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## Protocol Section
### Identification Module
**NCT ID:** NCT06436768
**Brief Title:** Efficacy and Safety of Sugammadex in Thoracoscopy Thymectomy for Chinese Adults With Myasthenia Gravis
**Official Title:** Effectiveness of Sugammadex Versus Neostigmine on the Reversal of Rocuronium-induced Neuromuscular Blockade in Patients With Myasthenia Gravis After Thoracoscopic Thymectomy: A Multicenter Randomized Controlled Trial
#### Organization Study ID Info
**ID:** TRRCKY202 l-009-GZ (2023)-003
#### Organization
**Class:** OTHER
**Full Name:** Beijing Tongren Hospital
#### Secondary ID Infos
**Domain:** Wu Jieping Medical Foundation
**ID:** 320.6750.2020-21-10
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**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:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** The First Affiliated Hospital with Nanjing Medical University
#### Lead Sponsor
**Class:** OTHER
**Name:** Beijing Tongren Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study was to demonstrate in patients with myasthenia gravis (MG) undergoing thoracoscopic thymectomy faster recovery from a moderate neuromuscular block induced by rocuronium after reversal at reappearance of T2 by 2.0 mg/kg sugammadex compared to 50 ug/kg neostigmine.
Methods: A total of 64 patients with MG undergoing thoracoscopic thymectomy will be randomly divided into two groups: Sugammadex group (S group) and Neostigmine group (N group). The same anesthesia methods will be applied in both groups. Patients of S group will receive a dose of 2.0 mg/kg sugammadex after the last dose of rocuronium, at reappearance of T2. Patients of N group will receive a dose of 50 ug/kg neostigmine after the last dose of rocuronium, at reappearance of T2. The primary endpoint is time from start of administration of sugammadex or neostigmine to recovery of train-of-four stimulation ratio (TOFr) to 0.9. Secondary end points include time from start of administration of sugammadex or neostigmine to recovery of TOFr to 0.8 and 0.7, time to extubation, clinical signs of neuromuscular recovery, hemodynamic changes after muscle relaxation antagonism, adverse effects, time to operating room (OR) discharge, time to post-anesthesia care unit (PACU) discharge, and pulmonary complications within 7 days after the operation.
**Detailed Description:** Due to neuromuscular transmission and functioning deficits, patients with myasthenia gravis (MG) are at increased risk of postoperative residual curarization (PORC), and may even develop into postoperative myasthenia crisis (PMC), which is a serious complication after thymectomy and increases the risk of death, with an incidence of up to 18.2%.
Effective reversal of neuromuscular blockade is crucial to ensure patient safety, reduce the incidence of PORC or PMC and prompt postoperative recovery. Traditionally, neostigmine, an acetylcholinesterase inhibitor, can be employed for neuromuscular blocking agent (NMBA) reversal. However, neostigmine is associated with potential drawbacks, such as delayed recovery and adverse muscarinic side effects.
Sugammadex, a selective relaxant binding agent, represents a relatively new alternative for NMBA reversal, specifically designed to encapsulate and inactivate aminosteroid NMBAs. The clinical benefits of sugammadex have been documented in several studies, demonstrating faster reversal of neuromuscular blockade and more predictable recovery profiles compared to neostigmine. However, the use of sugammadex in patients with MG remains an area of limited evidence. To date, to the best of our knowledge, there is a lack of prospective research to elucidate the application value of sugammadex in thymectomy in patients with MG.
This study is a prospective randomized controlled trial aimed at exploring the efficacy and safety of sugammadex compared to neostigmine for the reversal of neuromuscular blockade in patients with myasthenia gravis after thoracoscopic thymectomy.
### Conditions Module
**Conditions:**
- Reversal of Neuromuscular Blockade
**Keywords:**
- neuromuscular blockade
- Sugammadex
- Neostigmine
- Myasthenia gravis
- Postoperative Residual Curarization
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized parallel controlled trial
##### Masking Info
**Masking:** TRIPLE
**Masking Description:** The doctors making the follow-up assessment were unaware of the treatment received, and none of the doctors who administered the injections carried out the follow- up evaluations. Thus, both the patients and the assessing doctors were remained unaware of the treatment received throughout the trial
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 64
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered.
**Intervention Names:**
- Drug: Sugammadex
**Label:** Sugammadex group (S group)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine plus atropine 0.02 mg/kg was administered.
**Intervention Names:**
- Drug: Neostigmine
**Label:** Neostigmine group (N group)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Sugammadex group (S group)
**Description:** After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered.
Dose will be according to participant actual body weight.
**Name:** Sugammadex
**Other Names:**
- S group
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Neostigmine group (N group)
**Description:** After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine (up to 5 mg maximum dose) plus atropine 0.02 mg/kg (up to 2 mg maximum dose) was administered.
Dose will be according to participant actual body weight.
**Name:** Neostigmine
**Other Names:**
- N group
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The comparison of the recovery periods between groups when the start of administering reversal agent to the recovery of TOF ratio≥ 0.9
**Measure:** Recovery time
**Time Frame:** After operation within 24 hours
#### Secondary Outcomes
**Description:** Muscle relaxation monitoring was performed with an accelero-myography (AMG) neuromuscular monitor by assessment of the TOF responses of adductor pollicis muscle to ulnar nerve stimulation every 15 seconds. T1 and T4 refer to the amplitudes of the first and fourth twitches, respectively, after TOF nerve stimulation. The TOFr, that is T4/T1 Ratio (expressed as a decimal of up to 1.0) represents the extent of recovery from neuromuscular blockade (NMB). A faster time to TOFr 0.8 indicates a faster recovery from NMB.
**Measure:** Time from start of administration of sugammadex or neostigmine to the train-of-four stimulation ratio (TOFr) 0.8
**Time Frame:** After operation within 120 minutes
**Description:** Muscle relaxation monitoring was performed with an accelero-myography (AMG) neuromuscular monitor by assessment of the TOF responses of adductor pollicis muscle to ulnar nerve stimulation every 15 seconds. T1 and T4 refer to the amplitudes of the first and fourth twitches, respectively, after TOF nerve stimulation. The TOFr, that is T4/T1 Ratio (expressed as a decimal of up to 1.0) represents the extent of recovery from neuromuscular blockade (NMB). A faster time to TOFr 0.7 indicates a faster recovery from NMB.
**Measure:** Time from start of administration of sugammadex or neostigmine to the train-of-four stimulation ratio (TOFr) 0.7.
**Time Frame:** After operation within 120 minutes
**Description:** The time period between administering a reversal agent to extubation
**Measure:** Extubation time
**Time Frame:** After operation within 60 minutes
**Description:** The time period between administering a reversal agent to operating room discharge
**Measure:** Time to discharge from the operating room
**Time Frame:** After operation within 60 minutes
**Description:** The time period between entering the recovery room amd discharge from recovery room
**Measure:** Time to discharge from recovery room
**Time Frame:** After operation within 120 minutes
**Description:** Incidence of postoperative residual neuromuscular blockade (rNMB) (defined as a train-of-four ratio, TOFR \<0.9) measured 30 min after administration of the reversal agent.
**Measure:** Incidence of postoperative residual neuromuscular blockade (rNMB)
**Time Frame:** After operation within 24 hours
**Description:** Unit: %; This value is a percentage. Any adverse effects in the operating room or in PACU include procedural pain, nausea, vomiting, dizziness, pruritus, reintubation, incision site complication, postprocedural nausea, vomiting, flatulence, procedural complication, insomnia, muscular weakness, headache, pharyngolaryngeal pain.
**Measure:** The incidence of adverse effects
**Time Frame:** Within 48 hours after operation
**Description:** After extubation to prior to discharge from the recovery room, record the number of patients who need rescue medication because of clinical signs of residual paralysis (i.e. if a patient complain about muscle weakness, difficulty breathing, or oxygen desaturation ≤ 95%)
**Measure:** Number of patients who need rescue medication
**Time Frame:** After operation within 24 hours
**Description:** The proportion of patients in this group who experience mean arterial blood pressure fluctuation ≥ 20% within 30 minutes after administration of antagonists compared with before administration of antagonists
**Measure:** The incidence of mean arterial blood pressure fluctuations ≥20%
**Time Frame:** After operation within 24 hours
**Description:** The proportion of patients in this group who experience heart rate fluctuation ≥ 20% within 30 minutes after administration of antagonists compared with before administration of antagonists
**Measure:** The incidence of heart rate fluctuations ≥20%
**Time Frame:** After operation within 24 hours
**Description:** Unit: %; This value is a percentage. Postoperative pulmonary complications include pneumonia; aspiration pneumonitis; atelectasis; respiratory failure; bronchospasm; pulmonary congestion; pleural effusion; pneumothorax.
**Measure:** The incidence of postoperative pulmonary complications
**Time Frame:** Within the first 7 days after surgery
**Description:** Unit: %; This value is a percentage.
**Measure:** Unplanned ICU hospitalization rate
**Time Frame:** 1 months after operation
**Description:** Blood oxygenation values will be measured using pulse oximetry from the time of PACU admission until discharge from the PACU
**Measure:** Hypoxemic events
**Time Frame:** participants will be followed for the duration of the PACU stay, an expected average of 2 hours, up to 7 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* • Patients with MG scheduled for elective thoracoscopic thymectomy
* Aged 18 to 65 years
* American society of Anesthesiologists (ASA) physical status classification system: I - III
Exclusion Criteria:
* Inability to obtain written informed consent
* With severe renal or hepatic dysfunction
* A plan to return to ICU with intubation postoperation
* A family history of malignant hyperthermia
* Suspected difficult airway
* Allergy to medications involved in the study
* A contraindication for neostigmine or sugammadex administration
* The patient's arm is not available for neuromuscular monitoring
* Patients receiving medication known to interfere with NMBAs (e.g., anticonvulsants, antibiotics, magnesium salts)
* Pregnant or lactating patients
**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:** Chunhua Hu
**Phone:** 0086-18310454243
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Chunhua Hu
- **Phone:** 0086-18310454243
- **Role:** CONTACT
**Country:** China
**Facility:** Beijing tongren Hospital, Capital Medical University
**State:** Beijing
**Zip:** 100000
**Location 2:**
**City:** Nanjing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Shijiang Liu
- **Phone:** 0086-13814001801
- **Role:** CONTACT
**Country:** China
**Facility:** The First Affiliated Hospital with Nanjing Medical University
**State:** Jiangsu
**Zip:** 210000
#### Overall Officials
**Official 1:**
**Affiliation:** Beijing Tongren Hospital
**Name:** Guyan Wang
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Cata JP, Lasala JD, Williams W, Mena GE. Myasthenia Gravis and Thymoma Surgery: A Clinical Update for the Cardiothoracic Anesthesiologist. J Cardiothorac Vasc Anesth. 2019 Sep;33(9):2537-2545. doi: 10.1053/j.jvca.2018.07.036. Epub 2018 Jul 29.
**PMID:** 30219643
**Citation:** Sheikh S, Alvi U, Soliven B, Rezania K. Drugs That Induce or Cause Deterioration of Myasthenia Gravis: An Update. J Clin Med. 2021 Apr 6;10(7):1537. doi: 10.3390/jcm10071537.
**PMID:** 33917535
**Citation:** Vymazal T, Krecmerova M, Bicek V, Lischke R. Feasibility of full and rapid neuromuscular blockade recovery with sugammadex in myasthenia gravis patients undergoing surgery - a series of 117 cases. Ther Clin Risk Manag. 2015 Oct 15;11:1593-6. doi: 10.2147/TCRM.S93009. eCollection 2015.
**PMID:** 26508869
**Citation:** van den Bersselaar LR, Gubbels M, Riazi S, Heytens L, Jungbluth H, Voermans NC, Snoeck MMJ. Mapping the current evidence on the anesthetic management of adult patients with neuromuscular disorders-a scoping review. Can J Anaesth. 2022 Jun;69(6):756-773. doi: 10.1007/s12630-022-02230-3. Epub 2022 Mar 23.
**PMID:** 35322378
**Citation:** Fernandes HDS, Ximenes JLS, Nunes DI, Ashmawi HA, Vieira JE. Failure of reversion of neuromuscular block with sugammadex in patient with myasthenia gravis: case report and brief review of literature. BMC Anesthesiol. 2019 Aug 17;19(1):160. doi: 10.1186/s12871-019-0829-0.
**PMID:** 31421671
**Citation:** No HJ, Yoo YC, Oh YJ, Lee HS, Jeon S, Kweon KH, Kim NY. Comparison between Sugammadex and Neostigmine after Video-Assisted Thoracoscopic Surgery-Thymectomy in Patients with Myasthenia Gravis: A Single-Center Retrospective Exploratory Analysis. J Pers Med. 2023 Sep 15;13(9):1380. doi: 10.3390/jpm13091380.
**PMID:** 37763148
**Citation:** Schaller SJ, Lewald H. Clinical pharmacology and efficacy of sugammadex in the reversal of neuromuscular blockade. Expert Opin Drug Metab Toxicol. 2016 Sep;12(9):1097-108. doi: 10.1080/17425255.2016.1215426. Epub 2016 Aug 3.
**PMID:** 27463265
**Citation:** Tsukada S, Shimizu S, Fushimi K. Rocuronium reversed with sugammadex for thymectomy in myasthenia gravis: A retrospective analysis of complications from Japan. Eur J Anaesthesiol. 2021 Aug 1;38(8):850-855. doi: 10.1097/EJA.0000000000001500.
**PMID:** 34226417
**Citation:** de Boer HD, Shields MO, Booij LH. Reversal of neuromuscular blockade with sugammadex in patients with myasthenia gravis: a case series of 21 patients and review of the literature. Eur J Anaesthesiol. 2014 Dec;31(12):715-21. doi: 10.1097/EJA.0000000000000153. No abstract available.
**PMID:** 25192270
**Citation:** Mouri H, Jo T, Matsui H, Fushimi K, Yasunaga H. Effect of Sugammadex on Postoperative Myasthenic Crisis in Myasthenia Gravis Patients: Propensity Score Analysis of a Japanese Nationwide Database. Anesth Analg. 2020 Feb;130(2):367-373. doi: 10.1213/ANE.0000000000004239.
**PMID:** 31124838
**Citation:** Fujimoto M, Terasaki S, Nishi M, Yamamoto T. Response to rocuronium and its determinants in patients with myasthenia gravis: A case-control study. Eur J Anaesthesiol. 2015 Oct;32(10):672-80. doi: 10.1097/EJA.0000000000000257.
**PMID:** 26086278
**Citation:** Lai HC, Huang TW, Tseng WC, Wu TS, Wu ZF. Sugammadex and postoperative myasthenic crisis. J Clin Anesth. 2019 Nov;57:63. doi: 10.1016/j.jclinane.2019.02.026. Epub 2019 Mar 12. No abstract available.
**PMID:** 30875518
**Citation:** Keating GM. Sugammadex: A Review of Neuromuscular Blockade Reversal. Drugs. 2016 Jul;76(10):1041-52. doi: 10.1007/s40265-016-0604-1.
**PMID:** 27324403
**Citation:** Petrun AM, Mekis D, Kamenik M. Successful use of rocuronium and sugammadex in a patient with myasthenia. Eur J Anaesthesiol. 2010 Oct;27(10):917-8. doi: 10.1097/EJA.0b013e3283392593. No abstract available.
**PMID:** 20375901
**Citation:** Kiss G, Lacour A, d'Hollander A. Fade of train-of-four ratio despite administration of more than 12 mg kg(-1) sugammadex in a myasthenia gravis patient receiving rocuronium. Br J Anaesth. 2013 May;110(5):854-5. doi: 10.1093/bja/aet098. No abstract available.
**PMID:** 23599531
**Citation:** Gurunathan U, Kunju SM, Stanton LML. Use of sugammadex in patients with neuromuscular disorders: a systematic review of case reports. BMC Anesthesiol. 2019 Nov 19;19(1):213. doi: 10.1186/s12871-019-0887-3.
**PMID:** 31744470
**Citation:** Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee.
**PMID:** 18946293
**Citation:** Blobner M, Eriksson LI, Scholz J, Motsch J, Della Rocca G, Prins ME. Reversal of rocuronium-induced neuromuscular blockade with sugammadex compared with neostigmine during sevoflurane anaesthesia: results of a randomised, controlled trial. Eur J Anaesthesiol. 2010 Oct;27(10):874-81. doi: 10.1097/EJA.0b013e32833d56b7.
**PMID:** 20683334
**Citation:** Suy K, Morias K, Cammu G, Hans P, van Duijnhoven WG, Heeringa M, Demeyer I. Effective reversal of moderate rocuronium- or vecuronium-induced neuromuscular block with sugammadex, a selective relaxant binding agent. Anesthesiology. 2007 Feb;106(2):283-8. doi: 10.1097/00000542-200702000-00016.
**PMID:** 17264722
**Citation:** Reid JE, Breslin DS, Mirakhur RK, Hayes AH. Neostigmine antagonism of rocuronium block during anesthesia with sevoflurane, isoflurane or propofol. Can J Anaesth. 2001 Apr;48(4):351-5. doi: 10.1007/BF03014962.
**PMID:** 11339776
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020361
- Term: Paraneoplastic Syndromes, Nervous System
- ID: D000009423
- Term: Nervous System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000010257
- Term: Paraneoplastic Syndromes
- ID: D000020274
- Term: Autoimmune Diseases of the Nervous System
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000020511
- Term: Neuromuscular Junction Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12112
- Name: Myasthenia Gravis
- Relevance: HIGH
- As Found: Myasthenia Gravis
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M13170
- Name: Paraneoplastic Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M22160
- Name: Paraneoplastic Syndromes, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M12367
- Name: Nervous System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22297
- Name: Neuromuscular Junction Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3973
- Name: Myasthenia Gravis
- Relevance: HIGH
- As Found: Myasthenia Gravis
### Condition Browse Module - Meshes
- ID: D000009157
- Term: Myasthenia Gravis
### Intervention Browse Module - Ancestors
- ID: D000002800
- Term: Cholinesterase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000018678
- Term: Cholinergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000010277
- Term: Parasympathomimetics
- ID: D000001337
- Term: Autonomic Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: AdjAn
- Name: Adjuvants, Anesthesia
- Abbrev: Resp
- Name: Respiratory System Agents
### Intervention Browse Module - Browse Leaves
- ID: M12333
- Name: Neostigmine
- Relevance: HIGH
- As Found: Head and Neck Cancer
- ID: M1666
- Name: Rocuronium
- Relevance: LOW
- As Found: Unknown
- ID: M4590
- Name: Atropine
- Relevance: LOW
- As Found: Unknown
- ID: M6040
- Name: Cholinesterase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M20758
- Name: Cholinergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000009388
- Term: Neostigmine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436755
**Brief Title:** Serratus Anterior Plane Block and Transthoracic Plane Block in Pectus Surgery
**Official Title:** Effect of Serratus Anterior Plane Block and Transthoracic Plane Block Combination on Postoperative Analgesia From Pectus Surgery
#### Organization Study ID Info
**ID:** 2024-271
#### Organization
**Class:** OTHER_GOV
**Full Name:** Başakşehir Çam & Sakura City Hospital
### Status Module
#### Completion Date
**Date:** 2025-11-21
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-11-21
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Başakşehir Çam & Sakura City Hospital
#### Responsible Party
**Investigator Affiliation:** Başakşehir Çam & Sakura City Hospital
**Investigator Full Name:** Cansu KILINC BERKTAS
**Investigator Title:** Specialist MD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The most important problem in the postoperative period in patients scheduled for pectus deformity correction surgery is pain. Due to the catastrophic neurological complications of thoracic epidural analgesia, the tendency towards plane blocks has been increasing in recent years. Serratus Plane Block (SAP Block), performed under ultrasound guidance, is used to treat pain in thoracic surgery. However, whether it has an effect on sternum pain is still controversial and there are not enough studies. Transversus thoracic plane block (TTP Block) provides effective analgesia in sternotomies. For this reason, we aimed to show that the TTP block added to the SAP block will provide more effective analgesia in order to provide adequate analgesia for the pressure and pain sensation of the bars placed on the sternum in pectus surgery.
**Detailed Description:** The most important problem in the postoperative period in patients scheduled for pectus deformity correction surgery is pain. It is very important for patients to start active breathing exercises and mobilize early. Complications develop less frequently in patients who actively breathe and mobilize early. The tolerability of the surgery by the patient and the absence of pain in the postoperative period ensure early discharge . Due to the catastrophic neurological complications of thoracic epidural analgesia, the tendency towards plane blocks has been increasing in recent years. Serratus Plane Block (SAP Block), performed under ultrasound guidance, is used to treat pain in thoracic surgery. However, whether it has an effect on sternum pain is still controversial and there are not enough studies. Transversus thoracic plane block (TTP Block) provides effective analgesia in sternotomies. For this reason, we aimed to show that the TTP block added to the SAP block will provide more effective analgesia in order to provide adequate analgesia for the pressure and pain sensation of the bars placed on the sternum in pectus surgery.
### Conditions Module
**Conditions:**
- Pectus Excavatum
**Keywords:**
- Transversus thoracic muscle plane block
- postoperative analgesia
- pectus excavatum
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients who underwent serratus anterior plane block
**Intervention Names:**
- Procedure: no intervention,this is a observational studies
**Label:** Serratus anterior plane block (SAP) group
#### Arm Group 2
**Description:** Patients who underwent Serratus anterior plane block (SAP) and Transversus thoracic plane block (TTP) group
**Intervention Names:**
- Procedure: no intervention,this is a observational studies
**Label:** Serratus anterior plane block (SAP) and Transversus thoracic plane block (TTP) group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Serratus anterior plane block (SAP) and Transversus thoracic plane block (TTP) group
- Serratus anterior plane block (SAP) group
**Description:** no intervention,this is a observational studies
**Name:** no intervention,this is a observational studies
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Serratus Plane Block (SAP Block), performed under ultrasound guidance, is used to treat pain in thoracic surgery. However, whether it has an effect on sternum pain is still controversial and there are not enough studies. Transversus thoracic plane block (TTP Block) provides effective analgesia in sternotomies. For this reason, TTP block will be added to the SAP block in order to provide adequate analgesia for the pressure and pain sensation of the bars placed on the sternum in pectus surgery.
The patient's pain score will be evaluated with the Numerical Rating Scale (NRS). Hourly pain scores in the postoperative period are 0./1./4./6./12./18./24./48.
Additional complications
**Measure:** Effect of Serratus Anterior Plane Block and Transthoracic Plane Block Combination on Postoperative Analgesia in Pectus Surgery
**Time Frame:** postoperative 48 hours
**Description:** Total amount of analgesia for 48 hours,
**Measure:** Postoperative Analgesia in Pectus Surgery
**Time Frame:** postoperative 48 hours
**Description:** Presence of need for additional analgesics,
**Measure:** Postoperative pain in Pectus Surgery
**Time Frame:** postoperative 48 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Patients who will undergo surgery due to pectus deformity All patients over the age of 15 who will be operated on due to pectus deformity
Exclusion Criteria:
* Known allergy to local anesthetics,
* Uncooperative patient,
* The patient who refuses to participate in the study,
* Patients under 18 years of age.
**Minimum Age:** 15 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** All patients over the age of 15 who will be operated on due to pectus deformity
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** CANSU KILINÇ BERKTAŞ
**Phone:** +9005542448087
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Başakşehir Çam Ve Sakura Şehir Hastanesi
**State:** İ̇stanbul
**Zip:** 34480
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001848
- Term: Bone Diseases, Developmental
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000009139
- Term: Musculoskeletal Abnormalities
- ID: D000000013
- Term: Congenital Abnormalities
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M8779
- Name: Funnel Chest
- Relevance: HIGH
- As Found: Pectus Excavatum
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5127
- Name: Bone Diseases, Developmental
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M12096
- Name: Musculoskeletal Abnormalities
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005660
- Term: Funnel Chest
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436742
**Brief Title:** A Phase 1b Study to Investigate Safety and Tolerability of ARGX-119 in Adult Participants With DOK7-Congenital Myasthenic Syndromes (CMS)
**Official Title:** A Phase 1b, Double-Blinded, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Efficacy of ARGX-119 in Adult Participants With DOK7-Congenital Myasthenic Syndromes
#### Organization Study ID Info
**ID:** ARGX-119-2302
#### Organization
**Class:** INDUSTRY
**Full Name:** argenx
#### Secondary ID Infos
**ID:** 2023-509872-41-00
**Type:** CTIS
### Status Module
#### Completion Date
**Date:** 2025-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** argenx
#### 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 safety and tolerability of ARGX-119 in adult participants with DOK7- Congenital Myasthenic Syndromes. The study will also assess how ARGX-119 is processed by the body (pharmacokinetics), how the immune system reacts to it (immunogenicity), and how it may improve the way patients feel and function.
After the screening period, eligible participants will be randomized in a 4:1 ratio to receive intravenous infusions of ARGX-119 or placebo during the treatment period. Participants will then enter the follow-up period. The full duration of the study is approximately 11 months.
### Conditions Module
**Conditions:**
- Congenital Myasthenic Syndrome
### 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:** 15
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants receiving intravenous infusion of ARGX-119 once every other week
**Intervention Names:**
- Biological: ARGX-119
**Label:** ARGX-119
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants receiving intravenous infusion of placebo once every other week
**Intervention Names:**
- Other: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ARGX-119
**Description:** Intravenous infusion of ARGX-119
**Name:** ARGX-119
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Intravenous infusion of placebo
**Name:** Placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Assessment of adverse events (AEs)
**Time Frame:** Up to week 42
#### Secondary Outcomes
**Measure:** Maximum observed serum concentration (Cmax) of ARGX-119
**Time Frame:** Up to week 42
**Measure:** Incidence of anti-drug antibodies (ADA) against ARGX-119
**Time Frame:** Up to week 42
**Measure:** Prevalence of anti-drug antibodies (ADA) against ARGX-119
**Time Frame:** Up to week 42
**Description:** Minimum value: 0 (no disease severity); Maximum value: 39 (highest disease severity)
**Measure:** Change from baseline over time for key components of the Quantitative Myasthenia Gravis (QMG) scale
**Time Frame:** Up to week 42
**Description:** Minimum value: 0 (normal symptoms); Maximum value: 24 (most severe symptoms)
**Measure:** Change from baseline over time for Myasthenia Gravis Activities of Daily Living (MG-ADL)
**Time Frame:** Up to week 42
**Description:** The participant records their response to each question on a 5-point Likert scale, with lower scores indicating poorer health (Minimum value: 0, Maximum value: 20)
**Measure:** Change from baseline over time for Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-GH) scale
**Time Frame:** Up to week 42
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* At least 18 years of age.
* Has genetically confirmed congenital myasthenic syndromes due to mutation of downstream of kinase 7 (DOK7-CMS).
* Participants taking oral beta agonists (eg, albuterol, salbutamol, ephedrine) must have been receiving the medication for more than 3 months and agree to remain on a same stable dosing regimen of the same medication until the end of the study.
Exclusion Criteria:
* Diagnosis of CMS due to mutation of any gene other than DOK7.
* Known medical condition that would interfere with an accurate assessment of CMS, confound the results of the study, or put the patient at undue risk, as assessed by the investigator.
* History of malignancy, cancer, unless considered cured by adequate treatment with no evidence of recurrence for more than 5 years. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological findings of prostate cancer.
* Different study drug received in another clinical study within 12 weeks or 5 half-lives before screening.
* Current participation in another interventional clinical study or prior participation in any gene therapy or cell therapy study.
* Pregnant or lactating state or intention to become pregnant during the study.
The complete list of exclusion criteria can be found in the protocol.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sabine Coppieters, MD
**Phone:** 857-350-4834
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000009157
- Term: Myasthenia Gravis
- ID: D000020361
- Term: Paraneoplastic Syndromes, Nervous System
- ID: D000009423
- Term: Nervous System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000010257
- Term: Paraneoplastic Syndromes
- ID: D000020274
- Term: Autoimmune Diseases of the Nervous System
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000020511
- Term: Neuromuscular Junction Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
- ID: D000030342
- Term: Genetic Diseases, Inborn
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M18224
- Name: Lambert-Eaton Myasthenic Syndrome
- Relevance: HIGH
- As Found: Myasthenic Syndrome
- ID: M22107
- Name: Myasthenic Syndromes, Congenital
- Relevance: HIGH
- As Found: Congenital Myasthenic Syndrome
- ID: M12112
- Name: Myasthenia Gravis
- Relevance: LOW
- As Found: Unknown
- ID: M13170
- Name: Paraneoplastic Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M22160
- Name: Paraneoplastic Syndromes, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M12367
- Name: Nervous System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22297
- Name: Neuromuscular Junction Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: T3299
- Name: Lambert Eaton Myasthenic Syndrome
- Relevance: HIGH
- As Found: Myasthenic Syndrome
- ID: T1538
- Name: Congenital Myasthenic Syndromes
- Relevance: HIGH
- As Found: Congenital Myasthenic Syndrome
- ID: T3973
- Name: Myasthenia Gravis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015624
- Term: Lambert-Eaton Myasthenic Syndrome
- ID: D000020294
- Term: Myasthenic Syndromes, Congenital
- ID: D000013577
- Term: Syndrome
### Intervention Browse Module - Browse Branches
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M229482
- Name: Bismuth subsalicylate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436729
**Brief Title:** Impact of MINST With and Without Splinting in Periodontitis Patients With Mobile Anterior Teeth
**Official Title:** Impact of MINST With and Without Splinting on Clinical Periodontal Parameters and OHRQoL in Periodontitis Patients With Mobile Anterior Teeth: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** Navi Bansal Perio 24/39
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Postgraduate Institute of Dental Sciences Rohtak
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this clinical trial is to evaluate impact of Minimally Invasive Non-Surgical Therapy (MINST) with and without splinting on clinical periodontal parameters and Oral Health Related Quality of Life (OHRQoL) in periodontitis patients with mobile anterior teeth. The main questions it aims to answer are:
* Does splinting provide additional benefit to MINST alone for improving the clinical periodontal parameters ?
* Does splinting provide additional benefit to MINST alone for improving OHRQoL ?
**Detailed Description:** The increased mobility of a periodontally affected tooth can be caused by a shift of centre of rotation of the tooth apically due to clinical attachment loss (CAL) and alveolar bone loss (ABL) and/or due to secondary occlusal trauma.
Tooth splinting continues to be a topic of controversy. It remains one of the most poorly understood and controversial areas of dental therapy.
Minimally invasive non-surgical periodontal therapy (MINST) has been introduced for minimizing tissue trauma and enhancing clinical outcomes by the adjunctive use of magnification devices .
This study aims to compare clinical periodontal parameters and Oral Health Related Quality of Life (OHRQoL) following Minimally Invasive Non-Surgical Therapy (MINST), both with and without splinting, in patients with Stage III and Stage IV periodontitis who have mobile anterior teeth.
Patients will be screened and enrolled based on specific eligibility criteria. Baseline measurements of outcome parameters will be taken, followed by supragingival scaling, and patients will be recalled after one week.
During the subsequent visit, patients will be randomized into either the test group or the control group. The test group will receive MINST along with splinting of the mobile anterior teeth, while the control group will receive MINST alone.
Patients will be recalled after 8 weeks and 6 months to assess changes in the outcome measurements.
### Conditions Module
**Conditions:**
- Tooth Mobility
- Periodontitis
**Keywords:**
- Splinting
- OHRQoL
- MINST
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Minimally Invasive Non-Surgical Therapy will be done along with splinting of mobile anterior teeth
**Intervention Names:**
- Procedure: Splinting
**Label:** MINST with Splinting
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Minimally Invasive Non-Surgical Therapy will be done without splinting of mobile anterior teeth
**Intervention Names:**
- Procedure: MINST alone
**Label:** MINST without Splinting
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MINST with Splinting
**Description:** The joining of two or more teeth into a rigid unit by means of a fixed or removable restorations/devices
**Name:** Splinting
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- MINST without Splinting
**Description:** Minimally invasive non surgical therapy alone
**Name:** MINST alone
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Clinical attachment level is the distance between the cemento-enamel junction and the base of pocket.
**Measure:** Changes in Clinical Attachment Level (CAL)
**Time Frame:** 12 - 14 months
**Description:** OHRQoL will be measured using a validated version of Oral Health Index Profile (OHIP)
**Measure:** Changes in Oral Health Related Quality of Life (OHRQoL)
**Time Frame:** 12 - 14 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Inclusion criteria at the patient level: systemically healthy patient with presence of stage III or IV periodontitis, age ≥ 18 years.
* Tooth-related inclusion criteria: presence of at least one anterior tooth with mobility in combination with a clinical attachment loss (CAL) ≥ 5 mm and a relative alveolar bone loss (ABL) of ≥ 50% at the affected tooth.
* Dentition with at least 3 antagonistic contact zones opposing posterior teeth, that is Eichner Class A1, A2, A3, B1
Exclusion Criteria:
* Patients with anterior cross bite
* Bruxism or signs of parafunction
* Implant in Anterior teeth
* Any active periodontal therapy in last 1 year
* Mobility of teeth due to acute trauma
* Pulpal or periapical pathology in anterior teeth
* Patient requiring any emergency dental procedure
* Patient on antibiotic therapy in last 1 month
* If patient want to undergo surgical treatment for management of periodontitis.
**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:** Ritika Arora, MDS
**Phone:** 9810734445
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rohtak
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sanjay Tewari, MDS
- **Phone:** 01262283876
- **Role:** CONTACT
**Country:** India
**Facility:** PGIDS
**State:** Haryana
**Zip:** 124001
#### Overall Officials
**Official 1:**
**Affiliation:** PGIDS, ROHTAK
**Name:** Navi Bansal, BDS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M13427
- Name: Periodontitis
- Relevance: HIGH
- As Found: Periodontitis
- ID: M16841
- Name: Tooth Mobility
- Relevance: HIGH
- As Found: Tooth Mobility
- 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: D000010518
- Term: Periodontitis
- ID: D000014086
- Term: Tooth Mobility
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436716
**Brief Title:** Artificial Intelligence Model for Traumatic Cervical Spinal Cord Injury Based on Radiomics and Genomics
**Official Title:** The Second Affiliated Hospital of Nantong University, Nantong First People's Hospital, Nantong University
#### Organization Study ID Info
**ID:** WuCS
#### Organization
**Class:** OTHER
**Full Name:** Affiliated 2 Hospital of Nantong University
### Status Module
#### Completion Date
**Date:** 2027-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2016-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Affiliated 2 Hospital of Nantong University
#### Responsible Party
**Investigator Affiliation:** Affiliated 2 Hospital of Nantong University
**Investigator Full Name:** Jiawei Jiang
**Investigator Title:** Clinical Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Collect standardized, structured, and comprehensive disease-specific information, produce high-quality and accurate clinical data, provide a sample basis for the analysis and mining of spinal cord injury clinical big data, and establish a spinal cord injury-specific disease data platform to serve clinical work. Promote multi-center cooperation in spinal cord injury research: Establish a unified, standardized, queryable, and sharable efficient spinal cord clinical research data platform to promote multi-center cooperation in spinal cord injury clinical research and enhance the international competitiveness of this research field. Help the region to prepare for the establishment of a spinal cord injury-specific disease data platform for various hospitals in the region, forming a spinal cord injury-specific disease network center to achieve data sharing.
### Conditions Module
**Conditions:**
- Spinal Cord Injuries
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Control: No spinal cord injury
**Intervention Names:**
- Radiation: MRI
**Label:** Control, SCI-1, SCI-2, SCI-3
#### Arm Group 2
**Description:** SCI-1: spinal cord injury and ASIA Grade A and B
**Intervention Names:**
- Radiation: MRI
**Label:** SCI-1
#### Arm Group 3
**Description:** SCI-2: spinal cord injury and ASIA Grade C
**Intervention Names:**
- Radiation: MRI
**Label:** SCI-2
#### Arm Group 4
**Description:** SCI-3: spinal cord injury and ASIA Grade D
**Intervention Names:**
- Radiation: MRI
**Label:** SCI-3
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control, SCI-1, SCI-2, SCI-3
- SCI-1
- SCI-2
- SCI-3
**Description:** Every patient needs an MRI to assess spinal cord injury. This is one of the clinically necessary examinations.
**Name:** MRI
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** original MRI image format DICOM to Nii was based on Python (Version: 3.10.6), and those would be loaded into the MRIcroGMRI imageL software (Version: 12.2). Three spinal surgeons (with 5, 8 and 18 years of experience in interpreting spinal MRI respectively) manually depict the region of interest (ROI) of the lesion area layer by layer, to form three dimensional (3D) volume of interest (VOI). After the primary spinal surgeon finished depicting the injured spinal cord, the senior spinal surgeon checked the quality of ROI and made some adjustments.
**Measure:** MRI image
**Time Frame:** From 2016 to 2027
**Description:** ASIA scores means American Spinal Injury Association Impairment Scale. ASIA has 5 grades depends on the severity of spinal cord injury. Grade A :No sensory or motor function is preserved in sacral segments S4-S5, no sacral sparing. Grade B:Sensory but not motor function is preserved below the neurological level and includes sacral segments S4-S5, AND No motor function is preserved more than three levels below the motor level on either side of the body. Grade C: Motor function is preserved below the neurological level AND More than half of the key muscle functions below the neurological level of injury have a muscle grade of less than 3 (Grades 0-2). Grade D: Motor function is preserved below the neurological level AND At least half (half or more) of the key muscle functions below the neurological level of injury have a muscle grade ≥ 3. Grade E: If sensation and motor function are graded as normal in all segments AND the patient had prior SCI-related deficits.
**Measure:** ASIA scores
**Time Frame:** From 2016 to 2027
#### Secondary Outcomes
**Description:** Years old, no need month nor day
**Measure:** Age
**Time Frame:** From 2016 to 2027
**Description:** male and female
**Measure:** Gender
**Time Frame:** From 2016 to 2027
**Description:** In kilograms
**Measure:** Weight
**Time Frame:** From 2016 to 2027
**Description:** In meters
**Measure:** Height
**Time Frame:** From 2016 to 2027
**Description:** In kg/m\^2
**Measure:** BMI
**Time Frame:** From 2016 to 2027
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. MRI Diagnosis of TCSCI
2. Clinic Diagnosis of TCSCI
3. The injury site must be in cervical spinal cord
4. MRI images of T2WI must be collected within 48 hours after injury
5. Complete and available imaging data, clinical data, including MRI, sex, age
Exclusion Criteria:
1. Spinal cord concussion and MRI scans have no obvious positive performance of spinal cord
2. The quality of MRI images is insufficient or there are serious motion artifacts
**Healthy Volunteers:** True
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** MRI image of patients within 48 hours after TCSCI in The First People's Hospital of Nantong
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Nantong
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Chunshuai Wu, Dr
- **Role:** CONTACT
***Contact 2:***
- **Name:** Hongqing Xu, Dr
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Affiliated 2 Hospital of Nantong University
**State:** Jiangsu
**Status:** RECRUITING
**Zip:** 0513
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000013118
- Term: Spinal Cord Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000020196
- Term: Trauma, Nervous System
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M15916
- Name: Spinal Cord Injuries
- Relevance: HIGH
- As Found: Spinal Cord Injury
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M15915
- Name: Spinal Cord Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22023
- Name: Trauma, Nervous System
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013119
- Term: Spinal Cord Injuries
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436703
**Brief Title:** A Study About Modified RNA Vaccines Against Influenza in Healthy Adults
**Official Title:** A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINES AGAINST INFLUENZA IN HEALTHY ADULTS
#### Organization Study ID Info
**ID:** C4781013
#### Organization
**Class:** INDUSTRY
**Full Name:** Pfizer
### Status Module
#### Completion Date
**Date:** 2025-02-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-02-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Pfizer
#### 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 learn if modified RNA (modRNA) vaccines for the prevention of influenza are:
* safe; and
* how these vaccines produce an immune response in generally healthy adults. Immune response is the way the body protects itself against things it sees as harmful or foreign.
RNA (also called ribonucleic acid) is one of two types of nucleic acid made by cells. RNA contains information that has been copied from DNA (the other type of nucleic acid). Cells make several different forms of RNA, and each form has a specific job in the cell. Many forms of RNA have functions related to making proteins. RNA is also the genetic material of some viruses instead of DNA. RNA can be made in the laboratory and used in research studies. Also called ribonucleic acid.
Influenza is term used for flu illness. It is an infection caused by a virus that affects your mouth, nose, and throat.
The study is seeking for participants who:
* are at least 18 years of age
* have not received an influenza vaccine within the last 6 months
* are generally healthy
This study will be divided into three sub-studies: Substudy A (SSA), Substudy B (SSB), and Substudy C (SSC).
All participants, regardless of sub-study, will receive 1 dose of either of the following vaccines as an injection into their arm:
* 1 of the modRNA influenza vaccines that is being studied; or
* an approved influenza vaccine approved for use in their respective age group.
Participants will be involved in this study for about 6 months. During this time, participants will have at least 3 clinic visits.
### Conditions Module
**Conditions:**
- Influenza, Human
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** This study will be an observer-blinded and Sponsor-unblinded study.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 1170
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** - Single Dose on Day 1
**Intervention Names:**
- Biological: Influenza ModRNA Vaccine
**Label:** SSA: Influenza ModRNA Vaccine 2A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** - Single Dose on Day 1
**Intervention Names:**
- Biological: Influenza ModRNA Vaccine
**Label:** SSA: Influenza ModRNA Vaccine 3A
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** - Single Dose on Day 1
**Intervention Names:**
- Biological: Influenza ModRNA Vaccine
**Label:** SSA: Influenza ModRNA Vaccine 4A
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** - Single dose on Day 1
**Intervention Names:**
- Biological: Influenza ModRNA Vaccine
**Label:** SSA: Influenza ModRNA Vaccine 5A
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** - Single dose on Day 1
**Intervention Names:**
- Biological: Quadrivalent Influenza Vaccine (QIV)
**Label:** SSA: QIV1
**Type:** ACTIVE_COMPARATOR
#### Arm Group 6
**Description:** - Single Dose on Day 1
**Intervention Names:**
- Biological: Influenza ModRNA Vaccine
**Label:** SSB: Influenza ModRNA Vaccine 3B
**Type:** EXPERIMENTAL
#### Arm Group 7
**Description:** - Single Dose on Day 1
**Intervention Names:**
- Biological: Influenza ModRNA Vaccine
**Label:** SSB: Influenza ModRNA Vaccine 4B
**Type:** EXPERIMENTAL
#### Arm Group 8
**Description:** - Single dose on Day 1
**Intervention Names:**
- Biological: Influenza ModRNA Vaccine
**Label:** SSB: Influenza ModRNA Vaccine 5B
**Type:** EXPERIMENTAL
#### Arm Group 9
**Description:** - Single Dose on Day 1
**Intervention Names:**
- Biological: Quadrivalent Influenza Vaccine (QIV)
**Label:** SSB: QIV2
**Type:** ACTIVE_COMPARATOR
#### Arm Group 10
**Description:** - Single Dose on Day 1
**Intervention Names:**
- Biological: Quadrivalent Influenza Vaccine (QIV)
**Label:** SSB: QIV3
**Type:** ACTIVE_COMPARATOR
#### Arm Group 11
**Description:** - Single Dose on Day 1
**Intervention Names:**
- Biological: Influenza ModRNA Vaccine
**Label:** SSC: Influenza ModRNA Vaccine 3C
**Type:** EXPERIMENTAL
#### Arm Group 12
**Description:** - Single Dose on Day 1
**Intervention Names:**
- Biological: Influenza ModRNA Vaccine
**Label:** SSC: Influenza ModRNA Vaccine 4C
**Type:** EXPERIMENTAL
#### Arm Group 13
**Description:** - Single Dose on Day 1
**Intervention Names:**
- Biological: Influenza ModRNA Vaccine
**Label:** SSC: Influenza ModRNA Vaccine 5C
**Type:** EXPERIMENTAL
#### Arm Group 14
**Description:** - Single Dose on Day 1
**Intervention Names:**
- Biological: Influenza ModRNA Vaccine
**Label:** SSC: Influenza ModRNA Vaccine 6C
**Type:** EXPERIMENTAL
#### Arm Group 15
**Description:** - Single Dose on Day 1
**Intervention Names:**
- Biological: Influenza ModRNA Vaccine
**Label:** SSC: Influenza ModRNA Vaccine 7C
**Type:** EXPERIMENTAL
#### Arm Group 16
**Description:** - Single Dose on Day 1
**Intervention Names:**
- Biological: Influenza ModRNA Vaccine
**Label:** SSC: Influenza ModRNA Vaccine 8C
**Type:** EXPERIMENTAL
#### Arm Group 17
**Description:** - Single dose on Day 1
**Intervention Names:**
- Biological: Influenza ModRNA Vaccine
**Label:** SSC: Influenza ModRNA Vaccine 9C
**Type:** EXPERIMENTAL
#### Arm Group 18
**Description:** - Single Dose on Day 1
**Intervention Names:**
- Biological: Quadrivalent Influenza Vaccine (QIV)
**Label:** SSC: QIV2
**Type:** ACTIVE_COMPARATOR
#### Arm Group 19
**Description:** - Single Dose on Day 1
**Intervention Names:**
- Biological: Quadrivalent Influenza Vaccine (QIV)
**Label:** SSC: QIV3
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SSA: Influenza ModRNA Vaccine 2A
- SSA: Influenza ModRNA Vaccine 3A
- SSA: Influenza ModRNA Vaccine 4A
- SSA: Influenza ModRNA Vaccine 5A
- SSB: Influenza ModRNA Vaccine 3B
- SSB: Influenza ModRNA Vaccine 4B
- SSB: Influenza ModRNA Vaccine 5B
- SSC: Influenza ModRNA Vaccine 3C
- SSC: Influenza ModRNA Vaccine 4C
- SSC: Influenza ModRNA Vaccine 5C
- SSC: Influenza ModRNA Vaccine 6C
- SSC: Influenza ModRNA Vaccine 7C
- SSC: Influenza ModRNA Vaccine 8C
- SSC: Influenza ModRNA Vaccine 9C
**Description:** Intramuscular injection
**Name:** Influenza ModRNA Vaccine
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- SSA: QIV1
- SSB: QIV2
- SSB: QIV3
- SSC: QIV2
- SSC: QIV3
**Description:** Intramuscular injection
**Name:** Quadrivalent Influenza Vaccine (QIV)
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Pain at the injection site, redness, and swelling.
**Measure:** SSA - Percentage of Participants Reporting Local Reactions After Vaccination
**Time Frame:** From Day 1 Through at least Day 7 After Vaccination
**Description:** Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.
**Measure:** SSA - Percentage of Participants Reporting Systemic Events After Vaccination
**Time Frame:** From Day 1 Through at least Day 7 After Vaccination
**Description:** As elicited by investigational site staff
**Measure:** SSA - Percentage of Participants Reporting Adverse Events After Vaccination
**Time Frame:** From Day 1 Through 4 Weeks After Vaccination
**Description:** As elicited by investigational site staff
**Measure:** SSA - Percentage of Participants Reporting Serious Adverse Events (SAE)
**Time Frame:** From Day 1 Through 6 Months After Vaccination
**Description:** As elicited by investigational site staff
**Measure:** SSA - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
**Time Frame:** From Day 1 Through 6 Months After Vaccination
**Description:** As elicited by investigational site staff
**Measure:** SSA - Percentage of Participants Reporting Medically Attended AEs (MAEs)
**Time Frame:** From Day 1 Through 6 Months After Vaccination
**Description:** Pain at injection site, redness, and swelling.
**Measure:** SSB - Percentage of Participants Reporting Local Reactions After Vaccination
**Time Frame:** From Day 1 Through at least Day 7 After Vaccination
**Description:** Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.
**Measure:** SSB - Percentage of Participants Reporting Systemic Events After Vaccination
**Time Frame:** From Day 1 Through at least Day 7 After Vaccination
**Description:** As elicited by investigational site staff
**Measure:** SSB - Percentage of Participants Reporting Adverse Events After Vaccination
**Time Frame:** From Day 1 Through 4 Weeks After Vaccination
**Description:** As elicited by investigational site staff
**Measure:** SSB - Percentage of Participants Reporting Serious Adverse Events (SAE)
**Time Frame:** From Day 1 Through 6 Months After Vaccination
**Description:** As elicited by investigational site staff
**Measure:** SSB - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
**Time Frame:** From Day 1 Through 6 Months After Vaccination
**Description:** As elicited by investigational site staff
**Measure:** SSB - Percentage of Participants Reporting Medically Attended AEs (MAEs)
**Time Frame:** From Day 1 Through 6 Months After Vaccination
**Description:** Pain at the injection site, redness, and swelling.
**Measure:** SSC - Percentage of Participants Reporting Local Reactions After Vaccination
**Time Frame:** From Day 1 Through at least Day 7 After Vaccination
**Description:** Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.
**Measure:** SSC - Percentage of Participants Reporting Systemic Events After Vaccination
**Time Frame:** From Day 1 Through at least Day 7 After Vaccination
**Description:** As elicited by investigational site staff
**Measure:** SSC - Percentage of Participants Reporting Adverse Events After Vaccination
**Time Frame:** From Day 1 Through 4 Weeks After Vaccination
**Description:** As elicited by investigational site staff
**Measure:** SSC - Percentage of Participants Reporting Serious Adverse Events (SAE)
**Time Frame:** From Day 1 Through 6 Months After Vaccination
**Description:** As elicited by investigational site staff
**Measure:** SSC - Percentage of Participants Reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
**Time Frame:** From Day 1 Through 6 Months After Vaccination
**Description:** As elicited by investigational site staff
**Measure:** SSC - Percentage of Participants Reporting Medically Attended AEs (MAEs)
**Time Frame:** From Day 1 Through 6 Months After Vaccination
#### Secondary Outcomes
**Description:** As measured at the central laboratory
**Measure:** SSA - HAI Geometric Mean Titers (GMTs) for each strain
**Time Frame:** 4 Weeks After Vaccination
**Description:** As measured at the central laboratory
**Measure:** SSA - HAI geometric mean fold rise (GMFR) for each strain
**Time Frame:** 4 Weeks After Vaccination
**Description:** As measured at the central laboratory
**Measure:** SSA - The proportion of participants achieving HAI seroconversion for each strain
**Time Frame:** 4 Weeks After Vaccination
**Description:** As measured at the central laboratory
**Measure:** SSA - The proportion of participants with HAI titers ≥1:40 for each strain
**Time Frame:** Baseline and 4 Weeks After Vaccination
**Description:** As measured at the central laboratory
**Measure:** SSB - HAI geometric mean titers (GMTs) for each strain
**Time Frame:** 4 Weeks After Vaccination
**Description:** As measured at the central laboratory
**Measure:** SSB - HAI geometric mean fold rise (GMFR) for each strain
**Time Frame:** 4 Weeks After Vaccination
**Description:** As measured at the central laboratory
**Measure:** SSB - The proportion of participants achieving HAI seroconversion for each strain
**Time Frame:** 4 Weeks After Vaccination
**Description:** As measured at the central laboratory
**Measure:** SSB - The proportion of participants with HAI titers ≥1:40 for each strain
**Time Frame:** Baseline and 4 Weeks After Vaccination
### Eligibility Module
**Eligibility Criteria:** Key Inclusion Criteria
Applies to all 3 substudies:
* participants ≥18 years of age.
* generally healthy participants.
Substudy C ONLY:
- receipt of licensed influenza vaccination for the 2023-2024 flu season at least 6 months ago.
Key Exclusion Criteria
All 3 substudies:
* diagnosis of influenza (by clinical testing) in the last 6 months.
* immunocompromised individuals with known or suspected immunodeficiency
* receipt of any investigational or licensed influenza vaccines within 6 months.
**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:** Pfizer CT.gov Call Center
**Phone:** 1-800-718-1021
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Scottsdale
**Country:** United States
**Facility:** Headlands Research - Scottsdale
**State:** Arizona
**Status:** NOT_YET_RECRUITING
**Zip:** 85260
**Location 2:**
**City:** Anaheim
**Country:** United States
**Facility:** Anaheim Clinical Trials, LLC
**State:** California
**Status:** NOT_YET_RECRUITING
**Zip:** 92801
**Location 3:**
**City:** Lake Forest
**Country:** United States
**Facility:** Orange County Research Center
**State:** California
**Status:** NOT_YET_RECRUITING
**Zip:** 92630
**Location 4:**
**City:** San Diego
**Country:** United States
**Facility:** Artemis Institute for Clinical Research
**State:** California
**Status:** NOT_YET_RECRUITING
**Zip:** 92103
**Location 5:**
**City:** Walnut Creek
**Country:** United States
**Facility:** Diablo Clinical Research, Inc.
**State:** California
**Status:** NOT_YET_RECRUITING
**Zip:** 94598
**Location 6:**
**City:** Milford
**Country:** United States
**Facility:** Clinical Research Consulting
**State:** Connecticut
**Status:** NOT_YET_RECRUITING
**Zip:** 06460
**Location 7:**
**City:** Hialeah
**Country:** United States
**Facility:** Indago Research & Health Center, Inc
**State:** Florida
**Status:** RECRUITING
**Zip:** 33012
**Location 8:**
**City:** Hollywood
**Country:** United States
**Facility:** Research Centers of America ( Hollywood )
**State:** Florida
**Status:** NOT_YET_RECRUITING
**Zip:** 33024
**Location 9:**
**City:** Hollywood
**Country:** United States
**Facility:** Research Centers of America
**State:** Florida
**Status:** NOT_YET_RECRUITING
**Zip:** 33024
**Location 10:**
**City:** Miami Lakes
**Country:** United States
**Facility:** Palm Springs Community Health Center
**State:** Florida
**Status:** NOT_YET_RECRUITING
**Zip:** 33014
**Location 11:**
**City:** Orlando
**Country:** United States
**Facility:** Clinical Neuroscience Solutions, Inc.
**State:** Florida
**Status:** RECRUITING
**Zip:** 32801
**Location 12:**
**City:** Orlando
**Country:** United States
**Facility:** Headlands Research Orlando
**State:** Florida
**Status:** NOT_YET_RECRUITING
**Zip:** 32819
**Location 13:**
**City:** South Miami
**Country:** United States
**Facility:** Qps-Mra, Llc
**State:** Florida
**Status:** NOT_YET_RECRUITING
**Zip:** 33143
**Location 14:**
**City:** Honolulu
**Country:** United States
**Facility:** East-West Medical Research Institute
**State:** Hawaii
**Status:** NOT_YET_RECRUITING
**Zip:** 96814
**Location 15:**
**City:** New Orleans
**Country:** United States
**Facility:** Alliance for Multispecialty Research, LLC
**State:** Louisiana
**Status:** NOT_YET_RECRUITING
**Zip:** 70119
**Location 16:**
**City:** Saint Paul
**Country:** United States
**Facility:** Prism Research LLC dba Nucleus Network
**State:** Minnesota
**Status:** NOT_YET_RECRUITING
**Zip:** 55114
**Location 17:**
**City:** Chesterfield
**Country:** United States
**Facility:** Clinical Research Professionals
**State:** Missouri
**Status:** NOT_YET_RECRUITING
**Zip:** 63005
**Location 18:**
**City:** Kansas City
**Country:** United States
**Facility:** Alliance for Multispecialty Research, LLC
**State:** Missouri
**Status:** NOT_YET_RECRUITING
**Zip:** 64114
**Location 19:**
**City:** Rochester
**Country:** United States
**Facility:** Rochester Clinical Research, LLC
**State:** New York
**Status:** NOT_YET_RECRUITING
**Zip:** 14609
**Location 20:**
**City:** Durham
**Country:** United States
**Facility:** Duke Vaccine and Trials Unit
**State:** North Carolina
**Status:** NOT_YET_RECRUITING
**Zip:** 27703
**Location 21:**
**City:** Raleigh
**Country:** United States
**Facility:** M3 Wake Research, Inc.
**State:** North Carolina
**Status:** NOT_YET_RECRUITING
**Zip:** 27612
**Location 22:**
**City:** Philadelphia
**Country:** United States
**Facility:** DM Clinical Research - Philadelphia
**State:** Pennsylvania
**Status:** NOT_YET_RECRUITING
**Zip:** 19107
**Location 23:**
**City:** Brownsville
**Country:** United States
**Facility:** Headlands Horizons LLC
**State:** Texas
**Status:** NOT_YET_RECRUITING
**Zip:** 78526
**Location 24:**
**City:** Mesquite
**Country:** United States
**Facility:** SMS Clinical Research
**State:** Texas
**Status:** NOT_YET_RECRUITING
**Zip:** 75149
**Location 25:**
**City:** San Antonio
**Country:** United States
**Facility:** Clinical Trials of Texas, LLC
**State:** Texas
**Status:** NOT_YET_RECRUITING
**Zip:** 78229
**Location 26:**
**City:** Tomball
**Country:** United States
**Facility:** Dynamed Clinical Research, LP d/b/a DM Clinical Research
**State:** Texas
**Status:** NOT_YET_RECRUITING
**Zip:** 77375
**Location 27:**
**City:** Salt Lake City
**Country:** United States
**Facility:** J. Lewis Research, Inc. / Foothill Family Clinic
**State:** Utah
**Status:** RECRUITING
**Zip:** 84109
**Location 28:**
**City:** Salt Lake City
**Country:** United States
**Facility:** J. Lewis Research, Inc. / Foothill Family Clinic South
**State:** Utah
**Status:** RECRUITING
**Zip:** 84121
**Location 29:**
**City:** Charlottesville
**Country:** United States
**Facility:** Charlottesville Medical Research
**State:** Virginia
**Status:** RECRUITING
**Zip:** 22911
#### Overall Officials
**Official 1:**
**Affiliation:** Pfizer
**Name:** Pfizer CT.gov Call Center
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
**IPD Sharing:** YES
**URL:** https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
### References Module
#### See Also Links
**Label:** To obtain contact information for a study center near you, click here.
**URL:** https://pmiform.com/clinical-trial-info-request?StudyID=C4781013
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000009976
- Term: Orthomyxoviridae Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000014777
- Term: Virus 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: M10295
- Name: Influenza, Human
- Relevance: HIGH
- As Found: Influenza
- 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: M12902
- Name: Orthomyxoviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007251
- Term: Influenza, Human
### Intervention Browse Module - Ancestors
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17360
- Name: Vaccines
- Relevance: HIGH
- As Found: Other
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000014612
- Term: Vaccines
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436690
**Brief Title:** Optimizing Antibiotics Prescription: A Stepped-Wedge Randomized Trial
**Official Title:** Optimizing Antibiotics Prescription: A Stepped-Wedge Randomized Trial
#### Organization Study ID Info
**ID:** STUDY00025143
#### Organization
**Class:** OTHER
**Full Name:** Penn State University
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-04-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Penn State University
#### Responsible Party
**Investigator Affiliation:** Penn State University
**Investigator Full Name:** Yubraj Acharya, Ph.D.
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Interventions that are low-cost, do not add substantially to the physician workload, are consistent with good physician practices and WHO guidelines, and serve as a reminder on the risks of overprescribing antibiotics are critically needed. The overall goal of the proposed project is to test the effect of a behavioral intervention targeted to junior physicians-specifically, requiring them to specify the diagnosis in the prescription note and providing feedback-on their antibiotics prescription rate; examine the intervention's effects across gender and caste; and draw lessons for scaling up the intervention.
**Detailed Description:** Antimicrobial resistance (AMR) is one of the top ten threats to global health. Limited existing evidence from Nepal, the site for the proposed study, suggests that physicians "err on the side of caution" by prescribing antibiotics even for viral conditions, which contributes to AMR. Interventions that are low-cost, do not add substantially to the physician workload, are consistent with good physician practices and WHO guidelines, and serve as a reminder on the risks of overprescribing antibiotics are critically needed. The overall goal of the proposed project is to test the effect of a behavioral intervention targeted to junior physicians-specifically, requiring them to specify the diagnosis in the prescription note and providing feedback-on their antibiotics prescription rate; examine the intervention's effects across gender and caste; and draw lessons for scaling up the intervention.
The specific objectives are the following:
Objective 1. Assess the effect of a behavioral intervention targeted to junior physicians on antibiotics prescription rate, including by caste and gender of the patient. A stepped-wedge randomized control trial (RCT) will be conducted among 60 junior physicians in five hospitals (1 government, 2 private teaching, and 2 community) in Nepal. The intervention will be rolled out sequentially across the hospitals and data will be collected from patients (n=3,600) both before and after the intervention. The intervention will consist of three components: (a) a Refresher Training on AMR, (b) a Diagnosis Mandate, and (c) an Individualized Feedback.
Objective 2. Identify barriers to scaling up the intervention beyond the study's site and strategies for their mitigation. After preliminary analysis of the quantitative data, key informant interviews with national- and provincial- level health policy makers (n=5), and in-depth interviews with physicians (n=5) and hospital managers (n=5) will be conducted.
Objective 3. Assess the extent to which physicians prescribe antibiotics correctly. From a subset of patients (n=120, i.e., 2 per physician), more detailed medical information will be collected and analyzed from their outpatient booklet.
This registration is for objective 1. Therefore, only details pertaining to that objective will be provided here.
### Conditions Module
**Conditions:**
- Antimicrobial Resistance
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SEQUENTIAL
**Intervention Model Description:** This is a stepped-wedge randomized controlled trial
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The intervention will consist of three components: (a) a Refresher Training on antimicrobial resistance, (b) a Diagnosis Mandate, and (c) an Individualized Feedback.
**Intervention Names:**
- Behavioral: Diagnosis Mandate and Feedback
**Label:** Diagnosis Mandate and Feedback
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Diagnosis Mandate and Feedback
**Description:** The intervention consists of: a) a Refresher Training on AMR, (b) a Diagnosis Mandate, and (c) an Individualized Feedback.
**Name:** Diagnosis Mandate and Feedback
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The number of patient visits in which antibiotics are prescribed by the total number of visits
**Measure:** Antibiotics prescription rate
**Time Frame:** 1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.
#### Secondary Outcomes
**Description:** The number of patient visits in which antibiotics are prescribed by the total number of visits, by male and female
**Measure:** Differences in prescription rates by patient's gender
**Time Frame:** 1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.
**Description:** The number of patient visits in which antibiotics are prescribed by the total number of visits, by advantaged and disadvantaged status
**Measure:** Differences in prescription rates by patient's ethnicity (advantaged versus disadvantaged)
**Time Frame:** 1-3 months before the intervention and 3-5 months after the intervention, depending on the timing of the intervention which varies by hospital.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
For physicians: 1) Age 18+, 2) working at an outpatient clinic in one of the participating hospitals.
For patients: 1) Age 18+, 2) Having sought care at one of the outpatient clinics in the participating hospitals.
Exclusion Criteria:
For physicians: \<18 years of age, For patients: \<18 years of age or falling into one of the vulnerable populations (pregnant women, cognitively impaired adults)
**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:** Yubraj Acharya, Ph.D.
**Phone:** 7347573571
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### 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: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4224
- Name: Antibiotics, Antitubercular
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436677
**Acronym:** AMITY
**Brief Title:** A Study of Molecular Subtyping-based Therapeutic Strategies for Cutaneous T-cell Lymphoma
**Official Title:** A Study of Molecular Subtyping-based Therapeutic Strategies for Cutaneous T-cell Lymphoma
#### Organization Study ID Info
**ID:** PKU2024162-002
#### Organization
**Class:** OTHER
**Full Name:** Peking University First Hospital
#### Secondary ID Infos
**Domain:** Capital's Funds for Health Improvement and Research
**ID:** SF2024-1-4074
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2030-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-09
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Peking University Third Hospital
**Class:** OTHER
**Name:** Peking University Cancer Hospital & Institute
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking University First Hospital
#### Responsible Party
**Investigator Affiliation:** Peking University First Hospital
**Investigator Full Name:** Yang WANG
**Investigator Title:** The Chief of Department of Dermatology and Venereology
**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:** Cutaneous T-cell lymphoma (CTCL) is a group of diseases resulting from clonal hyperplasia of memory T cells in the skin. The increasing incidence and high treatment costs have posed significant challenges to public health and the economy. Current treatment guidelines only provide partial control, leading to varying remission times and recurrence rates. This study aims to use molecular subtyping and immunohistochemistry to guide treatment selection for CTCL patients, aiming to prolong clinical benefit, improve treatment safety, and reduce economic burden.
**Detailed Description:** The study focuses on the impact of treatment strategy selection based on molecular typing for patients with cutaneous T-cell lymphoma. The study aims to evaluate the effect on clinical benefit time and long-term prognosis, assess the safety of the treatment strategy, and explore the interaction between baseline factors and treatment regimens. This research could potentially provide valuable evidence for precision treatment in the context of cutaneous T-cell lymphoma.
### Conditions Module
**Conditions:**
- Cutaneous T-Cell Lymphoma/Mycosis Fungoides
- Cutaneous T Cell Lymphoma
**Keywords:**
- cutaneous T-cell lymphoma
- mycosis fungoides
- Sezary syndrome
### Design Module
#### Bio Spec
**Description:** Formalin fixed and paraffin embedded skin biopsy tissue
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 2 Years
### Arms Interventions Module
#### Arm Group 1
**Description:** The group included patients with confirmed cutaneous T-cell lymphoma (CTCL) based on clinical features and histopathology from three research units: Peking University First Hospital, Peking University Third Hospital, and Beijing Institute of Cancer Prevention and Treatment. According to the immunohistochemistry algorithm established previously, the formalin-fixed and paraffin-embedded skin lesions of the patients will be stained. Patients will be assigned to different molecular subtypes, and the treatment strategy will be selected based on the classification.
**Intervention Names:**
- Other: molecular subtype based treatment
**Label:** Prospective study group
#### Arm Group 2
**Description:** The control group included patients with complete baseline information and previous follow-up data in the TACTICAL database, established by Peking University First Hospital in 2009 for cutaneous lymphoma cases.
**Label:** Retrospective control group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Prospective study group
**Description:** The immunohistochemistry algorithm established by the previous research group was used to determine the molecular subtype, and the corresponding treatment plan was selected according to the subtype. Such as for TCyEM patients, interferon-based immunomodulatory therapy was selected, and TCM-type patients were treated with retinoids.
**Name:** molecular subtype based treatment
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** Adverse events and adverse effects: The Preferred Term (PT) for adverse events and the Systemic Organ Classification (SOC) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). For the statistics of adverse event rates, each patient will be counted at most once per SOC and per PT. For the same adverse event that occurs multiple times in the same patient, the severity will be counted according to the severity of multiple occurrences. All adverse events (pre- and intra-treatment adverse events) are included in the list of adverse events
**Measure:** adverse events and adverse effects
**Time Frame:** From enrollment to the end of treatment at 2 years
#### Primary Outcomes
**Description:** The time to treatment failure (TTNT) is defined as the duration from the start of treatment to when the treatment is switched to the next systemic therapy or until the patient passes away. Introducing new skin-directed therapy (SDT) alongside topical therapy doesn't indicate treatment failure unless the systemic treatment is changed. If the skin lesion worsens and needs local radiotherapy, it's considered that the systemic therapy has failed. The date of discontinuation of systemic therapy is used when treatment is stopped due to disease progression without further treatment.
**Measure:** time to next treatment (TTNT)
**Time Frame:** From enrollment to the end of treatment at 2 years
#### Secondary Outcomes
**Description:** The objective response rate (ORR) is defined as the proportion of patients with complete response (CR) and partial response (PR) as per the Primary cutaneous lymphoma: recommendations for clinical trial design and staging update from the ISCL, USCLC, and EORTC (2022). The first CR or PR is achieved and repeated after 4 weeks for confirmation.
**Measure:** objective response rate (ORR)
**Time Frame:** From enrollment to the end of treatment at 2 years
**Description:** Time to response (TTR) is defined as the duration from the start of treatment to the first meeting of CR or PR criteria.
**Measure:** time to response (TTR)
**Time Frame:** From enrollment to the end of treatment at 2 years
**Description:** The progression-free survival (PFS) is defined as the period from the beginning of treatment until the first instance of disease progression or death from any cause. Disease progression is defined as advancement to a higher TNMB stage (excluding changes from T1a or T2a to T1b or T2b) or death due to the disease.
**Measure:** progression-free survival (PFS)
**Time Frame:** From enrollment to the end of treatment at 2 years
**Description:** The overall survival (OS) is defined as the period from the beginning of treatment to the point of death from any cause.
**Measure:** overall survival (OS)
**Time Frame:** From enrollment to the end of treatment at 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Signed informed consent;
* Patients with CTCL who do not respond well to targeted skin therapy (topical corticosteroids, nitrogen mustard, or phototherapy) in the early stage (stage I-IIA) and advanced stage (stage IIB-IV);
* Age 18-75 years;
* Expected survival time greater than 3 months (follow-up for the historical control group was greater than 3 months);
Exclusion Criteria:
* Received other anti-tumor therapy other than skin-targeted therapy (phototherapy, topical hormones or nitrogen mustard) within the past 1 month prior to enrollment;
* Patients with 2 or more types of primary cutaneous T-cell lymphoma at the same time;
* Combined with other malignant tumors, still receiving anti-tumor therapy;
* Has any other active disease that may increase the risk of protocol therapy or impair the patient\&amp;#39;s ability to receive protocol therapy, including but not limited to:
* Comorbid epilepsy;
* Comorbid autoimmune diseases;
* Combined with hepatic decompensation;
* Patients with renal insufficiency and creatinine clearance \&amp;lt; 50ml/min;
* Have an uncontrollable medical condition, including but not limited to:
* Ongoing or active infection;
* Clinically significant healing or non-healing wounds;
* Symptomatic congestive heart failure, unstable angina, clinically significant arrhythmias;
* Significant lung disease (e.g., shortness of breath at rest or light activity, or need for supplemental oxygen for any reason);
* Diseases/conditions that affect study compliance, such as infectious diseases or psychiatric illnesses/social situations, that are uncontrollable;
* Pregnant (or intending to become pregnant within 2 years) or lactating females;
* Concomitant participation in interventional clinical trials of other clinical trial drugs, except for questionnaire surveys or observational studies;
* Any situation in which the programme is not in compliance;
* Other conditions that in the opinion of the investigator are not suitable for participation in this study.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** In this study, retrospective controls were selected from patients with complete baseline information and previous follow-up information in the cutaneous lymphoma case registry system (TACTICAL database) established in 2009. The prospective study group was a prospective enrollment of patients who met the inclusion criteria, and the immunohistochemistry algorithm established by the previous research group was used to determine the molecular subtype. The corresponding treatment regimen was selected according to the subtype. Follow-up was conducted according to the study design and updated by the ISCL, USCLC, and EORTC (2022) as they evaluate treatment response in patients. The primary outcome was time to clinical benefit (TTNT) of first-line therapy, defined as the time from treatment.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yang Wang, MD
**Phone:** 86-10-83572350
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** YANG ZHANG, MD
- **Phone:** 86-10-83572350
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** ZHUOJING CHEN, MD
- **Phone:** 86+01083572350
- **Role:** CONTACT
***Contact 3:***
- **Name:** YANG WANG, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** ZHUOJING CHEN, MD
- **Role:** SUB_INVESTIGATOR
**Country:** China
**Facility:** Peking University First Hospital
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100034
**Location 2:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** WENQING LI, MD
- **Role:** CONTACT
**Country:** China
**Facility:** Beijing Cancer Hospital
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100142
**Location 3:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** CHUNLEI ZHANG, MD
- **Role:** CONTACT
**Country:** China
**Facility:** Peking University Third Hospital
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100191
#### Overall Officials
**Official 1:**
**Affiliation:** Peking University First Hospital
**Name:** YANG WANG, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** IPD will only be shared within the participating medical units in the study, including study protocol, informed consent form, clinical study report and statistical analysis plan. Any other institutes requesting for IPD needs to be reviewed by the National Clinical Center for Skin and Immune Diseases in China.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Olsen EA, Whittaker S, Willemze R, Pinter-Brown L, Foss F, Geskin L, Schwartz L, Horwitz S, Guitart J, Zic J, Kim YH, Wood GS, Duvic M, Ai W, Girardi M, Gru A, Guenova E, Hodak E, Hoppe R, Kempf W, Kim E, Lechowicz MJ, Ortiz-Romero P, Papadavid E, Quaglino P, Pittelkow M, Prince HM, Sanches JA, Sugaya M, Vermeer M, Zain J, Knobler R, Stadler R, Bagot M, Scarisbrick J. Primary cutaneous lymphoma: recommendations for clinical trial design and staging update from the ISCL, USCLC, and EORTC. Blood. 2022 Aug 4;140(5):419-437. doi: 10.1182/blood.2021012057.
**PMID:** 34758074
**Citation:** Chen Z, Lin Y, Qin Y, Qu H, Zhang Q, Li Y, Wen Y, Sun J, Tu P, Gao P, Wang Y. Prognostic Factors and Survival Outcomes Among Patients With Mycosis Fungoides in China: A 12-Year Review. JAMA Dermatol. 2023 Oct 1;159(10):1059-1067. doi: 10.1001/jamadermatol.2023.2634.
**PMID:** 37585188
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
- ID: D000008228
- Term: Lymphoma, Non-Hodgkin
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000007239
- Term: Infections
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC01
- Name: Infections
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M11220
- Name: Lymphoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: M12136
- Name: Mycoses
- Relevance: HIGH
- As Found: Mycosis
- ID: M18829
- Name: Lymphoma, T-Cell
- Relevance: HIGH
- As Found: T-cell Lymphoma
- ID: M18833
- Name: Lymphoma, T-Cell, Peripheral
- Relevance: HIGH
- As Found: T-cell Lymphoma
- ID: M12137
- Name: Mycosis Fungoides
- Relevance: HIGH
- As Found: Mycosis Fungoides
- ID: M18832
- Name: Lymphoma, T-Cell, Cutaneous
- Relevance: HIGH
- As Found: Cutaneous T-Cell Lymphoma
- ID: M15560
- Name: Sezary Syndrome
- Relevance: LOW
- As Found: Unknown
- 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: M4722
- Name: Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: T3543
- Name: Lymphosarcoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: T4496
- Name: Peripheral T-cell Lymphoma
- Relevance: HIGH
- As Found: T-cell Lymphoma
- ID: T3986
- Name: Mycosis Fungoides
- Relevance: HIGH
- As Found: Mycosis Fungoides
- ID: T1689
- Name: Cutaneous T-cell Lymphoma
- Relevance: HIGH
- As Found: Cutaneous T-Cell Lymphoma
- ID: T5200
- Name: Sezary Syndrome
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009181
- Term: Mycoses
- ID: D000008223
- Term: Lymphoma
- ID: D000016399
- Term: Lymphoma, T-Cell
- ID: D000016411
- Term: Lymphoma, T-Cell, Peripheral
- ID: D000009182
- Term: Mycosis Fungoides
- ID: D000016410
- Term: Lymphoma, T-Cell, Cutaneous
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10407
- Name: Interferons
- Relevance: LOW
- As Found: Unknown
- ID: M8681
- Name: Formaldehyde
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436664
**Brief Title:** The Effects of Different Tooth Brushing Explanations in Fixed Orthodontic Treatment
**Official Title:** Evaluation of the Effects of Different Tooth Brushing Explanations on Oral Hygiene in Patients With Fixed Orthodontic Treatment
#### Organization Study ID Info
**ID:** 2024/01-04
#### Organization
**Class:** OTHER
**Full Name:** Yuzuncu Yıl University
### Status Module
#### Completion Date
**Date:** 2024-07-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-03-04
**Type:** ACTUAL
#### Start Date
**Date:** 2024-02-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Yuzuncu Yıl University
#### Responsible Party
**Investigator Affiliation:** Yuzuncu Yıl University
**Investigator Full Name:** Yasemin Tunca
**Investigator Title:** PhD, DDS, 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 aim of this study is to investigate the effects of tooth brushing training methods on orthodontic patients and to determine the most effective oral hygiene methods for individuals receiving orthodontic treatment.
**Detailed Description:** Because orthodontic appliances cause food retention, a good level of oral hygiene is needed to maintain dental health. Inadequate tooth brushing can lead to gingival diseases on periodontal tissue, cavities and white lesions on tooth enamel. Antimicrobial agents and fluoride products are useful but it cannot replace the mechanical removal of plaque. Because the mechanical plaque control is still considered the most important oral hygiene tool during orthodontic treatment.
In the literature, it has been reported that the motivation to maintain oral hygiene during the orthodontic fixed treatment phase has a very positive effect on periodontal health, and in the same studies, plaque index scores increased over time in control groups that were not given repeated oral treatment. If patients are not given repeated and regular oral hygiene motivation in every session in the clinical routine, gum health may deteriorate. More invasive methods may be required to correct this condition. Because poor oral hygiene, if left unchecked, can compromise the outcome of orthodontic treatment.
When performing manual tooth brushing, the modified Bass technique (MBT) is often recommended to provide optimum plaque reduction by protecting oral tissues from mechanical irritation. The problem with this brushing technique is that it consists of a complex sequence of movements. First of all, the toothbrush should be positioned at a 45° angle to the gingival edge. Secondly, the brush should be moved back and forth with small horizontal vibrations. Thirdly, debris must be removed by sweeping the brush towards the occlusal face in a vertical motion (upward in the lower jaw, downwards in the upper jaw). This sequence of movements requires dexterity and attention to technique. Brushing demonstration techniques or sequences have been developed through a brochure, a model, or video.
### Conditions Module
**Conditions:**
- Orthodontic Treatment
- Dental Plaque Induced Gingival Disease
**Keywords:**
- tooth brushing
- fixed orthodontic treatment
- microbial dental plaque
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 80
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In patients receiving fixed orthodontic treatment, the orthodontic plaque index, Turesky modified index and gingival index will be recorded at the beginning, 1st and 3rd months. No special instructions will be given to these patients regarding the tooth brushing process.
**Intervention Names:**
- Other: Tooth brushing
**Label:** Control group
**Type:** OTHER
#### Arm Group 2
**Description:** Patients will receive a standard brochure and oral presentation on tooth brushing in the Group 1. The orthodontic plaque index, Turesky modified index and gingival index will be recorded at the beginning, 1st and 3rd months. These patients will receive a standardized brochure for tooth brushing.
**Intervention Names:**
- Other: Tooth brushing
**Label:** Group 1
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Patients will receive a standard tooth brushing on a dental model in the Group 2. The orthodontic plaque index, Turesky modified index and gingival index will be recorded at the beginning, 1st and 3rd months.
**Intervention Names:**
- Other: Tooth brushing
**Label:** Group 2
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** In patients undergoing fixed orthodontic treatment, the orthodontic plaque index, Turesky modified index and gingival index will be recorded at the beginning, 1st and 3rd months. Patients will be taught standard tooth brushing with a video in Group 3.
**Intervention Names:**
- Other: Tooth brushing
**Label:** Group 3
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control group
- Group 1
- Group 2
- Group 3
**Description:** Firstly, the toothbrush must be positioned at a 45° angle to the gingival margin. Secondly, the brush should be moved back and forth in small horizontal jerks. Thirdly, with a vertical movement, the brush should be moved in the occlusal direction, i.e. upwards in the lower jaw and downwards in the upper jaw to remove debris.
**Name:** Tooth brushing
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Turesky modified index, plaque on the buccal and lingual surfaces of all teeth. TMQHI scores were recorded as follows:
0, no dental plaque present,
1. isolated areas of dental plaque,
2. A thin dental plaque tape of ≤1 mm,
3. dental plaque covered up to 1/3 of the tooth surface,
4. dental plaque covered between 1/3 and 2/3 of the tooth surface,
5. dental plaque covers ≥2/3 of the tooth surface.
**Measure:** The Turesky modified index
**Time Frame:** Baseline, 1st month, 3rd month
**Description:** Score 0: No plaque accumulation Score 1: There is plaque accumulation covering one side of the bracket base Score 2: There is plaque accumulation covering two sides of the bracket base Score 3: There is plaque accumulation covering three sides of the bracket base Score 4: There is plaque accumulation covering all four sides of the bracket base. and/or the presence of gingival inflammation
**Measure:** Orthodontic plaque index
**Time Frame:** Baseline, 1st month, 3rd month
#### Secondary Outcomes
**Description:** Score 0: Healthy gingiva, Score 1: Gingival characterised by mild inflammation, mild discolouration, mild oedema, no bleeding on probing, Score 2: Moderate inflammation, gingiva shiny, red and oedematous. There is bleeding on probing, Score 3: Severe inflammation, marked redness and oedema. There is a tendency to spontaneous bleeding.
**Measure:** Gingival Index
**Time Frame:** Baseline, 1st month, 3rd month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The patient with orthodontic attachments at least 4 months
* with permanent dentition
Exclusion Criteria:
* impacted or atypically erupted teeth
* with prosthetic restorations such as crowns or implants
* open bite
* deep bite
* crowding more than 7 mm or polydiastema cases
* Individuals diagnosed with periodontitis
* ndividuals with cleft lip and palate or other craniofacial anomalies
**Healthy Volunteers:** True
**Maximum Age:** 20 Years
**Minimum Age:** 14 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Van
**Country:** Turkey
**Facility:** Yasemin TUNCA
**Zip:** 65080
#### Overall Officials
**Official 1:**
**Affiliation:** Van Yuzuncu Yil University
**Name:** Yasemin TUNCA, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Van Yuzuncu Yil University
**Name:** Dicle ALTINDAL, DDS
**Role:** STUDY_DIRECTOR
**Official 3:**
**Affiliation:** Van Yuzuncu Yil University
**Name:** Nihal FAHRZADEH, DDS
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Cozzani M, Ragazzini G, Delucchi A, Mutinelli S, Barreca C, Rinchuse DJ, Servetto R, Piras V. Oral hygiene compliance in orthodontic patients: a randomized controlled study on the effects of a post-treatment communication. Prog Orthod. 2016 Dec;17(1):41. doi: 10.1186/s40510-016-0154-9. Epub 2016 Dec 19.
**PMID:** 27891568
**Citation:** Renton-Harper P, Addy M, Newcombe RG. Video instruction to establish a panel of experts to compare tooth cleaning by 4 electric toothbrushes. J Clin Periodontol. 2001 Oct;28(10):917-22. doi: 10.1034/j.1600-051x.2001.028010917.x.
**PMID:** 11686809
**Citation:** Diamanti-Kipioti A, Gusberti FA, Lang NP. Clinical and microbiological effects of fixed orthodontic appliances. J Clin Periodontol. 1987 Jul;14(6):326-33. doi: 10.1111/j.1600-051x.1987.tb00979.x. Erratum In: J Clin Periodontol 1990 Jan;17(1):66.
**PMID:** 3509967
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003741
- Term: Dental Deposits
- ID: D000014076
- Term: Tooth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6970
- Name: Dental Plaque
- Relevance: HIGH
- As Found: Dental Plaque
- ID: M8994
- Name: Gingival Diseases
- Relevance: HIGH
- As Found: Gingival Diseases
- ID: M6938
- Name: Dental Deposits
- Relevance: LOW
- As Found: Unknown
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13419
- Name: Periodontal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003773
- Term: Dental Plaque
- ID: D000005882
- Term: Gingival Diseases
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21989
- Name: Salicylic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436651
**Brief Title:** Digital Storytelling in Symptom Management Pediatric Oncology
**Official Title:** Evaluation of the Effectiveness of Digital Storytelling Method in Symptom Method in Children With Oncological Problems
#### Organization Study ID Info
**ID:** E.795978
#### Organization
**Class:** OTHER
**Full Name:** Kocaeli University
### Status Module
#### Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-11-13
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-29
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Gazi University
#### Lead Sponsor
**Class:** OTHER
**Name:** Kocaeli University
#### Responsible Party
**Investigator Affiliation:** Kocaeli University
**Investigator Full Name:** Birgul Erdogan
**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:** The aim of this clinical study is to evaluate the effectiveness of the digital storytelling method in symptom management in children diagnosed with oncology. It will also provide information about children's experiences with Digital Storytelling and the use of the method. The main questions it aims to answer are:
* Is there a difference between the anxiety scores of children who applied the Digital Storytelling Method and those who did not?
* Is there a difference between the fatigue scores of children who applied the Digital Storytelling Method and those who did not?
* Is there a difference between the nausea scores of children who applied the Digital Storytelling Method and those who did not?
* Is there a difference between the pain scores of children who applied and did not apply the Digital Storytelling Method?
Participants:
Complete the first stage data forms. Visit the clinic every 7-15 days for the digital storytelling process, which consists of 4 stages. After the storytelling process is completed, have a process evaluation meeting with the researcher.
**Detailed Description:** Participants; Enterprise Group,
1. Interview (Week 1); Meeting the child, conducting a qualitative interview for needs analysis and introducing the forms
2. Interview (Week 2); Finding a digital story topic
3. Interview (Week 3); Writing a story on the specified topic
4. Interview (Week 4); Converting the story into digital form
5. Interview (Week 5); Showing the created story
6. Interview (Week 6); Conducting a qualitative interview regarding the digital storytelling process.
Each meeting will be held in 1-week periods. Primary outcome tools will be applied as pretest and posttest once in the 1st and 6th interviews, and twice in the other interviews.
Control Group;
1. Interview (Week 1); Meeting the child, introducing and applying the forms
2. Interview (Week 6); Conducting a qualitative interview regarding the digital storytelling process. Showing the videos prepared by the children in the initiative group. Application of primary outcome tools.
### Conditions Module
**Conditions:**
- Child, Only
- Cancer
- Symptoms and Signs
- Narration
**Keywords:**
- child
- cancer
- nursing
- symptom management
- digital storytelling
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Children's group where digital storytelling method was applied and stories were created
**Intervention Names:**
- Other: Digital Storytelling
**Label:** Experimental group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Children's group where the stories of children in the initiative group will be watched
**Intervention Names:**
- Other: Digital Storytelling
**Label:** Control group
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control group
- Experimental group
**Description:** 4 stages of digital storytelling will be implemented.
**Name:** Digital Storytelling
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** It will be used to evaluate children's state anxiety.
**Measure:** State-Trait Anxiety Inventory for Children
**Time Frame:** It will be used in the 1st and 6th interviews with the child (1st week-6th week).
**Description:** It is a single-item scale used to determine the intensity of fatigue in patients. The patient is asked to score his or her fatigue on a scale of 0-10. 0 means no fatigue, while 10 is considered a lot of fatigue.
**Measure:** Visual Analogue Scale for Fatigue
**Time Frame:** It will be applied in all interviews with the child (6 interviews), before and after the interview. It will be applied 12 times in 6 weeks.
**Description:** The scale is applied to children/adolescents in the 7-18 age group. There are a total of six items in the scale, ranging from no force to vomiting, and six facial expressions indicating each item. While the scale can be used by asking the child to choose the face that best suits him/her, the cartoon can also be shown and evaluated through observation. The average application time of the scale is 2 minutes and scores are given between 0-10. Using 0 as 'no nausea' and 10 as 'vomiting'
**Measure:** The Baxter Retching Faces Scale
**Time Frame:** It will be applied in all interviews with the child (6 interviews), before and after the interview. It will be applied 12 times in 6 weeks.
**Description:** This scale is used to diagnose pain in children aged 3-18. This scale has six faces representing increasing pain intensity from zero to five from left to right. The far left face has a smiling expression, indicating a pain-free state, while the far right face has a crying expression, corresponding to the most severe pain. Six facial expressions are scored from left to right on a scale of 0 to 10 points (0 points = very happy/no pain, 10 points = most severe pain). As the score from the scale increases, pain tolerance decreases, and as the score decreases, tolerance increases. The child is told to choose the face that best expresses his or her emotions.
**Measure:** Wong-Baker FACES pain rating scale (WB-FACES)
**Time Frame:** It will be applied in all interviews with the child (6 interviews), before and after the interview. It will be applied 12 times in 6 weeks.
#### Secondary Outcomes
**Description:** The screening tool includes 15 symptoms that evaluate the symptoms children have experienced in the last two days. Each symptom is evaluated with a 5-point Likert-type scoring system, and the score range varies between 0-60. Higher scores indicate that the number of symptoms and the discomfort they cause increase.
**Measure:** SSPedi: Symptom Screening Scale in Pediatric Patients
**Time Frame:** It will be used in the 1st and 6th interviews with the child (1st week-6th week).
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 7-18 years old,
* Having received at least 1 cure of treatment,
* Completed the induction phase and is in the consolidation phase,
* Children who and their parents agree to participate in the study.
Exclusion Criteria:
* who cannot speak Turkish,
* Having a secondary chronic disease
* Having a second disease that will affect the cognitive process,
* Children/adolescents who cannot complete the 4 stages of the digital storytelling process.
* Children/adolescents who cannot complete the 4 stages of the digital storytelling process.
* Children/adolescents who take a break of more than 3 weeks between storytelling processes.
**Maximum Age:** 18 Years
**Minimum Age:** 7 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kocaeli
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Birgül Erdoğan, Msc
- **Phone:** 0262 303 47 33
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Kocaeli Universıty
**State:** İzmit
**Status:** RECRUITING
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436638
**Brief Title:** Comparison of Nasal Continuous Positive Airway Pressure (CPAP) Mask and Nasal Airway in Molar Tooth Extraction Under Deep Sedation
**Official Title:** Comparison of Nasal Continuous Positive Airway Pressure (CPAP) Mask and Nasal Airway in Terms of Intraoperative Anesthesia Quality and Postoperative Associated Complications in Impacted Molar Tooth Extraction Patients Under Deep Sedation; A Multi-Center Study
#### Organization Study ID Info
**ID:** KU-ERKAN-001
#### Organization
**Class:** OTHER
**Full Name:** Kırıkkale University
### Status Module
#### Completion Date
**Date:** 2025-06-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-04-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-03
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** TC Erciyes University
**Class:** OTHER
**Name:** Kırıkkale University
#### Lead Sponsor
**Class:** OTHER
**Name:** Gözde Nur Erkan
#### Responsible Party
**Investigator Affiliation:** Kırıkkale University
**Investigator Full Name:** Gözde Nur Erkan
**Investigator Title:** Assistant Professor Doctor, Medical Doctor
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In patients with high levels of fear and anxiety, it is recommended to perform dental procedures under sedation or general anesthesia depending on the nature of the procedure. In dental treatment under anesthesia, it is important that the procedure is comfortable and well tolerated by the patient. In addition, patient comfort is important in all dental procedures to prevent the development of avoidance behavior.
During dental procedures performed under anesthesia, the oral cavity is completely within the scope of the surgical or procedure field. In this respect, sedation and general anesthesia in dental procedures and operations have specific risks and challenges.Since there is a risk of respiratory depression, hypoxia and hypercarbia during deep sedation, non-invasive ventilation support provided to patients with airway devices would be beneficial. In the research clinics where the study will be conducted, deep sedation with non-invasive mechanical ventilation support using a nasal CPAP (Continuous Positive Airway Pressure) mask or nasal airway is applied during the extraction of impacted molars. Thus, many dental procedures are routinely performed under deep sedation without the need for general anesthesia. There are very limited data in the literature on the use of a nasal CPAP mask during sedation for different procedures in patients with obstructive sleep apnea or obesity. However, no study comparing ventilation support during deep sedation with nasal CPAP mask and nasal airway has been found in the literature.
The aim of this study is to compare the non-invasive ventilation support provided with 2 different airway devices during the procedure in terms of intraoperative and postoperative related complications, ventilation parameters, patient and surgeon satisfaction.
The hypothesis of the study is that two different ventilation support methods during deep sedation may be superior to each other in terms of anesthesia quality, postoperative complications related to airway devices, patient and surgeon satisfaction.
In the study, a total of 60 patients (Group airway, n;30, Group Mask, n;30) from 2 centers are planned to be included in the study by performing power analysis with a statistical power of the trial \>0.8.
The permutation method will be applied within the scope of the restricted randomization method to determine the group of patients to be included.
**Detailed Description:** In the study to be conducted in two dental faculties, it is planned to use a total of 60 patient data, 30 patients with nasal CPAP mask and 30 patients with nasal airway. In the centers where the study will be conducted, deep sedation during dental procedures with ventilatory support via nasal airway and nasal CPAP mask, which will be compared in the study, is applied in routine practice. In this context, anxiolysis with 2 mg IV midazolam is administered to the patients before they are taken to the operating room on the day of the procedure. Patients are administered 1.5 mg/kg propofol and 0.5 mcg/kg fentanyl intravenously for sedation induction. Non-invasive ventilation support is then applied with a nasal airway or nasal CPAP mask and ventilation parameters are screened. Sevoflurane at 1 MAC (minimum alveolar concentration) level is administered inhalationally for sedation maintenance and the level of sedation is evaluated using the Ramsey sedation scale. Surgical dental extraction procedures between 20-60 minutes will be included in the study. For postoperative analgesia, paracetamol 1 g and dexketoprofen trometamol 50 mg are administered intravenously. The data planned to be collected within the scope of the study are blood pressure, heart rate, peripheral oxygen saturation (number of desaturation episodes), respiratory rate, ventilation parameters (Tidal volume (TV); set and actual, minute volume , end tidal CO2-EtCO2, and Peak pressure (Peak P). The total dose of agents used for sedation will also be recorded. During the post-operative follow-up period, the presence of nausea-vomiting, nasal pain, dryness in the nasal mucosa, epistaxis, sore throat, and dryness in the throat will be evaluated. Patient and surgeon satisfaction scores will be recorded.
### Conditions Module
**Conditions:**
- Deep Sedation
- Non-invasive Ventilation Support
- Nasal Airway
- Nasal CPAP Mask
- Impacted Molar
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Group to receive non-invasive ventilation support via nasal airway during dental extraction under deep sedation.
**Intervention Names:**
- Device: Non-invasive ventilation support equipment
**Label:** Group Airway
#### Arm Group 2
**Description:** Group to receive non-invasive ventilation support via nasal CPAP mask during dental extraction under deep sedation
**Intervention Names:**
- Device: Non-invasive ventilation support equipment
**Label:** Group Mask
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group Airway
- Group Mask
**Description:** Non-invasive ventilation support is provided by nasal airway and nasal CPAP mask to avoid respiratory complications such as hypoxia, desaturation, hypercarbia, respiratory depression etc. during extraction of impacted molars under deep sedation.
**Name:** Non-invasive ventilation support equipment
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** It is planned to record non-invasive blood pressure values of the patients at regular intervals during the operation, recovery unit and inpatient ward follow-up. Changes in blood pressure above 20% from baseline will be recorded additionally.
**Measure:** Non-invasive blood pressure
**Time Frame:** Intraoperative period and for 4 hours after surgery
**Description:** It is planned to record heart rate values of the patients at regular intervals during the operation, recovery unit and inpatient ward follow-up. Changes in heart rate greater than 20% of baseline will be recorded additionally.
**Measure:** ECG
**Time Frame:** Intraoperative period and for 4 hours after surgery
**Description:** It is planned to record peripheral oxygen saturation values of the patients at regular intervals during the operation, recovery unit and inpatient ward follow-up. Hypoxia (SpO2\<90%) will be recorded additionally.
**Measure:** Peripheral oxygen saturation
**Time Frame:** Intraoperative period and for 4 hours after surgery
**Description:** It is planned to record respiratory rate values of the patients at regular intervals during the operation, recovery unit and inpatient ward follow-up. Respiratory depression will be recorded additionally.
**Measure:** Respiratory rate
**Time Frame:** Intraoperative period and for 4 hours after surgery
**Description:** Number of episodes during deep sedation when the procedure has to be interrupted due to desaturation or patient movement will be recorded
**Measure:** Number of interruptions for an anesthesia-related reason
**Time Frame:** Intraoperative period
**Description:** During non-invasive ventilatory support, set and actual tidal volume values will be recorded at regular intervals during the operation.
**Measure:** Tidal volume
**Time Frame:** Intraoperative period
**Description:** During non-invasive ventilatory support, peak pressure values will be recorded at regular intervals during the operation.
**Measure:** Peak pressure
**Time Frame:** Intraoperative period
**Description:** During non-invasive ventilatory support, end tidal carbon dioxide values will be recorded at regular intervals during the operation.
**Measure:** End tidal carbon dioxide level (EtCO2)
**Time Frame:** Intraoperative period
**Description:** During non-invasive ventilatory support, minute ventilation values will be recorded.
**Measure:** Minute ventilation
**Time Frame:** Intraoperative period
#### Secondary Outcomes
**Description:** During the recovery unit and inpatient ward follow-up, patients will be monitored for the presence of nausea/vomiting, pain and/or itching/dryness in the nose and/or throat. A 10-point Likert scale would be used for nausea and vomiting assessment (0 points: No nausea, 1-2 points: Very mild nausea, 3-4 points: Mild nausea, 5-6 points: Moderate nausea, 7-8 points: Severe nausea and 9-10 points: worst nausea). For pain, a 10-point visual analog scale would be used. Additionally, the development of epistaxis will be recorded.
**Measure:** Postoperative complications related non-invasive ventilation support devices and sedation
**Time Frame:** During the next 3 hours after the end of the operation
**Description:** Using a 5-point Likert scale, the satisfaction level of the patients and the surgeon will be questioned and recorded. In the Likert scale, 5 indicates the highest level of satisfaction and 1 indicates the lowest level of satisfaction.
**Measure:** Patient and surgeon satisfaction
**Time Frame:** Perioperative period
**Description:** The total dose of anesthetic medications required to provide a depth of sedation with a Ramsey sedation score of 5 or higher during the surgical procedure will be recorded
**Measure:** Total dose of medications used for sedation during the procedure
**Time Frame:** Intraoperative period
**Description:** The time until the Modified Aldrete Score is 9 or higher during the recovery period
**Measure:** Recovery duration from anesthesia
**Time Frame:** From the end of the operation until discharge to the ward
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Volunteer adult patients aged 18-60 years
* Patients scheduled for impacted tooth extraction
* Cases with surgical time ≥20 minutes and ≤60 minutes
* American Society of Anaesthesiologists (ASA) physical status I and II patients
* Patients with BMI≤30
Exclusion Criteria:
* Patients under 18 years old-over 60 years old
* Surgeries with a procedure time over 1 hour or less than 20 minutes
* American Society of Anaesthesiologists (ASA) physical status III and higher patients
* Presence of conditions such as mental retardation that impair the patient's ability to make decisions about himself/herself
* Patients with respiratory system diseases such as asthma, chronic obstructive pulmonary disease (COPD) or airway hyperreactivity
* Patients with a condition that severely narrows the nasal passage opening (e.g. adenoid hypertrophy, etc.)
* Patients with BMI\>30
* Patients who refused to participate in the study
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
**Study Population:** It is planned to investigate patients with a diagnosis of impacted molars, who have an indication for dental extraction, and who are scheduled for dental extraction under sedation.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Gözde Nur Erkan, Asst. Prof.
**Phone:** +905054334692
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Appukuttan DP. Strategies to manage patients with dental anxiety and dental phobia: literature review. Clin Cosmet Investig Dent. 2016 Mar 10;8:35-50. doi: 10.2147/CCIDE.S63626. eCollection 2016.
**PMID:** 27022303
**Citation:** Cukierman DS, Perez M, Guerra-Londono JJ, Carlson R, Hagan K, Ghebremichael S, Hagberg C, Ge PS, Raju GS, Rhim A, Cata JP. Nasal continuous positive pressure versus simple face mask oxygenation for adult obese and obstructive sleep apnea patients undergoing colonoscopy under propofol-based general anesthesia without tracheal intubation: A randomized controlled trial. J Clin Anesth. 2023 Oct;89:111196. doi: 10.1016/j.jclinane.2023.111196. Epub 2023 Jul 3. Erratum In: J Clin Anesth. 2023 Nov 20;:111346.
**PMID:** 37406462
**Citation:** Bai Y, Xu Z, Chandrashekar M, St Jacques PJ, Liang Y, Jiang Y, Kla K. Comparison of a simplified nasal continuous positive airways pressure device with nasal cannula in obese patients undergoing colonoscopy during deep sedation: A randomised clinical trial. Eur J Anaesthesiol. 2019 Sep;36(9):633-640. doi: 10.1097/EJA.0000000000001052.
**PMID:** 31313720
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014076
- Term: Tooth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M16850
- Name: Tooth, Impacted
- Relevance: HIGH
- As Found: Impacted
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000014095
- Term: Tooth, Impacted
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436625
**Acronym:** OPAL
**Brief Title:** Outpatient Pulmonary Rehabilitation in Non-small-cell Lung Cancer Receiving Immunotherapy
**Official Title:** Outpatient Pulmonary Rehabilitation in Patients With Advanced Stage Non-small Cell Lung Cancer Receiving Immunotherapy: a Randomized Controlled Trial (OPAL-study)
#### Organization Study ID Info
**ID:** OPAL Version 1.1
#### Organization
**Class:** OTHER
**Full Name:** Karl Landsteiner Institute for Lung Research and Pneumological Oncology
### Status Module
#### Completion Date
**Date:** 2026-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Klinik Pirawarth
**Class:** UNKNOWN
**Name:** Therme Wien Med
#### Lead Sponsor
**Class:** OTHER
**Name:** Karl Landsteiner Institute for Lung Research and Pneumological Oncology
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The aim of this prospective study is to evaluate the effects of an outpatient pulmonary rehabilitation program on the quality of life, performance and tumor growth of metastatic lung cancer patients receiving ongoing immunotherapy.
The main questions it aims to answer are:
The primary objective of the study is to assess the effects of outpatient pulmonary rehabilitation (OPR) on exercise capacity measured by difference in the 6-minute walking test (6MWT) in patients with advanced stage lung cancer receiving immunotherapy measured by difference in the 6-minute walking test (6MWT).
Secondary endpoints in this study include progression free survival (PFS) and the effect of OPR on long term exercise capacity measured by 6MWT (difference in 6MWT after week 15 and 24).
Researchers will compare two groups of patients: one group of patients receives 6 weeks of outpatient pulmonary rehabilitation (intervention group), while the other patient group serves as control since this is standard of care to evaluate the effects of outpatient pulmonary rehabilitation.
**Detailed Description:** The effect of an outpatient pulmonary rehabilitation program on the quality of life, performance and tumor growth of metastatic lung cancer patients receiving ongoing immunotherapy will be investigated. Comparable data on rehabilitation under ongoing immunotherapy are almost non-existent in a prospective setting.
In addition, all patients with metastatic lung cancer could benefit from the study results if the benefit of outpatient rehabilitation can be proven in this patient population.
Patients will be randomized into two treatment arms and will be allocated due to randomization process. Both arms will receive standard-of care oncologic therapy according to national and international guidelines. In addition, one arm will receive 6 weeks of a standardized OPR (intervention group).
Patients who were randomized into the intervention group will be referred to one of the rehabilitation centers (Therme Wien Med or Klinik Pirawarth in Vienna) regarding of patients choice. The OPR is performed identical at both rehabilitation centers and according to Austrian guidelines (consistency was reassured by both heads of institutes).
Before the intervention (T0-baseline, week 0) patients will perform a 6-minute walking test (6MWT) (primary endpoint) together with additional secondary objective measurements (see section secondary endpoints or graphical overview). A follow-up will be performed after completion of OPR (T1, week 6) and every 9 weeks thereafter for the first 52 weeks (T1, FUP-T2, FUP-T3, FUP-T4-T6). After 52 weeks (FUP-T≥7) the intervals for follow-up visits is determined by the treating physician.
The end of study is reached if patient shows tumor progression (according to RECIST 1.1 criteria) after FUP-T3 (week 24) or - if patients has experienced tumor progression before FUP-T3 - after FUP-T3 (week 24).
### Conditions Module
**Conditions:**
- NSCLC Stage IV
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The intervention group will receive 6 weeks of outpatient pulmonary rehabilitation in one of the rehabilitation centers (Therme Wien Med, Klinik Pirawarth in Wien).
**Intervention Names:**
- Other: outpatient pulmonary rehabilitation
**Label:** Outpatient Pulmonary Rehabilitation
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** The control group receives no pulmonary rehabilitation since this is standard of care.
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Outpatient Pulmonary Rehabilitation
**Description:** Patients undergo six weeks of an outpatient rehabilitation program in one of the rehabilitation centers (Therme Wien Med, Klinik Pirawarth in Wien).
**Name:** outpatient pulmonary rehabilitation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity and will be measured at baseline and 8 weeks afterwards.
**Measure:** Six Minute Walking Test
**Time Frame:** Measured at baseline and 8 weeks afterwards
#### Secondary Outcomes
**Description:** Progression-free survival is defined as the time from therapy until the date of progressive disease using RECIST 1.1 assessments, or date of death due to any cause, whichever occurs first.
**Measure:** Progression-free survival (PFS)
**Time Frame:** from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
**Description:** Effect of OPR on long term exercise capacity measured by 6MWT (difference in 6MWT after week 15 and 24)
**Measure:** Six Minute Walking Test (longterm)
**Time Frame:** Measured at week 15 and 24
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria
* Capable and willing to give signed informed consent, which includes compliance with the requirements
* Age ≥ 18 years at the time of screening
* Histological or cytological confirmed non-squamous non-small cell lung cancer
* Previously untreated patients with histologically or cytologically documented metastatic (Stage IV according to Version 9 on the IASLC Staging Manual in Thoracic oncology) or recurrent NSCLC
* World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
* At least 1 lesion not previously irradiated that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by CT or MRI scan must be performed within 28 days prior to randomization.
* Stable disease (SD), partial response (PR) or complete response (CR) (according to RECIST 1.1) after four cycles of first line chemo-immunotherapy and planned maintenance therapy
* No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies in advanced or metastatic therapy setting except ongoing first line immunotherapy
Exclusion criteria
* Physical or cognitive condition or symptoms that contraindicate execution of physical exercise or participation in a clinical exercise-based trial
* Symptomatic brain metastases
* Bone metastases with risk of pathological fracture with exercise training as assessed by treating physician
* Contraindication for immunotherapy
* Existence of more than one primary tumor such as: mixed small cell and NSCLC histology; synchronous or metachronous tumors that could represent distinct primary tumors
* Evidence of other active cancer disease
* Any medical condition that might be worsened by exercise training including, but not restricted to severe congestive heart failure (NYHA III/IV), unstable angina pectoris, myocardial infarction or cardiac surgery 6 months prior to randomization
* Major surgical procedure (as defined by the investigator) within 28 days prior to randomization or planned during the next 56 days
* Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control
* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements
**Maximum Age:** 120 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Oliver Illini, Dr.
**Phone:** + 43 1 27700 72227
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Klinik Floridsdorf
**Name:** Oliver Illini, Dr.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002283
- Term: Carcinoma, Bronchogenic
- ID: D000001984
- Term: Bronchial Neoplasms
- ID: D000008175
- Term: Lung Neoplasms
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M11172
- Name: Lung Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: HIGH
- As Found: Non-Small Cell Lung Cancer
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M5540
- Name: Carcinoma, Bronchogenic
- Relevance: LOW
- As Found: Unknown
- ID: M5260
- Name: Bronchial Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002289
- Term: Carcinoma, Non-Small-Cell Lung
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436612
**Brief Title:** Study of Magnetic Resonance Image and Computed Tomography-Guided Stereotactic Body Radiation Therapy for Abdominopelvic Sarcomas (MARS Trial)
**Official Title:** Phase II Study of Magnetic Resonance Image and Computed Tomography-Guided Stereotactic Body Radiation Therapy for Abdominopelvic Sarcomas (MARS Trial)
#### Organization Study ID Info
**ID:** 23-001583
#### Organization
**Class:** OTHER
**Full Name:** Jonsson Comprehensive Cancer Center
#### Secondary ID Infos
**Domain:** Clinical Trials Reporting Program
**ID:** NCI-2024-04364
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2025-10-26
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-10-26
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Jonsson Comprehensive Cancer Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** Recent advances in radiation treatment have allowed for higher doses per treatment to be delivered safely. This study plans to use an MRI-guided linear accelerator to deliver the radiation treatment to ensure that the radiation dose is administered to the cancerous tumor, not the vital body organs.
Potential participants with a sarcoma diagnosis will be referred to Radiation Oncology during this study. If the participant is interested in participating in this study, s/he receives radiation treatment daily for 5 consecutive days except for weekends and holidays. Within 12 weeks of completing the radiation therapy, the participant will have the primary tumor surgically removed. The radiation oncology team will follow the patients for 5 years after completing radiation therapy.
**Detailed Description:** Each patient will undergo radiation simulation and planning. A custom vac-lok bag, alpha cradle, or equivalent immobilization device will be used. Both CT and MRI simulation will be obtained, which is standard of care for any patient undergoing radiation therapy for soft tissue sarcomas.
The study investigator will be responsible for delineating the gross tumor volume (GTV) using the CT as well as MRI performed as part of staging. Guidelines for contouring will be as per the currently open NRG trial for sarcomas. In general, this may entail expansions by 5-15 mm isotropically, should include any suspicious areas be identified on T2 weighted MRI, and should be cropped to natural anatomic borders. This clinical target volume (CTV) will then be expanded to a planning treatment volume (PTV) using a 3-5 mm expansion.
A prescription dose of 5-6 Gy x 5 fractions (25-30 Gy) will be delivered to at least 95% of the PTV. Stereotactic body radiotherapy (SBRT) and/or intensity modulated radiotherapy (IMRT) planning techniques may be used to minimize radiation dose to nearby organs at risk (OAR) but is not required.
Delineation of normal structures will be performed and verified by the responsible study investigator. The radiation physicist or dosimetrist will optimize the treatment plan prior to approval for treatment. Dose volume histograms (DVH) and normal tissue constraint parameters specified below will be used to judge the plan quality and optimize PTV coverage with OAR sparing prior to approval.
Radiation will be delivered daily for 5 consecutive days with the exception of weekends and holidays. In instances where the radiation treatment week contains a holiday or scheduling availability is limited, two fractions of radiation may be given on the same day providing that the fractions are administered ≥ 6 hours apart (this is considered standard of care treatment).
Surgical resection of at least the primary tumor will follow within 12 weeks of completing radiation therapy. Surgical specimens will be sent to pathology for evaluation and for review by a multidisciplinary tumor board.
### Conditions Module
**Conditions:**
- Abdominopelvic Sarcomas
### 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:** MRI or CT-guided SBRT will be delivered in the pre-operative setting. Patients will receive 5.0-6.0 Gy x 5 fractions delivered daily.
**Intervention Names:**
- Radiation: Magnetic Resonance Image and Computed Tomography-Guided Stereotactic Body Radiation Therapy
**Label:** Arm I
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Arm I
**Description:** stereotactic body radiation therapy (SBRT) administered over 5 days x 5.0 - 6.0 Gy for patients with abdominopelvic sarcomas.
**Name:** Magnetic Resonance Image and Computed Tomography-Guided Stereotactic Body Radiation Therapy
**Other Names:**
- Pre-operative stereotactic body radiation therapy (SBRT)
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluate the 2 year rate of grade ≥2 radiation morbidity, according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
**Measure:** Radiation morbidity at 2 years
**Time Frame:** At 2 years
#### Secondary Outcomes
**Description:** Defined as freedom from radiographic progression of the treated site. It will be evaluated using CT and/or MRI of the abdomen and pelvis.
**Measure:** Local Control
**Time Frame:** At 2 years
**Description:** Defined as freedom from radiographic progression in the abdomen or pelvis outside of the treated site. It will be evaluated using CT and/or MRI of the abdomen and pelvis.
**Measure:** Regional Control
**Time Frame:** At 2 years
**Measure:** Distant metastasis
**Time Frame:** At 2 years
**Measure:** Progression free survival
**Time Frame:** At 2 years
**Measure:** Overall survival
**Time Frame:** At 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Histologically confirmed sarcoma
* Primary or recurrent disease involving the abdomen or pelvis
* Resectable primary lesion
* Age ≥ 12 years old
* Karnofsky performance status (KPS) ≥ 70 or Eastern Cooperative Oncology Group (ECOG) 0-2
* If a woman is of childbearing potential, a negative serum or urine pregnancy test must be documented
Exclusion Criteria:
* Active treatment of a separate malignancy
* History of prior irradiation to the area targeted for treatment
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Christy Palodichuk
**Phone:** 3107942971
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Vincent Basehart
**Phone:** 3102678954
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Los Angeles
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Vincent Basehart
- **Phone:** 310-267-8954
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Christine Palodichuk
- **Phone:** 3107942971
- **Role:** CONTACT
***Contact 3:***
- **Name:** Vishruth Reddy, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** UCLA / Jonsson Comprehensive Cancer Center
**State:** California
**Status:** RECRUITING
**Zip:** 90095
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000018204
- Term: Neoplasms, Connective and Soft Tissue
- 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: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M15327
- Name: Sarcoma
- Relevance: HIGH
- As Found: Sarcoma
- ID: M20350
- Name: Neoplasms, Connective and Soft Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: T5284
- Name: Soft Tissue Sarcoma
- Relevance: HIGH
- As Found: Sarcoma
### Condition Browse Module - Meshes
- ID: D000012509
- Term: Sarcoma
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436599
**Brief Title:** Comparison of Analgesic Efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in Breast Surgery
**Official Title:** Comparison of Analgesic Efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in Breast Surgery
#### Organization Study ID Info
**ID:** Medeniyet University
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Medeniyet University
### Status Module
#### Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-12-13
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Mustafa Burgac
#### Responsible Party
**Investigator Affiliation:** Istanbul Medeniyet University
**Investigator Full Name:** Mustafa Burgac
**Investigator Title:** principal 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 application of regional anaesthetic procedures in breast surgery is associated with a lower incidence of chronic pain, reduced morbidity, shorter hospital stay and less opioid requirement. Therefore, we aimed to evaluate the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.
**Detailed Description:** Breast conserving surgery is one of the most common operations performed by General Surgery and may be associated with acute postoperative pain. Acute postoperative pain is an independent risk factor for the development of chronic pain after mastectomy. Various regional anaesthetic procedures have been tried to achieve better acute pain control and thus less chronic pain. The use of regional anaesthetic procedures in breast surgery is associated with a lower incidence of chronic pain, reduced morbidity, shorter hospital stay and less opioid requirement.
Interfascial plane blocks have become popular because they are easy to perform and safe. Since interfascial plan blocks are based on the injection of local anaesthetic between two fasciae, the complication rate such as nerve damage is very low. With this method, effective analgesia can be provided in various areas such as abdominal, thoracic and lumbar regions while reducing opioid consumption and avoiding neuraxial methods.
In randomised controlled trials investigating the efficacy of Serratus Anterior Plane Block for postoperative analgesia management after breast surgery, adequate analgesia was reported.
Serratus posterior superior intercostal plan block, a newly defined interfascial plan block, has been shown to provide a wide sensory blockade between intercostal muscles. Postoperative analgesic efficacy has been demonstrated in thoracic, breast and shoulder surgeries.
The aim of our study was to evaluate the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.
### Conditions Module
**Conditions:**
- Analgesia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Serratus posterior superior intercostal plane block was applied to a certain group of patients for postoperative anaesthesia.
**Intervention Names:**
- Drug: plane block with %0.25 30 ml bupivacaine
**Label:** Patients with serratus posterior superior intercostal plan block
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Serratus anterior plane block was applied to a certain group of patients for postoperative anaesthesia.
**Intervention Names:**
- Drug: plane block with %0.25 30 ml bupivacaine
**Label:** Patients with serratus anterior plan block
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients with serratus anterior plan block
- Patients with serratus posterior superior intercostal plan block
**Description:** evaluation of the efficacy of two different plan blocks for postoperative anaesthesia
**Name:** plane block with %0.25 30 ml bupivacaine
**Other Names:**
- postoperative anaesthesia
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluation of which of the two plan blocks is more effective in postoperative anaesthesia.
Postoperative pain scores will be evaluated with a numerical pain score. Evaluation will be performed postoperatively at 30. minutes, 1. hour, 4. hours, 8. hours, 12. hours and 24. hours.
**Measure:** evaluation of anelgesic efficacy of postoperative plan blocks with numerical pain score
**Time Frame:** postoperative 24 hours
#### Secondary Outcomes
**Description:** Before the end of the surgical procedure, the patient will be administered 1 mg/kg tramadol and 1 g paracetamol.
Intra venous tramadol will be administered with a pain pump for pain control for 24 hours postoperatively.
The amount of tramadol used in both plane blocks will be compared.
**Measure:** postoperative used anelgesic quantity
**Time Frame:** postoperative 24 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* unilateral mastectomy
* ASA I-III risk group
Exclusion Criteria:
* Coagulopathy
* Wound and infection in the block area
* Local anaesthetic allergy
* Mental retardation
* Non-cooperative
* Pregnant patients
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mustafa Burgaç
**Phone:** 05389848198
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** İstanbul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mustafa Burgaç
- **Phone:** +905389848198
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Istanbul Professor Doctor Süleyman Yalçın City Hospital
**Status:** RECRUITING
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000000779
- Term: Anesthetics, Local
- ID: D000000777
- Term: Anesthetics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M5315
- Name: Bupivacaine
- Relevance: HIGH
- As Found: Following
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000002045
- Term: Bupivacaine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436586
**Brief Title:** Impact of HLA Evolutionary Divergence and HLA Donor-recipient Molecular Mismatches on Kidney Allograft Rejection
**Official Title:** Impact of HLA Evolutionary Divergence and HLA Donor-recipient Molecular Mismatches on Kidney Allograft Rejection: a Population-based Study
#### Organization Study ID Info
**ID:** HLA_kidney_001
#### Organization
**Class:** OTHER
**Full Name:** Paris Translational Research Center for Organ Transplantation
### Status Module
#### Completion Date
**Date:** 2023-01-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-01-01
**Type:** ACTUAL
#### Start Date
**Date:** 2022-02-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Paris Translational Research Center for Organ Transplantation
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The Human Leucocyte Antigen (HLA) system is pivotal in kidney transplant rejection. In-silico methods such as HLA eplet mismatches and PIRCHE-II scores have emerged to refine HLA immunogenicity assessment and stratify patients for immunological risk. However, large-scale studies in unselected large kidney transplant cohorts are lacking to support their broader clinical applicability. Additionally, recent studies on HLA evolutionary divergence (HED), quantifying HLA polymorphism, highlight its potential impact on rejection. Yet, the association of HED with kidney allograft rejection or de novo DSA occurrence remains unexplored in kidney transplantation.
The complexity introduced by diverse in-silico methods for assessing HLA immunogenicity necessitates further research to comprehensively understand their role in relation to kidney allograft rejection.
This project thus aims to investigate the association between various aspects of HLA immunogenicity, including HLA molecular mismatches and HLA evolutionary divergence, along with standard immunological and clinical parameters assessed at the time of transplantation, with the occurrence of antibody-mediated rejection and de novo DSA formation post-transplant in a large, comprehensively annotated kidney transplant cohort.
### Conditions Module
**Conditions:**
- Kidney Transplantation
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 5159
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** No intervention
**Name:** No intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Antibody-mediated rejection
**Time Frame:** from 02/01/2004 to 25/01/2021
#### Secondary Outcomes
**Measure:** De novo anti-HLA donor-specific antibody
**Time Frame:** from 02/01/2004 to 25/01/2021
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Living or deceased donor kidney recipient transplanted after 2004
* Kidney recipient older than 18 years of age
* Written informed consent at the time of transplantation for the center database
Exclusion Criteria:
* Combined transplantation
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Kidney transplant recipients from four French referral centers
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Paris
**Country:** France
**Facility:** Paris Translational Research Center for Organ Transplantation
**Zip:** 75015
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Bestard O, Thaunat O, Bellini MI, Bohmig GA, Budde K, Claas F, Couzi L, Furian L, Heemann U, Mamode N, Oberbauer R, Pengel L, Schneeberger S, Naesens M. Alloimmune Risk Stratification for Kidney Transplant Rejection. Transpl Int. 2022 May 20;35:10138. doi: 10.3389/ti.2022.10138. eCollection 2022.
**PMID:** 35669972
**Citation:** Sellares J, de Freitas DG, Mengel M, Reeve J, Einecke G, Sis B, Hidalgo LG, Famulski K, Matas A, Halloran PF. Understanding the causes of kidney transplant failure: the dominant role of antibody-mediated rejection and nonadherence. Am J Transplant. 2012 Feb;12(2):388-99. doi: 10.1111/j.1600-6143.2011.03840.x. Epub 2011 Nov 14.
**PMID:** 22081892
**Citation:** Wiebe C, Rush DN, Nevins TE, Birk PE, Blydt-Hansen T, Gibson IW, Goldberg A, Ho J, Karpinski M, Pochinco D, Sharma A, Storsley L, Matas AJ, Nickerson PW. Class II Eplet Mismatch Modulates Tacrolimus Trough Levels Required to Prevent Donor-Specific Antibody Development. J Am Soc Nephrol. 2017 Nov;28(11):3353-3362. doi: 10.1681/ASN.2017030287. Epub 2017 Jul 20.
**PMID:** 28729289
**Citation:** Lachmann N, Niemann M, Reinke P, Budde K, Schmidt D, Halleck F, Pruss A, Schonemann C, Spierings E, Staeck O. Donor-Recipient Matching Based on Predicted Indirectly Recognizable HLA Epitopes Independently Predicts the Incidence of De Novo Donor-Specific HLA Antibodies Following Renal Transplantation. Am J Transplant. 2017 Dec;17(12):3076-3086. doi: 10.1111/ajt.14393. Epub 2017 Jul 28.
**PMID:** 28613392
**Citation:** Feray C, Taupin JL, Sebagh M, Allain V, Demir Z, Allard MA, Desterke C, Coilly A, Saliba F, Vibert E, Azoulay D, Guettier C, Chatton A, Debray D, Caillat-Zucman S, Samuel D. Donor HLA Class 1 Evolutionary Divergence Is a Major Predictor of Liver Allograft Rejection : A Retrospective Cohort Study. Ann Intern Med. 2021 Oct;174(10):1385-1394. doi: 10.7326/M20-7957. Epub 2021 Aug 24.
**PMID:** 34424731
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436573
**Brief Title:** Mitro-annular Disjunction in Cardiac Magnetic Resonance
**Official Title:** Mitro-annular Disjunction in Cardiac Magnetic Resonance
#### Organization Study ID Info
**ID:** MAD-SIRM
#### Organization
**Class:** OTHER
**Full Name:** IRCCS San Raffaele
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-27
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** IRCCS San Raffaele
#### Responsible Party
**Investigator Affiliation:** IRCCS San Raffaele
**Investigator Full Name:** Antonio Esposito
**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:** Mitral annular disjunction (MAD) is an abnormal atrial displacement of the mitral valve leaflet hinge point. MAD is gaining clinical importance for several studies reporting its association to mitral valve prolapse (MVP), complex ventricular arrhythmias and sudden cardiac death.
On the other hand, other studies found MAD as an extremely diffuse anatomical variant of mitral valve annulus without any pathological implication.
Cardiac Magnetic Resonance is the non-invasive gold standard for myocardial characterization, with the possibility of accurate anatomical and functional evaluation associated to the evaluation of focal and interstitial fibrosis, resulting useful in the identification of arrhythmic substrate and for patients risk stratification. Additionally, Cardiac Magnetic Resonance (CMR) was found to be superior to echocardiography not only in term of tissue characterization, but also in the identification of small MAD.
Therefore, in relation to the scarcity of data about MAD prevalence and pathological potential, we set a large multicenter retrospective study aimed to evaluate prevalence of MAD in patients submitted to CMR independently by the clinical suspicion, and to evaluate the association with prolapse and arrhythmias.
**Detailed Description:** Multicenter retrospective study. All cardiac MRI study obtained during the first semester of 2019 will be screened in order to identify the presence and severity of MAD, it association to other myocardial condition such as bileaflet mitral valve prolapse, miltral regurgitation, curling, and focal and interstitial fibrosis at LGE and ECV evaluation.
Finally, the association between MAD and arrhythmias will be investigated.
### Conditions Module
**Conditions:**
- Mitral Valve Prolapse Syndrome
- Arrhythmogenic Bileaflet Mitral Prolapse
- Mitral Valve Disorder
**Keywords:**
- Mitral annular disjunction, mitral prolapse, arrhthymia
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 4000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Consecutive adult patients (age ≥18 years-old), submitted to Cardiac Magnetic Resonance independently by the clinical suspicions in the first semester of 2019 (from January to June 2019) that have signed an Informed Consent authorizing data collection for future retrospective clinical research protocols.
Timelapse has been chosen to avoid the impact of COVID-19 pandemic.
**Label:** Retrospective cohort
### Outcomes Module
#### Primary Outcomes
**Description:** The main objective of the present study is to investigate the prevalence of MAD in a large population undergoing CMR independently by the clinical suspicion. Therefore, the endpoint will be the prevalence of MAD in the examined population and the outcome will be the presence of MAD.
**Measure:** the outcome will be the presence of MAD
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
• Consecutive adult patients (age ≥18 years-old), submitted to Cardiac Magnetic Resonance independently by the clinical suspicions in the first 6 month of 2019 (from January to June 2019) that have signed an Informed Consent authorizing data collection for future retrospective clinical research protocols
Exclusion Criteria:
• Pediatric patients (age \<18 years-old), cardiac devices (implantable devices), previous mitral valve surgery, lack of LGE images, lack of clinical information about presence of arrhythmias. The timeline was selected to avoid the impact of COVID-19 pandemic on CMR availability, scheduling, and findings.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Consecutive adult patients (age ≥18 years-old), submitted to Cardiac Magnetic Resonance independently by the clinical suspicions in the first semesterof 2019 (from January to June 2019)
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Antonio Esposito
**Phone:** 0226436102
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Anna Palmisano, MD, PhD
**Phone:** 0226432489
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** IRCCS San Raffaele Institute
**Name:** Antonio Esposito, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Kulkarni AA, Chudgar PD, Burkule NJ, Kamat NV. Mitral Annulus Disjunction and Arrhythmic Mitral Valve Prolapse: Emerging Role of Cardiac Magnetic Resonance Imaging in the Workup. Indian J Radiol Imaging. 2022 Aug 30;32(4):576-581. doi: 10.1055/s-0042-1754357. eCollection 2022 Dec.
**PMID:** 36451946
**Citation:** Bennett S, Thamman R, Griffiths T, Oxley C, Khan JN, Phan T, Patwala A, Heatlie G, Kwok CS. Mitral annular disjunction: A systematic review of the literature. Echocardiography. 2019 Aug;36(8):1549-1558. doi: 10.1111/echo.14437. Epub 2019 Aug 5.
**PMID:** 31385360
**Citation:** Chess RJ, Mazur W, Palmer C. Stop the Madness: Mitral Annular Disjunction. CASE (Phila). 2023 Jan 18;7(3):116-118. doi: 10.1016/j.case.2022.12.004. eCollection 2023 Mar.
**PMID:** 37065832
**Citation:** Faletra FF, Leo LA, Paiocchi VL, Schlossbauer SA, Pavon AG, Ho SY, Maisano F. Morphology of Mitral Annular Disjunction in Mitral Valve Prolapse. J Am Soc Echocardiogr. 2022 Feb;35(2):176-186. doi: 10.1016/j.echo.2021.09.002. Epub 2021 Sep 8.
**PMID:** 34508838
**Citation:** Bennett S, Tafuro J, Duckett S, Appaji A, Khan JN, Heatlie G, Cubukcu A, Kwok CS. Definition, prevalence, and clinical significance of mitral annular disjunction in different patient cohorts: A systematic review. Echocardiography. 2022 Mar;39(3):514-523. doi: 10.1111/echo.15299. Epub 2022 Feb 4.
**PMID:** 35122307
**Citation:** Dejgaard LA, Skjolsvik ET, Lie OH, Ribe M, Stokke MK, Hegbom F, Scheirlynck ES, Gjertsen E, Andresen K, Helle-Valle TM, Hopp E, Edvardsen T, Haugaa KH. The Mitral Annulus Disjunction Arrhythmic Syndrome. J Am Coll Cardiol. 2018 Oct 2;72(14):1600-1609. doi: 10.1016/j.jacc.2018.07.070.
**PMID:** 30261961
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000016127
- Term: Heart Valve Prolapse
- ID: D000006349
- Term: Heart Valve Diseases
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M11911
- Name: Mitral Valve Prolapse
- Relevance: HIGH
- As Found: Mitral Valve Prolapse
- ID: M14261
- Name: Prolapse
- Relevance: HIGH
- As Found: Prolapse
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M9437
- Name: Heart Valve Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008945
- Term: Mitral Valve Prolapse
- ID: D000011391
- Term: Prolapse
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436560
**Acronym:** STRIVE
**Brief Title:** Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty Study
**Official Title:** Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty (STRIVE) Study
#### Organization Study ID Info
**ID:** STUDY00026957
#### Organization
**Class:** OTHER
**Full Name:** Oregon Health and Science University
#### Secondary ID Infos
**Domain:** Patient-Centered Outcomes Research Institute (PCORI)
**ID:** 1023677
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2028-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-11
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Patient-Centered Outcomes Research Institute
**Class:** OTHER
**Name:** NYU Langone Health
**Class:** OTHER
**Name:** Rush University
**Class:** OTHER
**Name:** University of Utah
**Class:** OTHER
**Name:** University of Minnesota
**Class:** OTHER
**Name:** Temple University
**Class:** OTHER
**Name:** University of California, San Francisco
**Class:** OTHER
**Name:** University of Washington
**Class:** UNKNOWN
**Name:** Trans Lifeline
**Class:** OTHER_GOV
**Name:** Whitman-Walker Institute
**Class:** OTHER
**Name:** Duke University
#### Lead Sponsor
**Class:** OTHER
**Name:** Oregon Health and Science University
#### Responsible Party
**Investigator Affiliation:** Oregon Health and Science University
**Investigator Full Name:** Geolani Dy
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The STRIVE study is the first national randomized trial to focus on improving well-being, access to surgical care and other health outcomes for transgender and nonbinary (referred to as trans) people seeking genital gender-affirming surgery (GGAS). Trans people have gender identities that are different from the sex they were assigned at birth. Due to discrimination based on their gender identity in settings such as schools, the workplace, housing and health care, trans people face much higher rates of distress as well as poorer health and quality of life. Trans people are often unable to access necessary surgeries and hormone therapy to help align their bodies with their gender identities due to a lack of trained medical providers and limited insurance coverage for gender-affirming care.
The most common GGAS that trans people seek is vaginoplasty, which is the surgical creation of vaginal anatomy. Because of the high demand for this surgery and limited number of medical centers that offer it, trans people face lengthy wait times and complicated health system processes, increasing stress, negative mental health effects and social isolation. Social and peer-support interventions have been shown to decrease isolation and improve health. Social support during the GGAS process was also identified by the Transgender and Non-Binary Surgery - Allied Research Collective (TRANS-ARC) as the top research priority. Due to limited information on this topic, the STRIVE study was developed to meet this need.
The research team's goals are to:
* Compare the effectiveness of two approaches to presurgical preparation for vaginoplasty: a virtual group-based peer support intervention led by trans peers who have had GGAS, or usual care delivered by gender-affirming surgical teams, enhanced with patient education materials.
* Determine if the intervention improves meeting presurgical criteria for vaginoplasty.
* Evaluate if patients, peer supporters and healthcare staff find the intervention acceptable.
The research team will conduct a pragmatic randomized controlled trial, meaning participants will be assigned by chance to one of two groups: peer-support group or usual care enhanced with written and web-based education materials. This study is pragmatic because it is happening under real-life conditions to understand if the intervention will work in practice.
The research team will work with five academic gender-affirming surgery programs across the country to recruit and enroll 260 trans adults ages 18 and older who are seeking vaginoplasty. Participants assigned to the peer support group will receive the intervention virtually over the course of three months, facilitated by peer facilitators from Trans Lifeline. The usual care group will receive education from their gender-affirming surgical team, with in-depth materials that cover the same topics as the virtual course.
The primary outcome to be measures at six months is coping self-efficacy, reported by patients, using a survey which assesses perceived ability to deal with stressors. The research team will explore additional outcomes at 12 months, including meeting GGAS presurgical criteria and other outcomes deemed important to trans community partners, surgeons and other gender-affirming providers (e.g., psychological stress, social support, resilience, quality of life, presurgical knowledge, surgical delays and cancellations). Postsurgical outcomes, including surgical satisfaction and other related outcomes, will be measured at 24 months. Finally, the team will conduct in-depth interviews with participants who undergo the intervention to understand their experiences at the beginning of the study and after six months. Researchers will also interview peer supporters and clinicians to understand how to improve and implement the support intervention more broadly.
In designing this study, the research team worked closely with trans community members and patients, health services and policy researchers, gender-affirming surgeons, advocates, gender program administrators and representatives from social support organizations. Collaboration with and input from the trans community during the conduct of this study will be critical to ensure that the STRIVE study is patient centered. Results from this study will be shared in multiple forms, including clinical guideline recommendations, policy briefs, patient-centered reports, web-based information and summaries for clinicians and researchers. Trans people seeking gender-affirming surgery can use the study findings to understand options for social support to improve quality of life and health outcomes. Clinicians, gender program administrators, health insurance companies and health policy advisors can use the findings from this study to better support and prepare patients who are seeking gender-affirming surgery.
**Detailed Description:** OUTLINE The STRIVE (Support for Transgender and Non-Binary Individuals Seeking Vaginoplasty) Study is a multi-site, two-arm randomized pragmatic trial to determine if an evidence-based peer support intervention improves patient-reported and patient-centered clinical outcomes for individuals seeking genital gender-affirming surgery (GGAS) compared with enhanced usual care.
PRIMARY OBJECTIVES Aim 1: To compare the effectiveness of a virtual, group-based perioperative peer support intervention with enhanced usual care on coping self-efficacy (primary outcome) among patients seeking vaginoplasty.
* Hypothesis 1: Patients in the intervention arm will have greater improvements in coping self-efficacy at 6 months post-enrollment compared to patients who receive enhanced usual care.
Aim 2: To determine whether our perioperative peer support intervention improves patient probability of meeting pre-operative GGAS criteria (secondary outcome), and other prioritized patient-centered outcomes (exploratory outcomes).
* Hypothesis 2a: More patients in the intervention arm will meet pre-operative GGAS criteria at 12 months post-enrollment compared with patients who receive enhanced usual care.
* Hypotheses 2b: Patients in the intervention arm will have decreased psychological distress (anxiety, depression, suicidal ideation) and gender minority stress, and greater social support, resilience, QOL, pre-operative surgical knowledge, and fewer surgical delays. For participants who undergo surgery during the follow-up period, those in the intervention arm will have fewer surgical complications, greater completion of vaginal dilation, greater surgical satisfaction, and fewer unplanned emergency department and clinic visits at 6 months post-operatively.
Aim 3: To evaluate the acceptability of this centralized, virtual, group-based perioperative peer support intervention among patients, peer support specialists and healthcare team members.
### Conditions Module
**Conditions:**
- Gender Affirmation Surgery
- Perioperative Care
- Transgender Health
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 260
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A virtual group-based peer support intervention led by trans peers who have had genital gender-affirming surgery.
**Intervention Names:**
- Other: STRIVE Peer Support Intervention
**Label:** STRIVE Peer Support Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Usual care enhanced with written and web-based education materials.
**Label:** Enhanced Usual Care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- STRIVE Peer Support Intervention
**Description:** A virtual group-based peer support intervention led by trans peers who have had genital gender-affirming surgery.
**Name:** STRIVE Peer Support Intervention
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v2.0. PROMIS tools were developed to be disease non-specific measures of health-related domains such as self-efficacy for symptom and medication management, depression, anxiety, fatigue, pain interference, sleep disturbance, and physical functioning. Each domain in composed of an item bank specific to a trait being measured. Item banks are calibrated on a common scale to facilitate comparability across varying populations. Raw scores are transformed to standardized T-score metrics, with a mean of 50 and standard deviation of 10.
**Measure:** Health-related quality of life assessed by the PROMIS-29 Profile v2.0
**Time Frame:** Enrollment, 6 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
**Description:** The Patient Depression Questionnaire-9 (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression. The PHQ-9 incorporates the Diagnostic and Statistical Manual of Mental Disorders (DSM) depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The score ranges from zero to 27, with zero representing no depression and 27 representing severe depression.
**Measure:** Depression assessed by the PHQ-9
**Time Frame:** Enrollment, 6 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
**Description:** The Generalised Anxiety Disorder Assessment (GAD-7) is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD). Scores range from zero, representing minimal anxiety, to 21, representing severe anxiety.
**Measure:** Anxiety assessed by the GAD-7
**Time Frame:** Enrollment, 6 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
**Description:** The GENDER-Q is a comprehensive patient-reported outcome measure used to evaluate outcomes of psychological, hormonal, and surgical gender-affirming treatments. The "Information" scale of the GENDER-Q assesses patient satisfaction with presurgical genital gender-affirming surgery (GGAS) knowledge. Scores range from 27 to 135, with 27 representing not at all satisfied and 135 representing extremely satisfied.
**Measure:** Presurgical GGAS knowledge assessed by the GENDER-Q "Information" scale
**Time Frame:** Enrollment, 6 months after enrollment, immediate pre-operative
**Description:** The GENDER-Q is a comprehensive patient-reported outcome measure used to evaluate outcomes of psychological, hormonal, and surgical gender-affirming treatments. The "Adverse Effects" scale of the GENDER-Q assesses patient concerns about ongoing problems caused by gender-affirming surgery. Scores range from 30 to 150, with 30 representing not at all concerned and 150 representing extremely concerned.
**Measure:** Complications and adverse effects assessed by the GENDER-Q "Adverse Effects" scale
**Time Frame:** Immediate pre-operative, 3 months post-operative, 6 months post-operative
**Description:** The GENDER-Q is a comprehensive patient-reported outcome measure used to evaluate outcomes of psychological, hormonal, and surgical gender-affirming treatments. Gender dysphoria describes a state of discomfort or distress a person can experience when their gender identity differs from their sex assigned at birth. The "Gender dysphoria life impact" scale of the GENDER-Q assesses how often gender dysphoria negatively interferes with the patient's life. Scores range from 16 to 80, with 16 representing gender dysphoria never negatively interferes and 80 representing gender dysphoria always negatively interferes.
**Measure:** Gender dysphoria life impact assessed by the GENDER-Q "Gender dysphoria life impact" scale
**Time Frame:** Enrollment, 6 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
**Description:** The Multi-Dimensional Scale of Perceived Social Support (MSPSS) is a 12-item measure of perceived adequacy of social support from three sources: family, friends, and significant other, using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree). To calculate mean scores, sum across all 12 items, then divide by 12. Scores ranging from 1 to 2.9 are low support; a score of 3 to 5 is moderate support; a score from 5.1 to 7 is considered high support.
**Measure:** Social support assessed by the MSPSS
**Time Frame:** Enrollment, 6 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
**Description:** The GENDER-Q is a comprehensive patient-reported outcome measure used to evaluate outcomes of psychological, hormonal, and surgical gender-affirming treatments. The "Sexual well-being" scale of the GENDER-Q assesses satisfaction with sexual activities. Scores range from 16 to 80, with 16 representing never satisfied with sexual activities and 80 always satisfied with sexual activities.
**Measure:** Sexual function assessed by the GENDER-Q "Sexual well-being" scale
**Time Frame:** Enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
**Description:** The GENDER-Q is a comprehensive patient-reported outcome measure used to evaluate outcomes of psychological, hormonal, and surgical gender-affirming treatments. The "Appearance" scale of the GENDER-Q assesses satisfaction with appearance in relation to gender identity. Scores range from 14 to 70, with 14 representing never satisfied with appearance and 70 always satisfied with appearance.
**Measure:** Bodily appearance satisfaction assessed by the GENDER-Q "Appearance" scale
**Time Frame:** Enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
**Description:** The GENDER-Q is a comprehensive patient-reported outcome measure used to evaluate outcomes of psychological, hormonal, and surgical gender-affirming treatments. The "Appearance" scale of the GENDER-Q assesses satisfaction with appearance in relation to gender identity. Scores range from 14 to 70, with 14 representing never satisfied with appearance and 70 always satisfied with appearance.
**Measure:** Urinary function assessed by the GENDER-Q "Urinary function" scale
**Time Frame:** Immediate pre-operative, 3 months post-operative, 6 months post-operative
**Description:** The GENDER-Q is a comprehensive patient-reported outcome measure used to evaluate outcomes of psychological, hormonal, and surgical gender-affirming treatments. The"Healthcare professional" and "Gender clinic" scales of the GENDER-Q assess the patient's satisfaction with the healthcare team providing gender-affirming care. Scores range from 54 to 324, with 54 representing very unsatisfied with the healthcare team and 324 representing completely satisfied with the healthcare team.
**Measure:** Satisfaction with healthcare team assessed by the GENDER-Q "Healthcare professional" and "Gender clinic" scales
**Time Frame:** Enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
**Description:** The GENDER-Q is a comprehensive patient-reported outcome measure used to evaluate outcomes of psychological, hormonal, and surgical gender-affirming treatments. The "Vagina" scale of the GENDER-Q assesses satisfaction with the patient's vagina after gender-affirming vaginoplasty. Scores range from 22 to 132, with 22 representing extremely dissatisfied and 132 representing extremely satisfied.
**Measure:** Satisfaction with vagina assessed by the GENDER-Q "Vagina" scale
**Time Frame:** Immediate post-operative, 3 months post-operative, 6 months post-operative
**Description:** The GENDER-Q is a comprehensive patient-reported outcome measure used to evaluate outcomes of psychological, hormonal, and surgical gender-affirming treatments. The "Outcome of surgery" scale of the GENDER-Q assesses the patient's overall satisfaction with the gender-affirming surgery. Scores range from 17 to 102, with 17 representing extremely dissatisfied and 102 representing extremely satisfied.
**Measure:** Satisfaction with surgical outcome assessed by the GENDER-Q "Outcome of surgery" scale
**Time Frame:** Immediate post-operative, 3 months post-operative, 6 months post-operative
**Description:** The Gender Minority Stress and Resilience (GMSR) measure was developed to assess aspects of minority stress and resilience faced by people whose gender identity or expression is different in any way from that socially expected based on their sex assigned at birth. The measure is scored in three subscales. For distal stressors (e.g., gender-related discrimination), scores range from zero, indicating no experience of distal minority stressors, to 60, indicating the greatest degree of experience of distal stressors. For proximal stressors (e.g., internalized transphobia), scores range from zero, indicating no experience of proximal minority stressors, to 88, indicating the greatest degree of experience of proximal stressors. For resilience factors (e.g., community connectedness), scores range from zero, indicating no resilience factors, to 52, indicating the greatest degree of resilience factors.
**Measure:** Gender minority stress and resilience assessed by the GMSR
**Time Frame:** Enrollment, 6 months after enrollment, immediate pre-operative, 3 months post-operative, 6 months post-operative
#### Primary Outcomes
**Description:** Patient-reported coping self-efficacy is measured using the Coping Self-Efficacy Scale (CSES), a survey that assesses the perceived ability to deal with stressors using a score range of 0-260. Zero is equivalent to no perceived ability to deal with stressors; 260 indicates the highest attainable level of perceived ability to deal with stressors.
**Measure:** Patient-reported coping self-efficacy as assessed by the CSES
**Time Frame:** Enrollment, 6 months after enrollment, 6 months post-operative
#### Secondary Outcomes
**Description:** Completion of pre-operative criteria for scheduling genital gender-affirming surgery (GGAS), a proxy for patient readiness that is assessed based on each patient's ability to meet criteria of the center at which they are seeking care. Pre-operative criteria generally follow the World Professional Association for Transgender Health (WPATH) Standards of Care (SOC), which have been adopted by most public and private insurers in making coverage decisions for GGAS. WPATH SOC criteria include: a letter of support from a mental health professional attesting to one's ability to provide informed consent stability of ones' gender identity and desire for surgery, and that any mental health and/or medical conditions are well-managed. Additional center-specific requirements may also include: meeting weight criteria; nicotine cessation; glycemic control; and attestation of adequate social support and post-operative housing stability.
**Measure:** Completion of preoperative criteria for scheduling GGAS
**Time Frame:** Enrollment, 12 months after enrollment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Self-identified trans or non-binary individual
* Seeking vaginoplasty
* Completed consultation with gender-affirming surgeon for vaginoplasty
* Documented recommendation by surgeon for vaginoplasty
* Can complete survey responses online, by phone or on paper.
* Willing and able to participate in virtual peer support intervention
* Aged 18 or older
* English speaking
* Able to provide independent written consent
Exclusion Criteria:
* Do not speak English
* Cannot complete survey responses online, by phone, or on paper
* Are unwilling to participate in a virtual peer support intervention
* Have co-morbidities or other conditions that exclude them from candidacy for vaginoplasty
* Are currently involved in delivery of the STRIVE Intervention
* Are unable or unwilling to participate.
**Gender Based:** True
**Gender Description:** Transgender and nonbinary persons seeking gender-affirming vaginoplasty.
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Elijah R Hart, MPH
**Phone:** 503-494-6687
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Samantha Underwood, MS
**Phone:** 503-494-8481
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** San Francisco
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Christi Butler, MD
- **Phone:** 415-476-1611
- **Role:** CONTACT
***Contact 2:***
- **Name:** Christi Butler, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of California San Francisco
**State:** California
**Zip:** 94143
**Location 2:**
**City:** Chicago
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Loren Schechter, MD
- **Phone:** 312-942-3640
- **Role:** CONTACT
***Contact 2:***
- **Name:** Loren Schechter, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Rush University
**State:** Illinois
**Zip:** 60612
**Location 3:**
**City:** Minneapolis
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Joseph Pariser, MD
- **Phone:** 612-884-0600
- **Role:** CONTACT
***Contact 2:***
- **Name:** Joseph Pariser, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Minnesota
**State:** Minnesota
**Zip:** 55455
**Location 4:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lee Zhao, MD MS
- **Phone:** 646-825-6300
- **Role:** CONTACT
***Contact 2:***
- **Name:** Lee Zhao, MD MS
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Rachel Bluebond-Langner, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** New York University Langone Health
**State:** New York
**Zip:** 10017
**Location 5:**
**City:** Portland
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Geolani Dy, MD
- **Phone:** 503-346-1500
- **Role:** CONTACT
***Contact 2:***
- **Name:** Geolani Dy, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Oregon Health and Science University
**State:** Oregon
**Zip:** 97239
**Location 6:**
**City:** Philadelphia
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Laura Douglass, MD
- **Phone:** 215-707-8427
- **Role:** CONTACT
***Contact 2:***
- **Name:** Laura Douglass, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Temple University
**State:** Pennsylvania
**Zip:** 19140
**Location 7:**
**City:** Salt Lake City
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Benjamin McCormick, MD
- **Phone:** 801-581-2121
- **Role:** CONTACT
***Contact 2:***
- **Name:** Benjamin Mccormick, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Cori Agarwal, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Utah
**State:** Utah
**Zip:** 84132
**Location 8:**
**City:** Seattle
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** John Gore, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Kemi Doll, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Washington
**State:** Washington
**Zip:** 98195
#### Overall Officials
**Official 1:**
**Affiliation:** Oregon Health and Science University
**Name:** Geolani Dy, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Due to safety concerns about the use of data expressed during patient engagement processes, the STRIVE Study does not currently plan to share individual participant data (IPD) publicly.
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436547
**Brief Title:** Subiculum Electrical Stimulation for Temporal Lobe Epilepsy With Biliteral Hippocampus Sclerosis(SESTB)
**Official Title:** The Efficacy and Safety of Subiculum Electrical Stimulation for Temporal Lobe Epilepsy With Bilateral Hippocampal Sclerosis: A Prospective, Single-Arm Trial
#### Organization Study ID Info
**ID:** 2024-112-002
#### Organization
**Class:** OTHER
**Full Name:** Xuanwu Hospital, Beijing
### Status Module
#### Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Xuanwu Hospital, Beijing
#### Responsible Party
**Investigator Affiliation:** Xuanwu Hospital, Beijing
**Investigator Full Name:** Liankun_Ren
**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:** The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Subiculum as adjunctive therapy for reducing the frequency of seizures in drug-resistant temporal lobe epilepsy with bilateral hippocampal sclerosis
**Detailed Description:** This project aims to include 6 participants, and evaluate the effectiveness and safety of bilateral hippocampal subcortical stimulation in patients with temporal lobe epilepsy and bilateral hippocampal sclerosis through A prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with temporal lobe epilepsy and bilateral hippocampal sclerosis with alternative treatment options.
### Conditions Module
**Conditions:**
- Epilepsy, Drug Resistant
**Keywords:**
- Deep Brain Stimulation
- Drug Resistant Epilepsy
- Subiculum
- Temporal lobe epilepsy with bilateral hippocampal sclerosis
- neuromodulation
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 6
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** participants will undergo subiculum-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study.
**Intervention Names:**
- Device: Subiculum-DBS ON
**Label:** subiculum-DBS group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- subiculum-DBS group
**Description:** The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for drug-resistant epilepsy.The targets used in this study are biliteral subiculum.The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the epilepsy specialist.
**Name:** Subiculum-DBS ON
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval:
SF28=(Total number of seizures in D days/D)\*28. In addition, the baseline seizure frequency is defined as mean of 3-month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100\*(double-blind SF28-baseline SF28)/baseline SF28.
**Measure:** Seizure frequency (SF28)
**Time Frame:** Up to 1 year after subculum-DBS
#### Secondary Outcomes
**Description:** The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency.
**Measure:** Seizure Responder Rate
**Time Frame:** Up to 1 year after subculum-DBS
**Description:** Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score.
**Measure:** Life quality evaluation
**Time Frame:** Up to 1 year after subculum-DBS
**Description:** Percentage change from baseline in Mini-Mental State Examination (MMSE) score.
**Measure:** Cognitive function evaluation (MMSE)
**Time Frame:** Up to 1 year after subculum-DBS
**Description:** Percentage change from baseline in Montreal Cognitive Assessment (MoCA) score.
**Measure:** Cognitive function evaluation (MoCA)
**Time Frame:** Up to 1 year after subculum-DBS
**Description:** Rate of adverse events which were judged to be study-related throughout the study.
**Measure:** Adverse Events
**Time Frame:** Up to 1 year after subculum-DBS
**Description:** The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up.
**Measure:** Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)
**Time Frame:** Up to 1 year after subculum-DBS
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants are between the ages of 14 -65 years of age
* Refractory to anti-seizure medications (ASMs).
* After comprehensive preoperative evaluation, patients who are considered unsuitable for or refuse resection surgery, or those for whom the effects of epileptic focus resection and thermocoagulation surgery are not satisfactory.
* Participants must have had a non-invasive video-EEG monitoring revealing seizure semiology and ictal EEG consistent with bilateral Temporal Lobe Epilepsy
* Biliteral hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging
* Informed consent signed.
Exclusion Criteria:
* Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
* Psychogenic non-epileptic seizures within 12 months;
* Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
* Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications;
* IQ \< 55 or severe cognitive dysfunction, unable to complete the study;
* Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
* Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
* Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function;
* Pregnant, or planning to pregnant within 2 years;
* Participation in another clinical study within 3 months;
* Not suitable for enrollment as assessed by the multidisciplinary team of the center.
**Maximum Age:** 65 Years
**Minimum Age:** 14 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Liankun Ren, MD
**Phone:** +86 13681576621
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Liankun Ren, MD
- **Phone:** +86 13681576621
- **Role:** CONTACT
***Contact 2:***
- **Name:** Liankun Ren, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Xuanwu Hospital,Capital Medical University
**State:** Beijing
**Zip:** 100053
#### Overall Officials
**Official 1:**
**Affiliation:** Xuanwu Hospital, Beijing
**Name:** Liankun Ren, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000004828
- Term: Epilepsies, Partial
- ID: D000073376
- Term: Epileptic Syndromes
- ID: D000065703
- Term: Malformations of Cortical Development, Group I
- ID: D000054220
- Term: Malformations of Cortical Development
- ID: D000009421
- Term: Nervous System Malformations
- ID: D000000013
- Term: Congenital Abnormalities
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
### Condition Browse Module - Browse Leaves
- ID: M7983
- Name: Epilepsy
- Relevance: HIGH
- As Found: Epilepsy
- ID: M15415
- Name: Sclerosis
- Relevance: HIGH
- As Found: Sclerosis
- ID: M7989
- Name: Epilepsy, Temporal Lobe
- Relevance: HIGH
- As Found: Temporal Lobe Epilepsy
- ID: M2908
- Name: Hippocampal Sclerosis
- Relevance: HIGH
- As Found: Hippocampal Sclerosis
- ID: M369
- Name: Drug Resistant Epilepsy
- Relevance: HIGH
- As Found: Epilepsy, Drug Resistant
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7984
- Name: Epilepsies, Partial
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M1165
- Name: Epileptic Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M27589
- Name: Malformations of Cortical Development
- Relevance: LOW
- As Found: Unknown
- ID: M12365
- Name: Nervous System Malformations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004827
- Term: Epilepsy
- ID: D000004833
- Term: Epilepsy, Temporal Lobe
- ID: D000092223
- Term: Hippocampal Sclerosis
- ID: D000069279
- Term: Drug Resistant Epilepsy
- ID: D000012598
- Term: Sclerosis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436534
**Brief Title:** Efficacy and Safety of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis
**Official Title:** A Randomized, Double-blind, Placebo-controlled, Single-center Clinical Trial of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis
#### Organization Study ID Info
**ID:** ENTAR-GCV20240205
#### Organization
**Class:** OTHER
**Full Name:** Wuhan Union Hospital, China
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Wuhan Union Hospital, China
#### Responsible Party
**Investigator Affiliation:** Wuhan Union Hospital, China
**Investigator Full Name:** Chen Jianjun
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to learn about the clinical efficacy and safety of ganciclovir (GCV) capsules in the treatment of refractory moderate-to-severe allergic rhinitis. The main questions it aims to answer are:
1. Whether ganciclovir improve nasal symptoms and life quality in patients with refractory moderate-to-severe allergic rhinitis.
2. Whether ganciclovir is safe for the treatment of allergic rhinitis.
Participants with refractory moderate-to-severe allergic rhinitis will be included in the trial based on the inclusion and exclusion criteria, and randomized into experimental and control groups.
The two groups will be treated with blinded ganciclovir capsules or placebo for two weeks, with the background therapy of mometasone furoate aqueous nasal spray. A placebo is a look-alike capsule that contains no active drug. Nasal symptom scores, nasal secretions, blood samples and adverse events will be collected during the visits.
Researchers will compare the experimental and control groups to see whether ganciclovir improve symptoms and is safe for the treatment of refractory moderate-to-severe allergic rhinitis.
**Detailed Description:** Ganciclovir (GCV) is clinically used for the treatment of DNA viral infections. In clinical practice, we have found that patients with refractory AR have improved nasal symptoms after oral administration of ganciclovir. In clinical practice, we have found that patients with refractory AR have improved nasal symptoms after oral administration of ganciclovir. To further explore the role of GCV in the treatment of refractory allergic rhinitis, we have conducted an interventional non-randomised cohort study of GCV for refractory AR. The results found that 65% of all refractory AR patients included in the observation were effectively treated with GCV. Based on the previous discovery in the clinical practice, the conjecture is proposed that ganciclovir may improve symptoms in allergic rhinitis patients, in particular the patients with refractory moderate-to-severe allergic rhinitis. Thus, the randomized, double-blind, placebo-controlled clinical trial was designed to explore the validity of this hypothesis.
The research involves three phases: screening phase(Day-14±2\~0)；baseline (Day1)；treatment phase (Day1\~14)；follow-up phase (Day14\~28).
In the screening phase, anterior rhinoscopy, serum specific IgE test, skin prick test, total nasal symptom scores (TNSS), visual analogue scale (VAS) scores, Allergic Rhinitis Control Test (ARCT) score will be performed for participants. Participants who meet the inclusion and exclusion criteria will enter the treatment phase and receive the medication for two weeks. At the end of the treatment, researchers will follow participants for two weeks to track efficacy and safety.
Researchers will collect participants' symptom scores, nasal secretions and blood. The biological specimens will be used to test for indicators that support the determination of therapeutic efficacy. Vital signs, blood routine examination, urine routines, liver function test, kidney function test and electrocardiograms will be measured for participants before and after treatment to assess the safety of ganciclovir.
The data collected will be statistically analyzed to examine the clinical efficacy and safety of ganciclovir capsules in the treatment of refractory moderate-to-severe allergic rhinitis.
### Conditions Module
**Conditions:**
- Rhinitis, Allergic
### 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:** A 2-week course of treatment: Ganciclovir capsules(250mg), take 2 capsules twice a day + Mometasone furoate aqueous nasal spray(50μg/spray), take 1 spray once a day.
**Intervention Names:**
- Drug: Ganciclovir Oral Capsule
- Drug: Mometasone Nasal
**Label:** Ganciclovir
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** A 2-week course of treatment: Ganciclovir simulant capsules(0mg), take 2 capsules twice a day + Mometasone furoate aqueous nasal spray(50μg/spray), take 1 spray once a day.
**Intervention Names:**
- Drug: Ganciclovir Simulant Oral Capsule
- Drug: Mometasone Nasal
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ganciclovir
**Description:** 2-week course：Ganciclovir capsules(250mg), take 2 capsules twice a day
**Name:** Ganciclovir Oral Capsule
**Other Names:**
- Ganciclovir
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** 2-week course：Ganciclovir simulant capsules(0mg), take 2 capsules twice a day
**Name:** Ganciclovir Simulant Oral Capsule
**Other Names:**
- Ganciclovir
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Ganciclovir
- Placebo
**Description:** 2-week course：Mometasone furoate aqueous nasal spray(50μg/spray), take 1 spray once a day
**Name:** Mometasone Nasal
**Other Names:**
- Mometasone furoate aqueous nasal spray
- NASONEX
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** After 2 weeks of medication, the investigator assessed the rate of change in the difference in TNSS from baseline. Calculated as (total post-treatment symptom score - total pre-treatment symptom score)/total pre-treatment symptom score × 100%.
**Measure:** Rate of improvement in TNSS scores
**Time Frame:** From baseline to the end of treatment (2 weeks)
#### Secondary Outcomes
**Description:** Participants with a \>30% decrease in total nasal symptom scores (TNSS) after 2 weeks of treatment are considered effective. The percentage of participants effective on treatment will be assessed as total effective rate.
**Measure:** Total effective rate
**Time Frame:** From baseline to the end of treatment (2 weeks)
**Description:** TNSS assesses symptom severity in four subdomains consisting of sneezing, rhinorrhea, nasal itching, and nasal obstruction. Each subdomain is rated on a scale of 0 (no symptoms) to 3 (severe symptoms that are difficult to tolerate and interfere with daily activity). The overall TNSS score is the sum of all four symptoms resulting in a maximum score of 12.
**Measure:** Rate and absolute value of change in TNSS and four subdomains.
**Time Frame:** From baseline to the end of treatment (2 weeks)
**Description:** The VAS ranges from 0 to 100. A score of 0 corresponds to no symptoms and 100 corresponds to the worst symptoms.
**Measure:** Rate and absolute value of change in visual analogue scale (VAS) scores
**Time Frame:** From baseline to the end of treatment (2 weeks)
**Description:** RQLQ is a validated QOL instrument consisting of 28 questions in seven domains (limited activity, sleep, practical problems, nasal symptoms, eye symptoms, emotional function, and non-nose/eye or other symptoms). Each domain is graded from zero (not impaired at all) to six (severely impaired), and the overall RQLQ is the mean score of all 28 responses
**Measure:** Rate and absolute value of change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
**Time Frame:** From baseline to the end of treatment (2 weeks)
**Description:** Participants assess the TNSS score on a daily basis. TNSS assesses symptom severity in four subdomains consisting of sneezing, rhinorrhea, nasal itching, and nasal obstruction. Each subdomain is rated on a scale of 0 (no symptoms) to 3 (severe symptoms that are difficult to tolerate and interfere with daily activity). The overall TNSS score is the sum of all four symptoms resulting in a maximum score of 12.
**Measure:** Change in mean TNSS during a 2-week administration period
**Time Frame:** During the 2-week administration period
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Aged between 18 and 65 years.
2. Diagnosed with moderate-to-severe perennial allergic rhinitis based on Chinese guideline for diagnosis and treatment of allergic rhinitis (2022, revision) with Allergic Rhinitis Control Test (ARCT) score \<20.
3. Total Nasal Symptom Score (TNSS) ≥6 or at least two of the four subdomains(sneezing, rhinorrhea, nasal itching, and nasal obstruction) ≥2 at the time of both screening and randomization. And the improvement in TNSS was assessed as \< 30% at randomization compared to screening.
4. The participant is allergic to dust mites or other perennial allergens
5. Voluntarily participate in the clinical trial and sign the informed consent.
Exclusion Criteria:
1. Participants with hypersensitivity to ganciclovir capsules and its excipients.
2. Have symptoms of viral infection, fever and other systemic symptoms in the past 2 weeks.
3. Pregnant or lactating women and participants who have pregnancy plan during the study period.
4. Participants with severe neutropenia (absolute neutrophil count less than 0.5\*10\^9/L) or severe thrombocytopenia (platelet count less than 2.5\*10\^10/L).
5. Comorbidities such as upper and lower respiratory tract infections, history of acute or chronic sinusitis, dry rhinitis, atrophic rhinitis, severe deviated septum and asthma.
6. Participants with other severe heart, lung, liver and kidney disease.
7. Participants who had received any live or attenuated vaccine within 4 weeks prior to baseline or intended to receive live or attenuated vaccine (or BCG treatment) during the study period or within 4 weeks after the last administration of the investigational drug product.
8. Participants with a history of HIV infection or who test positive for HIV serology.
9. Participants currently infected or chronically infected with hepatitis B virus (HBV) or hepatitis C virus (HCV).
10. Participants with cirrhosis and/or chronic hepatitis.
11. Participants who have been diagnosed with active parasitic infections or are at high risk of developing such infections.。
12. Participants with a known or suspected history of immunosuppression, including a history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumosporidiosis, aspergillosis). Or participants with what researchers believe to be unusually frequent, recurring, or prolonged infections.
13. Participants with a known history of malignancy within 5 years prior to screening.
14. Participants with severe co-morbidities that, in the opinion of the investigator, would adversely affect their participation in this study.
15. Participants with combined neurological or psychiatric disorders who are unable or reluctant to cooperate.
16. Participants with disabilities prescribed by law (blind, deaf, mute, mentally challenged, mentally handicapped, etc.).
17. Participants suspected or having a history of alcohol and drug abuse.
18. Other participants who have been involved in other clinical trials within 3 months before the screening.
19. The researchers consider it inappropriate to participate in this clinical trial.
**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:** Jianjun Chen
**Phone:** +86-13659851719
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Wuhan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jianjun Chen
- **Phone:** +86-13659851719
- **Role:** CONTACT
**Country:** China
**Facility:** Wuhan Union Hospital
**State:** Hubei
**Status:** RECRUITING
**Zip:** 430022
#### Overall Officials
**Official 1:**
**Affiliation:** Wuhan Union Hospital, China
**Name:** Jianjun Chen
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Mathur V, Burai R, Vest RT, Bonanno LN, Lehallier B, Zardeneta ME, Mistry KN, Do D, Marsh SE, Abud EM, Blurton-Jones M, Li L, Lashuel HA, Wyss-Coray T. Activation of the STING-Dependent Type I Interferon Response Reduces Microglial Reactivity and Neuroinflammation. Neuron. 2017 Dec 20;96(6):1290-1302.e6. doi: 10.1016/j.neuron.2017.11.032.
**PMID:** 29268096
**Citation:** Ding Z, Mathur V, Ho PP, James ML, Lucin KM, Hoehne A, Alabsi H, Gambhir SS, Steinman L, Luo J, Wyss-Coray T. Antiviral drug ganciclovir is a potent inhibitor of microglial proliferation and neuroinflammation. J Exp Med. 2014 Feb 10;211(2):189-98. doi: 10.1084/jem.20120696. Epub 2014 Feb 3.
**PMID:** 24493798
**Citation:** Crumpacker CS. Ganciclovir. N Engl J Med. 1996 Sep 5;335(10):721-9. doi: 10.1056/NEJM199609053351007. No abstract available.
**PMID:** 8786764
**Citation:** Demoly P, Calderon MA, Casale T, Scadding G, Annesi-Maesano I, Braun JJ, Delaisi B, Haddad T, Malard O, Trebuchon F, Serrano E. Assessment of disease control in allergic rhinitis. Clin Transl Allergy. 2013 Feb 18;3(1):7. doi: 10.1186/2045-7022-3-7.
**PMID:** 23419058
**Citation:** Demoly P, Jankowski R, Chassany O, Bessah Y, Allaert FA. Validation of a self-questionnaire for assessing the control of allergic rhinitis. Clin Exp Allergy. 2011 Jun;41(6):860-8. doi: 10.1111/j.1365-2222.2011.03734.x. Epub 2011 Apr 25.
**PMID:** 21518040
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000009668
- Term: Nose Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
- ID: D000012130
- Term: Respiratory Hypersensitivity
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC09
- Name: Ear, Nose, and Throat 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: M15049
- Name: Rhinitis
- Relevance: HIGH
- As Found: Rhinitis
- ID: M30545
- Name: Rhinitis, Allergic
- Relevance: HIGH
- As Found: Rhinitis, Allergic
- 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: M12604
- Name: Nose Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M14967
- Name: Respiratory Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012220
- Term: Rhinitis
- ID: D000065631
- Term: Rhinitis, Allergic
### Intervention Browse Module - Ancestors
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000003879
- Term: Dermatologic Agents
- ID: D000018926
- Term: Anti-Allergic Agents
- ID: D000000998
- Term: Antiviral Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000019384
- Term: Nucleic Acid Synthesis Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: AAll
- Name: Anti-Allergic Agents
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
### Intervention Browse Module - Browse Leaves
- ID: M290
- Name: Mometasone Furoate
- Relevance: HIGH
- As Found: Engagement
- ID: M18331
- Name: Ganciclovir
- Relevance: HIGH
- As Found: Leaflet
- ID: M340476
- Name: Ganciclovir triphosphate
- Relevance: HIGH
- As Found: Leaflet
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7074
- Name: Dermatologic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20962
- Name: Anti-Allergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4314
- Name: Antiviral Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000068656
- Term: Mometasone Furoate
- ID: D000015774
- Term: Ganciclovir
- ID: C000092309
- Term: Ganciclovir triphosphate
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436521
**Brief Title:** The Efficacy of Online Brief Positive Cognitive Behavior Therapy Compared to Traditional Cognitive Behavior Therapy
**Official Title:** The Efficacy of Online Brief Positive Cognitive Behavior Therapy Compared to Traditional Cognitive Behavior Therapy on Improving Well-Being and Goal Attainment in Young Adults
#### Organization Study ID Info
**ID:** MDStudy
#### Organization
**Class:** OTHER
**Full Name:** Babes-Bolyai University
### Status Module
#### Completion Date
**Date:** 2015-03
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2015-03
**Type:** ACTUAL
#### Start Date
**Date:** 2014-10
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-22
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Babes-Bolyai University
#### Responsible Party
**Investigator Affiliation:** Babes-Bolyai University
**Investigator Full Name:** Comsa Loana
**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:** Positive Cognitive Behavioral Therapy (P-CBT) has emerged as the fourth Cognitive Behavioral Therapy waive, based on critiques brought to Cognitive Behavioral Therapy for being grounded in the deficit-based medical model. The study aim to identify which of the two Cognitive Behavioral Therapy approaches, Positive or Traditional, is more effective in a brief format in terms of improving emotional state, attaining goals, and changing attitudes in young adults.
**Detailed Description:** This study is a randomized controlled trial that aims to explore the effectiveness of two Cognitive Behavioral approaches: Positive and Traditional, in terms of improving emotional state, attaining goals, and changing attitudes in young adults. Thirty-eight participants divided into two groups, received four therapy sessions for four weeks. The outcomes were measured four times: pre-, mid- (after two sessions), post-intervention (after four sessions), and at two-month follow-up.
### Conditions Module
**Conditions:**
- Emotional Distress
- Well-Being, Psychological
- Performance
**Keywords:**
- Solution-focused
- Problem-solving
- Positive CBT
- Traditional CBT
- Well-being
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Participants were assigned to one approach: Positive CBT or Traditional CBT, through simple randomization.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 38
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants received P-CBT intervention after a standard protocol. The intervention used Solution-focused questioning.
**Intervention Names:**
- Behavioral: Positive Cognitive Behavioral Therapy
**Label:** Positive CBT (P-CBT)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants received T-CBT intervention after a standard protocol. The intervention used Problem-solving questioning.
**Intervention Names:**
- Behavioral: Traditional Cognitive Behavioral Therapy
**Label:** Traditional CBT (T-CBT)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Positive CBT (P-CBT)
**Description:** Positive CBT integrates brief Solution-Focused Brief Therapy with Positive Psychology techniques, within a cognitive-behavioral framework. It is considered a competency and strengths-based model.
**Name:** Positive Cognitive Behavioral Therapy
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Traditional CBT (T-CBT)
**Description:** Traditional cognitive behavioral therapy is a form of psychological treatment that emphasizes that psychological problems are based on faulty or unhelpful ways of thinking and the focus is to change thinking patterns.
**Name:** Traditional Cognitive Behavioral Therapy
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The level of negative emotions, measured with Profile of Affective Distress plus. The items are ranked with a 5-point Likert scale. Higher scores mean a worse outcome.
**Measure:** Distress
**Time Frame:** Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 month.
**Description:** The level of positive emotions, measured with Profile of Affective Distress plus; The items are ranked with a 5-point Likert scale.Higher scores mean a better outcome.
**Measure:** Positive Emotions
**Time Frame:** Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 month.
**Description:** Performance was measured using a Visual Analogue Scale -type item. The outcome had a one-item ranging from 1 to 10. Participants had to assess the statement: - How close are you to solving the problem/attaining your goal? Higher scores mean a better outcome.
**Measure:** Performance
**Time Frame:** Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 months.
**Description:** Measured with Solution Focused Inventory; The items are ranked with a 6-point Likert scale. Higher scores mean a better outcome.
**Measure:** Attitude towards problems
**Time Frame:** Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 months.
**Description:** Measured with Solution Focused Inventory; The items are ranked with a 6-point Likert scale. Higher scores mean a better outcome.
**Measure:** Attitude towards goals
**Time Frame:** Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 months.
**Description:** Measured with Solution Focused Inventory; The items are ranked with a 6-point Likert scale. Higher scores mean a better outcome.
**Measure:** Attitude towards resources
**Time Frame:** Baseline, pre-intervention; in the middle of intervention, after 2 sessions (2 weeks); immediately after the intervention (4 weeks); 2 months.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Students in the master's program in psychology
Exclusion Criteria:
-
**Healthy Volunteers:** True
**Maximum Age:** 30 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cluj-Napoca
**Country:** Romania
**Facility:** Departement of Clinical Psychology and and Psychotherapy, Babes-Bolyai University
**State:** Cluj
**Zip:** 40015
#### Overall Officials
**Official 1:**
**Affiliation:** Babes-Bolyai University Cluj-Napoca
**Name:** Loana T Comsa, Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Bannink, F. (2012). Practicing positive CBT: From reducing distress to building success. John Wiley & Sons https://doi.org/10.1002/9781118328941
**Citation:** Bannink, F., & Geschwind, N. (2021). , Positive CBT: Individual and Group Treatment Protocols for Positive Cognitive Behavioral Therapy. In Positive CBT: Individual and Group Treatment Protocols for Positive Cognitive Behavioral Therapy. https://doi.org/10.1027/00578-000
**Citation:** Bhattacharya S, Goicoechea C, Heshmati S, Carpenter JK, Hofmann SG. Efficacy of Cognitive Behavioral Therapy for Anxiety-Related Disorders: A Meta-Analysis of Recent Literature. Curr Psychiatry Rep. 2023 Jan;25(1):19-30. doi: 10.1007/s11920-022-01402-8. Epub 2022 Dec 19.
**PMID:** 36534317
**Citation:** Braunstein, K., & Grant, A. M. (2016). Approaching solutions or avoiding problems? The differential effects of approach and avoidance goals with solution-focused and problem-focused coaching questions. Coaching, 9(2). https://doi.org/10.1080/17521882.2016.1186705
**Citation:** Cohen, J. (1988a). Statistical power analysis for the behavioral sciences (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum Associates.
**Citation:** Cuijpers P, Miguel C, Harrer M, Plessen CY, Ciharova M, Ebert D, Karyotaki E. Cognitive behavior therapy vs. control conditions, other psychotherapies, pharmacotherapies and combined treatment for depression: a comprehensive meta-analysis including 409 trials with 52,702 patients. World Psychiatry. 2023 Feb;22(1):105-115. doi: 10.1002/wps.21069.
**PMID:** 36640411
**Citation:** de Boer AG, van Lanschot JJ, Stalmeier PF, van Sandick JW, Hulscher JB, de Haes JC, Sprangers MA. Is a single-item visual analogue scale as valid, reliable and responsive as multi-item scales in measuring quality of life? Qual Life Res. 2004 Mar;13(2):311-20. doi: 10.1023/B:QURE.0000018499.64574.1f.
**PMID:** 15085903
**Citation:** De Shazer, S., & Berg, I. K. (1997). "What works?" Remarks on research aspects of Solution-Focused Brief Therapy. Journal of Family Therapy, 19(2). https://doi.org/10.1111/1467-6427.00043
**Citation:** De Shazer S, Berg IK, Lipchik E, Nunnally E, Molnar A, Gingerich W, Weiner-Davis M. Brief therapy: focused solution development. Fam Process. 1986 Jun;25(2):207-21. doi: 10.1111/j.1545-5300.1986.00207.x.
**PMID:** 3732502
**Citation:** Erbe D, Eichert HC, Riper H, Ebert DD. Blending Face-to-Face and Internet-Based Interventions for the Treatment of Mental Disorders in Adults: Systematic Review. J Med Internet Res. 2017 Sep 15;19(9):e306. doi: 10.2196/jmir.6588.
**PMID:** 28916506
**Citation:** Geschwind N, Arntz A, Bannink F, Peeters F. Positive cognitive behavior therapy in the treatment of depression: A randomized order within-subject comparison with traditional cognitive behavior therapy. Behav Res Ther. 2019 May;116:119-130. doi: 10.1016/j.brat.2019.03.005. Epub 2019 Mar 9.
**PMID:** 30897464
**Citation:** Grant, A. M. (2012). Making Positive Change: A Randomized Study Comparing Solution-Focused vs. Problem-Focused Coaching Questions. Journal of Systemic Therapies, 31(2). https://doi.org/10.1521/jsyt.2012.31.2.21
**Citation:** Grant, A. M., & O'Connor, S. A. (2010). The differential effects of solution-focused and problem-focused coaching questions: A pilot study with implications for practice. Industrial and Commercial Training, 42(2). https://doi.org/10.1108/00197851011026090
**Citation:** Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31.
**PMID:** 23459093
**Citation:** Padesky CA, Mooney KA. Strengths-based cognitive-behavioural therapy: a four-step model to build resilience. Clin Psychol Psychother. 2012 Jul-Aug;19(4):283-90. doi: 10.1002/cpp.1795. Epub 2012 Jun 1.
**PMID:** 22653834
**Citation:** Seligman, M. E. (2002). Positive psychology, positive prevention, and positive therapy. Handbook of positive psychology, 2(2002), 3-12.
**Citation:** Seligman, M. E. (2002). Authentic happiness: Using the new positive psychology to realize your potential for lasting fulfillment. Simon and Schuster.
**Citation:** Tomoiagă, C., & David, O. (2023). Is cognitive-behavioral coaching an empirically supported approach to coaching? a meta-analysis to investigate its outcomes and moderators. Journal of Rational-Emotive & Cognitive-Behavior Therapy, 41(2), 489-510. https://doi.org/10.1007/s10942-023-00498-y
## 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436508
**Brief Title:** The Investigation of the Impact of Early Mobilization on the Outcome in Patients With Aneurysmal Subarachnoid Hemorrhage.
**Official Title:** The Investigation of the Impact of Early Mobilization on the Outcome, the Appearance of Early Ischemic Damage, the Functional Status, and the Length of Intensive Care Treatment in Patients With Aneurysmal Subarachnoid Hemorrhage.
#### Organization Study ID Info
**ID:** HunSAHEMob
#### Organization
**Class:** OTHER
**Full Name:** University of Pecs
### Status Module
#### Completion Date
**Date:** 2026-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-01-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-06-14
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-27
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** National Institute of Mental, Neurological and Neurosurgery
**Class:** UNKNOWN
**Name:** Borsod-Abaúj-Zemplén County Central Hospital and University Teaching Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Pecs
#### Responsible Party
**Investigator Affiliation:** University of Pecs
**Investigator Full Name:** Péter Csécsei
**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 the randomized clinical trial is to examine the effect of early mobilization on primary and secondary outcomes in patients with subarachnoid hemorrhage caused by aneurysm rupture.
Researchers will compare early mobiliziation vs. standrad bed rest care.
### Conditions Module
**Conditions:**
- Early Ambulation
- Standard of Care
- Subarachnoid Hemorrhage, Aneurysmal
**Keywords:**
- subarachnoid hemorrhage
- early mobilization
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This group is mobilized in the intensive care unit by the institutional physiotherapist with the assistance of specialized personnel. Mobilization is carried out according to the Early Mobilization Protocol (EMP)
Early mobilization protocol:
* Step 1 - Day 1: Bed rest, elevation of the head end to 30°
* Step 2 - Day 2: Bed rest, elevation of the head end to 60°
* Step 3 - Day 3: Bed rest, elevation of the head end to 80°
* Step 4 - Day 4: Sitting on the edge of the bed
* Step 5 - Day 5: Sitting in a chair, standing up
* Step 6 - Day 6: Walking with or without assistance
* Step 7 - Day 7: Walking with or without assistance from today
**Intervention Names:**
- Behavioral: Early mobilization protocol
**Label:** Early mobilization
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** No early mobilization
**Intervention Names:**
- Behavioral: Standard care
**Label:** Standard bed rest
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Early mobilization
**Description:** * Step 1 - Day 1: Bed rest, elevation of the head end to 30°
* Step 2 - Day 2: Bed rest, elevation of the head end to 60°
* Step 3 - Day 3: Bed rest, elevation of the head end to 80°
* Step 4 - Day 4: Sitting on the edge of the bed
* Step 5 - Day 5: Sitting in a chair, standing up
* Step 6 - Day 6: Walking with or without assistance
* Step 7 - Day 7: Walking with or without assistance from today
**Name:** Early mobilization protocol
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Standard bed rest
**Description:** During standard care, early mobilization does not take place in the intensive care unit; the patient receives only standard supportive care in bed rest.
**Name:** Standard care
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Outcome assessments will include:
Modified Rankin Scale
Disability is assessed by the modified Rankin Scale, dichotomized at a score of 0 to 3 versus 4 to 6 (6=death).Assessment is performed by a blinded investigator of the local study center by personal visit.
**Measure:** Disability in early mobilization group (EM) vs. standard care group (SC) - modified Rankin score
**Time Frame:** 14 day; 3 months
**Description:** Extended Glasgow Outcome Scale
Description of the neurological outcome by using extended Glasgow Outcome Score
1. Death
2. Vegetative sate
3. Lower severe disability
4. Upper severe disability
5. Lower moderate disability
6. Upper moderate disability
7. Lower good recovery
8. Upper good recovery
Assessment is performed by a blinded investigator of the local study center by personal visit.
**Measure:** Disability in early mobilization group (EM) vs. standard care group (SC) - Extended Glasgow Outcome Scale
**Time Frame:** 14 day; 3 months
#### Secondary Outcomes
**Description:** Occurence of DCI after aneurysmal subarachnoid hemorrhage
**Measure:** Onset of delayed cerebral ischemia (DCI)
**Time Frame:** 3-21 days
**Description:** based on cerebral vasospasm grade
Grade 0 All intracranial vessels show a physiological shape Grade 1 Vasospasm affects the A2, A1, and M2 segments Grade 2 Vasospasm expands to the M1 and terminal segment of the internal carotid artery Grade 3 Severe reduction in the intradural internal carotid artery with filiform A1 and M1 segments, which sometimes appears like a ghost (ghost sign)
**Measure:** Onset of severity of macrovascular vasospasm
**Time Frame:** Up to 14 days
**Description:** Length of stay in the Intensive Care Unit (ICU)
**Measure:** Stay in the Intensive Care Unit (ICU)
**Time Frame:** Up to 28 days
**Description:** home discharge, rehabilitation, chronic care, etc.
**Measure:** Type of post-hospital discharge placement
**Time Frame:** Up to 30 days
**Description:** repeated ICU treatment following ward discharge
**Measure:** Readmission to the ICU
**Time Frame:** Up to 30 days
**Description:** infection and its time in the intensive care unit
**Measure:** Occurrence of infection and its time in the intensive care unit
**Time Frame:** Up to 30 days
**Description:** For assessing activities of daily living in patients with aneurysmal subarachnoid hemorrhage; ordinal scale rates bowel function, bladder function, grooming, toilet use, feeding independence, transfer independence, mobility, dressing ability, stair use, and bathing ability to tabulate a composite score ranging from 0 to 100. Score of 100 represents totally independent.
Assessment is performed by a blinded investigator of the local study center by personal visit.
**Measure:** Barthel score
**Time Frame:** 14 day; 3 months
**Description:** The FIM's assessment of degree of disability depends on the patient's score in 18 categories, focusing on motor and cognitive function. Each category or item is rated on a 7-point scale (1 = \<25% independence; total assistance required, 7 = 100% independence)
Assessment is performed by a blinded investigator of the local study center by personal visit.
**Measure:** Functional Independence Measure (FIM) scale
**Time Frame:** 14 day
**Description:** MoCA scores range between 0 and 30.
The MoCA is used for assessment for detecting cognitive impairment. A score of 26 or over is considered to be normal.
Assessment is performed by a blinded investigator of the local study center by personal visit.
**Measure:** Montreal Cognitive Assessment (MoCA)
**Time Frame:** 14 day; 3 months
**Description:** Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case.
Assessment is performed by a blinded investigator of the local study center by personal visit.
**Measure:** Hospital Anxiety and Depression Scale (HADS)
**Time Frame:** 14 day; 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age \>18 ys
* Premorbid modified Rankin Scale score of 0-2
* WFNS I-IV at enrollment
* Aneurysm occlusion has occurred through open or endovascular means
* Minimum 24 hours elapsed after aneurysm occlusion
* The patient has not received thrombolytic therapy
* Vital parameters are appropriate (mean arterial pressure \[MAP\] \>80 or \>110 mm Hg)
* Signed patient information and consent form
* Enrollment occurs within 72 hours following ictus
Exclusion Criteria:
* Age under 18 years
* Traumatic subarachnoid hemorrhage
* Incapacitated or limited capacity for action before ictus
* Confirmed pregnancy
* Aneurysm multiplicity (unless all aneurysms are treated)
**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:** Peter Csecsei, MD. PhD
**Phone:** +0672535900
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Pécs
**Contacts:**
***Contact 1:***
- **Name:** Peter Csecsei, MD. PhD
- **Role:** CONTACT
**Country:** Hungary
**Facility:** University of Pecs
**State:** Baranya
**Status:** RECRUITING
**Zip:** 7624
**Location 2:**
**City:** Miskolc
**Contacts:**
***Contact 1:***
- **Name:** Csaba Olah, MD. PhD
- **Role:** CONTACT
**Country:** Hungary
**Facility:** Central Hospital of B.A.Z. County
**State:** BAZ
**Status:** RECRUITING
**Zip:** 3526
**Location 3:**
**City:** Budapest
**Contacts:**
***Contact 1:***
- **Name:** Sandor Nardai, MD. PhD
- **Role:** CONTACT
**Country:** Hungary
**Facility:** National Institute of Mental Health, Neurology, and Neurosurgery
**Status:** RECRUITING
**Zip:** 1145
#### Overall Officials
**Official 1:**
**Affiliation:** University of Pecs
**Name:** Peter Csecsei, MD. PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** upon reasonable request
**Description:** Investigators will use external resources for an appropriate repository for their data
**Info Types:**
- STUDY_PROTOCOL
- SAP
**IPD Sharing:** YES
**Time Frame:** After study completion for 3 years.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020300
- Term: Intracranial Hemorrhages
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M16135
- Name: Subarachnoid Hemorrhage
- Relevance: HIGH
- As Found: Subarachnoid Hemorrhage
- ID: M9556
- Name: Hemorrhage
- Relevance: HIGH
- As Found: Hemorrhage
- ID: M22113
- Name: Intracranial Hemorrhages
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013345
- Term: Subarachnoid Hemorrhage
- ID: D000006470
- Term: Hemorrhage
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436495
**Brief Title:** Methodology Validation: Correlating Adherent Scalp Flaking Score (ASFS) With Phototrichogram for Scalp Dandruff Evaluation in Adult Subjects
**Official Title:** Validation of Methodologies: Correlating Adherent Scalp Flaking Score (ASFS) With Phototrichogram for Comprehensive Evaluation of Scalp Dandruff in Adults
#### Organization Study ID Info
**ID:** NB240024-NB-V
#### Organization
**Class:** OTHER
**Full Name:** NovoBliss Research Pvt Ltd
### Status Module
#### Completion Date
**Date:** 2024-05-22
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-05-22
**Type:** ACTUAL
#### Start Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** NovoBliss Research Pvt Ltd
#### Responsible Party
**Investigator Affiliation:** NovoBliss Research Pvt Ltd
**Investigator Full Name:** Maheshvari Patel
**Investigator Title:** Principal Investigator - Director (Operations)
**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 aims to validate methods for assessing scalp hair dandruff by comparing three evaluation techniques: the Adherent Scalp Flaking Score (ASFS), Phototrichogram, and 60-second hair combing.
These assessments will be conducted before and after hair wash interventions on adult human subjects to evaluate adherent and non-adherent scalp flakes. By comparing the results of these evaluations, the study aims to determine the consistency and reliability of each method in assessing the presence and severity of dandruff. Establishing correlation between these assessment techniques is essential for validating their usefulness in evaluating the effectiveness of hair care products and treatments in reducing scalp dandruff. This research aims to improve the accuracy and reliability of dandruff evaluation methods, benefiting both dermatological research and clinical practice in managing this prevalent condition.
### Conditions Module
**Conditions:**
- Dandruff
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 12
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The complete study group will be given hair-wash intervention post baseline evaluations.
**Intervention Names:**
- Other: Hair Wash Shampoo
**Label:** Study Cohort
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Study Cohort
**Description:** A standard marketed hair wash shampoo is to be used for the hair wash intervention post baseline evaluations of the scalp.
**Name:** Hair Wash Shampoo
**Other Names:**
- Dove Hair Wash Shampoo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The score will be assessed by Dermatological Evaluation
**Measure:** Adherent Scalp Flaking Score
**Time Frame:** On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.
**Description:** The phototrichogram will be captured using CASLite Nova
**Measure:** Scalp Condition using Phototrichogram
**Time Frame:** On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.
#### Secondary Outcomes
**Description:** The assessment will be done via 60-second hair combing methods by dermatological assessment
**Measure:** Non-adherent scalp flakes evaluation
**Time Frame:** On Day 1 - pre hair wash, and post hair wash and drying at T30 minutes.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age between 18 and 55 years (both inclusive).
* Good general health as determined from recent medical history.
* No previous history of adverse skin conditions, and not under any medication likely to interfere with the results.
Exclusion Criteria:
* Non-willing subjects and subjects with a history of allergies or specific allergic reactions upon using dermatological/cosmetic products will not be included.
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Gandhinagar
**Country:** India
**Facility:** NovoBliss Research Pvt Ltd
**State:** Gujarat
**Zip:** 382421
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003872
- Term: Dermatitis
- ID: D000012871
- Term: Skin Diseases
- ID: D000012536
- Term: Scalp Dermatoses
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M30157
- Name: Dandruff
- Relevance: HIGH
- As Found: Dandruff
- ID: M7067
- Name: Dermatitis
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15354
- Name: Scalp Dermatoses
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000063807
- Term: Dandruff
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436482
**Acronym:** EBOCTIPCOPD
**Brief Title:** Research of Endobronchial Optical Coherence Tomography in Pre-COPD
**Official Title:** Research of Endobronchial Optical Coherence Tomography in Pre-stage of Chronic Obstructive Pulmonary Disease
#### Organization Study ID Info
**ID:** SichuanPPHGZ02
#### Organization
**Class:** OTHER
**Full Name:** Sichuan Provincial People's Hospital
### Status Module
#### Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sichuan Provincial People's Hospital
#### Responsible Party
**Investigator Affiliation:** Sichuan Provincial People's Hospital
**Investigator Full Name:** Guanghong Zhou
**Investigator Title:** Attending physician
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The pre-stage of Chronic Obstructive Pulmonary Disease (Pre-COPD) is challenging to diagnose. However, identifying Pre-COPD is a crucial step in the prevention and management of COPD. Endobronchial optical coherence tomography showed the value of diagnosis in Pre-COPD and COPD in previous researchs.
**Detailed Description:** We recruited COPD patients (stage I-II, n=15; stage III-IV, n= 15), Pre-COPD (n= 20) and healthy never-smokers (healthy human, n=21). Age,gender,BMI, smoking history, spirometry, chest computed tomography (CT), bronchoscopy and EB-OCT were performed. Inner luminal area (Ai) and airway wall area (Aw) of bronchi which inner perimeter was 10mm, 20mm and 30mm were measured using EB-OCT respectively. By analyzing and studying the above situation, we aim to discover the application value of OCT in Pre-COPD
### Conditions Module
**Conditions:**
- Chronic Obstructive Pulmonary Disease
- Optical Coherence Tomography
- Pulmonary Function
**Keywords:**
- Chronic Obstructive Pulmonary Disease
- Optical Coherence Tomography
- pre-stage
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** non-smoking with normal lung function, no other pulmonary diseases besides pulmonary nodule as indicated by chest computed tomography (CT).
**Intervention Names:**
- Device: Optical Coherence Tomography
**Label:** Control group
#### Arm Group 2
**Description:** Patients exhibit early pulmonary abnormalities, such as, CT scans show the presence of emphysema, bullae, and air trapping; pulmonary function manifested as preserved ratio impaired spirometry (PRISm). PRISm was defined as a normal ratio \[the forced expiratory volume in one second (FEV1) / forced vital capacity (FVC) ≥ 0.7\] after inhalation of a bronchodilator, but impaired ventilatory function \[percentage of forced expiratory volume in the first second to the expected value (FEV1%) and/or percentage of FVC to the expected value (FVC%) \< 80%\], with concurrent structural changes in the lungs (such as emphysema) and/or physiological abnormalities (such as hyperinflation, decreased diffusion capacity, rapid decline in FEV1 )
**Intervention Names:**
- Device: Optical Coherence Tomography
**Label:** Pre-stage of Chronic Obstructive Pulmonary Disease (Pre-COPD)
#### Arm Group 3
**Description:** COPD was diagnosed based on GOLD guideline \[1\]; No acute exacerbations within 4 weeks; CT scans show no other pulmonary diseases besides COPD; pulmonary function test results were available from within the last 3 days. All COPD patients were treatment-naive except for those with at stage III-IV who received maintenance therapy
**Intervention Names:**
- Device: Optical Coherence Tomography
**Label:** Chronic Obstructive Pulmonary Disease (COPD)
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Chronic Obstructive Pulmonary Disease (COPD)
- Control group
- Pre-stage of Chronic Obstructive Pulmonary Disease (Pre-COPD)
**Description:** Placing the probe of OCT in RB10c through the working channel of bronchoscope for real time dynamic scanning and collecting OCT parameters from participants in different groups.
**Name:** Optical Coherence Tomography
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Representative EB-OCT images(airway remodeling, mucosa thickening ) in CP，Pre-COPD and COPD
**Measure:** Representative EB-OCT images of airway disorders
**Time Frame:** baseline
**Description:** Inner luminal area (Ai，mm) and airway wall area (Aw,mm2) of bronchi which inner perimeter was 10mm, 20mm and 30mm were measured using EB-OCT respectively.
**Measure:** EB-OCT parameters in different stages of COPD
**Time Frame:** baseline
#### Secondary Outcomes
**Description:** Age（year）, gender(Male/female), smoking history(yes/no)
**Measure:** Baseline clinical characteristics
**Time Frame:** baseline
**Measure:** BMI（Kg/m2)）
**Time Frame:** baseline
**Description:** Baseline clinical characteristics
**Measure:** pulmonary function test (FEV1 predicted %)
**Time Frame:** baseline
**Measure:** FEV1/FVC ratio
**Time Frame:** baseline
**Description:** Baseline clinical characteristics
**Measure:** MMEF 25/75
**Time Frame:** baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* non-smoking with normal lung function, no other pulmonary diseases besides pulmonary nodule as indicated by chest computed tomography (CT).
Exclusion Criteria:
* (1) patients with contraindication of bronchoscopy, (2) patients who are participating in other clinical studies, (3) patients with poor compliance who are believed by the researchers to be unable to cooperate for the completion of the examination and follow-up, and (4) women who were pregnant.
**Healthy Volunteers:** True
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Pre-COPD: Pre-COPD was diagnosed based on GOLD 2022; Patients exhibit early pulmonary abnormalities, such as, CT scans show the presence of emphysema, bullae, and air trapping; COPD: COPD was diagnosed based on GOLD guideline; No acute exacerbations within 4 weeks; CT scans show no other pulmonary diseases besides COPD; pulmonary function test results were available from within the last 3 days. All COPD patients were treatment-naive except for those with at stage III-IV who received maintenance therapy.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Guanghong G Zhou, Master
**Phone:** 86-18302880040
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Guanghong G Zhou, Master
**Phone:** 18302880040
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chengdu
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Guanghong Zhou, master
- **Phone:** 18302880040
- **Role:** CONTACT
**Country:** China
**Facility:** Sichuan Provincial People's Hospital
**State:** Sichuan
**Status:** RECRUITING
**Zip:** 610072
#### Overall Officials
**Official 1:**
**Affiliation:** Sichuan Provincial People's Hospital
**Name:** Guanghong G Zhou, Master
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11168
- Name: Lung Diseases
- Relevance: HIGH
- As Found: Pulmonary Disease
- ID: M11170
- Name: Lung Diseases, Obstructive
- Relevance: HIGH
- As Found: Obstructive Pulmonary Disease
- ID: M23449
- Name: Pulmonary Disease, Chronic Obstructive
- Relevance: HIGH
- As Found: Chronic Obstructive Pulmonary Disease
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008171
- Term: Lung Diseases
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000029424
- Term: Pulmonary Disease, Chronic Obstructive
### Intervention Browse Module - Browse Branches
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5269
- Name: Bronchodilator Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436469
**Brief Title:** MBSR Programs to Reduce Compassion Fatigue in Nurses
**Official Title:** Mindfulness-based Stress Reduction Programs to Reduce Compassion Fatigue in Nurses
#### Organization Study ID Info
**ID:** 2024-280-NSU
#### Organization
**Class:** OTHER
**Full Name:** Nova Southeastern University
### Status Module
#### Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Nova Southeastern University
#### Responsible Party
**Investigator Affiliation:** Nova Southeastern University
**Investigator Full Name:** Ruthlande Nore
**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 goal of this observational study is to evaluate the effectiveness of a mindfulness-based stress reduction (MBSR) program in reducing compassion fatigue among nurses. The main question it aims to answer is:
Does participation in an MBSR program decrease levels of compassion fatigue among nurses? The primary hypothesis is that nurses who participate in the MBSR program will experience a significant reduction in compassion fatigue after implementing the interventions.
Participants will include psychiatric nurse practitioners working in high-stress environments.
Participants will:
Attend a series of MBSR sessions over a specified period. Engage in mindfulness practices such as body scans, and deep breathing. Complete self-report measures to assess levels of compassion fatigue before and after the intervention.
**Detailed Description:** This observational study aims to assess the impact of a mindfulness-based stress reduction (MBSR) program on reducing compassion fatigue among psychiatric nurse practitioners working in high-stress environments. The primary question it seeks to address is whether participation in the MBSR program leads to decreased levels of compassion fatigue among nurses.
The primary hypothesis posits that nurses who engage in the MBSR program will experience a significant reduction in compassion fatigue following the intervention.
Participants in this study will be psychiatric nurse practitioners who work in demanding healthcare settings. These individuals will be invited to participate voluntarily in the MBSR program.
The intervention will involve participants attending a series of MBSR sessions conducted over a specified period, typically lasting around 4 weeks. During these sessions, participants will be guided through various mindfulness practices, including body scans and deep breathing exercises. These techniques are designed to enhance participants' awareness of their thoughts, emotions, and bodily sensations, promoting a nonjudgmental acceptance of their experiences.
To assess the effectiveness of the intervention, participants will complete self-report measures to evaluate their levels of compassion fatigue. These assessments will be administered both before the start of the MBSR program (baseline/pretest) and after its completion (follow-up/posttest). By comparing pre- and post-intervention scores, researchers will evaluate any changes in compassion fatigue levels among participants.
Overall, this study aims to contribute to our understanding of the potential benefits of mindfulness-based interventions in mitigating compassion fatigue among psychiatric nurse practitioners, with implications for improving the well-being and resilience of healthcare professionals in high-stress environments.
### Conditions Module
**Conditions:**
- Compassion Fatigue
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** The model for this study is a single-group pretest-posttest design.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** The intervention involves participation in a structured Mindfulness-Based Stress Reduction (MBSR) program. Participants engage in a series of sessions over a four week period. During these sessions, participants learn and practice mindfulness techniques such as deep breathing and body scans. The program is designed to enhance participants' awareness of their thoughts, emotions, and bodily sensations in the present moment, promoting a nonjudgmental acceptance of their experiences. By cultivating mindfulness skills, participants aim to reduce stress, enhance emotional regulation, and develop resilience in coping with the challenges of their work environment.
**Name:** Mindfulness-Based Stress Reduction (MBSR) Program
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The primary outcome measure involves assessing participants' levels of compassion fatigue using a validated instrument, such as the Professional Quality of Life (ProQOL) questionnaire. This questionnaire evaluates various dimensions of compassion fatigue, including emotional exhaustion, depersonalization, and reduced personal accomplishment.
**Measure:** Compassion Fatigue Assessment
**Time Frame:** Participants will complete the compassion fatigue assessment at two time points: before starting the mindfulness-based stress reduction (MBSR) program (baseline/pretest) and after completing the program (follow-up/posttest) over a period of 4 weeks.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Psychiatric Nurse Practitioner
* At least one year of nursing experience
* Participants would need to be able to read and understand English.
Exclusion Criteria:
* Is not a Psychiatric Nurse practitioner
* Reservations against the program
* Have \<1 yr. nursing experience
**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:** Ruthlande Nore
**Phone:** 9548650277
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Nova Southeastern University
**Name:** Charmaine Coffman
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Access Criteria:** Access criteria for obtaining anonymized IPD include: clear research purpose related to compassion fatigue, affiliation with recognized institutions, ethical approval evidence, compliance with data security protocols, signing data sharing agreements, and adherence to regulatory requirements.
**Description:** The IPD sharing plan involves sharing anonymized participant data (demographics, baseline characteristics, outcome measures, intervention details) for collaboration, further analysis, or meta-analyses. Before sharing, informed consent will be obtained, and identifying information will be removed to protect confidentiality. Sharing will comply with institutional policies, ethical guidelines, and data sharing agreements, ensuring regulatory and privacy compliance.
**Info Types:**
- SAP
**IPD Sharing:** YES
**Time Frame:** The data from this observational study will become available for sharing after completion of the study and publication of the primary study findings and will be available for up to 36 months after.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005222
- Term: Mental Fatigue
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000073397
- Term: Occupational Stress
- ID: D000013315
- Term: Stress, Psychological
### 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: BC24
- Name: Occupational Diseases
### Condition Browse Module - Browse Leaves
- ID: M8364
- Name: Fatigue
- Relevance: HIGH
- As Found: Fatigue
- ID: M259
- Name: Compassion Fatigue
- Relevance: HIGH
- As Found: Compassion Fatigue
- ID: M8365
- Name: Mental Fatigue
- Relevance: LOW
- As Found: Unknown
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M1167
- Name: Occupational Stress
- Relevance: LOW
- As Found: Unknown
- ID: M16105
- Name: Stress, Psychological
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005221
- Term: Fatigue
- ID: D000068376
- Term: Compassion Fatigue
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436456
**Brief Title:** Use of an Online Intervention for the Treatment of Diabetes Distress in Patients With Type 1-Diabetes
**Official Title:** The Feasibility, Acceptability and Preliminary Effectiveness of an Internet-based Intervention for Diabetes Distress in Patients With Type 1 Diabetes
#### Organization Study ID Info
**ID:** 22/57849
#### Organization
**Class:** OTHER
**Full Name:** Odense University Hospital
### Status Module
#### Completion Date
**Date:** 2025-05-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-23
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Center for Digital Psykiatri
#### Lead Sponsor
**Class:** OTHER
**Name:** Odense University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study will investigate whether an online intervention can be helpful in reducing diabetes distress in people with type 1 diabetes and elevated diabetes distress, compared to individual counselling sessions (online, phone-based or face-to-face, depending on the preference of the person with type 1 diabetes). Half of the participants will receive the online intervention, while the other half will receive individual counseling sessions with a psychologist.
Objectives: The main aim of this study is to investigate if the online intervention is feasible and liked by people with type 1 diabetes and diabetes distress, in comparison with individual counselling sessions.
Hypotheses: The investigators predict that both interventions will be feasible to use, shown by how many people join, stay engaged, and complete the interventions. The investigators also think that people will find both interventions acceptable, as shown by the positive feedback given in interviews after they finish.
**Detailed Description:** Individuals with diabetes are primarily responsible for managing their disease. Therefore, their ability to effectively self-treat their diabetes is critical for their prognosis. These significant treatment responsibilities place considerable demands on individual patients. These demands can lead to high levels of diabetes distress. Diabetes distress encompasses the emotional distress arising from the constant self-care burden that is required to self-manage diabetes, but also feelings of insufficient support and understanding from others, and challenges in communication with healthcare professionals. Diabetes distress is prevalent among individuals with diabetes. International research indicates that approximately 20-25% of individuals with diabetes experience high levels of diabetes distress. Studies exploring the impact of diabetes distress on diabetes management reveal that significant diabetes distress not only diminishes overall well-being but also correlates with suboptimal self-management of diabetes. This includes insufficient physical activity, unhealthy dietary choices, reduced medication adherence, infrequent blood glucose monitoring, and elevated HbA1c levels.
At Steno Diabetes Center Odense (SDCO), there are provisions for individual psychological intervention aimed at patients facing psychological challenges associated with their diabetes. However, due to resource constraints, priority is given to those patients experiencing the most severe impact.
As part of a new initiative at SDCO, Patient-Reported Outcome (PRO) data has been incorporated alongside diabetes same-day micro- and macrovascular complication screening, which includes an assessment of mental well-being (i.e. diabetes distress). These assessments will contribute to higher recognition rates of elevated diabetes distress, thereby exacerbating the strain on already limited resources available for individual psychological intervention. Moreover, not all patients may have the requisite time, necessity, or opportunity to partake in such individual intervention.
In order to expand existing psychological services at SDCO in an affordable way, an online psychological intervention needs to be developed. The objective of the online psychological intervention is to cater to a larger group of people with type 1 diabetes, who can autonomously engage with evidence-based components of the intervention, thereby averting the progression of patients' diabetes distress towards adverse or pathological conditions, such as anxiety or depression. Studies indicate that therapist-supported online therapy yields comparable efficacy to traditional face-to-face therapy. Additionally, online therapy offers the benefit of flexibility, allowing patients to engage with the intervention at their convenience, thereby obviating the need for patients to take time away from their professional commitments to attend sessions with a psychologist.
Aims:
The primary aim of this study is to evaluate the feasibility and acceptability of an online intervention with written support for patients with type 1-diabetes and elevated diabetes distress, comparing this with an individual intervention by a psychologist (online, phone-based or face-to-face, depending on the preference of the person with type 1 diabetes). Following the intervention, qualitative data will be collected through interviews conducted with both patients and clinical staff to assess this aim. Also metadata from the platform of the online intervention will be collected to evaluate this aim.
A secondary aim is to explore the efficacy of the interventions to improve different domains of diabetes-stress. This secondary aim will be evaluated through survey data.
Further aims are to explore whether both interventions impact diabetes-related quality of life, acceptance of diabetes, patient engagement in healthcare, negative effects of the intervention, useability of the intervention and glucometrics (e.g. estimated HbA1c, time in range (TIR), time above range (TAR), time below range (TBR)).
Hypotheses:
Primary aim hypotheses: It is hypothesized that both interventions will show high feasibility and acceptability, demonstrated by acceptable recruitment strategies, high rates of retention and high completion of modules/sessions. It is expected though, that the dropout rates will be higher in the online intervention group. It is also hypothesized that both interventions are acceptable, as demonstrated by satisfactory feedback obtained through post-intervention interviews.
Secondary aim hypotheses. It is hypothesized that in both interventions there will be a significant reduction in participants' diabetes distress from pre-intervention to post-intervention, and from pre-intervention to 3-months follow-up.
Further, it is also hypothesized that the interventions will yield positive changes in diabetes-related quality of life, acceptance of diabetes, and patient engagement in healthcare. It is further hypothesized that the interventions has no negative effect on the patients, and that the patients find the interventions useful. Glucometrics are included as a secondary outcome but as the interventions does not target this, the investigators hypothesize no changes in these measures will be found.
Recruitment and procedure:
Participants for the study will be recruited at Steno Diabetes Center Odense (SDCO) in Denmark. Patients with a total score on the questionnaire Problem Areas in Diabetes (PAID5) of ≥ 8 will receive information about the study. If interested in participating, they can contact the study leader to receive more information about the study and schedule a screening appointment with a study psychologist.
During the screening appointment, the patient will have further opportunity to learn more about the study and ask questions. If they wish to participate, they will receive a consent form to sign. Subsequently, the patient will receive a questionnaire including an extended measure of diabetes distress i.e. The Diabetes Distress Scale for type 1-diabetes (DDS-type1). In the screening appointment, the inclusion and exclusion criteria will be evaluated. If the psychologist deems the patient suitable for participation, the patient will be randomized to either receive an online psychological intervention or an individual psychological intervention with 20 patients in each arm.
Following the conclusion of the intervention and during the 3-month follow-up period, participants will be administered a questionnaire.
Subsequent to the feasibility study, semi-structured interviews will be conducted with approx. 12 patients, 2-3 psychologists, and possibly further clinical staff. These interviews will explore aspects related to screening procedures, recruitment strategies, and the acceptance of the online psychological intervention.
The online intervention will subsequently be evaluated using a mini Model for Assessment of Telemedicine (MAST), where the following domains will be assessed:
* Health problems and technology characteristics
* Patient safety
* Clinical effectiveness
* Patient assessment
* Economic aspects
* Organizational aspects
* Sociocultural, ethical, and legal aspects.
### Conditions Module
**Conditions:**
- Diabetes Mellitus, Type 1
- Diabetes Distress
**Keywords:**
- Diabetes Mellitus, Type 1
- Diabetes distress
- Online intervention
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** 1. Online psychological intervention
2. Individual psychological intervention
##### 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:** Online psychological intervention with written support from a psychologist
**Intervention Names:**
- Behavioral: Online psychological intervention
**Label:** Online psychological intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Individual therapy sessions with a psychologist
**Intervention Names:**
- Behavioral: Individual psychological intervention
**Label:** Individual psychological intervention
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Online psychological intervention
**Description:** The online intervention constitutes a psychological intervention rooted in therapeutic principals of Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT). Comprising 7 obligatory modules and 4 optional modules, the intervention is facilitated through an online platform, offering a text-based self-help program. Patients receive written guidance from a psychologist at Steno Diabetes Center Odense (SDCO). While undergoing intervention, patients have the option to seek clarification or assistance from the psychologist if encountered with queries or difficulties. It is anticipated that patients will progress through approximately one module per week. Following completion of the intervention, patients retain access to the online intervention for a duration of 3 months.
**Name:** Online psychological intervention
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Individual psychological intervention
**Description:** In the individual intervention, patients undergo personalized therapy administered by the assigned psychologist from SDCO. This treatment approach is grounded in the principles of Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT). Delivery of treatment can occur through various modalities, including telephone, video conferencing, or in-person sessions, tailored to accommodate the preferences and requirements of the patient. A maximum of 10 treatment sessions are available for each patient.
**Name:** Individual psychological intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The number of eligible patients who agree to participate in the interventions
**Measure:** The proportion of eligible patients who agree to participate in the interventions throughout the study period
**Time Frame:** Throughout the duration of the study approx. 12 months
**Description:** The number of patients completing the survey measures at pre- and post-intervention as well as at three months follow-up
**Measure:** The completion rates of survey measures at pre- and post-intervention and at three months follow-up
**Time Frame:** Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention
**Description:** Patient characteristics assessed through survey data
**Measure:** Characteristics of patients receiving the interventions and those who drop out assessed through survey data.
**Time Frame:** Throughout study participation, an average of 6 months
**Description:** Will be assess by expressions of patients through qualitative semi structured interviews
**Measure:** Acceptability of the online intervention expressed by patients
**Time Frame:** After completion of the intervention, an average of 3-12 months
**Description:** Will be assess by expressions of participating clinical staff through qualitative semi structured interviews
**Measure:** Acceptability of the online intervention expressed by participating clinical staff
**Time Frame:** Obtained after study completion approx.12 months
**Description:** The number of log ins on the platform by patients in the online intervention
**Measure:** Number of log ins on the platform
**Time Frame:** Obtained after completion of the online intervention, an average of 3-6 months
**Description:** The time points of log ins to the platform by patients in the online intervention during their access to the platform
**Measure:** Time points of log ins on the platform
**Time Frame:** Obtained after completion of the online intervention, an average of 3-6 months
**Description:** The number of hours the patients in the online intervention spend on the platform during their access to the platform
**Measure:** Numbers of hours spend on the platform
**Time Frame:** Obtained after completion of the online intervention, an average of 3-6 months
**Description:** The number of modules completed by the patients in the online intervention
**Measure:** Numbers of modules completed in the online intervention
**Time Frame:** Obtained after completion of the online intervention, an average of 3-6 months
**Description:** The number of messages sent between the patients in the online intervention and their psychologist
**Measure:** Number of messages sent between patients and psychologist
**Time Frame:** Obtained after completion of the online intervention, an average of 3-6 months
#### Secondary Outcomes
**Description:** The T1 DDS measures diabetes distress. The scale consists of 28 items with each item with 6 answer categories ranging from 1 'Not a problem' to 6 'A serious problem'. A total score is calculated by adding all the items together and diving the number by 28. A score between 2,0 and 2,99 indicated moderate diabetes distress and a score of ≥ 3 indicate high levels of diabetes distress
**Measure:** Diabetes Distress Scale for type 1 diabetes (T1 DDS)
**Time Frame:** Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention
**Description:** The AADQ-6 measures diabetes acceptance through 6 items with scores ranging from 1 'Never' to 5 'Almost always'.The scores range from 6-30 with higher values indicate greater non-acceptance
**Measure:** Acceptance & Action Diabetes Questionnaire (AADQ-6)
**Time Frame:** Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention
**Description:** The PAM assesses patient engagement in healthcare. Three key domains are assessed to understand a person's self-management ability: Knowledge, Skills, Confidence. The scale has 13 items with four answer categories from 'Highly agree' to 'Highly disagree' and a 'Do not know' category. The scores are calculated through an excel spreadsheet created by InsigniaHealth and range from 0-100 with higher scores indicating higher patient activation.
**Measure:** The Patient Activation Measure (PAM)
**Time Frame:** Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention
**Description:** The DIPD measures diabetes-related quality of life. There scale has 6 items assessing how diabetes affect the following areas (physical health, mental health, relationships, leisure activities, work or studies, financial situation), and two optional items (ability to eat what one wants and overall happiness). Each item can be evaluated using a 7-point scale, where 1 indicates 'A very positive impact', 4 indicates 'No impact', and 7 indicates 'A very negative impact'. Additionally, there is a "not applicable" (N/A) response option available for each item. A higher score indicates lower diabetes-related quality of life.
**Measure:** The DAWN (Diabetes Attitudes, Wishes and Needs study) Impact of Diabetes Profile (DIDP)
**Time Frame:** Immediately before enrollment in the intervention, immediately after the intervention and three months after the intervention
**Description:** The NEQ measures negative effects in psychological treatments. It consists of 20 items. First, participants indicate whether specific items occurred during treatment with a binary response (1 for 'Yes', 0 for 'No'). Second, they rate the severity of negative effects on a four-point Likert scale, ranging from 0 'Not at all' to 4 'Extremely'. Third, respondents attribute negative effects to either 1 'The treatment received' or 0 'Other circumstances'. The sum of these items provides a frequency measure of the negative effects experienced by respondents, categorized by treatment or other circumstances.
**Measure:** Negative Effect Questionnaire (NEQ)
**Time Frame:** Immediately after the intervention
**Description:** The SUS generates a singular numerical value representing a composite measure of the overall usability of the system being studied. Each item's contribution ranges from 1 'Strongly disagree' to 5 'Strongly agree'. For items 1, 3, 5, 7, and 9, the contribution equals the position on the scale minus 1. Conversely, for items 2, 4, 6, 8, and 10, the contribution equals 5 minus the scale position. After summing the scores, the total is multiplied by 2.5 to acquire the overall SUS value. SUS scores range from 0 to 100.
**Measure:** System Usability Scale (SUS)
**Time Frame:** Immediately after the online intervention
**Description:** HbA1c is calculated based on data from the patients' sensor. The unit for reporting HbA1c concentration is mmol/mol
**Measure:** Estimated HbA1c
**Time Frame:** Pre-intervention (approx. one month before the intervention) and after the intervention (approx. one month after the intervention)
**Description:** TIR is calculated based on data from the patients' sensor - set at the range 3.9-10.0 mmol/L
**Measure:** Time in range (TIR) is the percentage of time the blood glucose levels in the recommended target range
**Time Frame:** Pre-intervention (approx. one month before the intervention) and after the intervention (approx. one month after the intervention)
**Description:** TBR is calculated based on data from the patients' sensor i.e. below 3.9 mmol/L
**Measure:** Time below range (TBR) is the percentage of time the blood glucose levels is below the recommended target range
**Time Frame:** Pre-intervention (approx. one month before the intervention) and after the intervention (approx. one month after the intervention)
**Description:** TAR is calculated based on data from the patients' sensor i.e. above 10.0 mmol/L
**Measure:** Time above range (TAR) is the percentage of time the blood glucose levels is above the recommended target range
**Time Frame:** Pre-intervention (approx. one month before the intervention) and after the intervention (approx. one month after the intervention)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* A total score or a score on one of the subscales of the Diabetes Distress Scale for type 1 diabetes which is 2 or above.
* Diagnosed with type 1-diabetes ≥ 12 months ago.
* Age ≥ 30 years.
* Receiving treatment at SDCO.
* Proficiency in Danish and basic IT skills.
Exclusion Criteria:
* Psychiatric diagnosis that may compromise participation in the intervention e.g. psychosis, schizophrenia, substance or alcohol abuse.
* Cognitive impairments that may compromise participation in the intervention e.g. dementia, Alzheimer's, brain injury.
* Complex issues best suited for individual treatment as assessed by the clinical psychologist.
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Christina M andersen, PhD
**Phone:** 0045 27591761
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Mette J Rothmann, PhD
**Phone:** 0045 24257094
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Odense
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Christina M Andersen, PhD
- **Phone:** 0045 27591761
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Mette J Rothmann, PhD
- **Phone:** 0045 24257094
- **Role:** CONTACT
**Country:** Denmark
**Facility:** Steno Diabetes Center Odense
**Zip:** 5000
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- 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
### 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: Diabetes Mellitus, Type 1
- 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
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436443
**Brief Title:** SMS Counseling on Gestational Diabetes
**Official Title:** The Effect of SMS Counseling for Gestational Diabetes on Self-Efficacy and Knowledge Levels
#### Organization Study ID Info
**ID:** MAKU GO 2020/193
#### Organization
**Class:** OTHER
**Full Name:** Mehmet Akif Ersoy University
### Status Module
#### Completion Date
**Date:** 2022-04-24
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-03-15
**Type:** ACTUAL
#### Start Date
**Date:** 2021-08-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Mehmet Akif Ersoy University
#### Responsible Party
**Investigator Affiliation:** Mehmet Akif Ersoy University
**Investigator Full Name:** Nurten Terkes
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The use of technology-based education and counseling services in the self-management of gestational diabetes contributes to better control of blood sugar levels, motivation and increased self-efficacy in women. Therefore, this study was planned as interventional research to determine the effect of SMS counseling given to individuals with gestational diabetes on self-efficacy and knowledge levels. This study was conducted descriptively with 95 patients with gestational diabetes who were treated in the endocrine service of a university hospital between August 15, 2021 and April 24, 2022. Personal information form created by the researchers, The Self-Efficacy Scale in Gestational Diabetes, and Diabetes Knowledge Scale were used to collect data.
### Conditions Module
**Conditions:**
- Gestational Diabetes
**Keywords:**
- Gestational diabetes mellitus,
- Self-Efficacy,
- SMS Counseling.
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Masking Description:** Single (Participant) They did not know if they were in the control and intervention group at the time of randomization.
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 95
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In addition to routine physician check-ups, an SMS group was created for the individuals in the intervention group, and basic information messages for diabetes control were sent to this group at regular intervals. In addition, individuals asked questions via this group. At the end of the eight-week follow-up, the data collection forms were filled out again and the study was terminated.
**Intervention Names:**
- Other: SMS Counseling
**Label:** Intervention group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** The same data collection forms were filled out at the first interview and eight weeks later by the pregnant women in the control group, and they continued to receive routine follow-ups.
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention group
**Description:** In addition to routine physician check-ups, an SMS group was created for the individuals in the intervention group, and basic information messages for diabetes control were sent to this group at regular intervals. In addition, individuals asked questions via this group. At the end of the eight-week follow-up, the data collection forms were filled out again and the study was terminated.
**Name:** SMS Counseling
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** This scale was first developed by Dunn et al.13 to measure diabetes knowledge. Afterward, it was developed by Carolan et al. to examine three effect domains: pregnant women's GDM knowledge, nutritional values, and GDM self-management principles. The scale consists of 18 questions. Cronbach's alpha value of the total scale was determined as 0.654.
**Measure:** Diabetes Knowledge Scale
**Time Frame:** 5 Minute
**Description:** This is a five-point Likert-type scale consisting of 23 items developed by Polat and Avdal in 2019 to evaluate the self-efficacy levels of individuals with gestational diabetes. It consists of four sub-dimensions: "diet-weight management"; "complication measures"; "compliance with nutrition education"; "medical therapy practices". As the total score on the scale increases, the level of self-efficacy increases, as well. Cronbach's alpha value of the total scale was determined as 0.654.
**Measure:** The Self-Efficacy Scale in Gestational Diabetes
**Time Frame:** 5 minute
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* diagnosed with gestational diabetes,
* being in the 30th week of pregnancy,
* having a smartphone,
* volunteering to participate in the study,
* having no communication problems,
* having no psychiatric problems
Exclusion Criteria:
* being non-literate,
* having communication problems (hearing or sight),
* not volunteering to participate in the research
**Gender Based:** True
**Gender Description:** Only women were taken.
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Burdur
**Country:** Turkey
**Facility:** Burdur Mehmet Akif Ersoy University
**Zip:** 15000
### IPD Sharing Statement Module
**Description:** All authors contributed to the interpretation, writing, and approval of the final manuscript.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Hemmati Maslakpak M, Razmara S, Niazkhani Z. Effects of Face-to-Face and Telephone-Based Family-Oriented Education on Self-Care Behavior and Patient Outcomes in Type 2 Diabetes: A Randomized Controlled Trial. J Diabetes Res. 2017;2017:8404328. doi: 10.1155/2017/8404328. Epub 2017 Nov 22.
**PMID:** 29359166
**Citation:** Guo Y, Zhou L, Sun B, Wang C, Zhang J. Application of online-offline integrated medical care management in patients with gestational diabetes. Ginekol Pol. 2021;92(10):720-725. doi: 10.5603/GP.a2021.0054. Epub 2021 Apr 29.
**PMID:** 33914304
**Citation:** Miremberg H, Ben-Ari T, Betzer T, Raphaeli H, Gasnier R, Barda G, Bar J, Weiner E. The impact of a daily smartphone-based feedback system among women with gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy outcome: a randomized controlled trial. Am J Obstet Gynecol. 2018 Apr;218(4):453.e1-453.e7. doi: 10.1016/j.ajog.2018.01.044. Epub 2018 Feb 7.
**PMID:** 29425836
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M19012
- Name: Diabetes, Gestational
- Relevance: HIGH
- As Found: Gestational Diabetes
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes
- 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: 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: D000016640
- Term: Diabetes, Gestational
- ID: D000003920
- Term: Diabetes Mellitus
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436417
**Acronym:** PreANI
**Brief Title:** Functional Capacity Through HRV in Multimodal Rehabilitation for Adult Surgery
**Official Title:** Monitoring Functional Capacity Through Heart Rate Variability Within the Multimodal Rehabilitation Program in Adult Surgery
#### Organization Study ID Info
**ID:** PreANI001
#### Organization
**Class:** NETWORK
**Full Name:** Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** NETWORK
**Name:** Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This prospective, observational cohort study investigates heart rate variability (HRV) monitoring using the Analgesia Nociception Index (ANI) monitor in adult patients undergoing major surgery within a multimodal rehabilitation program. The objective is to correlate HRV indices with functional capacity, physiological reserve, and frailty during the prehabilitation phase.
**Detailed Description:** The study evaluates HRV using the ANI monitor to determine adaptation to training load, optimize analgesic and anesthetic dosing, and predict postoperative complications. The HRV indices of Energy (SDNN) and ANI (HFnu) are monitored at two points: the initial pre-anesthesia consultation and one week before surgery. Results will be compared with the 6-minute walk test, MUST nutrition screening scale, and clinical frailty and FRAIL scales.
### Conditions Module
**Conditions:**
- Frailty in Adult Surgery
**Keywords:**
- Heart rate variability, prehabilitation, major surgery, frailty, physiological reserve
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 490
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients who do not undergo prehabilitation.
**Intervention Names:**
- Device: Analgesia Nociception Index (ANI) Monitor
**Label:** Control
#### Arm Group 2
**Description:** Patients who undergo trimodal prehabilitation including physical exercise, nutritional supplementation, and psychological support.
**Intervention Names:**
- Device: Analgesia Nociception Index (ANI) Monitor
- Behavioral: Trimodal Prehabilitation
**Label:** Prehabilitation
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control
- Prehabilitation
**Description:** Non-invasive monitoring of HRV to evaluate autonomic nervous system activity using the indices of Energy (SDNN) and ANI (HFnu).
**Name:** Analgesia Nociception Index (ANI) Monitor
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Prehabilitation
**Description:** Program of physical exercise, nutritional supplementation, and psychological support according to the RICA guidelines of the Spanish Group for Multimodal Rehabilitation.
**Name:** Trimodal Prehabilitation
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluation of the correlation between HRV indices (Energy and ANI) and current parameters used to assess functional capacity, physiological reserve, and frailty.
**Measure:** Correlation of HRV indices with functional capacity and frailty
**Time Frame:** From initial pre-anesthesia consultation to 30 days postoperatively
#### Secondary Outcomes
**Description:** Evaluation of the relationship between higher preoperative functional reserve and lower number of complications, mortality, and hospital stay at 30 days postoperatively.
**Measure:** Reduction of postoperative complications
**Time Frame:** 30 days postoperatively
**Description:** Analysis of whether HRV monitoring guides the workload during prehabilitation and the titration of drugs during surgery.
**Measure:** Intraoperative decisions based on HRV
**Time Frame:** During the perioperative period
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients over 18 years of age
* Scheduled for major adult surgery
* Any ASA classification
* Signed informed consent
Exclusion Criteria:
* Urgent surgery
* Severe cognitive impairment
* Patient refusal to participate
* Pediatric patients
* Cardiac arrhythmia or atrial fibrillation
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adult patients undergoing major surgery within a multimodal rehabilitation program in various hospitals in Spain.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Cristian Aragón-Benedí, M.D., Ph.D.,
**Phone:** +34625408866
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Zaragoza
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Cristian Aragón-Benedí
- **Role:** CONTACT
**Country:** Spain
**Facility:** Miguel Servet University Hospital
**Status:** RECRUITING
**Zip:** 50009
#### Overall Officials
**Official 1:**
**Affiliation:** Miguel Servet University Hospital
**Name:** Cristian Aragón-Benedí, M.D., Ph.D.,
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Description:** There are no plans to share individual participant data (IPD) with other researchers.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M1175
- Name: Frailty
- Relevance: HIGH
- As Found: Frailty
### Condition Browse Module - Meshes
- ID: D000073496
- Term: Frailty
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436404
**Brief Title:** Hammock Position and Kangaroo Care
**Official Title:** Effect of Two Different Positions on Pain, Stress, Comfort and Physiological Parameters of the Premature Infants: Randomized Controlled Trial
#### Organization Study ID Info
**ID:** He2
#### Organization
**Class:** OTHER
**Full Name:** Nigde Omer Halisdemir University
### Status Module
#### Completion Date
**Date:** 2024-10-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Selcuk University
#### Lead Sponsor
**Class:** OTHER
**Name:** Nigde Omer Halisdemir University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study was planned to evaluate the effectiveness of two positions that may have an effect on pain, stress, comfort and physiological parameters in premature infants.
**Detailed Description:** Providing adequate therapeutic positioning in preterms can minimize postural abnormalities and asymmetries associated with prematurity and NICU stay, as well as support the development of spontaneous and functional motor abilities of infants. Studies show that positioning directly affects cardiovascular, respiratory and sleep-wake states. When the literature is examined; Although the vital signs, pain levels and comfort levels of babies in the NICU have been examined in many applications, the number of studies comparing the hammock position and Kangaroo care in preterms is very limited. Therefore, this study will try to determine the effect of hammock position and kangaroo care on the pain, stress, comfort and physiological parameters of the infants. It is thought that the study will provide new data to the literature and lead to many researches.
### Conditions Module
**Conditions:**
- Infant Development
- Premature
**Keywords:**
- Premature
- Pain
- Stress
- Comfort
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized controlled, single-blind parallel design experimental study.In the study, premature infants will be divided into three groups by randomization. Each group will be referred to as A, B or C for convenience. The type of intervention will be determined by drawing lots for A, B and C. For example, A= Hammock Position, B= Kangaroo Care c=Control Group. When applying the hammock position to a group; The other group will receive kangaroo care, while the other group will receive standard care. For randomization, blocks of 6 will be created for 36 infants and this process will be done by an independent statistician.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Single blinding (Participant)
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A hammock inside the incubator, developed by researchers to prevent heat loss and support posture, will be used.
**Intervention Names:**
- Other: Hammock intervention
**Label:** Hammock position group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Kangaroo care will be applied to these preterm infants.
**Intervention Names:**
- Other: Kangaroo care intervention
**Label:** Kangaroo care group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** The group will not receive any other intervention.
**Label:** Contol group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Hammock position group
**Description:** It is a hammock made of 100% cotton fabric that prevents heat loss and has an internal apparatus to support the position, which can be adapted to the incubator by the researchers.
**Name:** Hammock intervention
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Kangaroo care group
**Description:** In the clinic, the baby will receive kangaroo care with his mother in a quiet room with reduced lighting.
**Name:** Kangaroo care intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** 1- Infant Introductory Form: The form includes introductory information about the baby (Postnatal day, gestational age, birth weight (g), weight on the day of the intervention, type of birth, gender, postnatal age, physiological weight loss, feeding style, 1st and 5th minute Apgar score, maternal age. It consists of questions containing).
**Measure:** Determining the descriptive characteristics of babies
**Time Frame:** 1 hour
**Description:** 2- The COMFORT-behavior scale (COMFORTneo): It is a Likert-type scale developed to be used in evaluating the sedation and comfort needs, pain and distress of newborns monitored in intensive care. The scale was revised for newborns. High scores indicate that the baby is not comfortable and needs interventions to provide comfort.
**Measure:** Hammock position and Kangaroo care increase comfort level in preterm infants
**Time Frame:** 1 hour
**Description:** 3- ALPS-Neo "Newborn Pain and Stress Assessment Scale": The scale was developed in 2014 to evaluate pain and stress in premature and term newborns. Measurement is made through observation. As the score obtained increases, stress and pain increase.
**Measure:** Hammock position and Kangaroo care decrease pain and stress level in preterm infants
**Time Frame:** 1 hour
#### Secondary Outcomes
**Description:** 1- Physiological Parameter Tracking Chart The follow-up chart prepared by the researcher is a form in which physiological parameters such as heart rate (min), oxygen saturation (%SpO2), body temperature (°C), respiratory rate (min) are recorded. Measurements will be taken 3 times in total: before, during and after the hammock position and kangaroo care application. A monitor device used in clinical routine will be used to measure physiological parameters.
**Measure:** Hammock position and Kangaroo care support physiological stability in premature infants.
**Time Frame:** 1 hour
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Infants having at least 2 days of inpatient treatment from,
* Infants 32-36+6. being born during the gestational week,
* Infants not receiving a medical diagnosis other than prematurity (serious respiratory, cardiological, endocrine and metabolic problems, hearing problems, hypoglycemia and sepsis),
* Apgar score above 6 at the 5th minute Infants will included.
Exclusion Criteria:
* Infants having at least 2 days of inpatient treatment from,
* Infants 32-36+6. being born during the gestational week,
* Infants not receiving a medical diagnosis other than prematurity (serious respiratory, cardiological, endocrine and metabolic problems, hearing problems, hypoglycemia and sepsis),
* Apgar score above 6 at the 5th minute Infants will included.
**Healthy Volunteers:** True
**Maximum Age:** 36 Weeks
**Minimum Age:** 32 Weeks
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Hilal KURT SEZER, Ph.D.
**Phone:** Central Contact Phone is requi
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Hatice ONAL, M.Sc.
**Phone:** +90 388 20112815
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Selcuk University
**Name:** Sibel KUCUKOGLU, Ph.D.
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Nigde Omer Halisdemir University
**Name:** Halil DEGIRMENCIOGLU, Md.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** It will be shared after the article is published
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Indyk HE, Woollard DC. Enzymatic determination of free carnitine in milk and infant formulas. J AOAC Int. 1995 Jan-Feb;78(1):69-74.
**PMID:** 7703730
**Citation:** Costa KSF, Fernandes DDS, Paula RAP, Guarda LEDA, Dare MF, Castral TC, Ribeiro LM. Hammock and nesting in preterm infants: randomized controlled trial. Rev Bras Enferm. 2019 Dec;72(suppl 3):96-102. doi: 10.1590/0034-7167-2018-0099. English, Portuguese.
**PMID:** 31851240
**Citation:** Gerull R, Cignacco E, Stoffel L, Sellam G, Nelle M. Physiological parameters after nonpharmacological analgesia in preterm infants: a randomized trial. Acta Paediatr. 2013 Aug;102(8):e368-73. doi: 10.1111/apa.12288. Epub 2013 May 28.
**PMID:** 23651076
**Citation:** Huang CM, Tung WS, Kuo LL, Ying-Ju C. Comparison of pain responses of premature infants to the heelstick between containment and swaddling. J Nurs Res. 2004 Mar;12(1):31-40. doi: 10.1097/01.jnr.0000387486.78685.c5.
**PMID:** 15136961
**Citation:** Schwendener RA, Schott H, Hartmann HR, Supersaxo A, Rubas W, Hengartner H. [Liposomes as carriers of lipophilic cytosine arabinoside and fluorodeoxyuridine derivatives. Their cytostatic effect and possibilities of tumor cell specific therapy]. Onkologie. 1987 Aug;10(4):232-9. doi: 10.1159/000216411. German.
**PMID:** 2959889
## 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
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M25869
- Name: Premature Birth
- Relevance: HIGH
- As Found: Premature
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- 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
### Condition Browse Module - Meshes
- ID: D000047928
- Term: Premature Birth
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436391
**Brief Title:** The Effectiveness of Two Different Methods in Heel Blood Collection
**Official Title:** Effect of Kinesio Tape and ShotBlocker on Pain, Comfort and Crying Duration in Heel Blood Collection in Infants: Randomized Controlled Trial
#### Organization Study ID Info
**ID:** He1
#### Organization
**Class:** OTHER
**Full Name:** Nigde Omer Halisdemir University
### Status Module
#### Completion Date
**Date:** 2024-10-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Selcuk University
#### Lead Sponsor
**Class:** OTHER
**Name:** Nigde Omer Halisdemir University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study aims to evaluate the effectiveness of 2 non-pharmacological methods that will reduce the traumatizing effect of routine heel pricking in infant babies within the scope of the metabolic endocrine screening program. One of the interventions to be used in the study is kinesio taping, a type of taping that does not contain any medication. Another intervention is Shotblocker, which does not belong to any drug or device group.
**Detailed Description:** Studies on pain indicate that severe pain experienced in the early period of life causes a weakening of the cognitive functions of the infant, especially by shrinking the thalamic volume. Pain management in the neonatal period aims to help the infant cope with pain by relieving it. For effective pain management, it is very important to diagnose and evaluate the baby's response to pain early and accurately within a multidisciplinary team approach, and to select appropriate interventions to alleviate the pain experience. It is stated that nonpharmacological methods in relieving procedural pain strengthen the baby's natural regulation and coping mechanisms when faced with painful intervention and reduce pain and stress. For this reason, this study aimed to determine the effect of kinesiology taping and ShotBlocker applied to the heel during heel blood collection in infant babies on pain, comfort and crying time.
### Conditions Module
**Conditions:**
- Infant Behavior
- Pain
**Keywords:**
- Pain Management
- Kinesiotape
- Nursing
- Therapy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The study will be conducted with infants of mothers who meet the inclusion criteria and agree to participate in the study. After explaining the study to the parents, the study will start after obtaining their verbal and written consent. Randomization will be random assignment to a control group or two intervention groups (1:1:1) with sequentially numbered, sealed, opaque envelopes containing randomly generated numbers after mothers have obtained informed consent. Randomization will be carried out via www.random.org using a table of random numbers. This will be done by an independent statistician and envelopes will be given to the researchers
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Single Blinded for mothers
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 72
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** To the infants in the experimental group; Kinesio tape application will be performed by an experienced physiotherapist whom has a M.Sc. degree and kinesio tape certificate.
**Intervention Names:**
- Other: Kinesio taping
**Label:** Kinesio tape group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** To the infants in the second experimental group; Shotblocker application will be performed by another researcher.
**Intervention Names:**
- Other: ShotBlocker
**Label:** ShotBlocker group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** These infants will not receive any intervention in the heel prick procedure. Routine heel blood collection will be performed.
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Kinesio tape group
**Description:** Kinesio taping will be applied to the lateral part of the baby's heel to increase blood flow. Blood collection will always be performed by the same nurse
**Name:** Kinesio taping
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- ShotBlocker group
**Description:** Shotblocker will be applied to the baby's heel average 10-15 seconds with minimal pressure.
**Name:** ShotBlocker
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** 1-Infant Introduction Form The questionnaire created by the researchers consisted of a total of 10 questions including infant gender, gestational age, postnatal age, birth weight and some demographic characteristics.
**Measure:** Determining the descriptive characteristics of infants
**Time Frame:** Average 5 minutes
**Description:** 2- Infant Follow-up Form: This form is the form to record the duration of the procedure and the duration of crying.
**Measure:** Follow-up of infants
**Time Frame:** Average 5 minutes
**Description:** 3- Neonatal Infant Pain Scale (NIPS):This scale, which was developed in 1993 to evaluate behavioral and physiological pain responses of preterm and term infants, was adapted into Turkish in 1999. A high score indicates that the severity of pain.
**Measure:** The effect of Kinesio tape and ShotBlocker on pain
**Time Frame:** Average 5 minutes
#### Secondary Outcomes
**Description:** 1-COMFORTneo scale: The scale was revised under the name COMFORTneo scale and its validity and reliability were established. COMFORTneo measures only behavioral parameters in the newborn without physiological parameters. It is Likert-type and evaluates the comfort needs, pain and distress of newborns followed up in intensive care. The lowest score that can be obtained from the scale is 6 and the highest score is 30. As the score increases, it is understood that the baby is not comfortable and needs interventions to provide comfort.
**Measure:** The effect of Kinesio tape and ShotBlocker application in infants in the experimental groups' comfort .
**Time Frame:** Average 5 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Term birth infants,
* Infants with a birth weight of 2500 g and above
* Infants with stable clinical condition
* Infants who can perform vital functions without support,
* Infants who were fed, calm and not crying within one hour before the procedure will be included.
Exclusion Criteria:
* With a genetic or congenital anomaly,
* Neurological, cardiological and metabolic diseases,
* In need of respiratory support,
* Infants receiving analgesics, antiepileptics before the procedure will be excluded.
**Healthy Volunteers:** True
**Maximum Age:** 41 Months
**Minimum Age:** 38 Weeks
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Hilal KURT SEZER, Ph.D.
**Phone:** +903882112815
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Saltuk Gazi SESIGUZEL, M.Sc.
**Phone:** +903882112815
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Selcuk University
**Name:** Sibel KUCUKOGLU, Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** It will be shared after the article is published
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Chik YM, Ip WY, Choi KC. The Effect of Upper Limb Massage on Infants' Venipuncture Pain. Pain Manag Nurs. 2017 Feb;18(1):50-57. doi: 10.1016/j.pmn.2016.10.001. Epub 2016 Dec 10.
**PMID:** 27964912
**Citation:** Anand KJ, Hickey PR. Pain and its effects in the human neonate and fetus. N Engl J Med. 1987 Nov 19;317(21):1321-9. doi: 10.1056/NEJM198711193172105. No abstract available.
**PMID:** 3317037
**Citation:** Erkut Z, Yildiz S. The Effect of Swaddling on Pain, Vital Signs, and Crying Duration during Heel Lance in Newborns. Pain Manag Nurs. 2017 Oct;18(5):328-336. doi: 10.1016/j.pmn.2017.05.007. Epub 2017 Aug 2.
**PMID:** 28779961
**Citation:** Foster JP, Taylor C, Spence K. Topical anaesthesia for needle-related pain in newborn infants. Cochrane Database Syst Rev. 2017 Feb 4;2(2):CD010331. doi: 10.1002/14651858.CD010331.pub2.
**PMID:** 28160271
**Citation:** Harvey EG. Kinesio taping to address post-sternotomy scars in pediatric patients: A case report. Scars Burn Heal. 2022 May 11;8:20595131221095355. doi: 10.1177/20595131221095355. eCollection 2022 Jan-Dec.
**PMID:** 35572360
**Citation:** Kurdahi Badr L, Demerjian T, Daaboul T, Abbas H, Hasan Zeineddine M, Charafeddine L. Preterm infants exhibited less pain during a heel stick when they were played the same music their mothers listened to during pregnancy. Acta Paediatr. 2017 Mar;106(3):438-445. doi: 10.1111/apa.13666. Epub 2016 Dec 13.
**PMID:** 27883227
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436378
**Acronym:** MusicCPP
**Brief Title:** Music Intervention in Chronic Pain Patients
**Official Title:** Feasibility and Efficacy of Music Intervention on Pain, Anxiety, and Well-being in Chronic Pain Patients
#### Organization Study ID Info
**ID:** 2023-6620
#### Organization
**Class:** OTHER
**Full Name:** Laval University
### Status Module
#### Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-28
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Université de Montréal
#### Lead Sponsor
**Class:** OTHER
**Name:** Laval University
#### Responsible Party
**Investigator Affiliation:** Laval University
**Investigator Full Name:** Josiane Bissonnette
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this randomized controlled trial is to evaluate the efficacy of a personalized music intervention program to improve the condition of individuals suffering from chronic pain.
The main objective is to evaluate if the intervention program will significantly reduce participants composite score of pain, anxiety, and well-being (reversed) as evaluated by the Edmonton symptom assessment scale (ESAS-r) immediately after the intervention, and whether this improvement will be significantly greater than that of control sessions.
**Detailed Description:** The participants (n = 36) will be randomized into two groups. The intervention will last for 4 weeks. Once per week for the first 2 weeks, the first group will have a personalized musical intervention in person on the university campus and will evaluate their pain, anxiety, and well-being scores before and after each session. For the following 2 weeks, the participants will have online access to their music sessions and will also assess their levels of pain, anxiety, and well-being before and after each intervention session.
The second group (control group) will evaluate their pain, anxiety, and well-being scores 20 minutes apart once per week for the first 2 weeks.Participants will continue their daily activities between the two measurement times. During the next 2 weeks, the participants will listen to online musical sessions once per week and will again evaluate their levels of pain, anxiety, and well-being before and after each intervention session.
The main objective of this randomized controlled trial is to evaluate the immediate effect of a personalized music intervention for the experimental group/in-person intervention on a composite score of pain, anxiety, and well-being (reversed), compared to the control group/no intervention sessions, as measured by the ESAS-r. The secondary objective is to assess the evolution of each of these three ESAS-r variables (pain, anxiety, well-being) from pre-test to post-test compared with changes in these variables in the control group/no intervention sessions.
The differences between in-person musical interventions and online musical sessions, as well as the feasibility and adherence of participants to an online music intervention program, will also be assessed. Furthermore, the effect of a music session preceded by a period of relaxation compared to the effect of a musical session alone, and the experiential dimensions experienced, will be evaluated.
At the end of the experiment, both groups will be interviewed to analyze their comments regarding the interventions.
### Conditions Module
**Conditions:**
- Chronic Pain
- Anxiety
- Well-Being, Psychological
**Keywords:**
- chronic pain
- music
- anxiety
- well-being
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This arm will receive a personalized music intervention.
**Intervention Names:**
- Behavioral: Music intervention in person
**Label:** Musical intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** This arm will carry out its daily activities and will be assessed using the same measures at the beginning of each session and after a delay comparable to the duration of the intervention administered in the experimental group.
**Label:** No musical intervention
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Musical intervention
**Description:** The music intervention consists of listening to two or three pieces of music chosen by each participant that bring them a sense of well-being. One of the two music intervention sessions will be preceded by a moment of relaxation, during which participants will be asked to focus their attention on their breathing, on relaxation, and on the process of self-absorption. This intervention, preceded by a brief moment of relaxation, will take place during the first session for half of the participants and during the second session for the other half.
**Name:** Music intervention in person
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Five open questions will be asked by the facilitator to inquire about the participant's experience. - Tell me about your experience with the intervention program. - What is your overall opinion of the intervention? - What did listening to the recordings bring you? - What did you like least about the intervention? - What would you change about the intervention? - Have you had any prior experience with this type of intervention?
**Measure:** Subjective experience
**Time Frame:** 5 week
#### Primary Outcomes
**Description:** Change in composite outcome score for pre-test to post-test for the experimental sessions compared with change in the control sessions. The composite score will be obtained by summing the pain (0-10), anxiety (0-10) and well-being (reversed) scores (0-10) from the Edmonton Symptom Assessment Scale Revised. (ESAS-r)
**Measure:** Changes in Composite pain, anxiety, and well-being (reversed) score
**Time Frame:** The posttest was administered 25 minutes after the pretest
#### Secondary Outcomes
**Description:** Change in pain level, as assessed by the Edmonton Symptom Assesment Scale Revised (ESAS-r) on a scale of 0 to 10.
**Measure:** Changes in Pain levels
**Time Frame:** The posttest was administered 25 minutes after the pretest.
**Description:** Change in anxiety level, as assessed by the Edmonton Symptom Assesment Scale Revised (ESAS-r) on a scale of 0 to 10.
**Measure:** Changes in Anxiety levels
**Time Frame:** The posttest was administered 25 minutes after the pretest.
**Description:** Change in well-being (reversed) level, as assessed by the Edmonton Symptom Assesment Scale Revised (ESAS-r) on a scale of 0 to 10.
**Measure:** Changes in well-being (reversed)
**Time Frame:** The posttest was administered 25 minutes after the pretest.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged 18 years and older;
* Suffering from chronic pain and actively attending the pain clinic at the CHU de Québec-Université Laval;
* Have an email and be able to respond to online questionnaires using a computer, tablet, or phone;
* Have satisfactory or corrected hearing;
* Understand French;
* Be able to travel to Université Laval.
Exclusion Criteria:
* None
**Gender Based:** True
**Gender Description:** All
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Josiane Bissonnette, Ph.D.
**Phone:** 418-656-2131
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Anne Marie Pinard, Md, MA
**Phone:** 418 656-2131
**Phone Ext:** 404519
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** CIRRIS
**Name:** Anne Marie Pinard, Md, MA
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
- 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: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M29442
- Name: Chronic Pain
- Relevance: HIGH
- As Found: Chronic Pain
- ID: M4324
- Name: Anxiety Disorders
- Relevance: HIGH
- As Found: Anxiety
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: HIGH
- As Found: Chronic
### Condition Browse Module - Meshes
- ID: D000059350
- Term: Chronic Pain
- ID: D000001008
- Term: Anxiety Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436365
**Brief Title:** Is the Expert Nail With Poller Screws Superior to the Distal Tibial Locked Plate in the Management of Short Oblique Distal Tibial Fractures?
**Official Title:** Is the Expert Nail With Poller Screws Superior to the Distal Tibial Locked Plate in the Management of Short Oblique Distal Tibial Fractures?
#### Organization Study ID Info
**ID:** MD-190-2020
#### Organization
**Class:** OTHER
**Full Name:** Kasr El Aini Hospital
### Status Module
#### Completion Date
**Date:** 2023-12-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-08-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-02-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kasr El Aini Hospital
#### Responsible Party
**Investigator Affiliation:** Kasr El Aini Hospital
**Investigator Full Name:** Ahmed Omar Sabry
**Investigator Title:** Dr.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** Distal tibial fracture management is difficult because of poor blood supply resulted from subcutaneous location. Therefore, the study aims to compare expert intramedullary nail (IMN) with poller screws to the distal tibial locked plate regarding operative and complications outcomes
**Detailed Description:** Stabilization of the fractured segments is the main goal in fracture fixation which will help to achieve proper healing, fasten early mobility, and get the full function of the injured limb. The fractures may be managed conservatively or by fixation whether internal or external .
Tibial fractures are the most common long bone fractures because of their subcutaneous location which makes them more liable to trauma. They are more common in young males as they are related to sports and traffic accidents. Elderly people come in second place of tibial fractures because they are more likely to occur from simple falls. Proper surgical management of displaced tibial fracture will help in increasing bone stability with the surrounding tissue and improving the bone alignment which in turn fastens the early movement, increases overall function, and prevents prolonged bedridden.
Distal tibia fractures represent from 7% to 10% of all lower limb fractures. Basically, there is controversy over the use of the term "distal tibial fractures" Some authors use the term to describe the distal metaphyseal fractures as defined by one Muller square as Giannoudis 2015 et al. Others use distal tibial fractures to refer to distal shaft fractures (meta-diaphyseal region) from 4 to 11 centimeters starting from the plafond as Polat 2015 et al . Others use the term for both regions, describing them as " two muller squares" as Mauffrey 2012 et al.
Management of distal tibial fracture management is difficult especially in old patients with mature skeletons and without involvement of knee joint because of a fracture near the position to the ankle joint with decreased blood flow resulting from the subcutaneous anatomical location \[8\]. There are common fixation techniques performed in distal tibial fracture management like open reduction with internal fixation, intramedullary nail insertion (IMN), minimally invasive percutaneous plate osteosynthesis, and external fixation with limited open reduction and internal fixation.
Despite these different management methods achieving success in proper reduction and enhancing the stability and union, they were associated with disadvantages that need to be considered during the management plan which makes no single method ideally preferred for all combined bone and soft tissue distal tibial traumas. Therefore, studies should address all advantages, disadvantages, and the proper application of each method.
We aim in our study to compare expert IMN with poller screws to the distal tibial locked plates in the management of the short oblique distal tibial fractures regarding clinical outcomes, radiological findings, complications, and the need for a secondary operation.
### Conditions Module
**Conditions:**
- Tibia Fracture
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The authors performed a prospective randomized controlled trial by including 42 patients to compare expert IMN with poller screws (Group One including 21 patients) versus distal tibial locked plate (Group Two including 21 patients) in fixation of extra-articular distal tibial fractures. The study was conducted after obtaining clearance from the Scientific Board and the Ethical Committee and all patients signed informed consents before starting the study.
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 42
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Twenty-one patients underwent IMN fixation by placing in a supine position with the knee flexed at 90 degrees above the radiolucent table to enable intraoperative imaging and a bolster was put below the thigh to enable knee flexion up to 110 degrees. Multiple interlocking screws were inserted in the expert nail which costed the double compared to the ordinary nail.
**Intervention Names:**
- Procedure: Locking expert intramedullary nail fixation
**Label:** expert IMN with poller screws
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** patients underwent distal locked plates by placing in a supine position and raising of the contralateral iliac crest which enhanced the rotation and made it easier for medial side access. Thigh was elevated and torniquet was put up to 300 mmHg. By reduction preservation, proximal screws were inserted by small incisions which was followed by insertion of the remained distal screws.
**Intervention Names:**
- Procedure: Distal locked plate
**Label:** distal tibial locked plate
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- expert IMN with poller screws
**Description:** the fracture was reduced to enable the insertion of the guide wire to restore the rotation, length, and angulation. Poller screws were used as control deformity by narrowing the medullary canal and were inserted on the deformity concave side between the nail and bone cortex. A ball-ended guidewire was placed through the entry point to the tibial canal and then to the tibial fracture site under the guidance of fluoroscopy. The guide wire should be inserted centrally within the distal segment on both lateral and anteroposterior views and be far about 1 to 0.5 centimeters from the ankle joint. Reamers with deep fluted and small diameters were used slowly to increase the diameter to reach 0.5 mm till the cortical chatter.
The nail was inserted by attachment of insertion device and locking of the proximal screw to the nail by directing its apex posteriorly. The nail insertion was done by flexing the knee to prevent any patellar impingement.
**Name:** Locking expert intramedullary nail fixation
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- distal tibial locked plate
**Description:** Cobb dissector was used in creation extra-periosteal subcutaneous tunnel for gentle introduction of a proper plate which was determined by choosing appropriate size and level guided by imaging which helped in prevention of any periosteal damage. Manual closed reduction was performed using the percutaneous clamps. Distal screws were positioned as the following, one was inserted above the medial malleolus, another one was inserted right and below the fracture, and the other screws were inserted to help in anatomical plate positioning. By reduction preservation, proximal screws were inserted by small incisions which was followed by insertion of the remained distal screws.
**Name:** Distal locked plate
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** questionnaire assessing main nine aspects (daily life activity, pain, supports, swelling, jumping, stiffness, squatting, stair climbing, and running) with a maximum score of 100 indicated normal and minimal score of zero indicated totally impaired function. The score was graded by excellent (for scores between 91 to 100), good (scores between 61 to 90), fair (scores between 31 to 60), and poor (scores between 0 to 30)
**Measure:** Olerud Molander Ankle Score (OMAS)
**Time Frame:** 2 weeks
#### Secondary Outcomes
**Description:** Complications were also assessed like malunion, delayed union, deep venous thrombosis, infection, and nonunion.
**Measure:** Complications
**Time Frame:** 2 weeks and 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Skeletally mature (18-60 years) male and female patients presented with short oblique fractures which were defined by a fracture with an oblique fracture line its an inclination equal to or greater than 30° with respect to the perpendicular to the axis of the tibia .
Exclusion Criteria:
* We excluded patients presented with other fracture patterns
* intraarticular distal tibial fractures, old fractures, infected fractures, open fractures, and pathological fractures.
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Kasr Alainy Hospital - Faculty of Medicine - Cairo University
**Zip:** 11765
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000007869
- Term: Leg Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M26370
- Name: Fractures, Bone
- Relevance: HIGH
- As Found: Fracture
- ID: M16737
- Name: Tibial Fractures
- Relevance: HIGH
- As Found: Tibial Fractures
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M10881
- Name: Leg Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000050723
- Term: Fractures, Bone
- ID: D000013978
- Term: Tibial Fractures
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436352
**Brief Title:** Does Capsulotomy in Closed Reduction of Femoral Neck Fractures Decrease Incidence of Avascular Necrosis?
**Official Title:** Does Capsulotomy in Closed Reduction of Femoral Neck Fractures Decrease Incidence of Avascular Necrosis?
#### Organization Study ID Info
**ID:** MD-143-2019
#### Organization
**Class:** OTHER
**Full Name:** Kasr El Aini Hospital
### Status Module
#### Completion Date
**Date:** 2023-02-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-02-01
**Type:** ACTUAL
#### Start Date
**Date:** 2021-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kasr El Aini Hospital
#### Responsible Party
**Investigator Affiliation:** Kasr El Aini Hospital
**Investigator Full Name:** Ahmed Omar Sabry
**Investigator Title:** Dr.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Femur's neck injuries are frequently encountered fractures. They are usually due to high energy or low energy indirect trauma. Healing of these fractures is usually hindered due to "avascular necrosis (AVN)" or "non-union" of the Femur's head. This study looks forward to investigating the impact of capsulotomy and internal fixation in lowering the incidence of complications and improving the functional outcomes.
**Detailed Description:** Femoral neck fractures constitute a frequent orthopaedic, usually due to indirect assault. It primarily affects older people, with younger people accounting for barely 2 - 3%. Nevertheless, since transportation has recently advanced rapidly, high-energy trauma has become increasingly widespread. The prevalence of femur neck injuries among youth is likewise growing in hospitals by an estimated rate of about 6000 yearly. Hip blood supply is especially important while addressing femoral neck fractures. Blood supply emerges from the capsular, intramedullary, and the ligamentum teres vessels. In adults, capsular vessels provide most of the femur's head blood supply. The arteries originate out of the "medial and lateral circumflex femoral arteries". Those areteries are in turn branced out of the profunda femoris in seventy nine of the population. There is an exception for 20% of population where one vessel originates from the femoral artery. Moreover, there is 1% of the population in which both vessels originate from the femoral artery. The effectiveness and benefits of capsulotomy in treating femur's neck fractures among youth were compared to "closed reduction and internal fixation (CRIF)". AVN and non-union are the most prevalent and difficult complications. In terms of "trauma degree index" (incision length, amount of lost blood, and operative time), capsulotomy and internal fixation are less effective than CRIF. However, it outperforms CRIF in functional effectiveness (Harris Hip Score.
Some differences exist between capsulotomy reduction and internal fixation. First and foremost is proper anatomical reduction. With direct sight and adequate exposure, an acceptable anatomical reduction can be obtained, laying the groundwork for the healing of fractures. Furthermore, it could unlock certain retinacular arteries that have been temporarily blocked by kinking or stretching, allowing for the the restoration of some vascular function. The second principal is "stable internal fixation" that can be achieved by proper placement of the screws under direct visualization.
Researchers have concluded that evacuating of the hematoma significantly lowers the capsular pressure and improves pulse perfusion of the femur's head. Our study aims to investigate the efficiency of capsulotomy in enhancing the healing process of femur's neck fractures.
### Conditions Module
**Conditions:**
- Femoral Neck Fractures
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** A prospective research was carried out between January 2021 and February 2023. Patients were randomized into two groups: Group I: cases with capsulotomy and Group II: cases without capsulotomy. The study was conducted after an ethical approval was obtained.
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** before fixation, We perform a guide wire insertion passing anterior to the Greater Trochanter and the neck is done. then passing a pointed Schanz 5 or 6mm ± scalpel, under X-ray in AP-lateral views until reaching the capsule (intra trochanteric line). Aspiration of hematoma with suction was done.
**Intervention Names:**
- Procedure: Capsulotomy and fixation
**Label:** Group I: cases with capsulotomy during fixation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** we fix the fracture without capsulotomy
**Intervention Names:**
- Procedure: Fixation only
**Label:** Group II: cases without capsulotomy during fixation
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group I: cases with capsulotomy during fixation
**Description:** Firstly, Guide wire insertion passing anterior to the GT and the neck is done. then passing a pointed Schanze 5 or 6 ± scalpel, under X-ray in AP-lateral views until reaching the capsule (intra trochanteric line). Aspiration of hematoma with suction was done.
Then we fix the fracture by proceeding with drilling over the wires using a "3.6 mm cannulated drill bit". Then, we place three "7.0 mm or 7.3 mm cannulated cancellous screws" over the wires. In younger patients with thick cancellous bone, a "cannulated tap" may be required to precut the thread. A washer may be used to prevent the screw head from penetrating the thin cortex.
**Name:** Capsulotomy and fixation
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Group II: cases without capsulotomy during fixation
**Description:** we fix the fracture by proceeding with drilling over the wires using a "3.6 mm cannulated drill bit". Then, we place three "7.0 mm or 7.3 mm cannulated cancellous screws" over the wires. In younger patients with thick cancellous bone, a "cannulated tap" may be required to precut the thread. A washer may be used to prevent the screw head from penetrating the thin cortex.
**Name:** Fixation only
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
**Measure:** Harris hip score
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** in ml
**Measure:** Intra-operative blood loss
**Time Frame:** during the operation
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Skeletally mature patients with fracture neck femur who will undergo urgent surgery within 48 hours.
* Male and female patients of any garden classification of femoral neck fractures
* within age group from 18 - 55 years
Exclusion Criteria:
* Patients of age below 18 years or above 55 years.
* those with metabolic bone disease, pathological fractures, stress fracture or delayed presentation more than 48 hours were excluded.
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Kasr Alainy Hospital - Faculty of Medicine - Cairo University
**Zip:** 11765
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000010335
- Term: Pathologic Processes
- ID: D000006620
- Term: Hip Fractures
- ID: D000005264
- Term: Femoral Fractures
- ID: D000025981
- Term: Hip Injuries
- ID: D000007869
- Term: Leg Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M26370
- Name: Fractures, Bone
- Relevance: HIGH
- As Found: Fracture
- ID: M8403
- Name: Femoral Neck Fractures
- Relevance: HIGH
- As Found: Femoral Neck Fractures
- ID: M12284
- Name: Necrosis
- Relevance: HIGH
- As Found: Necrosis
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M9696
- Name: Hip Fractures
- Relevance: LOW
- As Found: Unknown
- ID: M8402
- Name: Femoral Fractures
- Relevance: LOW
- As Found: Unknown
- ID: M23105
- Name: Hip Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M10881
- Name: Leg Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009336
- Term: Necrosis
- ID: D000050723
- Term: Fractures, Bone
- ID: D000005265
- Term: Femoral Neck Fractures
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436339
**Brief Title:** Association Between Apical Periodontitis and Psoriasis Vulgaris
**Official Title:** Association Between Apical Periodontitis and Psoriasis Vulgaris: a Cross-sectional Study
#### Organization Study ID Info
**ID:** PSY003
#### Organization
**Class:** OTHER
**Full Name:** University of Siena
### Status Module
#### Completion Date
**Date:** 2023-11-25
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-11-25
**Type:** ACTUAL
#### Start Date
**Date:** 2022-02-02
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Siena
#### Responsible Party
**Investigator Affiliation:** University of Siena
**Investigator Full Name:** Simone Grandini
**Investigator Title:** Head of Department of Endodontics, Periodontology, Restorative and Paediatric Dentistry
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of the present cross-sectional study is to assess the presence of AP and caries in psoriasis vulgaris individuals and to examine whether these medications influence these oral conditions. Therefore, 154 patients diagnosed with psoriasis were included in the study and subjected to oral examination to assess for presence of periapical lesions and caries experience.
**Detailed Description:** The aim of the study is to evaluate the prevalence of apical periodontitis (AP) and caries in subjects with psoriasis vulgaris. 152 patients with psoriasis vulgaris were included in the study. The severity and extent of psoriasis were assessed according to The Psoriasis Area Severity Index (PASI), the Body Surface Area (BSA), and the Physician's Global Assessment Scale (PGA). Periapical status was assessed through dental examination and periapical radiographs. Data regarding Periapical Index (PAI), caries experience expressed as the Decayed, Missing, Filled Teeth Index (DMFT), and psoriasis medications were recorded. A predictive logistic regression model for the presence of AP and a linear regression model were then built to relate the severity and extent of AP to the type of drug therapy taken for psoriasis and to the severity and extent of the skin disease.
### Conditions Module
**Conditions:**
- Apical Periodontitis
**Keywords:**
- Psoriasis vulgaris
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 152
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** The periapical status was investigated by palpation, percussion, thermal cold testing, and panoramic radiographs. Afterward, teeth that exhibited deep carious lesions, deep restorations, no response to pulp testing, or painful response to biting and/or percussion or palpation were suspected of AP. Those teeth underwent further periapical radiograph using the long cone paralleling technique with a film holder. AP cases were diagnosed based on the identification of at least one tooth with periapical radiolucency outpacing twice the width of the periodontal ligament space and having PAI \> 2.
**Measure:** Apical Periodontitis
**Time Frame:** The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point
**Description:** Periapical health was assessed radiographically using the PAI score that was determined through visual inspection of the periapical area, assigning a numerical value based on the extent and severity of inflammation. Scores ranged from 0 to 5
**Measure:** Periapical Index Score (PAI)
**Time Frame:** The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point
**Description:** The DMFT index is calculated by summing the scores for decayed (D), missing (M), and filled (F) teeth for an individual or a group of individuals
**Measure:** The DMFT index is calculated by summing the scores for decayed (D), missing (M), and filled (F) teeth for an individual or a group of individuals
**Time Frame:** The time frame for this observational study is defined by the initial assessment conducted at baseline. No follow-up measurements are scheduled, and the study aims to explore associations and characteristics at a single time point
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age between 18 and 70
* Ability and willingness to give written consent;
* Presence of at least 6 teeth.
* Diagnosis of Psoriasis Vulgaris
* Other systemic diseases apart from psoriasis
Exclusion Criteria:
* diagnosis of periodontitis
* inability or unwillingness to give informed consent;
* periodontal treatment within the previous 6 months;
* ongoing immunosuppressive treatments or antibiotic therapy for other systemic diseases;
* pregnant or on lactation;
* additional comorbidities
* non endodontic lesions in maxilla/mandible;
* AP diagnosed on teeth with inadequate endodontic treatments and coronal restorations
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Participants were recruited from a specialty outpatient dermatology clinic (Unit of Dermatology, Azienda Ospedaliero-Universitaria Senese, Siena, Italy) from February 2022 to November 2023. Patients were eligible based on the inclusion criteria. Individuals were included in the study after they read and signed the written informed consent, in accordance with the Declaration of Helsinki.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Siena
**Country:** Italy
**Facility:** Azienda Ospedaliera Universitaria Senese
**State:** Toscana
**Zip:** 53100
### IPD Sharing Statement Module
**Description:** no plan to share IPD
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000017444
- Term: Skin Diseases, Papulosquamous
- ID: D000012871
- Term: Skin Diseases
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000010483
- Term: Periapical Diseases
- ID: D000007571
- Term: Jaw Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13427
- Name: Periodontitis
- Relevance: HIGH
- As Found: Periodontitis
- ID: M13395
- Name: Periapical Periodontitis
- Relevance: HIGH
- As Found: Apical Periodontitis
- ID: M14422
- Name: Psoriasis
- Relevance: HIGH
- As Found: Psoriasis
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19713
- Name: Skin Diseases, Papulosquamous
- Relevance: LOW
- As Found: Unknown
- ID: M13419
- Name: Periodontal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13393
- Name: Periapical Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10601
- Name: Jaw Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010518
- Term: Periodontitis
- ID: D000010485
- Term: Periapical Periodontitis
- ID: D000011565
- Term: Psoriasis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436326
**Brief Title:** The Impact of Continuous Glucose Monitoring on Maternal and Infant's Outcomes in Gestational Diabetes
**Official Title:** The Impact of Continuous Glucose Monitoring on Maternal and Infant's Outcomes in Gestational Diabetes: Testing the Moderating Effects of Socioeconomic and Cultural Factors
#### Organization Study ID Info
**ID:** 202311035RINC
#### Organization
**Class:** OTHER
**Full Name:** National Taiwan University Hospital
### Status Module
#### Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** National Taiwan University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study will discuss the impact of continuous glucose monitoring on maternal and infant's outcomes in gestational diabetes mellitus, and test the moderating effect of socioeconomic and cultural factors (dietary habits, socioeconomic status and income).
**Detailed Description:** Background: The global prevalence of gestational diabetes mellitus is increasing. To reduce the negative impact of gestational diabetes mellitus on maternal and fetal health, managing blood glucose during pregnancy is important, which also shows the importance of blood glucose monitoring. Continuous glucose monitoring (CGM) is different from traditional blood glucose meters (BGM). Continuous glucose monitoring is now known to have good control effects in type 1 and type 2 diabetes mellitus. However, there are still few randomized controlled trials for gestational diabetes mellitus and there are not consistent results. In addition, blood glucose management conditions vary among groups with different dietary habits, socioeconomic status and income. Food culture of Taiwan is diverse and it is easy to consume sugar or high carbohydrate foods. Continuous glucose monitoring can be more sensitive to measure glucose fluctuations, but it is still unknown whether it will have different maternal and infant health effects for groups whose glucose is prone to exceed the target range.
Objective: To explore the impact of continuous glucose monitoring on the health outcomes of mothers and infants with gestational diabetes mellitus, and to test the moderating effect of socioeconomic and cultural factors (dietary habits, socioeconomic status and income) on the relationship between continuous glucose monitoring and the health outcomes among mothers with gestational diabetes mellitus and their infants.
Methods: This study was a randomized controlled trial. It was expected that 120 pregnant women with gestational diabetes mellitus would be randomly assigned to the " Control group" (40 people) using blood glucose meters (BGM), or the "experimental group" (80 people) using continuous glucose monitoring (CGM) at a ratio of 1:2. In the "experimental group", they would be assigned to the " Experimental group1-Continuous glucose monitoring (CGM) group" (40 people) or the " Experimental group2-Continuous glucose monitoring (CGM) with nursing care group" (40 people). The " Experimental group2-Continuous glucose monitoring (CGM) with nursing care group " would provide nursing intervention during the perinatal period. The outcome variables of the three groups would be tracked and compared with 3 time points, which were 24 to 32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, and 4 to 12 weeks after delivery. The primary outcomes were maternal glycemic parameters, cardiometabolic risk factors, and fetal macrosomia. Secondary outcomes included gestational weight, depression and infant growth curve.
### Conditions Module
**Conditions:**
- Gestational Diabetes Mellitus
- Continuous Glucose Monitoring
**Keywords:**
- Gestational Diabetes Mellitus
- Continuous Glucose Monitoring
- Health Interventions
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The participants will receive structured questionnaires and blood tests (glycated albumin, fasting plasma glucose, insulin, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein) at 24-32 weeks of pregnancy, 35 weeks of pregnancy to before delivery, and 4-12 weeks postpartum, respectively.
Participants are required to use blood glucose meters (BGM) at "24-32 weeks of pregnancy" and "33 weeks to before delivery". After 14 days of glucose monitoring at "24-32 weeks of pregnancy", a glucose monitor report will be given to the participants. After the 14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor report will be given to the participants.
**Intervention Names:**
- Other: Blood glucose meters (BGM)
**Label:** Controlled group-Blood glucose meters (BGM) group
**Type:** OTHER
#### Arm Group 2
**Description:** The participants will receive structured questionnaires and blood tests (glycated albumin, fasting plasma glucose, insulin, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein) at 24-32 weeks of pregnancy, 35 weeks of pregnancy to before delivery, and 4-12 weeks postpartum, respectively.
Participants will receive a set of continuous glucose monitor (CGM) respectively at "24-32 weeks of pregnancy (first set)" and "33 weeks of pregnancy to before delivery (second set)".
**Intervention Names:**
- Device: Continuous glucose monitor
**Label:** Experimental group1-Continuous glucose monitoring (CGM) group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** The participants will receive structured questionnaires and blood tests (glycated albumin, fasting plasma glucose, insulin, total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein) at 24-32 weeks of pregnancy, 35 weeks of pregnancy to before delivery, and 4-12 weeks postpartum, respectively.
Participants will receive a set of continuous glucose monitor (CGM) respectively at "24-32 weeks of pregnancy (first set)" and "33 weeks of pregnancy to before delivery (second set)".
Participants will receive perinatal nursing care for gestational diabetes.
**Intervention Names:**
- Device: Continuous glucose monitor
- Behavioral: Perinatal nursing care for gestational diabetes
**Label:** Experimental group2-Continuous glucose monitoring (CGM) with nursing care group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental group1-Continuous glucose monitoring (CGM) group
- Experimental group2-Continuous glucose monitoring (CGM) with nursing care group
**Description:** Participants will receive a set of continuous glucose monitor (CGM) at "24-32 weeks of pregnancy (first set)" and "33 weeks of pregnancy to before delivery (second set)," respectively.
CGM wearing instruction will be provided before the first wearing at "24-32 weeks of pregnancy". After completing the first wearing (approximately 14 days after starting to wear), we will provide a glucose monitor report. The second CGM was worn from the 33rd week of pregnancy to before delivery, and another glucose monitor report was given approximately 14 days after starting to wear.
**Name:** Continuous glucose monitor
**Other Names:**
- Abbott FreeStyle Libre 2 (CGM)
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Experimental group2-Continuous glucose monitoring (CGM) with nursing care group
**Description:** Individual nursing care and consultation for pregnant women with gestational diabetes mellitus, including glucose monitor suggestions, dietary suggestions, emotional support, breastfeeding support.
**Name:** Perinatal nursing care for gestational diabetes
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- Controlled group-Blood glucose meters (BGM) group
**Description:** Participants are required to use blood glucose meters (BGM) at "24-32 weeks of pregnancy" and "33 weeks to before delivery". After 14 days of glucose monitoring at "24-32 weeks of pregnancy", a glucose monitor report will be given to the participants. After the 14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor report will be given to the participants.
**Name:** Blood glucose meters (BGM)
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Oral glucose tolerance test (OGTT) including fasting, 1-hour, and 2-hour glucose levels.
**Measure:** Maternal Oral glucose tolerance test
**Time Frame:** 24-32 weeks of pregnancy, 4-12 weeks postpartum
**Description:** glycated albumin
**Measure:** Maternal glycated albumin
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** albumin
**Measure:** Maternal albumin
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** fasting plasma glucose
**Measure:** Maternal fasting plasma glucose
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** insulin
**Measure:** Maternal insulin
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** total cholesterol
**Measure:** Total cholesterol
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** triglycerides
**Measure:** Triglycerides
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** high-density lipoprotein
**Measure:** High-density lipoprotein
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** low-density lipoprotein
**Measure:** Low-density lipoprotein
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** Fetal macrosomia is defined as a birth weight ≥4,000 g.
**Measure:** Fetal macrosomia
**Time Frame:** 4-12 weeks postpartum
#### Secondary Outcomes
**Description:** Gestational weight gain will be based on pre-pregnancy Body Mass Index (BMI) and classified according to the Institute of Medicine (IOM) recommendations.
**Measure:** Gestational weight gain
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
**Description:** Edinburgh Postnatal Depression Scale (EPDS)
**Measure:** Depression
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** infant growth curve
**Measure:** Infant growth curve
**Time Frame:** 4-12 weeks postpartum
**Description:** average fasting plasma glucose
**Measure:** Maternal average fasting plasma glucose
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** average plasma glucose, Post-cibum
**Measure:** Maternal average plasma glucose, Post-cibum
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** the weight change from pre-pregnancy to a period postpartum
**Measure:** Postpartum weight retention
**Time Frame:** 4-12 weeks postpartum
**Description:** dosage and insulin form
**Measure:** Insulin medications
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** preeclampsia-eclampsia, gestational hypertension
**Measure:** Hypertensive disorders in pregnancy
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery
**Description:** Cesarean Section
**Measure:** Cesarean Section
**Time Frame:** 4-12 weeks postpartum
**Description:** Physical Activity Questionnaire
**Measure:** Physical Activity
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** Likert scale based on Transtheoretical model, including self-monitoring of glucose level, diet and physical activity.
**Measure:** Health behavior change of glycemic control
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** Likert scale based on Health belief Model
**Measure:** Health Belief of glycemic control
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** WHOQOL-BREF
**Measure:** Quality of life assessment
**Time Frame:** 24-32 weeks of pregnancy, 33 weeks of pregnancy to before delivery, 4-12 weeks postpartum
**Description:** Satisfaction using continuous glucose monitoring (CGM) or blood glucose meters (BGM) access by Likert scale.
**Measure:** Glucose monitoring satisfaction
**Time Frame:** 33 weeks of pregnancy to before delivery
**Description:** Benefit of CGM (BenCGM) and Burdens of CGM (BurCGM) Questionnaires
**Measure:** Perceived benefits and barriers of CGM
**Time Frame:** 33 weeks of pregnancy to before delivery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged 18 years or above
* Pregnant women diagnosed with gestational diabetes mellitus
* Those who are willing to participate in this study
Exclusion Criteria:
* Those who have been diagnosed with diabetes mellitus "before pregnancy"
* Those whose skin is likely allergic to some materials such as tapes (signs and symptoms such as redness, swelling, itching, painful, presenting blisters or rashes caused by wearing breathable tapes, patches, etc.)
* Those who is with abnormal coagulation function
**Gender Based:** True
**Gender Description:** The participants of this study are pregnant women with gestational diabetes mellitus.
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** HUNG-HUI CHEN, PhD
**Phone:** 886-2-2394-7109
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hsinchu
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** HUNG-HUI CHEN
- **Phone:** +886-2-23947109
- **Role:** CONTACT
**Country:** Taiwan
**Facility:** National Taiwan University Hospital Hsin-Chu Branch BioMedical Park Hospital
**Zip:** 302058
#### Overall Officials
**Official 1:**
**Affiliation:** National Taiwan University Hostiptal
**Name:** HUNG-HUI CHEN, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M19012
- Name: Diabetes, Gestational
- Relevance: HIGH
- As Found: Gestational Diabetes
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes Mellitus
- 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: 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: D000016640
- Term: Diabetes, Gestational
- ID: D000003920
- Term: Diabetes Mellitus
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: LOW
- As Found: Unknown
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436313
**Brief Title:** DBS Virtual Learning Experience
**Official Title:** The Value of Virtual Education on Deep Brain Stimulation for Surgical Candidates
#### Organization Study ID Info
**ID:** 23-5018
#### Organization
**Class:** OTHER
**Full Name:** University of Toronto
### Status Module
#### Completion Date
**Date:** 2025-02-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Toronto
#### Responsible Party
**Investigator Affiliation:** University of Toronto
**Investigator Full Name:** Alfonso Fasano
**Investigator Title:** Professor, Department of Medicine, Division of Neurology at University of Toronto, Toronto Western Hospital
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The success of Deep Brain Stimulation (DBS) is more correlated to fulfillment of patients' expectations, than merely improvement of motor status1. Therefore, it is of utmost importance to inform the DBS candidates as good as possible to set realistic expectations. Currently, the patient - most of the time accompanied by a family member - is informed about the surgery and its benefits and risks during the outpatient consultation of the neurologist, and later on during the consultation of the neurosurgeon. Written information is provided in the form of a booklet that the patients take home.
Due to the large amount of information, not all of it can be captured by the patient. Therefore, we would like to investigate whether an additional online immersive educational session on DBS would better educate the patient. The online session is a 1-hour video call with a small group of DBS candidates and their caregivers, lead by DBS experts, where testimonials of other patients are shown, together with multiple infographics. Two weeks later their will be a second online session summarizing the information and providing the opportunity for Q\&A.
### Conditions Module
**Conditions:**
- Parkinson Disease
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will receive two extra virtual educational sessions.
**Intervention Names:**
- Other: Educational Sessions
**Label:** Educational Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients will not receive any extra educational sessions. Their education will be provided as per standard-of-care by the clinical team.
**Label:** Standard-of-Care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Educational Group
**Description:** Two online educational sessions will be organized before DBS surgery. These will be scheduled between consultation with the neurologist and the consultation with the neurosurgeon. Each virtual session will last about 1 hour. Patients can login from home, together with their caregivers. The virtual sessions will be held on MS Teams virtual platform.
One of the sessions will include a DBS patient where patients will have the opportunity to ask peer-to-peer questions. The session includes testimonials from patient before and after their surgery.
The second session (about two weeks later) is a summary presentation, a quiz and time for Q\&A. During one of the sessions (first or second), a DBS patient (who has been implanted) can be invited to participate togive the attendees the opportunity to ask peer-to-peer questions. The quiz contains questions to assess the patients' knowledge of DBS.
**Name:** Educational Sessions
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** This questionnaire assesses how often people with Parkinson's experience difficulties. across 8 dimensions of daily living. The total score for each dimension ranges from 0 (never have difficulty) to 100 (always have difficulty). Lower scores indicate better quality of life.
**Measure:** The Parkinson's Disease Questionnaire (PDQ-39)
**Time Frame:** Baseline, 3 months post op
**Description:** Is composed of 4 parts4. Part 1 in on the non-motor aspects of experiences of daily living, with the first half begin rated by the health care professional, based on input from the patient and the caregiver; and the second half a patient questionnaire. Part 2 is on the motor aspects of experiences of daily living, which is a questionnaire filled out by the patient and the caregiver. In the 3rd part the motor condition of the patient evaluated by the physician or nurse practitioner, in meds-ON and DBS-ON condition. The fourth and final part evaluates the motor complications and is rated by the health care professional, based on input from the patient and the caregiver.
The total score on the MDS-UPDRS ranges from 0 to 260. The score indicates:
0: No disability 260: Total disability.
**Measure:** MDS-UPDRS (Movement Disorders Society Unified Parkinson's Disease Rating Scale)
**Time Frame:** Baseline, 3 months post op
**Description:** is a 12-item observer or patient-rated scale with three subscales, for persistent and episodic anxiety, and avoidance behaviour. The total score on the PAS can range from 0 to 48.
Higher scores indicate greater experiences of anxiety
**Measure:** Parkinson Anxiety Scale (PAS)
**Time Frame:** Baseline, 3 months post op
**Description:** Is a 21-items questionnaire that is filled out by the patient to self-rate mood-related statements. The total score can range from 0 to 63.
Higher scores indicate greater severity of depressive symptoms.
**Measure:** The Beck Depression Inventory (BDI)
**Time Frame:** Baseline, 3 months post op
**Description:** Assesses the level of knowledge (score range: 0-110), anxiety (score range: 0-100), expectation (score range: 0-100), satisfaction (score range: 0-80).
**Measure:** Structured survey
**Time Frame:** Baseline, one day before surgery, 3 months post op
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients of any age over 18 who are capable of understanding and granting informed consent.
2. Consecutive enrollment of Parkinson's disease patients, eligible for DBS surgery who will be operated in Toronto Western Hospital.
3. Targets of surgery (STN or GPi) equally in each study arm.
4. Patients must be able to follow the assessment procedure.
Exclusion Criteria:
1. people with limited digital skills (to the discretion of the PI).
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Toronto
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Alfonso Fasano, MD, PhD
- **Phone:** (416) 603-5800
- **Phone Ext:** 5961
- **Role:** CONTACT
**Country:** Canada
**Facility:** Movement Disorders Centre - Toronto Western Hospital
**State:** Ontario
**Status:** RECRUITING
**Zip:** M5T 2S8
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020734
- Term: Parkinsonian Disorders
- ID: D000001480
- Term: Basal Ganglia Diseases
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009069
- Term: Movement Disorders
- ID: D000080874
- Term: Synucleinopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M13213
- Name: Parkinson Disease
- Relevance: HIGH
- As Found: Parkinson's Disease
- ID: M22494
- Name: Parkinsonian Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M25603
- Name: Ganglion Cysts
- Relevance: LOW
- As Found: Unknown
- ID: M16358
- Name: Synovial Cyst
- Relevance: LOW
- As Found: Unknown
- ID: M4774
- Name: Basal Ganglia Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12029
- Name: Movement Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M2217
- Name: Synucleinopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010300
- Term: Parkinson Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436300
**Brief Title:** Colorectal Cancer Screening in Alaska Native Men
**Official Title:** Increasing Colorectal Cancer Screening in Alaska Native Men
#### Organization Study ID Info
**ID:** R21NR019362
**Link:** https://reporter.nih.gov/quickSearch/R21NR019362
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** Washington State University
### Status Module
#### Completion Date
**Date:** 2024-01-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-01-31
**Type:** ACTUAL
#### Start Date
**Date:** 2023-08-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Southcentral Foundation
#### Lead Sponsor
**Class:** OTHER
**Name:** Washington State University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Alaska Native men have the highest rates of colorectal cancer incidence and mortality in the US. Screening can prevent disease and improve survival. We previously developed an intervention that uses text messages to increase colorectal cancer screening in Alaska Native patients of the Southcentral Foundation healthcare system in Anchorage, Alaska. The intervention improved screening by 50% in women, but it had no effect in men. We propose to culturally tailor the intervention for Alaska Native Men, and to test it with a randomized controlled trial among 600 patients at the Southcentral Foundation. This will be the first trial of an intervention designed to increase colorectal cancer screening in Alaska Native men.
**Detailed Description:** Alaska Native men have higher colorectal cancer (CRC) incidence and mortality than any other US racial or ethnic group. Screening can prevent CRC and improve treatment outcomes by detecting disease in early stages, but Alaska Native men also have low CRC screening uptake. Colonoscopy is the most accurate CRC screening method and results in the most years of life saved. It only requires rescreening every 10 years, but it is a clinic- based procedure and needs extensive preparation. Other screening options include home-based tests that detect blood in the stool and require rescreening every year. More recently, a home-based method has been developed that tests stool for DNA indicative of CRC and requires rescreening every 3 years. Current guidelines recommend CRC screening for average risk adults starting between ages 45-50, but people at higher risk should start at younger ages. Many interventions have been developed to promote CRC screening. Among these, interventions that use text messaging or other electronic health messages to reach people outside of the clinical setting have shown promise for improving CRC screening. In a previous study, our research team developed an intervention that sends up to 3 text messages to Alaska Native people patients of the Southcentral Foundation (SCF) healthcare system in Anchorage, Alaska. We tested the intervention in a randomized controlled trial with 2,386 Alaska Native SCF patients ages 40-75. The intervention increased CRC screening by 50% in women, but it had no effect in men. In the current implementation study, we propose a theory-based approach to culturally tailor the existing text message intervention for Alaska Native men. We will use surveys and focus groups with SCF patients, and key informant interviews with SCF healthcare providers, to assess barriers and facilitators to optimize colorectal cancer screening in Alaska Native men. We anticipate that revisions will include changing the content and frequency of the text messages, and promoting home-based stool DNA screening in addition to colonoscopy. We will then test the effectiveness of the tailored intervention with 600 Alaska Native men ages 40-75 who are active patients at SCF. Eligible men will be identified from the electronic medical record and randomized in equal proportions to the intervention or usual care control conditions. The primary outcome is CRC screening completed within 6 months of sending the first text message. Secondary outcomes include clinical findings and follow-up procedures associated with screening. All data will be collected from the electronic medical record, and we will obtain a waiver of consent for direct patient recruitment. Follow-up interviews will assess patient response to the intervention. If effective, this study has implications for increasing CRC screening in men from other racial and ethnic minority groups who experience CRC disparities.
Public Health Relevance Statement
### Conditions Module
**Conditions:**
- Colorectal Cancer
**Keywords:**
- screening
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Parallel arm randomized controlled trial
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 998
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Usual care arm receives established methods for scheduling colorectal cancer screening with clinic patients.
**Label:** Control
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Receives motivational messages to promote colorectal cancer screening plus usual care.
**Intervention Names:**
- Behavioral: Motivational text messaging
**Label:** Messages only
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Receives motivational messages to promote colorectal cancer screening, plus offer of a $50 gift card for completing screening, plus usual care.
**Intervention Names:**
- Behavioral: Motivational text messaging
**Label:** Messages plus gift card
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Receives motivational messages to promote colorectal cancer screening, plus offer of entry into a raffle for a prize worth approximately $200 if they complete screening, plus usual care.
**Intervention Names:**
- Behavioral: Motivational text messaging
**Label:** Messages plus raffle
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Messages only
- Messages plus gift card
- Messages plus raffle
**Description:** Intervention sends up to 4 motivational messages by text or email to Alaska Native men who are active patients and due for colorectal cancer screening. Incentive arms include promise of a $50 gift card or entry into a raffle for prize worth about $200 if they complete screening.
**Name:** Motivational text messaging
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Screening procedure documented in the electronic medical record
**Measure:** Colorectal cancer screening
**Time Frame:** Six months
**Description:** Scheduling colonoscopy pre-op appointment
**Measure:** Screening behavior
**Time Frame:** Six months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Alaska Native or American Indian racial identity
* Male gender identity
* Active patient of the Southcentral Foundation in Anchorage, Alaska
* Empanelled to primary care provider in the Anchorage or local Valley area
* Eligible for routine preventive colorectal cancer screening
Exclusion Criteria:
* None
**Gender Based:** True
**Gender Description:** Eligibility determined in the electronic medical record, which reflects gender identity.
**Healthy Volunteers:** True
**Maximum Age:** 75 Years
**Minimum Age:** 40 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Anchorage
**Country:** United States
**Facility:** Southcentral Foundation
**State:** Alaska
**Zip:** 99508
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436287
**Brief Title:** Handwriting Analysis in Movement Disorders.
**Official Title:** Handwriting Analysis in Movement Disorders.
#### Organization Study ID Info
**ID:** 123953
#### Organization
**Class:** OTHER
**Full Name:** Western University
### Status Module
#### Completion Date
**Date:** 2030-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Western University
#### Responsible Party
**Investigator Affiliation:** Western University
**Investigator Full Name:** Aditya Murgai
**Investigator Title:** Assistant Professor in Neurology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Movement disorders are a group of neurological conditions that cause problems with movement, either in the form of excessive, reduced, or slow movements. Some commonly known movement disorders include Parkinson disease, dystonia, ataxia, and Tourette syndrome. Multiple movement disorders have unique handwriting characteristics that can be measured using an inkless pen and a digitalized tablet. Handwriting is a complex skill that requires a combination of cognition, motor planning, and visuomotor integration. Handwriting deteriorates in patients with neurodegenerative diseases.
This study aims to discern variations in the kinematics (movement patterns) involved in handwriting between individuals with movement disorders and healthy controls. Participants will be invited to carry out a series of handwriting tasks. The pen motions will be captured using an inkless pen and a digitizing tablet linked to a laptop. The entire set of tasks is designed to be completed within 30 minutes. The data will then be collected, processed, and analyzed utilizing a handwriting analysis software.
**Detailed Description:** Background: Handwriting is a complex skill that requires a combination of cognition, motor planning, and visuomotor integration. Various brain structures including the cerebral cortex, basal ganglia, and cerebellum are involved in learning and performing handwriting. Many neurological disorders impact these brain structures in unique ways, leading to distinct effects on handwriting. Changes in handwriting performance are a prominent feature of Parkinson disease (PD), ataxias, and other movement disorders. Handwriting analysis can serve as a tool to distinguish and monitor the progression of movement disorders. Patients suffering from PD exhibit impairments of previously learned motor skills, including handwriting. It has been demonstrated that patients in the early stages of Parkinson disease exhibit variations in handwriting when compared to healthy individuals. The current research will investigate kinematics, visuospatial adaptation, and learning in different movement disorders through handwriting analysis.
Data collection and Measurement techniques: The subject will be seated comfortably at a table with the digitalized tablet positioned to allow a natural writing position for the subject. Pen movements will be recorded using a non-inking pen and Wacom Cintiq 16-inch digitizing tablet connected to a laptop. A practice session will be provided to each participant to familiarize them with the inkless writing pen and tablet. Before each task, participants will be given instructions on how to perform the task. Participants will be instructed to complete several writing exercises aimed at evaluating various aspects of their handwriting skills. Each task will be repeated multiple times and the entire set of handwriting exercises will be completed within 30 minutes.
### Conditions Module
**Conditions:**
- Movement Disorders
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Day
### Arms Interventions Module
#### Arm Group 1
**Description:** Diagnosed with a movement disorder
**Label:** Cases
#### Arm Group 2
**Description:** Healthy controls
**Label:** Control
### Outcomes Module
#### Primary Outcomes
**Description:** Average absolute vertical velocity (cm/s)
**Measure:** Primary handwriting kinematic parameter (velocity)
**Time Frame:** Day 1
#### Secondary Outcomes
**Description:** Average absolute vertical acceleration (cm/s²)
**Measure:** Secondary handwriting kinematic parameter (acceleration)
**Time Frame:** Day 1
**Description:** Average stroke duration (msec)
**Measure:** Secondary handwriting kinematic parameter (duration)
**Time Frame:** Day 1
**Description:** Average pen pressure (levels)
**Measure:** Pen pressure
**Time Frame:** Day 1
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
(1) Diagnosed with a movement disorder.
Exclusion Criteria:
1. Action tremor or weakness in the dominant hand interfering with writing task.
2. Unable to write or understand English
**Healthy Volunteers:** True
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Movement disorder patients will be recruited from the London Movement Disorder Clinic.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Aditya Murgai
**Phone:** 519-685-8500
**Phone Ext:** 33121
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** London
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Aditya Murgai, MBBS, MD, DM
- **Phone:** 5196633121
- **Role:** CONTACT
**Country:** Canada
**Facility:** Aditya Murgai
**State:** Ontario
**Zip:** N6A5A5
## Derived Section
### Condition Browse Module - Ancestors
- 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: M12029
- Name: Movement Disorders
- Relevance: HIGH
- As Found: Movement Disorders
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009069
- Term: Movement Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436274
**Acronym:** HOPE II
**Brief Title:** Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV.
**Official Title:** Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study.
#### Organization Study ID Info
**ID:** 2024P000880
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts General Hospital
### Status Module
#### Completion Date
**Date:** 2027-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Witwatersrand, South Africa
**Class:** OTHER
**Name:** Botswana Harvard AIDS Institute Partnership
**Class:** OTHER_GOV
**Name:** Ministry of Health, Rwanda
**Class:** OTHER
**Name:** Fred Hutchinson Cancer Center
**Class:** NIH
**Name:** National Cancer Institute (NCI)
#### Lead Sponsor
**Class:** OTHER
**Name:** Massachusetts General Hospital
#### Responsible Party
**Investigator Affiliation:** Massachusetts General Hospital
**Investigator Full Name:** Ruanne Barnabas, MBChB, MSc, DPhil.
**Investigator Title:** Chief of the Division of Infectious Diseases
**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 Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living with HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study is evaluating immediate or delayed single-dose nonavalent HPV vaccination among women living with HIV who received one HPV vaccination prior to HIV diagnosis.
**Detailed Description:** The HOPE II Study is an individual-level, randomized trial of immediate or delayed vaccination with a single-dose of the nonavalent HPV vaccine. The primary outcome is single-dose HPV 16/18/31/33/45/52/58 vaccine efficacy (VE). The study will provide evidence on the efficacy of single-dose HPV 16/18/31/33/45/52/58 vaccination among women living with HIV.
Participants will be randomized 1:1 into two different Groups.
* Group 1: Will receive nonavalent HPV vaccine at Day 0 and meningococcal vaccine at Month 18
* Group 2: Will receive the meningococcal vaccine at Day 0 and nonavalent HPV at Month 18
The meningococcal vaccine was chosen as the control vaccination because meningococcal vaccination has no activity against HPV infection. Further, the meningococcal vaccine has the potential to be of benefit in a meningitis outbreak context and could be beneficial for young persons in a congregate setting such as tertiary institutions.
### Conditions Module
**Conditions:**
- Human Papilloma Virus
- Hiv
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Participants will be randomized 1:1 into two different Groups. Group 1: Will receive nonavalent HPV vaccine at Day 0 and meningococcal vaccine at Month 18. Group 2: Will receive the meningococcal vaccine at Day 0 and nonavalent HPV at Month 18.
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 750
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Will receive GARDASIL®9 vaccine at Day 0 and Menveo®/Menactra® vaccine at Month 18
**Intervention Names:**
- Biological: GARDASIL®9
- Biological: Menveo®/Menactra®
**Label:** Group 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Will receive the Menveo®/Menactra® vaccine at Day 0 and GARDASIL®9 at Month 18
**Intervention Names:**
- Biological: GARDASIL®9
- Biological: Menveo®/Menactra®
**Label:** Group 2
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 1
- Group 2
**Description:** GARDASIL®9 or equivalent vaccines will be used for this study. These are FDA-approved vaccines.
**Name:** GARDASIL®9
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Group 1
- Group 2
**Description:** Menveo®/Menactra® or equivalent vaccines will be used for this study. These are FDA-approved vaccines.
**Name:** Menveo®/Menactra®
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Efficacy will be measured by the incidence of persistent infection from at least one of these HPV 16/18/31/33/45/52/58, where persistence is defined as a positive test at two consecutive visits at least 4.5 months apart.
**Measure:** Efficacy of single-dose HPV among women living with HIV who were vaccinated against HPV 16/18 before their HIV diagnosis.
**Time Frame:** 18 Months
#### Secondary Outcomes
**Description:** This will be evaluated by comparing the occurrence of serious adverse events reported among each study arm.
**Measure:** Safety and tolerability of single-dose nonavalent HPV vaccination in women living with HIV.
**Time Frame:** 18 Months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Assigned female at birth
2. Age 16 years and above on the day of signing the informed consent form
3. Living with HIV with confirmed test results or clinic records
4. History of receiving a single dose of an HPV vaccine before HIV diagnosis
5. Self-reported sexually active in the last six months
6. Lives within the study area and willing to provide updated locator information over the course of the study
7. Does not have an autoimmune, degenerative, or genetic disease
8. Does not have known advanced HIV (as per stage IV World Health Organization clinical staging criteria for HIV)
9. No other Investigator-determined factor would limit participation in the trial
10. Has not and is not enrolled in a monoclonal, investigational vaccine, or a large quantity blood draw study
11. The participant has a cervix
Exclusion Criteria:
1. Anyone with cervical abnormality on examination
2. Anyone with an allergy to vaccine components or yeast
**Gender Based:** True
**Gender Description:** Assigned female at birth
**Minimum Age:** 16 Years
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Diane Kanjilal, FNP
**Phone:** 617-643-9958
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Mass General Brigham
**Name:** Ruanne Barnabas, MBChB, MSc, DPhil
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Wits RHI, University of The Witwatersrand
**Name:** Sinead Delany-Moretlwe, MBBCh, PhD, DTM&H
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000018307
- Term: Neoplasms, Squamous Cell
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC04
- Name: Neoplasms
### Condition Browse Module - Browse Leaves
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M18250
- Name: HIV Infections
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13131
- Name: Papilloma
- Relevance: HIGH
- As Found: Papilloma
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M20451
- Name: Neoplasms, Squamous Cell
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010212
- Term: Papilloma
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17360
- Name: Vaccines
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436261
**Brief Title:** Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Hybrid-Fractional Laser for Facial Rejuvenation
**Official Title:** A Randomized, Multi-Center, Double-Blinded, Split-Face, Controlled Study Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With a Hybrid-Factional Laser for Facial Rejuvenation
#### Organization Study ID Info
**ID:** RS-2021-03
#### Organization
**Class:** INDUSTRY
**Full Name:** Revision Skincare
### Status Module
#### Completion Date
**Date:** 2022-07-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-07-01
**Type:** ACTUAL
#### Start Date
**Date:** 2021-12-14
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Revision Skincare
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This randomized, multi-center, double-blinded, split-face, controlled clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after hybrid-fractional laser treatment and for 7 days post-procedure with three times daily application in healthy female subjects aged 35-65 years with moderate to severe global face photodamage (score of 4 to 7 out of the 10-point Modified Griffiths' scale). Furthermore, this clinical trial compared the active post-procedure cream to a comparator moisturizer often paired with skin rejuvenation procedures. This is a cosmetic study with an FDA-regulated device.
A total of 16 healthy female subjects completed the study (8 subjects at both sites).
**Detailed Description:** This randomized, multi-center, double-blinded, split-face, controlled clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after hybrid-fractional laser treatment and for 7 days post-procedure with three times daily application in healthy female subjects aged 35-65 years with moderate to severe global face photodamage (score of 4 to 7 out of the 10-point modified Griffith's scale). The ability of the post-procedure cream to soothe skin and improve patient downtime post-procedure was investigated by evaluating tolerability parameters (erythema, edema, dryness, burning, itching, stinging) over the course of the study. Furthermore, this clinical trial compared the active post-procedure cream to a comparator moisturizer often paired with skin rejuvenation procedures.
A 7-day washout period was required of all subjects prior to hybrid-fractional laser treatment. Tolerability (investigator: erythema, edema, dryness; subject: burning, itching, stinging) and safety were assessed through grading at screening, pre-procedure, post-procedure, post-procedure/post-product application, and days 1, 3, 5, and 7 post-procedure.
In addition, efficacy evaluation using the Modified Griffiths' scale was performed at screening, pre-procedure, and day 7 post-procedure. Self-assessment questionnaires were completed by subjects post-procedure/post-product application and days 1, 5, and 7 post-procedure. Clinical photography was completed at screening, pre-procedure, post-procedure/post-product application, and days 1, 3, 5, and 7 post-procedure.
A total of 16 healthy female subjects completed the study (8 subjects at both sites).
### Conditions Module
**Conditions:**
- Photoaging
- Wrinkle
- Skin Laxity
**Keywords:**
- Post-Procedure
- Hybrid Fractional Laser
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized, Multi-Center, Double-Blinded, Split-Face, Controlled
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Subjects were randomly assigned to use the active post-procedure cream on one side of the face and the comparator moisturizer on the opposite side of the face.
The products were packaged in the same container and labelled post-procedure cream. This was a double-blinded study, where the investigator, study subject, and other study personnel involved in the evaluation of efficacy or safety were blinded to the group during the study.
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Active (Experimental) Post-Procedure Cream
Dosage Form: reverse emulsion (water in oil) cream containing bioactive ingredients, botanical actives, peptides, and antioxidants.
Frequency of Dosage: Three times daily (morning, afternoon, and evening). Subjects were asked to apply to the face, forehead, under eyes, cheeks, upper lips, chin, and nose. The product was labelled with Right or Left depending on split-face randomization.
Study Duration: 14 days. Active Post-Procedure Cream duration 14 days.
**Intervention Names:**
- Procedure: Hybrid Fractional Laser
- Other: Facial Cleanser
- Other: Facial Moisturizer
- Other: Sunscreen
**Label:** Split-Face Application of Active
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** COMPARATOR:
Dosage Form: moisturizer formulation
Comparator Moisturizer Frequency of Dosage: Three times daily (morning, afternoon, and evening). Subjects were asked to apply to the face, forehead, under eyes, cheeks, upper lips, chin, and nose. The product was labelled with Right or Left depending on split-face randomization.
Study Duration: 14 days. Comparator duration 14 days.
**Intervention Names:**
- Procedure: Hybrid Fractional Laser
- Other: Facial Cleanser
- Other: Facial Moisturizer
- Other: Sunscreen
**Label:** Split-Face Application of Comparator
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Split-Face Application of Active
- Split-Face Application of Comparator
**Description:** A hybrid fractional HALO™ laser treatment was performed after a 7-day washout period. Subjects were numbed for 30 minutes to 1 hour prior to the procedure with a topical numbing cream containing benzocaine, lidocaine, and/or tetracaine. After numbing was completed, patients received one full-face HALO™ laser treatment with settings 350/20/20.
**Name:** Hybrid Fractional Laser
**Other Names:**
- HALO™ laser treatment
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Split-Face Application of Active
- Split-Face Application of Comparator
**Description:** Subjects were to use the provided cleanser twice daily (morning and evening) during the 7-day washout period and 7-day post-procedure timeline.
**Name:** Facial Cleanser
**Other Names:**
- Gentle Cleansing Lotion, Revision Skincare
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Split-Face Application of Active
- Split-Face Application of Comparator
**Description:** Subjects were to use the provided bland facial moisturizer as follows:
WASHOUT PERIOD (7 days): After cleansing, 1-2 pumps were to be applied twice daily (morning and evening) to the full face avoiding the eye area
POST-PROCEDURE (7 days): After applying the Post-Procedure Cream and Active Comparator based on split-face randomization, the facial moisturizer was to be applied twice daily (morning and afternoon).
**Name:** Facial Moisturizer
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- Split-Face Application of Active
- Split-Face Application of Comparator
**Description:** During the 7-day washout period and 7-day post-procedure timeline, subjects were to apply the provided basic sunscreen in the morning and afternoon after applying facial moisturizer. Sunscreen was to be reapplied as needed throughout the day per FDA recommendations.
**Name:** Sunscreen
**Other Names:**
- Aveeno Positively Mineral Sensitive Skin with sun protection factor (SPF) 40+
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The primary tolerability endpoint will be Investigator Tolerability Assessment of erythema, edema, and dryness. A change in score of lack of significant change post-procedure/post-product application and days 1, 3, 5, and 7 post-procedure in comparison to immediately post-procedure indicates tolerability/safety of the test material.
A four-point scale will be used with a lower score indicating a better outcome:
0 = None
1. = Mild
2. = Moderate
3. = Severe
**Measure:** Investigator Tolerability
**Time Frame:** 7 days
**Description:** The primary safety endpoint will be determined by the incidence and severity of adverse events in healthy subjects, including immediately post-procedure and throughout the length of the study.
**Measure:** Incidence of Adverse Events
**Time Frame:** 7 days
**Description:** The subject tolerability endpoint will be Subject Tolerability Assessment of burning, itching, and stinging. A change in score of lack of significant change post-procedure/post-product application and days 1, 3, 5, and 7 post-procedure in comparison to immediately post-procedure indicates tolerability/safety of the test material.
A four-point scale will be used with a lower score indicating a better outcome:
0 = None
1. = Mild
2. = Moderate
3. = Severe
**Measure:** Subject Tolerability
**Time Frame:** 7 days
#### Secondary Outcomes
**Description:** A change in response values at days 1, 5, and 7 compared to post-procedure/post-product application response values indicates an improvement. Baseline responses will be set to post-procedure/post-product application. Subjects are asked to rate statements based on a scoring system ranging from 5 (completely agree) to 1 (completely disagree). The best outcome is to Completely Agree with the statement / question being asked.
**Measure:** Self-Assessment Questionnaire
**Time Frame:** 7 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Healthy female subjects 35-65 years of age
* Fitzpatrick Skin Type I to III
* Moderate to severe global face photodamage (score of 4 to 7 out of the 10-point Modified Griffiths' scale, where 0 = none and 9 = severe)
* No known medical conditions that, in the Investigator's opinion, may interfere with study participation.
* Willing to discontinue all active topical facial products and only use the assigned test products for the duration of the study.
* Female subjects of childbearing potential must be willing to use a form of birth control during the study.
Exclusion Criteria:
* Nursing, pregnant, or planning a pregnancy during this study.
* Having undergone a chemical peel, dermabrasion, or microneedling (mechanical and radiofrequency) in the last 6 months; laser resurfacing (ablative, fractional, non-ablative) in the last 12 months
* Not willing to discontinue active topical facial products for 7 days prior to the Baseline Visit
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 35 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Atlanta
**Country:** United States
**Facility:** AYA™ Medical Spa
**State:** Georgia
**Zip:** 30305
**Location 2:**
**City:** Dallas
**Country:** United States
**Facility:** Resurrect Skin MD
**State:** Texas
**Zip:** 75225
#### Overall Officials
**Official 1:**
**Affiliation:** Resurrect Skin MD
**Name:** Jay Burns, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** AYA™ Medical Spa
**Name:** James Namnoum, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012873
- Term: Skin Diseases, Genetic
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000003240
- Term: Connective Tissue Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M6692
- Name: Cutis Laxa
- Relevance: HIGH
- As Found: Skin Laxity
- ID: M21089
- Name: Facies
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15676
- Name: Skin Diseases, Genetic
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1692
- Name: Cutis Laxa
- Relevance: HIGH
- As Found: Skin Laxity
### Condition Browse Module - Meshes
- ID: D000003483
- Term: Cutis Laxa
### Intervention Browse Module - Ancestors
- ID: D000011837
- Term: Radiation-Protective Agents
- ID: D000020011
- Term: Protective Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000003879
- Term: Dermatologic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M11014
- Name: Lidocaine
- Relevance: LOW
- As Found: Unknown
- ID: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
- ID: M16255
- Name: Sunscreening Agents
- Relevance: HIGH
- As Found: Laryngeal Mask
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: M16517
- Name: Tetracaine
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M14684
- Name: Radiation-Protective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M7074
- Name: Dermatologic Agents
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000013473
- Term: Sunscreening Agents
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436248
**Acronym:** PROMISE
**Brief Title:** Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer
**Official Title:** Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer
#### Organization Study ID Info
**ID:** 855461
#### Organization
**Class:** OTHER
**Full Name:** University of Pennsylvania
### Status Module
#### Completion Date
**Date:** 2027-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2026-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Susan G. Komen Breast Cancer Foundation
**Class:** OTHER
**Name:** Memorial Sloan Kettering Cancer Center
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Pennsylvania
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The overall goal of the Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer (PROMISE) study is to better understand how women may incorporate both polygenic risk score (PRS) and novel early detection strategies in their decisions regarding cancer screening and risk reducing surgery. This study will conduct qualitative interviews to better understand women's attitudes regarding polygenic risk score (PRS) and early detection assays.
**Detailed Description:** First, the investigators will conduct qualitative interviews to better understand women's attitudes regarding polygenic risk score (PRS) and early detection assays. Participants will include English-speaking adult women with BRCA1 or BRCA2 pathogenic variants (PV) who have not previously undergone risk-reducing salpingo-oophorectomy (RRSO) (n=24). Interviews will be led by a trained member of the study team using a semi-structured interview guide in order to review definitions of test characteristics (e.g., sensitivity, specificity) and discuss participants' understanding and perceived importance of such test characteristics, and the potential impact of polygenic risk score (PRS) and early detection assay results in informing their cancer prevention decisions. Interviews will be audio-recorded utilizing Zoom audio recording and transcribed using 3Play Media transcription service (Health Insurance Portability and Accountability Act/HIPAA compliant). The investigators will lead analysis of the de-identified transcripts through a process of independent and collaborative thematic content analysis, an established method in qualitative research in order to establish key themes related to clarifying participants' willingness and concerns (e.g., discomfort with test characteristics, perceived ambiguity) for adopting these emerging tests.
Findings from these qualitative interviews will also inform development of hypothetical scenarios that will then be evaluated in a subsequent questionnaire administered to 175-200 English-speaking adult women with BRCA1 or BRCA2 Pathogenic Variants who have not previously undergone risk-reducing oophorectomy or risk-reducing mastectomy. The objective of this survey will be to further evaluate women's decision-making responses to hypothetical polygenic risk score (PRS) and early detection assays, and to determine if there are test characteristics and result thresholds that appear meaningful. Details of this questionnaire and its administration will be included in a future amendment to this current protocol.
Results from year 1 will be used to develop patient materials to use in providing individualized polygenic risk score (PRS) and early detection assay results back to patients in years 2-3. Taken together, investigators hope that this project will provide an estimate on the absolute magnitude of risk which would result in risk reducing surgery within a year, and how a negative early detection assay might modulate such action.
### Conditions Module
**Conditions:**
- Ovarian Cancer
- BRCA Mutation
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** The investigators will assess how women will use information regarding polygenic risk score (PRS) and early detection assays to inform prophylactic surgery decisions through semi-structured interviews and thematic content analyses.
**Measure:** To assess how women will use information regarding polygenic risk score (PRS) and early detection assays to inform prophylactic surgery decisions through interviews
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Female, age 25 or older (given that women under this age are not generally recommended to receive BRCA1/2 genetic testing)
* Completed full sequence or targeted genetic testing with a clinically confirmed BRCA1 or BRCA2 deleterious mutation identified.
* English-fluent; the surveys and interviews were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
Exclusion Criteria:
* Previous receipt of any prophylactic oophorectomy
* Personal history of ovarian cancer
* Major psychiatric illness or cognitive impairment that in the judgment of the study investigators would preclude study participation.
* Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff.
**Healthy Volunteers:** True
**Minimum Age:** 25 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Target population is women, age 25 or over, with likely pathogenic or pathogenic variants in BRCA1 or BRCA2 and no personal history of ovarian cancer or risk-reducing oophorectomy surgery.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Philadelphia
**Country:** United States
**Facility:** Abramson Cancer Center
**State:** Pennsylvania
**Zip:** 19104
#### Overall Officials
**Official 1:**
**Affiliation:** University of Pennsylvania
**Name:** Susan Domchek, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000010049
- Term: Ovarian Diseases
- ID: D000000291
- Term: Adnexal Diseases
- ID: D000005831
- Term: Genital Diseases, Female
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000005833
- Term: Genital Neoplasms, Female
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000091662
- Term: Genital Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000006058
- Term: Gonadal Disorders
- ID: D000002277
- Term: Carcinoma
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000020022
- Term: Genetic Predisposition to Disease
- ID: D000004198
- Term: Disease Susceptibility
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12974
- Name: Ovarian Neoplasms
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M1704
- Name: Carcinoma, Ovarian Epithelial
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M3234
- Name: Genetic Risk Score
- Relevance: HIGH
- As Found: Polygenic Risk Score
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12972
- Name: Ovarian Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3643
- Name: Adnexal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8945
- Name: Genital Neoplasms, Female
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9163
- Name: Gonadal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M21875
- Name: Genetic Predisposition to Disease
- Relevance: LOW
- As Found: Unknown
- ID: M7380
- Name: Disease Susceptibility
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T4352
- Name: Ovarian Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: T4354
- Name: Ovarian Epithelial Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
### Condition Browse Module - Meshes
- ID: D000010051
- Term: Ovarian Neoplasms
- ID: D000077216
- Term: Carcinoma, Ovarian Epithelial
- ID: D000096442
- Term: Genetic Risk Score
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436235
**Brief Title:** Kidney Stone Inflammation
**Official Title:** Inflammation and Insulin Resistance in Kidney Stone Patients
#### Organization Study ID Info
**ID:** IRB24-0024
#### Organization
**Class:** OTHER
**Full Name:** University of Chicago
### Status Module
#### Completion Date
**Date:** 2026-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-05-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Chicago
#### 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 observational study aims to look at the connections between kidney stones, insulin resistance, and inflammation. The researchers hypothesize that people who form calcium kidney stones and have insulin resistance may have higher levels of inflammation because they have more visceral fat (fat around the abdominal organs).
The study will recruit 20 people who have had calcium kidney stones but don't have diabetes, and 20 healthy people who haven't had kidney stones. All the participants will come to the research center at the University of Chicago Medicine. Participants will have a dual-energy X-ray absorptiometry (DEXA) scan to measure their visceral fat, and give blood and urine samples. The blood will be tested for insulin resistance, inflammatory markers, and other metabolic factors. The urine will be analyzed for substances that increase kidney stone risk.
The main goal is to see if the kidney stone formers with insulin resistance have more visceral fat compared to those without insulin resistance and the healthy participants. The researchers will also compare inflammatory marker levels between groups, and look at how visceral fat, inflammatory markers, insulin resistance, and urine stone risk factors are related.
The findings may help explain how kidney stones are connected to metabolic conditions like diabetes and cardiovascular disease. Researchers hope this information will help identify stone formers at risk early and develop preventive treatments in the future.
**Detailed Description:** Participants will be recruited from the University of Chicago Medicine Kidney Stone Clinic (stone formers) and research participant registries (controls). After providing informed consent, participants will complete the following procedures:
Pre-Study:
1. One week prior, participants will discontinue vitamin C, multivitamins, calcium supplements, and diuretics.
2. One day prior, participants will complete a 24-hour urine collection and food frequency questionnaire at home.
Study Visit:
2. Participants will be admitted to the University of Chicago's Clinical Research Center (CRC) in a fasted state.
3. Three timed (45 minute) urine and blood specimen collections will occur.
4. Three seated blood pressure measurements will be taken.
5. Anthropometric measurements including height, weight, waist and neck circumference will be obtained.
6. A dual-energy X-ray absorptiometry (DEXA) scan will be performed to measure visceral fat content and bone density.
7. A brief clinical history will be obtained, including data on kidney stone episodes, procedures, and current stone burden.
8. Participants will remain fasted until all biological samples have been collected. Water intake will be allowed ad libitum.
Sample Analysis:
Urine:
1.24-hour and timed urine samples will be analyzed for kidney stone risk chemistries including volume, pH, solutes (calcium, oxalate, uric acid, citrate, etc).
2. Urine supersaturations for calcium oxalate, calcium phosphate, and uric acid will be calculated using EQUIL2 software.
3. Urine albumin and creatinine will be measured.
4. Remaining urine will be stored at -80°C for potential future assays.
Blood:
1. Serum glucose will be measured at the CRC laboratory.
2. Serum insulin, C-peptide, glucagon, GLP-1, and inflammatory markers (high-sensitivity CRP \[C-reactive protein\], IL-6, MMPs \[matrix metalloproteinases\], TNF-alpha, endotrophin) will be measured at the Diabetes Research and Training Center at the University of Chicago.
3. Other serum chemistries (electrolytes, calcium, creatinine, HbA1c, lipids) will be measured at the clinical laboratory.
4. Remaining serum will be stored at -80°C.
### Conditions Module
**Conditions:**
- Kidney Stone
- Stone, Kidney
### Design Module
#### Bio Spec
**Description:** Any urine or serum/plasma that is not utilized for the specified measurements in this study will be frozen at -80°C and retained as biospecimens.
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The study team plans to enroll 20 non-diabetic participants with a history of at least one calcium-based kidney stone. Activities are the same for both cohorts, as follows:
* Before clinic visit, participants will halt specific supplements and diuretics for a week.
* At home, they complete a dietary questionnaire and collect 24-hour urine.
* On the 7th day, they visit University of Chicago CRC. There, we will take measurements (height, weight) and DEXA scan, alongside kidney stone history review.
* Throughout the day, participants provide urine and blood samples, undergo blood pressure checks, and fast until sample collection.
* Samples undergo testing for kidney stone, inflammation, and diabetes risk factors and are stored for future research.
**Label:** Kidney stone formers
#### Arm Group 2
**Description:** The study team plans to enroll 20 healthy control participants with no history of kidney stones or family history of kidney stones. Activities are the same for both cohorts, as follows:
* Before clinic visit, participants will halt specific supplements and diuretics for a week.
* At home, they complete a dietary questionnaire and collect 24-hour urine.
* On the 7th day, they visit University of Chicago CRC. There, we will take measurements (height, weight) and DEXA scan, alongside kidney stone history review.
* Throughout the day, participants provide urine and blood samples, undergo blood pressure checks, and fast until sample collection.
* Samples undergo testing for kidney stone, inflammation, and diabetes risk factors and are stored for future research.
**Label:** Control cohort
### Outcomes Module
#### Primary Outcomes
**Description:** Levels of visceral fat as measured by dual x-ray absorptiometry (DEXA).
**Measure:** Difference in visceral fat content in participants who form kidney stones with insulin resistance compared to participants who form kidney stones without insulin resistance and controls
**Time Frame:** 1 week total, one half day in the CRC
**Description:** Markers of systemic inflammation, including high-sensitivity CRP, interleukin-6, MMP-7, MMP-9, TNF-alpha, and endotrophin.
**Measure:** Difference in inflammatory markers between participants who form kidney stones and controls
**Time Frame:** 1 week total, one half day in the CRC
#### Secondary Outcomes
**Description:** Correlation between visceral fat levels (measured by dual x-ray absorptiometry \[DEXA\]) and the following markers of systemic inflammation:
* High-sensitivity C-reactive protein (CRP)
* Interleukin-6 (IL-6)
* Matrix metalloproteinase-7 (MMP-7)
* Matrix metalloproteinase-9 (MMP-9)
* Tumor necrosis factor-alpha (TNF-alpha)
* Endotrophin
**Measure:** Correlation between visceral fat and inflammatory markers
**Time Frame:** 1 week total, one half day in the CRC
**Description:** Differences in urine composition based on:
* Levels of insulin resistance
* Visceral fat content (measured by DEXA)
* Levels of inflammatory markers (CRP, IL-6, MMP-7, MMP-9, TNF-alpha, endotrophin)
**Measure:** Differences in urine composition
**Time Frame:** 1 week total, one half day in the CRC
**Description:** Differences in visceral fat levels (measured by DEXA) between kidney stone patients and controls
**Measure:** Differences in visceral fat levels
**Time Frame:** 1 week total, one half day in the CRC
**Description:** Differences in insulin resistance between kidney stone patients and controls, measured by:
* Fasting blood glucose
* Fasting insulin
* Homeostatic model assessment of insulin resistance (HOMA-IR)
**Measure:** Differences in insulin resistance between kidney stone patients and controls
**Time Frame:** Time Frame: 1 week total, one half day in the CRC
**Description:** Differences in markers of systemic inflammation between kidney stone patients and controls, including:
* High-sensitivity C-reactive protein (CRP)
* Interleukin-6 (IL-6)
* Matrix metalloproteinase-7 (MMP-7)
* Matrix metalloproteinase-9 (MMP-9)
* Tumor necrosis factor-alpha (TNF-alpha)
* Endotrophin
**Measure:** Differences in markers of systemic inflammation between kidney stone patients and controls
**Time Frame:** Time Frame: 1 week total, one half day in the CRC
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Stone formers:
* Age 18-70
* History of at least one calcium-based kidney stone
* Healthy Controls:
* Age 18-70
* No history of kidney stone or family history of kidney stones
Exclusion Criteria (for both groups):
* History of primarily uric acid
* Cysteine, or struvite stones
* History of diabetes or impaired glucose tolerance
* Previous thiazide use
* Anyone on a medication that cannot be stopped that may affect urine composition
* Previous bariatric surgery or ileostomy
* Primary hyperparathyroidism and elevated serum calcium.
**Healthy Volunteers:** True
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Kidney Stone Former Group:
Age 18-70 years old History of at least one calcium-based kidney stone
Control Group:
Age 18-70 years old No personal history of kidney stones No family history of kidney stones
Exclusion Criteria for Both Groups:
History of primarily uric acid, cysteine, or struvite stones History of diabetes or impaired glucose tolerance Previous thiazide diuretic use Medications that cannot be stopped that may affect urine composition Previous bariatric surgery or ileostomy Primary hyperparathyroidism and elevated serum calcium
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Megan Prochaska, MD
**Phone:** 773-702-1000
**Phone Ext:** 45488
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Elaine Worcester, MD
**Phone:** 773-702-3630
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chicago
**Country:** United States
**Facility:** University of Chicago Medical Center
**State:** Illinois
**Zip:** 60637
#### Overall Officials
**Official 1:**
**Affiliation:** University of Chicago
**Name:** Megan Prochaska, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000007674
- Term: Kidney Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052878
- Term: Urolithiasis
- ID: D000014545
- Term: Urinary Calculi
- ID: D000052801
- Term: Male Urogenital 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: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: HIGH
- As Found: Inflammation
- ID: M10693
- Name: Kidney Calculi
- Relevance: HIGH
- As Found: Kidney Stone
- ID: M27126
- Name: Nephrolithiasis
- Relevance: HIGH
- As Found: Kidney Stone
- ID: M5399
- Name: Calculi
- Relevance: HIGH
- As Found: Stone
- ID: M10370
- Name: Insulin Resistance
- Relevance: LOW
- As Found: Unknown
- ID: M22519
- Name: Pathological Conditions, Anatomical
- 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: 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: M27103
- Name: Urolithiasis
- Relevance: LOW
- As Found: Unknown
- ID: M17295
- Name: Urinary Calculi
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007669
- Term: Kidney Calculi
- ID: D000053040
- Term: Nephrolithiasis
- ID: D000007249
- Term: Inflammation
- ID: D000002137
- Term: Calculi
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: LOW
- As Found: Unknown
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M7411
- Name: Diuretics
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436222
**Brief Title:** Effectiveness of HVNI in Preterm Infants With Moderate Respiratory Distress
**Official Title:** Effectiveness of High Velocity Nasal Insufflation (HVNI) in Infants <32 Weeks Gestational Age(GA) or Birth Weight <1500 Grams With Moderate Respiratory Distress in Dr.Cipto Mangunkusumo Hospital
#### Organization Study ID Info
**ID:** 336/UN2.F1/ETIK/PPM.00.02/2024
#### Organization
**Class:** OTHER
**Full Name:** Indonesia University
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Indonesia University
#### Responsible Party
**Investigator Affiliation:** Indonesia University
**Investigator Full Name:** Dr. dr. Putri Maharani Tristanita Marsubrin, Sp. A(K)
**Investigator Title:** Principal Investigator of Perinatology Division
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Neonatal respiratory distress is a common problem in preterm infants. The application of CPAP is widely used in neonatal units as a primary mode of respiratory support for respiratory distress. However, discomfort, nasal injuries, and fixation difficulties have been reported as obstacles when applying CPAP. High velocity nasal insufflation (HVNI) may serve as an alternative to CPAP. Trials are needed to evaluate the effectiveness of HVNI in reducing the incidence of respiratory distress. The aim of this study is to compare the clinical effectiveness and safety of HVNI as an alternative therapy to CPAP in premature infants with moderate respiratory distress. This study is a prospective, non-inferiority, randomized, unblinded controlled trial to compare the efficacy of HVNI and CPAP. The subjects were randomly allocated to receive either HVNI or CPAP according to the study protocol. They were randomly assigned using blocks of four. The completion of HVNI therapy was determined by therapeutic failure within 72 hours following enrollment, indicated by the need for intubation.
### Conditions Module
**Conditions:**
- Respiratory Distress, Newborn
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Participants are assigned to two groups either HVNI (intervention group) or CPAP (control group)
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The infant was given therapy using HVNI with an initial flow of 6 L/min. Inspiratory fraction of oxygen (FiO2) started with 30% following the SpO2 target. The maximum flow is 8L/min. FiO2 can be increased by 5% until the target SpO2 is reached.
**Intervention Names:**
- Device: HVNI
**Label:** HVNI (Intervention Group)
**Type:** OTHER
#### Arm Group 2
**Description:** The infant was given therapy using CPAP with an initial pressure of 7 cmH20. Inspiratory fraction of oxygen (FiO2) starting with 30% following the SpO2 target.The maximum of CPAP pressure is 8 cmH2O. FiO2 can be increased by 5% until the target SpO2 is reached.
**Intervention Names:**
- Device: HVNI
**Label:** CPAP(Control Group)
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CPAP(Control Group)
- HVNI (Intervention Group)
**Description:** Preterm infants with gestational age (GA) less than 32 weeks or birth weight less than 1500 grams. The infant has moderate respiratory distress (Downe score ≤ 6) detected within 24 hours after birth.
**Name:** HVNI
**Type:** DEVICE
### Outcomes Module
#### Other Outcomes
**Description:** The occurrence of bleeding in lateral and third or fourth ventricles characterized by hyper-attenuating fluid typically seen as layering within the ventricles in imaging studies
**Measure:** Intraventricular Hemmorhage (IVH)
**Time Frame:** one week
**Description:** Prolonged need for supplemental oxygen in preterm infants after 28 days of age or after 36 weeks postmenstrual age and who do not have other conditions requiring oxygen
**Measure:** Bronchopulmonary Dysplasia (BPD)
**Time Frame:** Within 28 days
#### Primary Outcomes
**Description:** The primary outcome was treatment failure/success within 72 hours of treatment between HVNI and CPAP
**Measure:** Effectiveness of HVNI to prevent intubation within 72 hours
**Time Frame:** Intubation rates within 72 hours
#### Secondary Outcomes
**Description:** Duration from birth until discharge
**Measure:** Length of stay
**Time Frame:** 30 days
### Eligibility Module
**Eligibility Criteria:** \*\*Inclusion Criteria:\*\*
* Preterm infants born in Cipto Mangunkusumo Hospital with gestational age (GA) less than 32 weeks or birth weight less than 1500 grams.
* Infants with moderate respiratory distress (Downe score ≤ 6) detected within 24 hours after birth.
* Parents are willing to participate in the study.
\*\*Exclusion Criteria:\*\*
* Infants with severe respiratory distress (Downe score ≥ 6) requiring invasive treatment in the form of mechanical ventilation, or apnea indicated by surfactant administration via endotracheal tube.
* Infants with contraindications to the use of non-invasive ventilation such as esophageal atresia, diaphragmatic hernia, air leak syndrome, and other conditions.
* Infants with respiratory distress due to non-pulmonary abnormalities.
* Infants with congenital metabolic disorders.
* Infants with congenital abnormalities that exacerbate respiratory distress.
**Healthy Volunteers:** True
**Maximum Age:** 32 Weeks
**Minimum Age:** 28 Weeks
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Putri Maharani Tristanita Marsubrin, MD, PhD
**Phone:** +62 812-8126-640
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
### Condition Browse Module - Browse Leaves
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
- ID: M25869
- Name: Premature Birth
- Relevance: LOW
- As Found: Unknown
- ID: M5006
- Name: Birth Weight
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436209
**Brief Title:** Cognitive Control & the Functional Organization of the Frontal Cortex
**Official Title:** Cognitive Control & the Functional Organization of the Frontal Cortex
#### Organization Study ID Info
**ID:** 0802992441
#### Organization
**Class:** OTHER
**Full Name:** Brown University
#### Secondary ID Infos
**ID:** 5R01MH125497
**Link:** https://reporter.nih.gov/quickSearch/5R01MH125497
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2026-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-27
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-17
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute of Mental Health (NIMH)
#### Lead Sponsor
**Class:** OTHER
**Name:** Brown University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this basic experimental clinical trial is to understand the effect of multitasking practice on the structure of neural representations of tasks in the human lateral prefrontal cortex and control brain regions. The main question it aims to answer is: What changes in neural representational structure predict improvements in multitasking behavior due to multitasking practice? Healthy human participants will learn two independent tasks, each mapping a set of stimuli to motor responses based on different rules. Participants will be randomized to one of two interventions. Participants assigned to the multitask practice intervention (MPI) will practice multitasking the two tasks over multiple days. Those assigned to the single-task practice intervention (SPI) will instead practice each task separately while controlling for the total number of practice opportunities associated with each task across the interventions. Both before and after the practice, the ability of all participants to perform both tasks simultaneously will be behaviorally measured using a well-established psychological refractory period (PRP) paradigm, and their neural representations will be measured using functional MRI while they perform the two tasks. Researchers will then compare improvements in multitasking behavior across the two groups, as well as changes in neural representational geometry of the tasks in the lateral prefrontal cortex and control brain regions, and test whether multitasking training is associated with specific changes in neural representations in the lateral prefrontal cortex.
**Detailed Description:** Background and Study Rationale:
Human performance on a task deteriorates when it is performed concurrently with another task. This multitasking cost has been attributed to competition for shared computational or biological resources and there is considerable debate in the field about the specific nature of these putative resources. Extensive multitasking practice is known to reduce, and sometimes, abolish these costs. These practice-related gains have been attributed to changes in central processing, more efficient task scheduling, or the learning of specialized task representations. The human prefrontal cortex is critical to flexible cognitive control of behavior, and is involved in representing tasks. However, it remains unknown what effect multitasking practice has on prefrontal task representations. In this study, we will directly address a gap in our knowledge by testing the link between multitasking costs and the geometry of neural manifolds representing task inputs in the lateral PFC.
Study Design:
Overview:
This study is a single-center, randomized controlled trial designed to examine the effect of multitask practice on multitasking behavior, the geometry of neural representations of tasks in the lateral prefrontal cortex and the relationship between these effects. A total of 60 healthy subjects are planned, 30 subjects being randomized to each, the multitask practice group (MPG), and the single task practice group (SPG). Baseline and endline assessments of multitasking behavior and neural representations in lateral PFC with fMRI will be conducted in all subjects.
Study Treatments:
Single-task practice treatment:
The single-task practice treatment will involve 3 sessions of practice during which subjects will practice instructed tasks in individual task blocks. Up to 48 blocks of practice will be performed. Subjects will be given feedback at the end of each block on their accuracy and speed of responding and they will be given an improvement target.
Multitask practice treatment:
The multitask practice treatment will involve 3 sessions of practice during which subjects will practice instructed tasks in the psychological refractory period paradigm. Up to 48 blocks of practice will be performed. Subjects will be given feedback at the end of each block on their accuracy and speed of responding and they will be given an improvement target.
Subject Selection:
Subjects will be recruited from the Providence community. Subjects will be screened over a phone call. Inclusion criteria include right-handedness, age between 18 and 35, and normal or corrected-to-normal vision. Exclusion criteria include history of psychiatric or neurological deficits and MR contraindications. Consenting procedures will be conducted in person during Study Session 1 and continuing consent will be periodically obtained during all lab Study visits.
Random Assignment:
Up to 60 eligible patients will be randomly assigned to SPG or MPG treatment groups in a 1:1 ratio by using a random number generator coded in MATLAB. Neither the experimenters nor the study subjects, will be blinded to the assignment.
Study Structure:
A total of 14 study sessions are planned for each subject. Study session 1 will be employed for informed consent, scheduling and familiarization with study tasks. Baseline evaluations will take place during study sessions 2 through 5. Treatment will be administered during study sessions 6 through 8 during which subjects will receive either 3 sessions of multi-task practice (MPG) or 3 sessions of single-task practice (SPG). Endline evaluations will take place during study sessions 9 through 12. Detailed descriptions of each Study session and all paradigms used for measurements are given below.
Behavioral paradigms:
All behavioral task paradigms will be implemented using Psychtoolbox 3 in MATLAB or in JSPsych. All tasks involve responding to visual objects presented on a computer screen with keypresses either on a keyboard or on a response box. Visual objects will vary along 4 dimensions - shape (square or circle), circle (orange or blue), pattern (dotted or striped) or size (small or large). Along with the visual object, a response panel consisting of the symbols @ and #. Subjects will be introduced to three different tasks: the shape task, color task and the pattern task. In each task, they will make a binary classification of the visual object relying on the relevant task feature (e.g. color in the color task). Each binary class will be associated with one of two categories associated with the @ and # symbols. Subjects will then select the response key associated with the relevant symbol. The left-right position of the two symbols will be varied randomly from trial to trial such that the position would be the same as the previous trial on approximately 50% of the trials, and each trial-type was associated with an equal number of left and right responses.
Single task paradigm: In the single-task paradigm, visual objects will be presented for up to 2.2 s. Responses deadline is 2.2s. Inter-trial interval will be 1 s. Trials are presented in pure single-task blocks with 64 trials per block.
Mixed tasks paradigm: In the mixed tasks paradigm, visual objects will be presented for up to 2.2 s. Response deadline is 2.2s. Inter-trial interval will be jittered between 2 and 10 seconds. Trials of multiple task types will be presented in the same block, with a word cue identifying the task to be performed on every trial.
Psychological Refractory Period paradigm: In the PRP paradigm, two visual objects will be presented on every trial, one in the upper half of the screen, and the other in the bottom half of the screen. Visual objects will be presented with a stimulus onset synchrony (SOA) varying between 50 ms and 1.5 s. Trial length will be up to 3 s. Response deadline will be 3 s for responding to both visual objects. Inter-trial interval will be either 1 s (behavioral blocks) or jittered between 2 and 10 seconds (MRI blocks). Subjects will be instructed to perform the tasks in a specific order (e.g. Color, then Shape), responding to the first stimulus that appears with the rule associated with the first task in the order and to the object that appears second. A total of 3 different task orders will be presented to subjects (e.g. Color -\> Shape, Shape -\> Color and Color -\> Pattern) and these orders will be counterbalanced across subjects such that each task has placed every role equally in each treatment group. All task orders will be administered during both baseline and endline.
MRI Protocol:
Each subject will under MRI procedures during Study Visits 2, 3, 9 and 10. Each visit will last 2 hrs during which subjects will first be provided refresher instruction on the behavioral tasks before undergoing MRI for 1 hr. During each 1 hr MRI scanning session, subjects will first be screened for metal, briefed on safety procedures and motion minimization requirements, and then situated on the scanning table in a supine position. Their head will be stabilized with soft padding, and their ears will be protected from MR noise with ear plugs. Subjects will view a computer screen through a mirror installed on a headstage and will be provided with two response boxes for performing the tasks and an emergency buzzer for communicating with the experimenters and radiographers on duty. They will then undergo a multiple echo MPRAGE scan (repetition time (TR) = 2530 ms, echo times (TE) = 1.69, 3.55, 5.41, and 7.27 ms, flip angle = 7 degrees, 176 sagittal slices, 1 × 1 × 1 mm voxels) for 6 minutes during which they may close their eyes. Following this, subjects will undergo 5-10 runs of Echo Planar Imaging (TR = 1000 ms, TE = 32.6 ms, flip angle = 64, SMS = 5, Echo spacing 0.59, 65 interleaved slices with voxel size of 2.4mm x 2.4mm x 2.4mm), each lasting between 4 to 9 minutes, during which they will perform multiple blocks of either the mixed tasks paradigm (Days 2 and 9) or the PRP paradigm (Days 3 and 10).
Study Session Descriptions:
Study Session 1:
During Study session 1, subjects will go through the consenting process with a trained research assistant. After informed consent is provided, subjects will be given an overview of the study and they will be introduced to the basic task procedure and the color, shape and pattern rules. They will practice each task in the single task paradigm for 2 blocks each. Following this they will be introduced to the PRP paradigm with their assigned task orders, for 6 blocks. At the end of the session, subjects will be debriefed and remunerated for their participation.
Study Session 2:
During Study session 2, subjects will undergo baseline measurements with the PRP paradigm with their assigned task orders, for 12 blocks. At the end of the session, subjects will be debriefed and remunerated for their participation.
Study Session 3:
During Study session 3, subjects will undergo baseline measurements with the Mixed tasks paradigm for 12 blocks. At the end of the session, subjects will be debriefed and remunerated for their participation.
Study Session 4:
During Study session 4, subjects will undergo baseline measurements of the neural representations of tasks. The MRI protocol will be administered with the Mixed tasks paradigm.
Study Session 5:
During Study session 5, subjects will undergo baseline measurements of the neural representations of tasks. The MRI protocol will be administered with the PRP paradigm.
Study Sessions 6-8:
Subjects will be administered the treatment during these sessions. The single-task practice treatment group will receive 12-24 blocks of practice with the single task paradigm and they will be provided feedback on their performance after every block along with targets for improvement. The multi-task practice treatment will practice one of the three orders in the PRP paradigm across 12-24 blocks Subjects will be given feedback at the end of each block on their accuracy and speed of responding and they will be given an improvement target.
Study Session 9:
During Study session 9, subjects will undergo endline measurements with the PRP paradigm with their assigned task orders, for 12 blocks. At the end of the session, subjects will be debriefed and remunerated for their participation.
Study Session 10:
During Study session 10, subjects will undergo endline measurements with the Mixed tasks paradigm for 12 blocks. At the end of the session, subjects will be debriefed and remunerated for their participation.
Study Session 11:
During Study session 11, subjects will undergo endline measurements of the neural representations of tasks. The MRI protocol will be administered with the Mixed tasks paradigm.
Study Session 12:
During Study session 12, subjects will undergo endline measurements of the neural representations of tasks. The MRI protocol will be administered with the PRP paradigm.
### Conditions Module
**Conditions:**
- Multitasking Behavior and Neural Representations Associated With Multitasking Ability
- Healthy Volunteers
- Executive Function
**Keywords:**
- psychological refractory period (PRP), behavioral training, neural representational geometry, lateral prefrontal cortex, separability and generalizability
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: Multitask Practice Intervention (MPI)
**Label:** Multitask Practice
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Behavioral: Single-task Practice Intervention (SPI)
**Label:** Single Task Practice
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Multitask Practice
**Description:** Multitask practice intervention (MPI) includes multiple behavioral testing sessions during which participants receive practice with multitasking two tasks using the psychological refractory period procedure.
**Name:** Multitask Practice Intervention (MPI)
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Single Task Practice
**Description:** Single task practice intervention (SPI) includes multiple behavioral testing sessions during which participants receive separate practice on two tasks.
**Name:** Single-task Practice Intervention (SPI)
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Overall neural separability (also referred to as shattering dimensionality) will be measured by employing cross-validated neural decoding of lateral PFC fMRI BOLD multi-voxel patterns, averaging decoding accuracies across all balanced dichotomies of the task inputs. Task-relevant neural separability will be measured by averaging decoding accuracies across all task-relevant variables.
**Measure:** Effect of the practice intervention on change in overall and task-relevant neural separability in lateral prefrontal cortex
**Time Frame:** through study completion, an average of 1.5 years
**Description:** Behavioral multitasking cost will be estimated by computing the difference in mean response time on task 2 on long SOAs and short SOAs in the Psychological Refractory Period paradigm. The effect of multitasking practice on behavioral multitasking will be estimated using linear mixed-effects regression, and is defined as the regression weight associated with the interaction effect of time point and intervention on multitasking cost.
**Measure:** Effect of multitasking practice on behavioral multitasking cost
**Time Frame:** through study completion, an average of 1.5 years
**Description:** The contribution of prefrontal neural separability change to the effect of multitasking practice on behavioral multitasking will be estimated using linear mixed-effects regression, and is defined as the regression weight associated with the interaction effect of time point, intervention and separability on multitasking cost.
**Measure:** Contribution of overall and task-relevant neural separability in lateral prefrontal cortex to the effect of multitasking practice on behavioral multitasking cost
**Time Frame:** through study completion, an average of 1.5 years
#### Secondary Outcomes
**Description:** Cross-classification generalization performance will be estimated by averaging decoding accuracies from cross-classification of individual task variables across subsets of task inputs in the lateral prefrontal cortex.
**Measure:** Cross-classification generalization performance of task-relevant variables in lateral prefrontal cortex
**Time Frame:** through study completion, an average of 1.5 years
**Description:** Coding axis angles will be estimated by computing the angle between the weight vectors of linear classifiers trained to decode stimulus features in each task context.
**Measure:** Coding axis angles between stimulus feature representations in two tasks in lateral prefrontal cortex
**Time Frame:** through study completion, an average of 1.5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Normal or corrected to normal vision.
Exclusion Criteria:
* Left handedness
* Presence or history of neurological or psychiatric disorders
* Usage of brain related medications
* Previous head injury and time spent unconscious
* Any implanted medial fragment or device in the body of the participant.
* Tattoos above the neck
* Injury to the eye or other body part involving a metallic object or fragment.
* Welding, grinding, or cutting of metal in lifetime of participant without usage of safety protection glasses.
* injury to the participant by a metallic object or foreign body (e.g., BB, bullet, shrapnel, etc.)
* Pregnancy or possibility of pregnancy
* Implants or devices including:
Electronic implant or device, Magnetically-activated implant or device, Cardiac pacemaker, Implanted cardioverter defibrillator (ICD), Aneurysm clip(s), Neurostimulation system, Spinal cord stimulator, Internal electrodes or wires, Bone growth/bone fusion stimulator, Cochlear, otologic, or other ear implant, Insulin or infusion pump, Implanted drug infusion device, Any type of prosthesis (eye, penile, etc.), Heart valve prosthesis, Eyelid spring or wire, Artificial or prosthetic limb, Metallic stent, filter, or coil, Shunt (spinal or intraventricular), Vascular access port and/or catheter, Radiation seeds or implants, Swan-Ganz or triple lumen catheter, Medication patch (Nicotine,Nitroglycerine), Any metallic fragment or foreign body, Wire mesh implant, Tissue expander (e.g., breast), Surgical staples, clips, or metallic sutures Joint replacement (hip, knee, etc.) Bone/joint pin, screw, nail, wire, plate, etc. IUD or diaphragm, Dentures or partial plates, Tattoo or permanent makeup above the neck, Body piercing jewelry that can not be removed, Breathing disorder, Motion disorder or tremors, Claustrophobia, Hearing aid
**Healthy Volunteers:** True
**Maximum Age:** 35 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** David Badre, PhD
**Phone:** 401-863-9563
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Providence
**Contacts:**
***Contact 1:***
- **Name:** Defne Buyukyazgan, BA
- **Role:** CONTACT
***Contact 2:***
- **Name:** David Badre, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Metcalf Research Building, Brown University & MRI Research Facility, Brown University
**State:** Rhode Island
**Status:** RECRUITING
**Zip:** 02912
#### Overall Officials
**Official 1:**
**Affiliation:** Brown University
**Name:** David Badre, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** YES
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436196
**Brief Title:** Video Laryngoscopy vs Direct Laryngoscopy in Paediatric Patients
**Official Title:** Video Laryngoscopy Versus Direct Laryngoscopy for Elective Airway Management in Pediatrics Anesthesia, Comparison of Out-comes
#### Organization Study ID Info
**ID:** CMH/614
#### Organization
**Class:** OTHER
**Full Name:** Watim Medical & Dental College
### Status Module
#### Completion Date
**Date:** 2025-01-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-25
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Watim Medical & Dental College
#### Responsible Party
**Investigator Affiliation:** Watim Medical & Dental College
**Investigator Full Name:** Muhammad Ilyas
**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 interventional study is to compare the effectiveness of direct laryngoscopy vs. video laryngoscopy in paediatric population aged 2 to 8 years presenting for elective surgeries having uncomplicated airways.
The primary outcome measures include:
1. Time taken for succesful insertion and confirmation of ETT in patients using both techniques seprately.
2. Rate of complications and failed attempts compared between both modalities.
**Detailed Description:** The comparision of efficacy of Video Laryngoscopy for pediatric airway vs Direct Laryngoscopy is the goal of this study, Safety of the patients will be the utmost priority with careful case selection alongwith proper informed detailed consent from the guardians of the children.
PROCEDURE:
After induction of General Anesthesia four minutes of proper bag mask ventilation to allow for proper intubating conditions will be done. The time taken from the insertion of the laryngoscopic blade to the best glottic view acheived by the specific technique will be noted seperately and then the time to the succesful acheivement of lung inflation with the proper placement of ETT will be noted seperately, both of these parameters will be recorded.
If in a patient airway is not secured even after 3 attempts by a specific technique the technique would be altered and patient would be excluded from our research.
MATERIALS:
Randomized allotment of patients into the 2 groups i.e Direct Laryngoscopy and Video Laryngoscopy would be done.
### Conditions Module
**Conditions:**
- Endotracheal Tube Wrongly Placed During Anesthetic Procedure
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Comparitive study between 2 groups.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Participants are not aware of the method which will be used to secure their airway.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 88
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Group of patients in which standard direct laryngoscopy will be used to secure airway.
**Intervention Names:**
- Device: Direct laryngoscope
**Label:** Direct Laryngoscopy Group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Group of patients in which Video Laryngoscopy will be used to secure airways.
**Intervention Names:**
- Device: Video Laryngoscope
**Label:** Video Laryngoscopy group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Video Laryngoscopy group
**Description:** Use of Video laryngoscope to secure airway
**Name:** Video Laryngoscope
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Direct Laryngoscopy Group
**Description:** Macintosh or Miller's laryngoscopes used to secure paediatric airways
**Name:** Direct laryngoscope
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The time from insertion of laryngoscope in the mouth to the best possible view of the glottis.
**Measure:** .Time taken to acheive the best possible view of the glottis.
**Time Frame:** 4 Min. post muscle relaxant administration to 6 Min. post muscle relaxant administration
**Description:** The time from the insertion of the laryngoscopic blade in the mouth to the correct placement of ETT confirmed by the waveform capnorgraphy.
**Measure:** Time taken to acheive succesful Endotracheal Intubation.
**Time Frame:** 4 Min 30 seconds post muscle relaxant administration to 7 Min post muscel relaxant administration.
**Description:** Total No. of attempts(max 3 attempts with the same technique) to secure airway.
**Measure:** No. of Intubation attempts needed
**Time Frame:** 4 Min. post muscle relaxation administration to 15 Min. post muscle relaxant administration.
#### Secondary Outcomes
**Description:** Changes in heart rate will be assesed during attempts and to a fixed amount of time after succesfully securing the airways.
**Measure:** Hemodynamic changes at different intervals.
**Time Frame:** During attempts to 1 min, 5 min, and 10 min post succesful intubation.
**Description:** Changes in blood pressure will be assesed during attempts and to a fixed amount of time after succesfully securing the airways.
**Measure:** Hemodynamic changes at different intervals.
**Time Frame:** During attempts to 1 min, 5 min, and 10 min post succesful intubation.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Pediatric patients of age between 2 - 8 years,
* American Society of Anesthesiologist (ASA) grades I-II Children
* Cormack-Lehane grade I, II and III who will need airway management for elective surgery under general anesthesia.
Exclusion Criteria:
* Patients with abnormal airway anatomy,
* Obese patients,
* Emergency surgery,
* Congenital syndrome involving any major organs
* Patients' guardians unwilling to participate .
* Patients in whom airway is not secured with a specific technique even after three attempts.
**Healthy Volunteers:** True
**Maximum Age:** 8 Years
**Minimum Age:** 2 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Muhammad Ilyas, FCPS,MBBS
**Phone:** 03007355742
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Muhammad Munim Ilyas, MBBS
**Phone:** 03335642984
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rawalpindi
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Muhammad Munim Ilyas, MBBS
- **Phone:** 03335642984
- **Role:** CONTACT
**Country:** Pakistan
**Facility:** Combined Millitary Hospital
**State:** Punjab
**Zip:** 46000
### IPD Sharing Statement Module
**Access Criteria:** not yet Decided
**Description:** The outcomes of the study will be shared eventually once concluded
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
**IPD Sharing:** YES
**Time Frame:** Undecided
### References Module
#### References
**Citation:** Rabiner JE, Auerbach M, Avner JR, Daswani D, Khine H. Comparison of GlideScope Videolaryngoscopy to Direct Laryngoscopy for Intubation of a Pediatric Simulator by Novice Physicians. Emerg Med Int. 2013;2013:407547. doi: 10.1155/2013/407547. Epub 2013 Oct 31.
**PMID:** 24288617
**Citation:** Sinha R, Sharma A, Ray BR, Kumar Pandey R, Darlong V, Punj J, Chandralekha C, Upadhyay AD. Comparison of the Success of Two Techniques for the Endotracheal Intubation with C-MAC Video Laryngoscope Miller Blade in Children: A Prospective Randomized Study. Anesthesiol Res Pract. 2016;2016:4196813. doi: 10.1155/2016/4196813. Epub 2016 May 15.
**PMID:** 27293429
**Citation:** Myatra SN, Patwa A, Divatia JV. Videolaryngoscopy for all intubations: Is direct laryngoscopy obsolete? Indian J Anaesth. 2022 Mar;66(3):169-173. doi: 10.4103/ija.ija_234_22. Epub 2022 Mar 24. No abstract available.
**PMID:** 35497693
**Citation:** Zhou M, Xi X, Li M, Wang S, Liu Z, Liu JQ. Video Laryngoscopy Improves the Success of Neonatal Tracheal Intubation for Novices but Not for Experienced Medical Staff. Front Pediatr. 2020 Aug 6;8:445. doi: 10.3389/fped.2020.00445. eCollection 2020.
**PMID:** 32850555
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436183
**Brief Title:** A Study of the Effects of Camoteskimab in Adults With Moderate to Severe Atopic Dermatitis
**Official Title:** A Phase 2a, Multicenter, Randomized, Double-blind, 16-week Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of Camoteskimab in Adults With Moderate to Severe Atopic Dermatitis
#### Organization Study ID Info
**ID:** AP43CP03
#### Organization
**Class:** INDUSTRY
**Full Name:** Apollo Therapeutics Ltd
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-09
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Apollo Therapeutics Ltd
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
### Description Module
**Brief Summary:** This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension to evaluate the efficacy and safety of camoteskimab in adults with moderate to severe AD.
**Detailed Description:** This study contains two parts: Parts 1 and Part 2.
Part 1 (Blinded Period):
Eligible patients will be randomized in a 1:1:1 ratio to receive either camoteskimab dose 1, camoteskimab dose 2 or placebo.
Part 2 (Extension Period):
In part 2, all participants will receive camoteskimab.
### Conditions Module
**Conditions:**
- Atopic Dermatitis
- Atopic
- Dermatitis
- Dermatologic Disease
- Eczema
- Eczema Atopic Dermatitis
- Eczema, Atopic
### 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:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Camoteskimab
**Intervention Names:**
- Drug: Camoteskimab
**Label:** Dose 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Camoteskimab
**Intervention Names:**
- Drug: Camoteskimab
- Drug: Placebo
**Label:** Dose 2
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Dummy version of the study drug
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dose 1
- Dose 2
**Description:** Drug Product
**Name:** Camoteskimab
**Other Names:**
- APL-9109
- AVTX-007
- CERC-007
- AEVI-007
- MEDI2338
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Dose 2
- Placebo
**Description:** Inactive substance
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage change from baseline in Eczema Area and Severity Index between camoteskimab and placebo at Week 16
**Measure:** To compare the clinical efficacy of camoteskimab with placebo in participants with AD
**Time Frame:** 16 weeks
#### Secondary Outcomes
**Description:** To further assess the efficacy of camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD).
**Measure:** Percent change from baseline in EASI score at Weeks 2, 4, 8, 12 and 16
**Time Frame:** Up to 16 weeks
**Description:** To further assess the efficacy of camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD).
**Measure:** Change from baseline in EASI score at Weeks 2, 4, 8, 12, and 16
**Time Frame:** Up to 16 weeks
**Description:** To further assess the efficacy of camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD).
**Measure:** Proportion of participants achieving a 50, 75, 90 and 100% improvement from baseline in EASI (EASI-50, 75, 90 and 100) at Weeks 2, 4, 8, 12, and 16
**Time Frame:** Up to 16 weeks
**Description:** To further assess the efficacy of camoteskimab in participants with AD via Investigator's Global Assessment Scale (IGA), which provides a global clinical assessment of AD severity.
**Measure:** Proportion of participants with an IGA 0/1 and a decrease in IGA of ≥ 2 points at Weeks 2, 4, 8, 12, and 16
**Time Frame:** Up to 16 weeks
**Description:** To further assess the efficacy of camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity.
**Measure:** Change from baseline in peak pruritus score at Weeks 2, 4, 8, 12, and 16
**Time Frame:** Up to 16 weeks
**Description:** To further assess the efficacy of camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity.
**Measure:** Proportion of participants with an improvement of ≥ 4 or more points in peak pruritus weekly score at Weeks 2, 4, 8, 12, and 16
**Time Frame:** Up to 16 weeks
**Description:** To further assess the efficacy of camoteskimab in participants with AD via the Patient-Oriented Eczema Measure (POEM) which assesses disease systems.
**Measure:** Change from baseline in POEM score at Weeks 2, 4, 8, 12, and 16
**Time Frame:** Up to 16 weeks
**Description:** To further assess the efficacy of camoteskimab in participants with AD via the Dermatology Life Quality Index (DLQI) which assesses quality of life.
**Measure:** Change from baseline in DLQI score at Weeks 2, 4, 8, 12, and 16
**Time Frame:** Up to 16 weeks
**Description:** To further assess the efficacy of camoteskimab in participants with AD via Body Surface Area (BSA) which assesses the percentage of the total skin affected by AD.
**Measure:** Change from baseline in AD involvement by BSA at Weeks 2, 4, 8, 12, and 16
**Time Frame:** Up to 16 weeks
**Description:** To further assess the efficacy of camoteskimab in participants with AD via the Skin Pain Numerical Rating Scale (SP-NRS) which assesses skin pain.
**Measure:** Change from baseline in SP-NRS at Weeks 2, 4, 8, 12, and 16
**Time Frame:** Up to 16 weeks
**Description:** To further assess the efficacy of camoteskimab in participants with AD via Patient Reported Outcomes Measurement Information System (PROMIS) which measures patient-reported health status for physical, mental, and social well-being.
**Measure:** Change from baseline in PROMIS-SRI-SF-8a score at Weeks 2, 4, 8, 12, and 16 reported outcomes
**Time Frame:** Up to 16 weeks
**Description:** To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD).
**Measure:** Percent change from baseline & change from W16 in EASI score at W20, 24, 28, 32
**Time Frame:** Up to 32 weeks
**Description:** To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD).
**Measure:** Change from baseline & change from W16 in EASI score at W20, 24, 28, 32
**Time Frame:** Up to 32 weeks
**Description:** To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD).
**Measure:** Proportion of participants achieving a 50, 75, 90 & 100% improvement from baseline line in EASI (EASI-50, 75, 90 & 100) at W20, 24, 28, 32
**Time Frame:** Up to 32 weeks
**Description:** To assess the efficacy of extended treatment with camoteskimab in participants with AD via Investigator's Global Assessment Scale (IGA), which provides a global clinical assessment of AD severity.
**Measure:** Proportion of participants with an IGA 0/1 & a decrease in IGA of ≥ 2 points at W20, 24, 28, 32
**Time Frame:** Up to 32 weeks
**Description:** To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity.
**Measure:** Change from baseline & change from W16 in peak pruritus score at W20, 24, 28, 32
**Time Frame:** Up to 32 weeks
**Description:** To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity.
**Measure:** Proportion of participants with an improvement of ≥ 4 or more points in peak pruritus weekly
**Time Frame:** Up to 32 weeks
**Description:** To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Patient-Oriented Eczema Measure (POEM) which assesses disease systems.
**Measure:** Change from baseline & change from W16 in POEM score at W20, 24, 28, 32
**Time Frame:** Up to 32 weeks
**Description:** To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Dermatology Life Quality Index (DLQI) which assesses quality of life.
**Measure:** Change from baseline & change from W16 in DLQI score at W20, 24, 28, 32
**Time Frame:** Up to 32 weeks
**Description:** To assess the efficacy of extended treatment with camoteskimab in participants with AD via Body Surface Area (BSA) which assesses the percentage of the total skin affected by AD.
**Measure:** Change from baseline & change from W16 in AD involvement by BSA at W20, 24, 28, 32
**Time Frame:** Up to 32 weeks
**Description:** To assess the efficacy of extended treatment with camoteskimab in participants with AD via the Skin Pain Numerical Rating Scale (SP-NRS) which assesses skin pain.
**Measure:** Change from baseline & change from W16 in SP-NRS at W20, 24, 28, 32
**Time Frame:** Up to 32 weeks
**Description:** To assess the efficacy of extended treatment with camoteskimab in participants with AD via Patient Reported Outcomes Measurement Information System (PROMIS) which measures patient-reported health status for physical, mental, and social well-being.
**Measure:** Change from baseline & change from W16 in PROMIS-SRI-SF-8a score at W20, 24, 28, 32
**Time Frame:** Up to 32 weeks
**Description:** All AEs and SAEs will be collected to assess the safety of camoteskimab versus placebo in participants with AD
**Measure:** All AEs and SAEs will be collected from the signing of the ICF until the EOS visit and all SAEs will be collected from the signing of the ICF until 3 months after the last dose of IMP
**Time Frame:** Through study completion, an average of 36 weeks
**Description:** A general PE or symptom directed PE will be performed and abnormalities will be recorded and reported as AEs if appropriate to assess the safety of camoteskimab versus placebo in participants with AD
**Measure:** Physical examinations
**Time Frame:** Through study completion, an average of 36 weeks
**Description:** Temperature in Celsius will be measured to assess the safety of camoteskimab versus placebo in participants with AD
**Measure:** Vital Signs Assessments - Temperature
**Time Frame:** Through study completion, an average of 36 weeks
**Description:** Systolic and diastolic blood pressure (mmHg) will be measured to assess the safety of camoteskimab versus placebo in participants with AD
**Measure:** Vital Signs Assessments - Blood Pressure
**Time Frame:** Through study completion, an average of 36 weeks
**Description:** Pulse (beats/min) will be measured to assess the safety of camoteskimab versus placebo in participants with AD
**Measure:** Vital Signs Assessments - Pulse
**Time Frame:** Through study completion, an average of 36 weeks
**Description:** Respiratory rate (breaths/min) will be measured to assess the safety of camoteskimab versus placebo in participants with AD
**Measure:** Vital Signs Assessments - Respiratory Rate
**Time Frame:** Through study completion, an average of 36 weeks
**Description:** O2 saturation (%) will be measured to assess the safety of camoteskimab versus placebo in participants with AD
**Measure:** Vital Signs Assessments - O2 Saturation
**Time Frame:** Through study completion, an average of 36 weeks
**Description:** PR, QRS, QT, and QTc(F) intervals will be collected to assess the safety of camoteskimab versus placebo in participants with AD
**Measure:** ECGs
**Time Frame:** Through study completion, an average of 36 weeks
**Description:** Heart rate will be collected to assess the safety of camoteskimab versus placebo in participants with AD
**Measure:** ECGs - Heart Rate
**Time Frame:** Through study completion, an average of 36 weeks
**Description:** To assess the PK of camoteskimab in participants with AD
**Measure:** PK sampling of unbound camoteskimab in nanograms per milliliter for all participants on Day 1, at Weeks 2 (Day 15), 4 (Day 29), 8 (Day 57), 12 (Day 85), 16 (Day 113), 20 (Day 141), 24 (Day 169), 28 (Day 197), and 32 (Day 225)
**Time Frame:** Through study completion, an average of 36 weeks
**Description:** To assess the PK of camoteskimab in participants with AD
**Measure:** PK Total LCMS sampling in ng/mL to determine camoteskimab exposures in the body over time for all participants on Day 1, at Weeks 2 (Day 15), 4 (Day 29), 8 (Day 57), 12 (Day 85), 16 (Day 113), 20 (Day 141), 24 (Day 169), 28 (Day 197), and 32 (Day 225)
**Time Frame:** Through study completion, an average of 36 weeks
**Description:** To assess the PK of camoteskimab in participants with AD
**Measure:** PK Total Immunoassay sampling (sum of bound and free) in ng/mL for all participants on Day 1, at Weeks 2 (Day 15), 4 (Day 29), 8 (Day 57), 12 (Day 85), 16 (Day 113), 20 (Day 141), 24 (Day 169), 28 (Day 197), and 32 (Day 225)
**Time Frame:** Through study completion, an average of 36 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Participants must be 18-75 years of age inclusive, at the time of signing the informed consent.
2. Chronic AD for at least 1 year.
3. Participants with moderate to severe AD defined by:
1. Investigator global assessment (IGA) score of ≥ 3 (on a scale of 0 to 4, in which three is moderate and four is severe) at Baseline.
2. AD involvement of ≥ 10% body surface area (BSA) at Baseline.
3. EASI score of ≥ 12 at Baseline.
4. Pruritus numerical rating scale (NRS) ≥ 4 at Baseline.
4. Participants who are candidates for systemic therapy, defined as inadequate response to treatment with topical medications, or for whom topical treatments are otherwise medically inadvisable.
5. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Female participants:
* Sexually active females of childbearing potential must agree to use two forms of accepted methods of highly effective forms of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes:
* IUD plus one barrier method.
* Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method.
* 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); or
* A vasectomized partner\*.
Male participants:
* Sexually active male participants and males and who are partners of females of childbearing potential agree to use two forms of contraception as above and to not donate sperm or try to conceive during the treatment period and for at least 3 months after the last dose of study drug.
6. Participant provides signed informed consent.
Exclusion Criteria:
1. Participant has history of use of more than two (2) prior systemic therapies for AD (e.g.
biologics or JAKi) and who used any of these medications as follows:
1. Dupilumab, tralokinumab, lebrikizumab within 8 weeks prior to Baseline.
2. Systemic JAKi within 4 weeks prior to Baseline.
3. TCS, TCI, topical phosphodiesterase-4 (PDE4) inhibitors, and topical JAKi within 7 days prior to enrollment (at Baseline) or more than five half-lives whichever is longer.
2. Participant has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of AD or would interfere with the study assessments.
3. Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma).
4. Any clinically significant abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically significant abnormalities in the 12- lead ECG as considered by the perfusion index that may interfere with the interpretation of QTc interval changes.
5. Participant has AD involving ocular symptoms, or blepharitis, conjunctivitis, or keratitis diagnosed within the last 60 days prior to the screening visit, requiring chronic ocular corticosteroid treatment.
6. Participant has severe or uncontrolled seasonal or allergic rhinitis, asthma or any other non-AD disease as judged by the Investigator. Participants with seasonal or allergic rhinitis, asthma or any other non-AD disease requiring use of intranasal or inhaled corticosteroid that is stable and well-controlled are not excluded.
7. Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIV Ab) test; Active hepatitis B virus (HBV): confirmed hepatitis B surface antigen (HBs Ag) positive (+) or hepatitis B core antibody (HBc Ab) positive (+); Active hepatitis C virus (HCV): Confirmed hepatitis C antibody positive (+); evidence of active or latent TB
8. Diagnosed with a malignancy within 5 years of enrollment (suspected malignancy should be ruled out by blood or tissue biopsy, as applicable) with the exception of
* Completely resected basal call or squamous cell carcinoma of the skin.
* Carcinoma in situ of the cervix.
9. Has had previous exposure to anti-IL-18 therapy.
10. Treatment with any investigational agent, or any investigational device or procedure, within 28 days (or 5 half- lives, whichever is greater) of screening.
11. Has any of the following laboratory findings
1. Glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2.
2. Hemoglobin ≤8 g/dL.
3. Neutrophils ≤1,500/μL.
4. Platelets ≤75,000/μL.
**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:** Apollo Therapeutics
**Phone:** +1 781 479 2267
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Phoenix
**Contacts:**
***Contact 1:***
- **Name:** Lindsay Ackerman
- **Role:** CONTACT
**Country:** United States
**Facility:** Medical Dermatology Specialists, PC/US Dermatology Partners
**State:** Arizona
**Status:** NOT_YET_RECRUITING
**Zip:** 85006
**Location 2:**
**City:** Encinitas
**Contacts:**
***Contact 1:***
- **Name:** Stacy Smith
- **Role:** CONTACT
**Country:** United States
**Facility:** California Dermatology & Clinical Research Institute
**State:** California
**Status:** NOT_YET_RECRUITING
**Zip:** 92024
**Location 3:**
**City:** Los Angeles
**Contacts:**
***Contact 1:***
- **Name:** Ricardo Tan
- **Role:** CONTACT
**Country:** United States
**Facility:** California Allergy and Asthma Medical Group
**State:** California
**Status:** NOT_YET_RECRUITING
**Zip:** 90025
**Location 4:**
**City:** Los Angeles
**Contacts:**
***Contact 1:***
- **Name:** April Armstrong
- **Role:** CONTACT
**Country:** United States
**Facility:** Keck School of Medicine of USC
**State:** California
**Status:** NOT_YET_RECRUITING
**Zip:** 90095
**Location 5:**
**City:** San Diego
**Contacts:**
***Contact 1:***
- **Name:** Henry Wong
- **Role:** CONTACT
**Country:** United States
**Facility:** VASDHS - Veterans Affairs San Diego Medical Center
**State:** California
**Status:** NOT_YET_RECRUITING
**Zip:** 92161
**Location 6:**
**City:** Fort Myers
**Contacts:**
***Contact 1:***
- **Name:** Alfonso Garcio-Bello
- **Role:** CONTACT
**Country:** United States
**Facility:** Floridian Research Institute, Llc
**State:** Florida
**Status:** NOT_YET_RECRUITING
**Zip:** 33901
**Location 7:**
**City:** Miami
**Contacts:**
***Contact 1:***
- **Name:** Brent Schillinger
- **Role:** CONTACT
**Country:** United States
**Facility:** D&H National Research Centers, Inc.
**State:** Florida
**Status:** NOT_YET_RECRUITING
**Zip:** 33155
**Location 8:**
**City:** Tampa
**Contacts:**
***Contact 1:***
- **Name:** Thomas Taylor
- **Role:** CONTACT
**Country:** United States
**Facility:** GCP Clinical Research
**State:** Florida
**Status:** NOT_YET_RECRUITING
**Zip:** 33613
**Location 9:**
**City:** Normal
**Contacts:**
***Contact 1:***
- **Name:** Dareen Siri
- **Role:** CONTACT
**Country:** United States
**Facility:** Sneeze, Wheeze & Itch Associates, LLC
**State:** Illinois
**Status:** NOT_YET_RECRUITING
**Zip:** 61761
**Location 10:**
**City:** Indianapolis
**Contacts:**
***Contact 1:***
- **Name:** Scott Fretzin
- **Role:** CONTACT
**Country:** United States
**Facility:** Dawes Fretzin Clinical Research
**State:** Indiana
**Status:** NOT_YET_RECRUITING
**Zip:** 46250
**Location 11:**
**City:** Louisville
**Contacts:**
***Contact 1:***
- **Name:** Leon Kircik
- **Role:** CONTACT
**Country:** United States
**Facility:** Skin Sciences, Pllc
**State:** Kentucky
**Status:** NOT_YET_RECRUITING
**Zip:** 40217
**Location 12:**
**City:** Owensboro
**Contacts:**
***Contact 1:***
- **Name:** Artis Truett
- **Role:** CONTACT
**Country:** United States
**Facility:** Owensboro Dermatology Associates
**State:** Kentucky
**Status:** RECRUITING
**Zip:** 42303
**Location 13:**
**City:** Troy
**Contacts:**
***Contact 1:***
- **Name:** George Murakawa
- **Role:** CONTACT
**Country:** United States
**Facility:** Somerset Skin Centre
**State:** Michigan
**Status:** NOT_YET_RECRUITING
**Zip:** 48084
**Location 14:**
**City:** Saint Joseph
**Contacts:**
***Contact 1:***
- **Name:** Melody Stone
- **Role:** CONTACT
**Country:** United States
**Facility:** Advanced Dermatology and Skin Cancer Center - Saint Joseph
**State:** Missouri
**Status:** NOT_YET_RECRUITING
**Zip:** 64506
**Location 15:**
**City:** Omaha
**Contacts:**
***Contact 1:***
- **Name:** Joel Schlessinger
- **Role:** CONTACT
**Country:** United States
**Facility:** Skin Specialists PC
**State:** Nebraska
**Status:** RECRUITING
**Zip:** 68144
**Location 16:**
**City:** Raleigh
**Contacts:**
***Contact 1:***
- **Name:** David Ginsberg
- **Role:** CONTACT
**Country:** United States
**Facility:** M3 Wake Research, Inc.
**State:** North Carolina
**Status:** NOT_YET_RECRUITING
**Zip:** 27612
**Location 17:**
**City:** Cleveland
**Contacts:**
***Contact 1:***
- **Name:** Neil Korman
- **Role:** CONTACT
**Country:** United States
**Facility:** University Hospitals Case Medical Center
**State:** Ohio
**Status:** NOT_YET_RECRUITING
**Zip:** 44106
**Location 18:**
**City:** Oklahoma City
**Contacts:**
***Contact 1:***
- **Name:** Yaohan Lam
- **Role:** CONTACT
**Country:** United States
**Facility:** Central Sooner Research
**State:** Oklahoma
**Status:** NOT_YET_RECRUITING
**Zip:** 73071
**Location 19:**
**City:** Philadelphia
**Contacts:**
***Contact 1:***
- **Name:** Lawrence Parish
- **Role:** CONTACT
**Country:** United States
**Facility:** Paddington Testing Co. Inc
**State:** Pennsylvania
**Status:** RECRUITING
**Zip:** 19103
**Location 20:**
**City:** Frisco
**Contacts:**
***Contact 1:***
- **Name:** Timothy Rodgers
- **Role:** CONTACT
**Country:** United States
**Facility:** Rodgers Dermatology
**State:** Texas
**Status:** NOT_YET_RECRUITING
**Zip:** 75034
**Location 21:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Name:** Stephen Tyring
- **Role:** CONTACT
**Country:** United States
**Facility:** Center for Clinical Studies
**State:** Texas
**Status:** NOT_YET_RECRUITING
**Zip:** 77004
**Location 22:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Name:** Mushtaq Khan
- **Role:** CONTACT
**Country:** United States
**Facility:** Clinical Trial Network
**State:** Texas
**Status:** NOT_YET_RECRUITING
**Zip:** 77074
**Location 23:**
**City:** Edmonton
**Contacts:**
***Contact 1:***
- **Name:** Mariusz Joseph Albert Sapijaszko
- **Role:** CONTACT
**Country:** Canada
**Facility:** Youthful Image
**State:** Alberta
**Status:** NOT_YET_RECRUITING
**Zip:** T5J 3S9
**Location 24:**
**City:** Edmonton
**Contacts:**
***Contact 1:***
- **Name:** Matthew Karpman
- **Role:** CONTACT
**Country:** Canada
**Facility:** Rejuvenation Dermatology Clinic Edmonton South
**State:** Alberta
**Status:** NOT_YET_RECRUITING
**Zip:** T6W 0J5
**Location 25:**
**City:** Etobicoke
**Contacts:**
***Contact 1:***
- **Name:** Marnie Fisher
- **Role:** CONTACT
**Country:** Canada
**Facility:** Kingsway Clinical Research
**State:** Ontario
**Status:** NOT_YET_RECRUITING
**Zip:** M8X 1Y9
**Location 26:**
**City:** Ottawa
**Contacts:**
***Contact 1:***
- **Name:** William Yang
- **Role:** CONTACT
**Country:** Canada
**Facility:** Ottawa Allergy Research Corporation
**State:** Ontario
**Status:** NOT_YET_RECRUITING
**Zip:** K1H 1E4
**Location 27:**
**City:** Québec
**Contacts:**
***Contact 1:***
- **Name:** Virginie Kelly
- **Role:** CONTACT
**Country:** Canada
**Facility:** Clinique Medicale Saint-Louis
**State:** Quebec
**Status:** NOT_YET_RECRUITING
**Zip:** G1W 4R4
**Location 28:**
**City:** Sherbrooke
**Contacts:**
***Contact 1:***
- **Name:** Evelyn Chinchilla
- **Role:** CONTACT
**Country:** Canada
**Facility:** Clinique Dermatologique de Sherbrooke
**State:** Quebec
**Status:** NOT_YET_RECRUITING
**Zip:** J1G 1X9
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012873
- Term: Skin Diseases, Genetic
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000017443
- Term: Skin Diseases, Eczematous
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7071
- Name: Dermatitis, Atopic
- Relevance: HIGH
- As Found: Atopic Dermatitis
- ID: M7067
- Name: Dermatitis
- Relevance: HIGH
- As Found: Dermatitis
- ID: M7655
- Name: Eczema
- Relevance: HIGH
- As Found: Atopic Dermatitis
- ID: M15674
- Name: Skin Diseases
- Relevance: HIGH
- As Found: Dermatologic Disease
- ID: M15676
- Name: Skin Diseases, Genetic
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M19712
- Name: Skin Diseases, Eczematous
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003876
- Term: Dermatitis, Atopic
- ID: D000003872
- Term: Dermatitis
- ID: D000004485
- Term: Eczema
- ID: D000012871
- Term: Skin Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436170
**Acronym:** OCTA and PMCE
**Brief Title:** The Role of Radial Peripapillary Vessel Density in Irvine-gass Syndrome
**Official Title:** Radial Peripapillary Vessel Density as a New Biomarker in Irvine-Gass Syndrome
#### Organization Study ID Info
**ID:** 05809852 Federico II
#### Organization
**Class:** OTHER
**Full Name:** Federico II University
### Status Module
#### Completion Date
**Date:** 2024-04-29
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-07-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Federico II University
#### Responsible Party
**Investigator Affiliation:** Federico II University
**Investigator Full Name:** Gilda Cennamo
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Pseudophakic cystoid macular edema (PCME), also known as Irvine-Gass syndrome (IGS), is an accumulation of fluid in the macula that occurs after cataract surgery, with an early or late presentation (cut-off 3 months) . It is the most common cause of decreased vision after uneventful phacoemulsification, with a rare incidence of 0.1-2.35% for clinically significant PCME .
Macular edema in IGS can be diagnosed and classified by optical coherence tomography (OCT), which enables its morphologic assessment. Fluorescein angiography (FA) is the gold standard to perform differential diagnosis for macular edema.
To date, OCT angiography (OCTA) has been proposed to study various retinal vascular diseases. In contrast to FA, OCTA is able to visualize Radial peripapillary vessel density (RCP).
The aim of this study was to investigate abnormalities in the vascular network of the optic nerve head in patients with IGS compared to healthy eyes, using OCT-A
### Conditions Module
**Conditions:**
- Cataract
- Macular Edema
**Keywords:**
- OCTA;RPC; IGS;PCME
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Diagnostic Test: OCTA
**Label:** 30 patiens with IGS mean age 70 ±6
#### Arm Group 2
**Intervention Names:**
- Diagnostic Test: OCTA
**Label:** 30 healthy controls mean age 70 ±5
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 30 healthy controls mean age 70 ±5
- 30 patiens with IGS mean age 70 ±6
**Description:** OCTA is a non invasive diagnostic technique to visualize RPC
**Name:** OCTA
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** To evaluate the vascolarization of RPC in IGS
**Measure:** the role of OCTA in diagnosis of IGS
**Time Frame:** 10 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Clinical diagnosis of PCME Cataract surgery
Exclusion Criteria:
diabetes vein occlusion uveitis vasculitis age-related macular degeneration hereditary macular dystrophy
-
**Healthy Volunteers:** True
**Maximum Age:** 75 Years
**Minimum Age:** 58 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** All patients with a diagnosis of PCME following phacoemulsification, addressed to our Unit, were enrolled in the study. The diagnostic criteria for PCME were: 1) vision loss in the operated eye within 3 months after surgery in patients with acute PCME and after 3 months for patients with chronic PCME; 2) changes on B-scan structural OCT with intraretinal cystoid spaces and central macular thickness (CMT) of at least 300 micron; 3) leakage and pooling of dye in macular cystoid spaces and late hyperfluorescence of the optic nerve head on FA. Clinical suspicion of PCME was confirmed using FA and structural OCT.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Naples
**Country:** Italy
**Facility:** University Federico II of Naples
**Zip:** 80121
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007905
- Term: Lens Diseases
- ID: D000005128
- Term: Eye Diseases
- ID: D000008268
- Term: Macular Degeneration
- ID: D000012162
- Term: Retinal Degeneration
- ID: D000012164
- Term: Retinal 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: M5638
- Name: Cataract
- Relevance: HIGH
- As Found: Cataract
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M11261
- Name: Macular Edema
- Relevance: HIGH
- As Found: Irvine-Gass Syndrome
- ID: M7657
- Name: Edema
- Relevance: LOW
- As Found: Unknown
- ID: M10917
- Name: Lens Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11260
- Name: Macular Degeneration
- Relevance: LOW
- As Found: Unknown
- ID: M14997
- Name: Retinal Degeneration
- Relevance: LOW
- As Found: Unknown
- ID: M14999
- Name: Retinal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002386
- Term: Cataract
- ID: D000008269
- Term: Macular Edema
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436157
**Acronym:** GENESIS
**Brief Title:** A Pilot Study of Genetic Testing Uptake Through Enhanced Oncology Nurse-Led Intervention
**Official Title:** Genetic Testing Uptake Through an Enhanced Oncology Nurse-Led Intervention in Patients With Solid Tumors (GENESIS): A Pilot Study
#### Organization Study ID Info
**ID:** Study #116
#### Organization
**Class:** OTHER
**Full Name:** Enloe Health
### Status Module
#### Completion Date
**Date:** 2025-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Robert A. Winn Diversity in Clinical Trials Award Program
#### Lead Sponsor
**Class:** OTHER
**Name:** Enloe 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:** Genetic factors are a significant determinant of the likelihood of developing various types of cancers. Identification of germline risk can have important implications for both patients and their families. Although estimates vary, pathogenic germline variants can be seen in \~3-17.5% of unselected patients with cancer with important clinical significance. Unfortunately, despite progress in multigene testing and the identification of heritable conditions, genetic counseling and testing (GCT) remains underutilized among cancer patients. Although there are multiple barriers to low testing, initial referral to GCT from the treating oncologist has been noted to be the most significant barrier.
Nurse navigation has been shown to improve the timeliness of cancer care and patient outcomes across various cancer types and improve the uptake of genomic testing in cancer patients. Despite proven benefits, community cancer centers often face resource limitations that prevent them from consistently assigning a dedicated nurse navigator to cancer patients. However, community centers universally have oncology nurses who routinely educate patients about their systemic therapies. By enhancing the "therapy education" sessions, the investigators hypothesize that oncology nurses can bridge this gap and potentially identify eligible patients, provide essential education on the importance of genetic testing, and facilitate the referral process. The investigators propose a pilot randomized study to evaluate the potential effectiveness, acceptability, and feasibility of a novel, nurse-led "enhanced education" intervention specifically designed to increase the uptake of GCT in adult cancer patients.
**Detailed Description:** Identification of germline risk can have important implications for both patients and their families: it can help patients develop tailored cancer surveillance, risk-reducing measures, reproductive planning, identify novel genotype-directed drug targets, and also optimally address the risk of malignancy in at-risk relatives. Although estimates vary, pathogenic germline variants (PGV) can be seen in \~3-17.5% of unselected patients with cancer with important clinical significance. Although national and international guidelines such as the National Comprehensive Cancer Network (NCCN) outline the criteria for who should be offered genetic counseling and testing (GCT) based on a patient's personal and/or family history, recent studies have found that broader testing of at-risk patients might help identify PGV in patients who otherwise would not have met guidelines for genetic testing.
Unfortunately, despite progress in multigene testing and the identification of heritable conditions, GCT remains underutilized among cancer patients. A recent study revealed that the uptake of germline testing among cancer patients remains strikingly low; in California and Georgia, between 2013 and 2019, less than 7% of patients diagnosed with cancer underwent such testing. While a study indicates a promising recent increase in the use of germline testing among women diagnosed with breast and ovarian cancer from 2012 to 2019, there is still a significant gap in ensuring that all eligible patients are provided with GCT. Although there are multiple barriers to low testing, initial referral to GCT from the treating oncologist has been noted to be the most significant barrier.
Community cancer centers are crucial in providing accessible care to a large segment of the cancer patient population. However, community cancer centers often face various challenges with limited resources for specialized genetic services variability in community oncologists' practice patterns and perceptions in GCT, and potentially urban-rural variability in patient awareness and understanding of the potential impact of genetic testing on their care.
Nurse navigation has been shown to improve the timeliness of cancer care and patient outcomes across various cancer types, in addition to improving the uptake of genomic testing in cancer patients. Despite proven benefits, community cancer centers often face resource limitations that prevent them from consistently assigning a dedicated nurse navigator to cancer patients. However, community centers universally have oncology nurses who routinely educate patients about their systemic therapies. By enhancing the "therapy education" sessions, the investigators hypothesize that oncology nurses can bridge this gap and potentially identify eligible patients, provide essential education on the importance of genetic testing, and facilitate the referral process. This approach leverages the trust and communication between nurses and patients and the principle that informed patients are more likely to engage in their healthcare decisions to potentially overcome barriers to genetic testing uptake.
The investigators propose a pilot randomized study to evaluate the potential effectiveness, acceptability, and feasibility of a novel, nurse-led "enhanced education" intervention specifically designed to increase the uptake of GCT in adult cancer patients. Patients in the enhanced education arm will be scheduled for an enhanced therapy education session with a trained oncology nurse for patients starting or switching their systemic therapies. In addition to the education conducted as part of the usual care, the nurse will: 1) provide detailed education on GCT; and 2) if the patient is eligible and agreeable to GCT, order a referral to GCT (if not already ordered). Nurses will provide a "nudge" to the referral coordinators within a week of the education session to ensure the referral process is completed.
### Conditions Module
**Conditions:**
- Solid Tumor, Adult
**Keywords:**
- Genetic Counseling and Testing
- NCCN guidelines
- Utilization
- Feasibility
- Nurse-led care coordination
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This pilot study will randomize patients who are starting or switching their systemic therapies for solid cancers, eligible for GCT, and have not undergone prior genetic testing into two groups: "enhanced education intervention" and "usual care education".
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients in the enhanced education intervention arm will be scheduled for a redesigned therapy education session with a trained oncology nurse.
**Intervention Names:**
- Other: Enhanced education
**Label:** Enhanced Education Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients in this arm will receive the usual care education provided to cancer patients undergoing systemic therapy, which includes information on treatment options, side effects, and support services without targeted genetic testing education.
**Intervention Names:**
- Other: Usual care education
**Label:** Usual Care Education Arm
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Enhanced Education Intervention
**Description:** In addition to the education conducted as part of usual care, the nurse will: 1) provide basic education on GCT; and 2) if the patient is eligible and agreeable to GCT, place a referral to GCT (if not already ordered).
Patients will also be provided with written materials reinforcing the key messages of GCT education, designed to be understandable to individuals without a medical background. Nurses will also conduct a follow-up "nudge" by sending an in basket message via electronic medical record to ensure that the referrals are processed by the referral coordinators.
**Name:** Enhanced education
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Usual Care Education Arm
**Description:** A brief introduction to GCT will be provided in accordance with the information covered in the "chemo education binder," which is the current standard of care at Enloe Regional Cancer Center. As per the usual care, referrals for genetic testing will be clinician-initiated without the proactive involvement of the RN.
**Name:** Usual care education
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** Recruitment rates (percentage of participants who agree to participate out of those approached), completion rate of follow-up assessments (percentage of patients that complete follow-up assessment), and retention rates (percentage of patients retained in the study throughout the study period).
**Measure:** Recruitment rates, completion rate of follow-up assessments, and retention rates.
**Time Frame:** Through study completion, an average of 9 months
**Measure:** Average scores on the AIM post intervention
**Time Frame:** Within 3 weeks of nursing education intervention
**Measure:** Average scores and qualitative feedback from post-intervention survey questionnaire to measure satisfaction with the study and recommendations for improvement from participants, nurses and genetic counselors
**Time Frame:** Within 3 weeks of nursing education intervention and through study completion, an average of 9 months
**Measure:** RN workload as measured by average time spent per patient and perception (Likert-scale-based and qualitative feedback)
**Time Frame:** Through study completion, an average of 9 months
#### Primary Outcomes
**Measure:** Percentage of patients in each arm who proceed to GCT consultation following the intervention.
**Time Frame:** Through study completion, an average of 9 months
#### Secondary Outcomes
**Measure:** Percentage of patients in each arm referred to GCT
**Time Frame:** Through study completion, an average of 9 months
**Measure:** Average time from GCT referral order to GCT consultation
**Time Frame:** Through study completion, an average of 9 months
**Measure:** Average time from GCT consultation to completion of genetic testing
**Time Frame:** Through study completion, an average of 9 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults (≥ 18 years)
* Diagnosed with a solid tumor cancer type that has established guidelines suggesting the utility of genetic testing in treatment (breast, ovarian, prostate, pancreatic, colon, Lynch syndrome-related cancers (colorectal, endometrial, gastric, ovarian, pancreatic, urothelial, brain (usually glioblastoma), biliary tract, small intestine), Li-Fraumeni syndrome tumor spectrum (e.g., soft tissue sarcoma, osteosarcoma, central nervous system tumors, breast cancer, adrenocortical carcinoma), etc.)
* Eligible for GCT based on the current NCCN guidelines
* Starting new systemic therapy or switching systemic therapy
* Eligible for GCT as per the current NCCN guidelines
* No prior genetic testing (or tested before 2014)
Exclusion Criteria:
* Prior GCT with test results available (if tested 2014 onwards)
* Patients scheduled for treatment education with Advanced Practice Provider (typically reserved for more complex regimens)
* Patients with cognitive impairments or severe psychological disorders that would limit their ability to understand the genetic counseling/testing information or give informed consent.
* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures (e.g., patients requiring urgent therapy and/or inpatient chemotherapy initiation).
* Patients who are currently participating in other clinical trials that could confound the outcomes of genetic testing uptake.
* Prospective participants who, in the investigator's opinion, may not be able to comply with all study procedures (including compliance issues related to logistics).
* Hematologic malignancy
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Tiffany Capuano, RN, BSN, OCN
**Phone:** 530-332-3858
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Enloe Health
**Name:** Ranjan Pathak, MD MHS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Kurian AW, Abrahamse P, Furgal A, Ward KC, Hamilton AS, Hodan R, Tocco R, Liu L, Berek JS, Hoang L, Yussuf A, Susswein L, Esplin ED, Slavin TP, Gomez SL, Hofer TP, Katz SJ. Germline Genetic Testing After Cancer Diagnosis. JAMA. 2023 Jul 3;330(1):43-51. doi: 10.1001/jama.2023.9526.
**PMID:** 37276540
**Citation:** Daly MB, Pal T, Maxwell KN, Churpek J, Kohlmann W, AlHilli Z, Arun B, Buys SS, Cheng H, Domchek SM, Friedman S, Giri V, Goggins M, Hagemann A, Hendrix A, Hutton ML, Karlan BY, Kassem N, Khan S, Khoury K, Kurian AW, Laronga C, Mak JS, Mansour J, McDonnell K, Menendez CS, Merajver SD, Norquist BS, Offit K, Rash D, Reiser G, Senter-Jamieson L, Shannon KM, Visvanathan K, Welborn J, Wick MJ, Wood M, Yurgelun MB, Dwyer MA, Darlow SD. NCCN Guidelines(R) Insights: Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic, Version 2.2024. J Natl Compr Canc Netw. 2023 Oct;21(10):1000-1010. doi: 10.6004/jnccn.2023.0051.
**PMID:** 37856201
**Citation:** Kurian AW, Ward KC, Abrahamse P, Bondarenko I, Hamilton AS, Deapen D, Morrow M, Berek JS, Hofer TP, Katz SJ. Time Trends in Receipt of Germline Genetic Testing and Results for Women Diagnosed With Breast Cancer or Ovarian Cancer, 2012-2019. J Clin Oncol. 2021 May 20;39(15):1631-1640. doi: 10.1200/JCO.20.02785. Epub 2021 Feb 9.
**PMID:** 33560870
**Citation:** Swink A, Nair A, Hoof P, Matthews A, Burden C, Johnson K, Blum JL. Barriers to the utilization of genetic testing and genetic counseling in patients with suspected hereditary breast and ovarian cancers. Proc (Bayl Univ Med Cent). 2019 Jun 11;32(3):340-344. doi: 10.1080/08998280.2019.1612702. eCollection 2019 Jul.
**PMID:** 31384183
**Citation:** McAllister KA, Schmitt ML. Impact of a nurse navigator on genomic testing and timely treatment decision making in patients with breast cancer. Clin J Oncol Nurs. 2015 Oct;19(5):510-2. doi: 10.1188/15.CJON.510-512.
**PMID:** 26414569
**Citation:** Rives TA, Pavlik H, Li N, Qasrawi L, Yan D, Pickarski J, Dietrich CS, Miller RW, Ueland FR, Kolesar JM. Implementation of Nurse Navigation Improves Rate of Molecular Tumor Testing for Ovarian Cancer in a Gynecologic Oncology Practice. Cancers (Basel). 2023 Jun 15;15(12):3192. doi: 10.3390/cancers15123192.
**PMID:** 37370804
**Citation:** DiBiase JF, Scharnetzki E, Edelman E, Lucas FL, Helbig P, Rueter J, Han PKJ, Ziller E, Jacobs EA, Anderson EC; MCGI Working Group. Urban-Rural and Socioeconomic Differences in Patient Knowledge and Perceptions of Genomic Tumor Testing. JCO Precis Oncol. 2023 Mar;7:e2200631. doi: 10.1200/PO.22.00631.
**PMID:** 36893376
**Citation:** Anderson EC, Hinton AC, Lary CW, Fenton ATHR, Antov A, Edelman E, Helbig P, Reed K, Miesfeldt S, Thomas CA, Hall MJ, Roberts JS, Rueter J, Han PKJ; MCGI Working Group. Community oncologists' perceptions and utilization of large-panel genomic tumor testing. BMC Cancer. 2021 Nov 25;21(1):1273. doi: 10.1186/s12885-021-08985-0.
**PMID:** 34823486
**Citation:** Idos GE, Kurian AW, Ricker C, Sturgeon D, Culver JO, Kingham KE, Koff R, Chun NM, Rowe-Teeter C, Lebensohn AP, Levonian P, Lowstuter K, Partynski K, Hong C, Mills MA, Petrovchich I, Ma CS, Hartman AR, Allen B, Wenstrup RJ, Lancaster JM, Brown K, Kidd J, Evans B, Mukherjee B, McDonnell KJ, Ladabaum U, Ford JM, Gruber SB. Multicenter Prospective Cohort Study of the Diagnostic Yield and Patient Experience of Multiplex Gene Panel Testing For Hereditary Cancer Risk. JCO Precis Oncol. 2019 Mar 28;3:PO.18.00217. doi: 10.1200/PO.18.00217. eCollection 2019 Mar.
**PMID:** 34322651
**Citation:** Samadder NJ, Riegert-Johnson D, Boardman L, Rhodes D, Wick M, Okuno S, Kunze KL, Golafshar M, Uson PLS Jr, Mountjoy L, Ertz-Archambault N, Patel N, Rodriguez EA, Lizaola-Mayo B, Lehrer M, Thorpe CS, Yu NY, Esplin ED, Nussbaum RL, Sharp RR, Azevedo C, Klint M, Hager M, Macklin-Mantia S, Bryce AH, Bekaii-Saab TS, Sekulic A, Stewart AK. Comparison of Universal Genetic Testing vs Guideline-Directed Targeted Testing for Patients With Hereditary Cancer Syndrome. JAMA Oncol. 2021 Feb 1;7(2):230-237. doi: 10.1001/jamaoncol.2020.6252. Erratum In: JAMA Oncol. 2021 Feb 1;7(2):312.
**PMID:** 33126242
**Citation:** Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
**PMID:** 34812790
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436144
**Brief Title:** Osimertinib and Etoposide as First-Line Treatment in Osimertinib-Resistant Advanced EGFR-Mutant NSCLC
**Official Title:** A Single-Center, Prospective, Single-Arm, Observational Study Evaluating the Efficacy and Safety of Osimertinib Combined With Etoposide as First-Line Treatment in Patients With Osimertinib-Resistant or -Insensitive, Advanced EGFR-Mutant Non-Small Cell Lung Cancer
#### Organization Study ID Info
**ID:** ABC2024521
#### Organization
**Class:** OTHER
**Full Name:** Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
### Status Module
#### Completion Date
**Date:** 2029-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
#### Responsible Party
**Investigator Affiliation:** Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
**Investigator Full Name:** Yong He
**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:** Osimertinib, though a standard first-line treatment for EGFR-mutant advanced NSCLC, shows primary resistance in 10-30% of patients, leading to disease progression within 3-4 months. This resistance is linked to co-mutations in genes like TP53, RB1, and PIK3CA, among others. Studies indicate that Topo II inhibitor Etoposide (VP-16) can reduce cell survival, enhance DNA damage, and delay resistance in Osimertinib-resistant cells, suggesting a potential combination therapy to manage resistance.This study is a single-center, prospective, single-arm study evaluating the efficacy and safety of osimertinib combined with etoposide as a first-line treatment in patients with osimertinib-resistant or -insensitive advanced non-small cell lung cancer (NSCLC). The study focuses on patients with advanced NSCLC (stage IIIB or IV) with EGFR-sensitive mutations who developed slow resistance to osimertinib and for whom secondary biopsy after resistance did not identify any therapeutic targets.
**Detailed Description:** Although Osimertinib has become the standard first-line treatment choice for EGFRm advanced NSCLC, a subset of patients still do not benefit from first-line Osimertinib treatment. Some patients even experience disease progression at the initial stages of Osimertinib treatment. As early as 2010 and 2016, studies published in J Clin Oncol and Onco Targets Ther noted that approximately 10-30% of patients either do not respond to initial EGFR TKI treatment or experience disease control for less than 3 months despite carrying EGFR mutations (PMID: 19949011, 27382309). Furthermore, the FLAURA study on first-line Osimertinib treatment for EGFRm advanced NSCLC patients found that 3% of patients did not respond to Osimertinib, indicating potential primary resistance to Osimertinib (PMID: 29151359). This primary resistance is characterized by disease progression or stabilization within 3-4 months of EGFR TKI treatment, with no evidence of objective response during treatment (PMID: 27382309). Thus, primary resistance to third-generation EGFR-TKI Osimertinib significantly limits its clinical efficacy and presents a critical clinical challenge.
The mechanisms underlying primary resistance to Osimertinib are complex and not well understood, and research data are limited. Current evidence suggests that primary resistance to first-line Osimertinib in EGFRm advanced NSCLC patients may be related to concomitant co-mutations, such as atypical EGFR mutations and downstream/bypass pathway gene abnormalities (see Figure 1). Approximately 20-30% of EGFR mutation patients present with co-mutations at initial diagnosis, with common co-mutated genes including TP53 (54.6-64.6%), RB1 (9.6-10.33%), ERBB2 (8-11%), CTNNB1 (9.6%), PIK3CA (9-12.4%), and cell cycle-related genes like CDK4/CDK6/CCNE1, MET, KEAP1/NFE2L2/CUL3 axis, etc. These gene abnormalities can mediate primary resistance to EGFR-TKI therapy by activating EGFR bypass or downstream signaling pathways (PMID: 38382773, 37093192). A 2023 article in Targeted Oncology noted that TP53mutations, high AXL mRNA expression, and low BIM mRNA expression might be associated with poor response to Osimertinib (PMID: 37017806). Additionally, a case study published in Lung Cancer in 2023 reported that a patient with primary resistance to Osimertinib had simultaneous EGFR L858R and EGFR S645C mutations. After one month of Osimertinib treatment, there was no reduction in the right upper lobe nodule size, and CEA levels continued to rise. The patient continued with Osimertinib combined with anlotinib for four months, with no reduction in the primary tumor and persistently elevated CEA levels, indicating primary resistance to Osimertinib (PMID: 37842288). Other studies suggest that primary EGFR 20ins and BIM polymorphism deletion may mediate primary resistance to Osimertinib (PMID: 34669648). EGFR TKI primarily works by competitively binding to the ATP binding site, blocking EGFR phosphorylation and downstream signaling pathway activation, thus inducing tumor cell apoptosis. However, the crystal structure of EGFR 20ins does not affect the ATP binding pocket, preventing increased affinity between EGFR TKI and EGFR protein, leading to insensitivity and resistance to EGFR TKI therapy (PMID: 34301786). In patients with BIM gene abnormalities, compared to wild-type BIM, EGFR mutation patients with concurrent BIM deletion had lower ORR (28% vs 52.5%, P=0.026) and shorter PFS (8.3m vs 10.5m, P=0.031) following Osimertinib treatment (PMID: 34669648). Additionally, NSCLC patients with concurrent SCLC components or SCLC transformation may also exhibit primary resistance to Osimertinib (PMID: 29290257).Recent research has found that the DNA topoisomerase II (Topo II) inhibitor Etoposide (VP-16) synergistically reduces cell survival, enhances DNA damage and apoptosis induction in Osimertinib-resistant cells, inhibits the growth of Osimertinib-resistant tumors, and delays the emergence of acquired resistance to Osimertinib. Mechanistically, Osimertinib promotes proteasomal degradation mediated by fbxw7, leading to DNA damage and reduced Topo IIα levels in NSCLC cells; these effects are absent in Osimertinib-resistant cell lines with high Topo IIα levels. Elevated Topo IIα levels have also been detected in most EGFRm NSCLC tissues that recur after EGFR-TKI treatment. In sensitive EGFRm NSCLC cells, forced expression of ectopic TOP2A confers resistance to Osimertinib, whereas knocking down TOP2A in Osimertinib-resistant cell lines restores their response to Osimertinib-induced DNA damage and apoptosis. Overall, these findings reveal the important role of Topo IIα inhibition in mediating the therapeutic effects of Osimertinib on EGFRm NSCLC and provide a scientific rationale for targeting Topo II with Etoposide (VP-16) to manage Osimertinib-insensitive or primary-resistant cases (PMID: 38451729).
### Conditions Module
**Conditions:**
- Non Small Cell Lung Cancer
- EGFR Gene Mutation
- Non Small Cell Lung Cancer Stage IIIB
- Non-small Cell Lung Cancer Stage IV
**Keywords:**
- Non Small Cell Lung Cancer
- EGFR Gene Mutation
- Primary drug resistance of oxitinib
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 93
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Osimertinib
**Label:** Osimertinib Combined With Etoposide Soft Capsule
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Osimertinib Combined With Etoposide Soft Capsule
**Description:** Etoposide Soft Capsules Dosage：25mg/tablet, 2 tablets/time, taken continuously for 21 days, and stopped for one week. Osimertinib Dosage：80mg/tablet, 1 tablet/time, QD, taken for two cycles.
**Name:** Osimertinib
**Other Names:**
- Etoposide Soft Capsules
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** To evaluate the efficacy of osimertinib combined with etoposide as first-line treatment in patients with osimertinib-resistant or -insensitive, advanced EGFR-mutant non-small cell lung cancer. ORR will be defined as the proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.
**Measure:** Objective Remission Rate (ORR) as assessed by RECIST v1.1
**Time Frame:** Within 1 month after treatment
#### Secondary Outcomes
**Description:** To observe the two-year overall survival rate of the treatment group receiving osimertinib combined with etoposide. OS will be measured from the start of treatment to the time of death from any cause.
**Measure:** Two-Year Overall Survival Rate
**Time Frame:** Up to 2 years after the start of treatment
**Description:** To observe the one-year tumor progression-free survival time in the treatment group receiving osimertinib combined with etoposide. PFS will be defined as the time from the start of treatment to the time of disease progression or death, whichever occurs first, as assessed by RECIST v1.1.
**Measure:** One-Year Progression-Free Survival Rate
**Time Frame:** Up to 1 year after the start of treatment
**Description:** To observe the disease control rate in the treatment group receiving osimertinib combined with etoposide. DCR will be defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1.
**Measure:** Disease Control Rate (DCR) within One Month
**Time Frame:** Within 1 month after treatment
**Description:** To observe the safety of osimertinib combined with etoposide in the treatment group. Safety will be assessed by the number of participants with treatment-related adverse events (AEs), graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
**Measure:** Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
**Time Frame:** Within 1 month after treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age 18 to 79 years.
2. Locally advanced (stage IIIB) or metastatic (stage IV) EGFR-mutant NSCLC.
3. Harboring an EGFR sensitizing mutation (Exon 19 deletion or L858R).
4. Received at least two cycles of first-line osimertinib treatment, with a best response of stable disease or slow progression.
5. Life expectancy greater than 3 months.
6. At least one measurable tumor lesion meeting the following criteria:
1.No prior radiation therapy; 2.Measurable by chest CT or PET-CT, with a longest diameter ≥ 10 mm at baseline (short axis ≥ 15 mm for lymph nodes); 3.Amenable to accurate repeated measurements.
Exclusion Criteria:
1. Currently receiving or planning to receive other anti-cancer therapies.
2. Having contraindications to osimertinib or etoposide.
3. Harboring known targetable osimertinib resistance mechanisms.
**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:** He Yong
**Phone:** 86-23-68757791
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000002283
- Term: Carcinoma, Bronchogenic
- ID: D000001984
- Term: Bronchial Neoplasms
### 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: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: HIGH
- As Found: Non-Small Cell Lung Cancer
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: 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: M5540
- Name: Carcinoma, Bronchogenic
- Relevance: LOW
- As Found: Unknown
- ID: M5260
- Name: Bronchial Neoplasms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008175
- Term: Lung Neoplasms
- ID: D000002289
- Term: Carcinoma, Non-Small-Cell Lung
### Intervention Browse Module - Ancestors
- ID: D000000972
- Term: Antineoplastic Agents, Phytogenic
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000059005
- Term: Topoisomerase II Inhibitors
- ID: D000059003
- Term: Topoisomerase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000092004
- Term: Tyrosine Kinase Inhibitors
- ID: D000047428
- Term: Protein Kinase Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AA
- Name: Amino Acids
### Intervention Browse Module - Browse Leaves
- ID: M8191
- Name: Etoposide
- Relevance: HIGH
- As Found: Tolerability
- ID: M145673
- Name: Osimertinib
- Relevance: HIGH
- As Found: Peri-
- ID: M341643
- Name: Etoposide phosphate
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M2889
- Name: Tyrosine Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M25820
- Name: Protein Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: T22
- Name: Tyrosine
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000005047
- Term: Etoposide
- ID: C000596361
- Term: Osimertinib
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436131
**Brief Title:** The Effects of In-phase Bilateral Exercise in People With Progressive Multiple Sclerosis
**Official Title:** The Effects of In-phase Bilateral Exercise on Cognitive and Motor Outcome Measures, in Patients With Progressive Multiple Sclerosis, a Randomized Control Trial.
#### Organization Study ID Info
**ID:** IBEPMS
#### Organization
**Class:** OTHER
**Full Name:** Cyprus University of Technology
### Status Module
#### Completion Date
**Date:** 2023-12-22
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-22
**Type:** ACTUAL
#### Start Date
**Date:** 2023-10-02
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-19
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Cyprus Institute of Neurology and Genetics
#### Lead Sponsor
**Class:** OTHER
**Name:** Cyprus University of Technology
#### Responsible Party
**Investigator Affiliation:** Cyprus University of Technology
**Investigator Full Name:** Dimitris Sokratous
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system. MS, typical presents with progression of clinical symptoms which mainly include motor and cognitive impairment, as well as reduction of patients' quality of life. Exercise is an effective approach in the management of the symptoms in people with progressive MS. Previous studies in healthy and in people with MS, reported a close relationship between cognitive functions and upper limb performance. Since patients with progressive MS facing difficulties with performing complex exercises due to cognitive dysfunctions and given the close relationship between cognitive functions and manual dexterity, a reasonable question arises whether a type of upper limbs exercises with less cognitive demands will improve the information processing speed in people with progressive MS. The aim of the current study is to investigate the effects of in-phase bilateral upper limbs exercises on the information processing speed, in patients with progressive MS, given that in-phase bilateral movements needs less attentional load than the other types of bilateral coordination. The intervention protocol lasted for 12 consecutive weeks (30-60 minutes /session x 3 sessions/week) and included in-phase bilateral exercises of the upper limbs, adapted to different sports activities and to functional training. Results from the statistical analysis indicated improvement of the experimental group compared to the control group, on the information processing speed alongside with improvement of motor skills.
**Detailed Description:** The term progressive multiple sclerosis (MS) includes both secondary progressive MS (SPMS) and primary progressive MS (PPMS). As it is well known, the course of MS is highly variable. On one hand, almost 50% of the patients who is characterized by the relapsing remitting MS, after 10-15 years of disease this pattern becomes progressive, in which individual clinical symptoms slowly progress, a disease type defined as a SPMS. On the other hand, in about 15% of people with MS, disease progression is persistent from onset defined as a PPMS. Patients with progressive MS except from physical impairment, often have cognitive dysfunctions, which negatively affect quality of life. Information processing speed is the most common cognitive deficit, between people with PPMS and those with SPMS.
Despite the fact that cognitive rehabilitation approaches are effective in treating MS-related cognitive dysfunctions, there are evidence from several studies which indicated the impact of different types of exercises in the improvement of cognitive in people with MS. Furthermore, evidences from previous studies in healthy and people with MS, reported a close relationship between cognitive functions and upper limbs performance, defined by the projections from the Anterior Cingulate Cortex to the motor cortex and spinal cord. Specifically, the decline of information processing speed indicates reduction of manual dexterity in people with MS. Manual dexterity is defined as the manual skill which contains coordination of fine and gross voluntary movements of the upper limbs. Manual dexterity dysfunction in MS contributes to reduced ability to perform activities of daily living (ADLs) and social activities, which causes reduction of independency and quality of life.
Moreover, evidence from previous studies, reported that in-phase bilateral movements needs less attentional load and less neural control than the unilateral or the other types of bilateral coordination, as a result to perform the specific type of movement (i.e., in-phase bilateral) more efficient and more easy. Therefore, given that patients with progressive MS characterized by decline of information processing speed, which affects manual dexterity, a reasonable question arises whether in-phase bilateral upper limbs exercises will improve information processing speed and thus, to improve manual dexterity in the specific clinical cohort.
The aim of the current study was to investigate primarily the hypothesis that a 12-week exercise program based on in-phase bilateral upper limbs movements, based on sport activities and functional training, could improve information processing speed compared to a conservative type of exercise, in people with progressive MS. A secondary aim was to evaluate whether the specific exercise program could improve manual dexterity and have a correlation with information processing speed.
Second aim of the study was to investigate the effects of the specific type of exercises on various clinical symptoms, fatigue and on quality of life, using clinical assessment tools and subjective questionnaires.
### Conditions Module
**Conditions:**
- Multiple Sclerosis, Primary Progressive
- Multiple Sclerosis, Secondary Progressive
**Keywords:**
- In-phase Bilateral
- exercise
- cognitive processing
- multiple sclerosis
- manual dexterity
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Subjects were randomized in two groups. Experimental group received an exercise program based on in-phase bilateral exercises, whereas the active control group receives conservative exercises. The duration of the study was 12 consecutive weeks for both groups.
##### Masking Info
**Masking:** TRIPLE
**Masking Description:** It was a double-blind study in which neither the participants nor the assessor and the trainer knew who's been assigned to either group.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The exercise program of the experimental group consisted of exercises based on in-phase bilateral movements of the upper and lower limbs, which they were adapted to different sport activities and to fitness functional exercises. The specific exercise program was organized in a group circuit training, performed simultaneously on each session from all the participants of the experimental group, considering the MS exercise recommendations. Specifically, the program included sports activities of basic technical skills of basketball (e.g., different types of passing, catching and throwing the ball) and volleyball (e.g., different types of passing and receiving the ball), whereas the fitness exercises included the diagonal movements from proprioceptive neuromuscular facilitation technique, by the use of a resistance bands.
**Intervention Names:**
- Behavioral: In-phase Bilateral Exercise
**Label:** IBPMS
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The participants of the active control group, underwent an exercise program based on conventional exercises, such as strengthening of the major muscle groups of the trunk, resistance exercises for the upper and lower limbs and body weight support treadmill exercise. All participants of the active control group performed the specific types of exercises individually, as opposed with the experimental group which was organized as a group training. Controls performed the specific type exercises once a week, for 12 consecutive weeks.
**Intervention Names:**
- Behavioral: Conservative exercises
**Label:** Controls
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- IBPMS
**Description:** The exercise program of the experimental group consisted of exercises based on in-phase bilateral movements of the upper and lower limbs, which were adapted to different sport activities and to fitness functional exercises.
The participants of experimental group performed the specific type exercises three times per week, for 12 consecutive weeks.
**Name:** In-phase Bilateral Exercise
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Controls
**Description:** The participants of the active control group, underwent an exercise program based on conventional exercises, such as strengthening of the major muscle groups of the trunk, resistance exercises for the upper and lower limbs and body weight support treadmill exercise.
**Name:** Conservative exercises
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** It is a commonly used test in pwMS, which measures processing speed as well as motor speed. The investigators employed the oral form of the test, in which participants were provided with the test sheet with nine symbols, each paired with a number on top of the page, defined as the "key". For example, the symbol "O" is matched with the number "6", so the correct response would be "six". The rest of the page consists of a randomized, sequential variety of these symbols. Participants are asked to verbally respond with the number that corresponds with each symbol. During the test, the participant is given two minutes to orally match symbols with digits as quickly as possible. The score is obtained by subtracting the number of errors from the number of items completed. To account for practice effects, the investigators created six different tests, as many as our assessment points, in which the order of the symbols and the numbers of the "key" were rearranged
**Measure:** Symbol Digit Modalities Test
**Time Frame:** Baseline (3 weeks) until the end of the Intervention (12 weeks)
#### Secondary Outcomes
**Description:** It is a set of generic, coherent, and easily administered quality-of-life measures, completed by the participants. There are 11 questions in the specific questionnaire administered by an assessor, with 36 items in total, which cover eight domains scaled from 0 to 100, with higher values indicating better health status. The eight domains include: general health, vitality, physical function, role physical, bodily pain, role emotional, social functioning and mental health. It takes between 5 and 10 min to complete it.
**Measure:** Medical Outcomes Study Short Form 36
**Time Frame:** Baseline (3rd week) until the end of the Intervention (12 weeks)
**Description:** It is a short questionnaire which requires the participants to describe the effects of fatigue during the past four weeks. The Modified Fatigue Impact Scale consists of 21 questions which are subjectively rated from "0" (low rate) to "4" (high rate) and it is divided into three subscales (i.e., physical, cognitive, and psychosocial). The assessor records the total score of the test as the final test result. The higher the score is, the greater is the impact of fatigue in individual daily life. Therefore, the Modified Fatigue Impact Scale it is used as the description of participants' attribution of functional restrictions to fatigue symptoms.
**Measure:** Modified Fatigue Impact Scale
**Time Frame:** Baseline (3rd week) until the end of the Intervention (12 weeks)
**Description:** It contains five conditions; the visual scanning, motor speed, number sequencing, letter sequencing, and number-letter switching. Trail Making Test also assesses attention, information processing speed and mental flexibility. This particular test consists of two parts, A and B, which involves 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the participant should connect the numbers in ascending order by drawing lines. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the participants connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (e.g., 1-A-2-B-3-C, etc.). The participants were instructed to connect the circles as quickly as possible, without lifting the pencil from the paper. During participants' connection of the "trails", the assessor notes possible errors, and the time needed to complete the task.
**Measure:** Trail Making Test
**Time Frame:** Baseline (3 weeks) until the end of the Intervention (12 weeks)
**Description:** It is a standardized test of manual dexterity. The Purdue Pegboard Test consists of four subtests, performed in a board in which pins, washers and collars are placed by the participants into two parallel columns of holes, according to the subtest task. The first two subtests are unimanual tasks, which measure dexterity of the right and left hand, respectively. The third subtest is a synchronous bimanual task that requires simultaneous use of both hands to grasp pins and place them in their corresponding columns of holes. During the fourth subtest, the participants should perform alternating movements of both hands to complete assemblies of different types of pegs. Standard scoring of the Purdue Pegboard Test is based on the number of pegs inserted in 30 s for the first three subtests, and in 1 min for the last subtest.
**Measure:** Purdue Pegboard Test
**Time Frame:** Baseline (3 weeks) until the end of the Intervention (12 weeks)
**Description:** It is a quantitative assessment for mobility and lower limb function. Participants are directed to one end of a marked 25-foot path and they are instructed to walk as quickly as possible. The time is recorded from the start and ended when participants reached the 25-foot mark. The same task is immediately run again by having the participants walked back the same distance. Due to the fact that our participants might be using assistive devices for walking, they are instructed to use them in order to be safe when doing this task. The final score for each participant, is the mean score from the two completed trials.
**Measure:** Timed 25-Foot Walk
**Time Frame:** Baseline (3 weeks) until the end of the Intervention (12 weeks)
**Description:** It is a measure replicating a complex range of sensorimotor functions, such as lower limb strength, spasticity, coordination, as well as balance. It is a timed walking test that involves kicking over a number of targets placed along a 5 meter path. The specific test is cognitive demanding, that also includes coordination and dynamic balance.
**Measure:** Six Spot Step Test
**Time Frame:** Baseline (3 weeks) until the end of the Intervention (12 weeks)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* diagnosis of progressive multiple sclerosis (MS) (primary or/and secondary progressive MS)
* Expanded Disability Status Scale score between three and six
* no relapse within 30 days
* aged between 30 and 70 years
* Mini Mental State of Examination score between 20 and 30 (mild to no cognitive impairment)
Exclusion Criteria:
* history of any disease affecting the central nervous system other than MS (e.g., stroke, Parkinson's disease, cerebral palsy)
* history of cardiovascular disease (e.g., known aneurism, myocardial infarction, hyper/hypotension, heart failure)
* severe orthopaedic disorders (e.g., knee or hip replacement, spondylosurgery, disk herniation, recent bone fracture)
* mental disorders (e.g., depression, schizophrenia, bipolar syndrome)
* pregnancy during the implementation of the study timeline
* hearing impairments (i.e., deafness)
* visual deficit (e.g., optic neuritis, blindness, diplopia, glaucoma, blurred vision)
* history of epileptic seizures
* spasticity level on upper or lower limbs more than 1+ (slight increase in muscle tone) according to Modified Ashworth Scale
**Maximum Age:** 70 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Limassol
**Country:** Cyprus
**Facility:** Dimitris Sokratous
**Zip:** 3036
#### Overall Officials
**Official 1:**
**Affiliation:** Cyprus University of Technology
**Name:** Dimitris Sokratous
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Raw data will available for any scientist who wants to analyze or for reproducibility
**Description:** The data from the two study groups will be available in protocls.io.
**Info Types:**
- STUDY_PROTOCOL
- SAP
**IPD Sharing:** YES
**Time Frame:** When summary data are published then all Data will be available
### References Module
#### References
**Citation:** DeLuca J, Chiaravalloti ND, Sandroff BM. Treatment and management of cognitive dysfunction in patients with multiple sclerosis. Nat Rev Neurol. 2020 Jun;16(6):319-332. doi: 10.1038/s41582-020-0355-1. Epub 2020 May 5.
**PMID:** 32372033
**Citation:** Bush G, Luu P, Posner MI. Cognitive and emotional influences in anterior cingulate cortex. Trends Cogn Sci. 2000 Jun;4(6):215-222. doi: 10.1016/s1364-6613(00)01483-2.
**PMID:** 10827444
**Citation:** Paus T. Primate anterior cingulate cortex: where motor control, drive and cognition interface. Nat Rev Neurosci. 2001 Jun;2(6):417-24. doi: 10.1038/35077500.
**PMID:** 11389475
**Citation:** Grefkes C, Eickhoff SB, Nowak DA, Dafotakis M, Fink GR. Dynamic intra- and interhemispheric interactions during unilateral and bilateral hand movements assessed with fMRI and DCM. Neuroimage. 2008 Jul 15;41(4):1382-94. doi: 10.1016/j.neuroimage.2008.03.048. Epub 2008 Apr 8.
**PMID:** 18486490
**Citation:** Swinnen SP, Wenderoth N. Two hands, one brain: cognitive neuroscience of bimanual skill. Trends Cogn Sci. 2004 Jan;8(1):18-25. doi: 10.1016/j.tics.2003.10.017.
**PMID:** 14697399
**Citation:** Sokratous D, Charalambous CC, Papanicolaou EZ, Michailidou K, Konstantinou N. Investigation of in-phase bilateral exercise effects on corticospinal plasticity in relapsing remitting multiple sclerosis: A registered report single-case concurrent multiple baseline design across five subjects. PLoS One. 2023 Mar 2;18(3):e0272114. doi: 10.1371/journal.pone.0272114. eCollection 2023.
**PMID:** 36862693
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020278
- Term: Demyelinating Autoimmune Diseases, CNS
- ID: D000020274
- Term: Autoimmune Diseases of the Nervous System
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000003711
- Term: Demyelinating Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12060
- Name: Multiple Sclerosis
- Relevance: HIGH
- As Found: Multiple Sclerosis
- ID: M15415
- Name: Sclerosis
- Relevance: HIGH
- As Found: Sclerosis
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: LOW
- As Found: Unknown
- ID: M22313
- Name: Multiple Sclerosis, Chronic Progressive
- Relevance: HIGH
- As Found: Multiple Sclerosis, Secondary Progressive
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22098
- Name: Demyelinating Autoimmune Diseases, CNS
- Relevance: LOW
- As Found: Unknown
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M6909
- Name: Demyelinating Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- 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: D000009103
- Term: Multiple Sclerosis
- ID: D000020528
- Term: Multiple Sclerosis, Chronic Progressive
- ID: D000012598
- Term: Sclerosis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436118
**Acronym:** RELAX
**Brief Title:** Evaluation of the Use of the RELAX® Glasses on the Anxiety of Patients Undergoing Emergency Hand Surgery Under Locoregional Anesthesia
**Official Title:** Evaluation of the Use of the RELAX® Glasses on the Anxiety of Patients Undergoing Emergency Hand Surgery Under Locoregional Anesthesia Compared to Those Who do Not Use the Glasses
#### Organization Study ID Info
**ID:** 2021-05
#### Organization
**Class:** NETWORK
**Full Name:** Centre Hospitalier de Valenciennes
### Status Module
#### Completion Date
**Date:** 2022-09-06
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-08-30
**Type:** ACTUAL
#### Start Date
**Date:** 2022-05-02
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2022-08-29
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** NETWORK
**Name:** Centre Hospitalier de Valenciennes
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** More than 90% of hand surgery is performed under local anesthesia and can be a source of anxiety, especially in an emergency context. The management of this intraoperative anxiety is essential for the comfort. The use of a virtual reality headset has shown its effectiveness in reducing anxiety in dental surgery or hand surgery under local anesthesia with the WALANT technique. On the other hand, virtual reality and the use of 3D can cause discomfort and side effects such as nausea and dizziness. It is known that audiovisual distraction also effectively reduces pain and anxiety in patients with fewer side effects.
The investigators have therefore chosen to use the RELAX® glasses. There are no publications examining the effectiveness of positive distraction as a non-pharmacological agent to improve the patient experience during emergency management in the operating room in the context of hand surgery under locoregional anesthesia. The investigatos would like to study its action on the anxiety, pain and global satisfaction.
### Conditions Module
**Conditions:**
- Surgery
**Keywords:**
- Audiovisual sedation
- anxiety
- hand surgery
- locoregional anesthesia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 171
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: RELAX® glasses
**Label:** Group with RELAX® glasses
**Type:** EXPERIMENTAL
#### Arm Group 2
**Label:** Group without RELAX® glasses
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group with RELAX® glasses
**Description:** Glasses which are a solution of audiovisual sedation by positive distraction for hospital medical use.
**Name:** RELAX® glasses
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The visual analogue anxiety scale from 0 to 10, with 0 meaning no anxiety and 10 very high anxiety.
**Measure:** Change from baseline in visual analogue scale anxiety scores after emergency hand surgery
**Time Frame:** In the 5 minutes after the end of emergency hand surgery
#### Secondary Outcomes
**Description:** The visual analogue satisfaction scale ranges from 0 to 10, with 0 meaning unsatisfaction and 10 indicating very high satisfaction.
**Measure:** Overall satisfaction between the group using RELAX glasses and the group following the usual course (without RELAX glasses) measured by a visual analogue scale
**Time Frame:** Immediate postoperative
**Description:** The visual analogue pain scale ranges from 0 to 10, with 0 meaning non pain and 10 meaning very high pain
**Measure:** Variation in pain between entering and leaving the operating theatre between the 2 arms using a visual analogue scale
**Time Frame:** In the 5 minutes after the end of emergency hand surgery
**Measure:** Rate of patients receiving at least one additional analgesic
**Time Frame:** Immediate after locoregional anaesthesia
**Measure:** Rate of patients receiving at least one additional anxiolytic
**Time Frame:** Immediate after locoregional anaesthesia
**Description:** Only in patients receiving RELAX glasses : If the STAI-YB score is higher than 65, the patient is considered to have pre-existing anxiety.
**Measure:** Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score
**Time Frame:** 7-days after emergency hand surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients treated for hand surgery under emergency locoregional anesthesia (Wounds, fractures and infections of the hand and wrist).
* Over 15 years and 3 months of age on the day of inclusion.
* Patient with written consent or additional parental consent in the case of minor patients.
* Socially insured patient.
* Patient willing to comply with all study procedures and duration.
Exclusion Criteria:
* Medical history contraindicating RELAX glasses: claustrophobia.
* Known and current alcohol and/or illicit drug abuse that may interfere with patient safety and/or compliance.
* Any condition that would make the patient unfit for the study: current presence of cognitive impairment (MMS \<15), severe psychiatric disorders (bipolar disorder, psychotic disorders according to the DSM-V classification).
* Pregnant or breastfeeding woman.
* Patient under court protection.
* Patient participating in another study.
* Patient's refusal to use the headset.
**Minimum Age:** 15 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Valenciennes
**Country:** France
**Facility:** Centre Hospitalier de Valenciennes
**Zip:** 59300
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M7796
- Name: Emergencies
- Relevance: HIGH
- As Found: Emergency
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004630
- Term: Emergencies
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436105
**Brief Title:** COMPARISON OF PERIOPERATIVE ANALGESIC EFFECTIVENESS OF PATIENTS WHO HAD FASIA ILIAC COMPARTMENT BLOCK AND 4IN1 BLOCK APPLIED IN TOTAL KNEE PROSTHESIS SURGERY
**Official Title:** COMPARISON OF PERIOPERATIVE ANALGESIC EFFECTIVENESS OF PATIENTS WHO HAD FASIA ILIAC COMPARTMENT BLOCK AND 4IN1 BLOCK APPLIED IN TOTAL KNEE PROSTHESIS SURGERY
#### Organization Study ID Info
**ID:** İsa Öteleş
#### Organization
**Class:** OTHER_GOV
**Full Name:** Diskapi Yildirim Beyazit Education and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Diskapi Yildirim Beyazit Education and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Diskapi Yildirim Beyazit Education and Research Hospital
**Investigator Full Name:** Savas Altinsoy
**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:** Patients who will undergo elective total knee arthroplasty surgery under spinal anesthesia will be included in the study according to the postoperative analgesia method applied: Group Control, Group FICB and Group 4in1. Peripheral nerve block will be performed with 30 ml %0.25 bupivacaine for Group FICB and Group 4 in 1 patients. Peripheral nerve block will not be performed on Group Control patients. Patient-controlled analgesia will be given to all three groups in the postoperative period. PCA is a pain palliation method routinely used in all patients postoperatively. NRS score, PCA tramadol consumption, PCA demand, need for additional analgesia, patient satisfaction, nausea and vomiting will be monitored 24 hours postoperatively. The aim of this study is to compare the perioperative analgesic effectiveness of patients who underwent fascia iliaca compartment block and 4 in 1 block in total knee arthroplasty surgery, with each other and with the control group.
**Detailed Description:** Total knee arthroplasty is a surgical procedure performed mostly on patients with osteoarthritis who have failed traditional conservative treatment. Increasing knee osteoarthritis due to reasons such as life expectancy and body mass index causes this surgical procedure to be performed more frequently. The knee joint which is innervated by the femoral, obturator, sciatic nerves and their branches has a complicated innervation and the pain following total knee arthrplasty is quite severe. It is aimed to provide effective analgesia by blocking these nerves or terminal branches with various peripheral nerve blockade methods under USG guidance. In recent years, interest in studies aiming to block these nerves with a single injection has been increasing. 4 in 1 block is a new technique applied from a single injection point to block the saphenous, obturator, sciatic and vastus medialis nerves that innervate the knee joint. Fascia iliaca compartment block is a reliable technique applied from a single injection point to block the femoral, lateral femoral cutaneous and obturator nerves behind the fascia iliaca.
Patients who will undergo elective total knee arthroplasty surgery under spinal anesthesia will be included in the study according to the postoperative analgesia method applied: Group Control, Group FICB and Group 4in1. Peripheral nerve block will be performed with 30 ml %0.25 bupivacaine for Group FICB and Group 4 in 1 patients. Peripheral nerve block will not be performed on Group Control patients. Patient-controlled analgesia will be given to all three groups in the postoperative period. PCA is a pain palliation method routinely used in all patients postoperatively. NRS score, PCA tramadol consumption, PCA demand, need for additional analgesia, patient satisfaction, nausea and vomiting will be monitored 24 hours postoperatively. The aim of this study is to compare the perioperative analgesic effectiveness of patients who underwent fascia iliaca compartment block and 4 in 1 block in total knee arthroplasty surgery, with each other and with the control group.
### Conditions Module
**Conditions:**
- Pain, Postoperative
**Keywords:**
- FICB
- 4 in 1 block
- Total knee arthroplasty
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Peripheral nerve block will not be performed on Group Control patients.
**Label:** Group Control
#### Arm Group 2
**Description:** FICB will be performed with 30 ml %0.25 bupivacaine for Group FICB patients.
**Intervention Names:**
- Other: FICB
**Label:** Group FICB
#### Arm Group 3
**Description:** 4 in 1 block will be performed with 30 ml %0.25 bupivacaine for Group 4 IN 1 patients.
**Intervention Names:**
- Other: 4 in 1 block
**Label:** Group 4 IN 1
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group FICB
**Description:** FICB is applied to the patients after spinal anesthesia.
**Name:** FICB
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Group 4 IN 1
**Description:** 4 in 1 block is applied to the patients after spinal anesthesia.
**Name:** 4 in 1 block
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Total tramadol consumption used in the first 24 hours postoperatively
**Measure:** Total tramadol consumption in 24 hours (mg)
**Time Frame:** 24 hours postoperatively
#### Secondary Outcomes
**Description:** NRS range was from 0-10 with being no pain and 10 the worst pain possible.
**Measure:** Pain on the Numeric Rating Scale (NRS)
**Time Frame:** 0 hours postoperatively
**Description:** NRS range was from 0-10 with being no pain and 10 the worst pain possible.
**Measure:** Pain on the Numeric Rating Scale (NRS)
**Time Frame:** 1 hours postoperatively
**Description:** NRS range was from 0-10 with being no pain and 10 the worst pain possible.
**Measure:** Pain on the Numeric Rating Scale (NRS)
**Time Frame:** 4 hours postoperatively
**Description:** NRS range was from 0-10 with being no pain and 10 the worst pain possible.
**Measure:** Pain on the Numeric Rating Scale (NRS)
**Time Frame:** 8 hours postoperatively
**Description:** NRS range was from 0-10 with being no pain and 10 the worst pain possible.
**Measure:** Pain on the Numeric Rating Scale (NRS)
**Time Frame:** 12 hours postoperatively
**Description:** NRS range was from 0-10 with being no pain and 10 the worst pain possible.
**Measure:** Pain on the Numeric Rating Scale (NRS)
**Time Frame:** 24 hours postoperatively
**Description:** Consumption of rescue analgesic used after 24 hours postoperatively.
**Measure:** Rescue Analgesic
**Time Frame:** 24 hours postoperatively
**Description:** The patient is satisfied or dissatisfied
**Measure:** Patient satisfaction
**Time Frame:** 24 hours postoperatively
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* With informed consent
* Elective total knee arthroplasty with spinal anesthesia
* Oriented and cooperative
* ASA Classification I-II-III
* 18-85 years old
Exclusion Criteria:
* Anticoagulant medication
* Coagulopathy
* Infection at the site of peripheral nerve block application
* Allergy to local anesthetics
* Pregnant or suspected pregnancy
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients who undergone total knee arthroplasty
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ankara
**Country:** Turkey
**Facility:** Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yıldırım Beyazit Training and Research Hospital
**Zip:** 06450
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Roy R, Agarwal G, Pradhan C, Kuanardr D, Mallick DJ. Ultrasound guided 4 in 1 block - a newer, single injection technique for complete postoperative analgesia for knee and below knee surgeries. Anaesthesia, Pain & Intensive Care. 2018;22(1):87-92.
**Citation:** Kanadli H, Dogru S, Karaman T, Karaman S, Tapar H, Sahin A, Asci M, Kanadli KA, Suren M. Comparison of the efficacy of femoral nerve block and fascia iliaca compartment block in patients with total knee replacement. Minerva Anestesiol. 2018 Oct;84(10):1134-1141. doi: 10.23736/S0375-9393.18.12062-1. Epub 2018 Jan 16.
**PMID:** 29338141
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Pain, Postoperative
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010149
- Term: Pain, Postoperative
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M5315
- Name: Bupivacaine
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436092
**Brief Title:** Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
**Official Title:** Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
#### Organization Study ID Info
**ID:** JDEPTH-LM Registry
#### Organization
**Class:** INDUSTRY
**Full Name:** TCROSS Co., Ltd.
#### Secondary ID Infos
**Domain:** Japan Registry of Clinical Trials
**ID:** jRCT1030240071
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2029-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-27
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Kaneka Corporation
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** TCROSS Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** JDEPTH-LM Registry is a prospective, observational, multi-center study designed for the efficacy and safety of Double-effect kissing balloon technique (W-KBT) in left main (LM) bifurcation percutaneous coronary intervention (PCI) using Perfusion balloon (PB) and Drug coated balloon (DCB) in patients with left main coronary artery disease (LMD) with left circumflex artery (LCx) ostium stenosis.
**Detailed Description:** JDEPTH-LM Registry is a prospective observational multi-center study. The investigators will enroll and treat patients in the registry who meet the selection criteria under usual care and for whom PCI with W-KBT following on crossover stenting for LMT-LAD direction, proximal optimization technique (POT), and conventional kissing balloon technique (C-KBT) is the optimal treatment. The operators shall obtain oral or written consent from patients who meet the criteria before performing PCI, indicating the intention to perform PCI with W-KBT, and shall keep records. The investigators will continuously register cases attempting PCI with W-KBT according to the protocol and evaluate its efficacy and safety using data from this multi-center registry.
### Conditions Module
**Conditions:**
- Stable Angina
- Non-ST-elevation Acute Coronary Syndrome
- Unstable Angina
**Keywords:**
- Ischemic heart disease
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 280
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 12 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects ≥ 18 years of age with de novo LMD with LCx ostium stenosis presenting with stable angina, non-ST-elevation myocardial infarction, or unstable angina that are suitable for percutaneous coronary intervention including W-KBT processes. Approximately 280 subjects at 17 sites in Japan will be enrolled. Subjects will be followed through discharge and 12 months in routine clinical practice.
**Label:** JDEPTH-LM Registry Participants
### Outcomes Module
#### Other Outcomes
**Description:** Fractional flow reserve (FFR) values will be measured before and after each KBT, using either a conventional balloon or PB
**Measure:** Assessment of distal LAD coronary flow preservation during C-KBT vs. W-KBT
**Time Frame:** During PCI procedure
**Description:** confirming that ECG changes can easily recover even after W-KBT for LMD
**Measure:** ST-change recovery time
**Time Frame:** During PCI procedure
**Measure:** Incidence of periprocedural MI defined by Fourth Universal Definition of Myocardial Infarction (4th UDMI), Academic Research Consortium (ARC)-2 and Society for Cardiovascular Angiography and Interventions (SCAI) definitions
**Time Frame:** Within 12 months of PCI
**Measure:** Incidence of LM stent deformation after W-KBT assessed by intravascular ultrasound (IVUS)
**Time Frame:** During PCI procedure
**Measure:** MACE at 12 months based on lesion characteristics at the LCx ostial lesions and the type of lesion preparation step
**Time Frame:** Within 12 months of PCI
**Measure:** Incidence of symptom onset during W-KBT and reviewing cases showing these symptoms
**Time Frame:** During PCI procedure
**Description:** The incidence rate will be calculated using the median LVEF or 40% as the cutoff
**Measure:** Incidence of Treatment Adverse Events [Safety and Tolerability] in patients with low left ventricular ejection fraction (LVEF)
**Time Frame:** During PCI procedure & Within 12 months of PCI
**Description:** comparing efficacy and safety among various groups based on PCI operators' experience
**Measure:** The procedural success rate based on the number of LM-PCI experiences
**Time Frame:** During PCI procedure & Within 12 months of PCI
**Description:** in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography)
**Measure:** Late lumen loss
**Time Frame:** During PCI procedure & Within 12 months of PCI
**Measure:** Assessment of ischemia including FFR or non-hyperemic pressure ratios (NHPRs) at follow-up visit
**Time Frame:** Within 12 months of PCI
#### Primary Outcomes
**Description:** indicating the proportion of cases meeting the following three conditions:
* Device delivery success
* Achievement of DCB expansion for 30 seconds or more
* No bailout stenting performed in the LCx
**Measure:** Procedure success rate
**Time Frame:** During PCI procedure
**Description:** consisting of all-cause mortality, nonfatal myocardial infarction (MI), and ischemia-driven unplanned revascularization for left main disease
**Measure:** Major adverse cardiovascular event (MACE) at 12 months
**Time Frame:** Within 12 months of PCI procedure
#### Secondary Outcomes
**Description:** confirming the time from the initiation of W-KBT to any ST elevation/depression in the electrocardiogram (ECG) to evaluate the safety of the procedure
**Measure:** Time to ST-change from DCB inflation
**Time Frame:** During PCI procedure
**Description:** confirming the duration for which the inflation of the DCB can be sustained during W-KBT, as the recommendation time of DCB inflation is at least 30 seconds
**Measure:** Total DCB Inflation time
**Time Frame:** During PCI procedure
**Description:** confirming the extent of blood pressure and heart rate changes resulting from maintaining W-KBT for 30 seconds or longer in the left main coronary trunk (LMT)
**Measure:** Maximum changes in blood pressure and heart rate
**Time Frame:** During PCI procedure
**Description:** confirming that hemodynamics is not disturbed by W-KBT for LMD
**Measure:** Rate of use of vasopressors, inotropes, and mechanical circulatory support systems after W-KBT
**Time Frame:** During PCI procedure
**Description:** confirming the frequency of occurrences for each component of MACE
**Measure:** Incidence cases for each component of MACE and ischemia-driven unplanned revascularization for lesions at the LCx ostium
**Time Frame:** Within 12 months of PCI
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥ 18 years
2. Patient with stable coronary artery disease, non-ST-elevation myocardial infarction, or unstable angina
3. Left main disease confirmed by coronary angiography or coronary CT angiography
4. Clinical and anatomical eligibility for PCI as agreed by the local Heart Team
5. Patient with consent prior to undergoing PCI
6. Left main Medina classification (1,1,1), (1,0,1), (0,1,1) confirmed by coronary angiography
7. De novo target lesion in LMT-LAD amenable for crossover stenting with provisional side-branch approach as determined by PCI operator
8. De novo ostial LCx lesions
9. Lesion indicated in No. 8 with a length of less than 10 mm or a stenosis of less than 70% confirmed by coronary angiography
Exclusion Criteria:
1. Inability to provide written informed consent
2. Patient with a history of ST-elevation myocardial infarction within the previous 1 week
3. Patient in a state of cardiogenic shock
4. Patient with a history of coronary artery bypass grafting
5. Patient with malignant tumors or other conditions with a life expectancy of less than one year
6. Patient considered suitable for stent placement in the ostial LCx from a medical perspective
7. Patient considered unsuitable for anti-thrombotic therapy after PCI
8. Other patient whom the investigator deems unsuitable for the safe conduct of LM-PCI, including W-KBT
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Subjects ≥ 18 years of age with de novo LMD with LCx ostium stenosis presenting with stable angina, non-ST-elevation myocardial infarction, or unstable angina that are suitable for percutaneous coronary intervention including W-KBT processes. Approximately 280 subjects at 17 sites in Japan will be enrolled. Subjects will be followed through discharge and 12 months in routine clinical practice.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Takayuki Warisawa, MD
**Phone:** 81-3-3448-6111
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ichinomiya
**Contacts:**
***Contact 1:***
- **Name:** Hisaaki Ishiguro
- **Role:** CONTACT
**Country:** Japan
**Facility:** Ichinomiya Municipal Hospital
**State:** Aichi
**Status:** NOT_YET_RECRUITING
**Location 2:**
**City:** Matsudo
**Contacts:**
***Contact 1:***
- **Name:** Koji Hozawa
- **Role:** CONTACT
**Country:** Japan
**Facility:** New Tokyo Hospital
**State:** Chiba
**Status:** NOT_YET_RECRUITING
**Location 3:**
**City:** Matsuyama
**Contacts:**
***Contact 1:***
- **Name:** Hideki Okayama
- **Role:** CONTACT
**Country:** Japan
**Facility:** Ehime Prefectural Central Hospital
**State:** Ehime
**Status:** RECRUITING
**Location 4:**
**City:** Hakodate
**Contacts:**
***Contact 1:***
- **Name:** Yusuke Tokuda
- **Role:** CONTACT
**Country:** Japan
**Facility:** Hakodate Municipal Hospital
**State:** Hokkaido
**Status:** NOT_YET_RECRUITING
**Location 5:**
**City:** Tsuchiura
**Contacts:**
***Contact 1:***
- **Name:** Tsunekazu Kakuta
- **Role:** CONTACT
**Country:** Japan
**Facility:** Tsuchiura Kyodo General Hospital
**State:** Ibaraki
**Status:** RECRUITING
**Location 6:**
**City:** Tsukuba
**Contacts:**
***Contact 1:***
- **Name:** Hidetaka Nishina
- **Role:** CONTACT
**Country:** Japan
**Facility:** Tsukuba Medical Center Hospital
**State:** Ibaraki
**Status:** NOT_YET_RECRUITING
**Location 7:**
**City:** Kanazawa
**Contacts:**
***Contact 1:***
- **Name:** Hidenobu Terai
- **Role:** CONTACT
**Country:** Japan
**Facility:** Kanazawa Cardiovascular Hospital
**State:** Ishikawa
**Status:** RECRUITING
**Location 8:**
**City:** Kamakura
**Contacts:**
***Contact 1:***
- **Name:** Koki Shishido
- **Role:** CONTACT
**Country:** Japan
**Facility:** Shonan Kamakura General Hospital
**State:** Kanagawa
**Status:** RECRUITING
**Location 9:**
**City:** Yokosuka
**Contacts:**
***Contact 1:***
- **Name:** Tadashi Murai
- **Role:** CONTACT
**Country:** Japan
**Facility:** Yokosuka Kyosai Hospital
**State:** Kanagawa
**Status:** RECRUITING
**Location 10:**
**City:** Urasoe
**Contacts:**
***Contact 1:***
- **Name:** Hiroki Uehara
- **Role:** CONTACT
**Country:** Japan
**Facility:** Urasoe General Hospital
**State:** Okinawa
**Status:** RECRUITING
**Location 11:**
**City:** Fuchu
**Contacts:**
***Contact 1:***
- **Name:** Kenichi Hagiya
- **Role:** CONTACT
**Country:** Japan
**Facility:** Sakakibara Heart Institute
**State:** Tokyo
**Status:** NOT_YET_RECRUITING
**Location 12:**
**City:** Shinagawa
**Contacts:**
***Contact 1:***
- **Name:** Takayuki Warisawa
- **Role:** CONTACT
**Country:** Japan
**Facility:** NTT Medical Center Tokyo
**State:** Tokyo
**Status:** RECRUITING
**Location 13:**
**City:** Fukuoka
**Contacts:**
***Contact 1:***
- **Name:** Yoshinobu Murasato
- **Role:** CONTACT
**Country:** Japan
**Facility:** National Hospital Organization Kyushu Medical Center
**Status:** NOT_YET_RECRUITING
**Location 14:**
**City:** Gifu
**Contacts:**
***Contact 1:***
- **Name:** Yoshiaki Kawase
- **Role:** CONTACT
**Country:** Japan
**Facility:** Gifu Heart Center
**Status:** RECRUITING
**Location 15:**
**City:** Kochi
**Contacts:**
***Contact 1:***
- **Name:** Ryu-Ichirou Imai
- **Role:** CONTACT
**Country:** Japan
**Facility:** Chikamori Hospital
**Status:** NOT_YET_RECRUITING
**Location 16:**
**City:** Kumamoto
**Contacts:**
***Contact 1:***
- **Name:** Kenichi Tsujita
- **Role:** CONTACT
**Country:** Japan
**Facility:** Kumamoto University Hospital
**Status:** NOT_YET_RECRUITING
**Location 17:**
**City:** Wakayama
**Contacts:**
***Contact 1:***
- **Name:** Junichi Tazaki
- **Role:** CONTACT
**Country:** Japan
**Facility:** Japanese Red Cross Wakayama Medical Center
**Status:** RECRUITING
### 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: D000003327
- Term: Coronary Disease
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: HIGH
- As Found: Left Main Disease
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M27545
- Name: Acute Coronary Syndrome
- Relevance: HIGH
- As Found: Acute Coronary Syndrome
- ID: M4117
- Name: Angina Pectoris
- Relevance: HIGH
- As Found: Angina
- ID: M29575
- Name: Angina, Stable
- Relevance: HIGH
- As Found: Stable Angina
- ID: M4119
- Name: Angina, Unstable
- Relevance: HIGH
- As Found: Unstable Angina
- ID: M6549
- Name: Coronary Disease
- 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: M4469
- Name: Arteriosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000054058
- Term: Acute Coronary Syndrome
- ID: D000000787
- Term: Angina Pectoris
- ID: D000060050
- Term: Angina, Stable
- ID: D000000789
- Term: Angina, Unstable
- ID: D000003324
- Term: Coronary Artery Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436079
**Brief Title:** Evaluation of the Effectiveness of a Nursing Intervention Program in Reducing Anxiety in Users Who Perform Scheduled Sessions in the Hyperbaric Chamber
**Official Title:** Evaluation of the Effectiveness of a Nursing Intervention Program in Reducing Anxiety in Users Who Perform Scheduled Sessions in the Hyperbaric Chamber
#### Organization Study ID Info
**ID:** 44519 ANSIETAT UMH
#### Organization
**Class:** OTHER
**Full Name:** Universitat de Girona
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-06
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Universitat de Girona
#### Responsible Party
**Investigator Affiliation:** Universitat de Girona
**Investigator Full Name:** Lyudmila Andrusenko Kalchenko
**Investigator Title:** Clinical professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The objective of this experimental study is to determine if the application of a nursing educational intervention reduces the anxiety of patients who are going to undergo treatment in the hyperbaric chamber.
The researchers will compare the nursing educational intervention with the usual practice that is currently carried out in the unit for patients who are going to begin treatment in the hyperbaric chamber.
Participants will:
* Receive explanatory information through a camera triptych when the treatment is indicated.
* Come half an hour before the first session to receive a nursing educational intervention, with audiovisual support, on the operation of the camera.
**Detailed Description:** The objective of this experimental study is to determine if the application of a nursing educational intervention reduces the anxiety of patients who are going to undergo treatment in the hyperbaric chamber.
An educational intervention will be applied to the intervention group that will begin on the same day that the treatment is indicated. That day, you will be given an informative brochure about the most important aspects you should know about the hyperbaric chamber. On the first day of the session, you will be asked to come half an hour early to explain, in more detail, what the hyperbaric chamber consists of and important aspects that you should take into account.
The control group will receive the same intervention that is currently being carried out. Once treatment is prescribed in the chamber, they come on the first day and receive a brief explanation of how it works before entering.
### Conditions Module
**Conditions:**
- Anxiety and Fear
- Nurse's Role
**Keywords:**
- Anxiety
- Nursing intervention
- Hyperbaric chamber
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 42
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The experimental group will receive a nursing educational intervention with an explanation, with audiovisual support, of the operation of the hyperbaric chamber.
**Intervention Names:**
- Behavioral: Intervention group
**Label:** Audiovisual educational program on treatment in a hyperbaric chamber
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control group will undergo the same procedure that is currently carried out, some basic explanations before entering the hyperbaric chamber.
**Intervention Names:**
- Behavioral: Intervention group
**Label:** Usual intervention
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Audiovisual educational program on treatment in a hyperbaric chamber
- Usual intervention
**Description:** Patients who begin the first session in the hyperbaric chamber will receive a nursing educational intervention, with audiovisual support, about the operation of the chamber and aspects that must be taken into account once inside.
**Name:** Intervention group
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Feelings of fear, dread, and uneasiness that may occur as a reaction to stress.
**Measure:** Prevalence of anxiety measured with the STAI questionnaire.
**Time Frame:** First week of treatment in the hyperbaric chamber
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Results in the Pfeiffer questionnaire\<2.
* That they understand Spanish or Catalan
Exclusion Criteria:
* That feel fear inside the hyperbaric chamber.
**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:** Dalmau Vila-Vidal, MsC
**Phone:** 972600160
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Palamós
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dalmau Vila Vidal, MsC
- **Phone:** 972600160
- **Role:** CONTACT
**Country:** Spain
**Facility:** Hospital de Palamós
**State:** Girona
**Status:** RECRUITING
**Zip:** 17230
## 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436066
**Brief Title:** Effect of Self-Acupressure on Peripheral Neuropathic Pain and HbA1c
**Official Title:** Effect of Self-Acupressure Application on Peripheral Neuropathic Pain and HbA1c in Patients With Type 2 Diabetes
#### Organization Study ID Info
**ID:** EAVSAR
#### Organization
**Class:** OTHER
**Full Name:** Yeditepe University
### Status Module
#### Completion Date
**Date:** 2025-05-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-25
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Yeditepe 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:** Aim: This study was conducted to examine the effect of self-applied acupressure on HbA1c and peripheral neuropathic pain in patients diagnosed with type 2 diabetes.
Background: Acupressure is an effective method for relieving pain, and this effectiveness is explained by the gate control theory and endorphin theory. There is only one study in the literature showing that acupressure reduces diabetic neuropathic pain. However, in this study, acupressure was performed by a trained health professional, not by the patient himself. Measurement of glycosylated hemoglobin (HbA1c) level is one of the standard methods for long-term management of diabetes and indicates the average blood glucose concentration over a three-month period. As a result of a meta-analysis study conducted in 2023, it was reported that acupressure significantly reduced the HbA1c level.
Design: This study was designed as a randomized controlled and experimental type study.
Methods: The study is conducted with patients with type 2 diabetes who are followed in the diabetes outpatient clinic of a training and research hospital between May-November 2024. There are 2 arms in the study. The study is conducted with a total of 60 patients, 30 in the control group and 30 in the intervention group. Data collection tools are "Patient Information Form", "Neuropathic Pain Questionnaire - DN4", "Neuropathic Pain Questionnaire - Short Form" and "Self-Acupressure - Satisfaction Evaluation Form with Visual Analogue Scale". While patients in the control group continue to receive routine care, patients in the intervention group are given self-acupressure training. Patients who receive training perform acupressure on their own 3 days a week for 3 months and record it on the follow-up form.
**Detailed Description:** Patients with diabetes need to maintain many factors such as appropriate lifestyle changes, nutrition regulation, exercise, regular use of medications and insulin in order to prevent the emergence of peripheral neuropathy and various symptoms that develop accordingly or to control the current problem. Patients with diabetes are increasingly turning to complementary medicine methods to support such a complex process. One of these methods is acupressure, which does not involve any invasive procedures. Acupressure regulates blood flow by providing vasodilation and reduces the release of epinephrine and norepinephrine. Acupressure is a safe technique because it is a non-invasive practice. There is only one study in the literature examining the effect of acupressure on diabetic peripheral neuropathic pain, but the method used in this study is not self-acupressure, but acupressure applied by a healthcare professional. There are also studies showing that acupressure reduces plasma blood glucose levels. Self-acupressure is a method that has no side effects, is simple, convenient, does not require special equipment, and can be applied cost-effectively by trained individuals. Nurses can easily learn acupressure, apply it in clinics to increase patients' comfort and reduce symptoms, and teach patients to apply it on their own. When a person learns how to apply acupressure on his own, he needs less help to complete his treatment.This study, which was conducted to determine whether self-applied acupressure by patients diagnosed with type 2 diabetes has an effect on HbA1c and peripheral neuropathic pain, will add innovation to the literature, will guide new research in this context, and can alleviate diabetic peripheral neuropathic pain thanks to self-acupressure training given to the patient. It is thought that it will provide blood glucose level regulation and sustainability, reduce the frequency of admission to healthcare institutions and be a cost-effective application.
### Conditions Module
**Conditions:**
- Diabetes Mellitus, Type 2
**Keywords:**
- Self-acupressure
- HbA1c
- Peripheral Neuropathic Pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A self-acupressure training booklet was created in line with the relevant literature. For the training booklet, expert opinions were received from 5 clinician nurses and 5 academic nurses who are experts in their fields. The training booklet includes the definition of self-acupressure, the areas in which it is used, its benefits, the purpose of the study, the points where acupressure will be applied and the application procedure. After 30 minutes of self-acupressure training was given to the patients in the intervention group, the relevant training booklet was delivered. Reminder messages will be sent to patients every week. They will be asked to do it 3 days a week and for 3 months. They were informed to come for a check-up after 3 months.
**Intervention Names:**
- Other: Self-Acupressure
**Label:** Intervention Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Routine clinical care continued to be provided to the patients in the control group.
Routine maintenance applications include the following parameters;
1. Patient Information Form
2. Neuropathic Pain Questionnaire - DN4
3. Neuropathic Pain Questionnaire - Short Form
4. Providing acupressure training to diabetic patients who wish to do so at the end of the study.
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention Group
**Description:** Applications include the following parameters;
1. Patient Information Form (before and after application)
2. Neuropathic Pain Questionnaire - DN4 (before and after application)
3. Neuropathic Pain Questionnaire - Short Form (before and after application)
4. Providing self-acupressure training (before application)
5. Delivery of the self-acupressure training booklet (before application)
6. Sending weekly reminder messages (during implementation)
7. Calling the patient for a check-up after 3 months and re-evaluating with the same scales (After the application)
8. Self-Acupressure - Satisfaction Evaluation Form with Visual Analogue Scale (After application)
**Name:** Self-Acupressure
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The form prepared by the researcher includes questions inquiring about the sociodemographic and background information of the patients, clinical characteristics and laboratory results.
**Measure:** Patient Information Form
**Time Frame:** First day and 3th months
**Description:** In the survey, neuropathic pain is evaluated with questions based on interview with the individual and clinical examination. The highest score that can be obtained is 10. The cutoff value for neuropathic pain is accepted as 4/10.
**Measure:** Neuropathic Pain Questionnaire - DN4
**Time Frame:** First day and 3th months
**Description:** Tingling, numbness and pain that increases with touch are evaluated. If the obtained scores are analyzed according to the calculation instructions, the result will reveal whether the pain in the individual is neuropathic or not.
**Measure:** Neuropathic Pain Questionnaire - Short Form
**Time Frame:** First day and 3th months
**Description:** Visual Analogue Scale (VAS) will be used to evaluate patients' satisfaction with acupressure self-administration. In the scale, a score of "1" indicates that they are not satisfied with self-acupressure, a score of "5" indicates that satisfaction is at a medium level, a score of "10" indicates that satisfaction is very high, and as the score increases, it will be stated that satisfaction increases. Patients will be asked to self-rate their acupressure satisfaction level.
**Measure:** Self-Acupressure - Satisfaction Evaluation Form with Visual Analogue Scale
**Time Frame:** 3th months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18 years and over,
* Diagnosed with type-2 diabetes,
* Diagnosed with peripheral neuropathy,
* DN4 score ≥ 4,
* Not diagnosed with a psychiatric disease,
* No hearing, visual or physical disabilities
* Knowing how to read and write,
* Able to communicate, no language problems,
* Having the equipment (smartphone, computer, tablet, etc.) to watch self-acupressure videos and receive reminder text messages,
* Patients who volunteer to participate in the study and give verbal and written consent will be included in the study.
Exclusion Criteria:
* Presence of lesion/scar/mass/open wound at the point where acupressure will be applied,
* Having a non-diabetic disease that causes neuropathy,
* Starting to use new medication to control neuropathic symptoms,
* Changing the dose of the current drug used to control neuropathic symptoms (if it is used routinely and the dose will not be changed, it can be included in the study),
* Adding a new oral antidiabetic drug to your current treatment,
* Not using insulin normally and starting a new insulin treatment,
* The need for a new insulin dose adjustment in insulin users (individuals who currently use insulin and whose dose will not be changed can be included in the study),
* Failure to comply with planned initiatives,
* Using psychiatric medication,
* Having a visual or hearing impairment,
* Having a mental disability or perception problem,
* Already doing self-acupressure,
* Not being willing to participate in the study is a criterion that will exclude individuals from the study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Emir Avşar, PhD
**Phone:** +905535341729
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Emir Avşar, PhD
- **Phone:** +905535341729
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Selda Çelik, PhD
- **Phone:** +905332253856
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Yeditepe University
**State:** Ataşehir
**Zip:** 34755
#### Overall Officials
**Official 1:**
**Affiliation:** Saglik Bilimleri Universitesi
**Name:** Selda Çelik, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** article
**URL:** https://ebcj.mums.ac.ir/http:/ebcj.mums.ac.ir/article_21893.html
**Label:** article
**URL:** https://pubmed.ncbi.nlm.nih.gov/30431314/
**Label:** article
**URL:** https://pubmed.ncbi.nlm.nih.gov/31613424/
**Label:** article
**URL:** https://pubmed.ncbi.nlm.nih.gov/31758688/
**Label:** article
**URL:** https://pubmed.ncbi.nlm.nih.gov/17641562/
**Label:** article
**URL:** https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6122868/
**Label:** article
**URL:** https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8053207/
**Label:** article
**URL:** https://pubmed.ncbi.nlm.nih.gov/33894577/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000010523
- Term: Peripheral Nervous System Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### 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: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M7119
- Name: Diabetes Mellitus, Type 2
- Relevance: HIGH
- As Found: Diabetes Mellitus, Type 2
- ID: M12381
- Name: Neuralgia
- Relevance: HIGH
- As Found: Neuropathic Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13432
- Name: Peripheral Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009437
- Term: Neuralgia
- ID: D000003924
- Term: Diabetes Mellitus, Type 2
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436053
**Brief Title:** Acute Response to Left Bundle Branch Area Pacing With SyncAV
**Official Title:** Acute Response to Left Bundle Branch Area Pacing With SyncAV
#### Organization Study ID Info
**ID:** ABT-CIP-10516
#### Organization
**Class:** INDUSTRY
**Full Name:** Abbott Medical Devices
### Status Module
#### Completion Date
**Date:** 2026-07-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-05-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Abbott Medical Devices
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This clinical investigation is a prospective, single-arm, post-market, non-randomized, single-center study designed to evaluate the effectiveness of the SyncAV CRT dynamic atrioventricular (AV) delay feature when used with left bundle branch area pacing (LBBAP).
### Conditions Module
**Conditions:**
- Heart Failure
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Device: LBBAP with SyncAV
**Label:** LBBAP with SyncAV
### Interventions
#### Intervention 1
**Arm Group Labels:**
- LBBAP with SyncAV
**Description:** Acute changes in surface ECG QRS duration resulting from left bundle branch area pacing using various pacing configurations will be evaluated.
**Name:** LBBAP with SyncAV
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Acute change in surface ECG QRS duration resulting from left bundle branch area pacing with optimized SyncAV, relative to intrinsic atrioventricular conduction.
**Measure:** QRS duration
**Time Frame:** During the intervention/procedure/surgery
#### Secondary Outcomes
**Description:** Acute change in left ventricular hemodynamics (i.e., maximum rise in pressure) resulting from left bundle branch area pacing with optimized SyncAV, relative to intrinsic atrioventricular conduction.
**Measure:** LV hemodynamics
**Time Frame:** During the intervention/procedure/surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patient is 18 years of age and willing to comply with the study requirements
2. Patients with approved indication for dual-chamber pacing or cardiac resynchronization therapy and scheduled to be implanted with an Abbott pacing system
3. Patient has documented left bundle branch block (LBBB) or intraventricular conduction delay (IVCD)
4. Patient has an intrinsic QRS duration ≥ 130 ms
5. Patient has intact AV conduction with PR interval ≤ 250 ms
Exclusion Criteria:
1. Patient has a resting ventricular rate \> 100 bpm
2. Patient has AV Block (2nd or 3rd degree)
3. Patient has documented persistent atrial tachycardia or atrial fibrillation
4. Patient has had a recent myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for pacing device programming changes in the opinion of the investigator
5. Patient is currently participating in another clinical investigation
6. Patient is pregnant or nursing
7. Patient has other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
8. Patient does not have legal authority
9. Patient is unable to read or write
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with approved indication for dual-chamber pacing or cardiac resynchronization therapy, with documented left bundle branch block or intraventricular conduction delay, long QRS duration, and intact AV conduction will be enrolled.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Nima Badie, PhD
**Phone:** 408-702-8604
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** San Donato Milanese
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Carlo Pappone, MD, PhD
- **Phone:** +39 -0252774260
- **Role:** CONTACT
**Country:** Italy
**Facility:** I.R.C.C.S. Policlinico San Donato
**State:** MI
**Status:** RECRUITING
**Zip:** 20097
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### 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
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436040
**Brief Title:** Mechanism Study to Investigate Difference in Efficacy of Neoadjuvant Chemoimmunotherapy in Lung Squamous Cell Carcinoma
**Official Title:** A Mechanism Study to Investigate the Difference in Efficacy of Neoadjuvant PD-1 Blockade Combined With Chemotherapy in the Treatment of IIA-IIIB Stage Lung Squamous Cell Carcinoma
#### Organization Study ID Info
**ID:** 202311-10
#### Organization
**Class:** OTHER
**Full Name:** Tang-Du Hospital
### Status Module
#### Completion Date
**Date:** 2025-05-16
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-11-16
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-24
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Tang-Du Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** To explore mechanisms of immunotherapy resistance and relation to changes in the TME before and after PD-1 blockade combined with chemotherapy
**Detailed Description:** The biobank of thoracic surgery department of Tangdu Hospital collected pre-treatment tissues from patients during endoscopy. The investigators retrospectively summarized the clinical characteristics of these patients and patients with operable locally advanced lung squamous cell carcinoma were selected and followed.
The investigators plan to employ snRNA-seq and scRNA-seq respectively to profile 20 samples of paired pre-treatment and post-treatment tumors from ten patients (discovery cohort) to create a cell atlas for analysis, and spatial transcriptomics to examine 8 samples from four patients. In discovery cohort, estimated 5 patients achieve major pathological response (MPR) and 5 patients achieve non-MPR after NICB.
After analyzing the results of discovery cohort, the investigators will collect frozen tissues and formalin-fixed, paraffin-embedded (FFPE) tissue from our biobank for bulk RNA-seq analysis or immunohistochemistry (IHC) staining as validation cohort to further investigate the predictive value and biological significance of our markers.
### Conditions Module
**Conditions:**
- Tumor Microenvironment
- Lung Squamous Cell Carcinoma
- Neoadjuvant Chemoimmunotherapy
### Design Module
#### Bio Spec
**Description:** pre-treatment and post-treatment tumors from patients with operable locally advanced lung squamous cell carcinoma
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** defned as having no more than 10% residual viable tumor cells by routine hematoxylin and eosin (H\&E) staining after therapy
**Intervention Names:**
- Other: Pathological response assessment
**Label:** MPR(major pathological response)
#### Arm Group 2
**Description:** defned as having more than 10% residual viable tumor cells by routine hematoxylin and eosin (H\&E) staining after therapy
**Intervention Names:**
- Other: Pathological response assessment
**Label:** non-MPR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MPR(major pathological response)
- non-MPR
**Description:** The pathological response classification in our study was based on the histopathologic examination of the surgically resected specimens reviewed by two experienced pathologists.
**Name:** Pathological response assessment
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** MPR: Resected tumors with ≤10% viable tumor cells were considered to have a MPR
**Measure:** Pathological response assessment
**Time Frame:** through study completion, an average of 2 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. aged 40 to 80 years;
2. had histologically confirmed LUSC with operable locally advanced stage
3. no prior anti-tumor therapy; received neoadjuvant immunotherapy consisting of three cycles of anti-PD-1 ICB plus nab-paclitaxel and carboplatin
4. pre-treatment tissues
Exclusion Criteria:
1. the presence of central nervous system metastases
2. the presence of immunodeficiency disease; previous therapies with immunosuppressants within 14 days prior to the initiation of study treatment;
3. uncontrolled hypertension
4. history of or having pulmonary fibrosis or interstitial lung disease
**Maximum Age:** 80 Years
**Minimum Age:** 40 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** patients enrolled in this study had histologically confirmed LUSC with operable locally advanced stage, no prior anti-tumor therapy, and received neoadjuvant immunotherapy consisting of three cycles of anti-PD-1 ICB plus nab-paclitaxel and carboplatin
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Xi'an
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hongtao Duan, Dr.
- **Phone:** 02984717569
- **Role:** CONTACT
**Country:** China
**Facility:** Hongtao Duan
**State:** Shanxi
**Status:** RECRUITING
**Zip:** 710038
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5550
- Name: Carcinoma, Squamous Cell
- Relevance: HIGH
- As Found: Squamous Cell Carcinoma
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M20451
- Name: Neoplasms, Squamous Cell
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000002294
- Term: Carcinoma, Squamous Cell
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436027
**Acronym:** Nano-Heart
**Brief Title:** Molecular Diagnosis of Heart Allograft Rejection Using Intra-Graft Targeted Gene Expression Profiling.
**Official Title:** Molecular Diagnosis of Heart Allograft Rejection Using Intra-Graft Targeted Gene Expression Profiling.
#### Organization Study ID Info
**ID:** NANOHEART
#### Organization
**Class:** OTHER
**Full Name:** Paris Translational Research Center for Organ Transplantation
### Status Module
#### Completion Date
**Date:** 2023-12-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-15
**Type:** ACTUAL
#### Start Date
**Date:** 2021-11-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Cedars Sinai Medical Center, Los Angeles, USA
**Class:** OTHER
**Name:** University of Padova
#### Lead Sponsor
**Class:** OTHER
**Name:** Paris Translational Research Center for Organ Transplantation
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this observational study is to develop and validate a molecular heart rejection diagnostic system based on targeted transcriptome as a novel monitoring companion tool for heart allograft precision diagnostics applicable to formalin-fixed paraffin-embedded endomyocardial biopsies.
The primary outcome will be the biopsy-proven rejection, that will be predicted with molecular classifiers (cellular and antibody-mediated rejection scores).
**Detailed Description:** Heart transplantation (HTx) remains the most valuable therapeutic option for patients with end-stage heart failure refractory to optimal medical therapy. Despite major improvements in immunosuppression and transplant care, acute and chronic rejection-induced allograft injuries remain one of the leading causes of mortality and morbidity after heart transplantation, thus limiting recipients' life expectancy. An improvement in the overall management of rejection remains an unmet medical need. As a first step, a precise diagnosis of rejection is crucial to guide patient care and optimize management.
Nowadays, the diagnosis of cardiac rejection relies exclusively on the pathological assessment of endomyocardial biopsies (EMBs) by identifying and grading cellular infiltrates and myocardial damage. While important advances have been made in the standardization of the rejection diagnosis, pathology remains an imperfect gold-standard, particularly due to the inter-observer variability, sample bias and the use of qualitative or semi-quantitative scales that oversimplify complex phenotypes. Additionally, disease severity, degree of myocardial injury and progression stage are crucial pieces of information poorly captured by the current working formulations. All these limits represent major barriers to achieve a precise and reliable diagnosis of rejection.
In this context, gene expression profiling analysis of fresh myocardial samples retrieved during an extra-core biopsy and using a whole transcriptome approach arose as a potential objective companion tool of pathology to refine the diagnosis of rejection. However, important drawbacks have limited the routine clinical applicability of whole-transcriptome based molecular diagnosis including extra-core sampling bias, low reproducibility, technical and analytical heaviness, with costs and sample turn-around that is not compatible with a clinical setting.
Recent technologies may overcome this limitation by allowing analysis of the same tissue used for histology assessment. Targeted molecular profiling applicable to formalin-fixed paraffin-embedded (FFPE) endomyocardial biopsies may allow the implementation of molecular diagnosis into the clinical routine. Recently, we have shown that the Banff Human Organ Transplant Panel (B-HOT) panel, a consortium-approved consensual targeted panel including 770 genes, developed by the Banff Molecular Diagnostics Working Group, accurately captured key molecular patterns of antibody-mediated rejection (AMR) in heart allograft biopsies and may serve as a proxy to whole transcriptome-based analysis.
The aim of the present study is therefore to identify gene expression signatures for AMR and acute cellular rejection in heart transplantation and to develop and validate a molecular heart rejection diagnostic system based on targeted transcriptome as a novel monitoring companion tool for heart allograft precision diagnostics applicable to FFPE-EMB.
### Conditions Module
**Conditions:**
- Heart Transplant Rejection
**Keywords:**
- molecular biology
- allograft rejection
- endomyocardial biopsy
- pathology
- precision diagnosis
- heart transplantation
### Design Module
#### Bio Spec
**Description:** Use of formalin-fixed paraffin-embedded endomyocardial biopsies collected prospectively as part of the standard clinical care of heart transplant recipients.
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 496
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Random selection of 80% of the overall cohort.
**Intervention Names:**
- Diagnostic Test: Nano-Heart tool: Intra-Graft Targeted Gene Expression Profiling
**Label:** Development cohort
#### Arm Group 2
**Description:** Random selection of 20% of the overall cohort.
**Intervention Names:**
- Diagnostic Test: Nano-Heart tool: Intra-Graft Targeted Gene Expression Profiling
**Label:** Validation cohort
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Development cohort
- Validation cohort
**Description:** Targeted molecular profiling will be performed on formalin-fixed paraffin-embedded (FFPE) endomyocardial biopsies using the NanoString nCounter technology. A consortium-approved consensual targeted panel including 770 genes, developed by the Banff Molecular Diagnostics Working Group (MDWG) will be used.
**Name:** Nano-Heart tool: Intra-Graft Targeted Gene Expression Profiling
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Prediction performances of the molecular classifiers (cellular and antibody-mediated rejection scores) to predict biopsy-proven rejection: diagnostic accuracy, Receiver Operating Characteristic - area under the curve, Precision Recall - area under the curve, Brier score, F1 score.
**Measure:** Biopsy-proven rejection: acute cellular-rejection and antibody-mediated rejection.
**Time Frame:** 1 month
#### Secondary Outcomes
**Description:** Confusion matrix, detailed review of the cases.
**Measure:** Discrepancies between molecular and pathology diagnosis of rejection.
**Time Frame:** 1-month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* heart transplant recipients ≥ 18 years old
* at least one endomyocardial biopsy performed as part of routine clinical care
* biopsy performed at least ≥ 1 month post transplant and less that 10-year post-transplant
* written informed consent
Exclusion Criteria:
* age below 18 years old
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** We designed an international multicenter study, building a deep phenotyped cohort of heart transplant recipients recruited at 4 referral centers (Pitié-Salpêtrière and Georges Pompidou hospitals in Paris, Center Gallucci of the University General Hospital of Padova and the Cedars Sinai Medical Center in Los Angeles, USA).
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Los Angeles
**Country:** United States
**Facility:** Cedars Sinai Medical Center
**State:** California
**Zip:** 90048
**Location 2:**
**City:** Paris
**Country:** France
**Facility:** Paris Translational Research Center for Organ Transplantation
**Location 3:**
**City:** Padova
**Country:** Italy
**Facility:** Center Gallucci of the University General Hospital of Padova
#### Overall Officials
**Official 1:**
**Affiliation:** Paris Translational Research Center for Organ Transplantation
**Name:** Alexandre Loupy, MD, PhD
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Paris Translational Research Center for Organ Transplantation
**Name:** Guillaume Coutance, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Berry GJ, Burke MM, Andersen C, Bruneval P, Fedrigo M, Fishbein MC, Goddard M, Hammond EH, Leone O, Marboe C, Miller D, Neil D, Rassl D, Revelo MP, Rice A, Rene Rodriguez E, Stewart S, Tan CD, Winters GL, West L, Mehra MR, Angelini A. The 2013 International Society for Heart and Lung Transplantation Working Formulation for the standardization of nomenclature in the pathologic diagnosis of antibody-mediated rejection in heart transplantation. J Heart Lung Transplant. 2013 Dec;32(12):1147-62. doi: 10.1016/j.healun.2013.08.011.
**PMID:** 24263017
**Citation:** Halloran PF, Venner JM, Madill-Thomsen KS, Einecke G, Parkes MD, Hidalgo LG, Famulski KS. Review: The transcripts associated with organ allograft rejection. Am J Transplant. 2018 Apr;18(4):785-795. doi: 10.1111/ajt.14600. Epub 2017 Dec 23.
**PMID:** 29178397
**Citation:** Halloran PF, Potena L, Van Huyen JD, Bruneval P, Leone O, Kim DH, Jouven X, Reeve J, Loupy A. Building a tissue-based molecular diagnostic system in heart transplant rejection: The heart Molecular Microscope Diagnostic (MMDx) System. J Heart Lung Transplant. 2017 Nov;36(11):1192-1200. doi: 10.1016/j.healun.2017.05.029. Epub 2017 May 29.
**PMID:** 28662985
**Citation:** Mengel M, Loupy A, Haas M, Roufosse C, Naesens M, Akalin E, Clahsen-van Groningen MC, Dagobert J, Demetris AJ, Duong van Huyen JP, Gueguen J, Issa F, Robin B, Rosales I, Von der Thusen JH, Sanchez-Fueyo A, Smith RN, Wood K, Adam B, Colvin RB. Banff 2019 Meeting Report: Molecular diagnostics in solid organ transplantation-Consensus for the Banff Human Organ Transplant (B-HOT) gene panel and open source multicenter validation. Am J Transplant. 2020 Sep;20(9):2305-2317. doi: 10.1111/ajt.16059. Epub 2020 Jun 27.
**PMID:** 32428337
**Citation:** Giarraputo A, Coutance G, Aubert O, Fedrigo M, Mezine F, Zielinski D, Mengel M, Bruneval P, Duong van Huyen JP, Angelini A, Loupy A. Banff Human Organ Transplant Consensus Gene Panel for the Detection of Antibody Mediated Rejection in Heart Allograft Biopsies. Transpl Int. 2023 Sep 4;36:11710. doi: 10.3389/ti.2023.11710. eCollection 2023.
**PMID:** 37745639
**Citation:** Coutance G, Zouhry I, Racape M, Drieux F, Viailly PJ, Rouvier P, Francois A, Chenard MP, Toquet C, Rabant M, Berry GJ, Angelini A, Bruneval P, Duong Van Huyen JP. Correlation Between Microvascular Inflammation in Endomyocardial Biopsies and Rejection Transcripts, Donor-specific Antibodies, and Graft Dysfunction in Antibody-mediated Rejection. Transplantation. 2022 Jul 1;106(7):1455-1464. doi: 10.1097/TP.0000000000004008. Epub 2021 Dec 21.
**PMID:** 34954735
**Citation:** Duong Van Huyen JP, Fedrigo M, Fishbein GA, Leone O, Neil D, Marboe C, Peyster E, von der Thusen J, Loupy A, Mengel M, Revelo MP, Adam B, Bruneval P, Angelini A, Miller DV, Berry GJ. The XVth Banff Conference on Allograft Pathology the Banff Workshop Heart Report: Improving the diagnostic yield from endomyocardial biopsies and Quilty effect revisited. Am J Transplant. 2020 Dec;20(12):3308-3318. doi: 10.1111/ajt.16083. Epub 2020 Jun 28.
**PMID:** 32476272
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Meshes
- ID: D000004194
- Term: Disease
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M8681
- Name: Formaldehyde
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436014
**Acronym:** Pain
**Brief Title:** Evaluation of the Effect of Virtual Reality Application on Postoperative Pain and Anxiety in Women Aged 50-70
**Official Title:** Evaluation of the Effect of Virtual Reality Application on Postoperative Pain and Anxiety in Women Aged 50-70 According to the Type of Surgery: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** OsmaniyeKorkutAtaUniversity
#### Organization
**Class:** OTHER
**Full Name:** Osmaniye Korkut Ata University
### Status Module
#### Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-02
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Osmaniye Korkut Ata University
#### Responsible Party
**Investigator Affiliation:** Osmaniye Korkut Ata University
**Investigator Full Name:** Songul Gungor
**Investigator Title:** Lecturer Phd
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Surgical interventions, while significant milestones in patients\' physical recovery processes, can be a major source of concern for patients due to postoperative pain, which is also an important component of postoperative care. If postoperative pain is not managed properly, it can lead to increased levels of anxiety and fear, as well as deterioration in overall comfort and quality of life. The ineffective management of postoperative pain has economic and medical consequences such as patient dissatisfaction, delayed hospital discharge, increased rates of hospital readmission, and dissatisfaction with medical care. Therefore, effective management of postoperative pain is of great importance for patient well-being. Factors associated with postoperative pain have been reported in many studies. For example, being female and the type of surgery. Therefore, considering gender and type of surgery in the management of postoperative pain is crucial to optimize the recovery process for patients. In recent years, research on the use of innovative technologies such as virtual reality in the management of postoperative pain has increased. Virtual reality can reduce postoperative pain by creating a sense of being in a different environment for patients and diverting their attention away from pain.
**Detailed Description:** Understanding the use of virtual reality applications in the medical field and their effects on pain perception and sensitivity in women is important. This study aims to evaluate the potential impact of virtual reality technology on pain and anxiety during the postoperative period in women aged 50-70. The research will be conducted at Osmaniye State Hospital. The general hypotheses of this study are that virtual reality application is effective in reducing postoperative pain and anxiety. The sub-hypotheses aim to determine the effect of virtual reality application among women undergoing two different types of surgeries (total knee replacement and hysterectomy). The method used in the research includes a randomized controlled trial design, involving application and control conditions across four different groups. Data will be collected through a questionnaire. The questionnaire will gather participants\' demographic information, and their pain levels will be assessed using the Visual Analogue Scale (VAS) while their anxiety levels will be evaluated using the Beck Anxiety Scale. After the pre-test, virtual reality application will be administered to experimental groups with two different types of surgeries. No intervention will be applied to the control group before the post-test. Ethical approval and written informed consent will be obtained from the participants. Participants\' postoperative pain and anxiety levels, analgesic usage amounts and frequencies will be recorded, and feedback related to their virtual reality experiences will be obtained. In the study, the rotation method will be used to randomly assign participants to experimental and control groups. The rotation method aims to place each patient sequentially into the next group. For example, the first patient undergoing total knee replacement surgery will be assigned to Group 1, and then the second patient undergoing total knee replacement surgery will be assigned to Group 2, the first patient undergoing hysterectomy surgery will be assigned to Group 3, and the second patient undergoing hysterectomy surgery will be assigned to Group 4. Thus, separate control and application groups will be formed for each type of surgery. This study is original and important as it will be the first study in our country to evaluate the impact of virtual reality on pain and anxiety in 50-70-year-old women according to the type of surgery.
### Conditions Module
**Conditions:**
- Pain Management After Surgery
**Keywords:**
- Virtual Reality (VR)
- Postoperative Pain
- Pain Management Patient Experience
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Group 1 ( Pre-Test + Intervention + Post-Test) (Participants undergoing total knee replacement surgery, subjected to pre-test followed by VR intervention) Group 2 (receiving only pre-test) Group 3 (Intervention Only + Post-Test) (Participants undergoing hysterectomy surgery, subjected to pre-test followed by VR intervention) Group 4 (Post-Test Only) (Participants undergoing hysterectomy surgery, receiving only pre-test)
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 76
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Pre-Test + Intervention + Post-Test) (Participants who underwent total knee replacement Participants who underwent total knee replacement surgery and received a pre-test, followed by VR intervention.Participants in this group are initially assessed with VAS and Beck Anxiety Scale.
Subsequently, VR intervention is administered to this group. After the intervention, participants are reassessed with VAS and Beck Anxiety Scale.
**Intervention Names:**
- Other: Providing VR experience
**Label:** Total Knee Replacement VR Intervention Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Pre-Test (Participants who underwent total knee replacement surgery and received only a pre-test).Participants in this group are initially assessed with VAS and Beck Anxiety Scale.
**Label:** Total Knee Replacement Control Group
**Type:** NO_INTERVENTION
#### Arm Group 3
**Description:** Pre-Test + Intervention + Post-Test) Participants who underwent hysterectomy surgery and received a pre-test, followed by VR intervention.Participants in this group are initially assessed with a pre-test, followed by VR intervention.
**Intervention Names:**
- Other: Providing VR experience
**Label:** Hysterectomy VR Intervention Group
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Participants who underwent hysterectomy surgery and received only a pre-test).Participants are assessed only with VAS and Beck Anxiety Scale after the intervention period.
**Label:** Hysterectomy Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Hysterectomy VR Intervention Group
- Total Knee Replacement VR Intervention Group
**Description:** Participants undergoing VR intervention will experience a VR program of their choice based on personal preferences. Among these programs are videos offering natural visual experiences. For instance, participants can opt for videos featuring seaside views, forest tours, or lake landscapes.
**Name:** Providing VR experience
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Pretest with VAS is administered on the first postopera tive day to women aged 50-70 undergoing total knee replacement and hysterectomy. • Subsequently, VR intervention is conducted. • Following the intervention, participants are re-evaluated with VAS.
**Measure:** The VR application is effective in changing postoperative pain.
**Time Frame:** The researcher's first visit to the patient on postoperative day 1.
#### Secondary Outcomes
**Description:** Pretest with Beck Anxiety Scale is administered on the first postoperative day
to women aged 50-70 undergoing total knee replacement and hysterectomy. • Subsequently, VR intervention is conducted. • Following the intervention, participants are re-evaluated with Beck Anxiety Scale.
**Measure:** The VR application is effective in changing postoperative anxiety.
**Time Frame:** The researcher's first visit to the patient on postoperative day 1.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being between the ages of 50-70,
* Being female,
* Having adequate vision and hearing,
* Having American Society of Anesthesiologists (ASA) physical status classification I and II,
* Undergoing elective total knee replacement or hysterectomy surgery,
* Having a similar analgesia protocol,
* Being on the first postoperative day,
* Scoring 5 or higher on the Visual Analogue Scale (VAS) assessment,
* Being able to speak and understand Turkish.
Exclusion Criteria:
* Having chronic pain,
* Scoring below 5 on the Visual Analogue Scale (VAS) assessment,
* Experiencing vertigo or motion-sensitive nausea,
* Being diagnosed with severe anxiety by a specialist physician,
* Having claustrophobia,
* Having head or neck conditions that prevent wearing virtual reality goggles,
* Having a Glasgow Coma Score \<15,
* Having psychiatric, cognitive, or neurological impairments,
* Having visual or hearing impairments.
**Gender Based:** True
**Gender Description:** Women aged 50-70 years
**Maximum Age:** 70 Years
**Minimum Age:** 50 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Songül GÜNGÖR, PhD
**Phone:** +905064546790
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Merkez
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Songül GÜNGÖR, PhD
- **Phone:** +9005064546790
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Phone Ext:** GÜNGÖR
- **Role:** CONTACT
***Contact 3:***
- **Name:** Songül GÜNGÖR, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Ayşe TAŞTEKİN, associate professor
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Turkey
**Facility:** Osmaniye Korkut Ata University
**State:** Osmani̇ye
**Zip:** 80010
**Location 2:**
**City:** Merkez
**Country:** Turkey
**Facility:** Osmaniye State Hospital
**State:** Osmani̇ye
**Zip:** 80010
#### Overall Officials
**Official 1:**
**Affiliation:** Osmaniye Korkut Ata University
**Name:** Songül GÜNGÖR, Phd
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Afyonkarahisar Health Sciences University
**Name:** Ayşe TAŞTEKİN, associate professor
**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: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Postoperative Pain
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010149
- Term: Pain, Postoperative
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06436001
**Brief Title:** Comparing BlueDop Vascular Expert to Ankle-Brachial Index in the Identification of Peripheral Vascular Disease
**Official Title:** Comparing BlueDop Vascular Expert to Ankle-Brachial Index in the Identification of Peripheral Vascular Disease in All-comers and Diabetic Patients
#### Organization Study ID Info
**ID:** BlueDop_DakotaVascular study
#### Organization
**Class:** OTHER
**Full Name:** Dakota Vascular
#### Secondary ID Infos
**Domain:** Advarra IRB
**ID:** CIRBI Link: CR00555039
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-03-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Dakota Vascular
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** To compare the screening capabilities of the BlueDop Vascular Expert (BVE) and ankle brachial index (ABI) in peripheral arterial disease for all-comer patients and those with diagnosed diabetes mellitus.
**Detailed Description:** This retrospective and prospective single-center study to compare the accuracy and screening capabilities of BVE and ABI with that of conventional Full Leg Arterial Duplex (FLAD) was performed at a private clinic in Sioux Falls, South Dakota, USA, with data collected from March 2023 to March 2024. Currently, BVE carries the European CE Mark but does not yet have FDA approval for use in the United States. This study was undertaken with local IRB approval.
Patients 18 years or older who presented to the center were consented to have BVE, ABI, and FLAD performed. BVE examination of lower extremity arteries were performed following the instruction for use (IFU). All examinations were performed by the same two registered vascular technologists. FLAD ultrasound was carried out with waveform interpretation interpreted by an outside cardiothoracic surgeon who specializes in treatment of arterial disease to determine the presence or absence of disease.
### Conditions Module
**Conditions:**
- Peripheral Arterial Disease
- Diabetes Mellitus
**Keywords:**
- peripheral arterial disease
- ankle brachial index
- arterial duplex
- Doppler waveform
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 104
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** BlueDop Vascular Expert assessment vs Full Leg Arterial Duplex
**Label:** BlueDop Vascular Expert
#### Arm Group 2
**Description:** ABI assessment verses Full Leg Arterial Duplex
**Label:** Ankle Brachial Index
### Outcomes Module
#### Primary Outcomes
**Description:** Comparing ABI and BVE findings to FLAD
**Measure:** Sensitivity
**Time Frame:** data collected from March 2023 to March 2024
**Description:** Comparing ABI and BVE findings to FLAD
**Measure:** Specificity
**Time Frame:** data collected from March 2023 to March 2024
**Description:** Comparing ABI and BVE findings to FLAD
**Measure:** Accuracy
**Time Frame:** data collected from March 2023 to March 2024
**Description:** Comparing ABI and BVE findings to FLAD
**Measure:** Cohen's Kappa coefficient
**Time Frame:** data collected from March 2023 to March 2024
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients 18 years or older who presented to the center were consented to have BVE, ABI, and FLAD performed.
Exclusion Criteria:
* Patients were excluded who had incomplete or inadequate data, if they were known to be currently pregnant, or if they had contraindications to Doppler ultrasound.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** This retrospective and prospective single-center study to compare the accuracy and screening capabilities of BVE and ABI with that of conventional Full Leg Arterial Duplex (FLAD) was performed at a private clinic in Sioux Falls, South Dakota, USA, with data collected from March 2023 to March 2024.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Sioux Falls
**Country:** United States
**Facility:** Dakota Vascular
**State:** South Dakota
**Zip:** 57105
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000050197
- Term: Atherosclerosis
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: HIGH
- As Found: Vascular Disease
- ID: M29213
- Name: Peripheral Arterial Disease
- Relevance: HIGH
- As Found: Peripheral Arterial Disease
- ID: M18894
- Name: Peripheral Vascular Diseases
- Relevance: HIGH
- As Found: Peripheral Vascular Disease
- ID: M26188
- Name: Atherosclerosis
- 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: D000058729
- Term: Peripheral Arterial Disease
- ID: D000016491
- Term: Peripheral Vascular Diseases
- ID: D000014652
- Term: Vascular Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435988
**Brief Title:** The Effect of Training With Pecha Kucha on Anxiety and Birth Satisfaction in Pregnant Women.
**Official Title:** The Effect of the Training Given Using the Pecha Kucha Technique on the Anxiety and Birth Satisfaction of the First Pregnant Women Followed in Labor.
#### Organization Study ID Info
**ID:** HGRecber
#### Organization
**Class:** OTHER
**Full Name:** Kocaeli University
### Status Module
#### Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-07-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kocaeli University
#### Responsible Party
**Investigator Affiliation:** Kocaeli University
**Investigator Full Name:** Hatice Gamze Recber
**Investigator Title:** principal ınvestigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** For this purpose, the distribution of Pecha Kucha user's birth information education on state/trait anxiety and birth hope in primiparous pregnant women is determined.
The main question the researcher aims to answer is:
Do anxiety and birth changes in pregnant women who receive Pecha Kucha's registered birth information training? There are 25 pregnant women in the experimental and 25 control groups. After the training, participants in the experimental groups will answer the satisfaction survey and questions about trait anxiety.
**Detailed Description:** The research was started after receiving ethics committee approval and written approval from the relevant institution. Pechka kucha presentation was prepared by the researcher in accordance with the literature information and the features required by the technique. For the content validity of the travay information presentation prepared with the PK technique, expert opinions were received from 10 academicians who have scientific studies on this subject.
After receiving expert approval of the presentation, the data collection process began. The research population consists of primiparous pregnant women who were admitted to the delivery room and followed during birth. The participants included in the study were assigned to groups through randomization, ensuring homogeneity in the distribution of the groups. "Random Allocation Software Program" was used to randomize the participants into groups, and the randomization list of the study was created by determining the number of each participant and the number of groups.
Participants admitted to the delivery room for normal birth, in the order on the randomization list; were assigned as a control and an experimental group by the researcher.
Only participants assigned to the randomization group were studied until completion. After the birth of the participants was completed, the first participant who was admitted to the delivery room and met the research criteria was assigned to the other group on the randomization list and the necessary interventions were carried out. If the participant has a cesarean section during the study or leaves the study for any reason; The first participant admitted to the delivery room and meeting the research criteria will be assigned to the other group on the randomization list.
The research was explained to the participant assigned to the experimental group, and if voluntary participation was required, the 'Informed Consent Form' was signed.
Participants in the experimental group were given 'Pecha Kucha Travay Information' training. The presentation was held in the TDL (Labor-Delivery-Postpartum) unit, in single rooms, with a seating arrangement facing each other. The presentation was made on the researcher's tablet with an 8-inch screen size. The position of the tablet was adjusted to the middle point in the seating arrangement of the participant and the researcher. Before the training, he was informed about the duration of the presentation and it was stated that he could talk about the questions he wanted to ask at the end of the presentation.
The presentation, prepared with the Pechka Kucha method and lasting 6 minutes and 20 seconds, was explained to the participant via tablet. Then, the introductory information form and the state-trait anxiety scale were filled out. After birth, participants in the experimental group filled out the 'Birth Satisfaction Scale' before being transferred from the delivery room to the ward.
### Conditions Module
**Conditions:**
- First Pregnancy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** no ıntervention
**Label:** no ıntervention
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Training in the pecha kucha technique
**Intervention Names:**
- Behavioral: Training in the pecha kucha technique
**Label:** experimental
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- experimental
**Description:** Providing labor training to pregnant women with the Pecha Kucha technique
**Name:** Training in the pecha kucha technique
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** After the total weights of the direct and reversed expressions are found separately, the total weight score of the reverse expressions is subtracted from the total weight score obtained for the direct expressions. A predetermined and unchanging value is added to this number. This constant value is 50 for the State Anxiety Scale and 35 for the Trait Anxiety Scale. The final value obtained represents the individual's anxiety score.
**Measure:** State and Trait Anxiety ScaleWomen.
**Time Frame:** 24 hours
**Description:** The scale, which was developed to measure women's birth experience in different dimensions, has four sub-dimensions and 22 items. The first 19 items of the scale are evaluated using a four-point scale and the last three items are evaluated using VAS. In DSS, the first 19 items are scored from 1 to 4; I completely agree = 1, I mostly agree = 2, I partially agree = 3, I completely disagree = 4.
The scores on the VAS scale are categorical; It is classified as 0-40 = 1, 41-60 = 2, 61-80 = 3, 81-100 = 4. Cronbach's alpha value of the scale; 0.56 for the Birth Process sub-dimension, 0.73 for the Professional Support/Help subscale, 0.63 for the Perceived Security/Memories subscale, 0.64 for Participation in Decisions sub-dimension The total scale Cronbach alpha reliability coefficient was found to be 0.76.
**Measure:** Birth Experience Scale
**Time Frame:** 24 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Primary pregnant women,
* Pregnant women aged 18 and over,
* Pregnant women in the latent phase of labor
* Pregnant women who do not have perinatological risk,
* Pregnant women who can understand and speak Turkish
Exclusion Criteria:
* • Risky pregnant women,
* Pregnant woman in active phase,
* Pregnant women who develop an obstetric complication during labor follow-up (Fetal distress, Cord prolapse, Uterine hyperstimulation, non-progressive labor, malpresentation, etc.).
* There is a problem that prevents communication
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Gamze Reçber
**Phone:** 905330921269
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Gebze
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** resmiye özdilek, doç
- **Phone:** 0 262 303 47 38
- **Role:** CONTACT
***Contact 2:***
- **Name:** hatice gamze reçber
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Turkey
**Facility:** Kocaeli Üniversitesi
**State:** Kocaeli̇
**Status:** RECRUITING
**Zip:** 41400
#### Overall Officials
**Official 1:**
**Affiliation:** Kocaeli University Faculty of Health Sciences
**Name:** resmiye özdilek, Asst.Prof.
**Role:** STUDY_DIRECTOR
### 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
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435975
**Brief Title:** Physical Activity in Rectal Cancer Survivors
**Official Title:** Pilot Study of Physical Activity Intervention to Manage Bowel Dysfunction in Rectal Cancer Survivors
#### Organization Study ID Info
**ID:** UPCC 20221
#### Organization
**Class:** OTHER
**Full Name:** Abramson Cancer Center at Penn Medicine
#### Secondary ID Infos
**Domain:** Abramson Cancer Center of the University of Pennsylvania
**ID:** 849585
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-03-06
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-06
**Type:** ACTUAL
#### Start Date
**Date:** 2022-06-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Abramson Cancer Center at Penn Medicine
#### Responsible Party
**Investigator Affiliation:** Abramson Cancer Center at Penn Medicine
**Investigator Full Name:** Erica Pettke, MD, MPH, FACS
**Investigator Title:** Physician
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to test a telehealth-based personalized physical activity intervention in adult patients diagnosed with Stage I-III rectal cancer. The main question it aims to answer are how to better understand the experiences of rectal cancer survivors who are coping with bowel dysfunction and how physical activity can improve their quality of life.
Participants will be asked to:
1. Complete surveys to assess bowel function and quality of life
2. Participate in 12 Telehealth Sessions (one session a week) to discuss and review bowel dysfunction
3. Perform daily physical activity
**Detailed Description:** The goal of this clinical trial is to administer and determine the feasibility of a personalized physical activity intervention for rectal cancer survivors. Structured physical activity interventions will be administered over a three-month period. An exit interview will be conducted at the completion of this time period.
### Conditions Module
**Conditions:**
- Rectal Cancer
- Rectosigmoid Cancer
**Keywords:**
- Rectal Cancer
- Physical Activity
- Bowel Dysfunction
- Telehealth
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in this arm will be asked to complete a series of surveys, participate in telehealth-based interventions, and engage in moderate physical activity.
**Intervention Names:**
- Other: Physical Activity
- Other: Survey
- Behavioral: Telehealth Lifestyle Coaching
**Label:** Experimental
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental
**Description:** Participants will perform a baseline +4000 steps/day for the duration of the study. Aerobic exercise, similar to a brisk walk, will be recommended as the primary mode of exercise.
**Name:** Physical Activity
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Experimental
**Description:** Participants will complete a series of survey at multiple points throughout this study to assess quality of life issues. Questionnaires may be completed via paper forms with prepaid postage envelopes or using a REDCap online survey.
**Name:** Survey
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Experimental
**Description:** Participants will meet with a health coach, the Principal Investigator, to review baseline bowel habits and symptoms as well as discuss physical activity and potential strategies to achieve this goal, on a weekly basis for 12 weeks.
**Name:** Telehealth Lifestyle Coaching
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Administer and determine the feasibility of a PA intervention. We will administer a telehealth physical activity intervention to 20 RC survivors (10 males and 10 females, at least 10 of which will be racial and/or ethnic minorities) over 12 weeks. Feasibility of the intervention will be measured by the percentage of participants who agree to participate of the total approached as well as completion of the intervention which will be defined as completion of ≥80% of the intervention (telehealth calls).
**Measure:** Feasibility of Physical Activity Intervention
**Time Frame:** From enrollment to the end of treatment at 12 weeks.
#### Secondary Outcomes
**Description:** Using qualitative methods, evaluate the acceptability of and satisfaction with the intervention as reported by survivors. After completion of the intervention or decision to discontinue participation, we will administer a semi-structured exit interview to evaluate the acceptability of the intervention.
**Measure:** Acceptability and Participant Satisfaction with Physical Activity Intervention
**Time Frame:** From enrollment to the end of treatment after 12 weeks.
**Description:** Using the Memorial Sloan Kettering bowel function instrument administered pre-post PA intervention, describe the change in total bowel symptom score in the pilot cohort.
**Measure:** Evaluation using Memorial Sloan Kettering Cancer Center Bowel Function Instrument Scale to describe the change in total bowel symptom score in the pilot cohort from minimum score of 13 to maximum score of 65, where the higher score is the better outcome.
**Time Frame:** At 0 weeks, 3 weeks, and 6 months after completion of the initial intervention.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Diagnosis of Stage I-III cancers of the rectum/rectosigmoid.
2. Age 18 or older
3. Three months to 5 years post-treatment completion
4. Have a rectal or anal anastomosis with a LARS score of 21-42
5. At least 10 participants must be racial/ethnic minority (Black/African American, Hispanic/Latino)
6. Ability to be physically active and cleared by MD
7. Patients must be able to read and understand English.
8. Participants must sign the informed consent form
The study is open to anyone regardless of gender or ethnicity. Efforts will be made to extend the accrual to a representative population, but in a trial which will accrue 20 subjects, a balance must be struck between subject safety considerations and limitations on the number of individuals exposed to potentially toxic or ineffective treatments on the one hand and the need to explore gender, racial, and ethnic aspects of clinical research on the other. If differences in outcome that correlate to gender, racial, or ethnic identity are noted, accrual may be expanded, or additional studies may be performed to investigate those differences more fully.
Exclusion Criteria:
1. Patients failing to meet all the above inclusion criteria will be excluded from the study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Philadelphia
**Country:** United States
**Facility:** Hospital of the University of Pennsylvania
**State:** Pennsylvania
**Zip:** 19104
#### Overall Officials
**Official 1:**
**Affiliation:** University of Pennsylvania
**Name:** Erica Pettke, MD, MPH, FACS
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Hendren SK, O'Connor BI, Liu M, Asano T, Cohen Z, Swallow CJ, Macrae HM, Gryfe R, McLeod RS. Prevalence of male and female sexual dysfunction is high following surgery for rectal cancer. Ann Surg. 2005 Aug;242(2):212-23. doi: 10.1097/01.sla.0000171299.43954.ce.
**PMID:** 16041212
**Citation:** Lange MM, van de Velde CJ. Urinary and sexual dysfunction after rectal cancer treatment. Nat Rev Urol. 2011 Jan;8(1):51-7. doi: 10.1038/nrurol.2010.206. Epub 2010 Dec 7.
**PMID:** 21135876
**Citation:** Bruheim K, Guren MG, Skovlund E, Hjermstad MJ, Dahl O, Frykholm G, Carlsen E, Tveit KM. Late side effects and quality of life after radiotherapy for rectal cancer. Int J Radiat Oncol Biol Phys. 2010 Mar 15;76(4):1005-11. doi: 10.1016/j.ijrobp.2009.03.010. Epub 2009 Jun 18.
**PMID:** 19540058
**Citation:** Hoerske C, Weber K, Goehl J, Hohenberger W, Merkel S. Long-term outcomes and quality of life after rectal carcinoma surgery. Br J Surg. 2010 Aug;97(8):1295-303. doi: 10.1002/bjs.7105.
**PMID:** 20602501
**Citation:** Sun V, Grant M, Wendel CS, McMullen CK, Bulkley JE, Altschuler A, Ramirez M, Baldwin CM, Herrinton LJ, Hornbrook MC, Krouse RS. Dietary and Behavioral Adjustments to Manage Bowel Dysfunction After Surgery in Long-Term Colorectal Cancer Survivors. Ann Surg Oncol. 2015 Dec;22(13):4317-24. doi: 10.1245/s10434-015-4731-9. Epub 2015 Jul 10.
**PMID:** 26159443
**Citation:** Krouse RS, Wendel CS, Garcia DO, Grant M, Temple LKF, Going SB, Hornbrook MC, Bulkley JE, McMullen CK, Herrinton LJ. Physical activity, bowel function, and quality of life among rectal cancer survivors. Qual Life Res. 2017 Nov;26(11):3131-3142. doi: 10.1007/s11136-017-1641-2. Epub 2017 Jul 4.
**PMID:** 28677077
**Citation:** Fong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70.
**PMID:** 22294757
**Citation:** Denlinger CS, Engstrom PF. Colorectal cancer survivorship: movement matters. Cancer Prev Res (Phila). 2011 Apr;4(4):502-11. doi: 10.1158/1940-6207.CAPR-11-0098.
**PMID:** 21464030
**Citation:** Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, Bandera EV, Hamilton KK, Grant B, McCullough M, Byers T, Gansler T. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012 Jul-Aug;62(4):243-74. doi: 10.3322/caac.21142. Epub 2012 Apr 26. Erratum In: CA Cancer J Clin. 2013 May;63(3):215.
**PMID:** 22539238
**Citation:** Grimmett C, Bridgewater J, Steptoe A, Wardle J. Lifestyle and quality of life in colorectal cancer survivors. Qual Life Res. 2011 Oct;20(8):1237-45. doi: 10.1007/s11136-011-9855-1. Epub 2011 Feb 1.
**PMID:** 21286822
**Citation:** Brown JC, Schmitz KH. The prescription or proscription of exercise in colorectal cancer care. Med Sci Sports Exerc. 2014 Dec;46(12):2202-9. doi: 10.1249/MSS.0000000000000355.
**PMID:** 24781887
**Citation:** Kushi LH, Doyle C, McCullough M, Rock CL, Demark-Wahnefried W, Bandera EV, Gapstur S, Patel AV, Andrews K, Gansler T; American Cancer Society 2010 Nutrition and Physical Activity Guidelines Advisory Committee. American Cancer Society Guidelines on nutrition and physical activity for cancer prevention: reducing the risk of cancer with healthy food choices and physical activity. CA Cancer J Clin. 2012 Jan-Feb;62(1):30-67. doi: 10.3322/caac.20140.
**PMID:** 22237782
**Citation:** Ottenbacher A, Yu M, Moser RP, Phillips SM, Alfano C, Perna FM. Population Estimates of Meeting Strength Training and Aerobic Guidelines, by Gender and Cancer Survivorship Status: Findings From the Health Information National Trends Survey (HINTS). J Phys Act Health. 2015 May;12(5):675-9. doi: 10.1123/jpah.2014-0003. Epub 2014 May 15.
**PMID:** 24834485
**Citation:** Bellizzi KM, Rowland JH, Jeffery DD, McNeel T. Health behaviors of cancer survivors: examining opportunities for cancer control intervention. J Clin Oncol. 2005 Dec 1;23(34):8884-93. doi: 10.1200/JCO.2005.02.2343.
**PMID:** 16314649
**Citation:** Courneya KS, Katzmarzyk PT, Bacon E. Physical activity and obesity in Canadian cancer survivors: population-based estimates from the 2005 Canadian Community Health Survey. Cancer. 2008 Jun;112(11):2475-82. doi: 10.1002/cncr.23455.
**PMID:** 18428195
**Citation:** Strid H, Simren M, Storsrud S, Stotzer PO, Sadik R. Effect of heavy exercise on gastrointestinal transit in endurance athletes. Scand J Gastroenterol. 2011 Jun;46(6):673-7. doi: 10.3109/00365521.2011.558110. Epub 2011 Mar 2.
**PMID:** 21366388
**Citation:** Loprinzi PD, Lee H. Rationale for promoting physical activity among cancer survivors: literature review and epidemiologic examination. Oncol Nurs Forum. 2014 Mar 1;41(2):117-25. doi: 10.1188/14.ONF.117-125.
**PMID:** 24578072
**Citation:** Schmitz KH, Holtzman J, Courneya KS, Masse LC, Duval S, Kane R. Controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. Cancer Epidemiol Biomarkers Prev. 2005 Jul;14(7):1588-95. doi: 10.1158/1055-9965.EPI-04-0703.
**PMID:** 16030088
**Citation:** Dainese R, Serra J, Azpiroz F, Malagelada JR. Effects of physical activity on intestinal gas transit and evacuation in healthy subjects. Am J Med. 2004 Apr 15;116(8):536-9. doi: 10.1016/j.amjmed.2003.12.018.
**PMID:** 15063815
**Citation:** Hawkes AL, Chambers SK, Pakenham KI, Patrao TA, Baade PD, Lynch BM, Aitken JF, Meng X, Courneya KS. Effects of a telephone-delivered multiple health behavior change intervention (CanChange) on health and behavioral outcomes in survivors of colorectal cancer: a randomized controlled trial. J Clin Oncol. 2013 Jun 20;31(18):2313-21. doi: 10.1200/JCO.2012.45.5873. Epub 2013 May 20.
**PMID:** 23690410
**Citation:** Hawkes AL, Pakenham KI, Courneya KS, Gollschewski S, Baade P, Gordon LG, Lynch BM, Aitken JF, Chambers SK. A randomised controlled trial of a tele-based lifestyle intervention for colorectal cancer survivors ('CanChange'): study protocol. BMC Cancer. 2009 Aug 18;9:286. doi: 10.1186/1471-2407-9-286.
**PMID:** 19689801
**Citation:** Jonk Y, Lawson K, O'Connor H, Riise KS, Eisenberg D, Dowd B, Kreitzer MJ. How effective is health coaching in reducing health services expenditures? Med Care. 2015 Feb;53(2):133-40. doi: 10.1097/MLR.0000000000000287.
**PMID:** 25588134
**Citation:** Goss F, Robertson R, DaSilva S, Suminski R, Kang J, Metz K. Ratings of perceived exertion and energy expenditure during light to moderate activity. Percept Mot Skills. 2003 Jun;96(3 Pt 1):739-47. doi: 10.2466/pms.2003.96.3.739.
**PMID:** 12831247
**Citation:** Pearson ES. Goal setting as a health behavior change strategy in overweight and obese adults: a systematic literature review examining intervention components. Patient Educ Couns. 2012 Apr;87(1):32-42. doi: 10.1016/j.pec.2011.07.018. Epub 2011 Aug 17.
**PMID:** 21852063
**Citation:** Demark-Wahnefried W, Rogers LQ, Alfano CM, Thomson CA, Courneya KS, Meyerhardt JA, Stout NL, Kvale E, Ganzer H, Ligibel JA. Practical clinical interventions for diet, physical activity, and weight control in cancer survivors. CA Cancer J Clin. 2015 May-Jun;65(3):167-89. doi: 10.3322/caac.21265. Epub 2015 Feb 13.
**PMID:** 25683894
#### See Also Links
**Label:** American Cancer Society. Cancer Facts \& Figures 2020
**URL:** https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html
**Label:** 2018 Physical Activity Guidelines for Americans. US Department of Health and Human Services; 2008
**URL:** https://health.gov/sites/default/files/2019-09/Physical_Activity_Guidelines_2nd_edition.pdf
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
### Condition Browse Module - Browse Leaves
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14846
- Name: Rectal Neoplasms
- Relevance: HIGH
- As Found: Rectal Cancer
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012004
- Term: Rectal Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435962
**Brief Title:** Productive Value of Sonographic Measurement of Optic Nerve in Transitional Multiple
**Official Title:** Productive Value of Sonographic Measurement of Optic Nerve in Transitional Multiple
#### Organization Study ID Info
**ID:** optic nerve affection in RRMS
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2026-03-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-02
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-02
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Randa Alkady
**Investigator Title:** resident doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** 1.to evaluate the potential role of the optic nerve diameter ( OND determined by ultrasonography and and visual nerve function by visual evoked potential as a biomarker of early axonal loss and disability in patients with relapsing remitting multiple sclerosis (RRMS).
**Detailed Description:** Multiple sclerosis (MS) is one of the leading disabling neurological diseases in young Adults. Characteristically reliable biomarkers for every independent MS pathogenic factor are extremely important.
1 Increasing evidence has demonstrated that neuronal and axonal damage within the central nervous system (CNS) contributes substantially to the development of permanent disability in patients with MS
* 2 Thus, reliable, economic and easily assessable complementary surrogate biomarkers for axonal Degeneration and consequently disability remain to be identified
* 3 The optic nerve can serve as a useful clinical tool for studying these characteristics and can be used to Measure and monitor the pathological process of the disease. The optic nerve is most commonly assessed by ophthalmoscopy and magnetic resonance imaging (MRI), But measurement of the optic nerve diameter (OND) by a simple ultrasound examination and measurement of optic nerve function by visual evoked potential might permit a rough estimation of the extent of brain parenchymal involvement and the consequent global cerebral atrophy and disability In relapsing-remitting MS (RRMS) patients.
The analysis of the diameter of the optic nerve showed that it is possible To detect its atrophy in the affected eyes (with optic neuritis ) and, to a lesser extent, in un affected eye Also the visual evoked potential study has the ability to quantify the unsuspected clinically silent lesions, hence, allows confirming the vague deterioration of visual functions.
### Conditions Module
**Conditions:**
- Relapsing Remitting Multiple Sclerosis
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** measurement of optic nerve in RRMS by sonography and visual evoked potential( VEP) as correlation of axonal affection in RRMS patient
**Name:** sonography
**Other Names:**
- visual evoked potential( VEP)
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** measurement of optic nerve diameter and optic nerve sheath diameter (in millimeter) in predicting progression in RRMS (Relapsing remitting multiple sclerosis)
**Measure:** optic nerve measurement and correlation with axonal affection in RRMS
**Time Frame:** baseline
#### Secondary Outcomes
**Description:** Correlation of ultrasonography and visual evoked potential (change in p100 latency) with physical disability and cognitive score and fatigue by Multiple Sclerosis Functional Composite The score is based on a combination of timed tests of walking, arm function, and cognitive ability An integrated Multiple Sclerosis Functional Composite (MSFC) score is calculated using z-scores
**Measure:** 2.Correlation of ultrasonography and visual evoked potential (change in p100 latency) with physical disability and cognitive score and fatigue by Multiple Sclerosis Functional Composite
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** 1. inclusion criteria
1. both sex
2. Age group from 15 to 50 yrs
3. Patient with RRMS without history of optic neuritis
2. Exclusion criteria :
1. History of previous optic neuritis
2. Medical illness of eye(e.g. diabetes and hypertension)
3. MS patient on fingolimod for 6 months or more
4. Relapsing or use of steroid in the past 3 months
5. Proved alternative diagnosis (neuromyelitis optica )
6. local eye disease or surgery
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 15 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
**Study Population:** both sex and RRMS with out previous optic neuritis
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Randa A Mohamed, resident
**Phone:** 01123668059
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Anwar M Ali, professor
**Phone:** 01030361010
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Assiut University
**Name:** Anwar M Ali, professor
**Role:** STUDY_DIRECTOR
### References Module
#### References
**Citation:** Koraysha NA, Kishk N, Hassan A, Samy El Gendy NM, Shehata HS, Al-Azayem SA, Kamal YS. Evaluating optic nerve diameter as a possible biomarker for disability in patients with multiple sclerosis. Neuropsychiatr Dis Treat. 2019 Sep 6;15:2571-2578. doi: 10.2147/NDT.S216079. eCollection 2019.
**PMID:** 31564882
**Citation:** De Masi R, Orlando S, Conte A, Pasca S, Scarpello R, Spagnolo P, Muscella A, De Donno A. Transbulbar B-Mode Sonography in Multiple Sclerosis: Clinical and Biological Relevance. Ultrasound Med Biol. 2016 Dec;42(12):3037-3042. doi: 10.1016/j.ultrasmedbio.2016.07.018. Epub 2016 Sep 15.
**PMID:** 27639433
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020278
- Term: Demyelinating Autoimmune Diseases, CNS
- ID: D000020274
- Term: Autoimmune Diseases of the Nervous System
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000003711
- Term: Demyelinating Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M12060
- Name: Multiple Sclerosis
- Relevance: HIGH
- As Found: Multiple Sclerosis
- ID: M15415
- Name: Sclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M22314
- Name: Multiple Sclerosis, Relapsing-Remitting
- Relevance: HIGH
- As Found: Relapsing Remitting Multiple Sclerosis
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22098
- Name: Demyelinating Autoimmune Diseases, CNS
- Relevance: LOW
- As Found: Unknown
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M6909
- Name: Demyelinating Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009103
- Term: Multiple Sclerosis
- ID: D000020529
- Term: Multiple Sclerosis, Relapsing-Remitting
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435949
**Brief Title:** Effect of Oxycodone on Anxiety State in Painless Abortion
**Official Title:** Effect of Propofol in Combination With Oxycodone on Anxiety State in Painless Abortion - A Multicenter Randomized Controlled Trial
#### Organization Study ID Info
**ID:** RJH-Anesth-HZH001
#### Organization
**Class:** OTHER
**Full Name:** Ruijin Hospital
### Status Module
#### Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-31
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ruijin Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** In this study, 300 patients who underwent painless abortion in Ruijin Hospital and sub-central hospitals were selected through a multi-center randomized controlled study, and 300 patients who underwent painless abortion in Ruijin Hospital and each sub-center hospital were divided into intravenous anesthesia with propofol with fentanyl (group F) and propofol with oxycodone (group O) by stratified group randomization method 1:1. The difference between the postoperative anxiety scores and depression scores of the two groups was observed, and the postoperative anxiety, depression and numerical pain scores were recorded. Finally, the relevant data were statistically analyzed and conclusions were drawn.
**Detailed Description:** This study is a multicenter, randomized controlled clinical study. A total of 300 patients who underwent elective painless abortion surgery in Ruijin Hospital and other sub-central hospitals were enrolled, and they were randomly divided into 1:1 patients who received intravenous anesthesia with propofol with fentanyl (group F) and propofol with oxycodone (group O). The scores of anxiety, depression and postoperative numerical rating scale (NRS) before and after surgery were observed, and the levels of serum stress response factors and inflammatory cytokines were monitored. The effects of oxycodone on anxiety, depression and postoperative acute pain in patients with painless abortion were investigated.
1. Main observation indicators:
The difference between the post-operative anxiety score and the preoperative anxiety score
2. Secondary Observational Indicators:
* Post-operative anxiety score
* The difference between the post-operative depression score and the preoperative depression score
* Post-operative depression score
* Pain assessment after surgical recovery (NRS)
* Laboratory tests
* Patient and family satisfaction with postoperative analgesic treatment
### Conditions Module
**Conditions:**
- Abortion Complication
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** intravenous anesthesia with propofol with fentanyl
**Intervention Names:**
- Drug: Fentanyl (as Citrate)
**Label:** group Fentanyl
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** intravenous anesthesia with propofol with oxycodone
**Intervention Names:**
- Drug: Fentanyl (as Citrate)
**Label:** group Oxycodone
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- group Fentanyl
- group Oxycodone
**Description:** intravenous anesthesia with propofol with fentanyl (group Fentanyl) and propofol with oxycodone (group Oxycodone)
**Name:** Fentanyl (as Citrate)
**Other Names:**
- Oxycodone
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** postoperative anxiety scores
**Measure:** anxiety scores
**Time Frame:** 20-30 minutes postoperative
#### Secondary Outcomes
**Description:** postoperative depression scores
**Measure:** depression scores
**Time Frame:** 20-30 minutes postoperative
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 18-45 years old
* Gestational age 6-12 weeks
* American Society of Anesthesiologists （ASA） Grading I-II
* Fluent communicator and able to complete self-rating scales on her own
* Voluntarily participate and sign the informed consent form
Exclusion Criteria:
* Patients who are allergic to anesthetic drugs such as propofol, oxycodone, fentanyl, etc., or who have had other anesthetic adverse events
* Patients with anxiety or depression
* Presence of organic mental disorders, mental retardation
* Severe acute and chronic infection, severe heart, liver and kidney insufficiency
* Patients with complications or bleeding \> 50ml during surgery
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### 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
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Ancestors
- ID: D000000701
- Term: Analgesics, Opioid
- ID: D000009294
- Term: Narcotics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000000759
- Term: Adjuvants, Anesthesia
- ID: D000018686
- Term: Anesthetics, Intravenous
- ID: D000018681
- Term: Anesthetics, General
- ID: D000000777
- Term: Anesthetics
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AdjAn
- Name: Adjuvants, Anesthesia
- Abbrev: AnCoag
- Name: Anticoagulants
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M13020
- Name: Oxycodone
- Relevance: HIGH
- As Found: Valve
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M8418
- Name: Fentanyl
- Relevance: HIGH
- As Found: Peptic Ulcer Perforation
- ID: M18307
- Name: Propofol
- Relevance: LOW
- As Found: Unknown
- ID: M21320
- Name: Citric Acid
- Relevance: LOW
- As Found: Unknown
- ID: M1837
- Name: Sodium Citrate
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M12245
- Name: Narcotics
- Relevance: LOW
- As Found: Unknown
- ID: M4089
- Name: Adjuvants, Anesthesia
- Relevance: LOW
- As Found: Unknown
- ID: M20766
- Name: Anesthetics, Intravenous
- Relevance: LOW
- As Found: Unknown
- ID: M20761
- Name: Anesthetics, General
- Relevance: LOW
- As Found: Unknown
- ID: T382
- Name: Citrate
- Relevance: HIGH
- As Found: And/or
### Intervention Browse Module - Meshes
- ID: D000005283
- Term: Fentanyl
- ID: D000010098
- Term: Oxycodone
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435936
**Acronym:** SAB-176-103
**Brief Title:** A Study to Assess the Safety of SAB-176 to Prevent the Flu, Given IM in Healthy Adults Compared With Placebo
**Official Title:** A Phase 1 Double-Blinded, Randomized, Placebo-Controlled Study Assessing Safety and Pharmacokinetics of Intramuscular SAB-176 (a Tc Bovine Derived Anti-Influenza Human Immunoglobulin) in Healthy Subjects
#### Organization Study ID Info
**ID:** SAB-176-103
#### Organization
**Class:** INDUSTRY
**Full Name:** SAb Biotherapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2025-02-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-02-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** SAb Biotherapeutics, 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:** This study will evaluate the safety and tolerability of an intramuscular injection of SAB-176 intended for use as a pre/post prophylactic for influenza.
This is a Phase 1, randomized, double-blind, placebo-controlled clinical trial in which a total of 28 subjects will receive an injection of either SAB-176 or placebo (normal saline). The investigational product will be administered intramuscularly (IM) on Day 1. Four dose escalation cohorts of 7 subjects (5 active and 2 placebo) each are planned. Subjects will be randomized to receive either SAB-176 or placebo in a double-blinded manner.
Progression to subsequent dose-escalating cohorts will be dependent on safety measured through Day 5 after dosing of the previous cohort.
Blood specimens will be collected at prescribed intervals to examine pharmacokinetics and immunogenicity. Safety will be actively monitored during investigational product administration and for 60 days following dosing. The decision to advance to the next cohort will be based solely on the safety assessment through Day 5. All safety data will be summarized and reviewed by the PI, the Sponsor's Clinical Monitor, and the Research Monitor prior to next cohort dose-escalation.
**Detailed Description:** The purpose of this study is to assess the safety of an experimental product for influenza. Influenza, commonly known as the flu, causes substantial illness and death worldwide despite available treatments and vaccines. The U.S. military is susceptible to large outbreaks from new strains of influenza and effective treatment options can be limited. Importantly, the DoD deploys people all over the world. Flu treatment may be more limited overseas. Thus, the military is trying to develop new products to treat and prevent influenza.
The experimental product being testing in this study is called SAB-176. It was developed by SAB Biotherapeutics, Inc. SAB-176 is an immunoglobulin product designed to prevent the flu and/or reduce its symptoms. Immunoglobulins are antibodies (disease fighting substances) made by the immune system that can prevent and treat infections. SAB-176 comes from the plasma (the light yellow liquid part of blood) of immunized cows. Antibodies in the plasma are collected and purified. Those purified antibodies are SAB-176.
This study will assess the safety of the experimental study product, SAB-176, in healthy adults. SAB-176 is not approved by the U.S. Food and Drug Administration (FDA) yet and is investigational. The FDA is aware of this trial though and this research is required before SAB- 176 can be approved. SAB-176 will be given by intramuscular injection (a shot into the muscle). The study is designed to find out if it is safe to give increasing doses of SAB-176. The investigators will look for any side effects. The study will also assess the amount of SAB-176 circulating in participant's bloodstream. The investigators want to find a safe dose of SAB-176 that also enables SAB-176 to circulate in the blood for a longer time. The investigators think this will provide longer lasting protection against the flu. Some participants will be given a placebo instead of SAB-176. The placebo contains normal saline (salt water). The placebo does not contain any of the active ingredients of SAB-176. The investigator and sponsor will compare the side effects of those who got the placebo to those who got SAB-176. This helps to know which side effects are caused by SAB-176. Neither Participants nor the study staff will know what Participants are getting until after the study is complete. Participants will be assigned to receive either SAB-176 or the placebo randomly (like rolling dice).
Participants will be in the study for about 3 months. Participants will need to attend a screening visit to determine if Participants are eligible to participate. If Participants are eligible and Participants agree to join the study, Participants will remain in the study for 2 months after Participants receive SAB-176 or placebo to monitor any side effects.
### Conditions Module
**Conditions:**
- PHA1A
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 35
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 1 mL (\~75 mg) SAB-176 dose
**Intervention Names:**
- Drug: Single Ascending Dose of SAB-176
**Label:** SAB-176 1 mL
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Normal Saline
**Intervention Names:**
- Drug: Single Ascending Dose of Placebo
**Label:** Placebo 1mL
**Type:** PLACEBO_COMPARATOR
#### Arm Group 3
**Description:** 3 mL (\~225 mg) SAB-176 dose
**Intervention Names:**
- Drug: Single Ascending Dose of SAB-176
**Label:** SAB-176 3mL
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Normal Saline
**Intervention Names:**
- Drug: Single Ascending Dose of Placebo
**Label:** Placebo 3mL
**Type:** PLACEBO_COMPARATOR
#### Arm Group 5
**Description:** 5 mL (\~375 mg) SAB-176 dose
**Intervention Names:**
- Drug: Single Ascending Dose of SAB-176
**Label:** SAB-176 5mL
**Type:** EXPERIMENTAL
#### Arm Group 6
**Description:** Normal Saline
**Intervention Names:**
- Drug: Single Ascending Dose of Placebo
**Label:** Placebo 5mL
**Type:** PLACEBO_COMPARATOR
#### Arm Group 7
**Description:** 20 mL (\~1500 mg) SAB-176 dose
**Intervention Names:**
- Drug: Single Ascending Dose of SAB-176
**Label:** SAB-176 20mL
**Type:** EXPERIMENTAL
#### Arm Group 8
**Description:** Normal Saline
**Intervention Names:**
- Drug: Single Ascending Dose of Placebo
**Label:** Placebo 20mL
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SAB-176 1 mL
- SAB-176 20mL
- SAB-176 3mL
- SAB-176 5mL
**Description:** Single ascending dose
**Name:** Single Ascending Dose of SAB-176
**Other Names:**
- SAB-176
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo 1mL
- Placebo 20mL
- Placebo 3mL
- Placebo 5mL
**Description:** Single ascending dose
**Name:** Single Ascending Dose of Placebo
**Other Names:**
- Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.
**Measure:** Occurrence of solicited local and systemic adverse events (AEs) through Day 29.
**Time Frame:** Dosing through Day 29
**Description:** Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.
**Measure:** Occurrence of IP-related unsolicited AEs through Day 61.
**Time Frame:** Dosing through Day 61
**Description:** Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.
**Measure:** Occurrence of serious adverse events (SAEs) through Day 61.
**Time Frame:** Dosing through Day 61
#### Secondary Outcomes
**Description:** The pharmacokinetic profile will be assessed based on hemagglutination inhibition against multiple influenza A strains (H1N1, H3N2).
**Measure:** Hemagglutination Inhibition (HAI) against influenza A strains (H1N1, H3N2)
**Time Frame:** 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
**Description:** The pharmacokinetic profile will be assessed based on microneutralization against multiple influenza A strains (H1N1, H3N2).
**Measure:** Microneutralization (MN) titers against influenza A strains (H1N1, H3N2)
**Time Frame:** 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
**Description:** The pharmacokinetic profile will be assessed based on hemagglutination inhibition against influenza B strains (B-Victoria lineage, B/Yamagata lineage).
**Measure:** Hemagglutination Inhibition (HAI) against influenza B strains (B-Victoria lineage, B/Yamagata lineage)
**Time Frame:** 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
**Description:** The pharmacokinetic profile will be assessed based on microneutralization against influenza B strains (B-Victoria lineage, B/Yamagata lineage).
**Measure:** Microneutralization (MN) titers against influenza B strains (B-Victoria lineage, B/Yamagata lineage)
**Time Frame:** 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
**Description:** The pharmacokinetic profile will be assessed using the following parameter: maximum titer value (Cmax)
**Measure:** Maximum titer value (Cmax)
**Time Frame:** 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
**Description:** The pharmacokinetic profile will be assessed using the following parameter: time of maximum titer value (Tmax)
**Measure:** Time of maximum titer value (Tmax)
**Time Frame:** 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
**Description:** The pharmacokinetic profile will be assessed using the following parameter: terminal phase elimination rate constant (λZ)
**Measure:** Terminal phase elimination rate constant (λZ)
**Time Frame:** 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
**Description:** The pharmacokinetic profile will be assessed using the following parameter: terminal elimination half-life (t½).
**Measure:** Terminal elimination half-life (t½)
**Time Frame:** 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
**Description:** The pharmacokinetic profile will be assessed using the following parameter: area under the curve (AUC).
**Measure:** Area under the curve (AUC)
**Time Frame:** 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. Healthy adult, male or female, aged 18 to 60 years (inclusive) at the time of enrollment.
2. Completion and review of assessment of understanding test (achieved \> 70% accuracy).
3. Signed informed consent document. 4. Available for the required follow-up period and scheduled clinic visits. 5. Women of childbearing potential: Negative urine pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within two (2) months following investigational product administration.
6. Willing to use an acceptable method of contraception during the study and for 2 months following investigational product administration. If a barrier method is the contraceptive of choice, concurrent use of a spermicide will be recommended.
7. Body mass index (BMI) between 19 and 35 kg/m2. 8. Agree to refrain from blood donation during the study and for at least 12 months (1 year) following injection with the study drug.
Exclusion Criteria:
* 1. Health problems (for example, intercurrent febrile illness, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension, or any other condition that might place the subject at increased risk of adverse events); study clinicians, in consultation with the PI, will use clinical judgment on a case-by-case basis to assess safety risks under this criterion.
2. Clinically significant abnormalities on physical examination that, in the PI's opinion, would place the subject at undue risk and/or preclude full evaluation of potential adverse events.
3. Immunosuppressive drugs (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) or inherited or acquired immunodeficiency (including IgA deficiency; defined by serum IgA \<7 mg/dL).
4. Women who are pregnant or planning to become pregnant during the study period plus 2 months beyond the last received dose, and currently nursing women.
5. History of buttock enhancement (e.g., silicone enhancement or implants) that may interfere with intramuscular injections.
6. Participation in research involving another investigational product (defined as receipt of an investigational product such as a drug or vaccine or exposure to an invasive investigational device) within 30 days prior to dosing or any time through the last study safety visit.
7. Receipt of any unapproved immunizations or vaccines within 30 days prior to planned dosing.
8. Positive blood test for HBsAg, HCV, or HIV-1/2. 9. Clinically significant abnormalities on basic laboratory screening. 10. Moderate or severe influenza requiring hospitalization in the 30 days prior to planned dosing.
11. Receipt of any blood product (e.g., RhoGam, IVIG) within 120 days prior to planned dosing.
12. Use of other drugs that, in the opinion of the investigator, could complicate the safety assessment of SAB-176 (e.g., medications or over-the-counter vitamins or supplements formulated in bovine gelatin).
13. Vaccination against influenza less than 90 days prior to product administration.
14. Known autoimmune condition requiring therapy more intensive than intermittent nonsteroidal anti-inflammatories in the 6 months prior to planned dosing (e.g., rheumatoid arthritis, lupus, inflammatory bowel disease).
15. Chronic respiratory disease including chronic obstructive pulmonary disease (COPD), emphysema, cystic fibrosis, pulmonary hypertension, or other chronic condition that requires the routine use of supplemental oxygen.
16. Chronic asthma requiring the use of oral steroids or hospitalization in the last six months; inhaled steroids are permitted.
17. Receipt of pooled immunoglobulin or plasma within 30 days prior to planned dosing.
18. History of allergy, anaphylaxis, or severe reaction to beef products (including dairy products and gelatin).
**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:** Angela Phillips, RN, BSN
**Phone:** 605-679-6980
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bethesda
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Nehkonti Adams, MD
- **Phone:** 301-295-4298
- **Role:** CONTACT
**Country:** United States
**Facility:** Naval Medical Research Command (NMRC)
**State:** Maryland
**Status:** RECRUITING
**Zip:** 20889
#### Overall Officials
**Official 1:**
**Affiliation:** Naval Medical Research Command (NMRC)
**Name:** Nehkonti Adams, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M10295
- Name: Influenza, Human
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M19117
- Name: Immunoglobulins, Intravenous
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435923
**Brief Title:** A Trial to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]-Darigabat After a Single Oral Dose in Healthy Male Participants
**Official Title:** A Phase 1, Open-Label Trial to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]-Darigabat Following a Single Oral Dose in Healthy Adult Male Participants
#### Organization Study ID Info
**ID:** CVL-865-HV-1004
#### Organization
**Class:** INDUSTRY
**Full Name:** Cerevel Therapeutics, LLC
### Status Module
#### Completion Date
**Date:** 2024-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Cerevel Therapeutics, LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The primary purpose of this trial is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of darigabat, and total radioactivity in plasma and whole blood following administration of a single oral dose of \[14C\]-darigabat in healthy adult male participants.
### Conditions Module
**Conditions:**
- Healthy Participants
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 8
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive a single oral dose of darigabat.
**Intervention Names:**
- Drug: [14C]-darigabat
**Label:** Darigabat
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Darigabat
**Description:** Oral capsule
**Name:** [14C]-darigabat
**Other Names:**
- CVL-865; PF-06372865
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Area Under the Concentration Time Curve (AUC) from Time Zero to Infinity (AUCinf) of Darigabat
**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15
**Measure:** AUC from Time 0 to the Time of the Last Measured Concentration (AUClast) of Darigabat
**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15
**Measure:** Maximum Observed Plasma Concentration (Cmax) of Darigabat
**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15
**Measure:** Time to Last Quantifiable (Tlast) Concentration of Darigabat
**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15
**Measure:** Time to Maximum Observed Concentration (Tmax) of Darigabat
**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15
**Measure:** Terminal Phase Half-life (t½) of Darigabat
**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15
**Measure:** Apparent Total Clearance After Oral Administration (CL/F) of Darigabat
**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15
**Measure:** Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Darigabat
**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15
**Measure:** Ratio of Plasma AUCinf for Darigabat to Total Radioactivity
**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15
**Measure:** Ratio of Whole Blood AUCinf for Total Radioactivity to Plasma Total Radioactivity
**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15
**Description:** Urine PK parameters will be assessed.
**Measure:** Amount Excreted in Urine (Aeu) of Total Radioactivity
**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15
**Description:** Fecal PK parameters will be assessed.
**Measure:** Amount Excreted in Feces (Aef) of Total Radioactivity
**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15
#### Secondary Outcomes
**Measure:** Metabolite Profile of [14C]-darigabat in Plasma, Urine and Feces
**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15
**Measure:** Identification of [14C]-darigabat Metabolites Found in Plasma, Urine and Feces
**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15
**Measure:** Structural Elucidation of [14C]-darigabat Metabolites ≥10% of the Total [14C]-darigabat Radioactivity Found in Plasma, Urine and Feces
**Time Frame:** Pre-dose and at multiple time points post-dose up to Day 15
**Measure:** Number of Participants with Adverse Events (AEs)
**Time Frame:** Up to Day 16
**Measure:** Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values
**Time Frame:** Up to Day 15
**Measure:** Number of Participants with Clinically Significant Changes in Vital Signs
**Time Frame:** Up to Day 15
**Measure:** Number of Participants with Clinically Significant Changes in Laboratory Assessments
**Time Frame:** Up to Day 15
**Measure:** Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results
**Time Frame:** Up to Day 15
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Body mass index of 18.5 to 35.0 kilograms per square meters (kg/m\^2), inclusive, and a total body weight ≥50 kg \[110 Pounds (lbs)\] at Screening.
2. A male participant who is sexually active with a pregnant or a nonpregnant partner of childbearing potential must agree to use a condom during the trial and for 93 days after the dose of investigational medicinal product (IMP). In addition, male participants should not donate sperm for a minimum of 93 days following the dose of IMP.
3. Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures.
Exclusion Criteria:
1. Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial.
2. "Yes" responses for any of the following items on the Columbia-Suicide Severity Rating Scale (C-SSRS) (within the individual's lifetime):
* Suicidal Ideation Item 3 (Active Suicidal Ideation with Any Methods \[Not Plan\] without Intent to Act)
* Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan)
* Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent)
* Any of the Suicidal Behavior items (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior) "Yes" responses for any of the following items on the C-SSRS (within past 12 months):
* Suicidal Ideation Item 1 (Wish to be Dead)
* Suicidal Ideation Item 2 (Non-Specific Active Suicidal Thoughts) Serious risk of suicide in the opinion of the investigator is also exclusionary.
3. Any condition or surgery that could possibly affect drug absorption, including, but not limited to, bowel resections, bariatric weight loss surgery/procedures, gastrectomy, and cholecystectomy.
4. Positive result for human immunodeficiency viruses (HIV) antibody, hepatitis B surface antigen, hepatitis B total core antibody, or hepatitis C antibody with detectable viral Ribonucleic acid (RNA) levels at Screening. Note: Positive or indeterminate test result for hepatitis C antibody should follow with hepatitis C virus polymerase chain reaction (PCR) RNA test. If result is positive, the participant is excluded.
5. Positive drug screen \[including cotinine and Tetrahydrocannabinol (THC)\] or a positive test for alcohol.
6. Known allergy or hypersensitivity to the IMP, closely related compounds, or any of their specified ingredients.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
**Gender Based:** True
**Gender Description:** U.S. Food and Drug Administration (FDA) recommends that radiation exposure to participants should be kept as low as is reasonably achievable, and there is no available data to suggest metabolism of the darigabat is different in women versus men. Hence, female participants are excluded from this study.
**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:** Cerevel Clinical Trial Support
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Austin
**Country:** United States
**Facility:** Austin, Texas
**State:** Texas
**Zip:** 78744
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000018757
- Term: GABA Modulators
- ID: D000018682
- Term: GABA Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M269476
- Name: PF-06372865
- Relevance: HIGH
- As Found: DTaP-IPV-
- ID: M20827
- Name: GABA Modulators
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000630159
- Term: PF-06372865
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435910
**Brief Title:** Engineered Dendritic Cell Vaccines for Multiple Myeloma
**Official Title:** Engineered Dendritic Cell Vaccines for Remission Maintenance in Multiple Myeloma Patients
#### Organization Study ID Info
**ID:** GIMI-IRB-24002
#### Organization
**Class:** OTHER
**Full Name:** Shenzhen Geno-Immune Medical Institute
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-07-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-11
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** The No.2 Clinical Hospital of the Ministry of Health
#### Lead Sponsor
**Class:** OTHER
**Name:** Shenzhen Geno-Immune Medical Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to determine the feasibility, safety, and efficacy of dendritic cell (DC) vaccines in the treatment of multiple myeloma (MM) or plasmacytoma based on immune-modified DC vaccines (DCvac). This approach is aimed to achieve prolonged maintenance of remission in multiple myeloma or plasmacytoma patients.
**Detailed Description:** Multiple myeloma (MM) is a plasma cell malignancy, characterized by the aberrant occupation of bone marrow with malignant plasma cells, and the destruction of bones together with the production of abnormal immunoglobulins. The clinical symptoms and signs can be manifested through various mechanisms. At present, the therapeutic drugs for MM include glucocorticoid, cytotoxic drugs, immunosuppressants, protease inhibitors, monoclonal antibodies and cell therapies including hematopoietic stem cell transplantation (HSCT). Among them, immunotherapy has been proven to be a revolutionary treatment with great potential of producing long term cure.
In the past decades, adoptively transferred T cells modified with chimeric antigen receptors (CARs) have demonstrated high effectiveness, and the CAR-T therapy has changed the treatment paradigm for many hematological malignancies. Currently, several antibody-based therapies and a few BCMA-based CAR-T cell therapies have been approved for MM treatment. However, in many MM patients, the disease may still relapse after extensive immunotherapies including auto- and allo-HSCT. We have previously reported a DC-based immune activation strategy against MM in a preclinical study. This study proposes to apply the individual patients' MM tumor antigen-based DCs as vaccines (DCvac) to booster anti-myeloma immunity, in order to prevent disease relapse. The MM patients who have achieved very good partial or complete remission will be treated with multiple DCvacs to achieve a prolonged remission without disease recurrence.
This trial protocol will inject DCvacs to MM or plasmacytoma patients who have been treated with a combination of anti-cancer regimens, including CAR-T cell therapy, and who have achieved partial or complete disease remission. The DCvacs are patient's own DCs which are immune modified to present target antigens and to activate anti-cancer immunity. The aim of this study is to evaluate the feasibility, safety, and efficacy of the innovative MM patient-based DC vaccines.
### Conditions Module
**Conditions:**
- Multiple Myeloma or Plasmacytoma
**Keywords:**
- MM
- CAR T
- DC vaccine
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Biological: DC vaccines
**Label:** DCvac cells to treat MM
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- DCvac cells to treat MM
**Description:** Antigen-presenting and immune modifying DCvacs to treat MM
**Name:** DC vaccines
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
**Measure:** Safety of DC injection
**Time Frame:** 1 Month
#### Secondary Outcomes
**Description:** Anti-tumor activity of the DCvacs by examination of anti-cancer immunity by measurement of tumor burden
**Measure:** Clinical response
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male and female subjects with multiple myeloma or plasmacytoma
* Very good partial or complete remission (CR) after prior combination therapies.
* Expected survival \> 12 weeks
* Adequate venous access for blood withdrawal or apheresis, and no other contraindications for blood withdrawal
* Voluntary informed consent is given with willingness to continue follow up
Exclusion Criteria:
* Pregnant or lactating women
* Uncontrolled active infection
* HIV or active hepatitis B or hepatitis C infection
* Concurrent use of systemic steroids; the use of inhaled steroids is not exclusionary
**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:** Lung-Ji Chang, ph.D
**Phone:** 86-0755-86725195
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shenzhen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lung-Ji Chang, ph.D
- **Phone:** 86-0755-86725195
- **Role:** CONTACT
**Country:** China
**Facility:** Shenzhen Geno-immune Medical Institute
**State:** Guangdong
**Status:** RECRUITING
**Zip:** 518000
**Location 2:**
**City:** Vladivostok
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Vitaly Dubov, MD
- **Phone:** 8(924)3321996
- **Role:** CONTACT
**Country:** Russian Federation
**Facility:** The Regional Hematology Center in Clinical Hospital No. 2 of the Ministry of Health
**Status:** RECRUITING
**Zip:** 690105
### 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: M13844
- Name: Plasmacytoma
- Relevance: HIGH
- As Found: Plasmacytoma
- 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
- ID: T4587
- Name: Plasmacytoma
- Relevance: HIGH
- As Found: Plasmacytoma
### Condition Browse Module - Meshes
- ID: D000009101
- Term: Multiple Myeloma
- ID: D000054219
- Term: Neoplasms, Plasma Cell
- ID: D000010954
- Term: Plasmacytoma
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17360
- Name: Vaccines
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435897
**Brief Title:** Autoimmune Disease Treatment With Mesenchymal Stem Cells (MSCs) and CAR-T Cells
**Official Title:** Management of Autoimmune Conditions With Mesenchymal Stem Cells (MSCs) and CAR-T Cells
#### Organization Study ID Info
**ID:** GIMI-IRB-24003
#### Organization
**Class:** OTHER
**Full Name:** Shenzhen Geno-Immune Medical Institute
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-07-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shenzhen Geno-Immune Medical Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to assess the feasibility, safety and efficacy of mesenchymal stem cells (MSCs) in combination with CAR-T cells in treating autoimmune disease. Another goal of the study is to learn more about the safety and function of the MSCs combined with CAR-T cells and their long term effects in autoimmune disease patients.
**Detailed Description:** Autoimmune disease refers to the disease in which the immune system reacts to the host's own body and causes damage to tissues and organs. At present, the pathogenesis of various autoimmune diseases is still not well understood, but an imbalanced immune tolerance plays a key role in this process.
An ideal therapy to autoimmune disease should eradicate pathogenic autoimmune cells but retain the protective immunity. The chimeric antigen receptor-modified T (CAR-T) cell technology has proven to be highly effective in targeting B cell malignancies, and the treatment-induced B cell and antibody deficiencies have implications for treating autoantibody-related autoimmune diseases. Studies have shown that CAR-T cells targeting B cell surface molecules can kill autoreactive B lymphocytes in pemphigus vulgaris (PV) and systemic lupus erythematosus (SLE) patients. Thus, CAR-T targeting antibody-producing cells has potential in treating autoimmune diseases including PV, SLE, autoimmune hemolytic anemia, Sjogren's syndrome etc..
MSCs have immune modulatory and immunosuppressive effects. MSCs have been extensively studied and clinically evaluated for the treatment of autoimmune diseases and graft versus host disease (GVHD) caused by hematopoietic stem cell transplantation (HSCT). In many studies, MSCs have demonstrated promising beneficial effects that can reduce severe autoimmune reactions. In recent years, MSCs have been used in synergy with CAR-T cells to address the shortcomings of CAR-T cells. Fetal tissue-derived clonal MSCs (fMSCs) have extended expansion potential and express rich levels of various growth factors. The fMSCs also resove a main limitation in MSC quality and reliability issues related to product consistency of MSCs. As such, innovative strategies to maximise the synergistic effects of CAR-Ts and MSCs have been proposed by either using MSCs as a supplementary intervention to assist in CAR-T based immunotherapies or as part of a sequential therapy regimen.
CD19- and BCMA-specific CAR is based on activation of intracellular signalijng domains of T cells by the extracellular single chain variable fragment (scFv) antibodies against CD19 and BCMA. The activated CAR-T cells can target and kill B cells. The investigation plans to use genetically modified T cells to express 4th generation lentiviral CARs with an inducible caspase 9 self-withdrawal gene (4SCAR) to increase the safety of this specific approach. Besides targeting CD19 and BCMA, other B cell and plasma cell surface molecules will also be targeted and included in the treatment design. Based on accumulated experiences, the 4SCAR T cells have shown high safety profile without serious cytokine release syndrome (CRS) or neural toxicities in patients. Through this trial, the safety and long-term efficacy of synergistic B-cell- and plasma-cell-specific 4SCAR T-cell therapy with MSCs will be evaluated, providing clinical evidence to support the use of 4SCAR-T cells and MSCs in the treatment of autoimmune diseases.
### Conditions Module
**Conditions:**
- Autoimmune Diseases
**Keywords:**
- CAR-T
- MSC
- autoimmune disease
- autoantibody
- B cell
- plasma cell
- CD19
- BCMA
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** nfusion of 4SCAR T cells at 10\^6 cells/kg body weight and MSCs at 3x10\^6 cells via IV
**Intervention Names:**
- Biological: fetal MSCs combined with 4SCAR T cells
**Label:** MSC combined with 4SCAR T-cell therapy for autoimmune diseases
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MSC combined with 4SCAR T-cell therapy for autoimmune diseases
**Description:** Infusion of 4SCAR T cells at 10\^6 cells/kg body weight and MSCs at 3x10\^6 cells via IV
**Name:** fetal MSCs combined with 4SCAR T cells
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
**Measure:** Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
**Time Frame:** 1 month
**Description:** Safety of 4SCAR T cells in patients with autoimmune diseases using CTCAE 5 standard to evaluate the level of adverse events with measuring cytokine response
**Measure:** Safety of 4SCAR T cells in patients with autoimmune diseases using CTCAE 5 standard to evaluate the level of adverse events
**Time Frame:** 12 week
#### Secondary Outcomes
**Description:** Number of participants with reduced symptoms or stabilized conditions after treatment assessed by short term clinical effects using study assessment table.
**Measure:** Number of participants with reduced symptoms or stabilized conditions after treatment assessed by short term clinical effects
**Time Frame:** 6 months
**Description:** B cell and immunoglobulin suppression activity of 4SCAR T cells in patients with autoimmune diseases
**Measure:** The activity of 4SCAR T cells in patients with autoimmune diseases
**Time Frame:** 1 year
**Description:** CAR copies in patients with autoimmune diseases
**Measure:** The activity of 4SCAR T cells in patients with autoimmune diseases
**Time Frame:** 1 year
**Description:** The immunoglobulin levels in patients with autoimmune diseases
**Measure:** The activity of 4SCAR T cells in patients with autoimmune diseases
**Time Frame:** 1 year year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. older than 18 years of age.
2. established autoimmune conditions.
3. the KPS score over 80 points, and survival time is more than 3 months.
4. greater than Hgb 80 g/L.
5. no contraindications to blood cell collection.
Exclusion Criteria:
1. accompanied with other active diseases and difficult to assess treatment response.
2. bacterial, fungal, or viral infection, unable to control.
3. living with HIV.
4. active HBV or HCV infection.
5. pregnant and nursing mothers.
6. under systemic steroid treatment within a week of the treatment.
7. prior failed CAR-T treatment.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lung-Ji Chang, PhD
**Phone:** 86-0755-86725195
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shenzhen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lung-Ji Chang, PhD
- **Phone:** 86-0755-86725195
- **Role:** CONTACT
**Country:** China
**Facility:** Shenzhen Geno-immune Medical Institute
**State:** Guangdong
**Status:** RECRUITING
**Zip:** 518000
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: HIGH
- As Found: Autoimmune Diseases
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001327
- Term: Autoimmune Diseases
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4625
- Name: Autoantibodies
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435884
**Brief Title:** Long-Term Follow-up of Adult With Atorpphic Scars Treated With TRTP-101
**Official Title:** Long-Term Follow-up of Adult With Atrophic Scars Treated With TRTP-101 in Study CIC101-01
#### Organization Study ID Info
**ID:** CIC101-01-LT
#### Organization
**Class:** INDUSTRY
**Full Name:** CellinCells
### Status Module
#### Completion Date
**Date:** 2029-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** CellinCells
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** CIC101-01-LT is a long-term follow-up study of subjects treated with TRTP-101 and will evaluate the long-term safety and efficacy of TRTP-101.
**Detailed Description:** The long-term safety of TRTP-101 was evaluated by participants in the CIC101-01 clinical trial and followed up for 5 years for serious adverse events.
### Conditions Module
**Conditions:**
- Atrophic Scar
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 6
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** SAE will be collected
**Measure:** Serious Adverse Event
**Time Frame:** Up to 5 years
#### Secondary Outcomes
**Description:** The depressed volume of atropic scar is measured at baseline in study CIC101-01
**Measure:** Mean percent change in atrophic scar volume
**Time Frame:** 6, 12, 18 and 24 months
**Description:** Patient's Satisfaction with treatment scored by a 100-mm VAS(Visual Analogie Scale). On this scale, 0 indicates no satisfaction and 100 indicate extreme satisfaction.
**Measure:** Patient's Satisfaction
**Time Frame:** 6, 12, 18 and 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Received TRTP-101 in clinical trial CIC101-01
* Provided written informed consent to participate in this study
Exclusion Criteria:
* Judged to be unsuitable to participate in this long-term follow-up
**Healthy Volunteers:** True
**Minimum Age:** 19 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adults with Atropic Scars Treated with TRTP-101 in Sutdy CIC101-01
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** HyeJung Park, Director
**Phone:** 82-70-4469-9115
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Dermatology, Samsung Medical Center, Sungkyunkwan University School of Medicine
**Name:** JongHee Lee, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020763
- Term: Pathological Conditions, Anatomical
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4589
- Name: Atrophy
- Relevance: HIGH
- As Found: Atrophic
- ID: M6160
- Name: Cicatrix
- Relevance: LOW
- As Found: Unknown
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001284
- Term: Atrophy
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435871
**Brief Title:** Developing Inclusive Support and Intervention for Spanish-speaking Latiné Prostate Cancer Survivors
**Official Title:** Developing Inclusive Support and Intervention for Spanish-speaking Latiné Prostate Cancer Survivors: Understanding Cultural Nuances in Survivorship Decision Making
#### Organization Study ID Info
**ID:** CASE9824
#### Organization
**Class:** OTHER
**Full Name:** Case Comprehensive Cancer Center
### Status Module
#### Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Case Comprehensive Cancer Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Prostate cancer is a significant concern for Latiné men, with over 17,000 new cases annually. Decision-making for treatment is complex, especially due to barriers like low health literacy and cultural factors. Research on survivorship and post-treatment issues like erectile dysfunction is lacking. To improve care, a study will engage 288 participants across various medical facilities, including 100 at Cleveland Clinic. Thirty subjects will participate in focus groups representing Spanish-speaking Latiné, bilingual Latiné, and English-speaking non-Latiné individuals to understand their perspectives and enhance communication. This aims to develop tailored resources, like Spanish-language educational videos, addressing language and cultural needs for informed decision-making.
**Detailed Description:** Prostate cancer is the most common non-skin cancer among Latiné men, with over 17,000 new cases yearly. While most men live with the disease rather than die from it, ensuring quality of life is crucial in treatment decisions. Latiné men face unique decision-making challenges due to low health literacy, barriers to healthcare access, and cultural differences in treatment understanding and communication. Decision aids that consider patient values and cultural nuances like familismo are essential for effective shared decision-making.
Despite the significance of racial and ethnic disparities in prostate cancer outcomes, research has been limited, especially among Latiné populations. The CEASAR study highlighted the need for more inclusive research, showing no significant outcome differences across racial groups but underrepresenting Latiné men. The Urology Care Foundation has provided Spanish-language resources, yet there's a gap in materials discussing treatment choices in the context of sexual, bowel and urinary health post-treatment.
This gap underlines the necessity for research focused on the Latiné community's perspectives on prostate cancer survivorship, particularly concerning erectile dysfunction, bowel function and urinary function. This study aims to fill this void through focus groups to better understand Latiné men's views and enhance patient education and shared decision-making. A Spanish-language educational video informed by these insights will address the critical need for culturally and linguistically appropriate resources, bridging the information gap for Spanish-speaking survivors
### Conditions Module
**Conditions:**
- Prostate Cancer
**Keywords:**
- Latinos
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 288
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The study population will be divided into three cohorts:
* Spanish-speaking preferred Latiné,
* English-speaking preferred Latiné,
* English-speaking non-Latiné patients.
Domain assessments between groups will be made using ANOVA with pairwise comparisons.
**Intervention Names:**
- Behavioral: Expanded Prostate Cancer Index Composite and Decision Regret Scale
**Label:** Prostate cancer treatment outcomes
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Prostate cancer treatment outcomes
**Description:** This comprehensive instrument measures urinary, sexual, and bowel symptoms in men treated for prostate cancer. It can provide a detailed view of the patient's quality of life post-treatment.
**Name:** Expanded Prostate Cancer Index Composite and Decision Regret Scale
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The EPIC questionnaire evaluates urinary health-related quality of life domains specific to prostate cancer patients: It is a 13-question survey, where 1-5 are focused on the urinary health. Responses are given on a Likert scale, ranging from "very poor" to "very good" or "no problem" to "big problem," depending on the question.One-way ANOVA test is used for comparison of EPIC domains between the three cohorts.
**Measure:** Urinary health-related QoL as measured using the validated EPIC-26 questionnaire
**Time Frame:** During group interview (minimum of three 90-minute sessions) post radical prostatectomy
**Description:** The EPIC questionnaire evaluates bowel health-related quality of life domains specific to prostate cancer patients: It is a 13-question survey, where questions 6-7 are focused on the bowel health. Responses are given on a Likert scale, ranging from "very poor" to "very good" or "no problem" to "big problem," depending on the question.One-way ANOVA test is used for comparison of EPIC domains between the three cohorts.
**Measure:** Bowel health-related QoL as measured using the validated EPIC-26 questionnaire
**Time Frame:** During group interview (minimum of three 90-minute sessions) post radical prostatectomy
**Description:** The EPIC questionnaire evaluates sexual health-related quality of life domains specific to prostate cancer patients: It is a 13-question survey, where questions 8-12 are focused on the sexual health. Responses are given on a Likert scale, ranging from "very poor" to "very good" or "no problem" to "big problem," depending on the question.One-way ANOVA test is used for comparison of EPIC domains between the three cohorts.
**Measure:** Sexual health-related QoL as measured using the validated EPIC-26 questionnaire
**Time Frame:** During group interview (minimum of three 90-minute sessions) post radical prostatectomy
**Description:** The EPIC questionnaire evaluates hormonal health-related quality of life domains specific to prostate cancer patients: It is a 13-question survey, where question 13 is focused on the hormonal health. Responses are given on a Likert scale, ranging from "very poor" to "very good" or "no problem" to "big problem," depending on the question.One-way ANOVA test is used for comparison of EPIC domains between the three cohorts.
**Measure:** Hormonal health-related QoL as measured using the validated EPIC-26 questionnaire
**Time Frame:** During group interview (minimum of three 90-minute sessions) post radical prostatectomy
**Description:** The EPIC questionnaire evaluates health-related quality of life domains specific to prostate cancer patients: It is a 13-question survey. Responses are given on a Likert scale, ranging from "very poor" to "very good" or "no problem" to "big problem," depending on the question.One-way ANOVA test is used for comparison of EPIC domains between the three cohorts.
**Measure:** QoL as measured using the combined score of EPIC-26 questionnaire
**Time Frame:** During group interview (minimum of three 90-minute sessions) post radical prostatectomy
#### Secondary Outcomes
**Description:** The DRS is a 5-item Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree), designed to evaluate distress or remorse following a healthcare decision. Comparison of decisional conflict scores between the study groups using one-way ANOVA testing.
**Measure:** Decisional conflict as assesed by decisional conflict scores
**Time Frame:** During group interview (minimum of three 90-minute sessions) post radical prostatectomy
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults \>18 years
* Diagnosis of Localized Prostate Cancer
* Underwent radical prostatectomy by their urological surgeon
* Subjects must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patient whose primary language is not English or Spanish
* Patients who had brachytherapy and/or radiation treatment as their initial treatment
* Patients with disease progression at time study recruitment who are requiring other treatments (ADT, chemotherapy, immunotherapy)
* Patients who underwent current non-standard prior treatment options for localized prostate cancer including cryotherapy and high intensity focused ultrasound (HIFU)
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Christophar Weight, MD
**Phone:** (216) 317- 8138
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cleveland
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Christopher Weight, MD
- **Role:** CONTACT
**Country:** United States
**Facility:** Cleveland Clinic Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
**State:** Ohio
**Zip:** 44195
#### Overall Officials
**Official 1:**
**Affiliation:** Cleveland Clinic Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
**Name:** Christopher Weight, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Each institution will collect their own patient data into their own RedCap. No PHI data will be shared amongst the institutions - only de-identified data will be shared from CCF to UCSD via REDCAP and included in analyses which will be performed by specialist data analysts at UCSD and by investigators listed on this IRB. Access to the data will be limited to authorized personnel only, who will be required to maintain strict confidentiality and adhere to data protection regulations.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Data will be available for the duration of the study \~ 2 years.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005834
- Term: Genital Neoplasms, Male
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000011469
- Term: Prostatic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435858
**Acronym:** SIDIA
**Brief Title:** Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease
**Official Title:** Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease
#### Organization Study ID Info
**ID:** 2024-00070
#### Organization
**Class:** OTHER
**Full Name:** Cantonal Hospital Graubuenden
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Zurich
#### Lead Sponsor
**Class:** OTHER
**Name:** Cantonal Hospital Graubuenden
#### Responsible Party
**Investigator Affiliation:** Cantonal Hospital Graubuenden
**Investigator Full Name:** Patrick Hofmann
**Investigator Title:** MD
**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:** This study aims to better understand electrolyte handling in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.
Patients will be randomized into two groups and take Empagliflozin or a Placebo for 2 weeks with a wash-out period of 2 weeks. The primary outcome is tubular handling of the divalent ions calcium, phosphate and magnesium. Secondary outcomes include diuresis, safety and tolerability.
**Detailed Description:** This investigator-initiated randomised, single-blind, placebo-controlled cross-over study aims to better understand tubular electrolyte handling of divalent ions in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin.
After randomization, at week 0, participants collect 24-hour urine sample and a patient visit to assess vitals and blood tests takes place. After this visit, period 1 starts with a 2-week treatment of either Empagliflozin 10mg or Placebo.
At week 2, the second 24-hour-urine sample and 2. patient visit and blood test take place. After this visit, wash-out period for 2 weeks starts where no study drug will be administered At week 4, the period 2, the crossover-period starts for an additional 2 weeks. At week 6; a final and third 24-hour urine sample, clinical visit and blood test takes place.
At week 3 \& 7, a phone consultation will assess safety.
### Conditions Module
**Conditions:**
- Autosomal Dominant Polycystic Kidney Disease
**Keywords:**
- phosphate
- calcium
- magnesium
- Empagliflozin
- ADPKD
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
**Intervention Model Description:** Investigator-initiated randomised, single-blind, placebo-controlled, cross-over study
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Empagliflozin 10mg
**Intervention Names:**
- Drug: Empagliflozin
**Label:** Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo
**Intervention Names:**
- Drug: Placebo
**Label:** Control
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention
**Description:** Empagliflozin 10mg
**Name:** Empagliflozin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Control
**Description:** Placebo capsule
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** - Ca2+, phosphate, Mg absolutely and measured by fractional excretions
**Measure:** Primary Outcome
**Time Frame:** After a two week intervention
#### Secondary Outcomes
**Description:** - diuresis (24-hour urine volume, 24-hour creatinine, ketonuria, osmolarity, urinary pH) - tubular handling of other electrolytes (Na, K, Cl) - inflammation metabolism (CRP, hemoglobin?) - kidney function (creatinine, uric acid, urea, hemoglobin?) - effect on standardized blood pressure (assessed every two weeks) - bone metabolism (FGF23, PTH, 25-(OH)-D3) - tolerability (patient-reported side effects (nycturia, urinary urgency, lightheadedness, syncope) - safety (bacteriuria, urinary tract infection requiring antibiotic treatment, genital mycosis)
**Measure:** Secondary Outcome
**Time Frame:** After a two week intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* - Patients 18-75 years old with ADPKD, defined according to international diagnostic and classification criteria14, treated at Cantonal Hospital Graubünden (KSGR) and the University Hospital Zürich (USZ) independent of baseline treatment with the vasopressin receptor antagonist Tolvaptan
* Informed consent as documented by signature
Exclusion Criteria:
* - renal replacement therapy or kidney allograft recipient
* chronic kidney disease CKD KDIGO Stage G4 (eGFR under 30ml/min/1.73m2)
* patients younger 18 years of age
* Diabetes mellitus type 1
* recurrent urinary tract infections (UTI) defined as more than 3 infections requiring antibiotic treatment or over 1 requiring hospitalization/year.
* Patients with uncontrolled hypertension (defined as ambulatory systolic BP over 180mmHg), liver cirrhosis (Child Pugh B and C)
* Patients not able or not willing to stop the following medications during the study period of participation in the trial:
* Thiazide diuretics
* Carbonic anhydrase inhibitors
* Sodium bicarbonate
* 1, 25 (OH) vitamin D (calcitriol)
* Bisphosphonate, denosumab, teriparatide
* Pregnant or lactating women
* Known allergy to study drug
* Inability to understand and follow the protocol
**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:** Patrick Hofmann, MD
**Phone:** +4181 256 6305
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Thomas Fehr, MD
**Phone:** +4181 256 6305
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chur
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Patrick Hofmann, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Lorena Roth, MD
- **Role:** SUB_INVESTIGATOR
**Country:** Switzerland
**Facility:** Cantonal Hospital Graubuenden
**State:** Graubuenden
**Zip:** 7000
#### Overall Officials
**Official 1:**
**Affiliation:** Cantonal Hospital Graubuenden
**Name:** Thomas Fehr, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Cantonal Hospital Graubuenden
**Name:** Patrick Hofmann, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** The local ethics committee approval does not include individual participant data sharing.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009139
- Term: Musculoskeletal Abnormalities
- ID: D000000013
- Term: Congenital Abnormalities
- ID: D000052177
- Term: Kidney Diseases, Cystic
- ID: D000000015
- Term: Abnormalities, Multiple
- ID: D000072661
- Term: Ciliopathies
- ID: D000030342
- Term: Genetic Diseases, Inborn
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Kidney Disease
- ID: M10712
- Name: Polycystic Kidney Diseases
- Relevance: HIGH
- As Found: Polycystic Kidney Disease
- ID: M19237
- Name: Polycystic Kidney, Autosomal Dominant
- Relevance: HIGH
- As Found: Autosomal Dominant Polycystic Kidney
- ID: M4484
- Name: Arthrogryposis
- Relevance: HIGH
- As Found: Autosomal Dominant
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M12096
- Name: Musculoskeletal Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M26983
- Name: Kidney Diseases, Cystic
- Relevance: LOW
- As Found: Unknown
- ID: M14
- Name: Abnormalities, Multiple
- Relevance: LOW
- As Found: Unknown
- ID: M1076
- Name: Ciliopathies
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: T591
- Name: Autosomal Dominant Multiple Pterygium Syndrome
- Relevance: HIGH
- As Found: Autosomal Dominant
- ID: T493
- Name: Arthrogryposis Multiplex Congenita
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001176
- Term: Arthrogryposis
- ID: D000007674
- Term: Kidney Diseases
- ID: D000007690
- Term: Polycystic Kidney Diseases
- ID: D000016891
- Term: Polycystic Kidney, Autosomal Dominant
### 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
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
### Intervention Browse Module - Browse Leaves
- ID: M258082
- Name: Empagliflozin
- Relevance: HIGH
- As Found: At home
- ID: M1691
- Name: Sodium-Glucose Transporter 2 Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000570240
- Term: Empagliflozin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435845
**Brief Title:** Phase 2 Study on the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization
**Official Title:** A Phase 2, Multicenter, Open-label Study to Evaluate the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization
#### Organization Study ID Info
**ID:** IPA2202
#### Organization
**Class:** INDUSTRY
**Full Name:** Rallybio IPA, LLC
#### Secondary ID Infos
**ID:** 2024-512651-20-00
**Type:** CTIS
### Status Module
#### Completion Date
**Date:** 2027-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Rallybio IPA, LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
### Description Module
**Brief Summary:** The purpose of this Phase 2 study is to assess the pharmacokinetics (PK) and safety of RLYB212 in HPA-1b/b pregnant women at higher risk for HPA-1a alloimmunization and FNAIT.
**Detailed Description:** This study is a single-arm, open-label, multicenter study of RLYB212 in HPA-1b/b pregnant participants at higher risk for the occurrence of HPA-1a alloimmunization and FNAIT. A laboratory testing paradigm will be applied at screening to identify women at higher risk for HPA-1a alloimmunization. Study IPA2202 is comprised of three phases: a two-part screening phase, an antenatal treatment phase, and a postpartum follow-up phase. Study duration for each participant is anticipated to be \~44 weeks, inclusive of the screening visits through the Week 10 postpartum visit.
### Conditions Module
**Conditions:**
- Fetal and Neonatal Alloimmune Thrombocytopenia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 8
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** RLYB212 Subcutaneous injection
**Intervention Names:**
- Drug: Anti-(integrin beta-3) human monoclonal antibody
**Label:** RLYB212
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- RLYB212
**Description:** human monoclonal anti-human platelet antigen (HPA)-1a immunoglobulin G antibody
**Name:** Anti-(integrin beta-3) human monoclonal antibody
**Other Names:**
- RLYB212
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Number of Participants with treatment related adverse events as defined by CTCAE 5.0
**Time Frame:** Approx. Gestational Week (GW) <16, 16, 18, 20, 24, 26, 28, 30, 32, 34, 36, 38; at birth (~40), Post Partum (PP) Week 4, 10 week
**Measure:** Maternal exposure to RLYB212 as measured in serum
**Time Frame:** Approx. GW 16, 18, 20, 24, 26, 28, 30, 32, 34, 36, 38, at birth (~40), PP Week 4
#### Secondary Outcomes
**Measure:** Neonatal exposure to RLYB212 as measured in cord blood
**Time Frame:** At birth (~GW 40)
**Measure:** Number of HPA-1a positive neonates with treatment related adverse events as defined by CTCAE v5.0
**Time Frame:** At birth (~GW 40), Approx. PP Week 4
**Measure:** Anti-RLYB212 antibodies as measured in serum
**Time Frame:** Approx. GW 16, 20, 24, 28, 32, 36, at birth (~40), PP Week 4
**Measure:** Pregnancy Outcomes: incidence of live births, spontaneous abortions, elective abortions, still births or premature births
**Time Frame:** At birth (~GW 40)
**Measure:** Frequency of Neonatal Thrombocytopenia as measured by platelet count within 72 hours of delivery
**Time Frame:** At birth (~GW 40)
**Measure:** Frequency of HPA-1a Alloimmunization as measured by anti-HPA-1a alloantibodies
**Time Frame:** Approx. PP Week 10
**Measure:** Neonatal Outcomes: general health and overall status as defined by absolute values and percentiles
**Time Frame:** 4-6 weeks following delivery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Pregnant women who present at Gestational Week 6 or after and confirmed to be: HPA-1b/b (HPA-1a negative), HLA-DRB3\*01:01 positive, Anti-HPA-1a alloantibody negative, Carrying an HPA-1a/b (HPA-1a positive) fetus
Exclusion Criteria:
* Prior history of HPA-1a related fetal and neonatal alloimmune thrombocytopenia
* Multiple pregnancy (more than 1 fetus)
* Prior history of platelet transfusion or other blood transfusions
* Known sensitivity and/or immediate hypersensitivity to any components of RLYB212 or its formulation
* Any co-morbid medical or obstetric condition(s), laboratory abnormality, concomitant treatment, or other reason that, in the investigator's opinion, could adversely affect the safety of the participant and/or fetus, impair the assessment of study results, or preclude compliance with the study
**Gender Based:** True
**Gender Description:** Pregnant women
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Chief Medical Officer
**Phone:** 2038593820
**Phone Ext:** 1
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001791
- Term: Blood Platelet Disorders
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000095542
- Term: Cytopenia
- ID: D000007232
- Term: Infant, Newborn, Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- 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: M16680
- Name: Thrombocytopenia
- Relevance: HIGH
- As Found: Thrombocytopenia
- ID: M27571
- Name: Thrombocytopenia, Neonatal Alloimmune
- Relevance: HIGH
- As Found: Neonatal Alloimmune Thrombocytopenia
- ID: M5072
- Name: Blood Platelet Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3170
- Name: Cytopenia
- Relevance: LOW
- As Found: Unknown
- ID: M10276
- Name: Infant, Newborn, Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2298
- Name: Fetal and Neonatal Alloimmune Thrombocytopenia
- Relevance: HIGH
- As Found: Fetal and Neonatal Alloimmune Thrombocytopenia
### Condition Browse Module - Meshes
- ID: D000013921
- Term: Thrombocytopenia
- ID: D000054098
- Term: Thrombocytopenia, Neonatal Alloimmune
### Intervention Browse Module - Ancestors
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: HIGH
- As Found: Chemotherapy
- ID: M4225
- Name: Antibodies
- Relevance: HIGH
- As Found: Given
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M10122
- Name: Immunoglobulin G
- Relevance: LOW
- As Found: Unknown
- ID: M19117
- Name: Immunoglobulins, Intravenous
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000906
- Term: Antibodies
- ID: D000000911
- Term: Antibodies, Monoclonal
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435832
**Brief Title:** Evaluations of the Effects of Tranexamic Acid and Chlorhexidine Gel on Alveolar Osteitis Incidence
**Official Title:** Evaluation of the Effects of Tranexamic Acid and Chlorhexidine Gel on Alveolar Osteitis Incidence
#### Organization Study ID Info
**ID:** RTEUni
#### Organization
**Class:** OTHER
**Full Name:** Recep Tayyip Erdogan University
### Status Module
#### Completion Date
**Date:** 2024-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-05-26
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Recep Tayyip Erdogan University
#### Responsible Party
**Investigator Affiliation:** Recep Tayyip Erdogan University
**Investigator Full Name:** Zeynep Gumrukcu
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** This intervention is the treatment of alveolar osteitis (alveolitis) with different effects, which occurs due to the formation of clot after extraction, which is one of the most common intervals after tooth extraction.98 healthy patients with molar and premolar teeth with indication for extraction were taken to the Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Oral and Maxillofacial Diseases and Surgery clinic between May 2024 and June 2024 (age: 38 sessions: 19). -62) 113 teeth (85 molar, 28 premolar teeth) were treated with Spongostan placed in the tooth socket after extraction, spongostan with Chlorhexidine gel and spongostan with tranexamic acid, randomly distributed. After extraction, alveolitis was observed and evaluated prospectively using spongostan, chlorhexidine gel and tranexamic acid in the dental sockets. The researcher checked the participants on the 3rd and 7th days after the tooth extraction. The researcher recorded the pain and edema levels by asking the participants between 0 and 10 using the Visual Analogue Scale (VAS). The researcher filled in the forms for the presence of halitosis, trismus and exposed bone socket on the 3rd and 7th days (YES-NO). Permanent analyzes of the study were created with the SPSS package program.
### Conditions Module
**Conditions:**
- Alveolar Osteitis
**Keywords:**
- Alveolar Osteitis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 98
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** After tooth extraction, only saline irrigation was applied and a absorbable gelatin sponge was placed in the socket.
**Intervention Names:**
- Drug: Absorbable Gelatin
**Label:** just absorbable gelatin
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** After tooth extraction, after irrigation with saline, 2% chlorhexidine gel was absorbed into gelatin sponges and placed into the socket.
**Intervention Names:**
- Drug: Chlorhexidine
**Label:** absorbable gelatin with Chlorhexidine gel
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Tranexamic acid 50mg/ml for injection after saline irrigation after tooth extraction solution into gelatin sponges was applied to the socket after it was cured.
**Intervention Names:**
- Drug: Tranexamic acid
**Label:** absorbable gelatin with tranexamic acid
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- just absorbable gelatin
**Description:** After tooth extraction, only saline irrigation was applied and a absorbable gelatin sponge was placed in the socket.
**Name:** Absorbable Gelatin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- absorbable gelatin with Chlorhexidine gel
**Description:** After tooth extraction, after irrigation with saline, 2% chlorhexidine gel was absorbed into gelatin sponges and placed into the socket.
**Name:** Chlorhexidine
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- absorbable gelatin with tranexamic acid
**Description:** Tranexamic acid 50mg/ml for injection after saline irrigation after tooth extraction solution into gelatin sponges was applied to the socket after it was cured.
**Name:** Tranexamic acid
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** scored on visual analog scale from 0 to 10
**Measure:** pain
**Time Frame:** 3.-7. days
**Description:** scored on visual analog scale from 0 to 10
**Measure:** edema
**Time Frame:** 3. day - 7. day
**Description:** marked yes or no based on clinical examination
**Measure:** trismus
**Time Frame:** 3. day - 7. day
**Description:** marked yes or no based on clinical examination
**Measure:** halitosis
**Time Frame:** 3. day - 7. day
**Description:** marked yes or no based on clinical examination
**Measure:** alveolar osteitis
**Time Frame:** 3. day - 7. day
**Description:** marked yes or no based on anamnesis
**Measure:** smoking habit
**Time Frame:** operated day
**Description:** marked yes or no based on anamnesis
**Measure:** age
**Time Frame:** operated day
**Description:** marked yes or no based on clinical examination
**Measure:** tooth type
**Time Frame:** operated day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Healthy individuals between the ages of 18-65
2. Molar and premolar teeth with extraction indication
Exclusion Criteria:
1. Against drugs or substances to be used in surgery (articaine, tranexamic acid, chlorhexidine) have allergies,
2. Those who used antibiotics 30 days before the dental extraction,
3. Clinical and radiological examinations in the operation area 30 days before dental extraction and/or on the day of the procedure.
Any signs of pathology and infection (such as periapical pathology, pericoronitis),
4. Those who routinely use oral antiseptics,
5. Systemic fever, absence of growth such as lymphadenopathy (LAP),
6. Women are lactating or pregnant,
7. Using oral contraceptives,
8. Procedures that were not attended to control appointments (day 3-7) were not included.
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Rize
**Country:** Turkey
**Facility:** Recep Tayyip Erdoğan University
**Zip:** 53020
#### Overall Officials
**Official 1:**
**Affiliation:** Recep Tayyip Erdogan University
**Name:** Zeynep Gümrükçü
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
### Condition Browse Module - Browse Leaves
- ID: M12923
- Name: Osteitis
- Relevance: HIGH
- As Found: Osteitis
- ID: M7542
- Name: Dry Socket
- Relevance: HIGH
- As Found: Alveolar Osteitis
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal 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: D000010000
- Term: Osteitis
- ID: D000004368
- Term: Dry Socket
### Intervention Browse Module - Ancestors
- ID: D000000891
- Term: Anti-Infective Agents, Local
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000004202
- Term: Disinfectants
- ID: D000000933
- Term: Antifibrinolytic Agents
- ID: D000050299
- Term: Fibrin Modulating Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000006490
- Term: Hemostatics
- ID: D000003029
- Term: Coagulants
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: Coag
- Name: Coagulants
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M5953
- Name: Chlorhexidine
- Relevance: HIGH
- As Found: tDCS
- ID: M344731
- Name: Chlorhexidine gluconate
- Relevance: LOW
- As Found: Unknown
- ID: M16902
- Name: Tranexamic Acid
- Relevance: HIGH
- As Found: Stage IV
- ID: M8896
- Name: Gelatin Sponge, Absorbable
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4215
- Name: Anti-Infective Agents, Local
- Relevance: LOW
- As Found: Unknown
- ID: M7383
- Name: Disinfectants
- Relevance: LOW
- As Found: Unknown
- ID: M4252
- Name: Antifibrinolytic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M9576
- Name: Hemostatics
- Relevance: LOW
- As Found: Unknown
- ID: M6259
- Name: Coagulants
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000002710
- Term: Chlorhexidine
- ID: D000014148
- Term: Tranexamic Acid
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435819
**Brief Title:** ECA-enhanced Document Explanation RCT
**Official Title:** Advancing Medical Illustration in Patient Education Materials: From Art to Science. Study 2: ECA-enhanced Document Explanation RCT
#### Organization Study ID Info
**ID:** 427441
#### Organization
**Class:** OTHER
**Full Name:** Northeastern University
### Status Module
#### Completion Date
**Date:** 2027-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2026-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Tufts Medical Center
**Class:** OTHER
**Name:** Boston University
#### Lead Sponsor
**Class:** OTHER
**Name:** Northeastern University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The investigators will evaluate a computer-animated character that explains medical illustrations to people, comparing the character to having people understand the illustrations on their own, and also comparing the computer character on a computer display to one in immersive virtual reality. The investigators will determine which method leads to the best understanding and lowest anxiety.
**Detailed Description:** The investigators are developing a new approach to explaining patient education documents and illustrations to patients with varying levels of health literacy, involving the use of Embodied Conversational Agents (ECAs). The investigators will evaluate our ECA-augmented Document Explanation tool to determine whether it improves patient learning relative to traditional static patient education documents. The investigators will conduct a 3-arm randomized between-subjects experiment, in which participants read a patient education document with embedded medical illustration, either unaided (CONTROL), with the assistance of an ECA rendered in 2D on a standard computer monitor (ECA-2D), or with the assistance of an ECA in immersive Virtual Reality (ECA-3D).
### Conditions Module
**Conditions:**
- Healthy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** 3-treatment between-subjects randomized experiment
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants read a patient education document with the assistance of an embodied conversational agent rendered in 2D on a computer monitor.
**Intervention Names:**
- Other: Embodied Conversational Agent (ECA)
**Label:** ECA-2D
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants read a patient education document with the assistance of an embodied conversational agent in virtual reality.
**Intervention Names:**
- Other: Embodied Conversational Agent (ECA)
**Label:** ECA-3D
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Participants read a patient education document without assistance.
**Label:** CONTROL
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ECA-2D
- ECA-3D
**Description:** A computer-animated character that can explain a medical illustration to laypersons.
**Name:** Embodied Conversational Agent (ECA)
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** A multiple-item knowledge test designed to test comprehension of the patient education document
**Measure:** Knowledge
**Time Frame:** Baseline and 30 minutes
**Description:** Self-report state anxiety scale from the State-Trait Anxiety Inventory. 20 items, 4-point Likert scale. A higher score indicates more severe anxiety with a potential range from 20 to 80.
**Measure:** State Anxiety scale from State-Trait Anxiety Inventory
**Time Frame:** 30 minutes
#### Secondary Outcomes
**Description:** Likert items to assess satisfaction with the document and illustration
**Measure:** Satisfaction with illustration
**Time Frame:** 30 minutes
**Description:** Likert items to assess perceived effort in reading a document and illustration
**Measure:** Reading Effort
**Time Frame:** 30 minutes
**Description:** Likert items to assess acceptability and appropriateness of the illustration
**Measure:** Acceptability
**Time Frame:** 30 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Over 18 years old
* Speaks English or Spanish fluently
* Is able to independently consent
* Has adequate corrected vision to read patient education documents
Exclusion Criteria:
\* None
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Timothy Bickmore, PhD
**Phone:** 6173735477
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Boston
**Country:** United States
**Facility:** Tufts Medical Center
**State:** Massachusetts
**Zip:** 02111
**Location 2:**
**City:** Boston
**Country:** United States
**Facility:** Northeastern University
**State:** Massachusetts
**Zip:** 02115
#### Overall Officials
**Official 1:**
**Affiliation:** Northeastern University
**Name:** Timothy Bickmore, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Sharing of de-identified human subjects data will be consistent with HIPAA guidelines and the Final NIH Statement on Sharing Research Data. We do not anticipate any limitations on sharing.
**Description:** Quantitative measures of comprehension and anxiety will be collected from participants who either have patient education documents explained to them by embodied conversational agents or read the documents themselves. We will create de-identified data sets of all quantitative human subjects data that will be preserved and shared. The purpose for creating this is to allow other investigators access to the data to both validate our findings and to further advance inquiry in the field.
**Info Types:**
- STUDY_PROTOCOL
- ICF
**IPD Sharing:** YES
**Time Frame:** Prior to end of the study.
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435806
**Brief Title:** Medical Illustration Design Characteristic Evaluation
**Official Title:** Advancing Medical Illustration in Patient Education Materials: From Art to Science. Study 1: Medical Illustration Design Characteristic Evaluation
#### Organization Study ID Info
**ID:** 427440
#### Organization
**Class:** OTHER
**Full Name:** Northeastern University
### Status Module
#### Completion Date
**Date:** 2027-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-25
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Tufts Medical Center
**Class:** OTHER
**Name:** Boston University
#### Lead Sponsor
**Class:** OTHER
**Name:** Northeastern University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this study is to understand what people understand from medical illustrations, and what meaning and emotions (such as anxiety) they derive from different design elements.
**Detailed Description:** The investigators will conduct cognitive interviews to understand the meaning laypersons obtain from different illustrations, their opinions on illustration styles, and their level of anxiety after viewing illustrations.
The investigators will also study the effect of systematically varying medical illustration designs on layperson understanding and anxiety.
### Conditions Module
**Conditions:**
- Healthy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** We will select 10 binary distinctions of medical illustration design elements and test each in a two-arm between-subjects evaluation.
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 8200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Medical Illustration Design Distinction 1, version A
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 1, version A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Medical Illustration Design Distinction 1, version B
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 1, version B
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Medical Illustration Design Distinction 2, version A
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 2, version A
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Medical Illustration Design Distinction 2, version B
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 2, version B
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** Medical Illustration Design Distinction 3, version A
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 3, version A
**Type:** EXPERIMENTAL
#### Arm Group 6
**Description:** Medical Illustration Design Distinction 3, version B
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 3, version B
**Type:** EXPERIMENTAL
#### Arm Group 7
**Description:** Medical Illustration Design Distinction 4, version A
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 4, version A
**Type:** EXPERIMENTAL
#### Arm Group 8
**Description:** Medical Illustration Design Distinction 4, version B
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 4, version B
**Type:** EXPERIMENTAL
#### Arm Group 9
**Description:** Medical Illustration Design Distinction 5, version A
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 5, version A
**Type:** EXPERIMENTAL
#### Arm Group 10
**Description:** Medical Illustration Design Distinction 5, version B
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 5, version B
**Type:** EXPERIMENTAL
#### Arm Group 11
**Description:** Medical Illustration Design Distinction 6, version A
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 6, version A
**Type:** EXPERIMENTAL
#### Arm Group 12
**Description:** Medical Illustration Design Distinction 6, version B
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 6, version B
**Type:** EXPERIMENTAL
#### Arm Group 13
**Description:** Medical Illustration Design Distinction 7, version A
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 7, version A
**Type:** EXPERIMENTAL
#### Arm Group 14
**Description:** Medical Illustration Design Distinction 7, version B
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 7, version B
**Type:** EXPERIMENTAL
#### Arm Group 15
**Description:** Medical Illustration Design Distinction 8, version A
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 8, version A
**Type:** EXPERIMENTAL
#### Arm Group 16
**Description:** Medical Illustration Design Distinction 8, version B
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 8, version B
**Type:** EXPERIMENTAL
#### Arm Group 17
**Description:** Medical Illustration Design Distinction 9, version A
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 9, version A
**Type:** EXPERIMENTAL
#### Arm Group 18
**Description:** Medical Illustration Design Distinction 9, version B
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 9, version B
**Type:** EXPERIMENTAL
#### Arm Group 19
**Description:** Medical Illustration Design Distinction 10, version A
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 10, version A
**Type:** EXPERIMENTAL
#### Arm Group 20
**Description:** Medical Illustration Design Distinction 10, version B
**Intervention Names:**
- Other: Medical Illustration design
**Label:** Medical Illustration Design Distinction 10, version B
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Medical Illustration Design Distinction 1, version A
- Medical Illustration Design Distinction 1, version B
- Medical Illustration Design Distinction 10, version A
- Medical Illustration Design Distinction 10, version B
- Medical Illustration Design Distinction 2, version A
- Medical Illustration Design Distinction 2, version B
- Medical Illustration Design Distinction 3, version A
- Medical Illustration Design Distinction 3, version B
- Medical Illustration Design Distinction 4, version A
- Medical Illustration Design Distinction 4, version B
- Medical Illustration Design Distinction 5, version A
- Medical Illustration Design Distinction 5, version B
- Medical Illustration Design Distinction 6, version A
- Medical Illustration Design Distinction 6, version B
- Medical Illustration Design Distinction 7, version A
- Medical Illustration Design Distinction 7, version B
- Medical Illustration Design Distinction 8, version A
- Medical Illustration Design Distinction 8, version B
- Medical Illustration Design Distinction 9, version A
- Medical Illustration Design Distinction 9, version B
**Description:** We will test 10 binary design variants for medical illustrations (for example, with and without cut-away, with and without text labels, etc). Specific variants to be identified during first task of project.
**Name:** Medical Illustration design
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** A multiple-item knowledge test designed to test comprehension of the patient education document
**Measure:** Knowledge
**Time Frame:** Baseline and 30 minutes
**Description:** Self-report state anxiety scale from the State-Trait Anxiety Inventory. 20 items, 4-point Likert scale. A higher score indicates more severe anxiety with a potential range from 20 to 80.
**Measure:** State Anxiety scale from State-Trait Anxiety Inventory
**Time Frame:** 30 minutes
#### Secondary Outcomes
**Description:** Likert items to assess satisfaction with the document and illustration
**Measure:** Satisfaction with the medical illustration
**Time Frame:** 30 minutes
**Description:** Likert items to assess perceived effort in reading a document and illustration
**Measure:** Reading Effort
**Time Frame:** 30 minutes
**Description:** Likert items to assess acceptability and appropriateness of the illustration
**Measure:** Acceptability
**Time Frame:** 30 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Over 18 years old
* Speaks English or Spanish fluently
* Is able to independently consent
* Has adequate corrected vision to read patient education documents
Exclusion Criteria:
\* None
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Timothy Bickmore, PhD
**Phone:** 6173735477
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Boston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Cameron Neeson
- **Phone:** 617-636-5747
- **Role:** CONTACT
**Country:** United States
**Facility:** Tufts Medical Center
**State:** Massachusetts
**Status:** NOT_YET_RECRUITING
**Zip:** 02111
**Location 2:**
**City:** Boston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Madison Blain
- **Phone:** 617-858-6727
- **Role:** CONTACT
**Country:** United States
**Facility:** Northeastern University
**State:** Massachusetts
**Status:** RECRUITING
**Zip:** 02115
#### Overall Officials
**Official 1:**
**Affiliation:** Northeastern University
**Name:** Timothy Bickmore, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Sharing of de-identified human subjects data will be consistent with HIPAA guidelines and the Final NIH Statement on Sharing Research Data. We do not anticipate any limitations on sharing.
**Description:** Transcripts from 100 cognitive interviews, and quantitative measures of comprehension and anxiety from 7,600 participant reactions to patient education documents will be generated. We will create de-identified data sets of all quantitative human subjects data that will be preserved and shared. The purpose for creating this is to allow other investigators access to the data to both validate our findings and to further advance inquiry in the field.
**Info Types:**
- STUDY_PROTOCOL
- ICF
**IPD Sharing:** YES
**Time Frame:** Prior to end of the study.
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435793
**Brief Title:** Expiratory Pressure in Healthy Individuals
**Official Title:** Determining Factors of the Maximal Expiratory Pressure in Healthy Individuals: Influence of the Mouthpiece Configuration
#### Organization Study ID Info
**ID:** P2024/081
#### Organization
**Class:** OTHER
**Full Name:** Laboratory of Movement, Condorcet, Tournai, Belgium
### Status Module
#### Completion Date
**Date:** 2025-09-18
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-18
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Mons
#### Lead Sponsor
**Class:** OTHER
**Name:** Laboratory of Movement, Condorcet, Tournai, Belgium
#### Responsible Party
**Investigator Affiliation:** University of Mons
**Investigator Full Name:** Dr F Duprez
**Investigator Title:** Physiotherapist / Professor at Provincial High School Condorcet (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 present study aims at enhancing our understanding of the influence of the mouthpiece configuration on the amplitude of oral pressures generated during a maximum expiratory pressure maneuver and on the neuromuscular recruitment of expiratory muscles (more specifically of the internal oblique and the transverse abdominal muscles).
Incidentally, it also aims at clarifying the role of orofacial muscles, if any, in the neuromuscular recruitment of the aforementioned muscles.
**Detailed Description:** Enhancing our understanding of the influence of the mouthpiece configuration on oral pressures and on the neuromuscular recruitment of the internal oblique and the transverse abdominal muscles during a maximum expiratory pressure (MEP) maneuver is the primary goal of this study
Maximal Respiratory Mouth Pressures (MIP and MEP):
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) are commonly used indices to assess respiratory muscle strength at the mouth.
MIP measures the strength of inspiratory muscles, while MEP assesses expiratory muscle strength.
These measurements are simple, convenient, and noninvasive. However, clear standards for these measurements are not well-established.
Choice of Mouthpiece:
We propose exploring different mouthpiece designs to know their impact on pressure measurements.
Influence of Mouthpiece Design:
The type of mouthpiece used can affect pressure measurements. Some investigators recommend including a small leak in the measuring circuit to dissipate pressure generated in the mouth and minimize measurement errors.
However, specific studies focusing on the influence of mouthpiece design on MEP and neuromuscular recruitment of expiratory muscles (such as the internal oblique and transverse muscles) during MEP maneuvers would be valuable.
Additional Considerations:
Factors like body position (sitting vs. half-lying) may also impact pressure measurements, although no significant differences were found in one study.
Among the objectives of our study, we aim at exploring ways to improve the accuracy and reliability of respiratory pressure measurements.
In summary, understanding the impact of mouthpiece design on oral pressures during MEP maneuvers is essential for accurate assessment of respiratory muscle function. Further research in this area could provide valuable insights for clinical practice and pulmonary function laboratories.
### Conditions Module
**Conditions:**
- Respiratory Physiology
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Procedure: MEP measurement - Surface EMG - IOPI
**Label:** Healthy subjects
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Healthy subjects
**Description:** Participants will undergo serial expiratory maneuvers using variously-sized circular mouthpieces and a reference ovoid-shaped mouthpiece.
At each maneuver, the maximal expiratory mouth pressure at total lung capacity will be measured, alongside with the degree of neuromuscular activation of the internal oblique and transverse abdominal muscles using surface electromyography.
The Orbicularis Oris strength will also be measured using the Iowa Oral Performance Instrument.
**Name:** MEP measurement - Surface EMG - IOPI
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Measure:** Maximal expiratory pressure
**Time Frame:** 120 minutes
**Measure:** Root mean square of the EMG signal
**Time Frame:** 120 minutes
#### Secondary Outcomes
**Description:** Obtained after computational processing of participant photographs using a MatLab based software. This index is a newly developed marker of the Orbicularis Oris function based on different anthropometric variables
**Measure:** Orbicularis Oris Performance Index
**Time Frame:** 5 minutes
**Description:** Obtained through the Iowa Oral Performance Instrument
**Measure:** Orbicularis Oris strength
**Time Frame:** 10 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age over 18
Exclusion Criteria:
* Any neuromuscular disease or condition susceptible to interfere with the results
* Pregnant women
* Any contraindications to the realization of maximal expiratory maneuvers, as defined in the ATS Pulmonary Function Laboratory Management And Procedure Manual (3rd Edition)
* Excessive abdominal gird, compromising ultrasonographic positioning of electrodes or altering signal quality
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Eliot Rudy Mbolo Ebubu (MD, PhD candidate)
**Phone:** 0032485114738
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Frederic Duprez (PhD)
**Phone:** 0032475857104
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Mons
**Name:** Alexandre Legrand (MD, PhD)
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Provincial High School of Hainaut, Condorcet
**Name:** Frederic Duprez (PhD)
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** University of Mons
**Name:** Eliot Rudy Mbolo Ebubu (MD, PhD candidate)
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435780
**Brief Title:** Novel Technique Versus Conventional Subepithelial Connective Tissue Graft in Treatment of Ridge Contour Defects
**Official Title:** Evaluation of a Novel Technique Versus Conventional Subepithelial Connective Tissue Graft in Treatment of Ridge Contour Defects. A Randomized Controlled Clinical Trial
#### Organization Study ID Info
**ID:** FWA #00022887
#### Organization
**Class:** OTHER
**Full Name:** Misr International University
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-04
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Misr International University
#### Responsible Party
**Investigator Affiliation:** Misr International University
**Investigator Full Name:** Ahmed Abo El Futtouh
**Investigator Title:** Clinical Director of International Implantology Program (IIP)
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The aim of the study is to clinically and radiographically evaluate and compare two techniques to augment soft tissues: the conventional subepithelial connective tissue graft technique and a novel denuded interpositional pedicled rolled flap technique (DIPRF) These techniques will be used to augment edentulous ridges that are recommended for rehabilitation by an implant or a fixed restoration.
**Detailed Description:** Fifty patients with soft tissue ridge contour defects in the maxillary premolar region and recommended for rehabilitation by an implant or a fixed restoration will be enrolled. Patients will be allocated randomly into two groups; group 1 (test group) will have augmentation for their soft tissue by a novel Denuded interpositional pedicled rolled flap technique (DIPRF); group 2 (control group) will be augmented by the conventional subepithelial connective tissue graft technique. Clinical volumetric change evaluation and ridge thickness analysis using digitally calibrated casts and CBCT analysis with a fusion software will be performed for every site as well as periodontal evaluation and patient centered outcomes, including pain and satisfaction after the procedure will be recorded for both techniques. For each site, an impression will be used to pour a cast that will be digitally scanned and vertical and horizontal ridge contours dimensions(tissue volumetric changes) will be recorded. These measurements will be obtained before the surgical procedure, 2 weeks, and 3 and 6 months post-surgical. CBCT analysis will be performed pre-operatively to confirm the diagnosis and eligibility of the case as having only soft tissue defect without bone defects, and 6 months postoperatively to analyze the amount of soft tissue gain in the two groups.
### Conditions Module
**Conditions:**
- Defect in Alveolar Ridge
**Keywords:**
- ridge contour defect
- soft tissue graft
- Rolling Technique
- Connective tissue graft
- Subepithelial palatal graft
- Seibert Class I
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Augmentation for their soft tissue by a novel Denuded interpositional pedicled rolled flap technique (DIPRF)
**Intervention Names:**
- Procedure: DIPRF
**Label:** Experimental group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Will be augmented by the conventional subepithelial connective tissue graft technique.
**Intervention Names:**
- Procedure: DIPRF
**Label:** Control group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control group
- Experimental group
**Description:** Denuded interpositional pedicled rolled flap technique
**Name:** DIPRF
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Ridge contour will be assessed using CBCT analysis using fusion software. The differences between measurement times will indicate the amount of bone gain
**Measure:** Ridge contour thickness gain
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Adults above the age of 18 to 50 years.
2. Males and females as confirmed by asking the female patients about whether they are pregnant or not
3. Patient's with Seibert classification class I requiring future rehabilitation of one or more premolar region and sound adjacent teeth.
4. Soft tissue thickness on the palatal tissues more than 6mm at the site of harvesting the graft.
5. Presence of Mandibular posterior teeth opposing the tooth to be replaced for occlusion.
6. Clinically healthy soft tissues with no signs of clinical pathology of the soft tissue.
7. Good oral hygiene.
8. Patient accepts to sign an informed consent.
9. ASA I or ASA II Patient.
Exclusion Criteria:
1. Patients with ridge defects due to bone defect
2. Smoker patients who smoke more than 10 cigarettes per day
3. Pregnant females
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Hebattallah A Mattar
**Phone:** 201207000253
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cairo
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Maqhassen M Farghaly, Professor
- **Phone:** 201006708522
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Misr International University
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Misr International University
**Name:** Hebattallah A Mattar
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Scharf DR, Tarnow DP. Modified roll technique for localized alveolar ridge augmentation. Int J Periodontics Restorative Dent. 1992;12(5):415-25.
**PMID:** 1343013
**Citation:** Su H, Gonzalez-Martin O, Weisgold A, Lee E. Considerations of implant abutment and crown contour: critical contour and subcritical contour. Int J Periodontics Restorative Dent. 2010 Aug;30(4):335-43.
**PMID:** 20664835
**Citation:** Seibert JS. Reconstruction of deformed, partially edentulous ridges, using full thickness onlay grafts. Part I. Technique and wound healing. Compend Contin Educ Dent (Lawrenceville). 1983 Sep-Oct;4(5):437-53. No abstract available.
**PMID:** 6578906
**Citation:** Meltzer JA. Edentulous area tissue graft correction of an esthetic defect. A case report. J Periodontol. 1979 Jun;50(6):320-2. doi: 10.1902/jop.1979.50.6.320.
**PMID:** 287786
**Citation:** Langer B, Calagna L. The subepithelial connective tissue graft. J Prosthet Dent. 1980 Oct;44(4):363-7. doi: 10.1016/0022-3913(80)90090-6.
**PMID:** 6931898
**Citation:** Kaldahl WB, Tussing GJ, Wentz FM, Walker JA. Achieving an esthetic appearance with a fixed prosthesis by submucosal grafts. J Am Dent Assoc. 1982 Apr;104(4):449-52. doi: 10.14219/jada.archive.1982.0209.
**PMID:** 6950973
**Citation:** Garber DA, Rosenberg ES. The edentulous ridge in fixed prosthodontics. Compend Contin Educ Dent (Lawrenceville). 1981 Jul-Aug;2(4):212-23. No abstract available.
**PMID:** 6950860
**Citation:** Abrams L. Augmentation of the deformed residual edentulous ridge for fixed prosthesis. Compend Contin Educ Gen Dent. 1980 May-Jun;1(3):205-13. No abstract available.
**PMID:** 6950834
**Citation:** Soehren SE, Allen AL, Cutright DE, Seibert JS. Clinical and histologic studies of donor tissues utilized for free grafts of masticatory mucosa. J Periodontol. 1973 Dec;44(12):727-41. doi: 10.1902/jop.1973.44.12.727. No abstract available.
**PMID:** 4586681
**Citation:** Akcali A, Schneider D, Unlu F, Bicakci N, Kose T, Hammerle CH. Soft tissue augmentation of ridge defects in the maxillary anterior area using two different methods: a randomized controlled clinical trial. Clin Oral Implants Res. 2015 Jun;26(6):688-95. doi: 10.1111/clr.12368. Epub 2014 Apr 10.
**PMID:** 24720375
**Citation:** Mormann W, Schaer F, Firestone AR. The relationship between success of free gingival grafts and transplant thickness. Revascularization and shrinkage--a one year clinical study. J Periodontol. 1981 Feb;52(2):74-80. doi: 10.1902/jop.1981.52.2.74.
**PMID:** 6164778
**Citation:** Studer SP, Lehner C, Bucher A, Scharer P. Soft tissue correction of a single-tooth pontic space: a comparative quantitative volume assessment. J Prosthet Dent. 2000 Apr;83(4):402-11. doi: 10.1016/s0022-3913(00)70034-5.
**PMID:** 10756289
**Citation:** Thoma DS, Benic GI, Zwahlen M, Hammerle CH, Jung RE. A systematic review assessing soft tissue augmentation techniques. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:146-65. doi: 10.1111/j.1600-0501.2009.01784.x.
**PMID:** 19663961
**Citation:** Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
**PMID:** 30211382
**Citation:** Gurlek O, Sonmez S, Guneri P, Nizam N. A novel soft tissue thickness measuring method using cone beam computed tomography. J Esthet Restor Dent. 2018 Nov;30(6):516-522. doi: 10.1111/jerd.12428. Epub 2018 Nov 15.
**PMID:** 30444040
**Citation:** Das G, Ahmed AR, Suleman G, Lal A, Rana MH, Ahmed N, Arora S. A Comparative Evaluation of Dentogingival Tissue Using Transgingival Probing and Cone-Beam Computed Tomography. Medicina (Kaunas). 2022 Sep 19;58(9):1312. doi: 10.3390/medicina58091312.
**PMID:** 36143989
**Citation:** Smeets EC, de Jong KJ, Abraham-Inpijn L. Detecting the medically compromised patient in dentistry by means of the medical risk-related history. A survey of 29,424 dental patients in The Netherlands. Prev Med. 1998 Jul-Aug;27(4):530-5. doi: 10.1006/pmed.1998.0285.
**PMID:** 9672946
**Citation:** Ammar AH, Ahmed E, ElBarbary A, Ghalwash D, Ezz Elarab A. Clinical Comparison of the Volumetric Changes in Single Pontic Site Development through Connective Tissue Grafting Using Modified Pouch Technique versus Pouch Technique in the Maxillary Esthetic Zone: A Randomized Controlled Clinical Trial. Int J Dent. 2022 Aug 25;2022:1677471. doi: 10.1155/2022/1677471. eCollection 2022.
**PMID:** 36059913
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435767
**Brief Title:** Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy
**Official Title:** Quantitative Nodal Burden as a Determinant Identifying Ampullary Adenocarcinoma Patients Benefiting From Adjuvant Chemotherapy: A Retrospective Cohort Study
#### Organization Study ID Info
**ID:** CICAMS
#### Organization
**Class:** OTHER
**Full Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2026-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences
#### Responsible Party
**Investigator Affiliation:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences
**Investigator Full Name:** Dong Bing Zhao
**Investigator Title:** Deputy director
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Ampullary cancer, a rare malignancy, lacks standardized guidelines for effective multimodal treatment following curative resection. The opinions on whether postoperative chemotherapy can improve the long-term survival of ampullary adenocarcinoma (AA) are discordant. This aspect remains poorly studied, with comparably scant research conducted on it.
log odds of positive lymph nodes (LODDS), a quantitative variable, can continuously and accurately reflect the burden of nodal involvement, which suggested a potential ability to identify AA patients benefiting from postoperative adjuvant chemotherapy (ACT). Therefore, Mainly focused issues of ACT addressed in the study are as follows: 1) the role of ACT in improving long-term survival for patients with AA after curative resection. 2) the role of LODDS in identifying postoperative AA patients benefiting from ACT. 3) compared with T and N classifications reported previously, the advantage of LODDS in identifying ACT-benefited patients.
In this cohort study, a large scale of sample size was conducted by drawing on the collective experience of the National Cancer Center of China. The patients treated with radiotherapy were excluded to concentrate on the effect of ACT.
### Conditions Module
**Conditions:**
- Ampullary Adenoma
- Chemotherapy Effect
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** In the Cancer Hospital, postoperative chemotherapy regimens and doses were planned by oncologists, with adjustments made based on drug toxicities or tumor responses.
**Name:** Adjuvant chemotherapy
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The association between ACT and Overall Survival (OS) of patients
**Measure:** The role of adjuvant chemotherapy(ACT)
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** The association between ACT and Cancer-specific Survival (CSS) of patients
**Measure:** The role of adjuvant chemotherapy(ACT)
**Time Frame:** 1 year
**Description:** The association between ACT and Recurrence-free Survival (RFS) of patients
**Measure:** The role of adjuvant chemotherapy(ACT)
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Pathologically confirmed AA patients without distant metastasis treated with curative-intent resection
Exclusion Criteria:
patients who received neoadjuvant therapy or radiotherapy, as well as those with missing clinical pathological or follow-up information
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** In this international, retrospective cohort study, the cohort of Chinese enrolled patients who underwent curative surgery for AA at the National Cancer Center of China, Chinese Academy of Medical Sciences, Cancer Hospital, from January 1, 1998, to December 31, 2020 (NCC cohort). The Ethics Committee of the National Cancer Center of China approved the study. Informed consent was secured from participants, authorizing the utilization for potential research. Additionally, patients with AA between January 1, 2004, and December 31, 2017, in the surveillance, epidemiology and end results program were collected as the Western cohort. In which, 12 registries were enrolled including Alaska Natives, California, Connecticut, Georgia, Hawaii, Iowa, Kentucky, Louisiana, New Jersey, New Mexico, Seattle (Puget Sound), and Utah.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zheng Li, M.D.
- **Phone:** 18745750740
- **Role:** CONTACT
**Country:** China
**Facility:** Department of Pancreatic and Gastric Surgical Oncology, National Cancer Center/ National Clinical Research for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
**Status:** RECRUITING
**Zip:** 100021
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002277
- Term: Carcinoma
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M3585
- Name: Adenocarcinoma
- Relevance: HIGH
- As Found: Adenocarcinoma
- ID: M3591
- Name: Adenoma
- Relevance: HIGH
- As Found: Adenoma
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000230
- Term: Adenocarcinoma
- ID: D000000236
- Term: Adenoma
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435754
**Brief Title:** Hard and Soft Tissue Changes Following Vestibular Socket Preservation Versus Ice Cream Cone Technique for Management of Defective Fresh Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial
**Official Title:** Hard and Soft Tissue Changes Following Vestibular Socket Preservation Versus Ice Cream Cone Technique for Management of Defective Fresh Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial
#### Organization Study ID Info
**ID:** 110589
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2025-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cairo University
#### Responsible Party
**Investigator Affiliation:** Cairo University
**Investigator Full Name:** Norai Ahmed Mohamed Zayed
**Investigator Title:** Dentist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Evaluation of hard and soft tissue changes following vestibular socket preservation versus ice cream cone technique for management of defective fresh extraction sockets in the esthetic zone.
**Detailed Description:** The aim of this randomized clinical trial is to assess the volumetric and radiographic ridge contour changes following alveolar ridge preservation using Vestibular socket preservation in patient with type II fresh extraction sockets, versus ice cream cone technique.
In patients needing extraction in anterior maxilla with type II sockets, there will be no difference between the Vestibular socket preservation and ice cream cone technique regarding the changes in alveolar ridge contour.
### Conditions Module
**Conditions:**
- Alveolar Ridge Preservation
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Alveolar ridge preservation following atraumatic extraction using Vestibular Socket preservation.
**Intervention Names:**
- Procedure: Intervention group Vestibular Socket Preservation
**Label:** Intervention group Vestibular Socket Preservation
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Alveolar ridge preservation following atraumatic extraction using ice cream cone technique.
**Intervention Names:**
- Procedure: Control Group ice cream cone technique
**Label:** Control group ice cream cone technique
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention group Vestibular Socket Preservation
**Description:** After atraumatic extraction Vestibular access horizontal incision will be made at the socket site, at the mucco-buccal fold. Subperiosteal tunnel will be created from the facial aspect of the socket orifice and extending apically until the extent of the vestibular access incision. A cortical shield will be introduced from the vestibular incision through the tunnel and the Socket will be filled by xenograft . Apical cut will be made at the palatal aspect to free the pedicle flap connective tissue and the pedicle flap will be raised using periosteal elevator and rotated and rolled occlusally to seal the socket and sutured using interrupted sutures . The primary palatal flap will be sutured in place over the donor site palatally using interrupted sutures.
**Name:** Intervention group Vestibular Socket Preservation
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Control group ice cream cone technique
**Description:** After atraumatic extraction Collagen barrier membrane will be shaped as an ice cream cone and placed in the extraction socket lining the buccal tissues. The socket will be filled with Demineralized Bovine Bone Matrix DBBM.The upper part of the membrane will be used to cover the socket and will be stabilized by interrupted sutures using prolene sutures of size 6-0
**Name:** Control Group ice cream cone technique
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Soft tissue linear buccal distance will be measured using 3D scans via intaoral digital scanner at baseline, 3 months and 6 months using 3D software (NemoSmile Design 3D, Nemotec, Madrid, Spain) and STL viewer (3Shape Ortho viewer, 3Shape, Denmark)
**Measure:** Linear buccal distance (mm)
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** Radiographic assessment using Cone Beam Computed Tomography to assess the labiopalatal alveolar ridge width reduction and changes in the height of the socket buccal and lingual ridges. Cone Beam Computed Tomography (CBCT) (Carestream Health, CS 8100 3D System) will be performed preoperative, baseline and 6 months postoperative.
**Measure:** Changes in the height of the socket buccal and palatal ridges (mm)
**Time Frame:** 6 months
**Description:** Labiopalatal volumetric ridge contour analysis will be measured using 3D scans via intaoral digital scanner at baseline, 3 months and 6 months using 3D software (NemoSmile Design 3D, Nemotec, Madrid, Spain) and STL viewer (3Shape Ortho viewer, 3Shape, Denmark) and scans will be superimposed on each other.
**Measure:** Labiopalatal volumetric ridge contour analysis (mm)
**Time Frame:** 6 months
**Description:** Patient satisfaction will be evaluated using questionnaires during the 2 weeks after ARP.
**Measure:** Patient satisfaction (Yes/No)
**Time Frame:** 2 weeks
**Description:** The severity of subjective pain and swelling will be evaluated using the visual analog scale (VAS) score (score range = 0-10, with 0 reflecting no pain and swelling), and durations of pain and swelling will be investigated during the 2 weeks after ARP
**Measure:** Pain (1-10)
**Time Frame:** 2 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults from the age of 18 - 40 years
* Patients with non-restorable maxillary teeth/tooth indicated for extraction in the area from 2nd premolar to 2nd premolar
* Type II sockets will be selected as revealed by Cone beam computed tomography (CBCT).
* Intact gingival tissue with at least 2mm keratinized tissue
* Absence of any systemic disease or drugs that contraindicate oral surgery using Modified
* Cornell Medical Index .
* Patients accepts to provide informed consent
Exclusion Criteria:
* Pregnant and lactating females.
* Smokers as smoking is a contraindication for any plastic periodontal surgery.
* Patients with BOP\>15%.
* Patients with periodontal diseases .
* Handicapped and mentally retarded patients.
* Patients undergoing radiotherapy.
* Presence of systemic disease that would affect wound healing.
* Presence of active infection with soft tissue communication.
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Norai Zayed, Masters
**Phone:** 01221444954
**Role:** CONTACT
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435741
**Brief Title:** Molecular Imaging of Gastric Cancer Metastatic Lymph Nodes with 99mTc-3PRGD2 Probe.
**Official Title:** Lymph Node Dissection of Gastric Cancer Based on Molecular Imaging of Metastatic Lymph Nodes of Gastric Cancer with 99mTc-3PRGD2 Probes
#### Organization Study ID Info
**ID:** QNJJ2022017
#### Organization
**Class:** OTHER
**Full Name:** Peking University Cancer Hospital & Institute
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Status Verified Date:** 2023-09
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking University Cancer Hospital & Institute
#### Responsible Party
**Investigator Affiliation:** Peking University Cancer Hospital & Institute
**Investigator Full Name:** jiayongning
**Investigator Title:** Doctor
**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:** Surgical lymph node dissection is the key to advanced gastric cancer. In recent years, after the overall implementation of standard D2 dissection, lymph node dissection for gastric cancer began to explore the direction of D1+ again. Current clinical studies of gastric cancer lymph node dissection based on intraoperative fluorescence navigation show that non-tumor specific lymph node fluorescence navigation surgery can only increase the total number of lymph nodes detected and ensure the completion of the dissection but not the accuracy. The sensitivity and specificity of the tracer metastatic lymph nodes are 56.3% (410/728), respectively. Specificity 46.1% (2669/5785). Tumor specific tracing of positive lymph nodes is the key to achieve accurate lymph node dissection for gastric cancer. Although tumor specific tracers are developing rapidly and related clinical studies are gradually being carried out, there are few reports on specific clinical studies on lymph node metastasis, suggesting that lymph node tracing is still a difficult problem. Previous basic studies have suggested that integrins play an important molecular biological role in the process of tumor lymph node metastasis. In the early stage, 99mTc3PRGD2 SPECT-CT showed good lymph node imaging effect in lung cancer and breast cancer, and 99mTc-oncoFAPI PET-CT also showed good lymph node imaging effect in gastric cancer. Therefore, this study aims to explore the application prospect of 99mTc3PRGD2 and other probes in molecular imaging of gastric cancer metastatic lymph nodes and guidance of lymph node dissection and tracer, so as to accumulate preliminary clinical data for exploring corresponding fluorescent probes for intraoperative tracer of gastric cancer lymph nodes.
### Conditions Module
**Conditions:**
- Stomach Neoplasm
- Lymph Node Metastasis
- RADIONUCLIDE IMAGING
**Keywords:**
- Gastric cancer
- Lymph node metastasis
- Tumor molecular imaging
- Integrin
- Fibroblast activating protein
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Outcomes Module
#### Primary Outcomes
**Measure:** Sensitivity and specificity of 99mTc-3PRGD2 SPECT-CT imaging of metastatic lymph nodes in gastric cancer.
**Time Frame:** the sensitivity and specificity were determined according to pathological finding after operation.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Gastric adenocarcinoma was confirmed by histological examination, and the clinical stage was cT2-4N+M0 locally advanced stage;
2. Age 18-75 years old;
3. No previous drug treatment, radiotherapy and other treatments;
4. ECOG 0\~1 points, KPS\>70 points;
5. The baseline blood routine and biochemical indexes of the subjects meet the following criteria: hemoglobin ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet ≥100×109/L; ALT, AST≤2.5 times the normal upper limit; ALP≤2.5 times the normal upper limit; Serum total bilirubin \<1.5 times the normal upper limit; Serum creatinine \<1 times the normal upper limit; Serum albumin ≥30g/L;
6. Radical surgical resection (D2 lymph dissection) was performed in all patients.
7. Willing and able to comply with the plan during the study;
8. Provide written informed consent before entering the study screening, and the patient has understood that he or she can withdraw from the study at any time of the study with no loss.
Exclusion Criteria:
1. Pregnant or nursing women;
2. Clinically serious (i.e., active) heart disease, such as symptomatic coronary heart disease, NYHA Class II or worse congestive heart failure, or severe arrhythmia requiring medical intervention (see Appendix 12), or a history of myocardial infarction within the last 12 months;
3. Moderate or severe renal impairment \[creatinine clearance equal to or less than 50 ml/min (calculated from Cockroft and Gault equations)\], or serum creatinine \> the upper limit of normal (ULN);
4. Patients with impaired liver function, ALT or AST less than or equal to 3×ULN, total bilirubin less than or equal to 1.5 ×ULN, or with proven Gilbert syndrome at baseline (unbound hyperbilirubinemia), serum albumin greater than or equal to 3.0 g/dL;
5. History of iodine allergy (ICG contains iodine) or allergy to ICG;
6. History of hyperthyroidism;
7. Under the physiological function state of the general elderly, the drug should be administered with caution.
**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:** yongning Jia
**Phone:** 0086-10-88196606
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009385
- Term: Neoplastic Processes
- ID: D000009369
- Term: Neoplasms
- ID: D000010335
- Term: Pathologic Processes
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000013272
- Term: Stomach Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- 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: M16064
- Name: Stomach Neoplasms
- Relevance: HIGH
- As Found: Stomach Neoplasms
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: HIGH
- As Found: Metastases
- ID: M11204
- Name: Lymphatic Metastasis
- Relevance: HIGH
- As Found: Lymph Node Metastasis
- ID: M12330
- Name: Neoplastic Processes
- 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: M16062
- Name: Stomach Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5486
- Name: Stomach Cancer
- Relevance: HIGH
- As Found: Gastric Cancer
### Condition Browse Module - Meshes
- ID: D000009362
- Term: Neoplasm Metastasis
- ID: D000013274
- Term: Stomach Neoplasms
- ID: D000008207
- Term: Lymphatic Metastasis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435728
**Brief Title:** Predictive Value of Combining AccuIMR and AccuFFR in Patients With STEMI
**Official Title:** Predictive Value of Combining Angio-Based Index of Microcirculatory Resistance and Fractional Flow Reserve in Patients With STEMI
#### Organization Study ID Info
**ID:** D2023173
#### Organization
**Class:** OTHER
**Full Name:** Peking University Third Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-04-30
**Type:** ACTUAL
#### Start Date
**Date:** 2024-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking University Third Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Patients with acute myocardial infarction were enrolled retrospectively. The fractional flow reserve (AccuFFR) and microcirculatory resistance index (AccuIMR) based on coronary angiography were analyzed, and the relationship between FFR and IMR and the prognosis of patients with acute myocardial infarction was analyzed
**Detailed Description:** We retrospectively enrolled STEMI patients who underwent PCI in Peking University Third Hospital. The fractional flow reserve (AccuFFR) and microcirculatory resistance index (AccuIMR) based on coronary angiography were obtained by analyzing the coronary angiography images. The prognosis of patients was obtained by searching inpatient and outpatient systems and telephone follow-up. The relationship between AccuFFR, AccuIMR and prognosis was statistically analyzed
### Conditions Module
**Conditions:**
- Acute ST Segment Elevation Myocardial Infarction
- Prognosis
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 1297
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with STEMI who underwent primary PCI and were hospitalized at Peking University Third Hospital between January 2017 and March 2022
**Intervention Names:**
- Diagnostic Test: AccuIMR and AccuFFR
**Label:** STEMI
### Interventions
#### Intervention 1
**Arm Group Labels:**
- STEMI
**Description:** AccuFFR and AccuIMR were obtained by reviewing coronary angiography at the time of primary PCI
**Name:** AccuIMR and AccuFFR
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** cardiovascular death, all-cause death, readmission for heart failure (HF), and recurrent coronary events
**Measure:** MACE
**Time Frame:** 3 years after myocardial infarction
#### Secondary Outcomes
**Description:** nonfatal myocardial infarction, unplanned PCI, and unplanned coronary artery bypass grafting
**Measure:** recurrent coronary events
**Time Frame:** 3 years after myocardial infarction
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age of \>18 years;
* Onset-to-treatment time of ≤12 h, meeting the diagnostic criteria for STEMI;
* underwent primary PCI within 12 h of symptom onset and achieved successful PCI in the culprit vessel;
* Availability of complete clinical data
Exclusion Criteria:
* severe tortuosity and overlap of the target vessel;
* poor-quality coronary angiography images;
* missing two coronary angiography images \>25° apart
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with STEMI who underwent primary PCI and were hospitalized at Peking University Third Hospital between January 2017 and March 2022.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Beijing
**Country:** China
**Facility:** Peking University Third Hospital
#### Overall Officials
**Official 1:**
**Affiliation:** Peking University Third Hospital
**Name:** Ming Cui, Dorctor
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007511
- Term: Ischemia
- ID: D000010335
- Term: Pathologic Processes
- ID: D000009336
- Term: Necrosis
- ID: D000017202
- Term: Myocardial Ischemia
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000014652
- Term: Vascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12155
- Name: Myocardial Infarction
- Relevance: HIGH
- As Found: Myocardial Infarction
- ID: M10282
- Name: Infarction
- Relevance: HIGH
- As Found: Infarction
- ID: M1072
- Name: ST Elevation Myocardial Infarction
- Relevance: HIGH
- As Found: ST-segment Elevation Myocardial Infarction
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M12284
- Name: Necrosis
- Relevance: LOW
- As Found: Unknown
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: LOW
- As Found: Unknown
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009203
- Term: Myocardial Infarction
- ID: D000072657
- Term: ST Elevation Myocardial Infarction
- ID: D000007238
- Term: Infarction
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435715
**Brief Title:** The Effect of 10 Repetitions of Deep Breathing Exercises
**Official Title:** The Effect of 10 Repetitions of Deep Breathing Exercises Compared to 3 Repetitions of Deep Breathing Exercises on The Sleep Quality of Post-Cardiac Surgery Patients
#### Organization Study ID Info
**ID:** DP.04.03/KEP071/EC027/2024
#### Organization
**Class:** OTHER
**Full Name:** Indonesia University
### Status Module
#### Completion Date
**Date:** 2024-05-20
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-05-20
**Type:** ACTUAL
#### Start Date
**Date:** 2024-04-29
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Indonesia University
#### Responsible Party
**Investigator Affiliation:** Indonesia University
**Investigator Full Name:** Indra Gilang Pamungkas
**Investigator Title:** Ns. Indra Gilang Pamungkas, S.Kep., M.Kep
**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 learn and assess the effect of 10 repetitions of deep breathing exercises every 3 hours compared to 3 repetitions of deep breathing exercises on the sleep quality of patients after heart surgery.
The main questions it aims to answer are:
How does 10 repetitions of deep breathing exercises every 3 hours affect the sleep quality of patients after heart surgery?
Researchers will compare 10 repetitions of deep breathing exercises every 3 hours to 3 repetitions of deep breathing exercises to see if 10 repetitions of deep breathing exercises every 3 hours work to improve sleep quality.
Participants will:
1. Respondents in the intervention group performed 10 repetitions of deep breathing exercises every 3 hours for 3 days.
2. Respondents in the control group performed 3 repetitions of deep breathing exercises for 3 days.
**Detailed Description:** 1. Researchers carried out recruitment when the patient had undergone surgery.
2. Researchers determine potential respondents who meet the inclusion criteria.
3. Researchers explain to potential respondents the procedures, objectives, benefits and risks of the research being conducted.
4. Researchers provide time and opportunity for potential respondents to confirm research procedures.
5. The researcher provided an informed consent sheet as a form of respondent's agreement to their involvement in the research.
6. Researchers determine respondents for the intervention and control groups.
7. Respondents do a pretest. The pretest was administered by administering a sleep characteristics and quality questionnaire.
8. Researchers provide education to patients regarding deep breathing exercise procedures.
9. Respondents in the intervention group performed deep breathing exercises with 10 repetitions every 3 hours for 3 days. Respondents in the control group did 3 repetitions of deep breathing exercises.
10. Respondents are monitored in the implementation process using a monitoring form.
11. Respondents who completed the exercise will conduct a post-test assessment.
### Conditions Module
**Conditions:**
- Heart; Surgery, Heart, Functional Disturbance as Result
**Keywords:**
- Breathing Exercise
- Sleep Quality
- Cardiac Surgical Procedures
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This study used a parallel Randomized Controlled Trial (RCT) with a 1:1 ratio.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Outcome assessors were not involved during the intervention process. Respondents were also asked not to inform the outcome assessor of the measures they received.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The group that carries out the intervention of the treatment being studied
**Intervention Names:**
- Other: 10 Repetitions of Deep Breathing Exercise
**Label:** Intervention Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The group that did usual care
**Intervention Names:**
- Other: 3 Repetitions of Deep Breathing Exercise
**Label:** Control Group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention Group
**Description:** Respondents in the intervention group performed 10 repetitions of deep breathing exercises every 3 hours for 3 days.
**Name:** 10 Repetitions of Deep Breathing Exercise
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Control Group
**Description:** Respondents in the control group performed 3 repetitions of deep breathing exercises for 3 days.
**Name:** 3 Repetitions of Deep Breathing Exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Sleep quality experienced by patients after undergoing heart surgery
**Measure:** Sleep Quality
**Time Frame:** 30 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients who have undergone cardiac surgery, both on-pump and off-pump.
* The patient's hemodynamic condition is stable.
* More than equal to 18 years old.
* Able to communicate, read and write in Indonesian.
Exclusion Criteria:
* Patients who receive sleeping medication or sedative therapy.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Jakarta
**Country:** Indonesia
**Facility:** National Cardiovascular Centre Harapan Kita
**State:** DKI Jakarta
**Zip:** 11420
#### Overall Officials
**Official 1:**
**Affiliation:** Indonesia University
**Name:** Indra G Pamungkas, Master
**Role:** STUDY_CHAIR
### References Module
#### References
**Citation:** Ghorbani A, Hajizadeh F, Sheykhi MR, Mohammad Poor Asl A. The Effects of Deep-Breathing Exercises on Postoperative Sleep Duration and Quality in Patients Undergoing Coronary Artery Bypass Graft (CABG): a Randomized Clinical Trial. J Caring Sci. 2018 Dec 1;8(4):219-224. doi: 10.15171/jcs.2019.031. eCollection 2019 Dec.
**PMID:** 31915624
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M27137
- Name: Respiratory Aspiration
- Relevance: HIGH
- As Found: Breathing
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000053120
- Term: Respiratory Aspiration
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435702
**Brief Title:** Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy: A Prospective Observational Cohort Study
**Official Title:** A Prospective Observational Cohort Study of Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy
#### Organization Study ID Info
**ID:** LM2023526
#### Organization
**Class:** OTHER
**Full Name:** Peking University Third Hospital
### Status Module
#### Completion Date
**Date:** 2029-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Bayer
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking University Third Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
### Description Module
**Brief Summary:** This study is an open, prospective, single-center observational clinical study to evaluate the efficacy and safety of immediate adjuvant ADT with darotarolimide in the treatment of patients with positive lymph nodes after radical prostatectomy for prostate cancer.
**Detailed Description:** This study is an open, prospective, single-center observational clinical study to evaluate the efficacy and safety of immediate adjuvant ADT with darotarolimide in the treatment of patients with positive lymph nodes after radical prostatectomy for prostate cancer. The study evaluates the efficacy of immediate adjuvant ADT with darotarolimide in patients with positive lymph nodes after radical prostatectomy for prostate cancer, using time to achieve CRPC as the primary study endpoint. OS will be examined in all patients after the primary study endpoint is achieved and will serve as the key secondary study endpoint. It is planned to enroll 108 patients with positive lymph nodes after radical prostatectomy for prostate cancer. It is divided into a screening period, a treatment period and a follow-up period. Patients will enter the screening period from the time they sign the informed consent form, and those who have been evaluated and qualified in the screening period will be entered into the study. Patients eligible for enrollment will receive 2 years of ADT treatment or ADT treatment + darotarotide adjuvant therapy with or without combination radiotherapy at the investigator's discretion.
### Conditions Module
**Conditions:**
- Prostate Cancer
**Keywords:**
- Lymph Node-positive
- Prostate Cancer
- Radical Prostatectomy
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 108
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Darolutamide 600mg twice daily. The ADT regimen was either a gonadotropin-releasing hormone analog agonist or a gonadotropin-releasing hormone antagonist.The ADT administration type, frequency, and dose were determined by the investigator.
**Intervention Names:**
- Drug: Darolutamide in addition to androgen deprivation therapy
**Label:** Darolutamide in addition to androgen deprivation therapy
#### Arm Group 2
**Description:** The ADT regimen was either a gonadotropin-releasing hormone analog agonist or a gonadotropin-releasing hormone antagonist.The ADT administration type, frequency, and dose were determined by the investigator.
**Intervention Names:**
- Drug: androgen deprivation therapy only
**Label:** androgen deprivation therapy only
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Darolutamide in addition to androgen deprivation therapy
**Description:** Darolutamide 600mg twice daily. The ADT regimen was either a gonadotropin-releasing hormone analog agonist or a gonadotropin-releasing hormone antagonist.The ADT administration
**Name:** Darolutamide in addition to androgen deprivation therapy
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- androgen deprivation therapy only
**Description:** The ADT regimen was either a gonadotropin-releasing hormone analog agonist or a gonadotropin-releasing hormone antagonist.The ADT administration type, frequency, and dose were determined by the investigator.
**Name:** androgen deprivation therapy only
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** castrate resistant prostate cancer
**Measure:** Time to CRPC
**Time Frame:** Time from initiation to the occurrence of PSA progression or imaging progression, whichever occurs first.
#### Secondary Outcomes
**Description:** metastasis-free survival
**Measure:** MFS
**Time Frame:** Time to metastasis or death confirmed from enrollment imaging, whichever occurred first
**Description:** radiography Progression-Free-Survival
**Measure:** rPFS
**Time Frame:** Time from initiation to imaging progression or death from any cause, whichever occurs first
**Description:** radiography Progression-Free-Survival
**Measure:** PSA-PFS
**Time Frame:** Time from initiation to PSA progression or death, whichever occurs first
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. patients voluntarily enrolled in the study and signed an informed consent form; 2. aged 18-80 years (including 18 and 80 years), male; 3. diagnosed with prostate adenocarcinoma by pathology or cytology; 4. Eastern Cooperative Oncology Group (ECOG) Physical Status (PS) score 0-1. 5. patients who have undergone radical prostatectomy (RP) and pelvic lymph node dissection (PLND) without non-regional lymph node metastasis, bone metastasis, or metastasis to other sites (e.g., visceral metastasis) as confirmed by conventional imaging (bone imaging, CT, or MRI) or PSMA PET/CT 6. have positive postoperative pathologic lymph nodes (pN1); 7. with their consent and have signed an informed consent form.
Exclusion Criteria:
* Patients will not be enrolled if they have any of the following:
1. have histologic features of neuroendocrine differentiation or small cell carcinoma;
2. have received prior treatment for prostate cancer: postoperative systemic therapy including ADT for \>3 months, conventional endocrine therapy (e.g., flutamide, bicalutamide) for \>3 months, novel endocrine therapy (e.g., dalotamide, abiraterone, abatacept, enzalutamide), chemotherapy (e.g., docetaxel), immunotherapy, and targeted therapies
3. Inability to tolerate Darotamine or ADT treatment;
4. persons who are allergic or have a known history of allergy to darotarolimide or ADT;
5. other conditions that the investigator considers inappropriate for inclusion.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study population consisted of patients with non-metastatic prostate cancer who underwent radical prostatectomy with positive pathologic lymph nodes
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Shudong Zhang, MD
**Phone:** +86 010-82266699
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Shudong Zhang, MD
- **Phone:** +86 010-82266699
- **Role:** CONTACT
**Country:** China
**Facility:** Peking University Third Hospital
**State:** Beijing
**Zip:** 100191
## 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
### Intervention Browse Module - Ancestors
- ID: D000006728
- Term: Hormones
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000975
- Term: Antioxidants
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000020011
- Term: Protective Agents
- ID: D000014815
- Term: Vitamins
- ID: D000018977
- Term: Micronutrients
- ID: D000004967
- Term: Estrogens
- ID: D000018931
- Term: Antineoplastic Agents, Hormonal
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000045930
- Term: Anabolic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M4059
- Name: Androgens
- Relevance: HIGH
- As Found: Geriatric
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: M4513
- Name: Ascorbic Acid
- Relevance: HIGH
- As Found: Geriatric
- ID: M11751
- Name: Methyltestosterone
- Relevance: HIGH
- As Found: Geriatric
- ID: M16509
- Name: Testosterone
- Relevance: LOW
- As Found: Unknown
- ID: M223475
- Name: Testosterone undecanoate
- Relevance: LOW
- As Found: Unknown
- ID: M223485
- Name: Testosterone enanthate
- Relevance: LOW
- As Found: Unknown
- ID: M235012
- Name: Testosterone 17 beta-cypionate
- Relevance: LOW
- As Found: Unknown
- ID: M8115
- Name: Estrogens, Conjugated (USP)
- Relevance: HIGH
- As Found: Geriatric
- ID: M8116
- Name: Estrogens
- Relevance: LOW
- As Found: Unknown
- ID: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
- ID: M21869
- Name: Protective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: M21009
- Name: Micronutrients
- Relevance: LOW
- As Found: Unknown
- ID: M16885
- Name: Trace Elements
- Relevance: LOW
- As Found: Unknown
- ID: M20966
- Name: Antineoplastic Agents, Hormonal
- Relevance: LOW
- As Found: Unknown
- ID: M3032
- Name: Anabolic Androgenic Steroids
- Relevance: LOW
- As Found: Unknown
- ID: M25605
- Name: Anabolic Agents
- Relevance: LOW
- As Found: Unknown
- ID: T437
- Name: Ascorbic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T477
- Name: Vitamin C
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000001205
- Term: Ascorbic Acid
- ID: D000008777
- Term: Methyltestosterone
- ID: D000000728
- Term: Androgens
- ID: D000004966
- Term: Estrogens, Conjugated (USP)
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435689
**Acronym:** I-COMET
**Brief Title:** Study and Modulation of Immune Responses in Primary and Metastatic Colon Cancers
**Official Title:** Etude et Modulation de la réponse Immunitaire Dans Les Cancers COlorectaux Primaires et METastatiques
#### Organization Study ID Info
**ID:** APHP231721
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
### Status Module
#### Completion Date
**Date:** 2039-06-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assistance Publique - Hôpitaux de Paris
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Colorectal cancer (CRC) is the 3rd most common cancer in France. Treatment of CRC relies primarily on surgical removal of the primary tumor and chemotherapy is the current standard of care for synchronous metastatic disease. Overall survival remains strongly correlated with the tumor stage at the time of surgery, from 90% at five years for localized disease (stages 1 and 2), to around 20% for metastatic forms of the disease (stage 4). Recent research in cancer highlights the role of the immune system in the development, evolution and fate of tumors. Understanding the nature of interactions between different immune cells infiltrating the tumor is important for the development of innovative therapies. Recently, the consensus molecular classification of CRC confirmed the importance of the immune response in CRC by showing that a "high immune response" is a good prognostic indicator for patients with this pathology. However, immunotherapies are effective for only a minority of patients with metastatic CRC. Indeed, anti Programmed cell Death 1 (anti-PD-1), -PD-L1 immune checkpoint blocking antibodies have only shown effectiveness in patients with microsatellite instability (MSI), which only represents 5% of metastatic CRCs.
Thus, the aim of this study is to better understand the role of the immune system on the development of CRC and its possible modulation to treat or prevent metastatic recurrences.
### Conditions Module
**Conditions:**
- Colon Cancer
- Peritoneal Carcinoma
**Keywords:**
- Organoids
- T-cells
- Metastasis
- Immunotherapies
### Design Module
#### Bio Spec
**Description:** Blood and surgical specimen sampling the day of surgery (primary tumor and metastases if applicable)
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 500
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: Sampling
**Label:** Patients undergoing surgery for the treatment of primary and/or metastatic colorectal cancers
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients undergoing surgery for the treatment of primary and/or metastatic colorectal cancers
**Description:** Blood and surgical specimen sampling the day of surgery
**Name:** Sampling
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Characterize effective immunotherapies in colorectal cancers by demonstrating their effectiveness in a co-culture model between cancer cells and autologous T cells.
**Measure:** Effectiveness of immunotherapies in a co-culture model
**Time Frame:** At 1 year
#### Secondary Outcomes
**Description:** Evaluation of transcriptomic differences between tissues or cells from the healthy mucosa compared to those from the primary or metastatic tumor: sequencing of mRNA in the two types of mucosa and comparison of mRNA expression profiles between the latter.
**Measure:** Evaluation of transcriptomic differences
**Time Frame:** At 5 years
**Description:** Evaluation of proteomic differences between tissues or cells from the healthy mucosa in comparison to those from the primary tumor by:
multiplexed immunodetection in situ in tissues detection and dosage of proteins in culture supernatants (ELISA), in a co-culture model between cancer cells and autologous T cells, with or without modulation of a pathway targeting the T lymphocyte response by immunotherapy.
**Measure:** Evaluation of proteomic differences
**Time Frame:** At 5 years
**Description:** Evaluation of the TCR repertoire by sequencing, carried out from:
patient blood, DNA from cancerous tissues and healthy mucosa DNA from the co-culture between cancer cells and autologous T cells, with or without modulation of a pathway targeting the T lymphocyte response by immunotherapy
**Measure:** Evaluation of the T Cell Receptor (TCR) repertoire
**Time Frame:** At 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male or female 18 years of age or older
* Diagnosis of colorectal adenocarcinoma
* Scheduled resection of tumor and/or metastasis(es)
Exclusion Criteria:
* Patient's opposition to research
* Patients under guardianship
* The following situations
1. Persons unable to understand and/or read the information leaflet
2. Patient with one of the following functions: Investigator or co-investigator, research assistant, pharmacist, study coordinator or, having any involvement in the study
3. Non-cooperative or potentially non-compliant person for the study and its procedures with foreseeable difficulties in regular follow-up over 5 years.
4. Non-affiliation with a social security scheme, Couverture Médicale Universelle or any equivalent scheme.
* Pregnant or breast-feeding women.
* HIV-positive patients.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients undergoing surgery for the treatment of primary and/or metastatic colorectal cancers
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Thomas Aparicio, Pr
**Phone:** 142499597
**Phone Ext:** +33
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jérôme Lambert, Pr
**Phone:** 142499742
**Phone Ext:** +33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Thomas Aparicio, Pr
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Saint Louis - gastoenterology
**Location 2:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Diane Goéré, Pr
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Saint Louis - visceral, oncological and endocrine surgery
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: LOW
- As Found: Unknown
- ID: M6338
- Name: Colonic Neoplasms
- Relevance: HIGH
- As Found: Colon Cancer
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003110
- Term: Colonic Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: LOW
- As Found: Unknown
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435676
**Brief Title:** A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects
**Official Title:** A Phase I Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of HRS9531 Tablets in Healthy Subjects
#### Organization Study ID Info
**ID:** HRS9531-T-101
#### Organization
**Class:** INDUSTRY
**Full Name:** Fujian Shengdi Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-26
### 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:** The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS9531tablets in healthy subjects.
### Conditions Module
**Conditions:**
- Overweight or Obesity; Type 2 Diabetes
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** randomized, double-blind, placebo-controlled
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 92
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Administered po once
**Intervention Names:**
- Drug: HRS9531
**Label:** SAD Stage: HRS9531
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Administered po once
**Intervention Names:**
- Drug: Placebo
**Label:** SAD Stage: placebo
**Type:** PLACEBO_COMPARATOR
#### Arm Group 3
**Description:** Administered po for multiple dose
**Intervention Names:**
- Drug: HRS9531
**Label:** MAD Stage: HRS9531
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Administered po for multiple dose
**Intervention Names:**
- Drug: Placebo
**Label:** MAD Stage: placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SAD Stage: HRS9531
**Description:** Single dose escalation of HRS9531 tablets in healthy subjects
**Name:** HRS9531
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- SAD Stage: placebo
**Description:** Single dose of placebo in healthy adults
**Name:** Placebo
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- MAD Stage: HRS9531
**Description:** Multiple dose escalation of HRS9531 tablets in healthy subjects
**Name:** HRS9531
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- MAD Stage: placebo
**Description:** Multiple dose of placebo in healthy adults
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** SAD Stage: Number of Adverse Events
**Time Frame:** 36 days
**Measure:** MAD Stage: Number of Adverse Events
**Time Frame:** 63 days
#### Secondary Outcomes
**Description:** Tmax of a single dose of HRS9531 tablets
**Measure:** Plasma Concentration-Time to Peak (Tmax) of HRS9531
**Time Frame:** 36 days
**Description:** AUC of a single dose of HRS9531 tablets
**Measure:** Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531
**Time Frame:** 36 days
**Description:** anti-HRS9531 antibody
**Measure:** Immunogenicity qualitative
**Time Frame:** 36 days
**Description:** Tmax of multiple dose of HRS9531 tablets
**Measure:** Plasma Concentration-Time to Peak (Tmax) of HRS9531
**Time Frame:** 63 days
**Description:** AUC of multiple dose of HRS9531 tablets
**Measure:** Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531
**Time Frame:** 63 days
**Description:** fasting plasma glucose
**Measure:** Glucose
**Time Frame:** 35 days
**Description:** anti-HRS9531 antibody
**Measure:** Immunogenicity qualitative
**Time Frame:** 63 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Ability to understand the trial procedures, be able and willing to provide a written informed consent.
2. 18-55 years of age at the time of signing informed consent.
3. SAD stage: Body weight ≥50 kg,19.0 ≤BMI≤ 35.0 kg/m2 at screening visit. MAD stage: 24.0 ≤BMI≤ 35.0 kg/m2 at screening visit.
4. Subjects with good general health, no clinically significant abnormalities.
Exclusion Criteria:
1. Known or suspected hypersensitivity to trial product(s) or related products.
2. With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study.
3. Abnormal and clinically significant blood pressure at screening.
4. Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
5. Participation in other clinical trials.
6. Presence of any clinically significant results in examination at screening visit.
7. Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
8. Presence of - clinically significant ECG results.
9. Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
10. Addiction to tobacco and alcohol.
11. In the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.
**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:** Hongcheng Hu
**Phone:** 0518-82342973
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jianting Han
**Phone:** 15620796974
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hefei
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Wei Hu, Doctor
- **Phone:** 86+13856086475
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Yijun Du, Doctor
- **Phone:** 86+13866700016
- **Role:** CONTACT
**Country:** China
**Facility:** The Second Hospital Of Anhui medical University
**State:** Anhui
**Zip:** 230601
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M7119
- Name: Diabetes Mellitus, Type 2
- Relevance: LOW
- As Found: Unknown
- ID: M26186
- Name: Overweight
- Relevance: HIGH
- As Found: Overweight
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000050177
- Term: Overweight
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435663
**Brief Title:** The Clinical Application of Ultramicro-flow Technique in the Treatment of Benign Uterine Tumors With High-intensity Focused Ultrasound
**Official Title:** Fellow Docotor, Master's Degree
#### Organization Study ID Info
**ID:** KY-2024-080
#### 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:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-26
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### 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:** High intensity focused ultrasound ablation (HIFUA) is a new non-invasive treatment method for uterine tumors. Traditionally, nuclear magnetic resonance imaging (NMRI), also known as magnetic resonance imaging (MRI), is used as guidance to focus ultrasound on the fibroid tissue, generating high temperatures of 65-85 ℃, causing protein inactivation, cell apoptosis, and coagulation necrosis of tumor cells. While accurately ablating fibroid tissue, it avoids damaging normal tissue outside the treatment area. Since 2000, a large number of clinical studies have demonstrated the safety and effectiveness of MRI for HIFUA in the treatment of uterine fibroids. In 2013, the Chinese FDA approved MRI guided HIFUA treatment for uterine fibroids. At present, more and more medical institutions in China have introduced this device and carried out non-invasive treatment of uterine fibroids. In March 2020, the Minimally Invasive Treatment Group of the Magnetic Resonance Application Professional Committee of the China Medical Equipment Association designated the "Chinese Expert for MRI Guided Focused Ultrasound Treatment of Uterine Fibroids", making HIFUA more standardized. Superb micro vascular imaging (SMI) is an improved Doppler technology that applies a new adaptive algorithm to remove tissue motion signals and blood flow overflow phenomena, and can clearly display the extremely low velocity blood flow inside the blood vessels. Previous studies have shown that SMI has a significantly higher ability to detect blood vessels in tumors than color Doppler flow imaging (CDFI), and can more sensitively detect the blood flow of microvessels within tumors. This provides a cheap and simple non-invasive examination method for clinical practice, and real-time guidance for treatment can be provided during the treatment process, making it easy to operate and promote in clinical practice.
This study randomly divided all adult patients diagnosed with uterine fibroids or adenomyosis admitted to our hospital from May 2024 to December 2024 into two groups based on the inclusion and exclusion of specimens: 1) Experimental group: HIFUA treatment, treatment efficacy evaluation using SMI technology; control group: HIFUA treatment, treatment efficacy evaluation using organ contrast-enhanced ultrasound technology.
Both groups of subjects need to be followed up: at 3 months, 6 months, and 12 months after treatment, patients will undergo gynecological uterine ultrasound examination at the outpatient department, and the volume of uterine fibroids or adenomyosis will be recorded. The aim of this study is to compare the accuracy data of two groups in evaluating treatment effectiveness, and to verify that ultra-fine blood flow imaging (SMI) technology is superior to organ contrast-enhanced ultrasound in evaluating the efficacy of HIFUA treatment。
**Detailed Description:** Research object All adult patients diagnosed with uterine fibroids or adenomyosis admitted to our hospital from May 2024 to December 2024.
Inclusion criteria Patients with clinically diagnosed uterine fibroids or adenomyosis who meet the following conditions: 1) Imaging shows that the uterine fibroids are located between the muscle walls, or are pedunculated subserosal or submucosal fibroids, which are classified as types 2-6 by the International Federation of Gynecology and Obstetrics (FIGO); The diagnosis of adenomyosis is clear; 2) The imaging shows that there is no intestinal obstruction between uterine fibroids or adenomyosis and the abdominal wall, or the impact of intestinal obstruction can be eliminated through treatment, making it a safe treatment path; 3) Abdominal subcutaneous fat thickness ≤ 4 cm; 4) The farthest distance from the abdominal wall skin to the target area for treating fibroids is ≤ 14 cm; 5) The patient is generally in good condition and can tolerate and maintain a prone position for 2 hours or longer. 6) Adult and infertile women.
Exclusion criteria
1) Unclear clinical diagnosis; 2) Uterine fibroids or adenomyosis rapidly increase in the short term, or imaging suggests a tendency for malignancy, or the malignant potential is uncertain; 3) Acute skin infection in the treatment area; 4) Uncontrolled acute pelvic inflammatory disease; 5) The general condition is poor, with severe dysfunction of important organs such as the heart, liver, and kidneys; 6) Severe coagulation dysfunction; 7) There are large skin scars in the treatment area of the lower abdomen. 8) Sedative and analgesic drugs cannot be used; 9) Postmenopausal enlarged uterine fibroids or adenomyosis. 10) Pregnant women, individuals with mental disorders, cognitive impairments, etc. who are unable to cooperate with treatment.
Materials and Methods Experimental materials
1. Haiying HY2900 ultrasound focusing equipment (Wuxi Haiying Medical Technology Co., Ltd.) Toshiba Aplio i800 color ultrasound diagnostic instrument (Toshiba Medical Systems Co., Ltd.), equipped with SMI imaging software, convex array probe, frequency 1-6MHz, using color mode ultra fine vessel imaging (eSMI);
2. The contrast agent used is sulfur hexafluoride microbubbles for injection (Shanghai Bolaike Xinyi Pharmaceutical Co., Ltd.).
Research methods
Randomly group the included subjects:
1. Experimental group: In HIFUA treatment, SMI technology was used to evaluate the therapeutic effect. The SMI technology used Toshiba Aplio 800 color ultrasound diagnostic instrument, equipped with SMI imaging software, convex array probe, frequency 1-6 MHz, and color mode ultra fine vessel imaging (eSMI). After the target lesion is determined by abdominal scanning, adjust the depth and gain, and record the number, location, size, shape and boundary of the lesion. CDFI and eSMI modes were used to observe the blood supply within the lesion, which were classified into 4 levels according to Adler grading criteria: 0 level, with no blood flow signal inside the fibroid; Grade 1, with a small amount of blood flow signal within the fibroid, with 1-2 short rod-shaped blood flows visible; Level 2, moderate to equal blood flow signal, with one clear blood vessel visible within the fibroid, with a length exceeding the lesion radius or 3-4 short rod-shaped blood flow signals visible; Level 3, rich blood flow, with 4 or more blood vessels visible within the fibroid. The surrounding blood vessels of the fibroid form a network around the entire fibroid, presenting a ball hugging sign, or have multiple branching branches extending into the fibroid, interweaving into a network or patchy pattern. Detect hemodynamic parameters, including peak systolic velocity (PSV) and resistance index (RD), and compare hemodynamic data to calculate the effectiveness of changes in uterine benign tumor physical examination after treatment.
2. Control group: In HIFUA treatment, organ ultrasound contrast evaluation technology was used for efficacy evaluation. Sono Vue (Bracco company) was used as the contrast agent. Before use, 5 ml of physiological saline was injected into the bottle, vigorously shaken until the freeze-dried powder was completely dispersed. 1.5 ml of contrast agent was extracted and rapidly injected through the anterior elbow vein, followed by 5 ml of physiological saline injection. After injecting contrast agent, start the timer at the same time, observe under ultrasound imaging, keep the probe stationary during examination, observe continuously for 2 minutes, and store dynamic images. The CEUS enhancement degree of uterine fibroids can be divided into: high enhancement: the enhancement degree is higher than that of the uterine muscle layer; Equal enhancement: The degree of enhancement is equal to the uterine muscle layer; Low enhancement: The degree of enhancement is lower than that of the uterine muscle layer. Calculate the effective rate of physical examination changes in benign uterine tumors after treatment by displaying ablation volume through contrast-enhanced ultrasound before and after treatment.
Both groups of subjects need to be followed up: at 3 months, 6 months, and 12 months after treatment, patients will undergo gynecological uterine ultrasound examination at the outpatient department, and the volume of uterine fibroids or adenomyosis will be recorded.
Efficacy evaluation: Calculate the volume of uterine fibroids before treatment, ablation rate, and volume reduction rate at 3 months, 6 months, and 12 months. Volume (cm3)=left and right diameter (cm) X anterior and posterior diameter (cm) X long diameter (cm) X 0.523, ablation rate=volume of non perfused area after treatment/volume of uterine fibroids before treatment X 100%, volume reduction rate=(volume of uterine fibroids before treatment - volume of uterine fibroids after 3.6.12 months after treatment)/volume of uterine fibroids before treatment X 100%. Ablation rate of 70% is considered satisfactory, 50% V ablation rate\<70% is partial ablation, and ablation rate V 5 (less than 50)% is considered ineffective. SMI evaluates the blood flow signal inside uterine fibroids. Level 0 indicates satisfactory ablation, level 1 indicates partial ablation, and levels 2-3 indicate ineffective ablation 2) Control group: In HIFUA treatment, organ ultrasound contrast evaluation technology was used for efficacy evaluation. Sono Vue (Bracco company) was used as the contrast agent. Before use, 5 ml of physiological saline was injected into the bottle, vigorously shaken until the freeze-dried powder was completely dispersed. 1.5 ml of contrast agent was extracted and rapidly injected through the anterior elbow vein, followed by 5 ml of physiological saline injection. After injecting contrast agent, start the timer at the same time, observe under ultrasound imaging, keep the probe stationary during examination, observe continuously for 2 minutes, and store dynamic images. The CEUS enhancement degree of uterine fibroids can be divided into: high enhancement: the enhancement degree is higher than that of the uterine muscle layer; Equal enhancement: The degree of enhancement is equal to the uterine muscle layer; Low enhancement: The degree of enhancement is lower than that of the uterine muscle layer. Calculate the effective rate of physical examination changes in benign uterine tumors after treatment by displaying ablation volume through contrast-enhanced ultrasound before and after treatment.
Both groups of subjects need to be followed up: at 3 months, 6 months, and 12 months after treatment, patients will undergo gynecological uterine ultrasound examination at the outpatient department, and the volume of uterine fibroids or adenomyosis will be recorded.
Efficacy evaluation: Calculate the volume of uterine fibroids before treatment, ablation rate, and volume reduction rate at 3 months, 6 months, and 12 months. Volume (cm3)=left and right diameter (cm) X anterior and posterior diameter (cm) X long diameter (cm) X 0.523, ablation rate=volume of non perfused area after treatment/volume of uterine fibroids before treatment X 100%, volume reduction rate=(volume of uterine fibroids before treatment - volume of uterine fibroids after 3.6.12 months after treatment)/volume of uterine fibroids before treatment X 100%. Ablation rate of 70% is considered satisfactory, 50% V ablation rate\<70% is partial ablation, and ablation rate V 5 (less than 50)% is considered ineffective. SMI evaluates the blood flow signal inside uterine fibroids. Level 0 indicates satisfactory ablation, level 1 indicates partial ablation, and levels 2-3 indicate ineffective ablation
### Conditions Module
**Conditions:**
- Patients With Uterine Fibroids Receiving HIFUA Treatment ,and Can Undergo Regular Follow-up
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In HIFUA treatment, SMI technology was used to evaluate the therapeutic effect. The SMI technology used Toshiba Aplio 800 color ultrasound diagnostic instrument, equipped with SMI imaging software, convex array probe, frequency 1-6 MHz, and color mode ultra fine vessel imaging (eSMI). After the target lesion is determined by abdominal scanning, adjust the depth and gain, and record the number, location, size, shape and boundary of the lesion. CDFI and eSMI models were used to observe the blood supply within the lesion, which were divided into four levels according to Adler grading criteria. Hemodynamic parameters were measured, including peak systolic velocity (PSV) and resistance index (RD). Hemodynamic data were compared to calculate the effectiveness of changes in uterine benign tumor examination after treatment.
**Intervention Names:**
- Other: Different methods of efficacy evaluation
**Label:** experimental group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** In HIFUA treatment, organ ultrasound contrast evaluation technology is used for efficacy evaluation. Sono Vue (Bracco company) is used as the contrast agent. Before use, 5 ml of physiological saline is injected into the bottle, vigorously shaken until the freeze-dried powder is completely dispersed. 1.5 ml of contrast agent is extracted and rapidly injected through the anterior elbow vein, followed by 5 ml of physiological saline injection. After injecting contrast agent, start the timer at the same time, observe under ultrasound imaging, keep the probe stationary during examination, observe continuously for 2 minutes, and store dynamic images. Calculate the effective rate of physical examination changes in benign uterine tumors after treatment by displaying ablation volume through contrast-enhanced ultrasound before and after treatment.
**Intervention Names:**
- Other: Different methods of efficacy evaluation
**Label:** control group
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- control group
- experimental group
**Description:** When the treatment method remains unchanged, compare the accuracy data of the effectiveness evaluation between the two groups, and verify that the ultra-fine blood flow imaging technology (SMI) is superior to the organ contrast-enhanced ultrasound evaluation method in the efficacy evaluation after HIFUA treatment.
**Name:** Different methods of efficacy evaluation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Record two sets of data on the uterus at 3 months, 6 months, and 12 months after treatment. Size of fibroids, record effective rate data, compare effective rate data between two groups, and compare differences between the two groups.
**Measure:** Treatment effectiveness
**Time Frame:** At 3 months, 6 months, and 12 months after treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:Patients with clinically diagnosed uterine fibroids or adenomyosis who meet the following conditions: 1) Imaging shows that the uterine fibroids are located between the muscle walls, or are pedunculated subserosal or submucosal fibroids, which are classified as types 2-6 by the International Federation of Gynecology and Obstetrics (FIGO); The diagnosis of adenomyosis is clear; 2) The imaging shows that there is no intestinal obstruction between uterine fibroids or adenomyosis and the abdominal wall, or the impact of intestinal obstruction can be eliminated through treatment, making it a safe treatment path; 3) Abdominal subcutaneous fat thickness ≤ 4 cm; 4) The farthest distance from the abdominal wall skin to the target area for treating fibroids is ≤ 14 cm; 5) The patient is generally in good condition and can tolerate and maintain a prone position for 2 hours or longer. 6) Adult and infertile women.Exclusion criteria：1) Unclear clinical diagnosis; 2) Uterine fibroids or adenomyosis rapidly increase in the short term, or imaging suggests a tendency for malignancy, or the malignant potential is uncertain; 3) Acute skin infection in the treatment area; 4) Uncontrolled acute pelvic inflammatory disease; 5) The general condition is poor, with severe dysfunction of important organs such as the heart, liver, and kidneys; 6) Severe coagulation dysfunction; 7) There are large skin scars in the treatment area of the lower abdomen. 8) Sedative and analgesic drugs cannot be used; 9) Postmenopausal enlarged uterine fibroids or adenomyosis. 10) Pregnant women, individuals with mental disorders, cognitive impairments, etc. who are unable to cooperate with treatment.
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009379
- Term: Neoplasms, Muscle Tissue
- ID: D000018204
- Term: Neoplasms, Connective and Soft Tissue
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M17342
- Name: Uterine Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M10901
- Name: Leiomyoma
- Relevance: HIGH
- As Found: Uterine Fibroids
- ID: M25846
- Name: Myofibroma
- Relevance: LOW
- As Found: Unknown
- ID: M20350
- Name: Neoplasms, Connective and Soft Tissue
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007889
- Term: Leiomyoma
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435650
**Brief Title:** The Use of Mindful Compassion and Cannabis Suppositories for Anal Pain Among Men Who Have Sex With Men
**Official Title:** The Use of Mindful Compassion and Cannabis Suppositories for Anal Pain Among Men Who Have Sex With Men
#### Organization Study ID Info
**ID:** London Metropolitan University
#### Organization
**Class:** OTHER
**Full Name:** London Metropolitan University
### Status Module
#### Completion Date
**Date:** 2024-04-24
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-07-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** London Metropolitan University
#### Responsible Party
**Investigator Affiliation:** London Metropolitan University
**Investigator Full Name:** Samantha Banbury
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Research aim: To determine how an online mindful-compassion intervention adjunct with cannabis suppositories might reduce anal pain during sexual intimacy among men who have sex with men. Outcomes are also hoped to increase sexual functioning, well-being and sexual self-efficacy.
Research intention: If the combined mindful compassion and cannabis suppository intervention reduces anal pain and supports sexual and general well-being, then this research would be repeated on a larger scale targeting psychosexual services.
A brief overview of the intervention:
Anal pain is pain experienced in the anus during anal penetration with a penis or other objects. Most research on anal pain during sexual intimacy has centred on men who have sex with men. Mindfulness has been anecdotally discussed in reducing symptoms of anal pain in men who have sex with men. A novel approach to pain management includes medical cannabis, which can be cannabidiol, tetrahydrocannabinol or both. Anal suppositories do not create a euphoric high in the same way as oral use, including inhalation.
Quantitatively, randomisation will be based on whether participants use cannabis suppositories or not. This study does not randomise to cannabis groups owing to the legalities in the United Kingdom. Participants included fifty-two consenting participants. Of these, thirty-three were using cannabis suppositories. The intervention was delivered for one month, and the follow-up was at twelve weeks. Qualitatively, participants were asked approximately eight open-ended feedback questions throughout the study.
**Detailed Description:** Research looking at mindfulness-based interventions or the use of medical cannabis to support sexual pain is limited, and often, sexual pain goes unreported, which might lead to compromised psychological well-being. Additionally, sexual problems associated with pain and related emotional suffering are frequently overlooked in patients with sexual pain. This research aims to establish the effectiveness of an online mindful compassion intervention adjunct with cannabis suppositories to help minimise sexual pain and increase well-being. This research decided to deliver mindful compassion online because it would economically target a more comprehensive and diverse group. This preliminary study examined how a mindful compassion intervention combined with cannabis suppositories might help minimise sexual pain whilst improving sexual function, well-being, and sexual self-efficacy.
The main exercises included mindfulness, breathing, relaxation techniques, Mindfulness of the senses and body, and understanding the self. These exercises incorporated the three-model system of emotions, how to attend to the cognitive and physical patterns associated with painful sex, and towards acceptance and self-compassion with fewer symptoms. The mindful-compassion intervention included psychosexual education and anal pain, the three-model system of emotions and sexual pain, practising mindful compassion and graded practice and self-care, efficacy, and the relationship with anatomy.
Homework exercises, including education, training, modelling, and enablement, were encouraged. Feedback and support, along with discussing the educational components, training, modelling, and enablement, were addressed throughout this study.
The development of mindful compassion intervention has been based on a taxonomy of behavioural change techniques. This has been used because the taxonomy of behavioural change techniques has been rigorously tested to evidence the effectiveness in supporting interventions associated with change behaviour. The 93 behaviour change techniques are the active ingredients of behaviour change, and each intervention is likely to consist of more than one behaviour change technique and serve as having more than one function. The intervention in this study included twelve domains, of which twenty-three out of the 93 behaviour change techniques listed in the behavioural change technique taxonomy were identified. The selection of these domains used a triangulation process to ensure consistency in mapping the behaviour change techniques to the intervention.
Randomisation was based on whether participants were already using cannabis suppositories or not. Those who did use cannabis suppositories as part of their sex life would have been doing so for at least a month. There was a total of four groups, including a cannabis suppository-only group, a mindful-compassion-only group, a combined mindful compassion and cannabis suppository group and a care-as-usual group.
### Conditions Module
**Conditions:**
- Pain;Sexual Intercourse;M
**Keywords:**
- Mindful-compassion
- Well-being
- Sexual self efficacy
- Sexual functioning
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The study phase is not applicable as whilst cannabis suppositories are part of this research study, participants are not randomised into cannabis groups. Participants would already be using cannabis suppositories for at least one month and are used as part of sexual intimacy.
Randomisation was based on whether participants were using cannabis suppositories and consisted of one of four groups, including a cannabis suppository-only group, mindful- compassion only group, a combined mindful-compassion and cannabis suppository group and a care-as-usual group
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 52
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Online mindful-compassion weekly for four weeks
**Intervention Names:**
- Behavioral: Mindful-compassion
**Label:** Mindful-compassion group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants were not prescribed cannabis as part of this study. Participants had been for at least one month before participating in the study. Participants used cannabis suppositories each time they engaged in anal intercourse (recipient). The average dose, based on participant reports, was approximately 500mg.
Online mindful-compassion weekly for four weeks
**Intervention Names:**
- Combination Product: Cannabis suppositories and mindful-compassion for anal pain
**Label:** Mindful-compassion and Cannabis suppository
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Mindful-compassion and Cannabis suppository
**Description:** This is a combined intervention that includes mindful-compassion and cannabis suppositories for anal pain
**Name:** Cannabis suppositories and mindful-compassion for anal pain
**Type:** COMBINATION_PRODUCT
#### Intervention 2
**Arm Group Labels:**
- Mindful-compassion group
**Description:** Mindful-compassion
**Name:** Mindful-compassion
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The frequency and severity of pain during anal sex, this is a 5-point Likert-type scale which ranges from never (5) to all the time (1) and no anal pain (5) to severe anal pain (1). The Cronbach alpha in this study= 0.70.
**Measure:** Changes in levels of anal pain taken at weeks 0, 4 and 12
**Time Frame:** 0, 4 and 12 weeks
**Description:** This is an 11-item questionnaire which focuses on sexual functioning including sexual desire, arousal and satisfaction and erectile functioning. The response categories include 0= not at all to 5= always or 0= no problem to 5= big problem (this varied pending question). The Cronbach alpha in this study = 0.75.
**Measure:** Changes in sexual functioning taken at weeks 0, 4 and 12
**Time Frame:** 0, 4 and 12 weeks
**Description:** This is a 7-item questionnaire with 5 response categories looking at functioning and feeling aspects of well-being. The response categories include 1=none of the time to 5=all of the time. Cronbach alpha- 0.89-0.91. There is no reverse scoring. Scores range from 7 to 35 where the latter is the highest level of wellbeing. The Cronbach alpha in this study = 0.85.
**Measure:** Changes in levels of well-being at weeks 0,4 and 12
**Time Frame:** 0, 4 and 12 weeks
**Description:** This is a 10-item questionnaire which focuses on sexual confidence and behaviour. The response categories include: 1 is the lowest level of self-efficacy and 10 is the highest. There are no reverse questions. Cronbach's alpha is α =0.88 (high). This questionnaire has been adapted to reflect the participants in a study looking at sexual self-efficacy and sexual function. Less than 5% of the original questionnaire remains. The Cronbach alpha in this study= 0.83.
**Measure:** Changes in levels of sexual self-efficacy at weeks 0, 4 and 12
**Time Frame:** 0, 4 and 12 weeks
**Description:** This is a 12-item measure with 5 response categories, 1 = almost never to 5 = almost always, with higher scores indicating higher levels of self-compassion. The questionnaire measures self-kindness vs. self-judgement, common humanity vs. isolation, and mindfulness vs. over-identification with painful thoughts and emotions. Reliability Cronbach's alphas range between 0.68 and 0.78. The Cronbach alpha in this study was 0.73.
**Measure:** Changes in levels of mindful-compassion
**Time Frame:** 0, 4 and 12
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants were allocated to cannabis only, and cannabis adjunct groups would already be using cannabis suppositories.
* Must have engaged in anal sex within the last month
* Must be based in the United Kingdom
* Must have experienced anal sexual pain
* An absence of co-occurring difficulties
* Must be aged 18 years or older
* Must be able to read and write English.
* Patient health screening score must range between 0-9 mild
* Generalised anxiety disorder screening score must range between 0-9, mild
Exclusion Criteria:
* Have not attempted anal intercourse in the last month
* Have co-occurring difficulties
* Aged below 18 years old
* Reading and writing English difficulties
* Not experiencing anal pain during sexual intercourse.
* Patient health screening score ranged between moderate to severe - 10-27
* Generalised anxiety screening score ranged between 10- 21.
**Gender Based:** True
**Gender Description:** Men who have sex with men Those who identify as male
**Healthy Volunteers:** True
**Maximum Age:** 100 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** London
**Country:** United Kingdom
**Facility:** Samantha Banbury
**Zip:** N7 8DB
#### Overall Officials
**Official 1:**
**Affiliation:** London Metropolitan University
**Name:** Samantha Banbury
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Barach E, Slavin MN, Earleywine M. Cannabis and Vulvodynia Symptoms: A Preliminary Report. Cannabis. 2020 Jul 3;3(2):139-147. doi: 10.26828/cannabis.2020.02.001.
**PMID:** 33426502
**Citation:** Bloomfield MA, Ashok AH, Volkow ND, Howes OD. The effects of Delta9-tetrahydrocannabinol on the dopamine system. Nature. 2016 Nov 17;539(7629):369-377. doi: 10.1038/nature20153.
**PMID:** 27853201
**Citation:** Boardman LA, Stockdale CK. Sexual pain. Clin Obstet Gynecol. 2009 Dec;52(4):682-90. doi: 10.1097/GRF.0b013e3181bf4a7e.
**PMID:** 20393420
**Citation:** Brenneisen R, Egli A, Elsohly MA, Henn V, Spiess Y. The effect of orally and rectally administered delta 9-tetrahydrocannabinol on spasticity: a pilot study with 2 patients. Int J Clin Pharmacol Ther. 1996 Oct;34(10):446-52.
**PMID:** 8897084
**Citation:** Brotto LA, Bergeron S, Zdaniuk B, Driscoll M, Grabovac A, Sadownik LA, Smith KB, Basson R. A Comparison of Mindfulness-Based Cognitive Therapy Vs Cognitive Behavioral Therapy for the Treatment of Provoked Vestibulodynia in a Hospital Clinic Setting. J Sex Med. 2019 Jun;16(6):909-923. doi: 10.1016/j.jsxm.2019.04.002. Epub 2019 May 15.
**PMID:** 31103481
**Citation:** Carey RN, Connell LE, Johnston M, Rothman AJ, de Bruin M, Kelly MP, Michie S. Behavior Change Techniques and Their Mechanisms of Action: A Synthesis of Links Described in Published Intervention Literature. Ann Behav Med. 2019 Jul 17;53(8):693-707. doi: 10.1093/abm/kay078.
**PMID:** 30304386
**Citation:** ElSohly MA, Gul W, Walker LA. Pharmacokinetics and Tolerability of Delta9-THC-Hemisuccinate in a Suppository Formulation as an Alternative to Capsules for the Systemic Delivery of Delta9-THC. Med Cannabis Cannabinoids. 2018 Jun 12;1(1):44-53. doi: 10.1159/000489037. eCollection 2018 Jun.
**PMID:** 34676321
**Citation:** Fisher E, Moore RA, Fogarty AE, Finn DP, Finnerup NB, Gilron I, Haroutounian S, Krane E, Rice ASC, Rowbotham M, Wallace M, Eccleston C. Cannabinoids, cannabis, and cannabis-based medicine for pain management: a systematic review of randomised controlled trials. Pain. 2021 Jul 1;162(Suppl 1):S45-S66. doi: 10.1097/j.pain.0000000000001929.
**PMID:** 32804836
**Citation:** Kondrad E. Medical marijuana for chronic pain. N C Med J. 2013 May-Jun;74(3):210-1. No abstract available.
**PMID:** 23940889
**Citation:** Liang AL, Gingher EL, Coleman JS. Medical Cannabis for Gynecologic Pain Conditions: A Systematic Review. Obstet Gynecol. 2022 Feb 1;139(2):287-296. doi: 10.1097/AOG.0000000000004656.
**PMID:** 35104069
**Citation:** Libman E, Rothenberg I, Fichten CS, Amsel R. The SSES-E: a measure of sexual self-efficacy in erectile functioning. J Sex Marital Ther. 1985 Winter;11(4):233-47. doi: 10.1080/00926238508405450.
**PMID:** 4078907
**Citation:** Vaishnava PP, Kimball CW, Matykiewicz JL, Fradin FY, Shenoy GK, Montano PA. Extended x-ray-absorption fine-structure observation of collinear ordering of Fe-Sn-Fe atoms in the Chevrel-phase superconductor SnFe0.05Mo6S8. Phys Rev B Condens Matter. 1986 Oct 1;34(7):4599-4603. doi: 10.1103/physrevb.34.4599. No abstract available.
**PMID:** 9940251
**Citation:** Haug T. Tolerance to the depressant effects of diazepam in the drug discrimination paradigm. Pharmacol Biochem Behav. 1984 Sep;21(3):409-15. doi: 10.1016/s0091-3057(84)80103-3.
**PMID:** 6494210
**Citation:** Nercessian TR, Banbury S, Chandler C. A Systematic Review Looking at Anodyspareunia Among Cisgender Men and Women. J Sex Marital Ther. 2023;49(7):829-841. doi: 10.1080/0092623X.2023.2196265. Epub 2023 Apr 23.
**PMID:** 37089031
**Citation:** Suarez Guglielmini H, Schurmann Ruppert R, O'Ryan Costa P. [Measles. Clinical and anatomo-pathologic study]. Rev Chil Pediatr. 1966 Aug-Sep;37(8):477-84. No abstract available. Spanish.
**PMID:** 5986896
**Citation:** Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
**PMID:** 10782451
**Citation:** Rycroft-Malone J, Gradinger F, Griffiths HO, Crane R, Gibson A, Mercer S, Anderson R, Kuyken W. Accessibility and implementation in the UK NHS services of an effective depression relapse prevention programme: learning from mindfulness-based cognitive therapy through a mixed-methods study. Southampton (UK): NIHR Journals Library; 2017 Mar. Available from http://www.ncbi.nlm.nih.gov/books/NBK425272/
**PMID:** 28368561
**Citation:** Bowman BH, Barnett DR, Hodgkinson KT, Schneider RG. Chemical characterization of haemoglobin G-St-I. Nature. 1966 Sep 17;211(5055):1305-6. doi: 10.1038/2111305a0. No abstract available.
**PMID:** 5969816
**Citation:** Munoz M, Munoz A, Gonzalez A. Distribution, morphology, and central projections of mesencephalic trigeminal neurons in the frog Rana ridibunda. Anat Rec. 1993 Jan;235(1):165-77. doi: 10.1002/ar.1092350117.
**PMID:** 8417625
**Citation:** Smith EJ, Palevsky S. Salt poisoning in a two-year-old child. Am J Emerg Med. 1990 Nov;8(6):571-2. doi: 10.1016/0735-6757(90)90183-z. No abstract available.
**PMID:** 2222612
**Citation:** Antonelli AR, Bellotto R, Bertazzoli M, Busnelli GP, Nunez Castro M, Felisati G, Romagnoli M. Auditory brain stem response test battery for multiple sclerosis patients: evaluation of test findings and assessment of diagnostic criteria. Audiology. 1986;25(4-5):227-38.
**PMID:** 3566631
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M5449
- Name: Marijuana Abuse
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435637
**Acronym:** CODIAK
**Brief Title:** Effects of Ingesting Multiple Boluses of Collagen on Muscle & Skin Connective Protein Synthesis in Vivo in Humans
**Official Title:** Collagen Digestion and Amino Acid Absorption Kinetics and the Effect on Muscle & Skin
#### Organization Study ID Info
**ID:** METC 22-018
#### Organization
**Class:** OTHER
**Full Name:** Maastricht University Medical Center
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-22
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Maastricht University Medical Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Rationale: Collagen protein is the central structural component of extracellular connective tissues within skeletal muscle, bone, cartilage and skin. Dietary collagen peptides are a promising protein source to deliver the specific amino acid precursors required to support an increase in connective tissue protein synthesis across several tissues (e.g. muscle, skin). However, the digestion and absorption kinetics of multiple boluses of collagen peptides and the subsequent impact on muscle and skin connective tissue protein synthesis rates have not yet been assessed in vivo in humans.
Objective: To assess the impact of ingestion of multiple boluses of collagen peptides on muscle connective and skin protein synthesis in vivo in humans.
Study design: Double-blind, parallel-group, placebo-controlled intervention study.
Study population: 20 healthy young males, aged 18-35 years.
Intervention : Participants will perform unilateral resistance exercise followed by the ingestion of either 100 g of collagen peptides (in boluses) or a non-caloric placebo (flavoured water) drinks, while all drinks will contain vitamin C. Continuous intravenous stable isotope amino acid tracer infusions will be applied, plasma, skin and muscle samples will be collected in order to assess protein synthesis rates in skin and muscle tissue.
Main study parameters/endpoints: Primary study parameters are muscle connective protein synthesis rates. Secondary study parameters are skin and myofibrillar protein synthesis rates, plasma amino acid concentrations and body composition.
### Conditions Module
**Conditions:**
- Muscle Protein Synthesis
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Double-blind, parallel-group, placebo-controlled intervention study
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 27
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 100 g of collagen peptides (in boluses) with vitamin C
**Intervention Names:**
- Dietary Supplement: Collagen protein
- Behavioral: Resistance exercise
**Label:** Collagen protein
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Non-caloric placebo (flavoured water) drinks, with vitamin C.
**Intervention Names:**
- Behavioral: Resistance exercise
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Collagen protein
**Description:** Ingestion of 40, 20, 20 and 20 gram of collagen protein right after and every 2 hours after a bout of exercise
**Name:** Collagen protein
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Collagen protein
- Placebo
**Description:** A single resistance exercise session of the leg press and leg extension exercise
**Name:** Resistance exercise
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** age in years
**Measure:** Age
**Time Frame:** baseline
**Description:** assessed by written dietary intake records
**Measure:** Dietary macronutrient intake
**Time Frame:** 2 days before test days
**Description:** body mass in kg
**Measure:** Body mass
**Time Frame:** baseline
**Description:** Height in m
**Measure:** Height
**Time Frame:** baseline
**Description:** Measured by DXA
**Measure:** Lean mass
**Time Frame:** baseline
**Description:** maximum strength of both legs
**Measure:** One repetition maximum of the legs
**Time Frame:** baseline
#### Primary Outcomes
**Description:** The primary analysis will be an independent t-test, comparing postprandial muscle connective protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the rested condition between groups.
**Measure:** Muscle connective protein synthesis rates rested leg
**Time Frame:** one value calculated over 8 hours
#### Secondary Outcomes
**Description:** Independent t-test, comparing postprandial muscle connective protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the exercised condition between groups.
**Measure:** Muscle connective protein synthesis rates exercised leg
**Time Frame:** one value calculated over 8 hours
**Description:** Independent t-test, comparing postprandial myofibrillar protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the rested condition between groups.
**Measure:** Myofibrillar protein synthesis rates rested leg
**Time Frame:** one value calculated over 8 hours
**Description:** Independent t-test, comparing postprandial myofibrillar protein synthesis rates over the 0-8 h period (i.e., one integrated value) in the exercised condition between groups.
**Measure:** Myofibrillar protein synthesis rates exercised leg
**Time Frame:** one value calculated over 8 hours
**Description:** Independent t-test, comparing postprandial skin protein synthesis rates over the 0-8 h period (i.e., one integrated value).
**Measure:** Skin protein synthesis rates
**Time Frame:** one value calculated over 8 hours
**Description:** Plasma insulin concentrations
**Measure:** Plasma insulin concentrations
**Time Frame:** measured over the 8 hour post-prandial period
**Description:** Plasma amino acids concentrations
**Measure:** Plasma amino acids concentrations
**Time Frame:** measured over the 8 hour post-prandial period
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged between 18-35 years
* Male
* Healthy, recreationally active (participating in recreational sports activities ≥ 1 and ≤ 6 h per week, with a maximum of 2 h resistance-type exercise)
* 18.5 ≤ BMI ≤ 30 kg/m2
* No physical limitations (i.e. able to perform all activities associated with daily living in an independent manner).
Exclusion Criteria:
* Female
* Smoking
* Musculoskeletal disorders
* Metabolic disorders
* Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
* Chronic use of gastric acid suppressing medication or anti-coagulants
* Unstable weight over the last three months
* Diagnosed GI tract disorders or diseases
* Blood donation in the past 2 months
**Healthy Volunteers:** True
**Maximum Age:** 35 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Luc JC van Loon, PhD
**Phone:** +31-43-3881397
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Maastricht
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Thorben Aussieker, MSc
- **Role:** CONTACT
***Contact 2:***
- **Name:** Luc JC van Loon, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Netherlands
**Facility:** Maastricht University Medical Centre
**Zip:** 6200 MD
#### Overall Officials
**Official 1:**
**Affiliation:** Maastricht University
**Name:** Luc JC van Loon, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: M4513
- Name: Ascorbic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T437
- Name: Ascorbic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T477
- Name: Vitamin C
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435624
**Brief Title:** Effectiveness of Intelligent Rehabilitation Robot Training System Combined With Repetitive Facilitative Exercise on Upper Limb Motor Function After Stroke: a Randomized Control Trial.
**Official Title:** Effectiveness of Intelligent Rehabilitation Robot Training System Combined With Repetitive Facilitative Exercise on Upper Limb Motor Function After Stroke: a Randomized Control Trial.
#### Organization Study ID Info
**ID:** NJKF202401001
#### Organization
**Class:** OTHER
**Full Name:** Nanjing Mingzhou Rehabilitation Hospital
### Status Module
#### Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**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:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Nanjing Mingzhou Rehabilitation Hospital
#### Responsible Party
**Investigator Affiliation:** Nanjing Mingzhou Rehabilitation Hospital
**Investigator Full Name:** Jingzhi Zhang
**Investigator Title:** technician
**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 learn if intelligent rehabilitation robot training system combined with repetitive facilitative exercise (RFE) work to treat stroke in adults. The main questions it aims to answer are:
Does drug intelligent rehabilitation robot training system combined with RFE improve the upper limb motor function of participants? Can the combination of intelligent rehabilitation robot training system and RFE achieve better effects?
Researchers will compare 3 groups (RFE, intelligent rehabilitation robot training system under RFE, and conventional therapy) to see if intelligent rehabilitation robot training system and RFE works to treat stroke.
Participants will:
Receive treatment for 4 weeks Receive scale and instrument testing before and after treatment
### Conditions Module
**Conditions:**
- Stroke
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Intelligent rehabilitation robot training system under repetitive facilitative exercise (RFE)
**Intervention Names:**
- Device: intelligent rehabilitation robot training system
- Other: repetitive facilitative exercise
**Label:** Combined group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Repetitive facilitative exercise (RFE)
**Intervention Names:**
- Other: repetitive facilitative exercise
**Label:** RFE group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Conventional therapy (CT)
**Intervention Names:**
- Other: conventional therapy
**Label:** CT group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Combined group
**Description:** Using an intelligent rehabilitation robot training system to simulate a real work environment, providing functional oriented treatment for stroke patients and improving upper limb motor function.
The instrument used is the Burt upper limb robot training system produced by Estun Medical Co., Ltd.
**Name:** intelligent rehabilitation robot training system
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Combined group
- RFE group
**Description:** Repetitive facilitative exercise (RFE) is a new technology that combines multiple sensory stimuli and achieves facilitation and reinforcement of the reconstruction of paralyzed neural pathways through repeated and extensive directional exercise.
**Name:** repetitive facilitative exercise
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- CT group
**Description:** Basic training, including passive joint movement and activities of daily living exercise.
**Name:** conventional therapy
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The FMA used to assess motor control such as sensation, range of motion, coordination, and speed. FMA in upper limb includes 33 items and ranges from 0 to 66; a maximum score indicates complete recovery of the limb.
**Measure:** Fugl-Meyer Assessment (FMA)
**Time Frame:** From enrollment to the end of treatment at 4 weeks
**Description:** Use the benchmark evaluation system included with intelligent rehabilitation robot training system (in %)
**Measure:** Active participation proportion
**Time Frame:** From enrollment to the end of treatment at 4 weeks
**Description:** Use the benchmark evaluation system included with intelligent rehabilitation robot training system (in mm)
**Measure:** Trajectory deviation
**Time Frame:** From enrollment to the end of treatment at 4 weeks
**Description:** Use the benchmark evaluation system included with intelligent rehabilitation robot training system (in mm)
**Measure:** Trajectory tracking error
**Time Frame:** From enrollment to the end of treatment at 4 weeks
**Description:** The ARAT is a measure of upper-extremity function that has 4 subsections: grip, grasp, pinch and gross movement. The ARAT score range is 0-57, with higher scores indicating better functionality.
**Measure:** Action Research Arm Test (ARAT)
**Time Frame:** From enrollment to the end of treatment at 4 weeks
#### Secondary Outcomes
**Measure:** Range of motion (ROM)
**Time Frame:** From enrollment to the end of treatment at 4 weeks
**Description:** The MAS score was used to evaluate spasticity of the affected upper limb. The higher the score of MAS (0, 1, 1+, 2, 3 and 4), the higher the degree of spasms.
**Measure:** Modified Ashworth Scale (MAS)
**Time Frame:** From enrollment to the end of treatment at 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* patients (18 to 74 years old) who suffered a first or second unilateral stroke
* chronic stroke (over 6 months from the onset)
* obvious upper limb movement disorders (FMA-UE scores from 25 to 42)
* ability to understand and follow simple directions
Exclusion Criteria:
* pregnant or lactating
* upper extremity contracture, pain, or trauma
* perceptual, apraxic, or cognitive deficits that lead to inability to follow verbal instructions
* unable to maintain sitting posture
* cerebellar lesion
* clinically unstable medical disorders
* inability to provide informed consent
**Maximum Age:** 74 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jingzhi Zhang
**Phone:** +86-16677137704
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435611
**Acronym:** ACNH
**Brief Title:** Adiposity, Cardiometabolic and Neurocognitive Health Among Ethnic Groups: a Feasibility and Pilot Study
**Official Title:** Adiposity, Cardiometabolic and Neurocognitive Health Among Ethnic Groups: a Feasibility and Pilot Study (ACNH Study)
#### Organization Study ID Info
**ID:** 329603
#### Organization
**Class:** OTHER
**Full Name:** King's College Hospital NHS Trust
### Status Module
#### Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2023-12-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-11-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-07-12
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** King's College Hospital NHS Trust
#### Responsible Party
**Investigator Affiliation:** King's College Hospital NHS Trust
**Investigator Full Name:** Georgios Dimitriadis
**Investigator Title:** Endocrinologist Consultant and Obesity Physician
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this pilot and feasibility study is to is to test the feasibility of conducting a cross-sectional study on adiposity and cardiometabolic and neurocognitive risk factors at Kings College Hospital NHS Foundation Trust (KCH).
The main aim is to assess and compare anthropometric measurements of adiposity (weight, Body Mass Index (BMI), Waist Circumference (WC), Waist-to-Hip ratio (WHR), Neck circumference (NC)), liver fat (hepatic steatosis and fibrosis), cardiometabolic risk factors (dyslipidemia, insulin resistance, hypertension) and neurocognitive risk factors among participants, according to their ethnic background.
Participants will come at KCH for one visit and will have their anthropometric measurements and cardio-metabolic profile assessed. They will also perform questionnaires on lifestyle, socio-economic status and neuro-cognitive health during their visit.
**Detailed Description:** The first objective of this study is to test the feasibility of conducting a cross-sectional study on adiposity and cardiometabolic and neurocognitive risk factors at Kings College Hospital NHS Foundation Trust.
The second objective is to assess and compare anthropometric measurements of adiposity (weight, Body Mass Index (BMI), Waist Circumference (WC), Waist-to-Hip ratio (WHR), Neck circumference (NC)), liver fat (hepatic steatosis and fibrosis), cardiometabolic risk factors (dyslipidemia, insulin resistance, hypertension) and neurocognitive risk factors among participants, according to their ethnic background.
The third objective is to test the feasibility of assessing cognitive function, in relation to adiposity, by using standardised tests measuring cognitive function (MMSE, MoCA or an adapted version) among ethnic groups of various education levels and literacy, lifestyle and from different cultures. Our objective is also to test the feasibility of using lifestyle questionnaires \[Food Frequencies Questionnaires (FFQ) and International Physical Activity Questionnaires -(IPAQ-S)\] in various ethnic groups with regard to geographic variation (urban, rural).
### Conditions Module
**Conditions:**
- Metabolic Disease
- Obesity
- Hepatic Steato-Fibrosis
- Cardiovascular Diseases
- Cognitive Impairment
**Keywords:**
- obesity
- multi-ethnicity
- cardiovascular diseases
- hepatic steatosis
- metabolic diseases
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Measured without shoes and reported in centimeters
**Measure:** Height
**Time Frame:** 1 minute
**Description:** random plasma glucose, glycated haemoglobin (HbA1c) using a blood test
**Measure:** Insulin resistance
**Time Frame:** 10 minutes
**Description:** random plasma glucose, glycated haemoglobin (HbA1c) using a blood test
**Measure:** Type 2 Diabetes
**Time Frame:** 10 minutes
**Description:** Assessed by a certified physician using transient elastography (TE) measurements using a Fibroscan (Model mini-430).
**Measure:** Hepatic steatosis, and stages of fibrosis
**Time Frame:** 10 minutes
**Description:** Result below 25 on the Montreal Cognitive Assessment test (MoCA). No minimum results, normal is above or equal to 26. The lower the result is the more the participant is at risk of presenting any form of neuro-cognitive impairment.
**Measure:** neurocognitive risk factors
**Time Frame:** 15 minutes
**Description:** Measured using an automatic scale, without shoes. Reported in kilograms.
**Measure:** Weight
**Time Frame:** 1 minute
**Description:** Will be calculated from weight and height results and will be presented in kg/m2.
**Measure:** BMI
**Time Frame:** 30 seconds
**Description:** Will be measured with a tape around the middle point halfway between the top of the hips and the bottom of the ribs, at expiration. Will be reported in centimeters.
**Measure:** Waist circumference
**Time Frame:** 1 minute
**Description:** Will be measure with a tape around the widest part of the hips. Will be reported in centimeters.
**Measure:** Hip circumference
**Time Frame:** 1 minute
**Description:** Will be diagnosed from lipid levels reported in a blood test
**Measure:** Dyslipidemia
**Time Frame:** 10 minutes
**Description:** Will be measure with a tape around a point just below the larynx (Adam's Apple) and perpendicular to the long axis of the neck. The participant should look straight ahead during measurement, with shoulders down (not hunched). Round the neck measurement up to nearest ½ centimeters. Result will be reported in centimeters.
**Measure:** Neck circumference
**Time Frame:** 1 minutes
**Description:** Will be derived from waist circumference and hip circumference.
**Measure:** Waist-to-Hip ratio
**Time Frame:** 30 seconds
**Description:** Will be derived from waist circumference and height.
**Measure:** Waist-to-Height ratio
**Time Frame:** 30 seconds
**Description:** blood pressure will consist of 3 systolic blood pressure and diastolic blood pressure measurements
**Measure:** Hypertension (estimated using blood pressure measurement)
**Time Frame:** 10minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Men and women aged ≥18 years old
* Body mass index (BMI) ≥ 30 kg/m2
Exclusion Criteria:
* Severe obesity (BMI \> 50 kg/m2)
* Pregnancy (positive urine hCG) or a recent pregnancy (in the past 6 months)
* Known active chronic hepatic diseases
* Known diagnosis of human immunodeficiency virus
* Pre-established diagnosis of advanced renal failure (estimated Glomerular Filtration Rate (eGFR) \<30 ml/min)
* Diagnosis of decompensated heart failure
* History of bariatric surgery
* Uncontrolled thyroid disease
* Current use of the following medication: steroids (oral or injections only), weight-loss medication including over-the-counter products, glucagon-like peptide 1 (GLP-1) agonists , Sodium-Glucose Transport Protein 2 (SGLT2) Inhibitors
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
**Study Population:** Adult male and female living with obesity (BMI ≥ 30 kg/m2 )
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Fannie Lajeunesse-Trempe, MD, Msc
**Phone:** 14384901454
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Georgios K. Dimitriadis, MD, PhD
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** London
**Country:** United Kingdom
**Facility:** King's College Hospital NHS Foundation Trust
**State:** United Kingdom Of Great Britain And Northern Ireland
**Status:** ACTIVE_NOT_RECRUITING
**Zip:** SE5 9RS
**Location 2:**
**City:** London
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Georgios K Dimitriadis
- **Phone:** 00441689863091
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** King's College Hospital NHS Foundation Trust
**Status:** RECRUITING
**Zip:** SE5 9RS
#### Overall Officials
**Official 1:**
**Affiliation:** Kings College Hospital
**Name:** Georgios K. Dimitriadis, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** To have collected 10 participants (5 males and 5 females) as per protocol and have agreed on a specific data sharing agreement signed by all parties.
**Description:** Data will be shared among different collaborative centers to compare outcomes among different ethnic groups from rural and urban environment of low- middle and high income countries.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
**IPD Sharing:** YES
**Time Frame:** 1 year
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M8375
- Name: Fatty Liver
- Relevance: LOW
- As Found: Unknown
- ID: M8485
- Name: Fibrosis
- Relevance: LOW
- As Found: Unknown
- ID: M29705
- Name: Cognitive Dysfunction
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: HIGH
- As Found: Metabolic Diseases
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: T5868
- Name: Visceral Steatosis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000008659
- Term: Metabolic Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435598
**Brief Title:** Tittle: Effect of Video-Based Health Education Intervention on Insulin Therapy Among Adults With Diabetes Mellitus in Dhulikhel Hospital
**Official Title:** Effect of Video-Based Health Education Intervention on Insulin Therapy Among Adults With Diabetes Mellitus in Dhulikhel Hospital: A Randomized Controlled Trial This Research Aims to Investigate the Effectiveness of Video-based Health Education in Supporting Insulin Therapy in Diabetes Mellitus Patients Visiting Dhulikhel Hospital. With the Increasing Patients With Insulin Therapy and the Need for Effective Patient Education, it is Essential to Evaluate the Impact of Video-based Educational Interventions Specifically Tailored for Patients Undergoing Insulin Therapy.
#### Organization Study ID Info
**ID:** 737/2023
#### Organization
**Class:** OTHER
**Full Name:** Kathmandu University School of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kathmandu University School of Medical Sciences
#### Responsible Party
**Investigator Affiliation:** Kathmandu University School of Medical Sciences
**Investigator Full Name:** Subina Manandhar
**Investigator Title:** Assistant Professor in Nursing Department
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Insulin is an essential therapy for treating diabetes, but many patients lack standard insulin injection skills. Learning the method of proper insulin injection technique is crucial for diabetes patients as it promotes treatment compliance, ensures safety, improves treatment efficacy, and contributes to better overall health outcomes. Adequate training and understanding of the proper technique enhance patient self-efficacy and empower them to take an active role in managing their diabetes mellitus. It empowers patients to effectively manage their diabetes and maintain optimal blood glucose control, ultimately leading to a better quality of life. This research aims to investigate the effectiveness of video-based health education in supporting insulin therapy in diabetes mellitus patients visiting Dhulikhel Hospital. With the increasing patients with insulin therapy and the need for effective patient education, it is essential to evaluate the impact of video-based educational interventions specifically tailored for patients undergoing insulin therapy. A randomized control trial method will be used for the study. Participants will be randomly assigned to either an experimental group receiving face to face educational session with video-based education or a control group receiving standard face-to-face educational session. Data will be collected through pre and post intervention assessments. The study's outcomes will help optimize patient care, increase accessibility to healthcare services and potentially reshape the way insulin therapy is delivered to Diabetes Mellitus patients.
**Detailed Description:** Background:
The prevalence of diabetes is high, and is expected to increase in developing countries or regions such as China, India, Brazil and Southeast Asia. Diabetes Mellitus is a chronic condition that requires lifelong management insulin therapy being a crucial component for many patients. Proper understanding and adherence to insulin are essential for achieving optimal health outcomes. Patient education plays a vital role in enhancing knowledge, self-management skills, and treatment adherence. Video- based health education offers several advantages including accessibility, flexibility and the ability to provide visual demonstrations. It can empower patients to actively participate in their self-care and improve their overall well-being.
Proper injection technique ensures the safe and effective delivery of insulin into the body. This helps minimize the risk of complications such as infections, bruising, discomfort, pain and incorrect dosage administration. Proper injection depth, angle and site rotation contribute to consistent absorption of insulin, leading better blood glucose control. This is possible when patients are confident in their ability to administer insulin correctly with the right training and education.
Overall, this study holds significant importance as it addresses the gap in knowledge regarding the effectiveness of video-based health education in supporting insulin therapy for Diabetes Mellitus patients. Its findings will have implication for optimizing patient education strategies, enhancing treatment adherence and ultimately improving the quality of life for individuals living with Diabetes Mellitus.
Rational/justification:
By conducting this randomized controlled trial, Investigator aim to contribute to the patient education in diabetes management. It will help to optimize patient education methods, enhance treatment adherence and ultimately lead to better health outcomes for Diabetes mellitus patients on insulin therapy.
General Objective:
To explore whether the use of video-based health education program results in better knowledge, practice of insulin therapy technique when compared to usual care among adults with diabetes mellitus in Dhulikhel Hospital.
Specific Objective:
* To determine video-based health education program compared with usual care improves the practice score of insulin therapy technique among adults with diabetes mellitus in Dhulikhel Hospital.
* To find out video-based health education program compared with usual care increases the knowledge score of insulin therapy technique among adults with diabetes mellitus in Dhulikhel Hospital.
* To find out the association of practice of insulin therapy technique before the intervention with selected socio demographic variable.
Research Hypothesis Video-based health education intervention improves knowledge and practice of insulin therapy technique among adults with diabetes mellitus attending Dhulikhel Hospital.
Study Variables:
Dependent Variables: Knowledge and Practice in Insulin Therapy Independent Variables: Socio Demography Data, Educational Video Intervention
Research Method:
Quantitative
This is an open-label two-arm randomized trial. Investigator will allocate half of the participants to the video-based health education and usual care, while the other half of the participants will receive usual care only. (Fig 1) Randomization: Block randomization will be done to allocate adults to intervention or usual care group. A random sequence number will be generated in blocks of size of ten using STATA 14 by a statistician. The random numbers will be copied in an excel form and median will be calculated for each block. The numbers below the median will be assigned as 'usual care group' and the numbers above the median will be assigned as 'intervention group'. Diabetic nurses and other nursing staff at the medical OPD and ward in Dhulikhel hospital will identify adults with diabetes and will check their eligibility. Investigator will explain ethical considerations, the importance of maintaining confidentiality during the research process, the voluntary nature of the participation, and the option to quit the study at any time. Investigator will enroll adults providing consent. After taking written consent, investigator will interview adults for baseline characteristics and their knowledge on insulin therapy. The interview will take 30-35 minutes.
Allocation concealment: A computer-based program will randomly allocate participants to either video-based education plus usual care or in a group with usual care only. Block randomization will be done to allocate adults to intervention or usual care group. A random sequence number will be generated in blocks of size of ten using STATA 14 by a statistician. The random numbers will be copied in an excel form and median will be calculated for each block. The numbers below the median will be assigned as 'usual care group' and the numbers above the median will be assigned as 'intervention group'. For randomization, the participants who have agreed to participate will be randomized into either the intervention or control group, with a 1:1 ratio based on allocation sequence. The allocation sequence will be concealed from the research nurse and participants using sequentially numbered opaque sealed envelopes (SNOSE) method. The principal investigator will provide the sealed envelopes to the research nurse who will then assign participants' to the intervention. The participants, the service provider, and the research nurse will be aware of the intervention.
Intervention: The video-based health education program guided by the Health Belief Model will be designed to provide tailored information on insulin therapy in diabetes. Health Belief Model(HBM) emphasizes changes in people's behavior are acquired through awareness of risk factors and perceived health benefits. The video will provide general information on insulin, types of insulin, its administration technique and storage.
Usual Care: Both intervention and control group will receive the usual standard diabetic care from Dhulikhel hospital which includes diabetic counseling, health teachings, etc.
### Conditions Module
**Conditions:**
- Knowledge on Insulin Therapy
- Practice on Insulin Administration
**Keywords:**
- Diabetes mellitus
- Educational Video on insulin therapy
- Insulin Therapy for diabetes mellitus
- Knowledge on insulin therapy
- Practice on insulin administration
- Usual Care on insulin administration
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This is an open-label two-arm randomized trial. Investigator will allocate half of the participants to the video-based health education and usual care, while the other half of the participants will receive usual care only. (Fig 1) Randomization: Block randomization will be done to allocate adults to intervention or usual care group.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 126
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Investigator will allocate sixty- three of the participants to the video-based health education and usual care
**Intervention Names:**
- Other: video-based health education
**Label:** Intervention Group (Educational video and usual care)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Investigator will allocate sixty-three of the participants to usual care only
**Label:** Control Group (Usual Care)
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention Group (Educational video and usual care)
**Description:** The video- based health education program guided by the Health Belief Model will be designed to provide tailored information on insulin therapy in diabetes. Health Belief Model(HBM) emphasizes changes in people's behavior are acquired through awareness of risk factors and perceived health benefits. The video will provide general information on insulin, types of insulin, its administration technique and storage.
**Name:** video-based health education
**Other Names:**
- Usual Care
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Knowledge on insulin therapy will cover structured questionnaire
**Measure:** Knowledge on insulin therapy
**Time Frame:** 4 months
**Description:** Practice of insulin administration will be assessed by checklist
**Measure:** Practice of insulin administration technique
**Time Frame:** 4 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult more than or equal to 18 years.
* Adult diagnosed with diabetes mellitus
* Adult under insulin therapy
* Adult owns smartphone with social media account
Exclusion Criteria:
* Patient with learning difficulties (dementia), hearing or visual impairment and hand tremors
**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:** Subina Manandhar, M.Sc
**Phone:** +977-9841726577
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Bhawana Shrestha, M.Sc.
**Phone:** +977-9802337704
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Kathmandu University School of Medical Sciences
**Name:** Subina Manandhar, M.Sc.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Kathmandu University School of Medical Sciences
**Name:** Kunta D Pun, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** Cui M, Wu X, Mao J, Wang X, Nie M (2016) T2DM Self-Management via Smartphone Applications: A Systematic Review and Meta-Analysis. PLOS ONE 11(11): e0166718
**URL:** https://doi.org/10.1371/journal.pone.0166718
**Label:** 12. Frid AH, Kreugel G, Grassi G, Halimi S, Hicks D, Hirsch LJ, et al. New Insulin Delivery Recommendations. Mayo Clin Proc \[Internet\]. 2016;91(9):1231-55
**URL:** http://dx.doi.org/10.1016/j.mayocp.2016.06.010
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes Mellitus
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003920
- Term: Diabetes Mellitus
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: LOW
- As Found: Unknown
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435585
**Acronym:** Responders
**Brief Title:** Responders and Non-responders in the Management of Heart Failure - Significance of Genetic Influence and Identification of Novel Informative Biomarkers
**Official Title:** Responders and Non-responders in the Management of Heart Failure - Significance of Genetic Influence and Identification of Novel Informative Biomarkers
#### Organization Study ID Info
**ID:** 218/443-31
#### Organization
**Class:** OTHER
**Full Name:** Karolinska University Hospital
### Status Module
#### Completion Date
**Date:** 2030-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2030-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-02-17
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University Hospital, Linkoeping
#### Lead Sponsor
**Class:** OTHER
**Name:** Karolinska University Hospital
#### Responsible Party
**Investigator Affiliation:** Karolinska University Hospital
**Investigator Full Name:** Camilla Hage
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** A biobank within the Swedish national heart failure quality registry SwedeHF.
**Detailed Description:** The national heart failure quality registry SwedeHF started in 2003. It is the world's largest continuous HF registry enrolling clinician-judged HF (regardless of LVEF) at time of hospital or clinical visit. Eighty variables are entered into an electronic database managed by the Uppsala Clinical Research Center (UCR). There are \>140,000 registrations from \>110,000 unique patients from 70 hospitals in Sweden.
University hospitals in Sweden with access to central biobanking will collect a high-quality biobank linked to SwedeHF consisting of blood plasma, whole blood and urine enabling genetic, proteomic and metabolomic analyses as well as analyses of different biomarkers of interest for HF patients. This will provide unique opportunities for future research within the national SwedeHF registry.
### Conditions Module
**Conditions:**
- Heart Failure
- Pathophysiology
### Design Module
#### Bio Spec
**Description:** Plasma, serum, whole blood, urine
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 5000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** To identify which patient will be a non-responder resulting in a poor outcome, despite being on recommended treatment according to guidelines.
**Measure:** Identify responders to guideline-directed medical therapy
**Time Frame:** 2 and 5 years
**Description:** To characterize differences between responders and non-responders in terms of morbidity after 2-years follow-up.
**Measure:** Differences in morbidity between responders and non-responders to guideline-directed medical therapy
**Time Frame:** 2 years
**Description:** To characterize differences between responders and non-responders in terms of mortality after 2-years follow-up.
**Measure:** Differences in mortality between responders and non-responders to guideline-directed medical therapy
**Time Frame:** 2 years
**Description:** To integrate information regarding clinical characteristics, diagnostic markers and genetics to determine underlying mechanisms behind different responses to treatment.
**Measure:** Predictors of responders and non-responders to guideline-directed medical therapy
**Time Frame:** 2 and 5 years
#### Secondary Outcomes
**Description:** To evaluate the differences between HFrEF and HFpEF patients in terms of mortality and after 2 and 5 years follow-up, respectively.
**Measure:** Differences between responders and non-responders regarding mortality
**Time Frame:** 2 and 5 years
**Description:** o evaluate the differences between HFrEF and HFpEF patients in terms of morbidity after 2 and 5 years follow-up, respectively.
**Measure:** Differences between responders and non-responders regarding morbidity
**Time Frame:** 2 and 5 years
**Description:** To evaluate the differences in mortality between patients with HFrEF and HFpEF by integrating information from clinical characteristics, diagnostic markers and genetics in order to have a further understanding of the underlying pathophysiology involved in HF development and prognosis with the aim to facilitate improved individualized therapy with less adverse effects and to identify novel treatment targets.
**Measure:** Predictors of mortality in responders and non-responders
**Time Frame:** 2 and 5 years
**Description:** To evaluate the differences in morbidity between patients with HFrEF and HFpEF by integrating information from clinical characteristics, diagnostic markers and genetics in order to have a further understanding of the underlying pathophysiology involved in HF development and prognosis with the aim to facilitate improved individualized therapy with less adverse effects and to identify novel treatment targets.
**Measure:** Predictors of morbidity in responders and non-responders
**Time Frame:** 2 and 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Written informed consent
2. Heart failure defined by symptoms and signs of heart failure as judged by the local investigator
3. Registered in SwedeHF
Exclusion Criteria:
1. Plasma donation within 1 month of enrolment or any blood donation/blood loss \>500 mL during the 3 months prior to enrolment
2. Previous allogeneic bone marrow transplant (genetics)
3. In the opinion of the investigator, condition/s that may either put the patient at risk on participation or influence the results or the patient's ability to participate in the study.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** PAtients with heart failure in Sweden with a registration in SwedeHF.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Camilla Hage, Ass prof
**Phone:** +46 (0)703340660
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ulf Dahlström, Prof
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Stockholm
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Camilla Hage, Ass prof
- **Phone:** +46 (0)703340660
- **Role:** CONTACT
***Contact 2:***
- **Name:** Ulf Dahlström, MD, Prof
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Erik Ostgärd Thunstrom, MD, Ass prof
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Christina Christersson, MD, Ass prof
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 5:***
- **Name:** Martin Magnusson, MD, Prof
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 6:***
- **Name:** Barna Szabo, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 7:***
- **Name:** Therese Andersson, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 8:***
- **Name:** Carin Cabrera, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 9:***
- **Name:** Patric Karlstrom, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Sweden
**Facility:** Karolinska University hospital
**Status:** RECRUITING
**Zip:** 17164
### IPD Sharing Statement Module
**Description:** Data sharing will only be within investigators. Beyond study investigators data sharing requires new ethical approval.
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435572
**Brief Title:** Comparison of Open and Closed Aspiration in Newborns
**Official Title:** Effect of Open and Closed Suction Systems on Newborn's Pain and Vital Signs in Neonatal Intensive Care
#### Organization Study ID Info
**ID:** aslialaca
#### Organization
**Class:** OTHER
**Full Name:** Izmir Katip Celebi University
### Status Module
#### Completion Date
**Date:** 2025-12-21
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-21
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-21
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Izmir Katip Celebi University
#### Responsible Party
**Investigator Affiliation:** Izmir Katip Celebi University
**Investigator Full Name:** Aslı Alaca
**Investigator Title:** MSc
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Endotracheal aspiration is a necessary procedure performed by nurses in neonatal intensive care units to increase oxygenation and remove secretions from the airways. It is one of the painful procedures that most frequently causes stress in intubated newborns.
**Detailed Description:** The aim of this study is to examine the effect of open and closed system suction, which is one of the invasive procedures frequently applied in neonatal intensive care, on the baby's pain and vital signs. There is a need for innovative, evidence-based practices to be implemented by nurses in clinics to minimize complications related to endotracheal suction.
### Conditions Module
**Conditions:**
- Newborn
**Keywords:**
- Closed system suctioning
- Open system suctioning
- Pain
- Neonatal intensive care
- Newborn
- Suction
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Each patient will be considered as both an experimental and a control group.Two different aspiration methods will be applied in line with the patient's aspiration needs, and the effect of the methods will be evaluated on the same patient. In the study, open aspiration applied to the patient will be evaluated as control, and closed aspiration will be considered as the experimental group.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Each patient will be evaluated as both the experimental and control group. In line with the patient's aspiration needs, two different suction methods will be applied and the effects of the methods will be evaluated on the same patient. In the study, open suction applied to the patient will be considered as the control group, and closed suction will be considered as the experimental group. The first suction of the same patient during the day will be performed as open suction, and the second suction will be performed as closed suction. Pain and physiological parameters will be evaluated before, during and 30 minutes after each sucking session.
**Intervention Names:**
- Other: Suction
**Label:** Experimental and A control group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental and A control group
**Description:** Each patient will be evaluated as both the experimental and control group. In the study, open suction applied to the patient will be evaluated as control, and closed suction will be considered as the experimental group. The first suction of the same patient during the day will be done as open suction, and the second suction will be done as closed suction.
**Name:** Suction
**Other Names:**
- open suction
- closed suction
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** differences in pain between open and closed suctioning systems
**Measure:** Pain score
**Time Frame:** Pain will be evaluated before, during and 30 minutes after each suction procedure.
**Description:** differences in oxygen saturation between open and closed suctioning systems
**Measure:** Oxygen saturation
**Time Frame:** Oxygen saturation will be evaluated before, during and 30 minutes after each suction procedure
**Description:** differences in heart rate between open and closed suctioning systems
**Measure:** Heart rate
**Time Frame:** Heart rate will be evaluated before, during and 30 minutes after each aspiration procedure
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Newborns monitored with mechanical ventilation
* Newborn who need suctioning,
* Newborn who did not undergo painful procedures one hour before aspiration.
* Hemodynamically stable newborn;
Exclusion Criteria:
* Newborn with any facial/skull deformities
* Newborn with chromosomal/genetic abnormalities
**Minimum Age:** 1 Day
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** ASLI ALACA, MSc
**Phone:** 05062741676
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Buca
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** ASLI ALACA
- **Phone:** 05062741676
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Phone Ext:** ALACA
- **Role:** CONTACT
***Contact 3:***
- **Name:** ASLI ALACA
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Turkey
**Facility:** Aslı Alaca
**State:** İ̇zmi̇r- Turkey
**Status:** RECRUITING
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435559
**Acronym:** CHEMOFOG
**Brief Title:** CHEmotherapy and Cognitive Deterioration in Patients With Operable Breast Cancer: Impact of Cognitive Rehabilitation (CHEMOFOG)
**Official Title:** CHEMioterapia e Deterioramento cOgnitivo Nelle Pazienti aFfette da Carcinoma Mammario
#### Organization Study ID Info
**ID:** CHEMOFOG
#### Organization
**Class:** OTHER
**Full Name:** Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
### Status Module
#### Completion Date
**Date:** 2026-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**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:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** An interventional, non-pharmacological, monocentric study evaluating the effectiveness of cognitive rehabilitation in counteracting chemotherapy-induced cognitive impairment (CRCI) in women with operable breast cancer treated with neo-adjuvant therapy and/ or adjuvant therapy.
**Detailed Description:** This interventional, non-pharmacological, monocentric study examines the effectiveness of cognitive rehabilitation in counteracting CRCI in women with operable breast cancer treated with neo-adjuvant therapy and/ or adjuvant therapy.
A total of 128 patients will be randomized 1:1 into two groups:
* Experimental group, which will participate in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises. To evaluate the efficacy of the cognitive rehabilitation program, neurocognitive evaluations will be performed.
* Control group, which will only carry out neuropsychological assessments.
Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
### Conditions Module
**Conditions:**
- Breast Cancer
**Keywords:**
- Chemotherapy-induced cognitive impairment
- Neuropsychological assessments
- Breast cancer
- Adjuvant chemotherapy
- Neo-adjuvant chemotherapy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 128
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patient enrolled in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises
**Intervention Names:**
- Other: Neurotablet® and Neuropsychological evaluations
**Label:** A-experimental group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patient NOT enrolled in a cognitive rehabilitation program using Neurotablet® and paper and pencil exercises.
**Intervention Names:**
- Other: Neuropsychological evaluations
**Label:** B-control group
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- A-experimental group
**Description:** The experimental group will carry out cognitive rehabilitation using the Neurotablet device. The cognitive rehabilitation will be performed for 10 consecutive weeks, once a week for 1 hour. Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
**Name:** Neurotablet® and Neuropsychological evaluations
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- B-control group
**Description:** Neuropsychological evaluations will be conducted before the start of chemotherapy (T0), 6 months (T1) and 12 months (T2) after the start of chemotherapy. Neuropsychological evaluations will include tests to analyze the main cognitive domains of memory, attention, executive functions and learning.
**Name:** Neuropsychological evaluations
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Test the effectiveness of a 10-week cognitive rehabilitation program in limiting or preventing chemotherapy-induced cognitive impairment. To test the efficacy of this cognitive rehabilitation program, neurocognitive evaluations will be performed.
**Measure:** The effectiveness of a 10-week cognitive rehabilitation program
**Time Frame:** Neurocognitive evaluations will be performed at T0 (before chemotherapy program start), T1 (after 6 months from chemotherapy started), and T2 (after 12 months from chemotherapy started)
#### Secondary Outcomes
**Description:** Analysis of cognitive function trends though neurocognitive evaluations
**Measure:** Analysis of cognitive function trends in the control group
**Time Frame:** Neurocognitive evaluations will be performed at T0 (before chemotherapy program start), T1 (after 6 months from chemotherapy started), and T2 (after 12 months from chemotherapy started)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Signature of informed consent
* Diagnosis of operable/operated breast cancer
* Patients candidate to be treated with Neo/adjuvant chemotherapy
Exclusion Criteria:
* Previous chemotherapy treatments
* Patients with Metastatic breast cancer
* Patients affected by pathologies of the brain, head trauma, and intellectual disabilities
* Patients affected by previous or current neurological and/or psychiatric disorders
* Patients currently treated with psychopharmacological drug
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ornella Garrone, MD
**Phone:** +390255032660
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-SC Oncologia Medica
**Name:** Ornella Garrone, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
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**PMID:** 26039523
**Citation:** Rodriguez Martin B, Fernandez Rodriguez EJ, Rihuete Galve MI, Cruz Hernandez JJ. Study of Chemotherapy-Induced Cognitive Impairment in Women with Breast Cancer. Int J Environ Res Public Health. 2020 Nov 30;17(23):8896. doi: 10.3390/ijerph17238896.
**PMID:** 33265966
**Citation:** Wefel JS, Saleeba AK, Buzdar AU, Meyers CA. Acute and late onset cognitive dysfunction associated with chemotherapy in women with breast cancer. Cancer. 2010 Jul 15;116(14):3348-56. doi: 10.1002/cncr.25098.
**PMID:** 20564075
**Citation:** Ercoli LM, Petersen L, Hunter AM, Castellon SA, Kwan L, Kahn-Mills BA, Embree LM, Cernin PA, Leuchter AF, Ganz PA. Cognitive rehabilitation group intervention for breast cancer survivors: results of a randomized clinical trial. Psychooncology. 2015 Nov;24(11):1360-7. doi: 10.1002/pon.3769. Epub 2015 Mar 10.
**PMID:** 25759235
**Citation:** Hurria A, Somlo G, Ahles T. Renaming "chemobrain". Cancer Invest. 2007 Sep;25(6):373-7. doi: 10.1080/07357900701506672.
**PMID:** 17882646
**Citation:** Argyriou AA, Assimakopoulos K, Iconomou G, Giannakopoulou F, Kalofonos HP. Either called "chemobrain" or "chemofog," the long-term chemotherapy-induced cognitive decline in cancer survivors is real. J Pain Symptom Manage. 2011 Jan;41(1):126-39. doi: 10.1016/j.jpainsymman.2010.04.021. Epub 2010 Sep 15.
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**Citation:** Sioka C, Kyritsis AP. Central and peripheral nervous system toxicity of common chemotherapeutic agents. Cancer Chemother Pharmacol. 2009 Apr;63(5):761-7. doi: 10.1007/s00280-008-0876-6. Epub 2008 Nov 25.
**PMID:** 19034447
**Citation:** Vezmar S, Schusseler P, Becker A, Bode U, Jaehde U. Methotrexate-associated alterations of the folate and methyl-transfer pathway in the CSF of ALL patients with and without symptoms of neurotoxicity. Pediatr Blood Cancer. 2009 Jan;52(1):26-32. doi: 10.1002/pbc.21827.
**PMID:** 19006245
**Citation:** Vardy J, Dhillon H. The fog hasn't lifted on "chemobrain" yet: ongoing uncertainty regarding the effects of chemotherapy and breast cancer on cognition. Breast Cancer Res Treat. 2010 Aug;123(1):35-7. doi: 10.1007/s10549-009-0719-0. Epub 2010 Jan 6. No abstract available.
**PMID:** 20052534
**Citation:** Iconomou G, Mega V, Koutras A, Iconomou AV, Kalofonos HP. Prospective assessment of emotional distress, cognitive function, and quality of life in patients with cancer treated with chemotherapy. Cancer. 2004 Jul 15;101(2):404-11. doi: 10.1002/cncr.20385.
**PMID:** 15241840
**Citation:** Hurria A, Rosen C, Hudis C, Zuckerman E, Panageas KS, Lachs MS, Witmer M, van Gorp WG, Fornier M, D'Andrea G, Moasser M, Dang C, Van Poznak C, Hurria A, Holland J. Cognitive function of older patients receiving adjuvant chemotherapy for breast cancer: a pilot prospective longitudinal study. J Am Geriatr Soc. 2006 Jun;54(6):925-31. doi: 10.1111/j.1532-5415.2006.00732.x.
**PMID:** 16776787
**Citation:** Von Ah D, Crouch A. Cognitive Rehabilitation for Cognitive Dysfunction after Cancer and Cancer Treatment: Implications for Nursing Practice. Semin Oncol Nurs. 2020 Feb;36(1):150977. doi: 10.1016/j.soncn.2019.150977. Epub 2020 Jan 17.
**PMID:** 31959511
**Citation:** Bray VJ, Dhillon HM, Bell ML, Kabourakis M, Fiero MH, Yip D, Boyle F, Price MA, Vardy JL. Evaluation of a Web-Based Cognitive Rehabilitation Program in Cancer Survivors Reporting Cognitive Symptoms After Chemotherapy. J Clin Oncol. 2017 Jan 10;35(2):217-225. doi: 10.1200/JCO.2016.67.8201. Epub 2016 Oct 28.
**PMID:** 28056205
**Citation:** Von Ah D. Cognitive changes associated with cancer and cancer treatment: state of the science. Clin J Oncol Nurs. 2015 Feb;19(1):47-56. doi: 10.1188/15.CJON.19-01AP.
**PMID:** 25689649
**Citation:** Foderaro G, Isella V, Mazzone A, Biglia E, Di Gangi M, Pasotti F, Sansotera F, Grobberio M, Raimondi V, Mapelli C, Ferri F, Impagnatiello V, Ferrarese C, Appollonio IM. Brand new norms for a good old test: Northern Italy normative study of MiniMental State Examination. Neurol Sci. 2022 May;43(5):3053-3063. doi: 10.1007/s10072-021-05845-4. Epub 2022 Jan 6. Erratum In: Neurol Sci. 2024 May 17;:
**PMID:** 34989910
**Citation:** Monaco M, Costa A, Caltagirone C, Carlesimo GA. Forward and backward span for verbal and visuo-spatial data: standardization and normative data from an Italian adult population. Neurol Sci. 2013 May;34(5):749-54. doi: 10.1007/s10072-012-1130-x. Epub 2012 Jun 12. Erratum In: Neurol Sci. 2015 Feb;36(2):345-7.
**PMID:** 22689311
**Citation:** Conca F, Esposito V, Rundo F, Quaranta D, Muscio C, Manenti R, Caruso G, Lucca U, Galbussera AA, Di Tella S, Baglio F, L'Abbate F, Canu E, Catania V, Filippi M, Mattavelli G, Poletti B, Silani V, Lodi R, De Matteis M, Stanzani Maserati M, Arighi A, Rotondo E, Tanzilli A, Pace A, Garramone F, Cavaliere C, Pardini M, Rizzetto C, Sorbi S, Perri R, Tiraboschi P, Canessa N, Cotelli M, Ferri R, Weintraub S, Marra C, Tagliavini F, Catricala E, Cappa SF. Italian adaptation of the Uniform Data Set Neuropsychological Test Battery (I-UDSNB 1.0): development and normative data. Alzheimers Res Ther. 2022 Aug 19;14(1):113. doi: 10.1186/s13195-022-01056-x. Erratum In: Alzheimers Res Ther. 2023 Mar 24;15(1):63. Alzheimers Res Ther. 2023 Jun 5;15(1):104.
**PMID:** 35982477
**Citation:** Costa DSJ, Loh V, Birney DP, Dhillon HM, Fardell JE, Gessler D, Vardy JL. The Structure of the FACT-Cog v3 in Cancer Patients, Students, and Older Adults. J Pain Symptom Manage. 2018 Apr;55(4):1173-1178. doi: 10.1016/j.jpainsymman.2017.12.486. Epub 2017 Dec 30.
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**Citation:** Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
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**Citation:** Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
**PMID:** 10568646
**Citation:** Fernandes HA, Richard NM, Edelstein K. Cognitive rehabilitation for cancer-related cognitive dysfunction: a systematic review. Support Care Cancer. 2019 Sep;27(9):3253-3279. doi: 10.1007/s00520-019-04866-2. Epub 2019 May 30.
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**Citation:** Carey CL, Woods SP, Gonzalez R, Conover E, Marcotte TD, Grant I, Heaton RK; HNRC Group. Predictive validity of global deficit scores in detecting neuropsychological impairment in HIV infection. J Clin Exp Neuropsychol. 2004 May;26(3):307-19. doi: 10.1080/13803390490510031.
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**Citation:** Costa A, Bagoj E, Monaco M, Zabberoni S, De Rosa S, Papantonio AM, Mundi C, Caltagirone C, Carlesimo GA. Standardization and normative data obtained in the Italian population for a new verbal fluency instrument, the phonemic/semantic alternate fluency test. Neurol Sci. 2014 Mar;35(3):365-72. doi: 10.1007/s10072-013-1520-8. Epub 2013 Aug 21.
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**PMID:** 11976975
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC25
- Name: Substance Related Disorders
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M29705
- Name: Cognitive Dysfunction
- Relevance: LOW
- As Found: Unknown
- ID: M2440
- Name: Chemotherapy-Related Cognitive Impairment
- Relevance: LOW
- As Found: Unknown
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435546
**Acronym:** AdOTAC
**Brief Title:** Adherence to Oral Therapies in Advanced Breast and Prostate Cancers
**Official Title:** Adherence to Oral Therapies in Advanced Breast and Prostate Cancers: a Pilot Study
#### Organization Study ID Info
**ID:** 2024-A00396-41
#### Organization
**Class:** OTHER
**Full Name:** Institut de Cancérologie de Lorraine
### Status Module
#### Completion Date
**Date:** 2025-06-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-12-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-11-27
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Institut de Cancérologie de Lorraine
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** AdOTAC is a pilot study, open, prospective, single-center, one-arm. The 200 patients will be included. Patient is included at Day 0. The included patient will have the opportunity to complete the self-questionnaires either at the ICL on Day 0, or at home up to 10 days after the date of inclusion in the study. Blood samples are collected the day of enrolment (Day 0) in order to measure the following biological markers: ferritin, serum iron, TSAT, albumin, and haemoglobin, except if performed as part of routine care in the previous 6 weeks.
### Conditions Module
**Conditions:**
- Breast Cancer
- Prostate Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Blood samples
**Intervention Names:**
- Diagnostic Test: Blood samples
- Other: Adherence to anti-cancer therapies questionnaires
**Label:** Adherence oral anticancer therapies questionnaire
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Adherence oral anticancer therapies questionnaire
**Description:** Ferritin, Transferrin Saturation (TSAT), Serum iron, Haemoglobin, Albumin
**Name:** Blood samples
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- Adherence oral anticancer therapies questionnaire
**Description:** GIRERD questionnaire, AdOT questionnaire, Use of social networks and alternatives and complementary medicines using patient questionnaire, EORTC QLQC30, HADS, MNA, MSPSS
**Name:** Adherence to anti-cancer therapies questionnaires
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Medication adherence to oral anticancer treatments will be assessed using a score based on the GIRERD adherence assessment (targeting oral anticancer treatments).
The score is a scale ranging from 0 to 6 (good compliance = 6; poor compliance = 4 to 5; non-adherence ≤ 3).
**Measure:** Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.
**Time Frame:** one day
#### Secondary Outcomes
**Description:** The performance status by the ECOG-PS score (0 to 4).
**Measure:** Identify if the performance status by the ECOG-PS score is associated with reduced adherence to oral anticancer treatments
**Time Frame:** one day
**Description:** Comorbidities using the Charlson score (0 to 37).
**Measure:** Identify if comorbitities is associated with reduced adherence to oral anticancer treatments
**Time Frame:** one day
**Description:** Polypharmacy by the use of five or more medications apart from the current oral anti-cancer medications (0 to \>5).
**Measure:** Identify if polypharmacy by the use of five or more medications apart from the current oral anti-cancer medications is associated with reduced adherence to oral anticancer treatments
**Time Frame:** one day
**Description:** The treatment regimen by a level of complexity (4 levels) given by an oncologist.
**Measure:** Identify if treatment regimen by a level of complexity is associated with reduced adherence to oral anticancer treatments
**Time Frame:** one day
**Description:** Biological markers (ferritin, TSAT, serum iron, haemoglobin, albumin) by a blood test.
**Measure:** Identify if biological markers are associated with reduced adherence to oral anticancer treatments
**Time Frame:** one day
**Description:** Sarcopenia by the body mass/fat mass ratio using imaging (SMI: skeletal muscle mass index).
**Measure:** Identify if sarcopenia is associated with reduced adherence to oral anticancer treatments
**Time Frame:** one day
**Description:** Quality of life using the EORTC-QLQ-C30 questionnaire score.
**Measure:** Identify if quality of life using the EORTC-QLQ-C30 questionnaire score is associated with reduced adherence to oral anticancer treatments
**Time Frame:** one day
**Description:** Social and emotional support by the MSPSS questionnaire (Multidimensional Scale of Perceived Social Support) (12-35: low perceived support; 36-60: medium perceived support; 61-84: hugh perceived support)
**Measure:** Identify if Social and emotional support by the MSPSS questionnaire is associated with reduced adherence to oral anticancer treatments
**Time Frame:** one day
**Description:** Anxiety and/or depression using the Hospital Anxiety and Depression Scale (HADS).
(If the score in a column is greater than or equal to 11, it means person suffer from anxiety or depression)
**Measure:** Identify if HADS scale is associated with reduced adherence to oral anticancer treatments
**Time Frame:** one day
**Description:** Malnutrition using the MNA (Mini-Nutritional Assessment) questionnaire (24-30 points: normal nutritional status; 17-23.5 points: at risk of malnutrition; less than 17 points: malnourished)
**Measure:** Identify if MNA is associated with reduced adherence to oral anticancer treatments
**Time Frame:** one day
**Description:** Use of social networks and alternatives and complementary medicines using patient questionnaire developed specifically for the study population.
**Measure:** Identify if Use of social networks and alternatives and complementary medicines using patient questionnaire is associated with reduced adherence to oral anticancer treatments
**Time Frame:** one day
**Description:** Medication adherence to oral anticancer treatments will also be assessed using the score from the new AdOT questionnaire. The score is a scale ranging from 0 (no adherence) to 100 (perfect adherence).
**Measure:** Assess medication adherence to oral treatments in patients with advanced breast or prostate cancer.
**Time Frame:** one day
**Description:** Subgroup analysis by cancer type (breast; prostate), use of alternatives and complementary medicines (yes; no) and use of social media and networks (yes; no).
**Measure:** Study the relationship between the two adherence questionnaires.
**Time Frame:** one day
**Description:** The correlation between the scores on the GIRERD and AdOT will be analysed.
**Measure:** Describe and compare medication adherence to oral treatments
**Time Frame:** one day
**Description:** Subgroup analysis by cancer type (breast; prostate), use of alternative and complementary medicines (yes; no) and use of social media and networks (yes; no).
**Measure:** Describe and compare patient characteristics (socio-demographic, clinical and contextual), medication adherence to oral anticancer treatments according to cancer type, use of alternative and complementary medicines and use of social media and networks.
**Time Frame:** one day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult over 18 years old.
* Patient with inoperable advanced breast cancer treated with oral endocrine therapy and/or targeted therapy and patient with inoperable advanced prostate cancer treated with oral hormonal therapy and/or targeted therapy.
* Oral anticancer medications started for at least 3 months.
* With a performance status ≤ 3.
* Patient has understood, signed and dated the consent form.
* Patient covered by the social security system.
Exclusion Criteria:
* Patient with early breast cancer or localized prostate cancer.
* Patient with life expectancy \< 3 months.
* Patient in progression
* Undergoing intravenous or oral cytotoxic chemotherapy (capecitabine, cyclophosphamide, vinorelbine).
* Patient who has not yet started oral anticancer therapies or who has started for less than 3 months.
* Patient unable to read or speak French.
* Patient already included in another therapeutic trial with an experimental molecule.
* Persons deprived of their liberty or under guardianship (including curatorship).
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Vincent Massard, MD
**Phone:** +33383598461
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jean-Louis Merlin, Pr
**Phone:** +33383656062
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Vandœuvre-lès-Nancy
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** VINCENT MASSARD
- **Phone:** +33 3 83 59 40 46
- **Role:** CONTACT
**Country:** France
**Facility:** Institut de Cancerologie de Lorraine
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Institut de Cancérologie de Lorraine
**Name:** Vincent Massard, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Institut de Cancérologie de Lorraine
**Name:** Naoual Boujedaini, PhD
**Role:** STUDY_CHAIR
## 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: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: LOW
- As Found: Unknown
- 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
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M10533
- Name: Iron
- Relevance: LOW
- As Found: Unknown
- ID: M207501
- Name: Chrysarobin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435533
**Acronym:** coldAPC
**Brief Title:** Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
**Official Title:** Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis
#### Organization Study ID Info
**ID:** 2023-101193-BO-ff
#### Organization
**Class:** OTHER
**Full Name:** Universitätsklinikum Hamburg-Eppendorf
### Status Module
#### Completion Date
**Date:** 2025-03-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-01-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-12-06
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-14
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Universitätsklinikum Hamburg-Eppendorf
#### Responsible Party
**Investigator Affiliation:** Universitätsklinikum Hamburg-Eppendorf
**Investigator Full Name:** Prof. Dr. Thomas Rösch
**Investigator Title:** Prof. Dr. Thomas Roesch Medical Director, Interdisciplinary Endoscopy Department and Clinic University Hospital Hamburg-Eppendorf
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The objective of this study is to investigate the feasibility for the treatment of precancerous peri-ampullary FAP polyps in the duodenum using low-thermal argonplasma.
**Detailed Description:** Familial adenomatous polyposis (FAP) is an autosomal dominantly inherited disorder, which results from a germ line mutation in the APC (adenomatous polyposis coli) gene. FAP is characterized by the formation of very high number of colorectal adenomatous polyps which could cause the development of colorectal cancer in the 5th decade of life. After colon surgery patients are still at risk of developing upper GI cancer e.g. in the duodenum. Because of the continuing risk for the development of duodenal cancer, regular endoscopic surveillance is recommended for these patients.
In this study a new APC modality (Precise mode E1) applied for the remission of FAP polyps during routine endoscopic surveillance is suggested. Argonplasma coagulation (APC) is widely used for the ablation and coagulation of superficial lesions in the GI tract. The application of high thermal tissue destroying APC in the duodenum is challenging due to the anatomy of the duodenal wall which is thin and therefore susceptible to thermal damage.
The application of low-thermal argonplasma in the GI tract could be just as useful as it was suggested for the treatment of neoplastic tissue in gynecology. Low-thermal APC using Erbe Standard 3.2 mm FiAPC probe and Precise mode was successfully applied for the remission of cervical intraepithelial neoplasia. The formation of reactive oxygen and nitric oxide species has been discussed as trigger for the effect on neoplasia tissue of low-thermal argonplasma.
Regarding current knowledge this is the first application of this APC modality in the GI tract.
### Conditions Module
**Conditions:**
- Adenomatous Polyposis Coli
- Familial Adenomatous Polyposis
- Duodenal Adenoma
**Keywords:**
- Familial Adenomatous Polyposis
- FAP
- duodenal adenoma
- argon plasma coagulation
- Spigelman classification stage III
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** peri-ampullary FAP polyps of size smaller than 10 mm will be treated with low energy argonplasma coagulation
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** low energy argonplasma coagulation
**Intervention Names:**
- Device: low energy argonplasma coagulation
**Label:** duodenal polyps <10 mm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- duodenal polyps <10 mm
**Description:** see above
**Name:** low energy argonplasma coagulation
**Other Names:**
- cold APC
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Significant reduction in the number of duodenal polyps at the next follow-up appointment
**Measure:** polyp number
**Time Frame:** 12 months
**Description:** Significant reduction in the size of duodenal polyps at the next follow-up appointment
**Measure:** polyp size
**Time Frame:** 12 months
#### Secondary Outcomes
**Description:** rate of acute adverse incidents: bleeding
**Measure:** acute haematemesis
**Time Frame:** 24 hours
**Description:** rate of acute adverse incidents: Hb drop \< 2g /dl (grammes per decilitre)
**Measure:** acute hemoglobin drop
**Time Frame:** 24 hours
**Description:** rate of acute adverse incidents: Hb drop = or \> 2g /dl (grammes per decilitre)
**Measure:** acute severe hemoglobin drop
**Time Frame:** 24 hours
**Description:** rate of acute adverse incidents: Hb drop = or \> 2g /dl (grammes per decilitre)
**Measure:** blood transfusion
**Time Frame:** 24 hours
**Description:** rate of acute adverse incidents: coagulation or clipping
**Measure:** endoscopic hemostasis
**Time Frame:** 24 hours
**Description:** rate of acute adverse incidents: endoscopic clipping
**Measure:** treatment of perforation
**Time Frame:** 24 hours
**Description:** rate of acute adverse incidents: bleeding or perforation which can not be handled by endoscopic treatment
**Measure:** need for surgical intervention
**Time Frame:** 24 hours
**Description:** rate of acute adverse incidents:pain
**Measure:** acute abdominal pain
**Time Frame:** 24 hours
**Description:** rate of acute adverse incidents: stenosis
**Measure:** acute dysphagia
**Time Frame:** 24 hours
**Description:** rate of acute adverse incidents: fever \<38°C (degrees Centigrade)
**Measure:** acute rise of temperature
**Time Frame:** 24 hours
**Description:** total EGD performing time
**Measure:** EGD (esophago-gastro-duodenoscopy) time
**Time Frame:** during EGD; up to 45 minutes
**Description:** total ablation time in minutes
**Measure:** therapy time
**Time Frame:** up to 30 minutes
**Description:** abdominal pain assessed by patient survey
**Measure:** abdominal pain
**Time Frame:** 4 days
**Description:** nausea assessed by patient survey
**Measure:** nausea
**Time Frame:** 4 days
**Description:** feeling of fullness assessed by patient survey
**Measure:** feeling of fullness
**Time Frame:** 4 days
**Description:** emesis assessed by patient survey
**Measure:** emesis
**Time Frame:** 4 days
**Description:** hematemesis or tar faeces assessed by patient survey
**Measure:** signs of bleeding
**Time Frame:** 4 days
**Description:** fever \>38°C
**Measure:** fever
**Time Frame:** 4 days
**Description:** visits in doctor's office or hospital
**Measure:** need for physician help
**Time Frame:** 4 days
**Description:** Change in stage/number of points in Spigelman classification compared to the previous examination
**Measure:** success rate
**Time Frame:** 12 months
**Description:** dysphagia caused by duodenal stricture
**Measure:** dysphagia
**Time Frame:** 12 months
**Description:** need for endoscopic dilatation of strictured duodenum
**Measure:** balloon dilatations
**Time Frame:** 12 months
**Description:** general abdominal pain assessed by patient survey
**Measure:** abdominal pain
**Time Frame:** 12 months
**Description:** postprandial abdominal pain assessed by patient survey
**Measure:** postprandial pain
**Time Frame:** 12 months
**Description:** regurgitation due to duodenal strictures assessed by EGD
**Measure:** emesis
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* confirmed FAP disease
* duodenal polyposis with recommendation of a follow-up EGD in 12 months corresponding to stage III (7-8 points) according to Spigelman
* presence of duodenal polyps \< 10 mm
* written Informed Consent
Exclusion Criteria:
* presence of lesions that are suspicious of the presence of high-grade dysplasia or carcinoma
* pregnancy or breastfeeding
* severe general illnesses (permanent ASA (American Society of Anesthesiologists) III and IV) who do not prognostically benefit from follow-up, life expectancy \< 1 year
* severe coagulopathy
* any visible state of duodenal surface that makes APC treatment impossible, e.g. inflammation, stricture, stenosis or scarring changes/scar areas
**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:** Thomas Rösch, Professor
**Phone:** +49407410
**Phone Ext:** 50098
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Tania Ruppenthal
**Phone:** +49407410
**Phone Ext:** 50089
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hamburg
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Thomas Rösch, Professor
- **Phone:** +49407410
- **Phone Ext:** 50098
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Tania Ruppenthal
- **Phone:** +49407410
- **Phone Ext:** 50089
- **Role:** CONTACT
***Contact 3:***
- **Name:** Thomas Rösch, Professor
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Jocelyn de Heer, PD Dr.
- **Role:** SUB_INVESTIGATOR
**Country:** Germany
**Facility:** University Hospital Hamburg-Eppendorf
**Status:** RECRUITING
**Zip:** 20246
#### Overall Officials
**Official 1:**
**Affiliation:** Universitätskrankenhaus Hamburg-Eppendorf
**Name:** Thomas Rösch, Professor
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Aelvoet AS, Buttitta F, Ricciardiello L, Dekker E. Management of familial adenomatous polyposis and MUTYH-associated polyposis; new insights. Best Pract Res Clin Gastroenterol. 2022 Jun-Aug;58-59:101793. doi: 10.1016/j.bpg.2022.101793. Epub 2022 Mar 16.
**PMID:** 35988966
**Citation:** Half E, Bercovich D, Rozen P. Familial adenomatous polyposis. Orphanet J Rare Dis. 2009 Oct 12;4:22. doi: 10.1186/1750-1172-4-22.
**PMID:** 19822006
**Citation:** Ghorbanoghli Z, Bastiaansen BA, Langers AM, Nagengast FM, Poley JW, Hardwick JC, Koornstra JJ, Sanduleanu S, de Vos Tot Nederveen Cappel WH, Witteman BJ, Morreau H, Dekker E, Vasen HF. Extracolonic cancer risk in Dutch patients with APC (adenomatous polyposis coli)-associated polyposis. J Med Genet. 2018 Jan;55(1):11-14. doi: 10.1136/jmedgenet-2017-104545. Epub 2017 May 10.
**PMID:** 28490611
**Citation:** Bulow S, Bjork J, Christensen IJ, Fausa O, Jarvinen H, Moesgaard F, Vasen HF; DAF Study Group. Duodenal adenomatosis in familial adenomatous polyposis. Gut. 2004 Mar;53(3):381-6. doi: 10.1136/gut.2003.027771.
**PMID:** 14960520
**Citation:** Kadmon M, Tandara A, Herfarth C. Duodenal adenomatosis in familial adenomatous polyposis coli. A review of the literature and results from the Heidelberg Polyposis Register. Int J Colorectal Dis. 2001 Apr;16(2):63-75. doi: 10.1007/s003840100290.
**PMID:** 11355321
**Citation:** Bjork J, Akerbrant H, Iselius L, Bergman A, Engwall Y, Wahlstrom J, Martinsson T, Nordling M, Hultcrantz R. Periampullary adenomas and adenocarcinomas in familial adenomatous polyposis: cumulative risks and APC gene mutations. Gastroenterology. 2001 Nov;121(5):1127-35. doi: 10.1053/gast.2001.28707.
**PMID:** 11677205
**Citation:** van Leerdam ME, Roos VH, van Hooft JE, Dekker E, Jover R, Kaminski MF, Latchford A, Neumann H, Pellise M, Saurin JC, Tanis PJ, Wagner A, Balaguer F, Ricciardiello L. Endoscopic management of polyposis syndromes: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2019 Sep;51(9):877-895. doi: 10.1055/a-0965-0605. Epub 2019 Jul 23.
**PMID:** 31342472
**Citation:** Spigelman AD, Williams CB, Talbot IC, Domizio P, Phillips RK. Upper gastrointestinal cancer in patients with familial adenomatous polyposis. Lancet. 1989 Sep 30;2(8666):783-5. doi: 10.1016/s0140-6736(89)90840-4.
**PMID:** 2571019
**Citation:** Manner H. Thermal ablative therapies in the gastrointestinal tract. Curr Opin Gastroenterol. 2023 Sep 1;39(5):370-374. doi: 10.1097/MOG.0000000000000954. Epub 2023 Jun 22.
**PMID:** 37389449
**Citation:** Manner H. Argon plasma coagulation therapy. Curr Opin Gastroenterol. 2008 Sep;24(5):612-6. doi: 10.1097/MOG.0b013e32830bf825.
**PMID:** 19122503
**Citation:** Martusevich AK, Surovegina AV, Bocharin IV, Nazarov VV, Minenko IA, Artamonov MY. Cold Argon Athmospheric Plasma for Biomedicine: Biological Effects, Applications and Possibilities. Antioxidants (Basel). 2022 Jun 27;11(7):1262. doi: 10.3390/antiox11071262.
**PMID:** 35883753
**Citation:** Marzi J, Stope MB, Henes M, Koch A, Wenzel T, Holl M, Layland SL, Neis F, Bosmuller H, Ruoff F, Templin M, Kramer B, Staebler A, Barz J, Carvajal Berrio DA, Enderle M, Loskill PM, Brucker SY, Schenke-Layland K, Weiss M. Noninvasive Physical Plasma as Innovative and Tissue-Preserving Therapy for Women Positive for Cervical Intraepithelial Neoplasia. Cancers (Basel). 2022 Apr 12;14(8):1933. doi: 10.3390/cancers14081933.
**PMID:** 35454839
**Citation:** Grund KE, Storek D, Farin G. Endoscopic argon plasma coagulation (APC) first clinical experiences in flexible endoscopy. Endosc Surg Allied Technol. 1994 Feb;2(1):42-6.
**PMID:** 8081915
**Citation:** Karamanolis G, Triantafyllou K, Tsiamoulos Z, Polymeros D, Kalli T, Misailidis N, Ladas SD. Argon plasma coagulation has a long-lasting therapeutic effect in patients with chronic radiation proctitis. Endoscopy. 2009 Jun;41(6):529-31. doi: 10.1055/s-0029-1214726. Epub 2009 May 13.
**PMID:** 19440956
**Citation:** Peng M, Guo X, Yi F, Shao X, Wang L, Wu Y, Wang C, Zhu M, Bian O, Ibrahim M, Chawla S, Qi X. Endoscopic treatment for gastric antral vascular ectasia. Ther Adv Chronic Dis. 2021 Aug 12;12:20406223211039696. doi: 10.1177/20406223211039696. eCollection 2021.
**PMID:** 34408826
**Citation:** Swanson E, Mahgoub A, MacDonald R, Shaukat A. Medical and endoscopic therapies for angiodysplasia and gastric antral vascular ectasia: a systematic review. Clin Gastroenterol Hepatol. 2014 Apr;12(4):571-82. doi: 10.1016/j.cgh.2013.08.038. Epub 2013 Sep 5.
**PMID:** 24013107
**Citation:** Lienert A, Bagshaw PF. Treatment of duodenal adenomas with endoscopic argon plasma coagulation. ANZ J Surg. 2007 May;77(5):371-3. doi: 10.1111/j.1445-2197.2007.04063.x.
**PMID:** 17497979
**Citation:** Manner H, May A, Faerber M, Rabenstein T, Ell C. Safety and efficacy of a new high power argon plasma coagulation system (hp-APC) in lesions of the upper gastrointestinal tract. Dig Liver Dis. 2006 Jul;38(7):471-8. doi: 10.1016/j.dld.2006.03.022. Epub 2006 May 15.
**PMID:** 16702032
**Citation:** Jaganmohan S, Lynch PM, Raju RP, Ross WA, Lee JE, Raju GS, Bhutani MS, Fleming JB, Lee JH. Endoscopic management of duodenal adenomas in familial adenomatous polyposis--a single-center experience. Dig Dis Sci. 2012 Mar;57(3):732-7. doi: 10.1007/s10620-011-1917-2. Epub 2011 Sep 30.
**PMID:** 21960285
**Citation:** Na HK, Kim DH, Ahn JY, Lee JH, Jung KW, Choi KD, Song HJ, Lee GH, Jung HY. Clinical Outcomes following Endoscopic Treatment for Sporadic Nonampullary Duodenal Adenoma. Dig Dis. 2020;38(5):364-372. doi: 10.1159/000504249. Epub 2020 Jun 9.
**PMID:** 32516770
**Citation:** Manner H, Enderle MD, Pech O, May A, Plum N, Riemann JF, Ell C, Eickhoff A. Second-generation argon plasma coagulation: two-center experience with 600 patients. J Gastroenterol Hepatol. 2008 Jun;23(6):872-8. doi: 10.1111/j.1440-1746.2008.05437.x.
**PMID:** 18565020
**Citation:** Eickhoff A, Hartmann D, Eickhoff JC, Riemann JF, Enderle MD. Pain sensation and neuromuscular stimulation during argon plasma coagulation in gastrointestinal endoscopy. Surg Endosc. 2008 Jul;22(7):1701-7. doi: 10.1007/s00464-007-9700-3. Epub 2007 Dec 11.
**PMID:** 18071803
**Citation:** Amoyel M, Belle A, Dhooge M, Ali EA, Hallit R, Prat F, Dohan A, Terris B, Chaussade S, Coriat R, Barret M. Endoscopic management of non-ampullary duodenal adenomas. Endosc Int Open. 2022 Jan 14;10(1):E96-E108. doi: 10.1055/a-1723-2847. eCollection 2022 Jan.
**PMID:** 35047339
**Citation:** Kim GE, Siddiqui UD. Endoscopic Resection Techniques for Duodenal and Ampullary Adenomas. VideoGIE. 2023 Jul 22;8(8):330-335. doi: 10.1016/j.vgie.2023.05.006. eCollection 2023 Aug.
**PMID:** 37575136
#### See Also Links
**Label:** German oncological guidelines for colorectal cancer
**URL:** http://www.leitlinienprogramm-onkologie.de/leitlinien/kolorektales-karzinom/
## 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: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
- ID: D000010610
- Term: Pharyngeal Neoplasms
- ID: D000010039
- Term: Otorhinolaryngologic Neoplasms
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000009302
- Term: Nasopharyngeal Diseases
- ID: D000010608
- Term: Pharyngeal Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
- ID: D000018256
- Term: Adenomatous Polyps
- ID: D000009386
- Term: Neoplastic Syndromes, Hereditary
- ID: D000044483
- Term: Intestinal Polyposis
- ID: D000030342
- Term: Genetic Diseases, Inborn
### 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
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14011
- Name: Polyps
- Relevance: LOW
- As Found: Unknown
- ID: M3591
- Name: Adenoma
- Relevance: HIGH
- As Found: Adenoma
- ID: M14009
- Name: Adenomatous Polyposis Coli
- Relevance: HIGH
- As Found: Familial Adenomatous Polyposis
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Polyposis
- ID: M12254
- Name: Nasopharyngeal Neoplasms
- Relevance: HIGH
- As Found: Polyposis
- 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: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13517
- Name: Pharyngeal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12962
- Name: Otorhinolaryngologic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12253
- Name: Nasopharyngeal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13515
- Name: Pharyngeal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20402
- Name: Adenomatous Polyps
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M12331
- Name: Neoplastic Syndromes, Hereditary
- Relevance: LOW
- As Found: Unknown
- ID: M25346
- Name: Intestinal Polyposis
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: T2191
- Name: Familial Adenomatous Polyposis
- Relevance: HIGH
- As Found: Familial Adenomatous Polyposis
- ID: T4001
- Name: MYH-associated Polyposis
- Relevance: HIGH
- As Found: Familial Adenomatous Polyposis
### Condition Browse Module - Meshes
- ID: D000000236
- Term: Adenoma
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000009303
- Term: Nasopharyngeal Neoplasms
- ID: D000011125
- Term: Adenomatous Polyposis Coli
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435520
**Brief Title:** Enhancing Hypnotic Medication Discontinuation in Primary Care
**Official Title:** Enhancing Hypnotic Medication Discontinuation in Primary Care Through Supervised Medication Tapering and Digital Cognitive Behavioral Insomnia Therapy
#### Organization Study ID Info
**ID:** HS4047
#### Organization
**Class:** OTHER
**Full Name:** National Jewish Health
### Status Module
#### Completion Date
**Date:** 2029-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** National Jewish Health
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Many individuals with insomnia seek treatment in primary care settings, where they often receive prescription hypnotic medications as their first and sometimes only treatment. However, extended use of these medications can lead to reliance and increased health risks, such as falls and cognitive impairments. While evidence-based approaches like physician-supervised medication tapering exist, they're not widely available in primary care.
Most primary care providers are willing to explore non-drug treatments like cognitive behavioral therapy for insomnia (CBTI), but accessing such treatments can be challenging outside of specialized sleep centers. This gap between research and practice underscores the need for cost-effective interventions to manage insomnia and help patients reduce their reliance on hypnotics in primary care.
In response to this need, the project aims to conduct a large randomized trial comparing a combined digital CBT (dCBTI) and medication tapering intervention with medication tapering alone. We'll recruit 430 patients reliant on hypnotics from 8-10 primary care clinics affiliated with the University of Colorado Medical School. The main goal is to assess the effectiveness of dCBTI+SMT compared to SMT alone in reducing hypnotic use and improving insomnia symptoms.
Additionally, we'll evaluate factors affecting the adoption and implementation of these interventions at the patient, provider, and system levels. This information will inform future implementation strategies to disseminate effective treatments in primary care.
Furthermore, we'll gather data to identify which patients benefit most from dCBTI+SMT. Overall, this study will provide valuable insights into the feasibility, clinical utility, and acceptability of these interventions in managing insomnia and reducing reliance on hypnotic medications in primary care. Ultimately, this project represents a crucial first step toward making accessible and cost-effective strategies available to improve the quality of life for millions of chronic users of sleep aids.
**Detailed Description:** Treatment-seeking insomnia sufferers most often present in primary care where their first and usually only treatment is a prescription hypnotic medication. More than 65% of individuals prescribed hypnotics use them for more than a year, and more than 30% remain on them for more than five years. Such agents may be useful for acute insomnia and certain cases with chronic sleep difficulties, but prolonged hypnotic use can lead to dependency and increased morbidity (e.g., falls, cognitive/driving impairments). Reducing or discontinuing hypnotics after prolonged use is a challenging task for both prescribing physicians and the patients who use them. Although evidenced-based physician-supervised medication tapering (SMT) protocols have shown efficacy, such interventions have yet to be disseminated widely in primary care. Most primary care providers (PCPs) are willing to refer their insomnia patients to alternative evidence-based non-drug treatments such as cognitive behavioral insomnia therapy (CBTI), but such treatment is often difficult to access outside of specialty sleep centers. Given this gap between research and clinical practice, there is a pressing need to develop and validate cost-effective interventions to facilitate the management of insomnia and hypnotic tapering in primary care. This study has been carefully designed to address these issues. Investigators will conduct a large randomized trial (RCT) to compare the combined digital CBT (dCBTI)/SMT intervention, to the SMT intervention delivered alone for producing hypnotic discontinuation and insomnia symptom improvement. A sample of 430 hypnotic-reliant patients drawn from 8-10 primary care clinics within a practice-based research network affiliated with the University of Colorado Medical School in Aurora, Colorado will serve as study participants. The main objective of the project is to compare the performance of dCBTI+SMT with SMT used alone for achieving hypnotic reduction/discontinuation and insomnia symptom improvement. In addition, investigators will incorporate an Effectiveness-Implementation assessment into the RCT to identify patient- provider- and system-level factors that may impact adoption, implementation and maintenance of the types of interventions tested. Findings from the effectiveness/implementation should help design future trials of implementation strategies identified herein to promote dissemination of dCBTI and SMT interventions into primary care should these treatments prove effective in the current trial. Investigators also will gather exploratory data to determine who responds best to dCBTI/SMT. This study will provide new and useful information about the feasibility, clinical utility, and patient-, provider-, and system-level acceptability of these interventions to manage insomnia and reduce/eliminate hypnotic use in primary care. This project should serve as a necessary first step toward the eventual dissemination of accessible, cost-effective strategies to manage a significant public health problem and improve the quality of life of millions of chronic users of controlled-substance sleep aids.
### Conditions Module
**Conditions:**
- Insomnia
- Hypnotic Dependence
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized trial to compare the combined digital cognitive behavioral therapy (dCBTI) / structured medication taper (SMT) intervention, to the SMT intervention delivered alone for producing hypnotic discontinuation and insomnia symptom improvement.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 430
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** dCBTI delivered in tandem with SMT during intervention phase.
**Intervention Names:**
- Behavioral: Digital Cognitive Behavioral Therapy
- Behavioral: Structured Medication Tapering
**Label:** Digital cognitive behavioral therapy combined with structured medication tapering
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Structured medication tapering delivered alone with general sleep hygiene information.
**Intervention Names:**
- Behavioral: Structured Medication Tapering
**Label:** Structured medication tapering alone
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Digital cognitive behavioral therapy combined with structured medication tapering
**Description:** Adaptive cloud-based software delivering cognitive behavioral therapy tailored to the needs of the individual patient.
**Name:** Digital Cognitive Behavioral Therapy
**Other Names:**
- dCBTI
- Sleepio
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Digital cognitive behavioral therapy combined with structured medication tapering
- Structured medication tapering alone
**Description:** A structured tapering of hypnotic (or other) medication to promote successful discontinuation by patients seeking to discontinue use.
**Name:** Structured Medication Tapering
**Other Names:**
- SMT
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Rates of successful hypnotic discontinuation among participants
**Measure:** Hypnotic discontinuation rates
**Time Frame:** Post-treatment at weeks 22 and 49 of participation
**Description:** Rates of insomnia remission among participants
**Measure:** Insomnia remission rates
**Time Frame:** Post-treatment at weeks 22 and 49 of participation
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* a history of extended (\> 6 consecutive months) and frequent (\>5 nights/week on average) use of benzodiazepine (BZD) or non-BZD hypnotic medications;
* a desire to decrease/eliminate hypnotic use;
* a history of insomnia that meets DSM-560 criteria for insomnia disorder; and
* willingness to provide written informed consent to participate.
Exclusion Criteria:
* a lifetime diagnosis of any psychotic disorder, suicide attempts, or bipolar disorder;
* presence of an unstable, untreated, or terminal major medical or psychiatric disorder;
* alcohol or drug abuse within the past year;
* current use of a BZD for another disorder in addition to insomnia (e.g., seizure disorder, restless leg syndrome, anxiety disorder);
* pregnancy;
* significant cognitive impairment as suggested by a score of ≤ 24 on the Folstein Mini-Mental State Examination (MMSE);
* current use of medications known to cause insomnia (e.g., high dose corticosteroids);
* untreated comorbid sleep disorders;
* use of a sedating antidepressant or antipsychotic medication solely for sleep; and
* consuming \>2 alcoholic beverages/day ≥5 times/week or any use of marijuana ≥5 times/week.
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** RJ Johnson, MA
**Phone:** 303-398-1058
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** Not planned.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020919
- Term: Sleep Disorders, Intrinsic
- ID: D000020920
- Term: Dyssomnias
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000009422
- Term: Nervous System Diseases
- 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: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M10356
- Name: Sleep Initiation and Maintenance Disorders
- Relevance: HIGH
- As Found: Insomnia
- 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
- 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: D000007319
- Term: Sleep Initiation and Maintenance Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435507
**Brief Title:** Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of IM-250 in Healthy Volunteers
**Official Title:** Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of IM-250 in Healthy Volunteers
#### Organization Study ID Info
**ID:** IM-101
#### Organization
**Class:** INDUSTRY
**Full Name:** Innovative Molecules GmbH
### Status Module
#### Completion Date
**Date:** 2024-08-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-01-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-04-25
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Innovative Molecules GmbH
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** This is a first-in-human, phase I, open-label, monocenter, single dose-escalation study with 4 cohorts. The total trial duration for each participant will be not more than 98 d from screening to the end of the follow-up.
Twenty-four participants are planned to be enrolled in the trial. Each cohort may be expanded by up to 6 additional volunteers, resulting in a maximum of 48 participants possibly enrolled in the trial.
Ninety-six volunteers may need to be screened to include 48 volunteers.
### Conditions Module
**Conditions:**
- Herpes Simplex Virus
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 6 participants
**Intervention Names:**
- Drug: IM-250 (50 mg)
**Label:** Cohort 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 6 participants
**Intervention Names:**
- Drug: IM-250 (100 mg)
**Label:** Cohort 2
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** 6 participants
**Intervention Names:**
- Drug: IM-250 (200 mg)
**Label:** Cohort 3
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** 6 participants
**Intervention Names:**
- Drug: IM-250 (400 mg)
**Label:** Cohort 4
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cohort 1
**Description:** Single dose
**Name:** IM-250 (50 mg)
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Cohort 2
**Description:** Single dose
**Name:** IM-250 (100 mg)
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Cohort 3
**Description:** Single dose
**Name:** IM-250 (200 mg)
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Cohort 4
**Description:** Single dose
**Name:** IM-250 (400 mg)
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Non-compartmental pharmacokinetic (PK) analysis (NCA) of IM-250 plasma concentrations (exposure with different doses)
**Measure:** PK: Time to reach Cmax (Tmax)
**Time Frame:** Follow-up 56 days
**Description:** Non-compartmental pharmacokinetic (PK) analysis (NCA) of IM-250 plasma concentrations (exposure with different doses)
**Measure:** PK: Half-life (t1/2)
**Time Frame:** Follow-up 56 days
**Description:** Non-compartmental pharmacokinetic (PK) analysis (NCA) of IM-250 plasma concentrations (exposure with different doses)
**Measure:** PK: Apparent clearance (CL/F)
**Time Frame:** Follow-up 56 days
**Description:** Non-compartmental pharmacokinetic (PK) analysis (NCA) of IM-250 plasma concentrations (exposure with different doses)
**Measure:** PK: Mean disposition residence time (MDRT)
**Time Frame:** Follow-up 56 days
**Description:** Non-compartmental pharmacokinetic (PK) analysis (NCA) of IM-250 plasma concentrations (exposure with different doses)
**Measure:** PK: Volume of distribution (Vz/F)
**Time Frame:** Follow-up 56 days
**Description:** Non-compartmental pharmacokinetic (PK) analysis (NCA) of IM-250 plasma concentrations (exposure with different doses).
Further derived parameters may be calculated, if deemed necessary.
**Measure:** PK: Amount excreted into urine (Ae)
**Time Frame:** Follow-up 56 days
**Description:** * System organ class (SOCs),
* Seriousness,
* Relatedness,
* Severity,
* Outcome.
**Measure:** Safety: Description of all AE and treatment-emerging AE
**Time Frame:** Follow-up 56 days
#### Primary Outcomes
**Description:** * Serious adverse reaction (i.e., a serious adverse event (SAE) considered at least possibly related to IMP administration)
* Severe (CTCAE grade III) non-serious adverse reactions (i.e., severe non-serious adverse event (AE) considered as, at least, possibly related to IMP administration) lasting more than 72 h
**Measure:** Occurrence (number) of dose-limiting toxicities (DLT)
**Time Frame:** within 28 days after exposure
#### Secondary Outcomes
**Description:** Non-compartmental pharmacokinetic (PK) analysis (NCA) of IM-250 plasma concentrations (exposure with different doses)
**Measure:** PK: The area under the plasma concentration-time curve extrapolated to infinity (AUC∞)
**Time Frame:** 56 days
**Description:** Non-compartmental pharmacokinetic (PK) analysis (NCA) of IM-250 plasma concentrations (exposure with different doses)
**Measure:** PK: Maximum plasma concentration (Cmax)
**Time Frame:** 8 days
**Description:** Non-compartmental pharmacokinetic (PK) analysis (NCA) of IM-250 plasma concentrations (exposure with different doses)
**Measure:** PK: Concentration at 24 h (C24h), 5 d (C5d), and 8 d (C8d)
**Time Frame:** 24 hours, 5 days and 8 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Signed Informed Consent Form (ICF),
2. Age 18-50 y inclusive at the time of consent,
3. An understanding, ability, and willingness to fully comply with study interventions and restrictions,
4. Males who are willing to use a condom for contraception during the treatment and for 60 d after IMP administration, or who are convincingly sexually abstinent, or who are refraining from heterosexual intercourse; females who are willing to use a highly effective method for contraception during the treatment and for 90 d after IMP administration, or who are convincingly sexually abstinent, or who are refraining from heterosexual intercourse, or women not of child-bearing potential (WNOCBP).
5. Satisfactory medical assessment without clinically significant or relevant abnormalities as determined by medical history, physical examination (PE), clinical (vital signs including normal heart rate \[50-90 bpm\]), laboratory (hematology, biochemistry, urinalysis), and electrocardiographic (ECG) evaluation (corrected QTc interval within normal range). First degree AV blocks may be acceptable, if the pulse rate complies with the inclusion criteria.
6. Ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related interventions.
Exclusion Criteria:
1. Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the IMP or study interventions.
2. Any intake of substances (prescription medication, over-the-counter medicine, or herbal preparations with active ingredients) known to inhibit drug-metabolizing enzymes or transport enzymes within a period of less than 5 times the respective elimination t1/2 with regard to the expected date of IMP administration (except iodine, hormone replacement therapy, hormonal contraception, and levothyroxine).
3. Any intake of substances (prescription medication, over-the-counter medicine, or herbal preparations with active ingredients) known to induce drug-metabolizing enzymes or transport enzymes within a period of 14 d with regard to the expected date of IMP administration.
4. A positive result in testing for illegal drugs at screening and enrollment.
5. Male participants who consume more than 21 units of alcohol per week or 3 units per day. Female participants who consume more than 14 units of alcohol per week or 2 units per day.
6. Consumption of alcohol within 24 h prior to Day 1 and until End of Study (EOS).
7. Clinically relevant abnormalities regarding ECG conduction (AV block), hematocrit, hemoglobin (Hb), platelets, or leucocytes. A Hb value \> 12 g / dl (males) or \> 11 g / dl (females) is acceptable.
8. Abnormal renal function as defined by estimated creatinine clearance: \< 90 ml / min (Cockcroft-Gault equation).
9. Alanine aminotransferase (ALT) \> ULN x 1.1; aspartate aminotransferase (AST) \> ULN x 1.2.
10. Thyroid-stimulating hormone (TSH) not within normal limits. If thyroid hormones are supplemented, reduced TSH values are acceptable, if free thyroxine (T4) and free triiodothyronine (T3), are within the normal range.
11. Total bilirubin \> upper limit of normal (ULN) x 1.2; In case of suspected Gilbert´s disease: total bilirubin ≤ ULN x 3 is acceptable.
12. Any history of severe allergic or anaphylactic reactions to drugs or food or any other clinically significant allergies.
13. Known allergy / hypersensitivity to additives used in the IMP.
14. Use of another IMP within 30 d prior to receiving the dose of IMP or active enrolment in another drug or vaccine clinical trial.
15. A positive human antibody screen for immunodeficiency virus (HIV), or chronic hepatitis C virus (HCV), or a positive hepatitis B antigen (HBsAg) test.
16. History of immunization within 14 d prior to expected dosing, including SARS-CoV-2 vaccinations, and / or plans to get vaccinated during the observation time
17. Pregnancy or breast feeding
18. Prior exposure in this trial.
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Heidelberg
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Walter Haefeli, Prof. Dr. med.
- **Phone:** +49 (0)6221 / 56-8740
- **Role:** CONTACT
**Country:** Germany
**Facility:** University Hospital Heidelberg, Department of Clinical Pharmacology and Pharmacoepidemiology
**Status:** RECRUITING
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006566
- Term: Herpesviridae Infections
- ID: D000004266
- Term: DNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000007239
- Term: Infections
- ID: D000017193
- Term: Skin Diseases, Viral
- ID: D000012874
- Term: Skin Diseases, Infectious
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9639
- Name: Herpes Simplex
- Relevance: HIGH
- As Found: Herpes Simplex
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9643
- Name: Herpesviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M7442
- Name: DNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19501
- Name: Skin Diseases, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M15677
- Name: Skin Diseases, Infectious
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006561
- Term: Herpes Simplex
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435494
**Acronym:** C-PRO
**Brief Title:** Cross-sectorial Use of Patient-Reported Outcomes in Chronic Degenerative Shoulder Conditions
**Official Title:** C-PRO - The Effect of Cross-sectorial Use of Patient-Reported Outcomes for Patients With Chronic Degenerative Shoulder Conditions
#### Organization Study ID Info
**ID:** H-23039139
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Gentofte, Copenhagen
### Status Module
#### Completion Date
**Date:** 2030-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Rigshospitalet, Denmark
**Class:** OTHER
**Name:** VIVE - The Danish Center for Social Science Research
**Class:** OTHER
**Name:** The Novo Nordic Foundation
**Class:** OTHER
**Name:** Region Capital Denmark
**Class:** UNKNOWN
**Name:** Mit Lægehus, Rødovre, Denmark
**Class:** UNKNOWN
**Name:** Genoptræning og Rehabilitering, Rødovre Kommune, Denmark
**Class:** UNKNOWN
**Name:** Center for Rehabilitering og Forebyggelse, Gentofte Kommune, Denmark
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Gentofte, Copenhagen
#### Responsible Party
**Investigator Affiliation:** University Hospital, Gentofte, Copenhagen
**Investigator Full Name:** Anne Marie Nyholm
**Investigator Title:** Principal investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This research project aims to test if systematic (extensive) use of patient-reported outcomes across treatment boundaries can
1. improve patients' and health professionals' understanding of individual patients' conditions and health changes,
2. improve indications for treatment,
3. strengthen patient empowerment, and
4. reduce patients' utilization of health services.
The study will be performed in the particular context of patients with chronic degenerative conditions of the shoulder. These patients are characterized by contact with numerous health professionals from different health sectors, such as general practitioner, physiotherapists and surgical referral centres, which challenges coherence and communication for the individual treatment decisions. The research project will be performed as a randomized controlled trial (RCT) with a 1-year inclusion period and two years of follow-up.
### Conditions Module
**Conditions:**
- Shoulder Disease
- Shoulder Impingement
- Shoulder Osteoarthritis
- Shoulder Frozen
- Shoulder Capsulitis
- Shoulder Bursitis
- Shoulder Impingement Syndrome
- Rotator Cuff Syndrome
- Rotator Cuff Syndrome of Shoulder and Allied Disorders
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Patients evaluated and treated for a degenerative shoulder disorder will be randomised into two groups before first evaluation. For the intervention group, Patient reported outcomes (PRO) will be a part of the evaluation and follow-up of treatment. In the control group, it will not. Evaluation with PRO will be conducted every 3 months for 2 years follow-up.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** It is not possible to perform any blinding during collection and use of PRO data as part of the evaluation and treatment of the shoulder condition. However, following the end of PRO collection (and use), the following data collection and evaluation of the use of healthcare services and satisfaction with the treatment given will be performed with information of randomization blinded to the evaluators (VIVE).
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 1000
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All patients will be asked to complete a number of questionaires: EQ5D-5L, a study specific questionaire (designed specifically for this study) and a shoulder-disease-specific questionaire (the Oxford Shoulder Score). For patients in the intervention group, the results of the questionaires will be accessable for patient and health-care professionals and will be used to illustrate the problems, make a prognostic model for the specific patient based on previous PRO results from other patients and will be used in monitoring the treatment of the patient.
**Intervention Names:**
- Other: Systematic use of patient reported outcome measures in clinical work with the patients
**Label:** Intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** All patients will be asked to complete a number of questionaires: EQ5D-5L, a study specific questionaire and a shoulder-disease-specific questionaire. For patients int he control group, this will be collected, but not accessed or used during the treatment of the patient. The data will be used in the final analyses of the study.
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention
**Description:** Se description of the arms
**Name:** Systematic use of patient reported outcome measures in clinical work with the patients
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The treatment cost during the study period expressed as the cost per improvement in life quality, similar to the cost per QALY (quality adjusted life years). The total cost will be calculated from hospital contacts, physiotherapy sessions and primary healthcare contacts. The EQ5D-5L will be used as a generic life quality measure. The primary outcome for the intervention and control group will be compared.
**Measure:** Treatment cost per change in life quality
**Time Frame:** From inclusion time and the 2 following years.
#### Secondary Outcomes
**Description:** The same as primary outcome, but stratified according to the specific shoulder diagnosis
**Measure:** Treatment cost per change in life quality stratisfied according to the specific shoulder diagnosis
**Time Frame:** From inclusion time and the 2 following years
**Description:** Measured by questionaire (specifically the question "are you satisfied with the treatment fo your shoulder so far"?
**Measure:** Patient satisfaction with the treatment of their shoulder problem
**Time Frame:** From inclusion time and the 2 following years
**Description:** To evaluate if any difference in referral to surgery occurs between the intervention group and the control group, and analyse if any reasons for a difference can be identified
**Measure:** Number of patients treated with surgery
**Time Frame:** From inclusion time and the 2 following years
**Description:** To evaluate if any difference in medical contacts due to the treated shoulder occurs between the intervention and the control groups, and analyse if any reasons for a difference can be identified
**Measure:** Number of contacts with either the hospital or the family doctor due to problems with the treated shoulder
**Time Frame:** From inclusion time and the 2 following years
**Description:** To evaluate if any difference in complications in relation to the treatment of the shoulder occurs between the intervention and the control groups, and analyse if any reasons for a difference can be identified
**Measure:** Number and types of complications during the treatment of the shoulder problem
**Time Frame:** From inclusion time and the 2 following years
**Description:** To evaluate if any difference in employment-status and/or sick-leave occurs between the intervention and the control groups, and analyse if any reasons for a difference can be identified
**Measure:** For patients still working: Number and duration (measured in days) of any periods of sick-leave/unemployment due to the shoulder problem
**Time Frame:** From inclusion time and the 2 following years
**Description:** To evaluate the development of PRO scores during a treatment of the included shoulder diseases with regards to the different treatment options, to create a reference for future treatments of these patients
**Measure:** Development in the PRO score, represented by Oxford Shoulder Score, over time for each specific shoulder disease
**Time Frame:** From inclusion time and the 2 following years
**Description:** To evaluate if a PRO score can differentiate patients with regards to who might benefit from specific treatment regimens/effect of treatments measured by PRO
**Measure:** PRO score, represented by Oxford Shoulder Score, as predictors?
**Time Frame:** From inclusion time and the 2 following years
**Description:** To evaluate if PRO scores has the potential to be used to screen patients before making a referral between sectors
**Measure:** If use of systematic PRO scores, represented by Oxford Shoulder Score, changes the referral-pattern between the involved sectors
**Time Frame:** From inclusion time and the 2 following years
**Description:** To evaluate if the involved professionals experience any gain in the use of the PRO scores in the daily treatment of the patients. This will be evaluated at every visit with the patient by a questionaire to the treating professionals.
**Measure:** Health professionals' assessments of history and usefulness of the prognosis tools developed for this study (the Database setup in Procordo).
**Time Frame:** From inclusion time and the 2 following years
**Description:** Satisfaction and qualitative assessment of history and prognosis tool (intervention group only). This will be investigated by questionaire in relation to the completion of the PROs every 3 month during the study period.
**Measure:** Patient satisfaction with the PRO score system build in the Database system (Procordo)
**Time Frame:** From inclusion time and the 2 following years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* shoulder pain with no acute trauma
Exclusion Criteria:
* Age \<18 years
* Non-Danish citizenship
* Unable to understand written or spoken Danish
* Inability to master electronic means of communication and/or not having an electronic communication (E-boks)
* Employee at participating centre or other relation to participating health professionals that might affect independent consent
* Psychiatric conditions, mental conditions and substance abuse that might affect the ability to provide informed consent or responding to PROMs
* Disseminated malignant condition, other serious medical conditions or other life crisis where the focus on a shoulder research project is unreasonable
* Already included in the study with the contralateral shoulder
**Maximum Age:** 120 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anne Marie Nyholm, MD, PhD
**Phone:** +4538673391
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Gentofte
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Carsten B Juhl, PhD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Hanne H Hornshøj
- **Role:** SUB_INVESTIGATOR
***Contact 3:***
- **Name:** Bjarke B Haugan
- **Role:** SUB_INVESTIGATOR
**Country:** Denmark
**Facility:** Department of Physiotherapy, Univesity Hospital Gentofte
**State:** Hellerup
**Zip:** 2900
**Location 2:**
**City:** Hellerup
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Therese T Jarløv
- **Phone:** 39987400
- **Role:** CONTACT
**Country:** Denmark
**Facility:** Department of rehabilitation, Gentofte Kommune
**Zip:** 2900
**Location 3:**
**City:** Hellerup
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Anne Marie Nyholm, MD, PhD
- **Phone:** +4538673391
- **Role:** CONTACT
***Contact 2:***
- **Name:** Hanne H Jensen, PT
- **Role:** SUB_INVESTIGATOR
***Contact 3:***
- **Name:** Bjarke B Haugan, PT
- **Role:** SUB_INVESTIGATOR
**Country:** Denmark
**Facility:** Division of shoulder and elbow surgery, Department of orthopaedics, Univesity Hospital Gentofte
**Zip:** 2900
**Location 4:**
**City:** Rødovre
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Henriette W Bjerrum
- **Phone:** +4536378176
- **Role:** CONTACT
**Country:** Denmark
**Facility:** Genoptræning og Rehabilitering, Rødovre Kommune
**Zip:** 2610
**Location 5:**
**City:** Rødovre
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Marie-Louise Hvass Sixhøj, MD
- **Role:** CONTACT
**Country:** Denmark
**Facility:** Mit Lægehus
**Zip:** 2610
#### Overall Officials
**Official 1:**
**Affiliation:** Rigshospitalet, Denmark
**Name:** Anders Odgaard, MD, DrMed
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** University Hospital, Gentofte, Copenhagen
**Name:** Anne M Nyholm, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** University Hospital, Gentofte, Copenhagen
**Name:** Bo S Olsen, MD, PhD
**Role:** STUDY_CHAIR
**Official 4:**
**Affiliation:** University Hospital, Gentofte, Copenhagen
**Name:** Carsten B Juhl, PT, MPH, PhD
**Role:** STUDY_CHAIR
**Official 5:**
**Affiliation:** Rigshospitalet, Denmark
**Name:** Bente A Esbensen, Cand.cur., PhD
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000070599
- Term: Shoulder Injuries
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000012421
- Term: Rupture
- ID: D000013708
- Term: Tendon Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M12926
- Name: Osteoarthritis
- Relevance: LOW
- As Found: Unknown
- ID: M5332
- Name: Bursitis
- Relevance: HIGH
- As Found: Bursitis
- ID: M21476
- Name: Shoulder Impingement Syndrome
- Relevance: HIGH
- As Found: Shoulder Impingement
- ID: M624
- Name: Rotator Cuff Injuries
- Relevance: HIGH
- As Found: Rotator Cuff Syndrome
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M602
- Name: Shoulder Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M15241
- Name: Rupture
- Relevance: LOW
- As Found: Unknown
- ID: M16479
- Name: Tendon Injuries
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002062
- Term: Bursitis
- ID: D000019534
- Term: Shoulder Impingement Syndrome
- ID: D000013577
- Term: Syndrome
- ID: D000070636
- Term: Rotator Cuff Injuries
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435481
**Brief Title:** Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics
**Official Title:** Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics
#### Organization Study ID Info
**ID:** HIDROGUM21
#### Organization
**Class:** OTHER
**Full Name:** Hospital Universitari Vall d'Hebron Research Institute
#### Secondary ID Infos
**ID:** 2021-001069-20
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2026-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospital Universitari Vall d'Hebron Research Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The study aims to evaluate the tolerability and acceptance of two compounded formulations of hydrocortisone prepared in the Vall d'Hebron University Hospital (VHUH) Pharmacy Service: one, an oral suspension and the other, chewable tablets prepared using a volume dosing device (M3DIMAKER 3D printer). The main goal is to enhance patient care and adherence among pediatric patients.
This prospective, experimental study employs a randomized, crossover design and will take place solely at VHUH. Approximately 25-30 eligible patients diagnosed with adrenal hyperplasia, isolated primary adrenal insufficiency, or panhypopituitarism will be recruited. Each patient will receive each hydrocortisone formulation for a period of 3 months, totaling 6 months of treatment per patient. All patients will receive the medication at their usual dose and both formulations to assess tolerability and acceptance.
**Detailed Description:** Adrenal insufficiency arises from inadequate synthesis of adrenal hormones, with primary, secondary, or tertiary forms depending on the defect's location-adrenal, pituitary, or hypothalamic. Hydrocortisone (17-Hydroxycorticosterone) is the preferred cortisol replacement.
Pediatric hydrocortisone formulations are not commercially available in any presentation. Consequently, compounded formulations are prepared as standard practice. Vall d'Hebron University Hospital's Pharmacy Service currently provides a liquid hydrocortisone formulation for these patients. While liquid formulations are often preferred due to their better dose adjustment and improved acceptability by pediatric patients, they have limitations such as shorter shelf life, possible special storage conditions, and taste problems due to bitter active ingredients. In some cases, particularly for chronic treatments with established and constant doses, other options such as capsules may be considered. Capsules offer longer stability, longer expiration dates, and do not require special storage conditions.
In this context, this study aims to determine the tolerability and acceptance of a new solid magistral formula in the form of chewable hydrocortisone tablets, prepared using a volume dosing device (M3DIMAKERTM 3D printer), compared to the usually preferred liquid formulation. Each of the formulations will be administered for three months. Evaluating the results will allow us to improve assistance to pediatric patients by offering the formulation with better tolerability and acceptance. The study will take place at Vall d'Hebron University Hospital, led by the Pharmacy Service in collaboration with the Pediatric Endocrinology Service.
### Conditions Module
**Conditions:**
- Adrenal Insufficiency
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 35
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Group of patients receiving a new hydrocortisone formulation in the form of chewable tablets. Patients in this group will take the 3D printed chewable tablets orally for a duration of three months.
**Intervention Names:**
- Drug: 3D printed chewable formulation of hydrocortisone
**Label:** Chewable Tablet Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Group of patients receiving the standard hydrocortisone formulation in the form of an oral solution. Patients in this group will orally ingest the solution over a period of three months.
**Intervention Names:**
- Drug: Oral suspension of hydrocortisone
**Label:** Oral Suspension Group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Chewable Tablet Group
**Description:** Administration of a novel hydrocortisone formulation provided as chewable tablets. Each tablet, manufactured with a volume dosing device (3D printer), contains a precise dosage of hydrocortisone.
**Name:** 3D printed chewable formulation of hydrocortisone
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Oral Suspension Group
**Description:** Administration of a standard hydrocortisone oral suspension. The solution, based on simple syrup, contains 1mg of hydrocortisone per milliliter.
**Name:** Oral suspension of hydrocortisone
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Tolerability will be assessed using a five-point questionnaire, while acceptability will be measured using the hedonic facial scale.
**Measure:** Tolerability and acceptance of the two compounded oral hydrocortisone formulations
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** Efficacy will be assessed by the variation in hydrocortisone dosage as a percentage compared to the previous visit, the presence of intercurrent issues, and emergency room visits resulting from the underlying condition.
Treatment adherence will be estimated through monitoring medication dispensations from the Pharmacy Service and counting returned medication.
Safety will be evaluated by reporting potential adverse effects of treatment, the presence of intercurrent issues, and emergency room visits during follow-up.
**Measure:** Efficacy, compliance and safety of each hydrocortisone formulation
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Outpatients of both sexes, ≥ 6 years old without swallowing problems and up to 17 years old, at the time of signing the informed consent document by parent(s) or guardian(s) and/or patients.
* Diagnosis of adrenal hyperplasia or isolated primary adrenal insufficiency or panhypopituitarism (secondary or tertiary adrenal insufficiency).
Exclusion Criteria:
* Known hypersensitivity to any of the excipients in the formulation of hydrocortisone.
* Any disorder or situation (decompensation) that, in the opinion of the investigating physician, poses a risk of non-compliance with the treatment.
**Maximum Age:** 18 Years
**Minimum Age:** 6 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Carlos Javier Parramón Teixidó
**Phone:** +3492746017
**Phone Ext:** 6017
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Hospital Universitari Vall d'Hebron Research Institute
**Phone:** +34934894010
**Phone Ext:** 4010
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Carlos Javier Parramón Teixidó
- **Phone:** +3492746017
- **Role:** CONTACT
**Country:** Spain
**Facility:** Hospital Universitari Vall d'Hebron
**Zip:** 08035
#### Overall Officials
**Official 1:**
**Affiliation:** Hospital Vall d'Hebron
**Name:** Hospital Universitari Vall d'Hebron
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000000307
- Term: Adrenal Gland Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M3661
- Name: Adrenal Insufficiency
- Relevance: HIGH
- As Found: Adrenal Insufficiency
- ID: M3659
- Name: Adrenal Gland Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000309
- Term: Adrenal Insufficiency
### Intervention Browse Module - Ancestors
- ID: D000000893
- Term: Anti-Inflammatory Agents
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: Derm
- Name: Dermatologic Agents
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M9912
- Name: Hydrocortisone
- Relevance: HIGH
- As Found: Aortic
- ID: M155245
- Name: Hydrocortisone 17-butyrate 21-propionate
- Relevance: HIGH
- As Found: Aortic
- ID: M228609
- Name: Hydrocortisone acetate
- Relevance: HIGH
- As Found: Aortic
- ID: M263259
- Name: Hydrocortisone hemisuccinate
- Relevance: HIGH
- As Found: Aortic
- ID: M242077
- Name: Hydrocortisone-17-butyrate
- Relevance: LOW
- As Found: Unknown
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000006854
- Term: Hydrocortisone
- ID: C000033014
- Term: Hydrocortisone 17-butyrate 21-propionate
- ID: C000021650
- Term: Hydrocortisone acetate
- ID: C000007133
- Term: Hydrocortisone hemisuccinate
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435468
**Acronym:** GENIALII
**Brief Title:** Biocollection of Rare Pediatric-onset of Autoimmune and Autoinflammatory Diseases
**Official Title:** Biocollection for the Study of Genetic and Immunological Abnormalities in Rare Pediatric-onset Autoimmune and Auto Inflammatory Diseases
#### Organization Study ID Info
**ID:** 69HCL23_1252
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2034-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2034-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-24
### 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:** Rare diseases are defined as those that affect one person in 2,000, or around three million people in France. The majority of rare diseases are caused by genetics and tend to be severe when they begin in childhood. Autoimmune and autoinflammatory diseases, such as systemic lupus, juvenile dermatomyositis, and juvenile idiopathic arthritis, are examples of rare pediatric diseases. While autoimmune diseases are characterized by an inappropriate adaptive immune response, autoinflammatory diseases involve an excess of the innate immune response. The precise mechanisms of these diseases are not yet fully understood, but recent research has led to advances in their diagnosis and identification, particularly in early onset and familial forms. However, the rarity of these diseases and limited availability of biological samples pose significant challenges.
This study aims to create a biological collection, which includes primary cells (PBMC), DNA, RNA, lymphoblastic lines, and serum, that will help identify genetic and immunological abnormalities in rare autoimmune and autoinflammatory diseases through various research projects.
**Detailed Description:** A disease is said to be "rare" when it affects one person in 2,000, which represents three million people in France. Most rare diseases (80%) are genetic in origin ; the earlier they start in childhood, the more severe they can be. Rare pediatric diseases include autoimmune diseases (systemic lupus, juvenile dermatomyositis and juvenile idiopathic arthritis) and autoimmune diseases (interferonopathies, FMF, CAPS, TRAPS, and DADA2). Systemic autoimmune diseases are characterized by an inappropriate adaptive immune response (mediated by autoreactive T and/or B lymphocytes) with the production of autoantibodies directed against the constituents of the self (tolerance breakdown). Autoinflammatory diseases, unlike autoimmune diseases, correspond to an excess in the innate immune response (cytokines, macrophages, NK cells, granulocytes, etc.)..The precise pathophysiological mechanisms of these diseases have yet to be fully elucidated. Recent research has led to advances in the diagnosis and identification of monogenic forms of these diseases, particularly in early onset, familial, and syndromic forms. Nevertheless, the rarity of these diseases and limited availability of biological samples are major challenges that need to be overcome.
Thus, the aims of this study were as follows:
- The creation of a biological collection: primary cells (PBMC), DNA, RNA, lymphoblastic lines, and serum, which, through various research projects, will help identify genetic and immunological abnormalities in rare autoimmune and autoinflammatory diseases.
### Conditions Module
**Conditions:**
- Systemic Lupus
- Autoimmune Diseases
- Autoinflammatory Disease
- Genetic Disease
**Keywords:**
- Systemic Lupus
- Genetic
- rare autoimmune disease
- rare autoinflammatory diseases
- Pediatric-onset disease
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** prospective, multicenter, national study
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 400
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** minors or adults of any age with a rare dysimmune disease characterized by autoimmunity, autoinflammation or early lymphoproliferation, with onset in childhood (\<18 years), or syndromic or familial.
**Intervention Names:**
- Genetic: Blood sample for genetic analysis
- Other: Blood sample for immunological response assessments
- Other: Blood sample to identify relevant biomarker of the disease
**Label:** Patient with with a rare dysimmune disease
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** minor or adult participant without age restriction weighing more than 5 kg
**Intervention Names:**
- Other: Blood sample for immunological response assessments
- Other: Blood sample to identify relevant biomarker of the disease
**Label:** Healthy volunteer participants
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patient with with a rare dysimmune disease
**Description:** genetic analysis (WES, WGS) for the identification of germline and somatic mutations responsible for rare autoimmune diseases or auto-inflammatory pathologies (pediatric or syndromic or familial) that began in childhood
**Name:** Blood sample for genetic analysis
**Type:** GENETIC
#### Intervention 2
**Arm Group Labels:**
- Healthy volunteer participants
- Patient with with a rare dysimmune disease
**Description:** Identifying specific immunological factors in patients with rare pediatric autoimmune and auto inflammatory diseases
**Name:** Blood sample for immunological response assessments
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Healthy volunteer participants
- Patient with with a rare dysimmune disease
**Description:** Research biomarkers for diagnosis, prognosis and monitoring of disease activity
**Name:** Blood sample to identify relevant biomarker of the disease
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Identification of germline or somatic genetic mutations, based on high-throughput sequencing data (exome, genome or transcriptome).
**Measure:** To Identify germline and somatic mutations responsible for rare autoimmune diseases or auto-inflammatory pathologies (pediatric or syndromic or familial) that began in childhood
**Time Frame:** Baseline
#### Secondary Outcomes
**Description:** score (Min value: 0 - Max value: 105), with higher values mean higher disease activity
**Measure:** Measurement of disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
**Time Frame:** Baseline
**Description:** in patients sera
**Measure:** Levels of anti-double stranded DNA
**Time Frame:** Baseline
**Description:** in patients sera
**Measure:** Levels of complement components C3 and C4
**Time Frame:** Baseline
**Description:** Mesured by 6-gene Type 1 IFN Signature Score
**Measure:** Level of IFN Signature score
**Time Frame:** Baseline
**Description:** In serum using single-molecule array digital ELISA technology (Simoa)
**Measure:** Concentration of circulating IFN-alpha
**Time Frame:** Baseline
**Description:** in patients sera
**Measure:** Presence or absence of anti-type I interferons autoantibodies
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients
* minor or adult patient of any age with a rare dysimmune disease characterized by autoimmunity or auto-inflammation or early lymphoproliferation, having started in childhood (\<18 years), or syndromic or familial
* relative of a minor or adult patient with a rare dysimmune disease characterized by autoimmunity or auto-inflammation or early lymphoproliferation, having started in childhood (\<18 years of age) or syndromic or familial,
* weight greater than 5 kg
* Patient/parents/guardians who were informed of the study and signed the consent form.
* patient affiliated to a social security scheme
Healthy volunteer participants
* minor or adult participants with no age restrictions
* weight over 5 kg
* Subject /Parents/guardians who were informed of the study and signed a consent form.
* Patient affiliated to a social security scheme
Exclusion Criteria:
Patients
- Subjects /Parents/guardians, refusing to participate in the study
Healthy volunteer participants :
* active infection (viral, bacterial, parasitic)
* history of neoplasia (\< 5 years) or current neoplasia
* participants with a personal or family history of autoimmune disease
* immunocompromised participant (immune deficiency or transplant recipient)
* Subjects/parents/guardians refusing to participate in the study
* Adults under legal protection (guardianship, curatorship)
**Healthy Volunteers:** True
**Minimum Age:** 1 Year
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** BELOT Alexandre, Pr
**Phone:** + 33 4 27 85 61 26
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** PLASSART Samira
**Phone:** + 33 4 27 85 54 42
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Saint-Étienne
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Franck Zekré, MD
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Nord (CHU ST-Etienne)
**State:** Saint Etienne
**Location 2:**
**City:** Bron
**Contacts:**
***Contact 1:***
- **Name:** BELOT Alexandre, Pr
- **Role:** CONTACT
**Country:** France
**Facility:** Service de rhumatologie pédiatrique Hôpital Femme-Mère-enfant
**Zip:** 69500
**Location 3:**
**City:** Grenoble
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** PAGNIER Anne, MD
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Couple Enfant
**Zip:** 38043
**Location 4:**
**City:** Lille
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** REUMAUX Héloïse, MD
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Jeanne de Flandre (CHU de Lille)
**Zip:** 59000
**Location 5:**
**City:** Lille
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** HACHULLA Éric, MD, PhD
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Claude Huriez (CHU de Lille)
**Zip:** 59037
**Location 6:**
**City:** Nice
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** DE GUILLEBON DE RESNES Jean-Marie, MD
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Archet 2
**Zip:** 06200
**Location 7:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Bader-Meunier Brigitte, MD
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Necker-Enfants Malades (AP-HP)
**Zip:** 75015
**Location 8:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Meinzer Ulrich, MD, PhD
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Robert Debré (AP-HP)
**Zip:** 75935 Paris
**Location 9:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Name:** Koné-Paut Isabelle, MD, PhD
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Kremlin-Bicêtre (AP-HP)
**Zip:** 94270
**Location 10:**
**City:** Rouen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** JARDIN Fabrice, MD, PhD
- **Role:** CONTACT
**Country:** France
**Facility:** CLCC Henri Becquerel
**Zip:** 76038
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: HIGH
- As Found: Autoimmune Diseases
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: HIGH
- As Found: Genetic Diseases
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000001327
- Term: Autoimmune Diseases
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |