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## Protocol Section
### Identification Module
**NCT ID:** NCT06425432
**Brief Title:** Higher Order Aberration and Relationship With Soft Contact Lens Modulus
**Official Title:** Higher Order Aberration and Relationship With Soft Contact Lens Modulus
#### Organization Study ID Info
**ID:** 6733
#### Organization
**Class:** OTHER
**Full Name:** Southern College of Optometry
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Southern College of Optometry
#### Responsible Party
**Investigator Affiliation:** Southern College of Optometry
**Investigator Full Name:** Yueren Wang, OD
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Higher order aberrations are imperfects in the eye that affect the quality of image projected onto the retina. Soft contact lenses are made of different materials with different stiffness. This study looks to see if the soft contact lens material affects the amount of higher order aberrations in an eye.
### Conditions Module
**Conditions:**
- Corneal Wavefront Aberration
**Keywords:**
- Contact Lens
- Higher order aberration
- Modulus
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subject will present wearing habitual contact lenses for the aberrometry measurement. They will then remove their contact lenses and measurement repeated uncorrected.
**Intervention Names:**
- Device: OVITZ xwave aberrometer
**Label:** CL first
#### Arm Group 2
**Description:** Subjects will refrain from contact lens wear on day of the visit. Initial aberrometry measurement will be performed uncorrected. They will be then asked to insert their contact lenses and aberrometry measurements repeated.
**Intervention Names:**
- Device: OVITZ xwave aberrometer
**Label:** Glasses first
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CL first
- Glasses first
**Description:** wavefront aberrometer
**Name:** OVITZ xwave aberrometer
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Measure HOA with contact lenses. And then measure HOA without contact lenses.
**Measure:** Mean change in HOA with and without contact lenses
**Time Frame:** Within the same study visit, measurements will be taken 15 minutes apart to allow for tear film to return to homeostasis after contact lens insertion/removal.
#### Secondary Outcomes
**Description:** Evaluate correlation between the lens modulus and changes in HOA
**Measure:** Correlation between contact lens modulus and changes in HOA with and without contact lenses
**Time Frame:** Within the same study visit, measurements will be taken 15 minutes apart to allow for tear film to return to homeostasis after contact lens insertion/removal.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Willing and able to provide informed consent
* Adults \> 18 years old regardless of gender, race, or ethnicity
* Habitual single vision soft CL wearer for at least 1 week in any modality.
Exclusion Criteria:
* Multifocal soft CL wear
* GP or ortho K wear in the last 3 months.
* Active eye infections and inflammations.
* Current use of ocular medication.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adults (\>18 years old) who are wearing single-vision soft contact lenses will be recruited.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yueren Wang, OD
**Phone:** 901-252-3691
**Role:** CONTACT
### IPD Sharing Statement Module
**Access Criteria:** Upon request
**Description:** all IPD that underlie results in a publication
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** 6 months - 3 years after publication
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-05-13
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 197197
- Type Abbrev: Prot
- Upload Date: 2024-05-20T13:06
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003316
- Term: Corneal Diseases
- ID: D000005128
- Term: Eye Diseases
- ID: D000012030
- Term: Refractive Errors
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M28721
- Name: Corneal Wavefront Aberration
- Relevance: HIGH
- As Found: Corneal Wavefront Aberration
- ID: M6539
- Name: Corneal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14872
- Name: Refractive Errors
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000057108
- Term: Corneal Wavefront Aberration
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425419
**Brief Title:** The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy
**Official Title:** The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy
#### Organization Study ID Info
**ID:** 2023P002259
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts Eye and Ear Infirmary
### Status Module
#### Completion Date
**Date:** 2026-03-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-09
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Massachusetts Eye and Ear Infirmary
#### Responsible Party
**Investigator Affiliation:** Massachusetts Eye and Ear Infirmary
**Investigator Full Name:** Leo Am Kim, M.D.
**Investigator Title:** Associate Professor of Ophthalmology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this clinical trial is to evaluate the safety and efficacy of intravitreal topotecan for the treatment of patients with rhegmatogenous retinal detachment due to proliferative vitreoretinopathy (PVR) or resulting from an open globe injury, and compare the outcomes to those who do no receive intravitreal topotecan. The main objectives it aims to achieve are:
* to study the safety profile of intravitreal topotecan in the treatment of PVR
* to evaluate the efficacy of intravitreal topotecan in treating PVR.
Post-consent, participants will:
* undergo vitrectomy (with or without scleral buckle) as part of standard treatment for retinal detachment.
* receive intravitreal topotecan at the time of surgery, post-operative day 7 and post-operative day 28 (if randomized to receive the medication)
* come in at post-operative day 1, 7, 28, 56, 84, 126 and 168 to undergo a complete ophthalmic exam along with a fundus photography and optical coherence tomography of the macula, have their intraocular pressure and visual acuity measured and their adverse events monitored, if any.
Researchers will compare participants who receive intravitreal topotecan for PVR to those who do not to see if there is a significant variability in recurrence of retinal detachment, rate of retinal reattachment and PVR grade 6 months after surgery.
**Detailed Description:** Rhegmatogenous retinal detachment (RRD) is an acute, sight-threatening condition that occurs after separation of the neurosensory retina from the underlying retinal pigment epithelium (RPE) due to the presence of a retinal break. Proliferative vitreoretinopathy (PVR) represents growth of ectopic fibrocellular growth on the surface of, within and underneath the retina. PVR is hypothesized to occur secondary to the migration of RPE cells to the peri-retina, leading to a mesenchymal transition into contractile myofibroblasts. PVR affects 5-10% of RRDs and is the most common cause of surgical failure in RRD.
Given that PVR involves a pro-inflammatory and pro-fibrotic cellular response, adjuvants such as corticosteroids and antimetabolites such as 5-fluorouracil have been attempted in the treatment of this condition. Overall, the efficacy results of these treatments have been mixed, and no standard of care adjuvant therapy has emerged.
Topotecan is a chemotherapeutic agent that acts as a topoisomerase inhibitor. It is most commonly administered intravitreally for patients with refractory or recurrent vitreous seeds from retinoblastoma, and shows high efficacy in this setting. At the same time, intravitreal topotecan administered at doses of 5-30µg has been associated with no ocular or systemic complications or adverse electroretinogram changes. To the best of available knowledge, topotecan has not been administered for the treatment of proliferative vitreoretinopathy. Topotecan has anti-inflammatory, anti-proliferative and anti-fibrotic activity that is hypothesized to exhibit high efficacy for the treatment of PVR. In this study, the efficacy and safety of intravitreal topotecan for the treatment of PVR will be investigated.
### Conditions Module
**Conditions:**
- Proliferative Vitreoretinopathy
- Proliferative Vitreo-Retinopathy
- Rhegmatogenous Retinal Detachment
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Half of the patients will receive intravitreal topotecan at the time of surgery. Randomization will be done based on a computer-generated list that would randomly allocate each of the 50 participants to being either in the treatment arm or in the control arm, in a particular order. Results will be printed on a card put in sealed envelopes that would be given to each research subject based on the allocation order given by that computer-generated list.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** These are the patients who will be receiving intravitreally 20 micrograms of topotecan in a 1cc syringe during surgery, at the post-operative day 7 and at the post-operative day 28.
**Intervention Names:**
- Drug: Topotecan
**Label:** Participants who received intravitreal topotecan
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** These patients will not be receiving any intervention.
**Label:** Participants who did not received intravitreal topotecan
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Participants who received intravitreal topotecan
**Description:** 20 micrograms of intravitreal topotecan given in a 1 cc tuberculin syringe at a concentration of 20 mcg/20mcL.
**Name:** Topotecan
**Other Names:**
- Hycamtin
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** an OCT of the macula will be taken to evaluate for any retinal changes throughout the study
**Measure:** Optical coherence tomography (OCT) of the macula
**Time Frame:** at the pre-operative assessment, and post-operative day1, 7, 28, 56, 84, 126, 168
#### Primary Outcomes
**Description:** Investigators will be evaluating whether participant develop a recurrent retinal detachment throughout their follow up after their initial surgery.
**Measure:** Recurrence of rhegmatogenous retinal detachment secondary to PVR
**Time Frame:** 6 months after initial surgery, or last follow-up visit available
#### Secondary Outcomes
**Description:** Investigators will be measuring the BCVA of participants throughout their follow up and see if they notice any change from surgery time to final follow up
**Measure:** Best corrected visual acuity (BCVA)
**Time Frame:** at the pre-operative assessment, and post-operative day1, 7, 28, 56, 84, 126, 168
**Description:** Investigators will be doing a dilated fundus exam and taking fundus photographies for all participants throughout their follow up time to see if the grade of the PVR changes over time. PVR grade goes from grade A to grade C-Anterior to equator/ C-Posterior to equator (grade C being worse than grade A)
**Measure:** Variation of PVR grade
**Time Frame:** at the pre-operative assessment, and post-operative day1, 7, 28, 56, 84, 126, 168
**Description:** Investigators will be doing a dilated fundus exam and taking fundus photographies for all participants throughout their follow up time to see if the retinal reattaches (whether completely or partially) after surgery
**Measure:** Retinal reattachment rate at month 6 or last follow up
**Time Frame:** at post-operative day 168 (or last follow-up visit available if the participant did not show up at post-operative day 168)
**Description:** Investigators will be measuring the BCVA of participants throughout their follow up and see if they notice any change from surgery time to final follow up
**Measure:** Recurrence of rhegmatogenous retinal detachment due to any cause
**Time Frame:** at the pre-operative assessment, and post-operative day1, 7, 28, 56, 84, 126, 168
**Description:** Any adverse event will be noted during surgery, and at each follow up visit for each participant if applicable.
**Measure:** Number of participants and type of intraoperative or postoperative complications
**Time Frame:** at time of surgery, and each follow up visit (post-operative day1, 7, 28, 56, 84, 126, 168)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients \> 18 years old
* Patients presenting with retinal detachment due with PVR (grade C or higher) or retinal detachment associated with open globe trauma
* Patients undergoing vitrectomy or vitrectomy with scleral buckle as part of standard care.
Exclusion Criteria:
* Patient unable to give consent
* Patient unable to follow-up
* Females of childbearing age who are pregnant at the time of recruitment. A pregnancy test will be done to all women of ages 18-55 prior to surgery to ensure they are not pregnant at the time of recruitment.
* Patients with a history of tractional or exudative retinal detachment.
* Patients with other planned ocular surgery following PPV
* Active or chronic or recurrent uncontrolled ocular or systemic disease
* Active or history of chronic or recurrent inflammatory eye disease
* Diagnosis of severe nonproliferative or proliferative diabetic retinopathy or vasoproliferative disease in the operative eye
* Signs of ocular infection at presentation in either eye
* Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively
* No Light Perception vision in the operative eye
* Failure to achieve intraoperative reattachment
* Patient with silicone oil instilled in the operative eye at time of presentation
**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:** Leo Kim, MD, PhD
**Phone:** 617-391-5896
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Massachusetts Eye and Ear
**Name:** Leo Kim, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Ohman T, Gawriyski L, Miettinen S, Varjosalo M, Loukovaara S. Molecular pathogenesis of rhegmatogenous retinal detachment. Sci Rep. 2021 Jan 13;11(1):966. doi: 10.1038/s41598-020-80005-w.
**PMID:** 33441730
**Citation:** Mysore Y, Del Amo EM, Loukovaara S, Hagstrom M, Urtti A, Kauppinen A. Statins for the prevention of proliferative vitreoretinopathy: cellular responses in cultured cells and clinical statin concentrations in the vitreous. Sci Rep. 2021 Jan 13;11(1):980. doi: 10.1038/s41598-020-80127-1. Erratum In: Sci Rep. 2021 Jul 22;11(1):15327.
**PMID:** 33441813
**Citation:** Claes C, Lafeta AP. Proliferative vitreoretinopathy. Dev Ophthalmol. 2014;54:188-95. doi: 10.1159/000360466. Epub 2014 Aug 26.
**PMID:** 25196769
**Citation:** Pastor JC, de la Rua ER, Martin F. Proliferative vitreoretinopathy: risk factors and pathobiology. Prog Retin Eye Res. 2002 Jan;21(1):127-44. doi: 10.1016/s1350-9462(01)00023-4.
**PMID:** 11906814
**Citation:** Sadaka A, Giuliari GP. Proliferative vitreoretinopathy: current and emerging treatments. Clin Ophthalmol. 2012;6:1325-33. doi: 10.2147/OPTH.S27896. Epub 2012 Aug 14.
**PMID:** 22942638
**Citation:** Rao R, Honavar SG, Sharma V, Reddy VAP. Intravitreal topotecan in the management of refractory and recurrent vitreous seeds in retinoblastoma. Br J Ophthalmol. 2018 Apr;102(4):490-495. doi: 10.1136/bjophthalmol-2017-310641. Epub 2017 Aug 26.
**PMID:** 28844050
**Citation:** Bogan CM, Kaczmarek JV, Pierce JM, Chen SC, Boyd KL, Calcutt MW, Bridges TM, Lindsley CW, Nadelmann JB, Liao A, Hsieh T, Abramson DH, Francis JH, Friedman DL, Richmond A, Daniels AB. Evaluation of intravitreal topotecan dose levels, toxicity and efficacy for retinoblastoma vitreous seeds: a preclinical and clinical study. Br J Ophthalmol. 2022 Feb;106(2):288-296. doi: 10.1136/bjophthalmol-2020-318529. Epub 2021 May 10.
**PMID:** 33972235
**Citation:** Nadelmann J, Francis JH, Brodie SE, Muca E, Abramson DH. Is intravitreal topotecan toxic to retinal function? Br J Ophthalmol. 2021 Jul;105(7):1016-1018. doi: 10.1136/bjophthalmol-2020-316588. Epub 2020 Jul 14.
**PMID:** 32665221
**Citation:** Ghassemi F, Shields CL, Ghadimi H, Khodabandeh A, Roohipoor R. Combined intravitreal melphalan and topotecan for refractory or recurrent vitreous seeding from retinoblastoma. JAMA Ophthalmol. 2014 Aug;132(8):936-41. doi: 10.1001/jamaophthalmol.2014.414.
**PMID:** 24789622
**Citation:** Cepeda MS, Boston R, Farrar JT, Strom BL. Comparison of logistic regression versus propensity score when the number of events is low and there are multiple confounders. Am J Epidemiol. 2003 Aug 1;158(3):280-7. doi: 10.1093/aje/kwg115.
**PMID:** 12882951
**Citation:** Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014 Mar;6(1):103-9. doi: 10.4055/cios.2014.6.1.103. Epub 2014 Feb 14.
**PMID:** 24605197
**Citation:** Machemer R, Aaberg TM, Freeman HM, Irvine AR, Lean JS, Michels RM. An updated classification of retinal detachment with proliferative vitreoretinopathy. Am J Ophthalmol. 1991 Aug 15;112(2):159-65. doi: 10.1016/s0002-9394(14)76695-4.
**PMID:** 1867299
## 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
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14998
- Name: Retinal Detachment
- Relevance: HIGH
- As Found: Retinal Detachment
- ID: M20719
- Name: Vitreoretinopathy, Proliferative
- Relevance: HIGH
- As Found: Proliferative Vitreoretinopathy
- ID: M14999
- Name: Retinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5871
- Name: Vitreoretinal Degeneration
- Relevance: HIGH
- As Found: Vitreoretinopathy
### Condition Browse Module - Meshes
- ID: D000012163
- Term: Retinal Detachment
- ID: D000018630
- Term: Vitreoretinopathy, Proliferative
### Intervention Browse Module - Ancestors
- ID: D000059004
- Term: Topoisomerase I Inhibitors
- ID: D000059003
- Term: Topoisomerase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21674
- Name: Topotecan
- Relevance: HIGH
- As Found: PD-1
- 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: D000019772
- Term: Topotecan
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425406
**Brief Title:** Application of HFNC for Children
**Official Title:** Application of HFNC for the Prevention of Hypoxemia During Perioperative Anesthetic-induced Intubation in Children: A Randomized Controlled Clinical Trial
#### Organization Study ID Info
**ID:** HFNC
#### Organization
**Class:** OTHER
**Full Name:** Henan Provincial People's Hospital
### Status Module
#### Completion Date
**Date:** 2025-05-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-12-04
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Henan Provincial People's Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Compared with adults, children have higher metabolic needs, and the airway is more likely to collapse. Before tracheal intubation after anesthesia induction, the patient 's spontaneous breathing completely disappears. At this critical stage, the residual oxygen of the lung is consumed, resulting in hypoxemia and atelectasis. Therefore, it is necessary to explore the best oxygenation strategy during intubation. In addition, ultrasound has become a common equipment in the operating room. It has the advantages of portability, repeatability, and no radiation, and can provide strong support for the diagnosis of gastric distension.
**Detailed Description:** At present, hypoxia is still the main cause of complications and death during perioperative period. Compared with adults, children have lower functional residual volume and lower tolerance to hypoxia caused by apnea due to their special physiological and functional characteristics. During anesthesia induction and tracheal intubation, spontaneous breathing completely disappears. At this critical stage, hypoxemia is prone to occur, which in turn causes various serious complications. Mask ventilation may occur mask ventilation difficulties and flatulence ; since the introduction of nasal high-flow oxygen therapy ( HFNC ) into the operating room in 2015, its oxygenation method has been shown to be able to significantly improve blood oxygen when used alone in pre-oxygenation. When tracheal intubation is performed, HFNC can still maintain ventilation in the patient 's nose, so HFNC can combine the advantages of both masks to perform pre-oxygenation. There are few studies on the effect of HFNC on apnea oxygenation in children in the operating room.
### Conditions Module
**Conditions:**
- High-flow Nasal Cannula
- Children
- Pre-oxygenation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 48
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In the HFNC group, the mask ventilation was performed after the patient lost spontaneous breathing until the end-tidal oxygen concentration reached 90 %. The mask was removed and HFNC ( AIRVO2, Fisher Parker Medical Company, Auckland, New Zealand ) was used to record the patient 's safe apnea time. After the end of positive pressure ventilation, intubation or laryngeal mask placement was performed after the end-tidal oxygen concentration reached 90 % or more. During the intubation or placement of the laryngeal mask, the HFNC nasal catheter was kept in the patient 's nose for apnea oxygenation.
**Intervention Names:**
- Device: high-flow nasal cannula
**Label:** Group HFNC
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** No intervention
**Label:** Group control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group HFNC
**Description:** In group H, mask ventilation was performed after the patient lost spontaneous breathing until the end-expiratory oxygen concentration reached 90 %. The lower mask was taken and HFNC was used to record the patient 's safe apnea time.
**Name:** high-flow nasal cannula
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Investigators will record the time of oxygen saturation drop to 95 % during intubation.
**Measure:** Apnoea time
**Time Frame:** 2-10min
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 2-10 years old;
* American Society of Anesthesiologists (ASA) Level I or II;
* Children with healthy lungs and hearts;
* Clear headed and able to cooperate with anesthesiologists for treatment.
Exclusion Criteria:
* Contraindications for HFNC: (1) Complete obstruction of the upper respiratory tract; (2) Skull base fracture or nasal bone fracture; (3) Patients who refuse to use HFNC;
* The American Society of Anesthesiologists (ASA) rating is greater than Level II;
* Children with upper respiratory tract infections within 2 weeks;
* Pulmonary dysfunction, congenital heart disease in children;
**Healthy Volunteers:** True
**Maximum Age:** 10 Years
**Minimum Age:** 2 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** KuangYu Zhao
**Phone:** +8613251535857
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jun Zhou, PHD
**Phone:** +8613592582222
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Zhengzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zhou Jun
- **Phone:** +8613592582222
- **Role:** CONTACT
**Country:** China
**Facility:** Department of Anaesthesiology and Perioperative Medicine, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital
**State:** Henan
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Henan Provincial People's Hospital
**Name:** Jun Zhou, PHD
**Role:** STUDY_CHAIR
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425393
**Brief Title:** Intrafamilial Helicobacter Pylori Infection in Hong Kong
**Official Title:** Prevalence and Risk Factors of Intrafamilial Helicobacter Pylori Infection in Hong Kong: a Prospective Cohort Study
#### Organization Study ID Info
**ID:** 2024.143
#### Organization
**Class:** OTHER
**Full Name:** Chinese University of Hong Kong
### Status Module
#### Completion Date
**Date:** 2026-12-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-11
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Chinese University of Hong Kong
#### Responsible Party
**Investigator Affiliation:** Chinese University of Hong Kong
**Investigator Full Name:** Lily Wan Ying LAI
**Investigator Title:** Resident doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** It is a single-centre, prospective cohort study, which will be conducted in a tertiary academic hospital. The study aims to investigate intrafamilial H. pylori infection status and to identify risk factors for H. pylori infection among household members.
The rate of intrafamilial H. pylori spread in Hong Kong is currently unknown. It is also not clear whether the same risk factors for intrafamilial spread of H. pylori infection also apply in Hong Kong. In contrast to mainland China and Taiwan , recent consensus guideline on H. pylori management in Hong Kong in 2023 recommends against routine testing of asymptomatic household members or family members of H. pylori-infected adults. There is a knowledge gap on whether the family-based H. pylori screening is cost effective in our locality. Thus, the investigator aim to investigate infection status of household members of H. pylori infected individuals and risk factors for household infection in Hong Kong. The result from this study will shed light on the role of family-based screening and can inform future healthcare policy making on the strategy of H. pylori management and treatment in Hong Kong, ameliorating H. pylori infection-related disease and gastric cancer burden for society.
**Detailed Description:** Helicobacter pylori infects around half of the population in the world, and it is believed to affect more than half of population in Hong Kong. H. pylori infection is a well-known cause of chronic gastritis, peptic ulcer diseases and gastric cancer. Early detection and eradication of H. pylori infection is of utmost importance.
H. pylori infection is mainly transmitted by oral-oral, faecal-oral routes and water sources . Emerging studies demonstrated that intrafamilial spread is common. Recent national, family-based epidemiological study on H. pylori infection in mainland China showed a high familial infection rate ranging from 50.27% to 85.06%. In another study in central China, it was found that all family members were infected with H. pylori in 27.8% of the H. pylori infected households. Therefore, detection and eradication of H. pylori infection in family are very important to prevent development of H. pylori related diseases. Instead of the traditional strategies for individual-based management of H. pylori infection like 'test and treat' and 'screen and treat' strategies, a new strategy 'family- based H. pylori infection control and management' has been introduced. In 2021, China published a consensus report on the Family-based H. pylori infection control and management with an aim to reduce intrafamilial H. pylori spread in the Chinese population. In Taiwan, where the incidence of GC is high, a preventive strategy with 13C-urea breath test screening using the index case method and outreach the family members of the positive index cases. Eradication therapies for those who test positive and to follow up 2 years later to test the reinfection rate has been implemented to reduce the incidence of gastric cancers and reduce the cancer health inequality in indigenous communities.
Previous studies have identified several risk factors for intrafamilial transmission of H. pylori infection. Large family size of 3 or more in a household and living in highly infected areas in Northwest China were risk factors for household H. pylori infection while family members with higher income and education level , using serving spoons or chopsticks , drinking boiled water from tap source were associated with lower risk of household infection.
There is concern on the re-infection rate of H. pylori after eradication therapy. A systemic review revealed that global annual recurrence, reinfection and recrudescence rates of H. pylori were 4.3% (95%CI: 4-5), 3.1% (95%CI: 2-5) and 2.2% (95%CI: 1-3), respectively. An observational study in Turkey found that for H. pylori infected patients with whole family testing and eradication, the recurrence rate was 7.1% 9 months after treatment. On the other hand, when only the infected patient was eradicated but the whole family infection was not treated, the recurrence rate was 38.6% 9 months after treatment. These results suggest that treatment of the whole infected family is of great value in controlling H. pylori re-infection and preventing recurrence.
### Conditions Module
**Conditions:**
- H.Pylori Infection
**Keywords:**
- H.pylori infection
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Patients who are diagnosed to have H. pylori infection by either histology, rapid urease test or urea breath test will be recruited. At least 1 household member of each H. pylori infected subject will also be recruited.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The H. pylori infected subject is responsible for providing details of the number of household members, family structure, family history of gastric diseases, family economy, living conditions, family hygiene and living habits. Patients also need to provide personal information including HKID, ethnicity.
**Label:** H. pylori positive subjects
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** The household members of the index subjects will be invited to complete a questionnaire which includes the baseline demographics, past medical history, personal hygiene and living habits. Also, they will be received urea beath test (UBT). Referral will be given to those positive result household members.
**Intervention Names:**
- Diagnostic Test: Urea beath test (UBT)
**Label:** H. pylori positive subjects' household members
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- H. pylori positive subjects' household members
**Description:** H. pylori infection will be tested using a 13C-urea breath test Kit for all enrolled family members, following the manufacturer's instructions. The sensitivity and specificity of the assay are both over 95%, according to the manufacturer's introduction.
**Name:** Urea beath test (UBT)
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The rate of H. pylori infection in household members of H. pylori infected subjects from the given UBT
**Measure:** Rate of H. pylori infection in household members
**Time Frame:** during the study period, 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults age\>=18 years of age
* For H. pylori infected patients only: Diagnosed to have H. pylori infection by either histology, rapid urease test or urea breath test
* Written informed consent obtained
Exclusion Criteria:
* Unable to perform urea breath test
* Contraindications for urea breath test
* Used antibiotics within the past month/proton pump inhibitors within two weeks
**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:** Felix Sia
**Phone:** 26370428
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** There will be no plan to share individual participant data.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: 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: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007239
- Term: Infections
- ID: D000003141
- Term: Communicable Diseases
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M1804
- Name: Carbamide Peroxide
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425380
**Brief Title:** Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
**Official Title:** Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
#### Organization Study ID Info
**ID:** HUM00251803
#### Organization
**Class:** OTHER
**Full Name:** University of Michigan
### Status Module
#### Completion Date
**Date:** 2026-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Michigan
#### Responsible Party
**Investigator Affiliation:** University of Michigan
**Investigator Full Name:** Patricia Bloom
**Investigator Title:** Assistant Professor of Internal Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** This research is studying how a food product (resistant potato starch) which is a dietary supplement made from potato starch affects the gut bacteria of people with cirrhosis and hepatic encephalopathy.
The researchers in this study want to understand how potato starch works in the subject's body and how the body will react to it. Along with taking the study product participants health-related information and stool will be collected for this research study.
### Conditions Module
**Conditions:**
- Hepatic Encephalopathy
- Cirrhosis
**Keywords:**
- Resistant Potato Starch
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This will be taken for four weeks by enrolled participants.
**Intervention Names:**
- Other: Resistant Potato Starch
**Label:** Resistant potato starch
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Resistant potato starch
**Description:** Participants will receive 4 weeks of resistant potato starch 20 grams (g) twice daily. Bob's Red Mill® potato starch will be used. Every patient will receive the same dose and there are no dose titrations.
**Name:** Resistant Potato Starch
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The study team will compare the total concentrations of the 3 most abundant SCFAs in humans (acetate, propionate, and butyrate) at baseline and week 4. Stool will undergo SCFA quantification by the University of Michigan Metabolomics core.
**Measure:** Change in stool short-chain fatty acid (SCFA) levels from baseline to week 4
**Time Frame:** Baseline, Week 4
#### Secondary Outcomes
**Description:** In this test patients name as many animals as they can in 60 seconds. The ANT score is the number of unique animals named.
**Measure:** Change in animal naming test (ANT) from baseline to week 4
**Time Frame:** Baseline, Week 4
**Description:** The severity or grade of an adverse event may be measured using the following definitions:
Mild: Noticeable to the subject, but does not interfere with subject's expected daily activities, usually does not require additional therapy or intervention, dose reduction, or discontinuation of the study.
Moderate: Interferes with the subject's expected daily activities, may require some additional therapy or intervention but does not require discontinuation of the study.
Severe: Extremely limits to the subject's daily activities and may require discontinuation of study therapy, and/or additional treatment or intervention to resolve and may be life-threatening or fatal.
**Measure:** Number and type of adverse events from baseline to week 8
**Time Frame:** baseline to week 8
**Description:** Gastrointestinal questionnaire has six questions with a total score ranging from 1-30 with the lower score indicating a healthier status.
**Measure:** Change in T-score for the Patient Reported Outcomes Measurement Information System (PROMIS) gastrointestinal diarrhea 6a baseline to week 4
**Time Frame:** Baseline, Week 4
**Description:** The Gas and Bloating scale has13 questions (scale 2-60; with higher scores corresponding to more severe gas/bloating).
**Measure:** Change in T-score for the PROMIS Gastrointestinal Gas and Bloating 13a scale baseline to week 4
**Time Frame:** Baseline, Week 4
**Measure:** Number of patients enrolled in the study as a proportion of the number of patients contacted by the study team
**Time Frame:** start of screening, end of enrollment (approximately 20 months)
**Description:** Proportion of study activities completed
**Measure:** Feasibility of completing study activities
**Time Frame:** baseline, week 8
**Description:** Proportion of study samples collected (number collected from all patients / number requested from patients).
**Measure:** Feasibility based on the number of specimens collected
**Time Frame:** baseline, week 4
**Description:** Proportion of drop outs
**Measure:** Retention to end of study
**Time Frame:** start of screening, end of enrollment (approximately 20 months)
**Description:** Proportion of doses consumed
**Measure:** Intervention adherence
**Time Frame:** baseline, week 4
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Able to provide consent, with signed and dated informed consent form.
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Diagnosis of cirrhosis based on liver biopsy, imaging, or evidence of clinical decompensation.
* History of at least one episode of overt Hepatic Encephalopathy (HE) in the last year.
* Defined by West Haven Criteria Grades II to IV
* Can be precipitated Hepatic Encephalopathy (HE) episode.
* Sexually active women of childbearing potential enrolled in the study must agree to use a highly-effective method of contraception (defined in the protocol) for the duration of the study.
Exclusion Criteria:
* Hospitalization in the last 4 weeks
* Current refractory ascites (requiring large volume paracentesis to manage ascites)
* Gut-absorbable or intravenous antibiotic therapy in the last 4 weeks (rifaximin is permitted)
* Anticipated antibiotics in the coming 4 weeks
* Use of lactulose in the last 4 weeks
* Alcohol or illicit drug intake in the last 4 weeks
* By history
* Alcohol use will be characterized as \>1 alcoholic drink / week
* History of inflammatory bowel disease
* History of primary sclerosing cholangitis
* Total bilirubin in the last 3 months \> 4 mg/dL
* Prior diagnosis of dementia or other primary neurocognitive disorder
* Pregnancy or breast feeding
* Placement of a portosystemic shunt or transjugular intrahepatic portosystemic shunt in the last 3 months (permissible if placed \>3 months before enrollment)
* Allergy to resistant potato starch
**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:** Max Macgregor
**Phone:** 734-764-0843
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ann Arbor
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Max Macgregor
- **Phone:** 734-764-0843
- **Role:** CONTACT
***Contact 2:***
- **Name:** Patricia Bloom, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Michigan
**State:** Michigan
**Zip:** 48109
#### Overall Officials
**Official 1:**
**Affiliation:** University of Michigan
**Name:** Patricia Bloom, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000008107
- Term: Liver Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000017093
- Term: Liver Failure
- ID: D000048550
- Term: Hepatic Insufficiency
- ID: D000001928
- Term: Brain Diseases, Metabolic
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11103
- Name: Liver Cirrhosis
- Relevance: HIGH
- As Found: Cirrhosis
- ID: M9587
- Name: Hepatic Encephalopathy
- Relevance: HIGH
- As Found: Hepatic Encephalopathy
- ID: M5204
- Name: Brain Diseases
- Relevance: HIGH
- As Found: Encephalopathy
- ID: M8485
- Name: Fibrosis
- Relevance: HIGH
- As Found: Cirrhosis
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19415
- Name: Liver Failure
- Relevance: LOW
- As Found: Unknown
- ID: M25970
- Name: Hepatic Insufficiency
- Relevance: LOW
- As Found: Unknown
- ID: M5205
- Name: Brain Diseases, Metabolic
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2722
- Name: Hepatic Encephalopathy
- Relevance: HIGH
- As Found: Hepatic Encephalopathy
### Condition Browse Module - Meshes
- ID: D000008103
- Term: Liver Cirrhosis
- ID: D000006501
- Term: Hepatic Encephalopathy
- ID: D000001927
- Term: Brain Diseases
- ID: D000005355
- Term: Fibrosis
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425367
**Acronym:** MHR-Blood
**Brief Title:** Impact of Performing a Rapid Antibiotic Susceptibility Test on Antibiotic Therapy Adaptation in Adult Patients With Enterobacterales Bacteremia
**Official Title:** Impact of Performing a Rapid Antibiotic Susceptibility Test (MHR-SIR) on Antibiotic Therapy Adaptation in Adult Patients With Enterobacterales Bacteremia, Controlled, Randomized Cluster and Cross-over Study
#### Organization Study ID Info
**ID:** 650-MHR Blood
#### Organization
**Class:** OTHER
**Full Name:** Fondation Hôpital Saint-Joseph
### Status Module
#### Completion Date
**Date:** 2025-06-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Fondation Hôpital Saint-Joseph
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Bacteremia is defined as the presence of bacteria in the blood. They can potentially lead to life-threatening septic shock.
Effective probabilistic antibiotic therapy must therefore be initiated immediately after blood cultures have been taken.
To diagnose bacteremia, blood culture bottles must first be incubated, which allows bacterial growth and early detection. Then, as soon as the sample is positive, an antibiogram of the incriminated bacterium is carried out by inoculation on MH (Mueller Hinton) medium. This diffusion antibiogram is the reference method and is obtained 24 hours after the vial is positive, i.e. around 48 hours after blood cultures are taken.
American recommendations agree that it is crucial to use rapid diagnostic tests to obtain the antibiogram. Antibiotic susceptibility test data can be used to broaden the spectrum of antibiotics in the event of ineffective therapy. They can also be used to reduce the spectrum of broad-spectrum antibiotics. This is part of the proper use of antibiotics and the reduction of multi-resistant bacteria (MRB) or highly resistant bacteria (HRB). Finally, it is also possible to carry out an early oral relay, thus avoiding intravenous infusions and their complications, and potentially reducing hospitalization times.
The investigators have evaluated a rapid antibiogram by diffusion on MHR-SIR (Mueller-Hinton Rapid-SIR) medium from the blood culture bottle. The investigators were able to obtain antibiogram results 7 hours after blood culture positivity, with excellent correlation compared with the standard method after 24 hours incubation on MH (Mueller-Hinton). The antibiotics tested were the same as with the standard method.
Secondly, The investigators were able to evaluate prospectively the impact of diffusion antibiotic susceptibility testing on MHR-SIR medium on early modification of antibiotic therapy in bacteremia, on 167 patients Antibiotic susceptibility test data on MHR-SIR enabled us to adapt antibiotic therapy 8 hours after blood culture positivity for 74 patients (44%). Antibiotic therapy was ineffective for 30 patients (18%) and was therefore extended. It also enabled us to reduce the spectrum of antibiotic therapy, in particular through early oral relay, for 44 patients (26%).
The aim of this multicenter trial is to validate on a large scale this strategy for obtaining rapid antibiotic susceptibility test results, with significant consequences in terms of optimizing antibiotic therapy.
### Conditions Module
**Conditions:**
- Bacteremia
**Keywords:**
- antibiogram
- bacteremia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** cluster cross-over randomized trial
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 960
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** rapid antibiotic susceptibility testing by diffusion on MHR-SIR (Mueller-Hinton Rapid-SIR) medium from the blood culture bottle. Antibiotic susceptibility test results are obtained 7 hours after blood culture positivity
**Intervention Names:**
- Diagnostic Test: Antibiotic susceptibility testing
**Label:** MHR SIR
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Standard antibiotic susceptibility testing by diffusion on MH (Mueller-Hinton ) medium from the blood culture bottle Antibiotic susceptibility test results are obtained 24 hours after blood culture positivity
**Intervention Names:**
- Diagnostic Test: Antibiotic susceptibility testing
**Label:** MH
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MH
- MHR SIR
**Description:** antibiotic susceptibility testing is performed on MHR-SIR or MH medium depending on randomization
**Name:** Antibiotic susceptibility testing
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** percentage of patients with Enterobacterales bacteremia for whom antibiotic therapy was effective against the incriminating bacterium within 12 hours of a positive blood culture, according to the results of the antibiogram.
**Measure:** Effective Antiobiotherapy
**Time Frame:** 12 hours
#### Secondary Outcomes
**Description:** Time between blood sampling and antibiogram results
**Measure:** Time Frame
**Time Frame:** 3days
**Description:** After obtaining the antibiogram result, was the antibiotherapy modified (Yes or No) and if yes, was it for narrowing the antibiotic spectra (yes or no)
**Measure:** type of Antibiotherapy spectra modification
**Time Frame:** 2 days
**Description:** in hours
**Measure:** Time necessary to modify the spectrum of probabilistic antibiotic therapy after the antibiogram results
**Time Frame:** 2 days
**Description:** in days
**Measure:** time between the start of intravenous antibiotic therapy and oral antibiotics.
**Time Frame:** 1month
**Description:** In days,
**Measure:** length of hospital stay
**Time Frame:** 1 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* age \>= 18
* Patient hospitalized in a clinical department of each participating center
* Patient managed in the context of bacteremia (microbiological criterion = positive blood culture)
* Patient with positive blood culture for Enterobacterales
* Patient affiliated to a health insurance scheme
* Patient/relative having given free, informed and express oral consent
Exclusion Criteria:
* Patients with non-enterobacterial bacteremia
* Patient under guardianship
* Patient deprived of liberty
* Patient under court protection
* Pregnant or breast-feeding patient
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Helene BEAUSSIER
**Phone:** +33144127038
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Juliette COURTIADE MAHLER
**Phone:** +33144127963
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Fondation Hôpital Saint-Joseph
**Name:** Jean Claude NGUYEN VAN, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000001424
- Term: Bacterial Infections
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000007239
- Term: Infections
- ID: D000018805
- Term: Sepsis
- ID: D000018746
- Term: Systemic Inflammatory Response Syndrome
- ID: D000007249
- Term: Inflammation
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M18877
- Name: Bacteremia
- Relevance: HIGH
- As Found: Bacteremia
- ID: M7380
- Name: Disease Susceptibility
- 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: M4722
- Name: Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M12136
- Name: Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M20864
- Name: Sepsis
- Relevance: LOW
- As Found: Unknown
- ID: M16869
- Name: Toxemia
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M20818
- Name: Systemic Inflammatory Response Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016470
- Term: Bacteremia
### Intervention Browse Module - Ancestors
- ID: D000000890
- Term: Anti-Infective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: HIGH
- As Found: Initial
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000900
- Term: Anti-Bacterial Agents
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425354
**Brief Title:** Use of 'Mechanical Power' as a Predictor of Increased Serum and Pulmonary Proinflammatory Cytokine Concentrations in Patients With Acute Hypoxemic Respiratory Failure: A Prospective Observational Study
**Official Title:** Use of 'Mechanical Power' as a Predictor of Increased Serum and Pulmonary Proinflammatory Cytokine Concentrations in Patients With Acute Hypoxemic Respiratory Failure: A Prospective Observational Study
#### Organization Study ID Info
**ID:** RIA24.1
#### Organization
**Class:** OTHER
**Full Name:** University of Roma La Sapienza
### Status Module
#### Completion Date
**Date:** 2027-06-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-04-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-04-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Roma La Sapienza
#### Responsible Party
**Investigator Affiliation:** University of Roma La Sapienza
**Investigator Full Name:** Francesco Alessandri
**Investigator Title:** Prof
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this study is to report the proportion of patients with acute hypoxemic respiratory failyre (AHRF) undergoing mechanical ventilation who exceed 17 J/min of mechanical power (MP) and the difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage.
The main questions it aims to answer are:
1. Which is the proportion of patients who exceed 17 J/min of mechanical power (MP) during the first 72 hours of mechanical ventilation?
2. Is there a difference in terms of cytokine concentration in patients undergoing mechanical power \>17 J/min compared to \<17 J/min?
Patients will be divided into two groups based on respiratory mechanics measurements: low MP group (average MP \<17 J/min) and high MP group (average MP ≥17 J/min). The researchers will collect blood and BAL samples and perform cytokine assays.
### Conditions Module
**Conditions:**
- Mechanical Power
### Design Module
#### Bio Spec
**Description:** plasma serum and BAL
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Mechanical ventilatiom
**Name:** Mechanical ventilation
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Proportion of patients with AHRF undergoing mechanical ventilation who exceed 17 J/min of MP
**Measure:** Patients who exceed 17 J/min of MP
**Time Frame:** 4 years
#### Secondary Outcomes
**Description:** Difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage.
**Measure:** Inflammatory cytokines
**Time Frame:** 4 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with AHRF (P/F \<300 mmHg) undergoing invasive mechanical ventilation within 7 days from the onset of symptoms
* Invasive mechanical ventilation for less than 6 hours
* Evidence of newly developed lung consolidation on chest imaging (X-ray, CT)
* Age ≥18 years
Exclusion Criteria:
* Prior invasive mechanical ventilation during the same hospitalization
* Tracheostomy
* Severe anemia (Hb\<7g/dL)
* Severe neutropenia
* Renal insufficiency or RRT (Renal Replacement Therapy)
* Noradrenaline \>0.5 mcg/kg/min
* Pregnancy
* Extracorporeal circulation (ECCO2R, ECMO)
* Life expectancy \<24 hours as clinically judged
* Lack of consent
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with AHRF undergoing mechanical ventilation
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Roma
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Francesco Alessandri
- **Phone:** 0039 0649978924
- **Role:** CONTACT
***Contact 2:***
- **Name:** Giovanni Giordano
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Italy
**Facility:** Sapienza University of Rome
**Status:** RECRUITING
**Zip:** 00161
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14968
- Name: Respiratory Insufficiency
- Relevance: HIGH
- As Found: Acute Hypoxemic Respiratory Failure
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012131
- Term: Respiratory Insufficiency
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425341
**Brief Title:** A Multicenter, Randomized, Open, Parallel-designed Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B
**Official Title:** A Multicenter, Randomized, Open, Parallel-designed Phase II Study to Evaluate the Efficacy and Safety of HRS-5635 Injection Alone or in Combination With Other Agents in Patients Treated for Chronic Hepatitis B
#### Organization Study ID Info
**ID:** HRS-5635-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Fujian Shengdi Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-09-19
**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:** 2026-05-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Fujian Shengdi Pharmaceutical Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** A multicenter, randomized, open, parallel-designed Phase II study to evaluate the efficacy and safety of HRS-5635 injection alone or in combination with other agents in patients treated for chronic hepatitis B.
### Conditions Module
**Conditions:**
- Chronic Hepatitis B
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Multi-center, random, open, parallel design
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 165
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: HRS-5635 Injection
**Label:** HRS-5635 Injection dose 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: HRS-5635 Injection
**Label:** HRS-5635 Injection dose 2
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Drug: HRS-5635 Injection
**Label:** HRS-5635 Injection dose 3
**Type:** EXPERIMENTAL
#### Arm Group 4
**Intervention Names:**
- Drug: HRS-5635 Injection
**Label:** HRS-5635 Injection dose 4
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- HRS-5635 Injection dose 1
**Description:** HRS-5635 Injection low dose administered by subcutaneous injection
**Name:** HRS-5635 Injection
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- HRS-5635 Injection dose 2
**Description:** HRS-5635 Injection medium dose administered by subcutaneous injection
**Name:** HRS-5635 Injection
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- HRS-5635 Injection dose 3
**Description:** HRS-5635 Injection high dose administered by subcutaneous injection
**Name:** HRS-5635 Injection
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- HRS-5635 Injection dose 4
**Description:** HRS-5635 Injection lowest dose administered by subcutaneous injection
**Name:** HRS-5635 Injection
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** PartA：Change in mean log10 serum hepatitis B surface antigen levels from baseline at week 12
**Time Frame:** Week 12
**Measure:** PartB：Proportion of subjects whose serum hepatitis B surface antigen (HBsAg) had turned negative at week 48
**Time Frame:** Week 48
#### Secondary Outcomes
**Measure:** Changes from baseline in mean log10 serum hepatitis B surface antigen levels
**Time Frame:** Pre-specified time points up to 72 weeks
**Measure:** Proportion of subjects with at least one log10 decline from baseline in serum hepatitis B surface antigen
**Time Frame:** Pre-specified time points up to 72 weeks
**Measure:** Proportion of subjects with serum hepatitis B surface antigen loss
**Time Frame:** Pre-specified time points up to 72 weeks
**Measure:** Proportion of subjects with serum hepatitis B surface antigen seroconversion
**Time Frame:** Pre-specified time points up to 72 weeks
**Measure:** Proportion of subjects with hepatitis B e-antigen loss
**Time Frame:** Pre-specified time points up to 72 weeks
**Measure:** Proportion of subjects with serum hepatitis B e-antigen seroconversion
**Time Frame:** Pre-specified time points up to 72 weeks
**Measure:** Proportion of subjects with virologic breakthrough
**Time Frame:** Pre-specified time points up to 72 weeks
**Measure:** Proportion of subjects with drug resistance
**Time Frame:** Pre-specified time points up to 72 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Meet the body mass index standard greater than or equal to 18.5 kg/m2 and less than 35 kg/m2;
2. Chronic hepatitis B defined as HBV infection documented for at least 6 months prior to screening;
3. Virologically suppressed on nucleoside or nucleotide analogues treatment with HBV DNA below the lower limit of quantitation;
4. On commercially available NAs monotherapy for at least 24 weeks before randomization, and the dosing regimen remained unchanged for at least 4 weeks before randomization;
5. Need to take effective contraceptive measures；
6. Volunteer to sign an informed consent.
Exclusion Criteria:
1. History of cirrhosis or clinical evidence of hepatic decompensation, confirmed or suspected liver cancer, with other liver diseases other than chronic hepatitis B that may affect the evaluation of the study;
2. With autoimmune disease;
3. History of solid organ transplantation or hematopoietic stem cell transplantation;
4. Clinically significant and unstable or uncontrolled severe cardiovascular and cerebrovascular diseases;
5. Malignant tumors were diagnosed within 5 years prior to randomization；
6. Infection requiring intervention within 2 weeks prior to randomization;
7. Major trauma or major surgery within the 12 weeks prior to randomization, or surgical plans or other treatment during the study period which the investigators determined may influence the evaluation of the study results;
8. Laboratory tests during the screening period were obviously abnormal;
9. Prolonged ECG QTcF or other clinically significant abnormal results that may pose a significant safety risk to the subject during the screening period;
10. History of drug use, alcohol or drug abuse in the 12 months prior to randomization;
11. Participated in clinical study of other drugs (received experimental drugs);
12. Pregnant or nursing women;
13. Allergic to a drug ingredient or component;
14. Other reasons for ineligibility as judged by the investigators.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xiaopeng Wang
**Phone:** 0518-82342973
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jinlin Hou
- **Phone:** 020-62787432
- **Role:** CONTACT
**Country:** China
**Facility:** Nanfang Hospital
**State:** Guangdong
**Zip:** 510515
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000008107
- Term: Liver Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000006525
- Term: Hepatitis, Viral, Human
- ID: D000014777
- Term: Virus Diseases
- ID: D000007239
- Term: Infections
- ID: D000004769
- Term: Enterovirus Infections
- ID: D000010850
- Term: Picornaviridae Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000086982
- Term: Blood-Borne Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000018347
- Term: Hepadnaviridae Infections
- ID: D000004266
- Term: DNA Virus Infections
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M9592
- Name: Hepatitis A
- Relevance: HIGH
- As Found: Hepatitis
- ID: M9591
- Name: Hepatitis
- Relevance: HIGH
- As Found: Hepatitis
- ID: M9595
- Name: Hepatitis B
- Relevance: HIGH
- As Found: Hepatitis B
- ID: M21609
- Name: Hepatitis B, Chronic
- Relevance: HIGH
- As Found: Chronic Hepatitis B
- ID: M9607
- Name: Hepatitis, Chronic
- Relevance: HIGH
- As Found: Chronic Hepatitis
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9610
- Name: Hepatitis, Viral, Human
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7930
- Name: Enterovirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M13745
- Name: Picornaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M2593
- Name: Blood-Borne Infections
- Relevance: LOW
- As Found: Unknown
- ID: M20487
- Name: Hepadnaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M7442
- Name: DNA Virus Infections
- 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: D000006506
- Term: Hepatitis A
- ID: D000006509
- Term: Hepatitis B
- ID: D000019694
- Term: Hepatitis B, Chronic
- ID: D000006505
- Term: Hepatitis
- ID: D000006521
- Term: Hepatitis, Chronic
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425328
**Brief Title:** Effect of Nutritional Habits on Oral Microbiota in Adolescents
**Official Title:** Effect of Nutritional Habits on Oral Microbiota in Adolescents
#### Organization Study ID Info
**ID:** ErciyesU-BVD-BAG-01
#### Organization
**Class:** OTHER
**Full Name:** TC Erciyes University
### Status Module
#### Completion Date
**Date:** 2023-11-17
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-11-17
**Type:** ACTUAL
#### Start Date
**Date:** 2023-06-14
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** TC Erciyes University
#### Responsible Party
**Investigator Affiliation:** TC Erciyes University
**Investigator Full Name:** Betül Cicek
**Investigator Title:** PhD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this study is to examine the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents.
**Detailed Description:** Oral microbiota; While it is associated with systemic diseases such as obesity, diabetes and cancer, it is also associated with oral diseases such as oral cancers, tooth decay and gum diseases. Nutrition is seen as an important factor in maintaining oral health. In particular, the amount and frequency of sugar consumption, the type and consistency of food, the frequency of eating, the consumption of cariogenic foods with other foods and the duration of carbohydrates remaining on the teeth are among the factors that affect oral health. The aim of this study is to examine the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents. The study is planned to be carried out in 4 stages. First stage; A survey form will be filled out that questions general information about children, oral health practices, nutritional habits and frequency of food consumption. In the second stage; Children's anthropometric measurements (body weight (kg), height (cm), waist circumference (cm) will be taken and bioelectrical impedance analysis (BIA) results will be recorded. In the third stage, oral examinations of the children will be performed. In the final stage, saliva samples of the children will be collected. Bacteria Logarithmic values will be used when comparing the concentrations between groups. The suitability of the parameters to normal distribution will be evaluated with q-q graphs and Shapiro-Wilk test. Student t test will be used for variables that comply with normal distribution and Mann Whitney U test will be used for changes that do not comply with normal distribution. The relationship will be evaluated with the Spearman or Pearson correlation test according to the normality distribution. IBM SPSS (Statistical Package for Social Sciences) 22.0 package program will be used when evaluating the data obtained as a result of the study. While examining the hypothesis tests, α = 0.05 and accordingly the confidence interval will be determined as 95%. It will be evaluated at p\<0.05 level. In order to enable healthy adolescents to reach a good standard of living, there is a need for a more accurate understanding of the relationship between oral microbiota, nutrition and sleep. As a result of this study, it is aimed to reveal the relationship between oral microbiota and eating habits, sleep quality and hedonic hunger in adolescents.
### Conditions Module
**Conditions:**
- Nutrition, Healthy
- Adolescent Behavior
- Microbial Colonization
**Keywords:**
- adolescent
- Nutritional Sciences
- Oral Health
### Design Module
#### Bio Spec
**Description:** Saliva samples were taken from all participants.
**Retention:** NONE_RETAINED
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 40
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, those with a BMI z score below -1 SD are defined as underweight.
**Label:** Underweight
#### Arm Group 2
**Description:** BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, BMI z scores between -1 SD +1 SD are defined as normal weight.
**Label:** Normal weight
#### Arm Group 3
**Description:** BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, those with a BMI z score between +1 SD +2 SD are defined as overweight
**Label:** Overweight
#### Arm Group 4
**Description:** BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19. Accordingly, those with a BMI z score above +2 SD are defined as obese.
**Label:** Obese
### Outcomes Module
#### Primary Outcomes
**Description:** For oral microbiota analysis, saliva samples were taken from children who had brushed their teeth in the morning and had not consumed any food until 2 hours before, and microbiological procedures were performed. Saliva samples taken from all patients participating in the study were stored at -80°C until analysis. Saliva samples collected during the research process were transported to the center where the analyzes were carried out by preserving the cold chain, and DNA isolation and sequence analysis were carried out together with molecular biologists.
**Measure:** Oral microbiome characteristics
**Time Frame:** 1 month
#### Secondary Outcomes
**Description:** BMI calculation was calculated with the equation "body weight (kg) / height (m)2" using body weight and height measurement results. BMI was evaluated according to the World Health Organization's BMI Z score classification for ages 5-19.
**Measure:** Anthropometric Measurements
**Time Frame:** Within 10 minutes during the meeting with the participant
**Description:** On the first day of the food consumption record, a 24-hour retrospective was taken by the researcher, and on the other days, it was recorded in detail by telephone.
**Measure:** 3 day food consumption record
**Time Frame:** 3 days
**Description:** Intraoral examination of all children in the study group was performed by sitting on a chair by the window and using a mirror-probe in daylight. Intraoral examination of all children was performed by a single pediatric dentist (E.D.) and recorded in the patient information form. The total number of decayed, missing and filled teeth (Decayed, Missing, And Filled Teeth: DMFT) and tooth surfaces (Decayed, Missing, And Filled Surfaces: DMFS) were calculated.
**Measure:** Oral Examination
**Time Frame:** Within 15 minutes during the meeting with the participant
**Description:** It is a 24-question survey that evaluates sleep quality and disorders by scoring them over a one-month period.
**Measure:** Pittsburg sleep quality index
**Time Frame:** Within 10 minutes during the meeting with the participant
**Description:** It is a 15-question survey developed to be used to determine hedonic hunger in school-age children.
**Measure:** Children's Power of Food Scale
**Time Frame:** Within 10 minutes during the meeting with the participant
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 14-16 years old
* Not receiving special medical nutrition therapy
* No chronic systemic disease, nutritional disorder and/or endocrine disease that may affect growth and development
* Adolescents without congenital developmental disorders
Exclusion Criteria:
* Those who had any severe oral disease or periodontal treatment including supragingival curettage and root planning before the study
* Those who used any antibiotic, anti-inflammatory or sedative medication until 3 months before the study
* Those with bleeding gums on the working day or within the previous 4 weeks
* Those who smoke
**Healthy Volunteers:** True
**Maximum Age:** 16 Years
**Minimum Age:** 14 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** The study included 40 adolescents aged 14-16, who were thin, healthy, slightly overweight and obese, who applied to İsmet Yılmaz Akansu Family Health Center and met the inclusion criteria.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kayseri
**Country:** Turkey
**Facility:** Erciyes University
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: 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: Microbial Colonization
- ID: M6368
- Name: Communicable Diseases
- Relevance: HIGH
- As Found: Microbial Colonization
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003141
- Term: Communicable Diseases
- ID: D000007239
- Term: Infections
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425315
**Brief Title:** Management of Malnutrition in Oncogeriatrics
**Official Title:** Does Targeted Management of Undernutrition in Oncogeriatric Patients Aged 70 and Over, Undergoing Cancer Treatment and Hospitalized From January 2022 to December 2023, Improve Their Nutritional and Functional Status?
#### Organization Study ID Info
**ID:** 69HCL23_5390
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2024-08-24
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospices Civils de Lyon
#### 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 France, undernutrition affects almost three million people, a third of whom are over 70 (Diagnosing undernutrition earlier in the elderly aged 70 and over, n.d.). In fact, 30 to 70% of hospitalized elderly patients suffer from protein-energy undernutrition (denutrition_personne_agee_2007_-_recommandations.pdf, n.d.).
The Nutricancer 2 study published in 2014, demonstrated that undernutrition is common among cancer patients. Indeed, 39% of patients suffer from undernutrition and its prevalence depends on the type of cancer, with a predominance of esophagus, stomach and pancreas (60% to 66%), colon/rectum, ovary/uterus and lung (39% to 45%), hematological malignancies (34%), as well as prostate and breast (13% to 20%) (Hébuterne et al., 2014). Moreover, over the past 30 years, undernutrition has been observed in 30% to 50% of the population at the time of diagnosis and before the start of cancer treatment (Boranian et al., n. d.).
Undernutrition is often associated with several terms such as malnutrition, anorexia, sarcopenia or cachexia, which refer to geriatric or metabolic syndromes of multifactorial origin that sometimes overlap, and are often observed in cancer patients. Cancer cachexia is a metabolic syndrome associated with undernutrition of multifactorial origin (Boranian et al., n.d.). Its prevalence is around 50% to 80% in cancer patients and is an independent indicator of morbidity and mortality in this population (Nicolini et al., 2013).
Undernutrition is a major health issue in elderly cancer patients. It is therefore crucial to diagnose it early, given its high prevalence in this population and the serious complications it can lead to. In 2021, the HAS updated its recommendations on the diagnosis of undernutrition in the elderly. The diagnosis of severe undernutrition is based on several criteria, including serum albumin levels. This is a commonly used marker of nutritional status, especially in patients with involuntary weight loss. However, it is important to note that hypoalbuminemia can be observed in many pathological conditions, including inflammatory syndromes common in cancer. Therefore, interpretation of albuminemia results must take into account the patient's inflammatory status, assessed by C-reactive protein. This analysis makes it possible to distinguish undernutrition due to insufficient food intake from that associated with an inflammatory syndrome and hypercatabolism (Patry \& Raynaud-Simon, 2010).
### Conditions Module
**Conditions:**
- Undernutrition
- Cancer
**Keywords:**
- Malnutrition
- Geriartric oncology
- Aged
- Antineoplastic agents
- Muscle strenght
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Our study population consists of oncogeriatric patients aged 70 and over, hospitalized in the oncogeriatric follow-up and referral unit (USSROG), with a diagnosis of moderate or severe undernutrition and undergoing cancer treatment. Patients will be recruited between January 1, 2022 and December 31, 2023.
We anticipate a sample size of between 100 and 120 patients over this period.
**Label:** Oncogeriatric patients with undernutrition
### Outcomes Module
#### Primary Outcomes
**Description:** the variation in albumin values associated with CRP values will be collected on admission and after the first month, at 2 months and then at 3 months of hospitalization.
These values will then be analyzed using statistical analysis software, to determine whether the results obtained are relevant and favor an improvement in albumin levels, and consequently in the patient's nutritional status.
**Measure:** The criterion chosen to demonstrate this is: absolute albumin values in g/l in patients with moderate undernutrition and in those with severe undernutrition after the first month of hospitalization, at 2 months and then at 3 months.
**Time Frame:** It will be measured at the start of hospitalization and after the first month, at 2 months and then at 3 months.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients aged 70 and over with a diagnosis of moderate or severe undernutrition
* All patients with diagnosed cancer and ongoing cancer treatment.
Exclusion Criteria:
* Patients under 70 years of age
* Hospitalized patients no longer undergoing anticancer treatment
* All patients undergoing pre-habilitation for surgery
**Minimum Age:** 70 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
**Study Population:** The population of this study will be made up of oncogeriatric patients aged 70 and over, hospitalized in the USSROG unit with a diagnosis of undernutrition and undergoing anticancer treatment.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lyon
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** KOUADJO Blé Evelyne
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** PIOT-BOISSIER Claude, Dr
- **Role:** CONTACT
**Country:** France
**Facility:** Hopital Pierre Garraud
**Zip:** 69005
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009748
- Term: Nutrition Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M25306
- Name: Malnutrition
- Relevance: HIGH
- As Found: Undernutrition
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000044342
- Term: Malnutrition
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425302
**Acronym:** GOLSEEK-2
**Brief Title:** A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma
**Official Title:** A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma
#### Organization Study ID Info
**ID:** CA073-1022
#### Organization
**Class:** INDUSTRY
**Full Name:** Celgene
#### Secondary ID Infos
**Domain:** WHO
**ID:** U1111-1303-4594
**Type:** OTHER
**Domain:** EU CTR
**ID:** 2024-511304-16
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-11-27
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-11-23
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-03
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### 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 purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).
### Conditions Module
**Conditions:**
- Lymphoma, Follicular
**Keywords:**
- Follicular lymphoma
- Grade 1-3a Follicular lymphoma
- BMS-986369
- CC-99282
- Lymphoma
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
**Intervention Names:**
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
- Drug: Bendamustine
**Label:** Rituximab + Chemotherapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Golcadomide
- Drug: Rituximab
**Label:** Golcadomide Dose 1 + Rituximab
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Drug: Golcadomide
- Drug: Rituximab
**Label:** Golcadomide Dose 2 + Rituximab
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Golcadomide Dose 1 + Rituximab
- Golcadomide Dose 2 + Rituximab
**Description:** Specified dose on specified days
**Name:** Golcadomide
**Other Names:**
- CC-99282
- BMS-986369
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Golcadomide Dose 1 + Rituximab
- Golcadomide Dose 2 + Rituximab
- Rituximab + Chemotherapy
**Description:** Specified dose on specified days
**Name:** Rituximab
**Other Names:**
- Mabthera
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Rituximab + Chemotherapy
**Description:** Specified dose on specified days
**Name:** Cyclophosphamide
**Other Names:**
- Endoxan
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Rituximab + Chemotherapy
**Description:** Specified dose on specified days
**Name:** Doxorubicin
**Other Names:**
- Caelyx
- pegylated liposomal doxorubicin
- PLD
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- Rituximab + Chemotherapy
**Description:** Specified dose on specified days
**Name:** Vincristine
**Type:** DRUG
#### Intervention 6
**Arm Group Labels:**
- Rituximab + Chemotherapy
**Description:** Specified dose on specified days
**Name:** Prednisone
**Type:** DRUG
#### Intervention 7
**Arm Group Labels:**
- Rituximab + Chemotherapy
**Description:** Specified dose on specified days
**Name:** Bendamustine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Golcadomide + Rituximab arms only
**Measure:** Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014
**Time Frame:** Up to approximately 12 months from participant randomization
#### Secondary Outcomes
**Measure:** Number of participants with Adverse Events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria, v.5.0
**Time Frame:** Up to 28 days after last dose
**Measure:** Number of participants with Treatment-emergent AEs (TEAEs) as assessed by the NCI CTCAE criteria, v.5.0
**Time Frame:** Up to 28 days after last dose
**Description:** Defined as achieving CMR or partial metabolic response (PMR) based on Lugano criteria 2014
**Measure:** Best Overall Response (OR)
**Time Frame:** Up to approximately 12 months from participant randomization
**Description:** Defined as time from first confirmed response (Complete Response (CR) or Partial Response (PR)) to disease progression, start of new anti-lymphoma therapy, or death
**Measure:** Duration of Response (DoR)
**Time Frame:** Up to approximately 3 years after randomization of the last participant
**Description:** Defined as achieving CR based on Lugano criteria at 30 months from randomization
**Measure:** Complete Response at 30 months (CR30)
**Time Frame:** At approximately 30 months from randomization
**Description:** Defined as achieving CMR based on Lugano criteria 2014 at 6 months from randomization
**Measure:** Complete Metabolic Response at 6 months from the randomization (CMR6)
**Time Frame:** At approximately 6 months from randomization
**Description:** Defined as achieving CMR based on Lugano criteria 2014 at 12 months from randomization
**Measure:** Complete Metabolic Response at 12 months from the randomization (CMR12)
**Time Frame:** At approximately 12 months from randomization
**Description:** Defined as time from date of randomization to first occurrence of disease progression or death from any cause
**Measure:** Progression Free Survival (PFS)
**Time Frame:** Up to approximately 3 years from randomization of last participant
**Description:** Defined as time from date of randomization to death from any cause
**Measure:** Overall Survival (OS)
**Time Frame:** Up to approximately 3 years from randomization of last participant
**Description:** Rituximab + Chemotherapy arm only
**Measure:** Number of participants who achieve CMR as assessed by Lugano criteria 2014
**Time Frame:** Up to approximately 6 months from randomization
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participant has histologically confirmed Grade 1, 2 or 3a follicular lymphoma (FL) or classic FL. Formalin-fixed paraffin embedded (FFPE) archival tissue from 1 year prior to screening is allowed. If more than 1 year has passed, then a fresh biopsy must be obtained to confirm the diagnosis.
* Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable.
* Stage II to IV disease.
* Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:.
i) Bulky disease defined as:.
A. A nodal or extra nodal (except spleen) mass \> 7cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than \>3 cm).
ii) Presence of at least one of the following B symptoms:.
A. Fever (\>38°C) of unclear etiology.
B. Night sweats.
C. Weight loss greater than 10% within the prior 6 months.
iii) Splenomegaly with inferior margin below the umbilical line.
iv) Any one of the following cytopenia due to lymphoma:.
A. Platelets \<100,000 cells/mm3 (100 x 109/L).
B. Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5 x 109/L).
C. Hemoglobin \< 10g/dL (6.25 mmol/L).
v) Pleural or peritoneal serous effusion (irrespective of cell content)
vi) Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal)
Exclusion Criteria:
* Clinical evidence of transformed lymphoma by investigator assessment.
* Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification.
* Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study.
* Other protocol-defined Inclusion/Exclusion criteria apply.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_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:** Birmingham
**Contacts:**
***Contact 1:***
- **Name:** Site 0152
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0152
**State:** Alabama
**Zip:** 35294-3300
**Location 2:**
**City:** Anchorage
**Contacts:**
***Contact 1:***
- **Name:** Site 0055
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0055
**State:** Alaska
**Zip:** 99508
**Location 3:**
**City:** Phoenix
**Contacts:**
***Contact 1:***
- **Name:** Site 0180
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0180
**State:** Arizona
**Zip:** 85054
**Location 4:**
**City:** Tucson
**Contacts:**
***Contact 1:***
- **Name:** Site 0190
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0190
**State:** Arizona
**Zip:** 85711
**Location 5:**
**City:** San Francisco
**Contacts:**
***Contact 1:***
- **Name:** Site 0035
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0035
**State:** California
**Zip:** 94143
**Location 6:**
**City:** Washington
**Contacts:**
***Contact 1:***
- **Name:** Site 0022
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0022
**State:** District of Columbia
**Zip:** 20007
**Location 7:**
**City:** Jacksonville
**Contacts:**
***Contact 1:***
- **Name:** Site 0005
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0005
**State:** Florida
**Zip:** 32224
**Location 8:**
**City:** Tampa
**Contacts:**
***Contact 1:***
- **Name:** Site 0026
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0026
**State:** Florida
**Zip:** 33606
**Location 9:**
**City:** Peoria
**Country:** United States
**Facility:** Local Institution - 0013
**State:** Illinois
**Zip:** 61615
**Location 10:**
**City:** Fairway
**Contacts:**
***Contact 1:***
- **Name:** Site 0019
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0019
**State:** Kansas
**Zip:** 66205
**Location 11:**
**City:** Jefferson
**Contacts:**
***Contact 1:***
- **Name:** Site 0173
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0173
**State:** Louisiana
**Zip:** 70121
**Location 12:**
**City:** Baltimore
**Contacts:**
***Contact 1:***
- **Name:** Site 0033
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0033
**State:** Maryland
**Zip:** 21287
**Location 13:**
**City:** Boston
**Country:** United States
**Facility:** Local Institution - 0001
**State:** Massachusetts
**Zip:** 02114
**Location 14:**
**City:** Boston
**Contacts:**
***Contact 1:***
- **Name:** Site 0004
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0004
**State:** Massachusetts
**Zip:** 02114
**Location 15:**
**City:** Rochester
**Contacts:**
***Contact 1:***
- **Name:** Site 0031
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0031
**State:** Minnesota
**Zip:** 55905
**Location 16:**
**City:** Henderson
**Contacts:**
***Contact 1:***
- **Name:** Site 0111
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0111
**State:** Nevada
**Zip:** 89074
**Location 17:**
**City:** Hackensack
**Contacts:**
***Contact 1:***
- **Name:** Site 0183
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0183
**State:** New Jersey
**Zip:** 07601
**Location 18:**
**City:** New Brunswick
**Country:** United States
**Facility:** Local Institution - 0020
**State:** New Jersey
**Zip:** 08903
**Location 19:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Name:** Site 0036
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0036
**State:** New York
**Zip:** 10029
**Location 20:**
**City:** Salt Lake City
**Contacts:**
***Contact 1:***
- **Name:** Site 0052
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0052
**State:** Utah
**Zip:** 84106
**Location 21:**
**City:** Norfolk
**Country:** United States
**Facility:** Local Institution - 0200
**State:** Virginia
**Zip:** 23502
**Location 22:**
**City:** Norfolk
**Contacts:**
***Contact 1:***
- **Name:** Site 0201
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0201
**State:** Virginia
**Zip:** 23502
**Location 23:**
**City:** Seattle
**Contacts:**
***Contact 1:***
- **Name:** Site 0166
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0166
**State:** Washington
**Zip:** 98104
**Location 24:**
**City:** Seattle
**Contacts:**
***Contact 1:***
- **Name:** Site 0202
- **Role:** CONTACT
**Country:** United States
**Facility:** Local Institution - 0202
**State:** Washington
**Zip:** 98109
**Location 25:**
**City:** Liverpool
**Contacts:**
***Contact 1:***
- **Name:** Site 0046
- **Role:** CONTACT
**Country:** Australia
**Facility:** Local Institution - 0046
**State:** New South Wales
**Zip:** 2170
**Location 26:**
**City:** Brisbane
**Contacts:**
***Contact 1:***
- **Name:** Site 0070
- **Role:** CONTACT
**Country:** Australia
**Facility:** Local Institution - 0070
**State:** Queensland
**Zip:** 4101
**Location 27:**
**City:** Traralgon
**Contacts:**
***Contact 1:***
- **Name:** Site 0181
- **Role:** CONTACT
**Country:** Australia
**Facility:** Local Institution - 0181
**State:** Victoria
**Zip:** 3844
**Location 28:**
**City:** Porto Alegre
**Contacts:**
***Contact 1:***
- **Name:** Site 0061
- **Role:** CONTACT
**Country:** Brazil
**Facility:** Local Institution - 0061
**State:** Rio Grande Do Sul
**Zip:** 90035-903
**Location 29:**
**City:** Sao Paulo
**Contacts:**
***Contact 1:***
- **Name:** Site 0058
- **Role:** CONTACT
**Country:** Brazil
**Facility:** Local Institution - 0058
**State:** São Paulo
**Zip:** 04543-000
**Location 30:**
**City:** Rio de Janeiro
**Contacts:**
***Contact 1:***
- **Name:** Site 0060
- **Role:** CONTACT
**Country:** Brazil
**Facility:** Local Institution - 0060
**Zip:** 22250-905
**Location 31:**
**City:** São Paulo
**Contacts:**
***Contact 1:***
- **Name:** Site 0056
- **Role:** CONTACT
**Country:** Brazil
**Facility:** Local Institution - 0056
**Zip:** 05652-900
**Location 32:**
**City:** Toronto
**Contacts:**
***Contact 1:***
- **Name:** Site 0064
- **Role:** CONTACT
**Country:** Canada
**Facility:** Local Institution - 0064
**State:** Ontario
**Zip:** M5G 2M9
**Location 33:**
**City:** Santiago
**Contacts:**
***Contact 1:***
- **Name:** Site 0049
- **Role:** CONTACT
**Country:** Chile
**Facility:** Local Institution - 0049
**State:** Región Metropolitana De Santiago
**Zip:** 7500921
**Location 34:**
**City:** Santiago
**Contacts:**
***Contact 1:***
- **Name:** Site 0050
- **Role:** CONTACT
**Country:** Chile
**Facility:** Local Institution - 0050
**State:** Región Metropolitana De Santiago
**Zip:** 7580206
**Location 35:**
**City:** Saint-Cloud
**Contacts:**
***Contact 1:***
- **Name:** Site 0101
- **Role:** CONTACT
**Country:** France
**Facility:** Local Institution - 0101
**State:** Hauts-de-Seine
**Zip:** 92210
**Location 36:**
**City:** Lille
**Contacts:**
***Contact 1:***
- **Name:** Site 0103
- **Role:** CONTACT
**Country:** France
**Facility:** Local Institution - 0103
**State:** Nord
**Zip:** 59000
**Location 37:**
**City:** Poitiers
**Contacts:**
***Contact 1:***
- **Name:** Site 0121
- **Role:** CONTACT
**Country:** France
**Facility:** Local Institution - 0121
**State:** Vienne
**Zip:** 86021
**Location 38:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Name:** Site 0118
- **Role:** CONTACT
**Country:** France
**Facility:** Local Institution - 0118
**Zip:** 75010
**Location 39:**
**City:** Regensburg
**Contacts:**
***Contact 1:***
- **Name:** Site 0197
- **Role:** CONTACT
**Country:** Germany
**Facility:** Local Institution - 0197
**State:** Bayern
**Zip:** 93049
**Location 40:**
**City:** Chemnitz
**Contacts:**
***Contact 1:***
- **Name:** Site 0188
- **Role:** CONTACT
**Country:** Germany
**Facility:** Local Institution - 0188
**State:** Sachsen
**Zip:** 09116
**Location 41:**
**City:** Dresden
**Contacts:**
***Contact 1:***
- **Name:** Site 0189
- **Role:** CONTACT
**Country:** Germany
**Facility:** Local Institution - 0189
**Zip:** 01307
**Location 42:**
**City:** Rome
**Contacts:**
***Contact 1:***
- **Name:** Site 0198
- **Role:** CONTACT
**Country:** Italy
**Facility:** Local Institution - 0198
**State:** Lazio
**Zip:** 00133
**Location 43:**
**City:** Rozzano
**Contacts:**
***Contact 1:***
- **Name:** Site 0179
- **Role:** CONTACT
**Country:** Italy
**Facility:** Local Institution - 0179
**State:** Milano
**Zip:** 20089
**Location 44:**
**City:** Bari
**Country:** Italy
**Facility:** Local Institution - 0096
**State:** Puglia
**Zip:** 70124
**Location 45:**
**City:** Bari
**Country:** Italy
**Facility:** Local Institution - 0098
**State:** Puglia
**Zip:** 70124
**Location 46:**
**City:** Bari
**Country:** Italy
**Facility:** Local Institution - 0097
**Zip:** 70124
**Location 47:**
**City:** Bologna
**Contacts:**
***Contact 1:***
- **Name:** Site 0076
- **Role:** CONTACT
**Country:** Italy
**Facility:** Local Institution - 0076
**Zip:** 40138
**Location 48:**
**City:** Napoli
**Contacts:**
***Contact 1:***
- **Name:** Site 0075
- **Role:** CONTACT
**Country:** Italy
**Facility:** Local Institution - 0075
**Zip:** 80131
**Location 49:**
**City:** Hwasun Gun
**Contacts:**
***Contact 1:***
- **Name:** Site 0104
- **Role:** CONTACT
**Country:** Korea, Republic of
**Facility:** Local Institution - 0104
**State:** Jeonranamdo
**Zip:** 58128
**Location 50:**
**City:** Busan
**Contacts:**
***Contact 1:***
- **Name:** Site 0100
- **Role:** CONTACT
**Country:** Korea, Republic of
**Facility:** Local Institution - 0100
**State:** Pusan-Kwangyǒkshi
**Zip:** 49241
**Location 51:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Name:** Site 0085
- **Role:** CONTACT
**Country:** Korea, Republic of
**Facility:** Local Institution - 0085
**State:** Seoul-teukbyeolsi [Seoul]
**Zip:** 03080
**Location 52:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Name:** Site 0086
- **Role:** CONTACT
**Country:** Korea, Republic of
**Facility:** Local Institution - 0086
**State:** Seoul-teukbyeolsi [Seoul]
**Zip:** 06351
**Location 53:**
**City:** Bydgoszcz
**Contacts:**
***Contact 1:***
- **Name:** Site 0186
- **Role:** CONTACT
**Country:** Poland
**Facility:** Local Institution - 0186
**State:** Kujawsko-pomorskie
**Zip:** 85-168
**Location 54:**
**City:** Warszawa
**Contacts:**
***Contact 1:***
- **Name:** Site 0185
- **Role:** CONTACT
**Country:** Poland
**Facility:** Local Institution - 0185
**State:** Mazowieckie
**Zip:** 01-748
**Location 55:**
**City:** Skorzewo
**Contacts:**
***Contact 1:***
- **Name:** Site 0187
- **Role:** CONTACT
**Country:** Poland
**Facility:** Local Institution - 0187
**State:** Wielkopolskie
**Zip:** 60-185
**Location 56:**
**City:** Palma
**Contacts:**
***Contact 1:***
- **Name:** Site 0196
- **Role:** CONTACT
**Country:** Spain
**Facility:** Local Institution - 0196
**State:** Balears [Baleares]
**Zip:** 07120
**Location 57:**
**City:** Valencia
**Contacts:**
***Contact 1:***
- **Name:** Site 0192
- **Role:** CONTACT
**Country:** Spain
**Facility:** Local Institution - 0192
**State:** Valenciana, Comunitat
**Zip:** 46017
**Location 58:**
**City:** Madrid
**Contacts:**
***Contact 1:***
- **Name:** Site 0191
- **Role:** CONTACT
**Country:** Spain
**Facility:** Local Institution - 0191
**Zip:** 28040
**Location 59:**
**City:** Kaohsiung
**Contacts:**
***Contact 1:***
- **Name:** Site 0094
- **Role:** CONTACT
**Country:** Taiwan
**Facility:** Local Institution - 0094
**Zip:** 807
**Location 60:**
**City:** Kaohsiung
**Contacts:**
***Contact 1:***
- **Name:** Site 0092
- **Role:** CONTACT
**Country:** Taiwan
**Facility:** Local Institution - 0092
**Zip:** 83301
**Location 61:**
**City:** Taipei
**Contacts:**
***Contact 1:***
- **Name:** Site 0123
- **Role:** CONTACT
**Country:** Taiwan
**Facility:** Local Institution - 0123
**Zip:** 10002
**Location 62:**
**City:** Southampton
**Contacts:**
***Contact 1:***
- **Name:** Site 0175
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** Local Institution - 0175
**State:** Hampshire
**Zip:** SO16 0YD
**Location 63:**
**City:** Canterbury
**Contacts:**
***Contact 1:***
- **Name:** Site 0112
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** Local Institution - 0112
**State:** Kent
**Zip:** CT1 3NG
**Location 64:**
**City:** Edinburgh
**Contacts:**
***Contact 1:***
- **Name:** Site 0115
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** Local Institution - 0115
**State:** Midlothian
**Zip:** EH4 2XU
**Location 65:**
**City:** Nottingham
**Contacts:**
***Contact 1:***
- **Name:** Site 0105
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** Local Institution - 0105
**Zip:** NG5 1PB
#### Overall Officials
**Official 1:**
**Affiliation:** Bristol-Myers Squibb
**Name:** Bristol-Myers Squibb
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** See plan description
**Description:** BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
**Info Types:**
- STUDY_PROTOCOL
- SAP
- CSR
**IPD Sharing:** YES
**Time Frame:** See plan description
**URL:** https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
### 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
### 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: M11221
- Name: Lymphoma, Follicular
- Relevance: HIGH
- As Found: Lymphoma, Follicular
- 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: T2361
- Name: Follicular Lymphoma
- Relevance: HIGH
- As Found: Follicular lymphoma
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
- ID: D000008224
- Term: Lymphoma, Follicular
### Intervention Browse Module - Ancestors
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000018906
- Term: Antineoplastic Agents, Alkylating
- ID: D000000477
- Term: Alkylating Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000019653
- Term: Myeloablative Agonists
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000903
- Term: Antibiotics, Antineoplastic
- ID: D000059005
- Term: Topoisomerase II Inhibitors
- ID: D000059003
- Term: Topoisomerase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000000893
- Term: Anti-Inflammatory 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: D000000972
- Term: Antineoplastic Agents, Phytogenic
- ID: D000050257
- Term: Tubulin Modulators
- ID: D000050256
- Term: Antimitotic Agents
- ID: D000050258
- Term: Mitosis Modulators
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M6727
- Name: Cyclophosphamide
- Relevance: HIGH
- As Found: Cycle
- ID: M7492
- Name: Doxorubicin
- Relevance: HIGH
- As Found: Women
- ID: M227339
- Name: Liposomal doxorubicin
- Relevance: HIGH
- As Found: Women
- ID: M14121
- Name: Prednisone
- Relevance: HIGH
- As Found: Min
- ID: M430
- Name: Bendamustine Hydrochloride
- Relevance: HIGH
- As Found: Dressing
- ID: M373
- Name: Rituximab
- Relevance: HIGH
- As Found: Healthy
- ID: M17495
- Name: Vincristine
- Relevance: HIGH
- As Found: Volume
- ID: M10212
- Name: Immunosuppressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20942
- Name: Antineoplastic Agents, Alkylating
- Relevance: LOW
- As Found: Unknown
- ID: M3820
- Name: Alkylating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- 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: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M9047
- Name: Glucocorticoids
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20966
- Name: Antineoplastic Agents, Hormonal
- Relevance: LOW
- As Found: Unknown
- ID: M26197
- Name: Tubulin Modulators
- Relevance: LOW
- As Found: Unknown
- ID: M26196
- Name: Antimitotic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000011241
- Term: Prednisone
- ID: D000003520
- Term: Cyclophosphamide
- ID: D000069461
- Term: Bendamustine Hydrochloride
- ID: D000069283
- Term: Rituximab
- ID: D000004317
- Term: Doxorubicin
- ID: C000506643
- Term: Liposomal doxorubicin
- ID: D000014750
- Term: Vincristine
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425289
**Brief Title:** Macrohemodynamic Impact of Fluid Removal With Net Ultrafiltration in Patients With Continuous Renal Replacement Therapy
**Official Title:** Macrohemodynamic Impact of Fluid Removal With Net Ultrafiltration in Patients With Continuous Renal Replacement Therapy: A Monocentric Ancillary Study of the EarlyDry Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 69HCL23_5388
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2026-02-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospices Civils de Lyon
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Macrohemodynamic impact of fluid removal with net ultrafiltration in patients with continuous renal replacement therapy. A monocentric ancillary study of the EarlyDry randomized controlled trial.
### Conditions Module
**Conditions:**
- Fluid Removal
- Critically Ill
- Continuous Renal Replacement Therapy
- Fluid Overload
**Keywords:**
- Fluid removal
- Hemodynamic
- Net ultrafiltration
- Continuous renal replacement therapy
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Procedure: Fluid balance negativation
During the RRT, UFnet will be settled on 2ml/kg/h and adapted to hemodynamic tolerance and tissue perfusion .
When the patient's baseline body weight is reached the UF net will be settled to maintain it.
In case of failure of the fluid balance negativation after 24h, UFnet will be settled on 3ml/kg/h. Then when the baseline body weight is reached UFnet will be settled on 0.5 et 1ml/kg/h or if necessary adapted to 1,5ml/kg/h to maintain it
In case of hemodynamic intolerance (NADN \> 0,5 µg/kg/min) or tissue hypoperfusion, UF net will be stopped during 6 hours and restarted if NADN \< 0,5 µg/kg/min and without tissue hypoperfusion.
**Intervention Names:**
- Other: Macrohemodynamic parameters
**Label:** Experimental: Corrective strategy
#### Arm Group 2
**Description:** Procedure: Body weight Stabilization
During the RRT, UFnet will be settled between 0 et 1 ml/kg/h and adapted in case of weight stabilization failure or hemodynamic intolerance.
In case of weight stabilisation failure (variation \>5%), the UF net can be increased to 1,5 ml/kg/h.
In case of hemodynamic intolerance (NADN \> 0,5 µg/kg/min), UF net will be stopped during 6 hours and restarted if NADN \< 0,5 µg/kg/min.
**Intervention Names:**
- Other: Macrohemodynamic parameters
**Label:** Other: Stabilizing strategy In the control group, all patients will have a UFnet 2 ml settled
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental: Corrective strategy
- Other: Stabilizing strategy In the control group, all patients will have a UFnet 2 ml settled
**Description:** Macrohemodynamic parameters will be estimated with transpulmonary thermodilution every 6 hours during the intervention period (5 days).
* Cardiac index
* Extravascular lung water index
* Pulmonary vascular permeability index
* Cardiac function index
* Global end-diastolic volume index
* Central venous pressure
* Fluid responsivness status (passive leg rising test)
**Name:** Macrohemodynamic parameters
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Area under the curve of a cardiac index \< 2.4 L/min/m2 (L/min/m2.hr), determined by transpulmonary thermodilution every 6 hours, with three boli of cold saline in the superior vena cava territory.
**Measure:** Area under the curve of a low cardiac index
**Time Frame:** Every 6 hours between day 0 to day 5 (intervention period)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Acute kidney injury treated by continuous renal replacement therapy in ICU less than 7 days,
* At least 1 organ failure during ICU in addition to AKI (mechanical ventilation or vasopressors administration\>12 hours),
* Cumulative UF net less than 1000ml before inclusion,
* Norepinephrine \< 0,5 µg/kg/min,
* Absence of hypoperfusion signs,
* Fluid overload defined as follows: fluid overload \> 5% of base weight (based on cumulative fluid balance or a weight gain) and/or peripheral edema (AKIKI edema scale \> 2).
Exclusion Criteria:
* Chronic renal failure hemodialyzed before admission to the ICU,
* Mechanical circulatory support (ECMO, LVAD),
* Pregnant, child -bearing age or lactating women,
* Stroke less than 30 days,
* Intestinal ischemia less than 7 days documented non-operated,
* Interventional study participation or exclusion period on going,
* Guardianship, curatorship or safeguard of justice,
* Absence of signature of free and informed consent by the patient and/or relative,
* Patients not affiliated to a social security scheme or beneficiaries of a similar scheme
* Absence of transpulmonary thermodilution monitoring
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Critically ill patients with fluid overload and renal replacement therapy for fluid overload, included in EarlyDry trial (NCT05817539) and monitored with transpulmonary thermodilution.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bron
**Contacts:**
***Contact 1:***
- **Name:** RUSTE MARTIN, Dr
- **Role:** CONTACT
**Country:** France
**Facility:** Service d'anesthésie-réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
**Zip:** 69500
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M19010
- Name: Critical Illness
- Relevance: HIGH
- As Found: Critically Ill
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016638
- Term: Critical Illness
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425276
**Brief Title:** Evaluate Safety and Efficacy of High-dose Melphalan HCL for Injection in MM Patients With Auto-HSC Transplantation
**Official Title:** A Multicenter, Open-Label, Safety and Efficacy Study of High Dose Melphalan Hydrochloride for Injection for Myeloablative Conditioning in Multiple Myeloma Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
#### Organization Study ID Info
**ID:** EVOM-CL-001
#### Organization
**Class:** INDUSTRY
**Full Name:** CASI Pharmaceuticals (China) Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2021-09-18
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-07-08
**Type:** ACTUAL
#### Start Date
**Date:** 2020-07-24
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** CASI Pharmaceuticals (China) Co., Ltd.
#### 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 learn if high-dose Melphalan HCl for Injection works to treat multiple myeloma. It will also learn about the safety of high dose Melphalan HCl for Injection. The main questions it aims to answer are:
Does high-dose Melphalan HCl for Injection deplete bone marrow activity which results in a better outcome of patients'own stem cell (blood-forming cell) transplantation? What medical problems do participants have when taking high-dose Melphalan HCl for Injection? How fast is the high-dose Melphalan HCl for Injection cleared out from blood?
Participants will:
* Take high-dose Melphalan HCl for Injection for 2 days
* Have stem cell transplantation one day after treatment
* Stay in the hospital for at least 10days and visit the clinic once every week for the first month after transplantation and every month after for checkups and tests.
**Detailed Description:** Autologous stem cell transplantation (ASCT) is a standard of care in transplant-eligible MM patients which has been demonstrated with a better complete remission rate (CR) and with longer survival. High-dose melphalan (200 mg/m2) has been the most commonly used conditioning regimen for ASCT in MM. EVOMELA (melphalan HCl for Injection) stabilized with Captisol, a specially modified cyclodextrin, has been believed to have better solubility and stability upon reconstitution which result in decreased toxicity, increased convenience and flexibility of administration without comprising efficacious data. Melphalan HCl for Injection has been approved by NMPA as a standard conditioning drug for ASCT in MM patients. The current study evaluated the efficacy, safety, and PK profile for high-dose Melphalan HCl for Injection as a myeloablative conditioning regimen in Chinese symptomatic transplant-eligible MM patients.
### Conditions Module
**Conditions:**
- Multiple Myeloma
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 67
**Type:** ACTUAL
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will receive Melphalan HCl for Injection dosed at 100 mg/m2 on Day -3 and Day -2. Following 1 day of rest after the myeloablative conditioning (Day -1), patients will receive an autologous graft with a minimum cell dose of 2 × 106 CD34+ cells/kg of patient body weight (Day 0).
**Intervention Names:**
- Drug: Melphalan Hydrochloride for Injection
**Label:** High-dose Melphalan HCl for Injection treatment arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- High-dose Melphalan HCl for Injection treatment arm
**Description:** During the Study Period, patients will receive Melphalan HCl for Injection dosed at 100 mg/m2 on Day -3 and Day -2.
**Name:** Melphalan Hydrochloride for Injection
**Other Names:**
- Evomela
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** To record the percentage of patients who achieve myeloablation which is defined as absolute neutrophil count \[ANC\] \<0.5 × 109/L, absolute lymphocyte count \[ALC\] \<0.1 × 109/L, or platelet count \<20,000/mm3 in 2 consecutive daily assessments.
**Measure:** Rate of patients achieveing myeloablation
**Time Frame:** 95±5 days after ASCT
**Description:** To record the time, in days, from the date of first dose of High-dose Melphalan HCL for Injection to the date of myoloablation which is defined as absolute neutrophil count \[ANC\] \<0.5 × 109/L, absolute lymphocyte count \[ALC\] \<0.1 × 109/L, or platelet count \<20,000/mm3 in 2 consecutive daily assessments.
**Measure:** Time to achieveing myeloablation
**Time Frame:** 95±5 days after ASCT
**Description:** To record the time, in days, from the date of Auto-HSCT to the date when absolute neutrophil count (ANC) \>0.5 × 109/L in 3 consecutive daily assessments.
**Measure:** Time to achieveing neutrophil engraftment
**Time Frame:** 95±5 days after ASCT
**Description:** To record the time, in days, from the date of Auto-HSCT to the date when untransfused platelet measurement \>20,000/mm3 in 3 consecutive daily assessments.
**Measure:** Time to achieving platelet engraftment
**Time Frame:** 95±5 days after ASCT
**Description:** To characterize the safety, tolerability of High-dose Melphalan HCL for Myeloablation in MM Patients With Auto-HSC Transplantation by recording the incidence of death without relapse or progression of the disease.
**Measure:** Incidence of Treatment-related Motality (TRM)
**Time Frame:** 95±5 days after ASCT
**Description:** To characterize the safety, tolerability of High-dose Melphalan HCL for Injection for Myeloablation in MM Patients With Auto-HSC Transplantation.
**Measure:** Incidence and severity of AEs and SAEs, including changes in laboratory values
**Time Frame:** 95±5 days after ASCT
#### Secondary Outcomes
**Description:** Response assessment per International Myeloma Working Group (IMWG) criteria
**Measure:** Overall Response (ORR)
**Time Frame:** 95±5 days after ASCT
**Description:** Tmax of Melphalan HCL for Injection derived from plasma concentrations of each administration
**Measure:** Tmax of Melphalan HCL for Injection derived from plasma concentrations
**Time Frame:** 24 Hours
**Description:** T1/2 of Melphalan HCL for Injection derived from plasma concentrations of each administration
**Measure:** T1/2 of Melphalan HCL for Injection derived from plasma concentrations
**Time Frame:** 24 Hours
**Description:** Cmax of Melphalan HCL for Injection derived from plasma concentrations of each administration
**Measure:** Cmax of Melphalan HCL for Injection derived from plasma concentrations
**Time Frame:** 24 Hours
**Description:** AUC of Melphalan HCL for Injection derived from plasma concentrations of each administration
**Measure:** AUC of Melphalan HCL for Injection derived from plasma concentrations
**Time Frame:** 24 Hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Diagnosed as symptomatic multiple myeloma, according to the International Myeloma Working Group's IMWG Guidelines for the Diagnosis and Treatment of Multiple Myeloma, treatment is necessary and suitable for autologous hematopoietic stem cell transplantation;
2. When signing the informed consent form, males and females aged ≥ 18 years and ≤ 65 years old;
3. Adequate autologous hematopoietic stem cells were collected, defined as peripheral blood stem cells containing at least 2 x 106 CD34+cells/kg that have not been manipulated or refrigerated;
4. Important organ functions meet the following conditions:
i. Echocardiography indicates left ventricular ejection fraction (LVEF) ≥ 40%;
ii. Serum total bilirubin\<2 times the upper limit of normal value, alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\<3 times the upper limit of normal value;
Iii. creatinine clearance rate\>60 mL/min ;
Iv. Blood oxygen saturation\>92% in non oxygenated state, without significant ventilation or ventilation dysfunction;
5. The Eastern Oncology Collaborative Group (ECOG) physical fitness status of the subjects is 0, 1, or 2;
6. The subject or their legal guardian voluntarily signs an informed consent form approved by the ethics committee before participating in the study, and agrees to complete the entire study treatment according to the clinical trial protocol.
Exclusion Criteria:
1. Multiple myeloma subjects without treatment indications;
2. Suffering from plasma cell leukemia;
3. Suffering from systemic amyloidosis;
4. Subjects with extramedullary plasma cell tumors did not reach PR after induction therapy;
5. Suffering from POEMS syndrome (multiple peripheral neuropathy, organ enlargement, endocrine disorders, M-proteinemia, skin changes);
6. Suffering from Fahrenheit macroglobulinemia;
7. Subjects with non secretory multiple myeloma;
8. Subjects with active bacterial, viral, or fungal infections who require oral or intravenous antibiotic treatment according to the researcher's judgment;
9. The expected survival period of the subjects is less than 6 months;
10. Previously suffering from other malignant tumors, except for cured basal cell carcinoma or cervical carcinoma in situ. Malignant tumors that have undergone curative treatment and achieved complete remission (CR) for more than 5 years can be enrolled. If malignant tumors receive curative treatment but have achieved complete remission (CR) for ≤ 5 years, they cannot be enrolled unless approved by the sponsor;
11. Pregnant or lactating women;
12. Subjects who have fertility and are unwilling to take appropriate contraceptive measures within 3 months after signing the informed consent form until the end of treatment in this study;
13. Positive for human immunodeficiency virus (HIV) antibodies;
14. Subjects with positive hepatitis B virus DNA;
15. The subject receives other concurrent anti-tumor treatments (including chemotherapy, radiation therapy, hormone therapy, or immunotherapy) within 30 days prior to autologous hematopoietic stem cell transplantation, or plans to receive any such treatments before the last study visit on day 95 ± 5;
16. The side effects of chemotherapy drugs received before administration have not yet recovered, defined as not regressing to level 0/1 of the National Cancer Institute's Common Terminology Standard for Adverse Events (NCI-CTCAE v5.0), or at the level specified in the inclusion/exclusion criteria, except for adverse events such as hair loss that the researcher assessed and deemed not to affect the safety of the subject's participation in this study;
17. Allergy or intolerance to any component of the investigational drug formulation;
18. Participants participate in other clinical trials within one month before signing the informed consent form;
19. According to the researcher's judgment, subjects who are not suitable for enrollment, may affect treatment evaluation, or are at inappropriate risk.
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Beijing
**Country:** China
**Facility:** Peking University People's Hospital
#### Overall Officials
**Official 1:**
**Affiliation:** Peking University People's Hospital
**Name:** Kaiyan Liu
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: 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: D000018906
- Term: Antineoplastic Agents, Alkylating
- ID: D000000477
- Term: Alkylating Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000019653
- Term: Myeloablative Agonists
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11541
- Name: Melphalan
- Relevance: HIGH
- As Found: FlutiForm
- ID: M20942
- Name: Antineoplastic Agents, Alkylating
- Relevance: LOW
- As Found: Unknown
- ID: M3820
- Name: Alkylating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10212
- Name: Immunosuppressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008558
- Term: Melphalan
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425263
**Brief Title:** Microfragmented Adipose Tissue Injection Compared to Hyaluronic Acid for Treatment of Temporomandibular Joint Osteoarthritis
**Official Title:** Microfragmented Adipose Tissue Injection Compared to Hyaluronic Acid for Treatment of Temporomandibular Joint Osteoarthritis
#### Organization Study ID Info
**ID:** OMFS 335
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cairo University
#### Responsible Party
**Investigator Affiliation:** Cairo University
**Investigator Full Name:** Mutaz Alkhair Hamad Elsayed
**Investigator Title:** principle investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis.
Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint.
**Detailed Description:** Rationale for conducting the research:
The rationale of this procedure is to remove inflammatory mediators, reduce friction, stimulate the production of new synovial fluid, eliminate suction-cup effect.
The purpose of this study was to evaluate the hypothesis that TMJ arthrocentesis with intraarticular injection of autologous micro fragmented adipose tissue leads to better clinical outcomes in terms of reducing pain and improving function
compared with arthrocentesis and intraarticular injection of hyaluronic acid (HA) in patients with TMJ internal derangement and osteoarthritis.
Preliminary results of this clinical trial show that the injection of micro fragmented adipose tissue can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic.
Further studies with a longer follow-up time are needed to evaluate the clinical stability of the achieved improvement in pain and function.
For this reason, this protocol has been designed with the aim to investigate whether injection in the TMJ of micro fragmented fat tissue can achieve the same improvements of pain and function, compare this technique with standard arthrocentesis with HA injection.
### Conditions Module
**Conditions:**
- Temporomandibular Joint Osteoarthritis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** comparison between injection of hyaluronic acids and adipose tissue in temporomandibular joint
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 28
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** After standard arthrocentesis of the temporomandibular joint
* Direct access to the buccal fat pad, is found at distobuccal depth of the maxillary tuberosity.
* It may be dissected during the resection an upper mucosal incision posterior to the second molar
* After a single scissor stab through the periosteum the (BFP)extrude into the operative site.
* Closure of the flap by suitable suture.
* Collection of lipids then manually manipulated with two syringes connecting together and pushing the lipids against each other to receive the injectable amount of micro fragmented adipose tissue .
**Intervention Names:**
- Biological: adipose tissue fragmented
**Label:** injection with adipose tissue
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Arthrocentesis of the superior joint compartment was performed in all patients under local anesthesia using the technique described by Nitzan et al.
Another 19-gauge needle was inserted into the distended compartment in the area of the articular eminence, and the superior joint space was irrigated with 200 mL saline solution, allowing a free flow through the first needle.
On termination of procedure, 2 mL commercially available hyaluronic injected into the superior compartment.
**Intervention Names:**
- Biological: adipose tissue fragmented
**Label:** injection with hyaluronic acids
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- injection with adipose tissue
- injection with hyaluronic acids
**Description:** harvested from the case form buccal pad of fat
**Name:** adipose tissue fragmented
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** by Vas measurement scale OF PAIN
**Measure:** VAS
**Time Frame:** 3 months
#### Secondary Outcomes
**Description:** degree of opening on each visit
**Measure:** mouth opening
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* \* TMJ osteoarthritis assessed by clinical examination and MRI imaging
* Presence of TMJ-related symptoms including at least limited mouth opening and joint pain
* Previously failed conservative treatment
* Age superior to 14 years
* No previous TMJ surgical procedures
* Acquisition of informed consent;
* Complete availability of the data acquired preoperatively and during each follow-up
* Patients free from any systemic disease that may affect the procedure.
Exclusion Criteria:
* \* Previously diagnosed hematological and neurological conditions;
* Previous malignant head and neck neoplasms;
* Contraindication to fat harvesting.
* Uncooperative patients.
**Gender Based:** True
**Gender Description:** age superior to 14 years of age
**Minimum Age:** 14 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### IPD Sharing Statement Module
**Description:** Dose Lipogems injection affect TMJ derangement more than hyaluronic acid in treatment of the temporomandibular joint osteoarthritis and internal derangement?
Statement of the problem:
Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis.
Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint.
**Info Types:**
- CSR
**IPD Sharing:** YES
**Time Frame:** WITH IN THIS YEAR
## 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: M12926
- Name: Osteoarthritis
- Relevance: HIGH
- As Found: Osteoarthritis
- ID: M4476
- Name: Arthritis
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010003
- Term: Osteoarthritis
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
### Intervention Browse Module - Browse Leaves
- ID: M9878
- Name: Hyaluronic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425250
**Acronym:** Campylo-BJI
**Brief Title:** Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study
**Official Title:** Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study
#### Organization Study ID Info
**ID:** 69HCL23_5284
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Start Date
**Date:** 2024-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospices Civils de Lyon
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Campylobacter bacteria, a Gram-negative bacillus commensal in the digestive tract of many animals and mainly responsible for human infections with digestive origins, has been little studied in the field of osteoarticular infections (OAI). Campylobacter spp. are, however, well described, mainly for C. fetus, and pose a dual therapeutic problem: i) a capacity for persistence due to the capacity of most strains to form biofilm; and ii) potential resistance to many antibiotics. The management of IOA caused by Campylobacter spp. is not codified, and is based on small series of cases reported in the literature.
### Conditions Module
**Conditions:**
- Campylobacter Infections
**Keywords:**
- Management
- Risk factors
- Campylobacter spp.
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022
**Intervention Names:**
- Other: Management, progression and risk factors for failure of BJI caused by Campylobacter spp.
- Other: Description of the evolution and risk factors for failure of osteoarticular infections caused by Campylobacter spp.
**Label:** Management, progression and risk factors for failure of BJI caused by Campylobacter spp.
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Management, progression and risk factors for failure of BJI caused by Campylobacter spp.
**Description:** Description of demographic data (sex, age), comorbidities (ASA and Charlson scores), orthopedic and septic history, and surgical and medical management (antibiotic therapy)
**Name:** Management, progression and risk factors for failure of BJI caused by Campylobacter spp.
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Management, progression and risk factors for failure of BJI caused by Campylobacter spp.
**Description:** Failure of treatment: defined according to a composite criterion bringing together
* persistence of the infection under treatment, and/or
* recurrence of the infection after stopping antibiotic therapy, and/or
* need for surgical revision for septic reasons more than 5 days after initial treatment, and/or
* superinfection, and/or
* definitive explantation of the material, and/or
* decision for suppressive antibiotic therapy, and/or
* amputation, and/or
* death linked to infection
**Name:** Description of the evolution and risk factors for failure of osteoarticular infections caused by Campylobacter spp.
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Treatment failure will be defined as: i) infection persistence under appropriate antimicrobial therapy; ii) infection relapse; iii) need for unplaned surgery; iv) superinfection and/or v) infection-related death
**Measure:** Outcome of Campylobacter spp. BJI, measured as the proportion of treatment failure.
**Time Frame:** Outcome will be measure at 1 year. For patients lost of follow-up or followed-up less than a year, the date of last visit will be used for survival curve analysis .
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* \> 18 years
* Osteoarticular infection (whatever its type), mono or polymicrobial with Campylobacter spp., diagnosed between 01/01/2013 and 12/31/2022:
* Septic arthritis: compatible clinical signs + joint fluid sample positive in culture and/or PCR positive for Campylobacter
* Spondylodiscitis: clinical signs and MRI compatible + blood cultures and/or disco-vertebral biopsy puncture positive in culture and/or PCR positive for Campylobacter
* Osteitis/osteomyelitis: compatible clinico-radiological picture + bone sample (biopsy or intraoperative sample) positive in culture and/or positive PCR for Campylobacter
* Infection on joint prosthesis or osteosynthesis equipment: documented Campylobacter infection and meeting the definition of probable or confirmed JIBS infections
* Patient who was informed and did not object to participating in the study
Exclusion Criteria:
-
**Maximum Age:** 100 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Lyon
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Florent VALOUR, Dr
- **Phone:** 04 72 07 11 07
- **Phone Ext:** +33
- **Role:** CONTACT
**Country:** France
**Facility:** Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse
**Status:** RECRUITING
**Zip:** 69317
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000016905
- Term: Gram-Negative Bacterial Infections
- ID: D000001424
- Term: Bacterial Infections
- 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: M5429
- Name: Campylobacter Infections
- Relevance: HIGH
- As Found: Campylobacter Infections
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M4722
- Name: Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M19249
- Name: Gram-Negative Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M12136
- Name: Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007239
- Term: Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000002169
- Term: Campylobacter Infections
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M16759
- Name: Tin Fluorides
- Relevance: LOW
- As Found: Unknown
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425237
**Acronym:** HERMES
**Brief Title:** Evaluation of the Influence of Aromatherapy and Music Therapy on Stress During the Management of Cerebral Arteriography
**Official Title:** Evaluation of the Influence of Aromatherapy and Music Therapy on Stress During the Management of Cerebral Arteriography
#### Organization Study ID Info
**ID:** 2020 0428 HP
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Rouen
### Status Module
#### Completion Date
**Date:** 2027-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-02
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-09
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Rouen
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Cerebral arteriography is a reference examination in medical imaging. This examination is performed to allow the diagnosis and therapeutic management of patients with vascular pathologies.
It is most often accompanied by a situation of stress, anxiety and apprehension related to the course of the examination or the announcement of the results.
These situations generate physiological reactions in patients, making the performance of cerebral arteriography more complex. In order to improve the quality of care for patients undergoing this invasive examination, it is proposed to use two non-medicinal techniques known for their soothing and relaxing properties: aromatherapy and music therapy alone or in combination. These two techniques will help to establish a common thread from the preparation of the patient before the examination to his return to the post-interventional surveillance room.
### Conditions Module
**Conditions:**
- Patients Scheduled for Cerebral Arteriography for Diagnostic or Therapeutic Purposes
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 224
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Label:** standard care
**Type:** NO_INTERVENTION
#### Arm Group 2
**Intervention Names:**
- Other: music therapy
**Label:** standard care and music therapy
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Other: aromatherapy
**Label:** standard care and aromatherapy
**Type:** EXPERIMENTAL
#### Arm Group 4
**Intervention Names:**
- Other: music therapy
- Other: aromatherapy
**Label:** standard care ansd music therapy and aromatherapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- standard care and music therapy
- standard care ansd music therapy and aromatherapy
**Description:** standard patient care in interventional radiology associated with a well-being atmosphere with the implementation of music therapy (soothing sound environment) in the preparation box and in the examination room.
**Name:** music therapy
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- standard care and aromatherapy
- standard care ansd music therapy and aromatherapy
**Description:** standard patient care in interventional radiology associated with a well being atmosphere with the implementation of aromatherapy (essential oil of Ylang Ylang) in the preparation box and in the examination room.
**Name:** aromatherapy
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** blood pressure
**Measure:** influence of aromatherapy and music therapy on the patient's stress when undergoing cerebral arteriography.
**Time Frame:** day 1
#### Secondary Outcomes
**Description:** scale :0 : no stress to 10 : a lot of stress
**Measure:** stress
**Time Frame:** day 1
**Description:** scale : 0 : no pain to 10 : unbearable pain
**Measure:** level of pain
**Time Frame:** day 1
**Description:** scale : 0 to 7: no anxiety no depressed and 7 to 10 : probably anxiety ans drepressed more than and 10 : symptomatology of anxiety and depressed
**Measure:** hospital anxiety and depression scale
**Time Frame:** day 1
**Measure:** Cumulative X-ray dose (mGy/cm2) received by the patient
**Time Frame:** day 1
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult (≥ 18 years old)
* Patient who is scheduled for a cerebral arteriography with local anaesthesia
* Patient who capable to read and understand the patient information and consent.
* Patient capable to read and sign the consent form
* Patient with social insurance
* Woman of childbearing age with effective contraception (see WHO definition), postmenopausal woman (≥ 12 months of amenorrhea not induced by therapy)
* Negative urine pregnancy test
Exclusion Criteria:
* Patients who have had a previous cerebral arteriogram
* Patient with allergy to iodinated contrast medium
* Patient with severe renal insufficiency
* Patient requiring sedation and artificial ventilation
* Patient who is deaf and/or hard of hearing
* Patient with a known allergy to essential oils
* Patient with anosmia
* Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship,
* Pregnant or breastfeeding woman
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Magali DUVAL, radiology technician
**Phone:** +33 2 32 88 83 83
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Déborah LEBEDIEFF
**Phone:** +33 2 32 88 89 90
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** CHU Rouen
**Name:** Magali DUVAL, radiology technician
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425224
**Acronym:** TENSPE2
**Brief Title:** Effectiveness and Safety of TENS Therapy for Premature Ejaculation
**Official Title:** Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation Therapy for the Management of Patients With Premature Ejaculation. Phase III Clinical Trial
#### Organization Study ID Info
**ID:** BMGC-M1
#### Organization
**Class:** INDUSTRY
**Full Name:** Boston Medical Group
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-06-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Boston Medical Group
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation. The main question to answer is:
Can the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment be evaluated in men with lifelong premature ejaculation, compared to standard pharmacological treatment with dapoxetine?
Patients will:
Be randomized in acontrolled clinical trial. Patients with a diagnosis of premature ejaculation who attend Boston Medical Group clinics in Mexico City will be included.
Be assigned by randomization to one of three treatment groups:
* Group 1: Tens therapy + dapoxetine placebo on demand.
* Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.
* Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).
### Conditions Module
**Conditions:**
- Premature Ejaculation
- Sex Disorder
- TEN
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 129
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows:
1. The active electrode is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia.
The second reference electrode is attached to the calcaneus.
Continuous current, Frequency: 20 Hz Pulse width: 200 µsec, Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation.
They will also receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.
**Intervention Names:**
- Device: Tens therapy
- Drug: Dapoxetine placebo
**Label:** Group 1: Tens therapy + dapoxetine placebo on demand.
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study. In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session.
**Intervention Names:**
- Drug: Standard treatment (dapoxetine 30 mg as needed)
- Device: Placebo therapy
**Label:** Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Tens therapy + standard treatment (dapoxetine 30 mg as needed).
Patients in this group will receive electrostimulation therapy of the posterior tibial nerve, 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance.
In addition to the therapy, patients in this group will receive dapoxetine as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.
**Intervention Names:**
- Device: Tens therapy
- Drug: Standard treatment (dapoxetine 30 mg as needed)
**Label:** Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 1: Tens therapy + dapoxetine placebo on demand.
- Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).
**Description:** There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows:
1. The active electrode (cathode - red) is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia.
The second reference electrode (anode - black) is attached to the calcaneus.
The equipment must previously be programmed under the following parameters:
Continuous current Frequency: 20 Hz. Pulse width: 200 µsec Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation.
**Name:** Tens therapy
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Group 1: Tens therapy + dapoxetine placebo on demand.
**Description:** Patients in this group will receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.
**Name:** Dapoxetine placebo
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.
- Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).
**Description:** Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study
**Name:** Standard treatment (dapoxetine 30 mg as needed)
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.
**Description:** In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session.
**Name:** Placebo therapy
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Average change in intravaginal latency time, measured with a stopwatch by the couple.
**Measure:** Change in intravaginal latency time
**Time Frame:** 12 weeks
#### Secondary Outcomes
**Description:** Average change in intravaginal latency time, measured with a stopwatch by the couple.
**Measure:** Change in intravaginal latency time
**Time Frame:** 24 weeks
**Description:** Proportion of patients with clinical improvement in premature ejaculation, defined as a three-fold increase in the intravaginal ejaculatory latency time.
**Measure:** Clinical improvement in premature ejaculation
**Time Frame:** At weeks 12 (end of therapy) and 24 (three months of follow-up).
**Description:** Proportion of patients with a change in the diagnosis of premature ejaculation according to the PEDT (Premature Ejaculation Diagnostic Tool) questionnaire score in the intervention groups
**Measure:** Change in the diagnosis of premature ejaculation
**Time Frame:** At weeks 12 and 24 (greater than 12 to less than 12).
**Description:** Global Impression of Change Scale score
**Measure:** Global Impression of Change Scale
**Time Frame:** Weeks 12 and 24.
**Description:** Change in the PEP (Premature Ejaculation Profile) questionnaire score
**Measure:** PEP (Premature Ejaculation Profile) questionnaire score
**Time Frame:** At weeks 12 and 24
**Description:** Type, frequency and severity of adverse events during therapy.
**Measure:** Adverse events
**Time Frame:** 24 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Primary premature ejaculation according to the definition of the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation always or almost always occurs within the first minute after penetration, b) inability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, annoyance, frustration and/or avoidance of sexual intimacy.
* Age between 18 and 62 years.
* PEDT score greater than 11.
* Stable heterosexual relationship for at least 6 months with interest in maintaining it for at least the duration of the study.
* Sexual activity at least once a week.
* Minimum chronicity of PD of 6 months.
* Voluntary participation in the study.
* Signing of the informed consent prior to participation in the study.
Exclusion Criteria:
* IIEF-EF score less than 26.
* Glaucoma
* Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotor, endocrine, oncological, renal or rheumatological.
* History of retroperitoneal surgery, radiotherapy or multiple sclerosis.
* History of mental illness: depression, anxiety, suicidal behavior, bipolar disorder, agoraphobia, dysthymia, social phobia, obsessive-compulsive disorder, post-traumatic stress disorder, psychiatric disorder, reported by the patient or due to the use of a medication for one of these conditions.
* Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
* Treatment for PE in the last 3 months.
* Treatment for epileptic syndromes or Parkinson's disease.
* Use of pacemaker or cardiac defibrillator.
* Skin lesions in the area where the electrodes are placed.
* Abuse or dependence on psychoactive substances: alcohol, hallucinogenic drugs.
* Couple who are pregnant or interested in conceiving a pregnancy in the next 3 months.
**Maximum Age:** 62 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Carolina Sandoval, Master
**Phone:** +573133920816
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Héctor Corredor, MD
**Phone:** +573174317162
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ciudad de México
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Carolina Sandoval, MSc
- **Phone:** +573133920816
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Héctor Corredor, Md
- **Phone:** +573174317162
- **Role:** CONTACT
**Country:** Mexico
**Facility:** Boston Medical Group
**Status:** RECRUITING
**Zip:** 01000
#### Overall Officials
**Official 1:**
**Affiliation:** Boston Medical Group
**Name:** Jorge Barba, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007752
- Term: Obstetric Labor, Premature
- ID: D000007744
- Term: Obstetric Labor Complications
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000097910
- Term: Ejaculatory Dysfunction
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000020018
- Term: Sexual Dysfunctions, Psychological
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M25869
- Name: Premature Birth
- Relevance: HIGH
- As Found: Premature
- ID: M29853
- Name: Premature Ejaculation
- Relevance: HIGH
- As Found: Premature Ejaculation
- ID: M15546
- Name: Sexual Dysfunction, Physiological
- Relevance: HIGH
- As Found: Sex Disorder
- ID: M10772
- Name: Obstetric Labor, Premature
- Relevance: LOW
- As Found: Unknown
- ID: M10764
- Name: Obstetric Labor Complications
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M3452
- Name: Ejaculatory Dysfunction
- 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: 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: D000047928
- Term: Premature Birth
- ID: D000061686
- Term: Premature Ejaculation
- ID: D000012735
- Term: Sexual Dysfunction, Physiological
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425211
**Brief Title:** Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
**Official Title:** Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
#### Organization Study ID Info
**ID:** BMGC-6
#### Organization
**Class:** INDUSTRY
**Full Name:** Boston Medical Group
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-10-30
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Boston Medical Group
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation. The main question to answer is:
What is the effectiveness of pelvic floor therapy (electrostimulation, biofeedback, and therapeutic exercise) for the treatment of patients with erectile dysfunction and or premature ejaculation?
Patients will:
* Have an initial consultation of pelvic floor rehabilitation before therapy.
* Be given pelvic floor therapy.
* Have a secondary consultation of pelvic floor rehabilitation after therapy.
Three intervention groups will be included: Group 1: Patients with premature ejaculation Group 2: Patients with erectile dysfunction Group 3: Patients with erectile dysfunction and premature ejaculation.
**Detailed Description:** The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation.
Methodology: Pre-post study. Erectile function or intravaginal latency time will be evaluated before and after pelvic floor therapy, in three groups of patients, independently:
* Group 1: Patients with premature ejaculation
* Group 2: Patients with erectile dysfunction
* Group 3: Patients with erectile dysfunction and premature ejaculation
66 patients will be included and will receive 24 sessions of pelvic floor therapy during 12 weeks. Outcomes will be evaluated at the end of therapy (12 weeks), 3 and 6 months follow-up.
### Conditions Module
**Conditions:**
- Erectile Dysfunction
- Premature (Early) Ejaculation
- Premature Ejaculation
- Pelvic Floor; Weak
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 66
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The therapy depends if patient is classified within muscular hyperactivity or muscular hypoactivity.
For muscular hypoactivity:
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: Session 24
For muscular hyperactivity they will be given:
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: session 24
These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation
**Intervention Names:**
- Behavioral: Therapeutic exercises
- Device: Perineal electromyographic biofeedback
- Device: Electrical stimulation
**Label:** Erectile Dysfunction
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-15 Muscle workout: sessions 16-19 Functional training: sessions 20-23 Final evaluation: session 24
These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation
**Intervention Names:**
- Behavioral: Therapeutic exercises
- Device: Perineal electromyographic biofeedback
- Device: Electrical stimulation
**Label:** Premature Ejaculation
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-12 Muscle workout: sessions 13-20 Functional training: sessions 20-23 Final evaluation: session 24
These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation
**Intervention Names:**
- Behavioral: Therapeutic exercises
- Device: Perineal electromyographic biofeedback
- Device: Electrical stimulation
**Label:** Premature Ejaculation + Erectile Dysfunction
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Erectile Dysfunction
- Premature Ejaculation
- Premature Ejaculation + Erectile Dysfunction
**Description:** Recognition of the pelvic area, respiratory management, lumbo-pelvic mobilization, discrimination of abdomino-pelvic contraction and myofascial release techniques.
**Name:** Therapeutic exercises
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Erectile Dysfunction
- Premature Ejaculation
- Premature Ejaculation + Erectile Dysfunction
**Description:** Free muscle work and gross motor coordination:
**Name:** Perineal electromyographic biofeedback
**Type:** DEVICE
#### Intervention 3
**Arm Group Labels:**
- Erectile Dysfunction
- Premature Ejaculation
- Premature Ejaculation + Erectile Dysfunction
**Description:** Muscular proprioceptive work: 50 Hz 300 µs
**Name:** Electrical stimulation
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Change in baseline intravaginal latency time (IVLT) at the end of therapy. (Groups 1,3)
**Measure:** Change in baseline intravaginal latency time (IVLT)
**Time Frame:** 12 weeks
**Description:** International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score change at the end of therapy. (Groups 2,3)
**Measure:** Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score
**Time Frame:** 12 weeks
#### Secondary Outcomes
**Description:** Change in IVLT at 3 and 6 months of follow-up. (Groups 1,3)
**Measure:** Change in baseline intravaginal latency time (IVLT) at follow-up
**Time Frame:** 3 and 6 months of follow-up.
**Description:** Change in baseline PEP score at the end of therapy, 3 and 6 months of follow-up. (Groups 1,3)
**Measure:** Change Premature Ejaculation Perfil (PEP) score
**Time Frame:** 12 weeks, 3 and 6 months follow-up.
**Description:** Change in baseline PEDT questionnaire score at the end of therapy, 3 and 6 months follow-up. (Groups 1,3)
**Measure:** Change in Premature Ejaculation Diagnosis Tool (PEDT) questionnnaire score
**Time Frame:** 12 weeks, 3 and 6 months follow-up.
**Description:** Change in the parameters of the baseline Intracavity Assessment at the end of therapy, 3 and 6 months follow-up.
**Measure:** Change Intracavity Assessment
**Time Frame:** 12 weeks, 3 and 6 months follow-up.
**Description:** Incidente of side effects related to therapy.
**Measure:** Side Effects
**Time Frame:** 12 weeks, 3 and 6 months follow-up.
**Description:** International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score change at the 3 and 6 months of follow-up. (Groups 2,3)
**Measure:** Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score at follow-up
**Time Frame:** 3 and 6 months of follow-up.
**Description:** Increase of 1 point in the baseline EHS at the end of therapy, 3 and 6 months of follow-up. (Groups 2,3)
**Measure:** Change in Erection Hardness Score (EHS)
**Time Frame:** 12 weeks, 3 and 6 months of follow-up.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Overall:
* Men over 18 years of age
* Erectile dysfunction or premature ejaculation for at least 6 months
* Sexual activity with a heterosexual partner at least once a week
* Signing of informed consent before the start of the study
For the premature ejaculation group:
* Premature ejaculation according to the International Society of Sexual Medicine (ISSM) criteria
* Premature Ejaculation Diagnosis Tool (PEDT) questionnaire score greater than 11
For the erectile dysfunction group:
* Clinical diagnosis of primary erectile dysfunction
* International Index Erectile Function - Erectile Function domain (IIEF-EF) score less than 26
Exclusion Criteria:
* Pharmacological treatment for erectile dysfunction or premature ejaculation in the last 3 months
* Erection Hardness Score (EHS) greater than 3 for patients with erectile dysfunction
* History of hypogonadism or suspected hypogonadism due to Aging Males Symptoms (AMS) score greater than 36 for patients with erectile dysfunction
* History of pelvic radiotherapy
* Pacemaker or cardiac arrhythmia, epilepsy
* History of spinal cord trauma or spinal surgeries.
* Inability to attend therapies or controls
* Illiteracy or cognitive disability that prevents you from completing the questionnaires
* Psychiatric, psychological disorders, or cognitive deficiencies
* Injuries in the area of application of the therapy
* Active pelvic organ cancer
**Maximum Age:** 100 Years
**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:** +573133920816
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Héctor Corredor, MD
**Phone:** +573174317162
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bogotá
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Carolina Sandoval, Master
- **Phone:** 57 3208899777
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Héctor Corredor, MD
- **Phone:** +57 3174317162
- **Role:** CONTACT
**Country:** Colombia
**Facility:** Boston Medical Group Colombia
**State:** Cundinamarca
**Status:** RECRUITING
**Zip:** 11022
#### Overall Officials
**Official 1:**
**Affiliation:** Boston Medical Group
**Name:** Cristina Amaya
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007752
- Term: Obstetric Labor, Premature
- ID: D000007744
- Term: Obstetric Labor Complications
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000012735
- Term: Sexual Dysfunction, Physiological
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000020018
- Term: Sexual Dysfunctions, Psychological
- ID: D000001523
- Term: Mental Disorders
- ID: D000097910
- Term: Ejaculatory Dysfunction
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M25869
- Name: Premature Birth
- Relevance: HIGH
- As Found: Premature
- ID: M10217
- Name: Erectile Dysfunction
- Relevance: HIGH
- As Found: Erectile Dysfunction
- ID: M29853
- Name: Premature Ejaculation
- Relevance: HIGH
- As Found: Premature Ejaculation
- ID: M10772
- Name: Obstetric Labor, Premature
- Relevance: LOW
- As Found: Unknown
- ID: M10764
- Name: Obstetric Labor Complications
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- 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
- ID: M3452
- Name: Ejaculatory Dysfunction
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000047928
- Term: Premature Birth
- ID: D000007172
- Term: Erectile Dysfunction
- ID: D000061686
- Term: Premature Ejaculation
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425198
**Brief Title:** Study to Assess Drug Levels and Safety of BMS-986278 in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
**Official Title:** A Phase 1, Multi-center, Open-label Study to Assess the Pharmacokinetics and Safety of BMS-986278 in Healthy Participants and Those With Mild, Moderate and Severe Hepatic Impairment
#### Organization Study ID Info
**ID:** IM027-1009
#### Organization
**Class:** INDUSTRY
**Full Name:** Bristol-Myers Squibb
### Status Module
#### Completion Date
**Date:** 2024-12-23
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-23
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Bristol-Myers Squibb
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to assess the drug levels and safety of BMS-986278 in participants with mild, moderate, and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function.
### Conditions Module
**Conditions:**
- Hepatic Impairment
- Healthy Participants
**Keywords:**
- Healthy Volunteers
- Pharmacokinetics
- Liver Diseases
- Mild, Moderate and Severe Hepatic Impairment
- BMS-986278
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 48
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: BMS-986278
**Label:** Group A: Mild Hepatic Impairment BMS-986278
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: BMS-986278
**Label:** Group B: Moderate Hepatic Impairment BMS-986278
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Drug: BMS-986278
**Label:** Group C: Severe Hepatic Impairment BMS-986278
**Type:** EXPERIMENTAL
#### Arm Group 4
**Intervention Names:**
- Drug: BMS-986278
**Label:** Group D: Normal Hepatic Function BMS-986278
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A: Mild Hepatic Impairment BMS-986278
- Group B: Moderate Hepatic Impairment BMS-986278
- Group C: Severe Hepatic Impairment BMS-986278
- Group D: Normal Hepatic Function BMS-986278
**Description:** Specified dose on specified days
**Name:** BMS-986278
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Maximum observed concentration (Cmax)
**Time Frame:** Up to day 9
**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 9
**Measure:** Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
**Time Frame:** Up to day 9
#### Secondary Outcomes
**Measure:** Incidence of adverse events (AEs)
**Time Frame:** Up to 62 days
**Measure:** Incidence of serious adverse events (SAEs)
**Time Frame:** Up to 62 days
**Measure:** Number of participants with physical examination abnormalities
**Time Frame:** Up to 62 days
**Measure:** Number of participants with vital sign abnormalities
**Time Frame:** Up to 62 days
**Measure:** Number of participants with electrocardiogram (ECG) abnormalities
**Time Frame:** Up to 62 days
**Measure:** Number of participants with clinical laboratory abnormalities
**Time Frame:** Up to 62 days
**Measure:** Time of maximum observed concentration (Tmax)
**Time Frame:** Up to day 9
**Measure:** Terminal elimination half-life (T-HALF)
**Time Frame:** Up to day 9
**Measure:** Apparent body clearance (CLT/F)
**Time Frame:** Up to day 9
**Measure:** Maximum observed plasma concentration of unbound drug (Cmax_u)
**Time Frame:** Up to day 9
**Measure:** Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration of unbound drug [AUC(0-T)_u]
**Time Frame:** Up to day 9
**Measure:** Area under the plasma concentration-time curve from time 0 extrapolated to infinite time of unbound drug [AUC(INF)_u]
**Time Frame:** Up to day 9
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
All Participants:
* Must have a body mass index (BMI) between 18 and 40 kg/m\^2 (inclusive), and body weight ≥ 50 kg.
Mild, Moderate, or Severe Hepatic Impairment Participants:
* Mild, moderate, or severe hepatic impairment (HI) or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
* Mild, moderate, and severe HI participants will be enrolled according to the Child-Pugh classification score.
Matched Healthy Participants:
* Free of any clinically significant disease that would interfere with the study evaluations.
* Normal hepatic function participants will be enrolled and matched individually with HI participants with respect to age (± 10 years), weight (± 20%), sex, and race/ethnicity (Japanese and Chinese participants vs non-Japanese and non-Chinese participants).
Exclusion Criteria:
All Participants:
* History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women, or 14 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
Mild, Moderate, or Severe Hepatic Impairment Participants:
* Acute liver disease (eg, caused by an acute infection or drug toxicity).
* History of initial stage/planned liver transplantation within 6 months of screening or has received a liver transplant.
Matched Healthy Participants:
* Any significant medical condition, or psychiatric illness that would prevent participant from participating in the study.
* Other protocol-defined inclusion/exclusion criteria apply.
**Healthy Volunteers:** True
**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:** BMS Study Connect Contact Center www.BMSStudyConnect.com
**Phone:** 855-907-3286
**Role:** CONTACT
**Contact 2:**
**Name:** First line of the email MUST contain NCT # and Site #.
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Bristol-Myers Squibb
**Name:** Bristol-Myers Squibb
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.
Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html
**IPD Sharing:** NO
### 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/s/US/English/USenHome
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M11107
- Name: Liver Diseases
- Relevance: HIGH
- As Found: Hepatic Impairment
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008107
- Term: Liver Diseases
### 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: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425185
**Brief Title:** Differences and Changes in Lower Limb Muscle Activation and Ankle Stability in Different Blackboard Configurations
**Official Title:** Differences in Electromyographic Activity of Ankle Stabilizer Muscles in the Different Configurations of a Specific Instability Device: an Observational Study
#### Organization Study ID Info
**ID:** 1271077
#### Organization
**Class:** OTHER
**Full Name:** University of Valencia
### Status Module
#### Completion Date
**Date:** 2024-05-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-09
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Valencia
#### Responsible Party
**Investigator Affiliation:** University of Valencia
**Investigator Full Name:** Rodrigo Martín-San-Agustin
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this observational study is to analyze the differences in muscle activation of six muscles of the lower leg (soleus, gastrocnemius medialis, gastrocnemius lateralis, tibialis anterior, peroneus longus, peroneus brevis) in seven possible configurations of a specific instability device, the Blackboard (BB), as well as on the floor, among healthy active subjects.
The main questions it aims to answer are:
1. Which configuration of the BB produces the highest activation for each studied muscle?
2. Which muscle is the most activated in each configuration of the BB?
3. What is the muscle activation pattern obtained in each configuration of the BB?
A single group of participants will be analyzed. Both the studied leg and the order of configurations of the instability device and ground condition will be randomly assigned. Participants will first undergo a 2-minute continuous walking warm-up, followed by a performance of a maximum voluntary isometric contraction (MVIC) for each muscle, during which the maximum activation produced will be recorded. Each participant will be allowed a 30-second familiarization period on the most unstable configuration of the BB. Three repetitions of 20 seconds will be recorded on both the ground and each configuration, with a 30-second rest between repetitions. The central 10 seconds of each trial will be used for subsequent analysis. The mean of the three repetitions for each muscle will be calculated and subsequently processed and normalized by the maximum activation value during the MIVC.
Finally, a statistical analysis of the differences in muscle activation in each configuration will be conducted with the intention of addressing the mentioned questions.
**Detailed Description:** The use of different instability devices is common in the clinical setting, both for preventive and therapeutic purposes. Numerous studies have demonstrated their effectiveness in improving stability and proprioception, although in most cases in a generalized manner. The need to selectively target specific structures and joints has led to the development of specific instability systems, such as the Blackboard (BB).
The BB is an instability device composed of two rectangular wooden boards, joined together, with Velcro on its base where rounded slats can be freely placed to generate the desired instability according to the patient's or subject's requirements. It is known for its portability, small size, and adaptability, and, as demonstrated in a previous study, similar to traditional devices (BOSU or Wobble board) in activating the Peroneus longus muscle, essential for single-leg stability. However, its detailed functioning is still not fully understood, as the muscle activation it produces during single-leg stance in its different configurations has not been analyzed yet.
This study is a single-group cross-sectional observational study and it will include a sample of 30 participants who will be analyzed in a single session, during single-leg stance on the floor and on the different configurations of the BB. Electrode placement will follow SENIAM guidelines. The session will begin with a 2-minute continuous walking warm-up, followed by the recording of muscle activation in a maximum voluntary isometric contraction (MVIC). Subsequently, the participant will be allowed a 30-second familiarization period on the most unstable configuration of the BB (Total - see description below). Muscle activation of six leg muscles (soleus, medial gastrocnemius, lateral gastrocnemius, tibialis anterior, peroneus longus, and peroneus brevis) will be measured during single-leg stance on the different configurations of the BB and on the ground, randomly.
The analyzed variable will be muscle activation, and the MuscleLab 4020e surface electromyography device from Ergotest Technology AS will be used. The maximum value obtained during the central 10 seconds of the measurement (which will last a total of 20 seconds) will be recorded, in three attempts with 30 seconds of rest between them.
The hypothesis of this study is that by selecting a BB configuration that reinforces the expected muscle function based on ankle biomechanics, its activation will increase. Thus, configurations that require movements such as eversion, to increase activation of the peroneus longus and brevis, or supination, aiming to increase activation of the tibialis anterior, among others, will be analyzed. The description of the different configurations is detailed below, for the right foot:
* Floor: single-leg stance on a firm surface, in this case, the floor
* Rear: single-leg stance on the BB, with the front table fixed and the rear table with the slat placed centrally
* Inver: single-leg stance on the BB, with the front table fixed and the rear table with the slat placed laterally (demanding an inversion movement of the heel)
* Ever: single-leg stance on the BB, with the front table fixed and the rear table with the slat placed medially (demanding an eversion movement of the heel)
* Sup: single-leg stance on the BB, with the rear table fixed and the front table with the slat placed laterally (demanding a supination movement of the forefoot)
* Pro: single-leg stance on the BB, with the rear table fixed and the front table with the slat placed medially (demanding a pronation movement of the forefoot)
* Fore: single-leg stance on the BB, with the rear table fixed and the front table with the slat placed centrally
* Total: single-leg stance on the BB, with both the front and rear tables with the slats placed centrally
In all cases, the subject's objective is to ensure that the edges of the BB are not in contact with the floor.
Thus, the aim of this study is to analyze the differences in electromyographic activity of the six studied muscles across the eight different conditions. This includes identifying the most activated muscles in each condition and determining which condition produces the highest activation of each muscle. Additionally, a secondary aim is to establish patterns of muscular activation for each condition, that is, for each requested movement of the foot and ankle.
### Conditions Module
**Conditions:**
- Electromyography
**Keywords:**
- Ankle stability
- Muscle activation
- Instability device
- Healthy
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The study group consists of 30 subjects who are free from any specific medical condition or injury affecting the lower extremities. These subjects are physically active individuals without any known musculoskeletal disorders or impairments. They all will be assessed in the same way.
Data collection will take place during single-leg stance on the BB in its different configurations and on the floor. Three attempts of 20 seconds each will be recorded for each condition. The subjects will perform these exercises under the guidance of a trained physiotherapist.
**Intervention Names:**
- Other: Single-leg stance under different instability conditions
**Label:** Cross-sectional study group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cross-sectional study group
**Description:** Participants will perform three attempts of 20 seconds of single-leg stance on the floor and on the 7 selected configurations of the BB. The order of measurement will be randomized. The description of the chosen configurations can be found in the Detailed Description section. In all cases, the participant's objective is to ensure that the edges of the BB are not in contact with the floor.
The position of the participant on the BB will be a single-leg stance on the randomly chosen foot, with the contralateral knee slightly flexed and hands placed on the hips. Participants will look at a fixed point placed 3 meters in front of them.
A rest period of 30 seconds will be allowed between trials. The physiotherapist responsible for supervising the measurements will be the one to adjust the BB configurations when needed.
**Name:** Single-leg stance under different instability conditions
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The electrode placement area will be shaved and cleaned with alcohol. Muscles analyzed will include soleus, gastrocnemius medialis, gastrocnemius lateralis, tibialis anterior, peroneus longus and peroneus brevis. The MuscleLab 4020e, Ergotest Technology AS surface electromyography device will be used, and adhesive electrode placement will follow SENIAM guidelines.
Muscle activity will be recorded during 3 periods of 20" with 30" of rest in between. The single-leg stance will be done on the Floor condition and on the 7 instability configurations of the BB.
The central 10" of the measurement will be used for subsequent analysis. The electromyography signal will be processed and cleaned, and the maximum value registered will be subsequently normalized by the muscle activation obtained during a maximal voluntary isometric contraction, yielding the normalized electromyography (nEMG) for each muscle. The average of the three attempts will be the value used for statistical analysis.
**Measure:** nEMG level of six leg muscles during single-leg stance across eight different conditions
**Time Frame:** Immediately after the MIVC test, during the single evaluation session, with an approximate duration of 30 minutes (20 minutes of measurement duration, plus time for familiarization and subject preparation)
#### Secondary Outcomes
**Description:** The maximum value of muscle activation during a maximal voluntary isometric contraction (MVIC) of the six muscles previously mentioned will be used to normalize the signal collected during the assessment.
For the peroneus longus, peroneus brevis, and tibialis anterior muscles, this value will be recorded with the participant in supine position, with the examiner resisting eversion and dorsiflexion movements in each case. For the soleus, medial gastrocnemius, and lateral gastrocnemius, the participant will be asked to perform a maximal plantar flexion on one leg, first with the knee slightly flexed and then with the knee extended.
After a practice trial, each muscle will be tested 3 times, each trial lasting 5", with a 2-minute interval between trials. Verbal encouragement will be provided during testing.
Finally, the average of the 3 peak values will be used as the maximum reference value for normalization.
**Measure:** Maximum value of muscle activation of six leg muscles during a maximal voluntary isometric contraction
**Time Frame:** Immediately after the warm-up, during the single evaluation session, with an approximate duration of 40 minutes (36 minutes of measurement duration, plus time for familiarization and subject preparation)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Not to have experienced lower limb injury or pain within the last year prior to the study
* Self-report as physically active, such that they perform at least 90 minutes of weekly physical activity
Exclusion Criteria:
* Previous participation in any lower limb balance or proprioception exercise program
* The presence of known balance impairments such as vertigo, vestibular or central alterations
**Healthy Volunteers:** True
**Maximum Age:** 30 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
**Study Population:** The participants are being sourced from the Faculty of Physiotherapy of the University of Valencia. They are undergraduate or master's students who have responded to an email invitation sent by one of the professors from the department involved in the study.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rodrigo Martín-San Agustín, Doctor
**Phone:** +34 963 983 853
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Mariana Sánchez-Barbadora, phD student
**Phone:** +34 671321931
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Valencia
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rodrigo Martin-San Agustin, Doctor
- **Phone:** +34 963 983 853
- **Role:** CONTACT
**Country:** Spain
**Facility:** Rodrigo Martin-San Agustin
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** University of Valencia
**Name:** Rodrigo Martín-San Agustín, Doctor
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425172
**Brief Title:** Monitoring System for Cranial Orthoses
**Official Title:** A Monitoring System for Cranial Remolding Orthoses
#### Organization Study ID Info
**ID:** STU-2022-0556
#### Organization
**Class:** OTHER
**Full Name:** University of Texas Southwestern Medical Center
### Status Module
#### Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** FED
**Name:** National Institute on Disability, Independent Living, and Rehabilitation Research
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Texas Southwestern Medical Center
#### Responsible Party
**Investigator Affiliation:** University of Texas Southwestern Medical Center
**Investigator Full Name:** Tiffany Graham
**Investigator Title:** Associate Professor
**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:** This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow).
**Detailed Description:** This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow). Although cranial remolding treatment has been used successfully for over 20 years, there is no clinical standard for objective monitoring of the fit and wear time.
In total, participation will consist of 7 visits over 11 weeks: (1) measurements and clinical evaluation \[approximately 60 minutes\], (2) fitting of standard helmet and pre-fitting and/or fitting of the research helmet \[approximately 60 minutes\], (3) fitting of research helmet (if not done at Visit #2) and in-office testing \[approximately 2 hours\], (4)/(5)/(6) follow up visits for research helmet \[approximately 30-60 minutes each\], and (7) final follow up visit and in-office testing for the research helmet \[approximately 2 hours\].
During the 8 weeks of wearing the research helmet, the child is expected to wear the it 23 hours per day, and caregivers will keep a log of helmet wear time and any side effects (such as skin irritations), if they occur. The child will be seen clinically every 2 weeks (or more often, if caregivers request additional checkups).
At the end of the trial, participants will return all research-related materials and the treating clinician will return the child to wearing the standard helmet.
### Conditions Module
**Conditions:**
- Plagiocephaly
- Brachycephaly
- Deformational Plagiocephaly
- Deformational Posterior Plagiocephaly
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 12
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Infants who have been referred for custom orthotic treatment for a deformational head shape such as deformational plagiocephaly or deformational brachycephaly.
**Intervention Names:**
- Device: Cranial Remolding Orthosis
**Label:** Infants with with deformational head shapes
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Infants with with deformational head shapes
**Description:** A custom made FDA-approved cranial remolding orthosis will be retrofit with sensors used in the research.
**Name:** Cranial Remolding Orthosis
**Other Names:**
- Custom Helmet
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The temperature readings from the custom temperature sensor within the research helmet will be compared to the collected temperature readings from the iButtons. Using established software compatible with the iButton, wear time will be calculated based on previously reported temperature thresholds which indicate the helmet is being worn. Using similar temperature thresholds, wear time data from the custom sensors will be compared to the wear time reported by the iButton software.
**Measure:** Wear time monitoring and validation
**Time Frame:** Data will be recorded for 8 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.
**Description:** We will examine pressure in the void space of the helmet throughout the 8 weeks of wear time. In theory, the pressure in this area should never increase as the cranium should not come in contact with this sensor no matter what position the infant is in (i.e. laying down, sitting, etc).
**Measure:** Fit monitoring
**Time Frame:** Data will be recorded for 8 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.
#### Secondary Outcomes
**Description:** Parents will take a survey regarding their experience with the research helmet
**Measure:** Survey Participation
**Time Frame:** Survey to be taken at completion of the study, anticipated to be complete on all subjects within 1 year.
**Description:** The wear time based on iButton and custom temperature readings will be compared to the caregiver-reported wear time log and any differences in log times reviewed.
**Measure:** Wear time comparison between objective and subjective reporting
**Time Frame:** Data will be recorded for 8 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly / brachycephaly)
Exclusion Criteria:
* non-English speaking caregivers
* infants with craniosynostosis or those not indicated for cranial remolding
* infants with developmental comorbidities which affect cranial growth
**Maximum Age:** 18 Months
**Minimum Age:** 3 Months
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** Infants who are clinically indicated for cranial remolding orthoses.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Tiffany Graham, MS
**Phone:** 2146458250
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Texas Southwestern Medical Center
**Name:** Tiffany Graham, MS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Individual participant data will be protected and only shared within the research team and treating practitioners.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019465
- Term: Craniofacial Abnormalities
- ID: D000009139
- Term: Musculoskeletal Abnormalities
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000000013
- Term: Congenital Abnormalities
- ID: D000013580
- Term: Synostosis
- ID: D000004413
- Term: Dysostoses
- ID: D000001848
- Term: Bone Diseases, Developmental
- ID: D000001847
- Term: Bone Diseases
### 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: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M29382
- Name: Plagiocephaly
- Relevance: HIGH
- As Found: Plagiocephaly
- ID: M26018
- Name: Plagiocephaly, Nonsynostotic
- Relevance: HIGH
- As Found: Deformational Plagiocephaly
- ID: M6613
- Name: Craniosynostoses
- Relevance: HIGH
- As Found: Brachycephaly
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M21420
- Name: Craniofacial Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M12096
- Name: Musculoskeletal Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16357
- Name: Synostosis
- Relevance: LOW
- As Found: Unknown
- ID: M7587
- Name: Dysostoses
- 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: T4584
- Name: Plagiocephaly
- Relevance: HIGH
- As Found: Plagiocephaly
- ID: T1638
- Name: Craniosynostosis
- Relevance: LOW
- As Found: Unknown
- ID: T5091
- Name: Saethre-Chotzen Syndrome
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000059041
- Term: Plagiocephaly
- ID: D000049068
- Term: Plagiocephaly, Nonsynostotic
- ID: D000003398
- Term: Craniosynostoses
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425159
**Acronym:** SHINE
**Brief Title:** A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures
**Official Title:** A Phase 2/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BHV-7000 as Adjunctive Therapy in Subjects With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures, With Open-label Extension
#### Organization Study ID Info
**ID:** BHV7000-304
#### Organization
**Class:** INDUSTRY
**Full Name:** Biohaven Pharmaceuticals, Inc.
#### Secondary ID Infos
**Domain:** EU CTR
**ID:** 2023-508812-45-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Biohaven Therapeutics Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of this study is to determine whether BHV-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase.
### Conditions Module
**Conditions:**
- Generalized Epilepsy
**Keywords:**
- Idiopathic Generalized Epilepsy
- Generalized
- Epilepsy
- tonic-clonic
- generalized tonic-clonic
- tonic
- clonic
- seizure
- refractory epilepsy
- generalized tonic-clonic alone
- juvenile myoclonic epilepsy
- juvenile absence epilepsy
### 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:** 242
**Type:** ESTIMATED
**Phases:**
- PHASE2
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: BHV-7000
**Label:** BHV-7000 75 mg
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- BHV-7000 75 mg
**Description:** BHV-7000 75mg. Participants will take blinded investigational product (IP) once daily
**Name:** BHV-7000
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Matching placebo taken once daily
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** To compare the efficacy of BHV-7000 to placebo as adjunctive therapy for subjects with idiopathic generalized epilepsy with generalized tonic-clonic (GTC) seizures as measured by the time to the second day with a GTC seizure during the double-blind phase
**Measure:** Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period
**Time Frame:** Baseline to Week 24 of Double-Blind Treatment Period
#### Secondary Outcomes
**Description:** To compare the efficacy of BHV-7000 to placebo in terms of the proportion of subjects that are free of GTC seizures as measured by the proportion of subjects with GTC seizure freedom during the 24-week DBP, estimated using Kaplan- Meier methods.
**Measure:** Percentage of Participants with freedom of GTC seizures during DBT Phase
**Time Frame:** Baseline to Week 24 of Double-Blind Treatment Period
**Description:** To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs
**Measure:** Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
**Time Frame:** Baseline to Week 24 of Double-Blind Treatment Period
**Description:** To assess the safety and tolerability of BHV-7000 as measured by the number of unique subjects with grade 3 and grade 4 laboratory abnormalities.
**Measure:** Number of Participants With Clinically Significant Laboratory Abnormalities
**Time Frame:** Baseline to Week 24 of Double-Blind Treatment Period
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male and Female participants 18 to 75 years of age at time of consent.
* Diagnosis of Idiopathic Generalized Epilepsy at least 6 months prior to the screening visit, defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.
1. Subject has probable GTC seizures in the setting of IGE, meaning GTC seizures and either classic 3-4 Hz generalized spike-wave (GSW) or 4-6 Hz polyspike-wave on EEG and no focal abnormality (asymmetric spike-wave fragment is allowed) AND/OR a clear history of absence seizures or myoclonic jerks
2. Subjects with possible GTC seizures in the setting of IGE, meaning GTC and either Normal EEG OR Generalized epileptiform EEG abnormality with atypical spike-wave and no focal abnormality (asymmetric spike-wave fragment is allowed).
* Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used ASM schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.
* Ability of subject or caregiver to keep accurate seizure diaries
* Current treatment with at least 1 to 3 ASMs as part of no more than 4 epilepsy treatments in total (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.).
* Accurate history of having at least 3 days with a GTC seizure evenly spread throughout the 16 weeks prior to the screening visit, such that a subject had at least 1 day with a GTC seizure during the first 8 weeks and at least 1 day with a GTC seizure during the second 8 weeks.
Exclusion Criteria:
* History of status epilepticus (convulsive status epilepticus for \> 5 minutes or focal status epilepticus with impaired conscious for \> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.
* History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit, or having an unknown GTC seizure count during the screening phase.
* Any condition that would interfere with and/or confound the interpretation of safety or efficacy data from the study, as judged 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:** Chief Medical Officer
**Phone:** 203-404-0410
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Jacksonville
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yasmeen Shabbir
- **Phone:** 904-244-9856
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Florida (Jacksonville)
**State:** Florida
**Zip:** 32209
**Location 2:**
**City:** Orlando
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Michelle Clevenger
- **Phone:** 407-652-6011
- **Role:** CONTACT
**Country:** United States
**Facility:** Research Institute of Orlando
**State:** Florida
**Zip:** 32806
**Location 3:**
**City:** Weston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Antonio Barreiro
- **Phone:** 954-777-8827
- **Role:** CONTACT
**Country:** United States
**Facility:** Encore Medical Research of Weston LLC.
**State:** Florida
**Zip:** 33331
**Location 4:**
**City:** Elgin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ayesha Fatima
- **Phone:** 847-497-0421
- **Role:** CONTACT
**Country:** United States
**Facility:** Revive Research Institute, Inc.
**State:** Illinois
**Zip:** 60123
**Location 5:**
**City:** Lexington
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Morgan Medley
- **Phone:** 859-313-4989
- **Role:** CONTACT
**Country:** United States
**Facility:** Bluegrass Epilepsy Research
**State:** Kentucky
**Zip:** 40504
**Location 6:**
**City:** Baton Rouge
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** JoAnne Hollingsworth
- **Phone:** 225-765-7659
- **Role:** CONTACT
**Country:** United States
**Facility:** OLOLRMC
**State:** Louisiana
**Zip:** 70808
**Location 7:**
**City:** Livingston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Munazza Malik
- **Phone:** 973-322-7425
- **Role:** CONTACT
**Country:** United States
**Facility:** Inst of Neurology
**State:** New Jersey
**Zip:** 07039
**Location 8:**
**City:** Amherst
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hailley Pearson
- **Phone:** 716-250-7002
- **Role:** CONTACT
**Country:** United States
**Facility:** Dent Neurosciences Research Center
**State:** New York
**Zip:** 14226
**Location 9:**
**City:** Chattanooga
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Arlann Erskine
- **Phone:** 423-698-4584
- **Role:** CONTACT
**Country:** United States
**Facility:** WR-ClinSearch
**State:** Tennessee
**Zip:** 37421
**Location 10:**
**City:** Nashville
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Melissa Osborn
- **Phone:** 615-322-8817
- **Role:** CONTACT
**Country:** United States
**Facility:** Vanderbilt University Medical Center
**State:** Tennessee
**Zip:** 37232
**Location 11:**
**City:** Dallas
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** J. Christina Howell
- **Phone:** 214-750-9977
- **Phone Ext:** 293
- **Role:** CONTACT
**Country:** United States
**Facility:** Neurology Consultants of Dallas, PA
**State:** Texas
**Zip:** 75243
**Location 12:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Saad Ahmad
- **Phone:** 713-500-7894
- **Role:** CONTACT
**Country:** United States
**Facility:** UTHealth Houston
**State:** Texas
**Zip:** 77030
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M7983
- Name: Epilepsy
- Relevance: HIGH
- As Found: Epilepsy
- ID: M369
- Name: Drug Resistant Epilepsy
- Relevance: LOW
- As Found: Unknown
- ID: M15452
- Name: Seizures
- Relevance: HIGH
- As Found: Generalized Tonic-Clonic Seizures
- ID: M7985
- Name: Epilepsy, Generalized
- Relevance: HIGH
- As Found: Generalized Epilepsy
- ID: M7987
- Name: Epilepsies, Myoclonic
- Relevance: LOW
- As Found: Unknown
- ID: M7988
- Name: Epilepsy, Absence
- Relevance: LOW
- As Found: Unknown
- ID: M22018
- Name: Myoclonic Epilepsy, Juvenile
- 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: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T2109
- Name: Epilepsy Juvenile Absence
- Relevance: LOW
- As Found: Unknown
- ID: T4008
- Name: Myoclonus Epilepsy
- Relevance: LOW
- As Found: Unknown
- ID: T3175
- Name: Juvenile Myoclonic Epilepsy
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004827
- Term: Epilepsy
- ID: D000012640
- Term: Seizures
- ID: D000004829
- Term: Epilepsy, Generalized
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425146
**Acronym:** TACO
**Brief Title:** Tobacco, Alcohol and Cancerization of the Oral Mucosa (TACO)
**Official Title:** Clinical-biological, Prospective, Monocentric Cohort Study to Describe Somatic Mutations in Healthy Oral Mucosa From Patients With Oral Squamous Cell Carcinoma (OSCC)
#### Organization Study ID Info
**ID:** ET23-384 TACO
#### Organization
**Class:** OTHER
**Full Name:** Centre Leon Berard
### Status Module
#### Completion Date
**Date:** 2025-09-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-17
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Centre Leon Berard
#### 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 project is to describe somatic mutations of healthy oral mucosa from patients with oral squamous cell carcinoma (OSCC).
**Detailed Description:** Epidermoid carcinomas of upper aerodigestive tract are the 8th most common cancers in the world. Worldwide, this represents more than 500.000 cases per year and 20.000 cases per year in France (statistics 2018-2020). Among these cancers, oral squamous cell carcinoma (OSCC) are the most common location, leading to significant morbidity and mortality.
Despite recent advances in diagnosis, treatment and monitoring, the overall 5-year survival rate of patients with epidermoid carcinomas of upper aerodigestive tract has not improved significantly and remains around 40-50 % for all combined locations. These pejorative survival rates, as well as the increase in the incidence of these cancers, have not changed much over the past 30 years. This situation can be attributed in part to a diagnosis too late. Indeed, only 1/3 of patients with high-risk squamous cell carcinoma of the head and neck are diagnosed at an early stage. This issue of early diagnosis is mainly due to the lack of suitable screening and diagnostic biomarkers. Beyond diagnosis, the identification of biomarkers is also a prognostic and predictive interest since they could predict the course of the disease as well as the response to treatment.
"Drivers" mutations, with oncogenic potential, can be present from the very early stages of epidermoid carcinomas of upper aerodigestive tract and therefore constitute potential biomarkers. However, recent studies have demonstrated the presence of driver mutations in different types of oral cavity's healthy tissue, some being even associated with a protective effect against tumor initiation. In order to improve prevention and early diagnosis of OSCC, it is important to better understand the evolutionary dynamics of somatic mutations in the oral mucosa, which is still poorly characterized.
### Conditions Module
**Conditions:**
- Oral Squamous Cell Carcinomas
**Keywords:**
- Somatic mutations
- Healthy oral mucosa
- oral cancer
- OSCC
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** A clinical-biological cohort of patients with epidermoid carcinomas of the oral cavity.
Blood sample and cytobrush sample at inclusion and before anti-cancer treatment.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A clinical-biological cohort of 30 patients with epidermoid carcinomas of the oral cavity.
Blood sample and cytobrush sample at inclusion and before anti-cancer treatment.
**Intervention Names:**
- Procedure: Cytobrush sample
- Procedure: Blood sampling
**Label:** Clinical-biological cohort
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Clinical-biological cohort
**Description:** Healthy oral mucosa will be collected using a cytobrush, which is a minimally invasive method for patients
**Name:** Cytobrush sample
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Clinical-biological cohort
**Description:** Blood sampling (6 mL), taken from a routine biological exam
**Name:** Blood sampling
**Type:** PROCEDURE
### Outcomes Module
#### Other Outcomes
**Description:** Selective advantage of the 62 driver genes already identified
**Measure:** Selective advantage of OSCC driver mutations in normal-looking mucosa
**Time Frame:** 1 year
**Description:** Selective advantage of non-driver OSCC genes
**Measure:** Non-drivers OSCC genes under positive selection in normal looking mucosa
**Time Frame:** 1 year
#### Primary Outcomes
**Description:** Identified mutations described by type and number
**Measure:** Identify somatic mutations of the driver genes from healthy oral mucosa from patients with epidermoid carcinomas of the upper aerodigestive tract
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Correlation between tobacco consumption and total number of somatic mutations detected
**Measure:** Correlation between tobacco consumption and the total number of somatic mutations detected in the healthy oral mucosa in patients with OSCC
**Time Frame:** 1 year
**Description:** Correlation between alcohol consumption and total number of somatic mutations
**Measure:** Correlation between alcohol consumption and the total number of somatic mutations detected in the healthy oral mucosa in patients with OSCC
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* I1. Male or female aged 18 years or older at the date of signature of the informed consent to participate.
* I2. Patient with histological diagnosis of epidermoid carcinomas of the oral cavity NB: All grades are eligible.
* I3. Patient naive of any systemic anti-cancer treatment (radio- or chemotherapy).
* I4. Patient able to understand, sign and date informed consent before the start of any study protocol procedure.
* I5. Patient affiliated or covered by a medical insurance
Exclusion Criteria:
* E1. Patients at high risk of bleeding, such as those on anticoagulant or antiplatelet aggregant treatment, with clotting disorders or a history of severe bleeding in the two weeks prior to inclusion.
* E2. Patient with lesions of all types on the mucosa of the cheek located on the opposite side of the area affected by an epidermoid carcinoma of the oral cavity which prevents painless removal of the healthy mucosa.
* E3. Patient who had surgery for their epidermoid carcinoma of the oral cavity more than 6 months ago.
* E4. Patient who uses cannabis.
* E5. Patient with another active tumor or HPV-positive tumors.
* E6. Patient under guardianship or curatorship or placed under the protection of justice.
* E7. Pregnant and/or nursing patient.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Philippe Zrounba, M.D.
**Phone:** (0)4 69 85 60 82
**Phone Ext:** +33
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Pierre Martinez, Ph.D.
**Phone:** (0)4 69 85 60 82
**Phone Ext:** +33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Lyon
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Philippe Zrounba, M.D.
- **Role:** CONTACT
**Country:** France
**Facility:** Centre Léon Bérard
**Zip:** 69008
#### Overall Officials
**Official 1:**
**Affiliation:** [email protected]
**Name:** Philippe Zrounba, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000018307
- Term: Neoplasms, Squamous Cell
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5550
- Name: Carcinoma, Squamous Cell
- Relevance: HIGH
- As Found: Squamous Cell Carcinoma
- ID: M12022
- Name: Mouth Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M1689
- Name: Squamous Cell Carcinoma of Head and Neck
- Relevance: HIGH
- As Found: Oral Squamous Cell Carcinoma
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M20451
- Name: Neoplasms, Squamous Cell
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: T4267
- Name: Oral Squamous Cell Carcinoma
- Relevance: HIGH
- As Found: Oral Squamous Cell Carcinoma
- ID: T4265
- Name: Oral Cancer
- Relevance: LOW
- As Found: Unknown
- ID: T3466
- Name: Lip and Oral Cavity Cancer
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000002294
- Term: Carcinoma, Squamous Cell
- ID: D000077195
- Term: Squamous Cell Carcinoma of Head and Neck
### Intervention Browse Module - Browse Branches
- Abbrev: 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: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425133
**Acronym:** CARE
**Brief Title:** Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers
**Official Title:** Impact of Regorafenib in Combination With Multimodal Metronomic Chemotherapy on Progression-free Survival Compared With Standard Regorafenib for the Treatment of Chemo-resistant Metastatic Colorectal Cancers
#### Organization Study ID Info
**ID:** 2023/805
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Besancon
### Status Module
#### Completion Date
**Date:** 2028-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Groupement Interrégional de Recherche Clinique et d'Innovation
#### Lead Sponsor
**Class:** OTHER
**Name:** Centre Hospitalier Universitaire de Besancon
#### 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 is to evaluate the impact of a Regorafenib combined with metronomic chemotherapy (capecitabine and cyclophosphamide) and low-dose aspirin compared to standard Regorafenib treatment in patients with metastatic colorectal cancer by assessing progression-free survival.
### Conditions Module
**Conditions:**
- Metastatic Colorectal Cancer
**Keywords:**
- Regorafenib
- metronomic chemotherapy
- colon cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 174
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** • Regorafenib will be administered 3 weeks out of 4 (1 cycle corresponding to 4 weeks) until progression or unacceptable toxicity.
For the first cycle: Regorafenib will be administered according to the "REDOS" schedule week 1: 80 mg regorafenib daily week 2: 120 mg regorafenib daily week 3: 160 mg regorafenib daily week 4 : no regorafenib
For the following cycles: regorafenib will be administered at 160mg in the absence of significant toxicity during cycle 1 or at a 80/120mg daily dose according to toxicity observed with the last dose used in the first cycle.
**Intervention Names:**
- Procedure: Blood sample
- Other: Quality of life questionnaires
- Procedure: Biopsy
- Drug: Regorafenib
**Label:** Regorafenib
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** • Regorafenib will be administered 3 weeks out of 4 (1 cycle corresponding to 4 weeks) until progression or unacceptable toxicity.
For the first cycle: Regorafenib will be administered according to the "REDOS" schedule: week 1: 80 mg daily week 2: 120 mg daily week 3: 160 mg daily week 4 : OFF. For the following cycles: regorafenib will be administered at 160mg in the absence of significant toxicity during cycle 1 or at a 80/120mg daily dose according to toxicity observed with the last dose used in the first cycle.
* Metronomic chemotherapy will be administrated as following:Cyclophosphamide: 50 mg per os, daily, for 6 months,Capecitabine: 625mg/m²/orally twice daily, for 6 months.
* Low-dose Aspirin: 75 mg orally, daily, until progression.
**Intervention Names:**
- Procedure: Blood sample
- Other: Quality of life questionnaires
- Procedure: Biopsy
- Combination Product: Regorafenib + metronomic chemotherapy
**Label:** Regorafenib+ metronomic chemotherapy + aspirin
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Regorafenib
- Regorafenib+ metronomic chemotherapy + aspirin
**Description:** Blood sample for plasma collection, Blood sample for ctDNA (circulating tumoral DNA) collection
**Name:** Blood sample
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Regorafenib
- Regorafenib+ metronomic chemotherapy + aspirin
**Description:** EORTC QLQ-C30 questionnaire (Quality of life questionnaire Cancer 30) CR29 questionnaire (Colo-rectal cancer 29) EQ-5D5L questionnaire (EuroQol-5 Dimensions, 5 levels): repeated measures at baseline, M2, M4, M6, M8, M10, M12 and during the end of treatment visit and during the follow-up
**Name:** Quality of life questionnaires
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Regorafenib
- Regorafenib+ metronomic chemotherapy + aspirin
**Description:** Fresh tumor biopsy at baseline and week 8
**Name:** Biopsy
**Type:** PROCEDURE
#### Intervention 4
**Arm Group Labels:**
- Regorafenib
**Description:** For the first cycle: Regorafenib will be administered according to the "REDOS" schedule: week 1: 80 mg regorafenib daily week 2: 120 mg regorafenib daily week 3: 160 mg regorafenib daily week 4 : OFF. For the following cycles: regorafenib will be administered at 160mg in the absence of significant toxicity during cycle 1 or at a 80/120mg daily dose according to toxicity observed with the last dose used in the first cycle.
**Name:** Regorafenib
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- Regorafenib+ metronomic chemotherapy + aspirin
**Description:** • Regorafenib will be administered 3 weeks out of 4 (1 cycle corresponding to 4 weeks) until progression or unacceptable toxicity.
For the first cycle: Regorafenib will be administered according to the "REDOS" schedule: week 1: 80 mg regorafenib daily week 2: 120 mg regorafenib daily week 3: 160 mg regorafenib daily week 4 : OFF. For the following cycles: regorafenib will be administered at 160mg in the absence of significant toxicity during cycle 1 or at a 80/120mg daily dose according to toxicity observed with the last dose used in the first cycle.
* Metronomic chemotherapy will be administrated as following:Cyclophosphamide: 50 mg per os, daily, for 6 months,Capecitabine: 625mg/m²/orally twice daily, for 6 months.
* Low-dose Aspirin: 75 mg orally, daily, until progression.
**Name:** Regorafenib + metronomic chemotherapy
**Type:** COMBINATION_PRODUCT
### Outcomes Module
#### Primary Outcomes
**Description:** Progression-free survival (PFS): defined as the time from the randomization to objective disease progression as per RECIST v1.1 or death from any cause, whichever occurs first. The time of the progression or recurrence event is determined using the first date when there is documented evidence that the criteria have been met, even in situations where progression is observed after one or more missed visits, treatment discontinuation, or new anti-cancer treatment.
Patients with no defined events observed during the follow up period will be censored at the date of last news
**Measure:** To evaluate the impact of a Regorafenib combined with metronomic chemotherapy and low-dose aspirin compared to standard Regorafenib treatment by assessing progression-free survival
**Time Frame:** 5 months average
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients with histologically proven metastatic colorectal cancer in progression after previous standard treatments (5FU, CPT11 (Irinotecan), oxaliplatin, anti-VEGF (vascular endothelial growth factor), trifluridine/tipiracil, anti-EGFR (epidermal growth factor receptor) therapy if KRAS (Kirsten rat sarcoma) and NRAS WT (wild type), anti-BRAF therapy if BRAF V600E mutated, and anti-PD1 (Programmed Death-1) if MSI-H (microsatellite instability) /dMMR (deficient MisMatch Repair) tumor, or not considered as candidate for these treatments.
2. Life expectancy of at least 3 months
3. Female or male with age \>18 years old
4. Performance status = 0 or 1 (Annex 1)
5. Measurable disease defined according to RECIST v1.1 guidelines (scanner or MRI)
6. Adequate bone marrow, liver and renal functions.
1. Haemoglobin ≥ 9 g/dL; absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L
2. Total serum bilirubin ≤ 1.5 times upper normal value (ULN), serum alkaline phosphatase \< 5 times ULN, aminotransferases (AST/ALT) ≤ 3 × ULN in absence of hepatic metastasis or ≤ 5 if presence of hepatic lesions
3. Cockcroft glomerular filtration rate \> 50 ml/min
4. Proteinuria \<2+ (dipstick urinalysis) or ≤1g/24hour
7. No contraindication to Iodine contrast media injection during CT
8. For female patients of childbearing potential, negative pregnancy test within 14 days before starting the study drug. Men and women are required to use adequate birth control during the study (when applicable),
9. Signed and dated informed consent,
10. Ability to comply with the study protocol, in the Investigator's judgment.
11. Registration in a national health care system (CMU included).
Exclusion Criteria:
1. Diagnosis of additional malignancy within 2 years prior to the inclusion (exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical and/or bladder cancer),
2. Current participation in a study of an investigational agent or in the period of exclusion
3. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before inclusion in the trial ;
4. Patient under judicial protection (curators, autorship) and/or deprived of freedom,
5. Previous exposition to regorafenib or anti-angiogenic treatment other than bevacizumab and aflibercept
6. Treatment with any other investigational medicinal product within 28 days prior to study entry, EXCEPT for ASPIRIN,
7. Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 3 weeks,
8. Chronic treatment with drug potentially interacting with regorafenib i.e. CYP3A4, CYP2C9 or UGT1A9 (UDP-glucuronosyltransferase 1-9) inductor/inhibitor; Epileptic disorder requiring medication; Recent or concomitant treatment with brivudine,
9. Complete deficit in dihydropyrimidine dehydrogenase (DPD),
10. Known hypersensitivity to any of the study drugs, study drug classes or excipient in the formulation:
* History of severe and unexpected reactions to fluoropyrimidine therapy,
* History of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines,
* Mastocytosis, for whom the use of acetylsalicylic acid can cause severe hypersensitivity reactions,
11. Unresolved toxicity higher than CTCAE (v5) Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neuropathy ≤ Grade 2,
12. Subject unable to swallow oral medications or any malabsorption condition,
13. Inadequate organ functions:
* known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition
* Congestive Heart Failure ≥ New York Heart Association (NYHA) class 2,
* Myocardial infarction less than 6 months before start of study drug, unstable angina (anginal symptoms at rest), new-onset angina (begun within the last 3 months), Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted),
* Uncontrolled hypertension (defined by systolic blood pressure ≥ 150 mmHg and/or diastolic pressure ≥ 100 mmHg despite optimal medical management), or history of hypertensive crisis, or hypertensive encephalopathy
* Pleural effusion or ascites that causes respiratory compromise (≥ CTCAE grade 2 dyspnea),
* Interstitial lung disease with ongoing signs or symptoms,
* Ongoing infection \>grade 2 CTCAE V5,
* Dehydration CTCAE v5 grade ≥1,
* Urinary tract obstruction
14. Constitutional or acquired hemorrhagic disease:
* Any haemorrhage or bleeding event ≥ CTCAE Grade 3 within 4 weeks prior to the start of study medication,
* History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to inclusion,
* Serious, Non-healing wound, active peptic ulcer or untreated bone fracture,
* Major surgical procedure, open biopsy or significant traumatic injury within 28 days before start of study medication,
15. Planned surgical procedure within the first month of treatment or any procedure that might change the timing of regorafenib administration during the first month of treatment,
16. Known History of human immunodeficiency virus (HIV) infection; Active hepatitis B or C or chronic hepatitis B or C requiring treatment with antiviral therapy,
17. Receipt of yellow fever vaccine within 28 days prior to study,
18. History of organ allograft,
19. Pregnant or breast-feeding subjects
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Angélique VIENOT, Dr
**Phone:** +33 370632278
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Christophe BORG, Pr
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Auxerre
**Contacts:**
***Contact 1:***
- **Name:** Anne VILLING, Dr
- **Role:** CONTACT
**Country:** France
**Facility:** CHU d'Auxerre
**Location 2:**
**City:** Besançon
**Contacts:**
***Contact 1:***
- **Name:** Angélique VIENOT, Dr
- **Role:** CONTACT
**Country:** France
**Facility:** Centre Hospitalier Universitaire de Besançon
**Zip:** 25000
**Location 3:**
**City:** Colmar
**Contacts:**
***Contact 1:***
- **Name:** Marion BOLLIET, Dr
- **Role:** CONTACT
**Country:** France
**Facility:** CH de Colmar
**Location 4:**
**City:** Dijon
**Contacts:**
***Contact 1:***
- **Name:** François GHIRINGHELLI, Pr
- **Role:** CONTACT
**Country:** France
**Facility:** Centre Georges-François Leclerc (CGFL)
**Location 5:**
**City:** Metz
**Contacts:**
***Contact 1:***
- **Name:** Theo LEGRAND, Dr
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Robert Schuman
**Location 6:**
**City:** Montbéliard
**Contacts:**
***Contact 1:***
- **Name:** Christophe BORG, Pr
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Nord Franche-Comté
**Location 7:**
**City:** Montpellier
**Contacts:**
***Contact 1:***
- **Name:** Eric ASSENAT, Dr
- **Role:** CONTACT
**Country:** France
**Facility:** CHU de Montpellier
**Location 8:**
**City:** Reims
**Contacts:**
***Contact 1:***
- **Name:** Olivier BOUCHE, Dr
- **Role:** CONTACT
**Country:** France
**Facility:** CHU de Reims - Hôpital Robert Debré
**Location 9:**
**City:** Strasbourg
**Country:** France
**Facility:** Clinique Privée de Strasbourg
**Location 10:**
**City:** Strasbourg
**Contacts:**
***Contact 1:***
- **Name:** Meher BEN ABDELGHANI, Dr
- **Role:** CONTACT
**Country:** France
**Facility:** ICANS
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M20559
- Name: Disease Progression
- Relevance: LOW
- As Found: Unknown
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Antipy
- Name: Antipyretics
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: FiAg
- Name: Fibrinolytic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: PlAggInh
- Name: Platelet Aggregation Inhibitors
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M377
- Name: Capecitabine
- Relevance: LOW
- As Found: Unknown
- ID: M6727
- Name: Cyclophosphamide
- Relevance: LOW
- As Found: Unknown
- ID: M4548
- Name: Aspirin
- Relevance: LOW
- As Found: Unknown
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425120
**Brief Title:** Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease
**Official Title:** Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
#### Organization Study ID Info
**ID:** 2023-ZX074
#### Organization
**Class:** OTHER_GOV
**Full Name:** China National Center for Cardiovascular Diseases
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** China National Center for Cardiovascular Diseases
#### Responsible Party
**Investigator Affiliation:** China National Center for Cardiovascular Diseases
**Investigator Full Name:** Jing Li
**Investigator Title:** JingLi, MD, PhD, professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This trials aims to assess, in 240 eligible patients with coronary heart disease, the effects on level of high-sensitivity C-reactive protein (hsCRP) changes from baseline to 12 weeks of Xuesaitong Soft Capsules.
**Detailed Description:** In this multicenter, randomized, double-blind, placebo-controlled trial in patients with coronary heart disease,240 eligible patients aged ≥18 years will be randomized to receive placebo or Xuesaitong Soft Capsules(1.32g/d) and be followed up for 3 months. The primary endpoint of this study is hsCRP change from baseline to 3 months. The secondary endpoint is the changes of following indicators or scores from baseline to 3 months:(Ⅰ)other inflammation indicators except for hsCRP. (Ⅱ) inhibition of platelet aggregation; (Ⅲ)endothelial function indicators; (Ⅳ)blood lipid levels; (Ⅴ) seattle angina questionnaire score; (Ⅵ)36-item short form health survey score. The safety of using Xuesaitong soft capsules in patients with coronary heart disease will also be evaluated. The generalized linear mixed effects model will be used to evaluate the efficacy endpoint for the "full analysis set". For the safety analysis set, Chi-square test will be used to evaluate the safety endpoint.
### Conditions Module
**Conditions:**
- Coronary Heart Disease
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 240
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Each participant in the Xuesaitong Soft Capsule treatment group will take a daily dose of 1.32g.
**Intervention Names:**
- Drug: Xuesaitong Soft Capsule
**Label:** Xuesaitong Soft Capsule
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Each participant in the placebo group will take matching placebo.
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Xuesaitong Soft Capsule
**Description:** Each participant in the xuesaitong soft capsule treatment group will take a daily dose of 1.32g.
**Name:** Xuesaitong Soft Capsule
**Other Names:**
- LixuwangⓇ
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Each participant in the placebo group will take matching placebo.
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Changes in high-sensitivity C-reactive protein level from baseline at 12 weeks
**Measure:** hsCRP
**Time Frame:** 12 weeks
#### Secondary Outcomes
**Description:** Changes in levels of interleukin-6, interleukin-10, interleukin-1β, tumor necrosis factor-α from baseline at 12 weeks
**Measure:** Other inflammation indicators
**Time Frame:** 12 weeks
**Description:** Changes in level of inhibition of platelet aggregation from baseline at 12 weeks
**Measure:** IPA
**Time Frame:** 12 weeks
**Description:** Changes in intercellular adhesion molecule-1, von Willebrand factor, and endothelin-1 levels from baseline at 12 weeks
**Measure:** Vascular endothelial function
**Time Frame:** 12 weeks
**Description:** Changes in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, small low-density lipoprotein cholesterol, and triglyceride levels from baseline at 12 weeks
**Measure:** Blood lipid profiles
**Time Frame:** 12 weeks
**Description:** Changes in Seattle angina scores from baseline at 12 weeks
**Measure:** Seattle Angina Questionnaire
**Time Frame:** 12 weeks
**Description:** Changes in Health Survey Scale (SF-36 Scale) scores from baseline at 12 weeks
**Measure:** SF-36
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥18 years old
2. Chronic coronary artery disease: meet any of the following conditions, and the condition is stable for at least 6 months:
1. History of myocardial infarction
2. Have received coronary interventional therapy
3. There are symptoms of myocardial ischemia (such as chest pain) and objective evidence (stress electrocardiogram or stress myocardial perfusion imaging indicated myocardial ischemia or coronary artery stenosis ≥50% )
3. High-sensitivity C-reactive protein ≥2mg/L
4. Currently taking moderate or above intensity statins lipid-lowering drugs
5. Currently taking antiplatelet drugs
6. Sign informed consent
Exclusion Criteria:
* Patients fulfilling any of the following criteria are not eligible for inclusion in this trial:
1. Acute coronary syndrome occurred or received percutaneous coronary intervention therapy within the past 6 months
2. Previously received coronary artery bypass grafting
3. Stroke occurred within the previous 6 months
4. Symptomatic heart failure (HF) in the past, or documented left ventricular ejection fraction \< 35%
5. Revascularization or surgical procedures are planned within the next 3 months
6. Progressive neuromuscular disease, or creatine kinase (CK) levels \> 3 times the normal upper limit (ULN)
7. Lupus, inflammatory bowel disease, severe arthritis and other inflammatory diseases
8. Immunosuppressants such as cyclosporine, tacrolimus, azathioprine, or systemic steroids are currently being taken or planned during the study
9. History of hereditary dyslipidemia such as familial hypercholesterolemia
10. There has been a change in lipid regulation treatment within the past 1 month, or there is a current adjustment plan
11. History of symptomatic non-traumatic cerebral hemorrhage at any time in the past
12. History of gastrointestinal bleeding or major surgery within the past 6 months
13. Use of Xuesaitong soft capsules or preparations containing the main ingredients of Xuesaitong in the past 1 month
14. There were clear adverse reactions to the main components of Xuesaitong in the past
15. Active liver disease, or alanine aminotransferase (ALT) levels \> 3 times the upper limit of normal (ULN)
16. Chronic kidney disease, or estimated glomerular filtration rate (eGFR) \<60ml/ (min×1.73m2)
17. Pregnancy or planned pregnancy, or breastfeeding
18. Malignant tumors, or other serious diseases with an estimated survival of less than 1 year
19. Mental disorders or communication disorders, cognitive impairment, or other serious medical conditions that may affect study participation
20. Have participated in or are participating in other clinical trials within the last 1 month
21. Poor adherence to follow-up or medication is known
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jing Li, MD, PhD
**Phone:** +86 (010) 6086 6077
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Yan Li, MD
**Phone:** +86 (010) 6086 6795
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ying Sun, BA
- **Phone:** 18310888612
- **Role:** CONTACT
**Country:** China
**Facility:** Fuwai Hospital, Chinese Academy of Medical Sciences
**State:** Beijing
**Zip:** 100087
#### Overall Officials
**Official 1:**
**Affiliation:** National Center for Cardiovascular Diseases
**Name:** Jing Li, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** National Center for Cardiovascular Diseases
**Name:** Jiamin Liu, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: HIGH
- As Found: Coronary Heart Disease
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: HIGH
- As Found: Coronary Heart Disease
- ID: M6549
- Name: Coronary Disease
- Relevance: HIGH
- As Found: Coronary Heart Disease
- ID: M9419
- Name: Heart Diseases
- Relevance: HIGH
- As Found: Heart Disease
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular 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
### Condition Browse Module - Meshes
- ID: D000006331
- Term: Heart Diseases
- ID: D000003327
- Term: Coronary Disease
- ID: D000003324
- Term: Coronary Artery Disease
- ID: D000017202
- Term: Myocardial Ischemia
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425107
**Acronym:** Bacon-Pocus
**Brief Title:** Point-of-Care Lung Ultrasound for Prognosis in Critically Ill Infants With Acute Lower Respiratory Tract Infection
**Official Title:** Point-of-Care Lung Ultrasound for Prognosis in Critically Ill Infants With Acute Lower Respiratory Tract Infection
#### Organization Study ID Info
**ID:** CET 23-2024
#### Organization
**Class:** OTHER
**Full Name:** Vittore Buzzi Children's Hospital
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Vittore Buzzi Children's Hospital
#### Responsible Party
**Investigator Affiliation:** Vittore Buzzi Children's Hospital
**Investigator Full Name:** Anna Camporesi
**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:** Prospective, observational multicentric study which aims at identifying lung POCUS (Point of Care UltraSound) findings associated with failure of noninvasive ICU-LRS (Intensive Care Unit Level Respiratory Support) (defined as escalation of settings or need for intubation and invasive mechanical ventilation) in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI (Low Respiratory Tract Infection) and at identifying lung, pleural, and diaphragm POCUS findings that are associated with a clinical improvement after escalation of ICU-LRS support by comparing POCUS findings from the first 24 hours of ICU stay to a subsequent study 1 day later.
**Detailed Description:** Lower respiratory tract infections, primarily viral bronchiolitis, are a common cause of PICU admission for infants. While overall hospitalization rates for bronchiolitis are declining, ICU admission rates are actually increasing. The trend in respiratory management of critically ill infants with LRTIs has shifted from frequent invasive mechanical ventilation to more common use of non-invasive modalities, including CPAP, BiPap, and HFNC. Currently, the overwhelming majority of infants requiring ICU-level respiratory support (ICU-LRS) for bronchiolitis receive only noninvasive support.
During the past decade, point-of-care lung ultrasound (POCUS) is increasingly being used in both adults and children to enhance diagnostic and prognostic ability in respiratory failure. Lung POCUS is appealing due to the lack of radiation exposure compared to x-rays, the added sensitivity and specificity that it can add compared to traditional imaging to help differentiate consolidation from atelectasis from edema (may all have similar appearance on x-rays), the dynamic nature of the study to evaluate the lung parenchyma, pleura, and diaphragm, and the fact that it can be easily applied and repeated at the bedside to guide adjustments to therapies and evaluate their response. Lung POCUS differs from traditional radiology-based lung ultrasound in that it is focused and goal-directed, is frequently performed serially by the clinician managing the patient at the bedside, and is frequently used to immediately direct care decisions in real-time.
While lung POCUS is quickly becoming a standard of care for adults with respiratory failure, pediatric data, particularly in critically ill infants with bronchiolitis and other lower respiratory tract infections (LRTI) is largely lacking. Investigators from some sites within the BACON research group have begun to evaluate the role of lung POCUS in infants with bronchiolitis. These studies have primarily focused on the emergency department, but they have identified POCUS findings that are associated with clinical deterioration and have developed a pediatric lung ultrasound score that can predict infants who will require ICU-LRS. There are only two pediatric ICU bronchiolitis studies-one looking at the lung/pleura but in invasively ventilated patients only, and the other focused on the diaphragm in patients requiring noninvasive support.
Unfortunately, there are minimal data on infants in the ICU with bronchiolitis, and all of these prior studies are limited by low sample size. Thus, there is a significant knowledge gap about the ability of lung POCUS and these previously identified findings and scoring systems to accurately predict failure of noninvasive ICU-LRS for infants in the ICU with bronchiolitis and other LRTIs. Furthermore, there are no data evaluating the role of lung POCUS in identifying patients who will have a favorable response to adjustments in ICU-LRS settings.
Endpoints of the study are:
1, To identify lung POCUS findings associated with failure of noninvasive ICU-LRS (defined as escalation of settings or need for intubation and invasive mechanical ventilation) in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI.
2. To identify lung, pleural, and diaphragm POCUS findings that are associated with a clinical improvement after escalation of ICU-LRS support by comparing POCUS findings from the first 24 hours of ICU stay to a subsequent study 1 day later.
There are no specific safety endpoints for this observational study. Families could end participation by their infant at any time, and the treating physician or investigator could withdraw the patient from the study but there are no pre-specified safety endpoints.
### Conditions Module
**Conditions:**
- Bronchiolitis
- Noninvasive Ventilation
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Ultrasound findings will be graded according to the scale proposed by the Italian Academy of thoracic Ultrasound: 0: normal A lines
1. short vertical artifacts and isolated B lines
2. multiple B lines (B lines with a distance of less than half centimeter to the confluence, remaining identifiable from each other)
3. white lung (subpleural field with various shades of grey/white without distinguishing B lines) and subpleural consolidations smaller than 1 cm
4. subpleural consolidations bigger than 1 cm
**Measure:** Lung Ultrasound findings associated with failure of noninvasive ICU-LRS (defined as escalation of settings or need for intubation and invasive mechanical ventilation) in infants requiring noninvasive ICU-LRS in the ICU for bronchiolitis and other LRTI.
**Time Frame:** First 24 hours after ICU admission
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age \<1 year at the time of hospital admission
2. Admission to PICU for suspected/confirmed LRTI
3. Treatment (within the 1st 12 hours of ICU stay) with noninvasive ICU-LRS for respiratory failure (HFNC \>1L/kg/min, negative pressure, or noninvasive PPV via any interface (CPAP, BiPap, NIMV, etc.)
Exclusion Criteria:
1. Invasive ventilation as initial support or within the 1st 12 hours of ICU stay, either via endotracheal tube or tracheostomy
2. Upper respiratory symptoms only (stridor, stertor)
3. Corrected gestational age \<37 weeks at time of ICU admission
4. ICU-LRS for only nonrespiratory reasons (e.g. shock) or for pulmonary edema felt to be solely due to noninfectious causes (cardiogenic, airway obstruction, drowning). Patients presenting with apnea can be included if they have a diagnosis of bronchiolitis or other LRTI
5. Prior inclusion in the study
**Maximum Age:** 12 Months
**Minimum Age:** 0 Months
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** Infants \<1 year old admitted to the ICU for bronchiolitis and other lower respiratory tract infection who require noninvasive respiratory support
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anna Camporesi, MD
**Phone:** +393355793744
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Milano
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Anna Camporesi, MD
- **Phone:** +393355793744
- **Role:** CONTACT
**Country:** Italy
**Facility:** Vittore Buzzi Children's Hospital
**Status:** RECRUITING
**Zip:** 20154
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Caiulo VA, Gargani L, Caiulo S, Fisicaro A, Moramarco F, Latini G, Picano E. Lung ultrasound in bronchiolitis: comparison with chest X-ray. Eur J Pediatr. 2011 Nov;170(11):1427-33. doi: 10.1007/s00431-011-1461-2. Epub 2011 Apr 6.
**PMID:** 21468639
**Citation:** Gori L, Amendolea A, Buonsenso D, Salvadori S, Supino MC, Musolino AM, Adamoli P, Coco AD, Trobia GL, Biagi C, Lucherini M, Leonardi A, Limoli G, Giampietri M, Sciacca TV, Morello R, Tursi F, Soldati G, Ecobron Group. Prognostic Role of Lung Ultrasound in Children with Bronchiolitis: Multicentric Prospective Study. J Clin Med. 2022 Jul 21;11(14):4233. doi: 10.3390/jcm11144233.
**PMID:** 35887997
**Citation:** Musolino AM, Toma P, De Rose C, Pitaro E, Boccuzzi E, De Santis R, Morello R, Supino MC, Villani A, Valentini P, Buonsenso D. Ten Years of Pediatric Lung Ultrasound: A Narrative Review. Front Physiol. 2022 Jan 6;12:721951. doi: 10.3389/fphys.2021.721951. eCollection 2021.
**PMID:** 35069230
**Citation:** Amendolea A, Gori L, Adamoli P, Limoli G, Supino MC, Coco AD, Trobia GL, Tursi F, Soldati G, Buonsenso D; Gruppo di studio Pediatrico AdET. Pleuropulmonary Ultrasound in Pediatrics: Proposal of a Reporting Model From the Academy of Thoracic Ultrasound. J Ultrasound Med. 2022 Oct;41(10):2637-2641. doi: 10.1002/jum.15924. Epub 2021 Dec 29.
**PMID:** 34964991
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007239
- Term: Infections
- ID: D000001991
- Term: Bronchitis
- ID: D000001982
- Term: Bronchial Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000008171
- Term: Lung Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M19010
- Name: Critical Illness
- 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: M5264
- Name: Bronchiolitis
- Relevance: HIGH
- As Found: Bronchiolitis
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: HIGH
- As Found: Respiratory Tract Infections
- ID: M5267
- Name: Bronchitis
- Relevance: LOW
- As Found: Unknown
- 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: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001988
- Term: Bronchiolitis
- ID: D000012141
- Term: Respiratory Tract Infections
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425094
**Acronym:** Tetrasol
**Brief Title:** Effects of a Microalgae Extract Dietary Supplement on Gut Health, Anxiety, and Immune Function
**Official Title:** Effects of a Microalgae Extract Dietary Supplement on Gut Health, Anxiety, and Immune Function
#### Organization Study ID Info
**ID:** 5162
#### Organization
**Class:** OTHER
**Full Name:** Colorado State University
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-24
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-05
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Colorado State University
#### Responsible Party
**Investigator Affiliation:** Colorado State University
**Investigator Full Name:** Tiffany Weir
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study will be conducted to determine the effect of daily Tetradesmus Dimorphus by Tetrasol consumption in supporting gut health using assessments of gastrointestinal symptoms (GSRS) and bowel habits (BSS) as primary outcome measures. The investigators also intend to explore fecal and blood biomarkers of intestinal permeability/function, determination of anxiety and stress levels through both validated assessments and saliva and blood biomarkers, establishment of intervention safety and tolerability through comprehensive metabolic panels and overall compliance, explore the effects of the intervention on inflammation and acute stress (Cold Presser Test), blood lipid profiles, and gut microbiota composition as secondary outcomes.
**Detailed Description:** 1. Total number of subjects who will be approached (including screen fails, controls, and subject withdrawals) to reach enrollment numbers for the lifetime of the study for this investigator's site: 100-125
2. Total number of subjects to be enrolled at this site: The investigators plan to enroll 60 participants for a target completion of 50 participants (25/arm). Enrolling 60 individuals allows for a conservative 20% attrition rate. This is the first human study of the commercial product Tetrasol, which looks at intestinal health outcomes. Therefore, this will be considered a pilot study, and the data will allow us to determine the appropriate sample size for a statistically powered study to identify differences in gastrointestinal health between Tetrasol consumers and placebo.
3. Brief Description/justification for the proposed sample size in lay terms:
The investigators have no human data related to our primary outcome measures for this product. Therefore, investigators propose a pilot study of 25 individuals in each study group.
4. Before the start of enrollment, 60 subjects will be randomly assigned using a random number generator. Upon enrollment, each subject will be assigned either intervention A or B, according to the randomization chart.
5. The study will be a double-blind, placebo-controlled study. Neither the investigators nor the participants will have knowledge of the contents of the capsules. The capsules will be labeled by Microphyt personnel who are not directly involved in the study, and they will maintain the code. Unlike the intervention capsules, the placebo does not contain rapeseed oil and calcium, as the product manufacturer developed these formulations. They wished to keep the placebo formula the same as the formula previously used in their in vitro assays and other clinical work for more equitable comparisons across studies. CSU clinical personnel will administer the two intervention capsules to the subjects according to the randomization strategy and will not be provided with the code for intervention groups until after all data analysis has been completed. In a very unlikely case of a severe adverse event (which is an event that requires the subject's hospitalization), the medical personnel will be provided information about the content of the capsules taken by the participant directly by the Microphyt personnel. The code will not be broken to the investigators until after all data has been analyzed and submitted as a preliminary report.
A. Recruitment:
Recruitment advertisements will be placed in the Coloradoan and other newspapers/newsletters as relevant and will be sent out electronically through the CSU faculty and administrative professionals list on the CSU State Classified list. The investigators will reach out to graduate students and undergraduates by sending the recruitment email to the appropriate administrative personnel in each department (i.e., Grad coordinators and academic success coordinators) and have them forward the study information to their students. Flyers will be posted and distributed throughout the CSU campus and at targeted locations within the community, including UC Health doctor's offices. Flyers will be sent out as direct mailers to individuals in the community; their names and addresses will be purchased from a reputable company that provides names and addresses of individuals in this age range (Alesco Data, http://www.alescodata.com/). To increase participant diversity, investigators will also reach out to student groups on campus, including the Adult Learner and Veterans Services, Asian Pacific American Cultural Center, Black/African American Cultural Center, El Centro, Native American Cultural Center, Pride Resource Center, and Women and Gender Advocacy Center, and cultural groups off campus such as the BIPOC Alliance. Finally, investigators will also contact individuals in our clinical database who participated in previous studies and indicated a willingness to be contacted for future studies.
B. Screening Procedures or Interview/questionnaire: After a preliminary telephone screening (questionnaire attached), volunteers will undergo an in-person screening (visit 1) and provide written informed consent. A questionnaire will assess medical and health history and demographic information, followed by an anthropometric assessment (height, weight, waist, and hip circumferences).
C. Informed consent process and timing of obtaining consent. Potential participants determined to be eligible through telephone screening will be emailed a copy of the consent form and asked to read it before their screening visit. At the screening visit, the study coordinator or other study personnel will review the consent form and encourage the participants to ask any questions about participation in the study. Study personnel conducting the consenting process will assess the ability of the individual to provide informed consent. They will also ensure that all participants know that consent can be withdrawn anytime.
On the first visit (Screening, visit 1), after the participant receives a verbal and written explanation of the project and after the participant provides informed consent, investigators will assess the participant's medical and health history and dietary intake. The investigators will measure the participant's height, weight, and waist and hip circumferences. If the participant qualifies for our study, the participant will be scheduled for the second visit (Baseline, Visit 2). The participant will be provided food diaries and instructed to record all dietary and beverage intake for 2 weekdays and one weekend day before the next study visit. The participant will also be given a worksheet to record the participant's daily bowel movements and a stool collection kit for fecal collection prior to the next study visit. During the second visit (Baseline Visit, visit 2), following an overnight fast, investigators will collect stool samples and bowel movement worksheets, and the participant's body weight, waist, and hip circumferences will be measured. The participant will participate in the cold pressor test, which involves immersing the participant's hand in ice water for 2 and a half minutes while the participant's blood pressure is assessed. The investigators will provide the participants with daily dosing/treatment records and diet records, and the participants will complete sleep, physical activity, gastrointestinal, and mental health questionnaires. The investigators will perform a blood draw and collect the participant's saliva. The participant will then be scheduled for the participant's next appointment and given a 2-week supply of the participant's randomly assigned treatment capsules. This is a double-blind study, meaning neither the participant nor the investigators will know which treatment the participant has been assigned to take. The participant will be provided food diaries and instructed to record all dietary and beverage intake for 2 weekdays and one weekend day before the next study visit. The participant will also be given a worksheet to record the participant's daily bowel movements and a stool collection kit for fecal collection before the next study visit. The participant will also be provided with monetary compensation. During the participant's third visit (Midpoint Visit, Visit/Week 2), following an overnight fast, investigators will collect stool samples and bowel movement worksheets, and the participant's body weight, waist and hip circumferences, supine blood pressure, and heart rate will be measured. The investigators will check the participant's daily dosing/treatment records and diet records and perform a physical activity questionnaire. The investigators will perform a blood draw and collect the participant's saliva. The investigators will review the participant's gastrointestinal and mental health questionnaires. The participant will then be scheduled for the participant's next appointment and given the participant's final allocation of the participant's assigned treatment capsules. The participant will be provided food diaries and instructed to record all dietary and beverage intake for 2 weekdays and one weekend day before the final study visit. The participant will also be given a worksheet to record the participant's daily bowel movements and a stool collection kit for fecal collection before the next study visit. The participant will also be provided with monetary compensation. During the participant's fourth visit (Final Visit, visit 4, Week 4), following an overnight fast, investigators will collect stool samples and bowel movement worksheets, and the participant's body weight, waist, and hip circumferences will be measured. The investigators will check the participant's daily dosing/treatment records and diet records and perform a physical activity questionnaire. The investigators will perform a blood draw and collect the participant's saliva. The participant will also be subjected to an acute stress test, during which the participant will alternate between placing the participant's hand in ice-cold water for 2 and a half minutes while the participant's blood pressure is assessed. This additional test is non-invasive, and the entire test (with an included instructional period) will last approximately 30 minutes. The investigators will review the participant's gastrointestinal and mental health questionnaires. The participant will be provided with monetary compensation and will have completed the study.
### Conditions Module
**Conditions:**
- Gastrointestinal Problem
- Anxiety
- Stress
- Gastrointestinal Symptoms
**Keywords:**
- Tetradesmus Dimorphus
- Gastrointestinal Symptoms
- Anxiety
- Stress
- Gastrointestinal Problem
- Bowel Habits
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized, parallel arm, double-blind, placebo-controlled diet intervention
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Tetradesum dimorphus by Tetrasol extract, maltodextrin, vegetable magnesium stearate, dicalcium phosphate, hydrogenated rapeseed oil, hydroxypropylmethylcellulose
**Intervention Names:**
- Dietary Supplement: Microalgae Extract Capsules
**Label:** Microalgae extract capsules
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** maltodextrin, vegetable magnesium stearate
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Microalgae extract capsules
**Description:** Tetradesum dimorphus by Tetrasol extract(50mg per capsule)
**Name:** Microalgae Extract Capsules
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** maltodextrin \& vegetable magnesium stearate
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** This is a parallel-arm study Where the participant will be asked to consume 100 mg/day(2capsules) for 4 weeks of either microalgae extract or placebo. Data will be taken on visit 2 (baseline), visit 3 (week 2) \& visit 4(week 4) to analyze.
**Measure:** The effect of daily Tetradesmus Dimorphus by Tetrasol consumption in supporting gut health using assessments of gastrointestinal symptoms (GSRS) and bowel habits (BSS)
**Time Frame:** 4weeks
**Description:** This is a parallel-arm study Where the participant will be asked to consume 100 mg/day(2capsules) for 4 weeks of either microalgae extract or placebo. Data will be taken on visit 2 (baseline), visit 3 (week 2) \& visit 4(week 4) to analyze.
**Measure:** Exploration fecal and blood biomarkers of intestinal permeability/function
**Time Frame:** 4 Weeks
**Description:** This is a parallel-arm study Where the participant will be asked to consume 100 mg/day(2capsules) for 4 weeks of either microalgae extract or placebo. Data will be taken on visit 2 (baseline), visit 3 (week 2) \& visit 4(week 4) to analyze.
**Measure:** Determination of anxiety and stress levels through both validated assessments and saliva and blood biomarkers
**Time Frame:** 4 Weeks
**Description:** This is a parallel-arm study Where the participant will be asked to consume 100 mg/day(2capsules) for 4 weeks of either microalgae extract or placebo. Data will be taken on visit 2 (baseline), visit 3 (week 2) \& visit 4(week 4) to analyze.
**Measure:** Establishment of intervention safety and tolerability through comprehensive metabolic panels and overall compliance
**Time Frame:** 4 Weeks
**Description:** This is a parallel-arm study Where the participant will be asked to consume 100 mg/day(2capsules) for 4 weeks of either microalgae extract or placebo. Data will be taken on visit 2 (baseline), visit 3 (week 2) \& visit 4(week 4) to analyze.
**Measure:** Exploration of the effects of the intervention on inflammation and acute stress (Cold Presser Test), blood lipid profiles, and gut microbiota composition
**Time Frame:** 4 Weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Healthy, normal to overweight (BMI of 18.0-29.9) adults between 18-55 years of age with mild to moderate gastrointestinal distress confirmed by one positive response to the Rome IV criteria (Appended).
Exclusion Criteria:
* BMI \>30.0 or \<18.0
* Smoking or other use of tobacco products
* Diagnosed intestinal diseases such as Celiac, Crohn's Disease, Ulcerative Colitis, or Gastrointestinal Cancers
* Pregnant or breastfeeding individuals
* Regular use of NSAIDs or MAO inhibitors
* Clinically diagnosed mental health disorders (clinical depression, bipolar disorder, etc.)
**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:** Tiffany L Weir, MSc,PhD
**Phone:** (970) 491-4631
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sarah A Johnson, RDN,MS,PhD
**Phone:** (970) 491-3807
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Fort Collins
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Tiffany L Weir, MSc,PhD
- **Phone:** 970-491-4631
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Sarah A Johnson, RDN,MS,PhD
- **Phone:** (970) 491-3807
- **Role:** CONTACT
**Country:** United States
**Facility:** Food and Nutrition Clinical Research Lab(FNCRL), Colorado State University
**State:** Colorado
**Status:** RECRUITING
**Zip:** 80526
#### Overall Officials
**Official 1:**
**Affiliation:** Colorado State University
**Name:** Tiffany L Weir, MSc,PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Merchant RE, Andre CA. A review of recent clinical trials of the nutritional supplement Chlorella pyrenoidosa in the treatment of fibromyalgia, hypertension, and ulcerative colitis. Altern Ther Health Med. 2001 May-Jun;7(3):79-91.
**PMID:** 11347287
**Citation:** Avila-Roman J, Talero E, Alcaide A, Reyes Cde L, Zubia E, Garcia-Maurino S, Motilva V. Preventive effect of the microalga Chlamydomonas debaryana on the acute phase of experimental colitis in rats. Br J Nutr. 2014 Oct 14;112(7):1055-64. doi: 10.1017/S0007114514001895. Epub 2014 Sep 5.
**PMID:** 25192306
**Citation:** Avila-Roman J, Talero E, Rodriguez-Luna A, Garcia-Maurino S, Motilva V. Anti-inflammatory effects of an oxylipin-containing lyophilised biomass from a microalga in a murine recurrent colitis model. Br J Nutr. 2016 Dec;116(12):2044-2052. doi: 10.1017/S0007114516004189. Epub 2016 Dec 27.
**PMID:** 28025954
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: HIGH
- As Found: Anxiety
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001008
- Term: Anxiety Disorders
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425081
**Acronym:** VIAB2L
**Brief Title:** Investigating the Impact of Humiome B2 (Colon Delivered Riboflavin) and Riboflavin-overproducer Probiotic Strain Limosilactobacillus Reuteri AMBV339 on Intestinal and Vaginal Microbiome and Health of Healthy Adult Women (The VIAB2L Project)
**Official Title:** Investigating the Impact of Humiome B2 (Colon Delivered Riboflavin) and Riboflavin-overproducer Probiotic Strain Limosilactobacillus Reuteri AMBV339 on Intestinal and Vaginal Microbiome and Health (The VIAB2L Project)
#### Organization Study ID Info
**ID:** 2023-07-14-VIAB
#### Organization
**Class:** INDUSTRY
**Full Name:** DSM Nutritional Products, Inc.
### Status Module
#### Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Universiteit Antwerpen
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** DSM Nutritional Products, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to learn if the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination can change the gut microbiome. It will also learn about the safety of the investigational product. The main questions it aims to answer are:
Do the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination modify gut microbiome? Do the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination modify gut microbiome?
Researchers will compare the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination to a placebo (a look-alike substance that contains no drug) to see if they can change gut and vaginal microbiome. Intervention period is 28 days.
**Detailed Description:** The goal of this clinical trial is to learn if the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination can change the gut microbiome. It will also learn about the safety of the investigational product. Participants are healthy adult females of reproductive age and will take the investigational products for 28 days. There will be several non-invasive measurements, including but not limited to gut microbiome measured in faecal samples and vaginal microbiome measured in vaginal samples. They will fill some questionnaires about their general health.
The investigational product is a probiotic strain (1 billion CFU), colon-delivered riboflavin,(10mg) and their combination.
Participants will:
Take the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination or a placebo every day for 28 days.
Visit the clinic once every 2 weeks for checkups and tests. Keep a diary of their bowel habits and provide fecal and vaginal sample at visits.
### Conditions Module
**Conditions:**
- Microbial Colonization
**Keywords:**
- Probiotic
- vitamin
- Riboflavin
- Vitamin B2
- lactobacillus
- microbiome
- gut microbiome
- vaginal microbiome
- women's health
- gut health
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Double-blinded, randomized and placebo-controlled clinical trial
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** The study will double blinded
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Probiotic strain, 1B CFU per day for 28 days in capsule format
**Intervention Names:**
- Dietary Supplement: Limosilactobacillus reuteri AMBV339
**Label:** L. reuteri AMBV339 (1x109 CFU per capsule)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** 73 mg colon delivered riboflavin containing 10 mg pure riboflavin
**Intervention Names:**
- Dietary Supplement: Humiome B2
**Label:** Humiome B2
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Combination of Arm 1 and Arm 2
**Intervention Names:**
- Dietary Supplement: L. reuteri AMBV339 ca. 1x109 CFU per capsule + Humiome B2
**Label:** L. reuteri AMBV339 ca. 1x109 CFU per capsule + Humiome B2
**Type:** ACTIVE_COMPARATOR
#### Arm Group 4
**Description:** Microcrystalline cellulose
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- L. reuteri AMBV339 (1x109 CFU per capsule)
**Description:** Limosilactobacillus reuteri AMBV339 is a probiotic strain
**Name:** Limosilactobacillus reuteri AMBV339
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Humiome B2
**Description:** Colon-delivered Riboflavin
**Name:** Humiome B2
**Type:** DIETARY_SUPPLEMENT
#### Intervention 3
**Arm Group Labels:**
- L. reuteri AMBV339 ca. 1x109 CFU per capsule + Humiome B2
**Description:** Combination of supplements used in arm 1 and 2
**Name:** L. reuteri AMBV339 ca. 1x109 CFU per capsule + Humiome B2
**Type:** DIETARY_SUPPLEMENT
#### Intervention 4
**Arm Group Labels:**
- Placebo
**Description:** Microcrystalline cellulose
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Other Outcomes
**Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on the excreted levels of riboflavin (in urine). Comparisons will be made between the active groups and with placebo.
**Measure:** Excreted levels of riboflavin (in urine)
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of 28 days of supplementation with either Humiome B2 or L. reuteri AMBV339 or their combination on key anti-inflammatory and cytokine markers in the vagina , assessed by ELISA (e.g., beta-defensin-1 and secretory IgA as well as a broad panel of protein biomarkers). Comparisons will be made between the active groups and with placebo.
**Measure:** Immune markers
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on GIT health will be measured using the GSRS questionnaire. Comparisons will be made between the active groups and with placebo.
**Measure:** General GIT health
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on general Vaginal health will measured using a Ph meter. Comparisons will be made between the active groups and with placebo.
**Measure:** General Vaginal health
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on host Body temperature using a thermometer. Comparisons will be made between the active groups and with placebo.
**Measure:** General host health: Body temperature
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on host Pulse rate using a pulse rate monitor. Comparisons will be made between the active groups and with placebo.
**Measure:** General host health: Pulse rate
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on host Respiration rate by counting the number of chest rises per minute in rest mode. Comparisons will be made between the active groups and with placebo.
**Measure:** General host health: Respiration rate
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on host Blood pressure sphygmomanometer. Comparisons will be made between the active groups and with placebo.
**Measure:** General host health: Blood pressure
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on user satisfaction levels based on a simple questionnaire of 10 point scale of how they felt before and after intervention (0 being the lowest point and 10 being the highest point). Comparisons will be made between the active groups and with placebo.
**Measure:** User satisfaction of investigational product
**Time Frame:** day 0 - day 28
#### Primary Outcomes
**Description:** 1. To investigate if daily supplementation (for 28 days) with either Humiome B2 or Limosilactobacillus reuteri AMBV339 or their combination modulate the microbiome composition (relative abundance of different taxa) in the gastrointestinal tract (GIT). Comparisons will be made between the active groups and with placebo.
**Measure:** Microbiome change in GUT
**Time Frame:** day 0 - day 28
#### Secondary Outcomes
**Description:** To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the microbiome composition (relative abundance of different taxa) in the vagina. Comparisons will be made between the active groups and with placebo.
**Measure:** Microbiome change in vagina
**Time Frame:** day 0 - day 28
**Description:** 2. To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the microbiome diversity in the GIT. Comparisons will be made between the active groups and with placebo.
**Measure:** Gut microbiome diversity
**Time Frame:** day 0 - day 28
**Description:** To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the microbiome diversity in the vagina. Comparisons will be made between the active groups and with placebo.
**Measure:** Vaginal microbiome diversity
**Time Frame:** day 0 - day 28
**Description:** To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the relative abundance levels of keystone taxa in the GIT. Comparisons will be made between the active groups and with placebo.
**Measure:** Keystone bacterial taxa in gut
**Time Frame:** day 0 - day 28
**Description:** To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the relative abundance levels of keystone taxa in the vagina. Comparisons will be made between the active groups and with placebo.
**Measure:** Keystone bacterial taxa in vagina
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of daily supplementation (for 28 days) with either L. reuteri AMBV339 or its combination with Humiome B2 on the presence, persistence and/or engraftment of L. reuteri AMBV339 in the GIT during the intervention and 1 week after the end of supplementation. Comparisons will be made between the active groups and with placebo.
**Measure:** Presence of L. reuteri AMBV339 in gut
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of daily supplementation (for 28 days) with either L. reuteri AMBV339 or its combination with Humiome B2 on the presence, persistence and/or engraftment of L. reuteri AMBV339 in the vagina during the intervention and 1 week after the end of supplementation. Comparisons will be made between the active groups and with placebo.
**Measure:** Presence of L. reuteri AMBV339 in vagina
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on co-occurrence patterns of different bacterial taxa in the GIT, with particular attention to the possible role of riboflavin as an extracellular electron transfer molecule. Comparisons will be made between the active groups and with placebo.
**Measure:** co-occurrence patterns of different bacterial taxa in the Gut microbiome
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on co-occurrence patterns of different bacterial taxa in the vagina, with particular attention to the possible role of riboflavin as an extracellular electron transfer molecule. Comparisons will be made between the active groups and with placebo.
**Measure:** co-occurrence patterns of different bacterial taxa in the vaginal microbiome
**Time Frame:** day 0 - day 28
**Description:** To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the metabolomic profile in the GIT. Comparisons will be made between the active groups and with placebo.
**Measure:** Gut metabolomic profile
**Time Frame:** day 0 - day 28
**Description:** To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the metabolomic profile in the vagina. Comparisons will be made between the active groups and with placebo.
**Measure:** Vaginal metabolomic profile
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on the levels of riboflavin in the GIT. Comparisons will be made between the active groups and with placebo.
**Measure:** levels of riboflavin in the gut
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination for 28 days on the levels of riboflavin in the vagina. Comparisons will be made between the active groups and with placebo.
**Measure:** levels of riboflavin in vagina
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of 28 days of supplementation with either Humiome B2 or L. reuteri AMBV339 or their combination on the systemic levels of riboflavin (in blood). Comparisons will be made between the active groups and with placebo.
**Measure:** systemic levels of riboflavin (in blood)
**Time Frame:** day 0 - day 28
**Description:** To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on the levels of short-chain fatty acids (SCFAs) and related metabolites in the GIT. Comparisons will be made between the active groups and with placebo.
**Measure:** Short chain Fatty Acid (SCFA) levels in gut
**Time Frame:** day 0 - day 28
**Description:** 7. To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on the levels of SCFAs and related metabolites in the vagina . Comparisons will be made between the active groups and with placebo.
**Measure:** Short chain Fatty Acid (SCFA) levels in vagina
**Time Frame:** day 0 - day 28
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Women of reproductive age (appr. 18-45 years old)
* Women of self-reported good general health
* Living in Flanders and speaking Dutch
* Using a combination contraceptive pill (without stop week) during the study and at least three months before the study
* Subjects willing and able to give written informed consent and to understand, to participate and to comply with the clinical study requirements.
Exclusion Criteria:
* Current pregnancy or breastfeeding
* Antibiotic/antimycotic use during the last three months before the study
* Use of group B vitamin supplements or vitamin C during the study (record vitamin use via questionnaires)
* Ketogenic diet during the study and during the last two weeks before the study
* Oral and vaginal probiotic, prebiotic, and postbiotic and synbiotic supplementation during the study or recent use during the last two weeks before the study
* Vaginal douching during the study
* Presence of general infection
* Having a reproductive disorder or current vaginal infection or vaginal symptoms (VVC, BV, AV, etc.)
* Having a gastro-intestinal disorder or current GIT infections or gastrointestinal disorders (Crohn, IBS, IBD, etc.)
* Having any other medical condition that gives rise to exclusion from the study according to the responsible clinician/principal investigator of the study
* Participation in another clinical trial
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sarah Ahannach, Dr
**Phone:** +32 3 265 32 17
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Mehdi Sadaghian, Dr
**Phone:** +41793074667
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Antwerp
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sarah Lebeer, Dr
- **Phone:** +32 3 265 32 85
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Veronique Verhoeven, Dr
- **Phone:** +32 3 265 25 18
- **Role:** CONTACT
**Country:** Belgium
**Facility:** Lab of Applied Microbiology and Biotechnology, University of Antwerp
**Status:** RECRUITING
**Zip:** 2020
#### Overall Officials
**Official 1:**
**Affiliation:** University of Antwerp Department of Family Medicine and Population Health
**Name:** Veronique Verhoeven, Dr
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of Antwerp Department of Bioscience Engineering
**Name:** Sarah Lebeer, Dr
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: 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: Microbial Colonization
- ID: M6368
- Name: Communicable Diseases
- Relevance: HIGH
- As Found: Microbial Colonization
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003141
- Term: Communicable Diseases
- ID: D000007239
- Term: Infections
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: Ot
- Name: Other Dietary Supplements
- Abbrev: HB
- Name: Herbal and Botanical
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: M17546
- Name: Vitamin B Complex
- Relevance: LOW
- As Found: Unknown
- ID: M15085
- Name: Riboflavin
- Relevance: LOW
- As Found: Unknown
- ID: T355
- Name: Acidophilus
- Relevance: LOW
- As Found: Unknown
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
- ID: T463
- Name: Riboflavin
- Relevance: LOW
- As Found: Unknown
- ID: T470
- Name: Vitamin B2
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425068
**Acronym:** Prepicare
**Brief Title:** Assessment of an Innovative Air Mattress On Critically Ill Infants
**Official Title:** Assessment of an Innovative Air Mattress On Critically Ill Infants
#### Organization Study ID Info
**ID:** Empa PSP 5211.02071
#### Organization
**Class:** OTHER
**Full Name:** Empa, Swiss Federal Laboratories for Materials Science and Technology
### Status Module
#### Completion Date
**Date:** 2024-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-07
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-11
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University Children's Hospital, Zurich
#### Lead Sponsor
**Class:** OTHER
**Name:** Simon Annaheim
#### Responsible Party
**Investigator Affiliation:** Empa, Swiss Federal Laboratories for Materials Science and Technology
**Investigator Full Name:** Simon Annaheim
**Investigator Title:** Principle Investigator
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The permanent bedding of critically ill neonates and infants in the pediatric intensive care unit (PICU) for an extended amount of time can result in the development of pressure injuries (PI). PIs can form due to high and permanent local interface pressure induced by contact with bed surfaces or other medical devices. The currently used state-of-the-art support systems consist of conventional foam mattresses. In this study, the investigators explore the effect of a newly developed air mattress with regard to contact are and reduction in the average interface pressure in infants assigned to the pediatric intensive care unit of the childrens hospital in Zurich.
**Detailed Description:** The permanent bedding of critically ill neonates and infants in the pediatric intensive care unit (PICU) for an extended amount of time can result in the development of pressure injuries (PI). This results in a further prolongation of the hospital stay, additional suffering of the patient, scarring, increased mortality and morbidity, and increased healthcare costs. Infants are at particular risk since their skin hasn't matured yet and is mechanically weak, and for example neonates lack a robust stratum corneum entirely. Furthermore, the thickness of their skin is reduced by 60% when compared to skin of adults. Thus, pressure cannot be equally absorbed leading to higher tissue internal stress. PIs can form due to high and permanent local interface pressure induced by contact with bed surfaces or other medical devices. Contact pressure can hamper blood flow in subcutaneous areas, increasing susceptibility for pressure injuries. While sophisticated equipment to manage the interface pressure and reduce the risk of developing pressure injuries is abundant for adults, very little is designed explicitly for neonates and infants. The currently available air mattresses are not being used due to safety concerns and impracticability. Furthermore, they are designed for infants from half a year of age and, thus, not considering the low body weight of premature babies or neonates. This is why the currently used conventional foam mattresses remain first choice. However, foam mattresses are designed for optimal support of a specific weight and, therefore, making them unsuitable for the use as a one-fits-all solution in a highly heterogenic patient cohort. In addition, compressed foam gets stiffer at compressed areas, increasing the local pressure impact and, thus, PI risk. On the other hand, the structures of the hereby-developed air mattress can freely move and optimally adjust to the patient's body shape. This increases contact area, reduces the average interface pressure and blunts local pressure peaks at the areas with the most indentation, ensuring a more homogenous pressure distribution at a lower level. This ultimately is expected to result in a lower PI incidence. As a side effect, lying comfort for the patient will be increased.
### Conditions Module
**Conditions:**
- Skin Abnormalities
- Skin; Injury, Superficial
- Skin; Ulcer, Decubitus
**Keywords:**
- Air mattress
- Skin interface pressure
- Skin contact area
- Lying comfort
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** The study population comprises 26 patients being exposed to the conventional foam mattress (active comparator) and the novel air mattress (experimental) for one hour each in a random order. Interface pressure and contact are will be measured by means of a pressure mattress applied on top of the support systems. The patient comfort will be assessed objectively based on vital sign readings and subjectively based on questionnaire filled by professional care personnel and parents.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 26
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Exposure of the patient to the novel air mattress. Recording of interface pressure and contact area between the patient and the air mattress for one hour.
Regular measurement of vital signs and comfort and assessment of risk to develop side effects, particularly skin pressure injuries.
**Intervention Names:**
- Device: Exposure of the patient to a novel air mattress.
**Label:** Investigation of contact pressure distribution in a novel air mattress
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Exposure of the patient to the conventional foam mattress. Recording of interface pressure and contact area between the patient and the foam mattress for one hour.
Regular measurement of vital signs and comfort and assessment of risk to develop side effects, particularly skin pressure injuries.
**Intervention Names:**
- Device: Exposure of the patient to a conventional foam mattress.
**Label:** Investigation of contact pressure distribution in a conventional foam mattress
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Investigation of contact pressure distribution in a novel air mattress
**Description:** see information provided in the "Arms" section (experimental)
**Name:** Exposure of the patient to a novel air mattress.
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Investigation of contact pressure distribution in a conventional foam mattress
**Description:** see information provided in the "Arms" section (active comparator)
**Name:** Exposure of the patient to a conventional foam mattress.
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Quantification of interface pressure between the patient and the mattress surfaces with emphasis on data of highest pressures (median for top 25% of pressure data observed; 4th quartile of pressure data).
**Measure:** Interface pressure resulting from the exposure of patients to the supportive structures as measured by a pressure sensitive mat (xsensor, LX100:100.160.05, XSENSOR Technology Corporation, Calgary, Canada).
**Time Frame:** baseline
**Description:** Quantification of interface pressure between the patient and the mattress surfaces with emphasis on data of highest pressures (median for top 25% of pressure data observed; 4th quartile of pressure data).
**Measure:** Interface pressure resulting from the exposure of patients to the supportive structures as measured by a pressure sensitive mat (xsensor, LX100:100.160.05, XSENSOR Technology Corporation, Calgary, Canada).
**Time Frame:** after 60 minutes of exposure to the mattress
#### Secondary Outcomes
**Description:** Quantification of contact are between the patient and the mattress surface.
**Measure:** Contact area resulting from the exposure of patients to the supportive structures as detected by a pressure sensitive mat (xsensor, LX100:100.160.05, XSENSOR Technology Corporation, Calgary, Canada)
**Time Frame:** baseline
**Description:** Quantification of contact are between the patient and the mattress surfaces.
**Measure:** Contact area resulting from the exposure of patients to the supportive structures as detected by a pressure sensitive mat (xsensor, LX100:100.160.05, XSENSOR Technology Corporation, Calgary, Canada)
**Time Frame:** after 60 minutes of exposure to the mattress
**Description:** Measurement of heart rate obtained from clinical routine patient surveillance.
**Measure:** Difference in stress assessment by means of heart rate
**Time Frame:** baseline
**Description:** Measurement of heart rate obtained from clinical routine patient surveillance.
**Measure:** Stress assessment by means of heart rate
**Time Frame:** after 60 minutes of exposure to the mattress
**Description:** Measurement of respiratory rate obtained from clinical routine patient surveillance.
**Measure:** Stress assessment by means of respiratory rate
**Time Frame:** baseline
**Description:** Measurement of respiratory rate obtained from clinical routine patient surveillance.
**Measure:** Stress assessment by means of respiratory rate
**Time Frame:** after 60 minutes of exposure to the mattress
**Description:** Measurement of blood pressure obtained from clinical routine patient surveillance.
**Measure:** Stress assessment by means of blood pressure (mean arterial pressure)
**Time Frame:** baseline
**Description:** Measurement of blood pressure obtained from clinical routine patient surveillance.
**Measure:** Stress assessment by means of blood pressure (mean arterial pressure)
**Time Frame:** after 60 minutes of exposure to the mattress
**Description:** Measurement of blood oxygen saturation obtained from clinical routine patient surveillance.
**Measure:** Stress assessment by means of blood oxygen saturation
**Time Frame:** baseline
**Description:** Measurement of blood oxygen saturation obtained from clinical routine patient surveillance.
**Measure:** Stress assessment by means of blood oxygen saturation
**Time Frame:** after 60 minutes of exposure to the mattress
**Description:** Measurement of body temperature obtained from clinical routine patient surveillance.
**Measure:** Stress assessment by means of body temperature
**Time Frame:** baseline
**Description:** Measurement of body temperature obtained from clinical routine patient surveillance.
**Measure:** Stress assessment by means of body temperature
**Time Frame:** after 60 minutes of exposure to the mattress
**Description:** Quantification of comfort level ranging from 0 \[very uncomfortable\] to 10 \[very comfortable\].
**Measure:** Comfort assessment by means of a visual analogue scale
**Time Frame:** baseline
**Description:** Quantification of comfort level ranging from 0 \[very uncomfortable\] to 10 \[very comfortable\].
**Measure:** Comfort assessment by means of a visual analogue scale
**Time Frame:** after 60 minutes of exposure to the mattress
**Description:** Quantification of stress level ranging from 0 \[totally relaxed\] to 10 \[very stressed\].
**Measure:** Stress assessment by means of a visual analogue scale
**Time Frame:** baseline
**Description:** Quantification of stress level ranging from 0 \[totally relaxed\] to 10 \[very stressed\].
**Measure:** Stress assessment by means of a visual analogue scale
**Time Frame:** after 60 minutes of exposure to the mattress
**Description:** Assessment of pain indicators (crying, facial expression, body tension, heart rate) ranging from 0 points (no pain indication) to 3 points (high pain indication). Total values \>5 points for premature babies and \>3 points for term babies is indicative for pain.
**Measure:** Pain assessment by means of the questionnaire "Bern pain score for newborns - Revised (BSN-R)"
**Time Frame:** baseline
**Description:** Assessment of pain indicators (crying, facial expression, body tension, heart rate) ranging from 0 points (no pain indication) to 3 points (high pain indication). Total values \>5 points for premature babies and \>3 points for term babies is indicative for pain.
**Measure:** Pain assessment by means of the questionnaire "Bern pain score for newborns - Revised (BSN-R)"
**Time Frame:** after 60 minutes of exposure to the mattress
**Description:** Values range from -1 (sleepy) to 0 (attentive and calm) to +4 (belligerent).
**Measure:** Unrest assessment by means of the Richmond Agitation-Sedation Scale (RASS) questionnaire
**Time Frame:** baseline
**Description:** Values range from -1 (sleepy) to 0 (attentive and calm) to +4 (belligerent).
**Measure:** Unrest assessment by means of the Richmond Agitation-Sedation Scale (RASS) questionnaire
**Time Frame:** after 60 minutes of exposure to the mattress
**Description:** Assessment of the capillary refill time according to Jevon and Gallier (2020).
**Measure:** Skin perfusion assessment by means of capillary refill time
**Time Frame:** baseline
**Description:** Assessment of the capillary refill time according to Jevon and Gallier (2020).
**Measure:** Skin perfusion assessment by means of capillary refill time
**Time Frame:** after 60 minutes of exposure to the mattress
**Description:** Identification and localisation (nose, mouth, occipital, face, ear, back, leg, foot, heel, others) of skin irregularities and evaluation of severity of irregularity (redness, partial injury of skin layers, all skin layers affected, complete tissue loss) according to clinical routine
**Measure:** Skin assessment according to standard clinical procedure
**Time Frame:** baseline
**Description:** Identification and localisation (nose, mouth, occipital, face, ear, back, leg, foot, heel, others) of skin irregularities and evaluation of severity of irregularity (redness, partial injury of skin layers, all skin layers affected, complete tissue loss) according to clinical routine
**Measure:** Skin assessment by means of questionnaire
**Time Frame:** after 60 minutes of exposure to the mattress
**Description:** Assessment of delirium indicators (eye contact, purposeful actions, awareness of surroundings, communication of needs, restlessness, refusal to be comforted, hypoactivity, response time) ranging from 0 points (not indicative for delirium) to 4 points (highly indicative for delirium). A delirium state is considered from a total value of \>8 points.
**Measure:** Delirium assessment by means of the Cornell Assessment of Pediatric Delirium score (CAPD)
**Time Frame:** baseline
**Description:** Assessment of delirium indicators (eye contact, purposeful actions, awareness of surroundings, communication of needs, restlessness, refusal to be comforted, hypoactivity, response time) ranging from 0 points (not indicative for delirium) to 4 points (highly indicative for delirium). A delirium state is considered from a total value of \>8 points.
**Measure:** Delirium assessment by means of the Cornell Assessment of Pediatric Delirium score (CAPD)
**Time Frame:** after 60 minutes of exposure to the mattress
**Description:** Assessment of withdrawal indicators (autonomic dysfunction \[4 aspects\], overstimulation of the central nervous system \[9 aspects\], dysfunction of the gastrointestinal tract \[2 aspects\] ranging from 0 points (not detectable) to 1 point (detectable). A withdrawal state is considered from a total value of \>3 points.
**Measure:** Withdrawal assessment by means of the Sophia Observation Withdrawal Symptoms scale (SOS)
**Time Frame:** baseline
**Description:** Assessment of withdrawal indicators (autonomic dysfunction \[4 aspects\], overstimulation of the central nervous system \[9 aspects\], dysfunction of the gastrointestinal tract \[2 aspects\] ranging from 0 points (not detectable) to 1 point (detectable). A withdrawal state is considered from a total value of \>3 points.
**Measure:** Withdrawal assessment by means of the Sophia Observation Withdrawal Symptoms scale (SOS)
**Time Frame:** after 60 minutes of exposure to the mattress
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Informed consent signed by the legal guardian
* Admitted to the pediatric intensive care unit (PICU)
* Age: late preterm (\>34 gestational age) up to 6 months
* Admission at least 24 hours to PICU prior to intervention
* Presence/availability of at least one parent/legal guardian
Exclusion Criteria:
* Life threatening condition
* Patients who cannot be positioned in supine position
* Skin injury at body area in contact with support surface
* Patients with congenital skin disorders
* Patients with omphalocele or gastroschisis
* Newborns with peripartum asphyxia and hypothermia therapy
* Language communication difficulties with the legal guardians
* Surgical patients on the day of surgery
* birth weight \<1250g
**Maximum Age:** 6 Months
**Minimum Age:** 10 Days
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Simon Annaheim, PhD
**Phone:** +41 58 765 77 68
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Barbara Brotschi, Prof
**Phone:** +41 44 266 71 71
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Zurich
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Barbara Brotschi, Prof
- **Phone:** +41 44 266 71 71
- **Role:** CONTACT
**Country:** Switzerland
**Facility:** University Children's Hospital Zurich
**Status:** RECRUITING
**Zip:** 8032
#### Overall Officials
**Official 1:**
**Affiliation:** Universitäts-Kinderspital Zürich, Zurich
**Name:** Barbara Brotschi, Prof
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Data will be made available upon request for scientific analysis of the data. Research objectives and data analysis plan needs to be provided.
**Description:** It is intended to publish the study in an open-access journal by December 2024. With this, the raw data of the interface pressure and contact area measurements will be made available upon request and fulfilling the access criteria as indicated below.
**Info Types:**
- STUDY_PROTOCOL
- SAP
**IPD Sharing:** YES
**Time Frame:** Data as indicated in the plan description will be available upon publication of the data Data will be available for an unlimited period of time.
### References Module
#### References
**Citation:** Jevon P, Gallier H. How to measure capillary refill time in patients who are acutely ill. Nursing Times [online]. 2020; 116(8): 29-30.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000000013
- Term: Congenital Abnormalities
- ID: D000012883
- Term: Skin Ulcer
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
### Condition Browse Module - Browse Leaves
- ID: M19010
- Name: Critical Illness
- Relevance: LOW
- As Found: Unknown
- ID: M6870
- Name: Pressure Ulcer
- Relevance: HIGH
- As Found: Skin; Ulcer, Decubitus
- ID: M17206
- Name: Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M15672
- Name: Skin Abnormalities
- Relevance: HIGH
- As Found: Skin Abnormalities
- ID: M15686
- Name: Skin Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012868
- Term: Skin Abnormalities
- ID: D000003668
- Term: Pressure Ulcer
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425055
**Acronym:** ALPESTRIA-1
**Brief Title:** Vonafexor ALPort Syndrome Efficacy & Safety TRIAl-1 (ALPESTRIA-1)
**Official Title:** Vonafexor Fixed Dose-escalation Safety and Proof-of-concept Study in Patients With at Risk of Progression Alport Syndrome
#### Organization Study ID Info
**ID:** EYP001-208
#### Organization
**Class:** INDUSTRY
**Full Name:** Enyo Pharma
### Status Module
#### Completion Date
**Date:** 2025-10-13
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-21
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Enyo Pharma
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is a proof-of-concept trial of vonafexor safety, its effects on kidney function in subjects with at risk of progression Alport syndrome.
**Detailed Description:** This is a multicenter study and several clinical sites and countries will be involved.
This single arm, fixed dose escalation, open-label, non-randomized study will evaluate three dose levels of vonafexor on safety, tolerability and their effect on kidney function and renal biomarkers in 20 patients with AS at risk of progression.
The total duration of study for a participant will be up to 40 weeks and include a screening period, a treatment period of 24 weeks and a follow-up period of 12 weeks.
### Conditions Module
**Conditions:**
- Alport Syndrome
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Single arm fixed dose escalation
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This is a single arm fixed dose escalation with three dose levels of vonafexor, all QD.
**Intervention Names:**
- Drug: Vonafexor
**Label:** Single arm fixed dose escalation
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Single arm fixed dose escalation
**Description:** * One tablet of a low dose of vonafexor QD from Day 1 to Week 4
* One tablet of a medium dose of vonafexor QD from Week 5 to Week 8
* One tablet of a high dose of vonafexor QD from Week 9 to Week 24
**Name:** Vonafexor
**Other Names:**
- EYP001a
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** To determine the effect of vonafexor on and off treatment on exploratory renal biomarkers
**Measure:** Change in albuminuria
**Time Frame:** During on-treatment (assessed up to 24 weeks) and off-treatment periods (assessed up to 36 weeks) compared to baseline
**Description:** To determine the effect of vonafexor on and off treatment on exploratory renal biomarkers
**Measure:** Change in proteinuria
**Time Frame:** During on-treatment (assessed up to 24 weeks) and off-treatment periods (assessed up to 36 weeks) compared to baseline
**Description:** To determine the effect of vonafexor on and off treatment on exploratory renal biomarkers
**Measure:** Change in Neutrophil Gelatinase Associated Lipocalin (NGAL)
**Time Frame:** During on-treatment (assessed up to 24 weeks) and off-treatment periods (assessed up to 36 weeks) compared to baseline
#### Primary Outcomes
**Description:** To assess the safety and tolerability of vonafexor
**Measure:** Number of Treatment-Emergent Adverse Event (TEAE)
**Time Frame:** From first dose of treatment until 2 weeks after last dose of treatment, i.e assessed up to 26 weeks
#### Secondary Outcomes
**Description:** To determine the on with the off-treatment effect of three dose levels of vonafexor on renal function
**Measure:** Change in eGFR
**Time Frame:** During on-treatment (assessed up to 24 weeks) and off-treatment periods (assessed up to 36 weeks) compared to baseline
**Description:** To determine vonafexor plasma concentrations levels
**Measure:** Vonafexor plasma concentrations
**Time Frame:** During on-treatment period, assessed up to 24 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Signed informed consent (also for legal representatives, as applicable in the US for under eighteen patients).
* Has confirmed diagnosis of Alport syndrome: clinical diagnosis (haematuria, family history, hearing loss, ocular change) OR a kidney biopsy showing glomerular basement membrane abnormalities consistent with AS, AND Genetic confirmation of AS.
* Has eGFR between ≥ 30 and \< 90 ml/min/1.73m2.
* Has increased albuminuria criteria i.e. UACR ≥ 300 mg/g.
* If on an angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB), should be on a stable well tolerated treatment during at least the 60 days prior D1.
* If on Sodium-Glucose Transport Protein 2 (SGLT2), should be on stable well tolerated treatment with SGLT2 during at least 60 days prior D1.
* If patient has a history of arterial hypertension, should be on stable anti-hypertensive therapy for at least 60 days prior to D1 and deemed controlled by the investigator at screening and D1.
* Sexually active female subjects of childbearing potential and sexually mature male subjects must use two acceptable effective methods of contraception for the entire duration of the study and for at least 6 weeks after last dose.
* Has negative results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV).
* Is able to understand all study procedures in the informed consent form (ICF) and willing to comply with all aspects of the protocol.
Exclusion Criteria:
* Is an employee of a site, clinical research organization, vendor, or sponsor involved with this study.
* Is pregnant or breastfeeding.
* Has participated in any investigational drug study within 60 days prior to D1.
* Any clinically significant illness within 30 days before D1 or surgical or medical condition (other than Alport syndrome) that could interfere with the subject's study compliance; confound the study results; impact subject safety.
* Any history of active malignancy within the last 1 year before D1.
* Any other condition or circumstance that, in the opinion of the investigator, may make the subject unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the subject's safety and well-being.
* Has a history of an allergic condition that required the prescription of an emergency epinephrine injection (such as the EpiPen® Auto-Injector).
* Any prohibited co-medications within 30 days prior D1.
* Has ALT or AST above near normal (\>1.5×ULN) at baseline.
* Are at high risk for atherosclerotic cardiovascular disease (ASCVD) risk, with an LDL-C level \> 160 mg/dL (4.15 mmol/L) and subjects at intermediate risk for ASCVD risk, with a LDL-C level \> 190 mg/dL (4.91 mmol/L).
* Has moderate or severe hepatic impairment (Child-Pugh score B or C).
* Is taking CYP3A4/5 inhibitors or inducers.
**Maximum Age:** 55 Years
**Minimum Age:** 16 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Isabelle Martin
**Phone:** 00 33 4 37 70 02 44
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Birmingham
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Alabama
**State:** Alabama
**Zip:** 35294
**Location 2:**
**City:** Los Angeles
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** United States
**Facility:** UCLA Health, David Geffen School of Medicine
**State:** California
**Zip:** 90095
**Location 3:**
**City:** Boise
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** United States
**Facility:** Boise Kidney & Hypertension
**State:** Idaho
**Zip:** 83703
**Location 4:**
**City:** Hinsdale
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** United States
**Facility:** NANI Research
**State:** Illinois
**Zip:** 60521
**Location 5:**
**City:** Saint Louis
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** United States
**Facility:** Washington University
**State:** Missouri
**Zip:** 63110
**Location 6:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** United States
**Facility:** Columbia University Medical Center
**State:** New York
**Zip:** 60521
**Location 7:**
**City:** Cleveland
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** United States
**Facility:** Cleveland Clinic Foundation
**State:** Ohio
**Zip:** 44195
**Location 8:**
**City:** Dallas
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** United States
**Facility:** Renal Disease Research Institute
**State:** Texas
**Zip:** 75126
**Location 9:**
**City:** Bordeaux
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** France
**Facility:** CHU De Bordeaux
**Zip:** 33076
**Location 10:**
**City:** Marseille
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital de la Conception
**Zip:** 13385
**Location 11:**
**City:** Montpellier
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** France
**Facility:** Hopital Lapeyronie
**Zip:** 34090
**Location 12:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** France
**Facility:** Necker Enfants Malades
**Zip:** 75015
**Location 13:**
**City:** Berlin
**Country:** Germany
**Facility:** Charite Universitatsmedizin Berlin
**Zip:** 10117
**Location 14:**
**City:** Göttingen
**Country:** Germany
**Facility:** University Medicine Goettingen
**Zip:** 37075
**Location 15:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** Spain
**Facility:** Fundacio Puigvert
**Zip:** 08025
**Location 16:**
**City:** El Palmar
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** Spain
**Facility:** Hospital Virgen de la Arrixaca
**Zip:** 30120
**Location 17:**
**City:** Madrid
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** Spain
**Facility:** Fundacion Jimenez Diaz
**Zip:** 28040
**Location 18:**
**City:** Sagunto
**Contacts:**
***Contact 1:***
- **Name:** ENYO Pharma
- **Role:** CONTACT
**Country:** Spain
**Facility:** Hospital De Sagunto
**Zip:** 46520
### IPD Sharing Statement Module
**Description:** Individual participant data that underline published results might be shared upon request with researchers who provide a methodologically sound proposal and to achieve objectives as set in the approved proposal.
IPD will be shared deidentified and from 3 months and ending 5 years following article publication.
**Info Types:**
- STUDY_PROTOCOL
- SAP
**IPD Sharing:** YES
**Time Frame:** From 3 months and ending 5 years following article publication.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000014564
- Term: Urogenital Abnormalities
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000009393
- Term: Nephritis
- ID: D000007674
- Term: Kidney Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000000013
- Term: Congenital Abnormalities
- ID: D000003095
- Term: Collagen Diseases
- ID: D000003240
- Term: Connective Tissue Diseases
### 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: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M20559
- Name: Disease Progression
- Relevance: LOW
- As Found: Unknown
- ID: M12338
- Name: Nephritis
- Relevance: LOW
- As Found: Unknown
- ID: M12339
- Name: Nephritis, Hereditary
- Relevance: HIGH
- As Found: Alport Syndrome
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M17314
- Name: Urogenital Abnormalities
- 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: M10698
- Name: Kidney Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: 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: T303
- Name: Alport Syndrome
- Relevance: HIGH
- As Found: Alport Syndrome
### Condition Browse Module - Meshes
- ID: D000009394
- Term: Nephritis, Hereditary
- ID: D000013577
- Term: Syndrome
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425042
**Acronym:** RESTORENAD
**Brief Title:** Nicotinamide Riboside Supplementation and Exercise Training to Promote Healthy Longevity
**Official Title:** Boosting the NAD+ Levels in Older Individuals Via Nicotinamide Riboside Supplementation and Exercise Training to Promote Metabolic Health
#### Organization Study ID Info
**ID:** 23-041
#### Organization
**Class:** OTHER
**Full Name:** Finis Terrae University
### Status Module
#### Completion Date
**Date:** 2026-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Finis Terrae University
#### Responsible Party
**Investigator Affiliation:** Finis Terrae University
**Investigator Full Name:** Rodrigo Mancilla
**Investigator Title:** Doctor, PhD
**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 prevalence of age-related chronic diseases (like obesity, type 2 diabetes and cardiovascular diseases) is mounting worldwide, reaching pandemic proportions. These age-related chronic diseases are associated with diminished skeletal muscle mitochondrial function in humans. Nicotinamide adenosine dinucleotide (NAD) is a coenzyme that regulates mitochondrial function, therefore, plays an important role in energy metabolism. Importantly, it has been shown that high cellular NAD+ levels as well as a high NAD+/NADH ratio promote metabolic and mitochondrial health. In contrast, NAD+ bioavailability declines upon aging in humans as well as in animal models of metabolic disorders and type 2 diabetes. These findings fuel the notion of boosting the NAD+ bioavailability in order to improve metabolic disturbances and mitochondrial dysfunction in aged individuals. Supplementation with nicotinamide riboside (NR), a naturally occurring form of vitamin B3, boosts cellular NAD+ levels. However, in contrast to animal studies, NR supplementation in humans has so far been unsuccessful in improving skeletal muscle mitochondrial function, exercise capacity or insulin sensitivity. Interestingly, Recently, it has been suggested that metabolic conditions where NAD+ levels become limited, is needed for NR supplementation to exert beneficial health effects. This metabolic condition could be achieved by exercise. However, studies combining NR and exercise are lacking, and that is why we will perform the present study.
### Conditions Module
**Conditions:**
- Healthy Aging
- Lifestyle-related Condition
- Metabolic Diseases
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Double blinded
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 28
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This arm will ingest NR orally and perform exercise training
**Intervention Names:**
- Dietary Supplement: Nicotinamide Riboside (NR)
**Label:** NR+EXTR
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** This arm will ingest placebo orally and perform exercise training
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** PLA+EXTR
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- NR+EXTR
**Description:** Participants will ingest 1g/d of NR orally during 12 weeks in parallel to a exercise training program
**Name:** Nicotinamide Riboside (NR)
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- PLA+EXTR
**Description:** Participants will ingest 1g/d of placebo orally during 12 weeks in parallel to a exercise training program
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Skeletal muscle mitochondrial respiratory capacity will be measured in permeabilized fibres.
**Measure:** Skeletal muscle mitochondrial respiratory capacity
**Time Frame:** 12 weeks
**Description:** Proteins content of oxidative phosphorylation system will be quantified from muscle biopsy
**Measure:** Skeletal muscle mitochondrial content
**Time Frame:** 12 weeks
#### Secondary Outcomes
**Description:** Quantification of proteins content of oxidative phosphorylation system in muscle biopsies
**Measure:** Quantification of proteins that regulate oxidative metabolism
**Time Frame:** 12 weeks
**Description:** Maximal aerobic capacity will be measure upon a progressive cycling test
**Measure:** Maximal aerobic capacity
**Time Frame:** 12 weeks
**Description:** Walking speed and distance will be measured via the 6-minutes walking test
**Measure:** Walking speed and distance
**Time Frame:** 12 weeks
**Description:** Time spent on performing seating and standing transitions will be measured upon the timed-up and go test
**Measure:** Seating and standing transitions
**Time Frame:** 12 weeks
**Description:** Exercise efficiency will be measured upon a sub maximal cycling test and indirect calorimetry
**Measure:** Exercise efficiency
**Time Frame:** 12 weeks
**Description:** Intrahepatic liver fat content will be measured by 1H-MRS
**Measure:** Intrahepatic liver fat content
**Time Frame:** 12 weeks
**Description:** body weight will be measured in kilograms
**Measure:** Body weight
**Time Frame:** 12 weeks
**Description:** total muscle mass will be measured in kilograms and/or percentage
**Measure:** Total muscle mass
**Time Frame:** 12 weeks
**Description:** Total fat mass will be measured in kilograms and/or percentage
**Measure:** Total fat mass
**Time Frame:** 12 weeks
**Description:** Fat-free mass will be measured in kilograms and/or percentage
**Measure:** Fat-free mass
**Time Frame:** 12 weeks
**Description:** NAD+ levels in circulation and in skeletal muscle
**Measure:** NAD+ levels
**Time Frame:** 12 weeks
**Description:** 24h Blood pressure will be measured with a continuous blood pressure holder device
**Measure:** 24h Blood pressure
**Time Frame:** 12 weeks
**Description:** Heart rate variability will be measured with a continuos electrocardiogram monitor device
**Measure:** Heart rate variability
**Time Frame:** 12 weeks
**Description:** Resting energy expenditure will be measured by indirect calorimetry
**Measure:** Resting energy expenditure
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants are able to provide signed and dated written informed consent prior to any study specific procedures
* Aged ≥ 60 and ≤ 80 years
* Body mass index (BMI) 25 - 35 kg/m2
* Stable dietary habits (no weight loss or gain \> 5 kg in the past 3 months)
* No signs of active cardiovascular disease, liver or kidney malfunction
Exclusion Criteria:
* Patients with congestive heart failure and and/or severe renal and or liver insufficiency
* Uncontrolled hypertension
* Any contra-indication for MRI scanning
* Alcohol consumption of \> 3 servings per day for man and \>2 servings per day for woman
* Smoking
* Unstable body weight (weight gain or loss \> 5kg in the last 3 months)
* Engagement in structured exercise activities \> 2 hours a week
* Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator which would possibly hamper our study results
* Use of food supplements containing NR or Resveratrol (similar working mechanisms)
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rodrigo Mancilla, PhD
**Phone:** +56953676588
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Santiago
**Contacts:**
***Contact 1:***
- **Name:** Rodrigo Mancilla, PhD
- **Role:** CONTACT
**Country:** Chile
**Facility:** Finis Terrae University
**State:** Region Metropolitana
**Status:** RECRUITING
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M11639
- Name: Metabolic Diseases
- Relevance: HIGH
- As Found: Metabolic Diseases
### Condition Browse Module - Meshes
- ID: D000008659
- Term: Metabolic Diseases
### Intervention Browse Module - Ancestors
- ID: D000014803
- Term: Vitamin B Complex
- ID: D000014815
- Term: Vitamins
- ID: D000018977
- Term: Micronutrients
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000960
- Term: Hypolipidemic Agents
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000057847
- Term: Lipid Regulating Agents
- ID: D000014665
- Term: Vasodilator Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: Lipd
- Name: Lipid Regulating Agents
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M12476
- Name: Niacinamide
- Relevance: HIGH
- As Found: Continuing
- ID: M12465
- Name: Niacin
- Relevance: HIGH
- As Found: Continuing
- ID: M12479
- Name: Nicotinic Acids
- Relevance: HIGH
- As Found: Continuing
- ID: M8618
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: M17546
- Name: Vitamin B Complex
- Relevance: LOW
- As Found: Unknown
- ID: M21009
- Name: Micronutrients
- Relevance: LOW
- As Found: Unknown
- ID: M16885
- Name: Trace Elements
- Relevance: LOW
- As Found: Unknown
- ID: M4278
- Name: Hypolipidemic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M28883
- Name: Lipid Regulating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M17412
- Name: Vasodilator Agents
- Relevance: LOW
- As Found: Unknown
- ID: T455
- Name: Nicotinamide
- Relevance: HIGH
- As Found: Continuing
- ID: T453
- Name: Niacin
- Relevance: HIGH
- As Found: Continuing
- ID: T454
- Name: Niacinamide
- Relevance: HIGH
- As Found: Continuing
- ID: T456
- Name: Nicotinic Acid
- Relevance: HIGH
- As Found: Continuing
- ID: T471
- Name: Vitamin B3
- Relevance: HIGH
- As Found: Continuing
- ID: T446
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T448
- Name: Folate
- Relevance: LOW
- As Found: Unknown
- ID: T475
- Name: Vitamin B9
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000009536
- Term: Niacinamide
- ID: D000009525
- Term: Niacin
- ID: D000009539
- Term: Nicotinic Acids
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425029
**Acronym:** SONATA
**Brief Title:** Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
**Official Title:** SONATA: Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application
#### Organization Study ID Info
**ID:** STUDY02002411
#### Organization
**Class:** OTHER
**Full Name:** Dartmouth-Hitchcock Medical Center
### Status Module
#### Completion Date
**Date:** 2026-03-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Dartmouth College
**Class:** OTHER
**Name:** University of Massachusetts, Worcester
#### Lead Sponsor
**Class:** OTHER
**Name:** Dartmouth-Hitchcock Medical Center
#### Responsible Party
**Investigator Affiliation:** Dartmouth-Hitchcock Medical Center
**Investigator Full Name:** Brian Fidali, MD
**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:** This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment.
**Detailed Description:** This study aims to replicate and extend findings from prior electrophysiological studies that demonstrated a reduction in epileptiform discharges and seizures in patients living with drug-resistant (medications are not effective) epilepsy after listening to specific music.
It is believed to be the first study to examine the effect of daily, self-administered musical stimuli in reduction of epileptiform event detections over days to weeks. The study will enroll a cohort of patients already implanted with NeuroPace Responsive Neurostimulator (RNS) device to treat their epilepsy. This device uses continuous, outpatient electrocorticographic recording data to provide immediate (or 'responsive') closed loop neurostimulation.
Primary hypothesis is that patients with drug resistant epilepsy, implanted with RNS, will have fewer epileptic activity episodes (RNS 'long episodes') during the weeks of experimental music intervention. The study team expect to see improvement with daily listening to specific music intervention (experimental, Music A), but not with active comparators (Music B or C). The effect, if any, of music intervention is expected to last at least one week after the intervention period (block) (for each music piece) ends.
Secondary hypothesis is that the music listening every day will be associated with improved self-report of mood, quality of life, and self-reported measures of cognition. The study team suspects that this effect will not be limited to just one specific musical piece.
This study will also look to determine the feasibility of an at-home, self-administered auditory intervention in drug resistant epilepsy.
### Conditions Module
**Conditions:**
- Epilepsy
- Refractory Epilepsy
- Music
**Keywords:**
- music
- epilepsy
- responsive neurostimulation
- interictal discharge
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** The primary endpoint is to assess the reduction in epileptiform activity (as defined by change in normalized RNS 'long episode' detection frequency) during the 14-day stimulus presentation block for three music pieces. 1) Music piece (A) previously shown to reduce interictal epileptiform discharges (IEDs)). 2) Music piece (B) (previously shown to not reduce IEDs in the same population despite rhythmic similarities), and 3) Music piece (C) - a selection from the participant's preferred musical style that is also matched for musical characteristics.
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Participants will not be informed of their group assignment. The study team will have no knowledge of randomization sequence until all participants complete the study.
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will be asked to listen to a musical excerpt previously shown to have a positive effect on epileptic activity in human brain.
**Intervention Names:**
- Other: Experimental Intervention (Music A)
**Label:** Music Piece A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will be asked to listen to a musical except very similar to the experimental stimuli that has not been shown to have a positive effect on epileptic activity.
**Intervention Names:**
- Other: Active Comparator Intervention (Music B)
**Label:** Music Piece B
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Participants will select a preferred excerpt from several popular musical genres. This piece is modified to have some similarities to the experimental musical excerpt.
**Intervention Names:**
- Other: Active Comparator Intervention (Music C)
**Label:** Music Piece C
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Music Piece A
**Description:** Participants will be asked to listen to Music A on their personal device daily, at a time most convenient for them.
**Name:** Experimental Intervention (Music A)
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Music Piece B
**Description:** Participants will be asked to listen to music B on their personal device daily, at a time most convenient for them.
**Name:** Active Comparator Intervention (Music B)
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Music Piece C
**Description:** Participants will be asked to listen to music C on their personal device daily, at a time most convenient for them.
**Name:** Active Comparator Intervention (Music C)
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** This measure aims to determine if specific music intervention has positive effect on epileptic activity in participants with responsive neurostimulation device (RNS) implanted for drug-resistant epilepsy (DRE). The effect will be measured as a change in the number of "long episodes" or epileptic activity in a participants' brain as detected and recorded by the RNS device before and after study music interventions.
**Measure:** Music Intervention and its effects on epileptic activity in human brain
**Time Frame:** Baseline, Week 3-4, Week 9-10, and Weeks 13-14, (Approximately 4 1/2 Months)
#### Secondary Outcomes
**Description:** The study team will collect and assess the number of seizures reported by participants during the 4-week period before enrollment (retrospective or going back in time) and 4 1/2 months throughout the study (prospective or going forward in time).
**Measure:** Reduction in patient-reported seizures
**Time Frame:** Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
**Description:** The study team will assess the time frame (seconds, hours, days, weeks, etc.) during which the reduction of "long episodes" or epileptic activity in participants' brain, as detected by the RNS system, lasts after each music intervention.
**Measure:** Determining duration of therapeutic effect of music intervention
**Time Frame:** Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
**Description:** The study team will measure this outcome by comparing the difference in individual scores collected via cognition questionnaire (BRIEF-A) done by all participants before study intervention (Enrollment Visit) and at the end of the study ("End of Study" visit).
**Measure:** Assessment of pre- and post-intervention cognition scores (BRIEF-A)
**Time Frame:** Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
**Description:** The study team will measure this outcome by comparing the difference in individual scores collected via mood questionnaire (DASS-21) done by all participants before study intervention (Enrollment Visit) and at the end of the study ("End of Study" visit).
**Measure:** Assessment of pre- and post-intervention mood (DASS-21)
**Time Frame:** Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
**Description:** The study team will measure this outcome by comparing the difference in individual scores collected via quality-of-life questionnaire (QOLIE-31) done by all participants before study intervention (Enrollment Visit) and at the end of the study ("End of Study" visit).
**Measure:** Assessment of pre- and post-intervention quality of life (QOLIE-31)
**Time Frame:** Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
**Description:** The study team will review participants' responses to study specific music questionnaire. The outcome will be measured as percentage of participants and their specific musical preferences pre- and post-intervention.
**Measure:** Assessment of music preferences pre- and post-intervention
**Time Frame:** Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
**Description:** The study team will assess participants' engagement with study interventions over the course of this study. This will be measured as a number of days each participant missed each music intervention.
**Measure:** Assess feasibility of real-world, at home auditory stimulus interventions for patients with drug resistant epilepsy
**Time Frame:** Throughout the study completion, an average of 5 1/2 months (4 weeks retrospective data collection and 4 1/2 months post enrollment)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults with medication-refractory focal epilepsy who have undergone RNS implantation at least six months prior and are in the judgement of the treating physician on a stable RNS regimen in terms of stimulation
* Willing to attend all study visits and complete all required study procedures
* Access to private or public wireless data service at regular intervals
* Access to personal mobile device
Exclusion Criteria:
* Documentation of a musicogenic, or auditory-triggered focal seizure semiology
* Participant is unable to reasonably participate in study tasks as determined by the investigator
* Inability to obtain informed consent from the patient or legally authorized representative
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anastasia Kanishcheva, MPH
**Phone:** 603-650-0260
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Brian C Fidali, MD
**Phone:** 603-650-5104
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Worcester
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** CJ Hill
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Natalie Erlich-Malona, MD
- **Role:** CONTACT
***Contact 3:***
- **Name:** Felicia Chu, MD
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Natalie Erlich-Malona, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Massachusetts Chan Medical School
**State:** Massachusetts
**Zip:** 01655
**Location 2:**
**City:** Lebanon
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Anastasia Kanishcheva, MPH
- **Phone:** 603-650-0260
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Brian C Fidali, MD
- **Phone:** 603-650-5104
- **Role:** CONTACT
***Contact 3:***
- **Name:** Brian C Fidali, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Barbara C Jobst, MD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Dartmouth-Hitchcock Medical Center
**State:** New Hampshire
**Zip:** 03756
#### Overall Officials
**Official 1:**
**Affiliation:** Dartmouth-Hitchcock Medical Center
**Name:** Brian C Fidali, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** The study results will be available on ClinicalTrials.gov and will be published in appropriate clinical journal upon completion.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Quon RJ, Casey MA, Camp EJ, Meisenhelter S, Steimel SA, Song Y, Testorf ME, Leslie GA, Bujarski KA, Ettinger AB, Jobst BC. Musical components important for the Mozart K448 effect in epilepsy. Sci Rep. 2021 Sep 16;11(1):16490. doi: 10.1038/s41598-021-95922-7.
**PMID:** 34531410
**Citation:** Feng Y, Quon RJ, Jobst BC, Casey MA. Evoked responses to note onsets and phrase boundaries in Mozart's K448. Sci Rep. 2022 Jun 10;12(1):9632. doi: 10.1038/s41598-022-13710-3.
**PMID:** 35688855
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7983
- Name: Epilepsy
- Relevance: HIGH
- As Found: Epilepsy
- ID: M369
- Name: Drug Resistant Epilepsy
- Relevance: HIGH
- As Found: Refractory 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: D000004827
- Term: Epilepsy
- ID: D000069279
- Term: Drug Resistant Epilepsy
### Intervention Browse Module - Browse Branches
- Abbrev: AntiConv
- Name: Anticonvulsants
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M250768
- Name: Zaleplon
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425016
**Acronym:** EARLY
**Brief Title:** Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy
**Official Title:** Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy (EARLY): A Randomized Controlled Trial on Early Postoperative Pain
#### Organization Study ID Info
**ID:** 23-551
#### Organization
**Class:** OTHER
**Full Name:** The Cleveland Clinic
### Status Module
#### Completion Date
**Date:** 2027-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-24
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ricard Corcelles
#### Responsible Party
**Investigator Affiliation:** The Cleveland Clinic
**Investigator Full Name:** Ricard Corcelles
**Investigator Title:** Principal Investigator, Professor of Surgery, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This will be a prospective, obesity-registry based, single-blind randomized controlled trial with a 1:1 allocation ratio. Specific inclusion criteria are all patients eligible to undergo a Laparoscopic sleeve gastrectomy (LSG) based on the current National Institute of Health (NIH) patient selection guidelines. Patients should be able to give consent, be deemed medically-cleared to undergo elective surgery, and tolerate general anesthesia. All enrollments and surgeries in this study will take place at the Cleveland Clinic Bariatric and Metabolic Institute. The study will consist of 2 interventions: laparoscopic sleeve gastrectomy (LSG) or robotic sleeve gastrectomy (RSG). The primary objective is early postoperative pain, but also surgeon ergonomics and patient quality of life will be compared. Additional outcomes include 30-day perioperative results, minor and major morbidities, serious adverse events, resolution of medical comorbidities, and weight loss in percent of excess weight lost (%EWL) at one year.
**Detailed Description:** Currently, bariatric surgery is the most effective long-term treatment for severe obesity. Bariatric surgery results in sustained weight loss, improved quality of life, and amelioration of obesity-related comorbidities. Laparoscopic sleeve gastrectomy (LSG) has become increasingly popular over the past decade due to its safety profile and excellent long-term efficacy, and is now the most common bariatric operation being performed in the U.S. LSG entails resecting the greater curvature and fundus of the stomach; the partial gastrectomy is oriented vertically, parallel to the lesser curvature of the stomach. Overall, LSG results in excellent weight loss and remission of most obesity-related comorbidities. LSG is also less morbid than some of the other bariatric operations, such as laparoscopic Roux-en-Y gastric bypass (LRYGB), because of its technical simplicity and its limited alteration of the normal anatomy.
Unfortunately, laparoscopic surgery is not exempt from limitations including: loss of freedom in a narrow abdominal cavity, limited rotational movements, reduced depth perception, 2D video system, and considerable ergonomic challenges. These limitations have led to an increase in the adoption of robotic surgery. In recent years, robotic surgery has been employed in different specialties, including metabolic and bariatric surgery. Robotic surgery confers multiple advantages including better visualization (3D vision) and wrist movements that are particularly helpful in bariatric procedures. In addition, the position of the head and the body of the operating surgeon at the robot console provides excellent ergonomic advantages.
Until now, the utilization of robotic surgery in bariatrics remains controversial. While prospective trials are lacking, retrospective data on robotic bariatric surgery have demonstrated a potential reduction in hospital length of stay (LOS) and postoperative morbidity compared to the standard laparoscopic approach. Laparoscopy is currently considered the gold standard surgical approach for Sleeve Gastrectomy (SG). However, laparoscopic bariatric surgery can be particularly painful in the early postoperative period, and one study reported 75% of patients in the post anesthesia care unit (PACU) reporting moderate to severe pain. The introduction of the robotic platform allows for several potential advantages versus the laparoscopic technique when performing SG. One advantage is the avoidance of port torque and subsequent abdominal wall trauma, which is often implicated as a source of post-operative pain following procedures. Two elements: less postoperative bleeding and abdominal wall trauma, could potentially contribute to the lower postoperative pain reported in some recent studies of robotic surgery.
Even with the rapid adoption of robotic technology for SG in the United States, to date, no prospective head-to-head trials have been performed. The investigators hypothesize that the robotic approach to perform a SG would provide a measurable clinical benefit in regard to early postoperative pain compared to the traditional laparoscopic technique. The expected outcome in the study is a significant decrease in early postoperative pain with the robotic group.
### Conditions Module
**Conditions:**
- Post Operative Pain
- Laparoscopic Sleeve Gastrectomy
- Robotic Sleeve Gastrectomy
- Obesity
- Bariatric Surgery Candidate
- Quality of Life
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Single-blind randomized controlled trial with a 1:1 allocation ratio. The study will consist of 2 interventions: laparoscopic sleeve gastrectomy (LSG) or robotic sleeve gastrectomy (RSG). All patients will be randomized during the preoperative evaluation process. An interim analysis will be performed upon completion of the primary endpoint assessment for 91 patients to determine whether a re-estimation of the total is required. Sample size re-estimation will be planned using the conditional power method proposed by Mehta and Pocock. The 91 patients data will be used to estimate the conditional power for detecting the difference in primary outcome between two groups in the final analysis. When the conditional power is between 0.36 and 0.8, the investigators will increase the sample size accordingly, up to a sample size of 360. Otherwise, the trial will continue using the planned sample size.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Subjects will be blinded to the intervention. An equal number of identical bandages will be applied to the abdomen in similar locations following each intervention.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 91
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Sleeve Gastrectomy completed using laparoscopic technique
**Intervention Names:**
- Procedure: Laparoscopic Sleeve Gastrectomy (LSG)
**Label:** Laparoscopic Sleeve Gastrectomy (LSG)
**Type:** OTHER
#### Arm Group 2
**Description:** Sleeve Gastrectomy completed using robot assistance
**Intervention Names:**
- Procedure: Robotic Sleeve Gastrectomy (RSG)
**Label:** Robotic Sleeve Gastrectomy (RSG)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Laparoscopic Sleeve Gastrectomy (LSG)
**Description:** Bariatric Surgery
**Name:** Laparoscopic Sleeve Gastrectomy (LSG)
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Robotic Sleeve Gastrectomy (RSG)
**Description:** Bariatric Surgery
**Name:** Robotic Sleeve Gastrectomy (RSG)
**Type:** PROCEDURE
### Outcomes Module
#### Other Outcomes
**Description:** Incidence of complications associated with Sleeve Gastrectomy: bleeding requiring transfusion, pulmonary adverse events, venous thromboembolism, cardiac events, renal failure requiring dialysis, gastrointestinal leak, bowel obstruction requiring surgery, gastric/anastomotic stricture or ulcer, readmission, and sepsis
**Measure:** 30-day perioperative complications and serious adverse event incidence
**Time Frame:** 30 days (±15 days) post-op
**Description:** Days spent in hospital after surgery until 30 days (±15 days) post-op
**Measure:** Length of hospital stay
**Time Frame:** 30 days (±15 days) post-op
**Description:** Resolution of medical comorbidities associated with obesity at one year post-op Diabetes Hypertension Hyperlipidemia, hypertriglyceridemia Obstructive Sleep Apnea Non-alcoholic Fatty Liver Disease Chronic Obstructive Pulmonary Disease/asthma Stress urinary incontinence Polycystic Ovary Syndrome Degenerative join disease Pseudotumor cerebrii
**Measure:** Number of participants with resolution of medical comorbidities
**Time Frame:** one year post-op
**Description:** weight loss divided by initial pre-operative weight in percent (%WL)
**Measure:** weight loss in percent of weight lost (%WL)
**Time Frame:** post-op up to one year of follow up
#### Primary Outcomes
**Description:** To determine if patients with obesity planned for robotic sleeve gastrectomy experience a decrease in opioid consumption (Morphine Equivalent Dose) in mg on postoperative day 1 compared to patients undergoing laparoscopic sleeve gastrectomy.
**Measure:** Comparing post-operative day-1 morphine equivalent dose consumption (mg)
**Time Frame:** 24 hours post-op
#### Secondary Outcomes
**Description:** Will be assessed using Numerical Rating Scale-11 (NRS-11), a patient reported outcome measure. Scale is measured from 0-10 with 0 being the least amount of pain and 10 being the most amount of pain.
**Measure:** Comparing postoperative pain score
**Time Frame:** on postoperative days 1 (±1 days), 7 (±3 days), and 30 days (±15 days) post-op
**Description:** Will be assessed using Patient Reported Outcome Measurement Information System (PROMIS) intensity pain short form 3a , a patient reported outcome measure. The Survey has two items on remote pain (past 7 days) and one item on the pain level at the time of the questionnaire. Each question is scored from 1-5, rating pain from "Had no pain" = 1 to "Very severe" = 5. Accumulative score between 3-15 have corresponding T scores with high values indicating severe symptoms.
**Measure:** Comparing day-7 PROMIS scores
**Time Frame:** 7 (±3 days) and 30 days (±15 days) post-op
**Description:** RULA provides an assessment of the postures of the neck, trunk, and upper limb along with muscle function and the external loads experienced by the body 16. To use the instrument, the evaluators (independent research team member who does not operate) subjectively score posture, muscle use, and force for one side of the body at a time. The scores are then added to obtain a grand score. A score of 5 to 6 indicates increased risk for musculoskeletal injury, and a grand score of 7 indicates imminent risk of injury.
**Measure:** Comparing rapid upper limb assessment (RULA) score in surgeons.
**Time Frame:** intraoperative
**Description:** Change from baseline in score of The 36-Item Short Form Health Survey (SF-36) (physical and mental components). Each item is given a score ranging from 0-100. Lower scores indicating poor outcomes. Final score is an average of all the items that were answered. Unanswered questions are not included in the final average. Research coordinator completes the survey with the patient.
**Measure:** Improvement in Quality of life of patients
**Time Frame:** 30 days (±15 days) post-op
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All patients eligible to undergo a SG based on the current National Institute of Health (NIH) patient selection guidelines. Patients should be able to give consent, be deemed medically cleared to undergo elective surgery, and tolerate general anesthesia.
Exclusion Criteria:
* patients with previous bariatric surgeries, emergency surgeries, with chronic opioid use (daily use of opioids for at least 3 months), and those who are not able to sign the written consent form.
**Healthy Volunteers:** True
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ricard Corcelles Codina, MD
**Phone:** 216-445-2665
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** The Cleveland Clinic
**Name:** Ricard Corcelles Codina, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Post Operative Pain
- ID: M12701
- Name: Obesity
- 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
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000010149
- Term: Pain, Postoperative
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06425003
**Brief Title:** Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration
**Official Title:** Mass Balance Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration
#### Organization Study ID Info
**ID:** M24-326
#### Organization
**Class:** INDUSTRY
**Full Name:** Calico Life Sciences LLC
### Status Module
#### Completion Date
**Date:** 2024-07-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** AbbVie
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Calico Life Sciences LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
### Description Module
**Brief Summary:** The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of \[14C\] ABBV-CLS-7262 in healthy, male volunteers following administration of a single oral dose.
### Conditions Module
**Conditions:**
- Healthy Volunteer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 7
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive \[14C\] ABBV-CLS-7262 on Day 1.
**Intervention Names:**
- Drug: [14C] ABBV-CLS-7262
**Label:** [14C] ABBV-CLS-7262
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- [14C] ABBV-CLS-7262
**Description:** Oral Solution
**Name:** [14C] ABBV-CLS-7262
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
**Measure:** Number of Participants with Adverse Events (AEs)
**Time Frame:** Up to approximately 30 days from last dose.
**Description:** Cmax will be assessed.
**Measure:** Maximum observed concentration (Cmax)
**Time Frame:** Up to approximately Day 15 from last dose
**Description:** Tmax will be assessed.
**Measure:** Time to Cmax (peak time, Tmax)
**Time Frame:** Up to approximately 15 days from last dose
**Description:** Terminal phase elimination half-life (t1/2) will be assessed.
**Measure:** Terminal phase elimination half-life (t1/2)
**Time Frame:** Up to approximately 15 days from last dose
**Description:** AUCt will be assessed.
**Measure:** Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt)
**Time Frame:** Up to approximately 15 days from last dose
**Description:** Percentage total radioactivity
**Measure:** Percent radioactivity excreted
**Time Frame:** Up to approximately 15 days from last dose
**Description:** Identification of the major metabolites
**Measure:** Identification of metabolites excreted
**Time Frame:** Up to approximately 15 days from last dose
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
* Body Max Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at screening.
Exclusion Criteria:
* Considering fathering a child or donating sperm during the study and for 94 days after study drug administration, or is unwilling to comply with protocol recommended contraception recommendations.
* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic, endocrinologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* Has had significant exposure to radiation for professional or medical reasons (e.g., serial x-rays or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring), except dental x-rays, within 12 months prior to study drug administration.
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** AbbVie Call Center
**Phone:** +1 (844) 663-3742
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Madison
**Country:** United States
**Facility:** Fortrea Clinical Research Unit Inc.
**State:** Wisconsin
**Status:** RECRUITING
**Zip:** 53704
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424990
**Brief Title:** Balance Training With TENS for Spastic Diplegic Cerebral Palsy
**Official Title:** Biodex Balance Training With Transcutaneous Electrical Nerve Stimulation for Children With Spastic Diplegia: A Double-blinded, Randomized, Placebo-controlled Trial
#### Organization Study ID Info
**ID:** balancing with TENS for CP
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2024-07-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cairo University
#### Responsible Party
**Investigator Affiliation:** Cairo University
**Investigator Full Name:** Marwa Shafiek Mustafa Saleh
**Investigator Title:** assistance professor doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Children with spastic diplegic Cerebral Palsy (CP) often show motor impairment due to a number of deficits; including poor muscle control, weakness, spasticity and reduced range of motion in the extremities. All these factors affect the ability of children with CP to maintain balance and walk which are the primary rehabilitation concerns of parents and clinicians. The Balance Trainer provides a safe balance environment and assists with muscle activation of ankle and hip joints, and it is hypothesized that to promote spasticity inhibition, the use of TENS may decrease hyper-excitability, modulate reciprocal inhibition, and increase presynaptic inhibition. To the best of the authors' knowledge, the current study is the first research to investigate the effect of using Biodex balance training with TENS in improving children with spastic diplegia.
### Conditions Module
**Conditions:**
- Diplegic Cerebral Palsy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: balance training with TENS
**Label:** study group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Other: Balance training with placebo TENS
**Label:** control group
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- study group
**Description:** children will receive Biodex balance training with TENS for 30 minutes a day, 5 days per week for 4 weeks
**Name:** balance training with TENS
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- control group
**Description:** children will receive Biodex balance training with placebo TENS for the same period.
**Name:** Balance training with placebo TENS
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** spasticity of hip adductors will be measured by the Modified Ashworth Scale. Modified ashworth scale grades of spasticity are as follows: 0 = normal muscle tone; 1= slight increase in muscle tone, manifested by catch and release or by minimal resistance at the end; 1+ = slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout; 2= more marked increase in muscle tone, but limb easily flexed; 3= considerable increase in muscle tone, passive movement difficult; and 4 = limb rigid in flexion or extension.
**Measure:** hip adductor spasticity
**Time Frame:** change from base line at 4 weeks.
**Description:** Spatiotemporal gait parameters (Walking Speed (WS) (m/s), Step Length (SL) (cm) and the Stance Time (ST) (%) on each limb) using GAITRite system which has excellent reliability for measuring most spatio-temporal gait parameters. The GAITRite is a 700 cm × 90 cm electronic walkway with an active sensor area of 610 cm long and 60 cm wide. The active area contains 23,040 embedded pressure-activated sensors with a spatial resolution of 1.27 cm and a sampling rate of 120 Hz. All data was processed and stored by an IBM compatible computer using GAITRite® gold, Version 3.2b software.
**Measure:** spatio-temporal gait parameters
**Time Frame:** change from base line at 4 weeks.
**Description:** anteroposterior stability index, mediolateral stability index, and overall stability index will be measured using Biodex balance system. Biodex Stability System has an intertester intraclass correlation coefficients (ICCs) equals 0.70 and an intratester ICCs equals 0.82. Biodex Stability System formed of a dynamic platform that allows movements to occur around the anterior-posterior (AP) and mediallateral (ML) axes simultaneously. Biodex Stability System has a screen displaying the child's position on it and a support handle that can be adjusted according to each child's height. The screen gives visual feedback about the degree of tilting that helps the child to maintain the cursor in the center of the screen to obtain a good score of balance. The higher the scores, the poorer the balance of the child
**Measure:** balance assessment
**Time Frame:** change from base line at 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* A diagnosis of spastic diplegia cerebral palsy.
* Age from 10 to 12 years.
* Spasticity grade 1 and 1+ according to the Modified Ashworth scale.
* Level II motor function according to the Growth Motor Function Classification System.
* Able to understand and follow instructions.
* Their heights are more than 100 cm and weights are more than 20 Kg which are the lower limits of height and weight needed by the Biodex stability system.
Exclusion Criteria:
* Epilepsy.
* Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination).
* Structural or fixed soft tissue deformities of the lower extremities.
* Neurological or orthopedic surgery in the past 12 months.
* Botox injection in the lower extremities in the past 6 months.
* Fracture, sprain, or strain injury of the lower extremities in the past 6 months.
**Maximum Age:** 12 Years
**Minimum Age:** 10 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001925
- Term: Brain Damage, Chronic
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5796
- Name: Cerebral Palsy
- Relevance: HIGH
- As Found: Cerebral Palsy
- ID: M13157
- Name: Paralysis
- Relevance: LOW
- As Found: Unknown
- ID: M12085
- Name: Muscle Spasticity
- Relevance: LOW
- As Found: Unknown
- ID: M5207
- Name: Brain Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M5202
- Name: Brain Damage, Chronic
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5292
- Name: Spastic Diplegia Cerebral Palsy
- Relevance: HIGH
- As Found: Diplegic Cerebral Palsy
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002547
- Term: Cerebral Palsy
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424977
**Acronym:** BTSEE
**Brief Title:** Biomarker Targeted Stimulation for Epileptiform Events
**Official Title:** Safety and Effectiveness of Biomarker Targeted Stimulation in Epilepsy
#### Organization Study ID Info
**ID:** CAD2004
#### Organization
**Class:** INDUSTRY
**Full Name:** Cadence Neuroscience
### Status Module
#### Completion Date
**Date:** 2028-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Cadence Neuroscience
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is Unapproved Device:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a multicenter, prospective, controlled study designed to evaluate treatment with the BTS System.
### Conditions Module
**Conditions:**
- Epilepsy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Device: Biomarker Targeted Stimulation (BTS)
**Label:** Treatment
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment
**Description:** Using continuous stimulation to target multiple network nodes, Biomarker Targeted Stimulation (BTS) is intended to suppress abnormal interictal activity, as determined by biomarkers including interictal epileptiform discharges (IED) and high frequency oscillations (HFO), with the intention to reduce brain hyperexcitability, thereby limiting seizure occurrence.
**Name:** Biomarker Targeted Stimulation (BTS)
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Determine adverse event rate, including adverse device effects and serious adverse events
**Measure:** Adverse event rate
**Time Frame:** Intervals through 7, 12, and 24 months post-implant
#### Secondary Outcomes
**Description:** Using seizure diaries, calculate disabling seizure frequency, normalized to months, compared to baseline.
**Measure:** Seizure frequency
**Time Frame:** Intervals calculated at 4 to 7 months and through 12 and 24 months post-implant.
**Description:** Neurocognitive tests, using the NIH Toolbox, including the Flanker Inhibitory Control and Attention Test, Picture Sequence Memory Test, and Picture Vocabulary Test, compared to baseline.
**Measure:** Neurocognitive testing
**Time Frame:** Evaluated at 7 months, 12 months, and 24 months post-implant.
**Description:** Patient reported depression evaluation using Child Depression Inventory (CDI) or Beck Depression Inventory (BDI) (depending on age), compared to baseline.
**Measure:** Depression testing
**Time Frame:** Evaluated at 7 months, 12 months, and 24 months post-implant.
**Description:** Patient reported anxiety evaluation using Revised Children's Manifest Anxiety Scale (RCMAS-2) or Beck Anxiety Inventory (depending on age), compared to baseline.
**Measure:** Anxiety testing
**Time Frame:** Evaluated at 7 months, 12 months, and 24 months post-implant.
**Description:** Patient reported quality of life evaluation using Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55), Quality of Life in Epilepsy Inventory for Adolescents (QOLIE-AD-48), or Quality of Life in Epilepsy (QOLIE-31) (depending on age), compared to baseline.
**Measure:** Quality of life testing
**Time Frame:** Evaluated at 7 months, 12 months, and 24 months post-implant.
**Description:** Patient reported sleep evaluation using Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) or Epworth Sleepiness Scale (ESS) (depending on age), compared to baseline.
**Measure:** Sleep testing
**Time Frame:** Evaluated at 7 months, 12 months, and 24 months post-implant.
**Description:** Patient reported seizure severity evaluation using Liverpool Seizure Severity Scale 2.0 (LSSS 2.0), compared to baseline.
**Measure:** Seizure severity testing
**Time Frame:** Evaluated at 7 months, 12 months, and 24 months post-implant.
**Description:** Caregiver reported burden evaluation using Caregiver Burden Inventory (CBI), compared to baseline.
**Measure:** Caregiver burden testing
**Time Frame:** Evaluated at 7 months, 12 months, and 24 months post-implant.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Subject is greater than or equal to 7 years of age.
2. Subject has focal onset seizures.
3. Subject has failed treatment with a minimum of two AED's used in typical therapeutic dosages.
4. Subject has seizures that are distinct, stereotypical events that can be reliably counted by the patient or caregiver.
5. Subject can reasonably be expected to maintain a seizure diary and the BTS System alone, or with the assistance of a competent individual.
6. For one month prior to enrollment, subject's anti-epileptic medication dosages and ketogenic diet (as applicable) have been stable (other than acute, intermittent use of benzodiazepines) and subject has had at least three primary, disabling seizures per month, on average. Seizures must be separated by a minimum of eight hours not to be considered part of a cluster. A cluster, for the purpose of this criterion, shall be considered a single seizure.
7. Subject is able to complete regular office visits and telephone appointments in accordance with the study protocol requirements.
8. A female subject of childbearing age must have a negative serum pregnancy test within two weeks prior to implant of the INSR, and, if sexually active, must be using a reliable form of birth control, be surgically sterile, or be at least two years post-menopausal.
9. Subject has been informed of their eligibility for resective surgery as a potential alternative to the study, if such surgery is a reasonable option.
10. Subject has had a brain MRI epilepsy evaluation within the past two years.
11. Subject's anatomy will permit implantation of the INSR within 20 mm of the skin surface.
Exclusion Criteria:
1. Subject has a history of substance abuse within the preceding two years.
2. Subject participated in another drug or device trial that may confound study results within the preceding 30 days.
3. Subject is implanted with pacemaker, implantable cardiac defibrillator, cardiac management product, or a medical device that interferes with the BTS System or with which the BTS System interferes. Patients with a vagus nerve stimulator (VNS) implanted may be enrolled, provided their clinical status has been stable for at least one month prior to enrollment at their current stimulation parameter settings.
4. Subject has anatomy that may interfere with electrode placement.
5. Subject is on anticoagulants and is unable to discontinue them perisurgically, as required by the neurosurgeon or Investigator.
6. Subject has significant platelet dysfunction from medical conditions or medications (including, particularly, aspirin or sodium valproate). If platelet dysfunction is suspected, subject can be enrolled only if a hematologist, the Investigator, and the neurosurgeon judge it to be advisable.
7. Subject has been diagnosed with psychogenic or non-epileptic seizures that cannot be distinguished from their epileptogenic events.
8. Subject is ineligible for cranial surgery.
**Minimum Age:** 7 Years
**Sex:** MALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** David Himes, BSEE
**Phone:** 425-679-9505
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Lundstrom BN, Worrell GA, Stead M, Van Gompel JJ. Chronic subthreshold cortical stimulation: a therapeutic and potentially restorative therapy for focal epilepsy. Expert Rev Neurother. 2017 Jul;17(7):661-666. doi: 10.1080/14737175.2017.1331129. Epub 2017 May 25.
**PMID:** 28532252
**Citation:** Kerezoudis P, Grewal SS, Stead M, Lundstrom BN, Britton JW, Shin C, Cascino GD, Brinkmann BH, Worrell GA, Van Gompel JJ. Chronic subthreshold cortical stimulation for adult drug-resistant focal epilepsy: safety, feasibility, and technique. J Neurosurg. 2018 Aug;129(2):533-543. doi: 10.3171/2017.5.JNS163134. Epub 2017 Oct 20.
**PMID:** 29053073
**Citation:** Lundstrom BN, Gompel JV, Khadjevand F, Worrell G, Stead M. Chronic subthreshold cortical stimulation and stimulation-related EEG biomarkers for focal epilepsy. Brain Commun. 2019;1(1):fcz010. doi: 10.1093/braincomms/fcz010. Epub 2019 Sep 6.
**PMID:** 31667473
**Citation:** Starnes K, Miller K, Wong-Kisiel L, Lundstrom BN. A Review of Neurostimulation for Epilepsy in Pediatrics. Brain Sci. 2019 Oct 18;9(10):283. doi: 10.3390/brainsci9100283.
**PMID:** 31635298
**Citation:** Alcala-Zermeno JL, Gregg NM, Van Gompel JJ, Stead M, Worrell GA, Lundstrom BN. Cortical and thalamic electrode implant followed by temporary continuous subthreshold stimulation yields long-term seizure freedom: A case report. Epilepsy Behav Rep. 2020 Sep 2;14:100390. doi: 10.1016/j.ebr.2020.100390. eCollection 2020.
**PMID:** 32995742
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7983
- Name: Epilepsy
- Relevance: HIGH
- As Found: 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: D000004827
- Term: Epilepsy
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424964
**Brief Title:** Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium
**Official Title:** Use of Long-Acting Injectable Cabotegravir/Rilpivirine for the Treatment of HIV in Belgium
#### Organization Study ID Info
**ID:** 2024/1-12
#### Organization
**Class:** OTHER
**Full Name:** Belgian Research on AIDS and HIV Consortium
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**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:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Belgian Research on AIDS and HIV Consortium
#### Responsible Party
**Investigator Affiliation:** Belgian Research on AIDS and HIV Consortium
**Investigator Full Name:** Rakan Nasreddine
**Investigator Title:** Head of Research
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This will be a multi-center, single arm observational cohort study with an assessment of patient-reported outcomes (PROs) and of clinical and virologic outcomes.
Primary outcome • Evaluate patient perception of, and satisfaction with, long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) for the treatment of HIV
Secondary outcomes
• Description of the demographic, HIV-, and non-HIV-related characteristics of participants included in this analysis
### Conditions Module
**Conditions:**
- Human Immunodeficiency Virus
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 600
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Participants will be asked to complete a 32-item paper questionnaire relating to their HIV treatment of LAI CAB/RPV. Questions will focus on how their daily life and quality of life has been affected by switching to LAI CAB/RPV. The questionnaire that will be used is not a standardized questionnaire but rather a questionnaire that was developped by the study team.
**Measure:** Evaluate participant perception of, and satisfaction with, LAI CAB/RPV for the treatment of HIV
**Time Frame:** Within the first 12 weeks of the study
#### Secondary Outcomes
**Measure:** Proportion of participants with virologic suppression at months 5 and 11 after initiation of LAI CAB/RPV
**Time Frame:** Months 5 and 11
**Measure:** Proportion of participants that experience loss of virologic suppression by month 11
**Time Frame:** Month 11
**Description:** If a participant experiences loss of virologic suppression, then if an HIV resistance test was performed at that time, the resistance-associated mutations observed will be reported.
**Measure:** Description of HIV resistance-associated mutations that are present at the time of loss of virologic suppression
**Time Frame:** Month 11
**Measure:** Proportion of participants with a viral blip at months 5 and 11
**Time Frame:** Months 5 and 11
**Measure:** Change, from baseline, of CD4+ T-cell count and CD4+/CD8+ ratio at months 5 and 11
**Time Frame:** Months 5 and 11
**Description:** LAI CAB/RPV must be taken every two months, which therefore requires that a target date be specified in advance of when the next treatment injection should be. This measure will evaluate the proportion of participants that presented to their clinic to receive their treatment either on the target date or within 7 days after (this will be considered adherent) and the proportion of participants that received their treatment more than 7 days after their target date (this will be considered non adherent)
**Measure:** Proportion of participants that are adherent to treatment at months 5 and 11
**Time Frame:** Months 5 and 11
**Measure:** Proportion of participants that discontinue their treatment over the study period
**Time Frame:** Month 11
**Description:** This measure will be reported in person/years
**Measure:** Incidence of discontinuation of treatment over the study period
**Time Frame:** Month 11
**Description:** This measure will report all the reasons for which participants discontinued their treatment
**Measure:** Reasons for discontinuation of treatment over the study period
**Time Frame:** Month 11
**Description:** This measure will be reported by median time to discontinuation (months) and inter-quartile range
**Measure:** Time to discontinuation of treatment over the study period
**Time Frame:** Month 11
**Measure:** Proportion of participants that experience injection-site reactions (ISRs) and acceptability of ISRs
**Time Frame:** Within the first 12 weeks of the study
**Measure:** Change in weight from baseline and a ≥10% weight gain from baseline at months 5 and 11
**Time Frame:** Months 5 and 11
**Measure:** Proportion of participants that become hepatitis B virus (HBV) seropositive at months 5 and 11
**Time Frame:** Months 5 and 11
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* HIV-1 patients, aged 18 years and above, having received at least 1 dose of LAI CAB/RPV between September 1, 2021, and March 31, 2024.
**Maximum Age:** 99 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Participants will be recruited at one of the participating HIV reference centers (HRCs). These centers are part of the 12 official HIV treatment centers in Belgium and work in concert as members of the Belgian Research on AIDS \& HIV Consortium (BREACH).
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rakan Nasreddine, MD
**Phone:** +32 2 535 4130
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Belgian Research on AIDS & HIV Consortium
**Name:** Stéphane De Wit, MD/PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007153
- Term: Immunologic Deficiency Syndromes
- ID: D000007154
- Term: Immune System Diseases
- ID: D000086982
- Term: Blood-Borne Infections
- ID: D000003141
- Term: Communicable Diseases
- ID: D000007239
- Term: Infections
- ID: D000015229
- Term: Sexually Transmitted Diseases, Viral
- ID: D000012749
- Term: Sexually Transmitted Diseases
- ID: D000016180
- Term: Lentivirus Infections
- ID: D000012192
- Term: Retroviridae Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000012897
- Term: Slow Virus Diseases
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: HIGH
- As Found: Human Immunodeficiency Virus
- ID: M18250
- Name: HIV Infections
- Relevance: HIGH
- As Found: Human Immunodeficiency Virus
- ID: M10199
- Name: Immunologic Deficiency Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- 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: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2593
- Name: Blood-Borne Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15558
- Name: Sexually Transmitted Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17933
- Name: Sexually Transmitted Diseases, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M18640
- Name: Lentivirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15026
- Name: Retroviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15700
- Name: Slow Virus Diseases
- 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
### Condition Browse Module - Meshes
- ID: D000000163
- Term: Acquired Immunodeficiency Syndrome
- ID: D000015658
- Term: HIV Infections
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M295
- Name: Rilpivirine
- Relevance: LOW
- As Found: Unknown
- ID: M254021
- Name: Cabotegravir
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424951
**Brief Title:** Kindness is Lesser Preferable Than Happiness: Investigating Interest in Different Effects of the Loving-kindness and Compassion Meditations
**Official Title:** Kindness is Lesser Preferable Than Happiness: Investigating Interest in Different Effects of the Loving-kindness and Compassion Meditations
#### Organization Study ID Info
**ID:** KM202210028001
#### Organization
**Class:** OTHER
**Full Name:** Beijing Normal University
### Status Module
#### Completion Date
**Date:** 2020-08-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2020-06-14
**Type:** ACTUAL
#### Start Date
**Date:** 2019-02-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Beijing Normal University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** As an initial step, Study 1 intended to compare the interest in different effects of LKCM among a convenient sample of university students. In order to separate different effects and close to application in real setting, the study will measure participants' interest in participating in proposed meditations, each of which aimed to generate one specific effect. The kind attitudes were represented by compassion for others, compassion for oneself, and appreciative joy for others, which were emphasized in the real LKCM trainings. The emotional well-being included increasing positive emotion, decreasing negative emotion and improving peacefulness, which were validated effects of LKCM. Other validated effects were also measured as fillers and used as additional explorations. The core hypothesis was that the interest in meditations on kind attitudes is significantly lower than interest in meditations on emotional well-being.
The current study created a measure called Willingness to Participate in Meditation Trainings (WPMT). Participants rated their willingness to participate in nine meditation trainings that serve different purposes. Each meditation was rated by one item ("if the purpose of meditation training is to xxx, how much are you willing to participate?" where "xxx" indicates the purposes listed below) and was measured with a 100-mm Visual Analogue Scale (0 = totally unwilling to participate, 100 = totally willing to participate).
Study 2 adopted WPMT in a 21-day online LKCM training. This make sure all participants really took part in meditation training, and allowed further exploration on how participants' WPMT were associated with the adherence and effects of training. To be more sensitive for the change during short training, the effects of training used state-like measures and still focused on two aspects: (1) personal happiness (happiness, sadness, peacefulness) which matched emotional well-being, and (2) interpersonal relationship (love, hate, gratitude) which reflected kind attitudes. The core hypotheses were that higher interest in meditations on Emotional Well-being and Kind attitudes predicted increases in personal happiness and interpersonal relationship, respectively.
### Conditions Module
**Conditions:**
- Meditation
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 1658
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: LKCM(Loving-kindness and Compassion Meditations)
**Label:** LKCMs
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- LKCMs
**Description:** Loving-kindness and Compassion Meditations
**Name:** LKCM(Loving-kindness and Compassion Meditations)
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The core hypothesis was that the interest in meditations on kind attitudes is significantly lower than interest in meditations on emotional well-being.
The study created a measure called Willingness to Participate in Meditation Trainings (WPMT). Participants rated their willingness to participate in nine meditation trainings that serve different purposes. Each meditation was rated by one item ("if the purpose of meditation training is to xxx, how much are you willing to participate?" where "xxx" indicates the purposes listed below) and was measured with a 100-mm Visual Analogue Scale (0 = totally unwilling to participate, 100 = totally willing to participate).
**Measure:** Interest in Different Effects of LKCM Training
**Time Frame:** 4 months
**Description:** The core hypotheses were that higher interest in meditations on Emotional Well-being and Kind attitudes predicted increases in personal happiness and interpersonal relationship, respectively.
The study adopted WPMT in a 21-day online LKCM training. The measure of WPMT was basically the same with that in Study 1, and it directly asked the interests in the current 21-day meditation training.
The measure for effects of training used word lists, which measured the frequency of 10 types of experience in the past week, with three items for each type.
**Measure:** Interest in Different Effects and Their Relation with Results of Training
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** For study 1 Participants were recruited from two universities in Mainland China with the help of university staff. No other eligibility tests were required.
For study 2 Participants with or without religious beliefs or meditation experience could participate in the study. Each person is required to complete a 21-day meditation course.
**Healthy Volunteers:** True
**Maximum Age:** 72 Years
**Minimum Age:** 16 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Normal University
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424938
**Brief Title:** Postoperative Analgesia in Major Gynecological Cancer Surgeries
**Official Title:** The Effect of Epidural Analgesia and Erector Spinae Plane Block on Intraoperative and Early Postoperative Outcomes in Open Gynecological Oncological Surgeries: a Prospective Randomized Study
#### Organization Study ID Info
**ID:** 2023-597
#### Organization
**Class:** OTHER_GOV
**Full Name:** Bakirkoy Dr. Sadi Konuk Research and Training Hospital
### Status Module
#### Completion Date
**Date:** 2025-01-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-13
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Duygu Akyol
#### Responsible Party
**Investigator Affiliation:** Bakirkoy Dr. Sadi Konuk Research and Training Hospital
**Investigator Full Name:** Duygu Akyol
**Investigator Title:** M.D
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of this study is to compare the effectiveness of epidural block or erector spinae plane block applied for postoperative analgesia in gynecological cancer surgeries.
The main question(s) it aims to answer are:
\[Is erector spinae plane block as effective as epidural block in postoperative analgesia?\] The study was designed as a prospective randomized study. Researchers evaluated the effects of epidural block or erector spinae plane block applied for postoperative analgesia on pain scores, postoperative opioid use, and mobilization in patients undergoing gynecological cancer surgery.
**Detailed Description:** Our study was designed as a prospective randomized study. The investigators evaluated the analgesia methods used in patients undergoing surgery for gynecologic cancer between May 2024 and December 2024. The investigators evaluated the effect of epidural block or erector spina plan block on postoperative analgesia, opioid use and mobilization.
Group 1: Epidural block group Group 2: Group with erector spina plan block
### Conditions Module
**Conditions:**
- Analgesia
- Analgesia, Epidural
- ERAS
**Keywords:**
- postoperative analgesia
- periferic nerve block
- neuraxial block
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This study was designed as a prospective randomized study. Patients with ASA II-III between the ages of 30 and 70 who will undergo major gynecological cancer surgery will be included in the study. They will be randomized into 2 groups: the group in which epidural block is applied for postoperative analgesia (Group Epidural) and the group in which erector spinae plane block is applied (Group ESP).
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The group in which epidural block is applied for postoperative analgesia (Group Epidural)
**Intervention Names:**
- Procedure: Patients who underwent epidural block
- Procedure: Patients who underwent erector spina plane block
**Label:** The group in which epidural block
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The group in which erector spinae plane block is applied (Group ESP)
**Intervention Names:**
- Procedure: Patients who underwent epidural block
- Procedure: Patients who underwent erector spina plane block
**Label:** The group in which erector spinae plane block
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- The group in which epidural block
- The group in which erector spinae plane block
**Description:** The researchers administered an epidural block to prevent post-operative pain to the epidural block group undergoing midline incision surgery for major gynecologic cancer.
**Name:** Patients who underwent epidural block
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- The group in which epidural block
- The group in which erector spinae plane block
**Description:** Researchers applied a erector spina plane block to prevent postoperative pain to the erector spina plane block group undergoing midline incision surgery for major gynecological cancer.
**Name:** Patients who underwent erector spina plane block
**Type:** PROCEDURE
### Outcomes Module
#### Other Outcomes
**Description:** The other purpose of this study is the first postoperative mobilization process
**Measure:** postoperative mobilization time
**Time Frame:** postoperatvely 24 hours
#### Primary Outcomes
**Description:** The primary purpose of this study is to compare NRS values at 0, 6, 12 and 24 hours in the first 24 hours postoperatively. Numeric rating scale was used to assess postoperative pain For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.
**Measure:** postoperative numerical rating scale
**Time Frame:** postoperatvely 24 hours
#### Secondary Outcomes
**Description:** The secondary aim of this study is to compare the amount of intraoperative remifentanyl
**Measure:** Intraoperative amount of remifentanyl
**Time Frame:** intraoperative process
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients who will undergo open abdominal surgery
* Patients with ASAII-III
* Those between the ages of 30-70
* Patients who are fully oriented and able to cooperate
Exclusion Criteria:
* Patients with ASAIV-V
* Presence of active infection in the area where the block will be applied
* Patients younger than 30 years old
* Patients with BMI \> 40
* Patients who are allergic to bupivacaine
* Chronic analgesic use
**Healthy Volunteers:** True
**Maximum Age:** 70 Years
**Minimum Age:** 30 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Duygu Akyol, M.d
**Phone:** +905447616034
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ceren Ganidağlı, M.d
**Phone:** +905319301828
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Nelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Gynecol Oncol. 2023 Jun;173:58-67. doi: 10.1016/j.ygyno.2023.04.009. Epub 2023 Apr 21.
**PMID:** 37086524
**Citation:** Bisch SP, Jago CA, Kalogera E, Ganshorn H, Meyer LA, Ramirez PT, Dowdy SC, Nelson G. Outcomes of enhanced recovery after surgery (ERAS) in gynecologic oncology - A systematic review and meta-analysis. Gynecol Oncol. 2021 Apr;161(1):46-55. doi: 10.1016/j.ygyno.2020.12.035. Epub 2020 Dec 30.
**PMID:** 33388155
**Citation:** Courtney-Brooks M, Tanner Kurtz KC, Pelkofski EB, Nakayama J, Duska LR. Continuous epidural infusion anesthesia and analgesia in gynecologic oncology patients: less pain, more gain? Gynecol Oncol. 2015 Jan;136(1):77-81. doi: 10.1016/j.ygyno.2014.10.015. Epub 2014 Oct 23.
**PMID:** 25449564
**Citation:** Chen LM, Weinberg VK, Chen C, Powell CB, Chen LL, Chan JK, Burkhardt DH 3rd. Perioperative outcomes comparing patient controlled epidural versus intravenous analgesia in gynecologic oncology surgery. Gynecol Oncol. 2009 Dec;115(3):357-61. doi: 10.1016/j.ygyno.2009.08.015. Epub 2009 Sep 23.
**PMID:** 19783285
**Citation:** Ferguson SE, Malhotra T, Seshan VE, Levine DA, Sonoda Y, Chi DS, Barakat RR, Abu-Rustum NR. A prospective randomized trial comparing patient-controlled epidural analgesia to patient-controlled intravenous analgesia on postoperative pain control and recovery after major open gynecologic cancer surgery. Gynecol Oncol. 2009 Jul;114(1):111-6. doi: 10.1016/j.ygyno.2009.03.014. Epub 2009 Apr 23.
**PMID:** 19395071
**Citation:** Lin C, Gill R, Kumar K. [Bilateral lower thoracic erector spinae plane block in open abdominal gynecologic oncology surgery: a cases series]. Braz J Anesthesiol. 2019 Sep-Oct;69(5):517-520. doi: 10.1016/j.bjan.2019.03.011. Epub 2019 Oct 19.
**PMID:** 31635757
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010468
- Term: Perceptual Disorders
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3727
- Name: Agnosia
- Relevance: HIGH
- As Found: Analgesia
- ID: M13379
- Name: Perceptual Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21826
- Name: Neurobehavioral Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T241
- Name: Agnosia
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000377
- Term: Agnosia
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424925
**Acronym:** AI COVID-19
**Brief Title:** Use of Artificial Intelligence (AI) to Predict Clinical Outcomes in Patients Hospitalized for COVID19 Pneumonia During the 4 Pandemic Waves
**Official Title:** Use of Artificial Intelligence (AI) for the Prediction of Clinical Outcomes Such as Death and Complications in Patients Hospitalized for COVID Pneumonia During the 4 Pandemic Waves at the ASST of Lecco.
#### Organization Study ID Info
**ID:** AI COVID-19
#### Organization
**Class:** OTHER
**Full Name:** Azienda Ospedaliera di Lecco
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Azienda Ospedaliera di Lecco
#### Responsible Party
**Investigator Affiliation:** Azienda Ospedaliera di Lecco
**Investigator Full Name:** Stefania Piconi
**Investigator Title:** Director of Infectious Diseases Unit
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Predictive models can be applied in different areas, during the emergency of the COVID-19 pandemic, in fact, they have proven important in supporting health systems in planning strategic decisions and in formulating health policies for the containment of the disease.
The Covid-19 pandemic, in particular, has represented a real challenge for our healthcare system. In Italy, it was divided into four main waves, each characterized by different types of patients and different therapeutic approaches progressively improved based on new scientific evidence.
The objective is to carry out a study on the data of patients hospitalized for COVID-19 at the ASST of Lecco during all four pandemic waves, with different degrees of severity of illness, collecting the data of interest and applying it to they use artificial intelligence to identify recurring patterns of clinical outcome in terms of survival and secondary infectious complications, so as to build new reliable predictive statistical models that can be used to predict the outcome of the patients themselves.
The strong ambition of this project is that the application of artificial intelligence to data of such significant quantity can allow us to build valid statistical models which can then be hypothetically applied to any patient to predict, based on anamnestic characteristics, blood chemical parameters. at baseline and at the set treatment, the probability of survival and complications
### Conditions Module
**Conditions:**
- COVID-19 Pandemic
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 5000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Hospitalized patients for COVID19 pneumonia during first wave (FEB-MAY 2020)
**Intervention Names:**
- Other: Artificial intelligence for the prediction of clinical outcomes
**Label:** COVID-19 1° wave
#### Arm Group 2
**Description:** Hospitalized patients for COVID19 pneumonia during the second wave (OCT-DEC 2020)
**Intervention Names:**
- Other: Artificial intelligence for the prediction of clinical outcomes
**Label:** COVID-19 2° wave
#### Arm Group 3
**Description:** Hospitalized patients for COVID19 pneumonia during the third wave (GEN-MAY 2021)
**Intervention Names:**
- Other: Artificial intelligence for the prediction of clinical outcomes
**Label:** COVID-19 3° wave
#### Arm Group 4
**Description:** Hospitalized patients for COVID19 pneumonia during the fourth wave (NOV 2021-MAR 2022)
**Intervention Names:**
- Other: Artificial intelligence for the prediction of clinical outcomes
**Label:** COVID-19 4° wave
### Interventions
#### Intervention 1
**Arm Group Labels:**
- COVID-19 1° wave
- COVID-19 2° wave
- COVID-19 3° wave
- COVID-19 4° wave
**Description:** Use of artificial intelligence (AI) for the prediction of clinical outcomes such as death and complications in patients hospitalized for COVID pneumonia during the 4 pandemic waves
**Name:** Artificial intelligence for the prediction of clinical outcomes
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Construction of predictive models to evaluate clinical outcomes such as death and/or onset of secondary infection based on the data collected relating to the 4 COVID-19 waves.
**Measure:** Construction of predictive models
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age \> 18 years;
* Hospitalization for COVID-19 pneumonia at ASST Lecco.
Exclusion Criteria:
* Hospitalization or finding of asymptomatic SARS CoV-2 infection.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** For each patient, information will be collected regarding:
* Personal data (i.e. age, sex, nationality);
* Date of hospitalization and discharge (or death)
* Comorbidities;
* Treatments undertaken for Covid19;
* Possible vaccination for Covid19, date and number of doses;
* Possible onset of secondary infections and/or complications;
* Blood chemistry tests upon admission
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Stefania Piconi, MD
**Phone:** +390341489890
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Silvia Pontiggia, MS
**Phone:** +390341253678
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Lecco
**Country:** Italy
**Facility:** Stefania Piconi
**Zip:** 23900
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011024
- Term: Pneumonia, Viral
- 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 Pandemic
- ID: M13904
- Name: Pneumonia
- Relevance: HIGH
- As Found: Pneumonia
- ID: M6845
- Name: Death
- 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: D000011014
- Term: Pneumonia
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424912
**Brief Title:** Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis
**Official Title:** Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis of the Internal Spermatic Vein and Ligation of the Deferential Vein
#### Organization Study ID Info
**ID:** CIP-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Vivifi Medical
### Status Module
#### Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-01-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** RQMplus
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Vivifi Medical
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The study objective is to evaluate the safety and feasibility of the Vivifi's Treatment.
The Vivifi's Treatment presents an innovative approach for addressing benign prostatic hyperplasia (BPH) as well as clinical/subclinical varicoceles in men. The scientific rationale for conducting this study is to assess the safety and feasibility of the Vivifi's Treatment (a surgical procedure) as a therapeutic intervention for patients with BPH.
**Detailed Description:** Current BPH treatments fall into two major categories:
1. Surgical removal/destruction of prostatic tissues:
1. Transurethral resection of the prostate (TURP)
2. Holmium laser enucleation of the prostate (HoLEP)
3. Aquablation - (Procept)
4. Prostatic artery embolization (PAE)
2. Minimally-invasive Surgical Therapies (MISTs)
1. Itind (now Olymus)
2. Urolift (now Teleflex)
3. Rezum (now Boston Scientific)
4. TUNA
5. Zenflow (in trials)
6. Butterfly Medical (in trials)
The solutions in the first category rely in removing or destroying prostatic tissue. Though effective at reducing urinary symptoms, this damage to the tissue can cause a number of complications. The "non-surgical" solutions fall into the second category. One of the best-studied of these, Urolift, is an implant-based therapy, using internal sutures that are deployed though the urethra that pull the prostatic tissue away from the urethra lumen, repristinating urethral patency. A significant percentage of cases show recurrence of symptoms due to the fact that the prostate continues to grow. Looking at the currently available treatment options, the longer-lasting surgical procedure (group 1). Group 1 procedures, especially TURP, remain "the gold standard" by which all other BPH treatment options are measured.
The Vivifi's Treatment aims to fill the therapeutic gap between the two-category approaches by offering patients a less invasive surgical approach that (1) fixes the root cause of the problem, guaranteeing long lasting effects and (2) does not cause any damage to the prostatic tissue and urethra, thereby preventing the side effects mentioned above. By replumbing a faulty localized vasculature, the Vivifi's technology leverage years of safety data for anastomotic coupling rings enabling it for vascular surgical approaches. These initial clinical studies will prove that this totally novel treatment approach to BPH is safe.
### Conditions Module
**Conditions:**
- Benign Prostatic Hyperplasia
- Varicocele Grade II
- Varicocele Grade III
**Keywords:**
- BPH
- Varicocele
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Prospective, non-randomized first-in-man study
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects undergo Vivifi's surgical procedure for treatment of BPH.
**Intervention Names:**
- Procedure: Vivifi's Surgical Procedure
**Label:** Treatment Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment Group
**Description:** Subjects undergo Vivifi's surgical procedure for treatment of BPH. The study procedure will be performed in the operating room, under general anesthesia.
Subject will undergo a bilateral anastomosis of the internal spermatic vein to the inferior epigastric vein and ligation of the deferential vein via bilateral inguinal/subinguinal incision.
The investigators can use of a coupler with appropriate ring size (to be measured intra-operatively based on vessel size) to perform the vascular anastomosis and standard sutures for ligation. The coupler is an FDA approved commercial device. Alternatively, the anastomosis can also be performed using sutures. Incision closure will proceed per institution standard of care.
**Name:** Vivifi's Surgical Procedure
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Assess the safety of the Vivifi's Treatment through the rate \& type of the procedure related complications, such as bleeding, infection or other tissue damage.
**Measure:** PRIMARY SAFETY ENDPOINT
**Time Frame:** will be assessed up to 12-month post-procedure follow-up.
**Description:** Assess the changes in International Prostate Symptoms Score (IPSS) from baseline to post-procedure. The score range of the questionnaire is 0 to 35. A higher score indicates worse symptomatic.
**Measure:** PRIMARY EFFICACY ENDPOINT
**Time Frame:** to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
#### Secondary Outcomes
**Description:** Changes in International Index of Erectile Function (IIEF) questionnaire scores. The questionnaire has 15 questions. Each question is scored from 0-5. A higher score indicates improved erectile function.
**Measure:** SECODARY EFFICACY ENDPOINT 1
**Time Frame:** to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
**Description:** Changes in size (volume) of the prostate measured by transrectal ultrasound and cystoscope in mL.
**Measure:** SECODARY EFFICACY ENDPOINT 2
**Time Frame:** to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
**Description:** Change in peak urinary flow (Qmax) in mL/sec.
**Measure:** SECODARY EFFICACY ENDPOINT 3
**Time Frame:** to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
**Description:** Change in post-void residual urine volume in mL.
**Measure:** SECODARY EFFICACY ENDPOINT 4
**Time Frame:** to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Male 40-75 years of age
2. Diagnosed with Benign prostatic hyperplasia (BPH)
3. Prostate volume: ≥ 30 ≤ 120 cc measured by transrectal ultrasound
4. Signed the study informed consent form (ICF)
5. Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12
6. Presence of clinical varicocele (preferably grade II or III - Dubin \& Amelar.
Exclusion Criteria:
1. Patients with prior history of spermatic vein or pampiniform plexus related surgeries or impairment, or vasectomy
2. Previous invasive prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.)
3. Prostate with large intravesical median lobe
4. Patients with sub-clinical varicocele
5. Post-void residual volume (PVR) \> 110ml
6. IPSS (International Prostate Symptoms Score) \>24
7. Patients with clinical history of chronic prostatitis.
8. Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days).
9. Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury
10. Patients that can not be under general anesthesia
11. Patients on blood thinners, or with coagulation related issues, TTP
12. Prior pelvic floor surgery or condition such as inguinal hernia, mesh, etc
13. History of cancer in genitourinary system, which is not considered being cured. A potential participant is considered cured if there has been no evidence of cancer within five years of the study.
14. Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all of the required follow-up requirements
15. Subject currently participating in other investigational studies unless approved by the Sponsor in writing
**Maximum Age:** 75 Years
**Minimum Age:** 40 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yiming Deng
**Phone:** 4083966040
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Tushar Sharma
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Panama City
**Country:** Panama
**Facility:** National Hospital
**State:** Punta Pacifica
#### Overall Officials
**Official 1:**
**Affiliation:** Vivifi Medical (Chief Medical Officer)
**Name:** Nathan Starke, MD
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000011469
- Term: Prostatic Diseases
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M14334
- Name: Prostatic Hyperplasia
- Relevance: HIGH
- As Found: Prostatic Hyperplasia
- ID: M17394
- Name: Varicocele
- Relevance: HIGH
- As Found: Varicocele
- ID: M10016
- Name: Hyperplasia
- Relevance: HIGH
- As Found: Hyperplasia
- ID: M14333
- Name: Prostatic Diseases
- 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: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011470
- Term: Prostatic Hyperplasia
- ID: D000014646
- Term: Varicocele
- ID: D000006965
- Term: Hyperplasia
### 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: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424899
**Brief Title:** A Study Comparing Neoadjuvant Chemoimmunotherapy and Immuno-consolidationafter Compared With Immunoconsolidation After Radical Chemoradiotherapy for Stage III Potentially Resectable NSCLC
**Official Title:** A Randomized, Controlled, Multicenter Phase II Clinical Study Comparing Neoadjuvant Chemoimmunotherapy and Immuno-consolidationafter Compared With Immunoconsolidation After Radical Chemoradiotherapy for Stage III Potentially Resectable NSCLC
#### Organization Study ID Info
**ID:** IRB-2024-106
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang Cancer Hospital
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-05-19
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-19
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Zeng Jian
#### Responsible Party
**Investigator Affiliation:** Zhejiang Cancer Hospital
**Investigator Full Name:** Zeng Jian
**Investigator Title:** Archiater, Thoracic Surgery Department
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To evaluate the efficacy and safety adebrelimab in Combination with chemotherapy after 3 cycles as neoadjuvant therapy and surgery or chemoradiotherapy based on MDT compared with adebrelimab after chemoradiotherapy in potentially operable stage III NSCLC.
**Detailed Description:** In recent years, tumor immunotherapy has become an important means of clinical treatment of tumor. The emergence of immunotherapy has provided a new direction for the exploration of neoadjuvant therapy for non-small cell lung cancer. The purpose of this study is to compare the use of adebrelimab in patients with stage III potentially resectable locally advanced NSCLC (non-small cell lung cancer). The study will directly compare the curative chemoradiotherapy plus immune maintenance therapy model (Pacific model) with the neoadjuvant immune therapy plus curative surgery plus immune maintenance therapy model (Keynote-671 model). This comparison aims to provide a basis for determining treatment plans for patients with locally advanced NSCLC.
### Conditions Module
**Conditions:**
- Non Small Cell Lung Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 92
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Adebrelimab 20mg/kg combined with platinum-based chemotherapy, q3w, MDT after 3 cycles, if the patient is suitable for surgery, surgery will be performed, and Adebrelimab adjuvant therapy will be performed for 35 cycles after surgery or until the disease recurrence or toxicity is difficult to tolerate as indicated by imaging; If the patient is not eligible for surgery after evaluation,, radical chemoradiotherapy will be performed, followed by Adebrelimab consolidation therapy for 35 cycles or until radiographically indicated disease recurrence or toxicity is difficult to tolerate.
**Intervention Names:**
- Drug: Adebrelimab
- Radiation: radical chemoradiotherapy
- Drug: Platinum based chemotherapy
**Label:** neoadjuvant: adebrelimab combined with platinum-based chemotherapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Consolidation therapy with adebrelimab , 20mg/kg, q3w, d1, was started within 1 to 42 days after radical chemoradiotherapy. The infusion time of adebrelimab was 60 minutes or more, and the treatment lasted for 38 consecutive cycles or until the disease recurred or the toxic reaction was difficult to tolerate as indicated by imaging.
**Intervention Names:**
- Drug: Adebrelimab
- Radiation: radical chemoradiotherapy
- Drug: Platinum based chemotherapy
**Label:** radical chemoradiotherapy and adebrelimab consolidation for 38 cycles
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- neoadjuvant: adebrelimab combined with platinum-based chemotherapy
- radical chemoradiotherapy and adebrelimab consolidation for 38 cycles
**Description:** This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).
**Name:** Adebrelimab
**Other Names:**
- SHR-1316
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- neoadjuvant: adebrelimab combined with platinum-based chemotherapy
- radical chemoradiotherapy and adebrelimab consolidation for 38 cycles
**Description:** The total dose of radiotherapy was 60 Gy ± 10% (54 Gy - 66 Gy). The minimum technical standard for radiotherapy is the three dimensional conformal radiotherapy (3D-CRT) planned by CT.
**Name:** radical chemoradiotherapy
**Type:** RADIATION
#### Intervention 3
**Arm Group Labels:**
- neoadjuvant: adebrelimab combined with platinum-based chemotherapy
- radical chemoradiotherapy and adebrelimab consolidation for 38 cycles
**Description:** Platinum based chemotherapy: Platinum drug must be one of cisplatin, carboplatin or nedaplatin; The other drug must contain one of the following: etoposide, vinorelbine, vinblastine, pemetrexed, taxanes (e.g., paclitaxel, docetaxel, albumin paclitaxel, paclitaxel liposomes) or gemcitabine (gemcitabine is not permitted in concurrent chemoradiotherapy regimens).
**Name:** Platinum based chemotherapy
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** From the start of randomization to 2 years, the proportion of participants who experience any of the following events: disease progression making surgical treatment impossible, local or distant recurrence, or death due to any cause.
Event-free Survival (EFS) is a term commonly used in the context of clinical trials and oncology to describe a period during which a patient with a disease, typically a cancer, remains free from any adverse events that are of clinical significance.
**Measure:** 2 year EFS rate
**Time Frame:** Up to 2 years
#### Secondary Outcomes
**Description:** Overall Survival, the time from the date of randomization until the death of the participant or the last follow-up.
**Measure:** OS
**Time Frame:** Up to 2 years
**Description:** the time from the initial diagnosis of a cancer until the first occurrence of distant metastasis.
**Measure:** TTDM
**Time Frame:** Up to 2 years
**Description:** Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0
**Measure:** TRAEs
**Time Frame:** Up to 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. Age 18-75 years old;
* 2. Histologically or cytologically confirmed non-small cell lung cancer. If the pathological type of the patient is adenocarcinoma, genetic testing should be performed to exclude EGFR/ALK mutations. Tumor tissue should be the first choice for genetic testing. If sufficient tumor tissue is not available, genetic testing using serum can be performed.
* 3. According to AJCC 8th Edition, the patient had stage IIIA-IIIB (T1-4N2M0). N2 was a non-giant type with lymph node diameter ≤3cm and no invasion or exocapsular invasion. Pathological biopsy of mediastinal lymph nodes is recommended to be clear, and patients without pathology should at least meet the short diameter of enhanced chest CT ≥1cm and high metabolism of PET-CT.
* 4. All lesions (including primary lesions and lymph nodes/metastases evaluated as metastases) of the patient should be evaluated jointly by surgeons, radiologists, and radiologists to be potentially resectable.
* 5. Subjects must have measurable target lesions (according to RECIST 1.1 criteria);
* 6. ECOG behavior status score 0-1;
* 7. No previous history of other malignant tumors;
* 8. Never received anti-tumor therapy such as surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy related to non-small cell lung cancer;
* 9. The patient should have adequate cardiopulmonary function: FEV1 and DLCO of the patient were ≥50% of the predicted value, and the ultrasonography suggested LVEF≥55%, and no clear signs of heart failure and severe coronary artery stenosis were found in various tests. The cardiopulmonary function was assessed by the surgeon as being able to tolerate surgical treatment.
* 10.The functional level of all vital organs must meet the following requirements:
1. Bone marrow: absolute neutrophil count (ANC) ≥1.5× 109/L, platelet ≥100 × 109/L, hemoglobin ≥9 g /dl;
2. Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
3. Liver: total bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5 times the upper limit of normal;
4. Kidney: serum creatinine ≤1.25 times the upper limit of normal or creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min;
* 11. Fertile men and women of childbearing age must consent to effective contraceptive use from the time they sign the master informed consent until 180 days after the final administration of the study drug. Women of reproductive age include premenopausal women and women within 2 years after menopause. Pregnancy test results of women of reproductive age must be negative within ≤ 7 days before the first study drug administration;
* 12. Voluntary participation in clinical research; Fully understand and know this study and sign ICF (Informed Consent).
Exclusion Criteria:
* 1. All lesions could not be completely resected by surgery;
* 2. Have any active autoimmune disease or history of autoimmune disease (such as uveitis, enteritis, hepatitis, pituitaritis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy), tuberculosis); Patients with complete remission of childhood asthma without any intervention or vitiligo in adulthood could be included, but patients requiring medical intervention with bronchodilators could not be included;
* 3. Have a congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (HCV antibody positive and HCV-RNA above the lower detection limit of analytical methods), or co-infection with hepatitis B and hepatitis C;
* 4. There is a third lacunar effusion that is difficult to control, such as a large amount of pleural effusion or ascites or pericardial effusion;
* 5. Subjects requiring systemic therapy with corticosteroids (\>10 mg/ day of prednisone or equivalent) or other immunosuppressants within 14 days prior to initial medication. In the absence of active autoimmune disease, inhaled or topical corticosteroids are permitted, as well as adrenal hormone replacement therapy at doses \> 10 mg/ day of prednisone efficacy;
* 6. Subjects who have been treated with anti-tumor vaccine or other immunostimulating anti-tumor drugs (interferon, interleukin, thymosin, immunocell therapy, etc.) within 1 month before the first administration;
* 7. Participants who are participating in another clinical study or whose first dose is less than 4 weeks (or 5 half-lives of the investigational drug) since the end (last dose) of the previous clinical study;
* 8. Evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiological pneumonia, drug-induced pneumonia, and severe impairment of lung function;
* 9. Major surgery, open biopsy, or significant trauma were performed within 28 days prior to enrollment;
* 10. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
* 11. Pregnant or lactating women; A fertile patient who is unwilling or unable to take effective contraceptive measures;
* 12. Known allergic reactions, hypersensitivities, or intolerances to study drugs;
* 13. There are other circumstances in which the investigator considers it inappropriate to participate in 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:** Jian Zeng, MD&PhD
**Phone:** +86 571 8812 8161
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Taobo Luo, MD&PhD
**Phone:** +86 136 7587 0286
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jian Zeng, Doctor
- **Phone:** +86 13675870286
- **Role:** CONTACT
**Country:** China
**Facility:** Zhejiang Cancer Hospital
**State:** Zhejiang
**Status:** RECRUITING
**Zip:** 310022
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002283
- Term: Carcinoma, Bronchogenic
- ID: D000001984
- Term: Bronchial Neoplasms
- ID: D000008175
- Term: Lung Neoplasms
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: HIGH
- As Found: Non-Small Cell Lung Cancer
- ID: M11172
- Name: Lung Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M5540
- Name: Carcinoma, Bronchogenic
- Relevance: LOW
- As Found: Unknown
- ID: M5260
- Name: Bronchial Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002289
- Term: Carcinoma, Non-Small-Cell Lung
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M19537
- Name: Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M18650
- Name: Carboplatin
- Relevance: LOW
- As Found: Unknown
- ID: M8191
- Name: Etoposide
- Relevance: LOW
- As Found: Unknown
- ID: M2985
- Name: Gemcitabine
- Relevance: LOW
- As Found: Unknown
- ID: M1710
- Name: Vinorelbine
- Relevance: LOW
- As Found: Unknown
- ID: M264
- Name: Pemetrexed
- Relevance: LOW
- As Found: Unknown
- ID: M1668
- Name: Docetaxel
- Relevance: LOW
- As Found: Unknown
- ID: M231
- Name: Albumin-Bound Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M6182
- Name: Cisplatin
- Relevance: LOW
- As Found: Unknown
- ID: M341643
- Name: Etoposide phosphate
- Relevance: LOW
- As Found: Unknown
- ID: M17492
- Name: Vinblastine
- Relevance: LOW
- As Found: Unknown
- ID: M147959
- Name: Taxane
- Relevance: LOW
- As Found: Unknown
- ID: M192636
- Name: Nedaplatin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424886
**Brief Title:** The Effect of Different Instruction Trainings in Semi-Professional Female Athletes
**Official Title:** The Effect of Verbal Combined Focus of Attention and Video Instruction Training on Landing Technique and Proprioception in Semi-Professional Female Athletes
#### Organization Study ID Info
**ID:** BT-FocusT
#### Organization
**Class:** OTHER
**Full Name:** Bahçeşehir University
### Status Module
#### Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Bahçeşehir University
#### Responsible Party
**Investigator Affiliation:** Bahçeşehir University
**Investigator Full Name:** Pelin Pişirici
**Investigator Title:** Assistant Professor, PT, PhD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Feedback is implanted into workouts to prevent lower extremity injuries. There are different studies where external focus and internal focus feedback were found to be superior. The main purpose of this study is to investigate the effects of training on vertical jump landing technique by comparing a verbal training group that receives instructions with an external focus of attention and an internal focus of attention combined, a visual training group with video instructions, and a control group in female athletes with knee valgus. It is also to examine whether possible beneficial results are still present in the retention test performed one week after the test session. The secondary aim of our study is to examine the effect of the training provided on knee joint position sense.
**Detailed Description:** Approximately 70% of lower extremity injuries occur during non-contact, single-leg landings, and jumping to the ground is a common injury mechanism in both genders. Additionally, female athletes have higher injury rates compared to men, potentially due to anatomical differences of the lower kinematic chain. Events in which athletes experience non-contact ACL injuries generally show many common biomechanical features such as increased ground reaction forces during single-leg landing, decreased joint flexion in the sagittal plane of the ankle, knee, hip and trunk, as well as increased knee internal rotation angles. Another critical ACL injury risk factor is performing a secondary task during sharp deceleration movements. Current rehabilitation programs focus on neuromuscular training programs to prevent adverse movement patterns and increase proper movement control. However, there is still a need to increase the effectiveness of these neuromuscular training programs to have a more significant impact on ACL injury rates. Therefore, the use of motor learning strategies and neuromuscular training programs with adequate and correct techniques in the rehabilitation of athletes should still be investigated.
There are various approaches to motor learning. One of the best-known approaches is the cognitive approach, where the athlete reaches the automation stage by receiving feedback and repeating the model technique as often as possible. The common denominator of motor learning strategies is the use of explicit instructions and feedback regarding desired landing positions. Instructions for the implementation of movements in rehabilitation programs aim to improve performance and motor learning. These instructions may address the action outcome or the course of action. There are many studies showing that feedback training changes jump landing biomechanics. In line with the results of these studies, using feedback techniques, especially to reduce the vertical ground reaction force and increase the knee flexion angle during landing from a jump, can reduce the stress and risk of injury in the lower extremity.
Motor skills can be learned with an internal focus of attention or with an external focus of attention. Although the difference in these instructions may seem insignificant, externally focused education; has been shown to result in better performance, retention, transfer, and greater movement automaticity. The main purpose of this study is to investigate the effects of training on vertical jump landing technique by comparing a verbal training group that receives instructions with an external focus of attention and an internal focus of attention combined, a visual training group with video instructions, and a control group in female athletes with knee valgus. It is also to examine whether possible beneficial results are still present in the retention test performed one week after the test session. The secondary aim of our study is to examine the effect of the training provided on knee joint position sense.
### Conditions Module
**Conditions:**
- Injury;Sports
**Keywords:**
- motor learning
- knee valgus
- landing biomechanics
- proprioception
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** a randomized, controlled, single-blind, prospective study
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Randomization will be done by sealed envelope method.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 39
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Before the study is conducted, the expert video that will be used for the VI group instructions will be created. The expert video will be created with an athlete with a LESS score of less than 4 and an FPPA of less than 100 who performs a DVJ task in accordance with the instructions. A video recording will be taken of the person designated as an expert performing the DVJ task. The video recording will be used only for the VI group instructions.
**Intervention Names:**
- Other: Landing error scoring system (LESS)
**Label:** Video Instructed Training Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** It was emphasized that the participants should jump from the 30 cm high box and immediately after landing, jump as high and forward as possible and maintain the final landing stance for 5 seconds. Participants were asked to perform 5 drop vertical jumps and the jumps performed were evaluated. After pretest evaluations were recorded, verbal training group participants performed two training blocks, receiving instructions specific to their group. Participants were given a combined verbal instruction such as "Focus on how hard you push yourself off the ground after the jump and how quickly you straighten your knees during this push", in which internal and external focus directions were given simultaneously. After receiving the instructions, the participants performed 2 drop vertical jumps, 10 times each.
**Intervention Names:**
- Other: Landing error scoring system (LESS)
**Label:** Verbal Combined Focus Instructed Training Group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Participants will be explained how to do the DVJ task in the same way as other groups. Then, after the participants' measurements will be taken, they will start the training blocks without any instructions. Participants will not receive any feedback during training blocks.
**Intervention Names:**
- Other: Landing error scoring system (LESS)
**Label:** Control Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control Group
- Verbal Combined Focus Instructed Training Group
- Video Instructed Training Group
**Description:** Each group will perform two training blocks of 10 drop vertical jumping (DVJ) tasks. Knee joint position sense (KJPS), frontal plane projection angle (FPPA), and Landing Error Scoring System (LESS) assessments will be performed before and after the training blocks, and follow-up assessments will be performed 1 week later. The dominant limb of the participants (the side limb they use when kicking the ball) will be taken into account during the measurement.
**Name:** Landing error scoring system (LESS)
**Other Names:**
- drop vertical jump landing task
- frontal plane projection angle (FPPA)
- knee joint position sense (KJPS)
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Two standard video cameras capture the frontal plane and sagittal plane view of each subject as they perform the test procedures (jumping from 30 cm height box). The participant's LESS score represents excellent (LESS score \<4), good (LESS score \>4 to 5), fair (LESS score \>5 to 6) and poor (LESS score \>6) jumping technique.
**Measure:** Landing Error Scoring System (LESS) Measurement
**Time Frame:** baseline, immediately after the intervention, one week after the baseline
#### Secondary Outcomes
**Description:** During the frontal plane projection angle (FPPA) measurement, a straight line will be drawn from the anterior superior spina iliaca along the femur to the midpoint of the patella, and the midpoint of the ankle will be determined as the reference point by a straight line drawn from the midpoint of the patella. Participants will stand with their feet aligned in the sagittal plane and their arms crossed across their chests. By prior instruction, subjects will be asked to squat up to 60º knee flexion in a controlled manner without losing their balance, before returning to the starting position. Digital recordings of the frontal plane will be made while individuals perform a single-leg squat test at 60º knee flexion 3 times. The FPPA degree is measured from the medial aspect of the knee and calculated by subtracting 360. FPPA of 195° and above will be considered pathological.
**Measure:** Frontal Plan Projection Angle (FPPA) Measurement
**Time Frame:** baseline, immediately after the intervention, one week after the baseline
**Description:** Participants are initially placed in a sitting position in 90° knee flexion. Participants' eyes are covered with a mask to block visual input. The smartphone that will perform the measurement is fixed to the participants' lower limb (15 cm from the apex of the fibular head) with a Velcro strap. From the starting position (90 knee flexion), the participants' knee is placed by the researcher at a target joint angle of 45. Participants actively hold the knee at the 45 target joint angle for five seconds to understand the exact angle of the knee. After these five seconds, the participants actively return their knee to the starting position and the researcher shows the target angle to the participant three times. With the command given by the researcher, the participants are directed to extend their knees as close as possible to the target joint angle without any external stimulation or assistance. Participants perform 3 trials and try to maintain the estimated position for 3 seconds.
**Measure:** Knee Joint Position Sense (KJPS) Measurement
**Time Frame:** baseline, immediately after the intervention, one week after the baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being female
* Being between the ages of 18-24
* Body mass index being between 18.5 kg/m2 and 25 kg/m2
* Becoming a minor league basketball or volleyball player
* Volunteers must not have suffered any trunk or lower extremity injuries in the last 6 months before participation in the study.
* Having a frontal plane projection angle greater than 100 during the single-leg squat test
Exclusion Criteria:
* • Having experienced a trunk or lower extremity injury in the last 6 months before the date of study
* Having a history of fracture or dislocation in the lower extremity
* Having suffered from back pain in the past years
* Having a musculoskeletal system abnormality
* Being unable to perform functional tasks (visual, auditory, vestibular or neurological impairment)
* Being pregnant
* Having malignancy and metabolic diseases
**Healthy Volunteers:** True
**Maximum Age:** 24 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Pelin Pişirici, PT, PhD
**Phone:** 05055016076
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Büşra Tamgüç, PT
**Phone:** 05313373355
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Kağıthane
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Büşra Tamgüç, PT
- **Phone:** 05313373335
- **Role:** CONTACT
***Contact 2:***
- **Name:** Tolga Dikmenli
- **Phone:** 0532 467 25 69
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Istanbul Panterler Sports Club
**State:** Istanbul
**Status:** RECRUITING
**Zip:** 34406
#### Overall Officials
**Official 1:**
**Affiliation:** Bahcesehir University, Faculty of Health Sciences, Department of Physiotherapy
**Name:** Pelin Pişirici, PT, PhD
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Bahcesehir University, Graduate Education Institute
**Name:** Büşra Tamgüç, PT
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4570
- Name: Athletic Injuries
- Relevance: HIGH
- As Found: Injury;Sports
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001265
- Term: Athletic Injuries
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424873
**Acronym:** Dynamic PET/CT
**Brief Title:** Dynamic Whole-body PET/CT Imaging in Clinical Oncology
**Official Title:** Dynamic Whole-body PET/CT Imaging in Clinical Oncology
#### Organization Study ID Info
**ID:** 2023-02102
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Geneva
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2023-11-09
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Valentina Garibotto
#### Responsible Party
**Investigator Affiliation:** University Hospital, Geneva
**Investigator Full Name:** Valentina Garibotto
**Investigator Title:** Head of the Division of Nuclear Medicine and Molecular imaging
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to to achieve robust quantitative whole- body parametric imaging in clinically feasible scan times in patient with oncologic pathology .
The main question\[s\] it aims to answer are:
* \[question 1\]
* \[question 2\] Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\].
**Detailed Description:** Whole body hybrid PET/CT imaging, making use of the standardized uptake value (SUV), is well established in clinical setting for diagnosis and staging, treatment response monitoring and radiation therapy treatment planning of a wide range of oncologic malignancies. However, the SUV metric derived from static PET data does not capture the dynamics of the PET probe biodistribution in the body.
The present work proposes to fill in this notable gap: namely to merge whole-body and dynamic PET/CT imaging, to achieve robust quantitative whole- body parametric imaging in clinically feasible scan times. Our proposed approach has the potential to significantly enhance diagnostic, prognostic and treatment response monitoring capabilities of PET/CT and to fundamentally alter routine clinical practice.
### Conditions Module
**Conditions:**
- Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** PET/CT
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Additionnal images during PET/CT
**Intervention Names:**
- Radiation: PET/CT with FDG or FES
**Label:** One arm study
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- One arm study
**Description:** The study consists of an additional 50 minutes of imaging during the radiotracer's uptake phase prior to their clinical scan (standard of care).
**Name:** PET/CT with FDG or FES
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** The standard SUV measurement metric will be compared with the measured influx rate Ki as obtained from dynamic PET/CT imaging for FDG-avid processes. We expect a correlation coefficient of at least 0.8.
**Measure:** Standard SUV measurement metric
**Time Frame:** through study completion , an average of 2 years
#### Secondary Outcomes
**Description:** This will be assessed by clinical PET/CT readers, on a 5 point scale.
**Measure:** Image quality
**Time Frame:** through study completion , an average of 2 years
**Description:** This will be assessed by clinical PET/CT readers, on a 5 point scale.
**Measure:** Certainty in diagnosis of FDG-avid processes
**Time Frame:** through study completion , an average of 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients clinically indicated for whole-body PET evaluation.
2. Patient must agree to lie still in the camera.
3. Patient must be able to comply with study procedures.
4. Patient must be able to provide informed consent.
Exclusion Criteria:
1. Patients \< 18 years of age.
2. Pregnant women are excluded.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Valentina Garibotto, Pr
**Phone:** +41223727252
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ismini Mainta, Dr
**Phone:** +41795534454
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Geneva
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Valentina Garibotto
- **Role:** CONTACT
**Country:** Switzerland
**Facility:** Geneva University Hospitals
**Status:** RECRUITING
**Zip:** 1205
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424860
**Brief Title:** Fish Oil, Metformin and Heart Health in PCOS
**Official Title:** Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS
#### Organization Study ID Info
**ID:** 00141704
#### Organization
**Class:** OTHER
**Full Name:** University of Alberta
### Status Module
#### Completion Date
**Date:** 2027-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Heart and Stroke Foundation of Canada
#### 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:** True
### Description Module
**Brief Summary:** Women with Polycystic Ovary Syndrome (PCOS) have high testosterone levels which is associated with altered insulin-glucose metabolism and an adverse blood lipid profile, predisposing them to the development of Type II Diabetes and Cardiovascular Disease (CVD). This study will investigate the use of dietary fish oil supplementation as a safe and effective intervention, and as an adjunct therapy to standard of care treatment with metformin to improve heart health, blood lipids and insulin-glucose metabolism in women with PCOS, and those with PCOS and Type 2 Diabetes.
**Detailed Description:** OBJECTIVES The objective in this proposed study is to determine the effect of dietary fish oil supplementation with metformin compared to standard of care metformin-alone treatment for 12 months on plasma lipids and apoB- remnant lipoprotein metabolism, and atherosclerotic cardiovascular disease and cardiac function in high-risk overweight-obese young individuals with PCOS.
This study will provide evidence-based research on the efficacy of fish oil, in the form as an adjunct therapy to standard treatment with metformin, as a safe nutritional treatment to add to therapeutic guidelines to reduce early CVD risk in young women with PCOS.
Specific Objectives;
1. To quantify carotid intimal medical thickness (cIMT) and plaque height before and after the intervention to assess the effect of fish oil supplementation combined with metformin standard of care on atherosclerotic cardiovascular disease and cardiac function.
2. To determine the effects of dietary fish oil supplementation combined with metformin and metformin standard of care on fasting and non-fasting plasma TG, apoB48 and apoB100-lipoprotein concentrations, and cardiac function variables including left ventricular (LV) posterior wall thickness, LV ejection fraction.
3. To assess the effect of dietary fish oil supplementation on insulin, glucose, and endocrine parameters.
### Conditions Module
**Conditions:**
- PCOS
- Cardiovascular Disease
- Atherosclerotic Cardiovascular Disease
- Atherosclerotic Plaque
- Cardiac Hypertrophy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 146
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** metformin (1500mg/d) and placebo (olive oil capsule)
**Intervention Names:**
- Drug: Metformin
**Label:** Metformin
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** metformin (1500mg/d) and fish oil (4000mg/d)
**Intervention Names:**
- Dietary Supplement: Fish oil
- Combination Product: Fish Oil and Metformin
**Label:** Fishoil and metformin
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Fishoil and metformin
**Description:** For 12 months
**Name:** Fish oil
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Metformin
**Description:** 12 months
**Name:** Metformin
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Fishoil and metformin
**Description:** 12 months
**Name:** Fish Oil and Metformin
**Type:** COMBINATION_PRODUCT
### Outcomes Module
#### Primary Outcomes
**Description:** mm
**Measure:** Carotid intimal medial thickness
**Time Frame:** 12 months
**Description:** mm
**Measure:** carotid plaque height
**Time Frame:** 12 months
**Description:** percent change in LVGLS
**Measure:** Left ventricular global longitudinal strain (LVGLS)
**Time Frame:** 12 months
#### Secondary Outcomes
**Description:** TG, LDL-C, HDL-C, non-HDL-C mmol/l
**Measure:** Blood lipids
**Time Frame:** 12 months
**Description:** apob48 and apoB100 mg/l
**Measure:** ApoB-lipoproteins
**Time Frame:** 12 months
**Description:** mmol/l
**Measure:** remnant-cholesterol
**Time Frame:** 12 months
**Description:** nmol/l
**Measure:** Testosterone
**Time Frame:** 12 months
**Description:** pmol/l
**Measure:** insulin
**Time Frame:** 12 months
**Description:** mmol/l
**Measure:** glucose
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* diagnosis of PCOS
* overweight-obese (BMI \>25 kg/m2)
* elevated fasting plasma TG (\>150 mg/dL)
* and/or apoB48-remnant cholesterol lipoproteins (\>20 ug/ml)
* impaired insulin sensitivity (glucose 100-125 mg/dL and/or insulin \>15 (uM/ml), and may be diagnosed with T2D (blood glucose \>126 mg/dL).
Exclusion Criteria:
-pregnancy, lactation
**Maximum Age:** 45 Years
**Minimum Age:** 25 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### IPD Sharing Statement Module
**Description:** no plan
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000006331
- Term: Heart Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M26188
- Name: Atherosclerosis
- Relevance: HIGH
- As Found: Atherosclerotic Cardiovascular Disease
- ID: M10035
- Name: Hypertrophy
- Relevance: HIGH
- As Found: Hypertrophy
- ID: M29003
- Name: Plaque, Atherosclerotic
- Relevance: HIGH
- As Found: Atherosclerotic Plaque
- ID: M9420
- Name: Cardiomegaly
- Relevance: HIGH
- As Found: Cardiac Hypertrophy
- ID: M22519
- Name: Pathological Conditions, Anatomical
- 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: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000050197
- Term: Atherosclerosis
- ID: D000006332
- Term: Cardiomegaly
- ID: D000006984
- Term: Hypertrophy
- ID: D000058226
- Term: Plaque, Atherosclerotic
### 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: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M11667
- Name: Metformin
- Relevance: HIGH
- As Found: Assessment
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
- ID: T242
- Name: Olive
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008687
- Term: Metformin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424847
**Acronym:** SPIRAL+
**Brief Title:** Effects of a Lifestyle and Sleep Intervention in Non-exercising Adults
**Official Title:** Effects of a Lifestyle and Sleep Intervention Program on Quality of Life and Physical Activity Levels in Non-exercising Adults, SPIRAL+ Randomized Controlled Trial
#### Organization Study ID Info
**ID:** SPIRAL+
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Grenoble
### Status Module
#### Completion Date
**Date:** 2028-05-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-05-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-02
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-25
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Grenoble
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Background. Cardiovascular diseases (CVDs) are the leading cause of premature mortality and disability accounting for one third of all deaths worldwide with considerable impacts on economics and on quality of life. Recent studies suggest that a lifestyle intervention might have a role in the reduction of CDV risk. Lifestyle intervention programs typically combine physical activity, diet and behavior modification components. Poor sleep health is highly prevalent in the general population and contributes to increased risk of several noncommunicable diseases. However, sleep is rarely addressed in lifestyle intervention programs in primary prevention. Given the high prevalence of poor sleep health in people without a diagnosed sleep disorder, and the associated health consequences, there is a clear need for broad-reaching, effective interventions to improve sleep quality in subclinical populations.
Aims. The main objective of this study is to compare a lifestyle intervention program including a sleep intervention compared to a lifestyle intervention program alone on the health-related quality of life (measured by the EQ-5D-5L) and physical activity levels of non-exercising adults.
Methods. Non-exercising adults (n=201) will be recruited in the community via advertisement or their primary care doctor and then randomized to one of the following 3 groups : lifestyle intervention, lifestyle and sleep intervention or standard care. The lifestyle intervention includes a physical activity component (physical activity initiation visit and 6 months of supervised physical activity, once weekly), a diet component (consultation with a dietician and 3 group sessions). The sleep intervention includes individualized face-to-face sessions aimed at improving and optimizing sleep hygiene.
At baseline and after 6 and 12 months, quality of life, physical activity levels, cardiovascular and metabolic risk factors will be evaluated.
Perspectives. This study should determine whether adding a sleep intervention dimension to a lifestyle intervention program provides significant benefits in terms of quality of life and physical activity levels. Based on this study, the modalities of real-life lifestyle intervention programs could be reconsidered in order to provide optimal primary prevention.
### Conditions Module
**Conditions:**
- Inactivity, Physical
- Lifestyle Risk Reduction
**Keywords:**
- lifestyle intervention
- sleep intervention
- physical activity
- behavior change techniques
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 201
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: Lifestyle intervention (physical activity and diet)
**Label:** Lifestyle intervention (physical activity and diet)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Behavioral: Lifestyle (physical activity and diet) and Sleep intervention
**Label:** Lifestyle (physical activity and diet) and Sleep intervention
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Intervention Names:**
- Behavioral: Health education intervention
**Label:** Health education intervention
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Lifestyle intervention (physical activity and diet)
**Description:** The physical activity intervention will be based on validated behavior change theories aimed at the initiation and long-term maintenance of physical activity.
Participants will be referred to specialists in Adapted Physical Activity for a 6-month program. Exercise sessions will include aerobic exercise and muscle strengthening exercises. Participants will participate in one supervised sessions per week. They will receive instructions for exercising on their own on the other days in order to reach physical activity guidelines. They will also receive instructions and tips to limit sedentary behavior and increase their physical activity throughout the day.
Participants will benefit from an initial consultation with a dietitian and 4 follow-up visits. The follow-up visits will be either group-based or individual, based on participants choice and availabilities. Dietary recommendations will be based on public health guidelines in France aimed at eating a healthy, balanced diet.
**Name:** Lifestyle intervention (physical activity and diet)
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Lifestyle (physical activity and diet) and Sleep intervention
**Description:** Participants will benefit from the physical activity and diet intervention detailed above and the following sleep intervention. Participants will fill out an online sleep diagnostic tool includes validated sleep questionnaires (Pittsburgh Sleep Quality Index, Epworth sleepiness scale, Insomnia Severity Index, Berlin questionnaire, Horne and Ostberg questionnaire).
Participants will also log their sleep habits in a 14-day sleep diary. Based on the sleep specialists' review of the results of the questionnaires, sleep diary and analysis of sleep-wake patterns, participants who require further exploration will be referred to a sleep specialist for a consultation and if necessary the appropriate treatment for their sleep disorder.
All participants in this group will benefit from an individualized sleep hygiene intervention. They will benefit from a baseline interview and 3 follow-up visits.
**Name:** Lifestyle (physical activity and diet) and Sleep intervention
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- Health education intervention
**Description:** Participants randomized to the control group will benefit from a health education intervention in order to limit deception bias.
**Name:** Health education intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Measured using an activity monitor (Actigraph)
**Measure:** Steps per day
**Time Frame:** 6 months after randomization
**Description:** EuroQol (Europe Quality of Life) EQ-5D-5L questionnaire.The EQ-5D-5L is a brief, multiattribute, generic, health status measure composed of 5 questions with Likert response options (descriptive system). The descriptive system covers 5 dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with 5 levels of severity in each dimension (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). The worst health state is (55555) and the best health state is (11111).
**Measure:** Health-related quality of life
**Time Frame:** 6 months after randomization
#### Secondary Outcomes
**Description:** Pittsburg Sleep Quality Index. The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
**Measure:** Subjective sleep quality
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Measured using an activity monitor (Actigraph GT3X) and Sunrise sleep
**Measure:** Sleep duration
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Measured using an activity monitor (Actigraph GT3X) and Sunrise
**Measure:** Sleep quality
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Time spent in moderate-to-vigorous physical activity measured by a physical activity monitor, Actigraph GT3X
**Measure:** Modrate to vigorous intensity physical activity time
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Time spent in light intensity physical activity measured by a physical activity monitor, Actigraph GT3X
**Measure:** Light intensity physical activity time
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Time spent in vigorous intensity physical activity measured by a physical activity monitor, Actigraph GT3X
**Measure:** Vigorous intensity physical activity time
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Sedentary time measured by a physical activity monitor Actigraph GT3X
**Measure:** Sedentary time
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Cardiorespiratory stress test
**Measure:** Cardiorespiratory fitness (VO2peak)
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Six-minute walk test: This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD)
**Measure:** 6 minute walk test distance
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Measured using an ambulatory BP device
**Measure:** 24-hr systolic and diastolic blood pressure
**Time Frame:** Baseline, 6 months and 12 months
**Description:** EuroQol (Europe Quality of Life) EQ-5D-5L questionnaire.The EQ-5D-5L is a brief, multiattribute, generic, health status measure composed of 5 questions with Likert response options (descriptive system). The descriptive system covers 5 dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with 5 levels of severity in each dimension (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). The worst health state is (55555) and the best health state is (11111).
**Measure:** Health-related quality of life
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Measured using bio-electrical impedance
**Measure:** Body composition
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Measured using a dynamometer
**Measure:** Grip strength
**Time Frame:** Baseline, 6 months and 12 months
**Description:** The 36-Item Short Form Health Survey questionnaire measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
**Measure:** Quality of life SF-36
**Time Frame:** Baseline, 6 months and 12 months
**Description:** General Anxiety Disorder-7 (GAD-7) questionnaire. The score is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21.
**Measure:** Anxiety symptoms
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Patient Health Questionnaire-9 (PHQ-9). Each item is evaluated on a severity scale ranging from 0 to 3 where the respondent is asked to rate how often each symptom occurred over the last 2 weeks (0-not at all; 1-several days; 2-more than half of the days or 3-nearly every day), yielding a total score ranging from 0-27.
**Measure:** Depressive symptoms
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Warwick-Edinburgh Mental Wellbeing Scale. The Likert scale represents a score for each item from 1 to 5 respectively, giving a minimum score of 14 and maximum score of 70. All items are scored positively. The overall score for the WEMWBS is calculated by totalling the scores for each item, with equal weights.
**Measure:** Mental well-being
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Motivation Scale towards Health-Oriented Physical Activity questionnaire. A higher score indicates higher motivation towards physical activity.
**Measure:** Motivation toward physical activity
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Social deprivation score. This questionnaire is designed to assess the level of precariousness by the means of 11 binary items. Among these 11 items, two are very frequent in material deprivation scales: items #4-5. Six are related to social deprivation: items #1, #3, #6-9. One is related to health and financial difficulties: item #1. The last two \[#10-11\] are specific to precariousness scales. The final score can vary from 0 (no precariousness), to 100 (extreme precariousness), each item having its own weight.
**Measure:** Social deprivation
**Time Frame:** Baseline, 6 months and 12 months
**Description:** The Dutch Eating Behavior Questionnaire (DEBQ) is a 33-item self-report questionnaire that is aimed to assess three distinct eating behaviors in adults: (1) emotional eating, (2) external eating, and (3) restrained eating. Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.
**Measure:** Eating behavior
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Insomnia Severity Index. The total score is the sum of all seven items. Total score ranges from 0-28. A higher score indicates more symptoms of insomnia.
**Measure:** Insomnia Severity
**Time Frame:** Baseline, 6 months and 12 months
**Description:** Epworth Sleepiness Score. The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
**Measure:** Subjective sleepiness
**Time Frame:** Baseline, 6 months and 12 months
**Description:** This scale measures the main psychological predictors of physical activity according to the theory of planned behaviour. Attitude is measured by 5 items. A higher score indicates more a favorable attitude.
**Measure:** Attitude towards physical activity practice
**Time Frame:** Baseline, 6 months and 12 months
**Description:** This scale measures the main psychological predictors of physical activity according to the theory of planned behaviour. Self-efficacy is measured by 3 items, a higher score indicates higher self-efficacy.
**Measure:** Self-efficacy
**Time Frame:** Baseline, 6 months and 12 months
**Description:** This scale measures the main psychological predictors of physical activity according to the theory of planned behaviour. Subjective norms is measured by 2 items, a higher score indicates more favorable subjective norms.
**Measure:** Subjective norms
**Time Frame:** Baseline, 6 months and 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participant who is physically inactive (i.e. less than 150 minutes of moderate intensity physical activity per week)
* Participant aged 18 to 80 years old
* Participant able to provide written informed consent
* Participant able to participate in regular physical activity (no medical contraindication to exercise)
* Participant affiliated to social security or a similar regimen
Exclusion Criteria:
* Any condition that in the opinion of the responsible physician or investigator makes the potential participant unsuitable for the study
* A participant who scores 11111 on the EQ-5D-5L questionnaire
* A diagnosed and treated sleep disturbance (sleep apnea, insomnia, restless legs syndrome)
* Persons concerned by articles L1121-5, L1121-6 and L1121-8 of the public health code (i.e. pregnancy, person deprived of liberty or subject to a legal protection measure, vulnerable person or legally protected adult)
* Person already included in another interventional 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:** Monique Mendelson, PhD
**Phone:** +33 4 76 76 72 26
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Marie Coudurier, MD
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Grenoble
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Monique Mendelson, PhD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Marie Coudurier, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Grenoble University Hospital
**Status:** RECRUITING
**Zip:** 38000
#### Overall Officials
**Official 1:**
**Affiliation:** [email protected]
**Name:** Marie Coudurier, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424834
**Acronym:** MVP-ANOCA
**Brief Title:** Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries
**Official Title:** A Randomized Controlled Study of Targeted Medical Therapy Versus Placebo for Angina and Non- Obstructive Coronary Arteries: The MVP-ANOCA Study
#### Organization Study ID Info
**ID:** IRB-75085
#### Organization
**Class:** OTHER
**Full Name:** Stanford University
#### Secondary ID Infos
**Domain:** American Heart Association
**ID:** 24POST1189688
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** American Heart Association
#### Lead Sponsor
**Class:** OTHER
**Name:** Stanford University
#### Responsible Party
**Investigator Affiliation:** Stanford University
**Investigator Full Name:** Christopher Chi-Yuen Wong
**Investigator Title:** Postdoc
**Type:** PRINCIPAL_INVESTIGATOR
### 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 learn if targeted medical therapy will improve symptoms and quality of life in patients with angina and non-obstructive coronary arteries compared to placebo, after the underlying cause of the chest pain has been ascertained by coronary function testing.
Participants will be treated with either medications that target the underlying cause of their chest pain or placebo for 50 days. They will be asked to complete a series of questionnaires to evaluate their quality of life at the beginning and end of the study.
### Conditions Module
**Conditions:**
- Angina Pectoris
- Microvascular Angina
- Vasospastic Angina
- Myocardial Bridge of Coronary Artery
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Phases:**
- PHASE2
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 1. Epicardial or microvascular coronary spasm: Amlodipine 2.5mg initial dose, 10mg max dose
2. Coronary microvascular dysfunction: Nebivolol 5mg initial dose, 20mg max dose
3. Myocardial Bridge: Nebivolol 5mg initial dose, 20mg max dose
4. Mixed epicardial/microvascular spasm and coronary microvascular dysfunction/myocardial bridge: Amlodipine 2.5mg initial dose, 10mg max dose; PLUS Nebivolol 5mg initial dose, 20mg max dose
Participants will take their assigned therapy after randomization. Weekly person via in-person visit or telephone is performed to uptitrate therapy to the maximally tolerated dose. After 3 weeks, the initial drug titration phase is completed and a final dose reached. Participants are then instructed to take the maximally tolerated dose for 4 weeks to the conclusion of the study.
**Intervention Names:**
- Drug: Amlodipine
- Drug: Nebivolol
**Label:** Targeted medical therapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 1. Epicardial or microvascular coronary spasm: Placebo
2. Coronary microvascular dysfunction: Placebo
3. Myocardial Bridge: Placebo
4. Mixed epicardial/microvascular spasm and coronary microvascular dysfunction/myocardial bridge: Placebo
Participants will take their assigned therapy after randomization. Weekly person via in-person visit or telephone is performed to uptitrate therapy to the maximally tolerated dose. After 3 weeks, the initial drug titration phase is completed and a final dose reached. Participants are then instructed to take the maximally tolerated dose for 4 weeks to the conclusion of the study.
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Targeted medical therapy
**Description:** Amlodipine taken once orally daily at a starting dose of 2.5mg, uptitrated to a maximum of 10mg if tolerated.
**Name:** Amlodipine
**Other Names:**
- Norvasc
- Katerzia
- Norliqva
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Targeted medical therapy
**Description:** Nebivolol taken once orally daily at a starting dose of 5mg, uptitrated to a maximum of 20mg if tolerated.
**Name:** Nebivolol
**Other Names:**
- Bystolic
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Placebo
**Description:** Placebo taken once orally daily.
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Change in Seattle Angina Questionnaire summary score at 7 weeks compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
**Measure:** Seattle Angina Questionnaire summary score
**Time Frame:** 7 weeks
#### Secondary Outcomes
**Description:** Change in EuroQol 5 dimension score - 5L index score at 7 weeks compared to baseline. The index ranges from -0.573 to 1.000, with a higher score indicating a better outcome.
**Measure:** EuroQol 5 dimension - 5L index score
**Time Frame:** 7 weeks
**Description:** Change in EuroQol 5 dimension score - 5L visual analogue score at 7 weeks compared to baseline. The index ranges from 0 - 100, with a higher score indicating a better outcome.
**Measure:** EuroQol 5 dimension - 5L visual analogue score
**Time Frame:** 7 weeks
**Description:** Change in PHQ-4 at 7 weeks compared to baseline. The score ranges from 0 - 12, with a higher score indicating a worse outcome.
**Measure:** PHQ-4 score
**Time Frame:** 7 weeks
**Description:** Change in Treatment Satisfaction Questionnaire for Medication score at 7 weeks compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
**Measure:** Treatment Satisfaction Questionnaire for Medication score
**Time Frame:** 7 weeks
**Description:** Change in Seattle Angina Questionnaire summary score at 7 weeks stratified by specific chest pain endotypes at 7 weeks compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
**Measure:** Seattle Angina Questionnaire summary score stratified by specific chest pain endotypes
**Time Frame:** 7 weeks
**Description:** EuroQol 5 dimension - 5L index score at 7 weeks stratified by specific chest pain endotypes at 7 weeks compared to baseline. The index ranges from -0.573 to 1.000, with a higher score indicating a better outcome.
**Measure:** EuroQol 5 dimension - 5L index score stratified by specific chest pain endotypes
**Time Frame:** 7 weeks
**Description:** EuroQol 5 dimensions - 5L visual analogue score at 7 weeks stratified by specific chest pain endotypes at 7 weeks compared to baseline. The index ranges from 0 - 100, with a higher score indicating a better outcome.
**Measure:** EuroQol 5 dimensions - 5L visual analogue score stratified by specific chest pain endotypes
**Time Frame:** 7 weeks
**Description:** PHQ-4 score at 7 weeks stratified by specific chest pain endotypes at 7 weeks compared to baseline. The score ranges from 0 - 12, with a higher score indicating a worse outcome.
**Measure:** PHQ-4 scores stratified by specific chest pain endotypes
**Time Frame:** 7 weeks
**Description:** Treatment Satisfaction Questionnaire for Medication scores at 7 weeks stratified by specific chest pain endotypes at 7 weeks compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
**Measure:** Treatment Satisfaction Questionnaire for Medication score stratified by specific chest pain endotypes
**Time Frame:** 7 weeks
**Description:** Change in Seattle Angina Questionnaire summary score stratified by baseline angina frequency at at 7 weeks compared to baseline. The score ranges from 0 - 100, with a higher score indicating a better outcome.
**Measure:** Seattle Angina Questionnaire summary score stratified by baseline angina frequency
**Time Frame:** 7 weeks
**Description:** Difference between targeted medical therapy group and placebo group in proportion of patients with good response (Seattle Angina Questionnaire summary score ≥ 10), no angina (Seattle Angina Questionnaire angina frequency score = 100), and excellent health status (Seattle Angina Questionnaire summary score ≥ 75).
**Measure:** Proportion of patients with good response, no angina, and excellent health status
**Time Frame:** 7 weeks
**Description:** Incidence of bleeding, coronary dissection, stroke, periprocedural myocardial infarction, non-self-limiting arrhythmias during the index coronary function testing procedure
**Measure:** Safety endpoints
**Time Frame:** Baseline
**Description:** Difference between targeted medical therapy group and placebo group in incidence of cardiac death, myocardial infarction, and hospital presentation for unstable angina.
**Measure:** Major adverse cardiac events
**Time Frame:** 7 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All patients with stable angina referred to the Stanford University Hospital cardiac catheterization laboratory for clinically indicated coronary function testing are eligible for inclusion into the study.
Specific inclusion criteria for randomization:
* Absence of significant epicardial coronary artery disease on angiography
* Fractional flow reserve \> 0.80
And ≥ 1 of the following:
* Epicardial coronary spasm on acetylcholine testing
* Microvascular spasm on acetylcholine testing
* Coronary flow reserve \< 2.0
* Index of microcirculatory resistance ≥ 25
* Myocardial bridge on intravascular ultrasound with dobutamine resting full-cycle ratio ≤ 0.76
Exclusion Criteria:
* Acute coronary syndrome less than one week prior to enrolment
* Cardiomyopathy
* Contraindications to beta-blockers or calcium channel blockers
* Baseline systolic blood pressure \< 95 mmHg
* Baseline heart rate \< 55 bpm
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Christopher Wong, MBBS, PhD
**Phone:** (650) 725 5909
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Palo Alto
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Christopher Wong, MBBS, PhD
- **Phone:** 650-725-5909
- **Role:** CONTACT
***Contact 2:***
- **Name:** Jennifer Tremmel, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Stanford Hospital
**State:** California
**Zip:** 94304
#### Overall Officials
**Official 1:**
**Affiliation:** Stanford University
**Name:** Jennifer Tremmel, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000017202
- Term: Myocardial Ischemia
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002637
- Term: Chest Pain
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000000789
- Term: Angina, Unstable
- ID: D000003330
- Term: Coronary Vessel Anomalies
- ID: D000006330
- Term: Heart Defects, Congenital
- ID: D000018376
- Term: Cardiovascular Abnormalities
- ID: D000000013
- Term: Congenital Abnormalities
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4117
- Name: Angina Pectoris
- Relevance: HIGH
- As Found: Angina
- ID: M19816
- Name: Microvascular Angina
- Relevance: HIGH
- As Found: Microvascular Angina
- ID: M4118
- Name: Angina Pectoris, Variant
- Relevance: HIGH
- As Found: Vasospastic Angina
- ID: M27563
- Name: Myocardial Bridging
- Relevance: HIGH
- As Found: Myocardial Bridge
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: LOW
- As Found: Unknown
- ID: M19506
- Name: Myocardial Ischemia
- 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: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M5882
- Name: Chest Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M4119
- Name: Angina, Unstable
- Relevance: LOW
- As Found: Unknown
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M6552
- Name: Coronary Vessel Anomalies
- Relevance: LOW
- As Found: Unknown
- ID: M9418
- Name: Heart Defects, Congenital
- Relevance: LOW
- As Found: Unknown
- ID: M20503
- Name: Cardiovascular Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: T4716
- Name: Prinzmetal's Variant Angina
- Relevance: HIGH
- As Found: Vasospastic Angina
### Condition Browse Module - Meshes
- ID: D000000787
- Term: Angina Pectoris
- ID: D000017566
- Term: Microvascular Angina
- ID: D000000788
- Term: Angina Pectoris, Variant
- ID: D000054084
- Term: Myocardial Bridging
### Intervention Browse Module - Ancestors
- ID: D000000959
- Term: Antihypertensive Agents
- ID: D000002121
- Term: Calcium Channel Blockers
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000077264
- Term: Calcium-Regulating Hormones and Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000014665
- Term: Vasodilator Agents
- ID: D000058665
- Term: Adrenergic beta-1 Receptor Agonists
- ID: D000000318
- Term: Adrenergic beta-Agonists
- ID: D000000322
- Term: Adrenergic Agonists
- ID: D000018663
- Term: Adrenergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
### Intervention Browse Module - Browse Branches
- Abbrev: AnAg
- Name: Antihypertensive Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
### Intervention Browse Module - Browse Leaves
- ID: M19600
- Name: Amlodipine
- Relevance: HIGH
- As Found: Diabetic
- ID: M276
- Name: Nebivolol
- Relevance: HIGH
- As Found: ICSI
- ID: M4277
- Name: Antihypertensive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M5384
- Name: Calcium Channel Blockers
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M17412
- Name: Vasodilator 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
### Intervention Browse Module - Meshes
- ID: D000017311
- Term: Amlodipine
- ID: D000068577
- Term: Nebivolol
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424821
**Acronym:** LungCadX
**Brief Title:** Cadonilimab Plus Chemotherapy as First-line Treatment for PD-L1 Negative NSCLC
**Official Title:** A Phase II Clinical Study of Cadonilimab in Combination With Chemotherapy as First-Line Treatment for PD-L1 Negative Advanced Non-Small Cell Lung Cancer
#### Organization Study ID Info
**ID:** 2023LY0204
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Pulmonary Hospital, Shanghai, China
### Status Module
#### Completion Date
**Date:** 2025-09-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-07-04
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shanghai Pulmonary Hospital, Shanghai, China
#### Responsible Party
**Investigator Affiliation:** Shanghai Pulmonary Hospital, Shanghai, China
**Investigator Full Name:** Chunxia Su
**Investigator Title:** Director of Clinical Research Center, Shanghai Pulmonary Hospital
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to investigate the efficacy, safety and tolerability of PD-1/CTLA-4 inhibitor (Cadonilimab) combination with chemotherapy as first-line treatment for PD-L1 negative advanced non small cell lung cancer patients. And also explore the potential biomarkers for predicting the efficacy of PD-1/CTLA-4 inhibitor for advanced non small cell lung cancer.
**Detailed Description:** LungCadX is a multi-center, open-label, single-arm, investigator initiated, phase Ⅱ study. Patients received cadonilimab (10 mg/kg, IV, every 3 weeks) plus platinum-based chemotherapy (carboplatin \[area under the curve (AUC) 5 mg/mL per min, IV\] and paclitaxel \[175 mg/m2, IV\] for squamous NSCLC, or carboplatin \[AUC 5 mg/mL per min, IV\] and pemetrexed \[500 mg/m2, IV\] for non-squamous NSCLC) for up to four cycles, followed by maintenance therapy with cadonilimab for squamous NSCLC, and intravenous cadonilimab plus pemetrexed for non-squamous NSCLC. The primary endpoint was 12-month PFS rate by investigator assessment per RECIST 1.1. Secondary endpoints included PFS, OS, ORR，DoR，DCR, and the safety. Exploratory objective was to assess blood/tumor/urine/faeces tissue for potential biomarkers study. Adverse events will be monitored throughout the trial and graded according to the CTCAE v5.0.
### Conditions Module
**Conditions:**
- NSCLC
**Keywords:**
- PD-L1 negative
- PD-1/CTLA-4 bispecific antibody
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 54
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Cadonilimab (10 mg/kg, IV, every 3 weeks) plus platinum-based chemotherapy (carboplatin \[area under the curve (AUC) 5 mg/mL per min, IV\] and paclitaxel \[175 mg/m2, IV\] for squamous NSCLC, or carboplatin \[AUC 5 mg/mL per min, IV\] and pemetrexed \[500 mg/m2, IV\] for non-squamous NSCLC) for up to four cycles, followed by maintenance therapy with cadonilimab for squamous NSCLC, and intravenous cadonilimab plus pemetrexed for non-squamous NSCLC
**Intervention Names:**
- Drug: Cadonilimab
**Label:** Trial group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Trial group
**Description:** Cadonilimab + chemotherapy
**Name:** Cadonilimab
**Other Names:**
- Cadonilimab group
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The 1-year Progression-Free Survival (PFS) rate refers to the proportion of patients who are alive and without disease progression one year after starting treatment.
**Measure:** 1-year Progression-Free Survival (PFS) rate
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Progression-free survival measures the length of time during and after treatment that a patient lives with the disease without it progressing.
**Measure:** Progression-free Survival
**Time Frame:** up to 60 months
**Description:** Overall survival measures the length of time from the start of treatment until death from any cause, indicating the effectiveness of the treatment in prolonging patients' lives.
**Measure:** Overall Survival
**Time Frame:** up to 100 months
**Description:** Objective response rate represents the proportion of patients showing a predefined level of tumor shrinkage or disappearance in response to treatment.
**Measure:** objective response rate
**Time Frame:** up to 24 months
**Description:** Duration of response refers to the length of time during which a patient's tumor remains in remission or shows a positive response to treatment.
**Measure:** duration of response
**Time Frame:** up to 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Written informed consent must be obtained before implementing any trial-related procedures;
* Aged 18-80 years;
* Expected survival of more than 3 months;
* The investigator confirms the presence of at least one measurable lesion according to RECIST 1.1 criteria;
* Wild-type EGFR/ALK;
* Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
* PD-L1 expression in tumor tissue with Tumor Proportion Score (TPS) \< 1%;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* No prior systemic anti-tumor treatment for advanced/metastatic disease; patients who have previously received platinum-based adjuvant chemotherapy/radiotherapy, neoadjuvant chemotherapy/radiotherapy, or curative radiotherapy for advanced disease and experienced disease progression more than 6 months after the last treatment can participate in this study;
* Adequate hematologic function, defined as absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L, platelet count \>= 100 x 10\^9/L, hemoglobin \>= 90 g/L (without transfusion history within 7 days);
* Adequate liver function, defined as total bilirubin level \<= 1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels \<= 2.5 times ULN in all patients, or \<= 5 times ULN in patients with liver metastases;
* Adequate renal function, defined as serum creatinine \<= 1.5 times ULN;
* Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) \<= 1.5 times ULN; for subjects receiving anticoagulant therapy, INR/PT should be within the range planned by the anticoagulant;
* Women of childbearing potential must have a negative pregnancy test within 7 days before starting treatment, and must use reliable contraceptive measures (such as intrauterine device, contraceptive pills, and condoms) during the trial and for 30 days after the end of the trial; male subjects of reproductive potential must use condoms for contraception during the trial and for 30 days after the end of the trial;
* Willingness to comply with regular follow-up visits and trial requirements.
Exclusion Criteria:
* Currently participating in interventional clinical research treatment;
* Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (such as CTLA-4, OX-40, CD137);
* Received traditional Chinese medicine or immunomodulatory drugs (such as thymopeptide, interferon, interleukin, etc.) with anti-tumor indications within 2 weeks prior to the first dose;
* Known allergy to the active ingredient or any excipients of Cadonilimab;
* Active hemoptysis, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal metastasis requiring clinical intervention;
* Uncontrolled pleural effusion/ascites clinically (patients who do not require drainage of effusion or whose effusion does not increase significantly for 3 days can be included);
* Tumor compression of important organs (such as the esophagus) with accompanying symptoms, compression of the superior vena cava, or invasion of mediastinal large blood vessels, heart, etc.;
* History of severe complications such as severe pulmonary or cardiac disease, with any arterial thrombosis, embolism, or ischemia occurring within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. History of deep vein thrombosis, pulmonary embolism, or any other serious thrombotic events within 3 months prior to enrollment (thrombotic events related to implanted venous infusion ports or catheters, or superficial vein thrombosis are not considered "serious" thrombotic events);
* History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, or glomerulonephritis related to antiphospholipid syndrome; Patients with stable hypothyroidism on replacement therapy with thyroid hormones are eligible to participate in this study; Patients with controlled type 1 diabetes after receiving a stable insulin treatment regimen are eligible to participate in this study;
* Received systemic corticosteroids (\> 10 mg/day of prednisone or equivalent) or other systemic immunosuppressive agents (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] drugs) within 2 weeks prior to randomization; Use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids is allowed;
* Active systemic infections, including tuberculosis (TB) (clinical diagnosis based on clinical history, physical examination, radiographic findings, and TB testing according to local medical practices), hepatitis B (known positive for hepatitis B surface antigen (HBsAg) with HBV DNA \>= 1,000 cps/mL or its lower limit of reference range), hepatitis C, or human immunodeficiency virus (HIV) (positive for HIV antibody);
* Known presence of mental illness or substance abuse that may affect compliance with trial requirements;
* History of conditions, diseases, treatments, or laboratory abnormalities that may interfere with trial results or hinder the subject's full participation in the study, or as determined by the investigator that participation in the study is not in the best interest of the subject.
**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:** Li Wang
**Phone:** 18170211997
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Tianqing Chu
- **Role:** CONTACT
**Country:** China
**Facility:** Shanghai Chest Hospital
**State:** Shanghai
**Status:** NOT_YET_RECRUITING
**Location 2:**
**City:** Ningbo
**Contacts:**
***Contact 1:***
- **Name:** Liangqing Nie
- **Phone:** 15356884370
- **Role:** CONTACT
**Country:** China
**Facility:** NINGBO No.2 Hospital
**State:** Zhejiang
**Status:** RECRUITING
**Zip:** 315016
#### Overall Officials
**Official 1:**
**Affiliation:** Shanghai Pulmonary Hospital, Shanghai, China
**Name:** Chunxia Su, Phd
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Access Criteria:** send request to research team for access to the data
**Description:** Public article
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** 2025.6-2026.6
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: LOW
- As Found: Unknown
- ID: M11172
- Name: Lung Neoplasms
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M19537
- Name: Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M18650
- Name: Carboplatin
- Relevance: LOW
- As Found: Unknown
- ID: M264
- Name: Pemetrexed
- Relevance: LOW
- As Found: Unknown
- ID: M231
- Name: Albumin-Bound Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M20194
- Name: Antibodies, Bispecific
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424808
**Brief Title:** Pilot Study for the Validity of a Content-based Information Provision Tool Aimed at Improving the Hospitalization Experience of Liver Transplant Patients
**Official Title:** Pilot Study for the Validity of a Content-based Information Provision Tool Aimed at Improving the Hospitalization Experience of Liver Transplant Patients
#### Organization Study ID Info
**ID:** 2024-04-078-001
#### Organization
**Class:** OTHER
**Full Name:** Samsung Medical Center
### Status Module
#### Completion Date
**Date:** 2024-11-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-21
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Samsung Medical Center
#### Responsible Party
**Investigator Affiliation:** Samsung Medical Center
**Investigator Full Name:** Taerim Kim
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The investigators aim to evaluate the improvement of the inpatient experience and the usability of a content-based tool (a brochure). This involves consolidating video content for inpatients on a single website and providing access to it via QR codes in a brochure format.
\[Patients\] Considering this as a pilot study, the investigators plan to recruit around 30 participants. Both the experimental and control groups will receive standard care and information, with the experimental group additionally receiving the brochure. Random assignment will be used for the experimental and control groups. Surveys and interviews will be conducted to assess changes in patient experience and usability before and after providing the brochure.
\[Medical Staff\] Among the medical staff involved in the liver transplant surgical process, researchers will select participants based on their degree of involvement with the intervention subjects. After obtaining their consent, interviews will be conducted concerning patient experiences and the brochure.
### Conditions Module
**Conditions:**
- Liver Transplantation
- Inpatients
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 1. The group assigned as the control group will receive information in the same manner as it is currently provided to patients.
2. A survey related to patient experience evaluation will be conducted before discharge. The survey will take about 10 minutes.
3. The control group will undergo two interviews, one during hospitalization and one before discharge. Each interview will last approximately 30 minutes. Interviews will be recorded or transcribed, and the recordings will be used until the research objectives are met, after which they will be disposed of.
**Label:** Control Group
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** 1. The group assigned as the experimental group will receive information in the same manner as it is currently provided to patients, with the addition of a brochure provided once when moving to a general ward after surgery. The brochure can then be used freely.
2. A survey related to patient experience evaluation will be conducted before discharge. For the experimental group, an additional survey regarding the provided brochure will be included. The survey will take about 15 minutes.
3. The experimental group will undergo two interviews, one during hospitalization and one before discharge. Each interview will last approximately 30 minutes. Interviews will be recorded or transcribed, and the recordings will be used until the research objectives are met, after which they will be disposed of.
**Intervention Names:**
- Other: Consolidating content on a single website and providing access to it via QR codes in a brochure format
**Label:** Experimental Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental Group
**Description:** The group assigned to the experimental group will receive information in the same manner as current patients do, with the addition of receiving a brochure once when moving to a general ward after surgery. Afterward, they are free to use the brochure. The control group will receive information only in the manner currently provided to patients.
**Name:** Consolidating content on a single website and providing access to it via QR codes in a brochure format
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Inpatient Experience Evaluation Score, which ranges from a minimum of 0 to a maximum of 100 points, with higher scores indicating better patient experiences.
**Measure:** Inpatient Experience 1
**Time Frame:** During the intervention
**Description:** Analysis of survey response trends and frequencies between the experimental and control groups
**Measure:** Inpatient Experience 2
**Time Frame:** During the intervention
**Description:** Qualitative research through interviews
**Measure:** Inpatient Experience 3
**Time Frame:** Patient: During the intervention and after intervention(Two times)/Medical staff: During the study period
#### Secondary Outcomes
**Description:** Asking informational value of the intervention tool from survey and interview
**Measure:** Informational value of the intervention tool
**Time Frame:** During the intervention
**Description:** Survey uses 'System Usability Scail' which ranges a minimum of 0 to a maximum of 100 points, with higher scores indicating better usability. Also related question will be asked by intervew.
**Measure:** Usability value of the intervention tool
**Time Frame:** During the intervention
**Description:** A survey and interview on the experience of utilization during hospitalization
**Measure:** Regarding utilization of the intervention tool
**Time Frame:** During the intervention
**Description:** A survey and interview on the advice for improvement
**Measure:** Areas for improvement
**Time Frame:** During the intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
\[Patients\]
* Adults aged 18 and over
* Patients who are scheduled to undergo or have undergone liver transplant surgery
* Recruited through a call for research participants and have consented to participate in this study
\[Medical Staff\]
* Adults aged 18 and over
* Medical staff at Samsung Medical Center involved in the post-liver transplant treatment process
Exclusion Criteria:
\[Patients\]
* Individuals who have not consented to participate in this study
* Individuals whose health condition makes it difficult to participate in the intervention
* During the research period, the researcher will check if the brochure content has been shared during surveys or interviews with the research participants (information dissemination). If information dissemination is confirmed, the participant will be excluded from the study.
\[Medical Staff\]
* Individuals who have not consented to participate in this study
* Medical staff not involved in the liver transplant treatment process
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Su Min Kim, Ph.D
**Phone:** 821020340550
**Role:** CONTACT
### IPD Sharing Statement Module
**Access Criteria:** Shared with all researchers approved by the IRB
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** From the start to the end of the study
## Derived Section
### 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: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424795
**Brief Title:** Molecular and Microbiome/Metagenome Correlates of Recurrent Wheeze in RSV Infected Infants
**Official Title:** Molecular and Microbiome/Metagenome Correlates of Recurrent Wheeze in RSV Infected Infants
#### Organization Study ID Info
**ID:** MISP 58711-062022-002
#### Organization
**Class:** OTHER
**Full Name:** University of Rochester
### Status Module
#### Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Start Date
**Date:** 2019-12-21
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Rochester
#### Responsible Party
**Investigator Affiliation:** University of Rochester
**Investigator Full Name:** Mary Caserta
**Investigator Title:** Professor of Pediatrics
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this observational study is to learn about further wheezing in infants with RSV infection.. The main question it aims to answer is:
If infant factors, the infant immune response in the nose and the bacteria that reside in the nose at the time of primary RSV infection can predict/classify infants with recurrent wheezing during the following year.
A secondary aim is to identify infant immune response factors in the nose and patterns of bacteria in the nose during primary RSV infection that may help us understand why recurrent wheezing occurs.
Researchers will compare infants with repeated episodes of wheezing to infants who do not have further wheezing.
Participants will be full term infants with their first RSV infection. We will collect information on the pregnancy and birth history as well as the signs and symptoms of RSV infection. Two nasal swabs and a nasal wash will be collected from the infants. Six weeks following the RSV infection we will begin contact with the families biweekly to determine if the infant has recurrent wheezing confirmed by a medical provider. Follow-up will continue for approximately 1 year, through a second winter season.
**Detailed Description:** Respiratory syncytial virus (RSV) causes yearly epidemics of respiratory infection with a significant burden of disease in those at the extremes of age. Infants with RSV infection develop a range of illness from mild or in apparent upper respiratory infections to severe lower respiratory disease with wheezing and/or pneumonia. RSV infection is the most common cause of hospitalization in infants in the US.
The great majority (85%) of hospitalized infants are diagnosed with bronchiolitis and 78% are noted to have wheezing. RSV infection leads to even greater outpatient utilization of medical care including Emergency Department visits (39-69 per 1000 under 6 months and 45-68 per 1000 from 6-11 months) and visits to pediatricians (108-157/1000 under 6 months and 160-194 per 1000 from 6-11 months).
Following primary RSV infection several epidemiological observations have identified an increased frequency of recurrent wheezing in 34 to 56% of infants.
The objectives of this study include:
Primary Objective: To test whether clinical factors, airway gene expression and microbiome/metagenome patterns in the nasal epithelium at the time of primary RSV infection can predict/classify infants with recurrent wheezing.
Secondary Objective 1: To identify airway gene expression and microbiome/metagenome correlates of primary RSV infection that may inform pathogenic mechanisms associated with recurrent wheeze.
Hypotheses
Primary Hypothesis: Infants with recurrent wheeze following primary RSV infection will have a defined set of clinical, airway gene expression and/or airway microbiome/metagenome characteristics associated with a post bronchial wheezing phenotype.
Secondary Hypothesis 1: Respiratory epithelial innate immune responses to primary RSV infection, and their interaction with microbiome composition and functional processes, will identify biological mechanisms contributing to post bronchial wheeze.
This is a single center, prospective, case-control observational study. Full term (\>36 and 0/7 gestation) infants born after the prior RSV season of the prior year with primary RSV infection and no prior episodes of wheezing will be enrolled during their first RSV season from both outpatient and inpatient locations in Rochester New York. During the subsequent seasons of enrollment infants will meet the above eligibility requirements and also be tested and negative for acute infection with Severe Acute Respiratory Syndrome-Coronavirus-2.100 infants total with RSV infection will be enrolled with approximately 50 from the hospital and 50 from the Emergency Department (ED) or outpatient clinic in order to enroll infants with a range of severity, but with a focus on those presenting for medical care due to symptoms. Active surveillance for subsequent wheezing episodes will be conducted by phone/text/email follow-up every two weeks over the subsequent year, including a second full winter season for all subjects, beginning six weeks after the index illness. At the first report of subsequent wheezing a research clinic or home visit will be conducted to confirm the presence of wheezing by a trained staff member. Recurrent wheeze will be defined by two separate episodes of wheezing separated by at least 14 days with the first episode confirmed by study staff. In addition to this active surveillance, caregiver's will be asked to sign a medical records release for their child at the first visit that will cover the period of participation in the study. At the end of the study we will review each subject's medical records to determine if the child has had wheezing documented by a medical provider and not reported by the family. Once recurrent wheeze has been confirmed the subject will have reached an endpoint. At the end of the follow-up period the clinical and biological characteristics of participants with recurrent wheeze and those without recurrent wheeze will be compared.
### Conditions Module
**Conditions:**
- Respiratory Syncytial Virus Infection
**Keywords:**
- wheeze
### Design Module
#### Bio Spec
**Description:** Two anterior nasal swabs and a nasal brush. Samples retained only if agreed to by Legally Authorized Representative on Parent Permission form
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Infants with recurrent wheeze in the year following primary RSV infection
**Label:** Infants with recurrent wheeze
#### Arm Group 2
**Description:** Infants without recurrent wheeze in the year following primary RSV infection
**Label:** Infants without recurrent wheeze
### Outcomes Module
#### Primary Outcomes
**Description:** Recurrent wheezing documented by a medical provider following primary RSV infection
**Measure:** Medically confirmed recurrent wheeze
**Time Frame:** Follow-up for recurrent wheeze begins 6 weeks after the primary RSV infection and ends approximately one year later (including a subsequent RSv season).
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Signed informed consent by Legally Authorized Representative
2. Confirmed infection with RSV
3. Gestational age at birth 36 and 0/7 weeks or greater
4. No prior wheezing episodes
5. Negative for acute infection with SARS-CoV-2
6. First RSV season
Exclusion Criteria:
1. Underlying disease (immune, cardiopulmonary, neuromuscular, renal) that would qualify for palivizumab
2. Receiving immunosuppressive medications
3. Live greater than 35 miles from University of Rochester Medical Center
4. Parental inability to read or understand English
**Maximum Age:** 10 Months
**Minimum Age:** 3 Days
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** The study will enroll previously healthy infants born after 36 0/7 weeks gestation during their first RSV infection
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Rochester
**Country:** United States
**Facility:** University of Rochester Medical Center
**State:** New York
**Zip:** 14642-0001
#### Overall Officials
**Official 1:**
**Affiliation:** University of Rochester
**Name:** Mary T Caserta
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA, Auinger P, Griffin MR, Poehling KA, Erdman D, Grijalva CG, Zhu Y, Szilagyi P. The burden of respiratory syncytial virus infection in young children. N Engl J Med. 2009 Feb 5;360(6):588-98. doi: 10.1056/NEJMoa0804877.
**PMID:** 19196675
**Citation:** Turi KN, Shankar J, Anderson LJ, Rajan D, Gaston K, Gebretsadik T, Das SR, Stone C, Larkin EK, Rosas-Salazar C, Brunwasser SM, Moore ML, Peebles RS Jr, Hartert TV. Infant Viral Respiratory Infection Nasal Immune-Response Patterns and Their Association with Subsequent Childhood Recurrent Wheeze. Am J Respir Crit Care Med. 2018 Oct 15;198(8):1064-1073. doi: 10.1164/rccm.201711-2348OC.
**PMID:** 29733679
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014777
- Term: Virus Diseases
- ID: D000007239
- Term: Infections
- ID: D000018186
- Term: Pneumovirus Infections
- ID: D000018184
- Term: Paramyxoviridae Infections
- ID: D000018701
- Term: Mononegavirales Infections
- ID: D000012327
- Term: RNA Virus Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20494
- Name: Respiratory Syncytial Virus Infections
- Relevance: HIGH
- As Found: Respiratory Syncytial Virus Infections
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20330
- Name: Paramyxoviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M20778
- Name: Mononegavirales Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000018357
- Term: Respiratory Syncytial Virus Infections
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424782
**Brief Title:** Therapeutic Effect of the Natural Mineral Water of the Well B-308 OKK in Győr (Gyirmót) on Knee Osteoarthrosis
**Official Title:** Investigation of the Therapeutic Effect of the Natural Mineral Water of the Well B-308 OKK in Győr (Gyirmót) Among People With Knee Arthrosis (Randomized, Controlled, Double-blind, Follow-up Study)
#### Organization Study ID Info
**ID:** B-308 OKK
#### Organization
**Class:** OTHER
**Full Name:** University of Pecs
### Status Module
#### Completion Date
**Date:** 2026-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Gyirmót Sport & Wellness Hotel
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Pecs
#### 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 purpose of the study is to investigate the therapeutic effect of the thermal water of Győr (Gyirmót) well No. B-308 OKK on patients with knee arthrosis, and to compare its therapeutic effect with tap water (placebo) group.
**Detailed Description:** After being informed about the study and the potential risks, all patients giving written informed consent will undergo a continuous screening period, until the number of 25-25 patients is reached, to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to medicinal water or placebo group.
### Conditions Module
**Conditions:**
- Knee Osteoarthritis
**Keywords:**
- medicinal water
- healing water
- balneotherapy
- WOMAC
### 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:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants receive medicinal water treatment in bath tub once daily (30 min) on weekdays for 3 weeks.
**Intervention Names:**
- Other: medicinal water
**Label:** Medicinal water treatment
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants receive placebo water treatment in bath tub once daily (30 min) on weekdays for 3 weeks.
**Intervention Names:**
- Other: medicinal water
**Label:** Tap water (placebo) treatment
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Medicinal water treatment
- Tap water (placebo) treatment
**Description:** Medicinal water treatment in bath tub once daily.
**Name:** medicinal water
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Goniometer is a range of motion measuring device. Its measuring range is 180 degrees. Change = (Week 3 degree - Baseline degree), Change = (Week 12 degree - Baseline degree)
**Measure:** Change from the baseline in range of motion of the knee measured with goniometer at week 3 and 12
**Time Frame:** Baseline and week 3 and 12
**Description:** The test counts the number of times the patient comes to a full standing position in 30 seconds. Change = (Week 3 number - Baseline number), Change = (Week 12 number - Baseline number)
**Measure:** 30-second Chair Stand Test
**Time Frame:** Baseline and week 3 and 12
**Description:** It is a simple test that measures how quickly you can stand up, walk 3 meters, turn around, walk back, and sit down. It is done to assess mobility in older adults or predict their risk of falls. Many healthy adults less than 80 years old can complete the TUG test in 10 seconds or less. Change = (Week 3 seconds - Baseline seconds), Change = (Week 12 seconds - Baseline seconds)
**Measure:** Timed Up and Go (TUG)
**Time Frame:** Baseline and week 3 and 12
**Description:** The visual analogue scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. Change = (Week 3 point - Baseline point), Change = (Week 12 point - Baseline point)
**Measure:** Change from baseline in pain on the 10-point Visual Analogue Scale (VAS) at week 3 and 12
**Time Frame:** Baseline and week 3 and 12
**Description:** The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The WOMAC is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. Change = (Week 3 score - Baseline score), Change = (Week 12 score - Baseline score)
**Measure:** Change from baseline in functional status with the Western Ontario and McMaster Universities Arthritis Index (WOMAC) index at week 3 and 12
**Time Frame:** Baseline and week 3 and 12
**Description:** The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). Scores ranges from 0 to 100. Higher scores indicate higher quality of life. Change = (Week 3 score - Baseline score), Change = (Week 12 score - Baseline score)
**Measure:** Change from baseline in quality of life with the Short Form 36 Health Survey Questionnaire (SF-36) at week 3 and 12
**Time Frame:** Baseline and week 3 and 12
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Knee osteoarthrosis that has existed for at least 3 months
* Age between 50 and 80 years
* Willingness to participate in 3-week outpatient rehabilitation treatment
* Pain in the knee joint lasting at least 3 months and at least 5 days a week
* At least mild pain during selection (1 point on the Likert scale)
* Does not have a serious disability
Exclusion Criteria:
* Any kind of physiotherapy treatment in the last 2 months (except home gymnastics)
* Any previous knee joint surgery
* Any trauma to the knee or hip joint in the 1 year prior to the examination
* Knee arthroscopy performed within 3 months prior to the examination
* Intra-articular corticosteroid treatment of the affected knee in the last 3 months
* Palpable Baker's cyst
* Any hip joint or spine surgery within a year before the examination
* Intra-articular hyaluronic injection within 2 months before the examination
* Appearance of lumbar radiculopathy
* Presence of serious internal medicine disease, urogenital or other diseases
* Uncooperative or psychoneurotic patients
* Lumbago, sciatica; and any other surgery or previous fracture in the hip joint
* Subluxation, luxation, algodystrophy, fibromyalgia, gout
* Balneotherapy in the last 6 months
* Systemic corticosteroid treatment in 1 month before the examination
* Starting the treatment of osteoarthritis SYSADOA (symptomatic slow-acting drugs for osteoarthritis) in 3 months before the examination
**Maximum Age:** 80 Years
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Katalin Szendi, M.D., Ph.D.
**Phone:** +36702654095
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Pécs
**Country:** Hungary
**Facility:** Katalin Dr Szendi
**State:** Baranya
**Zip:** 7624
#### Overall Officials
**Official 1:**
**Affiliation:** University of Pecs
**Name:** Adrienn Hanzel, Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Data will be provided upon researcher request.
**Description:** The outcome measures as individual participant data can be shared. Outcome measures are the followings: range of motion, 30-second Chair Stand Test, Timed Up and Go (TUG), VAS scale, WOMAC index, SF-36 questionnaire
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** April 2025 - December 2025
### References Module
#### References
**Citation:** Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. doi: 10.1136/ard.2003.011742.
**PMID:** 14644851
**Citation:** Fernandes L, Hagen KB, Bijlsma JW, Andreassen O, Christensen P, Conaghan PG, Doherty M, Geenen R, Hammond A, Kjeken I, Lohmander LS, Lund H, Mallen CD, Nava T, Oliver S, Pavelka K, Pitsillidou I, da Silva JA, de la Torre J, Zanoli G, Vliet Vlieland TP; European League Against Rheumatism (EULAR). EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013 Jul;72(7):1125-35. doi: 10.1136/annrheumdis-2012-202745. Epub 2013 Apr 17.
**PMID:** 23595142
**Citation:** Kulisch A, Benko A, Bergmann A, Gyarmati N, Horvath H, Kranicz A, Mando ZS, Matan A, Nemeth A, Szakal E, Szanto D, Szekeres L, Bender T. Evaluation of the effect of Lake Heviz thermal mineral water in patients with osteoarthritis of the knee: a randomized, controlled, single-blind, follow-up study. Eur J Phys Rehabil Med. 2014 Aug;50(4):373-81. Epub 2014 Mar 5.
**PMID:** 24594851
**Citation:** Gyarmati N, Kulisch A, Nemeth A, Bergmann A, Horvath J, Mando Z, Matan A, Szakal E, Sasne Peter T, Szanto D, Bender T. Evaluation of the Effect of Heviz Mud in Patients with Hand Osteoarthritis: A Randomized, Controlled, Single-Blind Follow-Up Study. Isr Med Assoc J. 2017 Mar;19(3):177-182.
**PMID:** 28457097
**Citation:** Ayan C, Carvalho P, Varela S, Cancela JM. Effects of Water-Based Exercise Training on the Cognitive Function and Quality of Life of Healthy Adult Women. J Phys Act Health. 2017 Nov 1;14(11):899-904. doi: 10.1123/jpah.2017-0036. Epub 2017 Sep 25.
**PMID:** 28682652
**Citation:** Bender T, Balint G, Prohaszka Z, Geher P, Tefner IK. Evidence-based hydro- and balneotherapy in Hungary--a systematic review and meta-analysis. Int J Biometeorol. 2014 Apr;58(3):311-23. doi: 10.1007/s00484-013-0667-6. Epub 2013 May 16.
**PMID:** 23677421
**Citation:** Karagulle M, Kardes S, Karagulle MZ. Long-term efficacy of spa therapy in patients with rheumatoid arthritis. Rheumatol Int. 2018 Mar;38(3):353-362. doi: 10.1007/s00296-017-3926-8. Epub 2018 Jan 11.
**PMID:** 29327104
**Citation:** Peter I, Jagicza A, Ajtay Z, Boncz I, Kiss I, Szendi K, Kustan P, Nemeth B. Balneotherapy in Psoriasis Rehabilitation. In Vivo. 2017 Nov-Dec;31(6):1163-1168. doi: 10.21873/invivo.11184.
**PMID:** 29102940
**Citation:** Gutenbrunner C, Bender T, Cantista P, Karagulle Z. A proposal for a worldwide definition of health resort medicine, balneology, medical hydrology and climatology. Int J Biometeorol. 2010 Sep;54(5):495-507. doi: 10.1007/s00484-010-0321-5. Epub 2010 Jun 9.
**PMID:** 20532921
**Citation:** McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
**PMID:** 24462672
## 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: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12926
- Name: Osteoarthritis
- Relevance: HIGH
- As Found: Osteoarthritis
- ID: M22168
- Name: Osteoarthritis, Knee
- Relevance: HIGH
- As Found: Knee Osteoarthritis
- ID: M4476
- Name: Arthritis
- 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
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424769
**Acronym:** PROMOTE IBD
**Brief Title:** Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management
**Official Title:** Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management (PROMOTE IBD)
#### Organization Study ID Info
**ID:** 24-0699
#### Organization
**Class:** OTHER
**Full Name:** University of North Carolina, Chapel Hill
#### Secondary ID Infos
**Domain:** University of Pennsylvania
**ID:** 855107
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Pennsylvania
**Class:** FED
**Name:** Centers for Disease Control and Prevention
#### Lead Sponsor
**Class:** OTHER
**Name:** University of North Carolina, Chapel Hill
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to learn whether IBD patients have better disease outcomes and feel more empowered to manage their condition if they have access to text messaging with their clinical team and if their symptoms are more regularly monitored through text-based surveys.
Researchers will compare participants who have access to text-based monitoring, communication and education to participants who have access to text-based education alone. Researchers will also examine if different social and other non-medical factors impact IBD symptoms and quality of life.
All participants will:
* complete 5 brief on-line surveys over 12 months about their IBD and social risk factors,
* receive IBD education content by text message up to 2 times a week.
Some participants will also:
* receive additional surveys by text to monitor their IBD progression,
* have the opportunity to directly text message their IBD medical team.
**Detailed Description:** Crohn's disease (CD) and ulcerative colitis (UC), collectively referred to as inflammatory bowel diseases (IBD), are chronic diseases with no cure. Patient activation, defined as having the knowledge, skill, and confidence to manage one's health, can improve outcomes in chronic diseases, including IBD. Tailored digital health interventions can facilitate proactive longitudinal care for IBD patients by improving patient activation, promoting self-management and remote monitoring and can be automated and implemented at scale.
The researchers are conducting a multi-center, open-label, randomized clinical trial to evaluate the effectiveness of a tailored digital health intervention versus usual care to improve disease management and patient activation among teenage and adult patients with IBD. The researchers hypothesize the intervention will lead to higher patient activation, improved outcomes and quality of life and reduced health disparities among children and adults with IBD. Within the usual care arm, researchers will measure Social Determinants of Health at enrollment and evaluate associations between these factors and time spent in remission over a 1-year follow-up period.
Participants in both arms will complete electronic surveys at baseline and then quarterly thereafter for 12-months. The baseline survey will include: 1) basic demographic information, 2) social risk assessment (adapted from the Health-related Social Needs Screening Tool by the Centers for Medicare \& Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) National Health Interview Survey (NHIS) survey, this measure will be completed by the parent/guardian for pediatric participants), 3) patient reported outcomes for ulcerative colitis and Crohn's disease (PRO-2-UC or PRO-2-CD), 4) IBD-related quality of life (Short Inflammatory Bowel Disease Questionnaire (SIBDQ)), 5) IBD-related healthcare utilization, 6) IBD-related medication adherence and 7) patient activation measure (PAM Survey). All of these except demographic questions will be repeated at 12 months. Quarterly surveys at 3, 6, and 9 months will only include questions on IBD patient-reported outcomes and unplanned healthcare utilization (\~8 questions) with the addition of medication adherence questions and the PAM at 6-months (12 additional questions).
In addition to these patient-reported data, providers and research coordinator at each site will perform chart abstraction to identify specific clinical disease-level factors (including disease severity and phenotype) and treatment-level factors (prior and current therapies).
Participants in both arms will receive texts approximately twice a week containing curated educational content. All participants will receive usual clinical care per discretion of their treating provider and will maintain usual healthcare interactions with the clinical team using their preferred method of interaction including phone or electronic communications within their Electronic Health Record (EHR).
Participants assigned to the intervention arm will receive enhanced electronic health care delivered through text messaging. This includes short monthly check in surveys to assess IBD disease progression. Survey cadence will increase to weekly for 4 weeks at a time if a participant reports severe symptoms. This also includes the opportunity to communicate with their clinical team through text messaging.
Among participants assigned to the usual care arm of the pragmatic trial, a cohort analysis will evaluate associations between social risk and IBD natural history and outcomes.
### Conditions Module
**Conditions:**
- Inflammatory Bowel Diseases
- Crohn Disease
- Ulcerative Colitis
- Colitis
**Keywords:**
- Text Messaging
- Symptom Monitoring
- Social Risk Factors
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** After completing their baseline survey, consented participants will be randomized to usual care and intervention groups in a 2:1 allocation ratio. A computer-generated, centralized randomization with permuted block randomization within sites to ensure allocation concealment will be utilized.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 900
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive brief check-in surveys about their IBD symptoms minimally once a month, via text messaging. Participants will also receive IBD educational text messages twice each week.
**Intervention Names:**
- Other: Enhanced Digital Care
- Other: Education
**Label:** Enhanced Digital Care Arm
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Participants in this arm will receive IBD educational text messages twice each week.
**Intervention Names:**
- Other: Education
**Label:** Specialized Education Arm
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Enhanced Digital Care Arm
**Description:** Participants will receive brief check-in surveys about their IBD symptoms once a month, via text messaging. If the survey response indicates significant symptoms, an alert will be sent to the participant's IBD care team and participant will receive more frequent surveys (weekly) over the next month. Participants and their IBD clinical team will be able to communicate by text for non-emergency IBD-related questions.
**Name:** Enhanced Digital Care
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Enhanced Digital Care Arm
- Specialized Education Arm
**Description:** Participants will receive education texts about IBD from trusted sources approximately twice a week. Topics will include: diet, medication adherence, fatigue, preventative care and other relevant issues.
**Name:** Education
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The primary outcome is the change in patient activation from baseline, with a 4-point improvement on Patient Activation Measure (PAM) scale considered a minimal clinically important difference (MCID). Patient activation is an assessment of the knowledge, skills and confidence of patients to manage their health. In chronic diseases, activated patients are more likely to adhere to treatment, perform regular self-monitoring at home and obtain regular chronic care. Activated patients are also more likely to make healthier lifestyle choices and preventative behaviors. Longitudinal improvement in patient activation measures is associated with improved clinical outcomes, decreased unplanned healthcare utilization and lower costs.
**Measure:** Change in Patient Activation using PAM
**Time Frame:** Baseline, 12 months
#### Secondary Outcomes
**Description:** Proportion of participants achieving Patient Reported Outcome (PRO) remission without steroids at end of study (among participants with active disease at baseline). This will be assessed for ulcerative colitis patients based on the 2-point PRO2-UC and assessed for Crohn's disease patients using the 2-point PRO2-CD. The PRO2-UC consists of the stool frequency and rectal bleeding subscores of the Mayo Clinic Score, and remission is defined as absence of rectal bleeding (rectal bleeding score = 0) and normal or near normal stool frequency (stool frequency score ≤1). The PRO2-CD consists of the 2 Crohn's Disease Activity Index (CDAI) component items: daily stool frequency and abdominal pain, and remission is defined as mean daily score of abdominal pain score ≤1 and stool frequency score ≤3.
**Measure:** Remission at 52 Weeks
**Time Frame:** 12 months
**Description:** IBD-related quality of life will be measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), a validated, 10-item questionnaire which measures quality of life across physical, social and emotional domains in patients with IBD. The score on this questionnaire ranges from 10 to 70, with a minimal clinically important difference (MCID) of 9 points. This will be measured at baseline and at 12 months.
**Measure:** IBD-Related Quality of Life
**Time Frame:** up to 12 months
**Description:** Unplanned healthcare utilization (defined as IBD-related Emergency Department (ED) visit, hospitalization, or abdominal/perianal surgery for IBD) will be measured by self-report every 3 months (Baseline and months 3, 6, 9, and 12).
**Measure:** Unplanned Healthcare Utilization
**Time Frame:** up to 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 13+ years old with IBD (Crohn's disease, ulcerative colitis, indeterminant colitis).
* Followed at a participating site with an office visit (in-person or virtual) within the preceding 12 months.
* Have access to a mobile phone and willing and able to receive and respond to text messages.
* Willing to answer questions on electronic surveys.
* Have the ability to read text messages and answer surveys in English or Spanish.
Exclusion Criteria:
* IBD patients s/p surgery with a current pouch or ostomy.
* Unable to provide informed consent and child assent for minors.
**Minimum Age:** 13 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Michael D Kappelman, MD, MPH
**Phone:** 919-962-9900
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Margie E Boccieri, MA
**Phone:** 919-962-9900
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** San Diego
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Siddharth Singh, MD, MS
- **Phone:** 858-246-2544
- **Role:** CONTACT
**Country:** United States
**Facility:** University of California San Diego
**State:** California
**Zip:** 92093
**Location 2:**
**City:** San Francisco
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sabina Ali, MD
- **Phone:** 415-353-7337
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Sofia Verstraete, MD
- **Phone:** 510-428-3058
- **Role:** CONTACT
**Country:** United States
**Facility:** University of California San Francisco Benioff Children's Hospital
**State:** California
**Zip:** 94158
**Location 3:**
**City:** Atlanta
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Julia Liu, MD
- **Phone:** 404-756-1389
- **Role:** CONTACT
**Country:** United States
**Facility:** Morehouse School of Medicine
**State:** Georgia
**Zip:** 30310
**Location 4:**
**City:** Boston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sharmeel Wasan, MD
- **Role:** CONTACT
**Country:** United States
**Facility:** Boston Medical Center
**State:** Massachusetts
**Zip:** 02118
**Location 5:**
**City:** Lake Success
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Tuvia Marciano, DO
- **Phone:** 516-663-4939
- **Role:** CONTACT
**Country:** United States
**Facility:** NYU Langone Health Lake Success
**State:** New York
**Zip:** 11042
**Location 6:**
**City:** Chapel Hill
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Micheal D Kappelman, MD, MPH
- **Phone:** 919-962-9900
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Edward Barnes, MD
- **Phone:** 919-962-9900
- **Role:** CONTACT
**Country:** United States
**Facility:** UNC-Chapel Hill School of Medicine
**State:** North Carolina
**Zip:** 27599
**Location 7:**
**City:** Charlotte
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** TIffany Linville, MD
- **Phone:** 704-381-8840
- **Role:** CONTACT
**Country:** United States
**Facility:** Atrium Health Levine Children's
**State:** North Carolina
**Zip:** 28203
**Location 8:**
**City:** Philadelphia
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Meenakshi Bewtra, MD, PhD, MPH
- **Phone:** 215-746-4922
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Pennsylvania
**State:** Pennsylvania
**Zip:** 19104
#### Overall Officials
**Official 1:**
**Affiliation:** University of North Carolina, Chapel Hill
**Name:** Michael D Kappelman, MD, MPH
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
**Description:** Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
**IPD Sharing:** YES
**Time Frame:** From 9 months after the end of the trial and publication of study results to up to 36 months.
### References Module
#### References
**Citation:** Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of Inflammatory Bowel Disease Among Adults Aged >/=18 Years - United States, 2015. MMWR Morb Mortal Wkly Rep. 2016 Oct 28;65(42):1166-1169. doi: 10.15585/mmwr.mm6542a3.
**PMID:** 27787492
**Citation:** Singh S, Qian AS, Nguyen NH, Ho SKM, Luo J, Jairath V, Sandborn WJ, Ma C. Trends in U.S. Health Care Spending on Inflammatory Bowel Diseases, 1996-2016. Inflamm Bowel Dis. 2022 Mar 2;28(3):364-372. doi: 10.1093/ibd/izab074.
**PMID:** 33988697
**Citation:** Baumgart DC, Le Berre C. Newer Biologic and Small-Molecule Therapies for Inflammatory Bowel Disease. N Engl J Med. 2021 Sep 30;385(14):1302-1315. doi: 10.1056/NEJMra1907607. No abstract available.
**PMID:** 34587387
**Citation:** Liu JJ, Abraham BP, Adamson P, Barnes EL, Brister KA, Damas OM, Glover SC, Hooks K, Ingram A, Kaplan GG, Loftus EV, McGovern DPB, Narain-Blackwell M, Odufalu FD, Quezada S, Reeves V, Shen B, Stappenbeck TS, Ward L. The Current State of Care for Black and Hispanic Inflammatory Bowel Disease Patients. Inflamm Bowel Dis. 2023 Feb 1;29(2):297-307. doi: 10.1093/ibd/izac124.
**PMID:** 35816130
**Citation:** Afzali A, Cross RK. Racial and Ethnic Minorities with Inflammatory Bowel Disease in the United States: A Systematic Review of Disease Characteristics and Differences. Inflamm Bowel Dis. 2016 Aug;22(8):2023-40. doi: 10.1097/MIB.0000000000000835.
**PMID:** 27379446
**Citation:** Barnes EL, Loftus EV Jr, Kappelman MD. Effects of Race and Ethnicity on Diagnosis and Management of Inflammatory Bowel Diseases. Gastroenterology. 2021 Feb;160(3):677-689. doi: 10.1053/j.gastro.2020.08.064. Epub 2020 Oct 21.
**PMID:** 33098884
**Citation:** Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
**PMID:** 15230939
**Citation:** Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.
**PMID:** 23381511
**Citation:** Anderson G, Rega ML, Casasanta D, Graffigna G, Damiani G, Barello S. The association between patient activation and healthcare resources utilization: a systematic review and meta-analysis. Public Health. 2022 Sep;210:134-141. doi: 10.1016/j.puhe.2022.06.021. Epub 2022 Aug 12.
**PMID:** 35970015
**Citation:** Barnes EL, Long MD, Kappelman MD, Martin CF, Sandler RS. High Patient Activation Is Associated With Remission in Patients With Inflammatory Bowel Disease. Inflamm Bowel Dis. 2019 Jun 18;25(7):1248-1254. doi: 10.1093/ibd/izy378.
**PMID:** 30590700
**Citation:** Haj O, Lipkin M, Kopylov U, Sigalit S, Magnezi R. Patient activation and its association with health indices among patients with inflammatory bowel disease. Therap Adv Gastroenterol. 2022 Oct 6;15:17562848221128757. doi: 10.1177/17562848221128757. eCollection 2022.
**PMID:** 36225610
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005759
- Term: Gastroenteritis
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000003108
- Term: Colonic 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: M17206
- Name: Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M6638
- Name: Crohn Disease
- Relevance: HIGH
- As Found: Crohn's Disease
- ID: M17917
- Name: Inflammatory Bowel Diseases
- Relevance: HIGH
- As Found: Inflammatory Bowel Disease
- ID: M10444
- Name: Intestinal Diseases
- Relevance: HIGH
- As Found: Bowel Disease
- ID: M6320
- Name: Colitis
- Relevance: HIGH
- As Found: Colitis
- ID: M6321
- Name: Colitis, Ulcerative
- Relevance: LOW
- As Found: Unknown
- ID: M8875
- Name: Gastroenteritis
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003424
- Term: Crohn Disease
- ID: D000003092
- Term: Colitis
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000015212
- Term: Inflammatory Bowel Diseases
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424756
**Brief Title:** Effects of an Antioxidant Supplement on Blood Vessel Health
**Official Title:** Role of Mitochondria-derived Oxidative Stress on Microvascular Endothelial Function in Healthy Non-Hispanic Black and White Adults
#### Organization Study ID Info
**ID:** PROJECT00009286
#### Organization
**Class:** OTHER
**Full Name:** University of Georgia
### Status Module
#### Completion Date
**Date:** 2030-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2030-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** S. Tony Wolf
#### Responsible Party
**Investigator Affiliation:** University of Georgia
**Investigator Full Name:** S. Tony Wolf
**Investigator Title:** Assistant Professor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Cardiovascular disease (CVD) is a leading cause of morbidity and mortality worldwide, and the non-Hispanic Black (NHB) population is disproportionately affected. Our research has previously demonstrated that oxidative stress may contribute to reduced vascular function in otherwise healthy NHB adults, potentially predisposing them to the development of hypertension and CVD. This study is designed to examine whether the mitochondria are an important source of oxidative stress-induced vascular dysfunction in healthy NHB adults.
### Conditions Module
**Conditions:**
- Healthy
**Keywords:**
- Vascular dysfunction
- Cardiovascular disease
- Hypertension
- Nitric oxide
- Endothelial function
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** For the experimental visits, participants will receive an antioxidant supplement in capsule form or a matching placebo pill in a randomized, double-blinded, crossover fashion. During each visit, participants will be given a single dose of the treatment to which they are randomized upon arrival at the laboratory (i.e., either 80 mg MitoQ or placebo will be administered on Visit 3, and the other treatment will be given on Visit 4). Peak concentrations of the antioxidant (MitoQ) occur after approximately 1 hour, allowing for appropriate time to prepare the participant for the experimental procedures.
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will be given a single dose of 80mg MitoQ supplement first following an overnight fast. Then they will receive a matched Placebo single dose within a minimum 14 days
**Intervention Names:**
- Dietary Supplement: MitoQ
- Dietary Supplement: Placebo
**Label:** MitoQ, then Placebo
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will be given a single dose of Placebo (matched to 80mg MitoQ) first following an overnight fast. Then they will receive 80mg MitoQ supplement single dose within a minimum of 14 days
**Intervention Names:**
- Dietary Supplement: MitoQ
- Dietary Supplement: Placebo
**Label:** Placebo, then MitoQ
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MitoQ, then Placebo
- Placebo, then MitoQ
**Description:** MitoQ supplement is composed of mitoquinol mesylate, which is a synthetic analog of coenzyme Q10
**Name:** MitoQ
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- MitoQ, then Placebo
- Placebo, then MitoQ
**Description:** MitoQ matched Placebo
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Using intradermal microdialysis, skin blood vessels will be locally treated with a mitochondria-targeted antioxidant (MitoTempo; 1 mM concentration). Nitric oxide (NO)-mediated skin vasodilation will be quantified via local inhibition of endothelial NO synthase during the course of the local skin heating protocol using L-NAME (15 mM concentration). Finally, maximal skin blood flow will be measured by heating the local area of skin to 43 degrees Celsius and locally perfusing sodium nitroprusside (SNP; an NO donor; 28 mM concentration). Two (2) thin fiber optic laser Doppler flowmeter probes and their holders, containing local heaters, will be used to measure skin blood flow.
**Measure:** Cutaneous microvascular responses to local heating
**Time Frame:** 1 hour post intervention
**Description:** FMD measures the health of blood vessels. The ultrasound makes sound waves to measure the size of blood vessels and the speed of the blood during rest and occlusion. The cuff is inflated to 220 mmHg (a commonly-used suprasystolic pressure; i.e., arterial blood flow is completely occluded) for 5 minutes to stop blood flow to and from the forearm.
**Measure:** Flow-mediated dilation responses
**Time Frame:** 1 hour post intervention
**Description:** Blood will be drawn for isolation of PBMCs and measurement of mitochondrial function and oxidative stress production.
**Measure:** Mitochondrial ROS production in peripheral blood mononuclear cells (PBMCs)
**Time Frame:** 1 hour post intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Self-identify as either non-Hispanic Black or non-Hispanic White.
* Men and women 18-60 years old.
* Non-hypertensive (systolic blood pressure \[SBP\]\<130 and diastolic blood pressure \[DBP\] \<85 mmHg).
* Have low density lipoprotein cholesterol \<150mg/dl.
* Have HbA1C \<6.0%.
Exclusion Criteria:
* Rash, skin disease, or disorders of pigmentation (e.g., psoriasis, eczema, vitiligo, or other skin inflammatory skin disorders)
* Known skin allergies to latex or adhesives
* Smoking and/or use of nicotine-containing products within the past year
* Use of illegal/recreational drugs
* Generalized kidney disease
* Taking chloramphenicol, cholestyramine, medication for seizures, methotrexate, nitrofurantoin, tetracycline, barbiturates, steroids, phenobarbital/phenytoin, orlistat or pyrimethamine
* Any current medications which could conceivably alter the cardiovascular control or responses
* Diagnosed or suspected metabolic or cardiovascular disease
* Current pregnancy or breastfeeding
* History of skin or other cancers
* Diagnosed or suspected diabetes (HbA1c ≥6.0)
* Anybody with narcolepsy or who has been diagnosed with any condition that impairs body temperature regulation.
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** S. Tony Wolf
**Phone:** 706-542-4378
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Melissa Gorejena
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M17201
- Name: Ubiquinone
- Relevance: LOW
- As Found: Unknown
- ID: M271049
- Name: Coenzyme Q10
- Relevance: LOW
- As Found: Unknown
- ID: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
- ID: M12507
- Name: Nitric Oxide
- Relevance: LOW
- As Found: Unknown
- ID: T383
- Name: Coenzyme Q10
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424743
**Brief Title:** Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training
**Official Title:** Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training: Clinical Trial Randomized Crossover
#### Organization Study ID Info
**ID:** UFRNpreference
#### Organization
**Class:** OTHER
**Full Name:** Universidade Federal do Rio Grande do Norte
### Status Module
#### Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Universidade Federal do Rio Grande do Norte
#### Responsible Party
**Investigator Affiliation:** Universidade Federal do Rio Grande do Norte
**Investigator Full Name:** Marcelo Cardoso de Souza, PT, PhD.
**Investigator Title:** PT, PhD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Fibromyalgia is a painful syndrome of unknown etiology, which affects 2% of world population, with symptoms such as: pain, unrefreshing sleep, fatigue and mood disorders. It is already established in the literature that resistance training is part of the non- pharmacological treatment for patients with fibromyalgia. The big gap is about the quantity adequate and/or recommended exercise volume, despite some studies with exercise volumes different resistance trainings show improvements, we do not have a direction, besides We still do not know whether there is a preference for these patients in different resistance training volumes.
**Detailed Description:** Objective: Assess training volume preference resisted in women with fibromyalgia.
Method: Crossover randomized clinical trial, randomized and blind. 36 women with fibromyalgia will be evaluated, who will undergo three resistance training programs with different training volumes. The primary outcome will be patient preference in relation to training volumes, and the secondary ones will be the patient expectation, pain intensity, affect and subjective perception of exertion.
Analysis statistics: For the primary outcome preference, the number of choices will be counted of the 3 types of training in percentage form. Regarding the analysis of the primary outcome we will summarize the patient's preference in a contingency table, we will compare the proportions using the Chi-square test, and finally we will check the effect size of the observed differences. For secondary outcomes, statistical analyzes will be performed by a blind statistician using commercial software. The Kolmogorov-Smirnov test will be applied to verify the distribution of data and Levene's test will be used to analyze the homogeneity of variance. The Bonferroni test will be used in post hoc analyzes to determine whether there are differences between the groups at different intervention times. One 5% significance level and 95% CI will be adopted for all statistical analyses. ethic and dissemination: The results of the study will be disseminated to participants and subjected to a peer-reviewed journal and scientific meetings.
### Conditions Module
**Conditions:**
- Fibromyalgia, Primary
- Chronic Pain
- Exercise Addiction
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Patients will be allocated to 1 of three groups: 1 set, 2 sets, or 3 sets of resistance exercise. In the next sessions they will be allocated to the series he has not performed yet.
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Training A Bench press, Pull front, Leg press and seated flexor
1 series 10 repetitions with 60% 1RM, 2' minute interval
**Intervention Names:**
- Other: exercise
**Label:** 1 set
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Training B Bench press, Pull front, Leg press and seated flexor 2 series 10 repetitions with 60% 1RM, 2' minute interval
**Intervention Names:**
- Other: exercise
**Label:** 2 sets
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Training C Bench press, Pull front, Leg press and seated flexor 3 series 10 repetitions with 60% 1RM, 2' minute interval
**Intervention Names:**
- Other: exercise
**Label:** 3 sets
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 1 set
- 2 sets
- 3 sets
**Description:** exercise programs with different volumes
**Name:** exercise
**Other Names:**
- resistance exercises
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Preference will be assessed through the following question: "After carrying out the training sessions, which one did you prefer? Why?".
**Measure:** Choose one of the workouts according to your preference
**Time Frame:** 28 day
#### Secondary Outcomes
**Description:** The Likert Scale will be used for expectations in relation to treatment. That scale aims to assess the participant's expectations at the beginning of the study in relation to the treatment they will receive with the following questions: • "Do you think that by starting the training session with 1 set, you will: (1) get much worse, (2) get a little worse, (3) neither get better nor get worse (4) get better little and (5) improve a lot".
* "Do you think that by starting the training session with 2 sets, you will: (1) get much worse, (2) get a little worse, (3) neither get better nor get worse (4) get better little and (5) improve a lot".
* "Do you think that by starting the training session with 3 sets, you will: (1) get much worse, (2) get a little worse, (3) neither get better nor get worse (4) get better little and (5) improve a lot".
**Measure:** Change in Expectation
**Time Frame:** baseline
**Description:** Generalized pain intensity will be assessed using the Numerical Pain Scale (END), a self-report instrument validated for Portuguese. END has a sequence of numbers (from 0 to 10), where 0 represents "no pain" and 10 represents "the worst pain that you can imagine."
**Measure:** Change in Pain intensity
**Time Frame:** baseline, 28 day
**Description:** Affect scale will monitor pleasure or displeasure during the three resistance training will be carried out through the application of the affective valence scale (VA).
The scale is quantified as follows: +5 to -5, corresponding, respectively, to the two antagonistic descriptors of feelings during physical exercise and/or physical activity, which may be: "very good" and "very bad".
**Measure:** Change in Affection
**Time Frame:** baseline, 28 day
**Description:** The quantification of the intensity of each resistance training session will be determined using the session's subjective perception of exertion (RPE) method
. To this end, the following question: "How was your training session?" The answer will be provided, as recommended, 30 min after the end of the session, based on an adapted Borg scale.
**Measure:** Change in Subjective perception of exertion
**Time Frame:** baseline, 28 day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Women aged 18 to 65
* Have a diagnosis of fibromyalgia according to the ACR 2016 criteria
Exclusion Criteria:
* Have performed resistance training in the last 6 months
* Having another associated rheumatic condition
* Have a trip or appointment scheduled that requires absence for the next 4 (four) weeks from the start of the survey;
* Women with musculoskeletal injuries in the upper and/or lower limbs
* Have heart problems that prevent maximal efforts and submaximums
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Marcelo C de Souza, PT, PhD
**Phone:** 55849994806892
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Natal
**Country:** Brazil
**Facility:** Marcelo Cardoso de Souza
**State:** RN
**Zip:** 59200-000
### IPD Sharing Statement Module
**Description:** there is not a plan to make individual participant data (IPD) available to other researchers.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Silva HJA, Assuncao Junior JC, de Oliveira FS, Oliveira JMP, Figueiredo Dantas GA, Lins CAA, de Souza MC. Sophrology versus resistance training for treatment of women with fibromyalgia: A randomized controlled trial. J Bodyw Mov Ther. 2019 Apr;23(2):382-389. doi: 10.1016/j.jbmt.2018.02.005. Epub 2018 Feb 12.
**PMID:** 31103124
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
- ID: D000009468
- Term: Neuromuscular 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: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M29442
- Name: Chronic Pain
- Relevance: HIGH
- As Found: Chronic Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M8486
- Name: Fibromyalgia
- Relevance: HIGH
- As Found: Fibromyalgia
- ID: M12161
- Name: Myofascial Pain Syndromes
- Relevance: HIGH
- As Found: Fibromyalgia
- ID: M19100
- Name: Behavior, Addictive
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005356
- Term: Fibromyalgia
- ID: D000009209
- Term: Myofascial Pain Syndromes
- ID: D000059350
- Term: Chronic Pain
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424730
**Brief Title:** Team Based Equity Conscious Telemedicine Approach to Hypertension
**Official Title:** Team Based Equity Conscious Telemedicine Approach to Improve Hypertension Among Black Patients
#### Organization Study ID Info
**ID:** IRB00113617
#### Organization
**Class:** OTHER
**Full Name:** Wake Forest University Health Sciences
### Status Module
#### Completion Date
**Date:** 2026-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-04
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Wake Forest University Health Sciences
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of study is to understand the different factors (patient, societal, provider, clinic, health system) relevant in recruitment and participation of patients in Team Based Equity Conscious Telemedicine Approach to Improve Hypertension clinical trial.
**Detailed Description:** Black patients suffer disproportionate hypertension (HTN) burden with worse control, resulting in HTN-related mortality rates twice those observed in non-Hispanic White patients. Contextually informed care approach is urgently needed in Black patients for HTN management. This study will evaluate multi-level barriers and facilitators for recruitment and participation of Black patients in a Team Based Equity Conscious Telemedicine Approach to Improve Hypertension (TET-HTN) clinical trial. This study will also evaluate the feasibility of TET-HTN intervention in a randomized comparison with usual clinic-based hypertension care approach.
### Conditions Module
**Conditions:**
- Hypertension
**Keywords:**
- high blood pressure
- telemedicine
- African-American
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This study has two main objectives. First, to evaluate multi-level barriers and facilitators for recruitment and participation of Black patients in a TET-HTN clinical trial (Aim 1). Second objective is to evaluate the feasibility of TET-HTN intervention in a randomized comparison with usual clinic-based hypertension care approach (Aim 2).
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 84
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Black patients or their family members; Black community faith leaders; primary care providers and research coordinators
**Intervention Names:**
- Other: Feasibility Interview
**Label:** Interview Group
**Type:** OTHER
#### Arm Group 2
**Description:** Black patients with systolic blood pressure \>140 mmHg on the last two clinic visits plus baseline systolic blood pressure \>130 mmHg - deliver the TET-HTN intervention over six months
**Intervention Names:**
- Behavioral: Team Based Equity Conscious Telemedicine Hypertension Intervention
**Label:** Team based Equity conscious Telemedicine Hypertension (TET-HTN) intervention
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Black patients with systolic blood pressure \>140 mmHg on the last two clinic visits plus baseline systolic blood pressure \>130 mmHg - usual clinic based hypertension care using routinely available clinic services including community health worker/social worker. Clinicians can offer self-management support (e.g., dietician referral) or recommend a home blood pressure monitor. These activities mirror current primary care practice.
**Intervention Names:**
- Behavioral: Usual Care
**Label:** Usual Care
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Interview Group
**Description:** One audio-recorded interview with the participants lasting about 30-minutes
**Name:** Feasibility Interview
**Other Names:**
- One audio-recorded interview
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Team based Equity conscious Telemedicine Hypertension (TET-HTN) intervention
**Description:** Will provide blood pressure monitor connected to a telehealth application. Patients will be asked to measure home blood pressure once daily. Will intensify medications as needed based on blood pressure measurement. Trained nurses or pharmacists will provide 4 self-management telephone calls (up to 30 minutes per call) to patients to address hypertension knowledge, medication adherence, healthy eating, physical activity, weight management, stress management, tobacco and alcohol use, and sleep apnea (with referrals if needed). Will support needs relevant in blood pressure control using locally available resources via community health worker and social workers.
**Name:** Team Based Equity Conscious Telemedicine Hypertension Intervention
**Other Names:**
- Team based Equity conscious Telemedicine Hypertension (TET-HTN) intervention
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- Usual Care
**Description:** Usual clinic based hypertension care using routinely available clinic services including community health worker/social worker. Clinicians can offer self-management support (e.g., dietician referral) or recommend a home blood pressure monitor. These activities mirror current primary care practice.
**Name:** Usual Care
**Other Names:**
- Standard of Care
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Number of clinic, urgent care and emergency department visits
**Measure:** Number of Emergency Department and Urgent Care Visits
**Time Frame:** Month 6
**Description:** Patient self-reported home BP monitor use
**Measure:** Number of Subjects using Blood Pressure Monitors
**Time Frame:** Month 6
#### Primary Outcomes
**Description:** Evaluate multi-level barriers and facilitators for recruitment and participation of Black patients in a Team based Equity conscious Telemedicine (TET-HTN) clinical trial - will be reported as themes from thematic analysis of qualitative data
**Measure:** Barriers / Facilitators for Recruitment
**Time Frame:** Day 1
**Description:** Evaluate the feasibility of Team Based Equity Conscious Telemedicine Hypertension intervention in a randomized comparison with usual clinic-based hypertension care. Feasibility will be measured using the proportion of patients screened, eligible, agree to participate and decline.
**Measure:** Feasibility of Telemedicine Approach - Proportion of Subjects
**Time Frame:** Month 6
#### Secondary Outcomes
**Description:** Changes in Systolic and Diastolic Blood Pressure
**Measure:** Change in Blood Pressure
**Time Frame:** Month 6
**Description:** Medication adherence using the Proportion of Days Covered
**Measure:** Percentage of Medication adherence
**Time Frame:** Month 6
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* African American or Black
* Patients with last clinic systolic Blood Pressure \>140 mmHg or diastolic Blood Pressure \>90 mmHg or both
Exclusion Criteria:
* Unable to read or speak English
* diminished ability to measure home BP (dementia, or psychosis)
* acute health changes in past 3 months increasing chance of BP instability (hospitalization);
* terminal illness.
**Maximum Age:** 100 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sunit Chhetri
**Phone:** 336-716-9309
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Winston-Salem
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sunet Chhetri
- **Phone:** 336-716-9309
- **Role:** CONTACT
**Country:** United States
**Facility:** Wake Forest University Health Sciences
**State:** North Carolina
**Zip:** 27157
#### Overall Officials
**Official 1:**
**Affiliation:** Wake Forest University Health Sciences
**Name:** Yashashwi Pokharel, MD, MSCR
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Hypertension
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006973
- Term: Hypertension
### Intervention Browse Module - Browse Branches
- Abbrev: 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: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424717
**Brief Title:** Study of Avelumab and Tuvusertib in Participants With Advanced Urothelial Cancer That Has Progressed on Prior Anti-PD-(L)1 Therapy (JAVELIN DDRiver Bladder)
**Official Title:** A Single Arm, Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Avelumab in Combination With the ATR Inhibitor Tuvusertib in Participants With Advanced Urothelial Carcinoma That Has Progressed on Prior Anti-PD-(L)1 Therapy (JAVELIN DDRiver Bladder)
#### Organization Study ID Info
**ID:** MS202611_0001
#### Organization
**Class:** INDUSTRY
**Full Name:** EMD Serono
#### Secondary ID Infos
**Domain:** EU CT Number
**ID:** 2024-511203-42-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-01-27
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-01-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-29
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### 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
### Description Module
**Brief Summary:** The purpose of this study is to assess the antitumor activity of avelumab in combination with tuvusertib in terms of objective response in participants with advanced urothelial carcinoma. Study details include:
Condition/Disease: Participants with urothelial carcinoma (locally advanced and unresectable, or metastatic) that has progressed on prior anti-PD-(L)1 therapy Treatment Duration: Participants will be treated until progressive disease, death, or discontinuation due to e.g. withdrawal of consent or lost to follow-up Visit Frequency: While receiving study intervention, participants will visit the site twice per every 21-day study intervention period. 1 week after end of study intervention, participants will visit the site for an End of Study Intervention Visit, followed by 2 Safety Follow-Up visits at 1 and 3 months after last dose, and thereafter have remote Long-Term Follow-up every 3 months.
Study Duration: The overall study is planned to close after the last participant has been followed up for at least 12 months.
### Conditions Module
**Conditions:**
- Urothelial Carcinoma
**Keywords:**
- M1774
- locally advanced and unresectable or metastatic urothelial carcinoma
- bladder cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Avelumab
- Drug: Tuvusertib
**Label:** Avelumab with tuvusertib
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Avelumab with tuvusertib
**Description:** Participants will be administered Avelumab intravenously (IV).
**Name:** Avelumab
**Other Names:**
- MSB0010718C
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Avelumab with tuvusertib
**Description:** Participants will be administered Tuvusertib orally.
**Name:** Tuvusertib
**Other Names:**
- M1774
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Confirmed Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 as Assessed by Investigator in Participants with Selected Tumor Chromatin Modifier Mutations
**Time Frame:** Up to 18 months
#### Secondary Outcomes
**Measure:** Confirmed Objective Response (OR) According to RECIST v1.1 as Assessed by Investigator
**Time Frame:** Up to 18 months
**Measure:** Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator
**Time Frame:** Up to 18 months
**Measure:** Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator
**Time Frame:** Up to 18 months
**Measure:** Overall Survival (OS)
**Time Frame:** From the date of randomization until death, assessed up to 1.5 years
**Measure:** Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs
**Time Frame:** Up to 18 months
**Measure:** Confirmed Objective Response (OR) According to RECIST v1.1 as Assessed by Investigator in Subpopulations as Defined by Selected Tumor Biomarkers
**Time Frame:** Up to 18 months
**Measure:** Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator in Subpopulations as Defined by Selected Tumor Biomarkers
**Time Frame:** Up to 18 months
**Measure:** Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator in Subpopulations as Defined by Selected Tumor Biomarkers
**Time Frame:** Up to 18 months
**Measure:** Overall Survival (OS) in Subpopulations as Defined by Selected Tumor Biomarkers
**Time Frame:** From the date of randomization until death, assessed up to 1.5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Histologically confirmed, locally advanced, and unresectable or metastatic urothelial carcinoma.
* No more than 2 lines of therapy for advanced disease. Chemotherapy followed by avelumab (switch maintenance) counts as 1 line of therapy. Additionally, (neo)-adjuvant chemotherapy for Muscle invasive bladder cancer with recurrence or progression within 12 months of last dose, counts as a line of therapy.
* Measurable disease by RECIST 1.1, as assessed by the Investigator.
* Eastern Cooperative Oncology Group Performance status 0 to 1.
* Adequate hematologic function as indicated by:
* Platelet count more than or equal to 100,000 per microliter
* Absolute neutrophil count more than or equal to 1,500 per microliter with no growth factor treatment within the last 14 days
* Hemoglobin more than or equal to 9.0 gram/deciliter with no erythropoietin or red blood cell transfusion within the last 14 days
* Only one line of an antibody-drug conjugate (ADC) is allowed.
* Other protocol defined inclusion criteria could apply.
Exclusion Criteria:
* Any condition, including any uncontrolled disease state other than aUC, that in the Investigator's opinion constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation.
* Any known additional malignancy that is progressing and/or requires active treatment including adjuvant hormonal therapy.
* Presence of brain metastases unless clinically stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study intervention and any neurologic symptoms have returned to baseline and sequelae that are a consequence of the treatment of the brain metastases are acceptable), no evidence of new brain metastases, and on a stable or decreasing dose or without steroids for at least 14 days prior to first dose of study intervention. Participants with carcinomatous meningitis are excluded regardless of clinical stability.
* Serious gastrointestinal bleeding within 3 months, refractory nausea and vomiting, uncontrolled diarrhea, known malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes, other chronic gastrointestinal disease (including exocrine pancreatic insufficiency requiring pancreatic enzyme replacement therapy), and/or other situations that may preclude adequate absorption of oral medications.
* Other protocol defined exclusion criteria could apply.
**Minimum Age:** 18 Years
**Sex:** ALL
**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: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5030
- Name: Urinary Bladder Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5551
- Name: Carcinoma, Transitional Cell
- Relevance: HIGH
- As Found: Urothelial Carcinoma
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: T5693
- Name: Transitional Cell Carcinoma
- Relevance: HIGH
- As Found: Urothelial Carcinoma
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000002295
- Term: Carcinoma, Transitional Cell
### Intervention Browse Module - Ancestors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M344580
- Name: Avelumab
- Relevance: HIGH
- As Found: Reach
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000609138
- Term: Avelumab
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424704
**Brief Title:** Chronic Suppurative Otitis Media Microbiology
**Official Title:** Microbiology of Chronic Suppurative Otitis Media: Prospective Study
#### Organization Study ID Info
**ID:** 2024/145
#### Organization
**Class:** OTHER
**Full Name:** Selcuk University
### Status Module
#### Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Selcuk University
#### Responsible Party
**Investigator Affiliation:** Selcuk University
**Investigator Full Name:** Bulent Ulusoy
**Investigator Title:** Selcuk University Faculty of Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study is planned to reveal the microbiological agents and drug sensitivities to these agents in patients diagnosed with chronic suppurative otitis media who complain of ear discharge.
**Detailed Description:** Patients with complaints of ear discharge and who were diagnosed with chronic suppurative otitis media will be included in the study. Patients will be divided into two groups: CSOM with cholesteatoma and CSOM without cholesteatoma. One hundred ten patients from each group will be included in the study. After a comprehensive medical history is taken for each patient, the patient's external auditory canal will be cleaned with sterile aspirators. A sterile culture will be taken from the discharge of the ear and sent to microbiology. With the data obtained from microbiological examination, pathogens will be classified as gram-positive, gram-negative, anaerobic, and fungal and examined according to monomicrobial and polymicrobial growth. Antibiotic susceptibility tests will be conducted to determine the effectiveness of antibiotics against the bacteria causing the infection.
### Conditions Module
**Conditions:**
- Otitis Media, Suppurative Chronic
- Cholesteatoma
- Microbial Colonization
**Keywords:**
- Chronic suppurative otitis media
- Cholesteatoma
- Ear discharge
### Design Module
#### Bio Spec
**Description:** Culture samples taken from the ears of patients with chronic suppurative otitis media with cholesteatoma and chronic suppurative otitis media without cholesteatom.
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 110
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 6 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients who applied to Selçuk University Faculty of Medicine Hospital, Department of Ear, Nose and Throat Diseases \& Head and Neck Surgery with complaints of ear discharge and were diagnosed with chronic suppurative otitis media with cholesteatoma were included in the study.
**Intervention Names:**
- Diagnostic Test: Microbiological culture
**Label:** Chronic suppurative otitis media with cholesteatoma (Chole)
#### Arm Group 2
**Description:** The study included patients who applied to Selçuk University Faculty of Medicine Hospital, Department of Ear, Nose and Throat Diseases \& Head and Neck Surgery, with complaints of ear discharge and were diagnosed with chronic suppurative otitis media without cholesteatoma.
**Intervention Names:**
- Diagnostic Test: Microbiological culture
**Label:** Chronic suppurative otitis media without cholesteatoma (CSOM)
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Chronic suppurative otitis media with cholesteatoma (Chole)
- Chronic suppurative otitis media without cholesteatoma (CSOM)
**Description:** Samples taken from chronic suppurative otitis media patients in the Medical Microbiology Laboratory of Selçuk University Faculty of Medicine will be planted in 5% sheep blood Columbia agar, eosin methylene blue agar and saboraud dextrose agar, and the media will be incubated at 37oC for 24-48 hours. Growing bacteria and fungi were examined using traditional methods \[Gram staining, catalase test, coagulase test, bacitracin disk, PYR test (L-pyrrolidonyl-β-naphthylamide), oxidase test, IMViC test, lactophenol cotton blue, etc.\] and VITEK 2 (bioMerieux, France).
**Name:** Microbiological culture
**Other Names:**
- Antibiotic susceptibility tests will be performed with the Kirby Bauer disc diffusion test and VITEK2 automated system (bioMerieux, France).
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Microbiology in patients diagnosed with chronic suppurative otitis media with and without cholesteatoma
**Measure:** Microbiology of chronic suppurative otitis media
**Time Frame:** 2024-2026 (24 months)
#### Secondary Outcomes
**Description:** Investigation of antibiotic susceptibility and resistance in patients diagnosed with chronic suppurative otitis media with and without cholesteatoma.
**Measure:** Antibiotic susceptibility in chronic suppurative otitis media
**Time Frame:** 2024-2026 (24 months)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients diagnosed with chronic suppurative otitis media
2. Patients over 18 years of age
Exclusion Criteria:
1. Chronic nonsuppurative otitis media patients
2. Patients diagnosed with external ear canal/middle ear malignancy
3. Patients who take immunosuppressive drugs
4. Immunosuppressive patients
5. Patients who used antibiotics (topical-systemic) in the last week
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study will include patients who applied to Selçuk University Faculty of Medicine Hospital, Department of Ear, Nose and Throat Diseases \& Head and Neck Surgery, with complaints of ear discharge and were diagnosed with chronic suppurative otitis media.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Burcu Tuğba Aldora
**Phone:** +905437608870
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Konya
**Contacts:**
***Contact 1:***
- **Name:** Bulent ulusoy
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Bulent ULUSOY
**State:** Selcuklu
**Zip:** 42100
**Location 2:**
**City:** Konya
**Country:** Turkey
**Facility:** Selcuk University
**State:** Selcuklu
**Zip:** 42100
#### Overall Officials
**Official 1:**
**Affiliation:** Selcuk University
**Name:** Bulent Ulusoy, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Khairkar M, Deshmukh P, Maity H, Deotale V. Chronic Suppurative Otitis Media: A Comprehensive Review of Epidemiology, Pathogenesis, Microbiology, and Complications. Cureus. 2023 Aug 18;15(8):e43729. doi: 10.7759/cureus.43729. eCollection 2023 Aug.
**PMID:** 37727177
**Citation:** Verhoeff M, van der Veen EL, Rovers MM, Sanders EA, Schilder AG. Chronic suppurative otitis media: a review. Int J Pediatr Otorhinolaryngol. 2006 Jan;70(1):1-12. doi: 10.1016/j.ijporl.2005.08.021. Epub 2005 Sep 27.
**PMID:** 16198004
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004427
- Term: Ear Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007249
- Term: Inflammation
- ID: D000007642
- Term: Keratosis
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: HIGH
- As Found: Suppurative
- ID: M6368
- Name: Communicable Diseases
- Relevance: HIGH
- As Found: Microbial Colonization
- ID: M12954
- Name: Otitis
- Relevance: HIGH
- As Found: Otitis
- ID: M12956
- Name: Otitis Media
- Relevance: HIGH
- As Found: Otitis Media
- ID: M16273
- Name: Suppuration
- Relevance: HIGH
- As Found: Suppurative
- ID: M12958
- Name: Otitis Media, Suppurative
- Relevance: HIGH
- As Found: Otitis Media, Suppurative
- ID: M6021
- Name: Cholesteatoma
- Relevance: HIGH
- As Found: Cholesteatoma
- ID: M7601
- Name: Ear Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
- ID: M28268
- Name: Keratosis, Actinic
- Relevance: LOW
- As Found: Unknown
- ID: M10668
- Name: Keratosis
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: HIGH
- As Found: Chronic
- ID: T1152
- Name: Cholesteatoma
- Relevance: HIGH
- As Found: Cholesteatoma
### Condition Browse Module - Meshes
- ID: D000003141
- Term: Communicable Diseases
- ID: D000007239
- Term: Infections
- ID: D000013492
- Term: Suppuration
- ID: D000010035
- Term: Otitis Media, Suppurative
- ID: D000010031
- Term: Otitis
- ID: D000010033
- Term: Otitis Media
- ID: D000002781
- Term: Cholesteatoma
### Intervention Browse Module - Ancestors
- ID: D000000890
- Term: Anti-Infective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Coag
- Name: Coagulants
### Intervention Browse Module - Browse Leaves
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: HIGH
- As Found: Initial
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
- ID: M11726
- Name: Methylene Blue
- Relevance: LOW
- As Found: Unknown
- ID: M5626
- Name: Catalase
- Relevance: LOW
- As Found: Unknown
- ID: M4712
- Name: Bacitracin
- Relevance: LOW
- As Found: Unknown
- ID: M6260
- Name: Coagulase
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000900
- Term: Anti-Bacterial Agents
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424691
**Brief Title:** Infant Restore: Efficacy of Microbiome Analysis and Education
**Official Title:** Infant Restore: Investigating the Efficacy of a Microbiome Analysis, Education, and Recommendation Program in Improving Infant Gut Health
#### Organization Study ID Info
**ID:** IR-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Seeding, Inc DBA Tiny Health
### Status Module
#### Completion Date
**Date:** 2025-04-14
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2025-04-14
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-05-04
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Seeding, Inc DBA Tiny Health
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to learn if a microbiome analysis, education, and recommendation program can improve gut health, reduce future health risks, and empower parents in their children's health in infants aged 0-3 months delivered via Cesarean section. The main questions it aims to answer are: Will the intervention increase bacteria considered beneficial, decrease the C- section microbiome signatures, promote a reduction in opportunistic pathogens, and improved functional potential for HMO digestion and SCFA production Will the intervention decrease microbiome signatures associated with atopic march conditions.
Researchers will compare participants in the intervention arm, who will receive microbiome reports, personalized action plans, and educational materials, to participants in the control arm, who will receive microbiome results and educational materials after the study's completion, to see if the intervention leads to improved gut health and reduced risk of health conditions.
Participants will:
* Provide two microbiome stool samples three months apart.
* Receive detailed infant gut health reports via the Tiny Health app.
* Receive personalized action plans tailored to their infant's gut health needs.
* Engage in gut health coaching sessions with a microbiome expert.
* Receive an educational email series on infant gut health.
* Complete a series of surveys/questionnaires on health history, symptoms, and diet.
This study seeks to demonstrate that targeted microbiome interventions can significantly improve early infant gut health, leading to potential long-term health benefits. These benefits may include reduced healthcare costs by lowering the incidence of related chronic conditions. By establishing a foundation for mitigating these conditions, the intervention could consequently result in fewer doctor visits, reduced need for medications, and a lower incidence of hospitalizations over the first 3-4 years of the infant's life.
### Conditions Module
**Conditions:**
- Microbiota
- Eczema
- Microbiome
- Gut Microbiome
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in the intervention arm will receive comprehensive support to improve their infant's gut health over six months.
**Intervention Names:**
- Dietary Supplement: Tailored Recommendations
- Behavioral: Consult Call
- Behavioral: Email Series
**Label:** Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in the control arm will serve as a comparison group and will not receive the intervention during the study period.
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention
**Description:** Based on the microbiome analysis, participants will receive personalized action plans. These plans include dietary, lifestyle, and supplemental suggestions to improve their infant's gut health.
**Name:** Tailored Recommendations
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Intervention
**Description:** Participants will have seven consult calls with a Gut Health Coach over the course of the study. These calls will provide guidance on the gut health reports, action plans, and any questions or concerns parents may have.
**Name:** Consult Call
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- Intervention
**Description:** Parents will receive a series of educational emails covering topics such as the importance of gut health, breastfeeding benefits, the impact of C-section delivery on the microbiome, and tips for introducing solid foods.
**Name:** Email Series
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Asses parental understanding and engagement in gut health.
**Measure:** Educational
**Time Frame:** 6 months
**Description:** Measure changes in newborn symptoms known to be influenced by gut microbiome e.g. colic, GI upset, sleep issues, eczema.
**Measure:** Gut reacted symptoms
**Time Frame:** 6 months
#### Primary Outcomes
**Description:** Assess changes in beneficial bacteria (Bifidobacterium) and C-section microbiome signatures. Detect levels of opportunistic pathogens, and changes in functional potential for HMO digestion and SCFA production.
**Measure:** Microbiota composition
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** Detect signature shifts from a C-section signature to a vaginally born signature
**Measure:** C-section signature
**Time Frame:** 6 months
**Description:** Compare atopic march signatures of intervention arm versus control subjects
**Measure:** Atopic march signature
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Infants are qualified for this study if they are 0 to 3 months of age at time of enrollment.
* Infant was delivered via Cesarean delivery (C-section).
Exclusion Criteria:
* Infants cannot have been given probiotic supplements in their life at recruitment. This includes probiotic powder or supplements or formula with probiotic addition or multivitamin with probiotic addition.
* Twin and multiple birth infants are not accepted in this study.
* Infants must be full term or no less than 36-weeks gestation at delivery.
* Infants must be residents of the United States with US postal service.
* Infants cannot have the following existing health conditions:
* Pre-existing gut conditions (Hirschsprung disease, eosinophilic gastrointestinal disorders (EGID) such as eosinophilic esophagitis (EoE), necrotizing enterocolitis (NEC), short bowel syndrome (SBS))
* Immune or auto-immune conditions (severe combined immunodeficiency (SCID), human immunodeficiency virus (HIV)), excluding eczema and rashes
* Congenital conditions (cleft lip or cleft palate, congenital heart disease, cerebral palsy, fragile X syndrome, down syndrome, spina bifida, cystic fibrosis, phenylketonuria (PKU), congenital hypothyroidism (CHT), galactosaemia)
* Blood disorders (sickle cell disease, thalassemia, hemophilia)
* Infants are excluded if they or any of their immediate family members have received results from an at-home microbiome stool test in the past. This does not include clinical workup such as culture or pathogen testing.
**Healthy Volunteers:** True
**Maximum Age:** 3 Months
**Minimum Age:** 0 Months
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Fredericksburg
**Country:** United States
**Facility:** Seeding INC
**State:** Texas
**Zip:** 78749
#### Overall Officials
**Official 1:**
**Affiliation:** Seeding INC
**Name:** Kimberley Sukhum, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Galazzo G, van Best N, Bervoets L, Dapaah IO, Savelkoul PH, Hornef MW; GI-MDH consortium; Lau S, Hamelmann E, Penders J. Development of the Microbiota and Associations With Birth Mode, Diet, and Atopic Disorders in a Longitudinal Analysis of Stool Samples, Collected From Infancy Through Early Childhood. Gastroenterology. 2020 May;158(6):1584-1596. doi: 10.1053/j.gastro.2020.01.024. Epub 2020 Jan 18.
**PMID:** 31958431
**Citation:** Shao Y, Forster SC, Tsaliki E, Vervier K, Strang A, Simpson N, Kumar N, Stares MD, Rodger A, Brocklehurst P, Field N, Lawley TD. Stunted microbiota and opportunistic pathogen colonization in caesarean-section birth. Nature. 2019 Oct;574(7776):117-121. doi: 10.1038/s41586-019-1560-1. Epub 2019 Sep 18.
**PMID:** 31534227
**Citation:** O'Neill I, Schofield Z, Hall LJ. Exploring the role of the microbiota member Bifidobacterium in modulating immune-linked diseases. Emerg Top Life Sci. 2017 Nov 30;1(4):333-349. doi: 10.1042/ETLS20170058.
**PMID:** 33525778
**Citation:** Roswall J, Olsson LM, Kovatcheva-Datchary P, Nilsson S, Tremaroli V, Simon MC, Kiilerich P, Akrami R, Kramer M, Uhlen M, Gummesson A, Kristiansen K, Dahlgren J, Backhed F. Developmental trajectory of the healthy human gut microbiota during the first 5 years of life. Cell Host Microbe. 2021 May 12;29(5):765-776.e3. doi: 10.1016/j.chom.2021.02.021. Epub 2021 Mar 31.
**PMID:** 33794185
**Citation:** Vandenplas Y, De Greef E, Veereman G. Prebiotics in infant formula. Gut Microbes. 2014;5(6):681-7. doi: 10.4161/19490976.2014.972237.
**PMID:** 25535999
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003872
- Term: Dermatitis
- ID: D000012871
- Term: Skin Diseases
- ID: D000017443
- Term: Skin Diseases, Eczematous
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7655
- Name: Eczema
- Relevance: HIGH
- As Found: Eczema
- ID: M7067
- Name: Dermatitis
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19712
- Name: Skin Diseases, Eczematous
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004485
- Term: Eczema
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424678
**Brief Title:** Study of Cardiorespiratory Arrests That Occurred in the Surgical Block and Adjacent Places
**Official Title:** Study of Cardiorespiratory Arrests That Occurred in the Surgical Block and Adjacent
#### Organization Study ID Info
**ID:** SeRCP022024
#### Organization
**Class:** OTHER
**Full Name:** Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
### Status Module
#### Completion Date
**Date:** 2029-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
#### Responsible Party
**Investigator Affiliation:** Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
**Investigator Full Name:** Maria Concepcion Ruiz-Villen
**Investigator Title:** Doctor (PhD) in Medicine and Surgery. Faculty specialist in Anaesthesiology, Intensive Care and Pain
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A protocol for recording cardiopulmonary arrest (CRP) data in the in-hospital surgical block has been designed with the Utstein template model. The database is hosted in accordance with European legislation on patient data protection.
Invitation to participate will be sent to Spanish hospitals in the first phase. Once this is over, participation in the registry will be opened to European hospitals. Survival and neurological outcome will be evaluated upon discharge from the surgical block. The study design is a prospective observational registry of a cohort of subjects who have suffered a CRP in the surgical block.
**Detailed Description:** Patients will be enrolled by participating researchers from Spanish hospitals that have a pediatric surgery service, in addition to surgery on adult patients, who will collect and upload the data into a protected web-based electronic database. The recorded variables are grouped as follows: patient variables, hospital data, data prior to cardiopulmonary arrest (CRP), data from cardiopulmonary arrest (CRP), data after cardiopulmonary resuscitation (CPR), results of cardiopulmonary resuscitation (CPR). For the study, cardiorespiratory arrest (CRP) is defined as cardiac arrest for which resuscitation is attempted with chest compressions, defibrillation, or both. In the pediatric population it may include patients receiving chest compressions for poor perfusion in the setting of severe bradycardia.
The inclusion criteria are: all patients older than 1 month who undergo sedation, anesthesia or monitored anesthetic surveillance performed by an anesthesiologist and suffer cardiorespiratory arrest in the surgical block. Subsequent episodes of cardiorespiratory arrest (CRP) in the same subject may be included. Exclusion criteria: hospitals that do not have a pediatric surgery service in their service portfolio, patients being treated with extracorporeal circulatory support (ECMO, extracorporeal circulation pump or ventricular assistance) at the time of cardiorespiratory arrest. Patients who suffer cardiac arrest and require any type of extracorporeal circulatory support for the recovery of spontaneous circulation after performing the corresponding cardiopulmonary resuscitation (CPR) will not be eliminated.
The data collection period will be valid for 48 months, starting on June 1, 2025 and the last day being June 1, 2029.
### Conditions Module
**Conditions:**
- Cardiorespiratory Arrest
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 4 Years
### Arms Interventions Module
#### Arm Group 1
**Description:** The epidemiology of the data collected in the Utstein template will be described in patients who suffer cardiac arrest in the surgical block and have an age between 1 month and 1 day to 18 years.
**Intervention Names:**
- Other: Only data collection in the Utstein template
**Label:** Cradiorespiratory arrest in paediatric patients
#### Arm Group 2
**Description:** The epidemiology of the data collected in the Utstein template will be described in patients who suffer cardiac arrest in the surgical block and are aged from 18 years and 1 day to 11o years.
**Intervention Names:**
- Other: Only data collection in the Utstein template
**Label:** cardiorespiratory arrest in adult patients
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cradiorespiratory arrest in paediatric patients
- cardiorespiratory arrest in adult patients
**Description:** The intervention that we will carry out in both groups will consist of collecting data from the patient (age, sex and race), on cardiopulmonary arrest, cardiopulmonary resuscitation, and the results of cardiopulmonary resuscitation.
**Name:** Only data collection in the Utstein template
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** We define survival upon discharge from the BQ as that patient with recovery of spontaneous circulation after cardiac arrest, who is discharged with signs of life to the hospital ward.
**Measure:** Survival to discharge from the surgical block will be evaluated
**Time Frame:** From June 1, 2025 to June 1, 2029
#### Secondary Outcomes
**Description:** Neurological outcome at 30 days or at hospital discharge if it occurs before that period. Registers as Cerebral Performance Category (CPC), Pediatric CPC (PCPC), or modified Rankin Scale (mRS) score, and can be measured face-to-face, telephone interview, or a combination. The PCC is a 5-point scale ranging from 1 (good brain performance) to 5 (dead). The PCPC is a scale that goes from 1 (good brain performance) to 6 (dead). The mRS is a scale that ranges from 0 (no symptoms) to 6 (dead). Survival with favorable neurological conditions is defined as a CPC of 1 or 2, mRS of 0 to 3, or no change in CPC or mRS with respect to the patient's pre-arrest status. Include a definition of how it was measured (face- to-face, extracted from notes, combination.
**Measure:** Survival to hospital discharge with good neurological status
**Time Frame:** From June 1, 2025 to June 1, 2029
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:Patients over 1 month of age who suffer cardiac arrest in the surgical unit and/or in those places where some type of monitored surveillance technique, sedation and/or anesthesia is performed by an anesthesiologist or internal resident specialist (EIR) of the specialty of Anesthesiology.
Exclusion Criteria:
* Patients with procedures defined as major outpatient surgery in the hospital where the cardiac arrest occurs.
* Patients in supportive treatment extracorporeal circulatory system (ECMO) or ventricular assist at the time of cardiac arrest.
**Minimum Age:** 1 Month
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** All patients over 1 month of age who suffer cardiac arrest in the surgical block (BQ). Cardiac arrest is defined by the application of chest compressions and/or defibrillation. In the pediatric population it may include patients receiving chest compressions for poor perfusion in the setting of severe bradycardia.
We define BQ as "the space in which all the operating rooms are grouped, with the equipment and characteristics necessary to carry out all the planned surgical procedures. The BQ includes the premises where the care process of the surgical procedure takes place (operating room and post-anesthesia recovery unit) and the support premises it requires. In these locations we include the pre-operating room where patients wait, within the surgical block, to enter the operating room.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** María Concepción Ruiz-Villen
**Phone:** +34670601969
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
**Name:** María Conepción Ruiz-Villén
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Data collected in the Utstein template can be shared with other SEDAR researchers. The data will be encrypted.
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Berg KM, Bray JE, Ng KC, Liley HG, Greif R, Carlson JN, Morley PT, Drennan IR, Smyth M, Scholefield BR, Weiner GM, Cheng A, Djarv T, Abelairas-Gomez C, Acworth J, Andersen LW, Atkins DL, Berry DC, Bhanji F, Bierens J, Bittencourt Couto T, Borra V, Bottiger BW, Bradley RN, Breckwoldt J, Cassan P, Chang WT, Charlton NP, Chung SP, Considine J, Costa-Nobre DT, Couper K, Dainty KN, Dassanayake V, Davis PG, Dawson JA, Fernanda de Almeida M, De Caen AR, Deakin CD, Dicker B, Douma MJ, Eastwood K, El-Naggar W, Fabres JG, Fawke J, Fijacko N, Finn JC, Flores GE, Foglia EE, Folke F, Gilfoyle E, Goolsby CA, Granfeldt A, Guerguerian AM, Guinsburg R, Hatanaka T, Hirsch KG, Holmberg MJ, Hosono S, Hsieh MJ, Hsu CH, Ikeyama T, Isayama T, Johnson NJ, Kapadia VS, Daripa Kawakami M, Kim HS, Kleinman ME, Kloeck DA, Kudenchuk P, Kule A, Kurosawa H, Lagina AT, Lauridsen KG, Lavonas EJ, Lee HC, Lin Y, Lockey AS, Macneil F, Maconochie IK, John Madar R, Malta Hansen C, Masterson S, Matsuyama T, McKinlay CJD, Meyran D, Monnelly V, Nadkarni V, Nakwa FL, Nation KJ, Nehme Z, Nemeth M, Neumar RW, Nicholson T, Nikolaou N, Nishiyama C, Norii T, Nuthall GA, Ohshimo S, Olasveengen TM, Gene Ong YK, Orkin AM, Parr MJ, Patocka C, Perkins GD, Perlman JM, Rabi Y, Raitt J, Ramachandran S, Ramaswamy VV, Raymond TT, Reis AG, Reynolds JC, Ristagno G, Rodriguez-Nunez A, Roehr CC, Rudiger M, Sakamoto T, Sandroni C, Sawyer TL, Schexnayder SM, Schmolzer GM, Schnaubelt S, Semeraro F, Singletary EM, Skrifvars MB, Smith CM, Soar J, Stassen W, Sugiura T, Tijssen JA, Topjian AA, Trevisanuto D, Vaillancourt C, Wyckoff MH, Wyllie JP, Yang CW, Yeung J, Zelop CM, Zideman DA, Nolan JP; ; and Collaborators. 2023 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations: Summary From the Basic Life Support; Advanced Life Support; Pediatric Life Support; Neonatal Life Support; Education, Implementation, and Teams; and First Aid Task Forces. Resuscitation. 2024 Feb;195:109992. doi: 10.1016/j.resuscitation.2023.109992. Epub 2023 Nov 9.
**PMID:** 37937881
**Citation:** Nolan JP, Berg RA, Andersen LW, Bhanji F, Chan PS, Donnino MW, Lim SH, Ma MH, Nadkarni VM, Starks MA, Perkins GD, Morley PT, Soar J. Cardiac Arrest and Cardiopulmonary Resuscitation Outcome Reports: Update of the Utstein Resuscitation Registry Template for In-Hospital Cardiac Arrest: A Consensus Report From a Task Force of the International Liaison Committee on Resuscitation (American Heart Association, European Resuscitation Council, Australian and New Zealand Council on Resuscitation, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, Resuscitation Council of Asia). Circulation. 2019 Oct 29;140(18):e746-e757. doi: 10.1161/CIR.0000000000000710. Epub 2019 Sep 16.
**PMID:** 31522544
**Citation:** Ministerio de Sanidad y política social.Bloque Quirúrgico. Estándares y recomendaciones. Madrid. Centro de publicaciones. 2009.301 p.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M9411
- Name: Heart Arrest
- Relevance: HIGH
- As Found: Cardiorespiratory Arrest
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006323
- Term: Heart Arrest
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424665
**Brief Title:** A Study of FZ-AD005 in Patients With Advanced Solid Tumors
**Official Title:** A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD005 in Patients With Advanced Solid Tumors
#### Organization Study ID Info
**ID:** F0041-101
#### Organization
**Class:** INDUSTRY
**Full Name:** Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A First-in-Human, Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with Advanced Solid Tumors.
### Conditions Module
**Conditions:**
- Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 162
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: FZ-AD005
**Label:** FZ-AD005
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- FZ-AD005
**Description:** Every 21 days for 1 cycle. Subjects will receive an intravenous infusion of FZ-AD005 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
**Name:** FZ-AD005
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** To determine the dose limiting toxicities (DLTs) of FZ-AD005
**Measure:** The dose limiting toxicity ( DLT)
**Time Frame:** 21 Days (first cycle)
**Description:** To determine the maximum tolerated dose (MTD) and/or recommended doses for expansion (RDEs). RDEs will not exceed MTD.
**Measure:** Maximum Tolerable Dose (MTD)
**Time Frame:** 21 Days (first cycle)
**Description:** To check the numbers of AEs happened during the course of trial.
**Measure:** Adverse Events (AEs）
**Time Frame:** Screening up to study completion, assessed up to 60 months
**Description:** To evaluate the objective response rate (ORR) \[Complete Response (CR) + Partial Response (PR)\] of FZ-AD005 according to RECIST 1.1
**Measure:** Objective Response Rate (ORR)
**Time Frame:** Up to 60 months
#### Secondary Outcomes
**Description:** Progression-free survival (PFS) was defined as the interval from the first dose start date to the date of disease progression defined as documented progressive disease (PD) or death from any cause, whichever occurs first.
**Measure:** Progression free survival(PFS)
**Time Frame:** Up to 60 months
**Description:** Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
**Measure:** Duration of Response(DOR)
**Time Frame:** Up to 60 months
**Description:** overall survival was defined as the time from the date of the first dose start date to the date of death due to any cause.
**Measure:** Overall Survival (OS)
**Time Frame:** Up to 60 months
**Description:** To check the" Anti Drug Antibody" develops in participants against the FZ-AD005 through blood sample
**Measure:** Anti Drug Antibody (ADA)
**Time Frame:** Up to 36 months
**Description:** To measure the time to reach the maximum contraction of Total Antibody, Free DXd and FZ-AD005 in study participants
**Measure:** Time to peak (Tmax)
**Time Frame:** Up to 18 weeks
**Description:** To measure the time of Total Antibody, Free DXd and FZ-AD005 will take to eliminate half of it's concentration from participants.
**Measure:** Terminal elimination half-life (t1/2)
**Time Frame:** Up to 18 weeks
**Description:** To measure the maximum concentration participants obtained of Total Antibody, Free DXd and FZ-AD004 in their blood plasma.
**Measure:** Maximum observed plasma concentration (Cmax)
**Time Frame:** Up to 18 weeks
**Description:** To measure the drug profile for absorption, distribution, metabolism and excretion for Total Antibody, Free DXd and FZ-AD005 in participants blood plasma
**Measure:** Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity
**Time Frame:** Up to 18 weeks
**Description:** To measure the time to reach the maximum contraction of Total Antibody, Free DXd and FZ-AD005 in study participants
**Measure:** Time to Cmax (Tmax)
**Time Frame:** Up to 18 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients able to give written informed consent;
2. Age ≥ 18 and ≤ 75 years old, male or female;
3. Patients have histological or cytological diagnosis with advanced solid tumors ( especially SCLC or LCNEC);
4. Willingness to provide tumor tissue for testing ;
5. Have measurable lesions defined in RECIST v. 1.1;
6. Expected survival ≥ 3 months;
7. Eastern Cancer Cooperative Group (ECOG) performance status 0-1;
8. Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.
Exclusion Criteria:
1. Patients who have had previous treatment with any anti-DLL3 antibody；
2. Have had other malignant tumors in the past 5 years;
3. Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose;
4. Have active CNS (central nervous system) metastasis；
5. Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;
6. Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;
7. Patients have psychiatric history;
8. Female patients who are breastfeeding or pregnant;
9. Other reasons that researchers believe are inappropriate to participate in this 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:** Mengli Zhou
**Phone:** 00-86-021-58953355
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Changsha
**Contacts:**
***Contact 1:***
- **Name:** Lin Wu
- **Role:** CONTACT
**Country:** China
**Facility:** Hunan Cancer Hospital
**State:** Hunan
**Zip:** 410013
**Location 2:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Name:** Caicun Zhou
- **Role:** CONTACT
**Country:** China
**Facility:** Shanghai East Hospital
**State:** Shanghai
**Zip:** 200120
**Location 3:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Name:** Shengxiang Ren
- **Role:** CONTACT
**Country:** China
**Facility:** Shanghai Pulmonary Hospital
**State:** Shanghai
**Zip:** 200120
**Location 4:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Name:** Zhengbo Song
- **Role:** CONTACT
**Country:** China
**Facility:** Zhejiang Cancer Hospital
**State:** Zhejiang
**Zip:** 310022
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009369
- Term: Neoplasms
- 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: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000018358
- Term: Neuroendocrine Tumors
- ID: D000017599
- Term: Neuroectodermal Tumors
- ID: D000009373
- Term: Neoplasms, Germ Cell and Embryonal
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000000230
- Term: Adenocarcinoma
- ID: D000002277
- Term: Carcinoma
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009380
- Term: Neoplasms, Nerve Tissue
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M11172
- Name: Lung Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M28323
- Name: Small Cell Lung Carcinoma
- Relevance: HIGH
- As Found: Small Cell Lung Cancer
- ID: M20423
- Name: Carcinoma, Neuroendocrine
- Relevance: HIGH
- As Found: Neuroendocrine Carcinoma
- 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
- ID: M20495
- Name: Neuroendocrine Tumors
- Relevance: LOW
- As Found: Unknown
- ID: M19845
- Name: Neuroectodermal Tumors
- Relevance: LOW
- As Found: Unknown
- ID: M20388
- Name: Neuroectodermal Tumors, Primitive
- Relevance: LOW
- As Found: Unknown
- ID: M12318
- Name: Neoplasms, Germ Cell and Embryonal
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M3585
- Name: Adenocarcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12325
- Name: Neoplasms, Nerve Tissue
- Relevance: LOW
- As Found: Unknown
- ID: T5271
- Name: Small Cell Lung Cancer
- Relevance: HIGH
- As Found: Small Cell Lung Cancer
- ID: T4091
- Name: Neuroendocrine Tumor
- Relevance: LOW
- As Found: Unknown
- ID: T4092
- Name: Neuroepithelioma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000055752
- Term: Small Cell Lung Carcinoma
- ID: D000018278
- Term: Carcinoma, Neuroendocrine
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424652
**Brief Title:** Effect of Physiologic Insulin Administration on Cognition
**Official Title:** Effect of Physiologic Insulin Administration on Cognition
#### Organization Study ID Info
**ID:** PBRC 2024-014
#### Organization
**Class:** OTHER
**Full Name:** Pennington Biomedical Research Center
### Status Module
#### Completion Date
**Date:** 2024-06-16
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-06-16
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Pennington Biomedical Research Center
#### Responsible Party
**Investigator Affiliation:** Pennington Biomedical Research Center
**Investigator Full Name:** Frank Greenway
**Investigator Title:** Professor-Chief Medical Officer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In humans, insulin is secreted in pulses from the pancreatic beta-cells, and these oscillations help to maintain fasting plasma glucose levels within a narrow normal range. These pulses become disrupted in the presence of insulin resistance. Some people have referred to Alzheimer's Disease as type 3 diabetes because the glucose uptake in the brain is reduced by 30%. Clinical observations in clinics that treat patients with insulin pulses every 5 minutes for 3 hours twice a week for 2 weeks followed by once a week for 6 weeks and followed by less frequency treatments suggest an improvement in type 2 diabetes control, reduction in insulin resistance and an improvement in diabetes complications. A patient with Parkinson's Disease was treated with this pulsed insulin paradigm and experienced dramatic improvement that has now been maintained over years. Parkinson's Disease has been reported to have a decreased glucose uptake in the brain, so pulsed insulin treatment was tried in a small number of patients with Alzheimer's Disease and there was an impression that they showed improvement. Clinics that use pulsed insulin treatment change more than one parameter of the insulin pulses which makes it difficult to determine what is giving the improvement. The euglycemic hyper-insulinemic clamp, also called a clamp, is a well-standardized test that measures insulin resistance and involves intravenous insulin infusion. This single patient study will enroll one patient with early Alzheimer's disease and insulin resistance. The subject will have one standard clamp test with continuous insulin followed by 4 clamps over a 2-week period using the same amount of insulin over the same period of time but administered in pulses every 5 minutes. This was the number of pulsed insulin treatments needed to see a dramatic improvement in Parkinson's disease. The cognition in the Alzheimer's disease patient will be thoroughly evaluated with questionnaires and walking on a special mat while doing arithmetic tasks before and after the 4 pulsed insulin clamps. If this study demonstrates an improvement in cognition, one will know that the only thing that changed from the standard clamp was the pulse nature of the insulin delivery.
**Detailed Description:** The purpose of this research study is to test the effect of an insulin treatment on Alzheimer's disease.
### Conditions Module
**Conditions:**
- Alzheimer Disease
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 1
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: Blood draws
- Other: Hyperinsulinemic Euglycemic Clamp Technique Insulin Sensitivity test
- Other: Resting Metabolic Rate (RMR)
**Label:** Single Participant with Evidence of cognitive impairment.
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Single Participant with Evidence of cognitive impairment.
**Description:** After passing the screening, participation in the research study will be approximately three weeks. The participant will have seven study visits all at the Pennington Center. On five occasions, the participant will have a five-hour visit in the inpatient unit. At the study visit blood will be drawn. The total amount of blood drawn during the study is approximately 12 fluid ounces.
**Name:** Blood draws
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Single Participant with Evidence of cognitive impairment.
**Description:** This procedure measures how the body responds to insulin. Insulin is normally produced by the body during meals and helps the body use sugar. There will be two IV lines, one in the participant's arm and one in the participant's hand on the opposite side. Small amounts of glucose and insulin will be infused into the participant's arm. The participant's blood sugar level will be checked every 5-10 minutes from the IV in the hand to determine how much glucose the participant should have to keep blood sugar at a normal level. The participant's hand will be placed inside a warming box to increase skin temperature to about 105 degrees Fahrenheit. The temperature will be warm, but not uncomfortable. During the IV procedure, a small amount of the participant's own blood (less than 1 teaspoon) will immediately be returned into the vein through the IV after each specimen is collected.
**Name:** Hyperinsulinemic Euglycemic Clamp Technique Insulin Sensitivity test
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Single Participant with Evidence of cognitive impairment.
**Description:** After the participant rests for 30 minutes, a clear plastic hood will be placed over the participant's head and chest area. The hood is ventilated with fresh air. The participant's oxygen intake and carbon dioxide output will be measured for 30 minutes to determine how many calories the participant burns during the time they are being tested.
**Name:** Resting Metabolic Rate (RMR)
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** To determine the effect of tissue sensitivity to insulin delivered in pulses compared to insulin delivered continuously during the hyperinsulinemic euglycemic clamp test (clamp). The hypothesis is that delivery of insulin in pulses during the clamp (pulsatile clamp) will increase glucose disposal rate (GDR) compared to continuous delivery during the clamp (continuous clamp). To test the hypothesis, we will measure GDR during one pulsatile clamp and one continuous clamp at 40mU/m2/min insulin infusion.
**Measure:** Effect of tissue sensitivity to insulin
**Time Frame:** Two weeks
#### Secondary Outcomes
**Description:** To determine the effect of the pulsatile clamp at 40mU/m2/min insulin infusion on signs and symptoms of Alzheimer's disease. The hypothesis is that the signs and symptoms of Alzheimer's disease will improve following four pulsatile clamp treatments. To test the hypothesis, we will conduct assessments of cognition, homeostatic model assessment of insulin resistance, and brain insulin resistance prior to and following four pulsatile insulin clamps conducted twice weekly for two weeks.
**Measure:** Effect of the pulsatile clamp at 40mU/m2/min insulin infusion on signs and symptoms of Alzheimer's disease
**Time Frame:** Two weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Early Alzheimer's Disease
* Insulin Resistance
Exclusion Criteria:
* Inability to walk
* Unable to read, understand or inability to complete questionnaire
* Belong to a vulnerable group like prisoners
**Maximum Age:** 75 Years
**Minimum Age:** 65 Years
**Sex:** MALE
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Baton Rouge
**Country:** United States
**Facility:** Penningto Biomedical Research Center
**State:** Louisiana
**Zip:** 70809
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Mergenthaler P, Lindauer U, Dienel GA, Meisel A. Sugar for the brain: the role of glucose in physiological and pathological brain function. Trends Neurosci. 2013 Oct;36(10):587-97. doi: 10.1016/j.tins.2013.07.001. Epub 2013 Aug 20.
**PMID:** 23968694
**Citation:** Leclerc M, Bourassa P, Tremblay C, Caron V, Sugere C, Emond V, Bennett DA, Calon F. Cerebrovascular insulin receptors are defective in Alzheimer's disease. Brain. 2023 Jan 5;146(1):75-90. doi: 10.1093/brain/awac309.
**PMID:** 36280236
**Citation:** Cull O, Al Qadi L, Stadler J, Martin M, El Helou A, Wagner J, Maillet D, Chamard-Witkowski L. Radiological markers of neurological manifestations of post-acute sequelae of SARS-CoV-2 infection: a mini-review. Front Neurol. 2023 Nov 24;14:1233079. doi: 10.3389/fneur.2023.1233079. eCollection 2023.
**PMID:** 38073629
**Citation:** Chun MY, Chung SJ, Kim SH, Park CW, Jeong SH, Lee HS, Lee PH, Sohn YH, Jeong Y, Kim YJ. Hippocampal Perfusion Affects Motor and Cognitive Functions in Parkinson Disease: An Early Phase 18 F-FP-CIT Positron Emission Tomography Study. Ann Neurol. 2024 Feb;95(2):388-399. doi: 10.1002/ana.26827. Epub 2023 Nov 28.
**PMID:** 37962393
**Citation:** Zhang Q, Fan C, Wang L, Li T, Wang M, Han Y, Jiang J; and for the Alzheimer's Disease Neuroimaging Initiative. Glucose metabolism in posterior cingulate cortex has supplementary value to predict the progression of cognitively unimpaired to dementia due to Alzheimer's disease: an exploratory study of 18F-FDG-PET. Geroscience. 2024 Feb;46(1):1407-1420. doi: 10.1007/s11357-023-00897-0. Epub 2023 Aug 23.
**PMID:** 37610594
**Citation:** Kapogiannis D, Boxer A, Schwartz JB, Abner EL, Biragyn A, Masharani U, Frassetto L, Petersen RC, Miller BL, Goetzl EJ. Dysfunctionally phosphorylated type 1 insulin receptor substrate in neural-derived blood exosomes of preclinical Alzheimer's disease. FASEB J. 2015 Feb;29(2):589-96. doi: 10.1096/fj.14-262048. Epub 2014 Oct 23.
**PMID:** 25342129
**Citation:** Tam CS, Xie W, Johnson WD, Cefalu WT, Redman LM, Ravussin E. Defining insulin resistance from hyperinsulinemic-euglycemic clamps. Diabetes Care. 2012 Jul;35(7):1605-10. doi: 10.2337/dc11-2339. Epub 2012 Apr 17.
**PMID:** 22511259
**Citation:** Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
**PMID:** 15817019
**Citation:** Lin JS, O'Connor E, Rossom RC, Perdue LA, Burda BU, Thompson M, Eckstrom E. Screening for Cognitive Impairment in Older Adults: An Evidence Update for the U.S. Preventive Services Task Force [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Nov. Report No.: 14-05198-EF-1. Available from http://www.ncbi.nlm.nih.gov/books/NBK174643/
**PMID:** 24354019
**Citation:** Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
**PMID:** 11556941
**Citation:** Feng YS, Kohlmann T, Janssen MF, Buchholz I. Psychometric properties of the EQ-5D-5L: a systematic review of the literature. Qual Life Res. 2021 Mar;30(3):647-673. doi: 10.1007/s11136-020-02688-y. Epub 2020 Dec 7.
**PMID:** 33284428
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003704
- Term: Dementia
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000024801
- Term: Tauopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3885
- Name: Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
- ID: M6904
- Name: Dementia
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23002
- Name: Tauopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T2192
- Name: Familial Alzheimer Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000544
- Term: Alzheimer Disease
### 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
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: HIGH
- As Found: Bristaxol
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000007328
- Term: Insulin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424639
**Brief Title:** Luspatercept Plus CsA vs CsA for the Treatment of Newly Diagnosed Non-Transfusion-Dependent NSAA
**Official Title:** A Randomized, Controlled Trial Comparing the Safety and Efficacy of Luspatercept Plus Cyclosporine Versus Cyclosporine Alone for the Treatment of Newly Diagnosed Non-transfusion-dependent Non-severe Aplastic Anemia (NSAA)
#### Organization Study ID Info
**ID:** LC-001
#### Organization
**Class:** OTHER
**Full Name:** Peking Union Medical College Hospital
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking Union Medical College Hospital
#### Responsible Party
**Investigator Affiliation:** Peking Union Medical College Hospital
**Investigator Full Name:** Bing Han
**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 a randomized, controlled clinical trial, the efficacy and safety of rodsipil combined with cyclosporine versus cyclosporine alone in the treatment of newly diagnosed non-transfusion-dependent NSAA were compared.
**Detailed Description:** Conduct a comparative evaluation of the effectiveness and safety of Luspatercept combined with cyclosporine versus cyclosporine monotherapy in the treatment of newly diagnosed non-transfusion-dependent non-severe aplastic anemia (NSAA). Patients were randomized in a 1:1 ratio and assigned to one of two groups: Group A, Luspatercept combined with cyclosporine: received Luspatercept (1.0 mg/kg, subcutaneous injection every 3 weeks), cyclosporine (3-5mg/kg/day), adjusted based on hematological parameters, for at least 6 months to assess efficacy. Effective patients continued to receive cyclosporine treatment for at least 1.5 years, with a gradual reduction in dosage; Group B, cyclosporine: received 3-5mg/kg/day, adjusted based on hematological parameters, for at least 6 months to assess efficacy, with effective patients continuing to receive cyclosporine treatment for at least 1.5 years, with a gradual reduction in dosage. Hgb below 60g/L was allowed, or in emergency conditions, blood transfusion was allowed. Platelets below 20×10\^9/L or with obvious bleeding tendency were allowed to receive platelet transfusion. If neutrophil count was below 1.0×10\^9/L, G-CSF was allowed until neutrophil count recovered to above 1.0×10\^9/L. Symptoms, treatment-related adverse events, signs, blood transfusion volume, and laboratory tests (including reticulocyte count) were recorded at least every 3 months for the first 3 months, and every 6 months thereafter until 6 months, and bone marrow aspiration, biopsy, and chromosome examination were performed at least every 6 months to observe efficacy and safety.
### Conditions Module
**Conditions:**
- Aplastic Anemia
**Keywords:**
- Aplastic Anemia
- Luspatercept
- CsA
- randomized controlled study
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 58
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Administered Luspatercept (1.0 mg/kg, subcutaneous injection every 3 weeks), and Cyclosporine (3-5mg/kg/day) adjusted according to hematological parameters, for at least 6 months to evaluate efficacy. Effective patients will continue to receive Cyclosporine treatment for at least 1.5 years, followed by a gradual reduction in dosage.
**Intervention Names:**
- Drug: Luspatercept
- Drug: cyclosporine
**Label:** Luspatercept combined with cyclosporine
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Give cyclosporine 3-5mg/kg/day, adjust the dose based on the blood count, and administer it for at least 6 months to evaluate the efficacy. If effective, the patient will continue to receive cyclosporine treatment for at least 1.5 years, followed by a gradual reduction in dosage.
**Intervention Names:**
- Drug: cyclosporine
**Label:** cyclosporine
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Luspatercept combined with cyclosporine
**Description:** Luspatercept (dose of 1.0 mg/kg, subcutaneous injection every 3 weeks) Cyclosporine (3-5mg/kg/day)
**Name:** Luspatercept
**Other Names:**
- cyclosporine
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Luspatercept combined with cyclosporine
- cyclosporine
**Description:** Cyclosporine (3-5mg/kg/day)
**Name:** cyclosporine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Proportion of patients who achieved complete response, partial response and hematological response
**Measure:** overall response rate (ORR)
**Time Frame:** 6 month
#### Secondary Outcomes
**Description:** Proportion of patients who achieved complete response, partial response and hematological response
**Measure:** overall response rate (ORR)
**Time Frame:** 12 month
**Description:** Proportion of patients with adverse events
**Measure:** adverse event rate
**Time Frame:** 12 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥ 18 years
2. Hemoglobin level of 6-10 g/dL
3. Definition of NSAA: Patients with AA diagnosis but not SAA or VSAA diagnosis (at least two of the following conditions can be diagnosed as AA: (i) Hemoglobin \< 100 g/L; (ii) Platelet count \< 50×10\^9/L; (iii) Neutrophil count \< 1.5×10\^9/L. SAA diagnosis criteria include less than 25% (or 25-50%, but residual hematopoietic cells \< 30%) of bone marrow cells, plus at least two of the following conditions: (i) Neutrophil count \< 0.5×10\^9/L; (ii) Platelet count \< 20×10\^9/L; (iii) Retroperitoneal lymph node count \< 20×10\^9/L. VSAA meets the criteria for SAA, but with neutrophil count \< 0.2×10\^9/L. (British guidelines, 2015))
4. No active infection
5. No other concurrent neoplasms (except in situ carcinoma)
6. Baseline liver and renal function within 1.5 times of normal value
7. No pregnancy or breastfeeding
8. Agree to sign informed consent form
9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Exclusion Criteria:
1. Congenital aplastic anemia
2. Presence of chromosomal aberrations
3. Cytogenetic evidence of clonal hematological myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML)
4. PNH clone ≥50%
5. Previous use of alemtuzumab, any ATG, or any dose of cyclosporine for immunosuppressive treatment
6. Previous hematopoietic stem cell transplant (HSCT)
7. Uncontrolled infection or bleeding under standard treatment
8. Allergy to rituximab, cyclosporine, or excipients
9. History of allergy to polyethylene glycol (PEG) 80
10. Active infection or cirrhosis of the liver or portal hypertension due to HIV, HCV, or HBV
11. Screening QTcF (Fridericia QT corrected formula) less than 450 milliseconds or less than 480 milliseconds of bundle branch block determined by three ECG averages, and assessed on-site; unstable angina; uncontrolled hypertension (\>180/100 mmHg); pulmonary hypertension
12. Any malignant tumor within 5 years, except local basal cell carcinoma; previous thromboembolic event, history of myocardial infarction or stroke (including antiphospholipid syndrome); currently using anticoagulants
13. Pregnant or lactating women
14. Participated in another clinical trial within 3 months
**Maximum Age:** 90 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Bing Bing, PhD
**Phone:** 13601059938
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** QLin Hu, PhD
**Phone:** 15810785167
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** QLin Hu
- **Phone:** 15810785167
- **Role:** CONTACT
***Contact 2:***
- **Name:** Bing Bing, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Peking Union Medical College Hospital
**State:** Beijing
**Zip:** 100730
#### Overall Officials
**Official 1:**
**Affiliation:** Peking Union Medical College Hospital
**Name:** Bing Bing, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Young NS. Aplastic anaemia. Lancet. 1995 Jul 22;346(8969):228-32. doi: 10.1016/s0140-6736(95)91273-8. No abstract available.
**PMID:** 7616805
**Citation:** Young NS. Aplastic Anemia. N Engl J Med. 2018 Oct 25;379(17):1643-1656. doi: 10.1056/NEJMra1413485. No abstract available.
**PMID:** 30354958
**Citation:** Bacigalupo A. How I treat acquired aplastic anemia. Blood. 2017 Mar 16;129(11):1428-1436. doi: 10.1182/blood-2016-08-693481. Epub 2017 Jan 17.
**PMID:** 28096088
**Citation:** Yang C, Zhang X. Incidence survey of aplastic anemia in China. Chin Med Sci J. 1991 Dec;6(4):203-7.
**PMID:** 1813058
**Citation:** Vaht K, Goransson M, Carlson K, Isaksson C, Lenhoff S, Sandstedt A, Uggla B, Winiarski J, Ljungman P, Brune M, Andersson PO. Incidence and outcome of acquired aplastic anemia: real-world data from patients diagnosed in Sweden from 2000-2011. Haematologica. 2017 Oct;102(10):1683-1690. doi: 10.3324/haematol.2017.169862. Epub 2017 Jul 27.
**PMID:** 28751565
**Citation:** Li H, Fu L, Yang B, Chen H, Ma J, Wu R. Cyclosporine Monotherapy in Pediatric Patients With Non-severe Aplastic Anemia: A Retrospective Analysis. Front Med (Lausanne). 2022 Mar 7;9:805197. doi: 10.3389/fmed.2022.805197. eCollection 2022.
**PMID:** 35342744
**Citation:** Kubasch AS, Fenaux P, Platzbecker U. Development of luspatercept to treat ineffective erythropoiesis. Blood Adv. 2021 Mar 9;5(5):1565-1575. doi: 10.1182/bloodadvances.2020002177.
**PMID:** 33687432
**Citation:** Attie KM, Allison MJ, McClure T, Boyd IE, Wilson DM, Pearsall AE, Sherman ML. A phase 1 study of ACE-536, a regulator of erythroid differentiation, in healthy volunteers. Am J Hematol. 2014 Jul;89(7):766-70. doi: 10.1002/ajh.23732. Epub 2014 Apr 26.
**PMID:** 24715706
**Citation:** Suragani RN, Cadena SM, Cawley SM, Sako D, Mitchell D, Li R, Davies MV, Alexander MJ, Devine M, Loveday KS, Underwood KW, Grinberg AV, Quisel JD, Chopra R, Pearsall RS, Seehra J, Kumar R. Transforming growth factor-beta superfamily ligand trap ACE-536 corrects anemia by promoting late-stage erythropoiesis. Nat Med. 2014 Apr;20(4):408-14. doi: 10.1038/nm.3512. Epub 2014 Mar 23.
**PMID:** 24658078
**Citation:** Markham A. Luspatercept: First Approval. Drugs. 2020 Jan;80(1):85-90. doi: 10.1007/s40265-019-01251-5.
**PMID:** 31939073
**Citation:** Fenaux P, Platzbecker U, Mufti GJ, Garcia-Manero G, Buckstein R, Santini V, Diez-Campelo M, Finelli C, Cazzola M, Ilhan O, Sekeres MA, Falantes JF, Arrizabalaga B, Salvi F, Giai V, Vyas P, Bowen D, Selleslag D, DeZern AE, Jurcic JG, Germing U, Gotze KS, Quesnel B, Beyne-Rauzy O, Cluzeau T, Voso MT, Mazure D, Vellenga E, Greenberg PL, Hellstrom-Lindberg E, Zeidan AM, Ades L, Verma A, Savona MR, Laadem A, Benzohra A, Zhang J, Rampersad A, Dunshee DR, Linde PG, Sherman ML, Komrokji RS, List AF. Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes. N Engl J Med. 2020 Jan 9;382(2):140-151. doi: 10.1056/NEJMoa1908892.
**PMID:** 31914241
**Citation:** Feld J, Navada SC, Silverman LR. Myelo-deception: Luspatercept & TGF-Beta ligand traps in myeloid diseases & anemia. Leuk Res. 2020 Oct;97:106430. doi: 10.1016/j.leukres.2020.106430. Epub 2020 Jul 30.
**PMID:** 32763582
**Citation:** Komrokji RS, Platzbecker U, Fenaux P, Zeidan AM, Garcia-Manero G, Mufti GJ, Santini V, Diez-Campelo M, Finelli C, Jurcic JG, Greenberg PL, Sekeres MA, DeZern AE, Savona MR, Shetty JK, Ito R, Zhang G, Ha X, Backstrom JT, Verma A. Luspatercept for myelodysplastic syndromes/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis. Leukemia. 2022 May;36(5):1432-1435. doi: 10.1038/s41375-022-01521-4. Epub 2022 Feb 26. No abstract available.
**PMID:** 35220402
**Citation:** Hellstrom-Lindberg E, Gulbrandsen N, Lindberg G, Ahlgren T, Dahl IM, Dybedal I, Grimfors G, Hesse-Sundin E, Hjorth M, Kanter-Lewensohn L, Linder O, Luthman M, Lofvenberg E, Oberg G, Porwit-MacDonald A, Radlund A, Samuelsson J, Tangen JM, Winquist I, Wisloff F; Scandinavian MDS Group. A validated decision model for treating the anaemia of myelodysplastic syndromes with erythropoietin + granulocyte colony-stimulating factor: significant effects on quality of life. Br J Haematol. 2003 Mar;120(6):1037-46. doi: 10.1046/j.1365-2141.2003.04153.x.
**PMID:** 12648074
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000080983
- Term: Bone Marrow Failure Disorders
- ID: D000001855
- Term: Bone Marrow Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4070
- Name: Anemia
- Relevance: HIGH
- As Found: Anemia
- ID: M4071
- Name: Anemia, Aplastic
- Relevance: HIGH
- As Found: Aplastic Anemia
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2241
- Name: Bone Marrow Failure Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M13118
- Name: Pancytopenia
- Relevance: LOW
- As Found: Unknown
- ID: M5134
- Name: Bone Marrow Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T460
- Name: Aplastic Anemia
- Relevance: HIGH
- As Found: Aplastic Anemia
### Condition Browse Module - Meshes
- ID: D000000740
- Term: Anemia
- ID: D000000741
- Term: Anemia, Aplastic
### Intervention Browse Module - Ancestors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000935
- Term: Antifungal Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000003879
- Term: Dermatologic Agents
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000065095
- Term: Calcineurin Inhibitors
- ID: D000006397
- Term: Hematinics
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hemat
- Name: Hematinics
### Intervention Browse Module - Browse Leaves
- ID: M18961
- Name: Cyclosporine
- Relevance: HIGH
- As Found: Target
- ID: M352828
- Name: Luspatercept
- Relevance: HIGH
- As Found: Catheter insertion
- ID: M6730
- Name: Cyclosporins
- Relevance: HIGH
- As Found: Target
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M10212
- Name: Immunosuppressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- 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
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7074
- Name: Dermatologic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M30452
- Name: Calcineurin Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M9485
- Name: Hematinics
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000016572
- Term: Cyclosporine
- ID: C000621232
- Term: Luspatercept
- ID: D000003524
- Term: Cyclosporins
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424626
**Brief Title:** A Trial of AK104 or AK112 in Combination With Axitinib in Patients With Metastatic Mucosal Melanoma
**Official Title:** A Phase Ib, Open, Mono-center, Dose-reduction Tolerability Study of AK104 or AK112 in Combination With Axitinib in Patients With Metastatic Mucosal Melanoma
#### Organization Study ID Info
**ID:** AK104-IIT-043
#### Organization
**Class:** OTHER
**Full Name:** Peking University Cancer Hospital & Institute
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-21
**Type:** ESTIMATED
**Status Verified Date:** 2023-12
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking University Cancer Hospital & Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study was a phase IB, single-center, open-label, two part(part A involved dose reduction, and part B involved cohort expansion) clinical trial evaluating the safety and clinical activity of AK104 or AK112 in combination with axitinib in patients with advanced mucosal melanoma.
**Detailed Description:** The planned cohorts in part A were axitinib 5mg twice a day plus AK104 or AK112 every 3 weeks. A minimum of three patients were initially enrolled at the first dose level. If a dose-limiting toxicity occurred, then the cohort would be expanded to a total of six patients. Responses were evaluated by investigators using both RECIST version 1.1 and Immune-Related RECIST (irRECIST). Patients with progressive disease or an intolerant toxicity were taken off the study. Patients who initially developed progressive disease per RECIST version 1.1 were allowed to continue therapy if the investigator considered patients to be benefiting from the treatment per irRECIST. Any dose-reduction cohort that did not exceed the maximum-tolerated dose could be expanded in part B for additional evaluation of safety and clinical activity. The primary end point of this study was dose-limiting toxicity within the first 4 weeks of treatment with AK104 or AK112 plus axitinib in part A.
### Conditions Module
**Conditions:**
- Melanoma
- Mucosal Melanoma
- Metastatic Melanoma
**Keywords:**
- Melanoma
- AK104
- AK112
- Mucosal Melanoma
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### 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:** The planned cohorts in part A were axitinib 5mg twice a day plus AK104 10mg/kg every 3 weeks. A minimum of three patients were initially enrolled at the first dose level. If a dose-limiting toxicity occurred, then the cohort would be expanded to a total of six patients. Responses were evaluated by investigators using both RECIST version 1.1 and Immune-Related RECIST (irRECIST).
**Intervention Names:**
- Drug: AK104+Axitinib
**Label:** AK104 in Combination With Axitinib
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The planned cohorts in part A were axitinib 5mg twice a day plus AK112 20mg/kg every 3 weeks. A minimum of three patients were initially enrolled at the first dose level. If a dose-limiting toxicity occurred, then the cohort would be expanded to a total of six patients. Responses were evaluated by investigators using both RECIST version 1.1 and Immune-Related RECIST (irRECIST).
**Intervention Names:**
- Drug: AK112+Axitinib
**Label:** AK112 in Combination With Axitinib
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- AK104 in Combination With Axitinib
**Description:** Subjects receive AK104 10mg/kg intravenously (IV) every 3-week cycle plus Axitinib until progression.
**Name:** AK104+Axitinib
**Other Names:**
- Cadonilimab
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- AK112 in Combination With Axitinib
**Description:** Subjects receive AK112 20mg/kg intravenously (IV) every 3-week cycle plus Axitinib until progression.
**Name:** AK112+Axitinib
**Other Names:**
- Ivonescimab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Safety assessments including vital signs, laboratory tests, and adverse event monitoring
**Measure:** Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
**Time Frame:** 3 years
#### Secondary Outcomes
**Description:** The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine tumor response.
**Measure:** Objective Response Rate (ORR) by irRC and RECIST 1.1
**Time Frame:** 3 years
**Description:** The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine duration of response.
**Measure:** Duration of Response (DOR) by irRC and RECIST 1.1
**Time Frame:** 3 years
**Description:** The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine disease control rate.
**Measure:** Disease Control Rate (DCR) by irRC and RECIST 1.1
**Time Frame:** 3 years
**Description:** The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine time to response.
**Measure:** Time to response (TTR) by irRC and RECIST 1.1
**Time Frame:** 3 years
**Description:** The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine progression-free survival time.
**Measure:** Progression-free survival(PFS) by irRC and RECIST 1.1
**Time Frame:** 3 years
**Description:** The treatment effect of AK104 or AK112 in combination with axitinib, will be assessed using irRC and RECIST 1.1 to determine overall survival.
**Measure:** Overall survival (OS) by irRC and RECIST 1.1
**Time Frame:** 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1、18 to 70 years old (at the time consent is obtained). 2、Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
3、Have histologically- or cytologically-confirmed diagnosis of Metastatic Mucosal Melanoma.
4、Have a life expectancy of at least 3 months 5、Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6、Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team 7、Has adequate organ function as defined by:Absolute neutrophil count ≥ 1,500/µL;Platelets ≥ 100,000/µL;Hemoglobin ≥ 9 g/dL;Crcl ≥ 50ml/min creatinine clearance may be calculated using the institutional/laboratory standard method.Serum total bilirubin ≤ 1.5 x ULN ;Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN ;Albumin ≥28g/L;International Normalized Ratio (INR) and aPTT \<1.5 x ULN. Left ventricular ejection fraction ≥50%.
8、Have recovered from the effects of any prior radiotherapy or surgery 9、All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
Exclusion Criteria:
1. Prior treatment with anti-PD-1/PD-L1/PD-L2 antibody and Axitinib
2. Is currently participating in a study of an investigational agent or using an investigational device
3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment
4. Has undergone major surgery within 30 days of Study Day 1
5. Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
6. Has known active central nervous system (CNS) metastases
7. Has carcinomatous meningitis
8. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study
9. Has an active infection requiring systemic therapy
10. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected)
11. History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment
**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:** Lu Si, MD
**Phone:** +86(10)88196951
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Country:** China
**Facility:** Beijing Cancer Hospital
**Zip:** 100142
#### Overall Officials
**Official 1:**
**Affiliation:** Peking University Cancer Hospital & Institute
**Name:** Jun Guo, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000018358
- Term: Neuroendocrine Tumors
- ID: D000017599
- Term: Neuroectodermal Tumors
- ID: D000009373
- Term: Neoplasms, Germ Cell and Embryonal
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000009380
- Term: Neoplasms, Nerve Tissue
- ID: D000018326
- Term: Nevi and Melanomas
- ID: D000012878
- Term: Skin Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11528
- Name: Melanoma
- Relevance: HIGH
- As Found: Melanoma
- ID: M20495
- Name: Neuroendocrine Tumors
- Relevance: LOW
- As Found: Unknown
- ID: M19845
- Name: Neuroectodermal Tumors
- Relevance: LOW
- As Found: Unknown
- ID: M20388
- Name: Neuroectodermal Tumors, Primitive
- Relevance: LOW
- As Found: Unknown
- ID: M12318
- Name: Neoplasms, Germ Cell and Embryonal
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M12325
- Name: Neoplasms, Nerve Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M12448
- Name: Nevus, Pigmented
- Relevance: LOW
- As Found: Unknown
- ID: M12446
- Name: Nevus
- Relevance: LOW
- As Found: Unknown
- ID: M20470
- Name: Nevi and Melanomas
- Relevance: LOW
- As Found: Unknown
- ID: M15681
- Name: Skin Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4091
- Name: Neuroendocrine Tumor
- Relevance: LOW
- As Found: Unknown
- ID: T4092
- Name: Neuroepithelioma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008545
- Term: Melanoma
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000047428
- Term: Protein Kinase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M1910
- Name: Axitinib
- Relevance: HIGH
- As Found: Chamber
- ID: M25820
- Name: Protein Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000077784
- Term: Axitinib
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424613
**Brief Title:** Effects of Lithium on Suicide Prevention in Adolescents and Young Adults With Bipolar Disorder in China
**Official Title:** Investigating the Effects of Lithium Carbonate on Suicide and Self-harm in Adolescents and Young Adults With Bipolar Disorder in China
#### Organization Study ID Info
**ID:** F2023-12-20-4-1
#### Organization
**Class:** OTHER
**Full Name:** Peking University
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-18
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Jiangsu Nhwa Pharmaceutical Co., Ltd.
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aims to use a retrospective cohort approach to explore the impact of lithium carbonate on suicide and self-harm related events among adolescents and young adults with bipolar disorder in China.The primary objective of this study is to investigate the effects of lithium carbonate on suicidal ideation in adolescents and young adults with bipolar disorder in China. Secondary objectives include exploring its effects on preventing suicide attempts, non-suicidal self-injury, and aggressive behaviors in this population.
### Conditions Module
**Conditions:**
- Bipolar Disorder
- Suicidal Ideation
- Suicide, Attempted
- Nonsuicidal Self Injury
**Keywords:**
- Lithium
- Bipolar disorder
- Suicide
- Nonsuicidal Self Injury
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 600
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Lithium Carbonate
**Label:** Lithium Group
#### Arm Group 2
**Intervention Names:**
- Drug: Non-lithium medication
**Label:** Non-lithium Group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Lithium Group
**Description:** Participants must have been prescribed lithium for the past year and demonstrate at least 80% adherence to their lithium medication regimen during the first six months of the study period.
**Name:** Lithium Carbonate
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Non-lithium Group
**Description:** No history of lithium use within the past year
**Name:** Non-lithium medication
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** measured by Beck Depression Inventory
**Measure:** Depressive symptoms
**Time Frame:** over the past two weeks
**Description:** measured by Mood Disorder Questionnaire
**Measure:** Mood symptoms
**Time Frame:** over the past year
#### Primary Outcomes
**Description:** Measured using the Columbia Suicide Severity Rating Scale (C-SSRS)
**Measure:** Suicidal ideation
**Time Frame:** over the past year
#### Secondary Outcomes
**Description:** measured using the Columbia Suicide Severity Rating Scale (C-SSRS)
**Measure:** Suicidal attempt
**Time Frame:** over the past year
**Measure:** Non-suicidal self-injury
**Time Frame:** over the past year
**Description:** measured using the Chinese version of the Buss \& Perry Aggression Questionnaire
**Measure:** Violent and aggressive behaviors
**Time Frame:** over the past year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
-
1 For Lithium group
1. Aged 12-45 years (adolescents 12-17, young adults 18-45).
2. Diagnosed with bipolar disorder using the the Mini-International Neuropsychiatric Interview (M.I.N.I.) (M.I.N.I.; version 5.0) based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria.
3. Adolescents diagnosed using the M.I.N.I. Kid version.
4. Lithium medication adherence of at least 80% in the first six months over the past year.
5. Not in an acute phase of illness.
6. Patient or guardian able to participate in assessment interviews.
7. Informed consent signed by participants and guardians (for adolescents).
2 for Non-lithium group
1. Aged 12-45 years (adolescents 12-17, young adults 18-45).
2. Diagnosed with bipolar disorder using the Mini-International Neuropsychiatric Interview (M.I.N.I.; version 5.0) based on DSM-IV criteria.
3. Adolescents diagnosed using the M.I.N.I. Kid version.
4. No lithium use over the past year.
5. Not in an acute phase of illness.
6. Patient or guardian able to participate in assessment interviews.
7. Informed consent signed by participants and guardians (for adolescents).
Exclusion Criteria:
1. Severe physical illness or active substance abuse.
2. Severe cognitive impairments, including developmental delays or dementia.
**Maximum Age:** 45 Years
**Minimum Age:** 12 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
**Study Population:** Individuals with bipolar disorder ranged in age from 12 to 45 years
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xin Yu
**Phone:** 86-10-82801999
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ni Xu
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xin Yu, Professor
- **Phone:** 86-10-82801999
- **Role:** CONTACT
**Country:** China
**Facility:** Mental Health Institute of Peking University
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100191
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000068105
- Term: Bipolar and Related Disorders
- ID: D000019964
- Term: Mood Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000001526
- Term: Behavioral Symptoms
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4996
- Name: Bipolar Disorder
- Relevance: HIGH
- As Found: Bipolar Disorder
- ID: M29364
- Name: Suicidal Ideation
- Relevance: HIGH
- As Found: Suicidal Ideation
- ID: M16191
- Name: Suicide
- Relevance: HIGH
- As Found: Suicide
- ID: M16192
- Name: Suicide, Attempted
- Relevance: HIGH
- As Found: Suicide, Attempted
- ID: M19089
- Name: Self-Injurious Behavior
- Relevance: HIGH
- As Found: Nonsuicidal Self-injury
- ID: M2958
- Name: Suicide Prevention
- Relevance: LOW
- As Found: Unknown
- ID: M226
- Name: Bipolar and Related Disorders
- 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: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001714
- Term: Bipolar Disorder
- ID: D000013405
- Term: Suicide
- ID: D000059020
- Term: Suicidal Ideation
- ID: D000013406
- Term: Suicide, Attempted
- ID: D000016728
- Term: Self-Injurious Behavior
### Intervention Browse Module - Ancestors
- ID: D000000928
- Term: Antidepressive Agents
- ID: D000011619
- Term: Psychotropic Drugs
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000018692
- Term: Antimanic Agents
- ID: D000014149
- Term: Tranquilizing Agents
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
### 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: M19022
- Name: Lithium Carbonate
- Relevance: HIGH
- As Found: Labeling
- ID: M4247
- Name: Antidepressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000016651
- Term: Lithium Carbonate
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424600
**Brief Title:** Ginglival Health Among Smokers Visiting Dental Hospital
**Official Title:** Effect of Various Forms of Nicotine Consumption on Gingival Health of Dental Patients.
#### Organization Study ID Info
**ID:** SOD/ERB/2023/32-02
#### Organization
**Class:** OTHER_GOV
**Full Name:** Pakistan Institute of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2024-02-04
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-02-04
**Type:** ACTUAL
#### Start Date
**Date:** 2023-02-03
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Pakistan Institute of Medical Sciences
#### Responsible Party
**Investigator Affiliation:** Pakistan Institute of Medical Sciences
**Investigator Full Name:** Afsheen Mansoor
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The effect of different forms of nicotine intake on the gingival health of dental patients that visited a public sector in Islamabad. A total of 300 dental patients that visited School of Dentistry, Islamabad. The nicotine consuming participants involved in this study were Smoke-Form users, E cigarette-form users, and Dual-Form users whose Gingival Index (G-I) was inspected to demonstrate an association between their smoking type and duration of developing severe gingivitis.
**Detailed Description:** A total of 300 dental patients that visited School of Dentistry, Islamabad, participated voluntarily in this study. The nicotine consuming participants involved in this study were Smoke-Form users, E cigarette-form users, and Dual-Form users whose Gingival Index (G-I) was inspected to demonstrate an association between their smoking type and duration of developing severe gingivitis. The G-I ranging between 0.5-2 was used to calculate the occurrence of severe gingival issues in participants with smoking habits where G-I between 0.50-1.00 displayed Light gingival inflammation, G-I between 1.10-2.00 revealed Moderate gingival inflammation and G-I \> 2.00 confirmed Severe gingival inflammation. A chi-Square test was used for the association by keeping significance \< 0.05.
### Conditions Module
**Conditions:**
- Smoking
**Keywords:**
- Gingival
- Smokers
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 300
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Smoke- form users
**Intervention Names:**
- Other: Gingival Index
**Label:** S-form users
#### Arm Group 2
**Description:** E-Cigarette users
**Intervention Names:**
- Other: Gingival Index
**Label:** E-form users
#### Arm Group 3
**Description:** Dual-Form users
**Intervention Names:**
- Other: Gingival Index
**Label:** D-form users
### Interventions
#### Intervention 1
**Arm Group Labels:**
- D-form users
- E-form users
- S-form users
**Description:** The G-I ranging between 0.5-2 was used to calculate the occurrence of severe gingival issues in participants with smoking habits where G-I between 0.50-1.00 displayed Light gingival inflammation, G-I between 1.10-2.00 revealed Moderate gingival inflammation and G-I \> 2.00 confirmed Severe gingival inflammation.
**Name:** Gingival Index
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The G-I ranging between 0.5-2 was used to calculate the occurrence of severe gingival issues in participants with smoking habits where G-I between 0.50-1.00 displayed Light gingival inflammation, G-I between 1.10-2.00 revealed Moderate gingival inflammation and G-I \> 2.00 confirmed Severe gingival inflammation.
**Measure:** Gingival Index
**Time Frame:** one year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Smokers with good general health status visiting dental hospital
Exclusion Criteria:
* Non-smoker dental patients
**Healthy Volunteers:** True
**Minimum Age:** 21 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients visiting Dental Outpatient Department with history of Smoking
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Islamabad
**Country:** Pakistan
**Facility:** Afsheen Mansoor
**Zip:** 44080
#### Overall Officials
**Official 1:**
**Affiliation:** Pakistan Institute of Medical Sciences
**Name:** Afsheen Mansoor
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Tomar SL, Hecht SS, Jaspers I, Gregory RL, Stepanov I. Oral Health Effects of Combusted and Smokeless Tobacco Products. Adv Dent Res. 2019 Oct;30(1):4-10. doi: 10.1177/0022034519872480.
**PMID:** 31538806
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M12478
- Name: Nicotine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424587
**Brief Title:** The Effect of Music Intervention on Anxiety, Fear, and Pain in Pediatric Patients Receiving Intrathecal Chemotherapy
**Official Title:** The Effect of Music Intervention on Anxiety, Fear, and Pain in Pediatric Patients Receiving Intrathecal Chemotherapy
#### Organization Study ID Info
**ID:** IT
#### Organization
**Class:** OTHER
**Full Name:** Ondokuz Mayıs University
### Status Module
#### Completion Date
**Date:** 2023-12-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ondokuz Mayıs University
#### Responsible Party
**Investigator Affiliation:** Ondokuz Mayıs University
**Investigator Full Name:** Hatice Uzşen
**Investigator Title:** Research assistant
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Intrathecal chemotherapy is often used to prevent the spread of cancer to the central nervous system in pediatric patients and is one of the most invasive procedures. It is believed that the way it is administered and the complications experienced after treatment negatively affect the comfort of the pediatric patient, leading them to refuse the treatment.
**Detailed Description:** Receiving sedation is one of the pharmacological procedures for intrathecal chemotherapy which creates a particularly difficult situation for the child. However, since pharmacological methods increase the cost and cause toxicity in children, in recent years, the symptoms that occur in cancer treatment have been tried to be controlled with non-pharmacological methods. Music intervention facilitates a sense of control in patients and provides mental distraction, emotional smoothness, and relaxation, which have been found to have pain relief effects.
### Conditions Module
**Conditions:**
- Nurse's Role
**Keywords:**
- anxiety
- hematology-oncology nursing
- pain intervention
- randomized controlled trial
- fear
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** a parallel group, randomized, controlled experimental study.
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 50
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In addition to the routine practice of the clinic, the pediatric patients in this group listened to music through headphones for 20 minutes just before the procedure to reduce the child's anxiety and fear. The therapeutic effect of music was used. Before the study, children between the ages of 6 and 12 who were inpatients at the clinic were asked what music they most liked to listen to, what kind of music they liked, and what their favorite artists and songs were. The music was selected based on the children's answers. In addition, the researcher added children's songs by a musician named Banu Kanıbelli.
**Intervention Names:**
- Behavioral: Music intervention
**Label:** Music intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Children were verbally informed about the treatment process and invasive procedures from the day they were diagnosed with the disease. The children in this group were verbally informed by the nurse in charge of the clinic about the intrathecal chemotherapy treatment and why it was performed
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Music intervention group
**Description:** : In addition to the routine practice of the clinic, the pediatric patients in this group listened to music through headphones for 20 minutes just before the procedure to reduce the child's anxiety and fear. The therapeutic effect of music was used. Before the study, children between the ages of 6 and 12 who were inpatients at the clinic were asked what music they most liked to listen to, what kind of music they liked, and what their favorite artists and songs were. The music was selected based on the children's answers. In addition, the researcher added children's songs by a musician named Banu Kanıbelli
**Name:** Music intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Child Anxiety Meter-State
**Measure:** anxiety
**Time Frame:** 30 minutes before intrathecal chemotherapy treatment and just after music intervention
**Description:** Children's Fear Scale
**Measure:** fear
**Time Frame:** 30 minutes before intrathecal chemotherapy treatment and just after music intervention
**Description:** Face, Legs, Activity, Cry, Consolability (FLACC) pain scale
**Measure:** pain scale
**Time Frame:** 60 minutes after intrathecal chemotherapy treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* To be between 6-12 years old,
* Being treated in the Hematology and Oncology Clinic,
* About to receive intrathecal chemotherapy treatment,
* The child not having pain before intrathecal chemotherapy treatment
Exclusion criteria were,
* Refusing to participate in the study,
* Being under 6 years of age and over 10 years of age,
* The child having pain prior to intrathecal chemotherapy treatment,
* Having any physical or mental disability,
* Not being able to speak Turkish.
**Maximum Age:** 12 Years
**Minimum Age:** 6 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Samsun
**Country:** Turkey
**Facility:** Ondokuz Mayis University
**State:** Black Sea
**Zip:** 55100
#### Overall Officials
**Official 1:**
**Affiliation:** ondokuz mayıs üniversity
**Name:** Hatice Uzsen, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424574
**Brief Title:** The Effect of Motivational Interviewing in Children With Type 1 Diabetes
**Official Title:** The Effect of Motivational Interviewing on Hypoglycemia Fear Caring Failure and Self-commission in Parents of Children With Type 1 Diabetes
#### Organization Study ID Info
**ID:** DBAYKAL1421
#### Organization
**Class:** OTHER
**Full Name:** Yuzuncu Yıl University
### Status Module
#### Completion Date
**Date:** 2022-08-19
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-08-19
**Type:** ACTUAL
#### Start Date
**Date:** 2021-07-26
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Yuzuncu Yıl University
#### Responsible Party
**Investigator Affiliation:** Yuzuncu Yıl University
**Investigator Full Name:** Dilek Çiftci Baykal
**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 research was conducted in a randomized controlled experimental way to determine the effect of motivational interviewing on hypoglycemia fear, caregiving, fatigue and self-compassion in parents of children with Type 1 diabetes. The research was conducted with the parents of the patients who came to the Pediatric Endocrinology polyclinic of the Van Training and Research Hospital of the University of Health Sciences between July 26, 2021 and August 19, 2022. The research was carried out in two stages. The first stage was carried out methodologically to determine the validity and reliability of the "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" in Turkish. The sample of the study was composed of 102 parents and the data were collected with the "Descriptive Information Form" and the " Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)". "Language", "scope" and "construct" validity analyzes were used to evaluate the validity of the scale. KMO and Bartlett's Tests and factor analysis were evaluated for construct validity. As a result of the reliability analysis the Cronbach Alpha coefficient of the scale was found to be 0.817. As a result it was seen that the two 19 item sub-dimensions of the Turkish form of the "Parental Version Of The Diabetes Specific Self-Compassion Scale SCS-(Dp)" were confirmed for the Turkish form in the same way. The sample of the second phase of the study consisted of 74 parents with Type 1 diabetes children, 37 of which were in the study group and 37 in the control group. İn the collection of data process, "Descriptive Information Form", "University of Virginia Parent Low Blood Sugar Scale", "BAKAS Care-Giving Impact Scale", "Fatigue Severity Scale", "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" was used.
**Detailed Description:** This research was conducted in a randomized controlled experimental way to determine the effect of motivational interviewing on hypoglycemia fear, caregiving, fatigue and self-compassion in parents of children with Type 1 diabetes. The research was conducted with the parents of the patients who came to the Pediatric Endocrinology polyclinic of the Van Training and Research Hospital of the University of Health Sciences between July 26, 2021 and August 19, 2022. The research was carried out in two stages. The first stage was carried out methodologically to determine the validity and reliability of the "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" in Turkish. The sample of the study was composed of 102 parents and the data were collected with the "Descriptive Information Form" and the " Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)". "Language", "scope" and "construct" validity analyzes were used to evaluate the validity of the scale. KMO and Bartlett's Tests and factor analysis were evaluated for construct validity. As a result of the reliability analysis the Cronbach Alpha coefficient of the scale was found to be 0.817. As a result it was seen that the two 19 item sub-dimensions of the Turkish form of the "Parental Version Of The Diabetes Specific Self-Compassion Scale SCS-(Dp)" were confirmed for the Turkish form in the same way. The sample of the second phase of the study consisted of 74 parents with Type 1 diabetes children, 37 of which were in the study group and 37 in the control group. İn the collection of data process, "Descriptive Information Form", "University of Virginia Parent Low Blood Sugar Scale", "BAKAS Care-Giving Impact Scale", "Fatigue Severity Scale", "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" was used.
The scales were applied at the beginning of the study and 10 weeks after the first data. After the first test data were obtained from each parent in our research group, four face-to-face motivational interviews were conducted at two-week intervals. In the interviews, attempts were made to change and improve the behaviors and skills that parents felt inadequate within the scope of fear of hypoglycemia, caregiving, fatigue and self-compassion.
### Conditions Module
**Conditions:**
- Motivational Interviewing
- Type 1 Diabetes
- Hypoglycemia
- Fatigue
- Self-Compassion
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 74
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** I. Interview: -Research for parents information was given about. Pretest forms were applied.
Pre-test forms from filling;
1. st interview after 2 weeks (45 min)
2. nd interview after 2 weeks (45 min)
3. Interviews after 2 weeks (45 min)
4. th interview after 2 weeks (45 min)
5. th interview: Post-test data were obtained 2 weeks after the last interview they were.
**Intervention Names:**
- Behavioral: motivational interview
**Label:** Motivational interviewing
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** I. Interview: -Research for parents information was given about. Pretest forms were applied.
II interview: Post-test data were obtained 2 weeks after the last interview they were.
Post-test data were obtained 10 weeks after the last interview (it was ensured that the same time period passed with the experimental group)
**Label:** Standard care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Motivational interviewing
**Description:** The sample of the second phase of the study consisted of 74 parents with Type 1 diabetes children, 37 of which were in the study group and 37 in the control group. İn the collection of data process, "Descriptive Information Form", "University of Virginia Parent Low Blood Sugar Scale", "BAKAS Care-Giving Impact Scale", "Fatigue Severity Scale", "Parental Version Of The Diabetes-Specific Self-Compassion Scale SCS-(Dp)" was used. The scales were applied at the beginning of the study and 10 weeks after the first data. After the first test data were obtained from each parent in our research group, four face-to-face motivational interviews were conducted at two-week intervals. In the xvii interviews, attempts were made to change and improve the behaviors and skills that parents felt inadequate within the scope of fear of hypoglycemia, caregiving, fatigue and self-compassion.
**Name:** motivational interview
**Other Names:**
- Experimental
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** "Virginia Parent Low Blood Sugar Scale (P-LBSS)" It was developed by Gonder-Frederick and colleagues to assess parents' fear of their children's HG . The validity and reliability of the Turkish version of the scale was measured by Şen Celasin et al. in 2018. According to the results of the factor analysis, the p-LBSS scale in Turkish version has two sub-dimensions as in the original. The scale is a 4-point Likert-type scale consisting of 25 questions and two subscales (behaviour, anxiety). Scoring on the scale is between 0 and 100 and the higher the score on the scale, the higher the rate of increase in HG fear
**Measure:** The effect of motivational interviewing on parents' fear of hyperglycaemia Diabetes-Specific Self-Compassion Scale SCS-(Dp)
**Time Frame:** 13 monts
**Description:** "Bakas Caregiving Impact Scale" is a measurement tool developed by Bakas and colleagues in 1999 to evaluate how the experiences of caregivers change with the caregiving process (Bakas et al., 2006). The scale consists of a total of 15 items and shows positive and negative effects. The scale is a Likert-type scale ranging from 1 to 7, scored from +3 (for the best) to -3 (for the worst). Scoring is done as -3=1, -2=2, -1=3, 0=4, +1=5, +2=6, +3=7. The lowest score that can be obtained from the scale is 15 and the highest score is 10. As the scores increase, it is interpreted as "change for the better" and as the scores decrease, it is interpreted as "change for the worse".
**Measure:** The effect of motivational interviewing on parents' caregiving effects
**Time Frame:** 13 months
**Description:** The Fatigue Severity Scale, which was also developed in the USA, was used for the first time in patients with multiple sclerosis.
was used. Turkish validity and reliability study of the scale It was conducted by Armutlu et al. in 2007. The scale has 9 questions and each question consists of 7 points. An increase in the scale score indicates an increase in the level of fatigue.
The scale determines the fatigue status of individuals in the last 1 month. The questions are scored as strongly disagree (1)- strongly agree (7). The scale score is the average value of the questions. If the average score is 4 and above, it is considered as "severe fatigue". The lower the total score, the less "fatigue".
**Measure:** The effect of motivational interviewing on parents' fatigue severity
**Time Frame:** 13 months
**Description:** The scale was developed by Tanenbaum et al. in 2020 to measure whether they have self-efficacy in coping with diabetes and coping with their emotions. The scale consists of 19 items and is a 5-point Likert-type scale (1="Almost never" and 5="Almost always"). Scale Positive dimension It has a two-factor structure as negative and negative dimension. The total score is calculated by averaging all items. Higher scores indicate higher diabetes-specific self-compassion
**Measure:** The effect of motivational interviewing on parents' level of self-compassion
**Time Frame:** 13 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
* with a child diagnosed with T1D between the ages of 2-18 years,
* Can read and write Turkish, can be reached and communicated with,
* Orientation and co-operation,
* Without hearing, understanding and vision problems,
* Parents who agreed to participate in the study
Exclusion Criteria
* Communication difficulties,
* It is determined as being illiterate.
**Gender Based:** True
**Healthy Volunteers:** True
**Maximum Age:** 18 Years
**Minimum Age:** 2 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Van
**Country:** Turkey
**Facility:** Van YUZUNCU YIL UNIVERSITY
**Zip:** 65100
#### Overall Officials
**Official 1:**
**Affiliation:** Van yuzuncu yil university
**Name:** Dilek ÇİFTCİ BAYKA
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Barnard K, Thomas S, Royle P, Noyes K, Waugh N. Fear of hypoglycaemia in parents of young children with type 1 diabetes: a systematic review. BMC Pediatr. 2010 Jul 15;10:50. doi: 10.1186/1471-2431-10-50.
**PMID:** 20633252
**Citation:** Channon S, Smith VJ, Gregory JW. A pilot study of motivational interviewing in adolescents with diabetes. Arch Dis Child. 2003 Aug;88(8):680-3. doi: 10.1136/adc.88.8.680.
**PMID:** 12876161
**Citation:** Channon SJ, Huws-Thomas MV, Rollnick S, Hood K, Cannings-John RL, Rogers C, Gregory JW. A multicenter randomized controlled trial of motivational interviewing in teenagers with diabetes. Diabetes Care. 2007 Jun;30(6):1390-5. doi: 10.2337/dc06-2260. Epub 2007 Mar 10.
**PMID:** 17351283
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes
- ID: M7117
- Name: Diabetes Mellitus, Type 1
- Relevance: HIGH
- As Found: Type 1 Diabetes
- ID: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
- ID: M10053
- Name: Hypoglycemia
- Relevance: HIGH
- As Found: Hypoglycemia
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000003922
- Term: Diabetes Mellitus, Type 1
- ID: D000007003
- Term: Hypoglycemia
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424561
**Brief Title:** The Influence of Systematic Psychological Intervention on Patients About VSD Drainage Surgery
**Official Title:** The Influence of Systematic Psychological Intervention on Patients Undergoing VSD Drainage Surgery for Chronic Infected Wounds
#### Organization Study ID Info
**ID:** KY-2024-085
#### Organization
**Class:** OTHER
**Full Name:** The Fourth Affiliated Hospital of Zhejiang University School of Medicine
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The Fourth Affiliated Hospital of Zhejiang University School of Medicine
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study focuses on providing clinical care to patients undergoing VSD drainage surgery for chronic wounds, while also paying attention to the impact of negative emotions such as depression and anxiety, as well as quality of life and social support, on the patients' physical and mental well-being. It observes the influence of psychology on patients.
**Detailed Description:** The chronic, difficult-to-heal wounds not recovering within the expected timeframe not only impact the quality of life for patients and hinder the recovery of the primary condition but also exacerbate their financial and psychological burdens, further affecting the quality of wound healing. The objective of this study is to employ psychological nursing interventions effectively combined with nursing techniques and communication strategies. By listening to patients' fears, anxieties, and tensions, it significantly alleviates their negative emotions, enhances compliance with medical advice, and predicts postoperative complications to mitigate them. Tailored and empathetic care, along with psychological counseling, is provided to expedite wound healing.
### Conditions Module
**Conditions:**
- Chronic Wounds
**Keywords:**
- VSD drainage surgery
- systematic psychological intervention
- chronic wounds
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- CARE_PROVIDER
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The patients in the intervention group received systematic psychological intervention on the basis of routine nursing after admission, the main steps were as follows: 1 preoperative and postoperative psychological assessment (self-rating anxiety scale (SAS) and self-rating depression scale (SDS-RRB- to assess the psychological status of patients) , this part through medical records, face-to-fAssessmentment and questionnaire survey; Timely attention to patients' psychological state. 2 at the end of the evaluation, we can start the psychological intervention, collect the pre-intervention scale and post-intervention scale, collect the data, and make records according to the collected data, so as to carry on the follow-up work in the later period. 3 the days of hospitalization, the satisfaction of hospitalization, the expenses of hospitalization and the psychological scale were recorded, and the influence of psychological intervention on the patients was compared with the routine group.
**Intervention Names:**
- Behavioral: Psychological Intervention Group
**Label:** Psychological Intervention Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Routine nursing care is carried out by the regular group based on the measures for VSD drainage procedure.
**Label:** Routine care group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Psychological Intervention Group
**Description:** The intervention group provides psychological education to patients, emphasizing participation in a "Surgery Success" patient group organized by researchers, and collects successful patient cases for promotion. Patients are encouraged to learn from successful cases within the group. Psychological intervention is also provided to family members, as they are the primary caregivers, and guiding their thoughts is crucial. Timely identification of patients with psychological abnormalities is conducted, with psychological consultations if necessary. Targeted measures are taken for patients with psychological abnormalities. Upon discharge, one-on-one consultation and tracking services are provided by designated nurses to alleviate patients' feelings of helplessness and despair, continuing until the patient fully recovers.
**Name:** Psychological Intervention Group
**Other Names:**
- Experimental group
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The Self-Rating Anxiety Scale (SAS) was developed by W.K. Zung in 1971. This scale consists of 20 items reflecting subjective feelings of anxiety, with each item rated on a four-point scale based on the frequency of symptoms. The scoring criteria are as follows: "1" indicates none or very little time; "2" indicates some of the time; "3" indicates a good part of the time; "4" indicates most or all of the time.According to normative results, in China, the standard deviation cutoff for SAS is 53 points. The divisions are as follows:53 to 62 points: Mild anxiety，63 to 72 points: Moderate anxiety，Above 72 points: Severe anxiety.
**Measure:** Self-rating anxiety scale (SAS)
**Time Frame:** After 4 weeks of intervention
**Description:** The Self-Rating Depression Scale (SDS) was developed by W.K. Zung in 1965. This scale comprises 20 items reflecting subjective feelings of depression, with each item rated on a four-point scale based on the frequency of symptoms. For positively scored items, the ratings are 1, 2, 3, 4 respectively, while for negatively scored items, they are 4, 3, 2, 1. The normal upper limit for the total raw score of SDS is 41 points, with lower scores indicating better states. The standard score is obtained by multiplying the total raw score by 1.25 and taking the integer part. The standard deviation cutoff for SDS is 53 points. The divisions are as follows:53 to 62points:Mild depression，63 to 72 points: Moderate depression，Above 73 points: Severe depression.
**Measure:** self-rating depression scale (SDS）
**Time Frame:** After 4 weeks of intervention
#### Secondary Outcomes
**Description:** The satisfaction was calculated using our hospital's unified discharge satisfaction questionnaire for inpatients. Each item is rated on a scale of 1 to 5, with a total of 20 items and a maximum score of 100 points. Scores above 95 are considered satisfied, scores between 90 and 95 are deemed basically satisfied, and scores below 90 indicate dissatisfaction.
**Measure:** Patient satisfaction with hospitalization
**Time Frame:** After 4 weeks of intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
- A mentally healthy, communicative adult. Patients and their families are cooperative, understanding, and supportive of this study.
Adult patients undergoing VSD surgery for chronic wounds.
Exclusion Criteria:
- Patients who are unable to effectively cooperate with nursing questionnaires due to auditory or visual impairments, cognitive impairments, or low levels of cultural literacy.
Patients with poor compliance or those who harbor skepticism and hostility towards this research.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Wound
- ID: M17684
- Name: Wound Infection
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000014947
- Term: Wounds and Injuries
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424548
**Brief Title:** Comparison of the Improvement and Safety of the Ankle Brachial Arterial Pressure Index of Sarpogrelate and Clopidogrel in Stroke Patients With Decreased Ankle Brachial Arterial Pressure Index and Intermittent Claudication of Lower Limb Vascular Atherosclerosis.
**Official Title:** A Randomized, Open-label, Investigator-initiated, Pilot Clinical Trial Comparing the Improvement for Ankle Brachial Index and Safety of Sarpogrelate and Clopidogrel in Stroke Patients Accompanying Lower Extremity Vascular Atherosclerosis With Decrease of Ankle Brachial Index and Intermittent Claudication.
#### Organization Study ID Info
**ID:** SEUMC 2023-10-009
#### Organization
**Class:** OTHER
**Full Name:** Ewha Womans University Seoul Hospital
### Status Module
#### Completion Date
**Date:** 2028-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-16
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-15
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ewha Womans University Seoul Hospital
#### Responsible Party
**Investigator Affiliation:** Ewha Womans University Seoul Hospital
**Investigator Full Name:** Tae-Jin Song, MD, PhD
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The clinical trial aims to confirm the improvement effect of the ankle brachial index and the safety of sarpogrelate administration compared to clopidogrel in stroke patients with decreased ankle brachial arterial pressure index and intermittent claudication of lower limb vascular atherosclerosis. Subjects are assigned to one of the two combinations through random allocation.
Intervention group: Aspirin 100mg + sarpogrelate 300mg dosing group, Control group: Aspirin 100mg + clopidogrel 75mg dosing group. This clinical trial is a prospective open study and will be conducted in compliance with the usual diagnosis and treatment process, and in particular, all trial subjects will be tested and treated appropriately in accordance with the standard treatment guidelines for ischemic stroke during the clinical trial period.
**Detailed Description:** A total of 100 subjects are recruited and divided into a intervention group and a control group through randomization.
In this clinical trial, the intervention group and the control group are assigned 1:1.
The researcher allocates 1:1 to the intervention group or control group through a two-way random number table on the assignment date in the order of the subjects who are satisfied with the Inclusion and exclusion criteria and agreed to the study.
This study is a prospective open randomized clinical trial that can confirm which group the subjects themselves were assigned to. After randomization, the drug is prescribed and the outcome variable is checked at 12 months.
During the course of the clinical trial, the examiner and researchers carefully observe the presence or absence of adverse events during the follow-up period after randomization, and closely observe outcome variables, including neurological changes.
Visit after 6 months and 12 months during the clinical trial period to confirm the effectiveness and safety. When an event corresponding to the outcome variable occurs, the researcher first plans to implement appropriate medical measures in this regard.
Both groups will be conducted in compliance with the usual diagnosis and treatment process, and in particular, all subjects will be tested and treated appropriately according to the standard treatment guidelines for ischemic stroke during the clinical trial period.
The purpose of this study is to determine whether there is a difference in the improvement and safety of the ankle-brachial arterial pressure index of aspirin+sarpogrelate and aspirin+clopidogrel in stroke patients with decreased ankle-brachial arterial pressure index and intermittent claudication.
### Conditions Module
**Conditions:**
- Stroke
- Atherosclerosis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The intervention group will receive aspirin 100mg plus sarpogrelate 100mg
**Intervention Names:**
- Drug: Administration of Sarpogrelate
**Label:** Administration of Sarpogrelate
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control group will receive aspirin 100mg plus clopidogrel 75mg
**Intervention Names:**
- Drug: Traditional administration of Clopidogrel
**Label:** Traditional administration of Clopidogrel
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Administration of Sarpogrelate
**Description:** Aspirin 100mg plus Sarpogrelate 100mg
**Name:** Administration of Sarpogrelate
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Traditional administration of Clopidogrel
**Description:** Aspirin 100mg plus Clopidogrel 75mg
**Name:** Traditional administration of Clopidogrel
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The value of the ankle brachial index evaluated 12 months after the first dose of the clinical trial drug. Ankle brachial index : normal range \> 0.9, abnormal range \< 0.9
**Measure:** Ankle brachial index
**Time Frame:** Baseline, 12months
#### Secondary Outcomes
**Description:** The value of the ankle brachial index evaluated 6 months after the first dose of the clinical trial drug. Ankle brachial index : normal range \> 0.9, abnormal range \< 0.9
**Measure:** Ankle brachial index
**Time Frame:** Baseline, 6months
**Description:** The value of Brachial ankle pulse wave velocity evaluated 6 months and 12months after the first dose of the clinical trial drug. Brachial ankle pulse wave velocity : normal range 1000\~1500 cm/sec, abnormal range \> 1600 cm/sec
**Measure:** Brachial ankle pulse wave velocity
**Time Frame:** Baseline, 6months, 12months
**Description:** Major cardio-cerebrovascular events that occurred within 6 months and 12 months after the first medication related to the clinical trial. (Stroke, myocardial infarction, non-stable angina, lower limb vascular intervention, surgery, death)
**Measure:** Major cardio-cerebrovascular events
**Time Frame:** Baseline, 6months, 12months
**Description:** Whether or not to perform lower limb angioplasty or re-operation, evaluated 6 months and 12 months after the first dose of the clinical trial drug.
**Measure:** Lower limb angioplasty or re-operation
**Time Frame:** Baseline, 6months, 12months
**Description:** Change of Rutherford category ratio, a symptom scale related to vascular stenosis of the lower extremities, evaluated 6 months and 12 months after the first dose of the clinical trial drug. (Grade 0-Asymptomatic, Grade 1-Mild claudication, Grade 2-Moderate claudication, Grade 3-Severe claudication, Grade 4-Ischemic rest pain, Grade 5-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia, Grade 6-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable)
**Measure:** Change of Rutherford category ratio
**Time Frame:** Baseline, 6months, 12months
**Description:** Modified Rankin scale evaluated 6 months and 12 months after the first dose of the clinical trial drug. (0-No symptoms at all, 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance, 4-Moderate to severe disability; unable to walk without assistance, and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention, 6-Death)
**Measure:** Modified Rankin scale
**Time Frame:** Baseline, 6months, 12months
**Description:** Changes in NIHSS evaluated at 6 months and 12 months after the first dose of the clinical trial drug. National Institutes of Health Stroke Scale score of 0 (lowest point) means normal, and a score of 42 (high point) means severe dysfunction caused by stroke, so the higher the score, the more severe the stroke.
**Measure:** National Institutes of Health Stroke Scale
**Time Frame:** Baseline, 6months, 12months
**Description:** Confirmation that coronary angioplasty was performed at 6 months and 12 months after the first dose of the drug in the clinical trial.
**Measure:** Coronary angioplasty
**Time Frame:** Baseline, 6months, 12months
**Description:** Confirmation that cerebrovascular angioplasty was performed at 6 months and 12 months after the first dose of the drug in the clinical trial.
**Measure:** Cerebrovascular angioplasty
**Time Frame:** Baseline, 6months, 12months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Aged 19 or over.
2. Neurologically stable patients after 7 days and within 6 months of diagnosis of ischemic stroke.
3. Patients with ankle-brachial index (ABI) \<0.9 performed within 6 months of screening, with lower limb vascular stenosis and intermittent claudication.
4. A person who voluntarily agrees to participate in this clinical trial in writing.
Exclusion Criteria:
1. Patients who are unable or contraindicated to administer antithrombotic drugs.
2. Patients with less than 80,000 platelets, less than 8.0 hemoglobin, liver levels and total bilirubin levels three times normal according to laboratory standards, according to blood tests conducted within one month.
3. Patients identified as undergoing renal replacement therapy such as dialysis due to acute or terminal nephropathy during screening.
4. Patients diagnosed with or treated for cancer within 6 months of screening, or identified as having recurrent or metastatic cancer.
5. Patients confirmed to be on medication for liver diseases such as liver cirrhosis during screening.
6. A pregnant and lactating women.
7. Patients with a history of hemorrhagic tendency, conventional cerebral hemorrhage, and gastrointestinal hemorrhage.
8. Patients who need oral anticoagulant therapy instead of antiplatelet drugs for screening.
9. Patients who are at least 3 in the Rutherford category and need lower-limb vascular procedure/surgery within 6 months, as judged by the doctor.
10. A patient with a loss of consciousness/cognition.
11. Any person who determines that the tester is not suitable for participating in the clinical trial for other reasons.
**Minimum Age:** 19 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sujin Han
**Phone:** 820269862635
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
- ID: D000058729
- Term: Peripheral Arterial Disease
- ID: D000016491
- Term: Peripheral Vascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M26188
- Name: Atherosclerosis
- Relevance: HIGH
- As Found: Atherosclerosis
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- ID: M10418
- Name: Intermittent Claudication
- Relevance: HIGH
- As Found: Intermittent Claudication
- 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: M4469
- Name: Arteriosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M29213
- Name: Peripheral Arterial Disease
- Relevance: LOW
- As Found: Unknown
- ID: M18894
- Name: Peripheral Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
- ID: D000050197
- Term: Atherosclerosis
- ID: D000007383
- Term: Intermittent Claudication
### Intervention Browse Module - Ancestors
- ID: D000010975
- Term: Platelet Aggregation Inhibitors
- ID: D000058921
- Term: Purinergic P2Y Receptor Antagonists
- ID: D000058919
- Term: Purinergic P2 Receptor Antagonists
- ID: D000058914
- Term: Purinergic Antagonists
- ID: D000058905
- Term: Purinergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000005343
- Term: Fibrinolytic Agents
- ID: D000050299
- Term: Fibrin Modulating Agents
- ID: D000012702
- Term: Serotonin Antagonists
- ID: D000018490
- Term: Serotonin Agents
### Intervention Browse Module - Browse Branches
- Abbrev: FiAg
- Name: Fibrinolytic Agents
- Abbrev: PlAggInh
- Name: Platelet Aggregation Inhibitors
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Antipy
- Name: Antipyretics
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M209351
- Name: Sarpogrelate
- Relevance: HIGH
- As Found: Recurrent adult Hodgkin lymphoma
- ID: M1669
- Name: Clopidogrel
- Relevance: HIGH
- As Found: Topical
- ID: M4548
- Name: Aspirin
- Relevance: LOW
- As Found: Unknown
- ID: M13865
- Name: Platelet Aggregation Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M29294
- Name: Purinergic P2Y Receptor Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M8473
- Name: Fibrinolytic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M15512
- Name: Serotonin
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000064294
- Term: Sarpogrelate
- ID: D000077144
- Term: Clopidogrel
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424535
**Brief Title:** Integrated Traditional Chinese and Western Medicine to Care for the Late Stage of Mild to Moderate Burns and Scalds
**Official Title:** Integrated Traditional Chinese and Western Medicine to Care for the Late Stage of Mild to Moderate Burns and Scalds
#### Organization Study ID Info
**ID:** CMUH113-REC1-055
#### Organization
**Class:** OTHER
**Full Name:** China Medical University Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-03-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** China Medical University 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:** To explore the effectiveness of TCM interventional treatment in shortening the recovery time and improving accompanying symptoms of burns and scalds. A single-center, randomized control crossover trial will compare TCM intervention to routine western medicine intervention.
**Detailed Description:** Burns are an irreversible traumatic injury. When the skin suffers severe burns, it will cause a systemic shock to the individual. Although in recent years, with the advancement of medical technology, the mortality rate from burns and scalds has dropped significantly compared with the past, patients with burns and scalds also face many challenges during the treatment process, including having to endure the pain of the wound and the risk of infection during hospitalization. During the rehabilitation period after discharge, scarring, limb contracture, skin itching and appearance changes caused by burns and scalds will cause a significant decline in the patient's quality of life and lead to depression, withdrawal, social isolation and other phenomena. Traditional Chinese medicine is based on empirical medicine and the observation records of doctors. It has been passed down from generation to generation, and also have experience in treating fever. There are external and internal treatments for treating burns and scalds. External medicinal powders and ointments, such as Sanhuang powder,Jinchuang ointment,Ziyun ointment, etc. For internal medicine,Huanglian Jiedu Decoction,Qingying Decoction,Xijiao Dihuang Decoction,Tuoli Disinfection Powder,Shenling Baizhu Powder, etc. can be used according to different syndrome types. In addition, past studies have also confirmed that acupuncture can relieve burns and scalds and inhibit scar formation. Acupuncture can also improve gastrointestinal function and can be used to maintain good nutrient absorption in patients during the treatment of burns and scalds.
There are few large-scale studies on the joint treatment of burns and scalds between Chinese and Western medicine. Therefore, the purpose of this project is to compare the wound healing status and healing time between two groups that simply received conventional Western medicine treatment and conventional treatment plus interventional treatment with Chinese medicine. The study investigate traditional Chinese medicine interventional treatment model for mild to moderate burns and scalds, and hope to implement it clinically in the future to improve medical quality and treatment efficiency.
A single-center, randomized control crossover trial. This study will be conducted at the Burn and Scald Center and Plastic Surgery/Traditional Chinese Medicine Clinic of China Medical University Hospital. When patients seek medical treatment for burns and scalds, they will be evaluated by a plastic surgeon and randomly assigned into two groups. One group will receive conventional Western medicine treatment plus TCM intervention. Different treatment strategies will be adopted depending on the severity of the condition, and the first assessment will be conducted before TCM interventional treatment. , a post-test was conducted four weeks after treatment. Afterward, the two groups will be alternated. The group that did not receive TCM intervention received TCM interventional treatment for four weeks, while the other group received only conventional Western medicine treatment. The assessment items included: assessment of wound and pain status. Pain status was assessed using the Visual Analogue Scale (VAS), and scars were assessed using the Vancouver Scar Scale (VSS). Assess, and record critical indicators according to clinical needs, such as caloric requirement (kcal), daily fluid requirement (ml), daily urine output (ml) and other physiological parameters, and record the burn area (Modified Lund-Browder chart) and depth. The control group will be treated with conventional Western medicine. Outcome measurements will be assessed at baseline, 4 weeks, and 4 weeks after crossover (8 weeks). The goal of our study is to measure the effectiveness of TCM interventional treatment in shortening recovery time and improving accompanying symptoms of burns and scalds.
### Conditions Module
**Conditions:**
- Burns and Scalds
**Keywords:**
- Acupuncture
- Chinese medicine
- Burns
- Scalds
- Low level laser
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** 1:1 randomized controlled crossover study
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 1. Traditional Chinese medicine for internal or external use
2. Acupuncture or laser acupuncture treatment
3. Acupoint massage
4. Traditional Chinese Medicine Cake Acupoint Application:
5. Nursing and health education and guidance
6. Dietary hygiene education
**Intervention Names:**
- Other: Chinese medicine for internal or external use、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application of traditional Chinese herbal medicinal cake
**Label:** intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Routine Western medicine burn and scald care prescribed by department doctor
**Intervention Names:**
- Other: Western medicine
**Label:** control group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- intervention group
**Description:** The treatment project a Chinese medicine practitioner based individual needs of the patient, and will be followed by a four-week treatment.
1. Traditional Chinese medicine for internal or external use: prescribe Chinese medicine based on syndrome differentiation and treatment of the patient's condition.
2. Acupuncture or laser acupuncture treatment: Traditional Chinese medicine practitioners select acupuncture points to treat based on the patient's condition, and treat them twice a week for 20 minutes each time.
3. Acupoint massage: Select treatment acupoints and techniques according to the patient's condition, 20 minutes at a time.
4. Traditional Chinese Medicine Cake Acupoint Application: Warm Navel Cream to the CV-4 (Guanyuan) acupoint once a day
5. Nursing and health education and guidance
6. Dietary hygiene education: personalized western nutrition and TCM dietary guidance suggestions based on TCM constitution syndromes.
**Name:** Chinese medicine for internal or external use、Acupuncture or Laser acupuncture pen treatment、Acupoint Tuina massage、Acupoint application of traditional Chinese herbal medicinal cake
**Other Names:**
- Traditional Chinese medicine
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- control group
**Description:** Patients will receive routine Western medicine treatments as per individual patient's needs. The medications and bandages can vary due to the depth and size of the burn and scald.
**Name:** Western medicine
**Other Names:**
- Routine Western medicine care
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Measured by the Visual Analogue Scale (VAS) 0-10: 0 =No Pain 2 = Mild 4 = Nagging 6 =Miserable 8 =Intense 10 = Worst
**Measure:** Visual Analogue Scale
**Time Frame:** At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
**Description:** Scars measurement will be assessed using the Vancouver Scar Scale (VSS)Each characteristic is given a score, which are added together to give an overall score between 0 and 13. Higher score indicate wrost outcome.
**Measure:** Vancouver Scar Scale
**Time Frame:** At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
#### Secondary Outcomes
**Description:** Amount of caloric (kcal) consumed per patient per day measured by department's nurse calculated by the amount of calories the patient consumed via feeding tube or oral feeding
**Measure:** Caloric intake per day
**Time Frame:** At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
**Description:** Amount of daily fluid requirement (ml) per patient per day measured by department's nurse in milliliters (ml) of fluid intake and intravenous infusion or oral intake.
**Measure:** Daily fluid requirement (ml)
**Time Frame:** At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
**Description:** Amount of Daily urine output measured by department's nurse in milliliters(ml) per patient patients Daily urine output measured by department's nurse in milliliters(ml) per day
**Measure:** Daily urine output
**Time Frame:** At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
**Description:** burn area measured by Modified Lund-Browder chart, the score represents percentage (%) of the body cover by the burn along with body area, it score 0-100 and a higher score indicate worst outcome
**Measure:** Lund-Browder chart
**Time Frame:** At baseline, 4 weeks, and 4 weeks after crossover (8 weeks)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age：20-90.
* Patients with mild to moderate injuries and burns that meet the American Burn Association (ABA) injury classification.
Exclusion Criteria:
* Patients refuse TCM intervention.
**Maximum Age:** 90 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yu-Chen Lee, Ph.D.
**Phone:** 886-4-22052121
**Phone Ext:** 14564
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Taichung city
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yu-Chen Lee, PHD
- **Role:** CONTACT
**Country:** Taiwan
**Facility:** China Medical University Hospital
**Status:** RECRUITING
**Zip:** 403
## 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: M5326
- Name: Burns
- Relevance: HIGH
- As Found: Burn
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002056
- Term: Burns
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424522
**Brief Title:** A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
**Official Title:** Low Anterior Resection Syndrome: Retrograde Enema Program vs Medical Management
#### Organization Study ID Info
**ID:** OSU-22312
#### Organization
**Class:** OTHER
**Full Name:** Ohio State University Comprehensive Cancer Center
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2024-03173
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-10-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ohio State University Comprehensive Cancer Center
#### Responsible Party
**Investigator Affiliation:** Ohio State University Comprehensive Cancer Center
**Investigator Full Name:** Alessandra
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This clinical trial studies if a bowel management program with a retrograde rectal enema (RRE) for the treatment of low anterior resection syndrome (LARS) in rectal cancer patients is better than medical management alone. Rectal cancer treatment can include a procedure where part of the rectum with cancer is removed and the remaining part of the rectum is reconnected to the colon, this is called a low anterior resection of the rectum. LARS is a common condition that can develop after undergoing a low anterior resection of the rectum. LARS consists of any change in how the body performs defecation, the discharge of feces from the body, after undergoing a resection procedure. Patients with LARS may experience fecal urgency, incontinence, increased frequency, constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Patients may experience individual symptoms of LARS or a combination of them. A bowel management program assists patient's with identifying a specific bowel management regimen that works best for managing symptoms of LARS. A RRE consists of inserting a catheter through the anus into the rectum. The RRE is designed to assist fecal emptying. Medical management of LARS can include the use of fiber, loperamide hydrochloride, or pelvic floor physical therapy. Fiber may help relieve constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Loperamide hydrocholoride may help lessen fecal urgency, incontinence, or increased frequency. Pelvic floor physical therapy may help restore strength in the rectum possibly helping to improve symptoms of LARS. Participating in a bowel management program with a RRE may be more effective in treating LARS than medical management alone.
**Detailed Description:** PRIMARY OBJECTIVE:
I. To compare two approved pathways for treatment of low anterior resection syndrome (LARS) - a retrograde enema program versus a medical management pathway.
SECONDARY OBJECTIVE:
I. The determination of feasibility to complete this treatment pathway.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo a bowel management program comprising a medical management pathway (fiber, loperamide hydrochloride, pelvic floor physical therapy) in combination with RRE treatment for 1 year. Patients use the RRE system to self administer an individualized enema regimen via the rectum. Patients may undergo abdominal film x-rays throughout the trial.
GROUP II: Patients receive medical management comprising fiber, loperamide hydrochloride, and pelvic floor therapy for 1 year. If medical management fails, patients may then be referred for surgery with sacral nerve stimulator placement.
Upon completion of study intervention all patients are followed up at 1 month, 3 months, and 1 year.
### Conditions Module
**Conditions:**
- Low Anterior Resection Syndrome
- Rectal Carcinoma
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients undergo a bowel management program comprising a medical management pathway (fiber, loperamide hydrochloride, pelvic floor physical therapy) in combination with RRE treatment for 1 year. Patients use the RRE system to self administer an individualized enema regimen via the rectum. Patients may undergo abdominal film x-rays throughout the trial.
**Intervention Names:**
- Dietary Supplement: Dietary Fiber
- Procedure: Enema Administration
- Drug: Loperamide Hydrochloride
- Procedure: Physical Therapy
- Other: Questionnaire Administration
- Procedure: X-Ray Imaging
**Label:** Group I (RRE, medical managment)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients receive medical management comprising fiber, loperamide hydrochloride, and pelvic floor therapy for 1 year. If medical management fails, patients may then be referred for surgery with sacral nerve stimulator placement.
**Intervention Names:**
- Dietary Supplement: Dietary Fiber
- Drug: Loperamide Hydrochloride
- Procedure: Physical Therapy
- Other: Questionnaire Administration
**Label:** Group II (medical management)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group I (RRE, medical managment)
- Group II (medical management)
**Description:** Receive dietary fiber
**Name:** Dietary Fiber
**Other Names:**
- Fiber
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Group I (RRE, medical managment)
**Description:** Undergo RRE
**Name:** Enema Administration
**Other Names:**
- Enema
- Enema Injection
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Group I (RRE, medical managment)
- Group II (medical management)
**Description:** Receive loperamide hydrochloride
**Name:** Loperamide Hydrochloride
**Other Names:**
- Imodium
- Imodium A-D
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Group I (RRE, medical managment)
- Group II (medical management)
**Description:** Undergo pelvic floor physical therapy
**Name:** Physical Therapy
**Other Names:**
- Physiatric Procedure
- Physical Medicine Procedure
- Physical Therapeutics
- Physical Therapy Procedure
- Physiotherapy
- Physiotherapy Procedure
- PT
**Type:** PROCEDURE
#### Intervention 5
**Arm Group Labels:**
- Group I (RRE, medical managment)
- Group II (medical management)
**Description:** Ancillary studies
**Name:** Questionnaire Administration
**Type:** OTHER
#### Intervention 6
**Arm Group Labels:**
- Group I (RRE, medical managment)
**Description:** Undergo abdominal film x-ray
**Name:** X-Ray Imaging
**Other Names:**
- Conventional X-Ray
- Diagnostic Radiology
- Medical Imaging, X-Ray
- Plain film radiographs
- Radiographic Imaging
- Radiographic imaging procedure (procedure)
- Radiography
- RG
- Static X-Ray
- X-Ray
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Will be measured using a validated scoring tool for LARS (Memorial Sloan Kettering Cancer Center Bowel Function Instrument Questionnaire \[MSKCC BFI\]). Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.
**Measure:** Fecal incontinence
**Time Frame:** Up to 1 year from start of treatment
**Description:** Will be assessed using LARS validated scoring tool. Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.
**Measure:** Effectiveness assessed using LARS validated scoring tool
**Time Frame:** Up to 1 year from start of treatment
#### Secondary Outcomes
**Description:** Will be assessed by administering a patient satisfaction survey post treatment. Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician.
**Measure:** Feasibility measured by Patient Satisfaction Survey
**Time Frame:** At 1 year from start of treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 years old
* LARS diagnosis
* Patients with history of rectal cancer
Exclusion Criteria:
* Patients presenting with significant stricture that need a definitive surgical management strategy; patients with minor or clinically negligible strictures can still be candidates. Patients who are able to pass the catheter and the balloon per rectum may be candidates after a digital rectal exam at their initial visit
* Patients with any chemo or radiation therapy in the last 6 months
* Patients who currently have colorectal cancer
* Patients with recurrent colorectal cancer
* Patients who have undergone a colorectal surgical procedure within the last three months
* Patients \< 18 years old
* Active sacral nerve simulator
* Altered mental status or mental disability that would alter ability to self-administer enema
* Any reason the research team believes the subject is not an appropriate candidate for this study (i.e., transportation issues, history of no-show appointments, lack of reliable communications, vulnerable population(s), etc.)
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** The Ohio State Comprehensive Cancer Center
**Phone:** 800-293-5066
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Columbus
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Alessandra C. Gasior, DO
- **Phone:** 614-722-3879
- **Role:** CONTACT
***Contact 2:***
- **Name:** Alessandra C. Gasior, DO
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Ohio State University Comprehensive Cancer Center
**State:** Ohio
**Zip:** 43210
#### Overall Officials
**Official 1:**
**Affiliation:** Ohio State University Comprehensive Cancer Center
**Name:** Alessandra C Gasior, DO
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** The Jamesline
**URL:** http://cancer.osu.edu
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000012002
- Term: Rectal Diseases
- ID: D000011183
- Term: Postoperative Complications
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M3018
- Name: Low Anterior Resection Syndrome
- Relevance: HIGH
- As Found: Low Anterior Resection Syndrome
- ID: M6336
- Name: Colonic Diseases
- 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
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000094123
- Term: Low Anterior Resection Syndrome
- ID: D000013577
- Term: Syndrome
### Intervention Browse Module - Ancestors
- ID: D000005765
- Term: Gastrointestinal Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Derm
- Name: Dermatologic Agents
### Intervention Browse Module - Browse Leaves
- ID: M11139
- Name: Loperamide
- Relevance: HIGH
- As Found: Hydroxamic Acid
- ID: M4249
- Name: Antidiarrheals
- Relevance: HIGH
- As Found: Hydroxamic Acid
- ID: M6263
- Name: Coal Tar
- Relevance: LOW
- As Found: Unknown
- ID: M8881
- Name: Gastrointestinal Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008139
- Term: Loperamide
- ID: D000000930
- Term: Antidiarrheals
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424509
**Brief Title:** Effects of Psychiatric Admissions on Self-harm and Suicide in People With Borderline Personality Disorder
**Official Title:** Effects of Psychiatric Admissions on Self-harm and Suicide in People With Borderline Personality Disorder
#### Organization Study ID Info
**ID:** 2024-00589-01
#### Organization
**Class:** OTHER
**Full Name:** Lund University
### Status Module
#### Completion Date
**Date:** 2027-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Linkoeping University
#### Lead Sponsor
**Class:** OTHER
**Name:** Lund University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The current study aims to evaluate the impact of long (\>5 days) and/or compulsory psychiatric inpatient care on subsequent healthcare utilization for self-harm and suicide in people with borderline personality disorder, a condition characterized by frequent self-harm.
The basis for this study is the diversity of clinical practices across Swedish regions. By categorizing clinics based on their practices with respect to long and/or compulsory psychiatric inpatient care, it is possible to explore the impact of these practices on subsequent somatic and psychiatric healthcare, including emergency care due to self-harm as well as on completed suicides.
All psychiatric clinics across Sweden authorized to administer compulsory care for adults, totalling 78 clinics will be included. Each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., Umeå2010, Linköping2013, Malmö2022).
Data collection will involve the utilization of the national registers to capture outcome measures and account for confounding factors. The participants will be ranked based on a composite variable, which includes the average number of days spent in inpatient compulsory care and other psychiatric inpatient care exceeding 5 days, among individuals diagnosed with BPD. We will compare the top quartile of participants with the bottom quartile.
### Conditions Module
**Conditions:**
- Borderline Personality Disorder
- Self-harm
- Non-suicidal Self-injury
- Suicide
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 390
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Year
### Arms Interventions Module
#### Arm Group 1
**Description:** The quartile of participants using the highest degree of long (\>5 days) and/or compulsory psychiatric inpatient care.
**Intervention Names:**
- Other: High degree of long (>5 days) and/or compulsory psychiatric inpatient care
**Label:** High admission
#### Arm Group 2
**Description:** The quartile of participants using the lowest degree of long (\>5 days) and/or compulsory psychiatric inpatient care.
**Label:** Low admission
### Interventions
#### Intervention 1
**Arm Group Labels:**
- High admission
**Description:** High degree of long (\>5 days) and/or compulsory psychiatric inpatient care
**Name:** High degree of long (>5 days) and/or compulsory psychiatric inpatient care
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Number of healthcare visits due to self-harm in specialized inpatient or outpatient care, as defined in the NPR (X60-X84; Intentional self-harm) divided by the number of individuals diagnosed with BPD per clinic and calendar year.
**Measure:** Number of healthcare visits due to self-harm
**Time Frame:** 1 year
**Description:** Number of deaths by suicide (X60-X84; Intentional self-harm or Y10-34; Events of undetermined intent) in individuals diagnosed with BPD divided by the number of individuals diagnosed with BPD per clinic and calendar year.
**Measure:** Number of deaths by suicide
**Time Frame:** 1 year
**Description:** Number of deaths by suicide (X60-X84; Intentional self-harm or Y10-34; Events of undetermined intent) within 30 days after discharge, in individuals diagnosed with BPD divided by the number of individuals diagnosed with BPD, per clinic and calendar year
**Measure:** Number of deaths by suicide within 30 days after discharge
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Number of days between admissions to psychiatric inpatient care for people diagnosed with BPD divided by the number of individuals diagnosed with BPD per clinic and calendar year.
**Measure:** Number of days between admissions to psychiatric inpatient care
**Time Frame:** 1 year
**Description:** Number of days between death by suicide (X60-X84; Intentional self-harm or Y10-34; Events of undetermined intent) and discharge in individuals diagnosed with BPD. For this variable, death by suicide during inpatient admission will be labelled 0.
**Measure:** Number of days between death by suicide and discharge
**Time Frame:** 1 year
**Description:** Number of days in somatic (non-psychiatric) inpatient care after self-harm (X60-X84; Intentional self-harm) divided by the number of individuals diagnosed with BPD per clinic and calendar year.
**Measure:** Number of days in somatic (non-psychiatric) inpatient care after self-harm
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Psychiatric clinic in Sweden authorized to administer compulsory care for adults. Each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., Umeå2010, Linköping2013, Malmö2022).
Exclusion Criteria:
* No authorization to administer compulsory care for adults
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** All psychiatric clinics across Sweden authorized to administer compulsory care for adults, totalling 78 clinics. Each clinic per specific calendar year will represent one participant, identified by the clinic's name and the respective year (e.g., Umeå2010, Linköping2013, Malmö2022).
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sofie Westling, MD, PhD
**Phone:** +46735626099
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Josefin Vikström Eckevall, MD, PhD
**Phone:** +46703320527
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Lund University
**Name:** Sofie Westling, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-05-03
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 265547
- Type Abbrev: Prot_SAP
- Upload Date: 2024-05-07T11:23
## 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: M13462
- Name: Personality Disorders
- Relevance: HIGH
- As Found: Personality Disorder
- ID: M5161
- Name: Borderline Personality Disorder
- Relevance: HIGH
- As Found: Borderline Personality Disorder
- ID: M16191
- Name: Suicide
- Relevance: HIGH
- As Found: Suicide
- ID: M19089
- Name: Self-Injurious Behavior
- Relevance: HIGH
- As Found: Self-harm
- 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: D000013405
- Term: Suicide
- ID: D000010554
- Term: Personality Disorders
- ID: D000001883
- Term: Borderline Personality Disorder
- ID: D000016728
- Term: Self-Injurious Behavior
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424496
**Acronym:** PPD
**Brief Title:** Effect of Targeted Health Education Program on Nurses' Awareness About Postpartum Depression
**Official Title:** Effect of Targeted Health Education Program on Nurses' Awareness About Postpartum Depression
#### Organization Study ID Info
**ID:** Nurses' Awareness About PPD
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2024-03-28
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-28
**Type:** ACTUAL
#### Start Date
**Date:** 2024-02-28
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ain Shams University
#### Responsible Party
**Investigator Affiliation:** Ain Shams University
**Investigator Full Name:** Rasha Saad
**Investigator Title:** Assistant professor of Epidemiology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** To assess nurses' knowledge of PPD at Ain Shams University Maternity Hospital and measure their knowledge level after an educational program on postpartum depression.
**Detailed Description:** Postpartum depression (PPD) is a serious mental illness that involves the brain and affects behavior and physical health of women after childbirth . Multiple factors may influence PPD, such as lack of support, interpersonal events, withdrawal of hormones after delivery, psychosocial stressors, psychological stressors, personality, environment, and ineffective adaptation.
Symptoms of PPD may include feeling restless or moody, feeling sad, crying a lot, having thoughts about hurting the baby or yourself, not feeling connected to the baby, having no energy or motivation, eating, or sleeping too little or too much, feeling worthless and guilty, losing interest or pleasure in activities, and withdrawing from friends and family .
PPD is one of the most important health problems due to its prevalence; 10-15% . and serious negative mother-baby outcomes. PPD affects the health of mothers and their newborns and is associated with long-term psychological and socioeconomic implications .
As the knowledge affects attitudes and practices of people, nurses' knowledge can affect profoundly women after birth specially regarding PPD .
In an American web-based study , nurses' self-efficacy about PPD was associated to their knowledge . In another American electronic survey of 372 nurses, 95% reported an association between post-partum education and mortality and 72% reported that it is their responsibility to provide education to mothers .
In a Ghanaian study, nurses had good knowledge about PPD but poor knowledge about screening and management . In a Kazakh study, 90% of nurses didn't attend training courses on PPD ).
Furthermore, in a Malaysian study, 44.4 % of participants were below than median total knowledge score and only 25.9% practiced screening. In a Saudi study, the confidence of nurses and midwives to educate women about PPD was associated with their knowledge. In a Turkish study, 84.4 % of nurses had little knowledge and 75.5% reported that psychological service for evaluating mothers wasn't offered.
PPD can have devastating effects on women, their infants, and families associated with lower levels of bonding and reduced breastfeeding initiation and duration. Consequently, women experiencing PPD may cause harm to their baby, themselves, or others.
As, nurses in Maternity Hospitals are poised to play a pivotal role in the early identification and prompt treatment of PPD, assessing their knowledge is very important. To date, according to our knowledge, there is no previous study in Egypt assessing the nurses' knowledge about PPD, therefore the present study will be conducted to compare their knowledge regarding PPD before and after the health education program.
### Conditions Module
**Conditions:**
- Postpartum Depression
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Quazi-Experimental study (pre/post design).
##### 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:** An intervention study (a quasi-experimental design)pre\&post
**Intervention Names:**
- Other: Effect of Targeted Health Education Program on Nurses' Awareness About Postpartum Depression
**Label:** An intervention study (a quasi-experimental design)
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- An intervention study (a quasi-experimental design)
**Description:** Quazi-Experimental study (pre/post design) to assess the Effect of Targeted Health Education Program on Nurses' Awareness About Postpartum Depression
**Name:** Effect of Targeted Health Education Program on Nurses' Awareness About Postpartum Depression
**Other Names:**
- Quazi-Experimental study (pre/post design).
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluate the effect of the targeted health education program on nurses' knowledge score using a self-administer questionnaire consisting of 28 items covering main issues regarding prevalence risk factors, symptoms, and treatment of PPD. The answer to each question had two options (true or false). The total score ranges from 0-28
**Measure:** To measure the mean change in the nurses' knowledge score after applying the health education program about postpartum depression
**Time Frame:** one month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Nurses at Ain Shams University Maternity Hospital
Exclusion Criteria:
none
-
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** faculty of medicine Ain shams university
**Zip:** 1181
#### Overall Officials
**Official 1:**
**Affiliation:** Faculty of medicine Ain shams univrsity
**Name:** rasha saad Hussein, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000019964
- Term: Mood Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000011644
- Term: Puerperal Disorders
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
### Condition Browse Module - Browse Leaves
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M7061
- Name: Depressive Disorder
- Relevance: HIGH
- As Found: Depression
- ID: M21076
- Name: Depression, Postpartum
- Relevance: HIGH
- As Found: Postpartum 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: M14499
- Name: Puerperal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019052
- Term: Depression, Postpartum
- ID: D000003863
- Term: Depression
- ID: D000003866
- Term: Depressive Disorder
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424483
**Brief Title:** Love Group for Geriatric Psychiatry Outpatients
**Official Title:** Awareness, Courage, and Love Group Psychotherapy for Geriatric Psychiatry Outpatients
#### Organization Study ID Info
**ID:** 14757
#### Organization
**Class:** OTHER
**Full Name:** Lawson Health Research Institute
### Status Module
#### Completion Date
**Date:** 2025-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Western University, Canada
#### Lead Sponsor
**Class:** OTHER
**Name:** Lawson Health Research Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Loneliness is a key predictor of mortality in older adults, and is a prominent risk factor for mental and physical illness in older adulthood. The goal of this study is to determine the feasibility and acceptability of a group loneliness intervention in geriatric psychiatry outpatients. This type of group loneliness intervention is based on functional analytic psychotherapy (FAP), called Awareness, Courage, and Love (ACL) Groups. The objective of our clinical trial is to adapt, implement, and evaluate the ACL group for outpatients.
**Detailed Description:** The objective of our clinical trial is to adapt, implement, and evaluate a type of loneliness group intervention called Awareness, Courage, and Love Groups for older adult outpatients diagnosed with a psychiatric disorder. The following research questions will be answered: (a) Are ACL groups with geriatric psychiatry outpatients feasible and acceptable? (b) Do such ACL groups demonstrate preliminary efficacy?
### Conditions Module
**Conditions:**
- Loneliness
**Keywords:**
- seniors
- mental health
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized waitlist control group
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Treatment
**Intervention Names:**
- Behavioral: Awareness, Courage, and Love Group Psychotherapy
**Label:** Treatment
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Waitlist
**Label:** Waitlist
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment
**Description:** Awareness, Courage, and Love (ACL) groups are an outgrowth of functional analytic psychotherapy, which is an empirically-based behavioural therapy that emphasizes the principle of positive reinforcement within relationships (Holman et al., 2017; Kanter et al., 2010; Kohlenberg \& Tsai, 1991; Tsai et al., 2009a). Awareness involves the practice of mindfulness, and in particular, the noticing of emotions within oneself and in others (Tsai et al., 2009b). Courage refers to engaging in vulnerable self-disclosures and practicing boundaried support. Love encompasses healthy caring for oneself and others, and in particular, responding affirmingly to another person's self-disclosures.
**Name:** Awareness, Courage, and Love Group Psychotherapy
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Brief open-ended questions about program satisfaction. Responses are qualitative.
**Measure:** Satisfaction Questionnaire
**Time Frame:** Up to 2 months
#### Primary Outcomes
**Description:** Brief measure of loneliness. The minimum value is 0, the maximum value is 11, and higher scores indicate a worse outcome.
**Measure:** De Jong Gierveld Loneliness Scale
**Time Frame:** Up to 2 months
**Description:** Measure of feasibility. Captured across 8 sessions, comparing pre to post.
**Measure:** Attendance and attrition
**Time Frame:** Up to 2 months
**Description:** Brief measure of program satisfaction. The minimum value is 0, the maximum value is 16, and higher scores indicate a better outcome.
**Measure:** Quantitative Program Satisfaction
**Time Frame:** Up to 2 months
#### Secondary Outcomes
**Description:** 1 item pictorial scale of subjective wellbeing from 0 (minimum) to 10 (maximum). A higher score indicates a better outcome.
**Measure:** Cantril Self-Anchoring Striving Scale
**Time Frame:** Up to 2 months
**Description:** Brief single-item pictorial measure of social closeness. The minimum value is 1, the maximum value is 7, and higher scores indicate a better outcome.
**Measure:** Adaptation of Inclusion of Other in Self Scale
**Time Frame:** Up to 2 months
**Description:** Brief measure of group relational health. The minimum value is 8, the maximum value is 40, and higher scores indicate a better outcome.
**Measure:** Relational Health Indices
**Time Frame:** Up to 2 months
**Description:** Brief measure of perceived sacred qualities, adapted from Pargament et al. (2014). The minimum value is 11, the maximum value is 55, and higher scores indicate a better outcome.
**Measure:** Sacred Moment Qualities
**Time Frame:** Up to 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Older adults with psychiatric disorder(s)
Exclusion Criteria:
* Individuals who are disoriented to person, delirious, unable to tolerate or participate meaningfully in the group, or otherwise unable to provide consent to research and psychotherapy
* Unable to speak English
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Serena Wong, Ph.D.
**Phone:** 5194555110
**Phone Ext:** 48155
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Frankie Lui
**Phone:** 5194555110
**Phone Ext:** 47028
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** St. Joseph's Health Care London
**Name:** Serena Wong, Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424470
**Brief Title:** Study on the Treatment of Prurigo Nodularis With Stapokibart Injection
**Official Title:** A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of Stapokibart Injection in Subjects With Prurigo Nodularis
#### Organization Study ID Info
**ID:** CM310-110201
#### Organization
**Class:** INDUSTRY
**Full Name:** Keymed Biosciences Co.Ltd
### Status Module
#### Completion Date
**Date:** 2026-07-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-07-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Keymed Biosciences 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, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of Stapokibart Injection in the treatment of subjects with prurigo nodularis, and observe pharmacokinetic characteristics, pharmacological effects, and immunogenicity.
**Detailed Description:** Chronic prurigo (CPG) is an independent chronic inflammatory skin disease characterized by chronic itching and multiple local or systemic prurigo lesions. Prurigo nodularis (PN) is the main subtype of CPG.
### Conditions Module
**Conditions:**
- Prurigo Nodularis
### 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:** Stapokibart Injection, subcutaneous injection (SC)
**Intervention Names:**
- Biological: Stapokibart
**Label:** Stapokibart
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** subcutaneous injection (SC)
**Intervention Names:**
- Other: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Stapokibart
**Description:** Stapokibart Injection
**Name:** Stapokibart
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Placebo
**Name:** Placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Worst Itch Numerical Rating Scale (WI-NR) is a patient-reported outcome (PRO) consisting of individual items with scores ranging from 0 ("no itching") to 10 ("the most severe itching imaginable"). Subjects are required to use this scale to rate the severity of their most severe itching in the past 24 hours.
**Measure:** Propotion of subjects improved by ≥ 4 points from baseline on the Worst Itch Numerical Rating Scale (WI-NRS) at week 24 of treatment.
**Time Frame:** Up to week 24
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Able to understand and agree to comply with the experimental process of this study and voluntarily sign the informed consent form.
* 18 ≤ Age ≤ 75 years old.
* Received at least 2 weeks of moderate or more potent topical corticosteroid therapy with insufficient efficacy.
Exclusion Criteria:
* With drug-induced prurigo nodularis.
* With clinically significant diseases.
* With severe liver and kidney function damage at the screening.
* With malignant tumors within the first 5 years before the screening.
* Plan to undergo major surgical procedures during this study.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012871
- Term: Skin Diseases
- ID: D000003872
- Term: Dermatitis
- ID: D000017443
- Term: Skin Diseases, Eczematous
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14395
- Name: Prurigo
- Relevance: HIGH
- As Found: Prurigo
- ID: M12394
- Name: Neurodermatitis
- Relevance: HIGH
- As Found: Prurigo Nodularis
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7067
- Name: Dermatitis
- Relevance: LOW
- As Found: Unknown
- ID: M19712
- Name: Skin Diseases, Eczematous
- Relevance: LOW
- As Found: Unknown
- ID: T4769
- Name: Prurigo Nodularis
- Relevance: HIGH
- As Found: Prurigo Nodularis
### Condition Browse Module - Meshes
- ID: D000011536
- Term: Prurigo
- ID: D000009450
- Term: Neurodermatitis
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424457
**Acronym:** VATS
**Brief Title:** Pediatric Video Assisted Thoracoscopic Surgery (VATS) in Management of Empyema
**Official Title:** Video Assisted Thoracoscopic Surgery (VATS) Versus Thoracotomy in Management of Empyema in Pediatric Patients
#### Organization Study ID Info
**ID:** 04-2024-100227
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2026-04-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-04-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Ali zein elabdein abd elaleim
**Investigator Title:** Principal investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Thoracic surgeons have developed a thoracoscopic procedure which is less intrusive method allows complete evacuation and washing of the debris from the pleural cavity. This approach may also have the benefit of less invasive maneuver, a shorter hospital stay and a decreased rate of postoperative complications.
The aim of this study is to evaluate the advantages and disadvantages of the video-assisted thoracoscopic surgery (VATS) approach in comparison with thoracotomy in management of empyema in pediatric patients.
**Detailed Description:** comparison between VATS decortication and open thoracotomy in cases of pediatric empyema
### Conditions Module
**Conditions:**
- Thoracic Empyema
**Keywords:**
- pediatric empyema
- VATS decortication
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 73
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** (group A) will receive VATS decortication as their definite management
**Intervention Names:**
- Procedure: video assisted thoracoscopy (VATS)
**Label:** group A (VATS)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** (group B) will be assigned to open thoracotomy
**Intervention Names:**
- Procedure: open thoracotomy
**Label:** group B (open thoracotomy)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- group A (VATS)
**Description:** the investigators compare the outcomes of intervention by VATS and doing complete decortication or open surgery thoracotomy
**Name:** video assisted thoracoscopy (VATS)
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- group B (open thoracotomy)
**Description:** the investigators assess the outcomes of intervention by doing complete decortication through open surgery thoracotomy
**Name:** open thoracotomy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** by centimeters
**Measure:** wound size
**Time Frame:** after 1week post operative
**Description:** which degree of infection or if there is a burst wound
**Measure:** wound infection
**Time Frame:** during 1week post operative
**Description:** by days post operative
**Measure:** hospital stay
**Time Frame:** 1week post operative
**Description:** by days and takes how many days to stop air leakage
**Measure:** air leak duration
**Time Frame:** during 1week post operative
**Description:** through pain score scale 0 No Pain 1-3 Mild Pain (nagging, annoying) 4-6 Moderate Pain 7-10 Severe Pain (disabling)
**Measure:** pain score
**Time Frame:** during 1week post operative.
**Description:** how many days
**Measure:** Early mobilization.
**Time Frame:** during 1week post operative
#### Secondary Outcomes
**Description:** presented or not
**Measure:** chronic pain
**Time Frame:** after 1month post operative
**Description:** which degree
**Measure:** avoidance of scoliosis
**Time Frame:** after 1month post operative
**Description:** yes or no
**Measure:** shoulder muscle girdle weakness and deformity.
**Time Frame:** after 1month post operative
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* pediatric patients 1 yrs. : ≤ 18 yrs.
* Patients with empyema due to pneumonia.
* Patients with empyema had lasted for fewer than 3 weeks.
Exclusion Criteria:
* Patients \< 1 yrs. old.
* Patients with whom pleural empyema had lasted for more than 3 weeks.
* Patients with empyema had been caused by trauma.
* Patients whose parents refuse to be included in the study.
* Patients with empyema due to ruptured lung abscess.
* Patients with empyema due to chest wall abscess.
* Patients with empyema due to rib osteomyelitis.
* Patients with bronchopleural fistula.
* Patients with post-surgical empyema.
**Maximum Age:** 18 Years
**Minimum Age:** 1 Year
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** ali zein eladein, Ass.Lect.
**Phone:** +201014566896
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** hussein Elkhayat, Assoc. Prof.
**Phone:** +201005549653
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Assiut
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** ali zein elabdein, MD
- **Phone:** +201014566896
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** hussein Elkhayat, prof.
- **Phone:** +201005549653
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Assiut University Hospital
**Status:** RECRUITING
**Zip:** +2088
#### Overall Officials
**Official 1:**
**Affiliation:** professor
**Name:** Mohamed Ayyad, prof.
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** doctor
**Name:** Mahmoud sallam, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Arnold DT, Hamilton FW, Morris TT, Suri T, Morley A, Frost V, Vipond IB, Medford AR, Payne RA, Muir P, Maskell NA. Epidemiology of pleural empyema in English hospitals and the impact of influenza. Eur Respir J. 2021 Jun 17;57(6):2003546. doi: 10.1183/13993003.03546-2020. Print 2021 Jun.
**PMID:** 33334937
**Citation:** Krenke K, Urbankowska E, Urbankowski T, Lange J, Kulus M. Clinical characteristics of 323 children with parapneumonic pleural effusion and pleural empyema due to community acquired pneumonia. J Infect Chemother. 2016 May;22(5):292-7. doi: 10.1016/j.jiac.2016.01.016. Epub 2016 Feb 23.
**PMID:** 26919911
**Citation:** Shojaee S, Lee HJ. Thoracoscopy: medical versus surgical-in the management of pleural diseases. J Thorac Dis. 2015 Dec;7(Suppl 4):S339-51. doi: 10.3978/j.issn.2072-1439.2015.11.66.
**PMID:** 26807282
**Citation:** Bedawi EO, Hassan M, McCracken D, Rahman NM. Pleural infection: a closer look at the etiopathogenesis, microbiology and role of antibiotics. Expert Rev Respir Med. 2019 Apr;13(4):337-347. doi: 10.1080/17476348.2019.1578212. Epub 2019 Feb 20.
**PMID:** 30707629
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013492
- Term: Suppuration
- ID: D000007239
- Term: Infections
- ID: D000007249
- Term: Inflammation
- ID: D000010335
- Term: Pathologic Processes
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000010995
- Term: Pleural Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M7819
- Name: Empyema
- Relevance: HIGH
- As Found: Empyema
- ID: M19086
- Name: Empyema, Pleural
- Relevance: HIGH
- As Found: Thoracic Empyema
- ID: M16273
- Name: Suppuration
- 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: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M13885
- Name: Pleural Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004653
- Term: Empyema
- ID: D000016724
- Term: Empyema, Pleural
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424444
**Brief Title:** A Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease
**Official Title:** A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
#### Organization Study ID Info
**ID:** ADX-102-DED-031
#### Organization
**Class:** INDUSTRY
**Full Name:** Aldeyra Therapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-17
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-29
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Aldeyra 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:** A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap
### Conditions Module
**Conditions:**
- Dry Eye Disease
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 400
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Reproxalap ophthalmic solution (0.25%)
**Label:** Reproxalap Ophthalmic Solution (0.25%)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Vehicle ophthalmic solution
**Label:** Vehicle Ophthalmic Solution
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Reproxalap Ophthalmic Solution (0.25%)
**Description:** Reproxalap ophthalmic solution (0.25%) administered QID for four weeks, followed by BID administration for two weeks
**Name:** Reproxalap ophthalmic solution (0.25%)
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Vehicle Ophthalmic Solution
**Description:** Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for two weeks
**Name:** Vehicle ophthalmic solution
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Measured using a 0 - 100 visual analog scale where 0 is "no discomfort" and 100 is "maximal discomfort"
**Measure:** Subject-reported ocular discomfort score over Week 1 to Week 6
**Time Frame:** From Day -14 to Day 43
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* at least 18 years of age;
* written informed consent and sign the Health Information Portability and Accountability Act (HIPAA) form;
* history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
Exclusion Criteria:
* ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
* contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the trial;
* eye drops within 2 hours of Visit 1;
* laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* topical ocular cyclosporine, lifitegrast, corticosteroid, or any other topical ocular prescription medication within 90 days of Visit 1
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Bill Cavanagh
**Phone:** 781-257-3063
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shelby
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Patrick M. Vollmer, OD
- **Phone:** 828-406-3878
- **Role:** CONTACT
**Country:** United States
**Facility:** Core, Inc.
**State:** North Carolina
**Status:** RECRUITING
**Zip:** 28150
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007766
- Term: Lacrimal Apparatus Diseases
- ID: D000007637
- Term: Keratoconjunctivitis
- ID: D000003231
- Term: Conjunctivitis
- ID: D000003229
- Term: Conjunctival Diseases
- ID: D000007634
- Term: Keratitis
- ID: D000003316
- Term: Corneal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M18040
- Name: Dry Eye Syndromes
- Relevance: HIGH
- As Found: Dry Eye Disease
- ID: M10664
- Name: Keratoconjunctivitis Sicca
- Relevance: HIGH
- As Found: Dry Eye Disease
- ID: M8271
- Name: Eye Diseases
- Relevance: HIGH
- As Found: Eye Disease
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M10663
- Name: Keratoconjunctivitis
- Relevance: LOW
- As Found: Unknown
- ID: M10786
- Name: Lacrimal Apparatus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6455
- Name: Conjunctivitis
- Relevance: LOW
- As Found: Unknown
- ID: M6453
- Name: Conjunctival Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10660
- Name: Keratitis
- Relevance: LOW
- As Found: Unknown
- ID: M6539
- Name: Corneal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015352
- Term: Dry Eye Syndromes
- ID: D000007638
- Term: Keratoconjunctivitis Sicca
- ID: D000005128
- Term: Eye Diseases
### 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: HIGH
- As Found: Procedure
- ID: M12814
- Name: Ophthalmic Solutions
- Relevance: HIGH
- As Found: Start
### Intervention Browse Module - Meshes
- ID: D000019999
- Term: Pharmaceutical Solutions
- ID: D000009883
- Term: Ophthalmic Solutions
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424431
**Brief Title:** Methods of Pancreatic Stump Closure for Distal Pancreatectomy
**Official Title:** Stapler Versus Stapler Combined With Electrocautery for Pancreatic Transection and Stump Closure for Distal Pancreatectomy
#### Organization Study ID Info
**ID:** CHEC2024-110
#### Organization
**Class:** OTHER
**Full Name:** Changhai Hospital
### Status Module
#### Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-01-31
**Type:** ACTUAL
#### Start Date
**Date:** 2019-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-03
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Changhai Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The aim of this study is to conduct a retrospective analysis of patients who underwent distal pancreatectomy in our hospital, aiming to evaluate the safety and feasibility of two methods for closure of the pancreatic remnant: simple closure with a closure device and closure combined with electrocoagulation.
**Detailed Description:** The aim of this study is to conduct a retrospective analysis of patients who underwent distal pancreatectomy in our hospital, aiming to evaluate the safety and feasibility of two methods for closure of the pancreatic remnant: simple closure with a closure device and closure combined with electrocoagulation. This study aims to determine which method is safer and more feasible, with the potential to reduce postoperative complications, improve outcomes, facilitate better patient recovery, and thereby provide better guidance for clinical practice.
### Conditions Module
**Conditions:**
- Pancreatectomy
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 487
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Simple closure with a closure device for closure of the pancreatic remnant in distal pancreatectomy.
**Intervention Names:**
- Procedure: simple closure with a closure device
**Label:** Stapler
**Type:** OTHER
#### Arm Group 2
**Description:** Closure with a closure device combined with electrocoagulation for closure of the pancreatic remnant in distal pancreatectomy.
**Intervention Names:**
- Procedure: stapler combined with electrocautery
**Label:** Stapler combined with electrocautery
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Stapler combined with electrocautery
**Description:** Closure with a closure device combined with electrocoagulation for pancreatic stump closure in distal pancreatectomy
**Name:** stapler combined with electrocautery
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Stapler
**Description:** Simple closure with a closure device for pancreatic stump closure in distal pancreatectomy
**Name:** simple closure with a closure device
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Postoperative pancreatic fistula
**Measure:** Postoperative pancreatic fistula
**Time Frame:** perioperatively
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients who underwent distal pancreatectomy performed by Director Jin Gang's team at Changhai Hospital affiliated with Naval Medical University between January 2019 and January 2023.
* Patients who underwent closure of the pancreatic remnant using either simple closure or closure combined with electrocoagulation during surgery.
Exclusion Criteria:
* Patients undergoing surgeries by other primary clinical teams during the same period.
* Patients undergoing closure of the pancreatic remnant using methods other than those mentioned.
* Patients who violate the requirements of the study protocol.
* Patients with incomplete data collection in the hospital's diagnostic and treatment system.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Shanghai
**Country:** China
**Facility:** Changhai Hospital
**State:** Shanghai
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424418
**Brief Title:** Robotic Scope Cleaning Device
**Official Title:** A Proof of Concept Study Validating The Safety And Efficacy of a Novel Robotic Scope Cleaner
#### Organization Study ID Info
**ID:** Scope1
#### Organization
**Class:** INDUSTRY
**Full Name:** Boehringer Labs LLC
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** NYU Langone Health
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Boehringer Labs LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is Unapproved Device:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** A novel device that works with robotic trocars to clean the scope when visualization is compromised during a surgical procedure.
### Conditions Module
**Conditions:**
- Surgery
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DEVICE_FEASIBILITY
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** The device is used to clean the scope when it visualization becomes obstructed during a surgical procedure.
**Name:** Robotic Scope Cleaner
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Study to determine if the device works as intended. A questionnaire will be filled out by the operating surgeon. Questions include the number of cleans, time to clean, ease of use, etc.
**Measure:** feasibility of device
**Time Frame:** [Estimated 6 months]
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* able to consent
* undergoing a surgical robotic procedure
Exclusion Criteria:
* not suitable for a surgical procedure with the robot
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Name:** Mark Bond
- **Phone:** 646-754-7217
- **Role:** CONTACT
***Contact 2:***
- **Name:** Micheal Zervos, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** William Huang, MD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** NYU Langone Health
**State:** New York
**Zip:** 10016
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424405
**Brief Title:** A New Objective Titration Procedure for the Treatment of Mandibular Advancement Device in OSAHS Patients
**Official Title:** A New Objective Titration Procedure Using Remotely Intelligent Sleep Monitoring System for the Treatment of Mandibular Advancement Device in OSAHS Patients
#### Organization Study ID Info
**ID:** BeijingJH
#### Organization
**Class:** OTHER
**Full Name:** Beijing Jishuitan Hospital
### Status Module
#### Completion Date
**Date:** 2025-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-25
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Beijing Jishuitan Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The aim of this clinical trial is to apply a new objective titration procedure in obstructive sleep apnea hypopnea syndrome (OSAHS) patients treated with mandibular advancement device (MAD), and to compare this new objective titration procedure with the subjective titration procedure which is commonly used in clinical practice. The remotely intelligent sleep monitoring system (RISMS) will be used in the new objective titration procedure. The main questions it aims to answer are:
1. The efficacy of MAD therapy after each titration procedure.
2. The titration time efficiency and the improvement of subjective symptoms after each titration procedure.
**Detailed Description:** In this study, patients diagnosed with OSAHS and referred for MAD treatment will be recruited. The amount of mandibular protrusion seems to be a key factor in the treatment of MAD. Patients will experience either of the two titration procedures to obtain the optimal mandibular protrusion. One procedure is a new objective titration procedure which will use the RISMS for the treatment of MAD, which will help the clinician instruct the titration according the objective therapeutic indicator. The other procedure is the subjective titration procedure which is commonly used in clinical practice. Finally, the researchers will compare the efficacy of the MAD therapy, the titration time efficiency and the improvement of subjective symptoms between the two titration procedures.
### Conditions Module
**Conditions:**
- Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
**Keywords:**
- Obstructive sleep apnea hypopnea syndrome
- Sleep monitoring
- contactless sensors
- Mandibular advancement device
- therapeutic outcomes
### 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:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Objective titration procedure will be based on the objective diagnosis and treatment indicator AHI（Apnea-hypopnea index）which will be provided by RISMS (Remotely intelligent sleep monitoring system). SC-500TM is a comfortable contactless under-mattress sleep monitor, as a main component of the RISMS will be given to patients to collect the sleep data every night at home setting. The sleep report will be generated automatically every day providing the value of AHI and uploaded to the clinicians in real-time. The clinicians will contact the patients by phone every 3-7 days and instruct them remotely to adjust the MAD to increase the mandibular advancement by 0.25-1mm each time, according to AHI together with the self-reported evolution of symptoms. The patients will adapt this new mandibular advancement for 3-7 days and the clinicians will contact them again for further adjustment until a significant improvement of AHI and resolution of symptoms occurs.
**Intervention Names:**
- Procedure: titration procedure for MAD treatment
**Label:** objective titration procedure
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The subjective titration procedure in this study will be based on self-reported evolution of symptoms and physical limits of the OSAHS patients. Patients will be recalled to the hospital every 1-2 weeks and will be asked about the subjective changes such as snoring, daytime sleepiness，ache of tooth, temporomandibular pain and so on. Then, the clinicians will adjust the MAD to increase degree of mandibular advancement by 0.5-1mm each time. The patients will adapt this new mandibular advancement for 1-2 weeks and have to come back to hospital for further adjustment until an improvement or a resolution of symptoms occurs, or until the patients could not tolerate any further advancement.
**Intervention Names:**
- Procedure: titration procedure for MAD treatment
**Label:** subjective titration procedure
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- objective titration procedure
- subjective titration procedure
**Description:** The OSAHS patients referred for MAD treatment will experience either the objective titration procedure or the subjective titration procedure.
**Name:** titration procedure for MAD treatment
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** The efficacy of MAD therapy is in terms of AHI (Apnea-hypopnea index) reduction compared to baseline, as well as the number of responders defined as patients with a reduction in AHI of 50% or more compared to baseline, and/or a follow-up AHI of 10 events/hour or less.
**Measure:** efficacy of MAD therapy
**Time Frame:** The parameter of AHI will be recorded at baseline before the titration and the end of the titration procedures (up to 60 days) using the same PSG device to diagnose OSAHS.
#### Secondary Outcomes
**Description:** The titration time efficiency is the percentage of saved time over the prescribed time.
**Measure:** titration time efficiency
**Time Frame:** The prescribed time is 60 days. The actual titration time is the time taken from the start to the end of the titration procedures (up to 60 days). The saved time is 60 days minus actual titration day.
**Description:** The ESS (Epworth Sleepiness Scale) is a self-administered questionnaire that evaluates subjective daytime sleepiness in quotidian situations. The score ranges from 0 to 24 and is usually elevated in sleep apnea patients, indicating a propensity to fall asleep. The score 0 means no sleepiness at daytime, and the score 24 means serious sleepiness. Lower scores mean a better treatment outcome.
**Measure:** Epworth sleepiness score(ESS)
**Time Frame:** ESS will be determined at baseline and the end of titration procedures (up to 60 days).
**Description:** SS （Snore Scale） is measured by A 10-point visual analogue scale (VAS) to assess the severity of snoring, with the VAS ranging from 0, representing no snoring, to 10, causing the bed partner to leave the room or sleep separately. Lower scores mean a better treatment outcome.
**Measure:** Snore Scale(SS）
**Time Frame:** SS will be determined at baseline and the end of titration procedures (up to 60 days).
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* OSAHS patients with AHI≥15
* 18≤age≤70 years;
* Subject is capable of giving informed consent
* refusal of or noncompliance with CPAP (continuous positive airway pressure) or unwilling to undergo upper airway surgery
* Normal clinical, periodontal and temporomandibular joint examination
Exclusion Criteria:
* Active periodontal problems including tooth mobility
* active temporomandibular joint dysfunction
* Edentulous patients or Insufficient teeth to support MAD
* patients with severe unstable systemic diseases or suffering from psychiatric disorders
* Enlarged palatine tonsils (Friedman grade IV tonsils)
**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:** Huijia HJ Lei, doctor
**Phone:** 8601058516688
**Phone Ext:** 7066
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Yanwei YW Lv, doctor
**Phone:** 8658517106
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Si S Chen, Doctor
- **Phone:** 8601058517158
- **Role:** CONTACT
**Country:** China
**Facility:** Beijing Jishuitan Hospetal
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100035
#### Overall Officials
**Official 1:**
**Affiliation:** Beijing Jishuitan Hospital
**Name:** Si S Chen, doctor
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001049
- Term: Apnea
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000020919
- Term: Sleep Disorders, Intrinsic
- ID: D000020920
- Term: Dyssomnias
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M4361
- Name: Apnea
- Relevance: LOW
- As Found: Unknown
- ID: M15694
- Name: Sleep Apnea Syndromes
- Relevance: HIGH
- As Found: Obstructive Sleep Apnea Hypopnea Syndrome
- ID: M22010
- Name: Sleep Apnea, Obstructive
- Relevance: HIGH
- As Found: Sleep Apnea Hypopnea Syndrome
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- 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: D000012891
- Term: Sleep Apnea Syndromes
- ID: D000020181
- Term: Sleep Apnea, Obstructive
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424392
**Acronym:** MALFPULM2
**Brief Title:** Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations
**Official Title:** Respiratory and Psychological Impact of Elective Surgery of Congenital Lung Malformations
#### Organization Study ID Info
**ID:** 2024-A00576-41
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
### Status Module
#### Completion Date
**Date:** 2026-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assistance Publique - Hôpitaux de Paris
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The absence of surgery of Congenital lung malformations (CLMs), if it avoids a stressfull event, is accompanied by a "medicalization" of the child, which will be regularly followed up in a specialized medical and surgical environment. The persistent risk of complication, albeit low, is likely to induce over-protective parental behaviours, and to be associated with a sustained family anxiety reaction. The main objective is to test the hypothesis that the absence of surgery has a significant impact on parental anxiety, measurable at 6- 9 years of age.
**Detailed Description:** The knowledge of CLMs has been revolutionized by prenatal imaging and the identification of large numbers of CLMs that remain asymptomatic. France is a leader in this field, having set up the only prospective multicentre cohort currently available internationally, with follow-up starting in the prenatal period (MALFPULM). This cohort has already enabled a better description of the prenatal history and the development of an algorithm predictive of the risk of neonatal respiratory distress. The children were followed up to the age of 2 years, and 66% of them were operated on between 0 and 2 years of age. This cohort is a unique opportunity to measure the mid-term impact of this surgical decision, in terms of both medical complications and psychological consequences.
In particular, the size of the cohort makes it possible to answer with a sufficient level of evidence to the following controversies:
* What is the risk of CLM infection in the absence of surgical removal, and is this risk dependent on the CLM phenotype?
* What is the functional respiratory impact of surgical techniques (thoracoscopy or thoracotomy), depending on the age of the surgery?
* What is the prevalence of musculoskeletal complications according to surgical techniques (thoracoscopy or thoracotomy)?
* What is the burden of the medical or surgical follow-up depending on the chosen therapeutic option?
* What is the psychological impact of the surgical decision on the parents and the child? Considering the psychological impact is a major issue for this malformative condition which mainly concerns asymptomatic children, and is of great originality because it has never been evaluated. The most recent literature clearly calls for integrating issues of family well-being and parental mental health into the follow-up of children with chronic disease and/or congenital anomalies. For this reason, the investigators chose maternal anxiety as the main criterion of this study. Specifically for CLM, demonstrating the impact of the investigator's decisions on the psychological state of the parents will be a strong encouragement to integrate this dimension in care, for a better detection of these anxious and/or depressive parental reactions, and a better personalization of the transmission of decisions.
### Conditions Module
**Conditions:**
- Congenital Lung Malformations
**Keywords:**
- Congenital lung malformations
- Psychological impact
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 434
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 6-9 years children with fetal diagnoses of CLM and included in MALFPULM who have had at least one follow-up visit between 0 and 2 years of age.
**Intervention Names:**
- Other: General Health Questionnaire (GHQ-28)
- Other: State-Trait Anxiety Inventory (STAI-Y)
- Other: Revised Children's Manifest Anxiety Scale (RCMAS)
- Other: World Health Organization Quality of Life (WHOQOL-BREF)
- Other: Quality of life measure for children (KIDSCREEN-27)
- Other: Parental Educational Competence Self-Evaluation Questionnaire "Questionnaire d'Auto-Évaluation de la Compétence Éducative Parentale (QAECEP)"
- Other: Parental interview
**Label:** 6-9 years children with fetal diagnoses of CLM
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 6-9 years children with fetal diagnoses of CLM
**Description:** Anxiety and depression self-reported scales for both parents
**Name:** General Health Questionnaire (GHQ-28)
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- 6-9 years children with fetal diagnoses of CLM
**Description:** Anxiety and depression self-reported scales for both parents
**Name:** State-Trait Anxiety Inventory (STAI-Y)
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- 6-9 years children with fetal diagnoses of CLM
**Description:** Anxiety and depression self-reported scales for children
**Name:** Revised Children's Manifest Anxiety Scale (RCMAS)
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- 6-9 years children with fetal diagnoses of CLM
**Description:** Quality of life self-reported scales for parents
**Name:** World Health Organization Quality of Life (WHOQOL-BREF)
**Type:** OTHER
#### Intervention 5
**Arm Group Labels:**
- 6-9 years children with fetal diagnoses of CLM
**Description:** Quality of life self-reported scales for children
**Name:** Quality of life measure for children (KIDSCREEN-27)
**Type:** OTHER
#### Intervention 6
**Arm Group Labels:**
- 6-9 years children with fetal diagnoses of CLM
**Description:** Parental Educational Competence Self-Evaluation self-reported Questionnaire for parents
**Name:** Parental Educational Competence Self-Evaluation Questionnaire "Questionnaire d'Auto-Évaluation de la Compétence Éducative Parentale (QAECEP)"
**Type:** OTHER
#### Intervention 7
**Arm Group Labels:**
- 6-9 years children with fetal diagnoses of CLM
**Description:** The interview will only last about ten minutes and will take place during the first call, if the parents have agreed and are sufficiently available to answer. If the parents are not available, an appointment can be made at a later date
**Name:** Parental interview
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** maternal anxiety level measured with the GHQ-28 anxiety scale
**Measure:** maternal anxiety level
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Number of lower respiratory tract infections, either documented (radiological opacity) or not, in the last 12 months and from birth to the date of evaluation
**Measure:** Impact of the surgical decision on respiratory morbidity - lower respiratory tract infections
**Time Frame:** 1 year
**Description:** Number of hospitalizations for respiratory reasons in the last 12 months and from birth to the date of evaluation
**Measure:** Impact of the surgical decision on respiratory morbidity - hospitalizations
**Time Frame:** 1 year
**Description:** Number of severe wheezing respiratory exacerbations in the last 12 months, defined as requiring oral corticosteroids, emergency visit and/or hospitalization
**Measure:** Impact of the surgical decision on respiratory morbidity - severe wheezing respiratory exacerbations
**Time Frame:** 1 year
**Description:** Current regular treatment for respiratory purposes, defined as daily treatment for at least 3 consecutive months in the last 12 months
**Measure:** Impact of the surgical decision on respiratory morbidity - treatment
**Time Frame:** 1 year
**Description:** Following parameters will be collected: date of performance, weight and height at date of performance, total lung capacity (TLC), forced vital capacity (FVC), forced expiratory volume in one second (FEV1), Forced expiratory flow at 25-75% (FEF25-75%), transfer factor of the lung for carbon monoxide (TLCO). FVC, FEV1, and FEF25-75%. These measurements will allow to identify following functional profiles:
* lung function restriction, defined by TLC lower than -1.645 Z score
* airway obstruction, defined by FEV1/FVC lower than -1.645 Z score, and its reversibility, defined by an improvement of at least 12% of the FV1 after inhalation of salbutamol.
* impaired diffusion capacity, defined by DLCO lower than -1.645 Z score.
**Measure:** Impact of the surgical decision on respiratory morbidity - lung function tests
**Time Frame:** 1 year
**Description:** The parents's declare rate of thoracic deformities
**Measure:** Impact of the surgical decision on respiratory morbidity - thoracic deformities
**Time Frame:** 1 year
**Description:** The burden of the medical or surgical follow-up will be evaluated by the number of specialist consultations and the number of CT or MRI scans
**Measure:** Impact of the surgical decision on respiratory morbidity - burden of the medical or surgical follow-up
**Time Frame:** 1 year
**Description:** The 28-item GHQ (General Health Questionnaire) was designed to be a self-administered screening test aimed at detecting minor psychiatric disorders and had been and validated in different languages, including French (34). It allows to estimate the prevalence of psychological distress in a given population. The GHQ-28 has been divided into four subscales. These are: somatic symptoms (items 1-7); anxiety/insomnia (items 8-14); social dysfunction (items 15-21), and severe depression (items 22-28). It is scored from 0 to 3 for each response with a total possible score on the ranging from 0 to 84. Using this method, a total score of 23/24 is the threshold for the presence of clinically important psychological distress.
**Measure:** Anxiety and depression - GHQ-28
**Time Frame:** 1 year
**Description:** The State-Trait Anxiety Inventory (STAI-Y) is a 20-item self-measure of state anxiety level in parents, complementary of GHQ-28. It reflects the current subjective feeling of tension, apprehension, nervousness, and worry and is widely used both in practice and in clinical research.
**Measure:** Anxiety and depression - STAI-Y
**Time Frame:** 1 year
**Description:** The RCMAS is a 37-item, self-report instrument designed to assess the level and nature of anxiety. A Total Anxiety score is computed based on 28 items, which are divided into three anxiety subscales: physiological anxiety (10 items about somatic manifestations of anxiety such as sleep difficulties, nausea and fatigue), worry/oversensitivity (11 items measuring obsessive concerns about a variety of things, most of which are typically vague and ill-defined, as well as fears about being hurt or emotionally isolated), and social concerns/concentration (7 items measuring distracting thoughts and fears that have a social or interpersonal nature). The remaining nine items on the RCMAS constitute the Lie subscale. A high score indicates a high level of anxiety or lie on that subscale.
**Measure:** Anxiety and depression - RCMAS
**Time Frame:** 1 year
**Description:** The WHOQOL-BREF is an abbreviated form of the WHOQOL-100 with only 26 items. It is an instrument for recording subjective quality of life. This is defined as an individual perception of one's own life situation in the context of culture and value system as well as personal goals, expectations, evaluation criteria and interests. It is a self-questionnaire that includes the four domains "physical health", "psychological well-being", "social relationships" and "environment". The items are answered using a five-level scale. The scales have a very high internal consistency. It is validated in several languages, including French.
**Measure:** Quality of life - WHOQOL-BREF
**Time Frame:** 1 year
**Description:** The questionnaire KIDSCREEN is used to assess the health-related quality of life of children and adolescents. It was constructed, tested, and normed using data from 3,000 children and adolescents from Europe. The KIDSCREEN-27 was developed to create a shorter version of the KIDSCREEN-52 with a minimum of loss of information and with good psychometric properties. The KIDSCREEN-27 measures the following five dimensions: physical well-being (5 items) ; psychological well-being (7 items) ; autonomy and parent relations (7 items) ; peers and social support (4 items) ; school environment (4 items).
**Measure:** Quality of life - KIDSCREEN
**Time Frame:** 1 year
**Description:** This questionnaire evaluates the parent's sense of competence in his or her role as an educator and has two components: the "skill/knowledge" factor, which evaluates the respondents' perception of the skills and knowledge they have acquired in order to be adequate parents (8 items); the "value/ease" factor, which evaluates the value that the respondent places on the role of parent, as well as his or her ease in this role (9 items).
**Measure:** Parenting Sense of Competence questionnaire
**Time Frame:** 1 year
**Description:** The over-protective parental behaviours is defined by the age of attendance in first community (5 or more children), the care arrangements between 0 and 2 years, the after-school activities in the previous year and the travel outside France in the last two years
**Measure:** Over-protective parental behaviours
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Child of the MALFPULM cohort, with their parents
* At least one follow-up visit between 0 and 2 years of age (n= 414 eligible children)
* Non-opposition of the family
Exclusion Criteria:
* Child with CLM, but not included in MALFPULM
* Parents who participated in MALPULM, but with prenatal fetal death, or neonatal death.
**Maximum Age:** 9 Years
**Minimum Age:** 6 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** The families of all children included in MALFPULM who have had at least one follow-up visit between 0 and 2 years of age.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Christophe DELACOURT, MD, PhD
**Phone:** +33 144494838
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Laure CHOUPEAUX, Msc
**Phone:** +33 144381711
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Assistance Publique - Hôpitaux de Paris
**Name:** Christophe DELACOURT
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12
- Name: Congenital Abnormalities
- Relevance: HIGH
- As Found: Malformations
### Condition Browse Module - Meshes
- ID: D000000013
- Term: Congenital Abnormalities
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424379
**Acronym:** BCL6-RINHL
**Brief Title:** BCL6-rearrangements Implications in Non-Hodgkin Lymphomas.
**Official Title:** Study of Clinical, Histological, Immunohistochemical and Molecular Impact of BCL6 Gene Rearrangement in Most Prevalent Non-Hodgkin Lymphomas
#### Organization Study ID Info
**ID:** 69HCL24_0515
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospices Civils de Lyon
#### 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-Hodgkin lymphomas (NHLs) constitute a heterogeneous group of malignant neoplasms, with diverse clinical behaviors and distinct pathologic and molecular characteristics. Among these lymphomas, follicular lymphomas (FLs), marginal zone lymphomas (MZLs) and diffuse large B-cell lymphomas (DLBCLs) emerge as the most prevalent entities. While FL and MZL are representative of indolent B-cell lymphomas, characterized by a slow progression of the disease and favorable clinical outcomes, DLBCL stands out as an aggressive lymphoma, often occuring from the transformation of a pre-existing indolent lymphoma.
Chromosome translocations are a hallmark of some NHL subtypes, offering insights into their molecular pathogenesis. For instance, the conventional FL is genetically characterized by the t(14;18) chromosomal translocation, found in 85-90% of cases, resulting in sustained elevation of the antiapoptotic protein B-cell lymphoma 2 (BCL2). However, certain FL cases lack BCL2 translocations and exhibit distinct clinical, morphological and phenotypical features with genetic heterogeneity.
A subset of BCL2-negative FLs displays rearrangements within chromosomal region 3q27, inducing abnormal modulation of B-cell lymphoma 6 (BCL6) expression. The BCL6 gene plays a critical role in germinal center development and B-cell differentiation. Previous investigations indicate that BCL6 rearrangements (BCL6-R) manifest distinct pathological and genetic features, diverging from classical FL presentations.
FLs carrying BCL6-R commonly share a specific CD10- Bcl-2- Bcl-6+ phenotype, often accompanied by a monocytoid component and increased frequency of diffuse architectural patterns. Patients with BCL6-R tend to exhibit advanced clinical stages and complex genetic profiles.
MZLs present differential diagnostic challenges due to shared monocytoid components, phenotypes traits, and common genetic features. The similarities observed between BCL6-R FL and MZL suggest a convergence in both morphological and genetic aspects, leading to intricate differentiation. Traditionally, these indolent NHLs with BCL6-R were categorized as FL and incorporated into the FL category in the WHO classification. However, few studies highlight the occurrence of BCL6-R in MZLs. This observation gives rise to the hypothesis that indolent NHLs exhibiting BCL6-R might correspond to a continuum comprising both FL and MZL.
Additionally, BCL6-R has been frequently documented in DLBCL cases with residual MZL component. These DLBCL cases might display a mutational profile reminiscent of MZL. This suggests a plausible origin of BCL6-R DLBCL from indolent BCL6-R MZLs or BCL6-R FLs cases.
### Conditions Module
**Conditions:**
- Non Hodgkin Lymphoma
- Follicular Lymphoma
- Marginal Zone Lymphoma
- Diffuse Large B Cell Lymphoma
**Keywords:**
- Non Hodgkin Lymphoma
- BCL6 gene rearrangement
- Next generation sequencing
### Design Module
#### Bio Spec
**Description:** The samples analyzed will have been collected as part of routine medical care for each patient before inclusion in the study.
These are formalin-fixed, paraffin-embedded (FFPE) tissue samples. They will be packaged and stored in the Biological Resources Center of the Hospices Civils de Lyon.
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 135
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Diagnoses of follicular lymphomas based on the last World Health Organization (WHO) classification of haematolymphoid tumours at the time of occurrence of the disease. Fluorescence in situ hybridization (FISH) utilizes Vysis' Dual-Color Break-Apart Rearrangement Probes to detect BCL6 gene alterations. FISH patterns have been interpreted following established protocols.
**Intervention Names:**
- Other: Histopathological analysis
- Genetic: Molecular analysis
**Label:** Follicular lymphomas with BCL6 gene rearrangement
#### Arm Group 2
**Description:** Diagnoses of marginal zone lymphomas based on the last WHO classification of haematolymphoid tumours at the time of occurrence of the disease. FISH utilizes Vysis' Dual-Color Break-Apart Rearrangement Probes to detect BCL6 gene alterations. FISH patterns have been interpreted following established protocols.
**Intervention Names:**
- Other: Histopathological analysis
- Genetic: Molecular analysis
**Label:** Marginal zone lymphomas with BCL6 gene rearrangement
#### Arm Group 3
**Description:** Diagnoses of diffuse large B-cells lymphomas based on the last WHO classification of haematolymphoid tumours at the time of occurrence of the disease. FISH utilizes Vysis' Dual-Color Break-Apart Rearrangement Probes to detect BCL6 gene alterations. FISH patterns have been interpreted following established protocols.
**Intervention Names:**
- Other: Histopathological analysis
- Genetic: Molecular analysis
**Label:** Diffuse large B-cells lymphomas with BCL6 gene rearrangement
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Diffuse large B-cells lymphomas with BCL6 gene rearrangement
- Follicular lymphomas with BCL6 gene rearrangement
- Marginal zone lymphomas with BCL6 gene rearrangement
**Description:** Morphological analysis will include the description of architectural patterns and cytological features on formalin-fixed and paraffin-embedded (FFPE) tissue samples retrieved from the routine diagnostic archives of the Pathology Department of the University Hospital Lyon Sud.
A panel of immunohistochemical staining will be analyzed including CD20, CD3, CD10, Bcl-6, Bcl-2, CD5, CD23, CD38, MUM1, Ig kappa, Ig lambda, MEF2B, LMO2, MNDA, IRTA1, P53, CMYC and Ki67 . /MIB1. Diffuse large B-cells lymphomas will be classified into two distinct subgroups: centro-germinative (GC) and non-centro-germinative (nGC), using the Hans algorithm.
**Name:** Histopathological analysis
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Diffuse large B-cells lymphomas with BCL6 gene rearrangement
- Follicular lymphomas with BCL6 gene rearrangement
- Marginal zone lymphomas with BCL6 gene rearrangement
**Description:** Next-generation sequencing (NGS) analysis will be performed on FFPE tissue samples retrieved from the routine diagnostic archives of the Pathology Department of the University Hospital Lyon Sud. A panel of 73 genes dedicated to lymphoma diagnosis determined by a consensus of French Lysa experts will be used. The identification of genetic variants will be followed by the attribution of pathogenicity class in accordance with the guidelines for validation of NGS-based oncology panels.
RNA extraction will classify DLBCLs into two distinct subgroups: germinal-centre B-cell-like (GCB-DLBCL) and activated B-cell-like (ABC-DLBCL).
**Name:** Molecular analysis
**Type:** GENETIC
### Outcomes Module
#### Primary Outcomes
**Description:** An examination of morphological attributes, including tissue architecture and cellular patterns will be performed on LF and MZL with BCL6-R. An extended immunohistochemical staining panel employing incorporated novel centro-germinative markers (LMO2 and MEF2B) and recently identified MZL-specific markers (IRTA1 and MNDA) is planned.
**Measure:** Comparison of LF and MZL with BCL6-R.
**Time Frame:** The primary outcome will be analyzed retrospectively, or through study completion, an average of 1 year
**Description:** Fluorescence in situ hybridization (FISH) will be employed for cytogenetic evaluation to detect BCL2 and BCL6 gene rearrangements. In parallel, targeted next-generation sequencing (NGS) analysis will enable genetic variant detection.
**Measure:** Comparison of LF and MZL with BCL6-R.
**Time Frame:** The primary outcome will be analyzed retrospectively, or through study completion, an average of 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnostic of non-Hodgkin's lymphoma at anatomy and cytology department of Lyon Sud hospital
* Rearrangement of the BCL6 gene detected by FISH analysis
* Diagnostic of the disease between january 2016 and december 2023
Exclusion Criteria:
* Patients diagnosed with primary cutaneous centrofollicular B lymphoma, composite lymphoma, anaplastic B lymphoma or primary B lymphoma of the mediastinum.
* Presence of a rearrangement of the BLC2 gene or the CMYC gene in FISH
* Presence of a non-significant BCL6 gene rearrangement (\<5% of rearranged cells)
**Maximum Age:** 100 Years
**Minimum Age:** 25 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** All patients diagnosed with non-Hodgkin lymphoma from the routine diagnostic archives of the pathology department of CHU Lyon Sud between January 2016 and August 2023 and with BCL6-R detected by FISH analysis will be included in the study. A cohort of 135 cases will be assembled and subjected to the analysis.
This dataset will be reviewed by two haematopathologists to ensure the inclusion of the most relevant cases. Selection will favor cases with substantial histological material and available clinical, immunophenotypic and cytogenetic data. Comparative assessments will be conducted between distinct subtypes of NHL exhibiting BCL6-R, including FLs, MZLs, and DLBCLs.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Pierre-Bénite
**Country:** France
**Facility:** Hopital Lyon Sud - HCL
**Zip:** 69495
### 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: D000016393
- Term: Lymphoma, B-Cell
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11220
- Name: Lymphoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: M11221
- Name: Lymphoma, Follicular
- Relevance: LOW
- As Found: Unknown
- ID: M20554
- Name: Lymphoma, B-Cell, Marginal Zone
- Relevance: HIGH
- As Found: Marginal zone lymphoma
- ID: M18831
- Name: Lymphoma, Large B-Cell, Diffuse
- Relevance: HIGH
- As Found: Diffuse Large B-Cell Lymphoma
- ID: M18828
- Name: Lymphoma, B-Cell
- Relevance: LOW
- As Found: Unknown
- ID: M11222
- Name: Lymphoma, Non-Hodgkin
- Relevance: HIGH
- As Found: Non-Hodgkin 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: T3543
- Name: Lymphosarcoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: T2361
- Name: Follicular Lymphoma
- Relevance: HIGH
- As Found: Follicular lymphoma
- ID: T640
- Name: B-cell Lymphoma
- Relevance: HIGH
- As Found: B-cell Lymphoma
- ID: T3612
- Name: Marginal Zone Lymphoma
- Relevance: HIGH
- As Found: Marginal zone lymphoma
- ID: T1866
- Name: Diffuse Large B-Cell Lymphoma
- Relevance: HIGH
- As Found: Diffuse Large B-Cell Lymphoma
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
- ID: D000008228
- Term: Lymphoma, Non-Hodgkin
- ID: D000018442
- Term: Lymphoma, B-Cell, Marginal Zone
- ID: D000016403
- Term: Lymphoma, Large B-Cell, Diffuse
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M8681
- Name: Formaldehyde
- Relevance: LOW
- As Found: Unknown
- ID: T114
- Name: Chrysanthemum
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424366
**Acronym:** ADAPT
**Brief Title:** Approach to Dance for Autism
**Official Title:** ADAPT: Approach to Dance for Autism
#### Organization Study ID Info
**ID:** STUDY-24-00144
#### Organization
**Class:** OTHER
**Full Name:** Icahn School of Medicine at Mount Sinai
### Status Module
#### Completion Date
**Date:** 2025-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Icahn School of Medicine at Mount Sinai
#### Responsible Party
**Investigator Affiliation:** Icahn School of Medicine at Mount Sinai
**Investigator Full Name:** Alexander Kolevzon
**Investigator Title:** Professor
**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:** This study will be a randomized trial that will examine the impact of a recreational ballet program on children with autism spectrum disorder (ASD). The research team are primarily interested in assessing changes in motor skills with secondary objectives focused on the social, psychological, and behavioral effects. The study will aim to collect data from 24 participants with ASD. Participants must be 7-12 years old, have a confirmed diagnosis of ASD, and speak English or Spanish. All participants will be enrolled in a 12 week ballet program. The ballet program is based off the curriculum and structure of Ballet for All Kids, a non-profit organization that has been tailoring ballet classes for children with ASD for over one decade. All research team members and volunteers will be trained in the BFAK program's curriculum and structure. Ballet instruction and all research materials will be provided in both English and Spanish. The research team will randomize the sample into an intervention group and waitlist control. The research team will measure outcomes through validated self-reports that caregivers will complete. For the intervention group, questionnaires will be completed at baseline and throughout the intervention (weeks 4, 8, and 12). For those in the waitlist control group, questionnaires will be completed at baseline, throughout the intervention group's ballet classes, and throughout their own participation in the program. Results of this study will help to determine if how a recreational ballet program can impact the motor, psychological, social, and behavioral skills of a child with ASD, informing the direction of future research and interventions.
### Conditions Module
**Conditions:**
- Autism Spectrum Disorder
**Keywords:**
- Ballet
- Autism
- Motor
- Recreational
- Children
- Dance
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The study will use a waitlist control design. The first arm will be the experimental arm and will immediately begin the intervention post recruitment. The second arm will be the waitlist control arm and will begin the intervention after the first arm's completion.
##### Masking Info
**Masking:** NONE
**Masking Description:** Due to the nature of the intervention (ballet classes) and that caregivers will be completing all questionnaires, masking is not possible.
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 12 weeks of ballet classes immediately after recruitment and randomization concludes.
**Intervention Names:**
- Behavioral: Ballet for All Kids
**Label:** Immediate Ballet Program
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 12 weeks of ballet classes after the first arm completes the intervention. Participants in this arm will continue to complete self-reports while they wait to begin the intervention.
**Intervention Names:**
- Behavioral: Ballet for All Kids
**Label:** Deferred Ballet Program
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Deferred Ballet Program
- Immediate Ballet Program
**Description:** The intervention consists of 12 weeks of ballet classes that follow the structure and curriculum of Ballet for All Kids (BFAK). BFAK is a non-profit organization that has been tailoring ballet classes for children with autism spectrum disorder for over one decade. Ballet classes will be held once a week for 45 minute sessions and led by trained medical and graduate students who have successfully completed BFAK's training and certification. BFAK instruction is based on the Schlachte Method, which combines auditory, visual, vestibular, and emotional learning to individualize instruction to match each child's skill level. In classroom accommodations include, but are not limited to a visual schedule, personal dance areas demarcated by tape on the floor, and one-on-one volunteer assistance.
**Name:** Ballet for All Kids
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Development Coordination Disorder Questionnaire will be completed by caregivers and will assess participants' motor skills throughout the study. Minimum score= 15. Maximum score= 75. A higher score indicates more advanced motor skills.
**Measure:** Development Coordination Disorder Questionnaire
**Time Frame:** at baseline and weeks 4, 8, and 12
#### Secondary Outcomes
**Description:** The Aberrant Behavior Checklist will be completed by caregivers and will assess participants' behaviors such as irritability; lethargy; stereotypy; hyperactivity; and inappropriate speech. Minimum score= 0. Maximum score= 174. A higher score indicates a greater degree of that behavior (i.e. higher scores on irritability would indicate that child tends to be more irritable).
**Measure:** Aberrant Behavior Checklist
**Time Frame:** at baseline and weeks 4, 8, and 12
**Description:** The Social Responsiveness Scale 2 will be completed by caregivers and will assess participants' social behaviors throughout the study. Minimum raw score = 65. Maximum raw score = 260. T-scores have a mean of 50 and a SD of 10. Raw scores are converted to T scores based on the child's gender. A higher score indicates more severe social impairments.
**Measure:** Social Responsiveness Scale 2
**Time Frame:** at baseline and weeks 4, 8, and 12
**Description:** The Children's Sleep Habits Questionnaire will be completed by caregivers and will assess participants' sleep throughout the study. Minimum score = 0. Maximum score = 154. A higher score indicates more sleep disturbances.
**Measure:** Children's Sleep Habits Questionnaire (Abbreviated)
**Time Frame:** at baseline and weeks 4, 8, and 12
**Description:** The Repetitive Behavior Scale will be completed by caregivers and will assess participants' repetitive behaviors and restricted interests throughout the study. Minimum score = 0. Maximum score = 129. A higher score indicates more severe behaviors.
**Measure:** The Repetitive Behavior Scale
**Time Frame:** at baseline and weeks 4, 8, and 12
**Description:** The Caregiver Strain Questionnaire will be completed by caregivers and will assess caregivers' stress related to parental/familial responsibilities throughout the study. Minimum score = 21. Maximum score = 105. A higher score indicates that a caregiver experiences more distress due to their familial responsibilities.
**Measure:** Caregiver Strain Questionnaire
**Time Frame:** at baseline and weeks 4, 8, and 12
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Confirmed diagnosis of autism spectrum disorder
* Fluent in English or Spanish
* Between 7-12 years old
Exclusion Criteria:
* For any reason the individual appears unable to participate in study procedures per the Principal Investigator
* Not fluent in English or Spanish
* Unable to commit to at least 8 of the 12 scheduled intervention sessions
**Maximum Age:** 12 Years
**Minimum Age:** 7 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Noy Alon
**Phone:** 212-241-0961
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Alexander Kolevzon, MD
- **Phone:** 212-659-8752
- **Role:** CONTACT
***Contact 2:***
- **Name:** Alexander Kolevzon
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Icahn School of Medicine at Mount Sinai
**State:** New York
**Zip:** 10029
#### Overall Officials
**Official 1:**
**Affiliation:** Icahn School of Medicine at Mount Sinai
**Name:** Alexander Kolevzon, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Due to the small sample size, recruitment of minor populations, and sensitive nature of some of the questionnaires, we will not be sharing IPD.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002659
- Term: Child Development Disorders, Pervasive
- ID: D000065886
- Term: Neurodevelopmental Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4623
- Name: Autistic Disorder
- Relevance: HIGH
- As Found: Autism
- ID: M206
- Name: Autism Spectrum Disorder
- Relevance: HIGH
- As Found: Autism Spectrum Disorder
- ID: M5903
- Name: Child Development Disorders, Pervasive
- Relevance: LOW
- As Found: Unknown
- ID: M5902
- Name: Developmental Disabilities
- Relevance: LOW
- As Found: Unknown
- ID: M30644
- Name: Neurodevelopmental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001321
- Term: Autistic Disorder
- ID: D000067877
- Term: Autism Spectrum Disorder
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424353
**Brief Title:** Postoperative Pain After Pulpectomy of Primary Molars
**Official Title:** Postoperative Pain After Pulpectomy of Primary Molars Using Two Different Root Canal Obturation Techniques: A Randomized Clinical Trial
#### Organization Study ID Info
**ID:** 87-577
#### Organization
**Class:** OTHER
**Full Name:** Minia University
### Status Module
#### Completion Date
**Date:** 2024-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Minia University
#### Responsible Party
**Investigator Affiliation:** Minia University
**Investigator Full Name:** Shaimaa Mohamed Abdel Hafeez
**Investigator Title:** postgraduate student at faculty of dentistry
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Testing postopertive pain after pulpectomy of primary molars with endoflas using modified Wong-Baker scale of pain.
**Detailed Description:** Testing postopertive pain after pulpectomy of primary molars with endoflas using lentilospiral files and pressure seringe by using modified Wong-Baker scale of pain.
### Conditions Module
**Conditions:**
- Postoperative Pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Obturation of primary molars with calcium hydroxide, eugenol and iodoform paste using paste carrier files(lentiospiral files)
**Intervention Names:**
- Procedure: Endoflas pulpectomy
**Label:** lentilospiral group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Obturation of primary molars with calcium hydroxide, eugenol and iodoform paste using pressure seringe
**Intervention Names:**
- Procedure: Endoflas pulpectomy
**Label:** pressure seringe group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- lentilospiral group
- pressure seringe group
**Description:** obturation of root canals of primary molars with Endoflas using pressure seringe and lentilospiral files
**Name:** Endoflas pulpectomy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Measuring post operative pain after pulpectomy with two different obturation techniques using (Modified Wong-backer scale of pain )which have four scales from( 0 to 3) which 0 is the better outcome( no pain) and 3 is the worst (severe pain)
**Measure:** postoperative pain
**Time Frame:** after one day and after one week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The current study will include children who meet the following clinical and radiographic criteria:
3.1a.Clinical:
1. 5-7-year old children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
2. Children rated as no.3 or 4 in Frankel behavior rating scale (FBRS).
3. Presence of at least one primary molar with deep carious lesion.
4. Asymptomatic necrotic molars confirmed by the absence of bleeding on opening of the pulp chamber.
3.1b. Radiographic:
1. Extensive caries approaching to the pulp.
2. Presence of at least two-thirds of root length.
Exclusion Criteria:
* A child's tooth with any of the following criteria:
3.2a. Clinical findings:
1. History of spontaneous unprovoked toothache.
2. Extensive crown destruction that preclude coronal restoration.
3. Presence of adjacent or opposing tooth with deep carious lesion "in the same side".
4. History of administering analgesics 12 hours before tooth obturation.
3.2b. Radiographic findings:
1. Presence of a large furcation or periapical radiolucency approximating the succedaneous tooth.
2. Presence of pathological internal/external root resorption.
3. Absence of underlying permanent successor.
**Maximum Age:** 7 Years
**Minimum Age:** 5 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** shimaa m abd elhafeez, postgraduate
**Phone:** +0201068976757
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Osama s Gad El-Hak, phD
**Phone:** 00201023449797
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Minya
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** shimaa m abd elhafeez, postgraduate
- **Phone:** 00201068976757
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Shimaa Mohamed Abd Elhafeez
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Pediatric Dentistry Department, Faculty of Dentistry, Minia University
**Name:** osama s gad elhak, phD
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Postoperative Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010149
- Term: Pain, Postoperative
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: M8197
- Name: Eugenol
- Relevance: LOW
- As Found: Unknown
- ID: T391
- Name: Eugenol
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424340
**Brief Title:** MB-dNPM1-TCR.1 in Relapsed/Refractory AML
**Official Title:** A Phase I/II Trial of MB-dNPM1-TCR.1 in HLA-A*02:01-positive Patients With Relapsed or Refractory NPM1-mutated AML to Determine Safety and Obtain First Data on Efficacy
#### Organization Study ID Info
**ID:** M-2020-358
#### Organization
**Class:** INDUSTRY
**Full Name:** Miltenyi Biomedicine GmbH
### Status Module
#### Completion Date
**Date:** 2028-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Miltenyi Biomedicine GmbH
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this Phase I/II, single arm, prospective, open label, dose escalation trial is to assess safety, feasibility and efficacy of ex vivo expanded autologous T cells genetically modified to express a T cell receptor (TCR) specific for dNPM1 peptides restricted to human leukocyte antigen (HLA) A\*02:01 in patients with relapsed or refractory AML.
**Detailed Description:** The investigational medicinal product (IMP) MB-dNPM1-TCR.1 is designed to effectively target malignant myeloid cells in patients suffering from relapsed or refractory Acute Myeloid Leukemia (AML) with mutated Nucleophosmin. Autologous T cells will be genetically engineered using a lentiviral vector to express a T cell receptor (TCR) specific for certain dNPM1 peptides restricted to human leukocyte antigen (HLA) A\*02:01. The dNPM1-TCR transduced T cells target specifically the HLA/dNPM1 peptide complex on the cell surface of leukemic myeloid cells and eliminate these. During the treatment, the patients will undergo a leukapheresis, a lymphodepleting chemotherapy and an administration of the expanded dNPM1-TCR transduced T cells.
Phase I: Since this is a first in human trial the primary goal in phase I is to establish the recommended dose of MB-dNPM1-TCR.1 for phase II. We assess the maximum tolerated dose (MTD) with toxicity defined as patients experiencing dose limiting toxicity (DLT) until day 28 after infusion of MB-dNPM1-TCR.1. Therefore a BOIN trial design will be used to guide dose escalation and de-escalation decisions in phase I.
Phase II: The second phase will evaluate the efficacy and safety in patients treated with the recommended dose from phase I. The phase II part follows a Simon's 'minimax' two stage design.
### Conditions Module
**Conditions:**
- Leukemia, Myeloid, Acute
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 29
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Biological: MB-dNPM1-TCR.1
**Intervention Names:**
- Biological: MB-dNPM1-TCR.1
**Label:** MB-dNPM1-TCR.1
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MB-dNPM1-TCR.1
**Description:** T Cell Receptor (TCR) T cell therapy
**Name:** MB-dNPM1-TCR.1
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Maximum tolerated dose (MTD), as identified by a Bayesian Optimal Interval (BOIN) design at a target toxicity rate of 30%, with toxicity defined as patients experiencing dose limiting toxicity (DLT) until day 28 (week 4) after infusion of MB-dNPM1-TCR.1.
**Measure:** Primary endpoint Phase I
**Time Frame:** day 28
**Description:** BOR rate to the treatment with MB-dNPM1-TCR.1 assessed at any time within the first 3 months (12 weeks) after infusion as described above.
**Measure:** Primary endpoint Phase II
**Time Frame:** week 12
#### Secondary Outcomes
**Description:** Percentage and total number of MB-dNPM1-TCR+ cells in peripheral blood and/or bone marrow over time.
**Measure:** Persistence
**Time Frame:** from day 6 to week 96
**Description:** Best objective response (BOR) during 12 weeks after infusion of MB-dNPM1-TCR.1. BOR is defined in relation to disease activity before thawing the leukapheresis for manufacturing (day -18 and -15).
**Measure:** Best objective response (BOR)
**Time Frame:** week 12
**Description:** Overall survival (OS) defined as the time between the date of infusion of MB-dNPM1-TCR.1 and the date of death from any cause.
**Measure:** Overall survival (OS)
**Time Frame:** up to week 96
**Description:** Progression-free survival (PFS) defined as the time between the date of infusion of MB-dNPM1-TCR.1 and the date of objective disease progression or death from any cause whichever occurs first.
**Measure:** Progression-free survival (PFS)
**Time Frame:** up to week 96
**Description:** Duration of response (DOR), defined as the time between the date of the first objective response (CRMRD- CR, CRi, MLFS, PR, SD) and the date of assessment of relapse or the date of death due to AML, whichever occurs first.
**Measure:** Duration of response (DOR)
**Time Frame:** up to week 96
**Description:** Safety and toxicity assessment of MB-dNPM1-TCR.1 per (serious) adverse events ((S)AE) reporting.
**Measure:** Safety and toxicity
**Time Frame:** up to week 96
**Description:** Proportion of thawed apheresis products, from which MB-dNPM1-TCR.1 drug products are produced.
**Measure:** Feasibility to manufacture
**Time Frame:** Day 0
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥ 18 years
2. Patients must be able to understand and be willing to give signed informed consent
3. Relapsed or refractory acute myeloid leukemia (last disease staging within 4 weeks prior to screening) without standard treatment options defined as:
* No morphological CR after at least two courses of intensive chemotherapy, decitabine or other standard therapy or
* MRD positive after at least two courses of intensive chemotherapy and not eligible for allogeneic stem cell transplantation or
* Relapsed bone marrow or blood disease after CR after first line treatment and not eligible to undergo allogeneic stem cell transplantation or
* Bone marrow or blood relapse, non-response or MRD positivity after allogeneic stem cell transplantation and not eligible to receive Donor Lymphocyte Infusion (DLI) according to local standards, relapse after DLI.
4. Positive for HLA-A\*02:01 according to genotyping results.
5. AML has NPM1 mutation which is recognized by dNPM1-TCR.1 and for which a specific Q-PCR is available for disease monitoring.
6. Number of circulating WBC above 1x109/L with less than 20% leukemic blasts and at least 0.3x109 T cells/L and 0.03 x 109 CD8+ T cells/L.
7. Life expectancy of at least 3 months.
8. ECOG performance status 0-3.
9. Negative pregnancy test in women of childbearing potential.
10. For fertile men and women, agreement to use highly effective contraceptive methods during the trial.
Exclusion Criteria:
1. Pregnant or breast feeding women.
2. Active infection with HIV-1, HIV-2, HBV, HCV, HTLV-I, HTLV-II, SARS-CoV-2 or Treponema Pallidum.
3. Any clinically significant, advanced or unstable disease or inadequate main organ function that may put the patient at increased risk for severe complications of trial participation at the discretion of the investigator.
4. Use of systemic immune suppression including, but not limited to:
immunosuppressive agents such as cyclosporine or corticosteroids (at an equivalent dose of 0.5 mg prednisone/kg body weight per day, or higher). Inhaled steroid and physiological replacement for adrenal insufficiency are allowed.
5. Unwillingness or inability to comply with procedures required in this clinical trial protocol.
6. Uncontrolled central nervous system (CNS) disease.
7. Uncontrolled life-threatening infections or uncontrolled disseminated intravascular coagulation; however, if these problems resolve, the start of treatment can be initiated on a delayed schedule.
8. Subjects currently on any other IMP (including within the last 30 days before start of treatment).
9. Current use of high dose immunosuppression for immune disorders interfering with T cell function (on discretion of the investigator).
10. Known hypersensitivity against any drug of the mandatory trial procedures.
11. Serum creatinine ≥ 2.0 × ULN or eGFR \< 30 mL/min calculated according to the modified MDRD formula.
12. BMI ≥40
13. Has received vaccination with live vaccines 6 weeks prior to treatment
14. Major surgery less than 30 days before start of treatment.
15. Committal to an institution on judicial or official order.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jörg Liebmann
**Phone:** +49151-2034-4392
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Leiden University Medical Center
**Name:** C.J.M. Halkes, Dr
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007938
- Term: Leukemia
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000006402
- Term: Hematologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10945
- Name: Leukemia
- Relevance: LOW
- As Found: Unknown
- ID: M10955
- Name: Leukemia, Myeloid
- Relevance: HIGH
- As Found: Leukemia, Myeloid
- ID: M18127
- Name: Leukemia, Myeloid, Acute
- Relevance: HIGH
- As Found: Leukemia, Myeloid, Acute
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007951
- Term: Leukemia, Myeloid
- ID: D000015470
- Term: Leukemia, Myeloid, Acute
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424327
**Brief Title:** A Registry for People With Lung Cancer
**Official Title:** Pulmonary Segmentectomy for Lung Cancer: A Real-World International Registry-TSOG 108
#### Organization Study ID Info
**ID:** 24-127
#### Organization
**Class:** OTHER
**Full Name:** Memorial Sloan Kettering Cancer Center
### Status Module
#### Completion Date
**Date:** 2029-05-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2029-05-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Memorial Sloan Kettering Cancer Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Participants will complete questionnaires before surgery, between 2 to 4 weeks after surgery, and 6 months after surgery.
### Conditions Module
**Conditions:**
- Lung Cancer
- Lung Cancer Stage I
**Keywords:**
- lung cancer
- lung cancer stage 1
- segmentectomy
- Memorial Sloan Kettering Cancer Center
- 24-127
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 600
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants undergoing planned pulmonary segmentectomy for primary lung cancer
**Intervention Names:**
- Other: Patient-Reported Outcomes Measurement Information System
**Label:** Participants with Lung Cancer
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Participants with Lung Cancer
**Description:** Participants-reported outcomes will be collected using the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS is a web-based platform developed by the National Institutes of Health. Scoring is standardized on a scale from 0 to 100, with a population mean of 50 and standard deviation of 10 units. High scores mean more of the concept being measured. This study will use PROMIS surveys assessing three domains: physical function (PROMIS bank version 2.0), pain interference (PROMIS bank version 1.1), and dyspnea severity (PROMIS bank version 1.0)
**Name:** Patient-Reported Outcomes Measurement Information System
**Other Names:**
- PROMIS
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** DFS is measured from the date of surgery to the date of recurrence or death
**Measure:** Determine 3-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer.
**Time Frame:** 3 years
**Description:** DFS is measured from the date of surgery to the date of recurrence or death
**Measure:** Determine 5-year disease-free survival/DFS among patients undergoing pulmonary segmentectomy for lung cancer.
**Time Frame:** 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥18 years
* Clinical stage I tumor (AJCC 8th edition) suitable for segmentectomy, according to the treating thoracic surgeon
* Pathology of NSCLC
o Tissue diagnosis of NSCLC is not required before enrollment. A pathologic diagnosis of NSCLC may be confirmed preoperatively with biopsy, intraoperatively with frozen section, or postoperatively on final pathology.
* Patients must undergo segmentectomy for a peripheral lesion ≤2 cm to be included in the primary analysis. Individual ligation of the segmental artery(s) and segmental bronchus is the minimum definition for a segmentectomy. Division of the segmental vein and intraoperative frozen section to assess surgical margins and N1 lymph nodes are strongly encouraged, but the absence of either is not a criterion for exclusion.
Other considerations:
* Patients with ground-glass opacities will have their tumor size recorded on the basis of the size of the solid component.
* Any non-lung cancer treated in the past with no obvious recurrence or ongoing treatment is not a criterion for exclusion.
* The registry study will be monitored by Thoracic Surgery team at MSK.
* This study will be in collaboration with the Thoracic Surgical Oncology Group (TSOG) of the American Association for Thoracic Surgery.
Exclusion Criteria:
* Actively receiving lung cancer treatment or a history of lung cancer in the previous 5 years
* History of chemotherapy or radiation therapy for a previous lung cancer
* Synchronous secondary cancer in the lung or elsewhere in the body at the time of surgery
* Carcinoid tumors
* History of other malignancies within the past 3 years, with the exception of non-melanoma skin cancer, superficial bladder cancer, and carcinoma in situ of the cervix
* Actively receiving treatment for other malignancies
* Cases of lobectomy in conjunction with segmentectomy from another lobe and ≥2 segmentectomies from different lobes either en bloc or separate will be excluded from the primary analysis.
* Multi-segmental resection from the same lobe is not a criterion for exclusion.
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** All study subjects will be recruited from their respective clinics (i.e., Thoracic Surgery, Pulmonary, Survivorship, etc.) at participating sites. Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team by screening patients' medical records. If eligible, the study will be discussed with each patient.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** David Jones, MD
**Phone:** 212-639-6428
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Bernard Park, MD
**Phone:** 646-888-3346
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Basking Ridge
**Contacts:**
***Contact 1:***
- **Name:** David Jones, MD
- **Phone:** 212-639-6428
- **Role:** CONTACT
**Country:** United States
**Facility:** Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
**State:** New Jersey
**Status:** RECRUITING
**Zip:** 07920
**Location 2:**
**City:** Middletown
**Contacts:**
***Contact 1:***
- **Name:** David Jones, MD
- **Phone:** 212-639-6428
- **Role:** CONTACT
**Country:** United States
**Facility:** Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
**State:** New Jersey
**Status:** RECRUITING
**Zip:** 07748
**Location 3:**
**City:** Montvale
**Contacts:**
***Contact 1:***
- **Name:** David Jones, MD
- **Phone:** 212-639-6428
- **Role:** CONTACT
**Country:** United States
**Facility:** Memorial Sloan Kettering Bergen (Limited Protocol Activities)
**State:** New Jersey
**Status:** RECRUITING
**Zip:** 07645
**Location 4:**
**City:** Commack
**Contacts:**
***Contact 1:***
- **Name:** David Jones, MD
- **Phone:** 212-639-6428
- **Role:** CONTACT
**Country:** United States
**Facility:** Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
**State:** New York
**Status:** RECRUITING
**Zip:** 11725
**Location 5:**
**City:** Harrison
**Contacts:**
***Contact 1:***
- **Name:** David Jones, MD
- **Phone:** 212-639-6428
- **Role:** CONTACT
**Country:** United States
**Facility:** Memorial Sloan Kettering Westchester (Limited Protocol Activities)
**State:** New York
**Status:** RECRUITING
**Zip:** 10604
**Location 6:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Name:** David Jones, MD
- **Phone:** 212-639-6428
- **Role:** CONTACT
***Contact 2:***
- **Name:** Yuan Liu, MD, PhD
- **Phone:** 646-888-3640
- **Role:** CONTACT
***Contact 3:***
- **Name:** David Jones, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Memorial Sloan Kettering Cancer Center (All Protocol Activities)
**State:** New York
**Status:** RECRUITING
**Zip:** 10065
**Location 7:**
**City:** Uniondale
**Contacts:**
***Contact 1:***
- **Name:** David Jones, MD
- **Phone:** 212-639-6428
- **Role:** CONTACT
**Country:** United States
**Facility:** Memorial Sloan Kettering Nassau (Limited Protocol Activities)
**State:** New York
**Status:** RECRUITING
**Zip:** 11553
#### Overall Officials
**Official 1:**
**Affiliation:** Memorial Sloan Kettering Cancer Center
**Name:** David Jones, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: [email protected].
**IPD Sharing:** YES
### References Module
#### See Also Links
**Label:** Memorial Sloan Kettering Cancer Center
**URL:** http://www.mskcc.org
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M11172
- Name: Lung Neoplasms
- Relevance: HIGH
- As Found: Lung Cancer
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008175
- Term: Lung Neoplasms
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424314
**Brief Title:** Exploration of Mechanisms for Weaning Failure
**Official Title:** Changes in Respiratory Mechanics in Patients With Failed Ventilator Withdrawal
#### Organization Study ID Info
**ID:** 202220252311
#### Organization
**Class:** OTHER
**Full Name:** The First Affiliated Hospital of Guangzhou Medical University
### Status Module
#### Completion Date
**Date:** 2025-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The First Affiliated Hospital of Guangzhou Medical University
#### Responsible Party
**Investigator Affiliation:** The First Affiliated Hospital of Guangzhou Medical University
**Investigator Full Name:** Guan Lili
**Investigator Title:** MD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study is a prospective physiologic study. The primary study population will be adult invasive tracheal intubated patients with COPD, and investigators will collect relevant demographic data, vital signs, and baseline physiologic parameters of the patients prior to the spontaneous breathing test（SBT).
The participants will be divided into a successful withdrawal group and a failed withdrawal group according to the SBT outcome, and the changes in the above parameters during SBT will be compared between the two groups .
**Detailed Description:** This observational study mainly include participants who had invasive mechanical ventilation for ≥48 h and are assessed to be ready for the SBT trial.The SBT approach is based on the low-level pressure support mode.
Prior to the SBT trial, baseline demographic and physiologic data of the participants will be collected, and the participants will be divided into two groups based on the results of the SBT trial: successful and unsuccessful, and the physiologic changes during the SBT trial will be compared between the two groups, respectively.
### Conditions Module
**Conditions:**
- Weaning Failure
- Central Respiratory Depression
- Diaphragm Injury
- Phrenic Nerve Disorder
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patient passed SBT test with no need to receive invasive mechanical ventilation 48 hours after extubation
**Intervention Names:**
- Diagnostic Test: Monitoring of respiratory mechanics parameters
**Label:** weaning success
#### Arm Group 2
**Description:** Patient failed SBT test or need to receive invasive mechanical ventilation 48 hours after extubation
**Intervention Names:**
- Diagnostic Test: Monitoring of respiratory mechanics parameters
**Label:** weaning failure
### Interventions
#### Intervention 1
**Arm Group Labels:**
- weaning failure
- weaning success
**Description:** Physiologic recording instrumentation measure maximal transdiaphragmatic pressure，twitch diaphragmatic pressure and maximal diaphragmatic electromyography
**Name:** Monitoring of respiratory mechanics parameters
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** passed SBT trial and weaning from mechanical ventilation success with no need of reintubation
**Measure:** weaning success
**Time Frame:** Day 2
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Invasive mechanical ventilation for at least 48 hours
Exclusion Criteria:
* neuromuscular disease； not first attempt at SBT for weaning
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients undergoing weaning from mechanical ventilation；Hemodynamic stability
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lili Guan, MD & PhD
**Phone:** 020-81566675
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Qiaoyun Huang
**Phone:** 020-81566675
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lili Guan, MD & PhD
- **Phone:** 020-81566675
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Qiaoyun Huang
- **Phone:** 020-81566675
- **Role:** CONTACT
**Country:** China
**Facility:** The First Hospital of Guangzhou Medical University
**State:** Guangdong
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
### 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
### Condition Browse Module - Browse Leaves
- ID: M7058
- Name: Depression
- Relevance: LOW
- As Found: Unknown
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M14968
- Name: Respiratory Insufficiency
- Relevance: HIGH
- As Found: Respiratory Depression
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012131
- Term: Respiratory Insufficiency
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424301
**Brief Title:** Targeting NUDT21 siRNA Drugs for Patients With Refractory Retinoblastoma
**Official Title:** Targeting NUDT21 siRNA Drugs for Patients With Refractory Retinoblastoma (A Two-center Prospective Single Arm Trial)
#### Organization Study ID Info
**ID:** FD-EENT-20240221
#### Organization
**Class:** OTHER
**Full Name:** Eye & ENT Hospital of Fudan University
### Status Module
#### Completion Date
**Date:** 2027-05-21
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-21
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-21
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** The Eye Hospital of Wenzhou Medical University
#### Lead Sponsor
**Class:** OTHER
**Name:** Eye & ENT Hospital of Fudan University
#### Responsible Party
**Investigator Affiliation:** Eye & ENT Hospital of Fudan University
**Investigator Full Name:** Chen Zhao
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Retinoblastoma (RB) is the most common intraocular malignancy in children and accounts for 11% of all cancers in children under the age of 1 year. Although the incidence of RB is low, approximately 1/15,000 \~ 1/20,000, it tends to metastasize to the intracranial area through the optic nerve pathway leading to poor prognosis for patients with RB. Currently, with the emergence of new administration routes, such as intravitreal and intrarterial chemotherapy, the rate of eye preservation has been effectively improved. However, the use of high doses of chemotherapeutic agents may lead to visual impairments due to long-term retinal toxicity and some tumors recur or become resistant to chemotherapeutic agents after treatment. In such cases, ocular resection is the only option to prevent extraocular metastasis and death.
Therefore, studies on retinoblastoma are currently focused on finding new targeted therapies to increase anti-tumor activity and reduce side effects. In this study, a novel targeting NUDT21 siRNA drug will be used to treat patients with refractory retinoblastoma. This drug promotes tumor apoptosis by regulating the 3'UTR plus tail of SMC1A, which makes the proliferative activity of tumor cells weaken and achieves tumor control. At the same time, since the targeted drug only focuses on tumor cells, it has reduced side effects compared with existing local chemotherapy regimens.
Based on the above background, this study will explore the feasibility and effectiveness of intravitreal injection of NUDT21 siRNA in patients with refractory retinoblastoma through a two-center prospective study.
### Conditions Module
**Conditions:**
- Retinoblastoma
- Refractory
**Keywords:**
- retinoblastoma
- intravitreal Chemotherapy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The enrolled patients underwent blood sample collection and clinical evaluation before the first injection of the targeted drug. Intravitreal injection of the targeted drug at a dosage of 100-1000 μg was performed on day 1 of week 1 and week 3, respectively. Collection of aqueous humor was performed on weeks 1, 3, and 7, respectively. Collection of blood samples and sputum specimens was performed on weeks 1, 3, 5, and 7. And clinical assessment was performed weekly with continuous follow-up until 12 weeks.
**Intervention Names:**
- Drug: Targeting NUDT21 siRNA drugs
**Label:** Intravitreal chemotherapy in patients with refractory retinoblastoma
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intravitreal chemotherapy in patients with refractory retinoblastoma
**Description:** It is performed for intravitreal chemotherapy.
**Name:** Targeting NUDT21 siRNA drugs
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Incidence of Treatment-Emergent Adverse Events
**Time Frame:** 49 days
#### Secondary Outcomes
**Description:** Tumor response rate (ORR) to targeting NUDT21 siRNA at 28 days post-administration.
**Measure:** Tumor response
**Time Frame:** 28 days
**Description:** To detect the presence of drugs in blood samples and aqueous humor. To find out the difference in drug concentrations before and after treatment to evaluate the excretion profile of the drug.
**Measure:** Targeting NUDT21 siRNA drugs
**Time Frame:** 49 days
**Description:** Inflammatory factor testing was performed on the patients' aqueous humor samples.
**Measure:** Immune response
**Time Frame:** 49 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. Patients with retinoblastoma with a somatic mutation of the gene RB1 and active tumor in a single eye, or germinal mutation of RB1 with active tumor/s in an eye and the contralateral eye unaffected, enucleated or without tumor activity. In both cases, relapsed or refractory with the use of systemic, intraarterial or intravitreal chemotherapy or radiotherapy, in accordance with the availability at his/her referral site, in whom enucleation is the only recommended treatment under opinion of the medical team treating the case at the originating referral site. But the patient has a strong desire to preserve the eye.
2. Normal renal function: serum creatinine: \< 45 μmol/L (0-2 years); \< 57 μmol/L (3-6 years); \< 60 μmol/L (7-10 years); \< 80 μmol/L (11-13 years).
3. Normal Hepatic function: serum ALT: \< 0,52 μkat/L (de 9 months -12 years); serum AST: 61-80 g/L (8 months - 5 years); 63-83 g/L (5-9 years); 63-82 g/L (9-12 years).
4. Adequate marrow reserve manifested in an absolute neutrophil count \> 1000 / mm3, platelets \> 100,000 / mm3 and hemoglobin\> 8 g / dl, without transfusional or cytokine support at least one month prior to study entry.
5. Age greater than 1 year and less than 12 years at the time of inclusion in the study.
6. Sign the informed consent form and be willing to follow up at the specified time.
Exclusion Criteria:
* 1. Presence of factors that require immediate enucleation of the affected eye such as glaucoma, rubeosis iridis, anterior chamber involvement.
2. Comorbidities: Uncontrolled epilepsy with anticonvulsant treatment, cardiac disease not compensated by treatment.
3. Active Infections. 4. Other chronic or active acute diseases that under the criterion of the researcher were an exclusion criterion.
5. History of having received attenuated or live vaccines in the 30 days prior to inclusion in the study.
6. Any cause of Immunosuppression. 7. Trilateral Retinoblastoma. 8. Extraocular spread. 9. History of having received treatment for retinoblastoma with chemotherapy or radiation therapy by any means within 30 days prior to inclusion in the study.
10. Patients who can not complete the study procedures for reasons psychological or Social.
**Maximum Age:** 12 Years
**Minimum Age:** 1 Year
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ruiqi Ma, MD
**Phone:** 86-021-64377134
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Fudan Eye & ENT Hospital
**Name:** Jiang Qian, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Fudan Eye & ENT Hospital
**Name:** Kang Xue, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** The Eye Hospital of Wenzhou Medical University
**Name:** Kang Zhang, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** IPD will be shared upon requirement.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000018302
- Term: Neoplasms, Neuroepithelial
- ID: D000017599
- Term: Neuroectodermal Tumors
- ID: D000009373
- Term: Neoplasms, Germ Cell and Embryonal
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009380
- Term: Neoplasms, Nerve Tissue
- ID: D000019572
- Term: Retinal Neoplasms
- ID: D000005134
- Term: Eye Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000015785
- Term: Eye Diseases, Hereditary
- ID: D000005128
- Term: Eye Diseases
- ID: D000012164
- Term: Retinal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M15010
- Name: Retinoblastoma
- Relevance: HIGH
- As Found: Retinoblastoma
- ID: M20446
- Name: Neoplasms, Neuroepithelial
- Relevance: LOW
- As Found: Unknown
- ID: M19845
- Name: Neuroectodermal Tumors
- Relevance: LOW
- As Found: Unknown
- ID: M20388
- Name: Neuroectodermal Tumors, Primitive
- Relevance: LOW
- As Found: Unknown
- ID: M12318
- Name: Neoplasms, Germ Cell and Embryonal
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12325
- Name: Neoplasms, Nerve Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M21508
- Name: Retinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8277
- Name: Eye Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M18339
- Name: Eye Diseases, Hereditary
- Relevance: LOW
- As Found: Unknown
- ID: M14999
- Name: Retinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4977
- Name: Retinoblastoma
- Relevance: HIGH
- As Found: Retinoblastoma
- ID: T4092
- Name: Neuroepithelioma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012175
- Term: Retinoblastoma
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424288
**Brief Title:** A Study to Test Whether BI 690517 in Combination With Empagliflozin Helps People With Heart Failure
**Official Title:** A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Used of Oral BI 690517 and Empagliflozin Compared With Placebo and Empagliflozin in Patients With Heart Failure (HF) (New York Heart Association [NYHA] Classes II to IV) and Left Ventricular Ejection Fraction (LVEF) ≥40%
#### Organization Study ID Info
**ID:** 1378-0020
#### Organization
**Class:** INDUSTRY
**Full Name:** Boehringer Ingelheim
#### Secondary ID Infos
**Domain:** CTIS
**ID:** 2023-509706-30-00
**Type:** REGISTRY
**Domain:** WHO International Clinical Trials Registry Platform (ICTRP)
**ID:** U1111-1302-4422
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2027-11-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-21
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-11-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-27
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Boehringer Ingelheim
#### 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 study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether BI 690517 in combination with empagliflozin helps people with heart failure.
Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are:
* BI 690517 and empagliflozin group: participants take BI 690517 and empagliflozin as tablets once a day.
* Placebo and empagliflozin group: participants take placebo and empagliflozin as tablets once a day.
Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being.
The study does not have a fixed duration. It continues until we have enough data to see if the treatment is working.
### Conditions Module
**Conditions:**
- Heart Failure
### 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:** 6000
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: BI 690517
- Drug: Empagliflozin
**Label:** BI 690517 + empagliflozin
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Empagliflozin
- Drug: Placebo
**Label:** Placebo + empagliflozin
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- BI 690517 + empagliflozin
**Description:** BI 690517
**Name:** BI 690517
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- BI 690517 + empagliflozin
- Placebo + empagliflozin
**Description:** Empagliflozin
**Name:** Empagliflozin
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Placebo + empagliflozin
**Description:** Placebo matching BI 690517
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Time to first event of Cardiovascular (CV) death or Hospitalisation for heart failure (HHF)
**Time Frame:** up to 42 months
#### Secondary Outcomes
**Measure:** Key secondary endpoint: Time to first event of CV death, HHF or urgent heart failure visit
**Time Frame:** up to 42 months
**Measure:** Key secondary endpoint: Occurrence of HHFs (first and recurrent)
**Time Frame:** up to 42 months
**Description:** The Kansas City Cardiomyopathy Questionnaire is a patient-reported outcome instrument for use in clinical investigations in heart failure.
The Total Symptom Score measures the following aspects of symptom experience in two domain scores:
The "Symptom Frequency Domain" assesses frequency of the following experiences:
* Lower extremity swelling in the morning
* Fatigue limiting patients' ability to do what they want
* Dyspnea limiting patients' ability to do what they want
* Dyspnea forcing patients to sleep upright/elevated
The "Symptom Burden Domain" assesses bothersomeness of the following symptoms:
* Fatigue
* Dyspnea
* Lower extremity swelling All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
**Measure:** Key secondary endpoint: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) at Week 32
**Time Frame:** at baseline, at week 32
**Measure:** Key secondary endpoint: Time to CV death
**Time Frame:** up to 42 months
**Measure:** Key secondary endpoint: Time to all-cause mortality
**Time Frame:** up to 42 months
**Measure:** Time to first HHF
**Time Frame:** up to 42 months
**Description:** \* chronic dialysis is defined as dialysis continuing for at least 30 days
\*\* using the Chronic Kidney Disease Epidemiology Collaboration creatinine equation ((CKD-EPI)cr)
**Measure:** Time to first occurrence of death from kidney failure, chronic dialysis* or renal transplant or sustained reduction of ≥40% estimated glomerular filtration rate (eGFR)** or sustained eGFR (CKD-EPI)cr <10 mL/min/1.73 m² (composite renal endpoint)
**Time Frame:** up to 42 months
**Description:** The KCCQ Clinical Summary Score is a composite of the Total Symptom Score and Physical Limitations Score.
The "Physical Limitations Score" measures the following physical limitations:
* Dressing
* Showering/bathing
* Walking one block on level ground
* Doing yardwork, housework or carrying groceries
* Climbing a flight of stairs without stopping
* Hurrying or jogging as if to catch a bus All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
**Measure:** Absolute change from baseline in KCCQ Clinical Summary Score (KCCQ-CSS) at Week 32
**Time Frame:** at baseline, at week 32
**Measure:** Absolute change from baseline in KCCQ-TSS at Week 52
**Time Frame:** at baseline, at week 52
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information
4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before Visit 2
5. Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2
6. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:
1. in participants with body mass index (BMI) \<27 kg/m²: ≥300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
2. in participants with BMI ≥27 kg/m² to \<35 kg/m²: ≥220 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
3. in participants with BMI ≥35 kg/m²: ≥125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
7. At least one of the following:
* Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1
* Documented hospitalisation for HF within 6 months prior to Visit 1
* Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1
* in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg/mL
* for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg/mL
8. Participants must be treated according to best possible standard of care (SOC) in accordance with applicable HF local/international guidelines (according to the judgment of the investigator)
Exclusion criteria:
1. Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study
2. Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator
3. Receiving the following treatments:
* a direct renin inhibitor (e.g. aliskiren) at Visit 2
* more than one angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI), or two simultaneously at Visit 2
* Acute decompensated HF requiring hospitalisation or i.v. therapy including diuretics, or i.v. inotropes or i.v. vasodilators, mechanical support (such as an intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device), or IV natriuretic peptide (e.g. nesiritide) within the past 7 days prior to Visit 2
4. Myocardial infarction (MI), cerebrovascular accident (CVA), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 1, or scheduled for major elective surgery (e.g. hip replacement, coronary artery bypass graft surgery/CABG)
5. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)
6. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2
7. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2
8. Known severe valvular heart disease (obstructive or regurgitant), as per investigator's judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study Further exclusion criteria apply.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Boehringer Ingelheim
**Phone:** 1-800-243-0127
**Role:** CONTACT
### IPD Sharing Statement Module
**Access Criteria:** For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
**Description:** Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- CSR
**IPD Sharing:** YES
**Time Frame:** One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
**URL:** https://www.mystudywindow.com/msw/datasharing
### References Module
#### See Also Links
**Label:** Related Info
**URL:** https://www.mystudywindow.com
## 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
### 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: M258082
- Name: Empagliflozin
- Relevance: HIGH
- As Found: Part 1
- 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: C000570240
- Term: Empagliflozin
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424275
**Acronym:** PRAISE-U
**Brief Title:** Prostate Cancer Awareness and Initiative for Screening in the European Union
**Official Title:** Prostate Cancer Awareness and Initiative for Screening in the European Union
#### Organization Study ID Info
**ID:** 101101217
#### Organization
**Class:** OTHER
**Full Name:** European Association of Urology Research Foundation
### Status Module
#### Completion Date
**Date:** 2026-04-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-04-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Erasmus Medical Center
**Class:** UNKNOWN
**Name:** European Randomised Study of Screening for Prostate Cancer
**Class:** OTHER
**Name:** Region MidtJylland Denmark
**Class:** OTHER_GOV
**Name:** Institute of Health Information and Statistics of the Czech Republic
**Class:** OTHER
**Name:** UMC Utrecht
**Class:** UNKNOWN
**Name:** EUROPEAN CANCER ORGANISATION
**Class:** UNKNOWN
**Name:** Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
**Class:** UNKNOWN
**Name:** Narodowy Instytut Zdrowia Publicznego
**Class:** UNKNOWN
**Name:** Conselleria de Sanidade de Galicia
**Class:** OTHER
**Name:** Althaia Xarxa Assistencial Universitària de Manresa
**Class:** OTHER_GOV
**Name:** Vastra Gotaland Region
**Class:** OTHER
**Name:** Region Skane
**Class:** NIH
**Name:** National Cancer Institute (NCI)
**Class:** OTHER
**Name:** University Ghent
**Class:** OTHER
**Name:** Health Service Executive, Ireland
**Class:** UNKNOWN
**Name:** Estonian Urological Association
**Class:** OTHER
**Name:** University College Dublin
**Class:** UNKNOWN
**Name:** WONCA Europe
**Class:** OTHER
**Name:** Movember Foundation
**Class:** OTHER
**Name:** International Agency for Research on Cancer
**Class:** OTHER
**Name:** European Society of Urogenital Radiology
**Class:** UNKNOWN
**Name:** Europa UOMO
**Class:** UNKNOWN
**Name:** Czech Urological Society
#### Lead Sponsor
**Class:** OTHER
**Name:** European Association of Urology Research Foundation
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** PRAISE-U was initiated on the 1st of April 2023 and is set to last for three years. This collaborative effort involves 25 institutions across 12 countries, all driven by a shared objective: to rationalize prostate cancer screening in Europe and enhance patient outcomes. PRAISE-U advocates for EU member states to offer exceptional clinical standards, incorporating cutting-edge personalized approaches to enable timely detection of prostate cancer in individuals who can benefit from early treatment. To assess the functionality, feasibility, and long-term viability of a risk-based algorithm, the consortium will collaborate with pilot sites in Spain, Poland, Ireland, and Lithuania.
**Detailed Description:** The project has several key deliverables that are instrumental in its success. In the early phase of the project, the consortium will prepare a living state-of-play document - a comprehensive review of diverse screening strategies for prostate cancer in the EU, as well their harm/benefit and cost effectiveness. At a later stage, clinical performance indicators of screening effectiveness will be established, and a protocol for implementation of population-based quality assured prostate cancer screening program will be developed. While the protocol will follow a standardized approach, it will also allow for flexibility to accommodate the unique characteristics of each country's healthcare system. The pilot studies will run for 12 months, and all collected data will be used to estimate pre-defined key performance indicators that will be included in the final report. This deliverable will be used to perform a thorough evaluation of how well the screening program worked during the pilot phase and how site characteristics and diagnostic algorithms are associated with performance. The reach, acceptability, and adoption of the screening programme, its cost-effectiveness, as well as attitudes of participants and physicians, will be the research outcomes of interest.
The project aims to have short-term and long-term effects on prostate cancer screening in EU member states. In the short-term (1-3 years), the focus is on advancing population-based risk-adapted prostate cancer screening and increasing awareness among key stakeholders. This will be achieved by providing evidence-based information on the benefits and drawbacks of risk-adapted screening, leading to improved knowledge and future endorsement by healthcare professionals. In the medium-term (4-9 years), the goal is to reduce costs by eliminating ineffective opportunistic screening and implementing an organized risk-based screening algorithm. Ultimately, in the long-term (10+ years), the project aims to decrease the burden of prostate cancer and improve quality of life by reducing mortality rates and the number of advanced/metastatic cases through effective screening practices. PRAISE-U is an important step in assessing how screening for prostate cancer may reduce the burden of the disease for every man in the European Union.
### Conditions Module
**Conditions:**
- Prostate Cancer
**Keywords:**
- prostate cancer
- early detection of prostate cancer
- cancer screening
- risk-based algorithm
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 20000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The pilot is run by the Althaia Foundation, driven by the director of primary care.
**Intervention Names:**
- Diagnostic Test: Risk-based screening algorithm
**Label:** Manresa, Spain
#### Arm Group 2
**Description:** The pilot is run by the Galician Healthcare Service (SERGAS), publicly funded healthcare system of Galicia, Spain.
**Intervention Names:**
- Diagnostic Test: Risk-based screening algorithm
**Label:** Region Galicia, Spain
#### Arm Group 3
**Description:** The pilot is run by the Health Service Executive, with University College Dublin as the academic institutional partner, in full support of the National Cancer Control programme (NCCP) and the National Screening Service (NSS) in Ireland
**Intervention Names:**
- Diagnostic Test: Risk-based screening algorithm
**Label:** Ireland
#### Arm Group 4
**Description:** The pilot is run by the Lower Silesian Oncology, Pulmonology and Haematology Center. Subdivision of Urology with support from the National Institute of Public Health.
**Intervention Names:**
- Diagnostic Test: Risk-based screening algorithm
**Label:** Poland
#### Arm Group 5
**Description:** The pilot is run by the National Cancer Institute, where residents of the capital Vilnius region are served.
**Intervention Names:**
- Diagnostic Test: Risk-based screening algorithm
**Label:** Lithuania
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ireland
- Lithuania
- Manresa, Spain
- Poland
- Region Galicia, Spain
**Description:** Risk-based screening algorithm
**Name:** Risk-based screening algorithm
**Other Names:**
- PSA
- Risk calculator
- MRI
- Biopsy
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Measure:** Incidence of clinically significant prostate cancer in each pilot site (with clinically significant prostate cancer defined as ISUP grade group ≥2).
**Time Frame:** 1 year
**Description:** The proportion of eligible individuals from the target population personally invited for screening within a given time frame.
**Measure:** Invitation coverage
**Time Frame:** 1 year
**Description:** The proportion of eligible individuals from the target population who had the recommended screening test within a given time frame
**Measure:** Examination coverage
**Time Frame:** 1 year
**Description:** The proportion of invited individuals who have undergone a screening test within a given time- frame following an active invitation.
**Measure:** Participation rate
**Time Frame:** 1 year
**Description:** The proportion of eligible individuals re-screened after a negative screening within a specified interval.
**Measure:** Retention rate
**Time Frame:** 1 year
**Description:** The results of the screening test.
**Measure:** Test result
**Time Frame:** 1 year
**Description:** The proportion of individuals who have histopathology confirmed PCa to all those who had positive test results (with PSA result of \>3 ng/ml) (including healthy subjects who were incorrectly diagnosed to have prostate cancer)
**Measure:** PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)
**Time Frame:** 1 year
**Description:** The proportion of individuals who have histopathologically confirmed clinically significant PCa to all those who had positive test results (with PSA result of \>3 ng/ml)
(including healthy subjects who were incorrectly diagnosed as clinically significant PCa).
**Measure:** PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)
**Time Frame:** 1 year
**Description:** The proportion of screened individuals who received a positive screening result in which no cancer was detected after workup and diagnostic procedures.
**Measure:** False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)
**Time Frame:** 1 year
**Description:** The proportion of screened individuals who received a positive screening result in which no clinically significant cancer was detected after workup and diagnostic procedures.
**Measure:** False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)
**Time Frame:** 1 year
**Description:** The proportion of individuals from the screened population undergoing risk assessment (as per protocol of the programme).
**Measure:** Compliance with risk assessment
**Time Frame:** 1 year
**Description:** The proportion of individuals referred for diagnostic work up based on elevated PSA and risk assessment (as per protocol of the programme) attending all workup and diagnostic procedures assigned.
**Measure:** Compliance with further assessment
**Time Frame:** 1 year
**Description:** The proportion of individuals with a screen positive test who underwent further assessment with histopathologically proven cancer detected \[expressed per 1,000 individuals screened\].
**Measure:** Detection rate of PCa
**Time Frame:** 1 year
**Description:** The proportion of individuals with cancer diagnosed within the screening program referred for treatment who initiated treatment (including active surveillance, when applicable).
**Measure:** Compliance with treatment
**Time Frame:** 1 year
**Description:** The proportion of individuals reporting at least one complication incurred during the screening procedure.
**Measure:** Complications in screening procedure
**Time Frame:** 1 year
**Description:** The proportion of individuals screened outside the population-based screening programme.
**Measure:** Opportunistic testing
**Time Frame:** 1 year
**Description:** The mortality from prostate cancer (primary cause of death only) per 100,000 target population in a defined 12-month period
**Measure:** Cause-specific mortality
**Time Frame:** 1 year
**Description:** The number of new cases of PCa arising in a specified population (expressed per 100,000) within a time frame of 12-months.\]
**Measure:** Crude Incidence rate
**Time Frame:** 1 year
**Description:** The proportion of individuals with a negative screening test or a positive screening test but negative further assessment results who were diagnosed with prostate cancer prior to the next screening round.
**Measure:** Interval cancer rate
**Time Frame:** 1 year
**Description:** Time from PSA test sample collection to histopathological confirmation of a malignant diagnosis (further disaggregated by different procedures) to treatment initiation
**Measure:** Delay time
**Time Frame:** 1 year
**Description:** Radiologist's assessment of MRI
**Measure:** Radiologist's assessment of MRI
**Time Frame:** 1 year
**Description:** Proportion of eligible men who underwent biopsy
**Measure:** Compliance with biopsy
**Time Frame:** 1 year
**Description:** The proportion of patients recommended AS due to low/low-intermediate risk PCa who accepted and initiated AS.
**Measure:** Active surveillance
**Time Frame:** 1 year
**Description:** Proportion of prostate cancers detected after positive screening test reported as ISUP grade (group) 1, 2, 3 and 4-5.
**Measure:** Tumour grade distribution
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 50-69 years old.
Exclusion Criteria:
* Previous diagnosis of prostate cancer.
* Unable to provide written informed consent.
* Had prostate biopsy or MRI within the past six months.
**Healthy Volunteers:** True
**Maximum Age:** 69 Years
**Minimum Age:** 50 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Healthy men aged 50-69 years old.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Vera Vasilyeva
**Phone:** 31622973853
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sarah Collen
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005834
- Term: Genital Neoplasms, Male
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000011469
- Term: Prostatic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424262
**Acronym:** DETECT
**Brief Title:** Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)
**Official Title:** A Pivotal, Prospective, Multi-centre, Randomised Controlled, Blinded Investigation Evaluating the Efficacy of a Dexamethasone Eluting Slim Straight Electrode (CI622D) in the Reduction of Impedance as Compared to a Standard Slim Straight Electrode (CI622) in a Newly Implanted Adult Population With Post-linguistic, Bilateral, Moderately Severe to Profound Sensorineural Hearing Loss.
#### Organization Study ID Info
**ID:** CLTD5815
#### Organization
**Class:** INDUSTRY
**Full Name:** Cochlear
### Status Module
#### Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** QbD Clinical
**Class:** INDUSTRY
**Name:** Avania
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Cochlear
#### 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 clinical study will test a newly developed cochlear implant known as CI622D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation, which is common after any surgical procedure. The goal is to learn if there are added benefits in implant performance and hearing outcomes with the dexamethasone-releasing cochlear implant (CI622D) vs. the standard cochlear implant (CI622) without dexamethasone. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve. The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing ability and their overall general health.
### Conditions Module
**Conditions:**
- Hearing Loss, Bilateral Sensorineural
- Hearing Loss, Sensorineural
- Hearing Loss, Bilateral
- Hearing Loss, Cochlear
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 48
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Investigational Medical Device (IMD)
**Intervention Names:**
- Device: CI622D
**Label:** CI622D
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** An approved medical device
**Intervention Names:**
- Device: CI622
**Label:** CI622
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CI622D
**Description:** A dexamethasone-eluting Slim Straight electrode
**Name:** CI622D
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- CI622
**Description:** A standard Slim Straight electrode
**Name:** CI622
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The impedance will be measured across the active electrodes of the implant for each participant.
**Measure:** Mean difference in the monopolar 1+2 (MP1+2) impedance between CI622D (Investigational Medical Device) and CI622 (control device) at 3 months post-activation
**Time Frame:** 3 months post-activation
#### Secondary Outcomes
**Description:** Adverse events will be recorded as overall, by severity, by relatedness to device or procedure, or by seriousness. Device deficiency will be recorded as overall and by type.
**Measure:** Proportion of participants who experience an adverse event and the proportion of participants who experience a device deficiency with CI622D and CI622
**Time Frame:** Throughout study (12 months)
**Description:** Unaided acoustic hearing thresholds will be measured pre-operatively, at activation, and 3, 6 and 12 months post-activation.
**Measure:** Difference in the mean unaided acoustic hearing thresholds pre-operatively, and from activation to post-activation between CI622D and CI622
**Time Frame:** Pre-operative, 0, 3, 6, 12 months post-activation
**Description:** Word recognition scores will be measured at pre-implantation and 3, 6 and 12 months post-activation.
**Measure:** Mean within-subject change in word recognition score in the preferred unilateral listening mode in quiet from pre-implantation to post-activation with CI622D
**Time Frame:** Pre-implantation, 3, 6, 12 months post-activation
**Description:** Word recognition scores will be measured at pre-implantation and 3, 6 and 12 months post-activation.
**Measure:** Mean change (within-subject) in word recognition score in the preferred bilateral listening mode in quiet from pre-implantation to post-activation with CI622D
**Time Frame:** Pre-implantation, 3, 6, 12 months post-activation
**Description:** Change in word recognition score will be measured from pre-implantation to 3, 6 and 12 months post-activation.
**Measure:** Difference in mean (within-subject) change in word recognition score in the preferred unilateral listening mode in quiet from pre-implantation to post-activation with CI622D compared with CI622
**Time Frame:** Pre-implantation, 3, 6, 12 months post-activation
**Description:** Change in word recognition score will be measured from pre-implantation to 3, 6 and 12 months post-activation.
**Measure:** Difference in mean (within-subject) change in word recognition score in the preferred bilateral listening mode in quiet from pre-implantation to post-activation with CI622D compared with CI622
**Time Frame:** Pre-implantation, 3, 6, 12 months post-activation
**Description:** Change in sentence recognition score (Matrix test + 10 SNR) will be measured from pre-implantation to 3, 6 and 12 months post-activation.
**Measure:** Difference in mean (within-subject) change in sentence recognition score in noise in the preferred unilateral listening mode from pre-implantation to post-implantation with CI622D compared with CI622
**Time Frame:** Pre-implantation, 3, 6, 12 months post-activation
**Description:** Change in sentence recognition score (Matrix test + 10 SNR) will be measured from pre-implantation to 3, 6 and 12 months post-activation.
**Measure:** Difference in mean (within-subject) change in sentence recognition score in noise in the preferred bilateral listening mode from pre-implantation to post-implantation with CI622D compared with CI622
**Time Frame:** Pre-implantation, 3, 6, 12 months post-activation
**Description:** Four-point monopolar and nested bipolar trans-impedances and MP1+2 impedances will be measured intraoperatively, at activation and 3,6,12 months post-activation.
**Measure:** Difference in the mean four-point monopolar and nested bipolar trans-impedances and MP1+2 impedances between CI622D and CI622 measured intraoperatively and from activation to post-activation
**Time Frame:** Intraoperative, 0, 3, 6, 12 months post-activation
**Description:** The estimated sound processor battery life (hours per day) will be measured at activation, 3, 6, and 12 months-post activation.
**Measure:** Difference in the mean estimated sound processor battery life for CI622D compared from activation to post-activation with CI622
**Time Frame:** 0, 3, 6,12 months post-activation
**Description:** Global SSQ12 scores will be measured between pre-implantation to 3, 6 and 12 months post-activation.
**Measure:** Difference in mean within-subject changes in global score on the Speech, Spatial, and Qualities of Hearing Scale (SSQ12) from pre-implantation to post-activation between CI622D and CI622
**Time Frame:** Pre-implantation, 3, 6, 12 months post-activation
**Description:** Global HUI3 scores will be measured between pre-implantation to 3, 6 and 12 months post-activation.
**Measure:** Difference in mean within-subject changes in global Health Utilities Index III (HUI3) from pre-implantation to post-activation between CI622D and CI622
**Time Frame:** Pre-implantation, 3, 6, 12 months post-activation
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged 18 years or older (at time of consent)
* Clinically established post-linguistic bilateral moderately severe to profound sensorineural hearing loss
* Meets local candidacy criteria for cochlear implantation
* Compromised functional hearing with a hearing aid in the ear to be implanted
* Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm
* Evidence of pneumococcal vaccination (e.g., Pneumovax) according to local guidelines prior to randomisation
* Candidate is proficient in the language used to assess speech perception performance
* Willing and able to provide written informed consent.
Exclusion Criteria:
* Planned for a partial insertion of the electrode array
* Deafness due to lesions of the acoustic nerve or central auditory pathway, affecting either ear
* Active middle-ear infection, in the ear to be implanted
* Active autoimmune disease, active immunosuppressive therapy, or use of anticoagulants that cannot be discontinued for surgery
* Surgery (including grommets), drainage, presence of an unhealed tympanic membrane, pain, or need for oral or topical antibiotics within 6 months prior to randomisation, in the ear to be implanted
* Previously reported diagnosis of auditory neuropathy, in either ear
* Previously reported diagnosis, in either ear, of Large Vestibular Aqueduct Syndrome (LVAS), Meniere's disease, or cochlear hydrops
* Ossification, otosclerosis, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by imaging, in the ear to be implanted
* Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula, temporo-parietal skull fracture or CSF leaks
* History of bacterial meningitis
* Known allergic reaction or contraindication to dexamethasone or corticosteroids
* Severe, or poorer, bilateral sensorineural hearing loss prior to 5 years of age, as reported by the subject
* Severe, or poorer, sensorineural hearing loss of more than 20 years, as reported by the subject, in the ear to be implanted
* Prior cochlear implantation, in either ear
* Medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted
* Medical or psychological conditions that contraindicate general anaesthesia, surgery or participation in the clinical investigation
* Women who are pregnant or breastfeeding or plan to become pregnant during the investigation
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator
* Additional disabilities that may affect the subject's participation or safety during the clinical investigation, as determined by the Investigator
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as spouse, parent, child, or sibling to the study candidate
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the Investigator or Sponsor to not impact this investigation)
* Subjects recruited at a French site who are not affiliated with social security
* Subjects recruited at a French site who are under legal protection.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Cherith Campbell-Bell
**Phone:** +6129428 6555
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Beatrice Reusens
**Phone:** +32485759196
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Sydney
**Contacts:**
***Contact 1:***
- **Name:** Catherine Birman, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Catherine Birman
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Australia
**Facility:** Royal Prince Alfred Hospital
**State:** New South Wales
**Location 2:**
**City:** Melbourne E.
**Contacts:**
***Contact 1:***
- **Name:** Stephen O'Leary, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Stephen O'Leary
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Australia
**Facility:** Royal Victorian Eye and Ear Hospital
**State:** Victoria
**Location 3:**
**City:** Lille
**Contacts:**
***Contact 1:***
- **Name:** Christophe Vincent, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Christophe Vincent, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Centre Hospitalier Universitaire de Lille
**Location 4:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Name:** Isabelle Mosnier, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Isabelle Mosnier
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Hôpital Universitaire Pitié-Salpêtrière
**Location 5:**
**City:** Toulouse
**Contacts:**
***Contact 1:***
- **Name:** Olivier Deguine, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Olivier Deguine
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Centre Hospitalier Universitaire Toulouse
**Location 6:**
**City:** Freiburg
**Contacts:**
***Contact 1:***
- **Name:** Antje Aschendorff, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Antje Aschendorff
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Germany
**Facility:** Universitätsklinikum Freiburg
**State:** Freiburg Im Breisgau
**Location 7:**
**City:** Hannover
**Contacts:**
***Contact 1:***
- **Name:** Thomas Lenarz, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Thomas Lenarz
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Germany
**Facility:** Medizinische Hochschule Hannover
**State:** Niedersachsen
**Location 8:**
**City:** Manchester
**Contacts:**
***Contact 1:***
- **Name:** Emma Stapleton, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Emma Stapleton, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United Kingdom
**Facility:** Manchester Royal Infirmary
**Location 9:**
**City:** Southampton
**Contacts:**
***Contact 1:***
- **Name:** William Hellier, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** William Hellier, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United Kingdom
**Facility:** University of Southampton
#### Overall Officials
**Official 1:**
**Affiliation:** Universitätsklinikum Freiburg
**Name:** Antje Aschendorff
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006311
- Term: Hearing Disorders
- ID: D000004427
- Term: Ear Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
- ID: D000012678
- Term: Sensation Disorders
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M24420
- Name: Hearing Loss
- Relevance: HIGH
- As Found: Hearing Loss
- ID: M6840
- Name: Deafness
- Relevance: HIGH
- As Found: Hearing Loss
- ID: M9407
- Name: Hearing Loss, Sensorineural
- Relevance: HIGH
- As Found: Hearing Loss, Sensorineural
- ID: M9401
- Name: Hearing Loss, Bilateral
- Relevance: HIGH
- As Found: Hearing Loss, Bilateral
- ID: M9400
- Name: Hearing Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7601
- Name: Ear Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15490
- Name: Sensation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000034381
- Term: Hearing Loss
- ID: D000003638
- Term: Deafness
- ID: D000006319
- Term: Hearing Loss, Sensorineural
- ID: D000006312
- Term: Hearing Loss, Bilateral
### 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: LOW
- As Found: Unknown
- ID: M235549
- Name: Dexamethasone acetate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424249
**Acronym:** EQUIL-ARC
**Brief Title:** Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation
**Official Title:** Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation
#### Organization Study ID Info
**ID:** Local/2023/EP-02
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Nīmes
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-16
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Centre Hospitalier Universitaire de Nīmes
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Amputation causes somatic and psychological damage. Prognostic factors for postoperative gait recovery include the need for proprioceptive re-education for dynamic balance. Improved gait patterns and use of the prosthesis contribute to an overall improvement in the amputee's autonomy. Virtual reality coupled with movement analysis allows personalization of treatment with objective assessment of progress.
The study authors hypothesize that a virtual reality protocol for the dynamic balance of a unilateral transtibial amputee in initial rehabilitation will improve the dynamic balance assessment criteria compared with a conventional rehabilitation protocol.
### Conditions Module
**Conditions:**
- Amputees / Rehabilitation
- Virtual Reality
- Postural Balance
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: Virtual Reality
**Label:** Virtual Reality group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Other: Standard rehabilitation
**Label:** Control group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Virtual Reality group
**Description:** A progressive rehabilitation protocol (different levels according to success scores) consisting of several exercises using virtual and augmented reality with mechanical perturbations (pitching of the treadmill), interaction with the virtual environment, interaction with the virtual environment and augmented reality (projection of obstacles on the treadmill), and modification of the gait pattern with visual and/or audio biofeedback
**Name:** Virtual Reality
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Control group
**Description:** A treadmill walking protocol with virtual reality to immerse the patient in a 3 x 5-minute walking session, without visual, mechanical or auditory disturbances, and without prompting the patient to modify their walking pattern.
**Name:** Standard rehabilitation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The number of gait cycles required to regain center of mass displacement (number of cycles \* cycle time), measured with the GRAIL rehabilitation and movement analysis platform
**Measure:** Mediolateral instability during mediolateral external perturbation between groups
**Time Frame:** Before rehabilitation (Day 1)
**Description:** The number of gait cycles required to regain center of mass displacement (number of cycles \* cycle time), measured with the GRAIL rehabilitation and movement analysis platform
**Measure:** Mediolateral instability during mediolateral external perturbation between groups
**Time Frame:** End of rehabilitation sessions (Day 45)
#### Secondary Outcomes
**Description:** Meters, measured with the GRAIL rehabilitation and movement analysis platform
**Measure:** Step length variability between groups
**Time Frame:** Before rehabilitation (Day 1)
**Description:** Meters, measured with the GRAIL rehabilitation and movement analysis platform
**Measure:** Step length variability between groups
**Time Frame:** End of rehabilitation sessions (Day 45)
**Description:** Meters, measured with the GRAIL rehabilitation and movement analysis platform
**Measure:** Step width variability between groups
**Time Frame:** Before rehabilitation (Day 1)
**Description:** Meters, measured with the GRAIL rehabilitation and movement analysis platform
**Measure:** Step width variability between groups
**Time Frame:** End of rehabilitation sessions (Day 45)
**Description:** Steps/minute, measured with the GRAIL rehabilitation and movement analysis platform
**Measure:** Cadence variability between groups
**Time Frame:** Before rehabilitation (Day 1)
**Description:** Steps/minute, measured with the GRAIL rehabilitation and movement analysis platform
**Measure:** Cadence variability between groups
**Time Frame:** End of rehabilitation sessions (Day 45)
**Description:** Meters, measured with the GRAIL rehabilitation and movement analysis platform
**Measure:** Center of mass variability between groups
**Time Frame:** Before rehabilitation (Day 1)
**Description:** Meters, measured with the GRAIL rehabilitation and movement analysis platform
**Measure:** Center of mass variability between groups
**Time Frame:** End of rehabilitation sessions (Day 45)
**Description:** Time Up and Go test, seconds
**Measure:** Mobility and balance between groups
**Time Frame:** Before rehabilitation (Day 1)
**Description:** Time Up and Go test, seconds
**Measure:** Mobility and balance between groups
**Time Frame:** End of rehabilitation sessions (Day 45)
**Description:** 2-minute walk test, meters
**Measure:** Aerobic endurance and functional capacity between groups
**Time Frame:** Before rehabilitation (Day 1)
**Description:** 2-minute walk test, meters
**Measure:** Aerobic endurance and functional capacity between groups
**Time Frame:** End of rehabilitation sessions (Day 45)
**Description:** Berg scale, score between 0 and 56 (no fall risk)
**Measure:** Fall risk between groups
**Time Frame:** Before rehabilitation (Day 1)
**Description:** Berg scale, score between 0 and 56 (no fall risk)
**Measure:** Fall risk between groups
**Time Frame:** End of rehabilitation sessions (Day 45)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Unilateral transtibial amputees in hospitalized in the rehabilitation of the musculoskeletal system service
* All etiologies: vascular, traumatic and septic.
* Adapted vascular equipment validated by physician.
* Able to walk for 5 minutes on a treadmill without technical assistance.
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
Exclusion Criteria:
* The subject is participating in an interventional study or one involving a drug or medical device, or is in a period of exclusion determined by a previous study
* Patient already included in the present study.
* The subject refuses to or is unable to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patients with uncorrected or untreated visual disorders.
* Patients with major cognitive disorders (MOCA\>23).
* Patients with vestibular disorders.
* Patient with uncontrolled epilepsy.
* Patient with an unhealed amputation stump.
* Patients weighing \> 135kg or \< 20kg.
* Patients with a functional ambulation category of 1 (i.e. patients requiring the firm, continuous assistance of another person to carry their weight and maintain their balance) or less.
* Patients with medication affecting exercise tolerance,
* Patients with sensory impairments
* Patients with significantly reduced bone density
* Patients for whom it is impossible to correctly adjust the harness to the corresponding body part due to:
* Body shape
* Colostomy bags
* Skin lesions that cannot be adequately protected.
* Any other reason that prevents proper, pain-free adjustment of the sling.
* Pregnant, parturient or breast-feeding patients.
* Appearance of a stump wound during the study requiring discharge.
* Patient with more than 50% absenteeism from rehabilitation sessions.
* Patient requiring a new prosthesis insert.
* Patient with a serious adverse event affecting dynamic balance rehabilitation.
**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:** Eric Pantera
**Phone:** 04 66 02 25 36
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nîmes
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Anissa Megzari
- **Phone:** 04.66.68.42.36
- **Role:** CONTACT
***Contact 2:***
- **Name:** Eric Pantera
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Nicolas Reneaud
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Antoine Brisset
- **Role:** SUB_INVESTIGATOR
**Country:** France
**Facility:** CHU de Nimes
#### Overall Officials
**Official 1:**
**Affiliation:** CHU de Nimes
**Name:** Eric Pantera
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424236
**Acronym:** DIAN-TU
**Brief Title:** Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia: A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation
**Official Title:** A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in Dominantly Inherited Alzheimer's Disease
#### Organization Study ID Info
**ID:** DIAN-TU-001 (Gant OLE)
#### Organization
**Class:** OTHER
**Full Name:** Washington University School of Medicine
#### Secondary ID Infos
**Domain:** DIAN TTU-12-243040
**ID:** The Alzheimer's Association
**Type:** OTHER_GRANT
**ID:** U01AG042791
**Link:** https://reporter.nih.gov/quickSearch/U01AG042791
**Type:** NIH
**ID:** 2013-000307-17
**Type:** EUDRACT_NUMBER
**ID:** R01AG046179
**Link:** https://reporter.nih.gov/quickSearch/R01AG046179
**Type:** NIH
**Domain:** Spanish Clinical Studies Registry
**ID:** REec-2014-0817
**Type:** REGISTRY
**Domain:** DIAN-TU Tau-15-347219
**ID:** The Alzheimer's Association
**Type:** OTHER_GRANT
**Domain:** File 4401
**ID:** GHR Foundation
**Type:** OTHER_GRANT
**Domain:** HDE 18S84914
**ID:** Alzheimer's Association
**Type:** OTHER
**Domain:** DIAN-TU NG-16-434362
**ID:** The Alzheimer's Association
**Type:** OTHER_GRANT
**ID:** R56AG053267
**Link:** https://reporter.nih.gov/quickSearch/R56AG053267
**Type:** NIH
**ID:** U01AG059798
**Link:** https://reporter.nih.gov/quickSearch/U01AG059798
**Type:** NIH
**ID:** R01AG053267
**Link:** https://reporter.nih.gov/quickSearch/R01AG053267
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2023-11-13
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** TERMINATED
#### Primary Completion Date
**Date:** 2023-08-12
**Type:** ACTUAL
#### Start Date
**Date:** 2020-06-30
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-16
**Study First Submit QC Date:** 2024-05-15
**Why Stopped:** DIAN-TU announced the discontinuation of the DIAN-TU-001 OLE based on findings from an interim efficacy analysis and the status of the drug program.
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Hoffmann-La Roche
**Class:** OTHER
**Name:** Alzheimer's Association
**Class:** NIH
**Name:** National Institute on Aging (NIA)
#### Lead Sponsor
**Class:** OTHER
**Name:** Washington University School of Medicine
#### 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 assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.
**Detailed Description:** Alzheimer's disease (AD) is defined by the presence of abnormal accumulations of amyloid protein (plaques) and tau protein (tangles) in the brain. The double-blind arm of DIAN-TU-001 Master protocol (NCT01760005) tested whether gantenerumab provided a clinical benefit by slowing the onset or the worsening of the disease. A clinical benefit was not observed in the double-blind part of the DIAN-TU-001 study. However, gantenerumab was associated with improvements in measures of amyloid and tau and an improvement in an overall measure of neurodegeneration (when nerve cells in the brain lose function over time). It is not known whether these changes may provide future clinical benefits. Based on this information, an exploratory Open Label Extension (OLE) will further study the effect of gantenerumab on these Alzheimer-related proteins and their relationship to disease progression.
After this final evaluation of study treatment with gantenerumab used in the gantenerumab / solanezumab double-blind arm of the Master protocol (NCT01760005), participants from the double-blind arm known to carry the genetic mutation for AD have been invited to participate in an OLE period to receive active gantenerumab study treatment as part of the DIAN-TU-001 Master protocol. The OLE period of the study planned to provide study treatment with gantenerumab for up to 3 years (36 months).
This study will continue to collect brain scans, blood, and spinal fluid tests (also called biomarkers), as well as cognitive testing. The idea is to determine if gantenerumab has favorable effects on these tests as it may prevent or delay the symptoms of AD.
Update:
Based on the completed studies of gantenerumab in sporadic AD in late 2022, it was decided to determine if dominantly inherited Alzheimer's disease (DIAD) participants in the DIAN-TU-001 OLE study were benefiting from gantenerumab high-dose treatment.
After evaluation, it was decided to discontinue the DIAN-TU-001 gantenerumab OLE.
### Conditions Module
**Conditions:**
- Alzheimers Disease
- Dementia
- Alzheimers Disease, Familial
**Keywords:**
- Alzheimer's
- Alzheimer's Disease
- Dementia
- Mutation
- Genetic Mutation
- Dominantly Inherited Alzheimer's Disease
- Dominantly Inherited Alzheimer Network
- Autosomal Dominant Alzheimer's Disease
- Early Onset Alzheimer's Disease
- DIAN
- DIAN-TU
- DIAN TU
- DIAD
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Masking Description:** Arm is Open-label as noted in the arm description
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 73
**Type:** ACTUAL
**Phases:**
- PHASE2
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Gantenerumab: Subcutaneously every 4 weeks, at escalating doses
**Intervention Names:**
- Drug: Gantenerumab
**Label:** Gantenerumab Open Label Extension
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Gantenerumab Open Label Extension
**Description:** Open-label administered Subcutaneously every 4 weeks at escalating doses
**Name:** Gantenerumab
**Other Names:**
- RO4909832
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The composite PiB partial volume corrected standardized uptake value ratio is used as the biomarker endpoint for amyloid deposition. Corresponding analyses based on conversion of SUVR to centiloid will be performed by Washington University.
**Measure:** Change in amyloid load as measured by [11C]PiB-PET composite standardized uptake value ration (C-SUVR)
**Time Frame:** Week 0 and Weeks 48, 104, and 156
#### Secondary Outcomes
**Description:** Evaluate the efficacy of gantenerumab in reducing disease progression as assessed in the CDR Sum of Boxes. Minimum score 0; maximum score 18. Higher score indicates worse performance.
**Measure:** Annual Rate of change in Clinical Dementia Rating (CDR) Sum of Boxes
**Time Frame:** Week 0 and Weeks 48, 104, and 156
**Description:** Evaluate the efficacy of gantenerumab in reducing disease progression as assessed in the CDR Global. Minimum score 0; maximum score 3. Higher score indicates worse performance.
**Measure:** Annual Rate of change in Clinical Dementia Rating (CDR) Global
**Time Frame:** Week 0 and Weeks 48, 104, and 156
**Description:** Evaluate the efficacy of gantenerumab in reducing disease progression as assessed in the Functional Assessment Scale (FAS). Higher score indicates worse performance.
**Measure:** Annual Rate of change in Functional Assessment Scale (FAS)
**Time Frame:** Week 0 and Weeks 48, 104, and 156
**Description:** Evaluate the efficacy of gantenerumab in reducing disease progression as assessed in the Mini-Mental State Examination (MMSE). Minimum score 0; maximum score 30. Lower score indicates worse performance.
**Measure:** Annual Rate of change in Mini-Mental State Examination (MMSE)
**Time Frame:** Week 0 and Weeks 48, 104, and 156
**Description:** Evaluate the efficacy of gantenerumab in reducing disease progression as assessed in the Tau PET Binding Partial Volume Corrected Standardized Uptake Value Ratio (Tau PET SUVR)
**Measure:** Annual Rate of change in Tau PET Binding Partial Volume Corrected Standardized Uptake Value Ratio (Tau PET SUVR)
**Time Frame:** Week 0 and Weeks 48, 104, and 156
**Description:** Evaluate the efficacy of gantenerumab in reducing disease progression as assessed in the Cerebrospinal Fluid (CSF) phosphorylated Tau (pTau)-181
**Measure:** Annual Rate of change in Cerebrospinal Fluid (CSF) phosphorylated Tau (pTau)-181
**Time Frame:** Week 0 and Weeks 48, 104, and 156
**Description:** Evaluate the efficacy of gantenerumab in reducing disease progression as assessed in the Neurofilament Light chain (NfL) in CSF (CSF NfL)
**Measure:** Annual Rate of change in Neurofilament Light chain (NfL) in CSF (CSF NfL)
**Time Frame:** Week 0 and Weeks 48, 104, and 156
**Description:** Evaluate the efficacy of gantenerumab in reducing disease progression as assessed in CSF Amyloid Beta1-42/40
**Measure:** Annual Rate of change in Cerebrospinal Fluid (CSF) Amyloid Beta1-42/40
**Time Frame:** Week 0 and Weeks 48, 104, and 156
**Description:** Evaluate the efficacy of gantenerumab in reducing disease progression as assessed in the DIAN-TU OLE Cognitive Composite. The Cognitive Composite is calculated using the WMS-R Digit Span Backward Recall (Minimum score 0; Maximum score 7. Lower indicates worse performance.), the Category Fluency (Animals) value (Minimum score 0; Maximum score Unlimited. Lower score indicates worse performance.), the Wechsler Adult Intelligence Scale Digit Symbol Substitution test (Minimum score 0; Maximum score 93. Lower score indicates worse performance.) , and the Mini Mental State Examination (Minimum score 0; Maximum score 30. Lower score indicates worse performance).
**Measure:** Annual Rate of change in DIAN-TU Open Label Extension Cognitive Composite
**Time Frame:** Week 0 and Weeks 48, 104, and 156
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Between 18-80 years of age
* Individuals who know they have an Alzheimer's disease-causing mutation
* Individuals who have participated in the double-blind period
* In the opinion of the investigator and sponsor, treatment is not contraindicated for safety
* Capable of receiving drug and appropriate clinical safety assessment
* Able to undergo Magnetic Resonance Imaging (MRI), Lumbar Puncture (LP), Positron Emission Tomography (PET), and complete all study related testing and evaluations.
* For women of childbearing potential, if partner is not sterilized, subject must agree to use effective contraceptive measures (hormonal contraception, intra-uterine device, sexual abstinence, barrier method with spermicide).
* Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
* Has a Study Partner who in the investigator's judgment is able to provide accurate information as to the subject's cognitive and functional abilities, who agrees to provide information at the study visits which require informant input for scale completion.
Exclusion Criteria:
* History or presence of brain MRI scans indicative of any other significant abnormality
* Alcohol or drug dependence currently or within the past 1 year
* Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would preclude MRI scan.
* History or presence of clinically significant cardiovascular disease, hepatic/renal disorders, infectious disease or immune disorder, or metabolic/endocrine disorders
* Anticoagulants except low dose (≤ 325 mg) aspirin.
* Have been exposed to a monoclonal antibody targeting beta amyloid peptide within the past six months.
* History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years.
* Positive urine or serum pregnancy test or plans or desires to become pregnant during the course of the trial.
* Subjects unable to complete all study related testing, including implanted metal that cannot be removed for MRI scanning, required anticoagulation and pregnancy.
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Birmingham
**Country:** United States
**Facility:** University of Alabama in Birmingham
**State:** Alabama
**Zip:** 35294
**Location 2:**
**City:** La Jolla
**Country:** United States
**Facility:** University of California San Diego Medical Center
**State:** California
**Zip:** 92037
**Location 3:**
**City:** New Haven
**Country:** United States
**Facility:** Yale University School of Medicine
**State:** Connecticut
**Zip:** 06510
**Location 4:**
**City:** Atlanta
**Country:** United States
**Facility:** Emory University
**State:** Georgia
**Zip:** 30329
**Location 5:**
**City:** Indianapolis
**Country:** United States
**Facility:** Indiana University School of Medicine
**State:** Indiana
**Zip:** 46202
**Location 6:**
**City:** Saint Louis
**Country:** United States
**Facility:** Washington University in St. Louis
**State:** Missouri
**Zip:** 63110
**Location 7:**
**City:** Pittsburgh
**Country:** United States
**Facility:** University of Pittsburgh
**State:** Pennsylvania
**Zip:** 15213
**Location 8:**
**City:** Providence
**Country:** United States
**Facility:** Butler Hospital
**State:** Rhode Island
**Zip:** 02096
**Location 9:**
**City:** Seattle
**Country:** United States
**Facility:** University of Washington
**State:** Washington
**Zip:** 98195
**Location 10:**
**City:** Randwick
**Country:** Australia
**Facility:** Neuroscience Research Australia
**State:** New South Wales
**Zip:** 2031
**Location 11:**
**City:** Melbourne
**Country:** Australia
**Facility:** Mental Health Research Institute
**State:** Victoria
**Zip:** 3010
**Location 12:**
**City:** Nedlands
**Country:** Australia
**Facility:** The McCuster Foundation of Alzheimer's Disease Research
**State:** Western Australia
**Zip:** 6009
**Location 13:**
**City:** Vancouver
**Country:** Canada
**Facility:** UBC Hospital
**State:** British Columbia
**Zip:** V6T 2B5
**Location 14:**
**City:** Toulouse
**Country:** France
**Facility:** CHU de Toulouse - Hôpital Purpan
**State:** Haute Garonne
**Zip:** 31059
**Location 15:**
**City:** Lille
**Country:** France
**Facility:** Hopital Roger Salengro - CHU Lille
**State:** Nord
**Zip:** 59037
**Location 16:**
**City:** Paris cedex 13
**Country:** France
**Facility:** Groupe Hospitalier Pitie-Salpetriere
**State:** Paris
**Zip:** 69677
**Location 17:**
**City:** Bron cedex
**Country:** France
**Facility:** Hopital Neurologique Pierre Wertheimer
**State:** Rhone
**Zip:** 69677
**Location 18:**
**City:** Rouen
**Country:** France
**Facility:** CHU de Rouen - Hôpital Charles Nicolle
**State:** Seine Maritime
**Zip:** 76031
**Location 19:**
**City:** Dublin
**Country:** Ireland
**Facility:** St Vincent's University Hospital
**Zip:** DUBLIN 4
**Location 20:**
**City:** San Juan
**Country:** Puerto Rico
**Facility:** University of Puerto Rico, School of Medicine
**Zip:** 00936
**Location 21:**
**City:** Barcelona
**Country:** Spain
**Facility:** Hospital Clínic I Provincial de Barcelona
**Zip:** 8036
**Location 22:**
**City:** London
**Country:** United Kingdom
**Facility:** The National Hospital for Neurology and Neurosurgery
**State:** Greater London
**Zip:** WC1B 3BG
#### Overall Officials
**Official 1:**
**Affiliation:** Washington University School of Medicine
**Name:** Randall J Bateman, MD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** Access to DIAN-TU trial data will follow the DIAN-TU data access policy, which complies with the guidelines established by the Collaboration for Alzheimer's Prevention \[CAP REF\].
**IPD Sharing:** YES
### References Module
#### References
**Citation:** Bateman RJ, Xiong C, Benzinger TL, Fagan AM, Goate A, Fox NC, Marcus DS, Cairns NJ, Xie X, Blazey TM, Holtzman DM, Santacruz A, Buckles V, Oliver A, Moulder K, Aisen PS, Ghetti B, Klunk WE, McDade E, Martins RN, Masters CL, Mayeux R, Ringman JM, Rossor MN, Schofield PR, Sperling RA, Salloway S, Morris JC; Dominantly Inherited Alzheimer Network. Clinical and biomarker changes in dominantly inherited Alzheimer's disease. N Engl J Med. 2012 Aug 30;367(9):795-804. doi: 10.1056/NEJMoa1202753. Epub 2012 Jul 11. Erratum In: N Engl J Med. 2012 Aug 23;367(8):780.
**PMID:** 22784036
**Citation:** Farlow M, Arnold SE, van Dyck CH, Aisen PS, Snider BJ, Porsteinsson AP, Friedrich S, Dean RA, Gonzales C, Sethuraman G, DeMattos RB, Mohs R, Paul SM, Siemers ER. Safety and biomarker effects of solanezumab in patients with Alzheimer's disease. Alzheimers Dement. 2012 Jul;8(4):261-71. doi: 10.1016/j.jalz.2011.09.224. Epub 2012 Jun 5.
**PMID:** 22672770
**Citation:** Bateman RJ, Benzinger TL, Berry S, Clifford DB, Duggan C, Fagan AM, Fanning K, Farlow MR, Hassenstab J, McDade EM, Mills S, Paumier K, Quintana M, Salloway SP, Santacruz A, Schneider LS, Wang G, Xiong C; DIAN-TU Pharma Consortium for the Dominantly Inherited Alzheimer Network. The DIAN-TU Next Generation Alzheimer's prevention trial: Adaptive design and disease progression model. Alzheimers Dement. 2017 Jan;13(1):8-19. doi: 10.1016/j.jalz.2016.07.005. Epub 2016 Aug 29.
**PMID:** 27583651
**Citation:** Mills SM, Mallmann J, Santacruz AM, Fuqua A, Carril M, Aisen PS, Althage MC, Belyew S, Benzinger TL, Brooks WS, Buckles VD, Cairns NJ, Clifford D, Danek A, Fagan AM, Farlow M, Fox N, Ghetti B, Goate AM, Heinrichs D, Hornbeck R, Jack C, Jucker M, Klunk WE, Marcus DS, Martins RN, Masters CM, Mayeux R, McDade E, Morris JC, Oliver A, Ringman JM, Rossor MN, Salloway S, Schofield PR, Snider J, Snyder P, Sperling RA, Stewart C, Thomas RG, Xiong C, Bateman RJ. Preclinical trials in autosomal dominant AD: implementation of the DIAN-TU trial. Rev Neurol (Paris). 2013 Oct;169(10):737-43. doi: 10.1016/j.neurol.2013.07.017. Epub 2013 Sep 6.
**PMID:** 24016464
**Citation:** Wang G, Berry S, Xiong C, Hassenstab J, Quintana M, McDade EM, Delmar P, Vestrucci M, Sethuraman G, Bateman RJ; Dominantly Inherited Alzheimer Network Trials Unit. A novel cognitive disease progression model for clinical trials in autosomal-dominant Alzheimer's disease. Stat Med. 2018 Sep 20;37(21):3047-3055. doi: 10.1002/sim.7811. Epub 2018 May 14.
**PMID:** 29761523
**Citation:** Weninger S, Carrillo MC, Dunn B, Aisen PS, Bateman RJ, Kotz JD, Langbaum JB, Mills SL, Reiman EM, Sperling R, Santacruz AM, Tariot PN, Welsh-Bohmer KA. Collaboration for Alzheimer's Prevention: Principles to guide data and sample sharing in preclinical Alzheimer's disease trials. Alzheimers Dement. 2016 May;12(5):631-2. doi: 10.1016/j.jalz.2016.04.001. No abstract available.
**PMID:** 27157073
**Citation:** Grill JD, Bateman RJ, Buckles V, Oliver A, Morris JC, Masters CL, Klunk WE, Ringman JM; Dominantly Inherited Alzheimer's Network. A survey of attitudes toward clinical trials and genetic disclosure in autosomal dominant Alzheimer's disease. Alzheimers Res Ther. 2015 Jul 22;7(1):50. doi: 10.1186/s13195-015-0135-0. eCollection 2015.
**PMID:** 26203303
**Citation:** McDade E, Bateman RJ. Stop Alzheimer's before it starts. Nature. 2017 Jul 12;547(7662):153-155. doi: 10.1038/547153a. No abstract available.
**PMID:** 28703214
**Citation:** McDade E, Wang G, Gordon BA, Hassenstab J, Benzinger TLS, Buckles V, Fagan AM, Holtzman DM, Cairns NJ, Goate AM, Marcus DS, Morris JC, Paumier K, Xiong C, Allegri R, Berman SB, Klunk W, Noble J, Ringman J, Ghetti B, Farlow M, Sperling RA, Chhatwal J, Salloway S, Graff-Radford NR, Schofield PR, Masters C, Rossor MN, Fox NC, Levin J, Jucker M, Bateman RJ; Dominantly Inherited Alzheimer Network. Longitudinal cognitive and biomarker changes in dominantly inherited Alzheimer disease. Neurology. 2018 Oct 2;91(14):e1295-e1306. doi: 10.1212/WNL.0000000000006277. Epub 2018 Sep 14.
**PMID:** 30217935
**Citation:** Ryman DC, Acosta-Baena N, Aisen PS, Bird T, Danek A, Fox NC, Goate A, Frommelt P, Ghetti B, Langbaum JB, Lopera F, Martins R, Masters CL, Mayeux RP, McDade E, Moreno S, Reiman EM, Ringman JM, Salloway S, Schofield PR, Sperling R, Tariot PN, Xiong C, Morris JC, Bateman RJ; Dominantly Inherited Alzheimer Network. Symptom onset in autosomal dominant Alzheimer disease: a systematic review and meta-analysis. Neurology. 2014 Jul 15;83(3):253-60. doi: 10.1212/WNL.0000000000000596. Epub 2014 Jun 13.
**PMID:** 24928124
**Citation:** Weng H, Bateman R, Morris JC, Xiong C. Validity and power of minimization algorithm in longitudinal analysis of clinical trials. Biostat Epidemiol. 2017;1(1):59-77. doi: 10.1080/24709360.2017.1331822. Epub 2017 Jun 13.
**PMID:** 29250611
#### See Also Links
**Label:** Expanded registry
**URL:** http://www.dianexr.org/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000024801
- Term: Tauopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M6904
- Name: Dementia
- Relevance: HIGH
- As Found: Dementia
- ID: M3885
- Name: Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23002
- Name: Tauopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T591
- Name: Autosomal Dominant Multiple Pterygium Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: T2192
- Name: Familial Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
### Condition Browse Module - Meshes
- ID: D000000544
- Term: Alzheimer Disease
- ID: D000003704
- Term: Dementia
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424223
**Brief Title:** Tunnel Access for Horizontal Alveolar Ridge Augmentation
**Official Title:** Tunnel Approach With Biphasic Calcium Phosphate and Acellular Dermal Matrix for Horizontal Ridge Augmentation.
#### Organization Study ID Info
**ID:** Mini-invasiveRidgeAugmentation
#### Organization
**Class:** OTHER
**Full Name:** University of Bari Aldo Moro
### Status Module
#### Completion Date
**Date:** 2025-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-15
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-02
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Bari Aldo Moro
#### Responsible Party
**Investigator Affiliation:** University of Bari Aldo Moro
**Investigator Full Name:** Giuseppe D'Albis
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Minimally invasive procedures with the tunnel technique have been suggested to decrease patient post-operative discomfort and morbidity in oral bone regeneration. In the ridge augmentation tunnel technique, crestal incision and the release of the connective tissue are avoided in order to enhance the blood supply of the flap. This approach preserves the blood circulation and does not damage the periosteum The purpose of this study is to evaluate the clinical outcome of a minimally invasive technique for maxillofacial horizontal bone augmentation .
**Detailed Description:** Several techniques have been introduced to minimize the invasiveness involved in oral bone regeneration, to prevent the coronal advancement of the flap, which in turn reduces postoperative discomfort, swelling, complications, and mobility.
The tunnel technique involves making a vertical incision to access the bone defect and inserting the grafts. The significant benefit of this approach is that it may be closed without the need for periosteal incisions. Several tunnel techniques have been described in the literature using various biomaterials including bovine bone, synthetic bone, bovine bone block, allograft block bone, hidroxiapatite. This clinical study assesses the efficiency of a minimally invasive surgical technique for horizontal ridge augmentation using Biphasic Calcium Phosphate and Acellular Dermal Matrix.
This minimally invasive procedure aims to increase the horizontal volume of the edentulous ridge in both its bone component (through the use of Biphasic Calcium Phosphate) and its mucosal component (through the use of Acellular Dermal Matrix). Compared to other traditional techniques, this procedure, performed through a tunnel approach, would significantly reduce the invasiveness of the treatment.
### Conditions Module
**Conditions:**
- Bone Atrophy, Alveolar
- Bone Loss
- Bone Resorption
- Alveolar Bone Loss
- Alveolar Bone Resorption
**Keywords:**
- Bone augmentation
- Bone regeneration
- Tissues augmentation
- Ridge augmentation
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 5
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Procedure: Horizontal Ridge augmentation
**Label:** Ridge augmentation
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ridge augmentation
**Description:** A vertical full-thickness incision in the mesial aspect of the defect ridge.Microsurgery instruments is subsequently use to carefully elevate the full thickness of the mucosa.
Extreme caution must be exercised during these maneuvers to avoid tissue perforation and to maintain the integrity of the periosteum.An dermal matrix is place into the tunnel. A pouch is create between the bone and the matrix and the Biphasic Calcium Phosphate is inserted into the tunnel until the desirable ridge dimensions are obtained. Primary closure of the vertical incisions was achieved with single interrupted sutures.
**Name:** Horizontal Ridge augmentation
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Digital intraoral casts will be superimposed to value the gained thickness of the ridge.
The assessment of volume increase in the alveolar ridge will be observed within the implant planning software by measuring the variation in the width of the edentulous ridge by matching three scans. The scans will be conducted at baseline (T0), five months after ridge augmentation (T1), and two months after implant insertion (T2). The matching will be performed using corresponding pairs of regions. The thickness of the alveolar ridges on the same cross-section at the level of the implants inserted will be measured in mm using the "distance" tool.
**Measure:** Evaluation of the achievement of an adequate thickness of the alveolar ridge ridge
**Time Frame:** 5 months
#### Secondary Outcomes
**Description:** A histological analysis will be conducted by the pathology laboratory of the Bari University Hospital on a bone biopsy taken at the same time as the implant placement.
**Measure:** Histological analysis of newly formed tissues.
**Time Frame:** 5 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients had to be healthy according to System of the American Society of Anesthesiology (ASA) and aged 18 years or older
* No general medical condition representing a contraindication to implant therapy
* minimum 2 missing teeth in the maxilla or mandible from the canine to the second molar
* No periodontal disease (periodontal probing depth \<4 mm) or treated periodontitis
* Good oral hygiene (full mouth plaque index\<25%)
* Adequate control of inflammation (full mouth bleeding on probing\<25%)
Exclusion Criteria:
* smoking of more than 15 cigarettes a day • untreated periodontal disease
* pregnancy or breastfeeding at date of inclusion • acute infections
* keratinized mucosal tissue less than 2 mm.
**Healthy Volunteers:** True
**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:** Giuseppe D'Albis
**Phone:** +393495103642
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Mola di Bari
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Giuseppe D'Albis
- **Phone:** +393495103642
- **Role:** CONTACT
**Country:** Italy
**Facility:** Giuseppe D'Albis
**State:** Bari
**Zip:** 70042
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000055093
- Term: Periodontal Atrophy
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
### Condition Browse Module - Browse Leaves
- ID: M4589
- Name: Atrophy
- Relevance: LOW
- As Found: Unknown
- ID: M5141
- Name: Bone Resorption
- Relevance: HIGH
- As Found: Bone Resorption
- ID: M18747
- Name: Alveolar Bone Loss
- Relevance: HIGH
- As Found: Alveolar Bone Loss
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M28025
- Name: Periodontal Atrophy
- Relevance: LOW
- As Found: Unknown
- ID: M13419
- Name: Periodontal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001862
- Term: Bone Resorption
- ID: D000016301
- Term: Alveolar Bone Loss
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424210
**Brief Title:** The Role of Surgery for Esophageal Cancer With Metastatic Disease (M1)
**Official Title:** The Role of Surgery for Esophageal Cancer With Metastatic Disease (M1)
#### Organization Study ID Info
**ID:** 202211084RIND
#### Organization
**Class:** OTHER
**Full Name:** National Taiwan University Hospital
### Status Module
#### Completion Date
**Date:** 2023-06-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-06-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-02-15
**Type:** ACTUAL
**Status Verified Date:** 2023-02
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-20
### 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
### Description Module
**Brief Summary:** Treatment of stage IV esophageal cancer is traditionally palliative, but treatment response is usually poor. The role of surgery in the treatment of advanced esophageal cancer remains controversial. We sought to determine whether surgical treatment followed by neoadjuvant chemoradiation therapy might provide survival benefits for these patients.
A retrospective review of esophageal cancer patients with M1 disease treated at National Taiwan University Hospital was performed from April 2002 to June 2021. Patient demographics and cancer staging, treatment, and disease recurrence, and time of follow up were included for analysis. Univariate and multivariate analysis was performed for overall survival and progression-free survival analysis. Propensity score matching based on patient age and tumor staging characteristics was also performed for analysis.
### Conditions Module
**Conditions:**
- Esophageal Cancer
- Metastatic Disease
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 163
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Overall survival (OS) and progression-free survival (PFS) curves of patients with or without esophagectomy in the entire study cohort of stage IV esophageal cancer with distant metastasis.
**Measure:** Overall survival and progression-free survival
**Time Frame:** 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Stage IV Esophageal Cancer patients
* Patients were treated with chemoradiation therapy (CCRT)
Exclusion Criteria:
* Not Stage IV Esophageal Cancer patients
* Patients were not treated with chemoradiation therapy (CCRT)
**Minimum Age:** 20 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** This study enrolled a cohort of patients diagnosed with stage IV esophageal cancer who had tumor metastasis to distant organs, including lymph node metastasis detected in the retroperitoneum, which could not be eradicated by surgery, from April 2002 to June 2021 in a tertiary medical center.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Taipei
**Country:** Taiwan
**Facility:** National Taiwan University Hospital
**State:** Zhongzheng
**Zip:** 100
#### Overall Officials
**Official 1:**
**Affiliation:** National Taiwan University Hospital
**Name:** Jang-Ming Lee
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000004935
- Term: Esophageal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000009385
- Term: Neoplastic Processes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: HIGH
- As Found: Metastatic Disease
- ID: M8088
- Name: Esophageal Neoplasms
- Relevance: HIGH
- As Found: Esophageal Cancer
- ID: M18989
- Name: Neoplasms, Second Primary
- Relevance: HIGH
- As Found: Metastatic Disease
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8085
- Name: Esophageal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12330
- Name: Neoplastic Processes
- Relevance: LOW
- As Found: Unknown
- ID: T2141
- Name: Esophageal Cancer
- Relevance: HIGH
- As Found: Esophageal Cancer
### Condition Browse Module - Meshes
- ID: D000004938
- Term: Esophageal Neoplasms
- ID: D000009362
- Term: Neoplasm Metastasis
- ID: D000016609
- Term: Neoplasms, Second Primary
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424197
**Brief Title:** Colorectal Cancer Screening Intervention Study
**Official Title:** Colorectal Screening Fear-reduction and Racially-targeted Norm Messaging Entreaties to Increase Colorectal Cancer Screening Rates Among African Americans
#### Organization Study ID Info
**ID:** IRB-FY2023-3
#### Organization
**Class:** OTHER
**Full Name:** Oakland University
#### Secondary ID Infos
**ID:** R21MD016506
**Link:** https://reporter.nih.gov/quickSearch/R21MD016506
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-04-23
**Type:** ACTUAL
#### Start Date
**Date:** 2023-10-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institutes of Health (NIH)
**Class:** NIH
**Name:** National Institute on Minority Health and Health Disparities (NIMHD)
#### Lead Sponsor
**Class:** OTHER
**Name:** Oakland 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:** Colorectal cancer (CRC) is one of the leading causes of cancer mortality in the United States, and African Americans (AfAms) still fare worse in CRC incidence and mortality compared to European Americans (EuAms). We propose to examine whether combining both fear-reduction and racially-targeted norm-based messages will increase at-home stool-based CRC screening receptivity and uptake for all African American regardless of level of racial identity. Given low return rates of at-home screening kits, we will also explore whether making an explicit commitment to return screening kits is associated with increased kit returns.
**Detailed Description:** Colorectal cancer (CRC) is one of the leading causes of cancer mortality in the United States, and African Americans (AfAms) still fare worse in CRC incidence and mortality compared to European Americans (EuAms).Interventions to increase CRC screening rates among AfAms are instrumental to address the disparities in CRC incidence and mortality. Despite literature indicating that AfAms' fears (e.g., of colonoscopy procedures or cancer diagnosis) serve as barriers to CRC screening, no interventions have used theory-guided methods to directly target fear-based beliefs. Additionally, no research has examined the extent to which racial identity moderates the effects of racially targeted messaging, despite the ubiquity of using targeted health messaging entreaties among minority groups. This is particularly relevant given our work showing that racially-targeted screening entreaties increased CRC screening intentions among AfAms who identified less strongly, but depressed those intentions among AfAms who identified more strongly with their racial group. Lack of focus on other salient CRC screening barriers may have been off-putting to highly identified African Americans. We propose to examine whether combining both fear-reduction and racially-targeted norm-based messages will increase at-home stool-based CRC screening receptivity and uptake for all African American regardless of level of racial identity. Given low return rates of at-home screening kits, we will also explore whether making an explicit commitment to return screening kits is associated with increased kit returns.
Aim 1: To develop and refine a fear-reduction intervention guided by the theory of planned behavior and by published literature, in conjunction with AfAm community experts.
Aim 2: To examine whether the fear-reduction entreaty increases receptivity to, and uptake of at-home CRC screening when coupled with racially-targeted norm-based messages.
Aim 3: To examine the moderating roles of racial identity and perceived CRC risk on the effects of fear-reduction and racially-targeted norm-based messaging entreaties.
Aim 4: We will explore whether participants who make explicit commitments to return FIT Kits return them at a higher rate compared to those who do not make such commitments.
### Conditions Module
**Conditions:**
- Colorectal Cancer
**Keywords:**
- Colorectcal Cancer Screening Targeted Message Intervention
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** FACTORIAL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 799
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** One of 3 messaging entreaties based on normative perceptions of colorectal cancer screening, and one no norm-based messaging arm.
**Intervention Names:**
- Other: Racial group-targeted messages
**Label:** Norm Based Messages
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants randomized to receive (or not receive) messaging entreaty to address colorectal cancer screening fears.
**Intervention Names:**
- Other: Racial group-targeted messages
**Label:** Fear Reduction Message
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Participants randomized to indicate explicit commitment to return FIT Kits for processing.
**Intervention Names:**
- Other: Explicit Commitment
**Label:** Commitment
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Participants receive no health messages.
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Fear Reduction Message
- Norm Based Messages
**Description:** Colorectal cancer screening messages targeted towards participants racial group.
**Name:** Racial group-targeted messages
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Commitment
**Description:** Indicate explicit commitment to return at home screening kit.
**Name:** Explicit Commitment
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** FIT Kit request
**Measure:** FIT Kit request
**Time Frame:** Immediately after survey
#### Secondary Outcomes
**Description:** Mailing completed FIT Kit to lab for processing
**Measure:** FIT Kit return
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
African American Overdue to colorectal cancer screening Has primary care physician Not at high risk for colorectal cancer
Exclusion Criteria:
Not meeting inclusion criteria
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 45 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Rochester
**Country:** United States
**Facility:** Oakland University
**State:** Michigan
**Zip:** 48309
#### Overall Officials
**Official 1:**
**Affiliation:** Oakland University
**Name:** Mark Manning, 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
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424184
**Brief Title:** Accelerated rTMS for Substance Use Disorder and Depression
**Official Title:** Substance Use Disorder Treatment With Accelerated Repetitive Transcranial Magnetic Stimulation for Depression (START-D)
#### Organization Study ID Info
**ID:** STU-2024-0232
#### Organization
**Class:** OTHER
**Full Name:** University of Texas Southwestern Medical Center
### Status Module
#### Completion Date
**Date:** 2027-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**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:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Texas Southwestern Medical Center
#### Responsible Party
**Investigator Affiliation:** University of Texas Southwestern Medical Center
**Investigator Full Name:** Manish Jha
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** This study is a small open-label feasibility trial of an accelerated course of repetitive transcranial magnetic stimulation (rTMS) for individuals with depression and stimulant use disorder \[including methamphetamine or cocaine use disorder (MUD/CUD)\].
**Detailed Description:** This research is an open label feasibility trial of accelerated course of repetitive transcranial magnetic stimulation (rTMS) for individuals with stimulant use disorder. Participants will be recruited from an existing and ongoing longitudinal study of stimulant use disorder (STIM-RAD) (NCT06073340). Prior to initiating the accelerated course of rTMS, participants will undergo screening procedures to evaluate eligibility. Those eligible will complete up to four (4) rTMS sessions of intermittent theta burst over left dorsolateral prefrontal cortex per day, up to five (5) days per week of the study, for a total of 50 sessions over a three (3) week period and will undergo electroencephalography (EEG), electrocardiography (ECG), urine drug screens, as well as self-report and clinician-rated assessments. A follow-up visit will be conducted 1 week after the last session of rTMS.
### Conditions Module
**Conditions:**
- Stimulant Use
- Depression
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Open label trial
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Eligible participants who are enrolled will receive an accelerated course of repetitive Transcranial Magnetic Stimulation.
**Intervention Names:**
- Device: Accelerated Repetitive Transcranial Magnetic Stimulation
**Label:** rTMS Intervention
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- rTMS Intervention
**Description:** The rTMS protocol implemented in this study will include approximately 10-minute long sessions of intermittent theta burst stimulation (iTBS) with at least 50 minutes in between iTBS sessions.
Study participants will receive the rTMS intervention for up to 50 sessions across a three-week period. The total of 50 sessions will be administered as up to 4 sessions each day, up to 5 days per week over an up to 3-week-long period.
**Name:** Accelerated Repetitive Transcranial Magnetic Stimulation
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Feasibility will be measured by completion of at least 30 out of 50 sessions of rTMS.
**Measure:** Feasibility of an accelerated course of repetitive Transcranial Magnetic Stimulation (rTMS).
**Time Frame:** 3 weeks
#### Secondary Outcomes
**Description:** Attainment of response is defined as 3 out of 5 negative urine samples for stimulants (cocaine, amphetamines), in week 3 of treatment.
**Measure:** Attainment of response of rTMS intervention on stimulant use assessed by Urine Drug Screens.
**Time Frame:** 1 week
**Description:** The Stimulant Craving Questionnaire (STCQ) is a 10-item self-report measure derived from the 10-item Cocaine Craving Questionnaire-Brief and the original 46-item Cocaine Craving Questionnaire-Now. The STCQ assesses current craving for stimulants (cocaine, methamphetamine, and other stimulants) using a seven-point scale, with answers ranging from "strongly disagree" to "agree."
**Measure:** Changes in stimulant craving during the 3-week treatment phase assessed by the Stimulant Craving Questionnaire (STCQ).
**Time Frame:** 3 weeks
**Description:** Craving for stimulants and other substances will be self-reported by participants on a Visual Analog Drug Craving Scale (VAS) which ranges from 0 (no craving) to 100 (most intense craving possible).
**Measure:** Changes in stimulant craving during the 3-week treatment phase assessed by a Visual Analog Drug Craving Scale (VAS).
**Time Frame:** 3 weeks
**Description:** Current craving for stimulants will be assessed using the Cue Craving Assessment. Participants will be asked about their current craving for and ability to resist stimulants on a 0-10 scale immediately after cue exposure prior to rTMS and after the completion of each rTMS session. A "0" rating indicates the absence of craving or the absence of the ability to resist use, whereas a "10" rating indicates the highest craving or strongest ability to resist use.
**Measure:** Changes in stimulant craving during the 3-week treatment phase assessed by the Cue Craving Assessment.
**Time Frame:** 3 weeks
**Description:** The Timeline Followback (TLFB) procedure will be used to elicit the participant's self-reported use of illicit substances, including but not limited to stimulants, and polysubstance use starting at the Screening Visit and continuing throughout study participation. During the Screening Visit, this form will be used to assess illicit use of substances for the 30-day period prior to written consent. During the study, TLFB will be administered to document the participant's self-reported use of illicit substances, nicotine, and tobacco for each visit since the previous TLFB assessment. Participant's drug of choice will be asked and determined by study coordinator and recorded along with the TLFB assessment.
**Measure:** Changes in frequency of self-reported stimulant use based on Timeline Followback (TLFB).
**Time Frame:** 6 weeks
**Description:** The Concise Health Risk Tracking - Self-Report (CHRT-SR) is a 14-item self-report assessment of suicidality and related thoughts and behaviors. The scale is designed to track suicidality quickly and easily in a manner consistent with the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Participants are asked to rate the extent that they have related to fourteen different statements on a scale of "strongly disagree" to "strongly agree." A higher score indicates higher suicidality.
**Measure:** Changes in self-reported symptoms of suicidality during the 3-week treatment phase.
**Time Frame:** 3 weeks
**Description:** The Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) will assess overall depressive symptoms. The total score of QIDS-SR (range of 0-27) is based on the nine DSM-lV criteria symptom domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease, and psychomotor agitation/retardation. Each question is scored on a 0-3 scale based on the participant's response. A higher score indicates higher depressive symptoms.
**Measure:** Changes in self-reported symptoms of depression during the 3-week treatment phase.
**Time Frame:** 3 weeks
**Description:** A 10-item version of the Concise Associated Symptom Tracking Scale Self-Report (CAST-IRR) will be used to assess associated mood symptoms. Participants are asked to rate the extent that they have related to ten different statements in the past week on a 5-point Likert scale (from 1, "strongly disagree," to 5, "strongly agree," where a higher score indicates increased symptoms). Some items in the CAST-IRR include: "I wish people would just leave me alone"; "I feel very uptight"; "I find myself saying or doing things without thinking"; "Lately everything seems to be annoying me"; and "I find people get on my nerves easily."
**Measure:** Changes in self-reported symptoms of irritability during the 3-week treatment phase.
**Time Frame:** 3 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Be aged 18-65 years, inclusive.
2. Be able to sufficiently understand, speak, and read English to provide informed consent and ask relevant questions, and be willing to comply with all study procedure instructions.
3. Self-report stimulant use (cocaine, methamphetamine, or prescription stimulants) at least 10 days in the 30-day period prior to consent.
4. Have a diagnosis of moderate or severe Cocaine or Methamphetamine Use Disorder (CUD/MUD) or other Stimulant Use Disorder over the past 12 months (as determined by the MINI International Neuropsychiatric Interview).
5. Have a PHQ9 of greater than or equal to five (5).
6. Be willing to provide urine samples, EEGs, and ECGs.
7. Be willing to use appropriate birth control method during the treatment phase of the study, if individual is of childbearing potential.
Exclusion Criteria:
1. Have a current pattern of alcohol, benzodiazepine, or other sedative/hypnotic use that would preclude safe participation in the study, as determined by the PI or their designee.
2. Have a history of a serious medical disorder that, in the opinion of the PI or their designee, would make it unsafe to participate in the study or may prevent collection of study data (e.g., disabling terminal diagnosis for which hospice care is being sought; serious illness requiring systemic treatment and/or hospitalization until participant either completes therapy and/or is clinically stable on therapy, in the opinion of the PI or their designee, prior to study entry).
3. Have a documented history of unprovoked seizure (lifetime) or any seizure in the past 6 months.
4. Have a documented history of brain lesion(s) and/or tumor(s).
5. Have metal implants or non-removable metal objects above the neck.
6. Current pregnancy as determined by a urine screening.
7. Current or lifetime manic or hypomanic episode, defined by MINI diagnostic interview.
8. Current psychotic disorder.
9. Are a prisoner or in police custody at the time of eligibility screening.
**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:** Taylor Helmbrecht, B.S.A.
**Phone:** (214) 998-6504
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Teresa Slettebo, B.A.
**Phone:** (214) 998-5649
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Dallas
**Country:** United States
**Facility:** UT Southwestern Medical Center
**State:** Texas
**Zip:** 75247
#### Overall Officials
**Official 1:**
**Affiliation:** UT Southwestern Medical Center
**Name:** Manish Jha, M.B.B.S
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Northrup TF, Green C, Walker R, Greer TL, Trivedi MH. On the invariance of the Stimulant Craving Questionnaire (STCQ) across cocaine and methamphetamine users. Addict Behav. 2015 Mar;42:144-7. doi: 10.1016/j.addbeh.2014.11.020. Epub 2014 Nov 25.
**PMID:** 25462663
**Citation:** Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.
**PMID:** 2197679
**Citation:** Sobell LC, Sobell MB, Leo GI, Cancilla A. Reliability of a timeline method: assessing normal drinkers' reports of recent drinking and a comparative evaluation across several populations. Br J Addict. 1988 Apr;83(4):393-402. doi: 10.1111/j.1360-0443.1988.tb00485.x. No abstract available.
**PMID:** 3395719
**Citation:** Trivedi MH, Wisniewski SR, Morris DW, Fava M, Gollan JK, Warden D, Nierenberg AA, Gaynes BN, Husain MM, Luther JF, Zisook S, Rush AJ. Concise Health Risk Tracking scale: a brief self-report and clinician rating of suicidal risk. J Clin Psychiatry. 2011 Jun;72(6):757-64. doi: 10.4088/JCP.11m06837.
**PMID:** 21733476
**Citation:** Posner K, Oquendo MA, Gould M, Stanley B, Davies M. Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Am J Psychiatry. 2007 Jul;164(7):1035-43. doi: 10.1176/ajp.2007.164.7.1035.
**PMID:** 17606655
**Citation:** Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8. Erratum In: Biol Psychiatry. 2003 Sep 1;54(5):585.
**PMID:** 12946886
**Citation:** Rush AJ, Bernstein IH, Trivedi MH, Carmody TJ, Wisniewski S, Mundt JC, Shores-Wilson K, Biggs MM, Woo A, Nierenberg AA, Fava M. An evaluation of the quick inventory of depressive symptomatology and the hamilton rating scale for depression: a sequenced treatment alternatives to relieve depression trial report. Biol Psychiatry. 2006 Mar 15;59(6):493-501. doi: 10.1016/j.biopsych.2005.08.022. Epub 2005 Sep 30.
**PMID:** 16199008
**Citation:** Trivedi MH, Wisniewski SR, Morris DW, Fava M, Kurian BT, Gollan JK, Nierenberg AA, Warden D, Gaynes BN, Luther JF, Rush AJ. Concise Associated Symptoms Tracking scale: a brief self-report and clinician rating of symptoms associated with suicidality. J Clin Psychiatry. 2011 Jun;72(6):765-74. doi: 10.4088/JCP.11m06840.
**PMID:** 21733477
**Citation:** Jha MK, Minhajuddin A, South C, Rush AJ, Trivedi MH. Irritability and Its Clinical Utility in Major Depressive Disorder: Prediction of Individual-Level Acute-Phase Outcomes Using Early Changes in Irritability and Depression Severity. Am J Psychiatry. 2019 May 1;176(5):358-366. doi: 10.1176/appi.ajp.2018.18030355. Epub 2019 Mar 29.
**PMID:** 30922100
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000019964
- Term: Mood Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000064419
- Term: Chemically-Induced Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC25
- Name: Substance Related Disorders
### Condition Browse Module - Browse Leaves
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M7061
- Name: Depressive Disorder
- Relevance: HIGH
- As Found: Depression
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: HIGH
- As Found: Substance Use Disorders
- 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: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000003863
- Term: Depression
- ID: D000003866
- Term: Depressive Disorder
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424171
**Acronym:** AFLETES-MRI
**Brief Title:** AFLETES-MRI: A Cardiac and Cerebral Magnetic Resonance Imaging Study in Athletes With Atrial Fibrillation
**Official Title:** Atrial Fibrillation and the Risk of Stroke in Veteran athLETES: a Pilot Cardiac and Cerebral Magnetic Resonance Imaging Study - AFLETES-MRI
#### Organization Study ID Info
**ID:** 0917
#### Organization
**Class:** OTHER
**Full Name:** University of Leicester
### Status Module
#### Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-22
**Type:** ACTUAL
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-26
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Leicester
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Participation in exercise improves cardiovascular health. However, long-term endurance exercise may increase the risk of an irregular heart rhythm called atrial fibrillation (AF).
In AF, blood flow is altered, increasing the risk of clot formation in the heart which may enter the circulation and cause a stroke. The risk of stroke can be reduced with the use of blood thinning medication. Athletes with atrial fibrillation, due to their healthy lifestyle, are generally felt to be at low risk of stroke and many would not be offered blood thinning treatment using risk scores used in clinical practice.
In a recent survey of almost one thousand athletes, the investigators found that there was an increased risk of stroke in those with atrial fibrillation, even in those without other risk factors for stroke.
To further investigate these findings, this study will use MRI scanning to look at the hearts and brains of athletes aged between 40-64 years old. The researchers will assess athletes with and without atrial fibrillation, as well as some athletes with atrial fibrillation who have had a stroke previously.
The MRI scans will measure heart size and function as well as blood flow patterns in the heart. The study will determine whether athletes with atrial fibrillation have evidence of stroke on brain MRI and whether these are related to abnormal flow patterns. The results will help us decide whether a larger study should be performed.
### Conditions Module
**Conditions:**
- Atrial Fibrillation
- Stroke
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 64
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: Cardiac and brain magnetic resonance imaging.
**Label:** Athletes with atrial fibrillation without diagnosed stroke.
#### Arm Group 2
**Intervention Names:**
- Diagnostic Test: Cardiac and brain magnetic resonance imaging.
**Label:** Athletes without atrial fibrillation.
#### Arm Group 3
**Intervention Names:**
- Diagnostic Test: Cardiac and brain magnetic resonance imaging.
**Label:** Athletes with atrial fibrillation and a diagnosed stroke.
#### Arm Group 4
**Intervention Names:**
- Diagnostic Test: Cardiac and brain magnetic resonance imaging.
**Label:** Healthy, non-athlete controls.
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Athletes with atrial fibrillation and a diagnosed stroke.
- Athletes with atrial fibrillation without diagnosed stroke.
- Athletes without atrial fibrillation.
- Healthy, non-athlete controls.
**Description:** Cardiac magnetic resonance imaging with analysis using 4D flow. Brain magnetic resonance imaging to detect strokes, including microvascular strokes.
**Name:** Cardiac and brain magnetic resonance imaging.
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The number of participants with ischaemic white matter lesions, micro-infarcts and old infarcts.
**Measure:** Stroke.
**Time Frame:** Baseline.
#### Secondary Outcomes
**Description:** Left ventricular volume (ml).
**Measure:** Cardiac structure.
**Time Frame:** Baseline.
**Description:** Presence of LGE. The number of participants with LGE will be compared between groups.
**Measure:** Late gadolinium enhancement (LGE).
**Time Frame:** Baseline.
**Description:** Direction of pathlines and streamlines. The number of areas of stasis will be calculated for each group.
**Measure:** Left atrial flow-pathlines and streamlines.
**Time Frame:** Baseline.
**Description:** Ejection fraction of the left ventricular (%).
**Measure:** Cardiac function.
**Time Frame:** Baseline.
**Description:** Number of areas of stasis in each group in the left atrium.
**Measure:** Left atrial stasis.
**Time Frame:** Baseline.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male, atrial fibrillation.
* 40-64 years of age at the time of enrolment.
* Primarily (≥50% of competition) competes in an endurance type sport as defined by European Society of Cardiology 2020 guidelines.
* Competitive athlete\*
* CHA2-DS2-VAsc =0/1 (excluding previous stroke).
* Competitive athlete defined by having trained ≥10 years, 6 hours per week as a self-reported average and having participated in at least one competitive event at regional level or above.
Exclusion Criteria:
* History of pre-existing cardiovascular disease
* Previous myocardial infarction, peripheral arterial disease
* Left ventricular systolic dysfunction (EF \<45%)
* Heart muscle disease
* Complex congenital heart disease.
* Moderate or severe valvular disease.
* Uncontrolled hypertension (180/100mmHg)
* Clotting or bleeding disorders, vasculitis
* Inherited cerebral disease
* Known to have an estimated glomerular filtration rate \<30 ml/min/1.73m2.
**Healthy Volunteers:** True
**Maximum Age:** 64 Years
**Minimum Age:** 40 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** MALE
**Standard Ages:**
- ADULT
**Study Population:** - Male, competitive, veteran athletes and age/sex matched controls will be included.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Susil Pallikadavath, MRCP(UK), MBChB(hons), BSc
**Phone:** 0116 252 2522
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Leicester
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Susil Pallikadavath, MRCP(UK), MBChB(hons), BSc
- **Phone:** +447926082259
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** Department of Cardiovascular Sciences, University of Leicester
**State:** Leicestershire
**Status:** RECRUITING
**Zip:** LE14AY
#### Overall Officials
**Official 1:**
**Affiliation:** University of Leicester
**Name:** Gerry P McCann, MD, MRCP(UK), MB,ChB
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** University of Leicester
**Name:** Susil Pallikadavath, MRCP(UK), MBChB(hons), BSc
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Newman W, Parry-Williams G, Wiles J, Edwards J, Hulbert S, Kipourou K, Papadakis M, Sharma R, O'Driscoll J. Risk of atrial fibrillation in athletes: a systematic review and meta-analysis. Br J Sports Med. 2021 Nov;55(21):1233-1238. doi: 10.1136/bjsports-2021-103994. Epub 2021 Jul 12.
**PMID:** 34253538
**Citation:** Pallikadavath S, Richards C, Bountziouka V, Sandilands AJ, Graham-Brown MPM, Robinson T, Singh A, McCann GP. The AFLETES Study: Atrial Fibrillation in Veteran Athletes and the Risk of Stroke. Clin J Sport Med. 2023 May 1;33(3):209-216. doi: 10.1097/JSM.0000000000001115. Epub 2023 Apr 6.
**PMID:** 37042823
**Citation:** Dyverfeldt P, Bissell M, Barker AJ, Bolger AF, Carlhall CJ, Ebbers T, Francios CJ, Frydrychowicz A, Geiger J, Giese D, Hope MD, Kilner PJ, Kozerke S, Myerson S, Neubauer S, Wieben O, Markl M. 4D flow cardiovascular magnetic resonance consensus statement. J Cardiovasc Magn Reson. 2015 Aug 10;17(1):72. doi: 10.1186/s12968-015-0174-5.
**PMID:** 26257141
**Citation:** Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19. Erratum In: Int J Stroke. 2020 Jan 28;:1747493020905964.
**PMID:** 31955707
**Citation:** Xu Y, Zhao L, Zhang L, Han Y, Wang P, Yu S. Left Atrial Enlargement and the Risk of Stroke: A Meta-Analysis of Prospective Cohort Studies. Front Neurol. 2020 Feb 14;11:26. doi: 10.3389/fneur.2020.00026. eCollection 2020.
**PMID:** 32117002
**Citation:** Androulakis E, Swoboda PP. The Role of Cardiovascular Magnetic Resonance in Sports Cardiology; Current Utility and Future Perspectives. Curr Treat Options Cardiovasc Med. 2018 Aug 31;20(10):86. doi: 10.1007/s11936-018-0679-y.
**PMID:** 30167977
**Citation:** Graham-Brown MP, Gulsin GS, Parke K, Wormleighton J, Lai FY, Athithan L, Arnold JR, Burton JO, McCann GP, Singh AS. A comparison of the reproducibility of two cine-derived strain software programmes in disease states. Eur J Radiol. 2019 Apr;113:51-58. doi: 10.1016/j.ejrad.2019.01.026. Epub 2019 Jan 23.
**PMID:** 30927959
**Citation:** D'Ascenzi F, Anselmi F, Focardi M, Mondillo S. Atrial Enlargement in the Athlete's Heart: Assessment of Atrial Function May Help Distinguish Adaptive from Pathologic Remodeling. J Am Soc Echocardiogr. 2018 Feb;31(2):148-157. doi: 10.1016/j.echo.2017.11.009. Epub 2017 Dec 13.
**PMID:** 29246514
**Citation:** Androulakis E, Mouselimis D, Tsarouchas A, Antonopoulos A, Bakogiannis C, Papagkikas P, Vlachopoulos C. The Role of Cardiovascular Magnetic Resonance Imaging in the Assessment of Myocardial Fibrosis in Young and Veteran Athletes: Insights From a Meta-Analysis. Front Cardiovasc Med. 2021 Dec 21;8:784474. doi: 10.3389/fcvm.2021.784474. eCollection 2021.
**PMID:** 34993239
**Citation:** Demirkiran A, van Ooij P, Westenberg JJM, Hofman MBM, van Assen HC, Schoonmade LJ, Asim U, Blanken CPS, Nederveen AJ, van Rossum AC, Gotte MJW. Clinical intra-cardiac 4D flow CMR: acquisition, analysis, and clinical applications. Eur Heart J Cardiovasc Imaging. 2022 Jan 24;23(2):154-165. doi: 10.1093/ehjci/jeab112.
**PMID:** 34143872
**Citation:** Suwa K, Saitoh T, Takehara Y, Sano M, Nobuhara M, Saotome M, Urushida T, Katoh H, Satoh H, Sugiyama M, Wakayama T, Alley M, Sakahara H, Hayashi H. Characteristics of intra-left atrial flow dynamics and factors affecting formation of the vortex flow - analysis with phase-resolved 3-dimensional cine phase contrast magnetic resonance imaging. Circ J. 2015;79(1):144-52. doi: 10.1253/circj.CJ-14-0562. Epub 2014 Nov 13.
**PMID:** 25391258
**Citation:** Fluckiger JU, Goldberger JJ, Lee DC, Ng J, Lee R, Goyal A, Markl M. Left atrial flow velocity distribution and flow coherence using four-dimensional FLOW MRI: a pilot study investigating the impact of age and Pre- and Postintervention atrial fibrillation on atrial hemodynamics. J Magn Reson Imaging. 2013 Sep;38(3):580-7. doi: 10.1002/jmri.23994. Epub 2013 Jan 4.
**PMID:** 23292793
**Citation:** Lee DC, Markl M, Ng J, Carr M, Benefield B, Carr JC, Goldberger JJ. Three-dimensional left atrial blood flow characteristics in patients with atrial fibrillation assessed by 4D flow CMR. Eur Heart J Cardiovasc Imaging. 2016 Nov;17(11):1259-1268. doi: 10.1093/ehjci/jev304. Epub 2015 Nov 20.
**PMID:** 26590397
**Citation:** Pelliccia A, Sharma S, Gati S, Back M, Borjesson M, Caselli S, Collet JP, Corrado D, Drezner JA, Halle M, Hansen D, Heidbuchel H, Myers J, Niebauer J, Papadakis M, Piepoli MF, Prescott E, Roos-Hesselink JW, Graham Stuart A, Taylor RS, Thompson PD, Tiberi M, Vanhees L, Wilhelm M; ESC Scientific Document Group. 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. Eur Heart J. 2021 Jan 1;42(1):17-96. doi: 10.1093/eurheartj/ehaa605. No abstract available. Erratum In: Eur Heart J. 2021 Feb 1;42(5):548-549.
**PMID:** 32860412
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000001145
- Term: Arrhythmias, Cardiac
- ID: D000006331
- Term: Heart Diseases
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M22306
- Name: Stroke
- Relevance: LOW
- As Found: Unknown
- ID: M4586
- Name: Atrial Fibrillation
- Relevance: HIGH
- As Found: Atrial Fibrillation
- ID: M4453
- Name: Arrhythmias, Cardiac
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001281
- Term: Atrial Fibrillation
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424158
**Brief Title:** Massage Therapy After Thoracic or Lumbar Surgery
**Official Title:** The Impact of Massage Therapy on Post-Surgical Pain, Anxiety, Quality of Life, and Opioid Analgesia Exposure on Children After Thoracic or Lumbar Surgery
#### Organization Study ID Info
**ID:** 2020-088
#### Organization
**Class:** OTHER
**Full Name:** Cook Children's Health Care System
### Status Module
#### Completion Date
**Date:** 2026-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-04-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-02-17
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-05
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cook Children's Health Care System
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this research is to look at the effect of massage therapy on the pain, anxiety, and quality of life that pediatric patients have after undergoing spinal fusion surgery. This is a single-site, prospective, randomized, interventional study design that will involve post-thoracic and post-lumbar spinal fusion surgeries of pediatric patients from 7 to 19 years of age that present to Cook Children's Medical Center in Fort Worth, Texas. These patients will be identified prior to their scheduled spinal fusion surgery and recruited to enroll in the study. The planned spinal fusion surgeries are not considered part of this research project, but rather considered standard of care and would occur whether the patient is enrolled in this project or not. Enrolled participants will be followed during their inpatient stay and through their subsequent follow-up visits at weeks 2, 6, and 12. Participants will be randomly assigned to either a massage therapy group or a group that receives the standard (normal) care for recovery after surgery. The final study involvement will occur at week 16 (post-hospital discharge) where a study team member will administer a quality of life (PedsQL) questionnaire via phone or mail with the subject. Data will be collected after study related procedures are completed.
**Detailed Description:** There has been an increasing amount of spinal fusion surgeries in the United States. These patients struggle with anxiety and stress before surgery, and experience significant hardship during postoperative recovery including management of opioid related side effects, effective pain control, delay in mobilization, and prolonged length of stay. A growing body of research, however, has shown massage therapy (MT) as an effective alternative to conventional treatments. MT raises the temperature of local tissues, dilates capillaries, accelerates the circulation of blood and lymph, promotes the absorption of local tissue metabolism and mass inflammation, improves the nutritional supply of surrounding muscle groups, promotes their growth and development, and relieves pain.
The aim of this present study is to assess the effect of MT on perceived post-surgical pain, anxiety, and quality of life experienced by pediatric patients who have undergone thoracic and lumbar spinal fusion.
Potential participants will be identified prior to their scheduled spinal fusion surgery and recruited to enroll in the study. The planned spinal fusion surgeries are not considered part of this research project, but rather considered standard of care and would occur whether the patient is enrolled in this project or not. After surgery, another review of inclusion and exclusion criteria will be done to determine the subject's continued eligibility for participation. If criteria are met, the child participant will be randomized into one of two study groups, 1) Massage Therapy Group or 2) A Control Group for their post-surgery recovery plan. Enrolled participants will be followed during their inpatient stay and through their subsequent follow-up visits at weeks 2, 6, and 12. The final study involvement will occur at week 16 (post-hospital discharge) where a study team member will administer a quality of life questionnaire via phone or mail with the subject.
All participants whom are randomized into the massage therapy group are treated by a certified pediatric massage therapist. At least two 30- minute massage therapy sessions are performed on postoperative days two and four or five. Either post-operative day 4 or 5 can be selected as a second in-patient massage therapy session as long as the session occurs Monday through Friday, as the massage therapy service is not offered during the weekend hours of Saturday or Sunday. If the participant's length of stay is six days or longer, the participant continues to receive treatment every other day for the duration of hospitalization. Each individual patient is treated according to what their needs are, which means one participant may prefer neck and shoulder massage and another may prefer legs and feet. The participant remains in a position of comfort which for spinal fusion patients is generally in the supine, sitting, or side laying position. A combination of therapies including myofascial release, compression, and Swedish massage will be employed. Light and medium touch are applied but never deep tissue. While scar mobilization is a desired outcome postoperatively, this is not an immediate goal. The incision site remains clean and covered without any manipulation. Rehabilitation goals are to maximize mobility and flexibility of surrounding structures but is only addressed by the physical therapy team. Massage therapy does not involve any form of stretching or range of motion techniques. The study team will obtain vital data (Blood Pressure, Heart Rate, and O2 stats) along with VAS pain scale and anxiety rating scale measures before and after every session from the patient's medical records.
For those participants randomized into the control group, they will continue to receive the normal standard of care as usual for their recovery and will be monitored by hospital staff in obtaining the same data points (e.g., BP values, HR value, O2 levels) recorded clinically for post-op days 2 and 4/5; as the investigators are collecting in the massage group; however, no therapeutic intervention will occur. If the participant's length of stay is greater than five days the study staff will continue to record these values every other day for the duration of hospitalization. Study staff will retrieve these data variables via the patient's electronic medical record and enter data into the study database. A study member will visit with the subject on day 2, day 4/5 (and every other day if length of stay is greater than five days) to collect anxiety and pain scores measurements.
### Conditions Module
**Conditions:**
- Scoliosis; Adolescence
- Adolescent Idiopathic Scoliosis, Thoracic Region
- Adolescent Idiopathic Scoliosis, Lumbar Region
**Keywords:**
- Spinal Fusion
- Massage Therapy
- Pain Management
- Scoliosis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in the massage therapy group are treated by a certified pediatric massage therapist for at least two 30- minute massage therapy sessions performed on postoperative days two and four or five. Participants will continue to receive standard of care, including any pain medications as needed.
**Intervention Names:**
- Other: Massage Therapy
**Label:** Massage Therapy Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in control group will continue to receive the normal standard of care as usual for their recovery and will be monitored by hospital staff in obtaining the same data points recorded clinically for post-op days 2 and 4/5; however, no therapeutic intervention will occur.
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Massage Therapy Group
**Description:** Massage therapy (MT) has been proven as an alternative non-opioid pain management intervention, particularly towards reducing pain, diminishing depression, improving immune function, and increasing alertness in the adult population. MT raises the temperature of local tissues, dilates capillaries, accelerates the circulation of blood and lymph, promotes the absorption of local tissue metabolism and mass inflammation, improves the nutritional supply of surrounding muscle groups, promotes their growth and development, and relieves pain.
**Name:** Massage Therapy
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** A questionnaire with 30 questions related to health-related quality of life. Each question is scored on 1-5 scale with the minimum value being 30 and the maximum 150. Higher scores indicate worse outcome.
**Measure:** Scoliosis Patient Questionnaire (SRS-30)
**Time Frame:** Baseline and 12-week post-op
#### Primary Outcomes
**Description:** A pain scale with 10 items. Responses range from "Never" (1) to "Almost Always" (5) with the minimum score being 10 and the maximum score being 50. Higher scores indicate worse outcome.
**Measure:** Pediatric Pain - Short Form (Neuro-QOL™)
**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12
**Description:** A pain scale with one question asking patients to choose a number from 0 to 10 that best describes their pain from "No Pain" (0) to "Unbearable Pain" (10) with the minimum score being 0 and the maximum being 10. Higher scores indicate worse outcome.
**Measure:** Visual Analogue Scale (VAS) Pain Rating Scale
**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12
**Description:** A pain scale with one question asking patients to choose a number from 0 to 5 that best describes their pain from "No Hurt" (0) to "Hurts Worst" (10) with the minimum score being 1 and the maximum score being 5. Higher scores indicate worse outcome.
**Measure:** Wong-Baker FACES® Pain Rating Scale
**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12
#### Secondary Outcomes
**Description:** An anxiety measure with 14 statements. Responses range from "Never" (1) to "Almost Always" (5). with the minimum score being 14 and the maximum being 70. Higher scores indicate worse outcome.
**Measure:** Pediatric Anxiety (PROMIS®)
**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12
**Description:** An anxiety scale with one question asking patients to choose a number between 1 "Calm and content" and 10 "Extremely anxious, unable to function" that best describes their level of anxiety. The minimum score is 1 and the maximum score is 10. Higher scores indicate worse outcome.
**Measure:** Anxiety Thermometer
**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12
**Description:** Measured as systolic blood pressure over diastolic blood pressure in units of millimeters of mercury (mmHg)
**Measure:** Blood pressure
**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12
**Description:** Measured as beats per minute
**Measure:** Heart Rate
**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12
**Description:** Oxygen saturation (%) measured before and after the participant's designated intervention
**Measure:** Respiratory Rate
**Time Frame:** Post-op day 2, day 4/5, week 2, week 6, and week 12
**Description:** A quality of life scale with 15 questions. Responses range from "Never" (1) to "Almost Always" (5) with the minimum score being 15 and the maximum being 75. Higher scores indicate worse outcome.
**Measure:** Pediatric Quality of Life Inventory (PedsQL™)
**Time Frame:** Baseline, and weeks 6, 12 and 16 post-op
**Description:** Count of opioid doses administered
**Measure:** Use of opioid analgesics post-surgery
**Time Frame:** Immediately after surgery, daily for up to 7 days after surgery, week 2, week 6, and week 12
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients scheduled to undergo their first thoracic or lumbar spinal fusion surgery
* Able to participate and perform in a massage therapy as a recovery option
* Participant needs to be verbal
* Ability to understand study procedures and to comply with them for the entire length of the study
Exclusion Criteria:
* Prospective patients scheduled to undergo any spinal fusion other than a thoracic or lumbar spinal fusion surgery.
* Prospective patients scheduled to undergo a second or multiple thoracic or lumbar spinal fusion surgery
* Previous cardiac surgery
* Chronic pain syndromes
* Chronic opioid usage
* History of psychosis
* Prolonged bleeding
* Intubation greater than 24 hours
* Illicit/recreation drug use
* Paralysis diagnosis
* History of chronic pain requiring medical intervention
* Neuromuscular scoliosis diagnosis
* Cerebral palsy diagnosis
* Developmental delay characteristics
**Maximum Age:** 19 Years
**Minimum Age:** 7 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Throy Campbell, PhD
**Phone:** 682-885-1044
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Kristy Reyes
**Phone:** 682-885-1044
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Fort Worth
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Laurie Bailey, PhD
- **Phone:** 682-885-2488
- **Role:** CONTACT
***Contact 2:***
- **Name:** Meredith Brooks, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Cook Children's Medical Center
**State:** Texas
**Status:** RECRUITING
**Zip:** 76104
#### Overall Officials
**Official 1:**
**Affiliation:** Cook Children's Health Care System
**Name:** Meredith Brooks, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** American Massage Therapy Association. Massage Therapy Industry Fact Sheet. (2019). American Massage Therapy Association website. https://www.amtamassage.org/globalassets/documents/src/2019-pdf.pdf. Published 2019. Accessed June 22, 2020.
**Citation:** Bauer BA, Cutshall SM, Wentworth LJ, Engen D, Messner PK, Wood CM, Brekke KM, Kelly RF, Sundt TM 3rd. Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study. Complement Ther Clin Pract. 2010 May;16(2):70-5. doi: 10.1016/j.ctcp.2009.06.012. Epub 2009 Jul 14.
**PMID:** 20347836
**Citation:** Beider S, Moyer CA. Randomized controlled trials of pediatric massage: a review. Evid Based Complement Alternat Med. 2007 Mar;4(1):23-34. doi: 10.1093/ecam/nel068. Epub 2006 Nov 3.
**PMID:** 17342238
**Citation:** Braun LA, Stanguts C, Casanelia L, Spitzer O, Paul E, Vardaxis NJ, Rosenfeldt F. Massage therapy for cardiac surgery patients--a randomized trial. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1453-9, 1459.e1. doi: 10.1016/j.jtcvs.2012.04.027. Epub 2012 Sep 7.
**PMID:** 22964355
**Citation:** Blanco JS, Perlman SL, Cha HS, Delpizzo K. Multimodal pain management after spinal surgery for adolescent idiopathic scoliosis. Orthopedics. 2013 Feb;36(2 Suppl):33-5. doi: 10.3928/01477447-20130122-55.
**PMID:** 23379574
**Citation:** Connelly M, Fulmer RD, Prohaska J, Anson L, Dryer L, Thomas V, Ariagno JE, Price N, Schwend R. Predictors of postoperative pain trajectories in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2014 Feb 1;39(3):E174-81. doi: 10.1097/BRS.0000000000000099.
**PMID:** 24173016
**Citation:** Erdogmus CB, Resch KL, Sabitzer R, Muller H, Nuhr M, Schoggl A, Posch M, Osterode W, Ungersbock K, Ebenbichler GR. Physiotherapy-based rehabilitation following disc herniation operation: results of a randomized clinical trial. Spine (Phila Pa 1976). 2007 Sep 1;32(19):2041-9. doi: 10.1097/BRS.0b013e318145a386.
**PMID:** 17762803
**Citation:** Falkensteiner M, Mantovan F, Muller I, Them C. The use of massage therapy for reducing pain, anxiety, and depression in oncological palliative care patients: a narrative review of the literature. ISRN Nurs. 2011;2011:929868. doi: 10.5402/2011/929868. Epub 2011 Aug 23.
**PMID:** 22007330
**Citation:** Field TM, Quintino O, Hernandez-Reif M, Koslovsky G. Adolescents with attention deficit hyperactivity disorder benefit from massage therapy. Adolescence. 1998 Spring;33(129):103-8.
**PMID:** 9583664
**Citation:** Field T, Grizzle N, Scafidi F, Schanberg S. Massage and relaxation therapies' effects on depressed adolescent mothers. Adolescence. 1996 Winter;31(124):903-11.
**PMID:** 8970662
**Citation:** Field T, Morrow C, Valdeon C, Larson S, Kuhn C, Schanberg S. Massage reduces anxiety in child and adolescent psychiatric patients. J Am Acad Child Adolesc Psychiatry. 1992 Jan;31(1):125-31. doi: 10.1097/00004583-199201000-00019.
**PMID:** 1537763
**Citation:** Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.
**PMID:** 24237004
**Citation:** Jadhav MP, Jadhav PM, Shelke P, Sharma Y, Nadkar M. Assessment of use of complementary alternative medicine and its impact on quality of life in the patients attending rheumatology clinic, in a tertiary care centre in India. Indian J Med Sci. 2011 Feb;65(2):50-7.
**PMID:** 23196313
**Citation:** Kain ZN. Postoperative maladaptive behavioral changes in children: incidence, risks factors and interventions. Acta Anaesthesiol Belg. 2000;51(4):217-26. No abstract available.
**PMID:** 11129622
**Citation:** Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.
**PMID:** 8953995
**Citation:** Martin CT, Pugely AJ, Gao Y, Mendoza-Lattes SA, Ilgenfritz RM, Callaghan JJ, Weinstein SL. Increasing hospital charges for adolescent idiopathic scoliosis in the United States. Spine (Phila Pa 1976). 2014 Sep 15;39(20):1676-82. doi: 10.1097/BRS.0000000000000501.
**PMID:** 24983937
**Citation:** Mathews L. Pain in children: neglected, unaddressed and mismanaged. Indian J Palliat Care. 2011 Jan;17(Suppl):S70-3. doi: 10.4103/0973-1075.76247.
**PMID:** 21811376
**Citation:** McGregor AH, Dore CJ, Morris TP, Morris S, Jamrozik K. Function after spinal treatment, exercise and rehabilitation (FASTER): improving the functional outcome of spinal surgery. BMC Musculoskelet Disord. 2010 Jan 26;11:17. doi: 10.1186/1471-2474-11-17.
**PMID:** 20102625
**Citation:** Muhly WT, Sankar WN, Ryan K, Norton A, Maxwell LG, DiMaggio T, Farrell S, Hughes R, Gornitzky A, Keren R, McCloskey JJ, Flynn JM. Rapid Recovery Pathway After Spinal Fusion for Idiopathic Scoliosis. Pediatrics. 2016 Apr;137(4):e20151568. doi: 10.1542/peds.2015-1568. Epub 2016 Mar 23.
**PMID:** 27009035
**Citation:** Noshchenko A, Hoffecker L, Lindley EM, Burger EL, Cain CM, Patel VV, Bradford AP. Predictors of spine deformity progression in adolescent idiopathic scoliosis: A systematic review with meta-analysis. World J Orthop. 2015 Aug 18;6(7):537-58. doi: 10.5312/wjo.v6.i7.537. eCollection 2015 Aug 18.
**PMID:** 26301183
**Citation:** Rumalla K, Yarbrough CK, Pugely AJ, Koester L, Dorward IG. Spinal fusion for pediatric neuromuscular scoliosis: national trends, complications, and in-hospital outcomes. J Neurosurg Spine. 2016 Oct;25(4):500-508. doi: 10.3171/2016.2.SPINE151377. Epub 2016 May 20.
**PMID:** 27203810
**Citation:** Smith SL, Lux R, Haley S, Slater H, Beachy J, Moyer-Mileur LJ. The effect of massage on heart rate variability in preterm infants. J Perinatol. 2013 Jan;33(1):59-64. doi: 10.1038/jp.2012.47. Epub 2012 Apr 26. Erratum In: J Perinatol. 2013 Mar;33(3):250. Beechy, J [corrected to Beachy, J].
**PMID:** 22538325
**Citation:** Staveski SL, Boulanger K, Erman L, Lin L, Almgren C, Journel C, Roth SJ, Golianu B. The Impact of Massage and Reading on Children's Pain and Anxiety After Cardiovascular Surgery: A Pilot Study. Pediatr Crit Care Med. 2018 Aug;19(8):725-732. doi: 10.1097/PCC.0000000000001615.
**PMID:** 29912070
**Citation:** Theologis AA, Sing DC, Chekeni F, Diab M. National Trends in the Surgical Management of Adolescent Idiopathic Scoliosis: Analysis of a National Estimate of 60,108 Children From the National Inpatient Sample Over a 13-Year Time Period in the United States. Spine Deform. 2017 Jan;5(1):56-65. doi: 10.1016/j.jspd.2016.09.001.
**PMID:** 28038695
**Citation:** Yang S, Werner BC. Risk Factors for Prolonged Postoperative Opioid Use After Spinal Fusion for Adolescent Idiopathic Scoliosis. J Pediatr Orthop. 2019 Nov/Dec;39(10):500-504. doi: 10.1097/BPO.0000000000001139.
**PMID:** 31599858
## 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: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC05
- Name: Musculoskeletal Diseases
### Condition Browse Module - Browse Leaves
- ID: M13069
- Name: Pain, Postoperative
- Relevance: LOW
- As Found: Unknown
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M15417
- Name: Scoliosis
- Relevance: HIGH
- As Found: Scoliosis
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- 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
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012600
- Term: Scoliosis
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
### Intervention Browse Module - Browse Leaves
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M20786
- Name: Analgesics, Non-Narcotic
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06424145
**Brief Title:** Effect of Local Anesthesia Position of Lidocaine Injection on the Success Rate of Radial Artery Puncture Tube
**Official Title:** A Single-center, Randomized and Controlled Clinical Research Projects
#### Organization Study ID Info
**ID:** 19981228
#### Organization
**Class:** OTHER
**Full Name:** Sichuan Provincial People's Hospital
### Status Module
#### Completion Date
**Date:** 2026-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-20
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2026-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-17
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-01
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ting Xu
#### Responsible Party
**Investigator Affiliation:** Sichuan Provincial People's Hospital
**Investigator Full Name:** Ting Xu
**Investigator Title:** Chief physician
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Objective: To investigate the effect of lidocaine injection location on the success rate of ultrasound-guided radial artery catheterization in a single-center, randomized, controlled clinical trial.
**Detailed Description:** Group A was randomly divided into two groups: 1% lidocaine 1 ml was injected above the artery during local anesthesia before arterial catheterization; Group B: 1ml of 1% lidocaine was injected into the right side of the artery. The proportion of subjects according to the number of PO was similar in all groups. After the screening, the scientific research personnel of each testing center will log in the random system, fill in the screening information, obtain the random number information, and distribute the corresponding scientific research drugs according to the random number. The total number of drugs is imported into the centralized random grouping system by generating random number by SAS software. The study was conducted by an evaluation researcher and a medication management researcher. Throughout the experiment, not only the subjects turned a blind eye, but also the evaluators turned a blind eye. This study set up evaluation investigators and administrative investigators. Administrative researchers were only involved in the randomization, allocation, and delivery process. Other procedures, including informed consent, screening, efficacy index and safety evaluation, and planned visits, were completed by the evaluation investigators.
### Conditions Module
**Conditions:**
- Radial Artery Injury
**Keywords:**
- Puncture site of radial artery
- Lidocaine injection
- Success ratio
- Invasive blood pressure measurement
- Radial artery puncture
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 216
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Injection of 1% lidocaine 1 ml above the artery
**Intervention Names:**
- Diagnostic Test: Superior radial artery
**Label:** Superior group of radial artery
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Injection of 1% lidocaine 1 ml to the right side of the artery
**Intervention Names:**
- Diagnostic Test: Right side of radial artery
**Label:** Right radial artery group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Superior group of radial artery
**Description:** Upper radial artery, 1 ml of lidocaine
**Name:** Superior radial artery
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- Right radial artery group
**Description:** Right side of the radial artery,1ml of lidocaine
**Name:** Right side of radial artery
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** What is the probability of success the first time?
**Measure:** Success ratio of first radial artery puncture
**Time Frame:** Day 1
#### Secondary Outcomes
**Description:** In millimeters, Increase or decrease
**Measure:** Before and after lidocaine local anesthesia, the radial artery longest diameter and shortest diameter, circumference, cross-sectional area and depth changes
**Time Frame:** Day 1
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. ASA Class I-III, patients aged 18-80 years
2. Planned surgery with radial artery catheterization
3. Allen test negative
4. Sign the informed consent form and voluntarily participate in this trial
Exclusion Criteria:
1. Inflamed skin at puncture site
2. Extremely nervous and unable to cooperate
3. Ultrasonographic assessment of aberrant radial artery
4. Significant abnormalities in coagulation function (PT prolongation exceeding the upper limit of normal for 3 s or APTT prolongation exceeding the upper limit of normal for 10 s)
5. The patient had undergone radial artery catheterization in the same arm in the past week
6. History of hypersensitivity to local anesthetics
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Chengdu
**Country:** China
**Facility:** Sichuan provincial Peopel'Hospital
**State:** Sichuan
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M11014
- Name: Lidocaine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
Subsets and Splits