Organization Study ID Info
**ID:** DIALYSS-CLI-CIP02
#### Organization
**Class:** INDUSTRY
**Full Name:** Nextkidney S.A.
### Status Module
#### Completion Date
**Date:** 2024-04-24
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-24
**Type:** ACTUAL
#### Start Date
**Date:** 2024-02-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Nextkidney S.A.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The primary aim of this early feasibility clinical trial is to assess the biochemical safety of dialysate regeneration with the optimised PAK HDsorbent cartridge in a limited number (n=3) of participants and treatments (one therapy per subject). As a secondary aim, we will assessthe therapy efficacy of the PAK HD sorbent therapy in short-daily hemodialysis (SDHD) and compare it to that of conventional CHD underthe same therapy settings.
Following up from the preceding FIH trial, this continuation aims at demonstrating that the optimised PAK HD sorbent system has overcome previous problems of increased dialysate acidity and provides improved control over the patient's acid-base balance.
### Conditions Module
**Conditions:**
- End Stage Renal Disease
- ESRD
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DEVICE_FEASIBILITY
#### Enrollment Info
**Count:** 3
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The study will be performed as a prospective, non-randomised, single arm two-period cross-over study comparing conventional CHD to PAK HD. All adverse events will be recorded and reviewed. Only one subject will enter each study period at a time.
**Intervention Names:**
- Device: PAK HD Sorbent Therapy
**Label:** PAK HD Sorbent Study
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- PAK HD Sorbent Study
**Description:** Study Period 1:
Subjects will receive their normal prescribed 4h CHD treatments Monday or Tuesday. On Wednesday or Thursday, one 4h CHD therapy will be performed at a dialysate flow rate (QD) of 300mL/min, identical to the dialysate flow rate of the PAK HD sorbent therapy. Blood and dialysate samples will be collected during treatment and sent for analysis, for comparison with PAK HD sorbent treatment.
Study Period 2:
Subjects will again receive their normal prescribed 4h CHD treatments Monday or Tuesday. On Wednesday or Thursday, a 2h PAK HD +/- 2h CHD therapy will be performed. Blood and dialysate samples will again be collected during treatment and sent for analysis, for comparison with the CHD therapy of the first period. After completion of study period 2 (PAK HD +/- CHD), subjects will be observed for a minimum duration of 1 h in the hospital after which they may go home if the post-dialysis period was uneventful.
**Name:** PAK HD Sorbent Therapy
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The clinical safety of the PAK HD will be evaluated in terms of the following primary endpoints:
a) Absence of serious adverse events (SAE) b) Absence of critical change in patient's clinical condition and vital parameters (Blood pressure, heart rate, body temperature and respiratory rate and pulse oximetry) during treatment.
c) Absence of critical change in haematology and biochemistry immediately before the start of therapy and immediately after completion of therapy, including acid-base state, electrolytes, and ammonia.
**Measure:** The primary objective of this early feasibility clinical trial is to assess the (short term) clinical safety of the PAK HD sorbent treatment in a limited number of patients and treatments.
**Time Frame:** 2 weeks
#### Secondary Outcomes
**Description:** The therapy efficacy will be evaluated with the secondary endpoint:
a) PAK HD therapy provides equivalent toxin clearances for urea, phosphate and creatinine as compared to CHD
**Measure:** The secondary objective of this study is to evaluate the efficacy of the PAK HD therapy in comparison to CHD, in terms of uremic toxin removal efficacy (urea, creatinine and phosphate).
**Time Frame:** 2 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Subjects must be adults \>/= 21 years old and \<80 years old.
2. Subjects must be weighing \>/= 55kg and \<90kg (patient's dry weight).
3. Subjects must have stable haemoglobin \>/= 10.5g/dL 2 months prior to enrolment
4. Subjects' pre-dialysis serum values must be within the following range, 2 months prior to enrolment:
Patient allowable serum biochemistry ranges Allowable pre-dialysis serum values Na \>/= 132 mmol/L or \</= 145mmol/L HCO3 \>/= 15mmol/L or \</= 30mmol/L K \>/= 3.5mmol/L or \</= 5.8mmol/L
5. Subjects on stable on thrice weekly 4-h HD schedule. Stability is defined as:
* Haemodynamic stability during dialysis (absence of hypotensive events and symptomatic arrhythmias), no angina pectoris, AND
* No altered level of consciousness during dialysis.
6. Subjects with a well-functioning vascular access (native fistula graft):
* capable of providing a blood flow rate of \>/= 250 mL/min, AND
* no vascular access revision and stable shunt flow for at least 4 weeks prior to enrolment.
7. Subjects capable of understanding the informed consent form and give informed consent.
8. Subjects willing and able to comply with study procedures and to attend all study follow-up visits.
9. Subjects who are female of reproducible age to practice birth control methods.
10. Subjects can be either gender.
Exclusion Criteria:
1. Subjects with haemoglobin level of \<10.5g/dL in any measurement 2 months prior to enrolment.
2. Subjects with the following pre-dialysis serum values in any measurement 2 months prior to enrolment:
* sodium concentration \<132 mmol/L or \> 145mmol/L
* bicarbonate \<15mmol/L or \>30mmol/L
* plasma potassium concentration \<3.5mmol/L or \>5.8mmol/L
* urea \<15mmol/L or \>28 mmol/L
3. Subjects with severe hypertension: systolic blood pressure \> /=180 mmHg, diastolic blood pressure \>/=120 mmHg in any officemeasurement less than 4 weeks prior to enrolment.
4. Subjects with chronic obstructive pulmonary disease or any respiratory disease that may predispose to CO2 retention.
5. Subjects with impaired liver function. Impaired liver function is defined as an elevated ALT (alanine aminotransferase) by 3-fold orgreater above the upper limit of normal.
6. Subjects with episodes of haemolysis in any measurement 3 months prior to enrolment.
7. Subjects with a central venous catheter.
8. Subjects with vascular access dysfunction (whether or not requiring an intervention), i.e. failure to achieve and/ or sustain a bloodflow of \>/=250 mL/min and/or signs of compromised vascular access patency (according to the opinion of the investigator) within 4weeks prior to enrolment.
9. Subjects with vascular access related infection less than 4 weeks prior to enrolment
10. Subjects requiring an average ultrafiltration volume \>2.8 L per 4-h treatment in mid-week dialysis session in the past 4 weeks priorto enrolment.
11. Subjects who are on heparin free dialysis
12. Subjects who are unable to provide informed consent.
13. Subjects who are unable to comply with study procedures.
14. Subjects with psychosocial problems which may negatively influence dialysis treatment.
15. Subjects who participated in another clinical intervention or device trial less than 12 weeks prior to enrolment, are currentlyparticipating or intend to participate in such a trial.
16. Subjects who are pregnant, breast feeding, or planning a pregnancy within the study period.
17. Subjects with a life expectancy \<1 year.
18. Subjects who are anticipating a living donor kidney transplantation within \< 2 months of the study period.
19. Subjects with recent history of drug and/or alcohol abuse in the last 3 months prior to enrolment.
**Maximum Age:** 79 Years
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Singapore
**Country:** Singapore
**Facility:** National University Hospital Investigational Medicine Unit
**Zip:** 119074
#### Overall Officials
**Official 1:**
**Affiliation:** National University Hospital, Singapore
**Name:** Titus Wai Leong Lau, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007674
- Term: Kidney Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000051436
- Term: Renal Insufficiency, Chronic
- ID: D000051437
- Term: Renal Insufficiency
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10699
- Name: Kidney Failure, Chronic
- Relevance: HIGH
- As Found: End Stage Renal Disease
- ID: M26718
- Name: Renal Insufficiency
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M26717
- Name: Renal Insufficiency, Chronic
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007676
- Term: Kidney Failure, Chronic
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M18008
- Name: Dialysis Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433180
**Acronym:** ICEBOAT
**Brief Title:** Study of Fecal Microbiota Transplantation (FMT) in Severe IBS Patients
**Official Title:** A Prospective, Multi-center, Double Blind Randomized Trial of Fecal Microbiota Transplantation (FMT) Delivered by Capsule Versus Placebo in Severe Irritable Bowel Syndrome (IBS).
#### Organization Study ID Info
**ID:** APHP180583
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
#### Secondary ID Infos
**ID:** 2019-003433-41
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2029-07-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-07-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-26
### 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:** True
### Description Module
**Brief Summary:** The objective of this protocol is to evaluate the efficacy of fecal microbiota transplantation (FMT) using oral capsules containing frozen stools vs sham FMT on IBS severity score at 12 weeks in patients with severe irritable bowel syndrome refractory to conventional treatments.
**Detailed Description:** Irritable bowel syndrome (IBS) is a chronic disease. It affects about 4.4 to 10 % of the French general population (according to Rome III or Rome IV definition) and is the most frequent functional bowel disorder in patients visiting general practitioners or gastroenterologists. The efficacy of treatments is often limited, in particular form the case severe of IBS (IBS-SSS\>300) which concerns at least 20 to 25% of patients and IBS can cause significant deterioration in quality of life.
In this context, microbiota could become a potential therapeutic target, and replacement of the abnormal fecal microbiota by an "healthy" one, especially in patients refractory to previous treatment and with severe symptoms, is a seducing new therapeutic strategy. The primary outcome is an improvement in the IBS-SSS score level at 12 weeks after taking a oral capsules of FMT in patients with severe IBS.
### Conditions Module
**Conditions:**
- Irritable Bowel Syndrome
**Keywords:**
- fecal microbiota transplantation
- irritable bowel syndrome
- frozen capsule
- Rome IV
- IBS-SSS
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Oral, capsulized, frozen capsules without fecal matter but containing cryopreservation solution will be administered at the same volume and same time point as in the experimental group. Taken in one day in two separate meals. Administration of the sham after colon cleaning.
**Intervention Names:**
- Drug: Administration of the sham (PLACEBO)
**Label:** Administration of the sham (PLACEBO)
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Description:** Oral, capsulized, frozen fecal microbiota transplantation FMT delivering approximatively 24 g of stools taken in one day in two separate meals. Administration of the FMT after colon cleaning.
**Intervention Names:**
- Drug: Administration of fecal microbiota transplantation ( FMT capsules)
**Label:** Administration of fecal microbiota transplantation ( FMT capsules)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Administration of fecal microbiota transplantation ( FMT capsules)
**Description:** Oral, capsulized, frozen fecal microbiota transplantation FMT delivering approximatively 24 g of stools taken in one day in two separate meals. Administration of the FMT after colon cleaning.
**Name:** Administration of fecal microbiota transplantation ( FMT capsules)
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Administration of the sham (PLACEBO)
**Description:** Oral, capsulized, frozen capsules without fecal matter but containing cryopreservation solution will be administered at the same volume and same time point as in the experimental group. Taken in one day in two separate meals. Administration of the sham after colon cleaning.
**Name:** Administration of the sham (PLACEBO)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** To evaluate the efficacy of oral capsules containing frozen fecal microbiota (FMT) vs sham FMT on IBS severity score at 12 weeks in patients with irritable bowel syndrome with severe disease refractory to conventional treatments.
Decrease in IBS severity at 12 weeks is defined by the percentage of patients having at least a 75 points decrease in IBS-SSS.
**Measure:** Decrease in IBS severity at 12 weeks defined by the percentage of patients having at least a 75 points decrease in IBS-SSS.
**Time Frame:** At 12 weeks
#### Secondary Outcomes
**Description:** To evaluate the efficacy of oral capsules containing frozen fecal microbiota (FMT) vs sham FMT on IBS severity score at 12 weeks in patients with irritable bowel syndrome with severe disease refractory to conventional treatments (at least a 50 points decrease in IBS-SSS)
**Measure:** Decrease in IBS severity at 12 weeks defined by the percentage of patients having at least a 50 points decrease in IBS-SSS.
**Time Frame:** At 12 weeks
**Description:** patient's microbiota 12 weeks after FMT closer to that of the donor than the patient's microbiota before FMT. The composition of the patient's fecal microbiota 12 weeks after FMT will be compared to the patient's microbiota before transplantation and to the donor using the Sorensen similarity index. The FMT will be considered as a success if the Sorensen index \[patient after FMT vs donor\] \> Sorensen index \[patient after FMT vs patient before FMT\] and if the Sorensen index \[patient after FMT vs donor\] ≥ 0,6. The composition of fecal microbiota will be measured by pyrosequencing (16S RNA).
**Measure:** FMT success
**Time Frame:** At 12 weeks
**Description:** Intestinal microbiota composition and diversity at week 12 and 24 assessed by 16s sequencing. Microbiota composition and diversity assessed by 16s sequencing at week 12 and 24, compared to baseline and to healthy volunteers donor's microbiota. Microbiota composition will be assessed using Qiime pipeline and analyzed at all phylogenetic levels.
Diversity will be evaluated using Shannon index, Simpson index, Chao1 index and number of observed species.
**Measure:** Intestinal microbiota composition at week 12 and 24 by 16s sequencing.
**Time Frame:** at week 12 and 24
**Description:** Efficacy (decrease in IBS severity \>75 points) according to FMT success.
**Measure:** Efficacy (decrease in IBS severity >75 points) at week 24 according to FMT success.
**Time Frame:** At 24 weeks
**Description:** Efficacy according to EMA (European Medical Agency) endpoint in IBS on composite criteria at 12 or 24 weeks
**Measure:** EMA Endpoint at week 12 and 24 defined as a patient who fulfils the response criteria (simultaneous improvement of transit and abdominal pain) displayed in the following for at least 50% of the observation time.
**Time Frame:** at week 12 and 24
**Description:** IBS severity at 12 weeks by donors (one donor giving FMT to several patients)
**Measure:** Percentage of responders in the different subgroups IBS-D, IBS-C and IBS-M using the primary endpoint at week 12 and 24.
**Time Frame:** at week 12 and 24
**Description:** IBS severity at 12 weeks and at 24 weeks by IBS subtypes according to transit pattern.
The score ranges from 0 to 500 ( Remission : 0 to 74, Mild : 75 to 175, Moderate : 175 to 300 and Severe : \>300).
**Measure:** Mean IBS-SSS (IBS severity), comparison between FMT and placebo at 12 and 24 weeks)
**Time Frame:** at week 12 and 24
**Description:** IBS Quality of life at 12 weeks and 24 weeks. Irritable Bowel Syndrom- Quality of Life (IBS-QoL) at 12 weeks and 24 weeks, IBS-QoL ranges from 0 ( worse) to 100 (better).
**Measure:** Mean IBS-QoL score (IBS Quality of life) comparison between FMT and placebo at 12 and 24 weeks (Drossman et al. 2000)
**Time Frame:** at week 12 and 24
**Description:** Patient's perception of FMT (questionnaire for correct assessment of FMT or placebo and FMT acceptability) (Annex D), secondary effects of FMT
**Measure:** Patient's perception of FMT : - Questionnaire for correct assessment of FMT or placebo and FMT acceptability) at V2 (FMT administration). - Questionnaire for assessment of FMT secondary effects at V3.
**Time Frame:** V2: five weeks after inclusion. V3:Four weeks after V2
**Description:** Safety (Serious Adverse Events, Adverse Events) compared between groups.
**Measure:** Safety (Serious Adverse Events, Adverse Events) compared between groups.
**Time Frame:** through study completion, at 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 years and \< 75 years
* IBS defined according to Rome IV definition (IBS-C, IBS-D or IBS-M)
* Severe disease (IBS-SSS \>300) and refractory to at least two previous treatment strategies:among the following : anti-spasmodic and/or laxatives (polyethylene glycol) or anti-diarrheal drug (loperamide) according to transit subtype for one month, antidepressants for 2 months, probiotics (ALFLOREX, SMEBIOCTA, PROBIOLOG FLORVIS) for 1 month, hypnosis for 5 hypnosis sessions in two months, Cognitive Behavioral Therapies for 2 months, colestyramine for IBS-D patients for 1 month, ondansetron for IBS-D patients and for 1 month, ebastine for 2 months, L-glutamine (5g x3/day, for 2 months, Gelsectan for one month, Biofeedback for 15 sessions in IBS-C (3 months), Low FODMAP diet for 1 month, gluten free diet for 1 month, standard dietary advice from the NICE (UK) for 1 month, increase in physical activity.
* Patient with health insurance (AME excepted)
* Informed written consent
* For women with childbearing potential, efficient contraception for the duration of the participation to the study
Exclusion Criteria:
* Other chronic gastrointestinal disease (celiac disease, inflammatory bowel disease)
* participants if there is a reason to suspect an alternative diagnosis to the IBS complaints
* Surgical intervention in the gastrointestinal region except for appendectomy, hernia repair, cholecystectomy and hemorroidectomy
* Treatment preceding FMT with: antibiotics, antifungic or probiotics treatment \< 4 weeks, or factors that may affect the composition of intestinal microbiota
* Abuse of alcohol or drugs
* Pregnancy or breastfeeding
* Participation in any other interventional study
* Patients under legal protection.
* Acute COVID-19 infection
* Presence of systemic disease, immune deficiency or treatment with immune-modulators
* Severe psychiatric disorder
* Participants who were assessed as likely to be noncompliant (ie, not adhering to the tasks they were to perform as participants)
**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:** Jean Marc SABATE, Pr
**Phone:** 01 48 95 54 34
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Nacira DARGHAL, PhD
**Phone:** 01 48 95 74 73
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bobigny
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jean MARC SABATE, Pr
- **Phone:** 01 48 95 54 34
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Nacira DARGHAL, PhD
- **Phone:** 01 48 95 74 73
- **Role:** CONTACT
**Country:** France
**Facility:** Gastro-enterology department, Avicenne Hospital
**Zip:** 93000
#### Overall Officials
**Official 1:**
**Affiliation:** Assistance Publique - Hôpitaux de Paris
**Name:** Jean Marc SABATE, Pr
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000003109
- Term: Colonic Diseases, Functional
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M25118
- Name: Irritable Bowel Syndrome
- Relevance: HIGH
- As Found: Irritable Bowel Syndrome
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6337
- Name: Colonic Diseases, Functional
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000043183
- Term: Irritable Bowel Syndrome
- ID: D000013577
- Term: Syndrome
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433167
**Brief Title:** Investigation of Gait Pattern in Idiopathic Scoliosis
**Official Title:** Investigation of Gait Pattern in Idiopathic Scoliosis
#### Organization Study ID Info
**ID:** Iayas9
#### Organization
**Class:** OTHER
**Full Name:** Gazi University
### Status Module
#### Completion Date
**Date:** 2025-01-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Gazi University
#### Responsible Party
**Investigator Affiliation:** Gazi University
**Investigator Full Name:** İnci Hazal Ayas
**Investigator Title:** Research asistant
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Scoliosis is a condition characterized by an abnormal curvature of the spine, which can affect an individual's gait. Scoliosis can alter body balance and weight distribution. Pedobarographic analysis identifies imbalances and abnormal pressure points by measuring the distribution of pressure applied to the sole of the foot. This examination helps detect abnormalities in the gait mechanics of individuals with scoliosis. Gait analysis can identify long-term foot and leg problems caused by scoliosis at an early stage, allowing for early interventions to prevent more serious issues.
The aim of this study is to analyze gait in individuals with idiopathic scoliosis and compare it with that of healthy individuals. The study will include 30 scoliosis patients who visited the Department of Orthopedics and Traumatology at Gazi University Hospital and were diagnosed with idiopathic scoliosis by a specialist physician. The gait patterns of the patients will be evaluated using pedobarography. Information about the type and degree of scoliosis will be obtained from hospital records. The results of this study may provide an objective and detailed evaluation of gait and pressure distribution disorders in individuals with scoliosis and may contribute to more effective treatment plans.
### Conditions Module
**Conditions:**
- Idiopathic Scoliosis
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The patient group for this research comprises patients diagnosed with idiopathic scoliosis, a condition characterized by abnormal lateral curvature of the spine of unknown cause.
**Intervention Names:**
- Other: Pedobarographic analysis
**Label:** Idiopathic Scoliosis
#### Arm Group 2
**Description:** Healthy control group is healthy individuals without any diagnosed disease.
**Intervention Names:**
- Other: Pedobarographic analysis
**Label:** Healthy control
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Healthy control
- Idiopathic Scoliosis
**Description:** During the pedobarographic analysis, the patient takes steps on the platform at a regular walking speed, with arms relaxed at the sides, following a natural gait. In static analysis, measurements are taken while the patient remains stationary on the platform with arms in a relaxed position beside the body. Five measurements are separately recorded for both feet during the phases of stepping, heel strike, and toe lift. These measurements capture the highest pressures on the back of the foot, the middle part of the foot, and the inner, middle, and lateral sides of the front of the foot, including the toes. The pressure, force, and pressure-time integral corresponding to each area are then used to determine how and for how long these areas are exposed to pressure.
**Name:** Pedobarographic analysis
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** This assessment uses a specialized device called a pedobarograph, which consists of pressure sensors embedded in a platform. When a person stands or walks on the pedobarograph, the sensors record the pressure exerted by different parts of the foot. The resulting data is then used to create detailed pressure maps and graphs that highlight areas of high and low pressure.
**Measure:** Pedobarography
**Time Frame:** Day 1
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosis of idiopathic scoliosis by an orthopedist
* The Cobb angle measured on the standard scoliosis radiograph should fall within the range of 10°-45°.
Exclusion Criteria:
* Presence of any orthopedic or neurological disease affecting trunk and extremity mobility, excluding scoliosis.
* History of previous spine or orthopedic surgery.
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 12 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** The study will include 30 scoliosis patients who visited the Department of Orthopedics and Traumatology at Gazi University Hospital and were diagnosed with idiopathic scoliosis by a specialist physician and 30 healty control without scoliosis.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** ukanatlı@gazi.edu.tr
**Name:** Ulunay Kanatlı, Proff
**Phone:** (0312) 216 26 01
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** İnci H Ayas, Msc
**Phone:** (0312) 216 26 01
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ankara
**Country:** Turkey
**Facility:** Gazi University Hospital
**Zip:** 06500
#### Overall Officials
**Official 1:**
**Affiliation:** Gazi University
**Name:** İnci H Ayas, Msc
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Gazi University
**Name:** Furkan Aral, MD
**Role:** STUDY_CHAIR
**Official 3:**
**Affiliation:** Gazi University
**Name:** Burak Oklaz, MD
**Role:** STUDY_CHAIR
**Official 4:**
**Affiliation:** Gazi University
**Name:** Ulunay Kanatlı, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013121
- Term: Spinal Curvatures
- ID: D000013122
- Term: Spinal Diseases
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M15417
- Name: Scoliosis
- Relevance: HIGH
- As Found: Scoliosis
- ID: M15918
- Name: Spinal Curvatures
- Relevance: LOW
- As Found: Unknown
- ID: M15919
- Name: Spinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012600
- Term: Scoliosis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433154
**Brief Title:** Arthroscopy of the Temporomandibular Joint. On Jaw Mobility, Pain and HRQoL
**Official Title:** Arthroscopic Lysis and Lavage in Patients With Internal Derangement of the Temporomandibular Joint: A Retrospective Cohort Study on Jaw Mobility, Pain and Health-related Quality of Life
#### Organization Study ID Info
**ID:** 230_20211018_073
#### Organization
**Class:** OTHER
**Full Name:** Lund University Hospital
### Status Module
#### Completion Date
**Date:** 2024-03-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-31
**Type:** ACTUAL
#### Start Date
**Date:** 2023-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Lund University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of the present study is to retrospectively investigate whether arthroscopic treatment in patients with TMD symptoms depending on internal derangement of the temporomandibular joint (TMJ) gives a satisfying result on the patient's quality of life.
Based on previous studies it is hypothesized that patients suffering from TMD depending on internal derangement would through Patient Reported Outcome Measures (PROM) evaluate the treatment efficacy from an arthroscopic treatment as a benefit to their quality of life.
Further, the study intends to find out if the patient reported outcome measures (PROM) on health-related quality of life (HRQoL) outcome correlates with clinical follow-up measures after arthroscopic treatment of internal derangement of the temporomandibular joint.
The primary objective is to measure the correlation between the results from a HRQoL questionnaire and mouth opening. Secondary, the effect of mouth opening on HRQoL is being explored.
The primary prediction variable is the surgical treatment. Outcome variables are treatment evaluation quality of life (PROM) based on a validated questionnaire; Jaw Functional Limitation Scale (JFLS), age, gender, time from diagnosis to treatment, severity of symptoms (pain, mouth opening ability) and time from treatment to evaluation.
**Detailed Description:** Sample Patients that on referral and examination in 2006 to 2019 at the department of Oral and Maxillofacial Surgery, Skåne University Hospital (SUS) was diagnosed with Temporo Mandibular dysfunction (TMD), will be recruited for participation in the study. Patients aged over 20 years with a dysfunction presenting painful clicking or locking of the Temporomandibular Joint (TMJ), that underwent an arthroscopic treatment the TMJ on one side will be asked for a follow-up. The indication for surgical treatment of these patients was anterior disc displacement combined with pain or "Closed Lock" (disc displacement without reduction). The clinical classification is based on general medical history, history of dysfunction (debut, duration, frequency, character, diurnal variation, symptoms relief, symptoms accentuation), clinical recordings (muscle palpation, joint palpation, recordings of jaw movements and provocation maneuvers, eg Krogh-Poulsen test). The referred patients with TMD were, before selected to arthroscopic treatment, separated into joint associated TMD or muscular associated TMD. Patients with only muscular or mainly muscular symptoms were excluded from arthroscopic treatment and were offered alternative treatment. An important measurement for this selection is the Krogh-Poulsen test. The surgical treatment was carried out by three Oral and Maxillofacial surgeons with equal clinical experience. The sample was during the study period equally distributed between the surgeons. Patients with generalized joint disease, previous surgical treatment in the TMJ, less than 12 months of follow up time and/or had additional surgical treatment during the study period will be excluded from the study.
Surgical Method Surgical approach to the TMJ was established through a transcutaneous preauricular stab entry with a sharp 1,9 mm trocar (KARL STORZ SE \& Co. KG, Tuttlingen, Germany) to the upper joint compartment. A second entry was made with a 1 mm syringe for drainage of the saline solution used for lavage of the upper joint compartment through the trocar cannula. Arthroscopic inspection and visual recording of the upper joint compartment was performed with an optical instrument placed through the trocar cannula. The optical instrument was replaced by a blunt tip, which was used for releasement of adherences between the joint surfaces, as well as stretching of the synovia (lysis). The upper joint compartment was flushed with a minimum of 200ml saline solution (lavage). Finally 1 ml morphine 10 mg/ml was injected through the drainage syringe for postoperative pain relief. Postoperatively the patient was instructed in a jaw mobility training programme, NSAID's (Ibuprofen 400mg orally every 6 to 8 hours) and jaw rest (not to chew) for at seven to thirty days. The duration of the postoperative regime was decided at weekly follow-ups.
Variables The primary prediction variable is the surgical treatment. The primary outcome variable is a treatment evaluation quality of life questionnaire score, based on a validated questionnaire; Jaw Functional Limitation Scale (JFLS). The questionnaire will be tested for reliability through repeated recording with at least 2 months gap between for 30 of the patients. Other predictor variables that could affect the treatment outcome are age, gender, time from diagnosis to treatment, severity of symptoms (pain, mouth opening ability), time from treatment to evaluation, postoperative jaw mobility and improvement of jaw mobility. After the patients have been consented for the study, they will be asked to fill in the Patient Reported Outcome Measures (PROM) questionnaire on self-perceived jaw function (JFLS). The questionnaire will be sent out to all included patients during 2022.
Retrospectively, the following data will be recorded from patient records: gender, age (at surgery), jaw movements, pain, pre surgical diagnosis (clinical) and surgical diagnosis (arthroscopic).
Statistical methods The sample size is based on a total number of 500 patients to be recruited for the enquiry study. In addition, 4000 patients will be included for analysis of journal records alone. Analysis will use mean values, confidence intervals, standard deviations, the Cox regression for evaluation of clinical records treatment outcome and logistic regression for the PROM evaluation. Differences in mouth opening and pain scores, preoperatively and postoperatively will be compared with McNemar's test.
Wilcoxon's paired-sample test will be used for analyzing mouth opening before and after surgery as a numeric variable. Mann-Whitney-test will be used to detect differences between questionnaire responses and clinical findings, i.e. pain and mouth opening. The limit for significant difference will be set to p=0.05. Two-sided p-values will be used. A correlation analysis (Spearman) for postoperative mouth opening and JFLS-score, and progression of mouth opening and JLFS-score will be used.
### Conditions Module
**Conditions:**
- Arthroscopic Surgery
- Temporomandibular Joint
- Health-Related Quality Of Life
- Follow-Up Studies
- Observational
**Keywords:**
- Arthroscopy
- TMJ
- PROM
- HRQoL
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 127
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Arthroscopic lysis and lavage in patients with internal derangement of the temporomandibular joint. Retrospective observational follow-up cohort trial.
**Intervention Names:**
- Procedure: Arthroscopic surgery
**Label:** Arthroscopic surgery to the temporomandibular joint
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Arthroscopic surgery to the temporomandibular joint
**Description:** Arthroscopic treatment (lysis and lavage) of internal derangement of the temporomandibular joint.
**Name:** Arthroscopic surgery
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Measured range of mandibular movements.
**Measure:** Jaw mobility
**Time Frame:** At least one year follow-up after surgery.
#### Secondary Outcomes
**Description:** Patient reported outcome measure with a HRQoL questionaire.
**Measure:** Health Related Quality of Life (HRQoL)
**Time Frame:** At least one year follow-up after surgery.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Patients referred to the Department of Oral and Maxillofacial Surgery, Lund University Hospital between 2006 to 2019 with a temporomandibular dysfunction presenting painful clicking or locking of the TMJ and has underwent an arthroscopic treatment the TMJ on one side.
Patients aged over 20.
Exclusion Criteria:
Patients with only muscular or mainly muscular originated TMJ symptoms. Present generalized joint disease, previous surgical treatment in the TMJ, less than 12 months of follow up time and patients which have had additional surgical treatment during the study period.
**Minimum Age:** 20 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients which had surgical treatment, were anterior disc displacement combined with pain or "Closed Lock" (disc displacement without reduction).
Patients aged over 20.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lund
**Country:** Sweden
**Facility:** Dept Oral and Maxillofacial Surgery
**Zip:** 22185
**Location 2:**
**City:** Lund
**Country:** Sweden
**Facility:** Martin Bengtsson
**Zip:** 22350
#### Overall Officials
**Official 1:**
**Affiliation:** Lund University Hospital
**Name:** Martin Bengtsson, DDS, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Bengtsson M, Fransson P. Do patient-reported outcome measures correlate with clinical follow-up after arthroscopic treatment of internal derangement of the temporomandibular joint? J Stomatol Oral Maxillofac Surg. 2021 Sep;122(4):e21-e26. doi: 10.1016/j.jormas.2021.03.003. Epub 2021 Apr 9.
**PMID:** 33845189
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433141
**Brief Title:** Evaluation of Bioflex Crowns Endocrowns Compared to Ready-Made Zirconia Crowns on Pulpotomized Primary Molars
**Official Title:** Evaluation of Clinical Performance, Parent's Satisfaction, Gingival Health and Bacterial Effects of Bioflex Crowns & Endocrowns Compared to Ready-Made Zirconia Crowns on Pulpotomized Primary Molars: A Randomized Clinical Trial
#### Organization Study ID Info
**ID:** 966/5604
#### Organization
**Class:** OTHER
**Full Name:** Al-Azhar University
### Status Module
#### Completion Date
**Date:** 2025-08-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-03-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-12-19
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Al-Azhar University
#### Responsible Party
**Investigator Affiliation:** Al-Azhar University
**Investigator Full Name:** kareem ragab abdallah el hosary
**Investigator Title:** head of dental depertment -tanta militery hospital
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study will be conducted to evaluate clinical performance, parent's satisfaction, gingival health and bacterial effects of Bioflex crowns \&Endocrowns compared to ready-made zirconia Crowns on Pulpotomized primary molars
**Detailed Description:** Intervention: Pulptomy Procedures The tooth will be anaesthetized. Then, it will be isolated using a rubber dam. Caries will be removed with a sterile non-end cutting bur # 558 to complete the removal of the pulp chamber roof under copious water coolant spray. Coronal pulp tissue remnants will be removed with a sharp, sterile excavator. A piece of cotton soaked with formocresol will be inserted into the pulp chamber for 5 minutes. After removing the formocresol pellet, a thick mix of zinc- oxide/eugenol paste will be packed into the pulp chamber to seal the orifices.
Restoration of the tooth:
According to the groups restoration will be as the following:
Group A: Endocrowns tooth preparation, scanning, cementation:
For the endocrowns A layer of light -cured glass ionomer cement ° of 1 mm thickness will be applied over the ZOE- to isolate it from the successive resin based restorations and adhesives- leaving a minimum of 3 mm of the pulp chamber to provide an adequate thickness for the endocrown core.
Round-end tapered stone will be used to achieve depth cuts of 1.5 mm for occlusal clearance A wheel stone will complete the occlusal reduction and making butt joint finish line.
Tapered stone of 8-degree angle will be used to prepare axial wall flared, the pulp chamber walls to a standard degree of divergence.
Abrasive rubber tip will be used to smoothening and rounding the internal angles giving a polished and smoothed preparation.
Endocrown will be manufactured using CAD/CAM technology internal wall of crown will be treated with etchant material, rinsed, dried then silane coupling agent Dual-cure resin cement will be applied on the crown fitting surface for endocrown cementation. Group B: Preformed Bioflex crowns
According to manufacturer instruction the preparation will be as the follow:
Light -cured glass ionomer filling of adequate thickness will be applied over the ZOE to seal the cavity before preparation A digital caliper will be used to measure a mesio-distal dimension of tooth then suitable sized preformed crown will be selected.
Tooth preparation will be carried out with a tapered diamond bur for occlusal reduction by 1-1.5 mm, including the central groove.
The proximal preparation will be around 0.5 mm to clear the contact area Placement of the crown will be achieved by a snug fit followed by contouring using a Hover's plier.
Crown cementation will be carried out using glass ionomer cement and removal of excess cement using floss or explorer.
Group C: performed zirconia crowns Light -cured glass ionomer filling of adequate thickness will be applied over the ZOE to seal the cavity before preparation.
A digital caliper will be used to measure a mesio-distal dimension of tooth then suitable sized preformed crown will be selected.
A diamond bur will reduce the occlusal surface by 1.5-2 mm Interproximal contacts will be prepared with a tapered fissure bur. About 1-2 mm sub gingival preparation will be performed The selected crown will be placed and checked. The passive fit of the crown will be assessed and will be luted with glass ionomer cement.
Consistent firm finger pressure will be applied during cementation. Observations:
Clinical Performance Assessment Retention, marginal adaption, fracture of the restoration were scored using a modified United States Public Health Service (USPHS) criterion.
Dental plaque accumulation and gingival condition were assessed using plaque index (PI) and GI.
Preparation time and cementation assessment using stop watch to record time from preparation start till final restoration cementation.
Clinical performance and oral status will be assessed at follow-up periods of 3 (T1), 6 (T2), and 12 (T3) months. At the end of the follow-up (T3), parent's satisfaction analysis toward the color, shape, and size of three restorations will be adopted to directly evaluate their satisfaction toward their children's restorations. Parents' responses were rated on a 5-point Likert-type scale.Microbiological analysis:
The swabs will be collected before preparation of crowns, 3 months, 6 months and 12 months after cementation. The number of Streptococcus Mutans, lactobacillus will be digitally counted. Swabs will be taken from occlusal surface by means of the tips of sterile cotton The number of Streptococcus Mutans, lactobacillus will be digitally counted. Swabs will be taken from occlusal surface by means of the tips of sterile cotton Samples will be preserved in a transporting medium tube containing 9ml thioglycolate broth medium. All specimens were transported immediately to microbiological lab.
### Conditions Module
**Conditions:**
- Primary Teeth
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** FACTORIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 74
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** bio-flex crown will be used as a final restoration for pulp treated primary molar, selection of suitable sized crown , it will be cement with glass ionomer cement after pulpotmy procdure clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year
**Intervention Names:**
- Procedure: treatment option for primary second molar
**Label:** bio-flex crown
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** endo-crown will be used as a final restoration for pulp treated primary molar, after pulpotomy procdure endo-crown preperation design will be done and CAD/CAM, endo crown will be luted according to e-max protocol clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year
**Intervention Names:**
- Procedure: treatment option for primary second molar
**Label:** endo-crown
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** zirconia crown will be used as a final restoration for pulp treated primary molar, selection of suitable sized crown after preperation of tooth and use try-in kit to select siutable size ,zirconia is sensitive for blood contamination , it will be cement with glass ionomer cement after pulpotmy procdure clincal performance, parent satsification ,bacterial adherence will be evaluated with a follow up period 1 year
**Intervention Names:**
- Procedure: treatment option for primary second molar
**Label:** zirconia crown
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- bio-flex crown
- endo-crown
- zirconia crown
**Description:** final restoration for primary second molars
**Name:** treatment option for primary second molar
**Type:** PROCEDURE
### Outcomes Module
#### Other Outcomes
**Description:** number of Streptococcus Mutans, lactobacillus will be digitally counted.
**Measure:** Microbiological analysis
**Time Frame:** follow up will be 3,6,9,12 month
#### Primary Outcomes
**Description:** Retention were scored using a modified United States Public Health Service (USPHS) criterion.
**Measure:** retention of bio-flex crown,zirconia, and endo-crown
**Time Frame:** follow up will be 3,6,9,12 month
**Description:** marginal adaptation were scored using a modified United States Public Health Service (USPHS) criterion.
**Measure:** marginal adaptation of bio-flex crown,zirconia, and endo-crown
**Time Frame:** follow up will be 3,6,9,12 month
**Description:** fracture of restoration were scored using a modified United States Public Health Service (USPHS) criterion.
**Measure:** fracture of restoration of bio-flex crown,zirconia, and endo-crown
**Time Frame:** follow up will be 3,6,9,12 month
**Description:** • Dental plaque accumulation and gingival condition were assessed using plaque index (PI) and GI.
**Measure:** gingival health of bio-flex crown,zirconia, and endo-crown
**Time Frame:** follow up will be 3,6,9,12 month
#### Secondary Outcomes
**Description:** Parents' responses were rated on a 5-point Likert-type scale.
**Measure:** parent's satisfaction analysis
**Time Frame:** follow up will be 3,6,9,12 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1 - Parents' and patients' acceptance and cooperation 2- Apparently Healthy children. 3- Child's age ranging from 4 to 8 years old. 4- Primary 2nd molars with deep carious lesion indicated for vital Pulptomy 5- No periapical pathological lesion 6- No root resorption exceeding more than 2/3 of root length.
Exclusion Criteria:
1. Medically compromised children (bleeding disorders, cardiac patient and any systemic diseases could affect oral and gingival health.
2. Presence of para-functional habits. Such bruxism, TMJ disorders
3. Non-restorable tooth.
4. Teeth with non-vital pulp
**Maximum Age:** 8 Years
**Minimum Age:** 4 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Faculity of Dentistry
**Zip:** 02
#### Overall Officials
**Official 1:**
**Affiliation:** Al-Azhar University
**Name:** kareem elhosary, master degree
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** after 1.5 years
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-02-19
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 909190
- Type Abbrev: Prot_SAP
- Upload Date: 2024-05-17T17:53
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433128
**Brief Title:** Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections
**Official Title:** Expanded Access to Fosmanogepix for Patients With Serious or Life-threatening Invasive Fungal Infections Who Have no Other Treatment Options
#### Organization Study ID Info
**ID:** EAP to Fosmanogepix
#### Organization
**Class:** INDUSTRY
**Full Name:** Basilea Pharmaceutica
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** AVAILABLE
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Basilea Pharmaceutica
#### Responsible Party
**Type:** SPONSOR
### Description Module
**Brief Summary:** The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.
### Conditions Module
**Conditions:**
- Invasive Fungal Infections
**Keywords:**
- Fungal infection
- Candida
- Anti-fungal
- Yeast
- Mold
- Rare mold
### Design Module
#### Expanded Access Types
**Individual:** True
**Study Type:** EXPANDED_ACCESS
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Fosmanogepix solution for infusion, 20 mg/mL for intravenous administration
**Name:** Fosmanogepix solution for infusion
**Type:** DRUG
#### Intervention 2
**Description:** Fosmanogepix 400 mg tablets for oral administration
**Name:** Fosmanogepix 400 mg tablets
**Type:** DRUG
### Eligibility Module
**Eligibility Criteria:** The EAP is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the EORTC-MSGERC criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** WEP-Clinical Pharmaceutical Services Provider
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Marc Engelhardt
**Phone:** +41 79 701 0551
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000001423
- Term: Bacterial Infections and Mycoses
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: HIGH
- As Found: Infection
- ID: M6368
- Name: Communicable Diseases
- Relevance: HIGH
- As Found: Infection
- ID: M12136
- Name: Mycoses
- Relevance: HIGH
- As Found: Fungal Infections
- ID: M1099
- Name: Invasive Fungal Infections
- Relevance: HIGH
- As Found: Invasive Fungal Infections
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M4722
- Name: Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007239
- Term: Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000009181
- Term: Mycoses
- ID: D000072742
- Term: Invasive Fungal Infections
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M6252
- Name: Clotrimazole
- Relevance: LOW
- As Found: Unknown
- ID: M11796
- Name: Miconazole
- Relevance: LOW
- As Found: Unknown
- ID: M4254
- Name: Antifungal Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433115
**Brief Title:** Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome
**Official Title:** Effects of Lean Beef Consumption on Cardiometabolic Health and Gut Microbiome
#### Organization Study ID Info
**ID:** 2097458
#### Organization
**Class:** OTHER
**Full Name:** University of Missouri-Columbia
#### Secondary ID Infos
**Domain:** University of Missouri
**ID:** 2097458
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Missouri-Columbia
#### Responsible Party
**Investigator Affiliation:** University of Missouri-Columbia
**Investigator Full Name:** Jaapna Dhillon
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study is investigating the benefits of lean beef consumption on cardiometabolic health and gut microbiome.
**Detailed Description:** The study is a 6-wk randomized, controlled, and parallel arm clinical trial. Participants will be randomized to consume either lean grain-fed beef, lean grass-fed beef, or plant-based meat for 6 weeks. Outcomes assessed will include metabolic, inflammatory, and gut microbiome markers.
### Conditions Module
**Conditions:**
- Diet Intervention
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Parallel Assignment
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Single Blind
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The quantity of beef will be adjusted or normalized based on their individual energy requirements. The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. Participants will consume meals for six weeks.
**Intervention Names:**
- Other: Lean (93%) Grass-Fed Beef
**Label:** Lean (93%) Grass-Fed Beef
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The quantity of beef will be adjusted or normalized based on their individual energy requirements. The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal. Participants will consume meals for six weeks.
**Intervention Names:**
- Other: Lean (93%) Grain-Fed Beef
**Label:** Lean (93%) Grain-Fed Beef
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Plant-based meat (beyond meat product) would be macronutrient matched to the same quantities of meat prescribed for a given energy level. Participants will consume meals for six weeks.
**Intervention Names:**
- Other: Plant-Based Meat
**Label:** Plant-Based Meat
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Lean (93%) Grass-Fed Beef
**Description:** The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal.
**Name:** Lean (93%) Grass-Fed Beef
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Lean (93%) Grain-Fed Beef
**Description:** The specified amount will be 4 oz. per day or 28 ounces per week for participants with an energy requirement of 2000 kcal.
**Name:** Lean (93%) Grain-Fed Beef
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Plant-Based Meat
**Description:** Plant-based meat would be macronutrient matched to the same quantities of meat prescribed for a given energy level.
**Name:** Plant-Based Meat
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** Untargeted and targeted metabolomics
**Measure:** Metabolite intensities
**Time Frame:** Baseline, week 6
**Description:** 24 hours dietary recall
**Measure:** Nutrient intakes
**Time Frame:** Baseline, week 3, week 6
#### Primary Outcomes
**Description:** Lipid profile
**Measure:** LDL-C concentrations
**Time Frame:** Baseline, week 6
**Description:** Inflammatory marker
**Measure:** Interleukin-6 concentrations
**Time Frame:** Baseline, week 6
**Description:** Assessed via16S rRNA sequencing
**Measure:** Gut microbial alpha-diversity
**Time Frame:** Baseline, week 6
#### Secondary Outcomes
**Description:** Lipid profile
**Measure:** HDL-C concentrations
**Time Frame:** Baseline, week 6
**Description:** Lipid profile
**Measure:** Total cholesterol concentrations
**Time Frame:** Baseline, week 6
**Description:** Lipid profile
**Measure:** Triglyceride concentrations
**Time Frame:** Baseline, week 6
**Description:** 16S rRNA sequencing
**Measure:** Gut microbiome abundance
**Time Frame:** Baseline, week 6
**Description:** Intestinal permeability marker
**Measure:** LPS-binding protein concentration
**Time Frame:** Baseline, week 6
**Description:** Blood Glucose
**Measure:** Glucose concentrations
**Time Frame:** Baseline, week 6
**Description:** Insulin
**Measure:** Insulin concentrations
**Time Frame:** Baseline, week 6
**Description:** Measured in kg
**Measure:** Body mass
**Time Frame:** Baseline, week 3, and week 6
**Description:** Fat mass
**Measure:** Fat mass
**Time Frame:** Baseline, week 3, and week 6
**Description:** Fat-free mass
**Measure:** Fat-free mass
**Time Frame:** Baseline, week 3, and week 6
**Description:** Waist circumference
**Measure:** Waist circumference
**Time Frame:** Baseline, week 3, and week 6
**Description:** Hip Circumference
**Measure:** Hip circumference
**Time Frame:** Baseline, week 3, and week 6
**Description:** Thigh Circumference
**Measure:** Thigh circumference
**Time Frame:** Baseline, week 3, and week 6
**Description:** 24-hour appetite ratings assessed on VAS
**Measure:** 24 hour appetite ratings
**Time Frame:** Baseline, week 6
**Description:** Activity assessment using Actigraphs
**Measure:** Physical activity scores
**Time Frame:** Baseline, week 6
**Description:** Sleep diary
**Measure:** Total hours of sleep
**Time Frame:** Baseline, week 6
**Description:** Hedonic general labelled magnitude scale (gLMS)
**Measure:** Palatability rating of foods
**Time Frame:** Baseline, week 3, week 6
**Description:** 9-point food action rating scale
**Measure:** Acceptance rating of foods
**Time Frame:** Baseline, week 3, week 6
**Description:** Sensory intensity scales
**Measure:** Taste and flavor intensity ratings of foods
**Time Frame:** Baseline
**Description:** Transcriptomics analyses
**Measure:** Gene expression levels
**Time Frame:** Baseline, week 6
**Description:** Inflammatory markers
**Measure:** Inflammatory marker concentrations
**Time Frame:** Baseline, week 6
**Description:** NCI diet history questionnaire
**Measure:** Healthy eating index score
**Time Frame:** Baseline, week 6
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age: 18-45 years of age
* BMI: 18-35 kg/m2
* Willingness to consume study foods.
* Willing to comply with study protocol.
* Consistent diet and activity patterns for 4 weeks
* Weight stable (≤5 kg change over the last 3 months)
* Non-smoker \>1 year or more
Exclusion Criteria:
* Allergies to foods provided in the study
* Diabetes
* Gastrointestinal disease and/or bariatric surgery
* Uncontrolled hypertension and blood pressure ≥ 180/110
* Illicit drug use
* Recent consumption of antibiotics
* Recent start of medications that affect metabolism or appetite.
* Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia
* Pregnant or lactating individuals
* Taste or smell disorders
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jaapna Dhillon
**Phone:** 573-884-2103
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Columbia
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jaapna Dhillon
- **Phone:** 573-884-2103
- **Role:** CONTACT
***Contact 2:***
- **Name:** Jaapna Dhillon, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Missouri-Columbia
**State:** Missouri
**Zip:** 65211
#### Overall Officials
**Official 1:**
**Affiliation:** University of Missouri-Columbia
**Name:** Jaapna Dhillon, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Data will be deposited in online repositories
**Description:** Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** Immediately following publication. No end date.
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433102
**Brief Title:** Evaluation of Visual Training System in Patients With Glaucoma
**Official Title:** Assessing the Effectiveness of Visual Perception Training Based on Lateral Masking Paradigm in Glaucoma Patients
#### Organization Study ID Info
**ID:** 2023KYPJ008
#### Organization
**Class:** OTHER
**Full Name:** Zhongshan Ophthalmic Center, Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2025-04-26
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-03
**Type:** ESTIMATED
**Status Verified Date:** 2024-02
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Zhongshan Ophthalmic Center, Sun Yat-sen University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study intends to conduct visual function examinations and follow-ups on two groups of glaucoma patients, one receiving visual perceptual training and the other serving as a control without training. The aim of this study is to explore the effects of visual perceptual training based on the lateral masking paradigm on patients' visual function. Additionally, synchronized EEG-fNIRS signals will be collected to investigate whether changes in patients' visual function are accompanied by corresponding alterations in brain function.
**Detailed Description:** Glaucoma is a chronic eye disease that causes irreversible damage to the optic nerve and can lead to severe vision loss and blindness. In China, the blindness rate among glaucoma patients is 22.7%, accounting for 8.8% of the total blind population. Among individuals aged 40 and above in urban and rural areas of China, approximately 9.2 million suffer from glaucoma, with 55% experiencing blindness in at least one eye and 18.1% experiencing blindness in both eyes \[1,2\]. Glaucoma patients may experience severe impairment in visual function, leading to significant limitations in vision-related activities such as mobility and visual searching. This has a negative impact on the quality of life (QOL) of patients, increasing the burden on individuals, families, and society.
Vision Rehabilitation (VR) is an integral component of the eye care continuum, spanning from diagnosis to treatment and rehabilitation \[3\]. It aims to assist visually impaired patients in maximizing their remaining vision, facilitating easier performance of daily activities, promoting independence, and enhancing quality of life (QOL). However, for glaucoma patients with visual field defects, traditional methods such as inverted telescopes and prism glasses are plagued by shortcomings such as unattractive appearance, bulkiness, blurred visual quality, and challenges in adaptation.
Perceptual Learning (PL) is a novel rehabilitation approach aimed at enhancing visual performance through intensified practice of visual tasks. Many studies have shown that visual perceptual training can improve visual function in patients with different types of amblyopia or presbyopia, as the nervous system exhibits significant neuroplasticity \[4-6\]. However, there is limited research on visual perceptual training in visual rehabilitation for glaucoma.
Therefore, this study intends to conduct visual function examinations and follow-ups on two groups of glaucoma patients, one receiving visual perceptual training and the other serving as a control without training. The aim of this study is to explore the effects of visual perceptual training based on the lateral masking paradigm on patients' visual function. Additionally, synchronized EEG-fNIRS signals will be collected to investigate whether changes in patients' visual function are accompanied by corresponding alterations in brain function.
### Conditions Module
**Conditions:**
- Glaucoma
**Keywords:**
- Visual perceptual training
- Vision rehabilitation
- Glaucoma
- Lateral masking paradigm
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** randomized controlled trial
##### Masking Info
**Masking:** SINGLE
**Masking Description:** The technical staff and research assistants involved in subject enrollment, outcome measurement, and data collection are blinded to the intervention allocation.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in this group received visual perceptual training based on the lateral masking paradigm every other day for 35 to 45 minutes, with each cycle consisting of 40 sessions, lasting approximately 3 months. The training began in the hospital during the first week and continued at home using personal computers thereafter. The personal computers were connected to a central server via the internet.
**Intervention Names:**
- Other: Visual perceptual training based on the lateral masking paradigm
**Label:** the training group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control group maintained the original treatment plan without any additional interventions.
**Label:** the control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- the training group
**Description:** Visual perceptual training is a novel rehabilitation approach aimed at enhancing visual performance through practice of visual tasks. Patients received visual perceptual training based on the lateral masking paradigm every other day. Each training session consisted of 9 stages, totaling 900 trials, lasting 35 to 45 minutes. The stimuli consisted of a central Gabor patch with relatively low contrast positioned in the central fixation area, along with co-linear high-contrast Gabor patches distributed above and below the central stimulus. These stimuli were presented on a Liquid Crystal Display (LCD) monitor, with a training distance of 150 cm.
**Name:** Visual perceptual training based on the lateral masking paradigm
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Contrast sensitivity function (CSF) was assessed using the qCSF method at baseline, and at 1 day, 3 months, and 6 months after the intervention. The qCSF method employed a Bayesian adaptive learning procedure. Data collected for analysis included contrast sensitivity at 19 spatial frequencies, the area under the log CSF (AULCSF), and the cutoff spatial frequency.
**Measure:** Contrast sensitivity function
**Time Frame:** 6 months after intervention
#### Secondary Outcomes
**Description:** Visual field testing was conducted using automated perimetry with the 30-2 Swedish interactive threshold algorithm. The examination was performed at baseline and 1 day, 3 months, and 6 months after the intervention.
**Measure:** Visual field
**Time Frame:** 6 months after intervention
**Description:** Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart was used. The examination was performed at baseline and 1 day, 3 months, and 6 months after the intervention.
**Measure:** Visual acuity
**Time Frame:** 6 months after intervention
**Description:** Stereoacuity was measured using the Titmus stereopsis test at baseline, as well as 1 day, 3 months, and 6 months after the intervention.
**Measure:** Stereoacuity
**Time Frame:** 6 months after intervention
**Description:** The GVFQ-40 consists of 40 items and measures the difficulty of daily activities of glaucoma patients in five domains of functioning (mobility, visual tracking, reading, identification and night vision ). Each item has six answer options, that is, no difficulty (score = 1), mild difficulty (score = 2), moderate difficulty (score = 3), extremely difficult (score = 4), completely unable to complete (score = 5), and do not perform for nonvisual reasons (no score). The GVFQ-40 was administered at baseline and 1 day, 3 months, and 6 months after the intervention.
**Measure:** Glaucoma Visual Functioning Questionnaire-40 (GVFQ-40)
**Time Frame:** 6 months after intervention
**Description:** The National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25) is a valid and reliable vision-related quality of life (QOL) questionnaire designed for persons who have chronic eye diseases or low vision. It includes 25 items that comprise 11 subscales on different aspects of vision-related functioning and QOL and 1 item on general health. NEI VFQ-25 scores range from 0 to 100, with a higher score representing better functioning. The NEI VFQ-25 was administered at baseline and 1 day, 3 months, and 6 months after the intervention.
**Measure:** National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25)
**Time Frame:** 6 months after intervention
**Description:** The reaching-and-grasping (prehension) task was conducted to assess patients' eye-hand coordination abilities at baseline and 1 day, 3 months, and 6 months post-intervention. The motion capture system recorded the movements of the preferred hand. Various metrics of prehension planning and online control were measured, including initiation time, total movement duration, peak velocity, and other relevant parameters.
**Measure:** Reach-and-Grasp Kinematics
**Time Frame:** 6 months after intervention
**Description:** Electroencephalogram was performed to track the electrical activity of the brain in real time at baseline and 1 day, 3 months, and 6 months after the intervention. Node efficiency was calculated. Node efficiency is a metric that characterizes the efficiency of a single node in connecting with all other parts of the network. It reflects the centrality and importance of a node within the network.
**Measure:** Electroencephalogram (EEG) node efficiency
**Time Frame:** 6 months after intervention
**Description:** Functional near-infrared spectroscopy (fNIRS) was conducted to capture spatial information on cerebral blood flow and oxygenation conditions at baseline, as well as 1 day, 3 months, and 6 months after the intervention.
**Measure:** Functional near-infrared spectroscopy (fNIRS)
**Time Frame:** 6 months after intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. age ≥ 10 years old
2. diagnosed with primary glaucoma or developmental glaucoma
3. the best corrected visual acuity ≥0.1 and the mean deviation of the visual field worse or equal to -6 dB
4. visual acuity, intraocular pressure, and other eye conditions have been stable for more than 3 months
5. participants capable of understanding the purpose of the study and providing informed consent
6. participants capable of cooperating with relevant examinations.
Exclusion Criteria:
1. a history of eye surgery or eye laser within three months
2. complicated with other ophthalmopathy affecting visual function (except cataract, ametropia), such as age-related macular degeneration, diabetic retinopathy, optic nerve disease, retinal vascular disease, etc.
3. serious systemic diseases, such as neurological diseases, cardiovascular diseases, psychological diseases, malignant tumors, etc
4. pregnant or lactating women.
**Healthy Volunteers:** True
**Minimum Age:** 10 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Guangzhou
**Country:** China
**Facility:** Zhongshan Opthalmic Center, Sun Yat-sen University
**State:** Guangdong
**Zip:** 510060
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Foster PJ, Johnson GJ. Glaucoma in China: how big is the problem? Br J Ophthalmol. 2001 Nov;85(11):1277-82. doi: 10.1136/bjo.85.11.1277.
**PMID:** 11673287
**Citation:** Fontenot JL, Bona MD, Kaleem MA, McLaughlin WM Jr, Morse AR, Schwartz TL, Shepherd JD, Jackson ML; American Academy of Ophthalmology Preferred Practice Pattern Vision Rehabilitation Committee. Vision Rehabilitation Preferred Practice Pattern(R). Ophthalmology. 2018 Jan;125(1):P228-P278. doi: 10.1016/j.ophtha.2017.09.030. Epub 2017 Nov 4. No abstract available.
**PMID:** 29108747
**Citation:** Matteo BM, Vigano B, Cerri CG, Perin C. Visual field restorative rehabilitation after brain injury. J Vis. 2016 Jul 1;16(9):11. doi: 10.1167/16.9.11.
**PMID:** 27472498
**Citation:** Polat U, Ma-Naim T, Belkin M, Sagi D. Improving vision in adult amblyopia by perceptual learning. Proc Natl Acad Sci U S A. 2004 Apr 27;101(17):6692-7. doi: 10.1073/pnas.0401200101. Epub 2004 Apr 19.
**PMID:** 15096608
**Citation:** Zhong J, Wang W, Li J, Wang Y, Hu X, Feng L, Ye Q, Luo Y, Zhu Z, Li J, Yuan J. Effects of Perceptual Learning on Deprivation Amblyopia in Children with Limbal Dermoid: A Randomized Controlled Trial. J Clin Med. 2022 Mar 28;11(7):1879. doi: 10.3390/jcm11071879.
**PMID:** 35407483
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009798
- Term: Ocular Hypertension
- ID: D000005128
- Term: Eye Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M9013
- Name: Glaucoma
- Relevance: HIGH
- As Found: Glaucoma
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M12731
- Name: Ocular Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005901
- Term: Glaucoma
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433089
**Brief Title:** Postoperative Pain for Patients After TA-BSM
**Official Title:** Effect of Thoracic Paravertebral Nerve Block on Postoperative Pain After Transapical Beating-heart Myectomy(TA-BSM) in Patients With Hypertrophic Obstructive Cardiomyopathy: a Retrospective Cohort Study
#### Organization Study ID Info
**ID:** TJMZK230601
#### Organization
**Class:** OTHER
**Full Name:** Tongji Hospital
### Status Module
#### Completion Date
**Date:** 2024-04-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-09-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Wenlong Yao (101480)
#### Responsible Party
**Investigator Affiliation:** Tongji Hospital
**Investigator Full Name:** Wenlong Yao (101480)
**Investigator Title:** Professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** To retrospectively analyze the intraoperative and postoperative status of patients with hypertrophic cardiomyopathy undergoing TA-BSM, and to estimate whether paravertebral nerve block can improve postoperative pain for these patients.
**Detailed Description:** Since conventional septal myectomy can be only assessed when the heart resumes beating, and the complications induced by cardiopulmonary bypass are inevitable, a novel transapical beating-heart septal myectomy (TA-BSM) has been invented, which provides real-time evaluation to guide resection while reducing surgical trauma. Postoperative pain after TA-BSM is unknown. Whether paravertebral nerve block can improve postoperative pain caused by TA-BSM is the objective of our study.
### Conditions Module
**Conditions:**
- Nerve Block
- Transapical Beating-heart Septal Myectomy
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 197
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The patients received General Anesthesia(GA) combined with Paravertebral Block(PVB).
**Intervention Names:**
- Procedure: Thoracic paravertebral block
**Label:** group GA+PVB
#### Arm Group 2
**Description:** The patients received general anesthesia only.
**Label:** group GA only
### Interventions
#### Intervention 1
**Arm Group Labels:**
- group GA+PVB
**Description:** Thoracic paravertebral block was performed before surgery
**Name:** Thoracic paravertebral block
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Cumulative morphine consumption
**Measure:** Morphine consumption
**Time Frame:** During the first 48 hours after surgery
#### Secondary Outcomes
**Description:** Visual Analogue Scale score(0-10 stands for the degree of pain, 0=no pain, 10=the worst pain ever)
**Measure:** Postoperative pain score 1
**Time Frame:** 24 hours after surgery and and 48 hours after surgery
**Description:** Brief Pain Inventory(The degree of pain \[0 no pain to 10 very painful\] and the impact of pain on daily life function \[0 no impact to 10 very impact\])
**Measure:** Postoperative pain score 2
**Time Frame:** Day 7 after surgery and month 3 after surgery
**Description:** Quality of recovery(Rating from 0 \[very poor\] to 150 \[excellent\])
**Measure:** Physical recovery after surgery
**Time Frame:** Day 7 after surgery
**Description:** The incidence of nausea and vomiting
**Measure:** Complications
**Time Frame:** 24 hours and 48 hours after surgery
**Description:** The usage of analgesic drug
**Measure:** Perioperative information 1
**Time Frame:** Immediately after the surgery
**Description:** Mean arterial blood pressure
**Measure:** Perioperative information 2
**Time Frame:** P1= before induction, P2= 5 minutes after tracheal intubation, P3= before skin incision, P4= 5 minutes after skin incision, P5=5 minutes after placed the rib spreader
**Description:** Heart reat
**Measure:** Perioperative information 3
**Time Frame:** P1= before induction, P2= 5 minutes after tracheal intubation, P3= before skin incision, P4= 5 minutes after skin incision, P5=5 minutes after placed the rib spreader
**Description:** Duration of anesthesia
**Measure:** Perioperative information 4
**Time Frame:** Immediately after the surgery
**Description:** Extubation time
**Measure:** Postoperative information 1
**Time Frame:** Postoperative in 24 hours
**Description:** The usage of analgesic drug
**Measure:** Postoperative information 2
**Time Frame:** Postoperative in 48 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 18\~75 years
* American society of anesthesiologists classification II-III
* Elective TA-BSM was performed
Exclusion Criteria:
* Underwent multiple surgical procedures or required cardiopulmonary bypass assistance
* Combined other function decompensation disease
* Patients with incomplete medical records
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The information of all patients with hypertrophic cardiomyopathy undergoing TA-BSM in our hospital from April 2023 to September 2023 was extracted and screened according to the inclusion criteria and exclusion criteria.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Wuhan
**Country:** China
**Facility:** Tongji Hospital, Tongji Medical College, Huazhong Science and Technology University
**State:** Hubei
**Zip:** 430030
#### Overall Officials
**Official 1:**
**Affiliation:** Tongji Hospital
**Name:** Wenlong Yao
**Role:** PRINCIPAL_INVESTIGATOR
## 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: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Postoperative Pain
- ID: M12154
- Name: Cardiomyopathies
- Relevance: LOW
- As Found: Unknown
- ID: M10035
- Name: Hypertrophy
- Relevance: LOW
- As Found: Unknown
- 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
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433076
**Acronym:** EFFORT-1
**Brief Title:** The Association Between Respiratory Effort Parameters During the First 48 Hours With Clinical Outcomes in Mechanically Ventilated Patients: A Prospective Observational Study.
**Official Title:** The Association Between Respiratory Effort Parameters During the First 48 Hours With Clinical Outcomes in Mechanically Ventilated Patients: A Prospective Observational Study.
#### Organization Study ID Info
**ID:** COA. MURA2022/317
#### Organization
**Class:** OTHER
**Full Name:** Ramathibodi Hospital
### Status Module
#### Completion Date
**Date:** 2024-04-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-31
**Type:** ACTUAL
#### Start Date
**Date:** 2022-06-08
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ramathibodi Hospital
#### Responsible Party
**Investigator Affiliation:** Ramathibodi Hospital
**Investigator Full Name:** Phruet Soipetkasem
**Investigator Title:** Critical care medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Over-assisted mechanical ventilation (MV) is linked to respiratory muscle disuse atrophy, while under-assisted MV can lead to patient self-inflicted lung injury (P-SILI) or respiratory muscle injuries. Both scenarios result in poor outcomes. This hypothesis aims to demonstrate the association between the degree of respiratory effort which was measured by P0.1, predicted Pmus, and predicted Δtranspulmonary pressure (ΔPL) with ventilator-free days (VFD) and 28-day mortality.
**Detailed Description:** Recently, the lung and diaphragm protective strategy is an important consideration when providing mechanical ventilation to critically ill patients. Although mechanical ventilation can be life-saving, improper management can cause harm. The harmful mechanical ventilator setting can result from over-assisted or under-assisted ventilation. Over-assisted ventilation can be caused by too much ventilatory support or calming down patients with high dosages of sedative drugs or muscle relaxants, which negatively affect the operation of the diaphragm leading to diaphragm muscle atrophy and weakness. This can make it more difficult to weaning and lead to prolonged use of mechanical ventilation. It appears that previous study found a correlation between percentage change in diaphragm thickness fraction, as measured by ultrasound, during the first week of mechanical ventilation and prolonged duration of mechanical ventilation, extended length of stay in the ICU, and complications. Additionally, in the study conclusions, a diaphragm thickness fraction of 15-30% during the first three days of mechanical ventilation was associated with the shortest duration of mechanical ventilation and this may potentially help guide the management of respiratory support.
On the other hand, the effect of under-assist breathing or allowing excessive respiratory effort could be harmful. Some reported in chronic obstructive pulmonary disease (COPD) exacerbation patients found that the increased negative intra-thoracic pressure potentially causes injury to the diaphragm sarcomeres, which are the muscle fibers responsible for generating force during breathing and it was proportional to the degree of obstruction. And compared light microscopy of the diaphragmatic muscles necropsy in patients who died of COPD with normal subjects. They found muscular necrosis and accumulation of fibrosis and collagen deposits. The cytoplasm was scattered, disrupted, and lipofuscin accumulation with hyper-eosinophilia was observed.
In addition, an excessive high respiratory effort can cause lung injury by patient-self known as patient self-inflicted lung injury (P-SILI), a theory first mentioned that the increased magnitude of negative intrathoracic pressure during inhalation may cause the fluid shift from the pulmonary capillaries to the alveoli causing pulmonary edema. This is relevant to the observational studies that the occurrence of negative intrathoracic pressure during large inhalations in obstruction airway patients, such as tracheal stenosis, also results in pulmonary edema. In latterly confirmed this hypothesis. Subsequent studies have supported this phenomenon and overall could be explained through the increase of transpulmonary pressure, pendelluft phenomenon and patient-ventilator asynchrony (PVA).
However, no current studies determine the relationship between respiratory effort measurement during mechanical ventilation and clinical outcomes. Therefore, we conduct the study to determine the relationship between respiratory effort parameters and clinical outcomes.
### Conditions Module
**Conditions:**
- Respiratory Effort
- Respiratory Distress Syndrome
- Lung Mechanics
**Keywords:**
- Respiratory effort
- Acute respiratory distress syndrome (ARDS)
- Dynamic transpulmonary pressure swing (Predicted ΔPL)
- Patient self-inflicted lung injury (P-SILI)
- Patient ventilator asynchrony (PVA)
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 163
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The preference respiratory effort group was defined by either 1.5≤P0.1≤3.5 cmH2O, 5≤ predicted Pmus≤10 cmH2O, or predicted ΔPL≤20 cmH2O.
**Label:** Preference respiratory effort
#### Arm Group 2
**Description:** The insufficiency respiratory effort group was defined by either P0.1\<1.5 cmH2O or predicted Pmus \< 5 cmH2O.
**Label:** Insufficiency respiratory effort
#### Arm Group 3
**Description:** The excessive respiratory effort group was defined by either P0.1 \> 3.5 cmH2O, predicted Pmus \> 10 cmH2O, or predicted ΔPL \> 20 cmH2O.
**Label:** Excessive respiratory effort
### Outcomes Module
#### Primary Outcomes
**Description:** The number of VFDs was defined as the number of days from the last day of mechanical ventilation to day 28. If a patient died during the first 28 days, their number of VFDs is equal to zero.
**Measure:** 28 days ventilator-free days (VFDs)
**Time Frame:** After intubated patients were recruited until successful extubation or dead/failed extubation with in 28 days.
#### Secondary Outcomes
**Description:** Short-term mortality was defined as death occurring within 28 days from the start of enrollment, documented as either alive or deceased 28 days after intubation.
**Measure:** 28 days all-cause mortality
**Time Frame:** After intubated patients were recruited until alive or dead with in 28 days.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Participants must be aged between 18-75 years.
2. Admitted to the critical care and semi-critical care units (ICUs) of the Department of -Internal Medicine, Ramathibodi Hospital (ICUs 9IC, 8IK, and 7NW).
3. Patients with acute respiratory failure admitted to the hospital with the following conditions within the first 48 hours:
* PaO2/FiO2 greater than 150 or
* PaO2 less than 60 mm Hg or
* SaO2 less than 90 mm Hg or
* Work of breathing more than 25 breaths per minute or requiring respiratory muscle assistance
4. Permission obtained from the attending physician.
5. Research participants or their direct relatives must sign informed consent.
6. The research can commence and data can be recorded within 48 hours after the patient has received treatment with the mechanical ventilator.
Exclusion Criteria:
1. Admitted to the hospital or had a history of hospital admission within a month before recruitment.
2. History of cardiovascular or cerebrovascular events within the last 12 months.
3. Pregnant.
4. Terminal-stage cancer patient, terminal illness-stage of disease who desire palliative care.
5. Active neurological or muscular disorders affecting stability.
6. Brain coma, brain death, or status epilepticus.
7. Severe mental health conditions, including active depression with psychotic features, bipolar disorder, or schizophrenia.
8. Uncontrolled thyroid conditions within a month before recruitment.
9. Uncorrectable patients with severe hypoxemia (P/F ratio less than 150).
10. Patients receiving neuromuscular blocking agents.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** A single-center analytical observational prospective study was conducted between June 2022 and April 2024. We enrolled acute respiratory failure patients who required mechanical ventilation from the intensive care units (ICUs) at Ramathibodi Hospital, Mahidol University.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bangkok
**Country:** Thailand
**Facility:** Mr. Phruet Soipetkasem
**Zip:** 10400
#### Overall Officials
**Official 1:**
**Affiliation:** Doctor of Critical care medicine Ramathibodi hospital
**Name:** Mr. Phruet Soipetkasem, Critical care doctor
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Head of Critical care medicine Ramathibodi hospital
**Name:** Pongdhep Theerawit, Assoc. Prof.
**Role:** STUDY_CHAIR
**Official 3:**
**Affiliation:** Clinical professor of Pulmonary and Critical care medicine Ramathibodi hospital
**Name:** Yuda Sutherasan, Assoc. Prof.
**Role:** STUDY_DIRECTOR
**Official 4:**
**Affiliation:** Clinical professor of Pulmonary and Critical care medicine Ramathibodi hospital
**Name:** Mr. Detajin Junhasavasdikul, Asst.Prof.
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Beduneau G, Pham T, Schortgen F, Piquilloud L, Zogheib E, Jonas M, Grelon F, Runge I, Nicolas Terzi, Grange S, Barberet G, Guitard PG, Frat JP, Constan A, Chretien JM, Mancebo J, Mercat A, Richard JM, Brochard L; WIND (Weaning according to a New Definition) Study Group and the REVA (Reseau Europeen de Recherche en Ventilation Artificielle) Network double dagger. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):772-783. doi: 10.1164/rccm.201602-0320OC.
**PMID:** 27626706
**Citation:** Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.
**PMID:** 28930478
**Citation:** Orozco-Levi M, Lloreta J, Minguella J, Serrano S, Broquetas JM, Gea J. Injury of the human diaphragm associated with exertion and chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1734-9. doi: 10.1164/ajrccm.164.9.2011150.
**PMID:** 11719318
**Citation:** Scott A, Wang X, Road JD, Reid WD. Increased injury and intramuscular collagen of the diaphragm in COPD: autopsy observations. Eur Respir J. 2006 Jan;27(1):51-9. doi: 10.1183/09031936.06.00143004.
**PMID:** 16387935
**Citation:** Loeb L. The Mechanism in the Development of Pulmonary Edema. Proceedings of the Society for Experimental Biology and Medicine. 1928;25(5):321-323. doi:10.3181/00379727-25-3837
**Citation:** Moore RL, Binger CA. THE RESPONSE TO RESPIRATORY RESISTANCE : A COMPARISON OF THE EFFECTS PRODUCED BY PARTIAL OBSTRUCTION IN THE INSPIRATORY AND EXPIRATORY PHASES OF RESPIRATION. J Exp Med. 1927 May 31;45(6):1065-80. doi: 10.1084/jem.45.6.1065.
**PMID:** 19869306
**Citation:** Barach AL, Eckman M. THE EFFECTS OF INHALATION OF HELIUM MIXED WITH OXYGEN ON THE MECHANICS OF RESPIRATION. J Clin Invest. 1936 Jan;15(1):47-61. doi: 10.1172/JCI100758. No abstract available.
**PMID:** 16694380
**Citation:** Dreyfuss D, Soler P, Basset G, Saumon G. High inflation pressure pulmonary edema. Respective effects of high airway pressure, high tidal volume, and positive end-expiratory pressure. Am Rev Respir Dis. 1988 May;137(5):1159-64. doi: 10.1164/ajrccm/137.5.1159.
**PMID:** 3057957
**Citation:** Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. The comparison of spontaneous breathing and muscle paralysis in two different severities of experimental lung injury. Crit Care Med. 2013 Feb;41(2):536-45. doi: 10.1097/CCM.0b013e3182711972.
**PMID:** 23263584
**Citation:** Bertoni M, Telias I, Urner M, Long M, Del Sorbo L, Fan E, Sinderby C, Beck J, Liu L, Qiu H, Wong J, Slutsky AS, Ferguson ND, Brochard LJ, Goligher EC. A novel non-invasive method to detect excessively high respiratory effort and dynamic transpulmonary driving pressure during mechanical ventilation. Crit Care. 2019 Nov 6;23(1):346. doi: 10.1186/s13054-019-2617-0.
**PMID:** 31694692
**Citation:** Mascheroni D, Kolobow T, Fumagalli R, Moretti MP, Chen V, Buckhold D. Acute respiratory failure following pharmacologically induced hyperventilation: an experimental animal study. Intensive Care Med. 1988;15(1):8-14. doi: 10.1007/BF00255628.
**PMID:** 3230208
**Citation:** Yoshida T, Torsani V, Gomes S, De Santis RR, Beraldo MA, Costa EL, Tucci MR, Zin WA, Kavanagh BP, Amato MB. Spontaneous effort causes occult pendelluft during mechanical ventilation. Am J Respir Crit Care Med. 2013 Dec 15;188(12):1420-7. doi: 10.1164/rccm.201303-0539OC.
**PMID:** 24199628
**Citation:** Dzierba AL, Khalil AM, Derry KL, Madahar P, Beitler JR. Discordance Between Respiratory Drive and Sedation Depth in Critically Ill Patients Receiving Mechanical Ventilation. Crit Care Med. 2021 Dec 1;49(12):2090-2101. doi: 10.1097/CCM.0000000000005113.
**PMID:** 34115638
**Citation:** Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.
**PMID:** 27334266
**Citation:** Loring SH, O'Donnell CR, Behazin N, Malhotra A, Sarge T, Ritz R, Novack V, Talmor D. Esophageal pressures in acute lung injury: do they represent artifact or useful information about transpulmonary pressure, chest wall mechanics, and lung stress? J Appl Physiol (1985). 2010 Mar;108(3):515-22. doi: 10.1152/japplphysiol.00835.2009. Epub 2009 Dec 17.
**PMID:** 20019160
**Citation:** Baedorf Kassis E, Loring SH, Talmor D. Mortality and pulmonary mechanics in relation to respiratory system and transpulmonary driving pressures in ARDS. Intensive Care Med. 2016 Aug;42(8):1206-13. doi: 10.1007/s00134-016-4403-7. Epub 2016 Jun 18.
**PMID:** 27318943
**Citation:** Taran Z, Namadian M, Faghihzadeh S, Naghibi T. The Effect of Sedation Protocol Using Richmond Agitation-Sedation Scale (RASS) on Some Clinical Outcomes of Mechanically Ventilated Patients in Intensive Care Units: a Randomized Clinical Trial. J Caring Sci. 2019 Dec 1;8(4):199-206. doi: 10.15171/jcs.2019.028. eCollection 2019 Dec.
**PMID:** 31915621
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-06-08
- Filename: ICF_000.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 166863
- Type Abbrev: ICF
- Upload Date: 2024-05-25T23:13
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000012120
- Term: Respiration Disorders
- ID: D000007235
- Term: Infant, Premature, Diseases
- ID: D000007232
- Term: Infant, Newborn, Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M28143
- Name: Lung Injury
- Relevance: LOW
- As Found: Unknown
- ID: M14965
- Name: Respiratory Distress Syndrome
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: M14964
- Name: Respiratory Distress Syndrome, Newborn
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M3385
- Name: Patient-Ventilator Asynchrony
- Relevance: LOW
- As Found: Unknown
- ID: M28144
- Name: Acute Lung Injury
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M25869
- Name: Premature Birth
- Relevance: LOW
- As Found: Unknown
- ID: M10279
- Name: Infant, Premature, Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10276
- Name: Infant, Newborn, Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4927
- Name: Respiratory Distress Syndrome, Infant
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: T192
- Name: Acute Respiratory Distress Syndrome
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012128
- Term: Respiratory Distress Syndrome
- ID: D000012127
- Term: Respiratory Distress Syndrome, Newborn
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433063
**Acronym:** LuMISO
**Brief Title:** Effect of Hypoxia on FMISO PET to Response to Lu-177 PSMA Treatment
**Official Title:** Effect of 18F-Fluoromisonidazole (18F-FMISO) PET Imaging on Evaluation of Hypoxia Before Lu-177 PSMA Treatment for Prostate Cancer
#### Organization Study ID Info
**ID:** LuMISO
#### Organization
**Class:** OTHER
**Full Name:** Ankara University
### Status Module
#### Completion Date
**Date:** 2026-02-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-02-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cigdem Soydal
#### Responsible Party
**Investigator Affiliation:** Ankara University
**Investigator Full Name:** Cigdem Soydal
**Investigator Title:** Asc Prof of Nuclear Medicine
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** It is aimed to evaluate hypoxia before Lu-177 PSMA treatment in prostate cancer and to show its effect on treatment success with 18F-FMISO PET imaging, which allows in-vivo evaluation and quantification of tumor hypoxia, which is known to be one of the factors affecting radiotherapy resistance.
**Detailed Description:** Prostate cancer is the second most common cancer in men and the fifth leading cause of cancer-related deaths. 20% of patients diagnosed with prostate cancer have metastatic disease, and survival rates of more than 5 years have been reported in only 26-30% of them. Androgen deprivation therapy (ADT) is the main treatment method used for years in the treatment of prostate cancer. However, a high rate of resistance develops to this treatment and becomes castration-resistant prostate cancer. Castration-resistant prostate cancer (CRPC) is defined as an increase in PSA levels, clinical or radiological progression, or the emergence of new distant metastases despite lowering serum testosterone to castration levels. FDA-approved drugs such as Sipuleucel-T, Docetaxel, Cabazitaxel, Abireterone, Enzalutamide, Radium-223, Rucaparib, and Olaparib have been shown to increase overall survival in mKDPK. Although there are many treatment classes that delay disease progression and increase survival, mKDPK remains incurable and fatal. Radionuclide therapy (Lu-177 PSMA) has emerged as a promising treatment in patients resistant to these treatments. Although some criteria have been defined to select patients who will benefit from treatment based on parameters such as SUVmax, some of the patients do not respond to radionuclide treatments, and PSA response can be achieved in only a little more than half of the patients in Lu-177 PSMA treatment, which stands out as one of the most effective therapies. The role of hypoxia, which is one of the possible factors affecting the treatment response other than PSMA avidity, in the success of Lu-177 PSMA treatment is currently unclear.
Radiation damage causing cell apoptosis and necrosis occurs through mechanisms such as ionizing radiation causing single or double chain breaks and creating reactive oxygen compounds in surrounding molecules. It is known that hypoxia causes radiotherapy resistance by preventing the formation of reactive oxygen compounds in tumors.
18F-Fluoromisonidazole (18F-FMISO) is an 18F-labelled PET radiopharmaceutical, like 18F-FDG, which has a half-life of 110 minutes and is frequently used in clinical practice. 18F-FMISO is a nitroimidazole class compound known to accumulate in hypoxic cells. After entering viable cells, 18F-FMISO is reduced to the RNO2 radical. In the presence of oxygen, 18F-FMISO can be oxidized again and freely exit the cell. However, since re-oxidation is not possible in hypoxic cells, 18F-FMISO is trapped in hypoxic but viable cells.
It has previously been shown that it is possible to predict radiotherapy response with 18F-FMISO PET imaging in malignancies such as head-neck and lung cancers and the feasibility of personalized treatment according to hypoxia demonstrated with 18F-FMISO. In a study, the presence of hypoxia was demonstrated with 18F-FMISO PET in high-grade tumors in patients receiving neoadjuvant ADT, and hypoxia was shown to regress with tumor response. However, to our knowledge, there is no study yet for Lu-177 PSMA treatment, which is one of the most important internal radiotherapies in prostate cancer. In this study, it was aimed to quantify hypoxia in primary tumors and metastases of prostate cancer with 18F-FMISO and to show its effect on treatment resistance.
Patients referred for Lu-177 PSMA treatment and found suitable for treatment will be included in the study. Within 4 weeks before Lu-177 PSMA treatment, patients will undergo PET imaging after 18F-FMISO injection and SUVmax, SUVmean, metabolic tumor volume and total 18F-FMISO retention parameters will be obtained from the tumors. Following this, patients will receive Lu-177 PSMA treatment in 4 cycles at 6-8 week intervals, as applied in standard clinical practice. Treatment response will be evaluated with Ga68 PSMA PET images taken after 4 cures of Lu-177 PSMA treatment. With 18F-FMISO findings, no changes will be made in the treatment process of the patients, and no additional imaging or examination will be performed after the treatment, other than routine clinical practice.
### Conditions Module
**Conditions:**
- Prostatic Neoplasms
- Hypoxia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Metastatic castration resistant prostate cancer patients who will receive Lu-177 PSMA radionuclide treatment
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients who underwent FMISO PET imaging before Lu-177 PSMA radionuclide treatment for CRPC
**Intervention Names:**
- Diagnostic Test: F-MISO PET
**Label:** Treatment arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment arm
**Description:** Evaluation of tumor hypoxia with F-MISO PET
**Name:** F-MISO PET
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluation of the effect of tumor hypoxia to PSA response after Lu-177 PSMA treatment
**Measure:** To evaluate tumor hypoxia with F-MISO PET to PSA response
**Time Frame:** 6. month after radionuclide treatment
**Description:** Evaluation of the effect of tumor hypoxia to radiological response with RECIST criteria after Lu-177 PSMA treatment
**Measure:** To evaluate tumor hypoxia with F-MISO PET to radiological response
**Time Frame:** 6. month after radionuclide treatment
**Description:** Evaluation of the effect of tumor hypoxia to PSMA response with RECIP criteria after Lu-177 PSMA treatment
**Measure:** To evaluate tumor hypoxia with F-MISO PET to PSMA PET response
**Time Frame:** 6. month after radionuclide treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* over 18 years old
* Patients diagnosed with prostate cancer who were referred to our clinic for Lu-177 PSMA treatment and were found suitable for treatment
Exclusion Criteria:
* Has a life expectancy of less than 3 months
* ECOG\>2
* contraindication for radionuclide treatment with Lu-177 PSMA
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Cigdem Soydal, Asc Prof
**Phone:** +903125956732
**Role:** CONTACT
**Contact 2:**
**Name:** Ecenur Dursun, Res Ass
**Phone:** +903125956732
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ankara
**Contacts:**
***Contact 1:***
- **Name:** Cigdem Soydal
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Ankara University Medical School
**Status:** RECRUITING
**Zip:** 06580
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
- ID: D000005834
- Term: Genital Neoplasms, Male
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000011469
- Term: Prostatic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
### Condition Browse Module - Browse Leaves
- ID: M4185
- Name: Hypoxia
- Relevance: HIGH
- As Found: Hypoxia
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostatic Neoplasms
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
- ID: D000000860
- Term: Hypoxia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433050
**Acronym:** SOTA-CROSS HCM
**Brief Title:** Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy
**Official Title:** Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy
#### Organization Study ID Info
**ID:** 855065
#### Organization
**Class:** OTHER
**Full Name:** University of Pennsylvania
#### Secondary ID Infos
**ID:** R61HL164376
**Link:** https://reporter.nih.gov/quickSearch/R61HL164376
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2027-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Heart, Lung, and Blood Institute (NHLBI)
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Pennsylvania
#### Responsible Party
**Investigator Affiliation:** University of Pennsylvania
**Investigator Full Name:** Sharlene Day
**Investigator Title:** Associate Professor of Cardiovascular Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this clinical trial is to learn if sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, works to treat symptomatic, nonobstructive hypertrophic cardiomyopathy (noHCM) in adult patients. It will also learn about the safety of sotagliflozin in this patient population. The main questions it aims to answer are:
1. Will sotagliflozin be well tolerated in patients with nonobstructive HCM?
2. Will sotaglifozin improve exercise capacity, diastolic dysfunction and/or physical functioning in patients with nonobstructive HCM?
3. Will sotagliflozin improve circulating markers of cardiac metabolism in patients with nonobstructive HCM?
Researchers will compare sotagliflozin to a placebo (a look-alike substance that contains no drug) to see if sotagliflozin is effective at treating hypertrophic cardiomyopathy (HCM).
Participants will:
Take sotagliflozin or a placebo every day for 12 weeks. They will then cross-over (or switch) to taking placebo or sotagliflozin (whichever one they did not take initially) for an additional 12 weeks.
Visit the clinic once every 4-12 weeks for checkups, surveys, and tests including a stress test and echocardiogram.
### Conditions Module
**Conditions:**
- Hypertrophic Cardiomyopathy Without Obstruction
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Double-blinded
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 26
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Matching placebo once daily will be administered in the first phase, Sotagliflozin 400 mg once daily will be administered in the second phase
**Intervention Names:**
- Drug: Sotagliflozin
**Label:** Placebo first phase, Sotagliflozin second phase
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Description:** Sotagliflozin 400 mg once daily will be administered in the first phase, matching placebo once daily will be administered in the second phase
**Intervention Names:**
- Drug: Sotagliflozin
**Label:** Sotagliflozin first phase, Placebo second phase
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Placebo first phase, Sotagliflozin second phase
- Sotagliflozin first phase, Placebo second phase
**Description:** Sotagliflozin or placebo will be administered to each participant in a cross over study design. Each participant will receive active drug and placebo with randomization of the order in which they receive them.
**Name:** Sotagliflozin
**Other Names:**
- Inpefa
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Adverse event reporting
**Measure:** Number of participants with treatment-related adverse events
**Time Frame:** Through study completion, 28 weeks
**Description:** Intracavitary left ventricular pressure gradient in mmHg
**Measure:** Intracavitary obstruction
**Time Frame:** Through study completion, 28 weeks
**Description:** New occurrence of cardiac arrhythmia measured by ambulatory monitoring
**Measure:** Cardiac rhythm
**Time Frame:** Through study completion, 28 weeks
**Description:** Peak oxygen consumption in mL/min
**Measure:** Maximal exercise capacity
**Time Frame:** Through study completion, 28 weeks
**Description:** Stroke volume augmentation at exercise steady state in mL/min
**Measure:** Submaximal exercise capacity
**Time Frame:** Through study completion, 28 weeks
#### Secondary Outcomes
**Description:** Left ventricular ejection fraction in % measured by echocardiography
**Measure:** Systolic function
**Time Frame:** Through study completion, 28 weeks
**Description:** Global longitudinal strain in % measured by echocardiography
**Measure:** Contractility
**Time Frame:** Through study completion, 28 weeks
**Description:** E/E' ratio measured by echocardiography
**Measure:** Diastolic function
**Time Frame:** Through study completion, 28 weeks
**Description:** Maximal left ventricular wall thickness in mm by echocardiography
**Measure:** Left ventricular hypertrophy
**Time Frame:** Through study completion, 28 weeks
**Description:** Kansas City Living with Heart Failure (KCCQ) Clinical Summary Score, scale 0-100 with lower scores being worse
**Measure:** Symptom scores
**Time Frame:** Through study completion, 28 weeks
**Description:** Kansas City Living with Heart Failure (KCCQ) Overall Summary Score, score 0-100 with lower scores being worse
**Measure:** Symptom scores and quality of life
**Time Frame:** Through study completion, 28 weeks
**Description:** Serum levels of N-terminal-proBNP
**Measure:** Biomarkers
**Time Frame:** Through study completion, 28 weeks
**Description:** Concentration of serum metabolites
**Measure:** Circulating metabolites
**Time Frame:** Through study completion, 28 weeks
**Description:** Daily step counts by actigraphy
**Measure:** Measurement of periods of activity and rest
**Time Frame:** Through study completion, 28 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age at least 18 years, both sexes
2. Provision of signed and dated informed consent form
3. Stated willingness to comply with all study procedures and availability for the duration of the study
4. Ability to take oral medication and be willing to adhere to the study intervention.
5. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 2 weeks after the end of administration of study drug.
6. Diagnosis of HCM with NYHA Class II-III functional class or New York Heart Association (NYHA) Class I with peak VO2 \< 90% on cardiopulmonary exercise stress testing performed at Visit 1.
7. Left ventricular outflow tract gradient \< 50 mmHg at rest, with valsalva, and with exercise.
7. Left ventricular ejection fraction \> 50% by echocardiogram or cardiac MRI based on the most recent assessment in the past year prior to screening and confirmed during Visit 1 echocardiogram.
8. Stable medical therapy for at least 1 month prior to study enrollment.
Exclusion Criteria:
1. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrollment or previous intolerance of an SGLT2 inhibitor
2. Type 1 diabetes mellitus
3. Age \<18 years old
4. Pregnant or lactating women: Women of childbearing potential will undergo a urine pregnancy test during the screening visit.
5. Uncontrolled atrial fibrillation, as defined by a resting heart rate \> 100 beats per minute at the time of the baseline assessment
6. Paroxysmal atrial fibrillation (Afib) or flutter with plans to attempt to restore sinus rhythm (with drug therapy, ablation, or DC cardioversion) during the study period.
7. Unable to attain a respiratory exchange ratio of at least 1.05 on cardiopulmonary exercise test (CPET) on the day of screening.
8. Septal reduction therapy within the previous 3 months.
9. Implantable cardio-defibrillator (ICD) implantation planned during the study period.
10. Implantation of a cardiac resynchronization therapy (CRT) device within 12 weeks prior to enrollment or intent to implant a CRT device during the study period
11. Hemoglobin \< 10 g/dL
12. Estimated glomerular filtration rate (eGFR) \< 25 mL/min/1.73m\^2, or unstable or rapidly progressing renal disease at the time of randomization
13. Subject inability/unwillingness to exercise
14. Greater than moderate left sided valvular disease (mitral regurgitation, aortic stenosis, aortic regurgitation), moderate or greater mitral stenosis, or severe right-sided valvular disease based on baseline echo at the time of enrollment
15. Current angina due to clinically significant epicardial coronary disease, as per investigator judgment
16. Acute coronary syndrome or coronary intervention within the past 2 months
17. Primary pulmonary artery hypertension (WHO Group 1 Pulmonary Arterial Hypertension)
18. Clinically significant lung disease as defined by: Chronic Obstructive Pulmonary Disease meeting Stage III or greater GOLD criteria (FEV1\<50% predicted), treatment with oral steroids within the past 6 months for an exacerbation of obstructive lung disease, or current use of supplemental oxygen aside from nocturnal oxygen for the treatment of obstructive sleep apnea.
19. Clinically-significant ischemia, as per investigator's judgement, on stress testing without either (1) subsequent revascularization, (2) an angiogram demonstrating the absence of clinically significant epicardial coronary artery disease, as per investigator judgment; (3) a follow-up 'negative' stress test, particularly when using a more specific technique (i.e., a negative perfusion imaging test following a 'positive' ECG stress test)
20. Symptomatic bradycardia or second- or third-degree heart block, in the absence of a pacemaker
21. Significant liver disease impacting synthetic function or volume control (ALT/AST \> 3x ULN, Albumin \< 3.0 g/dL)
22. Severe right ventricular dysfunction on baseline echocardiogram
23. Orthostatic blood pressure response to the transition from supine to standing (\>20 mmHg reduction in systolic blood pressure 2-3 minutes after standing)
24. Active participation in another study that utilizes an investigational agent (observational studies/registries allowed)
25. Any condition that, in the opinion of the investigator, will interfere with the completion of the study. This may include comorbid or psychiatric conditions that may impede successful completion of the protocol, or logistical concerns (e.g. inability to travel to the exercise unit).
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sharlene Day, MD
**Phone:** 734-548-0394
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Kim Clinton
**Phone:** 215-431-4545
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Pennsylvania
**Name:** Sharlene Day, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** No individual participant data will be available to other researchers
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000001020
- Term: Aortic Stenosis, Subvalvular
- ID: D000001024
- Term: Aortic Valve Stenosis
- ID: D000082862
- Term: Aortic Valve Disease
- ID: D000006349
- Term: Heart Valve Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12154
- Name: Cardiomyopathies
- Relevance: HIGH
- As Found: Cardiomyopathy
- ID: M10035
- Name: Hypertrophy
- Relevance: HIGH
- As Found: Hypertrophic
- ID: M5568
- Name: Cardiomyopathy, Hypertrophic
- Relevance: HIGH
- As Found: Hypertrophic Cardiomyopathy
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M6475
- Name: Constriction, Pathologic
- Relevance: LOW
- As Found: Unknown
- ID: M4340
- Name: Aortic Valve Stenosis
- Relevance: LOW
- As Found: Unknown
- ID: M2379
- Name: Aortic Valve Disease
- Relevance: LOW
- As Found: Unknown
- ID: M9437
- Name: Heart Valve Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T449
- Name: Aortic Valve Stenosis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009202
- Term: Cardiomyopathies
- ID: D000002312
- Term: Cardiomyopathy, Hypertrophic
- ID: D000006984
- Term: Hypertrophy
### Intervention Browse Module - Ancestors
- ID: D000077203
- Term: Sodium-Glucose Transporter 2 Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M254783
- Name: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
- Relevance: HIGH
- As Found: Videoconferencing
- ID: M1691
- Name: Sodium-Glucose Transporter 2 Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000575681
- Term: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433037
**Acronym:** PRECODE
**Brief Title:** Gut-brain Health Effects of PREbiotics in Older Adults With Suspected COgnitive DEcline
**Official Title:** Gut-brain Health Effects of PREbiotics in Older Adults With Suspected COgnitive DEcline: The PRECODE Study
#### Organization Study ID Info
**ID:** NL85910.091.23
#### Organization
**Class:** OTHER
**Full Name:** Wageningen University
### Status Module
#### Completion Date
**Date:** 2026-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Sensus BV
**Class:** UNKNOWN
**Name:** Cosun Nutrition Center
**Class:** UNKNOWN
**Name:** Roquette Frères
**Class:** UNKNOWN
**Name:** Oceanium Ltd.
**Class:** UNKNOWN
**Name:** Technical University of Eindhoven (TU/e)
#### Lead Sponsor
**Class:** OTHER
**Name:** Wageningen University
#### Responsible Party
**Investigator Affiliation:** Wageningen University
**Investigator Full Name:** Yannick Vermeiren
**Investigator Title:** Assistant Professor in Nutrition, Brain and Cognitive Aging
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** As people around the world are living longer, the number of individuals with dementia, particularly Alzheimer's disease (AD), is expected to triple by 2050. There's growing evidence suggesting that our gut health might play a role in the prevention of dementia. The connection between our gut and brain, known as the gut-brain axis, is becoming an important area of study. Research in animals has shown that different types of dietary fibre can improve gut health, brain function, mood, blood sugar level and the immune system and may even prevent certain harmful brain changes seen in Alzheimer's disease. Subjective Cognitive Decline (SCD) is a condition where individuals notice a decline in their mental abilities, and it can be an early sign of Alzheimer's disease.
The goal of this clinical trial is to learn if dietary fibres can improve gut and brain health in older individuals, between the ages of 60 and 79 years, who notice problems in their mental abilities, and meet the criteria of SCD. Three different dietary fibres will be given, and researchers will compare three different fibres to a placebo product to see if there is a difference between the fibres and the placebo.
The main questions it aims to answer are:
1. Does dietary fibre improve working memory?
2. Does dietary fibre improve other markers of brain function?
3. Does dietary fibre improve gut health?
4. Does dietary fibre improve the immune system and blood glucose levels?
5. Does dietary fibre improve mood?
Participants will:
* Consume dietary fibres twice a day, mixed in water, tea or coffee, for a period of 26 weeks
* Have two functional MRI scans, and three additional study visits, where blood, urine and feces will be collected
* Undergo a number of neuropsychological tests, aimed at evaluating brain function
* Fill out questionnaires on their general health, mood, dietary habits, gut health
* Wear smartwatches for one week, at the beginning and the end of the study
**Detailed Description:** Rationale: Due to the greying of society, a triplication of the number of people with dementia worldwide, with Alzheimer's disease (AD) as the commonest form, is expected by 2050. Compelling evidence points towards a crucial role of intestinal health as one potential etiological modifier of dementia, with the (microbiota) gut-brain axis (MGBA) receiving increasing attention. A number of preclinical studies have demonstrated benefit of various sources of dietary fibre for their capacity to improve gut health, cognitive functioning, general mood, glycaemia, immunogenicity, and, to inhibit tau phosphorylation, the latter which is a hallmark in AD brain. Subjective cognitive decline (SCD) lies on the continuum of AD, and subjects with this condition are at increased risk of further conversion to mild cognitive impairment (MCI) or AD. Currently, no cure is available for AD. Various symptomatic and a few disease-modifying treatments are available, but these treatments only have very limited or mild clinical effects and are often accompanied by severe side effects. Clinical follow-up studies to evaluate the effect of dietary fibre in older adults with suspected cognitive decline are required, but are still lacking to date.
Objective: The primary objective of this study is to investigate the effect of 26 weeks of supplementation with three different dietary fibres (chicory inulin, resistant dextrin, and seaweed polysaccharide) compared to a placebo (maltodextrin) on microbiota gut-brain health effects in older adults (aged 60-79) with Subjective Cognitive Decline Plus (SCD+) by assessing changes in brain function and working memory by blood oxygen level dependant (BOLD) signal activity and task accuracy during n-back task functional magnetic resonance imaging (fMRI) assessment.
The secondary objectives are to investigate the effects of 26 weeks of supplementation with dietary fibre (chicory inulin, resistant dextrin, and, seaweed polysaccharide) compared to placebo (maltodextrin) in older adults on the following parameters related to potential gut-brain pathways:
1. neuropsychological test battery scoring,
2. other relevant brain health parameters,
3. relevant intestinal health parameters, and
4. immune and metabolic parameters.
Study population: 164 older adults (60-79 years) with SCD+.
Study design implementation:
Participants will undergo assessments at baseline (T0), mid-study (T1/2, after 13 weeks) and at study end (T1, after 26 weeks. Each participant will have five study visits in total: two at T0, one at T1/2 and two at T1.
At each of the timepoints the following will be collected/performed at WUR: Sample collection (blood, urine (omitted in week 13), faeces); general cognitive assessments (see NTB; Cognitive Failure Questionnaire (CFQ) (baseline and end only), GDS-15, GAD-7); general physiological measures (blood pressure, BMI, grip-strength); dietary assessment (MIND-adjusted Eetscore, FFQ). At ZGV working memory will be evaluated using BOLD fMRI signalling and task accuracy using an n-back task paradigm. Additionally, high-resolution T1- and T2-weighted anatomical images of main regions of interest (hippocampi, (pre)frontal-, and temporal cortices) will be acquired.
For two periods of one week, corresponding with the baseline and week 26 visits, participants will wear smartwatches. These watches will be worn continuously and data will be gathered regarding cardiovascular functioning (heart rate), physical activity and mood (push messages).
### Conditions Module
**Conditions:**
- Subjective Cognitive Decline
**Keywords:**
- gut-brain axis
- working memory
- gut health
- dietary fibres
- prebiotics
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomised, double-blinded, placebo-controlled intervention study with parallel design and four arms.
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 164
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** Maltodextrin
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Dietary Supplement: Chicory inulin
**Label:** Chicory inulin
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Dietary Supplement: Resistant dextrin
**Label:** Resistant dextrin
**Type:** EXPERIMENTAL
#### Arm Group 4
**Intervention Names:**
- Dietary Supplement: Seaweed polysaccharide
**Label:** Seaweed polysaccharide
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Chicory inulin
**Description:** Chicory inulin (12g/day) divided over two dosages (6g per dose)
**Name:** Chicory inulin
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Resistant dextrin
**Description:** Resistant dextrin (14g/day) divided over two dosages (7g per dose)
**Name:** Resistant dextrin
**Type:** DIETARY_SUPPLEMENT
#### Intervention 3
**Arm Group Labels:**
- Seaweed polysaccharide
**Description:** Seaweed polysaccharide (1g/day) divided over two dosages (0.5g per dose). Additionally contains 7g/day of placebo as a volumetric and isocaloric filler.
**Name:** Seaweed polysaccharide
**Type:** DIETARY_SUPPLEMENT
#### Intervention 4
**Arm Group Labels:**
- Maltodextrin
**Description:** Maltodextrin (7g/day) will be provided in two divided doses (3.5g per dose)
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Other Outcomes
**Description:** Heart rate as determined by wearable Samsung Active 2.0 Smartwatches
**Measure:** Effect on heart rate
**Time Frame:** Measured at baseline and week 26
**Description:** Physical activity (pedometer) as determined by wearable Samsung Active 2.0 Smartwatches
**Measure:** Effect on physical activity
**Time Frame:** Measured at baseline and week 26
**Description:** Measured in kg/m\^2
**Measure:** Effect on BMI
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Systolic and diastolic blood pressure as measured by sphygmomanometer
**Measure:** Effect on blood pressure
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Mood determined by push notifications (sad, stressed, neutral, happy, or angry) as determined by wearable Samsung Active 2.0 Smartwatches
**Measure:** Effect on mood as measured by Samsung Active 2.0 Smartwatches
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Self-reported depressive symptoms by Geriatric Depression Scale-15 (GDS-15) questionnaire
**Measure:** Effect on mood as determined by GDS-15 questionnaire
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Self-reported anxiety symptoms by Generalised Anxiety Disorder-7 (GAD-7) questionnaire
**Measure:** Effect on mood as determined by GAD-7 questionnaire
**Time Frame:** Measured at baseline, week 13 and week 26
#### Primary Outcomes
**Description:** Effects on working memory will be assessed by blood-oxygen level dependant (BOLD) signal activity during 2-back task performed during fMRI scanning
**Measure:** Effect on working memory during n-back task fMRI
**Time Frame:** Measured at baseline and week 26
**Description:** Effects on working memory performance will be assessed by task accuracy during 2-back task performed during fMRI scanning
**Measure:** Effect on working memory performance during n-back task fMRI
**Time Frame:** Measured at baseline and week 26
#### Secondary Outcomes
**Description:** Effect on z-scoring of cognitive domains- episodic memory, executive function and working memory as measured by Cognitive Function Composite test battery
**Measure:** Effect on cognitive functioning as measured by a neuropsychological test battery
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Mean number of correct responses across three trials; Score 0 to 10. Higher score indicates better outcome.
**Measure:** Effect on ADAS-Cog Word Recall cognitive assessment (episodic memory)
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Mean number of correct responses across three trials. Score 0 to 12. Higher score indicates better outcome.
**Measure:** Effect on ADAS-Cog Word Recognition cognitive assessment (episodic memory)
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Amount of symbols correctly substituted. Score 0 - 90. Higher score indicates better outcome
**Measure:** Effect on Digit Symbol Substitution Test cognitive assessment (executive function)
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Longest span of digits correctly recalled. Score 2-8. Higher score indicates better outcome
**Measure:** Effect on Digit Span Backward Task cognitive assessment (working memory)
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Number of uniquely named items from category within 60 seconds. Higher score indicates better outcome
**Measure:** Effect on Category Fluency Test cognitive assessment (executive function)
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** The number of correct responses on orientation. Score 0 to 8. Higher score indicates better outcome
**Measure:** Effect on ADAS-Cog Orientation cognitive assessment (episodic memory)
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Tryptophan related neurotransmitters and metabolites (plasma)
**Measure:** Effect on tryptophan metabolites
**Time Frame:** Measured at baseline and week 26
**Description:** Aβ1-42/Aβ1-40 ratio (plasma)
**Measure:** Effect on amyloid-beta (Aβ) biomarker
**Time Frame:** Measured at baseline and week 26
**Description:** Brain-derived neurotrophic factor (BDNF) levels (serum)
**Measure:** Effect on neuroplasticity
**Time Frame:** Measured at baseline and week 26
**Description:** Structural MRI with T1- and T2-weighted anatomical images of regions of interest (hippocampi, (pre)frontal-and temporal cortices)
**Measure:** Effect on brain regions of interest
**Time Frame:** Measured at baseline and week 26
**Description:** Cortisol levels (serum)
**Measure:** Effect on hypothalamic-pituitary adrenal axis
**Time Frame:** Measured at baseline and week 26
**Description:** Assay-based panel of intestinal barrier integrity markers measured in blood
**Measure:** Effect on intestinal barrier integrity
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Assay-based panel of intestinal inflammatory markers measured in faeces
**Measure:** Effect on intestinal inflammation
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Gut transit time measured by blue muffin consumption and appearance of blue colour in faeces
**Measure:** Effect on gastrointestinal transit time
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Self-rated gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire
**Measure:** Effect on gastrointestinal symptoms
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Effect on stool consistency as measured by Bristol Stool Scale (BSS)
**Measure:** Effect on self-reported stool consistency
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Effect on stool consistency as measured by faecal water content
**Measure:** Effect on stool consistency
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Qualitative faecal microbiota composition as measured by 16s rRNA sequencing
**Measure:** Effect on qualitative faecal microbiota composition
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Quantitative faecal microbiota composition as measured by digital droplet PCR
**Measure:** Effect on quantitative faecal microbiota composition
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Faecal short-chain fatty acids (acetic acid, propionic acid, butyric acid, valeric acid, hexanoic acid, heptanoic acid) and branched-chain fatty acids (isobutyric acid, isovaleric acid, 4-methyl valeric acid) as measured by gas chromatography-flame ionization detection (GC-FID)
**Measure:** Effect on faecal metabolites
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Faecal pH measurement
**Measure:** Effect on faecal pH
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Inflammatory cytokine panel measured in blood
**Measure:** Effect on immune parameters
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Assay-based panel of markers to evaluate glucose homestasis in blood
**Measure:** Effect on glucose homeostasis
**Time Frame:** Measured at baseline, week 13 and week 26
**Description:** Assay-based panel of markers to analyse lipid profile in blood
**Measure:** Effect on lipid profile
**Time Frame:** Measured at baseline, week 13 and week 26
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Written informed consent
2. Fluency in Dutch (speaking, reading, writing)
3. Age between 60-79 years (at screening)
4. Subjective cognitive decline plus (SCD+), (criteria of Jessen et al.):
4.1 Self-reported worsening of memory; 4.2 Indication of repetitive concerns (worries) associated with SCD; 4.3 With at least one of the following two features present: (i) onset of SCD within the last 5 years; (ii) age at onset ≥60 years of age;
5. Presence of at least 2 self-reported risk factors for cognitive decline (based on LIBRA criteria): (i) Diabetes mellitus type II (ii) High cholesterol (iii) Hypertension (iv) High BMI (v) Heart disease (vi) Unhealthy diet (lower regular adherence to Mediterranean diet components such as fish, vegetables, olive oil, pasta and red wine)
Exclusion Criteria:
1. Current participation in other intervention trials
2. Technologically illiterate (complete incompetence in working with computers, apps, online questionnaires, smartwatches etc.)
3. No internet access from home
4. Clinical diagnosis of ≥1 of the following:
* Neurological pathology (e.g. MCI, dementia, multiple sclerosis, Parkinson's disease, epilepsy);
* Current malignant disease(s), with or without treatment;
* Current psychiatric disorder(s) (e.g. major depressive disorder, bipolar disorder, schizophrenia, anxiety, psychosis, PTSD);
* Symptomatic/decompensated cardiovascular disease (e.g. stroke, angina pectoris, heart failure, recent myocardial infarction);
* Severe visual impairment or blindness
* Hearing or communicative impairment.
* Gastrointestinal tract disorder such as irritable bowel syndrome or inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis).
5. Current or recent (\<6 weeks) use of prebiotic, probiotic, or dietary fibre supplement that may modulate the microbiota, or unwilling to stop the use of supplements during the study
6. Current or recent (\<6 weeks) of algae/phytoplankton supplements such as spirulina or chlorella, or unwilling to stop the use of supplements during the study
7. Use of psychotropic medication (anti-depressants, anti-psychotics)
8. Use of antibiotics in the 3 months before starting the study or planned use during the study
9. Being an employee of the Human Nutrition and Health Division of Wageningen University.
10. Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICS-m score \<23)
11. Request to have Apo-E genotype result disclosed
12. Allergies to fish or shellfish
13. Having a contra-indication to MRI scanning including:
* Ferromagnetic implants:
* Active implantable medical devices such as: insulin pump / medicine pump / neurostimulator; pacemaker / defibrillator;
* Other passive implants such as: punctured port-a-cath; synthetic heart valve
* Intra-orbital or intra-ocular metallic fragments
* Claustrophobia
**Maximum Age:** 79 Years
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yannick Vermeiren, PhD
**Phone:** +31618520620
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Kirsten Kruger, MD
**Phone:** +31633713080
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Wageningen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yannick Vermeiren, PhD
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Wageningen University
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** PRECODE study Wageningen University
**URL:** http://www.wur.nl/en/research-results/research-institutes/food-biobased-research/show-fbr/gut-brain-health-effects-of-prebiotics-in-older-adults-with-suspected-cognitive-decline-the-precode-study.htm
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003072
- Term: Cognition Disorders
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M29705
- Name: Cognitive Dysfunction
- Relevance: HIGH
- As Found: Cognitive Decline
- ID: M6301
- Name: Cognition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000060825
- Term: Cognitive Dysfunction
### Intervention Browse Module - Browse Branches
- Abbrev: Ot
- Name: Other Dietary Supplements
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: T401
- Name: Inulin
- Relevance: HIGH
- As Found: Myelogenous
- ID: T105
- Name: Chicory
- Relevance: HIGH
- As Found: Buckwheat
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433024
**Brief Title:** Training of a Artificial Intelligence Model to Detect Venous Diseases Using PPG Technology
**Official Title:** A Pilot Study Using AI Algorithms and PPG Technology for the Detection of Venous Diseases
#### Organization Study ID Info
**ID:** TWC-SD-2024-05
#### Organization
**Class:** OTHER
**Full Name:** The Whiteley Clinic
### Status Module
#### Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The Whiteley Clinic
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This clinical research aims to evaluate the effectiveness of using Photoplethysmography (PPG) signals combined with Artificial Intelligence (AI) algorithms, for the precise classification and diagnosis of Venous Diseases of the lower limb. This study invites a group of participants who currently undergoing investigations for venous disease at The Whiteley Clinic (hereinafter referred to as TWC). The Participants will be classified into control (healthy individuals with no significant venous disease) and chronic venous disease (CVD) (diagnosed with proven venous disease) groups. Prospective participants who express an interest in being included in the study will be given a patient information sheet and will undergo a briefing of the pilot study. If they consent and sign the relevant consent forms, the participants will perform a series of standardized exercises under the supervision of a consultant vascular surgeon. Throughout the exercises, a data acquisition device attached to the ankle records the PPG signals, capturing the changes in blood volume due to the reflected PPG signals from the red blood cells during the movement. Thus, once the data is collected and recorded, this allows for the analysis of the data of the control group and CVD group against each other. During the analysis of the two groups' PPG signals, the objective lies within the capability to detect subtle nuances in the patterns of the PPG signals during the performed movements using AI algorithms. The AI algorithms will distinguish patterns or features indicating the presence or absence of venous disease. This study seeks to contribute valuable insights into enhancing the diagnosis of venous disease using PPG and AI algorithms, paving novel approaches to Venous healthcare.
### Conditions Module
**Conditions:**
- Venous Disease
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants who have been diagnosed with Chronic Venous Disease (CVD).
**Intervention Names:**
- Diagnostic Test: PPG Diagnostic
**Label:** Individuals with CVD (Treatment Group)
#### Arm Group 2
**Description:** Participants who have not been diagnosed with CVD.
**Intervention Names:**
- Diagnostic Test: PPG Diagnostic
**Label:** Individuals Without CVD (Control Group)
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Individuals Without CVD (Control Group)
- Individuals with CVD (Treatment Group)
**Description:** The study investigates venous competence through three distinct exercises using photoplethysmography (PPG) technology to record blood flow in the leg veins of 20 subjects, split into two groups: those with chronic venous disease (CVD) and those without. The null hypothesis is that there will be no significant difference in venous filling times (VFT) and PPG trace variations between subjects with CVD and those without under different physical conditions. The alternative hypothesis suggests that individuals with CVD will show distinct PPG patterns, particularly shorter VFT and varied pressure changes, indicative of venous reflux or obstruction. This hypothesis is chosen based on prior evidence suggesting observable differences in venous function between affected and non-affected individuals.
**Name:** PPG Diagnostic
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The primary outcome measure of this study is to evaluate the diagnostic accuracy of an AI model in detecting venous disease through the using PPG signals. This will be quantified by assessing the sensitivity and specificity of the AI model when analysing PPG signals from healthy participants without venous diease, and non-healthy participants with venous disease, without the need for direct intervention of a vascular consultant. These results will help evaluate the AI model in terms of how accurately it can identify Venous disease.
**Measure:** Diagnostic Accuracy of an AI Model for Venous Disease Detection Using PPG Signals
**Time Frame:** June 2024 - September 2024
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients are attending for investigation of suspected venous disease. Patients must be able to walk and mobile normally and have good skin integrity of the lower leg, where the PPG is attached.
All patients attending TWC are 18 years or older.
Exclusion Criteria:
* Subjects with known arterial occlusive disease or physical disability affecting gait or ankle movement will be excluded.
Patients unable to have a PPG attached to the lower leg (ie: active ulceration) will be excluded.
Patients unable to give consent. Pregnant female.
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** This study invites a group of participants who have attended The Whiteley Clinic (hereinafter referred to as TWC). The Participants are split into control (healthy individuals) and treatment (previously diagnosed with Venous disease) groups.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sergio Da Silva, PhD
**Phone:** 01483477199
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Serah Duro, MSc
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guildford
**Country:** United Kingdom
**Facility:** The Whiteley Clinic
**Zip:** GU2 7RF
#### Overall Officials
**Official 1:**
**Affiliation:** The Whiteley Clinic
**Name:** Mark Whiteley
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06433011
**Brief Title:** The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism
**Official Title:** The RAPID - PE Study: RESCUE Advanced Protocol Without ICU Stay and no Lytic Drip - for the Treatment of Pulmonary Embolism
#### Organization Study ID Info
**ID:** THRO-CLIN-2024-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Thrombolex, Inc.
### Status Module
#### Completion Date
**Date:** 2027-08-25
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-06-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-25
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Thrombolex, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To demonstrate the efficacy and safety of the 8F BASHIR™ .035 Endovascular Catheter and the 8F BASHIR™ S-B .035 Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse sprays of r-tPA into the pulmonary arteries for the treatment of intermediate risk pulmonary embolism (PE).
**Detailed Description:** The BASHIR™ .035 Endovascular Catheter (BEC) and the BEC Short Basket .035 (S-B) are devices intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. The distal infusion segment of the device contains an expandable radial array of conduits with a total of 48 laser drilled orifices used for the delivery of the therapeutic agents at multiple cross-sectional points of the target vessel location. The infusion segment can be expanded and collapsed by the actuator (slider) located on the handle at the proximal end of the device. The infusion line connector is also located on the handle. The difference between the BEC .035 and the BEC S-B.035 is solely in the length of the basket. In its unexpanded state, the basket of the BEC .035 is 12.5cm long and the BEC S-B .035 basket is 10cm long. The choice of device used will be at the physician's discretion based on the patient's anatomy.
### Conditions Module
**Conditions:**
- Pulmonary Embolism
**Keywords:**
- Pulmonary Embolism
- Catheter Directed Therapy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Single Group Assignment Pulse Spray and Infusion of r-tPA
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 500
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
**Intervention Names:**
- Device: The Bashir™ Endovascular Catheter
- Drug: r-tPA
**Label:** BEC Treatment
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- BEC Treatment
**Description:** The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
**Name:** The Bashir™ Endovascular Catheter
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- BEC Treatment
**Description:** Pulse spray and infusion
**Name:** r-tPA
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Observe death from any cause or hemodynamic decompensation (or collapse) through 7-day follow-up, defined as need for cardiopulmonary resuscitation; or
1. SBP \< 90 mmHg for at least 15 minutes; or
2. drop in SBP by at least 40 mmHg for at least 15 minutes with signs of end-organ hypoperfusion (cold extremities or low urinary output \< 30 mL/h or mental confusion); or
3. need for catecholamine administration to maintain adequate organ perfusion and a SBP \> 90 mmHg (including dopamine at the rate of \> 5 micrograms / kg per minute).
**Measure:** Efficacy: Death from any cause or hemodynamic decompensation (or collapse)
**Time Frame:** Procedure through 7-day follow-up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
1. Willing and able to provide informed consent;
2. PE symptom duration ≤ 15 days;
3. Filling defect in at least one major lobar pulmonary artery as determined by CTA;
4. Patient is diagnosed with intermediate risk PE;
5. RV/LV diameter ratio ≥ 0.9 by CTA, as determined by investigative site;
6. Willing and able to comply with all study procedures and 7-day and 30-day telephone follow-up visit.
Exclusion Criteria:
1. Previous history of stroke with residual hemiplegia;
2. Major surgery ≤ 10 days prior to inclusion in the study;
3. Platelet count \< 100,000/μL;
4. Pulmonary thrombectomy within the previous 4 days;
5. Uncontrolled hypertension defined as systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>110 mm Hg at the time of the procedure;
6. Administration of thrombolytic agents within the previous 4 days;
7. Absolute contraindication to anticoagulation;
8. Clinician deems high-risk for catastrophic bleeding;
9. Pregnancy;
10. Any vasopressor or inotropic support;
11. Cardiac arrest (including pulseless electrical activity (PEA) and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
12. Planning to administer r-tPA by infusion after the r-tPA is administered by pulse sprays;
13. Currently participating in another study;
14. In the opinion of the investigator, the subject is not a suitable candidate for the study.
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Chris Schultz, BS
**Phone:** 971-506-7552
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Lynn Begovac, MS
**Phone:** 928-600-3599
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Thrombolex, Inc.
**Name:** Jeff Mifek
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000016769
- Term: Embolism and Thrombosis
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14509
- Name: Pulmonary Embolism
- Relevance: HIGH
- As Found: Pulmonary Embolism
- ID: M7784
- Name: Embolism
- Relevance: HIGH
- As Found: Embolism
- ID: M16686
- Name: Thrombosis
- Relevance: LOW
- As Found: Unknown
- ID: M19128
- Name: Embolism and Thrombosis
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: 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: D000011655
- Term: Pulmonary Embolism
- ID: D000004617
- Term: Embolism
### Intervention Browse Module - Browse Branches
- Abbrev: FiAg
- Name: Fibrinolytic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M13849
- Name: Tissue Plasminogen Activator
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432998
**Brief Title:** Perineal Massage in Women With Gynecological Cancer
**Official Title:** Oncological Perineal Massage in Vaginal Stenosis and Dyspareunia in Women With Gynecological Cancer
#### Organization Study ID Info
**ID:** CHUNSC_2023_104
#### Organization
**Class:** OTHER
**Full Name:** University of Alcala
### Status Module
#### Completion Date
**Date:** 2024-12-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Alcala
#### Responsible Party
**Investigator Affiliation:** University of Alcala
**Investigator Full Name:** Prof. Dr. Daniel Pecos Martín
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The high incidence of gynecological cancers, together with dyspareunia and vaginal stenosis, some of its most frequent sequelae, create the need to continue studying and researching oncological physiotherapy techniques that treat and prevent these sequelae, in order to preserve and/or improve the quality of life of cancer patients. Therefore, through this study, we sought to verify the effectiveness of oncological perineal massage to treat pain during sexual intercourse and vaginal stenosis.
The objective of this study will be to demonstrate the effectiveness of a treatment that will consist of a health education session related to the pelvic floor and the consequences related to cancer along with ten sessions of oncological perineal massage that will be carried out for fifty minutes, once a week.
### Conditions Module
**Conditions:**
- Cancer Pain
- Neck Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 86
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Ten sessions of perineal massage, which will be carried out for fifty minutes, once a week, together with a health education program.
**Intervention Names:**
- Other: Perineal massage
**Label:** Perineal massage
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** A health education session will be held but then the use of vaginal dilators will be done according to the gold standard treatment.
**Intervention Names:**
- Other: Standard treatment
**Label:** Treatment with dilators
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Perineal massage
**Description:** The technique will be applied for approximately twenty minutes and will be carried out as follows: the vaginal dilator is introduced progressively using crescent-shaped movements. Once the dilator is fully inserted, movements will be made from bottom to top and from one side to the other, and then continue with the crescent-shaped movements.
**Name:** Perineal massage
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Treatment with dilators
**Description:** The treatment will consist of the use of vaginal dilators according to the gold standard proposed in the literature. It will consist of introducing the same dilators as for the experimental group, with the same time schedule, but without massage, only introducing the dilator and keeping it in the vagina for 20 minutes.
**Name:** Standard treatment
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Visual Analogical Scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left "0" (worst) to the right "10"(best)
**Measure:** Pain (Visual Analoge Scale)
**Time Frame:** Change from baseline at six months
#### Secondary Outcomes
**Description:** Grade refers to the severity of the Adverse Events. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on a general guideline where grade 1 and grade 5 are the best and worst result respectively.
**Measure:** Criteria for Adverse Events (CTCAE)
**Time Frame:** Change from baseline at six months
**Description:** The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients. The scores obtained can have values between 0 and 100, which determines the level of impact of the cancer on the patient of each of the scales. High values on the global health and function status scales indicate a better quality of life, while on the symptoms scale it would indicate a decrease in quality of life since it indicates the presence of symptoms associated with cancer.
**Measure:** Quality of life (EORCT QLQ-C30)
**Time Frame:** Change from baseline at six months
**Description:** Female sexual function index (FSFI) is a survey measuring the sexual functioning of women in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain.The items are then scaled to achieve a maximum score of 36.
**Measure:** Female sexual function index
**Time Frame:** Change from baseline at six months
**Description:** Likert scales are a structured way for researchers to gather diverse opinions and attitudes. They allow respondents to express agreement, disagreement, or neutrality concerning statements or questions. The scale values range from 1 to 5, with 1 being the worst result and 5 being the best result.
**Measure:** Likert questionnaire by sexual dysfunction
**Time Frame:** Change from baseline at six months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Women between 18 and 52 years old
* Oncology patients with a diagnosis of dyspareunia and vaginal stenosis related to treatments.
* Patients with QT/RT/BT treatment who have a diagnosis of dyspareunia and vaginal stenosis.
* Patients on hormonal suppressive treatment with a diagnosis of dyspareunia and vaginal stenosis.
Exclusion Criteria:
* Patients who do not accept intracavitary treatment.
* Patients with abdominopelvic surgical treatment prior to oncological process.
* Patients with a diagnosis of dyspareunia prior to cancer.
* Patients with vaginal narrowing prior to cancer.
* Patients with menopause at the time of cancer diagnosis
**Gender Based:** True
**Gender Description:** Women diagnosed with vaginal stenosis and dyspareunia due to cancer
**Maximum Age:** 52 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Raquel Perez-Garcia
**Phone:** +34 922276912
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Santa cruz de Tenerife.
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Raquel Perez-Garcia
- **Phone:** +34 922276912
- **Role:** CONTACT
**Country:** Spain
**Facility:** Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife.
**State:** Tenerife
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife.
**Name:** Raquel Perez-García
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M6475
- Name: Constriction, Pathologic
- Relevance: LOW
- As Found: Unknown
- ID: M1091
- Name: Cancer Pain
- Relevance: HIGH
- As Found: Cancer Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M7588
- Name: Dyspareunia
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000072716
- Term: Cancer Pain
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432985
**Acronym:** CM_TUD_Cancer
**Brief Title:** Smoking Cessation CM for Veterans With or at Risk for Cancer
**Official Title:** Contingency Management for Veteran Smokers With or at Risk for Cancer
#### Organization Study ID Info
**ID:** NURA-006-23F
#### Organization
**Class:** FED
**Full Name:** VA Office of Research and Development
#### Secondary ID Infos
**Domain:** University Of California, San Francisco
**ID:** 24-40951
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2030-03-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2030-03-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of California, San Francisco
#### Lead Sponsor
**Class:** FED
**Name:** VA Office of Research and Development
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Tobacco use among US Veterans poses significant health problems and challenges to their overall well-being. The aim of this project is to evaluate the effectiveness of a program called Contingency Management (CM) in helping Veterans quit smoking during lung cancer screening or cancer care at VA clinics. CM is a behavioral treatment that uses rewards to encourage smoking cessation when verified through biological testing. In the first year, the researchers will develop a mobile CM protocol based on feedback from Veterans and healthcare staff through focus groups. In the second year, they will conduct a pilot study to test the feasibility of the mobile CM program along with counseling and medication for 20 Veterans over a five-week period. The success of the pilot study will determine whether to proceed with a larger randomized controlled trial (RCT) in years three to six, comparing the efficacy of mobile CM with standard treatment. The project will take place at SFVA.
**Detailed Description:** Smoking at the time of lung cancer screening (LCS) or cancer diagnosis is associated with treatment failure, shortened lifespan, and diminished quality of life. Beyond the increased morbidity and mortality, smoking after a cancer diagnosis is associated with an estimated $3.4 billion in healthcare costs. Despite these risks, the VA does not routinely integrate smoking cessation treatment into LCS screening or cancer care, and quit rates are low.
Contingency Management (C) is a behavioral therapy approach that reinforces desired behaviors, such as smoking cessation, through the provision of tangible rewards or incentives. The goal of this Proof of Concept and Clinical Trial project is to evaluate the acceptability, feasibility, and efficacy of Contingency Management (CM) for smoking cessation among Veterans in lung cancer screening (LCS) or cancer care in Veterans Affairs (VA) clinics.
Research indicates that CM must be tailored to the clinical population and context. This staged investigation will occur in three phases. First, the investigators will conduct Focus Groups, to iteratively develop an acceptable mobile CM protocol using qualitative feedback from Veterans in VA patients in LCS or in cancer care and LCS and oncology staff. Afterward, the investigators will conduct a Pilot Study to examine the feasibility of mobile smoking cessation CM with for VA patients in LCS or in cancer care. In a single arm study, Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks. If successful, the investigators will conduct a Randomized Controlled Trial (RCT) to assess efficacy of mobile CM compared with treatment as usual (TAU). Veterans diagnosed with cancer or in LCS will be randomized to receive a 5-week CM condition (CM plus behavioral counseling) or TAU (referral to VA Tobacco Cessation Clinic and VA quitline). Both groups will receive pharmacotherapy.
The primary aims of this study are to develop an acceptable mobile CM protocol through qualitative feedback from Veterans and VA staff, to examine the feasibility of mobile smoking cessation CM among Veterans in LCS or cancer care through a pilot study, and to assess the efficacy of mobile CM compared to treatment as usual through a randomized controlled trial among Veterans diagnosed with cancer or in LCS.
### Conditions Module
**Conditions:**
- Tobacco Use Disorder
- Substance Use Disorder
**Keywords:**
- Tobacco
- Contingency Management
- Lung Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Parallel Assignment
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Double-blind Masking
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 95
**Type:** ESTIMATED
**Phases:**
- PHASE2
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The investigators will iteratively develop an acceptable mobile CM protocol using qualitative feedback from Veterans in VA patients in LCS or in cancer care and LCS and oncology staff.
**Intervention Names:**
- Behavioral: Focus Group
**Label:** Focus Group
**Type:** OTHER
#### Arm Group 2
**Description:** Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks.
**Intervention Names:**
- Behavioral: Contingency Management
- Behavioral: Behavioral Counseling (Cognitive Behavioral Therapy, CBT)
**Label:** Contingency Management
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Participants assigned to TAU will receive time-matched Medication Management plus usual care (referral to VA Tobacco Cessation Clinic and provision of the VA Telequit quitline).
**Intervention Names:**
- Behavioral: Behavioral Counseling (Cognitive Behavioral Therapy, CBT)
- Behavioral: TUD Treatment as Usual (TAU)
**Label:** TUD Treatment as Usual
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Focus Group
**Description:** In 60-minute focus groups, participants will be categorized based on their survey responses and engaged in semi-structured discussions using open-ended questions and probes to gather detailed information. The moderators will follow best practices in qualitative research, introducing the topic of smoking cessation in the context of cancer screening and treatment and guiding the discussions from broader issues to participant-generated examples.
**Name:** Focus Group
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Contingency Management
**Description:** Participants will provide baseline data on their recent substance use and smoking habits and severity. They will receive a CO monitor and iCO app and will upload videos verifying smoking abstinence a minimum of once per day, 5 times per week. Financial incentives will be provided at weekly visits contingent on tobacco abstinence verified through Remote (mobile) CO monitoring. They will receive clinician feedback at the time of each CO reading, following established VA protocols for CM.
**Name:** Contingency Management
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- Contingency Management
- TUD Treatment as Usual
**Description:** Participants will receive a 5-session smoking cessation behavioral counseling for approximately 15-20 minutes weekly. Sessions may be held by secure video conference or by telephone, per participant preference. Sessions will use CBT principles with MI incorporated for resolving reluctance to quit.
**Name:** Behavioral Counseling (Cognitive Behavioral Therapy, CBT)
**Type:** BEHAVIORAL
#### Intervention 4
**Arm Group Labels:**
- TUD Treatment as Usual
**Description:** Participants assigned to TAU will receive referral to VA Tobacco Cessation Clinic and provision of the VA Telequit quitline. The VA Tobacco Cessation Clinic is modeled after VA Tobacco Cessation Clinics across all VA facilities and involves delivery of brief counseling and pharmacotherapy for TUD if desired. VA Telequit is a national toll-free number available to Veterans that allows them to speak with a smoking cessation counselor for a recommended minimum of five sessions to develop a quit plan and receive counseling, strategies to prevent relapse, and weekly proactive follow-up calls based on National Cancer Institute guidelines.
**Name:** TUD Treatment as Usual (TAU)
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Audio recordings will be analyzed by the research team using a template-based rapid analysis technique developed for health services research. A structured summary will be prepared, organized by topical areas drawn from the interview/focus group guide, to identify and describe themes within each topical domain.
**Measure:** Focus Groups
**Time Frame:** Baseline
**Description:** Assesses age at first use, duration of use, use of all forms of nicotine and tobacco, prior quit attempts (defined as a period of intentionally not smoking for 24 hours), duration of cessation (if any), and presence of other tobacco users in the home. It will be used in the analytic process to correlate findings/themes with characteristics.
**Measure:** Veteran Nicotine and Tobacco Use Questionnaire
**Time Frame:** Phase 1, Baseline
**Description:** It is a validated 46 item instrument that evaluates smoking-related knowledge, beliefs, self-efficacy, cessation treatment practices, and barriers to cessation treatment delivery among healthcare providers. The scores are from the summed items. Higher scores equal more tobacco treatment and the range of scores is 0-26.
**Measure:** Smoking Knowledge, Attitudes and Practices Scale (S-KAP)
**Time Frame:** Phase 1, Baseline
**Description:** Assesses age, gender identity, sexual orientation, ethnicity, race, relationship status, income, education level, military history, service-connected disability status, housing status, and employment status. It will be analyzed through bivariate associations with outcomes (attendance, rate of video uploads).
**Measure:** Participant Demographic Questionnaire
**Time Frame:** Phase 2, week 0
**Description:** Study engagement will be assessed by tracking the number of participants attend each intervention session over the course of the 5-week intervention period. It will be analyzed through bivariate associations with participant demographics. Differences over time in measurements will be examined using generalized mixed models.
**Measure:** Session Attendance
**Time Frame:** Up to 5 Weeks
**Description:** Study engagement will be assessed by the proportion of videos uploaded. Videos will be uploaded from Monday to Friday. It will be analyzed through bivariate associations with participant demographics. Differences over time in measurements will be examined using generalized mixed models.
**Measure:** Remote (mobile) CO monitoring
**Time Frame:** Phase 2, Weeks 2-5
**Description:** Study feasibility will be assessed by recruitment yield, i.e., tracking the number of participants who initiated treatment.
**Measure:** Recruitment yield number of participants enrolled
**Time Frame:** Phase 2, Up to 5 Weeks
**Description:** Study retention as assessed by the number of participants that completed the study.
**Measure:** Study Retention
**Time Frame:** Phase 2, 5 weeks
**Description:** Assesses age, gender identity, sexual orientation, ethnicity, race, relationship status, income, education level, military history, service-connected disability status, housing status, and employment status. It will be analyzed through bivariate associations with outcome variables and primary independent variables.
**Measure:** Participant Demographic Questionnaire
**Time Frame:** Phase 3, week 0
**Description:** Self-reported use of medication for tobacco use disorder will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use.
**Measure:** Timeline Follow-Back (TLFB): TUD medication
**Time Frame:** Phase 3, Weeks 0, 5, 12, 24
**Description:** The Contemplation Ladder is a visual analog comprised of 11 rungs and 5 anchor statements, representing stages of change. The response options (0) to (3) corresponded with the stage of precontemplation, (4) to (6) represented the stage of contemplation, (7) and (8) referred to the stage of preparation, (9) and (10) represented the stage of action and stage of maintenance respectively. It is a brief measure of motivation or readiness to change, where (0) is the least motivated and (10) is the most motivated. This measure has been validated for cigarette and other substance use.
**Measure:** Change in Score on the Contemplation Ladder
**Time Frame:** Phase 3, Weeks 0, 5, 12, 24
**Description:** Assesses age at first use, duration of use, use of all forms of nicotine and tobacco, prior quit attempts (defined as a period of intentionally not smoking for 24 hours), duration of cessation, and presence of other tobacco users in the home and will be completed in Week 0. At Follow Ups (Weeks 5, 12 and 24), the survey will inquire about frequency and duration of quit attempts
**Measure:** Changes in Nicotine and Tobacco Use Survey
**Time Frame:** Phase 3, Weeks 0, 5, 12, 24
**Description:** The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. In scoring the Fagerström Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.
**Measure:** Change in Scores on the Fagerström Test for Nicotine Dependence (FTND)
**Time Frame:** Phase 3, Weeks 0, 5, 12, 24
**Description:** The QSU-Brief consists of 10 statements about the respondent's feelings and thoughts about his or her desire to smoke cigarettes as he or she is completing the questionnaire (i.e., right now). Each response is scored a number ranging from 1 (strongly disagree) to 7 (strongly agree) and scores are calculated by summing the item scores. The higher the total QSU score, the more intense are the participant's smoking urges.
**Measure:** Change in Scores on the Questionnaire on Smoking Urges (QSU-Brief)
**Time Frame:** Phase 3, Weeks 0, 5, 12, 24
**Description:** Weekly self-reported use of cigarettes will be assessed with TLFB which uses a calendar with specific anchor dates to identify the quantity and frequency of use.
**Measure:** Change in Timeline Followback (TLFB): Tobacco
**Time Frame:** Phase 3, Weeks 2-5
**Description:** Self-reported use of tobacco will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use.
**Measure:** Change in Timeline Followback (TLFB): Tobacco
**Time Frame:** Phase 3, Weeks 12, 24
**Description:** An iCO CO monitor will be used for the bio-verification of cigarette abstinence. Exhaled CO will be obtained using a study-issued iPad equipped with the iCO CO monitor and compatible app and the results will be shared through videos uploaded using VA-provided apps. Participants that report not smoking in the past 7 days and have CO levels \<6 parts per million (ppm) will be considered abstinent. For individuals with CO levels\> 6 ppm that report smoking cannabis who are not receiving NRT, salivary cotinine \<10 nanograms/ milliliter (ng/ml) will be used.
**Measure:** Change in carbon monoxide (CO) levels
**Time Frame:** Phase 3, Weeks 2-5
**Description:** Salivary Cotinine levels are an established method to biochemically verify a participant's smoking status. Participants will follow instructions provided to them in plain language describing procedures to test saliva for the presence or absence of cotinine to confirm abstinence. The cotinine test has several zones (0-6). Any result of with color in Zone 0 will be considered negative for tobacco use.
**Measure:** Mean Salivary Cotinine Levels
**Time Frame:** Phase 3, Weeks 5, 12, 24
#### Secondary Outcomes
**Description:** Self-reported use of other substances will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity of use.
**Measure:** Timeline Follow-Back (TLFB): Other substances
**Time Frame:** Phase 2, Weeks 0, 5
**Description:** Self-reported use of medication for tobacco use disorder will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the frequency of use.
**Measure:** Change in Timeline Follow-Back (TLFB): TUD medication
**Time Frame:** Phase 2, Weeks 0, 5
**Description:** Self-reported use of e-cigarettes will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity of use.
**Measure:** Change in Timeline Follow-Back (TLFB): E-cigarettes
**Time Frame:** Phase 2, Weeks 0, 5
**Description:** Self-reported use of any other tobacco products will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity of use.
**Measure:** Change in Timeline Follow-Back (TLFB): Other tobacco products
**Time Frame:** Phase 2, Weeks 0, 5
**Description:** Seven-day point prevalence cigarette abstinence will be defined as the percentage of participants who have reported no smoking or nicotine use on the 7 consecutive days prior to the assessment with biochemically verified cotinine levels of \< 10 nanograms/ milliliter.
**Measure:** Change in Percentage of Participants with Point Prevalent Abstinence
**Time Frame:** Phase 3, Weeks 5, 12, 24
**Description:** Self-reported use of other substances will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the frequency of use.
**Measure:** Timeline Follow-Back (TLFB): Other substances
**Time Frame:** Phase 2, Weeks 0, 5
**Description:** Self-reported use of medication for tobacco use disorder will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity use.
**Measure:** Change in Timeline Follow-Back (TLFB): TUD medication
**Time Frame:** Phase 2, Weeks 0, 5
**Description:** Self-reported use of e-cigarettes will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the frequency of use.
**Measure:** Change in Timeline Follow-Back (TLFB): E-cigarettes
**Time Frame:** Phase 2, Weeks 0, 5
**Description:** Self-reported use of any other tobacco products will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the frequency of use.
**Measure:** Change in Timeline Follow-Back (TLFB): Other tobacco products
**Time Frame:** Phase 2, Weeks 0, 5
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Human Subjects Involvement and Characteristics: This Proof of Concept and Clinical Trial has three stages. The Proof-of-Concept Phase (Years 1-2) includes a Focus Group phase (Year 1) in which the investigators will recruit both Veterans and non-Veterans (VA clinical staff); and a Pilot Study (Year 2) in which the investigators will recruit Veterans in LCS or cancer treatment at San Francisco VA Healthcare System (SFVAHCS). If the Pilot Study is successful, the investigators will recruit Veterans in LCS or cancer treatment for the RCT (Years 3-6).
* Focus Groups: For Focus Groups (Year 1), the investigators will recruit both Veterans and VA clinical staff at SFVAHCS.
Veterans:
* Age 18 years or older
* Veteran eligible for VA healthcare
* English-speaking
* Received SFVAHCS cancer monitoring or treatment or LCS within the past 24 months
* Active cigarette smoking within the past 24 months
* Have access to Wi-Fi and a device that supports audio and video communication
VA Clinical Staff:
* Current member of clinical staff at the SFVAHCS
* Have participated in the care of at least 5 VA cancer or LCS patients in the past 6 months
Pilot Feasibility Study (Year 2) and Randomized Controlled Trial
Inclusion criteria:
* Age 18 years or older
* Veteran currently receiving medical care at SFVAHCS (at least one clinical visit same calendar year for cancer)
* English-speaking
* Current, active (same calendar year) enrollment in VA LCS, or current (same calendar year) diagnosis of cancer documented in the VA medical record, confirmed through medical record review
* Current (past 30 days) cigarette smoking a minimum of 1 cigarette per day (average), assessed by Timeline Followback (TLFB)92, 99-101
* Open to receiving smoking cessation interventions
Exclusion Criteria:
Focus Groups: For Focus Groups (Year 1), the investigators will recruit both Veterans and VA clinical staff at SFVAHCS.
Veterans:
Exclusion criteria: Assessed by Co-PIs' medical record review:
* Current severe, untreated mental illness (i.e., psychosis, bipolar disorder, and/or substance use disorder (SUD)) and/or
* Current (past 30 days) active suicidal/homicidal ideation or severe behavioral instability that would prevent participation
* Never smokers or quit smoking for longer than 36 months prior to consent (4) no access to Wi-Fi or devices that support audio and video communication
VA Clinical Staff:
Exclusion Criteria:
* Unable to commit 1.5 hours (60 min focus group and self-report questionnaires)
Pilot Feasibility Study (Year 2) and Randomized Controlled Trial
Exclusion Criteria:
* An individual who meets any of the following criteria will be excluded from participation in this study:
* Evaluated by investigative team medical record review and clinical assessment:
* Psychotic disorders, bipolar disorder, neurocognitive disorder, substance use disorders, or other psychiatric or medical conditions judged by the PI to be unstable in the past 30 days, based on M.I.N.I. Neuropsychiatric Inventory (M.I.N.I.) and/or medical record review, including conditions for which large sums of money would be potentially destabilizing
* Untreated, current, active problem gambling, assessed by medical record diagnosis and/ or Problem Gambling Severity Index (PGSI) score 8
* Metastatic cancer or enrollment in end of life/ palliative care
* Unable to commit to time commitment required for participation
* Currently pregnant or planning to become pregnant during the study (people of childbearing potential ages 18-55 who are pregnant or state that they plan to become pregnant during the study)
* A suicide attempt or suicidal ideation with intent in the 30 days prior to enrollment
* Concurrent enrollment in a tobacco cessation clinical trial
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ellen Herbst, MD
**Phone:** (415) 221-4810
**Phone Ext:** 24926
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Madeline Martinez Rivas, PhD
**Phone:** (415) 221-4810
**Phone Ext:** 24926
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** San Francisco
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ellen Herbst, MD
- **Phone:** 415-221-4810
- **Phone Ext:** 24926
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Madeline Martinez Rivas, PhD
- **Phone:** (415) 221-4810
- **Phone Ext:** 24926
- **Role:** CONTACT
***Contact 3:***
- **Name:** Ellen Herbst, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** San Francisco VA Medical Center, San Francisco, CA
**State:** California
**Zip:** 94121-1563
#### Overall Officials
**Official 1:**
**Affiliation:** San Francisco VA Medical Center, San Francisco, CA
**Name:** Ellen Herbst, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** Provides Link to CM_TUD_Cancer Study
**URL:** https://addictionresearch.ucsf.edu/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M11172
- Name: Lung Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16785
- Name: Tobacco Use Disorder
- Relevance: HIGH
- As Found: Tobacco Use Disorder
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: HIGH
- As Found: Substance Use Disorders
- ID: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000014029
- Term: Tobacco Use Disorder
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432972
**Acronym:** PREHAB
**Brief Title:** Accelerated Pulmonary Rehabilitation in the Preoperative Period
**Official Title:** Accelerated Pulmonary Rehabilitation in the Preoperative Period
#### Organization Study ID Info
**ID:** STUDY00002705
#### Organization
**Class:** OTHER
**Full Name:** University of Vermont
#### Secondary ID Infos
**Domain:** American Lung Association
**ID:** 1143233
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-02
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Vermont
#### Responsible Party
**Investigator Affiliation:** University of Vermont
**Investigator Full Name:** Katherine Menson
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This proposed project will be a single arm, non-masked study. Participants who are actively smoking with a diagnosis of COPD and new lung nodule, either confirmed or suspicious for lung cancer, with a plan for surgical resection will be recruited from the University of Vermont Medical Center (UVMMC) Lung Multidisciplinary Clinic (LMDC). All patients will be enrolled in prehab and offered smoking cessation therapy. The acceptability and feasibility of this intervention will be measured by percent enrollment in study, attendance, barriers to completion, and monitoring of adverse events. The effect of prehab will be measured by traditional metrics, including fitness, respiratory symptoms, and depression scale. Research outcomes will be measured by smoking habits, anxiety, and surgical complications.
Investigators estimate that 20 participants over a two-year period will be sufficient to measure the safety and feasibility of this study. Investigators aim to enroll, on average, 2 participants per month in order to complete this study in a timely fashion. Participants will be enrolled in prehab on a rolling basis, as to not delay surgical timeline.
**Detailed Description:** The benefits of pulmonary rehab (PR) prior to lung resection have not been well-studied in the population that could benefit from it the most, patients with COPD who smoke. This study would be innovative in two major ways. First, the impact of prehab in those who smoke could be established. Secondly, the optimal model of prehab, which meets the clinical needs of the patient in the pre-surgical window, and aligns with the current model of PR, could be determined.
Screening and Recruitment Investigators estimate that 20 participants over a two-year period will be sufficient to measure the safety and feasibility of this study. Investigators aim to enroll, on average, 2 participants per month in order to complete this study in a timely fashion. Participants will be enrolled in prehab on a rolling basis, as to not delay surgical timeline.
Some procedures will be performed as a component of standard of care and some will be for research purposes only. This distinction is outlined in the sections below.
Intake and Baseline Assessment After informed consent, participants will complete the initial assessment with study coordinator. This will include anthropometrics, demographics like age, sex, race and ethnicity, and other sociodemographic and economic characteristics such as education, marital status, income, etc. This assessment will also include thorough medical, surgical and COPD history review, healthcare resource utilization, medication usage, substance use and smoking history, specifically recall of average cigarettes per day, carbon monoxide measurements, Fagerström nicotine dependence scale, and readiness to change. Investigators will also administer the General Anxiety Disorder-7 (GAD-7) questionnaire to assess for anxiety. Following intake, participants will be enrolled in the prehab program, which will include standard of care intake measurements including 6-minute walk distance (6MWD), mMRC, SGRQ, short physical performance battery (SPPB), and PHQ-9. For ease of the patient, Investigators will offer that this be performed on the same day, in a private medical setting at the PR facility. If the patient chooses, Investigators can offer intake at the Vermont Lung Center on a separate day.
Prehab Prehab will include 2, one-hour sequential sessions of PR per day as is standard, however this intervention will increase the frequency from 2 days to 4 days per week, for 2 weeks, thus completing 16 sessions of PR prior to surgery. An exercise prescription will be written by the medical director based on initial 6MWD, age, height, weight, and co-morbidities, as is standard of care. Prior to each session, patients are evaluated for symptoms and vital signs are measured. Exercise will include 30 minutes of warm-up and upper and lower extremity resistance training, either against gravity or with resistance bands as appropriate. Exercise will then move to the open gym, where patients utilize endurance equipment of their choosing, such as a treadmill or recumbent bicycle. As with traditional PR, participants will be given online education videos regarding lung health to complete at home, with a supplementary video on breathing techniques to reduce atelectasis from pain.
Smoking Cessation Intervention Regarding smoking cessation, patients will be offered and prescribed the gold standard therapies in an attempt at smoking cessation, including a one-hour individual counseling session with a mental health therapist trained in smoking cessation therapy, varenicline treatment, dual acting NRT, and referral to the state smoking cessation program. Education modules on the benefits of smoking cessation will also be created for participants to review in the education portion of prehab. None of these interventions will be required, but offered as is standard of care.
Assessments Post-Prehab and 30 Days Post- Lung Resection Surgery Following completion of prehab prior to lung resection surgery Pulmonary Rehabilitation standard of care assessments and research-based assessments will be repeated. This will include interim health history, healthcare resource utilization, and medication usage, assessment for adverse events and COPD exacerbations, substance use and smoking status including recall of average cigarettes per day, carbon monoxide measurements, Fagerström nicotine dependence scale, readiness to change, GAD-7 and the study evaluation. 30 days following lung resection surgery, the study team will review the participants medical record for any adverse events.
### Conditions Module
**Conditions:**
- Chronic Obstructive Pulmonary Disease
- Lung Cancer Stage I
- Lung Cancer Stage II
- Lung Cancer Stage III
**Keywords:**
- Pulmonary Rehab
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: Pulmonary Rehab
**Label:** Prehab
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Prehab
**Description:** Prehab will include 2, one-hour sequential sessions of PR per day as is standard, however this intervention will increase the frequency from 2 days to 4 days per week, for 2 weeks, thus completing 16 sessions of PR prior to surgery. An exercise prescription will be written by the medical director based on initial 6MWD, age, height, weight, and co-morbidities, as is standard of care. Prior to each session, patients are evaluated for symptoms and vital signs are measured. Exercise will include 30 minutes of warm-up and upper and lower extremity resistance training, either against gravity or with resistance bands as appropriate. Exercise will then move to the open gym, where patients utilize endurance equipment of their choosing, such as a treadmill or recumbent bicycle. As with traditional PR, participants will be given online education videos regarding lung health to complete at home, with a supplementary video on breathing techniques to reduce atelectasis from pain.
**Name:** Pulmonary Rehab
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Acceptability and feasibility will be documented by percent of those eligible enrolling in the study.
**Measure:** Proportion of patients determined eligible who enroll in the study
**Time Frame:** Through study completion, approximately 2 years
**Description:** Acceptability and feasibility will be determined by the proportion of pulmonary rehab sessions completed during this condensed pulmonary rehab program
**Measure:** Average Pulmonary Rehab sessions completed
**Time Frame:** The 14 day (up to 21 day) intervention period
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 18 years or older
* Physician diagnosis of COPD
* Lung nodule that is deemed highly suspicious for lung cancer based on: nodule characteristics, risk factors, CT-PET avidity, previous biopsy results, and assessment by LMDC physicians specializing in lung cancers
* Eligible for surgical resection
* Stage I, II, IIIa lung cancer with plan for lobectomy, pneumonectomy, or wedge resection
* Current cigarette smoking ≥5 cigarettes per day
* Willing to attempt smoking cessation during prehab period
* Willing to take nicotine replacement therapy (NRT) and varenicline
* Able to attend PR at UVMMC for 2, one-hour sequential sessions for a total of 16 sessions over 8 days in a 2-week time frame
* Willing and able to provide informed consent; ability determined by study physician and/or LMDC treatment physicians
Exclusion Criteria:
* Unable to safely participate in PR due to unstable cardiac disease, unstable peripheral vascular disease, musculoskeletal disease that would prevent exercise, significant psychiatric or neurocognitive disease that would limit ability to exercise safely in a group setting as determined by the study physician and/or LMDC treatment physicians
* Ineligible for surgical resection (including suspicion for metastatic disease) as determined by the study physician and/or LMDC treatment physicians
* Inability to consistently attend PR over a 2-week period
* Pregnancy, per patient self-report
* Active or recent participation in another clinical trial that, in the opinion of the investigator would impact outcomes measured in this study
* Any other condition in the opinion of the investigator/study physician and or LMDC treatment physicians that would jeopardize patient safety or integrity of research results
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Olivia J Garrow, MS, RDN
**Phone:** 802-847-2160
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sophie Macner
**Phone:** 802-847-2193
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Burlington
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Olivia J Garrow, MS, RDN
- **Phone:** 802-847-2160
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Sophie Macner, BS
- **Phone:** 802-847-2193
- **Role:** CONTACT
***Contact 3:***
- **Name:** Katherine Menson, DO
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Anne Dixon, MD
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Abraham Sender, PA-C
- **Role:** SUB_INVESTIGATOR
***Contact 6:***
- **Name:** Hannah Kooperkamp, MD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** University of Vermont Medical Center
**State:** Vermont
**Status:** RECRUITING
**Zip:** 05401
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-05-14
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 601853
- Type Abbrev: Prot_SAP
- Upload Date: 2024-05-24T14:57
- Date: 2024-05-14
- Filename: ICF_001.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 374554
- Type Abbrev: ICF
- Upload Date: 2024-05-24T14:57
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11172
- Name: Lung Neoplasms
- Relevance: HIGH
- As Found: Lung Cancer
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11170
- Name: Lung Diseases, Obstructive
- Relevance: HIGH
- As Found: Obstructive Pulmonary Disease
- ID: M23449
- Name: Pulmonary Disease, Chronic Obstructive
- Relevance: HIGH
- As Found: Chronic Obstructive Pulmonary Disease
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008175
- Term: Lung Neoplasms
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000029424
- Term: Pulmonary Disease, Chronic Obstructive
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432959
**Acronym:** PAPA
**Brief Title:** Incorporating Positive Affect Promoting Activities Into Cognitive Behavioral Therapies
**Official Title:** Incorporating Positive Affect Into Cognitive Behavioral Therapy for Depression and Dialectical Behavior Therapy for Borderline Personality Disorder and Severe Emotion Dysregulation
#### Organization Study ID Info
**ID:** 2022B0257
#### Organization
**Class:** OTHER
**Full Name:** Ohio State University
### Status Module
#### Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2023-03-22
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ohio State University
#### Responsible Party
**Investigator Affiliation:** Ohio State University
**Investigator Full Name:** Jennifer Cheavens
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In this study, the investigators will test whether the incorporation of positive affect promoting activities in treatment sessions improves outcomes in the context of CBT for depression and DBT for problems of emotion dysregulation. In clinics focused on each of these treatments, the investigators will evaluate these treatments with and without the addition of positive affect promoting activities.
**Detailed Description:** The investigators will randomize participants to treatment with or without positive affect promoting activities in two samples of adults with emotional disorders participating in a form of cognitive behavioral therapy. One sample will be drawn from a clinic providing CBT for depression and the other will be drawn from a clinic providing dialectical behavior therapy.
This study is a two-clinic randomized clinical trial. Eligible participants will be randomized to standard treatment or standard treatment + positive affect promoting activities. A total of 50 participants (25 per condition) will be randomized in a clinic providing CBT for depression. A total of 40 (20 per condition) will be randomized in a clinic providing CBT for problems of emotion dysregulation. Treatment will be provided over 12 weeks in the CBT for depression clinic sample and 24 weeks in the DBT clinic sample. At pre-treatment, 4-weeks, and 12-weeks, participants will complete symptoms measures in addition to measures of diagnosis-relevant processes (e.g., rumination), personality, therapy skills, treatment engagement, and treatment history. Additionally, participants and providers will complete measures before and after each therapy session to assess alliance, engagement, symptoms, skills, and mood. Sessions will be recorded to later code psychotherapy process measures.
CBT. Clients will participate in a course of CBT for depression. CBT consists of a series of structured, collaborative sessions with a focus on promoting behavioral activation and helping patients to re-evaluate unduly negative views (e.g., "I am worthless"). Treatment will be informed by the primary treatment manual for CBT of depression. Additional cognitive-behavioral treatment procedures for co-occurring conditions may be used as judged appropriate. Study personnel will provide treatment and all clinical assessments. Clinical supervision will be provided by a licensed psychologist.
The protocol for CBT will be to have twice weekly sessions for the first four weeks. From week 4 to week 8, the therapist and client will collaboratively decide whether to maintain twice weekly sessions or switch to once weekly sessions. From week 8 to week 12, sessions will be weekly. Acute treatment will end after 12 weeks. Clients will have the option of consulting with their therapist or another therapist (which would be likely when a therapist is no longer providing treatment for the study) for up to two booster sessions in the six months following their 12-week acute treatment period.
DBT. Clients will participate in a six-month (24 to 26-week) course of DBT. DBT consists of weekly individual and group psychotherapy sessions that focus on enhancing skills in mindfulness, interpersonal effectiveness, emotion regulation, and distress tolerance. Individual sessions will be approximately one hour per week, with optional additional or longer sessions available if deemed clinically necessary, and group sessions will be scheduled for two hours once per week. At study end, participants who wish to continue treatment will be provided with referrals in the community or in the clinic, if therapists are available.
Study personnel will provide treatment and all clinical assessments. Clinical supervision will be provided by a licensed psychologist. Recent evidence suggests that 6-months of DBT results in similar outcomes when compared to 12-months of DBT. The research group has demonstrated that DBT delivered in a training clinic with this protocol is associated with gains in the domains targeted in the treatment.
Positive Affect Promoting Activities Participants will be randomized to either the Positive Affect Promotion Activities (PAPA) condition or the treatment-as-usual (TAU) condition. Patients in the TAU condition will receive either CBT or DBT as described above. Those assigned to the PAPA condition will also receive either CBT or DBT, as described above, and additionally will be asked to participate in a positive affective promoting activities once per week for the first four weeks of treatment and up to once per session for the remaining sessions. Following the first four weeks, therapists will work with clients to identify occasions to use positive affect induction procedures as part of between session coping strategies and as method to facilitate subsequent use of additional strategies (both in session and between sessions).
The specific activities that constitute the positive affect interventions will be determined by the therapist and participant collaboratively. Given that there are individual differences in the ways that people appraise various stimuli, it is important to be flexible in determining what might be an effective positive affect promoting activity for each participant. Some examples of positive affect promoting activities that might be incorporated into therapy sessions or between therapy sessions include:
* Watch videos of animals (e.g., dogs, pandas, penguins) and babies (e.g., laughing, discovering)
* Eat a piece of candy
* Recall and describe a past positive experience (e.g., talk about success, interest / goal pursuit)
* Describe the positive attributes of the participant
* Engage in gratitude practice
* Do something nice for someone (e.g., write thank you notes for deployed troops, notes of encouragement for children in the hospital, volunteer)
* Listen to music
* Draw or create
* Practice mindfulness, including loving kindness meditations
* Take a walk or dance
* Watch clips of comedians
* Go outside and sit in the sun
* View pictures of loved ones/animals
The in-session positive affect activities will last approximately five minutes. For the first four weeks, the positive affect activities will be completed at the beginning of the session. After that, therapists will look for opportunities to incorporate positive affect activities at "stuck points" or before learning a new skill in-session. Additionally, therapists will work with participants to identify ways in which the participants can incorporate positive affect activities into their lives between sessions. Participants and therapists will work together to identify activities that reliably lead to feeling joy, curiosity, pride, or love, for example. Then, therapists will work with participants to find opportunities to engage in these activities to help motivate themselves to engage in difficult tasks, learn new things, or regulate their emotions.
### Conditions Module
**Conditions:**
- Depression
- Borderline Personality Disorder
- Emotion Regulation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized Controlled Trial
##### Masking Info
**Masking:** NONE
**Masking Description:** Participants will be randomized to treatment as usual (i.e., CBT or DBT) or treatment-as-usual plus positive affect promoting activities (i.e., CBT with PAPA, DBT with PAPA). Randomization will occur within clinic (i.e., one clinic provides CBT, the other provides DBT). In the clinic providing CBT for depression, a total of 50 participants will be randomized (25 each to CBT or CBT with PAPA). In the clinic providing DBT, 40 participants will be randomized (20 each to CBT or CBT with PAPA). Given the treatments under investigation, neither the interventionist nor the participant could be kept unaware of condition.
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in the TAU arm will receive either Cognitive Behavioral Therapy (CBT) or Dialectical Behavior Therapy (DBT), depending on eligibility. CBT will be twice weekly sessions for the first four weeks. From week 4 to week 8, the therapist and client will collaboratively decide whether to have once or twice weekly sessions. From week 8 to week 12, sessions will be weekly. Acute treatment will end after 12 weeks. In DBT, individual sessions will be approximately one hour per week, with optional additional or longer sessions available if deemed clinically necessary, and group sessions will be scheduled for two hours once per week.
**Intervention Names:**
- Behavioral: Psychotherapy
**Label:** Treatment as Usual
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Those assigned to the PAPA condition will also receive either CBT or DBT, as described above, and additionally will be asked to participate in positive affective promoting activities. In session positive affective promoting activities are to be provided once per week for the first four weeks of treatment and up to once per session for the remaining sessions. Clients will also be encouraged to utilize positive affect promoting activities between sessions.
**Intervention Names:**
- Behavioral: Psychotherapy, Positive Affect Promoting Activities
- Behavioral: Psychotherapy
**Label:** TAU + Positive Affect Promoting Activities
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- TAU + Positive Affect Promoting Activities
**Description:** The specific activities that constitute the positive affect interventions will be determined by the therapist and participant collaboratively. Some examples of positive affect promoting activities are:
* Watch videos of animals and babies
* Eat a piece of candy
* Recall and describe a past positive experience
* Describe the positive attributes of the participant
* Engage in gratitude practice
* Do something nice for someone
The in-session positive affect activities will last approximately five minutes. For the first four weeks, the positive affect activities will be completed at the beginning of the session. After that, therapists will look for opportunities to incorporate positive affect activities at "stuck points" or before learning a new skill in-session. Additionally, therapists will work with participants to identify ways in which the participants can incorporate positive affect activities into their lives between sessions.
**Name:** Psychotherapy, Positive Affect Promoting Activities
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- TAU + Positive Affect Promoting Activities
- Treatment as Usual
**Description:** Meet with treatment providers individually or in group to learn skills to address symptoms associated with depression and emotion dysregulation
**Name:** Psychotherapy
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** 24-item self-report assessment of BPD features, will be used as an outcome measure for those in the DBT clinic. Each item is rated as "false," "slightly true," "mainly true," or "very true." Higher scores suggest more severe BPD features.
**Measure:** Change in Personality Assessment Inventory - Borderline Personality Disorder Subscale
**Time Frame:** 12 weeks
**Description:** 100 item self-report measure of personality traits, including specifically for this study antagonism, neuroticism, and disinhibition. Each item is rated on a scale from 0 - 3 with higher scores reflecting more of a given trait.
**Measure:** Change in Personality Inventory for DSM-5 - Faceted Brief Form
**Time Frame:** 12 weeks
#### Primary Outcomes
**Description:** 16 item self-report assessment of symptoms of depression with each item scored on a 0-3 scale. Higher scores indicate more severe symptoms of depression.
**Measure:** Weekly Change in Quick Inventory of Depressive Symptoms, Self-Report
**Time Frame:** weekly over 12 weeks
**Description:** 20 item self-rated assessment of positive and negative affect in the moment with each item scored on a 1-9 scale. Higher scores reflect higher levels of affect.
**Measure:** Weekly Change in Positive and Negative Affect Schedule
**Time Frame:** weekly over 12 weeks
#### Secondary Outcomes
**Description:** Measure developed for this study to assess use, understanding, and confidence in using therapy skills. There are seven items, each rated on a scale of 1-7. Higher scores indicate that the participant more fully understood the skills taught in session and is confident they will be able to use the skills outside of session.
**Measure:** Weekly Change in Impressions of Skills Scale
**Time Frame:** weekly over 12 weeks
**Description:** 6 item questionnaire used to assess expectations of treatment with four items measuring confidence or expectations for the treatment (scored 1 - 9) and two items assessing anticipated improvement in symptoms (scored 0 - 100%). Higher scores reflect more confidence and expected improvement.
**Measure:** Change in Credibility/Expectancy Questionnaire
**Time Frame:** 4 weeks
**Description:** Completed by both participants and providers to assess quality of the therapeutic relationship. This scale has 12-items and each is scored 0 - 6. Higher scores reflect a better therapeutic relationship.
**Measure:** Weekly Change in Working Alliance Inventory
**Time Frame:** weekly for 12 weeks
### Eligibility Module
**Eligibility Criteria:** Clinic-specific inclusion criteria are as follows. For the clinic providing CBT for depression, participants must meet criteria for a diagnosis of major depressive disorder according to Diagnostic and Statistical Manual-5 (DSM-5). They must also be able to attend in-person sessions or have access to a reliable internet connection to participate in virtual sessions.
For the clinic providing DBT, participants must evidence severe emotion dysregulation defined as (1) meeting criteria for borderline personality disorder (BPD) or (2) elevated indicators of borderline personality pathology defined as average scores of 1.5 on the Personality Inventory for DSM-5 (PID-5) Negative Affectivity scale and 1.25 on the Antagonism scale and/or 1.25 on the Disinhibition scale. They must also be willing and able to attend in-person sessions.
Across both clinics, the following inclusion and exclusion criteria will be applied:
Inclusion Criteria:
1. 18 years old or older
2. residence in the state of Ohio
3. able and willing to give informed consent
Exclusion Criteria:
1. current or past diagnosis of bipolar disorder or a psychotic disorder
2. presence of a psychiatric disorder other than Major Depressive Disorder (MDD) or BPD, if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that being offered (including substance use disorders involving heroin, cocaine, and methamphetamine deemed inappropriate at pre-screening)
3. currently participating in a psychosocial treatment for an emotional disorder, including any individual psychotherapy
4. if on psychiatric medication, no changes to medication regimen (drugs or dosage) in the past month and no intention to modify medication regimen for the next 12 weeks
5. clear indication of secondary gain (e.g., court-ordered treatment)
6. current suicide risk of medical instability (e.g., low weight) to preclude treatment on an outpatient basis
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jennifer S Cheavens, PhD
**Phone:** 614-247-6733
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Daniel R. Strunk, Ph.D.
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Columbus
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Daniel R Strunk, PhD
- **Phone:** 614-688-4891
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Jennifer S Cheavens, PhD
- **Phone:** 614-247-6733
- **Role:** CONTACT
***Contact 3:***
- **Name:** Daniel R Strunk, PhD
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Jennifer S Cheavens, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Department of Psychology, The Ohio State University
**State:** Ohio
**Status:** RECRUITING
**Zip:** 43210
### IPD Sharing Statement Module
**Description:** We will consider requests for data sharing, pending approval from our Institutional Review Board (IRB).
**IPD Sharing:** NO
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-03-16
- Filename: ICF_000.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form: ICF for Participants in the DBT Clinic
- Size: 192105
- Type Abbrev: ICF
- Upload Date: 2024-05-24T12:39
- Date: 2022-08-11
- Filename: ICF_001.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form: ICF for Participants in the Depression Clinic
- Size: 210104
- Type Abbrev: ICF
- Upload Date: 2024-05-24T12:42
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M13462
- Name: Personality Disorders
- Relevance: HIGH
- As Found: Personality Disorder
- ID: M5161
- Name: Borderline Personality Disorder
- Relevance: HIGH
- As Found: Borderline Personality Disorder
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003863
- Term: Depression
- ID: D000010554
- Term: Personality Disorders
- ID: D000001883
- Term: Borderline Personality Disorder
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432946
**Brief Title:** Sensing-glove System in Manual Therapy
**Official Title:** Effect of Two Facilitating Interventions on the Acceptability and Usability Towards a Sensing-glove System to Measure Force-time Characteristics of Spinal Manipulative Therapy: a Mixed-methods Cross-over Study
#### Organization Study ID Info
**ID:** UQTR_IP_Acceptabilite_2021
#### Organization
**Class:** OTHER
**Full Name:** Université du Québec à Trois-Rivières
### Status Module
#### Completion Date
**Date:** 2021-08-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-08-31
**Type:** ACTUAL
#### Start Date
**Date:** 2021-06-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Université du Québec à Trois-Rivières
#### Responsible Party
**Investigator Affiliation:** Université du Québec à Trois-Rivières
**Investigator Full Name:** Isabelle Pagé
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The objective of this clinical trial is to assess manual therapists' attitudes towards using a sensing-glove system for measuring spinal manipulation force and to compare the effectiveness of two interventions in enhancing their attitudes. The primary questions it aims to address are:
* Are manual therapists receptive to employing a sensing-glove system to measure the force applied during spinal manipulations on patients?
* Can we enhance manual therapists' attitudes towards this system through either a brief informational video demonstration or a supervised practice session with the system?
Researchers will compare the impact of a 7-minute informational video to that of a 20-minute supervised practice session to determine if manual therapists' attitudes towards the use of a sensing-glove while treating their patients can be positively influenced.
Participants will:
* Engage in a single experimental session.
* Complete a questionnaire at the beginning of the experimental session.
* Undergo one of the two interventions and promptly complete two questionnaires following this intervention.
* Undergo the other intervention and promptly complete the same two questionnaires following this intervention.
**Detailed Description:** This study aimed to evaluate manual therapists' acceptability of a sensing-glove system for measuring spinal manipulation's force-time characteristics and compare the effectiveness of two interventions in enhancing their acceptability and usability perception. Participants will undergo two acceptability-enhancing interventions in randomized order: a 7-minute informational video and a 20-minute supervised practice session. At the start of the session and after each intervention, the acceptability and perception of usability towards the system will be assessed.
### Conditions Module
**Conditions:**
- Spinal Manipulation
**Keywords:**
- Chiropractic
- Manual therapy
- Acceptability
- Usability
- Force-time characteristics
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Participants will undergo two interventions consecutively, with the order of evaluation randomized.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 16
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will initially view a 7-minute informational video followed by a 20-minute supervised practice session with the sensing-glove system. Acceptability and usability perception will be assessed after each intervention.
**Intervention Names:**
- Other: Video
- Other: Practice session
**Label:** Video followed by practice
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will initially participate in a 20-minute supervised practice session with the sensing-glove system followed by viewing a 7-minute informational video. Acceptability and usability perception will be assessed after each intervention.
**Intervention Names:**
- Other: Video
- Other: Practice session
**Label:** Practice followed by video
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Practice followed by video
- Video followed by practice
**Description:** A 7-minute video demonstrating the sensing-glove system, how it can be used to assess manual therapy biomechanics, and its relevance in research and clinical contexts. The video was created by the research team via a voiceover PowerPoint presentation.
**Name:** Video
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Practice followed by video
- Video followed by practice
**Description:** A 20-minute practice session during which participants received verbal information about the sensing-glove system. While wearing the sensing glove, participants performed palpation and manual therapy techniques (palpation, spinal mobilization/manipulation to the cervical and thoracic spine) on a human-sized manikin, guided by the researcher.
**Name:** Practice session
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** French version of the questionnaire based on the extended version of the Unified Theory of Acceptance and Use of Technology (UTAUT2)
**Measure:** Acceptability
**Time Frame:** Immediately following each intervention and at baseline
**Description:** French version of the System usability scale (F-SUS).
**Measure:** Usability
**Time Frame:** Immediately following each intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being a licensed chiropractor or a last-year intern in a University outpatient chiropractic clinic
Exclusion Criteria:
* Reported any upper limb injury preventing them from executing manual therapies during the time of the study
* Previous experience with the sensing-glove system
**Healthy Volunteers:** True
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Trois-Rivières
**Country:** Canada
**Facility:** Université du Québec à Trois-Rivières
**State:** Quebec
**Zip:** G8Z 4M3
#### Overall Officials
**Official 1:**
**Affiliation:** Université du Québec à Trois-Rivières
**Name:** Isabelle Pagé, DC, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: Rare
- Name: Rare Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432933
**Acronym:** OXYBAR
**Brief Title:** Comparison of Apnea-Hypopnea Index in Patients With or Without Preventive Oxygen Therapy After Bariatric Surgery
**Official Title:** Comparison of Apnea-Hypopnea Index, in Patients With Potentially Undiagnosed Obstructive Sleep Apnea, Treated With or Without Preventive Oxygen Therapy, During the First Night After Bariatric Surgery
#### Organization Study ID Info
**ID:** 2023-2352
#### Organization
**Class:** OTHER
**Full Name:** Rijnstate Hospital
### Status Module
#### Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-09
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-03
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Rijnstate Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The best perioperative strategy for obstructive sleep apnea (OSA) in bariatric surgery remains unclear. A strategy is to monitor patients and administer preventive oxygen therapy during the first postoperative night. However it is unknown what if preventive oxygen therapy is necessary.
The goal of this trial is to compare the Apnea-Hypopnea Index (AHI) in participants with or without preventive oxygen therapy.
Methods:
Participants are patients who underwent bariatric surgery without treated OSA and will be will be randomized into arm A or arm B:
Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention).
**Detailed Description:** Rationale: The prevalence of obstructive sleep apnea (OSA) in the bariatric surgery population is high and mostly undiagnosed. The best perioperative strategy to manage sleep apnea in bariatric patients remains unclear. A recent study found that monitoring patients with pulsoximetry and giving them preventive oxygen therapy during the first postoperative night is safe and cost effective. In a population with patients with OSA but without obesity, no significant difference in apnea hypopnea index (AHI) was found between patients with and without oxygen therapy during the first postoperative night. The question was raised if preventive oxygen therapy during the first postoperative night after bariatric surgery is needed.
Objective: The primary objective of this study is to compare AHI in patients with potentially undiagnosed OSA, treated with or without preventive oxygen therapy, during the first night after bariatric surgery. The secondary objective of this study is to compare sleep architecture in these patients
Study design: This is a randomized controlled non-inferiority trial consisting of two arms; Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention).
Study population: Patients scheduled for primary bariatric surgery without treated OSA Intervention: During the first postoperative night at the hospital patients in intervention arm B will not receive preventive oxygen therapy.
Main study parameters/endpoints: Primary endpoint is AHI and secondary endpoints are 30 days complications rate, nursing intervention rate and parameters for sleep architecture and sleep related breathing, score of the Epworth Sleepiness Scale (ESS) and STOP BANG.
### Conditions Module
**Conditions:**
- Obstructive Sleep Apnea
- Obesity
- Bariatric Surgery Candidate
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 152
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: No preventive oxygen therapy (2L)
**Label:** Without preventive oxygen therapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Other: Preventive oxygen therapy (2L) standard care
**Label:** With preventive oxygentherapy
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Without preventive oxygen therapy
**Description:** Participants will not receive preventive oxygen 2L during the first postoperative night after bariatric surgery.
**Name:** No preventive oxygen therapy (2L)
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- With preventive oxygentherapy
**Description:** Participants will receive preventive oxygen 2L during the first postoperative night after bariatric surgery, standard care.
**Name:** Preventive oxygen therapy (2L) standard care
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** AHI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms, the higher the AHI the more severe the sleep apnea
**Measure:** Apnea-Hypopnea Index (AHI)
**Time Frame:** First postoperative night
#### Secondary Outcomes
**Description:** All complication will be scored and will be compared between both arms
**Measure:** Complication rate
**Time Frame:** Until 30 days after surgery
**Description:** Nursing interventions will be scored on a form and the number of nursing interventions will be compared between both arms
**Measure:** The number of nursing interventions
**Time Frame:** First postoperative night
**Description:** e.g. waking up the patient or starting or increasing oxygen therapy/flow, this will be compared between both arms.
**Measure:** Type of nursing interventions
**Time Frame:** First postoperative night
**Description:** ODI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Oxygen Desaturation Index (ODI)
**Time Frame:** First postoperative night
**Description:** AHI during REM sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** AHI during Rapid Eye Movement (REM) sleep
**Time Frame:** First postoperative night
**Description:** RDI will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Respiratory disturbance index (RDI)
**Time Frame:** First postoperative night
**Description:** Mean saturation will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Mean saturation
**Time Frame:** First postoperative night
**Description:** Mean saturation during desaturations will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Mean saturation during desaturations,
**Time Frame:** First postoperative night
**Description:** Number of desaturations will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Number of desaturations
**Time Frame:** First postoperative night
**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Percentage of saturation <90%
**Time Frame:** First postoperative night
**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Percentage of saturation <88%
**Time Frame:** First postoperative night
**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Percentage of saturation <85%
**Time Frame:** First postoperative night
**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Percentage of saturation <80%
**Time Frame:** First postoperative night
**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Percentage of saturation <70%
**Time Frame:** First postoperative night
**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Time (minutes) of saturation <90%
**Time Frame:** First postoperative night
**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Time (minutes) of saturation <88%
**Time Frame:** First postoperative night
**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Time (minutes) of saturation <85%
**Time Frame:** First postoperative night
**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Time (minutes) of saturation <80%
**Time Frame:** First postoperative night
**Description:** will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Time (minutes) of saturation <70%
**Time Frame:** First postoperative night
**Description:** Total sleep time will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Total sleep time (minutes)
**Time Frame:** First postoperative night
**Description:** Percentage of REM sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Percentage of REM sleep in total sleep time
**Time Frame:** First postoperative night
**Description:** Percentage of Deep sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Percentage of Deep sleep in total sleep time
**Time Frame:** First postoperative night
**Description:** Percentage of light sleep will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Percentage of light sleep in total sleep time
**Time Frame:** First postoperative night
**Description:** Percentage of awake time will be measured by a home sleep study device (Watchpat300) and will be compared between both arms
**Measure:** Percentage of awake time
**Time Frame:** First postoperative night
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Undergo primary bariatric surgery (RYGB or SG)
* Speak and read the Dutch language
Exclusion Criteria:
* Revisional bariatric surgery (e.g. sleeve conversion, RYGB after gastric banding)
* Same-day discharge after bariatric surgery
* Diagnosed OSA with treatment (CPAP, oral appliances)
* Professional drivers
* Use of alpha blockers
* Unable to speak or read the Dutch language
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Claudia Berends, Msc
**Phone:** +31880055970
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Elst
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Claudia Berends
- **Phone:** +31880055970
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Vitalys
**Status:** RECRUITING
**Zip:** 6662 NC
#### Overall Officials
**Official 1:**
**Affiliation:** Rijnstate Hospital
**Name:** Eric Hazebroek, Prof.dr.
**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
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
- ID: D000020919
- Term: Sleep Disorders, Intrinsic
- ID: D000020920
- Term: Dyssomnias
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M15694
- Name: Sleep Apnea Syndromes
- Relevance: HIGH
- As Found: Sleep Apnea
- ID: M22010
- Name: Sleep Apnea, Obstructive
- Relevance: HIGH
- As Found: Obstructive Sleep Apnea
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M4361
- Name: Apnea
- Relevance: HIGH
- As Found: Apnea
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
- ID: M22242
- Name: Parasomnias
- Relevance: LOW
- As Found: Unknown
- ID: M22654
- Name: Sleep Disorders, Intrinsic
- Relevance: LOW
- As Found: Unknown
- ID: M22655
- Name: Dyssomnias
- Relevance: LOW
- As Found: Unknown
- ID: M15696
- Name: Sleep Wake Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001049
- Term: Apnea
- ID: D000012891
- Term: Sleep Apnea Syndromes
- ID: D000020181
- Term: Sleep Apnea, Obstructive
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432920
**Acronym:** ResWave
**Brief Title:** A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD: a First-in-human Exploratory Study
**Official Title:** A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD: a First-in-human Exploratory Study
#### Organization Study ID Info
**ID:** RW-CIP 1.2
#### Organization
**Class:** INDUSTRY
**Full Name:** Elevre Medical Ltd.
### Status Module
#### Completion Date
**Date:** 2024-01-26
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-01-26
**Type:** ACTUAL
#### Start Date
**Date:** 2023-07-06
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Beacon Hospital
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Elevre Medical 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:** The goal of this exploratory clinical trial is to evaluate the initial clinical safety and performance of a prototype wearable chest wall vibration (CWV) device intended to relieve exertional dyspnea in adults with Chronic Obstructive Pulmonary Disease. The main questions it aims to answer are:
* Can CWV be delivered safely to participants via a wearable device?
* Is there evidence of an effect on participant-reported dyspnea, endurance time and other measures of cardiorespiratory function?
Participants will undergo two cycle-ergometer exercise testing sessions while wearing the prototype wearable device. The device will be active in one session (intervention) and inactive in the other (control). The order in which intervention or control occurs will be randomised. Researchers gather data relating to adverse events, device deficiencies, participant-reported symptom severity, endurance time and measures of cardiorespiratory function recorded via standard CPET apparatus.
**Detailed Description:** The purpose of this Clinical Investigation is to evaluate the device design in a small number of human subjects with respect to initial clinical safety, and to gather preliminary data regarding the effect of the device on patient reported dyspnoea and physiological measures of cardiorespiratory function. This will facilitate planning of further steps of device development and validation, guide design modifications and define parameters for a future pivotal clinical investigation.
The investigational device is at Pilot stage of Clinical Development, and the proposed Clinical investigation is a first-in-human exploratory study. It is not a superiority, non-inferiority, or equivalence study.
The primary objective of this Clinical Investigation is to evaluate the investigational device with respect to initial clinical safety when used by subjects with Chronic Obstructive Pulmonary Disease during physical exertion in the form of cycle ergometer-based Cardiopulmonary Exercise Testing.
The secondary objective of this Clinical Investigation is to gather preliminary data regarding the effect of the device on patient-reported dyspnoea and physiological measures of cardiorespiratory function.
Each subject will attend the investigation site for a Pre-Study visit during which formal written consent will be obtained, clinical history and medications will be reviewed as part of standard CPET pre-assessment, and enrolment in the Clinical Investigation will be complete.
An initial Incremental Cardiopulmonary Exercise Testing (CPET) session will then be conducted to determine baseline Peak Work Rate capacity. This is necessary so that the intensity of CPET that will be required to achieve 75% of each subject's individual Peak Work Rate capacity can be determined. Peak Work Rate capacity will be defined as the highest work rate that the Subject is able to maintain for ≥30 seconds.
Following initial CPET, subjects will return for device testing on a non-consecutive day. Each subject will undergo 2 study arms during this visit: the Intervention (ResWave) and Control arms, in the random order. Both arms will be conducted on the same day, with a recovery period of 60 minutes between each arm. Subjects will undergo sub-maximal exercise testing at a Constant Work Rate (CWR) of 75% of their peak work rate capacity in both arms. Borg CR10 scores will be recorded at 2 minute intervals throughout. Endurance time will be recorded at test completion. Adverse Events will be recorded throughout testing and at 72-hour follow-up via phone call. Device Deficiencies will be recorded throughout testing.
### Conditions Module
**Conditions:**
- Chronic Obstructive Pulmonary Disease
- Dyspnea
**Keywords:**
- dyspnea
- COPD
- chronic obstructive pulmonary disease
- cpet
- cardiopulmonary exercise testing
- chest wall vibration
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Participants undergo constant-work rate cardiopulmonary exercise testing 2 times: once while wearing the active prototype device (intervention) and once wearing the inactive prototype device (control). Order of intervention/control is randomised.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In-phase Chest Wall Vibration worn and active during constant work rate exercise testing.
**Intervention Names:**
- Device: ResWave
**Label:** ResWave
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** In-phase Chest Wall Vibration worn and inactive (off) during constant work rate exercise testing.
**Intervention Names:**
- Device: ResWave
**Label:** Control
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control
- ResWave
**Description:** Prototype wearable in-phase chest wall vibration device
**Name:** ResWave
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Adverse Events during or following use of the prototype device and/or exercise testing protocol
**Measure:** Adverse Events
**Time Frame:** 72 hours
**Description:** Performance data of the device during use
**Measure:** Device Deficiencies
**Time Frame:** During active use in exercise testing
#### Secondary Outcomes
**Description:** Borg Category-Ratio scale (Borg CR10). Scale from 0 (lowest intensity, better) to 10 (maximal intensity, worse).
**Measure:** Dyspnea severity
**Time Frame:** Recorded at 2 minute intervals during exercise testing. Outcome measure at isotime.
**Description:** Exercise testing endurance time
**Measure:** Endurance time
**Time Frame:** Duration of exercise testing
**Description:** Whether participant stopped exercise testing due to dyspnea or other reason
**Measure:** Reason for stopping
**Time Frame:** During exercise testing
**Description:** Minute Ventilation in millilitres/minute (mL/min)
**Measure:** Minute Ventilation (VE)
**Time Frame:** During exercise testing
**Description:** Heart rate in beats per minute (BPM)
**Measure:** Heart Rate (HR)
**Time Frame:** During exercise testing
**Description:** Oxygen Pulse (VO2/HR) in millilitres/minute (mL/min)
**Measure:** Oxygen Pulse
**Time Frame:** During exercise testing
**Description:** Oxygen Consumption (VO2) in millilitres/minute (mL/min)
**Measure:** Oxygen Consumption
**Time Frame:** During exercise testing
**Description:** Carbon Dioxide Production (VCO2) in millilitres/minute (mL/min)
**Measure:** Carbon Dioxide Production
**Time Frame:** During exercise testing
**Description:** Work (W) in watts
**Measure:** Work
**Time Frame:** During exercise testing
**Description:** Tidal Volume in Litres (L) at body temperature and pressure saturated (BTPS)
**Measure:** Tidal Volume (VT)
**Time Frame:** During exercise testing
**Description:** Respiratory Quotient (CO2 produced / O2 consumed; no unit as it is a ratio value)
**Measure:** Respiratory Quotient (RQ)
**Time Frame:** During exercise testing
**Description:** End-tidal carbon dioxide tension (PETCO2) in millimetres of mercury (mmHg)
**Measure:** End-tidal carbon dioxide tension (PETCO2)
**Time Frame:** During exercise testing
**Description:** End-tidal oxygen tension (PETO2) in millimetres of mercury (mmHg)
**Measure:** End-tidal oxygen tension (PETO2)
**Time Frame:** During exercise testing
**Description:** Oxygen Saturation (SpO2) (%, percentage)
**Measure:** Oxygen Saturation (SpO2)
**Time Frame:** During exercise testing
**Description:** Respiratory Reserve in Litres
**Measure:** Respiratory Reserve
**Time Frame:** During exercise testing
**Description:** Expiration Time in seconds
**Measure:** Expiration Time
**Time Frame:** During exercise testing
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with FEV1 / FVC ratio of \< 75% and deemed clinically stable
* Moderate to severe airflow limitation on Spirometry (FEV1: 30 to 75% predicted)
* Pulmonary Function Testing completed in the last 6 months
Exclusion Criteria:
* Active pulmonary infection or exacerbation within last 6 weeks
* Unstable cardiac disease - cardiac intervention, change in symptoms or medication within last 6 weeks
* BMI \> 35
* Receiving domiciliary oxygen therapy
* Diagnosis of COVID-19 within the last 12 weeks or persistent symptoms directly attributable to previous COVID-19 infection
* Presence of comorbid condition that is deemed to be a significant contributor to dyspnoea: Heart Failure, Chronic Thromboembolic Disease, Neuromuscular Disease, Primary Pulmonary Hypertension
* Pulmonary Embolism in last 3 months
* Abdominal or Thoracic surgery in last 3 months
* Pneumothorax in last 6 months
* Active malignancy
* Active chest wall pain, active skin condition or open wound on thorax
* Pregnant or breastfeeding
* Women of child-bearing age (premenopausal, under age 50, or without previous sterilisation surgery)
* Any implantable electronic device
* On anticoagulants or with known history of coagulopathy
* Any absolute or relative contraindication to CPET testing
* Disability or comorbid condition that prevents exercise training and/or use of CPET apparatus and/or wearing the investigational device
* Previous experience of Chest Wall Vibration therapies for relief of breathlessness
* Currently enrolled in any other clinical trial or research study
* People deemed to be incapable of giving consent, or with reduced capacity to consent or diminished autonomy as a result of mental or cognitive impairment, or deemed otherwise vulnerable on clinical grounds
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Sandyford
**Country:** Ireland
**Facility:** Beacon Hospital
**State:** Dublin 18
**Zip:** D18 AK68
#### Overall Officials
**Official 1:**
**Affiliation:** Beacon Hospital
**Name:** Professor Seamus Linnane (MB BCh BAO FRCP FRCPI)
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** At present there is no plan to share individual participant data (IPD). As this is a novel medical device prototype currently undergoing development, IPD sharing could undermine future research and development activities relating proprietary aspects of the technology.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11168
- Name: Lung Diseases
- Relevance: HIGH
- As Found: Pulmonary Disease
- ID: M7591
- Name: Dyspnea
- Relevance: HIGH
- As Found: Dyspnea
- ID: M11170
- Name: Lung Diseases, Obstructive
- Relevance: HIGH
- As Found: Obstructive Pulmonary Disease
- ID: M23449
- Name: Pulmonary Disease, Chronic Obstructive
- Relevance: HIGH
- As Found: Chronic Obstructive Pulmonary Disease
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008171
- Term: Lung Diseases
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000029424
- Term: Pulmonary Disease, Chronic Obstructive
- ID: D000004417
- Term: Dyspnea
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432907
**Brief Title:** StereoEEG Motor Neuronal Potentials Decoding
**Official Title:** Decoding of Neuronal Potentials Associated With Motor Performance and Motor Imagery Obtained Using Intracranial stereoEEG Electrodes
#### Organization Study ID Info
**ID:** Stereo-iBCI
#### Organization
**Class:** OTHER_GOV
**Full Name:** Research Center of Neurology, Russia
### Status Module
#### Completion Date
**Date:** 2026-12-25
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Institute of Higher Nervous Activity and Neurophysiology of RAS
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Research Center of Neurology, Russia
#### 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 goals of this study are (1) to evaluate the rate of stereoEEG brain-computer interface (BCI) classification accuracy and (2) to collect the dataset of neuronal signals recorded from stereoEEG electrodes during motor performance, motor imagery or brain-computer interface control. The study enrolls hospitalised patients suffering from resistant epilepsy with already implanted intracranial stereoEEG electrodes for medical reasons (i.e. for preoperative localization of the epileptogenic foci). The number and location of electrodes are determined solely for the clinical purposes of stereoEEG monitoring and are not related to the protocol of the current study.
After obtaining informed consent to participate in the study, each patient will participate in one experimental session lasting no more than 60 minutes, recording brain signals associated with hand movement, motor imagery, and BCI control. All tasks and instructions presented during the study session are not pro-epileptogenic and cannot provoke an epileptic attack. The experiments will take place in the patient's room, without interruption of observation by the department's medical staff.
The data recorded in this study will be used to improve or develop new algorithms for decoding motor signals from deep brain structures for their potential use in invasive BCIs.
### Conditions Module
**Conditions:**
- Drug Resistant Epilepsy
- Brain-Computer Interfaces
**Keywords:**
- Brain-Computer Interface
- Motor Imagery
- Motor Performance
- Intracranial Electroencephalography
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Each patient will participate in one experimental session lasting no more than 60 minutes, recording brain signals associated with hand movement, motor imagery, and brain-computer interface (BCI) control.
**Intervention Names:**
- Other: motor tasks
**Label:** StereoEEG
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- StereoEEG
**Description:** During the study session, the patient will sit at a table in front of a computer monitor. The stereoEEG electrodes will be connected to the Neurovisor-BMM52 electroencephalograph (Medical Computer Systems, Russia) and to a computer with a software for recording and decoding brain signals (BCI classifier). One microsensor (Ascension TrekStar, Ascension Technology, USA) and two disposable cutaneous electrodes (connected to the Neurovisor-BMM52 system) will be put on each patient's hand for electromyogram recording.
The session consists from 3 blocks (1-3). The participant is asked to:
1. execute simple motor tasks (thumbs up, open hand or clench hand into fist - 30 times with each hand with 5-second brakes), according to the instruction on the computer screen;
2. to imagine the same movements - 30 times with each hand with 5-second brakes;
3. to imagine the same movements with the feedback (brain-computer interface control).
The blocks are separated by 5-minute brakes.
**Name:** motor tasks
**Other Names:**
- motor execution, motor imagery, brain-computer interface control with motor imagery paradigm
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The proportion (%) of cases with correct identification of the task among all presentations of the corresponding command.
**Measure:** Rate of BCI classification recall
**Time Frame:** During the procedure
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* male and female patients who have had stereoEEG electrodes implanted for medical reasons;
* voluntary informed consent to participate in the study;
* age from 18 to 70 years.
Exclusion Criteria:
* patient refusal to participate in the study;
* cognitive impairment that prevents following the study instructions;
* severe visual impairment that does not allow viewing visual instructions on a computer screen;
* upper limb paresis or other motor disorders;
* pain in the hand of any etiology;
* any acute diseases, exacerbation of chronic diseases, acute life-threatening conditions;
* occurrence of an epileptic attack during the experiment.
**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:** Olesya A Mokienko, MD PhD
**Phone:** +74953747776
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Roman Kh Lyukmanov, MD PhD
**Phone:** +74953747776
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Moscow
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Natalia A Suponeva, MD
- **Phone:** +79161894988
- **Role:** CONTACT
***Contact 2:***
- **Name:** Olesya A Mokienko, MD PhD
- **Role:** SUB_INVESTIGATOR
***Contact 3:***
- **Name:** Roman Kh Lyukmanov, MD PhD
- **Role:** SUB_INVESTIGATOR
**Country:** Russian Federation
**Facility:** Research center of neurology, Department of neurorehabilitation and physiotherapy
**Status:** RECRUITING
**Zip:** 125367
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004827
- Term: Epilepsy
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7983
- Name: Epilepsy
- Relevance: LOW
- As Found: Unknown
- ID: M369
- Name: Drug Resistant Epilepsy
- Relevance: HIGH
- As Found: Drug Resistant Epilepsy
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000069279
- Term: Drug Resistant Epilepsy
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432894
**Brief Title:** Performance Evaluation of ANI in Patients Under General Anesthesia With Remimazolam
**Official Title:** Performance Evaluation of Analgesia Nociception Index (ANI) in Patients Under General Anaesthesia With Remimazolam: a Prospective Observational Study
#### Organization Study ID Info
**ID:** Ilsan_Cha_2023-04-003-005
#### Organization
**Class:** OTHER
**Full Name:** Catholic Kwandong University
### Status Module
#### Completion Date
**Date:** 2025-06-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-23
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Catholic Kwandong University
#### Responsible Party
**Investigator Affiliation:** Catholic Kwandong University
**Investigator Full Name:** Jungmin Lee
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The purpose of this study is to determine whether Analgesia Nociception Index (ANI) can effectively reduce the dose of opioid in patients who underwent general anesthesia using remimazolam.
### Conditions Module
**Conditions:**
- Pain Measurement
**Keywords:**
- Remimazolam
- Remifentanil
- Analgesia Nociception Index (ANI)
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 20 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients
* aged 20-80 years under general anaesthesia with remimazolam
* scheduled to undergo robotic surgery
* in American Society of Anesthesiologists physical class 1, 2 or 3
**Intervention Names:**
- Combination Product: Analgesia Nociception Index, remimazolam
**Label:** observation
### Interventions
#### Intervention 1
**Arm Group Labels:**
- observation
**Description:** The purpose of this study is to determine the validity of ANI in patients undergoing surgery with remifentanil and remimazolam.
During this study, remimazolam infusion rate is determined by the pharmacopoeia.
Remifentanil infusion rate is determined based on the patient's vital signs, systemic status and pain levels. And remifentanil is administrated via targeted infusion control using the Minto model.
ANI scores, vital signs, remifentanil infusion rate are collected at predetermined time points according to the protocol from the start to the end of the surgery.
**Name:** Analgesia Nociception Index, remimazolam
**Type:** COMBINATION_PRODUCT
### Outcomes Module
#### Other Outcomes
**Description:** When there are changes of heart rate or blood pressure more than 20% from baseline within 5 minutes of pain stimulus
**Measure:** Hemodynamic change
**Time Frame:** within 5 minutes of pain stimulus
#### Primary Outcomes
**Description:** A value indicating the degree of pain calculated by ANI's algorithm
**Measure:** ANI values
**Time Frame:** During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)
#### Secondary Outcomes
**Description:** Because the ANI value is calculated using the change in HR, it is measured to correlate the change in ANI value with the change in HR due to pain.
**Measure:** Heart Rate (HR) change
**Time Frame:** Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation
**Description:** The PSI is an indicator of a patient's depth of sedation and is calculated based on EEG, which can change in response to painful stimuli. The PSI score is expressed as a number between 0 and 100, and it is usually recommended to maintain under 60 during surgery. An increase in the PSI score can indicates the degree of pain stimulus and can be used as an indicator to assess the validity of the ANI value.
**Measure:** Patient state index (PSI) change
**Time Frame:** Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation
**Description:** When a patient feels pain, it stimulates the autonomic nervous system to change blood pressure. This change is measured to determine how much pain the patient is feeling
**Measure:** Blood Pressure change
**Time Frame:** Every 2 seconds for 2.5 minutes before and Every 2 seconds for 2.5 minutes after pain stimulation
**Description:** Remimazolam is a sedative. The infusion rate of remimazolam correlates with sedation level. And it is measured to determine if sedation level correlates with ANI values when pain stimuli are given.
**Measure:** Remimazolam infusion rate
**Time Frame:** During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)
**Description:** Remifentanil is an opioid and can affect pain levels when given a pain stimulus.
**Measure:** Effect site concentration of remifentanil
**Time Frame:** During Surgery (at the points of intubation, skin incision, CO2 insufflation, TOF stimulation, and hemodynamic change)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Patients
* aged 20-79 years under general anaesthesia with remimazolam
* scheduled to undergo robotic surgery
* in American Society of Anesthesiologists physical class 1, 2 or 3
* voluntarily agree in writing to participate in this clinical study
Exclusion Criteria:
* Conditions affecting the autonomic nervous system
* other conditions or disease that may cause acute or chronic pain
* the NRS before induction of anesthesia is 1 or over
* When taking medications that may affect the autonomic nervous system
* In other cases where the investigator deems the subject unsuitable for this trial
**Maximum Age:** 79 Years
**Minimum Age:** 20 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients who visit the hospital and undergo surgery
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jungmin Lee
**Phone:** 821041929159
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Joohyun Lee
**Phone:** 821074200912
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Incheon
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jungmin Lee, MD
- **Phone:** 821041929159
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Joohyun Lee, MD
- **Phone:** 821074200912
- **Role:** CONTACT
**Country:** Korea, Republic of
**Facility:** Catholic-Kwandong University, School of Medicine
**Status:** RECRUITING
**Zip:** 22711
#### Overall Officials
**Official 1:**
**Affiliation:** Ilsan Cha hospital
**Name:** Young Joo
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M1696
- Name: Remifentanil
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432881
**Brief Title:** Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)
**Official Title:** Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)
#### Organization Study ID Info
**ID:** GOOD0001
#### Organization
**Class:** INDUSTRY
**Full Name:** Masimo Corporation
### Status Module
#### Completion Date
**Date:** 2025-02-21
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-02-21
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-12-21
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-23
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Masimo Corporation
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** The objective of this study is to evaluate the performance of Masimo RD SET® SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area.
### Conditions Module
**Conditions:**
- Hypoxemia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 152
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All subjects are enrolled into this arm and will have Sp02 measurements obtained.
**Intervention Names:**
- Device: RD SET Sensor
**Label:** RD SET Sensor
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- RD SET Sensor
**Description:** All subjects are enrolled into this arm and will have Sp02 measurements obtained.
**Name:** RD SET Sensor
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The study is designed to evaluate the performance of Masimo RD SET SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area. SpO2 accuracy will be determined by calculating the ARMS value which will be reported as percent of oxygen saturated hemoglobin.
**Measure:** Investigation of skin pigmentation effect on performance of Masimo pulse oximetry
**Time Frame:** Approximately 30 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subject is 18 years of age or older.
* Subject is receiving care in an intensive care unit.
* Subject with an arterial catheter in place.
* Subject is experiencing hypoxemia as defined by 1) need for supplement oxygen or 2) peripheral oxygenation ≤ 94% on room air
Exclusion Criteria:
* Subjects in whom pulse oximetry cannot be reliably performed on both the third and fourth digit on the hand ipsilateral to the arterial line, precluding application of the sensor (e.g., amputation and deformity).
* Subjects with a skin condition affecting the digits, where the sensor is applied, which would preclude sensor placement as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.).
* Subjects with distinct geographic variances in skin pigmentation (e.g., vitiligo) on the digit where the sensor is applied, which would preclude sensor placement as standard of care.
* Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied.
* Subjects with known allergic reactions to adhesive tapes.
* Subjects with arterial catheter placed in a lower extremity.
* Subjects not suitable for the investigation at the discretion of the investigator or the clinical team.
**Maximum Age:** 89 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Chelsea Frank
**Phone:** 949-297-7000
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Charleston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Chelsea Frank
- **Phone:** 949-297-7000
- **Role:** CONTACT
**Country:** United States
**Facility:** Medical University of South Carolina
**State:** South Carolina
**Status:** RECRUITING
**Zip:** 29425
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4185
- Name: Hypoxia
- Relevance: HIGH
- As Found: Hypoxemia
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000860
- Term: Hypoxia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432868
**Brief Title:** Solarplast (R) Supplementation Effects Following High-intensity Resistance Exercise
**Official Title:** Effects of Solarplast (R) Supplementation on Biomarkers of Muscle Damage, Inflammation and Recovery of Physical Performance Following High-intensity Resistance Exercise
#### Organization Study ID Info
**ID:** 927
#### Organization
**Class:** OTHER
**Full Name:** Kent State University
### Status Module
#### Completion Date
**Date:** 2025-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-17
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kent State University
#### Responsible Party
**Investigator Affiliation:** Kent State University
**Investigator Full Name:** Adam Jajtner
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The primary goal of this investigation is to assess whether Solarplast (R) supplementation will improve recovery following heavy resistance exercise in active adults. The primary questions to be addressed are:
Does Solarplast (R) decrease muscle damage and inflammation associated with heavy resistance exercise?
Does Solarplast (R) reduce the decline in performance associate with heavy resistance exercise?
Researchers will compare Solarplast (R) to a placebo (a look-alike substance that contains no active ingredients) to see if Solarplast (R) is effective at improving recovery.
Participants will be asked to:
Take Solarplast (R) or placebo daily for 4 weeks
Visit the laboratory at least once per week to receive their supplement
Report to the lab for 3 consecutive visits following supplementation to complete a heavy resistance training session and follow-up testing.
### Conditions Module
**Conditions:**
- Muscle Damage
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 46
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 100mg/day of Solarplast (R) supplementation (28 days).
**Intervention Names:**
- Dietary Supplement: Solarplast (R)
**Label:** Solarplast (R)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** 100mg/day of Placebo (maltodextrin (98.8%) and medium chain triglycerides (1.2%)).
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Solarplast (R)
**Description:** Daily supplementation for 28 days prior to heavy resistance exercise.
**Name:** Solarplast (R)
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Daily supplementation for 28 days prior to heavy resistance exercise.
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Other Outcomes
**Description:** Measure of Performance Change
**Measure:** Rate of Muscular Fatigue
**Time Frame:** Acute changes following exercise for 48 hours
**Description:** Measure of Performance Change
**Measure:** Rate of Muscular Fatigue
**Time Frame:** Change in Resting Values over 4 weeks of supplementation
**Description:** Marker of Muscle Damage
**Measure:** Lactate Dehydrogenase Activity
**Time Frame:** Acute changes following exercise for 48 hours
**Description:** Circulating Marker of Stress
**Measure:** Cortisol Concentration
**Time Frame:** Acute changes following exercise for 48 hours
**Description:** Circulating Marker of Stress
**Measure:** Cortisol Concentration
**Time Frame:** Change in Resting Values over 4 weeks of supplementation
**Description:** Circulating Marker of Oxidative Stress
**Measure:** Glutathione (GSH) Activity
**Time Frame:** Change in Resting Values over 4 weeks of supplementation
**Description:** Circulating Marker of Oxidative Stress
**Measure:** Glutathione (GSH) Activity
**Time Frame:** Acute changes following exercise for 48 hours
**Description:** Circulating Marker of Oxidative Stress
**Measure:** Total Antioxidant Capacity
**Time Frame:** Change in Resting Values over 4 weeks of supplementation
**Description:** Circulating Marker of Oxidative Stress
**Measure:** Total Antioxidant Capacity
**Time Frame:** Acute changes following exercise for 48 hours
**Description:** Circulating Marker of Inflammation
**Measure:** Interleukin 6 (IL-6) Concentration
**Time Frame:** Change in Resting Values over 4 weeks of supplementation
**Description:** Circulating Marker of Inflammation
**Measure:** Interleukin 6 (IL-6) Concentration
**Time Frame:** Acute changes following exercise for 48 hours
**Description:** Circulating Marker of Inflammation
**Measure:** Interleukin 10 (IL-10) Concentration
**Time Frame:** Change in Resting Values over 4 weeks of supplementation
**Description:** Circulating Marker of Inflammation
**Measure:** Interleukin 10 (IL-10) Concentration
**Time Frame:** Acute changes following exercise for 48 hours
**Description:** Circulating Marker of Inflammation
**Measure:** Tumor Necrosis Factor - alpha (TNFa) Concentration
**Time Frame:** Change in Resting Values over 4 weeks of supplementation
**Description:** Circulating Marker of Inflammation
**Measure:** Tumor Necrosis Factor - alpha (TNFa) Concentration
**Time Frame:** Acute changes following exercise for 48 hours
**Description:** Measure of Performance Change
**Measure:** Rate of Force Development
**Time Frame:** Change in Resting Values over 4 weeks of supplementation
**Description:** Measure of Performance Change
**Measure:** Peak Muscle Force
**Time Frame:** Acute changes following exercise for 48 hours
**Description:** Measure of Performance Change
**Measure:** Vertical Jump Height
**Time Frame:** Change in Resting Values over 4 weeks of supplementation
#### Primary Outcomes
**Description:** Marker of Muscle Damage
**Measure:** Creatine Kinase Activity
**Time Frame:** Acute changes following exercise for 48 hours
#### Secondary Outcomes
**Description:** Marker of Muscle Damage
**Measure:** Myoglobin Concentration
**Time Frame:** Acute changes following exercise for 24 hours
**Description:** Measure of Performance Change
**Measure:** Vertical Jump Height
**Time Frame:** Acute changes following exercise for 48 hours
**Description:** Measure of Performance Change
**Measure:** Mean Squat Velocity
**Time Frame:** Acute changes following exercise for 48 hours
**Description:** Measure of Performance Change
**Measure:** Peak Isometric Muscle Force
**Time Frame:** Acute changes following exercise for 48 hours
**Description:** Measure of Performance Change
**Measure:** Rate of Force Development
**Time Frame:** Acute changes following exercise for 48 hours
**Description:** Visual Analog Scale (1-100mm; low values indicate reduced soreness)
**Measure:** Ratings of Perceived Soreness
**Time Frame:** Acute changes following exercise for 48 hours
**Description:** Visual Analog Scale (1-100mm; low values indicated reduced fatigue)
**Measure:** Ratings of Perceived Fatigue
**Time Frame:** Acute changes following exercise for 48 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Recreationally-active (participated in at least 2 weight training workouts per week over the previous year) and participates in at least 3h of total structured exercise/week as determined by the health and activity questionnaire.
* Subject is judged by the Investigator to be healthy and free of any physical limitations (determined by health and activity questionnaire)
* Subject has a body mass index of 18.0-34.9 kg/m2, inclusive
* Subject is willing to maintain habitual diet throughout the study period
* Subject is willing to abstain from dietary supplementation throughout the duration of the study.
* Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators
Exclusion Criteria:
* Subject is currently or will be enrolled in another clinical trial.
* Subject is a habitual consumer of tea/antioxidants defined as \> 8 oz/day of either green or black tea within the 14 days prior to the screening visit.
* Subject has a history or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder.
* Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
* Subject is unable to perform physical exercise (determined by health and activity questionnaire)
* Subject is engaged in an extreme diet including but not limited to, Atkins, South Beach, Intermittent Fasting, etc.
* Subject is allergic to the study product or placebo
* Subject is taking any other nutritional supplement or performance enhancing drug (determined from health and activity questionnaire)
* Subject has any chronic illness that causes continuous medical care
* Taking any type of prescription or over-the-counter medication including but not limited to corticosteroids, non-steroidal anti-inflammatory drugs, and antibiotics within the 14 days prior to the screening visit.
**Healthy Volunteers:** True
**Maximum Age:** 35 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Adam R Jajtner, PhD
**Phone:** 330-672-0212
**Phone Ext:** 20212
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Kent
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Adam R Jajtner, PhD
- **Phone:** 330-672-0212
- **Phone Ext:** 20212
- **Role:** CONTACT
**Country:** United States
**Facility:** Kent State University - Exercise Science & Exercise Physiology
**State:** Ohio
**Status:** RECRUITING
**Zip:** 44242
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06432855
**Acronym:** GEDIPOP
**Brief Title:** Genetic Determinants of the Antiviral Immune Response in Oceanian Populations
**Official Title:** Genetic Determinants of the Antiviral Immune Response in Oceanian Populations
#### Organization Study ID Info
**ID:** 2022-035
#### Organization
**Class:** INDUSTRY
**Full Name:** Institut Pasteur
#### Secondary ID Infos
**Domain:** ID RCB
**ID:** 2023-A02206-39
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-12-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Institut Pasteur
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Oceania's populations, including Melanesians, are paying a heavy price for dengue fever, which has been circulating actively in the region since the Second World War. In New Caledonia (NC), the incidence of dengue fever is higher among municipalities predominantly populated by Melanesians, suggesting that Melanesians may have an increased susceptibility to symptomatic dengue fever. Differences in antiviral immune responses between populations of different geographical origins are partly the result of population-specific immune regulatory variants. In turn, viruses have imposed considerable selective pressure on human populations. Although crucial to understanding their susceptibility to viral infections, the genetic determinants of the antiviral immune response of Oceanians remain to be characterized.
In this context, we hypothesize that the genetic origin of Oceanians, and Melanesians in particular, has shaped their antiviral immune response and contributes to their greater susceptibility to certain viral infections. We aim to characterize the immune response to pathogens affecting the New Caledonian population, and in particular to dengue virus, of Melanesian and European populations, and to identify its genetic determinants. We will also explore whether saliva can be used as a non-invasive sample to study the seroprevalence of dengue in Oceanian populations.
**Detailed Description:** Cross-sectional observational study with prospective sample and data collection Individuals will be identified from among eligible participants in the STEP-BSA21 and COVCAL studies.
Information and consent Questionnaire, saliva collection on Oragene tube, buccal swabbing and 20 mL blood collection on CPT tube
DNA extraction and low-coverage sequencing of participants' complete genomes And Isolation and in vitro stimulation of peripheral blood mononuclear cells (PBMCs) with dengue virus
* single-cell RNA sequencing (scRNAseq)
* multiplex quantification of cytokines and chemokines
* bioinformatics analysis to identify genetic markers associated with a differential transcriptomic and secretory response to dengue virus stimulation.
### Conditions Module
**Conditions:**
- Virus
**Keywords:**
- dengue
- immunity
- genetics
- Ocenian populations
- New Caledonia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 220
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Saliva samples and 20 mL blood samples from individuals of Melanesian and European origin from NC
**Intervention Names:**
- Other: Blood collection
- Other: saliva collection
**Label:** Non-febrile adults of Melanesian and European origin
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Non-febrile adults of Melanesian and European origin
**Description:** 20 ml-blood sample
**Name:** Blood collection
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Non-febrile adults of Melanesian and European origin
**Description:** saliva sample
**Name:** saliva collection
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Identification by genomic techniques of expression Quantitative Trait Loci (eQTL) specifically associated with the innate immune response of Peripheral Blood Mononuclear Cells (PBMCs) collected from individuals of Melanesian and European origin and stimulated in vitro by DENV.
**Measure:** Identify the genetic determinants of the innate immune response to pathogens affecting the New Caledonian population, and in particular to the dengue virus in individuals of Melanesian and European origin.
**Time Frame:** 3 years
#### Secondary Outcomes
**Description:** Low-coverage DNA sequencing of the complete genome of individuals of Melanesian and European origin.
**Measure:** To describe the genetic diversity of Melanesian and European populations in NC in relation to the determinants of susceptibility to health problems affecting NC populations.
**Time Frame:** 3 years
**Description:** Quantification by single cell RNAseq techniques of differentially expressed transcripts in response to in vitro dengue virus stimulation by Peripheral Blood Mononuclear Cells (PBMCs) collected from individuals of Melanesian and European origin.
**Measure:** Characterizing the transcriptomic response to DENV in individuals of Melanesian and European origin.
**Time Frame:** 3 years
**Description:** Quantification by multiplex techniques of the concentration of cytokines and chemokines differentially secreted in response to in vitro stimulation by dengue virus by Peripheral Blood Mononuclear Cells (PBMCs) collected from individuals of Melanesian and European origin.
**Measure:** Characterize the cytokine and chemokine response to DENV in individuals of Melanesian and European origin.
**Time Frame:** 3 years
**Description:** Quantification by multiplex techniques of the concentration of cytokines and chemokines differentially secreted in response to in vitro stimulation by dengue virus by Peripheral Blood Mononuclear Cells (PBMCs) collected from individuals of Melanesian and European origin.
Multivariate analyses of the association of environmental factors collected during the inclusion visit (questionnaire and measurements) or during analyses conducted as part of the present research with the immune response targeting the dengue virus.
**Measure:** Study the effect of environmental factors (smoking/non-smoking status, history of Cytomegalovirus or dengue virus infection, presence of diabetes, etc.) on the immune response to dengue virus.
**Time Frame:** 3 years
**Description:** Next-generation sequencing and analysis of the oral microbiome on a saliva sample
**Measure:** Study the oral microbiome of individuals of Melanesian and European origin and analyze its association with the immune response to pathogens.
**Time Frame:** 3 years
**Description:** Luminex quantification of dengue virus antibodies in serum and saliva from Melanesian and European individuals.
**Measure:** Determine whether history of dengue virus infection can be demonstrated by testing saliva for antibodies using the Luminex technique.
**Time Frame:** 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult
* Non-febrile
* Self-declared member of the Melanesian or European community
* Having given consent to participate in the study
Exclusion Criteria:
* People who have taken part in a clinical study in the last 6 months in which they were exposed to a health product as part of the investigation (pharmaceutical product or device or placebo).
* People taking part in an ongoing clinical study
* People declaring themselves to belong to two communities (e.g. people of mixed European and Melanesian descent)
* Pregnant and breast-feeding women (in whom the immune response could be modified)
* People with a long-term medical condition (as defined by the French social security system) that could have an effect on the immune response, excluding dengue risk factors prevalent in New Caledonia such as diabetes, overweight/obesity and hypertension.
* Individuals with an acute infection (viral, bacterial or fungal) within 3 months of inclusion.
* Chronic administration (for more than 14 days) of immunosuppressants or treatments affecting the immune system in the 6 months prior to inclusion. For corticosteroids, this corresponds to a dose equivalent to 20 mg/day of prednisone or equivalent for more than two weeks (inhaled or topical steroids are permitted).
* Administration of a vaccine within 3 months prior to inclusion.
* Administration of blood products or immunoglobulins within 3 months of inclusion.
* People with known allergies to antibiotics, which could have an impact on the in vitro culture of PBMCs in the presence of antibiotics
* Persons not intellectually capable of answering the questionnaire
* Persons under guardianship, curatorship or any other legal incapacity
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Catherine Inizan, PhD
**Phone:** +687 27 26 66
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Myrielle Dupont-Rouzeyrol, PhD
**Phone:** +687 27 75 30
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nouméa
**Contacts:**
***Contact 1:***
- **Name:** Marc Jouan, MD
- **Role:** CONTACT
**Country:** New Caledonia
**Facility:** Institut Pasteur de Nouvelle-Calédonie
**Zip:** 98 835
#### Overall Officials
**Official 1:**
**Affiliation:** Institut Pasteur de Nouvelle-Calédonie
**Name:** Marc Jouan, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6913
- Name: Dengue
- Relevance: LOW
- As Found: Unknown
- ID: T1794
- Name: Dengue Fever
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4314
- Name: Antiviral Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |