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## 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:** clinicaltrials@rallybio.com
**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: M4225
- Name: Antibodies
- Relevance: HIGH
- As Found: Given
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: HIGH
- As Found: Chemotherapy
- 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: 2024-05-31
|
## 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: 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
- ID: D000000891
- Term: Anti-Infective Agents, Local
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000004202
- Term: Disinfectants
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Coag
- Name: Coagulants
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: Derm
- Name: Dermatologic Agents
### Intervention Browse Module - Browse Leaves
- ID: M5953
- Name: Chlorhexidine
- Relevance: HIGH
- As Found: Needs
- ID: M16902
- Name: Tranexamic Acid
- Relevance: HIGH
- As Found: Stage IV
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M344731
- Name: Chlorhexidine gluconate
- Relevance: LOW
- As Found: Unknown
- ID: M8896
- Name: Gelatin Sponge, Absorbable
- 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
- 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
### Intervention Browse Module - Meshes
- ID: D000002710
- Term: Chlorhexidine
- ID: D000014148
- Term: Tranexamic Acid
### Misc Info Module
- Version Holder: 2024-05-31
|
## 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:** t.bickmore@northeastern.edu
**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: 2024-05-31
|
## 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:** t.bickmore@northeastern.edu
**Name:** Timothy Bickmore, PhD
**Phone:** 6173735477
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Boston
**Contacts:**
***Contact 1:***
- **Email:** cameron.neeson@tuftsmedicalcenter.org
- **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:** m.blain@northeastern.edu
- **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: 2024-05-31
|
## 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:** 535678@umons.ac.be
**Name:** Eliot Rudy Mbolo Ebubu (MD, PhD candidate)
**Phone:** 0032485114738
**Role:** CONTACT
**Contact 2:**
**Email:** frederic.duprez@condorcet.be
**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: 2024-05-31
|
## 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:** hebatullah.mater@miuegypt.edu.eg
**Name:** Hebattallah A Mattar
**Phone:** 201207000253
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cairo
**Contacts:**
***Contact 1:***
- **Email:** mahassen.farghaly@miuegypt.edu.eg
- **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: 2024-05-31
|
## 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:** drlizheng1008@126.com
- **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: 2024-05-31
|
## 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:** norai.zayed@dentistry.cu.edu.eg
**Name:** Norai Zayed, Masters
**Phone:** 01221444954
**Role:** CONTACT
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## 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:** yongningjia@bjmu.edu.cn
**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: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: HIGH
- As Found: Metastases
- ID: M16064
- Name: Stomach Neoplasms
- Relevance: HIGH
- As Found: Stomach Neoplasms
- 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: 2024-05-31
|
## 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: M1072
- Name: ST Elevation Myocardial Infarction
- Relevance: HIGH
- As Found: ST-segment Elevation Myocardial Infarction
- ID: M10282
- Name: Infarction
- Relevance: HIGH
- As Found: Infarction
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M12284
- Name: Necrosis
- Relevance: LOW
- As Found: Unknown
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: LOW
- As Found: Unknown
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- 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: 2024-05-31
|
## 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: 2024-05-31
|
## 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:** bysy@bjmu.edu.cn
**Name:** Shudong Zhang, MD
**Phone:** +86 010-82266699
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** bysy@bjmu.edu.cn
- **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: Assistance
- 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: Assistance
- ID: M11751
- Name: Methyltestosterone
- Relevance: HIGH
- As Found: Assistance
- 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: Assistance
- 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: T477
- Name: Vitamin C
- Relevance: LOW
- As Found: Unknown
- ID: T437
- Name: Ascorbic Acid
- 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: 2024-05-31
|
## 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:** thomas.aparicio@aphp.fr
**Name:** Thomas Aparicio, Pr
**Phone:** 142499597
**Phone Ext:** +33
**Role:** CONTACT
**Contact 2:**
**Email:** jerome.lambert@u-paris.fr
**Name:** Jérôme Lambert, Pr
**Phone:** 142499742
**Phone Ext:** +33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Email:** thomas.aparicio@aphp.fr
- **Name:** Thomas Aparicio, Pr
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Saint Louis - gastoenterology
**Location 2:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Email:** diane.goere@aphp.fr
- **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: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: LOW
- As Found: Unknown
- ID: M5534
- Name: Carcinoma
- 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: 2024-05-31
|
## 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:** hongcheng.hu@hengrui.com
**Name:** Hongcheng Hu
**Phone:** 0518-82342973
**Role:** CONTACT
**Contact 2:**
**Email:** jianting.han.jh27@hengrui.com
**Name:** Jianting Han
**Phone:** 15620796974
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hefei
**Contacts:**
***Contact 1:***
- **Email:** hwgcp@ayefy.com
- **Name:** Wei Hu, Doctor
- **Phone:** 86+13856086475
- **Role:** CONTACT
***Contact 2:***
- **Email:** 2460679232@qq.com
- **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: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- 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: 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: 2024-05-31
|
## 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: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
### Condition Browse Module - Browse Leaves
- ID: M10901
- Name: Leiomyoma
- Relevance: HIGH
- As Found: Uterine Fibroids
- ID: M25846
- Name: Myofibroma
- Relevance: LOW
- As Found: Unknown
- ID: M17342
- Name: Uterine Neoplasms
- 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: 2024-05-31
|
## 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: 2024-05-31
|
## 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:** l.vanloon@maastrichtuniversity.nl
**Name:** Luc JC van Loon, PhD
**Phone:** +31-43-3881397
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Maastricht
**Contacts:**
***Contact 1:***
- **Email:** t.aussieker@maastrichtuniversity.nl
- **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: M4513
- Name: Ascorbic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: T477
- Name: Vitamin C
- Relevance: LOW
- As Found: Unknown
- ID: T437
- Name: Ascorbic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## 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:** 170787717@qq.com
**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: 2024-05-31
|
## 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:** fanny.lajeunesse-trempe.1@ulaval.ca
**Name:** Fannie Lajeunesse-Trempe, MD, Msc
**Phone:** 14384901454
**Role:** CONTACT
**Contact 2:**
**Email:** g.dimitriadis@nhs.net
**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:** georgios.dimitriadis@kcl.ac.uk
- **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: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- 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: M8375
- Name: Fatty Liver
- Relevance: LOW
- As Found: Unknown
- ID: M8485
- Name: Fibrosis
- 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: 2024-05-31
|
## 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:** subina.manandhar@kusms.edu.np
**Name:** Subina Manandhar, M.Sc
**Phone:** +977-9841726577
**Role:** CONTACT
**Contact 2:**
**Email:** bhawanakoju@gmail.com
**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: 2024-05-31
|
## 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:** camilla.hage@regionstockholm.se
**Name:** Camilla Hage, Ass prof
**Phone:** +46 (0)703340660
**Role:** CONTACT
**Contact 2:**
**Email:** ulf.dahlstrom@liu.se
**Name:** Ulf Dahlström, Prof
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Stockholm
**Contacts:**
***Contact 1:***
- **Email:** camilla.hage@regionstockholm.se
- **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: 2024-05-31
|
## 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:** alaca_asli_1992@hotmail.com
**Name:** ASLI ALACA, MSc
**Phone:** 05062741676
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Buca
**Contacts:**
***Contact 1:***
- **Email:** alaca_asli_1992@hotmail.com
- **Name:** ASLI ALACA
- **Phone:** 05062741676
- **Role:** CONTACT
***Contact 2:***
- **Email:** alaca_asli_1992@hotmail.com
- **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: 2024-05-31
|
## 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:** ornella.garrone@policlinico.mi.it
**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
**Citation:** Lauby-Secretan B, Scoccianti C, Loomis D, Benbrahim-Tallaa L, Bouvard V, Bianchini F, Straif K; International Agency for Research on Cancer Handbook Working Group. Breast-cancer screening--viewpoint of the IARC Working Group. N Engl J Med. 2015 Jun 11;372(24):2353-8. doi: 10.1056/NEJMsr1504363. Epub 2015 Jun 3. No abstract available.
**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.
**PMID:** 20832978
**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.
**PMID:** 29291932
**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.
**PMID:** 16717171
**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.
**PMID:** 31147780
**Citation:** Sullivan GM, Feinn R. Using Effect Size-or Why the P Value Is Not Enough. J Grad Med Educ. 2012 Sep;4(3):279-82. doi: 10.4300/JGME-D-12-00156.1. No abstract available.
**PMID:** 23997866
**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.
**PMID:** 15512922
**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.
**PMID:** 23963806
**Citation:** Catricala E, Della Rosa PA, Ginex V, Mussetti Z, Plebani V, Cappa SF. An Italian battery for the assessment of semantic memory disorders. Neurol Sci. 2013 Jun;34(6):985-93. doi: 10.1007/s10072-012-1181-z. Epub 2012 Sep 9.
**PMID:** 22960873
**Citation:** Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
**PMID:** 11556941
**Citation:** Caffarra P, Vezzadini G, Dieci F, Zonato F, Venneri A. Rey-Osterrieth complex figure: normative values in an Italian population sample. Neurol Sci. 2002 Mar;22(6):443-7. doi: 10.1007/s100720200003.
**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: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC25
- Name: Substance Related Disorders
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M29705
- Name: Cognitive Dysfunction
- Relevance: LOW
- As Found: Unknown
- ID: M5534
- Name: Carcinoma
- 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: 2024-05-31
|
## 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:** 2025-08-25
**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:** 2024-12-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-24
**Type:** ESTIMATED
**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:** v.massard@nancy.unicancer.fr
**Name:** Vincent Massard, MD
**Phone:** +33383598461
**Role:** CONTACT
**Contact 2:**
**Email:** jl.merlin@nancy.unicancer.fr
**Name:** Jean-Louis Merlin, Pr
**Phone:** +33383656062
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Vandœuvre-lès-Nancy
**Country:** France
**Facility:** Institut de Cancerologie de Lorraine
#### 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: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
### Intervention Browse Module - Browse Leaves
- ID: M207501
- Name: Chrysarobin
- Relevance: LOW
- As Found: Unknown
- ID: M10533
- Name: Iron
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## 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:** t.roesch@uke.de
**Name:** Thomas Rösch, Professor
**Phone:** +49407410
**Phone Ext:** 50098
**Role:** CONTACT
**Contact 2:**
**Email:** t.ruppenthal@uke.de
**Name:** Tania Ruppenthal
**Phone:** +49407410
**Phone Ext:** 50089
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hamburg
**Contacts:**
***Contact 1:***
- **Email:** t.roesch@uke.de
- **Name:** Thomas Rösch, Professor
- **Phone:** +49407410
- **Phone Ext:** 50098
- **Role:** CONTACT
***Contact 2:***
- **Email:** t.ruppenthal@uke.de
- **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: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- 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: BC23
- Name: Symptoms and General Pathology
- 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: 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: M14011
- Name: Polyps
- 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: 2024-05-31
|
## 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:** johnsonr@njhealth.org
**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: 2024-05-31
|
## 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:** Walter-Emil.Haefeli@med.uni-heidelberg.de
- **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: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M9639
- Name: Herpes Simplex
- Relevance: HIGH
- As Found: Herpes Simplex
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: 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: 2024-05-31
|
## 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:** anne.marie.nyholm.01@regionh.dk
**Name:** Anne Marie Nyholm, MD, PhD
**Phone:** +4538673391
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Gentofte
**Contacts:**
***Contact 1:***
- **Email:** Carsten.Bogh.Juhl@regionh.dk
- **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:** ttj@gentofte.dk
- **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:** anne.marie.nyholm.01@regionh.dk
- **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:** cn26232@rk.dk
- **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:** mlhh@mail.dk
- **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: 2024-05-31
|
## 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:** carlosjavier.parramon@vallhebron.cat
**Name:** Carlos Javier Parramón Teixidó
**Phone:** +3492746017
**Phone Ext:** 6017
**Role:** CONTACT
**Contact 2:**
**Email:** ceic@vhir.org
**Name:** Hospital Universitari Vall d'Hebron Research Institute
**Phone:** +34934894010
**Phone Ext:** 4010
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Email:** carlosjavier.parramon@vallhebron.cat
- **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: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: Derm
- Name: Dermatologic Agents
### Intervention Browse Module - Browse Leaves
- ID: M9912
- Name: Hydrocortisone
- Relevance: HIGH
- As Found: Group A
- ID: M155245
- Name: Hydrocortisone 17-butyrate 21-propionate
- Relevance: HIGH
- As Found: Group A
- ID: M228609
- Name: Hydrocortisone acetate
- Relevance: HIGH
- As Found: Group A
- ID: M263259
- Name: Hydrocortisone hemisuccinate
- Relevance: HIGH
- As Found: Group A
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- 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: 2024-05-31
|
## 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:** Alexandre.belot@chu-lyon.fr
**Name:** BELOT Alexandre, Pr
**Phone:** + 33 4 27 85 61 26
**Role:** CONTACT
**Contact 2:**
**Email:** Samira.plassart@chu-lyon.fr
**Name:** PLASSART Samira
**Phone:** + 33 4 27 85 54 42
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Saint-Étienne
**Contacts:**
***Contact 1:***
- **Email:** Franck.ZEKRE@chu-st-etienne.fr
- **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:** apagnier@chu-grenoble.fr
- **Name:** PAGNIER Anne, MD
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Couple Enfant
**Zip:** 38043
**Location 4:**
**City:** Lille
**Contacts:**
***Contact 1:***
- **Email:** Heloise.REUMAUX@chu-lille.fr
- **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:** eric.hachulla@chru-lille.fr
- **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:** de-guillebon-de-resnes.jm@chu-nice.fr
- **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:** brigitte.bader-meunier@aphp.fr
- **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:** ulrich.meinzer@aphp.fr
- **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:** fabrice.jardin@chb.unicancer.fr
- **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: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435455
**Brief Title:** GH21 Combined With D-1553 With Advanced Solid Tumors
**Official Title:** A Multicenter, Open-label Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GH21 Combined With D-1553 in Patients With Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation
#### Organization Study ID Info
**ID:** GH21C203
#### Organization
**Class:** OTHER
**Full Name:** Suzhou Genhouse Bio Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Zhejiang Cancer Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Suzhou Genhouse Bio Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This s a multi-center, open-label phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GH21 combined with D-1553 in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation.
**Detailed Description:** This study includes 2 parts: dose escalation(Phase Ib) and dose expansion (Phase II). The objective of the dose escalation part is to evaluate the safety, tolerability and pharmacokinetics of GH21 in combination with D-1553 in patients with advanced solid tumors harboring KRAS G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion part, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS G12C mutation.
### Conditions Module
**Conditions:**
- KRAS G12C Mutant Solid Tumors
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 126
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** GH21 capsules combined with D-1553 tablets were administrated orally
**Intervention Names:**
- Drug: GH21+D-1553
**Label:** "GH21 + D-1553" Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- "GH21 + D-1553" Group
**Description:** The combination of GH21 and D-1553 is expected to benefit solid tumors harboring the KRASG12C mutation.
**Name:** GH21+D-1553
**Other Names:**
- GH21 capsules combined with D-1553 tablets
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Incidence of dose limiting toxicities (DLTs) in the dose escalation phase.
**Measure:** Number of participants with dose limiting toxicities
**Time Frame:** 2 years
**Description:** All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs , etc
**Measure:** Number of participants with adverse events
**Time Frame:** 2 years
#### Secondary Outcomes
**Description:** ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
**Measure:** Objective response rate (ORR)
**Time Frame:** 2 years
**Description:** DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.
**Measure:** Duration of response (DOR)
**Time Frame:** 2 years
**Description:** DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD).
**Measure:** Disease Control Rate (DCR)
**Time Frame:** 2 years
**Description:** PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first.
**Measure:** Progression-free survival (PFS)
**Time Frame:** 2 years
**Description:** OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor
**Measure:** Overall survival (OS)
**Time Frame:** 2 years
**Description:** Peak Plasma concentration
**Measure:** Cmax
**Time Frame:** 2 years
**Description:** Time to achieve Cmax
**Measure:** Tmax
**Time Frame:** 2 years
**Description:** Area under the plasma concentration-time curve
**Measure:** AUC
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The patient or his legal representative is able to understand and voluntarily sign a written informed consent (before commencing this study and any research procedure);
* Age ≥18 years old, male or female;
* Dose escalation stage (Stage Ib) : advanced solid tumors with KRAS G12C mutation in patients who have previously failed standard therapy or have no standard therapy or are intolerant to standard therapy.
* Dose Expansion Phase (Phase II) :
Cohort 1: advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation; .
Cohort 2: G12Ci naïve advanced solid tumors with KRAS G12C mutation. Cohort 3: G12Ci treated advanced solid tumors with KRAS G12C.
* The patient must have at least one measurable lesion that meets the RECIST v1.1 definition (tumor lesion located in the area of prior radiotherapy or other local regional treatment site is generally not considered as a measurable lesion unless there is definite progression of the lesion);
* Expected survival ≥3 months;
* ECOG Physical strength score: 0-1;
* The patient must have adequate organ function, defined as follows:
blood Absolute neutrophil count (ANC) ≥1.5×109/L within 14 days without the support of granulocyte colony-stimulating factor; No blood transfusion within 14 days, platelets ≥100×109/L without the use of thrombopoietin (TPO) and interleukin-11 (IL-11); Hemoglobin ≥90 g/L without blood transfusion within 14 days, without erythropoietin (EPO); kidney Serum creatinine ≤1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60ml/min calculated using the modified Cockcroft-Gault equation or eGFR≥ 60ml/min estimated by the MDRD equation; liver albumin ≥3.0 g/dL; Total bilirubin ≤1.5×ULN; In patients with liver metastasis, total bilirubin ≤2.5×ULN; AST/ALT≤2.5 x ULN; In patients with liver metastasis, AST/ALT≤5×ULN; Coagulation function International Normalized ratio (INR) and prothrombin time (PT) ≤1.5×ULN, unless the patient is being treated with anticoagulants (INR\<2.5×ULN) and PT or PTT is within the therapeutic range for which the anticoagulant is intended to be used; Activated partial thromboplastin time (APTT) ≤1.5×ULN, unless the patient is being treated with an anticoagulant (APTT\<2.5×ULN) and PT or PTT is within the therapeutic range for which the anticoagulant is intended to be used.
* Fertile men and women of childbearing age must agree to use reliable contraception (hormonal or barrier or abstinence) from the time they sign an informed consent until 6 months after the final administration of the investigational drug. Pregnancy test results for women of reproductive age must be negative within ≤7 days before the first study drug administration.
Exclusion Criteria:
* Received biological agents of chemotherapy and anti-tumor therapy within 3 weeks before the first administration, and received anti-tumor drugs such as radiotherapy and endocrine therapy within 4 weeks before the first administration, except for the following:
nitrosourea or mitomycin C within 6 weeks prior to first use of the study drug; Oral fluorouracil, small molecule targeted drugs, and Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 5 half-lives or 2 weeks prior to the first use of the study drug (whichever is shorter); local palliative radiotherapy within 2 weeks prior to the first use of the study drug;
* Received other investigational drugs or treatments that are not on the market within 5 half-lives or 4 weeks (whichever is shorter) prior to initial administration;
* Had major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose, or required elective surgery during the trial;
* Use of CYP3A4 or P-gp suppressor or strong inducer within 2 weeks or 5 half-lives prior to initial administration;
* There is evidence of the following heart diseases:
acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months before first administration; Grade III-IV heart failure based on the New York Heart Association Cardiac Function Scale at screening; During screening, echocardiography (ECHO) showed left ventricular ejection fraction (LVEF) ≤50%.
Fridericia adjusted QT interval (QTcF) ≥450ms (male), ≥470ms (female) at screening; The presence of poorly controlled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) after medication at screening;
* Has difficulty swallowing or has a gastrointestinal disease or other malabsorption condition that affects drug absorption, such as intestinal obstruction, Crohn's disease, ulcerative colitis, short bowel syndrome, gastric emptying disorder, or has severe gastrointestinal related toxicity before first administration and does not recover below grade 2; Or confirmed clinically significant or acute gastrointestinal disease;
* Uncontrolled pleural effusion, pericardial effusion, or pleural effusion requiring repeated drainage (once a month or more frequently);
* Patients with active brain metastases or with symptoms of active central nervous system metastases, including headache, vomiting, and vertigo, are eligible only if they meet all of the following criteria and are asymptomatic and have treated or untreated CNS lesions:
The presence of measurable lesions outside the CNS as determined by RECIST v1.1; Stable brain metastases after treatment, defined as no evidence of disease progression or bleeding during the 28 days prior to initiation of treatment and discontinuation of steroid hormones and other therapeutic agents for at least 14 days prior to enrollment;
* Patients with interstitial pneumonia, or any evidence of clinically active interstitial lung disease, within 6 months prior to first dosing;
* Arteriovenous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, occurred within 6 months prior to initial administration;
* Have a history of other malignancies (except skin squamous cell carcinoma in situ that has been cured and has not recurred for 5 years, basal cell carcinoma and cervical carcinoma in situ, etc., which are considered by researchers to be eligible for inclusion; Dose escalation phase, except for those deemed acceptable by the investigator);
* Patients who have a history of severe allergy, or have a history of allergy to the experimental drug/any excipient/combination drug, or have a history of allergy to multiple drugs;
* Hepatitis B virus infection (HBsAg positive and DNA copy number \>1000 IU/ml); Or infected with hepatitis C virus (HCV antibody positive and HCV RNA \> the upper limit of normal); Or infected with human immunodeficiency virus (HIV antibody positive); Or infected with treponema pallidum (defined as TP-Ab positive);
* There is an active infection (≥ grade 2) requiring anti-infective treatment or an unexplained fever exceeding 38 ° C within 28 days before the first dose;
* Active stage of autoimmune disease as determined by the investigator within 28 days before the first dose;
* Any toxicity from previous antitumor therapy prior to initial administration has not returned to CTCAE 5.0 rating ≤ Class 1 (unless hair loss, grade 2 peripheral neuropathy, and/or other grade ≤2 adverse events that do not pose a safety risk);
* Pregnant and lactating women;
* The investigator considers that there are any clinical or laboratory abnormalities or other reasons to be unsuitable for participating in this clinical study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** tangjieqi@genhousebio.com
**Name:** Jieqi Tang, bachelor
**Phone:** +8613311557758
**Role:** CONTACT
**Contact 2:**
**Email:** zjccgcp_phase1@126.com
**Name:** Zhengbo Song, Doctorate
**Phone:** +8613857153345
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435442
**Brief Title:** PK,PD and DDI of Epaminurad and Naproxen in Healthy Volunteers
**Official Title:** A Phase 1 Study to Evaluate the Safety and PK/PD Drug-drug Interaction Between Epaminurad and Naproxen or to Assess the Safety and Multiple-Dose PK/PD Characteristics of Epaminurad in Healthy Volunteers
#### Organization Study ID Info
**ID:** JW23103
#### Organization
**Class:** INDUSTRY
**Full Name:** JW Pharmaceutical
### 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:** 2024-05
**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:** JW Pharmaceutical
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** A Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and Naproxen in Healthy Volunteers
**Detailed Description:** Part 1: to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and Naproxen in Healthy Koreans/ Part 2: to evaluate the safety, PK/PD of Epaminurad in Healthy Caucasians
### Conditions Module
**Conditions:**
- Healthy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** PART 1: A open-label, multiple-dose, single group/ PART 2: A placebo-controlled, randomized, double-blind, multiple-dose, parallel group
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** PART 1: None (Open Label)/ PART 2: Double (Participant, Investigator)
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 28
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Epaminurad 9 mg, Naproxen 500 mg
**Intervention Names:**
- Drug: Epaminurad, Naproxen
**Label:** Part 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Epaminurad 9 mg
**Intervention Names:**
- Drug: Epaminurad
**Label:** Part 2(Test group)
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Epaminurad 9 mg placebo
**Intervention Names:**
- Drug: Epaminurad placebo
**Label:** Part 2(Control group)
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Part 1
**Description:** Period 1: Epaminurad/ Period 2: Naproxen -\> Epaminurad+Naproxen
**Name:** Epaminurad, Naproxen
**Other Names:**
- URC102, Naxen
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Part 2(Test group)
**Description:** Epaminurad
**Name:** Epaminurad
**Other Names:**
- URC102
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Part 2(Control group)
**Description:** Epaminurad placebo
**Name:** Epaminurad placebo
**Other Names:**
- URC102 placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** To evaluate the AUC of Epaminurad and Naproxen
**Measure:** Area under the plasma concentration versus time curve (AUC)
**Time Frame:** 7 days
**Description:** To evaluate the Cmax of Epaminurad and Naproxen
**Measure:** Peak plasma concentrations (Cmax)
**Time Frame:** 7 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age: 19\~50
2. Weight: between 50.0 kg\~90.0 kg, Body Mass Index(BMI): 18.0 kg/m\^2 or heavier and below 30.0 kg/m\^2
3. Part 1: Korean/ Part 2: Caucasian
Exclusion Criteria:
1. Medical history- chronic liver disease, acute gout attack, uric acid stone, diabetes, hypertension, hyperlipidemia or lipid abnormality
2. Clinical examination- eGFR (CKD-EPI) \< 90mL/min/1.73m\^2, Serum uric acid \< 3 mg/dL or \> 7 mg/dL, AST (SGOT), ALT (SGPT) \> upper limit of normal ranges X 1.5, Total bilirubin, γ-GTP \> upper limit of normal ranges X 1.5, CK \> upper limit of normal ranges X 2, Positive serologic results
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 19 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** jy.park@jwhealthcare.com
**Name:** JW Pharmaceutical
**Phone:** +82-2-840-6852
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Name:** Kyung-sang Yu
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Korea, Republic of
**Facility:** Seoul National University Hospital
#### Overall Officials
**Official 1:**
**Affiliation:** Seoul National University Hospital
**Name:** Kyung-sang Yu, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000000894
- Term: Anti-Inflammatory Agents, Non-Steroidal
- ID: D000018712
- Term: Analgesics, Non-Narcotic
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000006074
- Term: Gout Suppressants
- ID: D000016861
- Term: Cyclooxygenase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M12239
- Name: Naproxen
- Relevance: HIGH
- As Found: ACT
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4218
- Name: Anti-Inflammatory Agents, Non-Steroidal
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M20786
- Name: Analgesics, Non-Narcotic
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M19209
- Name: Cyclooxygenase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000009288
- Term: Naproxen
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435429
**Brief Title:** A Phase 3, Randomized, Open-label, Controlled Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer
**Official Title:** A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to Trastuzumab in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, or Are Intolerant to, Previous Trastuzumab Deruxtecan Treatment
#### Organization Study ID Info
**ID:** JZP598-303
#### Organization
**Class:** INDUSTRY
**Full Name:** Jazz Pharmaceuticals
#### Secondary ID Infos
**Domain:** EU CTR
**ID:** 2023-508960-31-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2031-04-25
**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:** 2031-04-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-16
**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:** Jazz Pharmaceuticals
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The efficacy and safety of zanidatamab in combination with physician's choice of chemotherapy compared with trastuzumab in combination with physician's choice of chemotherapy will be evaluated for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.
**Detailed Description:** Zanidatamab, as a monotherapy or in combination with other antineoplastic agents, has shown clinically meaningful efficacy against multiple HER2-positive advanced/metastatic tumors, including in patients with metastatic breast cancer (mBC). Zanidatamab may offer a viable treatment option for patients with metastatic HER2-positive breast cancer.
The primary objective of the study is to compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy. The secondary objectives of the study will include further comparing the efficacy, safety and tolerability, patient-reported tolerability, and patient-reported physical functioning of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy. The pharmacokinetics and immunogenicity of zanidatamab in combination with chemotherapy will also be evaluated.
### Conditions Module
**Conditions:**
- Metastatic HER2-positive Breast Cancer
**Keywords:**
- Zanidatamab
- Trastuzumab
- Metastatic HER2-positive breast cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 550
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants with HER2-positive metastatic breast cancer (mBC) who have progressed on, or are intolerant to, previous T-DXd treatment will be randomized to receive intravenous infusion of zanidatamab plus physician's choice of chemotherapy (eribulin, or vinorelbine, or gemcitabine, or capecitabine).
**Intervention Names:**
- Drug: Zanidatamab
- Drug: Eribulin
- Drug: Vinorelbine
- Drug: Gemcitabine
- Drug: Capecitabine
**Label:** Zanidatamab plus physician's choice of chemotherapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants with HER2-positive metastatic breast cancer (mBC) who have progressed on, or are intolerant to, previous T-DXd treatment will be randomized to receive intravenous infusion of trastuzumab plus physician's choice of chemotherapy (eribulin, or gemcitabine, or vinorelbine, or capecitabine).
**Intervention Names:**
- Drug: Trastuzumab
- Drug: Eribulin
- Drug: Vinorelbine
- Drug: Gemcitabine
- Drug: Capecitabine
**Label:** Trastuzumab plus physician's choice of chemotherapy
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Zanidatamab plus physician's choice of chemotherapy
**Description:** Administered by intravenous infusion
**Name:** Zanidatamab
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Trastuzumab plus physician's choice of chemotherapy
**Description:** Administered by intravenous infusion
**Name:** Trastuzumab
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Trastuzumab plus physician's choice of chemotherapy
- Zanidatamab plus physician's choice of chemotherapy
**Description:** Administered by intravenous infusion
**Name:** Eribulin
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Trastuzumab plus physician's choice of chemotherapy
- Zanidatamab plus physician's choice of chemotherapy
**Description:** Administered by intravenous infusion
**Name:** Vinorelbine
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- Trastuzumab plus physician's choice of chemotherapy
- Zanidatamab plus physician's choice of chemotherapy
**Description:** Administered by intravenous infusion
**Name:** Gemcitabine
**Type:** DRUG
#### Intervention 6
**Arm Group Labels:**
- Trastuzumab plus physician's choice of chemotherapy
- Zanidatamab plus physician's choice of chemotherapy
**Description:** Given orally
**Name:** Capecitabine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** PFS is defined as the time in months from randomization to the date of first documented disease progression (as assessed by BICR according to RECIST v1.1) or death from any cause, whichever occurs first.
**Measure:** Progression-free Survival (PFS) Per RECIST Version 1.1 As Assessed by Blinded Independent Central Review (BICR)
**Time Frame:** Until disease progression or death, up to approximately 44 months
#### Secondary Outcomes
**Description:** OS is defined as the time in months from randomization to the date of death due to any cause.
**Measure:** Overall Survival (OS)
**Time Frame:** Until death, up to approximately 80 months
**Description:** The BICR-assessed confirmed ORR is defined as the proportion of participants who had a best overall response of BICR-assessed Complete Response (CR) or Partial Response (PR) after randomization.
**Measure:** Confirmed Objective Response Rate (ORR) Per RECIST Version 1.1, As Assessed by BICR
**Time Frame:** Until disease progression or death, up to approximately 44 months
**Description:** BICR-assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) as assessed by BICR per RECIST v1.1 or death from any cause.
**Measure:** Duration of Response (DOR) Per RECIST Version 1.1, As Assessed by BICR
**Time Frame:** Until disease progression or death, up to approximately 44 months
**Description:** Investigator-assessed PFS is defined as the time in months from randomization to the date of first documented disease progression (as assessed by investigator according to RECIST v1.1) or death from any cause, whichever occurs first
**Measure:** PFS Per RECIST Version 1.1, As Assessed By Investigator
**Time Frame:** Until disease progression or death, up to approximately 44 months
**Description:** The investigator-assessed confirmed ORR is defined as the proportion of participants who had a best overall response of investigator-assessed confirmed CR or PR after randomization.
**Measure:** Confirmed ORR Per RECIST Version 1.1, As Assessed By Investigator
**Time Frame:** Until disease progression or death, up to approximately 44 months
**Description:** Investigator-assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented PD as assessed by the investigator per RECIST v1.1 or death from any cause.
**Measure:** DOR Per RECIST Version 1.1, As Assessed By Investigator
**Time Frame:** Until disease progression or death, up to approximately 44 months
**Measure:** Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events As Graded by NCI CTCAE Version 5.0
**Time Frame:** Up to approximately 44 months
**Measure:** Number of Participants With Dose Reductions
**Time Frame:** Up to approximately 44 months
**Measure:** Number of Participants Discontinuing Study Treatment Due to TEAEs
**Time Frame:** Up to approximately 44 months
**Measure:** Serum Concentrations of Zanidatamab
**Time Frame:** Up to approximately 44 months
**Measure:** Number of Participants Positive for Anti-drug Antibodies to Zanidatamab
**Time Frame:** Up to approximately 44 months
**Measure:** Proportion of All Treated Participants, As Treated, Reporting Symptomatic Adverse Events While On Treatment Based on PRO-CTCAE and EORTC Item Library
**Time Frame:** Up to approximately 44 months
**Measure:** Proportion of All Treated Participants, As Treated, Reporting Overall Side-effect Bother on the FACIT-GP5
**Time Frame:** Up to approximately 44 months
**Measure:** Proportion of Treated Participants, As Treated, With Maintained or Improved Physical Function While On Treatment Based On The Physical Functioning Subscale of the EORTC QLQ-C30
**Time Frame:** Up to approximately 44 months
### Eligibility Module
**Eligibility Criteria:** Participants are eligible to be included in the study only if all of the following criteria apply:
1. Is 18 years of age or of the legal adult age per local standard at the time of signing the informed consent.
2. Has histologically confirmed HER2-positive breast cancer according to ASCO-CAP Guidelines as evaluated by a central laboratory
3. Participants with unresectable or metastatic HER2 positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.
4. Has measurable disease per RECIST version 1.1.
5. Is eligible to receive one of the chemotherapy options listed in the physician's choice of chemotherapy (eribulin, gemcitabine, vinorelbine, or capecitabine).
6. Participants with history of treated or clinically inactive CNS metastases are eligible as specified in the protocol.
7. Has a life expectancy of at least 6 months, in the opinion of the investigator.
8. Has adequate hematologic parameters as defined in the protocol.
9. Has adequate hepatic function as specified in the protocol.
10. Has creatinine clearance ≥ 30 mL/minute as calculated per local institutional guidelines.
11. Has LVEF ≥ 50% as determined by either echocardiogram or MUGA obtained within 4 weeks before the first dose of study intervention.
12. Has ECOG performance status of 0 or 1.
13. Participant agrees to the following based on sex assigned at birth.
1. Male participants:
Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 5 months after the last dose of study intervention or the contraception period for the combination chemotherapy of choice per local guidance/standard practice, whichever is longer:
* Refrain from donating fresh unwashed semen.
* Use contraception as follows as specified in the protocol
2. Female participants:
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
* Is a women of nonchildbearing potential OR
* Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of \< 1% per year), with low user dependency during the study intervention period and for at least 5 months after the last dose of study intervention or the contraception period for the combination chemotherapy of choice per local guidance/standard practice, whichever is longer.
* A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 3 days before the first dose of study intervention.
* Additional requirements for pregnancy testing during and after study intervention are provided in the protocol.
* The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
14. Is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol.
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. Has known or suspected leptomeningeal disease.
2. Has uncontrolled or significant cardiovascular disease.
3. Has toxicity related to prior cancer therapy that has not resolved to ≤ Grade 1, with exceptions as stated in the protocol.
4. Has uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
5. Has known HIV infection.
6. Has active hepatitis B or C infection.
7. Has an active SARS-CoV-2 infection. Participants with prior infection that has resolved per local institutions' requirements and screening guidance are eligible.
8. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab.
9. Is unable to receive trastuzumab treatment due to medical contraindications.
10. Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site.
11. Has any condition that would prevent treatment with the physician's choice of chemotherapy.
12. Has any issue or condition that in the opinion of the investigator would contraindicate the participant's participation in the study or confound the results of the study.
Prior/Concomitant Therapy
13. Has a history of prior allogeneic bone marrow, stem cell, or solid organ transplantation.
14. Was treated with any local or systemic antineoplastic therapy (including hormonal therapies for breast cancer) or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to randomization.
15. Has a history of trauma or major surgery within 4 weeks prior to randomization.
Other Exclusions
16. Has a known hypersensitivity to any components of the study drugs, including chemotherapy.
17. Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** ClinicalTrialDisclosure@JazzPharma.com
**Name:** Clinical Trial Disclosure & Transparency
**Phone:** 215-832-3750
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000972
- Term: Antineoplastic Agents, Phytogenic
- ID: D000050257
- Term: Tubulin Modulators
- ID: D000050256
- Term: Antimitotic Agents
- ID: D000050258
- Term: Mitosis Modulators
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M2985
- Name: Gemcitabine
- Relevance: HIGH
- As Found: Activity
- ID: M377
- Name: Capecitabine
- Relevance: HIGH
- As Found: Function
- ID: M325
- Name: Trastuzumab
- Relevance: HIGH
- As Found: Medication
- ID: M1710
- Name: Vinorelbine
- Relevance: HIGH
- As Found: Subsequent
- ID: M233243
- Name: Trastuzumab deruxtecan
- Relevance: LOW
- As Found: Unknown
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- ID: M26197
- Name: Tubulin Modulators
- Relevance: LOW
- As Found: Unknown
- ID: M26196
- Name: Antimitotic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000093542
- Term: Gemcitabine
- ID: D000069287
- Term: Capecitabine
- ID: D000068878
- Term: Trastuzumab
- ID: D000077235
- Term: Vinorelbine
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435416
**Brief Title:** Predictive Value of Postoperative Prognostic Nutritional Index Trajectory on 1-year Mortality After Off-pump Coronary Artery Bypass Surgery
**Official Title:** Predictive Value of Postoperative Prognostic Nutritional Index Trajectory on 1-year Mortality After Off-pump Coronary Artery Bypass Surgery
#### Organization Study ID Info
**ID:** 3-2023-0184
#### Organization
**Class:** OTHER
**Full Name:** Gangnam Severance Hospital
### Status Module
#### Completion Date
**Date:** 2025-07-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-07-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-07-12
**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:** Gangnam Severance Hospital
#### Responsible Party
**Investigator Affiliation:** Gangnam Severance Hospital
**Investigator Full Name:** Myung Il Bae
**Investigator Title:** Clinical Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study investigated the changing pattern of postoperative Prognostic Nutritional Index (PNI) after off-pump coronary artery bypass surgery using a trajectory analysis. The investigators aimed to investigate the correlation between postoperative PNI recovery patterns and mortality in patients undergoing off-pump coronary artery bypass surgery.
### Conditions Module
**Conditions:**
- Patients Undergoing Off-pump Coronary Artery by Pass Surgery
**Keywords:**
- Prognostic Nutritional Index (PNI)
- Off-pump coronary artery bypass (OPCAB),
- Coronary artery bypass graft surgery (CABG)
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 983
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: No intervention
**Label:** PNI trajectory group 1
#### Arm Group 2
**Intervention Names:**
- Other: No intervention
**Label:** PNI trajectory group 2
### Interventions
#### Intervention 1
**Arm Group Labels:**
- PNI trajectory group 1
- PNI trajectory group 2
**Description:** No intervention
**Name:** No intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** 1 year after surgery
**Measure:** one-year mortality
**Time Frame:** one-year mortality after surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
• Patients aged ≥ 18 years who underwent off-pump coronary artery bypass surgery
Exclusion Criteria:
* Patients without PNI value between 1 and 3 days after surgery
* Patients without PNI value between 20 and 60 days after surgery
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients undergoing off-pump coronary artery bypass surgery
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** bmi87@yuhs.ac
**Name:** Myung Il Bae
**Phone:** 82-2-2019-6611
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Email:** bmi87@yuhs.ac
- **Name:** Myung Il Bae
- **Phone:** 82-2-2019-6611
- **Role:** CONTACT
**Country:** Korea, Republic of
**Facility:** Gangnam Severnace Hospital
**State:** GangnamGu
**Status:** RECRUITING
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435403
**Acronym:** CoVICIS
**Brief Title:** SARS-CoV-2 Specific Antibody Responses and Impact for COVID-19 Disease in Ethiopia
**Official Title:** SARS-CoV-2 Specific Antibody Responses and Impact for COVID-19 Disease in Health Care Worker and Community Members From Ethiopian Related to Natural SARS CoV-2 Infection and COVID-19 Vaccination
#### Organization Study ID Info
**ID:** ETH-02
#### Organization
**Class:** OTHER
**Full Name:** Ludwig-Maximilians - University of Munich
### Status Module
#### Completion Date
**Date:** 2025-02-28
**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:** 2025-02-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-11-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** St. Paul's Hospital Millennium Medical College, Ethiopia
**Class:** OTHER
**Name:** Jimma University
#### Lead Sponsor
**Class:** OTHER
**Name:** Michael Hoelscher
#### Responsible Party
**Investigator Affiliation:** Ludwig-Maximilians - University of Munich
**Investigator Full Name:** Michael Hoelscher
**Investigator Title:** Director, Division of Infectious Diseases and Tropical Medicine, LMU Munich
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In this study we aim to characterize SARS CoV-2 strain specific immune response (SARS-CoV-2 Spike IgG) in health care workers and general populations at the Jimma Medical Center and the St. Paul Hospital in Addis Ababa in association to clinical immune protection and Covid-19 disease. Participants, stratified by SARS-CoV-2 infection and vaccination status, will be followed at 3-month intervals for a maximum of 2 years. Prevalence, incidence, and dynamics of SARS-CoV-2 specific antibodies as well as clinical assessments especially related to COVID-19 breakthrough disease in previously exposed/vaccinated participants will be performed. From a subset of selected participant blood sample, more in depth immunological analysis will be performed that include virus culture-based neutralization assays, antibody avidity assays, SARS-CoV-2 specific antibody epitope recognition using peptide arrays, and T-cell immunity assays (IGRA).
We also plan to analyze and model cost-effectiveness considerations related to adapted COVID-19 vaccine strategies, specifically if SARS-CoV-2 the costs for routine sero-diagnosis in high SARS-CoV-2 prevalent population prior to vaccination will impact the decision to vaccinate (no vaccination for low-risk populations or reduced vaccine dosing) and is cost-efficient. The study is largely exploratory, providing deeper insights in SARS-CoV-2 specific immune responses and interaction with SARS-CoV-2 viral variants.
**Detailed Description:** The COVID-19 pandemic has severely impacted health systems, interventions for infection control and resulting preventive public life restrictions. In a recent study, we determined high rates of previous SARS-CoV-2 infection in health care worker (over 70%) and communities in Ethiopia (up to 60%), with resulting potential natural acquired SARS-CoV-2 specific immunity. In contrast to the situation in Europe, the scale out of COVID-19 vaccination is however very low, and currently there is a scarcity of COVID-19 vaccines available all over Africa. Naturally acquired or vaccine induced SARS-CoV-2 immune responses have shown to protect against (severe) COVID-19 disease. However, immune responses are waning over time and new SARS-CoV-2 viral variants increasingly demonstrate immune escape properties. Correlates of clinical immune protections are currently investigated including binding SARS-CoV-2 spike IgG or neutralizing antibody levels, as well as cellular immune responses. However, threshold of immune protection are not yet defined that would guide the need of booster vaccinations, including for individuals with natural acquired immunity. There is evidence, that vaccination regimens in those individuals could be abbreviated to single shot booster, that would greatly economize challenged COVID-19 strategies in Africa.
The CoVICIS is a network of European and African researcher who collaborate on the overall objective to investigate SARS-CoV-2 specific immune response and correlates of immune protection in the context of circulating SARS-CoV-2 viral variants. In this affiliated study, we aim to investigate these outcomes in Ethiopian health care worker and community members throughout a longitudinal, prospective cohort study. Participants, stratified according to their SARS-CoV-2 infection and vaccination status, will be followed-up in 3-monthly intervals To characterize SARS CoV-2 strain specific immune response (SARS-CoV-2 Spike IgG) in health care workers and general populations stratified by previous (1) SARS CoV-2 exposure (SARS-CoV-2 anti-nucleocapsid antibody positive versus negative) and (2) vaccination status at the Jimma Medical Center (JMC) and the St. Paul Hospital in Addis Ababa in association to clinical immune protection and Covid-19 disease. Prevalence, incidence, and dynamics of SARS-CoV-2 specific antibodies as well as clinical assessments will be performed in 3-monthly intervals over a maximum period of 24 months.
At each study visits, immune responses including SARS-CoV-2 spike IgG and neutralizing antibody will be measured. In addition, SARS CoV-2-specific T cell responses will be studied in each of the study groups. COVID-19 disease or SARS-CoV-2 infections will be assessed throughout the study by clinical history, SARS-CoV-2 PCR diagnostics, and seroconversion of SARS-CoV-2 anti-nucleocapsid antibody testing as appropriate. In addition, more in-depth analysis will be performed in a subset of stored blood samples at collaborating specialized laboratories in Germany and Switzerland, including peptide array mapping, T-cell assays and affinity/avidity analysis against the ACE-II receptor. We further aim to characterize circulating SARS CoV-2 strains from PCR isolates in the context of investigated immune responses. Outcome results will be provided for computational analysis, integrating models for immune protection. Finally, we will explore the feasibility and cost-effectiveness of abbreviated single shot COVID-19 vaccination for individuals with pre-existing natural immunity to assess COVID-19 vaccine strategies that are especially applicable in African settings.
Findings from this study aim to help in guiding the current Covid-19 control strategy in Ethiopia. It might also give the first insight about the dynamics and level of antibodies produced against SARS-CoV-2 in the Ethiopian population.
### Conditions Module
**Conditions:**
- SARS CoV 2 Infection
- COVID-19 Breakthrough
- COVID-19 Recurrent
**Keywords:**
- COVID-19
- Seroepidemiologic Studies
- Longitudinal Studies
- Ethiopia / epidemiology
- SARS-CoV-2
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 1000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** SARS-CoV-2 anti-nucleocapsid positive, vaccinated
**Label:** Group 1 (N=300)
#### Arm Group 2
**Description:** SARS-CoV-2 anti-nucleocapsid positive, not vaccinated
**Label:** Group 2 (N=300)
#### Arm Group 3
**Description:** SARS-CoV-2 anti-nucleocapsid negative, vaccinated
**Label:** Group 3 (N=300)
#### Arm Group 4
**Description:** SARS-CoV-2 anti-nucleocapsid negative, not vaccinated
**Label:** Group 4 (N=100)
### Outcomes Module
#### Other Outcomes
**Measure:** Difference of extended humoral (e.g. neutralizing antibodies) and cellular immune responses in a subset of participants by study groups at different time points
**Time Frame:** 24 months
**Measure:** Recognition of SARS-CoV-2 specific peptide in a subset of participants by study groups at different time points
**Time Frame:** 24 months
**Measure:** Detection and description of COVID19 and determination of upper respiratory viral load in subjects with (re)infection
**Time Frame:** 24 months
#### Primary Outcomes
**Measure:** Difference of antibody levels between study groups by month 12
**Time Frame:** 12 months
**Measure:** Proportion of participants with suspected clinically reported severe COVID-19 disease or evidence of SARS-CoV-2 exposure between study groups by month 12
**Time Frame:** 12 months
**Measure:** Proportion of SARS-CoV-2 breakthrough infections in previously exposed/vaccinated participants
**Time Frame:** 24 months
#### Secondary Outcomes
**Measure:** Difference of antibody levels between groups by month 6, 18 and 24
**Time Frame:** 24 months
**Measure:** Antibody levels after single 1st vaccination in previously infected persons
**Time Frame:** 24 months
**Measure:** Proportion of participants with suspected clinically reported severe COVID-19 disease or evidence of SARS-CoV-2 exposure between study groups by month 6, 18 and 24
**Time Frame:** 24 months
**Measure:** Prevalence and distribution of circulating SARS-CoV-2 variants around baseline and during the study period
**Time Frame:** 24 months
**Measure:** Costs related to SARS-CoV-2 anti-nucleocapsid diagnostics in relation to spared costs by abbreviated/not performed COVID-19 vaccine regimen
**Time Frame:** 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
1. Adults, 18 years of above
2. Provision of oral as well as written informed consent
3. Available estimation of the period or the time-point when SARS-CoV-2 infection occurred (e.g. confirmed or highly suspected COVID-19 disease, SARS-CoV-2 anti-nucleocapsid seroconversion) (only applicable for participants included in group 1 and 2).
4. Employed/working in hospital (medical doctors, nurses/midwives, students, auxiliary personnel such as cleaner, runner, social worker) for HCW
5. Willingness to provide blood samples by venipuncture for serology and immunological characterization
6. Willingness to provide health information, report medical events and to performed SARS-CoV-2 diagnostics (swabs for PCR) in the case of suspected COVID-19 disease
Exclusion criteria:
1. Prisoners
2. Mentally disturbed persons
3. Persons for whom study participation will induce an unacceptable risk or burden as judged by the investigator (e.g. seriously sick persons)
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Healthcare workers (clinical staff, practicing medical interns, cleaners, guards, food handlers, and receptionists) at the two hospitals and potentially participants from the general urban population in Jimma and Addis Ababa will be included. N=500 participants at each site (N=1000 in total) will be stratified according to their SARS CoV-2 sero-s and Covid-19 vaccination status at inclusion into 4 groups. We aim to target at least 30% representation of HCW's, respectively community participants for each study group.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** Arne.Kroidl@med.uni-muenchen.de
**Name:** Arne Kroidl, MD
**Phone:** +49-89-4400
**Phone Ext:** 59816
**Role:** CONTACT
**Contact 2:**
**Name:** Rebecca Kisch
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Addis Ababa
**Contacts:**
***Contact 1:***
- **Email:** solomon.ali@sphmmc.edu.et
- **Name:** Solomon Ali, PhD
- **Phone:** +251911488680
- **Role:** CONTACT
**Country:** Ethiopia
**Facility:** Department of Microbiology Immunology and Parasitology
**Status:** RECRUITING
**Location 2:**
**City:** Jimma
**Contacts:**
***Contact 1:***
- **Email:** Esayas.kebede@ju.edu.et
- **Name:** Esayas K Gudina, MD, PhD
- **Phone:** +251917550576
- **Role:** CONTACT
**Country:** Ethiopia
**Facility:** Jimma University
**Status:** RECRUITING
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011024
- Term: Pneumonia, Viral
- ID: D000011014
- Term: Pneumonia
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000018352
- Term: Coronavirus Infections
- ID: D000003333
- Term: Coronaviridae Infections
- ID: D000030341
- Term: Nidovirales Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: HIGH
- As Found: Infection
- ID: M2561
- Name: COVID-19
- Relevance: HIGH
- As Found: COVID-19
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13904
- Name: Pneumonia
- Relevance: LOW
- As Found: Unknown
- ID: M13914
- Name: Pneumonia, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20490
- Name: Coronavirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6555
- Name: Coronaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M23685
- Name: Nidovirales Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007239
- Term: Infections
- ID: D000086382
- Term: COVID-19
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435390
**Brief Title:** Coronavirus Disease 2019 (COVID-19) Pandemic on the Oral Hygiene Status of Children
**Official Title:** The Impact of the COVID-19 Pandemic on the Oral Hygiene Status of Children With High Caries Risk and Their Parents
#### Organization Study ID Info
**ID:** E.630276
#### Organization
**Class:** OTHER
**Full Name:** Gazi University
### Status Module
#### Completion Date
**Date:** 2022-05-15
**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:** 2022-03-15
**Type:** ACTUAL
#### Start Date
**Date:** 2019-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-28
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Gazi University
#### Responsible Party
**Investigator Affiliation:** Gazi University
**Investigator Full Name:** Hanife ALTINIŞIK
**Investigator Title:** Doç. Dr.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The purpose of this study is to compare oral hygiene status and dietary habits of 3-5 years old children and their parents with a questionnaire and clinic examination between pre- and post-COVID-19 period.
**Detailed Description:** Study Rationale and Objectives:
The primary motivation behind this study lies in understanding the impact of the COVID-19 pandemic on oral health behaviors, specifically focusing on children at high risk for dental caries.
Objectives include assessing changes in tooth brushing habits and dietary patterns among both children and their parents.
Study Design:
The study employs a prospective observational design. Participants are parents of 155 children aged 3-5 years. Data collection occurs at two time points: before and after the COVID-19 pandemic.
Data Collection Instruments:
A structured questionnaire is administered to parents. It covers:
Children's and parents' dietary habits (frequency of sugary food consumption). Oral hygiene practices (tooth brushing frequency). The index of decayed-missing-filled deciduous teeth (dmft) is used to assess dental caries status in children.
The COVID-19 pandemic had a limited impact on high-caries-risk children's tooth brushing habits.
However, increased sugary food consumption by both children and parents exacerbated caries risk.
Collaborative efforts between healthcare professionals and parents are crucial to mitigate negative oral health effects during such challenging times.
### Conditions Module
**Conditions:**
- COVID-19 Pandemic
**Keywords:**
- COVID-19
- oral hygiene
- dietary habits
- parents
- pediatric dentistry
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 155
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 3-5 year old 155 children with high caries risk and their parents before and after COVID-19
**Label:** 3-5 year old 155 children with high caries risk and their parents
### Outcomes Module
#### Primary Outcomes
**Description:** Changing tooth brushing and diet habits of 155 children aged 3-5 with high risk of caries during the COVID-19 pandemic period
**Measure:** Changing tooth brushing and diet habits during the COVID-19 pandemic
**Time Frame:** from 15 March to 15 May 2022
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 3-5 year old children with high caries risk. To identify high caries-risk children, the criteria used by the the American Academy of Pediatric Dentistry (AAPD) for assessing a child's dental caries risk were applied.
Exclusion Criteria:
* Childrens with systemic health problems and childrens with any space maintainers.
**Healthy Volunteers:** True
**Maximum Age:** 5 Years
**Minimum Age:** 3 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** This study used retrospective information for healthy 3-5 year old children with high caries risk and their parents who applied to the our University Pediatric Dentistry clinic between September 2019 and March 2020 (in the last six months before COVID-19)
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ankara
**Country:** Turkey
**Facility:** Zeliha Hatipoğlu Palaz
**State:** Biskek Street/ Emek
**Zip:** 06490
#### Overall Officials
**Official 1:**
**Affiliation:** Gazi University
**Name:** ZELIHA HATİPOĞLU PALAZ
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Gazi University
**Name:** NAGEHAN AKTAŞ
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Docimo R, Costacurta M, Gualtieri P, Pujia A, Leggeri C, Attina A, Cinelli G, Giannattasio S, Rampello T, Di Renzo L. Cariogenic Risk and COVID-19 Lockdown in a Paediatric Population. Int J Environ Res Public Health. 2021 Jul 15;18(14):7558. doi: 10.3390/ijerph18147558.
**PMID:** 34300008
**Citation:** Gotler M, Oren L, Spierer S, Yarom N, Ashkenazi M. The impact of COVID-19 lockdown on maintenance of children's dental health: A questionnaire-based survey. J Am Dent Assoc. 2022 May;153(5):440-449. doi: 10.1016/j.adaj.2021.10.004. Epub 2021 Oct 19.
**PMID:** 35221097
**Citation:** Mohapatra RK, Pintilie L, Kandi V, Sarangi AK, Das D, Sahu R, Perekhoda L. The recent challenges of highly contagious COVID-19, causing respiratory infections: Symptoms, diagnosis, transmission, possible vaccines, animal models, and immunotherapy. Chem Biol Drug Des. 2020 Nov;96(5):1187-1208. doi: 10.1111/cbdd.13761. Epub 2020 Jul 26.
**PMID:** 32654267
**Citation:** Daly J, Black EAM. The impact of COVID-19 on population oral health. Community Dent Health. 2020 Nov 30;37(4):236-238. doi: 10.1922/CDH_Dec20editorialDalyBlack03.
**PMID:** 33269826
**Citation:** Greuter W. [Practical industrial medicine in Switzerland]. Soz Praventivmed. 1981 Jul;26(3):126-9. doi: 10.1007/BF02081368. German.
**PMID:** 7293495
**Citation:** Bonneau JC. [Contact allergy to sulfites: contact allergens, sources of exposure, and clinical profile]. Allerg Immunol (Paris). 1994 Nov;26(9):324-6. French.
**PMID:** 7865116
**Citation:** Blumer S, Dagon N, Peretz B, Ratson T, Kharouba J. Function of the Family Unit, Oral Hygiene Rules and Attitudes to Dental Health in Children During First-Wave 2020 COVID-19 Lockdown. J Clin Pediatr Dent. 2021 Jan 1;45(1):1-7. doi: 10.17796/1053-4625-45.1.1.
**PMID:** 33690823
**Citation:** Angelopoulou MV, Seremidi K, Papaioannou W, Gizani S. Impact of the COVID-19 lockdown on the oral health status of paediatric dental patients in Greece. Int J Paediatr Dent. 2023 May;33(3):246-253. doi: 10.1111/ipd.13048. Epub 2023 Mar 13.
**PMID:** 36680387
**Citation:** Goswami M, Grewal M, Garg A. Attitude and practices of parents toward their children's oral health care during COVID-19 pandemic. J Indian Soc Pedod Prev Dent. 2021 Jan-Mar;39(1):22-28. doi: 10.4103/jisppd.jisppd_478_20.
**PMID:** 33885383
**Citation:** Mahagna M, Nir I, Larbier M, Nitsan Z. Effect of age and exogenous amylase and protease on development of the digestive tract, pancreatic enzyme activities and digestibility of nutrients in young meat-type chicks. Reprod Nutr Dev. 1995;35(2):201-12. doi: 10.1051/rnd:19950208.
**PMID:** 7537505
**Citation:** Dickson-Swift V, Kangutkar T, Knevel R, Down S. The impact of COVID-19 on individual oral health: a scoping review. BMC Oral Health. 2022 Sep 22;22(1):422. doi: 10.1186/s12903-022-02463-0.
**PMID:** 36138456
**Citation:** Navarro-Perez CF, Fernandez-Aparicio A, Gonzalez-Jimenez E, Montero-Alonso MA, Schmidt-RioValle J. Effects of COVID-19 lockdown on the dietary habits and lifestyle in a population in southern Spain: a cross-sectional questionnaire. Eur J Clin Nutr. 2022 Jun;76(6):883-890. doi: 10.1038/s41430-021-01034-w. Epub 2021 Oct 28.
**PMID:** 34711931
**Citation:** Olszewska A, Paszynska E, Roszak M, Czajka-Jakubowska A. Management of the Oral Health of Children During the COVID-19 Pandemic in Poland. Front Public Health. 2021 Jul 29;9:635081. doi: 10.3389/fpubh.2021.635081. eCollection 2021.
**PMID:** 34395353
**Citation:** Tellez M, Gomez J, Pretty I, Ellwood R, Ismail AI. Evidence on existing caries risk assessment systems: are they predictive of future caries? Community Dent Oral Epidemiol. 2013 Feb;41(1):67-78. doi: 10.1111/cdoe.12003.
**PMID:** 22978796
**Citation:** Costa AL, Pereira JL, Franco L, Guinot F. COVID-19 Lockdown: Impact on Oral Health-Related Behaviors and Practices of Portuguese and Spanish Children. Int J Environ Res Public Health. 2022 Nov 30;19(23):16004. doi: 10.3390/ijerph192316004.
**PMID:** 36498079
**Citation:** Caramida M, Dumitrache MA, Tancu AMC, Ilici RR, Ilinca R, Sfeatcu R. Oral Habits during the Lockdown from the SARS-CoV-2 Pandemic in the Romanian Population. Medicina (Kaunas). 2022 Mar 5;58(3):387. doi: 10.3390/medicina58030387.
**PMID:** 35334563
**Citation:** Ruiz-Roso MB, de Carvalho Padilha P, Mantilla-Escalante DC, Ulloa N, Brun P, Acevedo-Correa D, Arantes Ferreira Peres W, Martorell M, Aires MT, de Oliveira Cardoso L, Carrasco-Marin F, Paternina-Sierra K, Rodriguez-Meza JE, Montero PM, Bernabe G, Pauletto A, Taci X, Visioli F, Davalos A. Covid-19 Confinement and Changes of Adolescent's Dietary Trends in Italy, Spain, Chile, Colombia and Brazil. Nutrients. 2020 Jun 17;12(6):1807. doi: 10.3390/nu12061807.
**PMID:** 32560550
**Citation:** Hamilton K, Cornish S, Kirkpatrick A, Kroon J, Schwarzer R. Parental supervision for their children's toothbrushing: Mediating effects of planning, self-efficacy, and action control. Br J Health Psychol. 2018 May;23(2):387-406. doi: 10.1111/bjhp.12294. Epub 2018 Jan 18.
**PMID:** 29349924
**Citation:** Kotha SB, AlFaraj NSM, Ramdan TH, Alsalam MA, Al Ameer MJ, Almuzin ZM. Associations between Diet, Dietary and Oral Hygiene Habits with Caries Occurrence and Severity in Children with Autism at Dammam City, Saudi Arabia. Open Access Maced J Med Sci. 2018 Jun 6;6(6):1104-1110. doi: 10.3889/oamjms.2018.245. eCollection 2018 Jun 20.
**PMID:** 29983812
#### See Also Links
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/34300008/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/35221097/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/32654267/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/33269826/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/32569870/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/33549091/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/33690823/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/36680387/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/33885383/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/32978848/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/36138456/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/34711931/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/34395353/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/22978796/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/36498079/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/35334563/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/32560550/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/29349924/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/29983812/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011024
- Term: Pneumonia, Viral
- ID: D000011014
- Term: Pneumonia
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000018352
- Term: Coronavirus Infections
- ID: D000003333
- Term: Coronaviridae Infections
- ID: D000030341
- Term: Nidovirales Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M2561
- Name: COVID-19
- Relevance: HIGH
- As Found: COVID-19
- ID: M20490
- Name: Coronavirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M13904
- Name: Pneumonia
- Relevance: LOW
- As Found: Unknown
- ID: M13914
- Name: Pneumonia, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6555
- Name: Coronaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M23685
- Name: Nidovirales Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000086382
- Term: COVID-19
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435377
**Acronym:** EMR+APC
**Brief Title:** Efficacy, Safety and Recurrence After Cold-EMR Plus APC for Large Colonic Lesions
**Official Title:** Prospective Observational Study APC AND BIOPSY POST COLD-EMR IN COLONIC LESIONS
#### Organization Study ID Info
**ID:** Cold-EMR plus APC
#### Organization
**Class:** OTHER
**Full Name:** Istituto Clinico Humanitas
### 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:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istituto Clinico Humanitas
#### 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 prospective observational study aims to evaluate the efficacy, safety and recurrence of cold-snaring for large colonic lesions combined with argon plasma coagulation of the resection bed.
### Conditions Module
**Conditions:**
- Colonic Disease
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** * Initial submucosal injection of saline solution and methylene blue, followed by 'piece-meal' resection using a dedicated cold snare
* Biopsy of the resection bed
* Ablation of the defect using argon plasma coagulation (APC).
**Name:** Procedure: Cold EMR + APC
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluation of residual in the biopsy of the defect after the cold-EMR. The specimen will be evaluated independently from the polyp sample.
**Measure:** Residual
**Time Frame:** 1 day
**Description:** The recurrence rate of adenomas at the site of any qualifying, previously resected lesions is measured after 3-6 and 12 months.
**Measure:** Recurrence
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Complete resection of polyp
**Measure:** Efficacy of procedure
**Time Frame:** 1 day
**Description:** Delayed-bleeding, defined was defined as clinical evidence of bleeding (hematemesis, hematochezia or melena or a decrease of hemoglobin concentration \> 2g/dL, which required transfusion or endoscopic reintervention with hemostasis within 30 days of hospital discharge)
**Measure:** Rate of delayed bleeding of the patient
**Time Frame:** 1 day
**Description:** The post-polipectomy syndrome is defined by the presence of fever or abdominal pain
**Measure:** Rate of post-polipectomy syndrome
**Time Frame:** 1 day
**Description:** Rate of perforation and delayed perforation
**Measure:** perforation
**Time Frame:** 1 day
**Description:** Average time of procedure and polyp resection time
**Measure:** Time
**Time Frame:** 1 day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All patients aged ≧ 18 years undergoing colonoscopy for any indication (screening, anemia, surveillance, or scheduled to undergo endoscopic mucosal resection)
* Lesions of 20 mm and larger.
* All colonic lesions removed using COLD-EMR technique, presenting both adenomatous (Kudo IIIL/IIIS pit pattern)
* Patients who were able to provide written informed consent
Exclusion Criteria:
* Suspected lesions for submucosal invasion (e.g., Kudo V or Paris 0-IIa-IIc with non-granular surface)
* Lesions with a wide Paris 0-Is component (\>10mm) that could increase the risk of submucosal invasion and could limit the mechanical cutting of the snare
* Pedunculated polyps
* Active/quiescent colitis
* Rectal lesions
* Residual or recurrent adenoma after endoscopic mucosal resection
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** All subjects will be evaluated for post-procedural pain (using a VAS scale) and need for pain-killers. As part of the standard care, the patient will receive a 30-day post procedure follow-up phone call or an ambulatory evaluation will be arranged 30-days after the endoscopic procedure, to discuss the histologic results and schedule a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the post procedural pain in the first four weeks after treatment, the need for pain-killers and, should these occur, the adverse events (included fever, hematochezia, need for hospital admission). The rate of recurrence will be calculated by endoscopic visualization of the EMR site at the follow-up (T1:3-6 months; T2 11-13Months) using endoscopic magnification and electronic chromoendoscopy.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Rozzano
**Country:** Italy
**Facility:** Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
**State:** Milano
**Zip:** 20089
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M6336
- Name: Colonic Diseases
- Relevance: HIGH
- As Found: Colonic Diseases
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003108
- Term: Colonic Diseases
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M11726
- Name: Methylene Blue
- Relevance: LOW
- As Found: Unknown
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435364
**Brief Title:** Cervical Manual Therapy and Vagus Nerve Stimulation in Patients With Nonspecific Neck Pain
**Official Title:** Investigation of the Effect of Instrument Supported Cervical Manual Therapy Methods and Vagus Nerve Stimulation in Patients With Nonspecific Neck Pain
#### Organization Study ID Info
**ID:** E-10840098-202.3.02-2983
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Medipol University Hospital
### Status Module
#### Completion Date
**Date:** 2024-08-21
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-17
**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:** Istanbul Medipol University Hospital
#### Responsible Party
**Investigator Affiliation:** Istanbul Medipol University Hospital
**Investigator Full Name:** hazal genc
**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:** People with chronic neck pain are becoming more and more common in society every day.
**Detailed Description:** In chronic neck pain investigations, it is generally reported that all people experience neck pain once in my life and more than half of the developed societies experience this problem. It has been stated that 48% of these continue as chronic neck pain, which significantly affects the quality of life due to the postponement of treatment due to its cost.
### Conditions Module
**Conditions:**
- Pain Syndrome
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This non-invasive system is activated by the cutaneous distribution of vagus nerve afferents via the external ear.
**Intervention Names:**
- Other: Vagus nerve stimilation
**Label:** Vagus nerve
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Manual therapy is effective in the treatment of musculoskeletal pain.
**Intervention Names:**
- Other: Manual therapy
**Label:** Manual therapy
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Vagus nerve
**Description:** This non-invasive system is activated by the cutaneous distribution of vagus nerve afferents through the external ear. Somatosensory innervation is provided by the auricular branch.
**Name:** Vagus nerve stimilation
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Manual therapy
**Description:** Manual therapy is mostly defined by the tissue targeted by the practitioner; it can be joint biased, muscle and connective tissue biased and/or neurovascular system biased techniques.
**Name:** Manual therapy
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Device is a heart rate sensor with the gold standard in high precision and accuracy that comes with a wearable chest strap. It can be connected to multiple training devices via Bluetooth and ANT+. The device features a soft, adjustable sensor that contacts the chest to capture heart rate in real time.
**Measure:** Autonomic nervous system device
**Time Frame:** 4 weeks
**Description:** The neck disability index is the most commonly used functional outcome tool for disabilities in the cervical region. This outcome assessment tool was created by modifying the Oswestry Disability Index and is highly reliable (Chad E. Cook, Amy E. Cook 2011).
Scoring is given for each question as A: 0 points, B: 1 point, C: 2 points, D: 3 points, E: 4 points, F: 5 points. The total score gives the test score. According to the test result 0-4=No disability 5-14= Mild disability 15-24= Moderate disability 25-34 = Severe disability
**Measure:** Neck disability index:
**Time Frame:** 4 weeks
**Description:** Range of motion is the ability of a joint to go through the full range of motion. The range of motion of a joint can be passive or active. Passive ROM - The maximum range of motion through which the joint can move with the aid of external force. Active ROM - the range of motion achieved by contracting and relaxing opposing muscles
**Measure:** Joint Range of Motion
**Time Frame:** 4 weeks
**Description:** The visual analogue scale (VAS) is a validated, subjective measure of acute and chronic pain. Scores are recorded by placing a handwritten mark on a 10 cm line representing the continuum between "no pain" and "worst pain"
**Measure:** The visual analogue scale (VAS)
**Time Frame:** 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria for volunteers and/or study participants;
* Presence of neck pain for at least three months
* Non-specific neck pain
* To have signed the voluntary consent form
Exclusion criteria for volunteers and/or participants;
* Having undergone surgery for the cervical region
* Rehabilitation of the neck area at least three months prior to treatment
* Traumatic medulla spinalis injury
* Neurological deficit
* Rheumatological disease
* Structural spinal disorders
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** hazaloksuz@gmail.com
**Name:** Hazal GENÇ, PhD
**Phone:** 05413204291
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Email:** hazaloksuz@gmail.com
- **Name:** Hazal GENÇ, phd
- **Phone:** +905413204291
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Bahçehir University
**Status:** RECRUITING
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M21485
- Name: Neck Pain
- Relevance: HIGH
- As Found: Neck Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019547
- Term: Neck Pain
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435351
**Brief Title:** Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy
**Official Title:** Precision DC: Personalized Neoantigen Dendritic Cell Vaccine Pilot Trial for High Risk Triple Negative Breast Cancer After Neoadjuvant Therapy
#### Organization Study ID Info
**ID:** MCC-23142
#### Organization
**Class:** OTHER
**Full Name:** H. Lee Moffitt Cancer Center and Research Institute
### Status Module
#### Completion Date
**Date:** 2029-05
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2029-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-17
**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:** H. Lee Moffitt Cancer Center and Research Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a pilot protocol to evaluate the safety, feasibility, and immunogenicity of a personalized breast cancer vaccine based utilizing whole exome sequencing data of a patient's residual breast tumor following neoadjuvant chemotherapy.
### Conditions Module
**Conditions:**
- Breast Cancer
- Triple Negative Breast Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 16
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The tumor specimen collected from the primary tumor will undergo whole exome sequencing (WES). The WES data will be analyzed to select up to 20 neoantigens. From this screen up to 10 peptides will be selected to be synthesized for testing and use on the DC pheresis product that will be collected.
The ready vaccine product will be cryopreserved and then thawed once the patient is ready to under the vaccination sequence.
**Intervention Names:**
- Procedure: Leukapheresis
- Biological: Dendritic Cell (DC) Vaccine
**Label:** Dendritic Cell (DC) Vaccine
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dendritic Cell (DC) Vaccine
**Description:** Removal of white blood cells (leukocytes) from the blood. The dendritic cells are harvested from the white blood cells that are collected and trained to recognize the specific abnormal proteins found in the tumor sample.
One needle is inserted in each arm. An apheresis machine removes blood from the vein in one arm, separates and retains the leukocytes from the blood, and then returns the rest of the blood to the other arm.
**Name:** Leukapheresis
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Dendritic Cell (DC) Vaccine
**Description:** The vaccine will be given intranodally (inguinal or axillary) under ultrasound guidance using a dose of 40-50 million cells three times spaced 2 weeks apart for the initial priming sequence.
3 doses of the priming vaccines are given once every 2 weeks. 2 booster shots (if available) will be given 6 months and 12 months following completion of initial priming vaccines.
**Name:** Dendritic Cell (DC) Vaccine
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Successful production and administration of DC1 priming vaccination sequence in greater than 60% of patients enrolled.
**Measure:** Percentage of patients enrolled who successfully undergo at least one vaccination.
**Time Frame:** Up to 3 Years
#### Secondary Outcomes
**Description:** Immunogenicity will be determined by ELISpot and reactive T-Cell Receptor (TCR) expansion.
ELISPot is an enzyme-linked immunospot assay. It is a highly sensitive immunoassay that measures the frequency of cytokine-secreting cells at the single-cell level.
**Measure:** Number of participants who achieve Immunogenicity after administration of vaccine
**Time Frame:** Up to 3 Years
**Description:** Disease Free Survival will be measured as the length of time after treatment to cancer recurrence or death from any cause.
**Measure:** Disease Free Survival (DFS)
**Time Frame:** Up to 3 Years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient has stage II-III ER/PR less than or equal to 10% HER2 negative by FISH and/or IHC breast cancer treated with standard of care neoadjuvant systemic chemotherapy and surgical resection with significant residual breast tumor (equivalent to RCB II or III) disease.
* Patient has sufficient residual viable primary breast tumor or ipsilateral breast axillary nodal metastatic cancer tissue accessible to Moffitt for whole exome sequencing.
* Patient is 18 years of age or older.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Patients must have adequate organ and marrow function.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Patients without radiologic evidence of active metastatic disease and who are within 18 months of their last dose curative intent chemotherapy and/or radiotherapy (whichever is later) for the purposes of study enrollment.
* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients with known active locally advanced unresectable or metastatic cancer.
* Patients with significant uncontrolled intercurrent illness or autoimmune disease requiring systemic immunosuppressants that would be deemed unsuitable to participate in the study by the Principal Investigator (PI).
* Patients who have a medical issue in the opinion of the treating physician and/or PI that would make them unsuitable for pheresis.
* Patients who are currently receiving any other investigational agents.
* Patients with psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** neveen.abdo@moffitt.org
**Name:** Neveen Abdo
**Phone:** 813-745-4412
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Tampa
**Contacts:**
***Contact 1:***
- **Email:** neveen.abdo@moffitt.org
- **Name:** Neveen Abdo
- **Phone:** 813-745-4412
- **Role:** CONTACT
***Contact 2:***
- **Name:** Hatem Soliman, MD
- **Role:** CONTACT
***Contact 3:***
- **Name:** Hatem Soliman, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Mohammed Al-Jumayl
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Avan Armaghani
- **Role:** SUB_INVESTIGATOR
***Contact 6:***
- **Name:** Ricardo Costa
- **Role:** SUB_INVESTIGATOR
***Contact 7:***
- **Name:** Martine Extermann
- **Role:** SUB_INVESTIGATOR
***Contact 8:***
- **Name:** Heather Han
- **Role:** SUB_INVESTIGATOR
***Contact 9:***
- **Name:** Susan Hoover
- **Role:** SUB_INVESTIGATOR
***Contact 10:***
- **Name:** Nazanin Khakpour
- **Role:** SUB_INVESTIGATOR
***Contact 11:***
- **Name:** John Kiluk
- **Role:** SUB_INVESTIGATOR
***Contact 12:***
- **Name:** Laura Kruper
- **Role:** SUB_INVESTIGATOR
***Contact 13:***
- **Name:** Marie Lee
- **Role:** SUB_INVESTIGATOR
***Contact 14:***
- **Name:** Loretta Loftus
- **Role:** SUB_INVESTIGATOR
***Contact 15:***
- **Name:** Tracey O'Connor
- **Role:** SUB_INVESTIGATOR
***Contact 16:***
- **Name:** Christine Sam
- **Role:** SUB_INVESTIGATOR
***Contact 17:***
- **Name:** Aixa Soyano Muller
- **Role:** SUB_INVESTIGATOR
***Contact 18:***
- **Name:** Brian Czerniecki
- **Role:** SUB_INVESTIGATOR
***Contact 19:***
- **Name:** Kimberly Lee
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Moffitt Cancer Center
**State:** Florida
**Status:** RECRUITING
**Zip:** 33612
#### Overall Officials
**Official 1:**
**Affiliation:** Moffitt Cancer Center
**Name:** Hatem Soliman, MD
**Role:** STUDY_DIRECTOR
### References Module
#### See Also Links
**Label:** Moffitt Cancer Center Clinical Trials Website
**URL:** http://www.moffitt.org/clinical-trials-research/clinical-trials/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M30373
- Name: Triple Negative Breast Neoplasms
- Relevance: HIGH
- As Found: Triple Negative Breast Cancer
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
- ID: D000064726
- Term: Triple Negative Breast Neoplasms
### 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: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435338
**Acronym:** HPV Decide
**Brief Title:** Patient Decision Aid Tool for HPV Vaccination Among Adults Ages 27-45 Years Old
**Official Title:** Patient Decision Aid Tool for HPV Vaccination Among Adults Ages 27-45 Years Old
#### Organization Study ID Info
**ID:** 100257
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Health Science Center at San Antonio
### Status Module
#### Completion Date
**Date:** 2024-01-18
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-01-18
**Type:** ACTUAL
#### Start Date
**Date:** 2023-12-13
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of North Texas Health Science Center
**Class:** OTHER
**Name:** University of South Florida
**Class:** OTHER
**Name:** Temple University
**Class:** OTHER
**Name:** Indiana University School of Medicine
**Class:** INDUSTRY
**Name:** Merck Sharp & Dohme LLC
#### Lead Sponsor
**Class:** OTHER
**Name:** The University of Texas Health Science Center at San Antonio
#### Responsible Party
**Investigator Affiliation:** The University of Texas Health Science Center at San Antonio
**Investigator Full Name:** Erika L. Thompson
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this study is to learn if a patient decision tool for HPV vaccination works for decision-making among adults ages 27-45. Researchers will compare a web-based patient decision tool to an information sheet to see if the tool works for decision-making. Participants will take a baseline survey, view the intervention or control condition, and then take a follow-up survey.
### Conditions Module
**Conditions:**
- Decision Aid
- Hpv
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 632
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patient decision aid on HPV vaccination on webpage.
**Intervention Names:**
- Behavioral: Patient decision aid
**Label:** Patient decision aid
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Vaccine information sheet on HPV vaccination view on webpage.
**Intervention Names:**
- Behavioral: Control
**Label:** Control
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patient decision aid
**Description:** The patient decision aid for HPV vaccination among mid-adults, named HPV Decide. It is delivered online on a website.
**Name:** Patient decision aid
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Control
**Description:** Vaccine information sheet on HPV vaccination. Attention control condition.
**Name:** Control
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** This scale has 16 items and 5 response categories. The decisional conflict scale (DCS) measures personal perceptions of: uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making (in full version) such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. The scores ranged from 0 "no conflict" to 100 "extreme decisional conflict."
**Measure:** Decisional conflict - 16 item scale
**Time Frame:** Immediate post-test
**Description:** Decision conflict scale recommended for every day clinical practice. It has 4 items and two response categories. Scores range from 0 \[extremely high decisional conflict\] to 4 \[no decisional conflict\].
**Measure:** Decisional conflict - 4 item scale
**Time Frame:** Immediate post-test
#### Secondary Outcomes
**Description:** 16-item knowledge item related to human papillomavirus and human papillomavirus vaccination. Scale from 0 \[low knowledge\] to 16 \[high knowledge\].
**Measure:** Knowledge
**Time Frame:** Immediate post-test
**Description:** Intentions for information seeking, talking to a healthcare provider, and getting vaccinated
**Measure:** Intentions
**Time Frame:** Immediate post-test
**Description:** Vaccine decision, including decide to get vaccinated, unsure, and decided not to get vaccinated
**Measure:** Decision
**Time Frame:** Immediate post-test
**Description:** Perceived expectation was assessed by asking participant agreement on a 5-point Likert scale to the following statement, "The effectiveness of the HPV vaccine will vary from person to person." Higher score indicates higher perceived effectiveness.
**Measure:** Perceived expectation
**Time Frame:** Immediate post-test
**Description:** Perceived risks of HPV infection were also assessed, including participants' perceptions of getting an HPV-associated infection genital/anal warts, or cancer in their lifetime. Response options ranged from very unlikely (lower score) to very likely (higher score).
How likely are you to get an HPV related cancer, like cervical, oral, or anal cancer, in your lifetime? How likely are you to get an HPV infection in your lifetime? How likely are you to get anal or genital warts in your lifetime?
**Measure:** Perceived risk
**Time Frame:** Immediate post-test
**Description:** The Decision Self-Efficacy Scale evaluates an individual's self-confidence to make decisions on their own or with support from other sources. Scores range from 0 \[extremely low self-efficacy\] to 100 \[extremely high self efficacy\].
**Measure:** Decision self-efficacy
**Time Frame:** Immediate post-test
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Unvaccinated for HPV
* 27-45 years
* Resides in the United States
* Reads English
* Consents to participate
Exclusion Criteria:
* none
**Gender Based:** True
**Gender Description:** Cis-gender male or female only due to randomization stratification
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 27 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** San Antonio
**Country:** United States
**Facility:** UT School of Public Health San Antonio
**State:** Texas
**Zip:** 78229
### IPD Sharing Statement Module
**Description:** Upon reasonable request to the PI, study materials will be shared.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** O'Connor AM. User Manual - Decisional Conflict Scale (16 item question format). Ottawa: Ottawa Hospital Research Institute. 1993. http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf
**Citation:** Legare F, Kearing S, Clay K, Gagnon S, D'Amours D, Rousseau M, O'Connor A. Are you SURE?: Assessing patient decisional conflict with a 4-item screening test. Can Fam Physician. 2010 Aug;56(8):e308-14.
**PMID:** 20705870
**Citation:** O'Connor AM. User Manual - Decision Self-Efficacy Scale. Ottawa: Ottawa Hospital Research Institute. 1993. http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf
**Citation:** Garg A, Wheldon CW, Galvin AM, Moore JD, Griner SB, Thompson EL. The Development and Psychometric Evaluation of the Mid-adult Human Papillomavirus Vaccine Knowledge Scale in the United States. Sex Transm Dis. 2022 Jun 1;49(6):423-428. doi: 10.1097/OLQ.0000000000001615. Epub 2022 Feb 8.
**PMID:** 35608097
## Derived Section
### 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: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435325
**Brief Title:** Effectiveness of a Precision Diet Based on Gene Expression Versus a Personalized Mediterranean-Style Diet in Weight Loss
**Official Title:** Effectiveness of a Precision Diet Based on Gene Expression Versus a Personalized Mediterranean-Style Diet in Weight Loss
#### Organization Study ID Info
**ID:** IIBSP-SOB-2022-109
#### Organization
**Class:** OTHER
**Full Name:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
### 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:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-03
**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 Barcelona
#### Lead Sponsor
**Class:** OTHER
**Name:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
#### Responsible Party
**Investigator Affiliation:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
**Investigator Full Name:** Jose Manuel Soria
**Investigator Title:** Director of the Genomics Unit in Complex Diseases
**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 randomized controlled trial aims to evaluate the relationship between gene expression profiling and the response to a precision diet compared to a personalized Mediterranean-style diet (control diet) in metabolically healthy individuals with overweight and obesity.
Compared to the control diet, the precision diet is expected to increase adherence to dietary recommendations (resulting in weight loss and maintenance). In addition, we postulate that the precision diet will lead to greater lifestyle changes, improving long-term well-being and health in people with overweight and obesity.
**Detailed Description:** The study aims to evaluate the effectiveness of a precision diet based on gene expression versus a personalized Mediterranean-style diet. For this purpose, a 24-week parallel randomized controlled trial will be conducted. Once eligible participants are recruited, each volunteer will attend three clinical visits (at baseline-week 0 \[T0\], week 12 \[T1\], and week 24 \[T2\]), a study initiation visit (at week 1), and five online follow-up visits (at weeks 3, 6, 9, 16 and 20).
First, the participants will come to the baseline visit \[T0\] in which, we will collect data related to health status, body composition, lifestyle, and well-being. In addition, a registered nurse will collect a blood sample for gene expression profiling, along with other biochemical parameters, such as glycemic and lipid markers.
In the following days, the biochemical results from the baseline visit will be evaluated to confirm that the volunteers are metabolically healthy. For this reason, it will not be until seven days after the baseline visit that the eligibility of the participants will be confirmed. After this confirmation, participants will be scheduled for the study initiation visit.
At this visit, the volunteers will be randomly assigned to one of the two study arms, intervention (precision diet) or control diet. Those assigned to the intervention arm will follow the precision diet (a hypocaloric Mediterranean-style diet based on gene expression), while those assigned to the control arm will follow the control diet (a personalized hypocaloric Mediterranean-style diet without considering gene expression).
Then, 12 weeks after the start of the intervention we will schedule the second study visit \[T1\] in which we will evaluate the same variables as in the baseline visit \[T0\]. Likewise, at the end of the intervention (week 24), we will schedule the third study visit \[T2\] in which we will evaluate the same variables as in the baseline visit \[T0\].
In addition, during the 24 weeks of the study, both groups will attend five online follow-up visits (every 3 to 4 weeks) to ensure adherence to the intervention, as well as continuous care and to adapt dietary recommendations when needed.
### Conditions Module
**Conditions:**
- Overweight and Obesity
**Keywords:**
- Personalized nutrition
- Epigenetics
- Metabotype
- Weight Loss
- Well-being
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 61
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The intervention arm will receive a hypocaloric Mediterranean-style diet (TEE - 500kcal, macronutrient distribution: 45 - 55% carbohydrates, 15 - 25% protein, and 25 - 35% fat) with dietary recommendations based on the participant's gene expression profile.
**Intervention Names:**
- Behavioral: Precision diet
**Label:** Intervention arm
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control arm will receive a hypocaloric Mediterranean-style diet (TEE - 500kcal, macronutrient distribution: 45 - 55% carbohydrates, 15 - 25% protein, and 25 - 35% fat) personalized to the participant's dietary and lifestyle habits.
**Intervention Names:**
- Behavioral: Control diet
**Label:** Control arm
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention arm
**Description:** After the recruitment and randomization, the participants will follow the assigned diet and recommendations for 6-months.
**Name:** Precision diet
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Control arm
**Description:** After the recruitment and randomization, the participants will follow the assigned diet and recommendations for 6-months.
**Name:** Control diet
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Calculated as weight (kg) divided by height (in squared meters), BMI= kg/m\^2.
**Measure:** Changes in body mass index (BMI) from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Measured as the percentage of body fat with a body composition analyzer (Inbody 120, Korea).
**Measure:** Changes in body fat from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
#### Secondary Outcomes
**Description:** The RNA from fasting blood samples will be sequenced using Illumina technology and then the Limma software package will be used to analyze gene expression data from the RNA sequence.
**Measure:** Changes in gene expression profiling from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Fasting measurement of triglycerides, total cholesterol, LDL-cholesterol and HDL-cholesterol (mmol/L) will be measured in venous blood with the standard methodology of the clinical analysis laboratory of the Hospital de Sant Pau.
**Measure:** Changes in fasting blood lipids from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Fasting measurement of glucose, insulin, and glycated hemoglobin (mmol/L) will be measured in venous blood with the standard methodology of the clinical analysis laboratory of the Hospital de Sant Pau.
**Measure:** Changes in glycemic markers from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Fasting measurement of CRP will be measured in venous blood with the standard methodology of the clinical analysis laboratory of the Hospital de Sant Pau.
**Measure:** Changes in C-Reactive Protein (CRP) levels from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Measured to the nearest 0.1 cm using a flexible steel anthropometric tape (CESCORF, Brazil) calibrated in centimeters.
**Measure:** Changes in waist and hip circumference from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Measured as the kilograms of muscle mass with a body composition analyzer (Inbody 120, Korea).
**Measure:** Changes in muscle mass from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Measured in Metabolic Equivalents of Task (METs) using the short version of the International Physical Activity Questionnaire (IPAQ).
**Measure:** Changes in physical activity from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Energy and nutrient intake will be assessed with a 151-item semi-quantitative food frequency questionnaire (Fernández-Ballart et al., 2010) and a 3-day dietary record.
**Measure:** Changes in energy and nutrient intake from baseline to week 24
**Time Frame:** Week 0 and 24
**Description:** Diet quality will be evaluated through the 17-item Mediterranean Diet Adherence Screener (MEDAS) (Schröder et al. 2021).
**Measure:** Changes in diet quality from baseline to week 24
**Time Frame:** Week 0 and 24
**Description:** Eating behaviors (emotional eating, uncontrolled eating and cognitive restraint) will be measured with the Spanish version of the Three Factor Eating Questionnaire (TFEQ-R21) (Martín-García et al. 2016).
**Measure:** Changes in eating behavior from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Well-being will be measured with the Spanish version of the World Health Organization (WHO-5) Well-being Index (Lucas-Carrasco et. al. 2012).
**Measure:** Changes in well-being from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Stress will be evaluated through the Perceived Stress Scale (PSS-10), validated for Spanish population (Remor et al. 2006).
**Measure:** Changes in stress levels from baseline to week 24.
**Time Frame:** Week 0 and 24
**Description:** Anxiety and depression state will be measured by the Hospital Anxiety and Depression Scale (HADS), validated for Spanish population (Herrero et al. 2003). It consists of two subscales: HADS-A, designed to detect anxious states, and HADS-D, designed to detect depressive states.
**Measure:** Changes in depression and anxiety degree from baseline to week 24.
**Time Frame:** Week 0 and 24
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* BMI 26-35 Kg/m\^2.
* Metabolically healthy.
Exclusion Criteria:
* Any comorbidity associated with obesity (such as type 2 diabetes mellitus, hypertension, dyslipidemia).
* Medications (Antidepressants; Antipsychotics; Anxiolytic; Statins; Antihypertensives; Insulin or anti-diabetics).
* Intragastric balloon or Bariatric surgery.
* History of weight loss treatment within the previous 3 months.
* Women with menopause, pregnancy, or breastfeeding.
* Smokers.
* Food allergies or intolerances.
* Eating disorders.
* Shift work.
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** maria_izquierdo@ub.edu
**Name:** Maria Izquiero-Pulido, Phd
**Phone:** +34934037293
**Role:** CONTACT
**Contact 2:**
**Email:** iparillim@ub.edu
**Name:** Isabella Parilli-Moser, Phd
**Phone:** +34638793344
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Email:** maria_izquierdo@ub.edu
- **Name:** Maria Izquierdo Pulido, Phd
- **Phone:** +34934037293
- **Role:** CONTACT
**Country:** Spain
**Facility:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
**Status:** RECRUITING
**Zip:** 08041
#### Overall Officials
**Official 1:**
**Affiliation:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
**Name:** Jose Manuel Soria, Phd
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of Barcelona
**Name:** Maria Izquierdo-Pulido, Phd
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
- ID: D000001836
- Term: Body Weight Changes
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M26186
- Name: Overweight
- Relevance: HIGH
- As Found: Overweight
- ID: M18102
- Name: Weight Loss
- Relevance: HIGH
- As Found: Weight Loss
- ID: M5114
- Name: Body Weight
- 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: M5115
- Name: Body Weight Changes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000050177
- Term: Overweight
- ID: D000015431
- Term: Weight Loss
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435312
**Acronym:** ziMyG+
**Brief Title:** An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
**Official Title:** An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Zilucoplan in Pediatric Study Participants With Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis
#### Organization Study ID Info
**ID:** MG0015
#### Organization
**Class:** INDUSTRY
**Full Name:** UCB Pharma
#### Secondary ID Infos
**Domain:** EU CT Number
**ID:** 2022-502073-42-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-12-07
**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:** 2027-10-26
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-13
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** UCB Biopharma SRL
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to assess the long-term safety and tolerability of an additional 52 weeks of Zilucoplan treatment administered by subcutaneous injection once daily in pediatric study participants
### Conditions Module
**Conditions:**
- Generalized Myasthenia Gravis
**Keywords:**
- generalized Myasthenia Gravis
- gMG
- RA101495
- Zilucoplan
- pediatric
- MG0015
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 8
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Study participants will receive Zilucoplan at a pre-defined dose based on their weight.
**Intervention Names:**
- Drug: Zilucoplan
**Label:** Zilucoplan Arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Zilucoplan Arm
**Description:** Zilucoplan will be administered subcutaneously to pediatric study participants
**Name:** Zilucoplan
**Other Names:**
- RA101495
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** An adverse event (AE) is any untoward medical occurence in a patient or clinical investigation where the study participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
**Measure:** Occurence of treatment emergent adverse events during the course of the study
**Time Frame:** Baseline (Day 1) to Safety Follow-up (up to Week 60)
**Description:** A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
Results in death Is life-threatening Requires inpatient hospitalization Results in persistent disability/incapacity Is a congenital anomaly/birth defect Important medical event.
**Measure:** Occurence of treatment-emergent serious adverse events (TESAEs)
**Time Frame:** Baseline (Day 1) to Safety Follow-up (up to Week 60)
**Description:** An adverse event (AE) is any untoward medical occurence in a participant or clinical investigation administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to permanent withdrawal of study medication.
**Measure:** Occurence of treatment-emergent advserse events leading to permanent withdrawal of investigational medicinal product
**Time Frame:** Baseline (Day 1) to Safety Follow-up (up to Week 60)
**Description:** Percentage of participants who experienced treatment-emergent infections as adverse events.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
**Measure:** Occurence of treatment-emergent infections
**Time Frame:** Baseline (Day 1) to Safety Follow-up (up to Week 60)
#### Secondary Outcomes
**Description:** Blood samples for the measurement of plasma concentrations of Zilucoplan will be collected at Week 52.
**Measure:** Plasma concentration of Zilucoplan at Week 52
**Time Frame:** Week 52
**Description:** Blood samples for measurement of sRBC lysis will be collected at Week 52.
**Measure:** Sheep red blood cell (sRBC) lysis activity at Week 52
**Time Frame:** Week 52
**Description:** Blood samples for measurement of C5 will be collected at Week 52.
**Measure:** Blood complement component 5 (C5) levels at Week 52
**Time Frame:** Week 52
**Description:** The MG-ADL score is an 8-item patient-reported outcome (PRO) instrument. The MG-ADL targets symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The item responses are scored from 0 to 3, and the total score of MG-ADL is the sum of the 8 items and ranges from 0 to 24, with a higher score indicating more disability.
**Measure:** Myasthenia Gravis Activity of Daily Living (MG-ADL) score at Week 52
**Time Frame:** Week 52
**Description:** QMG score is a standardized and validated quantitative strength scoring system that was developed specifically for MG. The QMG total score is obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3). The score ranges from 0 to 39, with lower scores indicating lower disease activity.
**Measure:** Quantitative Myasthenia Gravis (QMG) score at Week 52
**Time Frame:** Week 52
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
United States of America (USA) specific inclusion criterion:
- Participant must be ≥ 12 years of age at the time of signing the Informed Consent/Assent according to local regulation.
Rest of World (ROW) specific inclusion criterion:
- Participant must be ≥ 2 years of age at the time of signing the Informed Consent/Assent according to local regulation.
Global specific inclusion criteria:
* Participant has completed the MG0014 according to the protocol, and further treatment with zilucoplan is in the interest of the participant in the investigator´s opinion
* Participant agrees to receive booster vaccinations against meningococcal infections during the study, if clinically indicated according to the local standard of care
Exclusion Criteria:
* Study participant met any mandatory investigational medicinal product (IMP) withdrawal or mandatory permanent discontinuation criteria in MG0014 or permanently discontinued IMP
* Participant has known positive serology for muscle-specific kinase
* Participant has known hypersensitivity to any components of the IMP
* Participant has a prior history of meningococcal disease
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** ucbcares@ucb.com
**Name:** UCB Cares
**Phone:** +18445992273
**Phone Ext:** (USA)
**Role:** CONTACT
**Contact 2:**
**Name:** UCB Cares
**Phone:** 001 844 599 2273
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** 001 844 599 2273 (UCB)
**Name:** UCB Cares
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
**Description:** Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- CSR
**IPD Sharing:** YES
**Time Frame:** Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
**URL:** https://www.Vivli.org
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000020879
- Term: Neuromuscular Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000010335
- Term: Pathologic Processes
- 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: 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: BC05
- Name: Musculoskeletal Diseases
- 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: M20944
- Name: Muscle Weakness
- Relevance: HIGH
- As Found: Myasthenia
- ID: M13204
- Name: Paresis
- Relevance: LOW
- As Found: Unknown
- ID: M4554
- Name: Asthenia
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22619
- Name: Neuromuscular Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- 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: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- 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
- ID: D000018908
- Term: Muscle Weakness
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: VaDiAg
- Name: Vasodilator Agents
### Intervention Browse Module - Browse Leaves
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M3473
- Name: Acetylcholine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435299
**Acronym:** CANNABITCH
**Brief Title:** Efficacy and Tolerance of Cannabidiol in Patients With Severe Pruritus: a Multicenter, Double-blind, Randomized, Placebo-controlled Study
**Official Title:** Efficacy and Tolerance of Cannabidiol in Patients With Severe Pruritus: a Multicenter, Double-blind, Randomized, Placebo-controlled Study
#### Organization Study ID Info
**ID:** 29BRC23.0164
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Brest
### Status Module
#### Completion Date
**Date:** 2024-09-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-14
**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:** 2024-03-27
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Brest
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Pruritus is defined as an unpleasant sensation leading to the need to scratch. Medications for pruritus are much less effective than those used for pain and it is imperative to find new therapeutic options.
Over the last 20 years, the understanding of the pathophysiology of pruritus has progressed significantly, opening new possible therapeutic fields. Among these, cannabinoids seem very promising because the physiological inhibitory role of endocannabinoids, mainly produced by neurons, has been well demonstrated. Data from the literature suggest that the antipruritic effects of cannabinoids are due to a combination of effects on neuronal activation, transmission along the afferent pathway, and local modulation of keratinocytes and mast cells. The antipruritic effect is peripheral and central, through modulation of CB1, CB2 or TRPV1 channels. CB1 and CB2 receptors are specific cannabinoid receptors, CB1 being present at the central and peripheral level while CB2 is only peripheral and very present in the skin. Cannabinoids can also bind to TRPV1, and thus inhibit neurogenic inflammation by antagonizing or stabilizing this ion channel, which prevents neuronal activation by pruritogenic mediators. Phytocannabinoids are derived from cannabis and are used for a variety of purposes, with their development for medical purposes expanding rapidly. The two best known are tetrahydrocannabinol (THC) and cannabidiol (CBD). THC binds to TRPV1, CB2 and CB1, the activation of the latter being at the origin of parallel psychotropic effects. CBD binds mainly to TRPV1, which allows us to expect very favorable effects on pruritus, neurogenic inflammation and skin pain, without fearing side effects of this type.
A limited number of studies suggest that cannabinoids may be useful topically or systemically, in humans or animals, but no comparative study with placebo has been performed. These encouraging results have been observed in cases of induced pruritus, idiopathic pruritus, eczema, uremic pruritus, cholestatic pruritus, prurigo, sensitive skin or even epidermolysis bullosa.
Currently, the ANSM is conducting an evaluation of the effects of medical cannabis on severe pain. We propose to evaluate the effects on severe pruritus in a randomized placebo-controlled study one of the products chosen by the ANSM in this context, the oil LITTLE GREEN PHARMA, which we choose for its dominant CBD ratio (THC \< 5 mg/ml, CBD \> 5 mg/ml).
### Conditions Module
**Conditions:**
- Pruritus
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 218
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Cannabis oil 50mg/mL arm :
An auto-titration phase will take place during the first 14 days of treatment: 0.2 ml on the first day then increase of 0.2 ml every 2 days in 2 daily doses, that is to say 1.4 ml/day maximum.
If any tolerable side-effects occurred, patients were advised not to increase the dose; if intolerable side-effects occurred, dose reduction was advised.
After initial titration, the dose will then be maintained for 4 consecutive weeks.
**Intervention Names:**
- Drug: Cannabis oil
**Label:** Cannabis oil
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo arm :
An auto-titration phase will take place during the first 14 days of treatment: 0.2 ml on the first day then increase of 0.2 ml every 2 days in 2 daily doses, that is to say 1.4 ml/day maximum.
If any tolerable side-effects occurred, patients were advised not to increase the dose; if intolerable side-effects occurred, dose reduction was advised.
After initial titration, the dose will then be maintained for 4 consecutive weeks.
**Intervention Names:**
- Drug: Placebo
**Label:** PLACEBO
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cannabis oil
**Description:** Patients in this arm will have to take Cannabis oil (50mg/mL) twice a day with the daily dose estimated during auto titration phase (from W0 to W2)
**Name:** Cannabis oil
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- PLACEBO
**Description:** Patients in this arm will have to take Placebo oil twice a day with the daily dose estimated during auto titration phase (from W0 to W2)
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6.
**Measure:** WI-NRS change
**Time Frame:** Week 0
**Description:** Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6.
**Measure:** WI-NRS change
**Time Frame:** Week 6
#### Secondary Outcomes
**Description:** - Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from inclusion visit to week 2.
**Measure:** WI-NRS change from W0 to W2
**Time Frame:** Week 0
**Description:** - Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from inclusion (= Week 0) visit to week 2.
**Measure:** WI-NRS change from W0 to W2
**Time Frame:** Week 2
**Description:** - Change in ItchyQoL score from inclusion (= Week 0) visit to week 2 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W2
**Time Frame:** Week 0
**Description:** - Change in ItchyQoL score from inclusion (= Week 0) visit to week 2 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W2
**Time Frame:** Week 2
**Description:** - Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 2 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W2
**Time Frame:** Week 0
**Description:** - Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 2(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W2
**Time Frame:** Week 2
**Description:** - Change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W6
**Time Frame:** Week 0
**Description:** - Change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W6
**Time Frame:** Week 2
**Description:** - Change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W6
**Time Frame:** Week 4
**Description:** - Change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W6
**Time Frame:** Week 6
**Description:** - Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL percent change from W0 to W6
**Time Frame:** Week 0
**Description:** - Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL percent change from W0 to W6
**Time Frame:** Week 2
**Description:** - Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL percent change from W0 to W6
**Time Frame:** Week 4
**Description:** - Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL percent change from W0 to W6
**Time Frame:** Week 6
**Description:** - Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W2
**Time Frame:** Week 0
**Description:** - Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W2
**Time Frame:** Week 2
**Description:** - Percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W2
**Time Frame:** Week 0
**Description:** - Percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W2
**Time Frame:** Week 2
**Description:** - Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W6
**Time Frame:** Week 0
**Description:** - Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W6
**Time Frame:** Week 2
**Description:** - Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W6
**Time Frame:** Week 4
**Description:** - Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6. (10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale evolution from W0 to W6
**Time Frame:** Week 6
**Description:** - Percent change and percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W6
**Time Frame:** Week 0
**Description:** - Percent change and percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W6
**Time Frame:** Week 2
**Description:** - Percent change and percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W6
**Time Frame:** Week 4
**Description:** - Percent change and percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W6
**Time Frame:** Week 6
**Description:** - Incidence and severity of treatment-emergent adverse events.
**Measure:** Treatment adverse events
**Time Frame:** Week 0
**Description:** - Incidence and severity of treatment-emergent adverse events.
**Measure:** Treatment adverse events
**Time Frame:** Week 2
**Description:** - Incidence and severity of treatment-emergent adverse events.
**Measure:** Treatment adverse events
**Time Frame:** Week 4
**Description:** - Incidence and severity of treatment-emergent adverse events.
**Measure:** Treatment adverse events
**Time Frame:** Week 6
**Description:** - Incidence and severity of treatment-emergent adverse events.
**Measure:** Treatment adverse events
**Time Frame:** Week 8
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 years
* Severe pruritus, defined by a mean WI-NRS score ≥7/10 (evaluated on one week before inclusion, regardless of the cause of the pruritus
* Insufficient relief (WI-NRS ≥7/10 ) or poor tolerance (adverse effects) of accessible drug and non-drug therapies
* Stable treatment (for treatment of the prurit) for at least 6 weeks
Exclusion Criteria:
* Inability of the patient to give free and informed consent
* Personal history of psychotic disorders
* Severe hepatic impairment (prothrombin level \<50%)
* Moderate to severe renal impairment (estimated glomerular filtration rate ≤ 44 mL/min/1.73 m2 ?)
* Disease or history of severe cardiovascular or cerebrovascular disorders (myocardial infraction, stroke)
* Pregnant or breastfeeding woman
* Lack of understanding of questionnaires or inability to follow up - Inability of the patient to give free and informed consent
* Personal history of psychotic disorders
* Severe hepatic impairment (prothrombin level \>50%) or predictive biological impairment
* Severe renal impairment (Estimated glomerular filtration rate ≤ 44 mL/min/1.73 m2 ? )
* Severe cardiovascular (myocardial infarction, cardiovascular accident) or cerebrovascular disease or history of such disease
* Pregnant or breastfeeding woman
* Lack of understanding of questionnaires or inability to follow up
* Cannabinoid use outside the clinical trial
* Use of cannabis or its derivatives less than one week before inclusion
* History of hypersensitivity or allergy to any cannabinoid product
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** laurent.misery@chu-brest.fr
**Name:** Laurent MISERY, PU-PH
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012871
- Term: Skin Diseases
- ID: D000012877
- Term: Skin Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14396
- Name: Pruritus
- Relevance: HIGH
- As Found: Pruritus
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15680
- Name: Skin Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011537
- Term: Pruritus
### Intervention Browse Module - Browse Branches
- Abbrev: AntiConv
- Name: Anticonvulsants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5445
- Name: Cannabidiol
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435286
**Brief Title:** Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States
**Official Title:** Effectiveness and Performance of a Mobile, Automated, Optical Biopsy Technology for Esophageal Cancer Screening: A Clinical Study in Brazil and the United States
#### Organization Study ID Info
**ID:** H-53483
#### Organization
**Class:** OTHER
**Full Name:** Baylor College of Medicine
### Status Module
#### Completion Date
**Date:** 2026-08-01
**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:** 2026-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-01
**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:** William Marsh Rice University
**Class:** OTHER
**Name:** M.D. Anderson Cancer Center
**Class:** OTHER
**Name:** Instituto do Cancer do Estado de São Paulo
**Class:** OTHER
**Name:** Hospital de Cancer de Barretos - Fundacao Pio XII
#### Lead Sponsor
**Class:** OTHER
**Name:** Baylor College of Medicine
#### Responsible Party
**Investigator Affiliation:** Baylor College of Medicine
**Investigator Full Name:** Sharmila Anandasabapathy
**Investigator Title:** Professor of Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** In a previous clinical trial in China and the United States (US), the investigators developed and validated a mobile, high-resolution microendoscope (mHRME) for screening and surveillance of esophageal squamous cell neoplasia (ESCN). The trial revealed higher specificity for qualitative (visual) interpretation by experts but not the novice and in the surveillance arm (100% vs. 19%, p \<0.05). In the screening arm, diagnostic yield (neoplastic biopsies/total biopsies) increased 3.6 times (8 to 29%); 16% of patients were correctly spared any biopsy, and 18% had a change in clinical plan. In a pilot study in Brazil, the investigators tested a software-assisted mHRME with deep-learning software algorithms to aid in the detection of neoplastic images and determine the performance, efficiency, and impact of the AI-mHRME when to Lugol's chromoendoscopy (LCE) alone and when using AI-mHRME with LCE. In this clinical trial, the investigators will build on the Brazil pilot trial data to optimize an artificial intelligence (AI) mHRME and evaluate its clinical impact and implementation potential in ethnically and socioeconomically diverse populations in the US and Brazil.
**Detailed Description:** The investigators' hypothesis is that the artificial intelligence (AI) mobile, high-resolution microendoscope (mHRME) will increase the accuracy of Lugol's chromoendoscopy (LCE) in endoscopic cancer detection in low- and middle-income countries (LMICs) and high-income countries (HICs).
Objective 1: The investigators' first objective is to evaluate the diagnostic performance, efficiency, and impact of this automated optical biopsy device. In a single-arm study (n=200) of high-risk subjects undergoing LCE followed by AI-mHRME for ESCN screening in Brazil and the US, the investigators will evaluate the diagnostic performance and efficiency of this automated optical biopsy device.
The investigators' other hypotheses are that the AI-mHRME will:
1. increase the mHRME accuracy in novices and be non-inferior to experts,
2. increase user confidence among experts and novices, and
3. increase the LCE efficiency and impact byreducing biopsies and second procedures.
The investigators will compare the accuracy of the AI-mHRME software read to novice and expert clinicians' subjective reading to gold-standard histopathology by an expert gastrointestinal (GI) pathologist. For clinician confidence and clinical impact, they will determine the clinician's confidence level in the software diagnosis and the potential clinical impact of this diagnosis among novice and expert endoscopists using AI-mHRME. The clinician reads will be part of the mHRME procedure and treatment "plan" (biopsy vs. not biopsy vs. treat). Clinicians are not considered study subjects in objective 1. The clinical impact will be determined by the change in the clinician's decision in the treatment "plan" before and after the AI-mHRME read. For efficiency (biopsy saving and diagnostic yield), they will determine the number of patients spared any biopsy due to AI-mHRME. The investigators will compare the diagnostic yield of AI-mHRME and LCE vs. LCE alone (diagnostic yield = neoplastic biopsies/total number of biopsies obtained in biopsied patients).
Objective 2: This objective will have three study populations, with a total sample size of n=50 subjects. To determine barriers and facilitators to implementing AI-mHRME, the team will form Health Sector Stakeholder Advisory Boards (HS-SAB) in the US and Brazil as the first study population. The HS-SABs will include academic partners, primary care providers referring patients, doctors performing esophageal cancer screening, hospital administrators, and patient and caregiver representatives. The HS-SAB sample size will be 6-10 members in the US and Brazil each, a standard number of participants for research advisory boards. The team will collect feedback and input through focus group discussions (FGDs) at 6 time points across the project period per HS-SAB. FGD objectives will match the research stage: clinical trial planning (recruitment and retention plan refinement), data collection (stakeholders identification), result interpretation, and dissemination.
For the second study population, the team will conduct semi-structured individual interviews with implementers to assess barriers and facilitators to implementing AI-assisted cancer technologies (n=40). Interviews will be with patients and caregivers(n=10), GI clinicians (n=10), primary care physicians (n=10), and hospital and health leadership (n=10).
There will be surveys with endoscopists (n=40) at the participating sites to understand their thoughts on HRME.
### Conditions Module
**Conditions:**
- Suspected or Known Squamous Cell Neoplasia
- Prior History of Squamous Cell Dysplasia and /or Neoplasia
**Keywords:**
- Squamous cell neoplasia
- Proflavine
- Lugol's chromoendoscopy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Participants will be enrolled based on criteria for surveillance or screening for esophageal squamous cell carcinoma. They will receive standard-of-care endoscopy and the artificial intelligence mobile high-resolution microendoscopy procedures.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All subjects will receive White Light Imaging (WLI) and Lugol's Chromoendoscopy (LCE), the current standard of care (SOC) procedure. Following LCE, all subjects will receive the artificial intelligence (AI) mobile high-resolution microendoscopy (mHRME) imaging with Proflavine Hemisulfate of any LCE abnormal and LCE normal areas (4:1 ratio). For both WLI and LCE, we will record the subjective clinician read (neoplastic, non-neoplastic), the confidence level in their diagnoses (high, low), and the action plan (biopsy vs. no biopsy vs. treat). With the AI-mHRME, we will image the same LCE abnormal and normal areas and record the software read, the clinician confidence level, and action plan. Finally, the imaged LCE abnormal areas will be biopsied or resected, and evaluated by a pathologist.
**Intervention Names:**
- Drug: Proflavine Hemisulfate
- Device: Artificial Intelligence Mobile High-Resolution Microendoscope
**Label:** Artificial Intelligence Mobile High Resolution Microendoscope (AI-mHRME) imaging
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Artificial Intelligence Mobile High Resolution Microendoscope (AI-mHRME) imaging
**Description:** Approximately 5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa.
**Name:** Proflavine Hemisulfate
**Other Names:**
- Proflavine
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Artificial Intelligence Mobile High Resolution Microendoscope (AI-mHRME) imaging
**Description:** The AI-mHRME will be inserted through the endoscope biopsy channel and gently placed against the mucosa where proflavine was sprayed. The probe will transmit images to the computer/laptop for the clinician to observe any abnormal tissues and save photos of these tissues.
**Name:** Artificial Intelligence Mobile High-Resolution Microendoscope
**Other Names:**
- AI-mHRME
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Change in clinical plan ('biopsy vs. no biopsy vs. treat') following AI-mHRME.
**Measure:** Clinical Impact
**Time Frame:** 18 months
**Description:** Sensitivity, specificity, positive and negative predictive values of AI-mHRME.
**Measure:** Performance Characteristics
**Time Frame:** 18 months
**Description:** Efficiency in the number of biopsies saved, procedures saved.
**Measure:** Procedure Efficiency
**Time Frame:** 18 months
**Description:** Confidence of expert and novice clinicians in clinically interpreting mHRME (pre- and post-use of AI-mHRME).
**Measure:** Clinician Confidence
**Time Frame:** 18 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Outpatients undergoing routine (standard of care) Lugol's chromoendoscopic screening for squamous cell neoplasia will be eligible for enrollment, including patients with a known history of head/neck squamous cell cancer; heavy smoking and alcohol, other dietary or geographic risk factors or prior dysplasia
* Patients \>18 years old.
* Patients of any sex or gender.
* Patients who are willing and able to give informed consent.
Exclusion Criteria:
* Allergy or prior reaction to the fluorescent contrast agent proflavine hemisulfate.
* Patients who are unable to give informed consent.
* Known advanced squamous cell carcinoma of the distal esophagus or dysplastic/suspected malignant esophageal lesion greater than or equal to 2 cm in size not amenable to endoscopic therapy.
* Patient unable to undergo routine endoscopy with biopsy:
* Women who are pregnant or breast feeding,
* Prothrombin time greater than 50% of control; PTT greater than 50 sec, or INR greater than 2.0,
* Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** sharmila.anandasabapathy@bcm.edu
**Name:** Sharmila Anandasabapathy, MD
**Phone:** 7137980950
**Role:** CONTACT
**Contact 2:**
**Email:** adrianna.maliga@bcm.edu
**Name:** Adrianna O Maliga, MPH
**Phone:** (713) 798-5987
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** adrianna.maliga@bcm.edu
- **Name:** Adrianna O Maliga, MPH
- **Phone:** 713-798-5987
- **Role:** CONTACT
***Contact 2:***
- **Name:** Sharmila Anandasabapathy, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Baylor St. Luke's Medical Center
**State:** Texas
**Zip:** 77030
**Location 2:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** adrianna.maliga@bcm.edu
- **Name:** Adrianna O Maliga, MPH
- **Phone:** 713-798-5987
- **Role:** CONTACT
***Contact 2:***
- **Name:** Mimi C Tan, MD, MPH
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Ben Taub Hospital (Harris Health Systems)
**State:** Texas
**Zip:** 77030
**Location 3:**
**City:** Barretos
**Contacts:**
***Contact 1:***
- **Email:** erbaba@uol.com.br
- **Name:** Elisa R Baba, MD, PhD
- **Phone:** +55-11-98501-9190
- **Role:** CONTACT
***Contact 2:***
- **Name:** Elisa R Baba, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Claudio Hashimoto, MD, MBA
- **Role:** SUB_INVESTIGATOR
**Country:** Brazil
**Facility:** Hospital de Cancer de Barretos - Fundacao Pio XII
**State:** São Paulo
**Zip:** 14784-400
**Location 4:**
**City:** São Paulo
**Contacts:**
***Contact 1:***
- **Email:** fauze.maluf@terra.com.br
- **Name:** Fauze Maluf-Filho, MD
- **Phone:** +55-11-9919-19014
- **Role:** CONTACT
***Contact 2:***
- **Email:** elaine.uuehara@hc.fm.usp.br
- **Name:** Elaine U Uehara, MS
- **Phone:** +55-11-3893-3535
- **Role:** CONTACT
***Contact 3:***
- **Name:** Fauze Maluf-Filho, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Evandro Sobroza de Mello, MD
- **Role:** SUB_INVESTIGATOR
**Country:** Brazil
**Facility:** Instituto do Câncer do Estado de São Paulo
**Zip:** 01246-000
#### Overall Officials
**Official 1:**
**Affiliation:** Baylor College of Medicine
**Name:** Sharmila Anandasabapathy, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-05-07
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 315623
- Type Abbrev: Prot_SAP
- Upload Date: 2024-05-23T16:17
- Date: 2024-05-07
- Filename: ICF_001.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 107478
- Type Abbrev: ICF
- Upload Date: 2024-05-23T16:17
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000004935
- Term: Esophageal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M8088
- Name: Esophageal Neoplasms
- Relevance: HIGH
- As Found: Esophageal Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8085
- Name: Esophageal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2141
- Name: Esophageal Cancer
- Relevance: HIGH
- As Found: Esophageal Cancer
### Condition Browse Module - Meshes
- ID: D000004938
- Term: Esophageal Neoplasms
- ID: D000009369
- Term: Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000000891
- Term: Anti-Infective Agents, Local
- ID: D000000890
- Term: Anti-Infective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Coag
- Name: Coagulants
### Intervention Browse Module - Browse Leaves
- ID: M14242
- Name: Proflavine
- Relevance: HIGH
- As Found: PSC
- ID: M193072
- Name: Lugol's solution
- 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
### Intervention Browse Module - Meshes
- ID: D000011370
- Term: Proflavine
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435273
**Acronym:** ARTEMISIA
**Brief Title:** A Randomised, Double-blind, Parallel Group, Placebo Controlled, 4-Week, Phase II Study to Evaluate the Effect of AZD4604 on Airway Inflammation and Biomarkers in Adults With Asthma
**Official Title:** A Randomised, Double-blind, Parallel Group, Placebo Controlled, 4-Week, Phase II Study to Evaluate the Effect of AZD4604 on Airway Inflammation and Biomarkers in Adults With Asthma
#### Organization Study ID Info
**ID:** D8210C00005
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
#### Secondary ID Infos
**Domain:** EMA
**ID:** 2023-510291-32-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-08-12
**Type:** ESTIMATED
#### 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:** 2026-08-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-31
**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:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** AstraZeneca
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of this study is to investigate the effect on airway inflammation and JAK1-associated signalling pathways of AZD4604 compared with placebo in participants with moderate-to-severe asthma.
Study details include:
* The study duration for each participant will be approximately 10 weeks.
* The duration of IMP administration will be approximately 4 weeks.
**Detailed Description:** This is a multicentre, randomised, placebo-controlled, double-blind study to investigate the effect on airway inflammation and JAK1-associated signalling pathways of AZD4604, administered over a 4-week treatment period to adult patients with moderate-to-severe asthma. The study will recruit patients receiving treatment with medium-to-high dose inhaled corticosteroid-long-acting beta-agonist (ICS-LABA) at screening and having a history of at least one severe asthma exacerbation within the year prior to Visit 1 or have an Asthma control questionnaire-6 (ACQ-6) score ≥ 1.5 at Visit 1. Enrolled participants will be randomised into the study to either AZD4604 or placebo. Participants discontinuing the study before the completion of Visit 6a (including the second bronchoscopy) will be replaced. Participants will be randomised using an interactive response technology/randomisation and trial supply management system at a ratio of 2:1 to AZD4604 or placebo, respectively. Randomisation will be stratified based on fractional exhaled nitric oxide (FeNO) levels to ensure a similar proportion of participants with FeNO above and below 25 parts per billion (ppb) in the 2 treatment arms. The study will be conducted at approximately 28 sites in approximately 5 countries.
### Conditions Module
**Conditions:**
- Asthma
**Keywords:**
- Asthma, Mechanistic Study, Bronchoscopy
### 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:** 48
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** AZD4604
**Intervention Names:**
- Drug: AZD4604
**Label:** AZD4604
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo to AZD4604
**Intervention Names:**
- Drug: Placebo to AZD4604
**Label:** Placebo to AZD4604
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- AZD4604
**Description:** Janus kinase 1 (JAK1) inhibitor
**Name:** AZD4604
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo to AZD4604
**Description:** Placebo to AZD4604
**Name:** Placebo to AZD4604
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Gene expression in airway epithelial cells
**Measure:** Change from baseline to end of investigational medicinal product (IMP) administration in expression of T2 and non-T2, and JAK1-related genes and gene signatures in bronchial brushings
**Time Frame:** 4 weeks
#### Secondary Outcomes
**Description:** To evaluate the effect of AZD4604 as compared to placebo on STAT phosphorylation in the airways
**Measure:** Change from baseline to end of IMP administration in STAT phosphorylation in bronchial biopsies
**Time Frame:** 4 weeks
**Description:** To explore the effect of AZD4604 on cellular pathology in the airways as compared to placebo
**Measure:** Change in number of airway cells, including but not limited to inflammatory cells, airway smooth muscle cells, and goblet cells from baseline to end of IMP administration in bronchial biopsies (cells per mm² determined by microscopic evaluation)
**Time Frame:** 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Documented physician-diagnosed asthma ≥ 12 months prior to screening (Visit 1).
* Participants treated with medium-to-high dose ICS in combination with LABA at a stable dose for at least 2 months prior to Visit 1 (the ICS can be contained within an ICS-LABA fixed dose combination product or as separate inhaled products regularly taken together). Treatment with additional asthma controller therapies (eg, long-acting muscarinic antagonist, leukotriene receptor antagonist) at a stable dose ≥ 2 months prior to Visit 1 is allowed. Treatment with maintenance systemic corticosteroids (oral or injectable) is not allowed.
* A documented history of ≥ 1 severe asthma exacerbation within 1 year prior to Visit 1 or ACQ-6 ≥ 1.5 at Visit 1. A severe asthma exacerbation is defined as a worsening of asthma that leads to an inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥ 24 hours) due to asthma.
* Morning pre-BD FEV1 ≥ 60% predicted at Visit 1.
* Able to perform acceptable lung function testing for FEV1 according to American Thoracic Society/ European Respiratory Society (ATS/ERS) 2019 acceptability criteria.
* Able and willing to undertake bronchoscopy. There should be no absolute contra-indications to bronchoscopy as outlined in the bronchoscopy manual.
* Documented evidence of asthma in the 5 years up to or including Visit 1.
* Able and willing to comply with the requirements of the protocol including ability to read, write, be fluent in the translated language of all participant-facing questionnaires used at the study site, and use electronic devices, eg, electronic patient reported outcomes (ePRO) device and spirometer.
* Body weight ≥ 40 kg and body mass index \< 35 kg/m2.
* All females must have a negative serum pregnancy test result at Visit 1.
* Females not of childbearing potential are defined as females who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
* All FOCBP who are sexually active with a non-sterilised male partner must agree to use one highly effective method of birth control.
Exclusion Criteria:
* A severe asthma exacerbation within 8 weeks prior to Visit 1.
* History of herpes zoster reactivation (shingles).
* Clinically important pulmonary disease other than asthma, eg, active lung infection, chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, history or planned lung lobectomy, alpha-1 anti-trypsin deficiency, primary ciliary dyskinesia, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, and hyper-eosinophilic syndrome.
* Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator.
* Any clinically significant cardiac or cerebrovascular disease.
* History of venous thromboembolism.
* Participants with a recent history of, or who have a positive test for, infective hepatitis or unexplained jaundice, or participants who have been treated for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Positivity for hepatitis B virus (HBV) surface antigen is a reason for exclusion.
* Current or prior history of alcohol or drug abuse (including marijuana), as judged by the investigator. Positive drug screening result that cannot be justified by participant's medical history and its relevant treatment (over-the-counter product or a valid prescription), or history of or current alcohol or drug abuse (including marijuana and marijuana-containing valid prescriptions), as judged by the investigator.
* History of malignancy other than superficial basal cell carcinoma.
* Treatment with systemic corticosteroid (short-term or maintenance) use within 8 weeks (oral) or 12 weeks (intramuscular) before Visit 1.
* Any immunosuppressive therapy (including hydroxychloroquine, methotrexate, cyclosporine, and tacrolimus) within 12 weeks prior to Visit 1.
* Treatment with marketed biologics including benralizumab, mepolizumab, reslizumab, omalizumab, dupilumab, and tezepelumab within 6 months or 5 half-lives of Visit 1, whichever is longer.
* Inhaled corticosteroid plus fast-acting β2 agonist as a rescue medication (eg, Symbicort, Fostair, or Airsupra Maintenance and Reliever Treatment) is not allowed 30 days prior to Visit 1, during screening, run-in and baseline periods, throughout the treatment period, and preferably until 1 week after the last administration of the IMP.
* Live, attenuated, or mRNA vaccines within 4 weeks of Visit 1.
* Immunoglobulin therapy or blood products within 4 weeks of Visit 1.
* Any immunotherapy within 6 months of Visit 1, except for stable maintenance dose allergen-specific immunotherapy started at least 4 weeks prior to Visit 1 and expected to continue through to the end of the follow-up period.
* Anticoagulants (including vitamin K antagonists and Factor Xa inhibitors). Antiplatelet agents are allowable if in the opinion of the investigator they can be safely withheld for 7 days prior to the procedure.
* Participants with a known hypersensitivity to AZD4604 or any of the excipients of the product.
* Abnormal findings identified on physical examination, ECG, or laboratory testing include, but not limited to: Alanine aminotransferase/transaminase (ALT) or aspartate aminotransferase/transaminase AST ≥ 1.5 × upper limit of normal (ULN), Total bilirubin (TBL) ≥ ULN (unless due to known Gilbert's disease), Evidence of chronic liver disease, International Normalised Ratio (INR) \> 1.5, Platelet count \< 150,000 per microliter, Abnormal vital signs, after 5 minutes of supine or sitting rest (confirmed by 1 controlled measurement), defined as any of the following: Systolic blood pressure (BP) \< 80 mmHg or ≥ 150 mmHg, Diastolic BP \< 50 mmHg or ≥ 95 mmHg, Pulse \< 50 bpm or \> 100 bpm, Signs of pulmonary oedema or volume overload, Any clinically significant rhythm, conduction, or morphology abnormalities in the ECG including but not limited to QT interval corrected using Fridericia's formula (QTcF) \> 450 ms.
For female participants only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
* Current smokers or participants with smoking history ≥ 10 pack-years.
* Participants with a known long-term exposure to occupational asbestos, silica, radon, heavy metals, and polycyclic aromatic hydrocarbons.
* Positive, first-degree family history of primary lung cancer.
* Positive urine cotinine test at Visit 1 and at any timepoint throughout the study.
* Major surgery within 8 weeks prior to Visit 1, or planned inpatient surgery, major dental procedure or hospitalisation during screening, treatment, or follow-up periods.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** information.center@astrazeneca.com
**Name:** AstraZeneca Clinical Study Information Center
**Phone:** 1-877-240-9479
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Calgary
**Country:** Canada
**Facility:** Research Site
**State:** Alberta
**Zip:** T2N 4Z6
**Location 2:**
**City:** North Vancouver
**Country:** Canada
**Facility:** Research Site
**State:** British Columbia
**Zip:** V7L 2L7
**Location 3:**
**City:** Montreal
**Country:** Canada
**Facility:** Research Site
**State:** Quebec
**Zip:** H4A 3J1
**Location 4:**
**City:** Quebec
**Country:** Canada
**Facility:** Research Site
**Zip:** G1V 4G5
**Location 5:**
**City:** Aalborg
**Country:** Denmark
**Facility:** Research Site
**Zip:** 9100
**Location 6:**
**City:** Hvidovre
**Country:** Denmark
**Facility:** Research Site
**Zip:** 2650
**Location 7:**
**City:** Vejle
**Country:** Denmark
**Facility:** Research Site
**Zip:** 7100
**Location 8:**
**City:** Essen
**Country:** Germany
**Facility:** Research Site
**Zip:** 45239
**Location 9:**
**City:** Frankfurt/Main
**Country:** Germany
**Facility:** Research Site
**Zip:** 60389
**Location 10:**
**City:** Frankfurt
**Country:** Germany
**Facility:** Research Site
**Zip:** 60596
**Location 11:**
**City:** Grosshansdorf
**Country:** Germany
**Facility:** Research Site
**Zip:** 22927
**Location 12:**
**City:** Peine
**Country:** Germany
**Facility:** Research Site
**Zip:** 31224
**Location 13:**
**City:** Barcelona
**Country:** Spain
**Facility:** Research Site
**Zip:** 08035
**Location 14:**
**City:** Santander
**Country:** Spain
**Facility:** Research Site
**Zip:** 39008
**Location 15:**
**City:** Birmingham
**Country:** United Kingdom
**Facility:** Research Site
**Zip:** B9 5SS
**Location 16:**
**City:** Leicester
**Country:** United Kingdom
**Facility:** Research Site
**Zip:** LE3 9QP
**Location 17:**
**City:** Liverpool
**Country:** United Kingdom
**Facility:** Research Site
**Zip:** L7 8YE
**Location 18:**
**City:** London
**Country:** United Kingdom
**Facility:** Research Site
**Zip:** W12 0HS
**Location 19:**
**City:** Manchester
**Country:** United Kingdom
**Facility:** Research Site
**Zip:** M23 9QZ
**Location 20:**
**City:** Oxford
**Country:** United Kingdom
**Facility:** Research Site
**Zip:** OX3 7LE
**Location 21:**
**City:** Southampton
**Country:** United Kingdom
**Facility:** Research Site
**Zip:** SO9 4XY
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001982
- Term: Bronchial Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000008171
- Term: Lung Diseases
- ID: D000012130
- Term: Respiratory Hypersensitivity
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M4556
- Name: Asthma
- Relevance: HIGH
- As Found: Asthma
- ID: M10293
- Name: Inflammation
- Relevance: HIGH
- As Found: Inflammation
- ID: M5258
- Name: Bronchial Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11170
- Name: Lung Diseases, Obstructive
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M14967
- Name: Respiratory Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001249
- Term: Asthma
- ID: D000007249
- Term: Inflammation
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435260
**Brief Title:** To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Locally Advanced Pancreatic Cancer
**Official Title:** To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Locally Advanced Pancreatic Cancer
#### Organization Study ID Info
**ID:** ARK-pancreatic-001
#### Organization
**Class:** OTHER
**Full Name:** Hebei Medical University Fourth Hospital
### Status Module
#### Completion Date
**Date:** 2027-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 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:** 2024-05-24
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hebei Medical University Fourth Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** The purpose of this study is to assess surgical conversion rate and the immediate and long-term outcomes to patients who receive hypofractionated radiotherapy and AG combined with camrelizumab immunotherapy of locally advanced pancreatic cancer.
### Conditions Module
**Conditions:**
- Pancreatic Cancer
### 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:** Efficacy evaluation was performed within 2 weeks after the end of neoadjuvant therapy, surgical treatment was performed in patients assessed as operable and in those with a clear intention to undergo surgery, postoperative adjuvant chemotherapy and ICIs were determined according to the patient's tolerance and independent will, and enter the follow-up period.
**Intervention Names:**
- Drug: Camrelizumab+chemotherapy
- Radiation: hypofractionated radiotherapy
**Label:** Hypofractionated radiotherapy+Camrelizumab+chemotherapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Hypofractionated radiotherapy+Camrelizumab+chemotherapy
**Description:** Chemotherapy combined with ICIs was started 5-7 days after the completion of radiotherapy:
AG: intravenous nab-paclitaxel 125 mg/m2 and gemcitabine 1000mg/m2 d1,8, q3w, 4 cycles.
Camrelizumab: 200mg, iv, 30min, q3w, 4 cycles.
**Name:** Camrelizumab+chemotherapy
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Hypofractionated radiotherapy+Camrelizumab+chemotherapy
**Description:** Hypofractionated radiotherapy: pGTV:40Gy/5F, PTV≥25Gy/5F.
**Name:** hypofractionated radiotherapy
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** There was no residual by the microscope
**Measure:** a.R0-resection rate
**Time Frame:** within 3 weeks after surgery
#### Secondary Outcomes
**Description:** The proportion of tumor markers in turned negative
**Measure:** Conversion to negative rate
**Time Frame:** up to 23 weeks
**Description:** Baseline to measured stable disease
**Measure:** Objective response rate (ORR)
**Time Frame:** tumor assessment every 6 weeks since the treatment began, up to 24 months
**Description:** Baseline to measured progressive disease
**Measure:** Disease control rate (DCR)
**Time Frame:** tumor assessment every 6 weeks since the treatment began, up to 24 months
**Description:** Baseline to measured date of death from any cause
**Measure:** 3-year Overall survival (OS)
**Time Frame:** 3 years
**Description:** DFS is defined as the time from registration to the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause. Patients without an event are censored at the date of last evaluation.
**Measure:** 3-year Disease Free Survival (DFS)
**Time Frame:** 3 years
**Description:** Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of participants with adverse events will be recorded at each treatment visit.
**Measure:** Adverse events
**Time Frame:** 3 years
**Description:** Evaluate the quality of life according to QOL-BREF. The number of participants with quality of life will be recorded at each treatment visit.
**Measure:** Quality of life
**Time Frame:** 1 years after therapy
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age:18 to 75 years old, male or female;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
3. Tumor was located in the pancreas;
4. Pathological diagnosis was pancreatic ductal adenocarcinoma or acinar cell carcinoma;
5. No distant metastasis;
6. Clinical assessment was locally advanced (at least qualified one of the following criteria:①Lymph node metastasis outside the surgical area;②tumor surrounded more than half of the superior mesenteric vein;③tumor was adjacent to or wrapped more than half of the celiac artery;④Superior mesenteric vein or portal vein occlusion is not suitable for revascularization;⑤Invasion or wrapping of the aorta).
7. There was no history of immune system diseases, other malignant tumors, myocarditis, coronary heart disease, other cardiovascular and cerebrovascular diseases, thyroid dysfunction, liver and kidney diseases, psychiatric diseases, infectious diseases, or systemic diseases other than those mentioned above.
Participants were willing to join in this study, good adherence and written informed consent.
Exclusion Criteria:
1. Patients who did not meet these inclusion criteria;
2. Poor cognitive ability, inability to answer questions, inability to fill out questionnaires, or mental disorders;
3. The investigators think inappropriate.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** pengli72@sina.com
**Name:** Li Peng
**Phone:** 13933868818
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shijiazhuang
**Country:** China
**Facility:** Fourth Hospital of Hebei Medical University
**State:** Hebei
**Zip:** 050011
#### Overall Officials
**Official 1:**
**Affiliation:** Fourth Hospital of Hebei Medical
**Name:** Li Peng
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Fourth Hospital of Hebei Medical
**Name:** Fengpeng Wu
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000010182
- Term: Pancreatic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13110
- Name: Pancreatic Neoplasms
- Relevance: HIGH
- As Found: Pancreatic Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland 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: M13102
- Name: Pancreatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4387
- Name: Pancreatic Cancer
- Relevance: HIGH
- As Found: Pancreatic Cancer
### Condition Browse Module - Meshes
- ID: D000010190
- Term: Pancreatic Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M19537
- Name: Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M2985
- Name: Gemcitabine
- Relevance: LOW
- As Found: Unknown
- ID: M231
- Name: Albumin-Bound Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435247
**Acronym:** AAR
**Brief Title:** The Effect of Accompainment by Older Adults on Anesthetic Recovery
**Official Title:** The Effect of Accompainment by Older Adults on Anaesthetic Recovery
#### Organization Study ID Info
**ID:** CMABC-24-18
#### Organization
**Class:** OTHER
**Full Name:** American British Cowdray Medical Center
### 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:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### 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:** American British Cowdray Medical Center
#### Responsible Party
**Investigator Affiliation:** American British Cowdray Medical Center
**Investigator Full Name:** Mariana Guadalupe García Hernandez
**Investigator Title:** Physician investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Summary:
In 2022, Mexico estimated a population of 17,958,707 older adults. With increased life expectancy, it is essential to seek strategies that improve the health of this population, as they are more vulnerable compared to other age groups due to functional and cognitive decline, along with an increase in chronic diseases and medication intake. During this stage of life, there is a possibility of requiring surgical treatment, which is the focus of this protocol proposing a maneuver that impacts patients' health without requiring economic costs. The proposal suggests the accompaniment of older adults by a family member during the immediate post-anesthetic period. Hypothesis: Accompaniment of older adults during the immediate postoperative period improves the quality of anesthetic recovery by 60%. This value is based on a study by Shem, where accompanying older adults prior to anesthetic induction resulted in a 61% reduction in anxiety among older adults. Anesthesiologists have expanded their role in perioperative medicine alongside geriatric medicine services for older surgical patients.
An experimental study will be conducted with two randomly divided groups: one group with accompaniment and one group without accompaniment in the recovery area. Both groups will be assessed using different questionnaires: 1. Pfeiffer Test for cognitive impairment diagnosis, 2. QoR-15 to assess the quality of anesthetic recovery, 3. Beck Anxiety Questionnaire, all of which will be administered 24 hours after surgery. Delirium will also be assessed using NuDESC at 24 hours, day 5, and 30 days after surgery. General data prior to surgery will be recorded, and vital signs such as heart rate, blood pressure, and pain on a verbal scale from 0 to 10 will be monitored during the postoperative period.
Statistical analysis will involve representing baseline characteristics of the population using mean and standard deviation or median and interquartile range, depending on the distribution type. X2 will be used to compare both groups in terms of outcomes. Finally, a multivariate analysis will be conducted using logistic regression to adjust for confounding variables.
**Detailed Description:** Justification:
Due to the increase in life expectancy and the growing number of older adults worldwide and in our country, it is important to search for and implement feasible and cost-free measures to improve the quality of medical care, specifically in surgical treatments that impact the reduction of complications, shorten recovery time, and indirectly improve the quality of life for these patients.
Feasibility and relevance:
* The research question aims to improve the quality of medical care for older adults with a humanistic approach.
* In a group of people that will continue to grow, with a longer life expectancy, they will require surgical treatments.
* There are no articles evaluating the quality of anesthetic recovery or its impact on their health with accompaniment.
* Approximately 222 surgeries are performed in this population every month, making it a frequent occurrence.
* It is a measure that does not incur any cost.
* It can be applied in any hospital setting.
Problem statement:
The increase in life expectancy worldwide has led to a larger population of older adults, and Mexico is no exception. Therefore, it is important to establish measures that improve the quality of medical care and reduce complications in this age group, using measures that do not incur any economic costs. Specifically, in the perioperative period, proposing the accompaniment of older adults in the anesthetic recovery area.
Research question:
Does the accompaniment of older adults improve the quality of anesthetic recovery with a score higher than 122 on the QoR15 scale?
Hypotheses:
Null hypothesis:
The accompaniment of older adults in the immediate postoperative period does not improve the quality of anesthetic recovery with a score lower than 121 on the QoR15 scale.
Alternative hypothesis:
The accompaniment of older adults in the immediate postoperative period improves the quality of anesthetic recovery with a score higher than 122 on the QoR15 scale.
Overall objective:
- Determine if the accompaniment of older adults improves the quality of anesthetic recovery, classified as good or excellent according to the QoR15 scale with a score of 122 to 150.
Specific objectives:
* Determine the incidence of anxiety in older adults in the anesthetic recovery area, considering anxiety with a score higher than 22 on the Beck scale.
* Determine the presence or absence of delirium in older adults in the perioperative period.
* Assess if the accompaniment of older adults reduces the length of stay in the anesthetic recovery area, aiming for a stay of no more than 60 minutes.
### Conditions Module
**Conditions:**
- Old Age; Debility
**Keywords:**
- ederly, quality of anesthetic recovery, accompaniment
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This is a randomized clinical trial design with two groups
* One group will have family accompaniment in the recovery area, the other will not
* The QoR-15 scale will be used to measure the quality of anesthetic recovery
* The randomization was done using the OpenEpi software
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 240
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The first group will have a family member accompany them in the recovery area
**Intervention Names:**
- Behavioral: With or without accompainment in the recovery anaesthetic area
**Label:** Accompainment in the recovery area
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The second group will not have accompainment as is currently standard practice
**Label:** without accompainment
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Accompainment in the recovery area
**Description:** one grup will have family accompainment in the recovery area and the other group will not in both groups the QoR15 scale will be used to measure the quality of anesthetic recovery
**Name:** With or without accompainment in the recovery anaesthetic area
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The goal is to evaluate the impact of this accompainment on enhancing the quality of patients anesthetic recovery, as measured by the QoR15 scale
**Measure:** The best score in the QoR15 scale
**Time Frame:** Within 24 hours followin the surgical procedure
#### Secondary Outcomes
**Description:** Anxiety will be measured in both groups: the intervetion grup and the control grup. This assessment will occur at two time points
**Measure:** Anxiety in both groups measured using the Beck Anxiety Scale
**Time Frame:** Before the surgical procedure and 24 hors after the surgical event
**Description:** Delirium will be measured in the two grups at 3 times points post surgery
**Measure:** Delirium
**Time Frame:** 24 hours, day 5 and day 30.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria: Scheduled for elective surgery under balanced anesthesia with a hospital stay not exceeding 48 hours.
* ASA I y II
* Education level Hight school or higher
Exclusion Criteria:
* History of diseasses associated with dementia
* Emergency surgery.
* Regional anesthesia or sedation
* Moderate to severe cognitive impairment
* History of smoking or drugs
* Surgerios with risk of major bleeding more or equal 1000ml
* Hip or long bone surgeries
**Healthy Volunteers:** True
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** mariana.26_11@hotmail.com
**Name:** Mariana Garcia, investigator
**Phone:** +525541922325
**Role:** CONTACT
**Contact 2:**
**Email:** jotalaverap@abchospital.com
**Name:** Juan Talavera, consultant
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Mexico City
**Contacts:**
***Contact 1:***
- **Email:** mariana.26_11@hotmail.com
- **Name:** Mariana Garcia, Investigator
- **Phone:** +525541922325
- **Role:** CONTACT
***Contact 2:***
- **Email:** jotalaverap@abchospital.com
- **Name:** Juan Talavera, consultor
- **Role:** CONTACT
**Country:** Mexico
**Facility:** The American Brithish Cowdray Medical Center, I.A.P
**Zip:** 01120
#### Overall Officials
**Official 1:**
**Affiliation:** American British Cowdray Medical Center
**Name:** Mariana Garcia, investigator
**Role:** PRINCIPAL_INVESTIGATOR
## 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: Debility
### Condition Browse Module - Meshes
- ID: D000073496
- Term: Frailty
### Intervention Browse Module - Ancestors
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: HIGH
- As Found: Process
### Intervention Browse Module - Meshes
- ID: D000000777
- Term: Anesthetics
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435234
**Brief Title:** Construction of a Risky Sexual Behaviour Intervention Programme for College Students Based on BCW Theory
**Official Title:** Construction of a Risky Sexual Behaviour Intervention Programme for College Students Based on BCW Theory
#### Organization Study ID Info
**ID:** HMUDQ20231116201
#### Organization
**Class:** OTHER
**Full Name:** Harbin Medical University
### Status Module
#### Completion Date
**Date:** 2024-09
**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:** 2024-09
**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:** Rong Zhang
#### Responsible Party
**Investigator Affiliation:** Harbin Medical University
**Investigator Full Name:** Rong Zhang
**Investigator Title:** researcher
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Using the intervention functions of Behavior Change Wheel (BCW) and BCTs, we constructed an intervention program for college students' risky sexual behaviors by combining literature analysis, qualitative research, Delphi's expert correspondence, and pre-experiment (20 students in the test group and 20 students in the control group). Before the intervention (T0) and at the end of the intervention (12 weeks, T1), we measured students' psychosexual health, social support, and sexual self-efficacy using relevant scales to ensure the effectiveness of the intervention. By clarifying the influencing factors of college students' risky sexual behaviors, the proposed intervention program for college students' risky sexual behaviors can effectively reduce the incidence of college students' risky sexual behaviors, improve the level of college students' psychosexual health, increase the level of social support, improve the sense of sexual self-efficacy, improve the level of risk perception, enhance the ability of risky decision-making, reduce the risky behaviors, and reduce the occurrence of adverse outcomes, thus providing a reference and reference for the prevention and control of college students' risky sexual behaviors. This will provide reference for the prevention and control of risky sexual behaviors among college students.
### Conditions Module
**Conditions:**
- Risky Sexual Behavior; BCW; College Students; Intervention Program
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: risky sexual behavior intervention
**Label:** intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Label:** control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- intervention group
**Description:** Intervening in risky sexual behaviors among college students
**Name:** risky sexual behavior intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Questionnaire on Sexual Mental Health of College Students.A total of 31 entries were made, each of which was scored using a Likert 5 scale (1=completely disagree, 5=completely agree), with 25 items scored positively and 6 items scored negatively.
Total scores ranged from 31-155, with higher scores indicating lower levels of psychosexual health
**Measure:** Sexual mental health
**Time Frame:** pre-intervention（T0）; At the end of the intervention（12 weeks, T1）
**Description:** Social Support Rating Scale for College Students.There are 17 entries in total. Each entry was scored on a Likert 5-point scale (1=very non-compliant, 5=very compliant), with a total score range of 17-85, with higher scores indicating that 5-point Likert scale (1=very poorly met, 5=very well met), with a total score ranging from 17-85, with higher scores indicating that college students received more social support
**Measure:** Social Support
**Time Frame:** pre-intervention（T0）; At the end of the intervention（12 weeks, T1）
**Description:** Sexual Self-Efficacy Scale.There are a total of 34 entries. The first five dimensions were each scored on a 5-point Likert scale (1=strongly disagree, 5=strongly agree), and the last two dimensions were each scored on a scale of 0 (never) to -4 (more than 5 times), for a total score of 130, with higher scores indicating higher sexual self-efficacy
**Measure:** Sexual self-efficacy
**Time Frame:** pre-intervention（T0）; At the end of the intervention（12 weeks, T1）
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria: (1) aged ≥16 years; (2) full-time undergraduate college students; (3) engaged in risky sexual behaviors (including multiple sexual partners, unprotected sex, and casual sex, and one of them is considered to have engaged in risky sexual behaviors) during their college years; (4) able to clearly recall and describe the incident; (5) signed an informed consent form
Exclusion Criteria: (1) not wanting to be asked sex-related questions; (2) being screened at the beginning of the semester using the Mental Health Survey and diagnosed by a psychiatrist as having a mental illness (schizophrenia, major depressive disorder, bipolar disorder)
**Healthy Volunteers:** True
**Maximum Age:** 24 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### IPD Sharing Statement Module
**Description:** Non-disclosure of study data due to ethical requirements and protection of subjects' privacy
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435221
**Acronym:** ORCA-OL
**Brief Title:** Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers
**Official Title:** A Multicenter, Open-Label Study Assessing Long-Term Exposure With Cytisinicline 3 mg TID
#### Organization Study ID Info
**ID:** ACH-CYT-13
#### Organization
**Class:** INDUSTRY
**Full Name:** Achieve Life Sciences
### 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:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-24
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Achieve Life Sciences
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Safety assessment of long-term 3 mg cytisinicline three times daily (TID) exposure for 52 weeks is the main purpose of this study, conducted in the United States.
### Conditions Module
**Conditions:**
- Smoking Cessation
- Vaping Cessation
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 650
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Cytisinicline 3 mg TID for 52 weeks.
**Intervention Names:**
- Drug: Cytisinicline
**Label:** Cytisinicline 3 mg TID
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cytisinicline 3 mg TID
**Description:** film-coated oral tablets containing 3 mg cytisinicline
**Name:** Cytisinicline
**Other Names:**
- Cytisine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Incidence Rate of Treatment Emergent Serious Adverse Events (SAEs)
**Time Frame:** up to Week 52
#### Secondary Outcomes
**Measure:** Incidence Rate of Related Treatment Emergent SAEs
**Time Frame:** up to Week 52
**Measure:** Incidence Rate of Treatment Emergent Adverse Events (TEAEs)
**Time Frame:** up to Week 52
**Measure:** Incidence Rate of Related TEAEs
**Time Frame:** up to Week 52
**Measure:** Number of Participants With Clinically Significant Abnormal Hematology and Chemistry Parameters
**Time Frame:** up to Week 52
**Measure:** Percentage of Participants With Clinically Significant Abnormal Hematology and Chemistry Parameters
**Time Frame:** up to Week 52
**Measure:** Number of Participants With Potentially Clinically Significant Abnormal Vital Signs
**Time Frame:** up to Week 52
**Measure:** Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs
**Time Frame:** up to Week 52
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Prior participation in the ORCA-2, ORCA-3 or ORCA-V1 clinical studies.
2. Former ORCA-2/ORCA-3 and ORCA-V1 subjects who are current daily cigarette smokers and/or daily nicotine-containing electronic cigarette users. Amount of daily combustible and/or nicotine containing electronic cigarette use at baseline is determined by subject self-report.
3. At Screening, subjects must have expired carbon monoxide (CO) ≥10 ppm if self-reporting as smokers or ≥30 ng/mL cotinine using a point-of-care cotinine oral fluid screening device if self-reporting as users of nicotine containing electronic cigarettes.
4. Willing to initiate cytisinicline treatment on the day after enrollment and set a quit date within 14 days of starting treatment.
5. Willing to actively participate in the study's cessation behavioral support provided throughout the study.
6. Able to fully understand study requirements, willing to participate, and comply with dosing schedule.
7. Sign the Informed Consent Form.
Exclusion Criteria:
1. Known hypersensitivity to cytisinicline or any of the excipients.
2. Clinically significant abnormal screening serum chemistry or hematology values.
3. Clinically significant abnormal screening 12-lead ECG determined after minimum of 5 minutes in supine position (ie, requiring treatment or further assessment).
4. Recent history (within 3 months prior to screening) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.
5. Current uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).
6. Currently psychotic or having had a psychotic event within 3 months prior to screening; currently having suicidal ideation or risk for suicide (corresponding to question 4 or 5 on the screening C-SSRS OR "Yes" to any suicidal behavior question on the screening C-SSRS with clear suicidal intent or previous attempt); or current symptoms of moderate to severe depression (depression score ≥11 on the HADS) at screening. If any subject becomes psychotic during the study, they must be removed from cytisinicline treatment and/or additional study visits.
7. Severe renal impairment defined as a creatinine clearance (CrCl) \<60 mL/min on screening lab (estimated with the Cockroft-Gault equation).
8. Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.0 x the upper limit of normal (ULN) on screening lab.
9. Women who are pregnant or breast-feeding.
10. Female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study. Acceptable methods of birth control include:
* True abstinence: When this is in line with the preferred and usual lifestyle of the subject. \[Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\].
* Barrier methods:
* diaphragm
* cervical cap
* contraceptive sponge
* Hormonal methods:
* Oral contraceptives
* Vaginal ring such as NuvaRing
* Skin patch such as Xulane
* Injection such as Depro-Provera
* Implantable rod such as Nexplanon
11. Participation in a clinical study with an investigational drug in the 4 weeks prior to enrollment.
12. Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** jball@achievelifesciences.com
**Name:** Julie Ball
**Phone:** 425.686.1540
**Role:** CONTACT
**Contact 2:**
**Email:** rbecco@achievelifesciences.com
**Name:** Roxann Becco
**Phone:** 425.686.1500
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Kansas City
**Contacts:**
***Contact 1:***
- **Name:** Martha S Fanning, ME
- **Role:** CONTACT
**Country:** United States
**Facility:** Alliance for Multispecialty Research, LLC
**State:** Missouri
**Zip:** 64114
#### Overall Officials
**Official 1:**
**Affiliation:** Achieve Life Sciences, Inc.
**Name:** Julie Ball
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435208
**Brief Title:** Impact of Subgingival Instrumentation on Psychological Distress and Mental Health Status in Bruxers With Periodontitis
**Official Title:** Impact of Subgingival Instrumentation on Psychological Distress and Mental Health Status in Bruxers With Periodontitis
#### Organization Study ID Info
**ID:** PRIYANKAPERIO2024
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### 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:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Postgraduate Institute of Dental Sciences Rohtak
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Bruxism is a non-functional repetitive jaw-muscle activity characterized by grinding or clenching the teeth. Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism.
**Detailed Description:** Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Although the etiology is not known exactly, it has been suggested that bruxism is a multifactorial disorder. Periodontitis, a prevalent inflammatory condition affecting the periodontium, has been linked to bruxism in several studies. The coexistence of bruxism and periodontitis poses unique challenges in clinical management of periodontitis. Also, as periodontitis became chronic, the occurrence of depression increased. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism. Therefore, this study aims to investigate impact of subgingival instrumentation on psychological distress and mental health status in bruxers with periodontitis.
### Conditions Module
**Conditions:**
- Periodontal Diseases
- Bruxism
- Periodontitis
- Distress, Emotional
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 45
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** subgingival instrumentation will be done in all participants
**Intervention Names:**
- Other: Subgingival instrumentation
**Label:** PERIODONTITIS BRUXISM
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- PERIODONTITIS BRUXISM
**Description:** All the participants will undergo scaling and root planning with hand scalers, curettes and ultrasonic scaler.
**Name:** Subgingival instrumentation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Assessment of psychological distress will be done by using Kessler Psychological distress(K10)
**Measure:** Psychological distress
**Time Frame:** BASELINE,2 MONTHS ,3 MONTHS
**Description:** Assessment of mental health status will be done by using mental health inventory 38
**Measure:** Mental Health Status
**Time Frame:** Baseline, 2 months, 3 months
#### Secondary Outcomes
**Description:** periodontal probing depth
**Measure:** periodontal parameter
**Time Frame:** Baseline, 2 month, 3 month
**Description:** bleeding on probing
**Measure:** periodontal inflammation
**Time Frame:** Baseline, 2 month, 3 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Systemically healthy patients
* Patient having periodontitis with bruxism
* Age between 30-50 years
Exclusion Criteria:
* History of mental health disorder
* History of systemic disease
* History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs
* Pregnant or lactating females
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** rksharmamds@yahoo.in
**Name:** RAJINDER KR SHARMA, MDS
**Phone:** 9416358222
**Role:** CONTACT
**Contact 2:**
**Email:** priyankachandela48@gmail.com
**Name:** Priyanka Chandela, BDS
**Phone:** +917027019277
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rohtak
**Country:** India
**Facility:** Post Graduate Institute of Dental Sciences
**State:** Haryana
**Zip:** 124001
#### Overall Officials
**Official 1:**
**Affiliation:** PGIDS , ROHTAK
**Name:** Priyanka Chandela, BDS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000014076
- Term: Tooth 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: M13419
- Name: Periodontal Diseases
- Relevance: HIGH
- As Found: Periodontal Diseases
- ID: M5286
- Name: Bruxism
- Relevance: HIGH
- As Found: Bruxism
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010518
- Term: Periodontitis
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000002012
- Term: Bruxism
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435195
**Brief Title:** Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases
**Official Title:** Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases
#### Organization Study ID Info
**ID:** K5112
#### Organization
**Class:** OTHER
**Full Name:** Peking Union Medical College Hospital
### Status Module
#### Completion Date
**Date:** 2026-12
**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:** 2026-09
**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:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking Union Medical College Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this observational study is to systematically describe the clinical characteristics and outcomes of patients with pituitary complex and rare diseases at Peking Union Medical College Hospital. The main questions it aims to answer are:
* What are the influencing factors and rates of remission?
* What are the comorbidities associated with these diseases?
* What are the perioperative events, radiological findings, and pathological features?
Researchers will compare different patient groups to see if there are significant differences in these outcomes.
Participants will:
* Undergo detailed clinical evaluations.
* Provide medical history and data for analysis.
* Participate in follow-up assessments to monitor disease progression and treatment outcomes.
**Detailed Description:** The study aims to provide a comprehensive analysis of pituitary complex and rare diseases at Peking Union Medical College Hospital. By leveraging a large cohort, the research will explore various clinical characteristics and outcomes. Specifically, the study will examine influencing factors and rates of remission, the presence of comorbidities, and perioperative events. Additionally, it will evaluate radiological findings and pathological features to better understand these conditions. Through this detailed investigation, the study seeks to enhance knowledge and inform clinical practice regarding the management and prognosis of pituitary complex and rare diseases.
### Conditions Module
**Conditions:**
- Pituitary Diseases
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 3000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The Pituitary Complex and Rare Diseases cohort consists of patients diagnosed with various pituitary disorders, including but not limited to pituitary adenomas, craniopharyngiomas, Rathke's cleft cysts, sellar region germ cell tumors, cavernous sinus syndrome, and other diseases. Patients requiring surgical resection or biopsy of pituitary pathologies will undergo transsphenoidal surgery or craniotomy.
**Intervention Names:**
- Procedure: Surgical Removal
- Procedure: Biopsy
**Label:** Pituitary Complex and Rare Diseases
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Pituitary Complex and Rare Diseases
**Description:** Resection of pituitary pathologies.
**Name:** Surgical Removal
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Pituitary Complex and Rare Diseases
**Description:** Taking a small tissue or liquid sample from the pituitary pathologies and the affected area for examination and diagnosis
**Name:** Biopsy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Hormonal normalization and free of pathologies
**Measure:** Remission
**Time Frame:** Postoperative one week and extends to the latest follow-up, estimated at up to 3 years
#### Secondary Outcomes
**Description:** Systemic changes accompanied with Pituitary Complex and Rare Diseases
**Measure:** Disease Comorbidities
**Time Frame:** From patient admission to an evaluation period extending up to the latest follow-up, estimately up to 3 years
**Description:** adverse events or medical issues that arise after a surgical procedure on the pituitary diseases.These complications can include various problems such as bleeding, infection, hormonal imbalances, cerebrospinal fluid leaks, vision changes, or neurological deficits
**Measure:** Postoperative complications
**Time Frame:** Postoperative one week and extends to the latest follow-up, estimated at up to 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosed with rare sellar diseases including but not limited to pituitary adenomas (such as Thyrotropin-secreting pituitary adenomas, GH-secreting adenomas), craniopharyngiomas, Rathke's cleft cysts, sellar region germ cell tumors, cavernous sinus syndrome, and other diseases
* Detailed medical history, including clinical symptoms, treatment plans and follow-up outcomes
Exclusion Criteria:
* Incomplete medical records, especially missing key imaging diagnostic results
* Patients with coexisting primary central nervous system diseases unrelated to sellar region diseases (such as severe traumatic brain injury)
* Patients whose sellar region pathological diagnosis was changed or overturned during the follow-up period
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Patients who are diagnosed with Pituitary Complex and Rare Diseases at Peking Union Medical College Hospital
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** yaoyong@pumch.cn
**Name:** Yong Yao, MD
**Phone:** +8669152530
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** yaoyong@pumch.cn
- **Name:** Yong Yao, MD
- **Phone:** +8669152530
- **Role:** CONTACT
**Country:** China
**Facility:** Peking Union Medical College Hospital
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100730
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Neurosurgery, Peking Union Medical College Hospital
**Name:** Yong Yao, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007027
- Term: Hypothalamic Diseases
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System 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: M13791
- Name: Pituitary Diseases
- Relevance: HIGH
- As Found: Pituitary
- ID: M24518
- Name: Rare Diseases
- Relevance: HIGH
- As Found: Rare disease
- ID: M10077
- Name: Hypothalamic 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: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010900
- Term: Pituitary Diseases
- ID: D000035583
- Term: Rare Diseases
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435182
**Brief Title:** Study of OT202 in Treating Moderate to Severe Dry Eye
**Official Title:** A Phase II, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of OT202 Eye Drops in the Treatment of Moderate to Severe Dry Eye
#### Organization Study ID Info
**ID:** OT202-02-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Ocumension Therapeutics (Shanghai) Co., Ltd
### Status Module
#### Completion Date
**Date:** 2024-01-26
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-01-26
**Type:** ACTUAL
#### Start Date
**Date:** 2023-04-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Ocumension Therapeutics (Shanghai) Co., Ltd
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a phase II study to explore the optimal dosage of OT202 in treating dry eye.
**Detailed Description:** Subjects successfully enrolled will enter a 2-week induction period of OT202 solvent eye drops, treated with OT202 three times daily (morning, afternoon, and evening), with 1-2 drops each time. On the day of the baseline visit (Visit 2), subjects will be assessed again to meet the inclusion and exclusion criteria. Subjects remain in the study are then randomized with a 1:1:1 ratio to 3 groups, the 0.5% OT202 eye drop group, 1% OT202 eye drop group, or OT202 solvent eye drop group, for an 8-week treatment period. Safety visits will be conducted 2 weeks after completion of the respective treatment.
### Conditions Module
**Conditions:**
- Dry Eye
**Keywords:**
- Moderate dry eye
- Severe dry eye
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Parallel assignment: 0.5% OT202 eye drop group；1% OT202 eye drop group；OT202 solvent eye drop group with a 1:1:1 ratio.
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 213
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Administered three times daily (morning, afternoon, and evening), with 1-2 drops each time, instilled into the conjunctival sac.
**Intervention Names:**
- Drug: OT202 conc 0.5%
**Label:** OT202 conc.0.5% group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Administered three times daily (morning, afternoon, and evening), with 1-2 drops each time, instilled into the conjunctival sac.
**Intervention Names:**
- Drug: OT202 conc 0.1%
**Label:** OT202 conc. 0.1% group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Administered three times daily (morning, afternoon, and evening), with 1-2 drops each time, instilled into the conjunctival sac.
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- OT202 conc.0.5% group
**Description:** Apply 1-2 drops of OT202 0.5% solution into the conjunctival sac. three times daily
**Name:** OT202 conc 0.5%
**Other Names:**
- Investigational product
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- OT202 conc. 0.1% group
**Description:** Apply 1-2 drops of OT202 0.1% solution into the conjunctival sac. three times daily
**Name:** OT202 conc 0.1%
**Other Names:**
- Investigational product
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Placebo group
**Description:** Apply 1-2 drops of placebo solution into the conjunctival sac. three times daily
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Compare the difference of changes in TCSS relative to baseline of three study groups on day 56.
**Measure:** Total Corneal Fluorescein Staining (TCSS) score
**Time Frame:** Day 56
#### Secondary Outcomes
**Description:** Compare the difference of changes in VAS scale relative to baseline of three study groups on day 28 \& 56.
**Measure:** Visual Analogue Scale (VAS) Score
**Time Frame:** DAY 28 & 56
**Description:** Compare the DAY 28 \& 56 OSDI scale results of the subjects with the baseline results.
**Measure:** Ocular Surface Disease Index (OSDI) Score
**Time Frame:** Day 28 & 56
**Description:** Compare the DAY 28 \& 56 Conjunctive Hyperemia data of the subjects with the baseline data.
**Measure:** Conjunctive Hyperemia
**Time Frame:** Day 28 & 56
**Description:** Compare the DAY 28 \& 56 Corneal Staining data of the subjects with the baseline data.
**Measure:** Corneal Staining
**Time Frame:** Day 28 & 56
**Description:** Compare the DAY 28 \& 56 SANDE scale results of the subjects with baseline .
**Measure:** A dry eye syndrome questionnaire - Symptom Assessment iN Dry Eye(SANDE)
**Time Frame:** Day 28 & 56
**Description:** Compare the DAY 28 \& 56 TFBUT scale results of the subjects with baseline .
**Measure:** Tear Film Breakup-time (TFBUT)
**Time Frame:** Day 28 & 56
**Description:** Compare the DAY 28 \& 56 Schirmer I Test scale results of the subjects with baseline .
**Measure:** Schirmer I Test
**Time Frame:** Day 28 & 56
### Eligibility Module
**Eligibility Criteria:** ---Inclusion Criteria ---
1. 18 to 75 years of age (inclusive) at the time of signing the ICF, either sex or ethnic group.
2. With history of dry eye for at least 6 months prior to screening, and history of use or willingness to use eye drops for the treatment of dry eye within 6 months prior to screening
.
3. Binocular BCVA ≥ 0.25 decimals (standard logarithmic visual acuity chart) at Screening and Baseline.
4. At least one eye (the same eye) meets all the following criteria at screening and baseline:
* TCSS ≥ 2 points
* Eye dryness score (EDS) ≥ 40 points in VAS
* Conjunctival hyperemia score ≥ 1 point
* TFBUT ≤ 5 seconds
* 1 mm/5 min ≤ Schirmer I test (without surface anesthesia) ≤ 10 mm/5 min
5. Must be able to understand and sign the ICF approved by Independent Ethics Committee (EC).
6. Willing and able to conduct protocol-required study visits, follow study guidelines, and take study drug as instructed.
---Exclusion Criteria ---
1. With contraindication or hypersensitivity to the study drug (OT202 and excipients) or diagnostic reagents (fluorescein sodium, lissamine green, etc.).
2. During the screening period and baseline period, any eye with ocular active inflammation or structural abnormalities that may affect the trial assessment, including but not limited to trichiasis, blepharospasm, blepharitis, meibomitis, severe meibomian gland dysfunction, bulbar conjunctival laxity, keratitis, recurrent corneal erosion, allergic conjunctivitis, iritis, anterior chamber inflammation, known retinal detachment, diabetic retinopathy, or history of any progressive retinal disease.
3. With history of possible or confirmed ocular infection (bacterial, viral, or fungal) or ocular herpes (simple or zoster) in either eye, as determined by the patient's medical history and/or at the screening and baseline examinations.
4. Those with intraocular pressure (non-contact tonometry) greater than 21 mmHg or less than 8 mmHg or diagnosed with glaucoma at screening and baseline, or those with ocular hypertension who underwent intraocular pressure reduction therapy, and those with a history or suspicion of glaucoma.
5. Those with any systemic disease expected to potentially affect the study results. It include but is not limited to Sjögren syndrome, Stevens-Johnson syndrome, rheumatoid arthritis, graft versus host disease, systemic lupus erythematosus, scleroderma, sarcoidosis, herpes, acne, rosacea, etc.
6. Those who cannot stop using any ocular medication or treatment during the clinical trial.
7. Those with recent clinically relevant history (e.g., hepatic, renal impairment) within 6 months prior to screening or current severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, autoimmune, and other relevant systemic diseases (e.g., severe chronic obstructive pulmonary disease, arrhythmia, significant heart failure, uncontrolled hypertension, type 2 diabetes mellitus), as assessed by the investigator.
8. Those on a chronic, systemic medication regimen used for less than 1 month at screening and baseline or with dose changed within 1 month (including initiation of new medication and discontinuation).
9. Those who have used any prohibited medications (topical ocular, systemic, and/or injectable medications) during the specified period prior to screening. These medications are also prohibited during the study. However, if a subject has a prohibited medication at screening, it needs to be stopped and washed out according to the washout period specified below, which can be included in the wash-out period. The minimum reasonable washout period for prohibited medications is as follows:
* Systemic and local immunosuppressant and immunotherapy (such as cyclosporine eye drops, tacrolimus eye drops, etc.): 60 days;
* Corticosteroids (any route): 14 days;
* Systemic or ocular topical mast cell stabilizers, antihistamines, antihistamines/mast cell stabilizer combination, vasoconstrictors, monoamine oxidase inhibitors: 7 days;
* Other topical ophthalmic preparations (including artificial tears): 3 days;
* Medications known to cause ocular dryness (e.g., anticholinergics, serotonin reuptake inhibitors, beta-blockers, diuretics, etc.): 14 days.
Note:Non-periocular, low-potency, over-the-counter corticosteroid topical skin creams are allowed for use in the study (e.g., hydrocortisone butyrate cream/ointment).
10. Previous use of spleen tyrosine kinase (Syk) inhibitors or eye drop products targeting the same as anti-vascular endothelial growth factor (VEGF).
11. Those who wore corneal contact lenses within 7 days prior to screening or required them during the study.
12. Those who underwent meibomian gland massage or moist chamber therapy within 7 days prior to screening, or non-drug therapies for dry eye such as intense pulsed light therapy, thermal pulsation therapy, etc., within the previous 6 months before screening.
13. Those who previously underwent dry eye surgery such as tear duct embolization (current tear duct embolization status or punctal plug use in the past 6 months) or amniotic membrane transplantation.
14. Those who underwent ocular surface surgery (e.g., LASIK excimer laser in situ keratomileusis) within 12 months prior to screening or intraocular surgery within 6 months prior to screening in either eye, as determined by the subject's medical history and/or examination, or anticipated ocular surgery during the study.
15. Those who use other investigational products or devices within 3 months prior to screening or concurrently during the study.
16. Non-compliance with drug administration (\< 80% or \> 120%) during the introduction period.
17. Females of childbearing potential who are currently pregnant, or have a positive pregnancy test result, or plan to get pregnant during the study, or are currently breastfeeding, or do not agree to use appropriate contraception methods to avoid pregnancy during the study period up to 1 month after the last dose of study drug.
18. Males who do not agree to use one or more acceptable effective contraception methods during the study period up to 1 month after the last dose of study drug.
19. Any condition or situation that, in the opinion of the investigator, may pose a safety risk to the subject in the trial or may interfere with the conduct of the study, or the investigator believes that the subject may not be able to complete or comply with the requirements of the study (due to administrative reasons or otherwise).
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Changsha
**Country:** China
**Facility:** The Third Xiangya Hospital Of Central South University
**Location 2:**
**City:** Hangzhou
**Country:** China
**Facility:** The Second Affiliated Hospital Zhejiang University School of Medicine
**Location 3:**
**City:** Kunming
**Country:** China
**Facility:** Then Second People's Hospital of Yunnan Province
**Location 4:**
**City:** Ningbo
**Country:** China
**Facility:** Ning Bo Eye Hospital
**Location 5:**
**City:** Tianjin
**Country:** China
**Facility:** Tianjin Eye Hospital
**Location 6:**
**City:** Tianjin
**Country:** China
**Facility:** Tianjin Medical University Eye Hospital
**Location 7:**
**City:** Wenzhou
**Country:** China
**Facility:** Eye Hospital, WMU
**Location 8:**
**City:** Wuhan
**Country:** China
**Facility:** Renmin Hospital of Wuhan University
**Location 9:**
**City:** Wuhan
**Country:** China
**Facility:** Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
**Location 10:**
**City:** Xi'an
**Country:** China
**Facility:** The First Affiliated Hospital of Xi'an Jiaotong University
#### Overall Officials
**Official 1:**
**Affiliation:** Eye Hospital, WMU
**Name:** Wei Chen
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Sponsor GmbH
**Name:** Jialu Xia
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007766
- Term: Lacrimal Apparatus Diseases
- ID: D000005128
- Term: Eye Diseases
- ID: D000007637
- Term: Keratoconjunctivitis
- ID: D000003231
- Term: Conjunctivitis
- ID: D000003229
- Term: Conjunctival Diseases
- ID: D000007634
- Term: Keratitis
- ID: D000003316
- Term: Corneal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M18040
- Name: Dry Eye Syndromes
- Relevance: HIGH
- As Found: Dry Eye
- ID: M10664
- Name: Keratoconjunctivitis Sicca
- Relevance: HIGH
- As Found: Dry Eye
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M10663
- Name: Keratoconjunctivitis
- Relevance: LOW
- As Found: Unknown
- ID: M10786
- Name: Lacrimal Apparatus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6455
- Name: Conjunctivitis
- Relevance: LOW
- As Found: Unknown
- ID: M6453
- Name: Conjunctival Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10660
- Name: Keratitis
- Relevance: LOW
- As Found: Unknown
- ID: M6539
- Name: Corneal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015352
- Term: Dry Eye Syndromes
- ID: D000007638
- Term: Keratoconjunctivitis Sicca
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M12814
- Name: Ophthalmic Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435169
**Brief Title:** Comparative Presence of Piriformis Syndrome in Patients With Lumbar Disc Bulging and Protrusion
**Official Title:** Comparative Presence of Piriformis Syndrome in Patients With Lumbar Disc Bulging and Protrusion
#### Organization Study ID Info
**ID:** Yuzuncu Yil University Türkiye
#### Organization
**Class:** OTHER
**Full Name:** Yuzuncu Yıl University
### Status Module
#### Completion Date
**Date:** 2024-05-20
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Start Date
**Date:** 2024-03-04
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Yuzuncu Yıl University
#### Responsible Party
**Investigator Affiliation:** Yuzuncu Yıl University
**Investigator Full Name:** Volkan Şah
**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:** Clinicians consider lumbar disc herniation more prominently in the differential diagnosis than piriformis syndrome, as it is the most common cause of sciatica, and this canalizes them to overlook that the sciatic nerve may be compressed by the piriformis muscle, below the L4-L5-S1 intervertebral disc levels.
As far as is known, there are no 'patient series' in the literature regarding the incidence of Piriformis syndrome in Lumbar Disc Herniation, only one case report has been found. This clinical study aims to reveal that Piriformis syndrome may also be present in patients with disc herniation on Magnetic Resonance Imaging (MRI), and that sometimes it may even be the main cause of sciatic nerve pain.
**Detailed Description:** In this study, the participants between the ages of 18-65, who were diagnosed with L4-L5 and/or L5-S1 Lumbar Disc Herniation (bulging and protrusion) by having a Lumbar MRI at the Faculty of Medicine Sports Medicine outpatient clinic, were reached through their contact numbers, and those who had not previously undergone waist/hip surgery and those who described unilateral sciatica complaints (hip-leg-foot pain and numbness) during the interview were invited to Yüzüncü Yıl University Faculty of Medicine Sports Medicine polyclinic and Lasegue's, Flexion Adduction Internal Rotation (FAIR) and Freiberg's tests were performed.
### Conditions Module
**Conditions:**
- Piriformis Syndrome
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 76
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Lasegue's test, FAIR (Flexion Adduction Internal Rotation) test and, Freiberg's test will be performed in a single check-up for patients diagnosed with L4-L5 and/or L5-S1 Lumbar Disc Herniation (bulging) by lumbar Magnetic Resonance Imaging (MRI). The presence of Piriformis syndrome was investigated in these patients with Freiberg and FAIR tests.
**Intervention Names:**
- Diagnostic Test: Lasegue's, Freiberg's and, FAIR (Flexion Adduction Internal Rotation) tests.
**Label:** 38 patients with lumbar disc bulging
#### Arm Group 2
**Description:** Lasegue's, FAIR (Flexion Adduction Internal Rotation) and, Freiberg's test will be performed in a single check-up for patients diagnosed with L4-L5 and/or L5-S1 Lumbar Disc Herniation (protrusion) by lumbar Magnetic Resonance Imaging (MRI). The presence of Piriformis syndrome was investigated in these patients with Freiberg and FAIR tests.
**Intervention Names:**
- Diagnostic Test: Lasegue's, Freiberg's and, FAIR (Flexion Adduction Internal Rotation) tests.
**Label:** 38 patients with lumbar disc protrusion
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 38 patients with lumbar disc bulging
- 38 patients with lumbar disc protrusion
**Description:** The Straight Leg Raise test or Lasegue test, is also crucial in detecting disc herniation and neural compression. Lasègue's sign is said to be positive if the angle to which the leg can be raised (upon straight leg raising) before eliciting pain is \<45°.The presence of Piriformis syndrome was investigated in these patients with Freiberg and FAIR tests. Freiberg's test elicits pain by passively internal rotation of the extended hip, when the patient is in supine. The purpose of this test is on the one hand stretching of the irritated Piriformis Muscle (PM), on the other hand provoking sciatic nerve compression. The FAIR test is a sensitive and specific test for detection if irritation of the sciatic nerve by the piriformis. FAIR stands for flexion, adduction and internal rotation. Also known as piriformis test.
**Name:** Lasegue's, Freiberg's and, FAIR (Flexion Adduction Internal Rotation) tests.
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The Straight Leg Raise test or Lasegue test, is also crucial in detecting disc herniation and neural compression. Lasègue's sign is said to be positive if the angle to which the leg can be raised (upon straight leg raising) before eliciting pain is \<45°.
**Measure:** Lasegue's Test
**Time Frame:** Baseline
**Description:** Freiberg's test elicits pain by passively internal rotation of the extended hip, when the patient is in supine. The purpose of this test is on the one hand stretching of the irritated piriformis muscle, on the other hand provoking sciatic nerve compression.
**Measure:** Freiberg's Test
**Time Frame:** Baseline
**Description:** The FAIR test is a sensitive and specific test for detection if irritation of the sciatic nerve by the piriformis. FAIR stands for flexion, adduction and internal rotation. Also known as piriformis test.
**Measure:** FAIR (Flexion Adduction Internal Rotation) test
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being between the ages of 18-65
* Having unilateral sciatica
* Having disk herniation in the form of bulging or protrusion in a previous Lumbar Magnetic Resonance Imaging (MRI)
Exclusion Criteria:
* Having bilateral sciatica
* Having disc herniation in the form of extrusion or sequestration in a previous Lumbar Magnetic Resonance Imaging (MRI)
* Previous back and/or hip surgery
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients of both genders between the ages of 18-65 with lumbar disc bulging or protrusion
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Van
**Country:** Turkey
**Facility:** Volkan Şah
**Zip:** 65080
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020426
- Term: Sciatic Neuropathy
- ID: D000020422
- Term: Mononeuropathies
- ID: D000010523
- Term: Peripheral Nervous System Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009408
- Term: Nerve Compression Syndromes
- ID: D000009437
- Term: Neuralgia
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000017699
- Term: Pelvic Pain
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- 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: M28404
- Name: Piriformis Muscle Syndrome
- Relevance: HIGH
- As Found: Piriformis Syndrome
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M22222
- Name: Sciatic Neuropathy
- Relevance: LOW
- As Found: Unknown
- ID: M22218
- Name: Mononeuropathies
- 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: M12352
- Name: Nerve Compression Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M5853
- Name: Charcot-Marie-Tooth Disease
- Relevance: LOW
- As Found: Unknown
- ID: M18092
- Name: Hereditary Sensory and Motor Neuropathy
- Relevance: LOW
- As Found: Unknown
- ID: M12381
- Name: Neuralgia
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M19918
- Name: Pelvic Pain
- Relevance: LOW
- As Found: Unknown
- ID: T4568
- Name: Piriformis Syndrome
- Relevance: HIGH
- As Found: Piriformis Syndrome
- ID: T1081
- Name: Charcot-Marie-Tooth Disease
- Relevance: LOW
- As Found: Unknown
- ID: T2761
- Name: Hereditary Motor and Sensory Neuropathy
- Relevance: LOW
- As Found: Unknown
- ID: T2766
- Name: Hereditary Neuropathy With Liability to Pressure Palsies
- Relevance: LOW
- As Found: Unknown
- ID: T5067
- Name: Roussy Levy Syndrome
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000055958
- Term: Piriformis Muscle Syndrome
- ID: D000013577
- Term: Syndrome
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435156
**Acronym:** SOPHIST
**Brief Title:** Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes
**Official Title:** A Phase 2 Double-blind Randomised Controlled Trial Studying the Effect of Sotagliflozin Versus Placebo in Individuals With Heart Failure and Type 1 Diabetes.
#### Organization Study ID Info
**ID:** 01-50-23
#### Organization
**Class:** OTHER
**Full Name:** University of Dundee
#### Secondary ID Infos
**Domain:** Juvenile Diabetes Research Foundation
**ID:** 3-SRA-2023-1376-M-B
**Type:** OTHER_GRANT
**Domain:** IRAS
**ID:** 1007807
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**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:** 2024-05-16
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Lexicon Pharmaceuticals
**Class:** OTHER
**Name:** Juvenile Diabetes Research Foundation
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Dundee
#### Responsible Party
**Investigator Affiliation:** University of Dundee
**Investigator Full Name:** Ify Mordi, MD
**Investigator Title:** Clinical Senior Lecturer and Honorary Consultant Cardiologist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** People with type 1 diabetes sometimes develop heart failure which can cause symptoms like breathlessness, tiredness or ankle swelling, reduced quality of life and lead to being admitted to hospital or suffering potential fatal consequences. This trial is investigating if a tablet called sotagliflozin, can improve quality of life in people with type 1 diabetes and heart failure. In addition, this trial will also assess the safety and tolerability of sotagliflozin in this population.
In previous trials that included people with type 2 diabetes and heart failure sotagliflozin was shown to improve patients' symptoms of heart failure, quality of life and reduce the chance of people with heart failure being admitted to hospital or dying. However, people with type 1 diabetes and heart failure were not included in these trials meaning that it is not known if these benefits also apply to this population.
This trial aims to recruit 320 people with type 1 diabetes and heart failure symptoms in multiple sites in the United Kingdom (UK). This trial will compare the health and quality of life of participants who take sotagliflozin tablets with participants who take placebo tablets, which is a dummy tablet that looks the same as sotagliflozin. Participants will be randomly allocated to one of two groups (i.e. one taking sotagliflozin and the other the placebo) and both the medical team and participants will not know in which group each participant is until the end of the study. Participants will be in the trial for approximately 6 months and will be given sotagliflozin or placebo tablets to take 1 per day for 4 months. The trial is expected to run for a total of 26 months.
**Detailed Description:** BACKGROUND Intensive insulin therapy designed to near-normalize glucose levels in people with type 1 diabetes significantly reduces an individual's risk of long-term micro- and macrovascular complications. Unfortunately, glycaemic targets are not achieved by the majority of people with type 1 diabetes and as such overall life expectancy remains reduced compared to those without type 1 diabetes. Cardiovascular disease remains a major cause of morbidity and mortality in type 1 diabetes. There is growing recognition that heart failure (HF) is an increasing problem in type 1 diabetes. Diabetes itself is an independent risk factor for HF, causing structural and functional cardiac changes that predispose to HF (known as diabetic cardiomyopathy). HF is the end result of many cardiovascular diseases such as hypertension and myocardial infarction, and improved treatments for these conditions and changing demographic trends mean that many more people are surviving longer and developing HF.
HF has a substantial healthcare burden. In the United States (US) and Europe, the prevalence of HF in the general population is around 1-2% - around 6 million adults in the US are estimated to be living with HF currently. In 2014 in the US there were \~1.1 million emergency department visits, 980 000 hospitalizations, and 84 000 deaths with HF as the primary cause, with an estimated cost of \~$11.3 billion (\~$11,500/per patient for each hospitalisation). Despite advances in management of HF over the past 30 years, the incidence of mortality and HF hospitalisation in recent HF clinical trials remained high at \~20-30% over 2 years.
The burden of HF in type 1 diabetes is less well characterised compared to HF in those with type 2 diabetes (and individuals without diabetes), however the data still indicate the substantial nature of this growing problem. One of the largest epidemiological studies was a Scottish national data study of 3.25 million individuals \>30 years old, where the crude incidence of HF hospitalisation was over twice that of the population without diabetes. While the crude incidence was less than in type 2 diabetes, type 1 diabetes patients were on average 20 years younger. Despite their younger age, 30-day mortality following HF hospitalisation was higher in individuals with type 1 diabetes after adjustment for age, sex and socioeconomic status, indicating that outcomes are worse in HF patients with type 1 diabetes compared to those with either type 2 diabetes or without diabetes. Data from Scandinavia supports this finding and suggests that the risk of both incident HF and cardiovascular mortality was higher for individuals with type 1 diabetes compared to type 2 diabetes after adjustment for age. The overall prevalence of HF in this study at baseline was 3.1% - extrapolated to the US this would equate to 57,000 of the 1.9 million individuals with type 1 diabetes. A recent meta-analysis of all available data suggested that the incidence of HF was 3.1 times higher in individuals with type 1 diabetes compared to controls (typically the general population). Assuming a 5% incidence of HF hospitalisation/year, HF hospitalizations cost the US healthcare system \~$29 million per year. In summary, these data suggest that not only is HF a significant problem in individuals with type 1 diabetes, but there is evidence of an outcome disparity compared to individuals with type 2 diabetes or those without diabetes.
Although there are some differences (e.g. presentation at a younger age), the pathophysiology of HF in type 1 diabetes is similar to type 2 diabetes. Risk factors are similar (e.g. glycaemic control, coronary artery disease and hypertension), leading to inflammation, endothelial dysfunction, fibrosis, and subsequent diastolic and systolic dysfunction. Given the pathophysiological similarities, there is little to suggest that HF therapies that have shown benefit in individuals with type 2 diabetes (or individuals without diabetes) would not also be efficacious in type 1 diabetes. In all current HF guidelines mainstay HF treatments (renin-angiotensin system blockers, beta-blockers, and mineralocorticoid receptor antagonists) are recommended for all patients with HF regardless of diabetes status.
Sodium-glucose co-transporter inhibitors (SGLTi) were initially developed as oral add-on treatments for glycaemic control in type 2 diabetes. A consistent finding in large cardiovascular outcome trials was a significant \~30% risk reduction in hospitalisation for HF, as well as overall reductions in cardiovascular mortality. Subsequently, SGLTi in addition to guideline-directed HF therapy have been studied in HF patients either with type 2 diabetes or without diabetes and have again shown a consistent benefit compared to placebo, with significant reductions in mortality and HF hospitalisation irrespective of cardiac function left ventricular ejection fraction (LVEF) at baseline without any concerning safety signals. SGLTi also improve HF-related quality of life (QoL) and renal outcomes. This has led to the inclusion of SGLTi in the most recent HF treatment guidelines as a cornerstone of therapy in addition to established pharmacological agents (e.g., renin-angiotensin system inhibitors, beta-blockers and mineralocorticoid receptor antagonists). However, there is one key issue - individuals with type 1 diabetes have been excluded from these HF trials, in part due to concerns around safety. At present there is no evidence to support the use of these life-saving therapies in this population that already has worse outcomes than other groups with HF.
In adult type 1 diabetes, Phase III trials with dapagliflozin, empagliflozin and sotagliflozin have been completed, collectively showing modest benefits of SGLT inhibition in terms of Haemoglobin A1c (HbA1c) reduction, increased time in range, reduced body weight and total insulin dose. However, SGLTi use in type 1 diabetes was also associated with an increased risk of diabetic ketoacidosis (DKA), which has limited their more widespread use in type 1 diabetes.
Sotagliflozin is a dual SGLT1 and 2 inhibitor that is currently approved in the United Kingdom for use in individuals with type 1 diabetes with a body mass index (BMI) of ≥27kg/m2 and taking insulin doses of at least 0.5 units/kg of body weight in patients with inadequate glycaemic control. As with selective SGLT2i, sotagliflozin also improves HF-related outcomes. The key evidence for this comes from two clinical trials. In the Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease (SCORED) trial including 10,584 patients with type 2 diabetes, chronic kidney disease and cardiovascular risk factors, sotagliflozin caused a 26% relative risk reduction in the primary endpoint of cardiovascular death, HF hospitalisation or urgent HF visit compared to placebo. There was also a 33% relative risk reduction in HF hospitalisation or urgent HF visits, figures consistent with other SGLT2i trials.
The second key trial was the Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure (SOLOIST-WHF) trial. In this trial 1,222 patients with type 2 diabetes and a recent HF hospitalisation were randomised to sotagliflozin 200mg once daily (with uptitration to 400mg once daily) or placebo. Patients were included regardless of left ventricular ejection fraction (LVEF) at baseline. The median follow-up duration was 9 months.
Sotagliflozin caused a 33% relative risk reduction in the primary outcome of cardiovascular death, HF hospitalisation or urgent HF visit, with a 36% reduction in HF hospitalisation or urgent HF visits that met statistical significance. Sotagliflozin also significantly improved QoL at 4 months measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Rates of serious adverse events (SAEs) leading to study drug withdrawal were similar in both sotagliflozin and placebo groups, though severe hypoglycaemia was more common with sotagliflozin than placebo (9 individuals vs. 2). There was no significant increase in incidence of DKA with sotagliflozin compared to placebo (2 vs. 4). Taken together, these two trials confirm the benefit of sotagliflozin on HF related outcomes, consistent with selective SGLT2i. Again, individuals with type 1 diabetes were excluded from both of these trials.
In summary, there is significant HF related morbidity and mortality in type 1 diabetes, and outcomes are worse than in HF patients with type 2 diabetes or without diabetes. Oral sotagliflozin 200mg daily is licensed for improving glycaemic control in type 1 diabetes in the UK. Although sotagliflozin improves HF related outcomes and QoL in patients with type 2 diabetes and patients with HF who do not have diabetes, studies are needed to determine whether these benefits might extend to patients with type 1 diabetes and heart failure.
RATIONALE As outlined above, HF is a significant problem in type 1 diabetes, with an estimated prevalence of 3-5%. Outcomes for individuals with type 1 diabetes and HF are worse than in those with type 2 diabetes or without diabetes, with increased mortality and hospitalisation rates. Critically, patients with type 1 diabetes have been excluded from pivotal trials of the latest advance in HF treatment (SGLT2i), potentially exacerbating these outcome disparities further.
The proposed trial will be the first to provide data on the efficacy and safety of sotagliflozin, in patients with type 1 diabetes and HF (regardless of LVEF). If a beneficial signal is found, this would provide strong support for extending the use of sotagliflozin in this group of patients with type 1 diabetes and adoption into clinical guidelines. A multi-centre, double-blind, randomised controlled trial to provide the strongest level of evidence for previous findings of the researchers will be conducted. Importantly, by choosing QoL measured using the KCCQ as the primary endpoint, an outcome that not only correlates strongly with mortality and hospitalisation but is also accepted by the US Food and Drug Administration (FDA) as a valid endpoint for regulatory approval has been selected. The KCCQ is a 23- item self-administered questionnaire that measures the patient's perception of their health status, including HF symptoms, impact on physical and social function, and how their HF impacts their QOL within the preceding 2 weeks. Improvements in KCCQ score map very well to reductions in mortality and hospitalisation and SGLT2i have consistently improved KCCQ scores. A 5-point increase in KCCQ score is traditionally considered clinically meaningful and is associated with a 7% reduction in mortality and HF hospitalisation. Given the prohibitive size of trial that would be required to demonstrate an improvement in mortality or HF hospitalizations with sotagliflozin in type 1 diabetes, the KCCQ represents an ideal endpoint for the trial. The proposed trial has the potential to be a high-impact, practice-changing trial.
### Conditions Module
**Conditions:**
- Type 1 Diabetes
- Heart Failure
**Keywords:**
- Type 1 Diabetes
- heart failure
- Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
- sotagliflozin
### 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:** 320
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Sotagliflozin oral tablet, 200mg once per day for 16 weeks.
**Intervention Names:**
- Drug: Sotagliflozin
**Label:** Sotagliflozin
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo oral tablet, 200mg once per day for 16 weeks.
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Sotagliflozin
**Description:** Sodium-glucose Co-transporter inhibitor
**Name:** Sotagliflozin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Matched placebo
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes
**Measure:** Change in New York Heart Association (NYHA) class
**Time Frame:** From baseline to weeks 16 and 20
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes
**Measure:** Change in daily loop diuretic dose
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes
**Measure:** Change in systolic and diastolic blood pressure.
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes
**Measure:** Number of hospitalizations and deaths (first and total number) due to heart failure
**Time Frame:** From baseline to weeks 16 and 20
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on renal parameters
**Measure:** Change in estimated glomerular filtration rate (eGFR)
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on renal parameters
**Measure:** Change in serum creatinine
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on renal parameters
**Measure:** Change in urine albumin to creatinine ratio
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on diabetes-related parameters
**Measure:** Change in total, basal and bolus insulin doses
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on diabetes-related parameters
**Measure:** Change in in body weight
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics
**Measure:** Mean blood glucose level over preceding 14 days
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics
**Measure:** Blood glucose percentage time in range (3.9-10.0 mmol/L) over preceding 14 days
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics
**Measure:** Blood glucose percentage time below range (3.0-3.8 mmol/L and <3.0 mmol/L) over preceding 14 days
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics
**Measure:** Blood glucose percentage time above range (10.1-13.9mmol/L and >13.9 mmol/L) over preceding 14 days
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics
**Measure:** Glycaemic variability index
**Time Frame:** From baseline to week 16
**Description:** To investigate if trial outcomes are associated with baseline c-peptide levels
**Measure:** C-peptide level
**Time Frame:** At baseline
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on ketone levels
**Measure:** Proportion of participants with non-acidotic ketosis
**Time Frame:** From baseline to week 16
#### Primary Outcomes
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on quality of life (QoL).
KCCQ clinical summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).
**Measure:** Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score
**Time Frame:** From baseline to week 16
#### Secondary Outcomes
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL.
KCCQ clinical summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).
**Measure:** Change in KCCQ clinical summary score
**Time Frame:** From baseline to week 4
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL.
KCCQ overall summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).
**Measure:** Change in KCCQ overall summary score
**Time Frame:** From baseline to weeks 4 and 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL.
KCCQ clinical summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).
KCCQ overall summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).
**Measure:** Proportion of participants with a ≥5, ≥10 and ≥15 point increase in KCCQ clinical and overall summary scores
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL.
Treatment satisfaction status score (no unit, ranges from 0 to 36, with higher scores reflecting greater treatment satisfaction).
Treatment satisfaction change score (no unit, designed to overcome ceiling effects and to detect changes in treatment satisfaction on a scale from -18 to 18 with negative scores reflecting decreased treatment satisfaction, 0 reflecting no change and positive scores reflecting increased treatment satisfaction).
**Measure:** Change in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc)
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL.
The instrument consists of two components: the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ-VAS).The first part consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels (level 1 "no problems", level 2 "slight problems", level 3 "moderate problems", level 4 "severe problems", and level 5 "extreme problems"), from which a single EQ-5D index score can be calculated ranging from 0 to 1 where higher scores indicate higher health utility. The EQ-VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health.
**Measure:** Change in EQ-5D-5L questionnaire score
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on walking distance
**Measure:** Change in distance covered during 6-minute walk test
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on NT-proBNP
**Measure:** Change in N-terminal pro b-type natriuretic peptide (NT-proBNP)
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on glycaemic control
**Measure:** Change in Haemoglobin A1c (HbA1c)
**Time Frame:** From baseline to week 16
**Description:** To provide information on safety and tolerability of sotagliflozin 200mg once daily in addition to standard of care compared to placebo
**Measure:** Proportion of participants with level 2 or level 3 hypoglycaemia
**Time Frame:** From baseline to weeks 16 and 20
**Description:** To provide information on safety and tolerability of sotagliflozin 200mg once daily in addition to standard of care compared to placebo
**Measure:** Proportion of participants with diabetic ketoacidosis (DKA)
**Time Frame:** From baseline to weeks 16 and 20
**Description:** To provide information on safety and tolerability of sotagliflozin 200mg once daily in addition to standard of care compared to placebo
**Measure:** Proportion of participants requiring hospitalisation due to heart failure (HF)
**Time Frame:** From baseline to weeks 16 and 20
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 18 years to \<85 years.
* Type 1 diabetes.
* Insulin dose ≥0.5 units/kg body weight at screening or body mass index (BMI) ≥25kg/m2 at screening
* Using continuous glucose monitor at screening or willing to use one for the duration of the trial.
* Diagnosis of heart failure (HF) regardless of left ventricular ejection fraction (LVEF), defined as one or more of the following:
Previous HF hospitalisation where HF was documented as the primary cause of hospitalisation and there was a requirement for loop diuretics
OR
Impaired left ventricular (LV) function (i.e. LVEF \<50% by any imaging modality) at any time
OR
Preserved LV systolic function (LVEF ≥50%) with left atrial enlargement (2-dimensional echocardiographic measurement of left atrial width ≥3.8cm or left atrial length ≥5.0 cm or left atrial area ≥20cm2 or left atrial volume index \>29 ml/m2) within the last 24 months.
OR
Preserved LV systolic function (LVEF ≥50%) with left ventricular hypertrophy (2-dimensional echocardiographic measurement of end-diastolic interventricular septal diameter ≥1.2cm or end-diastolic left ventricular posterior wall diameter ≥1.2cm) within the last 24 months.
OR
Preserved LV systolic function (LVEF ≥50%) with echocardiographic diastolic dysfunction (septal e' \<7cm/sec or lateral e' \<10cm/sec or average E/e' ≥15) within the last 24 months.
* New York Heart Association Class II-IV at screening.
* Elevated N-terminal pro-B-type natriuretic peptide (≥250 ng/L for those in sinus rhythm, ≥400 ng/L if in atrial fibrillation) or B-type natriuretic peptide (≥75 ng/L for those in sinus rhythm, ≥100 ng/L if in atrial fibrillation) within 12 months of screening.
* Kansas City Cardiomyopathy clinical summary score \<85 at screening.
Exclusion Criteria:
* Cardiac surgery (coronary artery bypass graft or valve replacement), type 1 myocardial infarction, implantation of cardiac device (including biventricular pacemaker) or cardiac mechanical support implantation within 1 month of screening, or between screening and randomisation, or planned during the trial.
* End-stage heart failure requiring left ventricular assist devices, intra-aortic balloon pump, or any type of mechanical support at the time of randomisation.
* Documented primary severe valvular heart disease, amyloidosis or hypertrophic cardiomyopathy as principal cause of heart failure as judged by the local investigator.
* Respiratory disease thought to be the primary cause of dyspnoea as assessed by the local investigator.
* Chronic kidney disease with estimated glomerular filtration rate \<25ml/min/1.73m2 at screening.
* Moderate or severe hepatic impairment (e.g. Child-Pugh B and C) at screening as judged by the local investigator.
* Use of sotagliflozin or any sodium-glucose co-transporter-2 inhibitors (SGLT2i) within 1 month of screening or between screening and randomisation.
* Previous hypersensitivity/intolerance to SGLT2i.
* Presence of malignancy with expected life expectancy \<1 year at screening.
* Severe hypoglycaemia (hospitalisation for hypoglycaemia or episode requiring external assistance to treat) within 1 month prior to screening or between screening and randomisation.
* One episode of diabetic ketoacidosis or nonketotic hyperosmolar state within 1 month of screening or between screening and randomisation, or ≥2 diabetic ketoacidosis or nonketotic hyperosmolar state events within 6 months of screening.
* Pregnant or lactating women.
* Women of childbearing age or male partners of women of childbearing age and not practicing an acceptable method of birth control
* On a ketogenic diet.
* Unwilling/unable to share glucose and ketone monitoring data.
* Unwilling to wear continuous glucose monitoring during the trial.
* Use of any investigational drugs within five times of the elimination half-life after the last dose or within 30 days, whichever is longer. Current enrolment in non-interventional, observational studies will be allowed.
**Maximum Age:** 84 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** i.mordi@dundee.ac.uk
**Name:** Ify Mordi, MBChB, MD
**Phone:** +44 1382 385591
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Dundee
**Name:** Ify Mordi, MBChB, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC14
- Name: Heart and Blood 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: Type 1 Diabetes
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- 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: M9419
- Name: Heart 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: D000006333
- Term: Heart Failure
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000003922
- Term: Diabetes Mellitus, Type 1
### Intervention Browse Module - Ancestors
- ID: D000077203
- Term: Sodium-Glucose Transporter 2 Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M254783
- Name: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
- Relevance: HIGH
- As Found: Approximate
- ID: M1691
- Name: Sodium-Glucose Transporter 2 Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000575681
- Term: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435143
**Acronym:** IESPI
**Brief Title:** Validation and Usability Study of Intermittent Electrical Simulation in Management of Pressure Injuries Stages 1 and 2
**Official Title:** Validation and Usability Study of Intermittent Electrical Simulation (Prelivia) IES in the Management of Pressure Injuries Stage 1 and Stage 2
#### Organization Study ID Info
**ID:** H24-00304
#### Organization
**Class:** OTHER
**Full Name:** University of British Columbia
### Status Module
#### Completion Date
**Date:** 2024-11-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-01
**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:** 2024-05-09
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Providence Health & Services
#### Lead Sponsor
**Class:** OTHER
**Name:** University of British Columbia
#### Responsible Party
**Investigator Affiliation:** University of British Columbia
**Investigator Full Name:** Lisa Maks
**Investigator Title:** Diabetes Clinical Nurse Specialist, Adjunct Professor UBC School of Nursing
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The focus of this study will be early stage pressure ulcers, which can quickly progress to stage 3, 4 or deep tissue injury The proposed study explores the feasibility of intermittent electrical stimulation (IES),Prelivia, a novel, non-invasive technology in the management of stage 1 and 2 pressure ulcers.
**Detailed Description:** Pressure ulcers (also known as pressure injuries or bedsores) constitute a major morbidity in critically ill patients due to immobilization, deranged tissue perfusion, and poor nutrition. It is estimated that the prevalence of pressure injuries is 2.2 to 23.9 percent or higher, depending on the hospital environment, significantly contributing to nosocomial risk and healthcare costs.
Particularly, they are one of the most common complications among people with limited mobility is increased pressure on certain areas of the body causing reduced blood flow and damage to the skin.
There has been extensive research that shows electrical stimulation can be useful in pressure ulcer treatment. (Arora et al, 2020) (5) Electrical stimulation is provided by an electrical current, which can be applied in many ways.
The study intervention applies Intermittent Electrical Stimulation (IES) to the affected area through surface electrodes. The device invokes muscle contractions for 10 seconds every 10 minutes, emulating the subconscious adjustments performed by able- bodied individuals in response to discomfort when seated or lying down. Animal studies demonstrate that IES reduces internal pressure at bone-muscle interfaces (the hypothesized mechanism for injury development), increases tissue oxygenation in surrounding areas, and reduces or eliminates deep tissue injury in muscles subjected to prolonged loading (Appendix A). (6) (L. Solis et al., 2008) (7) Clinical studies support the safety, feasibility, and general acceptability of gluteal IES in human participants. (Appendix B) (Ahmetovic et al., 2015) (8) (Kane et al., 2017) (9) This technology has been studied and has shown, with strong evidence, the capacity of IES to prevent sacral and ischial pressure injuries.
Prelivia uses RHT's patented Intermittent Electrical Stimulation (IES) technology which counteracts damaging tissue compression and increases blood flow to parts of the body that are at risk. Prelivia acts by mimicking the physiological micro-contractions that normally occur in mobile individuals when they fidget or shift their weight. Prelivia works by restoring subconscious muscle contractions and movements, or a 'fidgeting' movement that able-bodied individuals are able do. These muscle contractions increase tissue perfusion - the process in which metabolic waste is removed and fresh blood, oxygen, and nutrients are brought into the tissue. The target muscles(such as the glutei maximi) are electrically stimulated for 10 seconds every 10 minutes to restore adequate tissue perfusion to the surrounding tissue.
The system consists of a battery-powered stimulator (Prelivia Stimulator) and disposable hydrogel electrodes. Prelivia's streamlined design, simple application, and low cost make it the ideal addition to existing standard of care procedures.
Prelivia is the only device on the market that addresses poor circulation and low oxygenation in compressed areas. Current pressure injury preventative interventions rely on either temporarily relieving pressure (nurses turn patients every 2 hrs) , creams, or redistributing pressure (specialized mattresses, cushions, etc.). However, neither of these interventions restore blood circulation, tissue oxygenation, or tissue perfusion.
Primary objective: To evaluate users' interaction with the device, safety and tolerability by patients when wearing Prelivia IES during management of pressure injuries stage 1 and 2 during their stay in the hospital, up to 30 days, until patient death or discharge whatever comes first.
Secondary objective : Compare the status and healing time of stage 1 and 2 pressure injuries matched with the historic controls, via retrospective data review. Historic controls will involve consideration of various factors:
Patients with documented stage 1 and 2 pressure injuries matched according to the age range, gender, location of pressure injury(ies), Body mass Index and comorbidities.
Data will be requested from the Providence Healthcare Integrated Health informatics Datalab.
Exploratory objective: Develop high level health economic model for pressure injury cost savings.
### Conditions Module
**Conditions:**
- Pressure Injury
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** This is a feasibility study of testing Prelivia in an in-patient setting
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patient admitted to hospital with a confirmed stage 1 and 2 pressure injuries. Prelivia device will be applied to skin around pressure injury. Intermittent electrical stimulation will be administered for 10 seconds every 10 minutes to improve blood flow and muscle contraction to the area, simulating movement
**Intervention Names:**
- Device: Prelivia
**Label:** Patient with pressure injury stage 1 and stage 2
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patient with pressure injury stage 1 and stage 2
**Description:** Pad applied to skin provide electrical stimulation for 10 seconds every 10 minutes
**Name:** Prelivia
**Other Names:**
- Intermittent electrical stimulation
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Will assess using qualitative questionnaire for both nursing staff and patient as to comfort and ease of use.
**Measure:** To evaluate users' interaction with the device, safety and tolerability by patients when wearing Prelivia IES during management of pressure injuries stage 1 and 2 during their stay in the hospital
**Time Frame:** 30 days
**Description:** Will perform an initial assessment of the wound (e.g. size, narrative description) and compare this pre-intervention with post-intervention after a maximum of 30 days of wear time.
**Measure:** Compare the status and healing time of stage 1 and 2 pressure injuries matched with historical controls via retrospective data review. Historic controls will involve consideration of a various factors:
**Time Frame:** 30 days
**Description:** Measurement of cost to treat patients that developed a severe pressure ulcer compared to those that did not.
**Measure:** Exploratory objective: to develop high level health economic model for pressure injury cost savings
**Time Frame:** 120 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria: Willing and able to provide written informed consent to participate and wear Prelivia for the duration of the study but not longer than 30 days Patients with new or already established stage 1 and 2 pressure injuries BMI \<40 Pressure injury location sacral/ischial region
-
Exclusion Criteria:
* existing pressure injury above stage 2 and injuries classified as DTI or unstageable continuous neuromuscular blocking drugs \& myasthenia gravis: may prevent the ability of IES to induce muscular contraction
* electrical stimulation to induce muscular contraction
* presence of permanent pacemaker or AICD, and for those with external wires after cardiac surgery, those who are using or at high risk for the development of a requirement for an external pacemaker
* unstable spinal, pelvic, or hop fractures that may be displaced by a forced contraction (for sacral and ischial ulcers)
* rhabdomyolysis
* skin breakdown or malignant skin involvement over the effected regions that would preclude the use of surface electrodes
* any implantable electrostimulation device
* have pacemaker or any other implantable neurostimulation devices,
* if your pressure injury is above stage 2, or
* if you are receiving neuromuscular blocking drugs,
* if you have myasthenia gravis,
* if you have unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction or
* if you are wearing an incontinence brief and have frequently loose bowel movements
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** lmaks@providencehealth.bc.ca
**Name:** Lisa J Maks, MN
**Phone:** 604-816-6523
**Role:** CONTACT
**Contact 2:**
**Email:** mdayrit@providencehealth.bc.ca
**Name:** Melodee Dayrit, BScN
**Phone:** 604-682-2344
**Phone Ext:** 62711
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** Unidentifyable research data will be shared with other team members
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012883
- Term: Skin Ulcer
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- 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: M834
- Name: Crush Injuries
- Relevance: HIGH
- As Found: Pressure Injury
- ID: M6870
- Name: Pressure Ulcer
- Relevance: HIGH
- As Found: Pressure Injury
- ID: M17206
- Name: Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Injury
- ID: M15686
- Name: Skin Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003668
- Term: Pressure Ulcer
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000071576
- Term: Crush Injuries
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435130
**Brief Title:** The Impact of Chokeberry Bioproducts on Metabolic Parameters and Antioxidant Potential
**Official Title:** The Impact of Chokeberry Bioproducts Consumption on Metabolic Parameters and the Antioxidant Potential of Serum
#### Organization Study ID Info
**ID:** MUBialystok2
#### Organization
**Class:** OTHER
**Full Name:** Medical University of Bialystok
### Status Module
#### Completion Date
**Date:** 2022-08-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-08-30
**Type:** ACTUAL
#### Start Date
**Date:** 2022-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Medical University of Bialystok
#### Responsible Party
**Investigator Affiliation:** Medical University of Bialystok
**Investigator Full Name:** Małgorzata Zujko
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Chokeberry can be used both in the prevention and treatment of various metabolic disorders due to its high antioxidant properties. The study assessed for the first time the synergistic effect of chokeberry juice and chokeberry fiber on selected metabolic and anthropometric parameters. 102 people (67 women and 35 men) took part in the intervention study. After 8 weeks of intervention with chokeberry juice and another 4 weeks of intervention with chokeberry juice and fiber, a change in waist circumference, blood pressure, glucose, glycated hemoglobin, LDL cholesterol, aspartate transaminase (AST) and the level of antioxidant potential was observed.
### Conditions Module
**Conditions:**
- Diet, Healthy
- Diabetes Mellitus
- Hypertension
- Obesity
- Hypercholesterolemia
**Keywords:**
- chokeberry
- juice
- fiber
- diet
- intervention
- diabetes
- obesity
- hypertension
- hypercholesterolemia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** 102 people (67 women and 35 men) with metabolic disorders were included in the interventional study
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 102
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Study participants consumed 100 mL of chokeberry juice daily for 8 weeks. After 8 weeks, participants consumed 100 ml of chokeberry juice and 10 g of chokeberry fiber daily for 4 weeks.
**Intervention Names:**
- Other: Dietary intervention with chokeberry juices
- Other: Dietary intervention with chokeberry juices and fibers
**Label:** Dietary intervention with chokeberry juice and fibre
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dietary intervention with chokeberry juice and fibre
**Description:** The first stage of the dietary intervention lasted 8 weeks. Study participants consumed 100 ml of chokeberry juice daily. Chokeberry juice came from ecological cultivation (Poland). Participants qualified for the study had specific biochemical parameters tested: fasting glucose and insulin level, lipid profile (triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol), glycated hemoglobin, uric acid, C-reactive protein (CRP), creatinine, liver enzymes: alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamylotranspeptydase (GGTP), homocysteine and antioxidant potential. Blood tests were performed in a certified external laboratory before and after 8 weeks of intervention. In addition, blood pressure and waist circumference were tested.
**Name:** Dietary intervention with chokeberry juices
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Dietary intervention with chokeberry juice and fibre
**Description:** The second stage of the dietary intervention lasted 4 weeks. Study participants consumed 100 ml of chokeberry juice daily and 10 g chokeberry fiber daily (from ecological cultivation, Poland). Blood tests were performed in a certified external laboratory after 4 weeks of intervention. The following blood tests were performed: fasting glucose and insulin level, lipid profile (triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol), glycated hemoglobin, uric acid, C-reactive protein (CRP), creatinine, liver enzymes: alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamylotranspeptydase (GGTP), homocysteine and antioxidant potential. In addition, blood pressure and waist circumference were tested.
**Name:** Dietary intervention with chokeberry juices and fibers
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in waist circumference was observed.
**Measure:** Change in waist circumference
**Time Frame:** 12 weeks
**Description:** After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in systolic and diastolic blood pressure was observed.
**Measure:** Change in blood pressure
**Time Frame:** 12 weeks
**Description:** After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in glycated hemoglobin was observed.
**Measure:** Change in glycated hemoglobin
**Time Frame:** 12 weeks
**Description:** After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in glucose level was observed.
**Measure:** Change in glucose level
**Time Frame:** 12 weeks
**Description:** After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in LDL-cholesterol level was observed.
**Measure:** Change in LDL-cholesterol
**Time Frame:** 12 weeks
**Description:** After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in aspartate transaminase (AST) level was observed.
**Measure:** Change in aspartate transaminase (AST) level
**Time Frame:** 12 weeks
**Description:** After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in antioxidant potential of serum was observed.
**Measure:** Change in antioxidant potential of serum
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* age 30-65 years,
* low or moderate physical activity.
Exclusion Criteria:
* age \<30 and \>65 years,
* high physical activity,
* obesity (class II),
* diabetes (all types),
* gastric ulcer,
* acute or chronic gastritis,
* intestinal diseases, including inflammatory bowel diseases and functional intestinal disorders,
* taking hypoglycemic, lipid-lowering, immunosuppressive, anticoagulant and antihypertensive drugs, use of steroid therapy,
* high physical activity,
* pregnancy,
* breastfeeding.
**Maximum Age:** 65 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Białystok
**Country:** Poland
**Facility:** Medical University of Bialystok
**Zip:** 15-089
#### Overall Officials
**Official 1:**
**Affiliation:** Medical University of Bialystok
**Name:** Malgorzata E. Zujko, Dr.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000006949
- Term: Hyperlipidemias
- ID: D000050171
- Term: Dyslipidemias
- ID: D000052439
- Term: Lipid Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Hypertension
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M9988
- Name: Hypercholesterolemia
- Relevance: HIGH
- As Found: Hypercholesterolemia
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10000
- Name: Hyperlipidemias
- Relevance: LOW
- As Found: Unknown
- ID: M10002
- Name: Hyperlipoproteinemias
- Relevance: LOW
- As Found: Unknown
- ID: M26181
- Name: Dyslipidemias
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27029
- Name: Lipid Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006973
- Term: Hypertension
- ID: D000006937
- Term: Hypercholesterolemia
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: AA
- Name: Amino Acids
### 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: M207501
- Name: Chrysarobin
- Relevance: LOW
- As Found: Unknown
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
- ID: M17277
- Name: Uric Acid
- Relevance: LOW
- As Found: Unknown
- ID: M18659
- Name: N-Methylaspartate
- Relevance: LOW
- As Found: Unknown
- ID: T0
- Name: Alanine
- Relevance: LOW
- As Found: Unknown
- ID: T3
- Name: Aspartic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435117
**Acronym:** CO-CAPTAIN
**Brief Title:** Cancer Prevention Among Individuals With Mental Ill-health: Patient Navigation for Primary Cancer Prevention
**Official Title:** Cancer Prevention Among Individuals With Mental Ill-health: Co-adapting and Implementing Patient Navigation for Primary Cancer Prevention
#### Organization Study ID Info
**ID:** 101104784
#### Organization
**Class:** OTHER
**Full Name:** Medical University of Vienna
### Status Module
#### Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09
**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:** 2024-03-28
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Senior Europa Sociedad Limitada
**Class:** OTHER
**Name:** Prolepsis Institute for Preventive, Environmental and Occupational Medicine
**Class:** OTHER
**Name:** Universitat Politècnica de València
**Class:** UNKNOWN
**Name:** STICHTING INTERNATIONAL FOUNDATION FOR INTEGRATED CARE
**Class:** OTHER
**Name:** Medical University of Lodz
**Class:** UNKNOWN
**Name:** Consejería de Familia, Juventud y Política Social, Comunidad de Madrid
**Class:** OTHER
**Name:** Servicio Madrileño de Salud, Madrid, Spain
**Class:** UNKNOWN
**Name:** Fundacion para la Investigacion e Innovacion Biosanitaria de Atencion Primaria
**Class:** UNKNOWN
**Name:** Mental Health Europe - Sante Mentale Europe
**Class:** OTHER
**Name:** University Mental Health Research Institute, Athens, Greece
**Class:** UNKNOWN
**Name:** Fundacion para el Fomento en Asturias de la Investigacion Cientifica Aplicada y Tecnologia
**Class:** UNKNOWN
**Name:** Consejeria de Salud - Principado de Asturias
**Class:** UNKNOWN
**Name:** Servicio de Salud del Principado de Asturias
#### Lead Sponsor
**Class:** OTHER
**Name:** Medical University of Vienna
#### Responsible Party
**Investigator Affiliation:** Medical University of Vienna
**Investigator Full Name:** Igor Grabovac
**Investigator Title:** Project coordinator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Prevention is essential for reducing cancer-related mortality. However, people with mental ill-health often face difficulties in accessing cancer prevention services. The EU-funded CO-CAPTAIN project aims to co-adapt and implement the Patient Navigation Model for primary cancer prevention in this underserved population. This evidence-based and patient-centred intervention aims to support patient empowerment through removal of systemic barriers, provide social support and promote timely access to primary prevention services.
**Detailed Description:** Cancer and mental ill-health constitute leading public health problems in Europe. More than 84 million people in the European Union (EU) report living with an on-going mental ill-health condition. While issues concerning mental health are of great importance, they often overshadow physical problems that people with mental ill-health face. Such is cancer, which is more prevalent in people with mental ill-health and is also the second most common cause of death in this population. People with mental ill-health often have difficulties in accessing quality cancer prevention services, but are also additionally overlooked in research which makes them overall an underserved population. What data is available, shows that potential reasons for these higher cancer morbidity and mortality rates are linked to more engagement in risky health behaviour (especially higher prevalence of smoking as well as overweight and obesity) but also experiences of significant barriers when accessing the highly fragmented heath care systems.
Timely and evidence-based preventive strategies including optimizing health care pathways provide a solution to the high cancer morbidity and could improve overall health outcomes in this disadvantaged population. One such mixed-skill strategy is Patient Navigation. Therefore, the overall goal of the CO-CAPTAIN project is to co-adapt the Patient Navigation (PN) model focusing on primary cancer prevention and to see if this model can prove to be beneficial in supporting individuals with mental ill-health through care services to reduce cancer risk factors by increasing knowledge, health literacy and empowerment. The Patient Navigation Model is an innovative, evidence-based and patient-centred intervention, which supports patient empowerment through removal of systemic barriers, providing social support and promoting timely access to primary prevention services. Based on implementation science and utilizing the Consolidated Framework for Implementation (CFIR) as well as the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks, the CO-CAPTAIN project aims to reduce the gap in health inequalities for people with mental ill-health by reducing cancer burden and improving overall health, which will, in turn, reduce associated costs across health and social care systems in Europe. Moreover, the CO-CAPTAIN project aims to harness the transformative potential of the integrated care pathways in cancer as well as provide health and social care policy recommendations for the adoption and implementation of the Patient Navigation Model across Europe.
The adapted Patient Navigation Model will be implemented in four European countries (Austria, Greece, Poland, Spain) and its potential to enable and improve access and utilization of primary cancer prevention measures for people with mental ill-health will be evaluated. The study will employ a mixed-methods design allowing for both exploratory and confirmatory research.
The project has been funded by the HORIZON EUROPE Framework Program (Call: Research and Innovation actions supporting the implementation of the Mission on Cancer (HORIZON-MISS-2022-CANCER-01-01) - Improving and upscaling primary prevention of cancer through implementation research) and is coordinated by the Medical University of Vienna.
### Conditions Module
**Conditions:**
- Cancer
**Keywords:**
- Europe
- Prevention
- Cancer
- Cancer prevention
- Primary prevention
- Mental health
- Mental health problems
- Patient Navigation
- Implementation science
- Co-design
- Longitudinal
- Person-centered
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 1240
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All people with mental ill-health aged 18 or older who visit one of the recruitment sites will be asked to participate. Further participants will be recruited through partner organizations (non-governmental organisations, patient groups and professional organisations) involved in care for individuals with mental ill-health, as well as personal contacts. Additionally, healthcare professionals involved in care of people with mental ill-health will be asked to participate in the qualitative part of the study.
**Intervention Names:**
- Other: Patient Navigation
**Label:** People with mental ill-health
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- People with mental ill-health
**Description:** CO-CAPTAIN focuses on co-designing and piloting and evaluating the implementation of patient navigation (PN) for primary cancer prevention in people with mental ill-health. Patient Navigators, trained professionals with experience working with people with mental ill-health, will assist people with mental ill-health in gaining access to and utilizing appropriate primary cancer prevention measures offered within the respective healthcare and social system (including smoking cessation and physical activity and nutritional interventions). For this purpose, Patient Navigators will offer regular appointment with participants, apply motivational interviewing and aid in accessing appropriate materials while aiming at empowering participants in taking an active role and making better and more informed decisions regarding their health.
**Name:** Patient Navigation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in health outcomes and socio-economic risk factors in the course of study participation. Next to socio-demographic data, participants will indicate their health status, alcohol consumption, sexual risk behavior, sun exposure, and vaccination status by self-report or electronic health reports.
**Measure:** Health data of participants as assessed by self-report or electronic health reports
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome nutritional intake. Nutritional intake will be assessed by the Rapid Prime Diet Quality Score Screener (rPDQS; range: 0-52, where higher values indicate healthier nutritional intake).
**Measure:** Nutritional intake of participants as assessed by the Rapid Prime Diet Quality Score Screener (rPDQS)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome smoking behavior. Smoking behavior will be assessed by the Fagerström Test for Nicotine Dependence (FND; range: 0-10, where higher values indicate higher nicotine dependence).
**Measure:** Smoking behavior of participants as assessed by the Fagerström Test for Nicotine Dependence (FND)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome physical activity. Physical activity will be assessed by the International Physical Activity Questionnaire (IPAQ; range: 0-19278 MET minutes per week, where higher values indicate more time spent on physical activity).
**Measure:** Physical activity of participants as assessed by the International Physical Activity Questionnaire (IPAQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome depressive symptoms. Depressive symptoms will be assessed by the Patient Health Questionnaire (PHQ-9; range: 0-27, where a higher score indicates more severe depressive symptoms).
**Measure:** Depressive symptoms of participants as assessed by the Patient Health Questionnaire (PHQ-9)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome generalized anxiety. Generalized anxiety will be assessed by the 7-item anxiety scale (GAD-7; range: 0-21, where higher values indicate more severe anxiety symptoms).
**Measure:** Generalized anxiety of participants as assessed by the 7-item anxiety scale (GAD-7)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome health-related anxiety. Health-related anxiety will be assessed by items from the Whiteley Index (Whiteley-6-R; range: 0-24, where higher values indicate more health anxiety symptoms).
**Measure:** Health-related anxiety of participants as assessed by the Whiteley Index (Whiteley-6-R)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in (health-related) quality of life. (Health-related) Quality of life will be assessed by items from the World Health Organization Quality of Life Brief Version (WHO-QOL-BREF; range: 4-20, where higher values indicate higher quality of life).
**Measure:** (Health-related) Quality of life of participants as assessed by the World Health Organization Quality of Life Brief Version (WHO-QOL-BREF)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in (health-related) quality of life. (Health-related) Quality of life will be assessed by items from the descriptive system of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L, where each dimension has a range from 1-5, where a higher value indicates more severe problems).
**Measure:** (Health-related) Quality of life of participants as assessed by the descriptive system of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in (health-related) quality of life. (Health-related) Quality of life will be assessed by items from the EQ visual analogue scale of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L, range: 0-100, where higher values indicate better subjective health).
**Measure:** (Health-related) Quality of life of participants as assessed by the EQ visual analogue scale of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in self-efficacy. Self-efficacy will be assessed by items from the General Self-Efficacy Scale (GSES; range: 10-40, where higher values indicate higher perceived self-efficacy).
**Measure:** Self-efficacy of participants as assessed by the General Self-Efficacy Scale (GSES)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in feeling understood and supported by healthcare providers (HPS) as part of health literacy. HPS as part of health literacy will be assessed by items of the HPS scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived HPS).
**Measure:** Feeling understood and supported by healthcare providers as part of health literacy of participants as assessed by the Feeling understood and supported by healthcare providers (HPS) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in having sufficient information to manage one's own health as part of health literacy. Having sufficient information to manage my health (HSI) as part of health literacy will be assessed by items of the HSI scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived HSI).
**Measure:** Having sufficient information to manage one's own health as part of health literacy of participants as assessed by the Having sufficient information to manage my health (HSI) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in actively managing one's own health as part of health literacy. Actively managing my health (AMH) as part of health literacy will be assessed by items of the AMH scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived AMH).
**Measure:** Actively managing one's own health as part of health literacy of participants as assessed by the Actively managing my health (AMH) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in social support as part of health literacy. Social support as part of health literacy will be assessed by items of the social support of health scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived social support for health).
**Measure:** Social support as part of health literacy of participants as assessed by the Social support of health scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in appraisal of health information as part of health literacy. Appraisal of health information (CA) as part of health literacy will be assessed by items of the CA scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived CA).
**Measure:** Appraisal of health information as part of health literacy of participants as assessed by the Appraisal of health information (CA) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to actively engage with healthcare providers as part of health literacy. Ability to actively engage with healthcare providers (AE) as part of health literacy will be assessed by items of the AE scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived AE).
**Measure:** Ability to actively engage with healthcare providers as part of health literacy of participants as assessed by the Ability to actively engage with healthcare providers (AE) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to navigate the healthcare system as part of health literacy. Navigating the healthcare system (NHS) as part of health literacy will be assessed by items of the NHS scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived NHS).
**Measure:** Navigating the healthcare system as part of health literacy of participants as assessed by the Navigating the healthcare system (NHS) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to find good health information as part of health literacy. Ability to find good health information (FHI) as part of health literacy will be assessed by items of the FHI scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived FHI).
**Measure:** Ability to find good health information as part of health literacy of participants as assessed by the Ability to find good health information (FHI) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to understand health information well enough to know what to do as part of health literacy. Understanding health information well enough to know what to do as part of health literacy will be assessed by items of the Understand health information well enough to know what to do (UHI) scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived UHI).
**Measure:** Understand health information well enough to know what to do as part of health literacy of participants as assessed by the Understand health information well enough to know what to do (UHI) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in use of healthcare services. Use of healthcare services will be assessed by self-reports.
**Measure:** Use of healthcare services of participants as assessed by self-reports
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by evaluating cost-effectiveness and cost-utility. To assess cost-effectiveness and cost-utility of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, an economic evaluation will be carried out by analyzing health outcomes and costs (healthcare costs, cancer costs, burden).
**Measure:** Cost-effectiveness and cost-utility of the Patient Navigation Model for primary cancer prevention in people with mental ill-health as assessed by an economic evaluation
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in satisfaction with care. Satisfaction with care will be assessed by self-reports and items from the Patient Satisfaction Questionnaire Short Form (PSQ-18, range of the mean score: 1-5, where higher scores indicate higher satisfaction with medical care).
**Measure:** Satisfaction with care of participants as assessed by self-reports and items from the Patient Satisfaction Questionnaire Short Form (PSQ-18)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in discrimination experiences. Discrimination experiences will be assessed by self-reports.
**Measure:** Discrimination experiences of participants as assessed by self-reports
**Time Frame:** 18 months
**Description:** The co-adapted Patient Navigation Model will be evaluated by assessing facilitators of the intervention to determine its effectiveness. Experiences of people with mental ill-health, navigators, and healthcare professionals involved in care of people with mental ill-health will be considered. Qualitative data will be gathered using semi-structured interviews.
**Measure:** Facilitators of the Patient Navigation Model as experienced by participants and assessed by qualitative semi-structured interviews
**Time Frame:** 18 months
**Description:** The co-adapted Patient Navigation Model will be evaluated by assessing barriers of the intervention to determine its effectiveness. Experiences of people with mental ill-health, navigators, and healthcare professionals involved in care of people with mental ill-health will be considered. Qualitative data will be gathered using semi-structured interviews.
**Measure:** Barriers of the Patient Navigation Model as experienced by participants and assessed by qualitative semi-structured interviews
**Time Frame:** 18 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18 years of age or older
* Individuals who have been diagnosed with one or more mental disorders OR healthcare professionals involved in care of individuals with mental ill-health
* Sufficient knowledge of language
Exclusion Criteria:
* Individuals unable to give consent due to diminished capacity
* Individuals who do not provide consent
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** igor.grabovac@meduniwien.ac.at
**Name:** Igor Grabovac, MD, PhD
**Phone:** +43 1 40160 34897
**Role:** CONTACT
**Contact 2:**
**Email:** hanna.muees@meduniwien.ac.at
**Name:** Hanna M. Mües, MSc
**Phone:** +43 1 40160 34662
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Vienna
**Contacts:**
***Contact 1:***
- **Name:** Hietzing Hospital
- **Role:** CONTACT
**Country:** Austria
**Facility:** Hietzing Hospital
**Location 2:**
**City:** Vienna
**Contacts:**
***Contact 1:***
- **Name:** Medical University of Vienna
- **Role:** CONTACT
**Country:** Austria
**Facility:** Medical University of Vienna
**Location 3:**
**City:** Athens
**Contacts:**
***Contact 1:***
- **Name:** Mental Health Clinic
- **Role:** CONTACT
**Country:** Greece
**Facility:** Mental Health Clinic
**Location 4:**
**City:** Athens
**Contacts:**
***Contact 1:***
- **Name:** The Day Hospital
- **Role:** CONTACT
**Country:** Greece
**Facility:** The Day Hospital
**Location 5:**
**City:** Athens
**Contacts:**
***Contact 1:***
- **Name:** The Guest House / Protected apartments
- **Role:** CONTACT
**Country:** Greece
**Facility:** The Guest House / Protected apartments
**Location 6:**
**City:** Łódź
**Contacts:**
***Contact 1:***
- **Name:** POMOST
- **Role:** CONTACT
**Country:** Poland
**Facility:** The Association of Youth and People with Mental Problems, Their Families and Friends POMOST
**Location 7:**
**City:** Madrid
**Country:** Spain
**Facility:** Servicio Madrileño de Salud (SERMAS)
#### Overall Officials
**Official 1:**
**Affiliation:** Medical University of Vienna
**Name:** Igor Grabovac, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Upon request
**Description:** Upon request from other researchers, the principal investigator may provide study materials and data in an anonymised and limited form, while adhering to the Data Security Department of the Medical University of Vienna.
**Info Types:**
- STUDY_PROTOCOL
- ICF
**IPD Sharing:** YES
**Time Frame:** Accessibility is expected after completion of the study as well as of related publications. Only data that does not allow identification of participants will be made available.
### References Module
#### See Also Links
**Label:** HORIZON EUROPE
**URL:** https://cordis.europa.eu/project/id/101104784
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435104
**Brief Title:** Aromatherapy in the Treatment of Early Breast Cancer
**Official Title:** Effects of Aromatherapy on Anxiety and Tumor Immunity of Early Breast Cancer Patients,a Pilot Study
#### Organization Study ID Info
**ID:** SYSKY-2024-063-02
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
### Status Module
#### Completion Date
**Date:** 2027-01
**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:** 2027-01
**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:** 2024-03-13
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Breast cancer is a major threat to women's health, and chemotherapy is one of the most important treatment method. Chemotherapy is cytotoxic , and has a positive tumor immune effect. However, it is worth noting that anxiety caused by breast cancer itself and adverse reactions of chemotherapy not only affects the patients' quality of life, but also reduces the treatment compliance and even survival benefits of patients. Previous literatures have shown that aromatherapy may improve chemotherapy-induced anxiety and even affect anti-tumor immunity.
Therefore,we envisage that aromatherapy conbimed with chemotherapy in the treatment of breast cancer in clinical practice has the advantages of improving efficacy and survival.
However, there is still a lack of relevant clinical studies. We planned to design a prospective clinical trial to evaluate the efficacy and safety of aromatherapy combined with chemotherapy on anxiety, relevant sympathetic neurotransmitters and tumor immunity in breast cancer patients.
**Detailed Description:** Breast cancer is the most common malignant tumor in women all over the world. In China, the incidence of breast cancer is increasing, especially in the economically developed cities. Studies have shown that the breast cancer patients have a higher incidence of anxiety and depression to the general population. Tumor burden is an important chronic stressor that can cause a wide range of negative emotions, such as anxiety and depression. According to the data published by the World Health Organization, the incidence of depression in cancer patients is between 20% to 45%, which is far more than the incidence of 6.1% to 9.5% in the general population.Among them, the depression tendency of breast cancer patients is particularly obvious, and up to 80% of breast cancer patients suffer from different degrees of depression. Depression and anxiety have a crucial influence on the physiological and psychological function, treatment compliance and the quality of life of breast cancer patients, and may even be an important factor affecting the mortality of breast cancer patients.
Therefore, how to improve the anxiety of breast cancer patients to improve the quality of life and even the survival time of patients has vital clinical value. Considering the adverse reactions and tolerance of current anti-anxiety drugs, more mild and effective anti-anxiety methods are expected in clinical practice. Among them, as an important means of rehabilitation treatment, aromatherapy has obtained surprising data in the prevention of adverse reactions of chemotherapy and the improvement of insomnia, so the value of aromatherapy in the improvement of anxiety is also expected.
In conclusion, Breast cancer is a major threat to women's health, and chemotherapy is one of the most important treatment method. Chemotherapy is cytotoxic , and has a positive tumor immune effect. However, it is worth noting that anxiety and depression caused by breast cancer disease itself and adverse reactions of chemotherapy not only affects the quality of life of patients, but also reduces the treatment compliance and even survival benefits of patients. Previous literatures have shown that aromatherapy may improve chemotherapy-induced anxiety and even have influence on tumor immunity. However, there is still lack of relevant clinical researches. Therefore, we plan to design a prospective clinical study to evaluate the effect of aromatherapy combined with neoadjuvant chemotherapy on anxiety, sympathetic neurotransmitters and tumor immunity in early breast cancer patients.
### Conditions Module
**Conditions:**
- Early Breast Cancer
**Keywords:**
- Early breast Cancer
- Anxiety
- Aromatherapy
- Neoadjuvant chemotherapy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The research model consists of two arms#
1. armA:neoadjuvant chemotherapy
2. armB:neoadjuvant chemotherapy+aromatherapy
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will receive effective neoadjuvant chemotherapy for at least 2 courses.
**Intervention Names:**
- Other: neoadjuvant chemotherapy
**Label:** neoadjuvant chemotherapy
**Type:** OTHER
#### Arm Group 2
**Description:** Patients will receive effective neoadjuvant chemotherapy for at least 2 courses, and the aromatherapy is recommended to continue throughout neoadjuvant chemotherapy.
**Intervention Names:**
- Other: neoadjuvant chemotherapy
- Other: aromatherapy
**Label:** neoadjuvant chemotherapy+aromatherapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- neoadjuvant chemotherapy
- neoadjuvant chemotherapy+aromatherapy
**Description:** The neoadjuvant chemotherapy plan will be selected according to the recommendations of the NCCN guidelines and the Chinese CSCO guidelines for early breast cancer.The neoadjuvant chemotherapy plans include:AC-T(HP),TCb(HP),AC-TCb, in which A represents anthracycline, C represents cyclophosphamide, T represents taxane, Cb represents carboplatin, H represents trastuzumab, and P represents pertuzumab.
**Name:** neoadjuvant chemotherapy
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- neoadjuvant chemotherapy+aromatherapy
**Description:** Patients will inhale essential oils during the neoadjuvant chemotherapy courses.
**Name:** aromatherapy
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Changes of anxiety scores (Hamilton Anxiety Scale and State-trait anxiety inventory scale) before and after two neoadjuvant chemotherapy courses.
**Measure:** Change in anxiety score
**Time Frame:** before neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy course 2 (each course is 21 days)
#### Secondary Outcomes
**Description:** The time from the start of randomization to death due to any cause
**Measure:** Overall Survival, OS
**Time Frame:** 2 years
**Description:** The function or quality of a patient's physical, psychological, and social adaptability is also known as quality, which is assessed according to the EROTC C30 scale.
**Measure:** Quality of life scale score,QoL
**Time Frame:** before neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy course 2 (each course is 21 days)
**Description:** Proportion of patients with pathologic complete response after neoadjuvant chemotherapy
**Measure:** Pathologic complete response,pCR
**Time Frame:** 2 years
**Description:** The time from diagnosis to first recurrence or death of the patient
**Measure:** Disease-free survival,DFS
**Time Frame:** 2 years
**Description:** All target lesions disappeared, no new lesions appeared, and tumor markers remained normal for at least 4 weeks.
**Measure:** Complete response,CR
**Time Frame:** 2 years
**Description:** The sum of the maximum diameters of the target lesions is reduced by≥30%,maintained for at least 4 weeks.
**Measure:** Partial response,PR
**Time Frame:** 2 years
**Description:** The sum of the maximum diameters of the target lesions is within the prescribed range of partial response and progressive disease.
**Measure:** Stable disease,SD
**Time Frame:** 2 years
**Description:** The sum of the maximum diameters of the target lesions increases by at least 20%, and their absolute value of diameters increases by at least 5mm, or new lesions appear.
**Measure:** Progressive disease,PD
**Time Frame:** 2 years
**Description:** The proportion of patients with a tumor volume reduction of ≥30% and a minimum timeframe according to accepted response evaluation criteria (e.g., RECIST version 1.1 in solid tumors), including cases of complete response (CR) and partial response (PR).
**Measure:** Objective Response Rate, ORR
**Time Frame:** 2 years
**Description:** Proportion of confirmed complete response, partial response, or stable disease ≥ 24 weeks.
**Measure:** Clinical Benefit Rate, CBR
**Time Frame:** 24 weeks after enrollment
**Description:** The scores of self-rating anxiety scale (SAS) before treatment, after each treatment and 3 months after the last treatment.
**Measure:** Anxiety rating scale
**Time Frame:** before treatment and 3 months after the last treatment
**Description:** The scores of Pittsburgh sleep quality index(PSQI) before treatment, after each treatment and 3 months after the last treatment.
**Measure:** Sleep rating scale
**Time Frame:** before treatment and 3 months after the last treatment
**Description:** The scores of Hamilton Depression Scale(HAMD) before treatment and after 2 times of treatment.
**Measure:** Depression scale
**Time Frame:** before neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy course 2 (each course is 21 days)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Adult female patients (age 18-80 years) with early breast cancer confirmed by pathology.
2. Patients have not received any anti-tumor treatment,and are planning to receive neoadjuvant chemotherapy.
3. Patients with mild anxiety scored 50 in Self-Rating Anxiety Scale.
4. ECOG physical status score ≤ 2 and expected survival of not less than 3 months.
5. At least one measurable lesion should be present in the imaging examination within 2 weeks prior to enrollment.
6. Adequate reserve of bone marrow function: white blood cell count ≥ 3.0×10\^9/L, neutrophil count ≥ 1.5 × 10\^9/L; Platelet count ≥ 70 × 10\^9/L.
7. Basically normal liver, kidney and cardiac function:total bilirubin≤3 times the upper limit of normal value,Alanine Transaminase/Aspartate Aminotransferase≤2.5 times the upper limit of normal value(patients with liver metastases≤5 times the upper limit of normal value)，serum creatinine≤1.5 times the upper limit of normal value or creatinine clearance rate≥60mL/min, left ventricular ejection fraction (LVEF) ≥ 55%,QTcF(Fridericia correction) ≤ 470 ms.
8. Be able to understand the research process, volunteer to participate in the study, and sign informed consent.
Exclusion Criteria:
1. Patients who are not able to receive aromatherapy:be allergic to aromatherapy materials or suffer from heterosmia.
2. Received surgery within 2 weeks prior to enrollment.
3. Patients with severe cardiovascular and cerebrovascular events within 12 months, including but not limited to unstable angina, myocardial infarction, cerebral hemorrhage, and cerebral infarction (except asymptomatic lacunar infarction requiring no treatment)
4. Patients with active autoimmune diseases requiring treatment (e.g., corticosteroids or immunosuppressive drugs) within the past 2 years. Patients who need corticosteroid replacement therapy for adrenal insufficiency were excluded.
5. Patients with a definite past medical history or present medical history of neurological or mental disorders, including epilepsy or dementia.
6. The researchers believe that patients are not suitable to participate in any other circumstances of this study, which may interfere with the accompanying diseases or conditions of the study, or have any serious medical obstacles that may affect the safety of the subjects.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** zhaojli5@mail.sysu.edu.cn
**Name:** Jianli J Zhao, doctorate
**Phone:** 15920589334
**Role:** CONTACT
**Contact 2:**
**Email:** songew@mail.sysu.edu.cn
**Name:** Erwei E Song, doctorate
**Phone:** 13926477694
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Country:** China
**Facility:** Sun Yat-sen Memorial Hospital, Sun Yat-sen University
**State:** Guangdong
**Zip:** 510120
#### Overall Officials
**Official 1:**
**Affiliation:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
**Name:** Jianli J Zhao, doctorate
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** As personal information of patients is involved, we decided not to share individual participant data of patients.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Harbeck N, Penault-Llorca F, Cortes J, Gnant M, Houssami N, Poortmans P, Ruddy K, Tsang J, Cardoso F. Breast cancer. Nat Rev Dis Primers. 2019 Sep 23;5(1):66. doi: 10.1038/s41572-019-0111-2.
**PMID:** 31548545
**Citation:** Xiong SY, Wen HZ, Dai LM, Lou YX, Wang ZQ, Yi YL, Yan XJ, Wu YR, Sun W, Chen PH, Yang SZ, Qi XW, Zhang Y, Wu GY. A brain-tumor neural circuit controls breast cancer progression in mice. J Clin Invest. 2023 Dec 15;133(24):e167725. doi: 10.1172/JCI167725.
**PMID:** 37847562
**Citation:** Wang X, Wang N, Zhong L, Wang S, Zheng Y, Yang B, Zhang J, Lin Y, Wang Z. Prognostic value of depression and anxiety on breast cancer recurrence and mortality: a systematic review and meta-analysis of 282,203 patients. Mol Psychiatry. 2020 Dec;25(12):3186-3197. doi: 10.1038/s41380-020-00865-6. Epub 2020 Aug 20.
**PMID:** 32820237
**Citation:** Carreira H, Williams R, Funston G, Stanway S, Bhaskaran K. Associations between breast cancer survivorship and adverse mental health outcomes: A matched population-based cohort study in the United Kingdom. PLoS Med. 2021 Jan 7;18(1):e1003504. doi: 10.1371/journal.pmed.1003504. eCollection 2021 Jan.
**PMID:** 33411711
**Citation:** Sharma M, Grewal K, Jandrotia R, Batish DR, Singh HP, Kohli RK. Essential oils as anticancer agents: Potential role in malignancies, drug delivery mechanisms, and immune system enhancement. Biomed Pharmacother. 2022 Feb;146:112514. doi: 10.1016/j.biopha.2021.112514. Epub 2021 Dec 25.
**PMID:** 34963087
**Citation:** Bayala B, Bassole IH, Gnoula C, Nebie R, Yonli A, Morel L, Figueredo G, Nikiema JB, Lobaccaro JM, Simpore J. Chemical composition, antioxidant, anti-inflammatory and anti-proliferative activities of essential oils of plants from Burkina Faso. PLoS One. 2014 Mar 24;9(3):e92122. doi: 10.1371/journal.pone.0092122. eCollection 2014.
**PMID:** 24662935
**Citation:** Peterfalvi A, Miko E, Nagy T, Reger B, Simon D, Miseta A, Czeh B, Szereday L. Much More Than a Pleasant Scent: A Review on Essential Oils Supporting the Immune System. Molecules. 2019 Dec 11;24(24):4530. doi: 10.3390/molecules24244530.
**PMID:** 31835699
**Citation:** Zhao ZJ, Sun YL, Ruan XF. Bornyl acetate: A promising agent in phytomedicine for inflammation and immune modulation. Phytomedicine. 2023 Jun;114:154781. doi: 10.1016/j.phymed.2023.154781. Epub 2023 Mar 22.
**PMID:** 37028250
**Citation:** Zhang Z, Liu Q, Wen P, Zhang J, Rao X, Zhou Z, Zhang H, He X, Li J, Zhou Z, Xu X, Zhang X, Luo R, Lv G, Li H, Cao P, Wang L, Xu F. Activation of the dopaminergic pathway from VTA to the medial olfactory tubercle generates odor-preference and reward. Elife. 2017 Dec 18;6:e25423. doi: 10.7554/eLife.25423.
**PMID:** 29251597
**Citation:** Bhimani RV, Yates R, Bass CE, Park J. Distinct limbic dopamine regulation across olfactory-tubercle subregions through integration of in vivo fast-scan cyclic voltammetry and optogenetics. J Neurochem. 2022 Apr;161(1):53-68. doi: 10.1111/jnc.15577. Epub 2022 Feb 5.
**PMID:** 35061915
**Citation:** Ben-Shaanan TL, Schiller M, Azulay-Debby H, Korin B, Boshnak N, Koren T, Krot M, Shakya J, Rahat MA, Hakim F, Rolls A. Modulation of anti-tumor immunity by the brain's reward system. Nat Commun. 2018 Jul 13;9(1):2723. doi: 10.1038/s41467-018-05283-5.
**PMID:** 30006573
**Citation:** Kite SM, Maher EJ, Anderson K, Young T, Young J, Wood J, Howells N, Bradburn J. Development of an aromatherapy service at a Cancer Centre. Palliat Med. 1998 May;12(3):171-80. doi: 10.1191/026921698671135743.
**PMID:** 9743836
**Citation:** Deng C, Xie Y, Liu Y, Li Y, Xiao Y. Aromatherapy Plus Music Therapy Improve Pain Intensity and Anxiety Scores in Patients With Breast Cancer During Perioperative Periods: A Randomized Controlled Trial. Clin Breast Cancer. 2022 Feb;22(2):115-120. doi: 10.1016/j.clbc.2021.05.006. Epub 2021 May 20.
**PMID:** 34134947
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M4324
- Name: Anxiety Disorders
- 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
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ARhu
- Name: Antirheumatic Agents
### Intervention Browse Module - Browse Leaves
- ID: M18650
- Name: Carboplatin
- Relevance: LOW
- As Found: Unknown
- ID: M325
- Name: Trastuzumab
- Relevance: LOW
- As Found: Unknown
- ID: M6727
- Name: Cyclophosphamide
- Relevance: LOW
- As Found: Unknown
- ID: M147959
- Name: Taxane
- Relevance: LOW
- As Found: Unknown
- ID: M289243
- Name: Pertuzumab
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435091
**Acronym:** REBECCA-3
**Brief Title:** REBECCA-3 Study, Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
**Official Title:** REBECCA-3 Study, Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
#### Organization Study ID Info
**ID:** REBECCA3SUH
#### Organization
**Class:** OTHER_GOV
**Full Name:** Helse Stavanger HF
### Status Module
#### Completion Date
**Date:** 2025-05
**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
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### 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_GOV
**Name:** Helse Stavanger HF
#### 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 aim of the REBECCA project is to exploit the potential of "real-world data" to support clinical research and improve existing clinical workflow. The primary aim of the REBECCA-3 study is to use multi-source "real-world data" to monitor the quality of life (QoL) of prostate cancer patients who are affected by cancer-related fatigue during and after treatment. This is to investigate whether the REBECCA monitoring is accepted by male patients and can be used within various forms of cancer.
Study design: 40 prostate cancer patients that undergo radiology and/or chemotherapy treatment will be included at the time of diagnosis. After end of primary treatment, the patients will receive a smartwatch, and have to download a REBECCA patient app on their mobile and a PC plug-in on their PC so that we can monitor their QoL for 4 months. In addition to collecting digital QoL parameters through the REBECCA-system, patient-reported QoL measures will also be collected through standardized PROMs and self-evaluation forms. Further, biological samples (blood, urine, and faeces) are collected at three time points of the study (i.e., at the time of: diagnosis, completed treatment, and 4 months post treatment), to investigate immunologic biomarkers, DNA methylation patterns and microbiota for assessment of new biological and prognostic information related to the development of cancer-related fatigue in prostate cancer patients.
### Conditions Module
**Conditions:**
- Cancer Related Fatigue
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Daily and weekly frequency of participant interactions with the REBECCA system.
**Measure:** Evaluation of the average REBECCA system usage rate throughout the monitoring period.
**Time Frame:** From the end of treatment to the 4-month post-treatment follow-up.
#### Secondary Outcomes
**Description:** The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ) C30 scores patients QoL on a scale of 0-100, where higher values indicate higher QoL.
**Measure:** Quality of life (QoL) measured by the EORTC-QLQ-C30.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** The SF36 scores the patients physical and mental health on a scale of 0-100, where higher values indicate better health.
**Measure:** Quality of life (QoL) measured by the SF36-questionnaire.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** The Expanded Prostate Cancer Index Composite short form 26 (EPIC-26) scores the patients QoL on a scale of 0-100, where higher values indicate better health.
**Measure:** Quality of life (QoL) measured by the EPIC-26-questionnaire.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** The fatigue Visual Analog Scale (fVAS) scores fatigue on a scale of 0-100, where lower values indicate less fatigue, thus a reduction in fVAS score between timepoints indicates a reduction of fatigue.
**Measure:** Fatigue in primary prostate cancer patients measured by the fVAS questionnaire.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** The Fatigue Severity Scale (FSS) scores fatigue on a scale of 1-7, where lower values indicate less fatigue, thus a reduction in FSS score between timepoints indicates a reduction of fatigue.
**Measure:** Fatigue in primary prostate cancer patients measured by the FSS questionnaire.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** The Fatigue Questionnaire (FQ) scores fatigue on a scale of 0-33, where lower values indicate less fatigue, thus a reduction in FQ score between timepoints indicates a reduction of fatigue.
**Measure:** Fatigue in primary prostate cancer patients measured by the FQ questionnaire.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** The REBECCA system index score is given as values between 0 and 100, where higher values indicate higher QoL.
**Measure:** REBECCA system index score
**Time Frame:** At the 4-month post-treatment follow-up.
**Description:** Weekly measurements over a 4-month period.
**Measure:** Longitudinal analysis of the effect of the use of REBECCA using Generalized Estimating Equation (GEE)
**Time Frame:** From the end of treatment to the 4-month post-treatment follow-up.
**Description:** Measure levels of fatigue biomarkers: HSP90, IL1β, IL6, IL10, IL1βRa, and DNA methylation.
**Measure:** Fatigue biomarkers in plasma of primary prostate cancer patients.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** Long-read 16S rRNA sequencing of faecal samples to characterize the gut microbiota composition.
**Measure:** Gut microbiota composition in primary prostate cancer patients.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** REBECCA score (scale 0-100) correlation to the EORTC-QLQ-C30 (scale 0-100), SF36 (scale 0-100), and EPIC-26 (scale 0-100).
**Measure:** Correlation between the REBECCA system index score and QoL questionnaire scores.
**Time Frame:** At the 4-month post-treatment follow-up.
**Description:** REBECCA score (scale 0-100) correlation to the fVAS (scale 0-100), FSS (scale 0-7) and FQ (scale 0-33).
**Measure:** Correlation between the REBECCA system index score and fatigue questionnaire scores.
**Time Frame:** At the 4-month post-treatment follow-up.
**Description:** REBECCA score (scale 0-100) correlation to fatigue biomarker levels of HSP90, IL1β, IL6, IL10, IL1βRa and DNA methylation in plasma.
**Measure:** Correlation between the REBECCA system index score and fatigue biomarker levels in plasma
**Time Frame:** At the 4-month post-treatment follow-up.
**Description:** REBECCA score (scale 0-100) correlation to fatigue biomarker levels of pro-inflammatory and anti-inflammatory microbes in feces.
**Measure:** Correlation between the REBECCA system index score and fatigue biomarker levels in feces.
**Time Frame:** At the 4-month post-treatment follow-up.
**Description:** The System Usability Scale measures user satisfaction on a scale from 0-100, where a score \>75 indicate system use satisfaction.
**Measure:** Subjective assessments of system usability measured by the System Usability Scale questionnaire.
**Time Frame:** At the 4-month post-treatment follow-up.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Prostate cancer patients with histologically detectable M0 prostate cancer requiring primary surgery or primary radiation therapy followed by hormone therapy at least and no more than 3 months of initiation prior to study start
* Male prostate cancer patients under 80 years of age.
* Patients who have an increased life expectancy beyond the first 3 months after starting treatment.
* Patients who have the ability to understand the protocol and can participate in the follow-up plan.
* Patients who have the absence of psychological, familial, sociological, or geographic condition potentially hindering compliance with the study protocol and follow-up schedule.
* Patients who have a smart phone.
Exclusion Criteria:
* Patients who do not consent to the study protocol.
* Patients with a previous cancer diagnosis (except skin cancer treated only by surgery).
* Patients who have previously been treated with any form of chemotherapy/radiotherapy.
* Foreign-language patients without sufficient Norwegian understanding
* Patients who do not have a smartphone
**Gender Based:** True
**Maximum Age:** 80 Years
**Minimum Age:** 19 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Prostate cancer patients at Stavanger University Hospital, Norway
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** tjensvollk@gmail.com
**Name:** Kjersti Tjensvoll, PhD
**Phone:** 004747809206
**Role:** CONTACT
**Contact 2:**
**Email:** sdmn@sus.no
**Name:** Marius Stensland, MD
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Stavanger
**Contacts:**
***Contact 1:***
- **Email:** tjensvollk@gmail.com
- **Name:** Kjersti Tjensvoll, PhD
- **Phone:** 004747809206
- **Role:** CONTACT
***Contact 2:***
- **Email:** sdmn@sus.no
- **Name:** Marius Stensland, MD
- **Role:** CONTACT
**Country:** Norway
**Facility:** Stavanger University Hospital
**Status:** RECRUITING
**Zip:** 4067
#### Overall Officials
**Official 1:**
**Affiliation:** Helse Stavanger HF
**Name:** Svein Skeie, PhD
**Role:** STUDY_DIRECTOR
### References Module
#### See Also Links
**Label:** REBECCA Project Site
**URL:** https://rebeccaproject.eu/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- 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: M5220
- Name: Breast Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: HIGH
- As Found: Chronic Conditions
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002908
- Term: Chronic Disease
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435078
**Brief Title:** Developments of Novel Virtual Visual and Haptic Stimulation Systems for the Elderly
**Official Title:** Developments of Novel Virtual Visual and Haptic Stimulation Systems for the Elderly
#### Organization Study ID Info
**ID:** B-ER-105-238
#### Organization
**Class:** OTHER
**Full Name:** National Cheng-Kung University Hospital
### Status Module
#### Completion Date
**Date:** 2017-08-21
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2017-08-21
**Type:** ACTUAL
#### Start Date
**Date:** 2017-03-06
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** National Cheng-Kung University Hospital
#### Responsible Party
**Investigator Affiliation:** National Cheng-Kung University Hospital
**Investigator Full Name:** Fong Chin Su
**Investigator Title:** Chair Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** previous studies indicated that sensory input can have positive impacts on finger force control in the elderly. Additionally, according to previous reports, apart from pharmacotherapy, nonpharmacologic interventions, such as psychosocial-environmental treatments, are emerging for the behavior and affective symptoms in AD . Moreover, enhanced finger force control and coordination lead to better hand dexterity and is believed to eventually improve life independence in the healthy elderly and the elderly with AD. Therefore, this study aims to develop novel virtual visual and haptic stimulation systems for the elderly to enhance their finger force control.
### Conditions Module
**Conditions:**
- Healthy Elderly
- Alzheimer Disease
**Keywords:**
- Pressing Evaluation and Training System
- Virtual Reality
- Augmented Reality
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 40
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** subjects will be instructed to execute simulated piano playing tasks with Augmented Reality.
**Intervention Names:**
- Device: mPETS(modified-PETS system)
**Label:** AR-mPETS
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** subjects will be instructed to execute simulated piano playing tasks with Virtual Reality.
**Intervention Names:**
- Device: mPETS(modified-PETS system)
**Label:** VR-mPETS
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- AR-mPETS
- VR-mPETS
**Description:** The pressing evaluation and training system (PETS) consists of five force transducers, a pad position-adjustable frame, and biofeedback system. Five force transducers are used to collect the applied normal force from five digits.
**Name:** mPETS(modified-PETS system)
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Subjects will be asked to track the target force and presses task digit to fit the target line until finish.
**Measure:** Force-track testing
**Time Frame:** Before and after intervention (4 weeks)
#### Secondary Outcomes
**Description:** In sequential testing, subjects will be asked to follow the pressing guide. The reaction time of sequential movements will be recorded and calculated.
**Measure:** Sequential testing( reaction time)
**Time Frame:** Before and after intervention (4 weeks)
**Description:** In sequential testing, subjects will be asked to follow the pressing guide. The correct ratio of sequential movements will be recorded and calculated.
**Measure:** Sequential testing( correct ratio )
**Time Frame:** Before and after intervention (4 weeks)
### Eligibility Module
**Eligibility Criteria:** Healthy elderly
Inclusion Criteria:
* Aged ≥ 65
* Healthy adult (no skeletal muscle, neurological disease that will affect training).
Exclusion Criteria:
* Neurological disorders
* Musculoskeletal problems
* History of surgery Patients with Alzheimer's disease
Inclusion Criteria:
* Diagnosed with Alzheimer's disease.
* No skeletal muscle, neurological disease that will affect training.
**Healthy Volunteers:** True
**Maximum Age:** 85 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Tainan
**Country:** Taiwan
**Facility:** National Cheng Kung University
**Zip:** 701
#### Overall Officials
**Official 1:**
**Affiliation:** Chair Professor
**Name:** Fong-Chin Su
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Organization, W.H., Global health and aging. Acedido março, 2011. 5: p. 2015.
**Citation:** Grabiner MD, Enoka RM. Changes in movement capabilities with aging. Exerc Sport Sci Rev. 1995;23:65-104. No abstract available.
**PMID:** 7556361
**Citation:** Ranganathan VK, Siemionow V, Sahgal V, Liu JZ, Yue GH. Skilled finger movement exercise improves hand function. J Gerontol A Biol Sci Med Sci. 2001 Aug;56(8):M518-22. doi: 10.1093/gerona/56.8.m518.
**PMID:** 11487606
**Citation:** Olafsdottir HB, Zatsiorsky VM, Latash ML. The effects of strength training on finger strength and hand dexterity in healthy elderly individuals. J Appl Physiol (1985). 2008 Oct;105(4):1166-78. doi: 10.1152/japplphysiol.00054.2008. Epub 2008 Aug 7.
**PMID:** 18687981
**Citation:** Keogh JW, Morrison S, Barrett R. Strength training improves the tri-digit finger-pinch force control of older adults. Arch Phys Med Rehabil. 2007 Aug;88(8):1055-63. doi: 10.1016/j.apmr.2007.05.014.
**PMID:** 17678670
**Citation:** Kwok TC, Lam KC, Wong PS, Chau WW, Yuen KS, Ting KT, Chung EW, Li JC, Ho FK. Effectiveness of coordination exercise in improving cognitive function in older adults: a prospective study. Clin Interv Aging. 2011;6:261-7. doi: 10.2147/CIA.S19883. Epub 2011 Sep 29.
**PMID:** 22087065
**Citation:** Zhang W, Scholz JP, Zatsiorsky VM, Latash ML. What do synergies do? Effects of secondary constraints on multidigit synergies in accurate force-production tasks. J Neurophysiol. 2008 Feb;99(2):500-13. doi: 10.1152/jn.01029.2007. Epub 2007 Nov 28.
**PMID:** 18046000
**Citation:** Kim SW, Shim JK, Zatsiorsky VM, Latash ML. Finger inter-dependence: linking the kinetic and kinematic variables. Hum Mov Sci. 2008 Jun;27(3):408-22. doi: 10.1016/j.humov.2007.08.005. Epub 2008 Feb 5.
**PMID:** 18255182
**Citation:** Shim JK, Lay BS, Zatsiorsky VM, Latash ML. Age-related changes in finger coordination in static prehension tasks. J Appl Physiol (1985). 2004 Jul;97(1):213-24. doi: 10.1152/japplphysiol.00045.2004. Epub 2004 Mar 5.
**PMID:** 15003998
**Citation:** Parikh PJ, Cole KJ. Handling objects in old age: forces and moments acting on the object. J Appl Physiol (1985). 2012 Apr;112(7):1095-104. doi: 10.1152/japplphysiol.01385.2011. Epub 2012 Jan 12.
**PMID:** 22241054
**Citation:** Shinohara M, Scholz JP, Zatsiorsky VM, Latash ML. Finger interaction during accurate multi-finger force production tasks in young and elderly persons. Exp Brain Res. 2004 Jun;156(3):282-92. doi: 10.1007/s00221-003-1786-9. Epub 2004 Feb 19.
**PMID:** 14985892
**Citation:** Shinohara M, Li S, Kang N, Zatsiorsky VM, Latash ML. Effects of age and gender on finger coordination in MVC and submaximal force-matching tasks. J Appl Physiol (1985). 2003 Jan;94(1):259-70. doi: 10.1152/japplphysiol.00643.2002. Epub 2002 Sep 13.
**PMID:** 12391031
**Citation:** Olafsdottir H, Zhang W, Zatsiorsky VM, Latash ML. Age-related changes in multifinger synergies in accurate moment of force production tasks. J Appl Physiol (1985). 2007 Apr;102(4):1490-501. doi: 10.1152/japplphysiol.00966.2006. Epub 2007 Jan 4.
**PMID:** 17204576
**Citation:** Cobos, F.J.M. and M.d.M.M. Rodríguez, A Review of psychological intervention in Alzheimer s disease. International Journal of Psychology and Psychological Therapy, 2012. 12(3): p. 373-388.
**Citation:** Franssen EH, Souren LE, Torossian CL, Reisberg B. Equilibrium and limb coordination in mild cognitive impairment and mild Alzheimer's disease. J Am Geriatr Soc. 1999 Apr;47(4):463-9. doi: 10.1111/j.1532-5415.1999.tb07240.x.
**PMID:** 10203123
**Citation:** Verheij S, Muilwijk D, Pel JJ, van der Cammen TJ, Mattace-Raso FU, van der Steen J. Visuomotor impairment in early-stage Alzheimer's disease: changes in relative timing of eye and hand movements. J Alzheimers Dis. 2012;30(1):131-43. doi: 10.3233/JAD-2012-111883.
**PMID:** 22377783
**Citation:** Wu YH, Pazin N, Zatsiorsky VM, Latash ML. Improving finger coordination in young and elderly persons. Exp Brain Res. 2013 Apr;226(2):273-83. doi: 10.1007/s00221-013-3433-4. Epub 2013 Feb 15.
**PMID:** 23411675
**Citation:** Langlois F, Vu TT, Chasse K, Dupuis G, Kergoat MJ, Bherer L. Benefits of physical exercise training on cognition and quality of life in frail older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):400-4. doi: 10.1093/geronb/gbs069. Epub 2012 Aug 28.
**PMID:** 22929394
**Citation:** Shim JK, Karol S, Kim YS, Seo NJ, Kim YH, Kim Y, Yoon BC. Tactile feedback plays a critical role in maximum finger force production. J Biomech. 2012 Feb 2;45(3):415-20. doi: 10.1016/j.jbiomech.2011.12.001. Epub 2012 Jan 4.
**PMID:** 22222494
**Citation:** Kim Y, Shim JK, Hong YK, Lee SH, Yoon BC. Cutaneous sensory feedback plays a critical role in agonist-antagonist co-activation. Exp Brain Res. 2013 Aug;229(2):149-56. doi: 10.1007/s00221-013-3601-6. Epub 2013 Jul 9.
**PMID:** 23836110
**Citation:** Li K, Marquardt TL, Li ZM. Removal of visual feedback lowers structural variability of inter-digit force coordination during sustained precision pinch. Neurosci Lett. 2013 Jun 17;545:1-5. doi: 10.1016/j.neulet.2013.04.011. Epub 2013 Apr 24.
**PMID:** 23624025
**Citation:** Ambike S, Zatsiorsky VM, Latash ML. Processes underlying unintentional finger-force changes in the absence of visual feedback. Exp Brain Res. 2015 Mar;233(3):711-21. doi: 10.1007/s00221-014-4148-x. Epub 2014 Nov 23.
**PMID:** 25417192
**Citation:** Hu X, Newell KM. Aging, visual information, and adaptation to task asymmetry in bimanual force coordination. J Appl Physiol (1985). 2011 Dec;111(6):1671-80. doi: 10.1152/japplphysiol.00760.2011. Epub 2011 Sep 29.
**PMID:** 21960656
**Citation:** Seo NJ, Fischer HW, Bogey RA, Rymer WZ, Kamper DG. Use of visual force feedback to improve digit force direction during pinch grip in persons with stroke: a pilot study. Arch Phys Med Rehabil. 2011 Jan;92(1):24-30. doi: 10.1016/j.apmr.2010.08.016. Epub 2010 Nov 18.
**PMID:** 21092931
**Citation:** Hu X, Loncharich M, Newell KM. Visual information interacts with neuromuscular factors in the coordination of bimanual isometric force. Exp Brain Res. 2011 Mar;209(1):129-38. doi: 10.1007/s00221-010-2528-4. Epub 2010 Dec 28.
**PMID:** 21188355
**Citation:** Loucks TM, Ofori E, Sosnoff JJ. Force control under auditory feedback: effector differences and audiomotor memory. Percept Mot Skills. 2012 Jun;114(3):915-35. doi: 10.2466/24.25.27.PMS.114.3.915-935.
**PMID:** 22913030
**Citation:** Jo HJ, Ambike S, Lewis MM, Huang X, Latash ML. Finger force changes in the absence of visual feedback in patients with Parkinson's disease. Clin Neurophysiol. 2016 Jan;127(1):684-692. doi: 10.1016/j.clinph.2015.05.023. Epub 2015 Jun 3.
**PMID:** 26072437
**Citation:** Stein J, Bishop J, Gillen G, Helbok R. A pilot study of robotic-assisted exercise for hand weakness after stroke. IEEE Int Conf Rehabil Robot. 2011;2011:5975426. doi: 10.1109/ICORR.2011.5975426.
**PMID:** 22275627
**Citation:** Wu YH, Truglio TS, Zatsiorsky VM, Latash ML. Learning to combine high variability with high precision: lack of transfer to a different task. J Mot Behav. 2015;47(2):153-65. doi: 10.1080/00222895.2014.961892. Epub 2014 Nov 3.
**PMID:** 25365477
**Citation:** Friedman N, Chan V, Reinkensmeyer AN, Beroukhim A, Zambrano GJ, Bachman M, Reinkensmeyer DJ. Retraining and assessing hand movement after stroke using the MusicGlove: comparison with conventional hand therapy and isometric grip training. J Neuroeng Rehabil. 2014 Apr 30;11:76. doi: 10.1186/1743-0003-11-76.
**PMID:** 24885076
**Citation:** Tsai, M.-F., 中風病人手指創新復健器. 成功大學生物醫學工程學系學位論文, 2016: p. 1-94.
**Citation:** Levanon Y. The advantages and disadvantages of using high technology in hand rehabilitation. J Hand Ther. 2013 Apr-Jun;26(2):179-83. doi: 10.1016/j.jht.2013.02.002.
**PMID:** 23598084
**Citation:** Manepalli, J., A. Desai, and P. Sharma, Psychosocial-environmental treatments for Alzheimer's disease. Primary Psychiatry, 2009. 16(6): p. 39.
**Citation:** Chiu HY, Hsu HY, Kuo LC, Chang JH, Su FC. Functional sensibility assessment. Part I: develop a reliable apparatus to assess momentary pinch force control. J Orthop Res. 2009 Aug;27(8):1116-21. doi: 10.1002/jor.20859.
**PMID:** 19195027
**Citation:** Hsu HY, Kuo LC, Chiu HY, Jou IM, Su FC. Functional sensibility assessment. Part II: Effects of sensory improvement on precise pinch force modulation after transverse carpal tunnel release. J Orthop Res. 2009 Nov;27(11):1534-9. doi: 10.1002/jor.20903.
**PMID:** 19402148
**Citation:** Shieh SJ, Hsu HY, Kuo LC, Su FC, Chiu HY. Correlation of digital sensibility and precision of pinch force modulation in patients with nerve repair. J Orthop Res. 2011 Aug;29(8):1210-5. doi: 10.1002/jor.21365. Epub 2011 Mar 4.
**PMID:** 21374708
**Citation:** Hsu HY, Kuo LC, Kuo YL, Chiu HY, Jou IM, Wu PT, Su FC. Feasibility of a novel functional sensibility test as an assisted examination for determining precision pinch performance in patients with carpal tunnel syndrome. PLoS One. 2013 Aug 20;8(8):e72064. doi: 10.1371/journal.pone.0072064. eCollection 2013.
**PMID:** 23977209
**Citation:** Yen WJ, Kuo YL, Kuo LC, Chen SM, Kuan TS, Hsu HY. Precision pinch performance in patients with sensory deficits of the median nerve at the carpal tunnel. Motor Control. 2014 Jan;18(1):29-43. doi: 10.1123/mc.2013-0004.
**PMID:** 24496877
**Citation:** Chiu HY, Hsu HY, Su FC, Jou IM, Lin CF, Kuo LC. Setup of a novel biofeedback prototype for sensorimotor control of the hand and preliminary application in patients with peripheral nerve injuries. Phys Ther. 2013 Feb;93(2):168-78. doi: 10.2522/ptj.20120050. Epub 2012 Sep 27.
**PMID:** 23023814
**Citation:** Hsu HY, Lin CF, Su FC, Kuo HT, Chiu HY, Kuo LC. Clinical application of computerized evaluation and re-education biofeedback prototype for sensorimotor control of the hand in stroke patients. J Neuroeng Rehabil. 2012 May 9;9:26. doi: 10.1186/1743-0003-9-26.
**PMID:** 22571177
**Citation:** Hsu HY, Kuo LC, Jou IM, Chen SM, Chiu HY, Su FC. Establishment of a proper manual tactile test for hands with sensory deficits. Arch Phys Med Rehabil. 2013 Mar;94(3):451-8. doi: 10.1016/j.apmr.2012.07.024. Epub 2012 Aug 9.
**PMID:** 22885285
**Citation:** Hsu HY, Kuo YL, Jou IM, Su FC, Chiu HY, Kuo LC. Diagnosis from functional perspectives: usefulness of a manual tactile test for predicting precision pinch performance and disease severity in subjects with carpal tunnel syndrome. Arch Phys Med Rehabil. 2014 Apr;95(4):717-25. doi: 10.1016/j.apmr.2013.11.017. Epub 2013 Dec 16.
**PMID:** 24355426
**Citation:** Hsu HY, Shieh SJ, Kuan TS, Yang HC, Su FC, Chiu HY, Kuo LC. Manual Tactile Test Predicts Sensorimotor Control Capability of Hands for Patients With Peripheral Nerve Injury. Arch Phys Med Rehabil. 2016 Jun;97(6):983-90. doi: 10.1016/j.apmr.2016.01.008. Epub 2016 Jan 30.
**PMID:** 26829761
**Citation:** Chiu HY, Hsu HY, Kuo LC, Su FC, Yu HI, Hua SC, Lu CH. How the impact of median neuropathy on sensorimotor control capability of hands for diabetes: an achievable assessment from functional perspectives. PLoS One. 2014 Apr 10;9(4):e94452. doi: 10.1371/journal.pone.0094452. eCollection 2014.
**PMID:** 24722361
**Citation:** Hsu HY, Chiu HY, Lin HT, Su FC, Lu CH, Kuo LC. Impacts of elevated glycaemic haemoglobin and disease duration on the sensorimotor control of hands in diabetes patients. Diabetes Metab Res Rev. 2015 May;31(4):385-94. doi: 10.1002/dmrr.2623. Epub 2015 Feb 3.
**PMID:** 25417846
**Citation:** Yang CJ, Hsu HY, Lu CH, Chao YL, Chiu HY, Kuo LC. The associations among hand dexterity, functional performance, and quality of life in diabetic patients with neuropathic hand from objective- and patient-perceived measurements. Qual Life Res. 2015 Jan;24(1):213-21. doi: 10.1007/s11136-014-0748-y. Epub 2014 Jul 14.
**PMID:** 25017499
**Citation:** Chen PT, Jou IM, Lin CJ, Chieh HF, Kuo LC, Su FC. Is the Control of Applied Digital Forces During Natural Five-digit Grasping Affected by Carpal Tunnel Syndrome? Clin Orthop Relat Res. 2015 Jul;473(7):2371-82. doi: 10.1007/s11999-015-4189-x. Epub 2015 Feb 18.
**PMID:** 25690168
**Citation:** Chen PT, Lin CJ, Jou IM, Chieh HF, Su FC, Kuo LC. One digit interruption: the altered force patterns during functionally cylindrical grasping tasks in patients with trigger digits. PLoS One. 2013 Dec 31;8(12):e83632. doi: 10.1371/journal.pone.0083632. eCollection 2013.
**PMID:** 24391799
**Citation:** Kuo LC, Chen SW, Lin CJ, Lin WJ, Lin SC, Su FC. The force synergy of human digits in static and dynamic cylindrical grasps. PLoS One. 2013;8(3):e60509. doi: 10.1371/journal.pone.0060509. Epub 2013 Mar 27.
**PMID:** 23544151
**Citation:** Kuo LC, Hsu HM, Wu PT, Lin SC, Hsu HY, Jou IM. Impact of distal median neuropathy on handwriting performance for patients with carpal tunnel syndrome in office and administrative support occupations. J Occup Rehabil. 2014 Jun;24(2):332-43. doi: 10.1007/s10926-013-9471-8.
**PMID:** 23934582
**Citation:** Hsu, H.-M., et al., Quantification of handwriting performance: Development of a force acquisition pen for measuring hand-grip and pen tip forces. Measurement, 2013. 46(1): p. 506-513.
**Citation:** Lai, K.-Y., et al., Effects of hand span size and right-left hand side on the piano playing performances: Exploration of the potential risk factors with regard to piano-related musculoskeletal disorders. International Journal of Industrial Ergonomics, 2015. 50: p. 97-104.
**Citation:** Park J, Wu YH, Lewis MM, Huang X, Latash ML. Changes in multifinger interaction and coordination in Parkinson's disease. J Neurophysiol. 2012 Aug 1;108(3):915-24. doi: 10.1152/jn.00043.2012. Epub 2012 May 2.
**PMID:** 22552184
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003704
- Term: Dementia
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000024801
- Term: Tauopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3885
- Name: Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
- ID: M6904
- Name: Dementia
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23002
- Name: Tauopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T2192
- Name: Familial Alzheimer Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000544
- Term: Alzheimer Disease
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435065
**Brief Title:** Direct Pulp Capping Agent on Human Pulp Tissue
**Official Title:** Histological and Radiographic Evaluation of the Effects of Direct Pulp Capping Agent on Human Pulp Tissue
#### Organization Study ID Info
**ID:** 2264
#### Organization
**Class:** OTHER
**Full Name:** Maharishi Markendeswar University (Deemed to be University)
### 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:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** DR SURINDER SACHDEVA
#### Responsible Party
**Investigator Affiliation:** Maharishi Markendeswar University (Deemed to be University)
**Investigator Full Name:** DR SURINDER SACHDEVA
**Investigator Title:** periodontist
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This in- vivo study was conducted to evaluate the response of human pulp tissue following direct pulp capping using four different pulp capping agents in premolars scheduled for extraction in patients undergoing orthodontic treatment.
**Detailed Description:** For the study 40 premolars from patients in the age group of 15-25 years, undergoing orthodontic treatment, in the Department of Orthodontics, MMCDSR, Mullana, Ambala, who had to get their premolars extracted as per their orthodontic treatment plan will be selected.
Only healthy premolars, with no caries, showing no signs and symptoms of pulpitis or periodontal diseases were selected. Medically compromised patients, or teeth with radiographic findings of external/internal resorption, bone loss, or calcifications in the pulp chamber will be excluded from the study. The selected premolars were then randomly divided into four equal groups namely: GROUP I - Direct pulp capping procedure performed using Biodentine. GROUP II - Direct pulp capping procedure performed using MTA. GROUP III - Direct pulp capping procedure performed using TheraCal LC. GROUP IV - Direct pulp capping procedure performed using Tristrontium aluminate.
The direct pulp capping procedure was carried out under rubber dam. The study protocol included class I cavity preparations on the premolars, followed by iatrogenic exposure of the pulp (0.5mm) using a sterile round bur, placement of the direct pulp capping agent according to the material of allotted to the study group. The teeth were permanently restored on the same visit, except for MTA group were the teeth were temporarily restored using Cavit G, and recalled after 1 day for permanent restoration. The patients were then enquired for any 94 SUMMARY 95 symptoms at 1 day and 7 days post operatively. The teeth were then, atraumatically extracted 3 months after the procedure. The extracted teeth were then put to CBCT as well as histopathological examination. Through CBCT evaluation, the completeness of the dentine bridge was evaluated. Histopathological examination was done to examine the pulpal response and the quality of the dentine bridge formed
### Conditions Module
**Conditions:**
- Reversible Pulpitis
**Keywords:**
- DIRCT PULP CAPPING
- Biodentine
- MTA
- TheraCal LC
- Tristrontium Aluminate
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### 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:** DIRECT PULP CAPPING WILL BE DONE USING BIODENTINE AS DIRECT PULP CAPPING AGENT
**Intervention Names:**
- Drug: Biodentine
**Label:** BIODENTINE
**Type:** SHAM_COMPARATOR
#### Arm Group 2
**Description:** DIRECT PULP CAPPING WILL BE DONE USING MTA AS DIRECT PULP CAPPING AGENT
**Intervention Names:**
- Drug: Mineral Tri-Oxide Aggregate
**Label:** MINERAL TRIOXIDE AGGREGATE
**Type:** SHAM_COMPARATOR
#### Arm Group 3
**Description:** DIRECT PULP CAPPING WILL BE DONE USING THERACAL LC AS DIRECT PULP CAPPING AGENT
**Intervention Names:**
- Drug: THERACAL LC
**Label:** THERACAL LC
**Type:** SHAM_COMPARATOR
#### Arm Group 4
**Description:** DIRECT PULP CAPPING WILL BE DONE USING TRISTRONTIUM ALUMINATE AS DIRECT PULP CAPPING AGENT
**Intervention Names:**
- Drug: TRISTRONTIUM ALUMINATE
**Label:** TRISTRONTIUM ALUMINATE
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- BIODENTINE
**Description:** DIRECT PULP CAPPINGWILL BE DONE USING BIODENTINE
**Name:** Biodentine
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- MINERAL TRIOXIDE AGGREGATE
**Description:** DIRECT PULP CAPPINGWILL BE DONE USING MTA
**Name:** Mineral Tri-Oxide Aggregate
**Other Names:**
- MTA
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- THERACAL LC
**Description:** DIRECT PULP CAPPINGWILL BE DONE USING THERACAL LC
**Name:** THERACAL LC
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- TRISTRONTIUM ALUMINATE
**Description:** DIRECT PULP CAPPINGWILL BE DONE USING TRISTRONTIUM ALUMINATE
**Name:** TRISTRONTIUM ALUMINATE
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** radiographic examination will be done after 90 days and presence or absence of secondary dentin formation and completeness of the dentinal bride formed will be evaluated by CBCT
**Measure:** RADIOGRAPHIC EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE
**Time Frame:** 90 DAYS
**Description:** Histological examination of the extracted teeth will be done after 90 days and evidence of dentinal bridge formation will be evaluated microscopically
**Measure:** HISTOLOGICAL EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE
**Time Frame:** 90 DAYS
### Eligibility Module
**Eligibility Criteria:** INCLUSION CRITERIA:
* CARIES-free, undamaged mature maxillary and mandibular premolars that were planned for extraction for orthodontic reasons.
* Teeth that show no reaction to percussion.
* Teeth with no previous restorations.
* Teeth that show vitality, when checked with an electric pulp tester.
* Teeth that show no signs of caries or periapical pathology when examined
* radiographically.
* Fully erupted teeth, that allowed proper application of rubber dam.
EXCLUSION CRITERIA:
* caries are present
* Teeth with signs and symptoms of irreversible pulpitis, such as nighttime severe pain
* or spontaneous pain.
* Teeth that show sensitivity to hot and/or cold.
* Radiographic examination reveals any signs of caries, periapical pathology,
* internal/external root resorption, furcal radiolucency/ inter-radicular bone destruction
* and/or calcifications in the pulp chamber or canals.
* Medically compromised patient.
* Pregnant patient.
**Healthy Volunteers:** True
**Maximum Age:** 25 Years
**Minimum Age:** 15 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** drswatichhabra@gmail.com
**Name:** swati chhabra, MDS
**Phone:** 7015070095
**Role:** CONTACT
**Contact 2:**
**Email:** navneetkukrejaendo@gmail.com
**Name:** navneet kukreja, MDS
**Phone:** 9416028633
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ambāla
**Contacts:**
***Contact 1:***
- **Name:** swati chhabra
- **Role:** CONTACT
**Country:** India
**Facility:** Swati
**State:** Haryana
**Status:** RECRUITING
**Zip:** 133207
#### Overall Officials
**Official 1:**
**Affiliation:** professor
**Name:** surinder sachdeva, mds
**Role:** STUDY_DIRECTOR
### References Module
#### References
**Citation:** Parolia A, Kundabala M, Rao NN, Acharya SR, Agrawal P, Mohan M, Thomas M. A comparative histological analysis of human pulp following direct pulp capping with Propolis, mineral trioxide aggregate and Dycal. Aust Dent J. 2010 Mar;55(1):59-64. doi: 10.1111/j.1834-7819.2009.01179.x.
**PMID:** 20415913
**Citation:** Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlinska J. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7. doi: 10.1016/j.joen.2013.01.005. Epub 2013 Apr 10.
**PMID:** 23683272
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003788
- Term: Dental Pulp Diseases
- ID: D000014076
- Term: Tooth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14525
- Name: Pulpitis
- Relevance: HIGH
- As Found: Pulpitis
- ID: M6984
- Name: Dental Pulp Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011671
- Term: Pulpitis
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435052
**Brief Title:** Efficacy of Eye Movement Desensitization & Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan
**Official Title:** Efficacy of Eye Movement Desensitization & Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan: A Full-fledged Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 111
#### Organization
**Class:** OTHER
**Full Name:** Khushal Khan Khattak Univeristy, Karak, Pakistan
### Status Module
#### Completion Date
**Date:** 2025-08-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-08-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-02-01
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Khushal Khan Khattak Univeristy, Karak, Pakistan
#### Responsible Party
**Investigator Affiliation:** Khushal Khan Khattak Univeristy, Karak, Pakistan
**Investigator Full Name:** Dr. Anwar Khan
**Investigator Title:** Dr. Anwar Khan, Assistant Professor of Organizational Psychology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This Randomized Controlled Trial will check the efficacy of Eye Movement Desensitization \& Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan
**Detailed Description:** This Randomized Controlled Trial will check the efficacy of Eye Movement Desensitization \& Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan.
It will be a single blind multi-center RCT with two arms (EMDR and CBT). This study will broadly work on following aims:
1. Initially the comparative efficacy of EMDR and CBT (i.e., standard face-to-face protcols) will be determined on large scale in Pakistan by:
1. Examining whether EMDR is non-inferior to CBT in the treatment of PTSD and its two comorbidities in Pakistan.
2. Studying changes in the symptoms (i.e., reduction in the PTSD and comorbid symptoms with the passage of time) after administering EMDR and CBT. The level of change in the symptoms will ultimately help in determining the extent of effectiveness of both therapies.
3. Examine the reciprocal relationship between PTSD and comorbid symptoms for knowing whether any reduction in the PTSD symptoms can help in reducing the comorbid symptoms after administering EMDR and CBT.
2. At the mean time work on the design and development of virtual EMDR and CBT therapies (i.e., Web-based and Mobile Applications) will also be started. The initial prototypes will be tested for its comparative efficacy. Later once the final versions will be developed then it will be also tested for its comparative efficacy on large scale in Pakistan.
### Conditions Module
**Conditions:**
- Post Traumatic Stress Disorder
- Depression, Anxiety
**Keywords:**
- Post Traumatic Stress Disorder
- EMDR
- CBT
- Pakistan
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Eye Movement Desensitization and Reprocessing (EMDR) therapy will be administered face-to-face by a psychotherapist in a total of 12 sessions, with one session per week. The efficacy of EMDR therapy will be compared with Cognitive Behavioral Therapy (CBT) in the treatment of Post-Traumatic Stress Disorder (PTSD) in Pakistan.
**Intervention Names:**
- Behavioral: Eye Movement Desensitization & Reprocessing Therapy
**Label:** Eye Movement Desensitization & Reprocessing Therapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Cognitive Behavioral Therapy (CBT) will be delivered face-to-face by a psychotherapist in a total of 14 sessions, with one session per week. The efficacy of CBT will be compared with Eye Movement Desensitization and Reprocessing therapy in the treatment of Post-Traumatic Stress Disorder in Pakistan.
**Intervention Names:**
- Behavioral: Cognitive Behavioral Therapy
**Label:** Cognitive Behavioral Therapy
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Eye Movement Desensitization & Reprocessing Therapy
**Description:** Eye Movement Desensitization and Reprocessing (EMDR) therapy will be administered face-to-face by a psychotherapist in a total of 12 sessions, with one session per week. The efficacy of EMDR therapy will be compared with Cognitive Behavioral Therapy in the treatment of Post-Traumatic Stress Disorder in Pakistan.
**Name:** Eye Movement Desensitization & Reprocessing Therapy
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Cognitive Behavioral Therapy
**Description:** Cognitive Behavioral Therapy will be comparatively checked with Eye Movement Desensitization \& Reprocessing Therapy for its efficacy. It will be administered by psychotherapist in 14 sessions (each session per week)
**Name:** Cognitive Behavioral Therapy
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Post-traumatic stress disorder (PTSD) will be assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 scores will be utilized to determine the severity of PTSD symptoms. Typically, a CAPS-5 score of 40 or above will serve as the cutoff point for diagnosing PTSD.
**Measure:** Post-traumatic stress disorder
**Time Frame:** 2 years
#### Secondary Outcomes
**Description:** Depressive and anxiety symptoms will be measured using the Hamilton Depression Rating Scale and the State-Trait Anxiety Inventory, respectively. A Hamilton Depression Rating Scale score of 20 or above, and a State-Trait Anxiety Inventory score of 40 or above, will serve as the cutoff points.
**Measure:** Depressive and Anxiety Symptoms
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
reverse of the exclusion critera
Exclusion Criteria:
The following patients will be excluded:
1. Patients below the age of 15 years and above 60 years, since this study is neither on children nor on old aged patients;
2. Patients who can't move their hands and eyes/or can't perform basic movements;
3. Patients who are unconscious for longer periods and unable to recover consciousness;
4. Patients not meeting the basic screening criteria of PTSD/ PTSD is not the main problem;
5. Patients with severe intellectual impairments, since such patients are difficult to communicate
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Karak
**Contacts:**
***Contact 1:***
- **Email:** akpashtoon1981@gmail.com
- **Name:** Anwar Khan
- **Phone:** 03345606406
- **Role:** CONTACT
**Country:** Pakistan
**Facility:** Anwar Khan
**Status:** RECRUITING
**Zip:** 27200
### IPD Sharing Statement Module
**Description:** can be shared on request
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000068099
- Term: Trauma and Stressor Related Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M7058
- Name: Depression
- Relevance: LOW
- As Found: Unknown
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M24916
- Name: Stress Disorders, Traumatic
- Relevance: HIGH
- As Found: Traumatic Stress Disorder
- ID: M16103
- Name: Stress Disorders, Post-Traumatic
- Relevance: HIGH
- As Found: Post Traumatic Stress Disorder
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M222
- Name: Trauma and Stressor Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000040921
- Term: Stress Disorders, Traumatic
- ID: D000013313
- Term: Stress Disorders, Post-Traumatic
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435039
**Brief Title:** A Study of APL-1501 Extended Release Capsules Compared to APL-1202 Immediate Release Tablets in Healthy Volunteers
**Official Title:** A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of APL-1501 ER Capsules Compared to APL-1202 IR Tablets in Healthy Volunteers
#### Organization Study ID Info
**ID:** YHGT-APL1501-NHS-103
#### Organization
**Class:** OTHER
**Full Name:** Syneos Health
### Status Module
#### Completion Date
**Date:** 2024-10-22
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-21
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-26
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Asieris Pharmaceuticals (AUS) Pty Ltd.
#### Lead Sponsor
**Class:** OTHER
**Name:** Syneos 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:** The primary objective of the study is to assess safety and tolerability following administration of single doses of APL-1202 (immediate release) IR tablets and APL-1501 extended release (ER) capsules in healthy participants.
### Conditions Module
**Conditions:**
- Healthy Volunteers
**Keywords:**
- Bladder Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 32
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive APL-1202 375 milligram (mg) IR tablets, orally, once on Day 1 of Period 1 (Treatment R1), followed by T1 APL-1501 764 mg ER capsules, orally, once, on Day 4 of Period 2 (Treatment T1). A washout period of more than or equal to (\>=) 72 hours will be maintained in between Period 1 and 2.
**Intervention Names:**
- Drug: APL-1202
- Drug: APL-1501
**Label:** Cohort 1, Sequence 1, R1T1: APL-1202 IR 375 mg + APL-1501 ER 764 mg
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive APL-1501 764 mg ER capsules, orally, once on Day 1 of Period 1 (Treatment T1), followed by APL-1202 375 mg IR tablets, orally, once, on Day 4 of Period 2 (Treatment R1). A washout period of \>=72 hours will be maintained in between Period 1 and 2.
**Intervention Names:**
- Drug: APL-1202
- Drug: APL-1501
**Label:** Cohort 1, Sequence 2, T1R1: APL-1501 ER 764 mg + APL-1202 IR 375 mg
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Participants will receive APL-1202 375 mg IR tablets, orally, once on Day 1 of Period 1 (Treatment R1), followed by APL-1501 1146 mg ER capsules, orally, once, on Day 4 of Period 2 (Treatment T2). A washout period of \>=72 hours will be maintained in between Period 1 and 2.
**Intervention Names:**
- Drug: APL-1202
- Drug: APL-1501
**Label:** Cohort 2, Sequence 1, R1T2: APL-1202 IR 375 mg + APL-1501 ER 1146 mg
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Participants will receive APL-1501 1146 mg ER capsules, orally, once on Day 1 of Period 1 (Treatment T2), followed by APL-1202 375 mg IR tablets, orally, once, on Day 4 of Period 2 (Treatment R1). A washout period of \>=72 hours will be maintained in between Period 1 and 2.
**Intervention Names:**
- Drug: APL-1202
- Drug: APL-1501
**Label:** Cohort 2, Sequence 2, T2R1: APL-1501 ER 1146 mg + APL-1202 IR 375 mg
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** Participants will receive APL-1501 1528 mg ER capsules, orally, once on Day 1.
**Intervention Names:**
- Drug: APL-1501
**Label:** Cohort 3: APL-1501 ER 1528 mg
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cohort 1, Sequence 1, R1T1: APL-1202 IR 375 mg + APL-1501 ER 764 mg
- Cohort 1, Sequence 2, T1R1: APL-1501 ER 764 mg + APL-1202 IR 375 mg
- Cohort 2, Sequence 1, R1T2: APL-1202 IR 375 mg + APL-1501 ER 1146 mg
- Cohort 2, Sequence 2, T2R1: APL-1501 ER 1146 mg + APL-1202 IR 375 mg
**Description:** APL-1202 IR tablets.
**Name:** APL-1202
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Cohort 1, Sequence 1, R1T1: APL-1202 IR 375 mg + APL-1501 ER 764 mg
- Cohort 1, Sequence 2, T1R1: APL-1501 ER 764 mg + APL-1202 IR 375 mg
- Cohort 2, Sequence 1, R1T2: APL-1202 IR 375 mg + APL-1501 ER 1146 mg
- Cohort 2, Sequence 2, T2R1: APL-1501 ER 1146 mg + APL-1202 IR 375 mg
- Cohort 3: APL-1501 ER 1528 mg
**Description:** APL-1501 ER capsules.
**Name:** APL-1501
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Number of Participants With Adverse Events (AEs)
**Time Frame:** From Baseline up to Day 9
**Measure:** Number of Participants With Abnormal Vital Sign Measurements
**Time Frame:** From Baseline up to Day 9
**Measure:** Number of Participants With Abnormal 12-Lead Electrocardiogram (ECGs) Recordings
**Time Frame:** From Baseline up to Day 9
**Measure:** Number of Participants With Abnormal Physical Examinations
**Time Frame:** From Baseline up to Day 9
**Measure:** Number of Participants With Abnormal Clinical Laboratory Values
**Time Frame:** From Baseline up to Day 9
#### Secondary Outcomes
**Measure:** AUC0-t: Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** AUC0-inf: Area Under the Concentration-time Curve From Time Zero to Infinity of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Cmax: Maximal Observed Concentration of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Tlast: Time When the Last Concentration is Observed of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Tmax: Time When the Cmax is Observed of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Description:** Residual area is defined as percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity and is calculated as, \[1-(AUC0-t/AUC0-inf)\]\*100.
**Measure:** Residual Area of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** T½ el: Terminal Elimination Half-life of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Kel: Terminal Elimination Rate Constant of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Cl/F: Apparent Clearance of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Vz/F: Apparent Volume of Distribution of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** DNAUC0-inf: Dose Normalized AUC0-inf of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** DNCmax: Dose Normalized Cmax of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Geometric Mean Ratio of Cmax of APL-1501 ER Capsules in Reference to APL-1202 IR Tablets
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Geometric Mean Ratio of AUC0-t of APL-1501 ER Capsules in Reference to APL-1202 IR Tablets
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Geometric Mean Ratio of AUC0-inf of APL-1501 ER Capsules in Reference to APL-1202 IR Tablets
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Description:** The relative bioavailability of APL-1501 versus APL-1202 will be assessed through linear mixed modelling.
**Measure:** Frel: Relative Bioavailability of APL-1501 ER Capsules and APL-1202 IR Tablets
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Description:** Dose proportionality will be assessed by visual inspection of dose normalised Cmax values versus dose.
**Measure:** Dose Proportionality of Cmax
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Description:** Dose proportionality will be assessed by visual inspection of dose normalised AUC0-t values versus dose.
**Measure:** Dose Proportionality of AUC0-t
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Description:** Dose proportionality will be assessed by visual inspection of dose normalised AUC0-inf values versus dose.
**Measure:** Dose Proportionality of AUC0-inf
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Participants must meet all of the following criteria to be included in the study:
1. Male, \>=18 and less than or equal to (\<=) 65 years of age, with body mass index (BMI) greater than (\>) 18.5 and less than (\<) 32.0 kilogram per square meter (kg/m\^2) and body weight \>=50.0 kilogram (kg).
2. Non-smoker (no use of tobacco or nicotine products, example, snuff, chewing tobacco, cigars, cigarettes, pipes, e-cigarettes \[vaping\] etc. within 3 months prior to screening).
3. Healthy as defined by:
1. the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
4. Sexually active non-sterile males must be willing to use an acceptable contraceptive method throughout the study.
5. Able to understand the study procedures and provide signed informed consent to participate in the study.
Exclusion Criteria:
Participants to whom any of the following applies will be excluded from the study:
1. Any clinically significant abnormal finding at physical examination.
2. Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV) antibody, or Human immunodeficiency virus (HIV) antigen and antibody.
3. Positive urine drug screen, cotinine test, or alcohol breath test.
4. History of significant allergic reactions (example, anaphylactic reaction, hypersensitivity, angioedema) to any drug.
5. Clinically significant Electrocardiograms (ECG) abnormalities or vital signs abnormalities (systolic blood pressure \[BP\] lower than 90 or over 140 millimeters of mercury \[mmHg\], diastolic BP lower than 50 or over 90 mmHg, heart rate \[HR\] less than 40 or over 100 beats per minute \[bpm\], or RR less than 10 or over 25 bpm) at screening.
6. History of drug abuse within 1 year prior to screening or recreational use of marijuana within 1 month or other illegal drugs such as cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives within 3 months prior to screening.
7. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units of alcohol per week (1 unit = 375 milliliter \[mL\] of beer 3.5 percent (%), or 100 mL of wine 13.5%, or 30 mL of distilled alcohol 40%).
8. Use of medications within the timeframes specified in section.
9. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
10. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
11. Optic nerve disease, cataracts, or a history of related conditions.
12. Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.
**Gender Based:** True
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** christopher.argent@scientiaclinicalresearch.com.au
**Name:** Dr Christopher Argent
**Phone:** +61 2 9382 5800
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Asieris Pharmaceuticals (AUS) Pty Ltd.
**Name:** Dr Christopher Argent
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5030
- Name: Urinary Bladder Neoplasms
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435026
**Brief Title:** Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1
**Official Title:** Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1
#### Organization Study ID Info
**ID:** 22-2056
#### Organization
**Class:** OTHER
**Full Name:** University of North Carolina, Chapel Hill
#### Secondary ID Infos
**ID:** R01AI157859
**Link:** https://reporter.nih.gov/quickSearch/R01AI157859
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute of Allergy and Infectious Diseases (NIAID)
#### Lead Sponsor
**Class:** OTHER
**Name:** University of North Carolina, Chapel Hill
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study aims: (1) to determine the optimal dose of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for daily oral pre-exposure prophylaxis (PrEP) during pregnancy based on drug pharmacokinetics, and (2) evaluate the maternal and infant safety of increased FTC/TDF doses during these periods.
**Detailed Description:** This is a staged study to assess the pharmacokinetics (PK) and safety of increased FTC/TDF doses for PrEP during pregnancy:
STAGE 1-Dose Identification: Phase 2a pharmacokinetic (PK) study. Using an intensive sampling approach, the following detailed PK information about three doses of daily oral PrEP in pregnancy will be collected: standard FTC/TDF dose (200mg/300mg, n=18), 150% standard dose (300mg/450mg, n=18), and 200% standard dose (400mg/600mg, n=18). Following a lead-in period-where participants receive PrEP for 14 days under direct observation to reach steady state concentrations-plasma, peripheral blood mononuclear cells (PBMC), and other specimens are collected over a 24-hour period to characterize key PK parameters. During pregnancy, two cycles will be performed (i.e., during the second and third trimester) at the assigned FTC/TDF dose. For all participants, this cycle will be repeated at 12 weeks postpartum using the standard FTC/TDF dose, providing a within-person non-pregnant comparator in the longitudinal assessment of bioequivalence. Standard dose FTC/TDF will be offered between periods of direct observation.
INTERMEDIARY STEP-Independent Review: Findings from the initial dose identification stage will be independently reviewed by the Study Monitoring Committee. Based on assessments of the PK, tolerability and preliminary safety data, the committee is expected to recommend an increased dosage of FTC/TDF (150% vs. 200% standard dose) for further investigation in Stage 2.
STAGE 2-Extended Safety Assessment: Phase 2b open-label randomized trial. In the second stage, the extended safety of increased dose PrEP that was identified via independent review will be assessed. Comparison of standard vs. increased FTC/TDF dosages via an open-label randomized trial of 112 pregnant women, allocated 1:1 will be done. Because safety is inextricably linked to adherence, direct observation will be used to confirm adherence, but extend the exposure period through the remainder of pregnancy. Maternal safety will be assessed using detailed medical histories, symptoms diaries, and routine laboratory screening. Information about fetal growth, birth outcomes, and infant growth will be collected; and assessment of maternal and infant bone mineral density will be done twice in the early postpartum period. Embedded in this second stage is population PK sampling (i.e., in plasma, PBMCs, dried blood spot (DBS), and cervicovaginal fluid) to inform models of FTC/TDF concentrations over the course of pregnancy, to be developed as part of this study (Aim 3). Again, following the period of directly observed PrEP at the assigned dose in pregnancy, standard dose FTC/TDF will be self-administered postpartum, in accordance with local HIV guidelines.
\*\* In this record, only activities related to Stage 1 of the study are described. When this advances to Stage 2, a separate entry record in clinicaltrials.gov will be created. \*\*
### Conditions Module
**Conditions:**
- HIV
- Prevention
- Pregnancy
**Keywords:**
- HIV
- PrEP
- Pregnancy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized controlled trial
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 54
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** daily oral FTC/TDF standard dose (200mg/300mg, n=18)
**Intervention Names:**
- Drug: FTC/TDF 200mg/300mg
**Label:** Standard Dose
**Type:** OTHER
#### Arm Group 2
**Description:** daily oral FTC/TDF dose (300mg/450mg, n=18),
**Intervention Names:**
- Drug: FTC/TDF 300mg/450mg
**Label:** 150% standard dose
**Type:** OTHER
#### Arm Group 3
**Description:** daily oral FTC/TDF (400mg/600mg, n=18)
**Intervention Names:**
- Drug: FTC/TDF 400mg/600mg
**Label:** 200% standard dose
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Standard Dose
**Description:** Standard Dose
**Name:** FTC/TDF 200mg/300mg
**Other Names:**
- PrEP
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- 150% standard dose
**Description:** 150% Standard Dose
**Name:** FTC/TDF 300mg/450mg
**Other Names:**
- PrEP
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- 200% standard dose
**Description:** 200% Standard Dose
**Name:** FTC/TDF 400mg/600mg
**Other Names:**
- PrEP
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** AUC of TFV-DP
**Measure:** Tenofovir diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs)
**Time Frame:** Up to 20 weeks after delivery
#### Secondary Outcomes
**Description:** The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS Adverse Event Grading Table), will be used to measure safety.
These include grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening) events. Relatedness of adverse events will be assessed by site teams as defined in the protocol.
**Measure:** Maternal grade >/= 2 adverse events
**Time Frame:** Up to 20 weeks after delivery
**Description:** This is a composite outcome that includes fetal death (spontaneous abortion or stillbirth), preterm birth (\<37 weeks gestation), and small for gestational age (\<10%tile birthweight for gestational age according to INTERGROWTH 21st standards)
**Measure:** Adverse pregnancy outcomes
**Time Frame:** At time of delivery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Maternal participants:
* Aged 16 years or older
* PrEP-eligible by local guidelines
* Pregnant with a viable singleton pregnancy of between 14 and 23 completed weeks of gestation (from 14 weeks + 0 days to 23 weeks + 6 days) by ultrasonography at study entry
* HIV-negative based on the study-specific screening algorithm
* Hepatitis B surface antigen (HBsAg)-negative
* Weight \>35 kg
* Provided informed consent and expressed willingness to participate in study activities with their infants, including daily administration of oral PrEP under direct observation
Infant participants:
Infant participants enter the study with their mother as unborn infants. There are no specific eligibility criteria for infant participation otherwise. If an infant is deemed too ill to undergo study procedures, procedures necessary for clinical management may be prioritized.
Exclusion Criteria:
Maternal participants will not enter the study if any of the following conditions are identified during the screening process:
* Grade 2 or greater laboratory parameters for alanine transaminase (ALT) or aspartate aminotransferase (AST), hemoglobin (HB), and absolute neutrophil count (ANC).
* Estimated creatinine clearance (CrCl) 90 mL/min or below, using the Cockcroft-Gault formula.
* Known history or evidence of current significant disease process, including: hematological conditions, renal disease, unexplained bone fractures, environmental enteric dysfunction, or allergies/sensitivities to FTC/TDF.
* Other current significant or uncontrolled disease process (active or chronic), substance use, or social circumstances that, in the judgment of the site investigator, would make participation in the study inappropriate or unsafe.
* Fetuses with known or suspected major fetal anomaly, either from screening ultrasound or via medical record
* Intention to leave the study site's catchment area before scheduled study exit.
* Current use of prohibited medications
* Concurrent use of other biomedical HIV prevention interventions (vaginal ring, injectable PrEP, any investigational prevention product).
**Gender Based:** True
**Gender Description:** Pregnant women
**Healthy Volunteers:** True
**Minimum Age:** 16 Years
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** Rassil_Barada@med.unc.edu
**Name:** Rassil Barada, MPH
**Phone:** 9194452864
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Lilongwe
**Contacts:**
***Contact 1:***
- **Email:** fsaidi@unclilongwe.org
- **Name:** Friday Saidi, MBBS, MMed
- **Role:** CONTACT
**Country:** Malawi
**Facility:** Bwaila District Hospital
**Location 2:**
**City:** Harare
**Contacts:**
***Contact 1:***
- **Email:** tnematadzira@uz-ctrc.org
- **Name:** Teacler Nematadzira, MBChB, MSc
- **Role:** CONTACT
**Country:** Zimbabwe
**Facility:** Seke North CRS
#### Overall Officials
**Official 1:**
**Affiliation:** University of North Carolina, Chapel Hill
**Name:** Benjamin Chi, MD, MSc
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of Zimbabwe
**Name:** Lynda Stranix-Chibanda, MBChB, MMed
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** University of Colorado - Anschutz Medical Campus
**Name:** Peter Anderson, PharmD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
**Description:** Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina (UNC).
**Info Types:**
- ICF
**IPD Sharing:** YES
**Time Frame:** Beginning 9 and continuing for 36 months following publication
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M18250
- Name: HIV Infections
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435013
**Brief Title:** Lenvatinib vs Bevacizumab Plus ICIs and HAIC in Unresectable HCC
**Official Title:** Lenvatinib Versus Bevacizumab Combined With Immune Checkpoint Inhibitors and Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: A Retrospective, Multi-center, and Propensity Score Matching Study
#### Organization Study ID Info
**ID:** LenBev-001
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen 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:** 2024-05-24
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-12-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sun Yat-sen University
#### Responsible Party
**Investigator Affiliation:** Sun Yat-sen University
**Investigator Full Name:** Shi Ming
**Investigator Title:** Ming Shi
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Previous studies had suggested hepatic arterial infusion chemotherapy (HAIC) combined with immune checkpoint inhibitors (ICIs) and anti-angiogenic drugs had promising anti-tumor activity in unresectable hepatocellular carcinoma (HCC). Two kinds of anti-angiogenic drugs (tyrosine kinase inhibitors \[lenvatinib\] and anti-VEGF antibody \[bevacizumab\]) were applied in first-line treatment of unresectable HCC. However, little is known about the difference of efficacy and safety between lenvatinib (LenHAP) or bevacizumab (BevHAP) combined with ICIs and HAIC in unresectable HCC.
### Conditions Module
**Conditions:**
- Hepatocellular Carcinoma
- Lenvatinib
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 208
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Lenvatinib combined with hepatic arterial infusion chemotherapy and PD-1/PD-L1;
**Intervention Names:**
- Drug: Lenvatinib
**Label:** LenHAP
#### Arm Group 2
**Description:** Bevacizumab combined with hepatic arterial infusion chemotherapy and PD-1/PD-L1;
**Label:** BevHAP
### Interventions
#### Intervention 1
**Arm Group Labels:**
- LenHAP
**Description:** Lenvatinib combined with hepatic arterial infusion chemotherapy and PD-1/PD-L1;
**Name:** Lenvatinib
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** progression-free survival
**Time Frame:** 2015-1 to 2023-4
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:patients aged 18 years or older, with unresectable, locally advanced, or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Disease criteria(15), who had received no previous treatment, had at least on measurable disease, as defined by Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) criteria(16), had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, had a Child-Pugh liver function score of 7 or less and had adequate hematologic and organ function (absolute neutrophil count ≥1.2×109/l, platelet count ≥60×109/l, total bilirubin \<30μmol/l, albumin ≥30g/l, aspartate transaminase and alanine transaminase ≤5×upper limit of the normal, creatinine clearance rate of ≤1.5×upper limit of the normal, and left ventricular ejection ≥45%) -
Exclusion Criteria:history of HIV, organ allograft, combined with other malignant tumors, evidence of hepatic decompensation, bleeding diathesis or event, and allergy to the investigational agents or any agent given in association with this trial and incomplete medical information.
-
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** patients with received the combination therapy of lenvatinib/bevacizumab, hepatic arterial infusion chemotherapy and PD-1/L1
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Guangzhou
**Country:** China
**Facility:** Cancer Center Sun Yat-sen University
**State:** Guangdong
**Zip:** 510060
### 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: D000000230
- Term: Adenocarcinoma
- ID: D000008113
- Term: Liver Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000008107
- Term: Liver Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M9613
- Name: Carcinoma, Hepatocellular
- Relevance: HIGH
- As Found: Hepatocellular 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: M3585
- Name: Adenocarcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M11113
- Name: Liver 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: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000006528
- Term: Carcinoma, Hepatocellular
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000047428
- Term: Protein Kinase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M353738
- Name: Lenvatinib
- Relevance: HIGH
- As Found: Primary care
- ID: M246
- Name: Bevacizumab
- Relevance: LOW
- As Found: Unknown
- ID: M2342
- Name: Immune Checkpoint Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M25820
- Name: Protein Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000531958
- Term: Lenvatinib
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06435000
**Acronym:** POLARIS
**Brief Title:** An Observational Study in Subjects to Follow the Progression of Stargardt Disease Type 1 (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ABCA4 Gene
**Official Title:** An Observational Study in Subjects to Follow the Progression of Stargardt Disease Type 1 (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ATP Binding Cassette Subfamily a Member 4 (ABCA4) Gene
#### Organization Study ID Info
**ID:** SB-CS-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Splice Bio
### Status Module
#### Completion Date
**Date:** 2027-02
**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:** 2026-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-29
**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:** INDUSTRY
**Name:** Splice Bio
#### 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:** This is an Observational Study to Follow the Progression of Stargardt Disease Type 1 (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ABCA4 Gene
This is a multicenter study which will enroll approximately 75 subjects
**Detailed Description:** Comprehensive knowledge of a disease is essential to the design and conduct of well-controlled, interventional clinical trials. Understanding of the disease state is important for identifying the patient population for a clinical trial, study duration, and selection of clinically meaningful endpoints.
Observational studies play an important role in the understanding of rare diseases and facilitating effective development of potential therapies. To support clinical research, observational studies can help define the clinical features of a rare disease, rate of progression, pathophysiology, and other important factors. Further, following the course of a disease over time allows investigators to identify demographic variables, genotypic and phenotypic features, and other characteristics that may correlate with disease and outcomes in the absence of treatment. Thus, observational studies are useful in guiding the design of therapeutic studies, including selection of the patient population, trial duration, and the types of outcome measures to evaluate efficacy and safety.
Results of a natural history study evaluating the progression of atrophy secondary to Stargardt Disease have been published using retrospective and prospective cohorts of patients (ProgStar, Strauss et al., 2016).
In summary, the current study is a prospective observational study of patients with STGD1, the aim of which is to further enhance understanding of disease progression and structural and functional markers that can be used to evaluate the efficacy and safety of therapeutic interventions, especially in light of advancements in imaging technology.
### Conditions Module
**Conditions:**
- Stargardt
- Stargardt's Disease
- Stargardt Disease
- STGD1
**Keywords:**
- POLARIS
- Splicebio
- STGD1
- ABCA4
### Design Module
#### Bio Spec
**Description:** Buccal saliva swab to determine a minimum of two pathogenic or likely pathogenic mutations in the ABCA4 gene to genetically confirm the disease, as per eligibility criteria
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 75
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Measure:** Document disease progression based on change from baseline in lesion size as measured by DDAF on FAF imaging
**Time Frame:** 96 weeks
#### Secondary Outcomes
**Measure:** Change from baseline in ellipsoid zone (EZ) area as measured by SD-OCT
**Time Frame:** 96 weeks
**Measure:** Change from baseline in BCVA using ETDRS
**Time Frame:** 96 weeks
**Measure:** Change from baseline in LLVA using ETDRS
**Time Frame:** 96 weeks
**Measure:** Change from baseline in retinal sensitivity based on macular microperimetry
**Time Frame:** 96 weeks
**Measure:** Change from baseline in contrast sensitivity scores
**Time Frame:** 96 weeks
**Measure:** Change from baseline using Patient Reported Outcome Questionnaires
**Time Frame:** 96 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Provide written consent
2. Are male or female aged 12-65 years old
3. Have a diagnosis of STGD1 caused by bi-allelic likely pathogenic or pathogenic variants in the ABCA4 gene confirmed genotypically by an accredited genotyping laboratory
4. Have a history of STGD1 progression within the last 2 years, in the opinion of the investigator.
5. Eligible eye(s) must have:
1. BCVA of between 24-88 ETDRS letters, inclusive (20/20 - 20/320 Snellen equivalent, 0.0-1.2 logMAR) at the Screening Visit.
2. Clinical evidence of a macular lesion phenotypically consistent with Stargardt Disease.
3. Fundus autofluorescence (FAF) measurement of definitely decreased autofluorescence (DDAF) as measured by the Central Reading Center (CRC).
4. Total lesion must be imaged in its entirety.
5. All total lesion borders must be ≥300 microns from all image edges.
6. Eligible eye(s) must have clear ocular media and adequate pupillary dilation, including no allergy to dilating eyedrops, to permit good quality retinal imaging.
Exclusion Criteria:
1. Are an immediate family member (e.g., child, sibling) of the Sponsor or study site personnel.
2. Have any concurrent ocular disease that would affect study procedures or outcomes (e.g., cataracts; subjects can be enrolled 90 days after successful cataract surgery) in eligible eyes.
3. Have two likely pathogenic or pathogenic variants (not STGD1) in autosomal recessive inherited retinal dystrophy (IRD) genes or a single likely pathogenic or pathogenic variant in autosomal dominant or X-linked IRD genes.
4. Have had any intraocular surgery or thermal laser within 90 days of study entry or any prior thermal laser in the macular region within the eligible eye(s).
5. Have any major surgical procedure within 30 days of the Screening Visit or planned or anticipated major surgery during the study period.
6. Are unwilling to stop taking the following products at Screening and throughout the study:
1. Supplements containing vitamin A or beta-carotene, liver-based products.
2. Prescription oral retinoids.
7. Have actively participated in an investigational therapy study or have received any investigational therapy within 90 days of the Screening Visit or 5 half-lives, whichever is longer. Note: any ophthalmic history of gene therapy, stem cell therapy, surgical implantation of prosthetic retinal chips, or intravitreal or sub-retinal injections exclude the subject from study participation.
8. Have known serious allergies to the fluorescein dye that might be used to measure intraocular pressure (IOP), ocular dilating drops, topical ocular anesthetic, or any history of anaphylaxis reaction.
9. Have a history of amblyopia in the eligible eye(s).
10. Have any significant ocular or non-ocular disease/disorder (or medication and/or laboratory test abnormalities) which, in the opinion of the investigator and with concurrence of the Medical Monitor, may either put the subject at risk because of participation in the study, may influence the results of the study, or affect the subject's ability to participate in the study.
**Maximum Age:** 65 Years
**Minimum Age:** 12 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Participants will be selected that have a genetic and clinical diagnosis of STGD1 and fulfil all other entry criteria.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** info@splice.bio
**Name:** SpliceBio SpliceBio
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** Sponsor will wait until data fully analyzed and published before considering sharing
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** SpliceBio
**URL:** https://splice.bio/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015785
- Term: Eye Diseases, Hereditary
- ID: D000005128
- Term: Eye Diseases
- ID: D000012162
- Term: Retinal Degeneration
- ID: D000012164
- Term: Retinal Diseases
- ID: D000030342
- Term: Genetic Diseases, Inborn
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M2147
- Name: Stargardt Disease
- Relevance: HIGH
- As Found: Stargardt Disease
- ID: M20559
- Name: Disease Progression
- Relevance: LOW
- As Found: Unknown
- ID: M11260
- Name: Macular Degeneration
- Relevance: HIGH
- As Found: Stargardt Disease
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M18339
- Name: Eye Diseases, Hereditary
- 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
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: T5470
- Name: Stargardt Disease
- Relevance: HIGH
- As Found: Stargardt Disease
### Condition Browse Module - Meshes
- ID: D000080362
- Term: Stargardt Disease
- ID: D000008268
- Term: Macular Degeneration
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434987
**Brief Title:** Impact of RIVP on GI Function in Patients Undergoing Surgical Repair for ATAAD
**Official Title:** Impact of Retrograde Inferior Vena Cava Perfusion on Gastrointestinal Function in Patients Undergoing Surgical Repair for Acute Type A Aortic Dissection: A Study Protocol and Prospective Evaluation.
#### Organization Study ID Info
**ID:** 2023-KY-215-01
#### Organization
**Class:** OTHER
**Full Name:** The Second Hospital of Nanjing Medical University
### 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:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-12-25
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The Second Hospital of Nanjing Medical University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Acute Type A Aortic Dissection (ATAAD) is a serious medical condition that requires immediate surgical intervention. The repair of Acute Type A Aortic Dissection (ATAAD) combines different surgical procedures, including the use of Cardiopulmonary Bypass (CPB). This study focuses on the gastrointestinal (GI) system and the complications arising in the gastrointestinal (GI) system as a result of this procedure. Retrograde Inferior Vena Cava Perfusion (RIVP) is a technique used during Cardiopulmonary Bypass (CPB) that could show potential in mitigating latent gastrointestinal (GI) complications. The study aims to evaluate the effectiveness of Retrograde Inferior Vena Cava Perfusion (RIVP) in patients receiving Acute Type A Aortic Dissection (ATAAD) repair with Cardiopulmonary Bypass (CPB) in reducing Ischemic Reperfusion (IR) injury and inflammatory responses that affect gastrointestinal (GI) integrity. It intends to compare the postoperative gastrointestinal (GI) complications and long-term gastrointestinal (GI) function between patients treated with Antegrade Cerebral Perfusion (ACP) and Retrograde Inferior Vena Cava Perfusion (RIVP), and those treated with Antegrade Cerebral Perfusion (ACP) alone. The patients will be placed in their respective groups as per the decision of the surgeons, perfusionists, and the condition of the patient. Data collection will be facilitated by a comprehensive Case Report Form (CRF). This pilot study, guided by established methodologies, places the study's sample size at 30 to ensure statistical reliability and prevent resource wastage. Through this approach of sample collection, baseline data collection, peri-operative data recording, and follow-up assessments, the study aims to shed light on the impact of Retrograde Inferior Vena Cava Perfusion (RIVP) during Acute Type A Aortic Dissection (ATAAD) repair on gastrointestinal (GI) complications and systemic/intestinal inflammation. The integration of specialized Case Report Forms (CRFs) and structured questionnaires ensures standardized data collection and management, while prioritizing patient confidentiality. The study's data analysis, powered by R software, will provide valuable insights into the efficacy of Retrograde Inferior Vena Cava Perfusion (RIVP) in enhancing clinical outcomes and improving patient's prognosis in the surgical treatment of Acute Type A Aortic Dissection (ATAAD).
**Detailed Description:** Retrograde Inferior Vena Cava Perfusion ( RIVP) is a adjunct technique used in surgery during the repair of Acute Type A Aortic Dissection (ATAAD). This procedure generally involves perfusing oxygenated blood into the inferior vena cava, directing it toward the visceral organs and lower extremities. This technique plays an important role in reducing the risk of ischemic injury to these vital regions during deep hypothermic circulatory arrest (DHCA) when combined with Antegrade Cerebral Perfusion (ACP).
Recent study showed that the use of Retrograde Inferior Vena Cava Perfusion (RIVP), in conjunction with Antegrade Cerebral Perfusion (ACP), may lead to lower rates of organ dysfunction in the lower body, reduced mortality and shorter Cardiopulmonary Bypass (CPB) duration. It has also been associated with maintaining higher higher body temperature during circulatory arrest which may be beneficial for the overall patient well-being.
However, despite these promising results , there is a need for further research to explore the scientific impact of Retrograde Inferior Vena Cava Perfusion (RIVP) on gastrointestinal function during and after Acute Type A Aortic Dissection (ATAAD) repair. Gastrointestinal complications are a crucial aspect of a patients outcomes, and more often neglected. Understanding the relationship between Retrograde Inferior Vena Cava Perfusion (RIVP) and these complications may be essential and have the potential to lead better prognosis among patients, resulting in improved outcomes.
In summary, Retrograde Inferior Vena Cava Perfusion (RIVP) is a valuable technique that helps protect abdominal organs and lower extremities during Acute Type A Aortic Dissection (ATAAD) surgery. While it shows promise in improving patient outcomes, ongoing research is necessary to comprehensively assess its effect on gastrointestinal function, thus optimizing its use in the surgical management of Acute Type A Aortic Dissection (ATAAD).
This study is designed as a single centered, prospective, cohort study with an exploratory framework. The study will be conducted at the Second Affiliated Hospital of Nanjing Medical University Cardiovascular Center. This study will focus on patients undergoing Acute Type A Aortic Dissection (ATAAD) repair with or without Retrograde Inferior Vena Cava Perfusion (RIVP). Patients will be assigned to these groups based on surgical and patient specific criteria in the ratio 1:1 and will follow patients in the Cardiovascular Critical Care Unit ( CCU) pre-operatively. Group A will receive selective ACP+RIVP, while group B will receive ACP alone under mild to moderate hypothermia. As per the general rule of thumb, the study anticipates to recruit up to 30 patients for the pilot study in total. 15 in each group.
Patients will undergo diagnostic assessments to confirm diagnosis of Acute Type A Aortic Dissection (ATAAD) and depending on urgency they will proceed either to surgery or Cardiovascular Critical Care Unit (CCU). Informed consent will be obtained, but this will in no way delay the treatment protocol for the patients. In case of urgent surgery, a surgical fellow will obtain the consent. Patients can withdraw without repercussions and no replacements will be sought.
All data will be collected and recorded systematically in a well drafted case report form. A protocol has been written to conduct this study and we have followed the SPIRITS guidelines. Any changes in the protocol will be timely reported and adjusted.
We will collect blood samples at specific time intervals, pre operatively (PO1), post operatively day 1 (PO2), day 3 (PO3), day 7 (PO4). The study will include biomarker evaluation: CRP, intestinal barrier indicators ( D-amine oxidase(DAO), Fatty Acid Binding Protein 2 (FABP2), D-Lactate, Endotoxins) and 12 cytokine panel.
All baseline data ranging from clinical parameters, anthropometric data, baseline gastrointestinal (GI) assessment and clinical data will be obtained before surgery and recorded in the case report form.
Peri operative data, duration of Cardiopulmonary Bypass (CPB), duration of deep hypothermic circulatory arrest (DHCA), cross clamp time, surgery time, number of units of whole blood, fresh frozen plasma, pooled platelets and cryoprecipitate administered will be collected within the surgical room by the perfusionist and the anesthesiologist.
A prospective longitudinal study will assess long term gastrointestinal (GI) dysfunction post surgery through follow up methods such as outpatient, Wechat application, in hospital or telephone based follow up evaluation at specified intervals (1,3,6,12 months) post hospital discharge. A meticulously drafted questionnaire will be used as a tool for assessment.
To establish presence of gut barrier dysfunction, the investigators will look at the specific patterns or deviation in values of the biomarkers from the normal or baseline levels. An increase in pro-inflammatory cytokines may suggest an inflammatory response associated with gut barrier dysfunction. Elevated levels of D- Lactate, Fatty Acid Binding Protein 2 (FABP2) and endotoxins and decreased activity levels of D-amine oxidase (DAO) could suggest gut barrier dysfunction.
The investigators will perform comprehensive statistical analysis to evaluate continuous variables, like inflammatory markers. This includes calculating the mean, standard deviation and interquartile range for values related to C- reactive protein (CRP), cytokines and intestinal barrier markers. The investigators will use the t-test to analyze differences in these variables. For ordinal data from the Case Report Form (CRF) and follow up questionnaire, wilcoxon rank sun test for hypothesis testing will be used. Categorical data will be presented as percentages , and the differences in these categories will be assessed using the chi-squared test. To handle data at multiple time points, ANOVA will be used to assess variance. When dealing with multiple dependant variables like various cytokine levels simultaneously , the investigators will employ a multivariate analysis of variance. We will consider results statistically significant if the p value is \<0.05, in lone with established research and data analysis practices.
### Conditions Module
**Conditions:**
- Type A Aortic Dissection
**Keywords:**
- Acute Type A Aortic Dissection
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** ACP+RIVP under mild to moderate hypothermia
**Intervention Names:**
- Procedure: Retrograde Inferior Vena Cava Perfusion
**Label:** ATAAD patients undergoing Cardiopulmonary Bypass (CPB) with RIVP
#### Arm Group 2
**Description:** ACP only under mild to moderate hypothermia.
**Intervention Names:**
- Procedure: Antegrade cerebral perfusion
**Label:** ATAAD patients undergoing Cardiopulmonary Bypass (CPB) without RIVP
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ATAAD patients undergoing Cardiopulmonary Bypass (CPB) with RIVP
**Description:** Retrograde inferior vena cava (RIVP) involves perfusing oxygenated blood into the inferior vena cava, which then flows towards the viscera, abdominal organs and lower extremities. By maintaining perfusion to these regions during cardiopulmonary bypass (CPB) and induced hypothermia, Retrograde inferior vena cava (RIVP) helps mitigate the risk of ischemic injury to the abdominal organs. Following the initiation of total cardiopulmonary bypass, the body temperature will be gradually lowered to achieve deep-moderate hypothermia ( 24-38°C). This procedure will involve the combination of selective antegrade cerebral perfusion and retrograde inferior vena cava perfusion. Antegrade perfusion will be maintained at a flow rate of 5-7mL/min/kg, while retrograde perfusion will be regulated to sustain the required pumm pressure and blood flow.
**Name:** Retrograde Inferior Vena Cava Perfusion
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- ATAAD patients undergoing Cardiopulmonary Bypass (CPB) without RIVP
**Description:** After mild to moderate hypothermia is achieved, a cannula will be inserted into the right axillary artery, brachiocephalic or innominate artery to provide continuous flow to the brain. A flow rate of 5-7mL/min/kg will be maintained.
**Name:** Antegrade cerebral perfusion
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Patients undergoing CPB with RIVP may have a better prognosis and less incidence of long term GI disturbance as compared to those patients undergoing CPB without RIVP. Measurement tools: 1. Biomarkers; levels of D-Lactate, FABP2 ( Fatty Acid Binding Protein 2), endotoxins and DAO (Diamine Oxidase). Measurement method: Samples of blood will be analyzed using ELISA ( Enzyme Linked Immunosorbent Assay)
**Measure:** RIVP will reduce post operative GI disturbances and gut barrier dysfunction.
**Time Frame:** Pre operatively, Post -operative day 1 ,day 2, day 3 and day 7
**Description:** Measurements: C-Reactive protein (CRP) and 12 cytokine panel. Method: blood samples will be analyzed using immunoassays
**Measure:** Inflammatory response will be possibly reduced in those undergoing RIVP
**Time Frame:** Pre operatively, Post -operative day 1 ,day 2, day 3 and day 7
**Description:** Measurement tools: clinical assessment for gastrointestinal function and questionnaire. Special formulated case report forms will contain a detailed questionnaire assessing the quality of life and gastrointestinal function. Method: Baseline gastrointestinal function will be assessed pre opratively and follow up questionnaire post operatively.
**Measure:** Gastrointestinal assessment and long term gastrointestinal dysfunction.
**Time Frame:** Follow up questionaires will be addressed at 1,3,6 and 12 months post hospital discharge. Follow up will be outpatient visits, telephone based calls and interviews, wechat application at the specified intervals
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients undergoing ATAAD repair under CPB.
2. Age: 18-70 years
3. Give consent
Exclusion Criteria:
1. Variables that can influence gut microbiome like antibiotics or probiotics 2 weeks prior to surgery
2. On chemotherapy
3. Evidence of pre-operative malperfusion of the GI system
4. Presence of GI any pathology (IBD,GERD,PU)
5. Continuous enteral feeding prior to surgery
6. Refuse to participate in the study
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study groups with be patients undergoing ATAAD repair under CPB with and without RIVP. This is a cohort study and the patients will not be assigned any specific group randomly or by a computer. The patients will be placed in their respective groups as per the decision of the surgeons, perfusionist and the condition of the patient. Patients admitted through the emergency department will be initially enrolled into the cardiovascular department and subsequently invited to participate in this study.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** sanaazim@yandex.com
**Name:** Sanaa Azim
**Phone:** +8615679202116
**Role:** CONTACT
**Contact 2:**
**Email:** q172278932@hotmail.com
**Name:** Xun Zhang
**Phone:** +8618502522060
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nanjing
**Contacts:**
***Contact 1:***
- **Email:** liqg@njmu.edu.cn
- **Name:** Qing Guo Li
- **Phone:** +86 139 1389 9923
- **Role:** CONTACT
**Country:** China
**Facility:** The Second Affiliated Hospital of Nanjing Medical University
**State:** Jiangsu
**Status:** RECRUITING
**Zip:** 210011
#### Overall Officials
**Official 1:**
**Affiliation:** The Second Hospital of Nanjing Medical University
**Name:** Qing Guo Li
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** The Second Affiliate Hospital of Nanjing Medical University
**Name:** Sanaa Azim
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Harris KM, Nienaber CA, Peterson MD, Woznicki EM, Braverman AC, Trimarchi S, Myrmel T, Pyeritz R, Hutchison S, Strauss C, Ehrlich MP, Gleason TG, Korach A, Montgomery DG, Isselbacher EM, Eagle KA. Early Mortality in Type A Acute Aortic Dissection: Insights From the International Registry of Acute Aortic Dissection. JAMA Cardiol. 2022 Oct 1;7(10):1009-1015. doi: 10.1001/jamacardio.2022.2718.
**PMID:** 36001309
**Citation:** Salomon J, Ericsson A, Price A, Manithody C, Murry DJ, Chhonker YS, Buchanan P, Lindsey ML, Singh AB, Jain AK. Dysbiosis and Intestinal Barrier Dysfunction in Pediatric Congenital Heart Disease Is Exacerbated Following Cardiopulmonary Bypass. JACC Basic Transl Sci. 2021 Mar 3;6(4):311-327. doi: 10.1016/j.jacbts.2020.12.012. eCollection 2021 Apr.
**PMID:** 33997519
**Citation:** Cheng LK, O'Grady G, Du P, Egbuji JU, Windsor JA, Pullan AJ. Gastrointestinal system. Wiley Interdiscip Rev Syst Biol Med. 2010 Jan-Feb;2(1):65-79. doi: 10.1002/wsbm.19.
**PMID:** 20836011
**Citation:** Sarkar M, Prabhu V. Basics of cardiopulmonary bypass. Indian J Anaesth. 2017 Sep;61(9):760-767. doi: 10.4103/ija.IJA_379_17.
**PMID:** 28970635
**Citation:** Halter J, Steinberg J, Fink G, Lutz C, Picone A, Maybury R, Fedors N, DiRocco J, Lee HM, Nieman G. Evidence of systemic cytokine release in patients undergoing cardiopulmonary bypass. J Extra Corpor Technol. 2005 Sep;37(3):272-7.
**PMID:** 16350379
**Citation:** Typpo KV, Larmonier CB, Deschenes J, Redford D, Kiela PR, Ghishan FK. Clinical characteristics associated with postoperative intestinal epithelial barrier dysfunction in children with congenital heart disease. Pediatr Crit Care Med. 2015 Jan;16(1):37-44. doi: 10.1097/PCC.0000000000000256.
**PMID:** 25162512
**Citation:** Yan TD, Bannon PG, Bavaria J, Coselli JS, Elefteriades JA, Griepp RB, Hughes GC, LeMaire SA, Kazui T, Kouchoukos NT, Misfeld M, Mohr FW, Oo A, Svensson LG, Tian DH. Consensus on hypothermia in aortic arch surgery. Ann Cardiothorac Surg. 2013 Mar;2(2):163-8. doi: 10.3978/j.issn.2225-319X.2013.03.03.
**PMID:** 23977577
**Citation:** Safi HJ, Miller CC 3rd, Lee TY, Estrera AL. Repair of ascending and transverse aortic arch. J Thorac Cardiovasc Surg. 2011 Sep;142(3):630-3. doi: 10.1016/j.jtcvs.2010.11.015. Epub 2011 Jan 26.
**PMID:** 21269650
**Citation:** Ehrlich M, Fang WC, Grabenwoger M, Cartes-Zumelzu F, Wolner E, Havel M. Perioperative risk factors for mortality in patients with acute type A aortic dissection. Circulation. 1998 Nov 10;98(19 Suppl):II294-8.
**PMID:** 9852917
**Citation:** Ziyaeifard M, Alizadehasl A, Massoumi G. Modified ultrafiltration during cardiopulmonary bypass and postoperative course of pediatric cardiac surgery. Res Cardiovasc Med. 2014 May;3(2):e17830. doi: 10.5812/cardiovascmed.17830. Epub 2014 Apr 1.
**PMID:** 25478538
**Citation:** Lin J, Qin Z, Liu X, Xiong J, Wu Z, Guo Y, Kang D, Du L. Retrograde inferior vena caval perfusion for total aortic arch replacement surgery: a randomized pilot study. BMC Cardiovasc Disord. 2021 Apr 20;21(1):193. doi: 10.1186/s12872-021-02002-9.
**PMID:** 33879045
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000094665
- Term: Dissection, Blood Vessel
- ID: D000000783
- Term: Aneurysm
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000094683
- Term: Acute Aortic Syndrome
- ID: D000001018
- Term: Aortic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4114
- Name: Aortic Dissection
- Relevance: HIGH
- As Found: Aortic Dissection
- ID: M3081
- Name: Dissection, Blood Vessel
- Relevance: LOW
- As Found: Unknown
- ID: M4113
- Name: Aneurysm
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M3085
- Name: Acute Aortic Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M4334
- Name: Aortic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000784
- Term: Aortic Dissection
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M16204
- Name: Sulfamethazine
- Relevance: LOW
- As Found: Unknown
- ID: T204
- Name: Kava
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434974
**Brief Title:** Prevalence of Birth Before Arrival and Associated Factors Among Postpartum Women in Southern Ethiopia
**Official Title:** Prevalence of Birth Before Arrival and Associated Factors Among Postpartum Women in Southern Ethiopia: Community-Based Cross-Sectional Study
#### Organization Study ID Info
**ID:** LMHB
#### Organization
**Class:** OTHER
**Full Name:** Wachemo University
### Status Module
#### Completion Date
**Date:** 2023-05-20
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-05-20
**Type:** ACTUAL
#### Start Date
**Date:** 2023-04-05
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Wachemo University
#### Responsible Party
**Investigator Affiliation:** Wachemo University
**Investigator Full Name:** Mitiku Desalegn
**Investigator Title:** Lecturer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Background: Birth before arrival is defined as unplanned deliveries without the attendance of skilled personnel just before arrival to a health facility. It constitutes a high-risk newborn population and has high perinatal morbidity and mortality. In Ethiopia, most studies and health surveys done, only look at home and hospital deliveries but do not consider deliveries taking place between the house and health facility. The aim of this study is to assess the prevalence of birth before arrival and its associated factors among postpartum women in Lemo woreda, Hadiya zone, SNNPR Ethiopia, 2023.
Methods: Community-based cross-sectional study was conducted among postpartum women in Lemo woreda, Hadiya zone, SNNPR Ethiopia from April, 05 to May 20, 2023. Three hundred eighty-two postpartum women who gave birth six months preceding this study were included. Twelve out of 36 kebeles were selected randomly and simple random sampling was employed for the selection of participant women. Interviewer-administered questionnaire was used for data collection. A binary logistic regression analysis was computed and variables with a p-value of \< 0.25 were recruited to the final multivariable logistic regression analysis. Model fitness was checked using Hosmer and Lemeshow goodness of fit test (x2 = 16.04, p-value = 0.250). Statistical significance was declared using odds ratios and 95% confidence intervals at p-value \< 0.05.
Result: The prevalence of birth before arrival among women who gave birth in the last six months preceding this study in the study area was 15.2% (95%CI: 11.8%, 19.1%). In the multi-variable analysis, the variables found to have an association with birth before arrival in the final model were having no antenatal care (AOR = 2.63; 95%CI: 1.23, 5.63), dependent women autonomy status (AOR = 3.32; 95%CI: 1.12, 9.89), being not knowledgeable about labor symptoms (AOR = 2.15; 95%CI: 1.11, 4.18), and having birth preparedness towards index birth (AOR = 0.13; 95%CI: 0.05, 0.35).
Conclusion: The prevalence of birth before arrival in the study area was unacceptably high. A statistically significant association was seen between birth before arrival and having no antenatal care, dependent women's autonomy status, being not knowledgeable about labor symptoms, and having birth preparedness towards index birth. Intervening to avert birth before arrival through effective antenatal care programs and enhancing women's autonomy may help to reduce birth before arrival and its adverse perinatal outcomes.
**Detailed Description:** Results Socio-demographic characteristics A total of 382 study participants were included in the analysis with a 100% response rate. The mean age of participant women was 30.3 years + 4.4 SD. The majority of participant women were in the age group 23-26 years (28.3%), but women in the age category of 27-30 were the most experienced birth before arrival (34.6%) and three fourth of them were rural residents (76.2%). Nearly half of women (45.5%) attained secondary education (grades 9-12). The majority of the participant mothers (83.8%) were housewives in their occupation whereas 68.0% of their husbands were farmers. The mean estimated monthly income of the family was 7,216 birr + 3,073.4 SD. The majority of participants (95.0%) had media exposure and radio was the commonest media (Table 2).
Table 2: Socio-demographic characteristics of women who gave birth in the last six months in Lemo district, Hadiya zone, Southern Ethiopia (n = 382).
Variables Category Frequency (percentage) Total
No BBA BBA Mother's age in years Range (23-38) 23-26 27-30 31-34 35-38 105 (97.2%) 70 (65.4%) 78 (88.6%) 71 (88.9%) 3 (2.8%) 37 (34.6%) 10 (11.4%) 8 (10.1%) 108 (28.3%) 107 (28.0%) 88 (23.0%) 79 (20.7%) Residence Urban Rural 74 (81.3%) 250 (85.9%) 17 (18.7%) 41 (14.1%) 91 (23.8%) 291 (76.2%) Women's educational status No formal education Primary Secondary Higher education 31 (60.8%) 154 (88.5%) 126 (89.4%) 13 (81.3%) 20 (39.2%) 20 (11.5%) 15 (10.6%) 3 (18.7%) 51 (13.4%) 174 (45.5%) 141 (36.9%) 16 (4.2%) Husband's educational status No formal education Primary Secondary Higher education 5 (41.7%) 132 (89.8%) 160 (86.5%) 27 (71.1%) 7 (58.3%) 15 (10.2%) 25 (13.5%) 11 (28.9%) 12 (3.1%) 147 (38.5%) 185 (48.4%) 38 (10.0%) Women's occupation Housewife Maid Civil servant 272 (85.0%) 38 (86.4%) 14 (77.8%) 48 (15.0%) 6 (13.6%) 4 (22.2%) 320 (83.8%) 44 (11.5%) 18 (4.7%) Husband's occupation Farmer Merchant Civil servant 229 (88.1%) 80 (77.7%) 15 (78.9%) 31 (11.9%) 23 (22.3%) 4 (21.1%) 260 (68.0%) 103 (27.0%) 19 (5.0%) Housing characteristics Private Rented 295 (85.3%) 29 (80.6%) 51 (14.7%) 7 (19.4%) 346 (90.6%) 36 (9.4%) The average estimated monthly income of the family in Birr 2,000-6,000 6,001-11,000 11,001-15,000 162 (89.0%) 126 (78.7%) 36 (90.0%) 20 (11.0%) 34 (21.3%) 4 (10.0%) 182 (47.6%) 160 (41.9%) 40 (10.5%) Media exposure Yes No 310 (85.4%) 14 (73.7%) 53 (14.6%) 5 (26.3%) 363 (95.0%) 19 (5.0%) Type of media (n = 363) Radio Television Social media 277 (88.8%) 28 (65.1%) 5 (62.5%) 35 (11.2%) 15 (34.9%) 3 (37.5%) 312 (81.7%) 43 (11.2%) 8 (2.1%) BBA: Birth Before Arrival; birr: Ethiopian currency Reproductive Health and Obstetric Characteristics The majority of participant women (76.7%) of them had antenatal care (ANC) follow-up for their last pregnancy. Two-thirds of women had 1-3 ANC contacts for their last delivery with a mean of 1.2 + 0.4 SD. The proportion of women who used contraceptives before their last pregnancy was 26.4%. Two-thirds of the participant women (71.7%) had postnatal care (PNC) follow-up for their last birth and 76.2% of women had planned and wanted the type of last pregnancy. The average value of the women's autonomy index was 0.68 and 26.7% of participant women were autonomous. The proportion of women with grand multigravida was 21.0%, the duration of labor of index birth \> 12 hours was 54.7%, birth preparedness towards index birth of 86.1%, women with knowledge of the expected date of delivery (EDD) of the index birth were 66.7%, and 66.1% of women know labor symptoms. The mean number of pregnancies was 3.0 + 1.6 SD and the median duration of labor of the last birth was 14 (IQR 12-24) (Table 3).
Table 3: Reproductive health and obstetric characteristics of participant women by birth before arrival in Lemo district, Hadiya zone, Southern Ethiopia (n = 382).
Variables Category Frequency (percentage) Total
No BBA BBA ANC for the last delivery Yes No 254 (86.7%) 70 (78.7%) 39 (13.3%) 19 (21.3%) 293 (76.7%) 89 (23.3%) Number of ANC contacts (n = 293) 1-3 contacts \> 4 contacts 178 (86.0%) 76 (88.4%) 29 (14.0%) 10 (11.6%) 207 (70.6%) 86 (29.4%) Type of health facility for ANC (n = 293) At hospital At health centre At health post 14 (82.4%) 177 (87.2%) 63 (86.3%) 3 (17.6%) 26 (12.8%) 10 (13.7%) 17 (5.8%) 203 (69.3%) 73 (24.9%) Used contraceptive before last pregnancy Yes No 83 (82.2%) 241 (85.8%) 18 (17.8%) 40 (14.2%) 101 (26.4%) 281 (73.6%) PNC for the last delivery Yes No 233 (85.0%) 91 (84.3%) 41 (15.0%) 17 (15.7%) 274 (71.7%) 108 (28.3%) Type of pregnancy Planned and wanted Unplanned but wanted Unplanned \& unwanted 249 (85.6%) 68 (91.9%) 7 (41.2%) 42 (14.4%) 6 (8.1%) 10 (58.8%) 291 (76.2%) 74 (19.4%) 17 (4.4%) Women autonomy Non-autonomous Autonomous 231 (82.5%) 93 (91.2%) 49 (17.5%) 9 (8.8%) 280 (73.3%) 102 (26.7%) Gravidity Multigravidae Grand multigravidae 259 (85.8%) 65 (81.3%) 43 (14.2%) 15 (18.7%) 302 (79.0%) 80 (21.0%) Duration of labor of index birth \< 12 hours \> 12 hours 155 (89.6%) 169 (80.9%) 18 (10.4%) 40 (19.1%) 173 (45.3%) 209 (54.7%) Know the EDD of the index birth Yes No 226 (88.6%) 98 (77.2%) 29 (11.4%) 29 (22.8%) 255 (66.7%) 127 (33.3%) Birth preparedness towards index birth Yes No 285 (86.6%) 39 (73.6%) 44 (13.4%) 14 (26.4%) 329 (86.1%) 53 (13.9%) Knowledge of labor symptoms (n=350) Not knowledgeable Knowledgeable 89 (74.8%) 205 (88.7%) 30 (25.2%) 26 (11.3%) 119 (34.0%) 231 (66.0%) Mode of previous delivery SVD Instrumental delivery SVD with episiotomy Cesarean section 217 (85.1%) 34 (94.4%) 72 (80.9%) 1 (50.0%) 38 (14.9%) 2 (5.6%) 17 (19.1%)
1 (50.0%) 255 (66.7%) 36 (9.4%) 89 (23.3%) 2 (0.6%) ANC: Antenatal Care; BBA: Birth Before Arrival; EDD: Expected Date of Delivery; PNC: Postnatal Care; SVD: Spontaneous Vaginal Delivery Access to a healthcare facility The median time of the delay to seek health care was 14 hours (IQR 12-24) and the mean duration of the second delay was 1.3 hours + 0.6 SD. One-fourth (25.9%) of women delayed \> 24 hours in deciding to seek health care and one-third (33.8%) travelled \> 2 hours to reach a health care facility. The major reason for the first delay was not realising the problem (28.8%) for women with birth before arrival and lack of transport (62.3%) was the major reason for the second delay. About means of transport, 35.8% of women used Horse/Donkey carts. Regarding the condition of the road, 29.3% of women replied that it is a wide road. More than half of women (51.6%) delivered their index birth at night (Table 4).
Table 4: Access to health care facility among women who gave birth in the last six months in Lemo district, Hadiya zone, Southern Ethiopia (n=382).
Variables Category Frequency (percentage) Total
No BBA BBA First delay Delayed \< 24 hours Delayed \> 24 hours 246 (86.9%) 78 (78.8%) 37 (13.1%) 21 (21.2%) 283 (74.1%) 99 (25.9%) Second delay (n = 317) Traveled \< 2 hours Traveled \> 2 hours 171 (81.4%) 88 (82.2%) 39 (18.6%) 19 (17.8%) 210 (66.2%) 107 (33.8%) Reasons for 1st delay Underestimate severity Did not realize the problem Essential person for decision making not around 195 (86.7%) 116 (71.2%) 78 (86.7%) 30 (13.3%) 47 (28.8%) 12 (13.3%) 225 (100%) 163 (100%) 90 (100%) Reasons for 2nd delay (n = 317) Lack of money Lack of transport Distant health facility 61 (87.1%) 159 (80.7%) 38 (77.6%) 9 (12.9%) 38 (19.3%) 11 (22.4%) 70 (22.1%) 197 (62.3%) 49 (15.6%) Means of transport (n = 317) Motorbike Ambulance Public transport Horse/Donkey cart On foot Carried by other people 39 (100.0%) 16 (48.5%) 62 (100.0%) 83 (73.5%) 14 (58.3%) 44 (97.8%) 0 (0.0%) 17 (51.5%) 0 (0.0%) 30 (26.5%) 10 (41.3%)
1 (2.2%) 39 (12.3%) 33 (10.4%) 62 (19.6%) 113 (35.8%) 24 (7.6%) 45 (14.2%) Status of the roadroad All weather road Weather raod 225 (83.3%) 99 (88.4%) 45 (16.7%) 13 (11.6%) 270 (70.7%) 112 (29.3%) Time of delivery of index birth Night Day 150 (76.1%) 174 (94.1%) 47 (23.9%) 11 (5.9%) 197 (51.6%) 185 (48.4%) Women who delivered their last birth at home were not asked for the second delay and its reasons.
Birth before arrival The prevalence of birth before arrival among women who gave birth in the last six months preceding this study in the study area was 15.2% (95%CI: 11.8%, 19.1%). Among them, 84.5% of women gave birth on the route to a health care facility (Table 5).
Table 5: Profile of birth before arrival among women who gave birth in the last six months in Lemo district, Hadiya zone, Southern Ethiopia (n = 382).
Variables Frequency Percentage Place of last delivery Home Before arrival to a health care facility Health care facility 67 58 257 17.5 15.2 67.3 The specific place of BBA to health care facility (n=58) On the route to health care facility In ambulance 49 9 84.5 15.5 BBA: Birth before Arrival. Factors associated with birth before arrival Using bivariate binary logistic regression analyses, variables with a p-value of \< 0.25 were recruited to be included in the final model. Thus, in the multi-variable analysis, the variables found to have an association with birth before arrival in the final model were having no antenatal care (AOR = 2.63; 95%CI: 1.23, 5.63), dependent women autonomy status (AOR = 3.32; 95%CI: 1.12, 9.89), being not knowledgeable about labor symptoms (AOR = 2.15; 95%CI: 1.11, 4.18), and having birth preparedness towards index birth (AOR = 0.13; 95%CI: 0.05, 0.35).
Therefore, this study found that women, who have no antenatal care visits during the index pregnancy, had three times higher odds of birth before arrival compared to women with antenatal care. The probability of having birth before arrival to a health care facility was three times higher for women who were dependent on their autonomy status compared with those who were autonomous. Moreover, those women who were not knowledgeable about labor symptoms had two times more likely to experience birth before arrival compared to those who were knowledgeable. Women who have birth preparedness towards index pregnancy were 87% less likely to experience birth before arrival compared to women with no birth preparedness plan. Having first and second delay, status of the road, time of delivery, and income were unrelated to the probability of birth before arrival (Table 6).
Table 6: Multivariate logistic regression showing factors associated with birth before arrival among women who gave birth in the last six months in Lemo district, Hadiya zone, Southern Ethiopia.
Variables Category COR (95% CI) AOR (95% CI) P-value Media exposure Yes No 1.00 2.09 (0.72, 6.04) 1.00 2.74 (0.82, 9.18) 0.103 Receive ANC in last pregnancy Yes No 1.00 1.77 (0.96, 3.25) 1.00 2.63 (1.23, 5.63) 0.013 Women autonomy Unautonomous Autonomous 2.19 (1.04, 4.64) 1.00 3.32 (1.12, 9.89) 1.00 0.031 Knowledge of labor symptoms Not knowledgeable Knowledgeable 2.66 (1.49, 4.75) 1.00 2.15 (1.11, 4.18) 1.00 0.023 Birth preparedness for the last birth Yes No 0.43 (0.22, 0.86) 1.00 0.13 (0.05, 0.35) 1.00 \< 0.001 Used contraceptive before last pregnancy Yes No 1.31 (0.71, 2.40) 1.00 1.70 (0.78, 3.69) 1.00 0.181 First delay Delayed \< 24 hours Delayed \> 24 hours 1.00 1.79 (1.00, 3.24) 1.00 1.86 (0.92, 3.76) 0.082 ANC: Antenatal Care; AOR: Adjusted Odds Ratio; CI: Confidence Interval; COR: Crude Odds Ratio Discussion The prevalence of birth before arrival among women who gave birth in the last six months preceding this study in the study area was unacceptably high. In the current study, the variables associated with birth before arrival in the Lemo district of Hadiya zone were having no antenatal care, dependent women's autonomy status, being not knowledgeable about labor symptoms, and having birth preparedness towards index birth.
Globally, the prevalence of birth before arrival to a healthcare facility is estimated to be less than 1% of all deliveries in developed countries (1,5,10,14,15). But the prevalence of BBA rises exponentially in low-income countries to greater than 50% (1,7). In the current study, the prevalence of birth before arrival is 15.2%. This is a high prevalence in the study area, as the rate of BBA is used as an index of accessibility to perinatal care and a rate greater than 1.5% signals challenges in health care provision where appropriate interventions are praiseworthy (9). Births occurred between home and health care facilities either en route to health care facilities or in ambulances were given less attention and no recent evidence was found in Ethiopia that indicated its prevalence. However, according to the mini EDHS 2019 report, 40% of the total live births were delivered in health facilities in rural areas and 58.7% were delivered at home and the gap 1.2% reported as other might be taken as the prevalence of BBA to health facility even though it was not reported (7).
The current study's finding was higher than EDHS's report and this difference might be due to the misclassification bias. Accordingly, in the EDHS questionnaire, there was no option indicated for BBA, so the BBA prevalence might be misclassified to home or health facility delivery prevalence; but in the current study option for birth before arrival to health facility was indicated in the questionnaire. Yet the prevalence of BBA in South Africa is 5.4%, and in rural Malawi was 9% (4,19). As per the current study's finding, the prevalence of BBA in Lemo district was higher than the prevalence in South Africa and rural Malawi. The difference might be due to the variation of level of socio-economic status across countries.
This study established that women, who have no antenatal care visits during the index pregnancy, had three times higher odds of birth before arrival compared to women with antenatal care. Similarly, a national register study in Finland documented that one of the predictors for deliveries before arrival to health care facility was fewer prenatal visits (26). Another study from Tharaka Nithi County of Kenya documented that the obstetric risk factors associated with BBA were; ANC attendance, timing of ANC attendance and number of ANC visits (20). A prospective case control study from Nkangala District, South Africa concluded that being unbooked was found to predict the occurrence of BBAs (4). The findings of these studies were concurrent to the current study's finding. Even though there is no similar evidence from Ethiopia, our finding was supported by the 2019's mini EDHS report that showed seventy-four percent of births to mothers who attended four or more ANC visits were delivered in a health facility, as compared with 14% of births to mothers with no ANC visits (7). This signals that the ANC program if properly delivered will be important for reducing birth before arrival to health care facilities and subsequently its adverse perinatal outcomes.
Dependent women in their autonomy status compared with those who were autonomous had three times higher odds of giving birth before arrival to a health care facility as per the current study. Similarly, one study shows that women's autonomy was positively associated with health facility delivery in Ethiopia (27). Another study revealed the strongest association between delivery at healthcare facilities attended by skilled birth attendants in the Southern African region among women who made decisions on household income solely (28). Women's autonomy can influence their decision to seek health care and could result in delays in reaching as early as possible to a health care facility to give birth if she is not adequately autonomous. So this results in birth before arrival. We required policy actions that increase women's autonomy at home and this could be effective in helping assure women's delivery at health care facilites.
Furthermore, the current study reveals that those women who were not knowledgeable about labor symptoms had two times more likely to experience birth before arrival compared to those who were knowledgeable. Our finding was supported by one study from Tharaka Nithi County of Kenya which documented that the obstetric risk factors associated with BBA were recognition of the onset of labor and knowledge of signs and symptoms of labor (20). The finding implies that having poor knowledge of labor symptoms could affect women in early and properly recognizing the onset of labor and seek for healthcare facility delivery in the early hours. Therefore, standard guidelines for ANC in Ethiopia were required and emphasised that every pregnant woman should receive ANC from a skilled provider(7), which must include counselling and enter-personal education with women concerning labor symptoms.
Additionally, women who have birth preparedness towards index pregnancy were less likely to experience birth before arrival compared to women with no birth preparedness plan as per the current study. Similarly, one study from Tharaka Nithi County of Kenya documented that the obstetric risk factors associated with BBA were the identification of healthcare facility for delivery, identification of means of transport, financial preparation for hospital delivery, and basic supplies for birth (20). These are the components of the birth preparedness plan that were revealed by the Kenya study and these were used in our study as constructs to measure and compute variables for birth preparedness. As Ethiopia has adopted the WHO's goal-oriented focused antenatal care for promoting the health and survival of mothers and babies; one of its basic components that's individualized birth plan, complication readiness and emergency preparedness' is expected to alleviate the problem of BBA if properly performed. Having first and second delay, status of the raod, time of delivery, and income were unrelated to the probability of birth before arrival.
Strengths and limitations of the study Our study revealed the delivery of babies occurred between home and health care facilities and came up with the prevalence of BBA and its associated factors as this issue was given less attention by literature in Ethiopia. The study has a limitation in that it was based on a cross-sectional design due to its unclearly indicated prevalence of BBA, but we recommend it be based on a community-based case-control study. The results obtained from the current study were based on women's interviews and cannot be free from recall and social desirability biases.
Conclusion The prevalence of birth before arrival among women who gave birth in the last six months preceding this study in the study area was unacceptably high. Statistically significant association was seen between birth before arrival and having no antenatal care, dependent women autonomy status, being not knowledgeable about labor symptoms, and having birth preparedness towards index birth. Intervening to avert birth before arrival through an effective antenatal acre program especially focusing on individualized counselling concerning knowledge of labor symptoms and birth preparedness plan and providing extra vigilant attention for enhancing women's autonomy in the community may help to reduce birth before arrival and its adverse perinatal outcomes.
Data-Sharing Statement All data generated or analyzed during this study are included in the manuscript and are also available from the corresponding author upon request.
Ethical Approval and Consent to Participate Ethical clearance was obtained from Wachemo University, the faculty of medicine and the public health institution review board with reference no (WCU/NEMMCSH/182/2023). Permission was granted from the concerned bodies of Lemo woreda and selected kebele administrators. Moreover, written informed consent was obtained from each woman. Confidentiality of the information was assured. Moreover, this study was conducted in compliance with the Declaration of Helsinki. Anonymous data were taken and the confidentiality of participant's information was secured.
Acknowledgment We would like to forward our appreciations to health office and health extension workers of study area for their kind cooperation. We are also thankful to data collectors and the study participants.
Author Contributions All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work. All authors reviewed the manuscript.
Funding No funding was received for this work Disclosure The authors declare that they have no competing interests.
### Conditions Module
**Conditions:**
- Safe Delivery of Baby
### Design Module
#### Design Info
**Observational Model:** ECOLOGIC_OR_COMMUNITY
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 382
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Interviewer administered questionnaire
**Name:** Interview
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Prevalence of Birth before Arrival
**Time Frame:** May, 2023
#### Secondary Outcomes
**Measure:** Associated Factors of Birth Before Arrival among Postpartum Women
**Time Frame:** May, 2023
### Eligibility Module
**Eligibility Criteria:** Postpartum women who were in a state of not being able to respond to the study questionnaires due to their health status were excluded from the study.
**Gender Based:** True
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** A community-based cross-sectional study was conducted among 382 postpartum women who gave birth in the last six months before the current study and reside in Lemo Woredas.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hosa'ina
**Country:** Ethiopia
**Facility:** Wachemo University
**Zip:** 667
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: Rare
- Name: Rare Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434961
**Brief Title:** The Trial of SHR6508 in Secondary Hyperparathyroidism
**Official Title:** A Multicenter, Randomised, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism
#### Organization Study ID Info
**ID:** SHR6508-301
#### Organization
**Class:** INDUSTRY
**Full Name:** Shanghai Hengrui Pharmaceutical Co., Ltd.
### 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:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Shanghai Hengrui 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 efficacy and safety of SHR6508 among Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.
### Conditions Module
**Conditions:**
- Secondary Hyperparathyroidism
### 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:** 486
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: SHR6508 plus oral placebo tablets
**Label:** Treatment group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Cinacalcet plus intravenous placebo
**Label:** Active Control group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment group
**Description:** SHR6508 plus oral placebo tablets
**Name:** SHR6508 plus oral placebo tablets
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Active Control group
**Description:** Cinacalcet plus intravenous placebo
**Name:** Cinacalcet plus intravenous placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** iPTH was tested at a central laboratory.
**Measure:** Proportion of Participants to End of Study whose iPTH decreased by>30% from baseline
**Time Frame:** efficacy assessment period, defined as Week 20-27
#### Secondary Outcomes
**Description:** iPTH was tested at a central laboratory.
**Measure:** Proportion of Participants to End of Study whose iPTH decreased by>50% from baseline
**Time Frame:** efficacy assessment period, defined as Week 20-27
**Description:** Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
**Measure:** Incidence of nausea and vomiting events
**Time Frame:** Day1 to End of Treatment, End of Treatment is about Week 27
**Description:** iPTH was tested at a central laboratory.
**Measure:** Proportion of Participants to End of Treatment whose iPTH decreased to 300 pg/mL from baseline
**Time Frame:** efficacy assessment period, defined as Week 20-27
**Description:** cCa and P were tested at a central laboratory.
**Measure:** Change From Baseline in serum cCa and P
**Time Frame:** efficacy assessment period, defined as Week 20-27
**Description:** Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
**Measure:** Participants With Treatment-Emergent Adverse Events (TEAEs)
**Time Frame:** Day1 to End of Study, End of Study is about Week 31
**Description:** Anti-SHR6508 Antibody was measured in patient serum samples using a validated enzyme-linked immunosorbent assay (ELISA) method.
**Measure:** Participants with Anti-SHR6508 Antibody at baseline and postbaseline
**Time Frame:** Day1 to End of Study, End of Study is about Week 31
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Able and willing to provide a written informed consent
2. Diagnosed with end stage renal disease receiving maintenance hemodialysis
3. Male or female
4. Meet the Body Mass Index standard
5. Stably use of concomitant medication of other therapies of SHPT
6. Meet the standard of iPTH level, cCa
Exclusion Criteria:
1. Subjects with a history of malignant tumor
2. Subjects with neuropsychiatric diseases
3. Subjects with a history of cardiovascular diseases
4. Subjects with gastrointestinal diseases
5. Subjects with a history of surgery
6. Subjects with a history of blood loss
7. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin
8. Subjects with a treatment history of similar drugs
9. Allergic to a drug ingredient or component
10. Pregnant or nursing women
11. No birth control during the specified period of time
12. Subject with a history of alcohol abuse and drug abuse
13. Participated in clinical trials of other drugs
14. The investigators determined that other conditions were inappropriate for participation in this clinical trial
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** kunming.li@hengrui.com
**Name:** Kunming Li
**Phone:** 0518-82342973
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Name:** Xueqing Yu
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Guangdong Provincial People's Hospital
**State:** Guangdong
**Zip:** 510000
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009385
- Term: Neoplastic Processes
- ID: D000009369
- Term: Neoplasms
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010279
- Term: Parathyroid Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
### Condition Browse Module - Browse Leaves
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: HIGH
- As Found: Secondary
- ID: M10012
- Name: Hyperparathyroidism
- Relevance: HIGH
- As Found: Hyperparathyroidism
- ID: M10013
- Name: Hyperparathyroidism, Secondary
- Relevance: HIGH
- As Found: Secondary Hyperparathyroidism
- ID: M12330
- Name: Neoplastic Processes
- Relevance: LOW
- As Found: Unknown
- ID: M13192
- Name: Parathyroid Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009362
- Term: Neoplasm Metastasis
- ID: D000006961
- Term: Hyperparathyroidism
- ID: D000006962
- Term: Hyperparathyroidism, Secondary
### Intervention Browse Module - Ancestors
- ID: D000077264
- Term: Calcium-Regulating Hormones and Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000057966
- Term: Calcimimetic Agents
- ID: D000006727
- Term: Hormone Antagonists
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
### Intervention Browse Module - Browse Leaves
- ID: M418
- Name: Cinacalcet
- Relevance: HIGH
- As Found: Solifenacin
- ID: M9789
- Name: Hormones
- 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: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000069449
- Term: Cinacalcet
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434948
**Brief Title:** The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery
**Official Title:** The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery: a Prospective, Randomized, Controlled Trial
#### Organization Study ID Info
**ID:** 2099184
#### Organization
**Class:** OTHER
**Full Name:** University of Missouri-Columbia
### 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:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Missouri-Columbia
#### Responsible Party
**Investigator Affiliation:** University of Missouri-Columbia
**Investigator Full Name:** Quinn Johnson
**Investigator Title:** Department Chair of Anesthesiology and Perioperative Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to determine whether giving omega-3 fatty acids prior to and after cardiac bypass surgeries decreases the incidence of postoperative delirium in patients aged 65 and over.
**Detailed Description:** Patients aged 65 years and over requiring elective cardiac bypass surgeries will receive either 0, 2, or 4 grams of omega-3 ethyl esters before their surgery and for 3 days postoperatively to determine whether there is an affect on the incidence of postoperative delirium. All patients will receive hospital standard of care therapy for their surgery and hospital stay.
### Conditions Module
**Conditions:**
- Postoperative Delirium
**Keywords:**
- postoperative delirium
- delirium
- fish oil
- omega 3
- Lovaza
- cardiac bypass
- omega 3 ethyl esters
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Arm 1: 4 grams of Omega-3 Ethyl Esters Arm 2: 2 grams of Omega-3 Ethyl Esters Arm 3: Standard of care
##### Masking Info
**Masking:** NONE
**Masking Description:** This study will not be blinded as there is no suitable placebo for omega-3 ethyl esters available at this time.
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will be given 4 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively.
**Intervention Names:**
- Drug: Omega-3 Ethyl Esters 4 g
**Label:** Omega-3 Ethyl Esters 4 g
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients will be given 2 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively.
**Intervention Names:**
- Drug: Omega-3 Ethyl Esters 2 g
**Label:** Omega-3 Ethyl Esters 2 g
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Patients will not receive any study drug.
**Label:** Standard of Care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Omega-3 Ethyl Esters 4 g
**Description:** 4 grams = 4 capsules, once daily
**Name:** Omega-3 Ethyl Esters 4 g
**Other Names:**
- Omega-3 ethyl esters
- Lovaza
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Omega-3 Ethyl Esters 2 g
**Description:** 2 grams = 2 capsules, once daily
**Name:** Omega-3 Ethyl Esters 2 g
**Other Names:**
- Lovaza
- Omega-3 ethyl esters
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Number of patients that experienced postoperative delirium during the study.
**Measure:** Presence of Postoperative Delirium
**Time Frame:** From the date of surgery until the patient is discharged, up to 30 days.
#### Secondary Outcomes
**Description:** Concentrations of cytokines in blood collected before patient is put on cardiac bypass, immediately after bypass, and 1, 2, and 3 days postoperative.
**Measure:** Cytokine Concentrations
**Time Frame:** 0, 1, 2, 3 days postoperatively
**Description:** Concentrations of polyunsaturated fatty acids in blood collected before patient is put on cardiac bypass, immediately after bypass, and 1, 2, and 3 days postoperative.
**Measure:** Polyunsaturated Fatty Acid Concentrations
**Time Frame:** 0, 1, 2, 3 days postoperatively
**Description:** Presence of any postoperative delirium symptoms during patient's hospital stay.
**Measure:** Postoperative Delirium Symptoms
**Time Frame:** From the date of surgery until the patient is discharged, up to 30 days.
**Description:** Number of days patient stayed in hospital from the time of admission to discharge.
**Measure:** Length of Stay
**Time Frame:** From the date of surgery until the patient is discharged, up to 30 days.
**Description:** Number of patients administered anesthesia using mainly propofol or sevoflurane.
**Measure:** Type of Anesthesia Used
**Time Frame:** Day of surgery
**Description:** Average morphine milligram equivalents given to patients postoperatively until their discharge from the hospital.
**Measure:** Amount of Pain Medication Given Postoperatively
**Time Frame:** From the date of surgery until the patient is discharged, up to 30 days.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 65 years
* American Society of Anesthesiologists (ASA) Class Physical Status I-IV
Exclusion Criteria:
* Inability to obtain written informed consent.
* Inability to take study drug due to intubation or other reason.
* Delirium present at screening.
* Known hypersensitivity (e.g. anaphylactic reaction) to omega-3 ethyl esters or any of its components
* Allergy to fish or shellfish
* Currently taking warfarin (Coumadin), apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa/Lixiana), rivaroxaban (Xarelto), or other anticoagulant drugs.
* Currently taking omega-3, omega-6, vitamin E, or fish oil supplements.
* Significant renal disease with a serum creatinine ≥ 2 mg/dL.
* Significant liver disease with alanine aminotransferase (ALT) levels 1.5 times the normal range of 6-45 units/liter and aspartate transferase (AST) levels 1.5 times the normal range of 10-42 units/liter.
* History or diagnosis of diabetes.
* History or diagnosis of neurodegenerative disease such as Parkinson's, Alzheimer's, or dementia.
* History or diagnosis of bleeding disorder.
* History or diagnosis of metabolic syndrome or disorder.
* History or diagnosis of thyroid problems such as hyperthyroidism or hypothyroidism.
**Minimum Age:** 65 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** aburger@umsystem.edu
**Name:** Antoinette Burger, PhD
**Phone:** 5738843740
**Role:** CONTACT
**Contact 2:**
**Email:** pasbxw@umsystem.edu
**Name:** Paige Spencer, BS
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Missouri-Columbia
**Name:** Quinn Johnson, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003221
- Term: Confusion
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6894
- Name: Delirium
- Relevance: HIGH
- As Found: Delirium
- ID: M772
- Name: Emergence Delirium
- Relevance: HIGH
- As Found: Postoperative Delirium
- ID: M6446
- Name: Confusion
- Relevance: LOW
- As Found: Unknown
- ID: M21826
- Name: Neurobehavioral Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003693
- Term: Delirium
- ID: D000071257
- Term: Emergence Delirium
### Intervention Browse Module - Browse Branches
- Abbrev: Ot
- Name: Other Dietary Supplements
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T415
- Name: Omega 3 Fatty Acid
- Relevance: HIGH
- As Found: Unacceptable
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434935
**Acronym:** VCAB-1
**Brief Title:** Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit
**Official Title:** Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit
#### Organization Study ID Info
**ID:** CIP-003
#### Organization
**Class:** INDUSTRY
**Full Name:** Vascudyne, Inc.
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2025-07-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-11-07
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Vascudyne, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The Vascudyne Coronary Artery Bypass Study (VCAB-1) is an initial safety and feasibility study of the Vascudyne, Inc. Coronary Artery Bypass Conduit (CAB A) for bypass of stenosed native coronary arteries in patients undergoing coronary artery bypass surgery.
**Detailed Description:** Prospective, non-randomized, initial evaluation clinical study to assess the feasibility of TRUE CAB for secondary coronary targets in patients needing multiple coronary artery bypass.
Patients will be implanted with a single TRUE CAB bypass (single proximal and distal anastomoses) to the second or third CA bypass target.
The primary target CA shall be bypassed using an arterial graft. The left anterior descending (LAD) CA bypass, if needed, shall be bypassed using the left internal mammary artery (LIMA). A saphenous vein shall be used for any additional targets as needed.
Estimated enrollment for first three patients (2 weeks), followed by enrollment over 4 months. Follow up through 24 months.
### Conditions Module
**Conditions:**
- Coronary Artery Disease
**Keywords:**
- CABG
- Coronary bypass
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will be implanted with a single TRUE CAB bypass (single proximal and distal anastomoses) to the second or third CA bypass target
**Intervention Names:**
- Combination Product: CABA
**Label:** True CABA
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- True CABA
**Description:** Coronary Bypass
**Name:** CABA
**Type:** COMBINATION_PRODUCT
### Outcomes Module
#### Primary Outcomes
**Description:** Intervention-free angiographic patency \[failure defined as \>50% stenosis or occlusion\].
**Measure:** Patency
**Time Frame:** 6 months
**Description:** Major Adverse Cardiac and Cerebrovascular events (MACCE)
**Measure:** MACE
**Time Frame:** 30 days
#### Secondary Outcomes
**Description:** Intervention-free angiographic patency \[failure defined as \>50% stenosis or occlusion\].
**Measure:** Patency
**Time Frame:** 30 days
**Description:** Intervention-free angiographic patency \[failure defined as \>50% stenosis or occlusion\].
**Measure:** Patency
**Time Frame:** 12 months
**Description:** Intervention-free angiographic patency \[failure defined as \>50% stenosis or occlusion\].
**Measure:** Patency
**Time Frame:** 18 months
**Description:** Fitzgibbon classification
**Measure:** Fitzgibbon classification
**Time Frame:** 30 days, 6 months and 12 months
**Description:** Freedom from MACCE
**Measure:** MACCE
**Time Frame:** 6, 12, 18 and 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients needing isolated coronary artery bypass grafting to multiple coronary arteries (CA) in which the first target CA must be an arterial bypass and the TRUE CAB target CA must be at least 2mm in diameter, have at least 75% stenosis (\>90% ideal) proximal to the bypass, have at least TIMI II flow (in non-100% stenosis), shall be among the following options: proximal right coronary artery (RCA), Ramus intermedius, left marginal arteries (M1, M2), or diagonal branches (D1, D2). In case of diagonal selection, ensure it will not impact LIMA patency.
2. Male or female patients between the ages of 45 and 75 years inclusive.
3. Elective patient, selected and accepted by the local Heart Team and confirmed by the Sponsor's Screening Committee for an on-pump full sternotomy CABG surgery.
4. Life expectancy of at least 4 years.
5. Female subjects must be of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening).
6. Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
7. Patient has been informed and agrees to pre- and post-procedure follow-up, including follow-up cardiac ultrasound and coronary angiogram or CT.
8. Patient is willing to be compliant with prescribed anticoagulant therapy (critical to preventing thrombus in the investigational device).
Exclusion Criteria:
1. Patients with left ventricular ejection fraction \< 35%.
2. Patients with diffusive coronary artery disease.
3. Patients requiring emergency surgery.
4. Patients with cardiogenic shock.
5. Patients undergoing repeat CABG.
6. Previous, concomitant, and/or planned cardiac procedure including:
1. heart valve surgery
2. Percutaneous Coronary Intervention (PCI)
3. Ablation
4. Patent Foramen Ovale (PFO) repair
5. Dor or Maze procedure
7. History of cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation.
8. Myocardial infarction (MI) within 21 days or cerebral vascular accident (CVA) within 90 days of the CABG procedure.
9. Patients with Type 1 Diabetes and Patients with Type II Diabetes having A1C\>8.
10. Abnormal platelet level defined as Plt Count \>400,000.
11. Severe kidney disease, Glomerular Filtration Rate (GFR) \< 50mL/min, or active dialysis patients
12. Moderate to severe chronic obstructive pulmonary disease (COPD) with a forced expiratory volume (FEV) \<1.5 lit/sec or 45% predicted FEV1.
13. Patient with underlying interstitial lung disease. Can be assessed via imaging or test like DLCO
14. Endocarditis, pericarditis, or any other active systemic infection that would interfere with patient safety.
15. Patient on preoperative anticoagulant (i.e. Warfarin).
16. Abnormal blood values (e.g. leukopenia, anemia, or thrombocytopenia) that could influence graft hemostasis or patient recovery.
17. Known allergies to study device components: Nitinol, Nickel, Titanium, or agents/medication such as contrast agents, antiplatelet therapy, beta-blocker, or statins required for study assessment or optimal post-CABG medical treatment (hospital standard of care).
18. Known need for emergency surgery for any reason and/or intervention/surgery prior to and within 12 months after the CABG surgery that requires antiplatelet therapy discontinuation.
19. History of heparin-induced thrombocytopenia.
20. Contraindication to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet and factor Xa inhibitor therapy.
21. Immunodeficiency including AIDS / HIV, active autoimmune disease, or on immunosuppressant therapy.
22. Treatment with any investigational drug or device within 60 days prior to study entry or ongoing participation in another clinical study of an investigational product.
23. Subject has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance.
24. Has any other condition, in the opinion of the principal investigator, which would put the patient at increased risk from participating in the study or otherwise prevent participation.
**Maximum Age:** 75 Years
**Minimum Age:** 45 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Asunción
**Country:** Paraguay
**Facility:** Sanatario Italiano
#### Overall Officials
**Official 1:**
**Affiliation:** Italian Hospital Asuncion Paraguay
**Name:** Adrian Ebner, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003327
- Term: Coronary Disease
- ID: D000017202
- Term: Myocardial Ischemia
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
- ID: D000014652
- Term: Vascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: HIGH
- As Found: Coronary Artery Disease
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M6549
- Name: Coronary Disease
- Relevance: LOW
- As Found: Unknown
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4469
- Name: Arteriosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003324
- Term: Coronary Artery Disease
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434922
**Brief Title:** Prevention and Early Detection of Ulcer Recurrence in Patients With Type II Diabetes Mellitus
**Official Title:** A Randomized Clinical Trial Study on the Prevention Strategy and Early Detection of Ulcer Recurrence in Patients With Type II Diabetes Mellitus Using the Risk of Recurrence Ulcer Tool
#### Organization Study ID Info
**ID:** ID01
#### Organization
**Class:** OTHER
**Full Name:** Institute Technology and Health Muhammadiyah West Kalimantan
### Status Module
#### Completion Date
**Date:** 2023-06-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-06-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Institute Technology and Health Muhammadiyah West Kalimantan
#### Responsible Party
**Investigator Affiliation:** Institute Technology and Health Muhammadiyah West Kalimantan
**Investigator Full Name:** Haryanto Haryanto
**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 clinical trial is to to evaluate the effectiveness of prevention strategies of recurrence in DFU's. It will also to detect the risk level of recurrence. The main question it aims to answer are:
* Does intervention of prevention strategies effective to prevent the recurrence of DFU's?
* How the risk level of the recurrence on DFU's patients?
* How the impact of quality of life on DFU's patients?
Researchers will compare intervention groups (receiving education covered various aspects, including they received guidance on foot examination, foot care, dietary habits, physical exercise, and stress management), and control groups (received standards follow-up care provided by healthcare providers, including pamphlets outlining care for DM patients based on the five pillars, including DM management, medication adherence, dietary practices, physical exercise routines, and foot care).
Participants will:
* For intervention group will be educated every month
* Data for both intervention and control groups were collected monthly until three months.
**Detailed Description:** 1. Introduction
A recurrence of a diabetic foot ulcer refers to the emergence of a new foot ulcer in individuals with a prior history of foot ulceration, irrespective of the specific location or duration since the occurrence of the previous ulcer. Even after the resolution of a foot ulcer, recurrence remains a common problem. In Indonesia, studies have indicated a recurrence rate of diabetic foot ulcers ranging from 13.30% to 35%, while global recurrence rates vary significantly among different countries. Thus, implementing prevention strategies is crucial in averting recurrence. These strategies, such as proper foot care, glycemic control, and early detection and management of risk factors, can significantly reduce the occurrence and recurrence of diabetic foot ulcers.
Several studies have highlighted various preventive treatments aimed at decreasing the likelihood of diabetic foot ulcer recurrence. These treatments include integrated foot care, self-management techniques, patient education, therapeutic footwear utilization, and surgical intervention. Recent research has also explored the potential of thermography in detecting foot ulcer risk among patients with diabetes mellitus. While numerous original studies and systematic reviews have reported prevention strategies for preventing diabetic foot recurrence, there is limited research on the combined approach of early detection and prevention of foot ulcer recurrence.
In Indonesia, preventive strategies for diabetes mellitus patients have been implemented through the PROLANIS program, a chronic disease management initiative launched in 2010 in community health centers. PROLANIS focuses on diabetes self-management and follows the five-pillar method established by the Indonesian Society of Endocrinology (PERKENI), encompassing dietary practices, physical activity, pharmaceutical interventions, glucose monitoring, and educational initiatives. Despite the nationwide adoption of these pillars since 2011, the prevalence of recurrence remains significant in Indonesia. Prevention strategies, carried out by healthcare provider teams, including nursing staff, are vital in addressing this challenge. Nurses are involved in physical assessment, early detection, foot care, and education, making their role crucial in implementing prevention strategies.
Early detection is integral to preventing ulcer recurrence. A systematic review identified three main types of interventions used in early ulcer recurrence detection: conventional physical assessment, 3D thermal camera assessment systems, and diabetic foot screening instruments. Hence, further development of early detection methods for recurrence risk is necessary.
The study utilized a multifaceted approach incorporating four techniques to reduce the risk of ulcer recurrence in patients with DM. These strategies included:1) conducting a thorough physical examination and assessing the foot, which involved utilizing a thermograph to identify variations in skin temperature; 2) implementing appropriate foot care practices; 3) providing patients with educational resources and guidance; and 4) promptly identifying and addressing factors that may increase the likelihood of ulcer recurrence.
1.1. Objective The primary objective of this study is to assess the efficacy of preventive measures while ascertaining the degree of risk associated with potential recurrences using the risk of recurrence ulcer tool. Additionally, an assessment was conducted to evaluate the impact on the quality of life.
2. Methods and Materials 2.1. Study Design and Participants This study is prospective clinical trial design to evaluate the effectiveness of prevention strategies utilizing an early detection tool for ulcer recurrence. The study had approved by the ethics committee of the Institute of Technology and Health Muhamamdiyah West Kalimantan. Conducted between January and July 2023 at two community health centers in Pontianak and Kubu Raya, West Kalimantan, Indonesia, the study followed the Consolidated Standards of Reporting Trials (CONSORT); randomized controlled trial (RCT) guidelines principles. Sixty participants were recruited using simple random allocation sampling, with 30 individuals assigned to each group based on calculated sample size requirements. G Power software was utilized to determine sample size, considering a significance level (α) of 0.05, power (β) of 0.95, proportion (p1) of 0.12 in group 1, and proportion (p2) of 0.54 in group 2. Inclusion criteria included the ability to perform everyday tasks, cooperation, and ulcer recovery for at least two weeks, while exclusion criteria comprised serious illnesses or sequelae, active foot ulcers, Charcot neuro-osteoarthropathy, persistent limb-threatening ischemia, and foot infections.
Participants who had received care at the community health centers and had recovered from their wounds constituted the intervention and control groups. Recruitment involved searching medical records and contacting eligible individuals. Written informed consent was obtained before enrollment. The 60 participants were divided into intervention and control groups. Both groups were encouraged to visit the community health centers, with researchers conducting home visits if necessary. The intervention group received the study's treatment, while the control group received standard follow-up care provided by healthcare providers, including pamphlets outlining care for DM patients based on the five pillars, including ulcer prevention.
2.2. Data Collection In this investigation, four research assistants underwent training following the study protocol to conduct examinations on diabetic feet, which included utilizing tools such as the thermograph, monofilament test, vascular Doppler ultrasound, conventional foot plantar scan, and diabetic foot and nail care. Additionally, they were trained in collecting demographic data, assessing diabetic wounds, and educating patients. Patient education covered various aspects, including regular monitoring of blood glucose levels, effective dietary management, consistent physical activity, routine foot inspections, adherence to prescribed medications, and appropriate footwear selection based on plantar foot pressure measurements. Following plantar foot pressure measurement, patients were educated on maintaining regular blood sugar control, dietary management, exercise routines, foot inspection practices, medication adherence, and proper footwear selection.
During the intervention procedure, data collection sessions lasted approximately 1 to 1.50 hours, with education and foot care provided once a month. Subsequently, patients underwent monthly follow-ups for three months, during which they received guidance on foot examination, foot care, dietary habits, physical exercise, and stress management.
For the control group, a comprehensive foot examination was conducted at the initial assessment to evaluate the overall foot health of participants. Patients in the control group were educated about DM management, medication adherence, dietary practices, physical exercise routines, and foot care through pamphlets. Data for both intervention and control groups were collected monthly through examinations and inspections, each conducted by two nurses who had completed preventive foot care training.
Throughout the study, data collection included vascular Doppler ultrasonography (BT-200 V, 8 MHz; Bistos Co., Ltd., Seongna, Korea) for assessing the ankle-brachial index (ABI) and the monofilament test using a 10-g (5.7) Semmes-Weinstein monofilament to evaluate neuropathic status. Additionally, plantar pressure distribution data were collected using a foot printer (Bauerfeind AG, Thuringia, Germany) and a callus removal device. Clinical examinations were conducted to assess structural and functional foot deformities, including claw/hammer toe, hallux rigidus, hallux valgus, bony prominences, pes cavus, pes planus, and metatarsal head abnormalities.
The risk level recurrence ulcer tool, INDIFURUTO (Indonesian Diabetic Foot Ulcer Recurrence Assessment Tool), was utilized to assess the risk level. INDIFURUTO considers factors such as history of amputation, smoking, serum glucose levels, ankle-brachial index, monofilament test results, and differences in foot skin temperature. Skin temperature measurements were obtained using smartphone-based thermography (FLIR ONE Gen 3, Teledyne FLIR LLC, Wilsonville, OR, USA). Subjects were categorized as high risk if they scored less than or equal to 22 points, medium risk if they scored between 23 and 45, and low risk if they scored more than or equal to 46. Previous studies have demonstrated high sensitivity (100%) and specificity (90%) of this tool. INDIFURUTO assessments were conducted at baseline, and at the second and third follow-up assessments for both groups.
The European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) version was utilized to evaluate participants' quality of life, a measure that has demonstrated reliability with a Cronbach's alpha coefficient of 0.79. Quality of life assessments were conducted at baseline, as well as at the second and third follow-up assessments for both intervention and control groups. Participants self-assessed their level of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression, with responses ranging from level 1 (indicating the best state) to level 3 (indicating the worst state). Additionally, participants reported their current health status using a visual analog scale (EQ-VAS) that ranged from 0 (indicating the lowest health status) to 100 (indicating the highest health status) points.
Demographic data were also collected, including information on gender, age, BMI, duration of diabetes mellitus (DM), fasting blood sugar value, ethnicity, occupation status, education level, religion, smoking status, type of diabetes, diabetes treatment, presence of DM complications, foot deformities, history of previous amputation, and time elapsed since the last ulcer healed.
2.3. Data Analysis All data were analyzed using SPSS software (version 26.0; IBM Corp., Armonk, NY, USA). The demographic variables were assessed using descriptive statistics (means, standard deviation, frequencies). A mixed model for repeated measures analysis was used to test the differences in quality of life and high-risk level on baseline and the third follow-ups between the two groups. p \< 0.05 was chosen as the level of significance
### Conditions Module
**Conditions:**
- Recurrence
- Diabetic Foot
- Thermography
- Quality of Life
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Intervention group: patient education covered various aspects, including regular monitoring of blood glucose levels, effective dietary management, consistent physical activity, routine foot inspections, adherence to prescribed medications, and appropriate footwear selection based on plantar foot pressure measurements.
During the intervention procedure, data collection sessions lasted approximately 1 to 1.50 hours, with education and foot care provided once a month. Subsequently, patients underwent monthly follow-ups for three months, during which they received guidance on foot examination, foot care, dietary habits, physical exercise, and stress management.
Control group: Patients were educated about DM management, medication adherence, dietary practices, physical exercise routines, and foot care through pamphlets.
##### Masking Info
**Masking:** NONE
**Masking Description:** The investigators known the groups.
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 60
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Groups received the prevention strategies to prevent the recurrence of DFU's
**Intervention Names:**
- Device: Prevention Strategies
**Label:** Prevention Strategies
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Groups received the standard strategies to prevent the recurrence of DFU's
**Intervention Names:**
- Device: Standard Strategiies
**Label:** Standard Strategies
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Prevention Strategies
**Description:** Data collection sessions lasted approximately 1 to 1.50 hours, with education and foot care provided once a month. Subsequently, patients underwent monthly follow-ups for three months, during which they received guidance on foot examination, foot care, dietary habits, physical exercise, and stress management.
**Name:** Prevention Strategies
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Standard Strategies
**Description:** Group were educated about DM management, medication adherence, dietary practices, physical exercise routines, and foot care through pamphlets
**Name:** Standard Strategiies
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The risk level recurrence ulcer tool, INDIFURUTO (Indonesian Diabetic Foot Ulcer Recurrence Assessment Tool), was used to assess the risk level. Subjects were categorized as high risk if they scored less than or equal to 22 points, medium risk if they scored between 23 and 45, and low risk if they scored more than or equal to 46.
**Measure:** The degree of risk of recurrence
**Time Frame:** up to three months
**Description:** Prevention stratagies is evaluated using INDIFURUTO tool (history of amputation, smoking, serum glucose levels, ankle-brachial index, monofilament test results, and differences in foot skin temperature). Good=INDIFURUTO total score increase than baseline and Poor=INDIFURUTO total score decrease than baseline
**Measure:** Efficacy of prevention strategies
**Time Frame:** up to three months
#### Secondary Outcomes
**Description:** The European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) version was used to evaluate participants' quality of life. Level 1 (indicating the best state) to Level 3 (indicating the worst state).
**Measure:** Quality of life of DFU's
**Time Frame:** up to three months
**Description:** Health status using a visual analog scale (EQ-VAS) that ranged from 0 (indicating the lowest health status) to 100 (indicating the highest health status).
**Measure:** Health status of DFU's
**Time Frame:** up to three months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants have a history of diabetic foot ulcers.
* signed an informed consent
Exclusion Criteria:
* Declined to participate
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Pontianak
**Country:** Indonesia
**Facility:** Haryanto Haryanto
**State:** Kalimantan Barat
**Zip:** 78164
#### Overall Officials
**Official 1:**
**Affiliation:** ITEKES Muhammadiyah Kalimantan Barat
**Name:** Haryanto Haryanto
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000003925
- Term: Diabetic Angiopathies
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000016523
- Term: Foot Ulcer
- ID: D000007871
- Term: Leg Ulcer
- ID: D000012883
- Term: Skin Ulcer
- ID: D000012871
- Term: Skin Diseases
- ID: D000048909
- Term: Diabetes Complications
- ID: D000003929
- Term: Diabetic Neuropathies
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M17206
- Name: Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes Mellitus
- ID: M7119
- Name: Diabetes Mellitus, Type 2
- Relevance: HIGH
- As Found: Type II Diabetes Mellitus
- ID: M19933
- Name: Diabetic Foot
- Relevance: HIGH
- As Found: Diabetic Foot
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrence
- 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: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M7120
- Name: Diabetic Angiopathies
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M18919
- Name: Foot Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M10883
- Name: Leg Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15686
- Name: Skin Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M26004
- Name: Diabetes Complications
- Relevance: LOW
- As Found: Unknown
- ID: M7124
- Name: Diabetic Neuropathies
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000017719
- Term: Diabetic Foot
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000003924
- Term: Diabetes Mellitus, Type 2
- ID: D000012008
- Term: Recurrence
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434909
**Brief Title:** CYTALUX™for the Intraoperative Imaging of Prostate Cancer
**Official Title:** An Investigator Sponsored Study to Investigate the Safety and Efficacy of CYTALUX™ (PAFOLACIANINE) INJECTION for the Intraoperative Imaging of Prostate Cancer
#### Organization Study ID Info
**ID:** IUSCCC-0890
#### Organization
**Class:** OTHER
**Full Name:** Indiana University
### Status Module
#### Completion Date
**Date:** 2025-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**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:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** On Target Laboratories
#### Lead Sponsor
**Class:** OTHER
**Name:** Clinton Bahler
#### Responsible Party
**Investigator Affiliation:** Indiana University
**Investigator Full Name:** Clinton Bahler
**Investigator Title:** Principal investigator
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study is being done to compare how much using Cytalux™ (pafolacianine) with NIR (Near InfraRed) fluorescent imaging improves the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
The U.S. Food and Drug Administration (FDA) has approved the targeted imaging agent pafolacianine (Cytalux) for use in ovarian cancer (2021) and lung cancer surgery (2022.)
**Detailed Description:** This is an open label trial in up to 15 subjects with biopsy confirmed prostate cancer (PCa) who have been scheduled to undergo a laparoscopic radical prostatectomy with or without robotic assistance, with pelvic lymph node dissection. This is a non-intervention trial to assess the accuracy of an imaging agent, folate targeted fluorescent dye (pafolacianine), during a standard of care radical prostatectomy.
Qualifying subjects will be Grade Group 3 to 5 (\>/= cT3) with either suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and/or seminal vesicle infiltration (SVI)), or suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission tomography (PSMA PET+).
Whether using an anterior or a posterior approach, the tissues planned for removal will be visualized first under normal light, and their locations marked on a provided template. All additional suspicious tissue or nodes will be similarly marked, whether removed or not. Prior to removal, the field must be illuminated with Near Infrared light (NIR) and fluorescent tissues must be marked on the template. This may proceed in an iterative fashion, switching from first normal light to NIR as the surgical field expands.
NIR imaging must be conducted in the timeframe of one hour to twenty-four hours following IV infusion of pafolacianine. Lymphatics to be examined are, at a minimum, the external iliac, internal iliac and obturator fossa, and common iliac. Fluorescence positive nodules and nodes will be removed at the surgeon's discretion and sent as labeled (specimen number, tissue, location) specimens to pathology without designation of florescence. Ink dots should ideally be applied to the spot suspected of being cancerous.
### Conditions Module
**Conditions:**
- Prostate Cancer
**Keywords:**
- fluorescent
- image guided intervention
- folate
- prostate cancer
- laparoscopic prostatectomy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with risk of EPE and having robotic prostatectomy for prostate cancer.
**Intervention Names:**
- Diagnostic Test: Cytalux™ (pafolacianine) for fluorescent imaging
**Label:** Fluorescent guided surgery
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Fluorescent guided surgery
**Description:** Cytalux™ (pafolacianine) injection: folate analog ligand conjugated with an indole cyanine green-like dye for real-time cancer margin status.
This is used in conjunction with appropriate imaging system.
**Name:** Cytalux™ (pafolacianine) for fluorescent imaging
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The proportion of subjects who have a Clinically Significant Event (CSE). A CSE is a composite endpoint defined as at least one of the following outcomes:
1. One or more resected "NIR only" positive lymph nodes that contain metastatic disease as confirmed by pathology.
2. Histologically confirmed cancer in resected "NIR only" residual non-nodal soft tissue following prostatectomy.
**Measure:** Detection of residual cancer
**Time Frame:** Day of surgery (visit 2)
#### Secondary Outcomes
**Description:** To evaluate the proportion of subjects whose surgical procedure changed in scope from the planned surgery based on the use of
**Measure:** Treatment change
**Time Frame:** Day of surgery (visit 2)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Signed and dated informed consent form
2. Male subjects 18 years of age and older
3. Known primary prostate cancer
4. Grade Group 3 to 5 with either:
1. suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and/or seminal vesicle infiltration (SVI)), or 3 or more biopsy cores of grade group 3-5;
2. suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission tomography (PSMA PET+));
3. or both.
5. Planned to undergo a laparoscopic prostatectomy with or without robotic assistance, and lymph node dissection
6. Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
7. Agree to stop folate or folic acid supplements at least 48 hours prior to injection of study agent
Exclusion Criteria:
1. The surgeon plans to perform an extraperitoneal approach
2. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
3. History of anaphylactic reactions to products containing indocyanine green
4. History of allergy to any of the components of PAFOLACIANINE
**Maximum Age:** 90 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** jgeck@iu.edu
**Name:** Jennifer Lehman, RN
**Phone:** 317-278-0340
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Carmel
**Contacts:**
***Contact 1:***
- **Email:** jgeck@iu.edu
- **Name:** Jennifer Lehman
- **Phone:** 317-278-0340
- **Role:** CONTACT
***Contact 2:***
- **Name:** Clinton Bahler, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** IU Health Joe and Shelly Schwarz Cancer Center
**State:** Indiana
**Zip:** 46032
**Location 2:**
**City:** Indianapolis
**Contacts:**
***Contact 1:***
- **Email:** jgeck@iu.edu
- **Name:** Jennifer Lehman
- **Phone:** 317-278-0340
- **Role:** CONTACT
***Contact 2:***
- **Name:** Clinton Bahler, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center
**State:** Indiana
**Zip:** 46202
**Location 3:**
**City:** Indianapolis
**Contacts:**
***Contact 1:***
- **Email:** jgeck@iu.edu
- **Name:** Jennifer Lehman
- **Phone:** 317-278-0340
- **Role:** CONTACT
***Contact 2:***
- **Name:** Clinton Bahler, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Indiana University Health Methodist Hospital
**State:** Indiana
**Zip:** 46202
#### Overall Officials
**Official 1:**
**Affiliation:** Indiana University
**Name:** Clinton Bahler, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005834
- Term: Genital Neoplasms, Male
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000011469
- Term: Prostatic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Vi
- Name: Vitamins
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M8618
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M17546
- Name: Vitamin B Complex
- Relevance: LOW
- As Found: Unknown
- ID: M8619
- Name: Folic Acid Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: T447
- Name: Folinic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T446
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T448
- Name: Folate
- Relevance: LOW
- As Found: Unknown
- ID: T475
- Name: Vitamin B9
- Relevance: LOW
- As Found: Unknown
- ID: T399
- Name: Indole
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434896
**Acronym:** CrEATE
**Brief Title:** Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
**Official Title:** Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
#### Organization Study ID Info
**ID:** NL71881.041.19
#### Organization
**Class:** OTHER
**Full Name:** UMC Utrecht
### Status Module
#### Completion Date
**Date:** 2035-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2035-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2020-03-05
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Personal Genome Diagnostics (PGDx)
**Class:** OTHER
**Name:** The Netherlands Cancer Institute
#### Lead Sponsor
**Class:** OTHER
**Name:** UMC Utrecht
#### Responsible Party
**Investigator Affiliation:** UMC Utrecht
**Investigator Full Name:** Miriam Koopman
**Investigator Title:** Prof. dr.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design).
Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.
### Conditions Module
**Conditions:**
- Circulating Tumor DNA
- Recurrence
- Colon Cancer Stage II
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized controlled trial
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 1320
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. Results are reported to the treating physician and patients. All patients with detectable ctDNA are considered high risk stage 2 patients and will be offered adjuvant chemotherapy for 3 months (4 cycles CAPOX) according to routine clinical practice. Patients with undetectable ctDNA will receive routine follow-up at the surgical department.
**Intervention Names:**
- Other: ctDNA analysis after surgery
**Label:** ctDNA-based treatment group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The treating physician and patient are not informed about the ctDNA result and these patients will receive routine follow-up at the surgical department.
**Label:** Standard of care group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ctDNA-based treatment group
**Description:** ctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.
**Name:** ctDNA analysis after surgery
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood.
**Time Frame:** 8-12 weeks after surgery
#### Secondary Outcomes
**Description:** Proportion of patients that will experience disease recurrence
**Measure:** Recurrence Rate
**Time Frame:** 2 and 5 years after surgery
**Description:** Proportion of patients that are alive and free of disease
**Measure:** Disease Free Survival rate
**Time Frame:** 2 and 5 years after surgery
**Description:** Proportion of patients that are alive
**Measure:** Disease-related Overall Survival rate
**Time Frame:** 5 years after surgery
**Measure:** Time to Recurrence
**Time Frame:** From date of randomization until the date of recurrence, assessed up to 5 years.
**Description:** Quality of Life will be measured using questionnaires that are provided to patients who have given informed consent for the collection of questionnaires within PLCRC.
**Measure:** Quality of Life after treatment
**Time Frame:** 10 years
**Measure:** Cost-effectiveness of the ctDNA-based treatment
**Time Frame:** 5 years after diagnosis
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 years
* Informed consent for PLCRC with specific consent for:
* additional blood withdrawals
* collection and use of tissue for scientific research
* invitation for future (experimental) research within the cohort, including TwiCs studies
* Inclusion in observational PLCRC -MEDOCC substudy
* Histological confirmed stage II colon cancer
* Fit enough to receive treatment with combination chemotherapy (fluoropyrimidine and oxaliplatin) according to the treating physician
Exclusion Criteria:
* Indication for adjuvant chemotherapy according to treating physician
* Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma
* Incomplete primary tumor resection (R1 or R2 resection)
* Contra-indication for fluoropyrimidines or oxaliplatin
* Pregnancy
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** plcrcmedocc@umcutrecht.nl
**Name:** Miriam Koopman, Prof. dr.
**Phone:** +316 46 91 95 66
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** 's Hertogenbosch
**Contacts:**
***Contact 1:***
- **Name:** J.F.M. Pruijt
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Jeroen Bosch Ziekenhuis
**Status:** RECRUITING
**Location 2:**
**City:** Alkmaar
**Contacts:**
***Contact 1:***
- **Name:** M.P. Hendriks
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Noordwest Ziekenhuisgroep
**Status:** RECRUITING
**Location 3:**
**City:** Almelo
**Contacts:**
***Contact 1:***
- **Name:** R. Hoekstra
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Ziekenhuisgroep Twente
**Status:** RECRUITING
**Location 4:**
**City:** Almere
**Contacts:**
***Contact 1:***
- **Name:** J.D.W. van der Bilt
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Flevoziekenhuis
**Status:** RECRUITING
**Location 5:**
**City:** Amersfoort
**Contacts:**
***Contact 1:***
- **Name:** J.M. van Dodewaard
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Meander Medisch Centrum
**Status:** RECRUITING
**Location 6:**
**City:** Arnhem
**Contacts:**
***Contact 1:***
- **Name:** I. Werter
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Rijnstate
**Status:** RECRUITING
**Location 7:**
**City:** Breda
**Contacts:**
***Contact 1:***
- **Name:** M. Streppel
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Amphia Ziekenhuis
**Status:** RECRUITING
**Location 8:**
**City:** Delft
**Contacts:**
***Contact 1:***
- **Name:** A.J. Verschoor
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Reinier de Graaf Gasthuis
**Status:** RECRUITING
**Location 9:**
**City:** Den Haag
**Contacts:**
***Contact 1:***
- **Name:** F.J.F. Jeurissen
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Haaglanden MC
**Status:** RECRUITING
**Location 10:**
**City:** Deventer
**Contacts:**
***Contact 1:***
- **Name:** L.W. Kessels
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Deventer Ziekenhuis
**Status:** RECRUITING
**Location 11:**
**City:** Dordrecht
**Contacts:**
***Contact 1:***
- **Name:** M. Vidakovic
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Albert Schweizer Ziekenhuis
**Status:** RECRUITING
**Location 12:**
**City:** Ede
**Contacts:**
***Contact 1:***
- **Name:** M. Verstappen
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Ziekenhuis Gelderse Vallei
**Status:** RECRUITING
**Location 13:**
**City:** Goes
**Contacts:**
***Contact 1:***
- **Name:** H.K. van Halteren
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Admiraal de Ruyter Ziekenhuis
**Status:** RECRUITING
**Location 14:**
**City:** Gorinchem
**Contacts:**
***Contact 1:***
- **Name:** M.A. Davidis
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Rivas
**Status:** RECRUITING
**Location 15:**
**City:** Haarlem
**Contacts:**
***Contact 1:***
- **Name:** H.B.A.C. Stockmann
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Spaarne Gasthuis
**Status:** RECRUITING
**Location 16:**
**City:** Harderwijk
**Contacts:**
***Contact 1:***
- **Name:** A.P. Schouten van der Velden
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Ziekenhuis St. Jansdal
**Status:** RECRUITING
**Location 17:**
**City:** Maastricht
**Contacts:**
***Contact 1:***
- **Name:** L.B.J. Valkenburg
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Maastricht UMC
**Status:** RECRUITING
**Location 18:**
**City:** Middelharnis
**Contacts:**
***Contact 1:***
- **Name:** A.I. de Vos
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Van Weel-Bethesda Ziekenhuis
**Status:** RECRUITING
**Location 19:**
**City:** Nieuwegein
**Contacts:**
***Contact 1:***
- **Name:** M. Los
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** St. Antonius Ziekenhuis
**Status:** RECRUITING
**Location 20:**
**City:** Nijmegen
**Contacts:**
***Contact 1:***
- **Name:** J. Janssen
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Canisius Wilhelmina Ziekenhuis
**Status:** RECRUITING
**Location 21:**
**City:** Roosendaal
**Contacts:**
***Contact 1:***
- **Name:** S. Boudewijns
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Bravis Ziekenhuis
**Status:** RECRUITING
**Location 22:**
**City:** Rotterdam
**Contacts:**
***Contact 1:***
- **Name:** F.E. de Jongh
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Ikazia Ziekenhuis
**Status:** RECRUITING
**Location 23:**
**City:** Uden
**Contacts:**
***Contact 1:***
- **Name:** J. van Extel
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Bernhoven
**Status:** RECRUITING
**Location 24:**
**City:** Utrecht
**Contacts:**
***Contact 1:***
- **Name:** L. van Leeuwen
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Diakonessenhuis
**Status:** RECRUITING
**Location 25:**
**City:** Utrecht
**Contacts:**
***Contact 1:***
- **Name:** Miriam Koopman
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** UMC Utrecht
**Status:** RECRUITING
**Location 26:**
**City:** Veldhoven
**Contacts:**
***Contact 1:***
- **Name:** L.H.J Simkens
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Maxima Medisch Centrum
**Status:** RECRUITING
**Location 27:**
**City:** Venlo
**Country:** Netherlands
**Facility:** VieCuri Medisch Centrum
**Status:** RECRUITING
**Location 28:**
**City:** Weert
**Contacts:**
***Contact 1:***
- **Name:** N.A.J.B. Peters
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** St. Jans Gasthuis
**Status:** RECRUITING
## 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
- 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: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrence
- 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
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003110
- Term: Colonic Neoplasms
- ID: D000012008
- Term: Recurrence
### Intervention Browse Module - Browse Branches
- Abbrev: HB
- Name: Herbal and Botanical
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434883
**Brief Title:** Assessment of an App-based Anxiety/Depression Program in a Population With Elevated Anxiety/Depression
**Official Title:** Assessment of an App-based Anxiety/Depression Program in a Population With Elevated Anxiety/Depression. A Clinical Randomized Controlled Trial.
#### Organization Study ID Info
**ID:** 434587
#### Organization
**Class:** OTHER
**Full Name:** University of Southern Denmark
### Status Module
#### Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-03-01
**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:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Virginia Polytechnic Institute and State University
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Southern Denmark
#### Responsible Party
**Investigator Affiliation:** University of Southern Denmark
**Investigator Full Name:** Ulrich Kirk
**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:** Generalized anxiety disorder is a mental health disorder characterized by feelings of tension and worry with physical symptoms including increased blood pressure (APA 2022). Approximately 20% of US adults reported an anxiety disorder in the past year (NIMH 2023) and an estimated 31% of US adults reported anxiety at some time in their lives (NIMH 2023). Anxiety can be experienced throughout one's life and levels of anxiety can increase with stressful life events, physical health conditions, and medication use (NIMH 2023). Chronic, untreated anxiety has been linked to headaches (Lampl 2016), dizziness (Neuhauser 2016), depression (Lampl et al., 2016), high blood pressure (Celano et al., 2016), heart disease (Celano et al., 2016), digestive disorders (Saha 2014), and a worsened immune system (Leonard et al., 1996) - greatly impacting one's overall quality of life (QOL).
Anxiety and depression are highly comorbid, with approximately 50-60% of those with anxiety symptoms also experiencing depression symptoms (NAMI 2023, Hirschfeld 2001). Experiencing these disorders and symptoms comorbidly may further worsen one's mental health and overall QOL. Untreated, chronic depression can heighten symptoms of depression leading to increased risk of heart disease, sleep disruptions, weight gain/loss, a weakened immune system, physical pains, and suicide attempts (CDC 2016, NIMH 2023).
Anxiety and depression are commonly treated using various psychotherapeutic techniques including cognitive behavioral therapy (CBT) and acceptance and commitment therapy techniques administered by a licensed therapist (NIMH 2023). However, therapy has many barriers to treatment including insurance not covering treatments, overall treatment cost, unsure where to seek treatment/no access to a therapist, and therapy being unavailable and inconvenient due to scheduling during the workday (Andradre et al., 2014). As such, app-based mental health tools have increased in popularity to improve access and affordability to effective mental health treatments.
The purpose of the study is to examine the effectiveness of a guided anxiety/depression app-based program by Headspace, which uses CBT with mindfulness to improve anxiety and depression symptoms in a population with elevated baseline anxiety and/or depression. The study will employ a 2-arm app-based intervention involving 1 active intervention and a waitlist control for a duration of 3 weeks, followed by a 3-week follow-up assessment.
**Detailed Description:** Participants who meet the inclusion criteria will complete the informed consent procedure and the baseline assessment consisting of the study's primary outcomes of anxiety (GAD-7) and depression (PHQ-8) and the secondary outcome measures including sleep quality using the PSQI, perceived stress using the PSS-10, mindfulness using the MAAS, well-being using the WEMWBS, and report use of prescription medication. After the baseline assessment, participants will be randomized into one of two groups (Headspace Anxiety/Depression Program or waitlist control). Participants will participate in the intervention/waitlist control group for 3 weeks. Having completed the 3 week intervention, participants will complete the post-intervention assessment consisting of the primary and secondary outcome measures. Finally, participants will complete the follow-up assessment 3 weeks after post-intervention with a questionnaire to assess changes in routines (including physical activity, prescription medication use or treatments), and the primary and secondary outcome measures.
### Conditions Module
**Conditions:**
- Depression Anxiety Disorder
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 168
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: Anxiety/Depression Program
**Label:** Anxiety/Depression Program
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Other: Waitlist
**Label:** Waitlist
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Anxiety/Depression Program
**Description:** Participants will complete the Headspace Anxiety/Depression Program, which is a 21 day program based on CBT, combined with mindfulness. The program is trans-diagnostic in nature (i.e. addresses both anxiety and depression symptoms).
**Name:** Anxiety/Depression Program
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Waitlist
**Description:** Participants will continue their regular routines for an 21 day period and will not be assigned to an intervention.
**Name:** Waitlist
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The PHQ-8 is used to measure depression symptoms. The PHQ-8 consists of 8 items. Participants use a Likert scale ranging from 0 = not at all to 3 = nearly every day. The range of PHQ-8 scores is 0-24.
**Measure:** Patient Health Questionnaire-8 (PHQ8)
**Time Frame:** Change from baseline to immediately post-intervention and 3-week follow-up
**Description:** The GAD-7 is a 7-item self-report scale based on the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for generalized anxiety disorder, with items scored from 0 (not at all) to 3 (nearly every day).
**Measure:** General Anxiety Disorder-7 (GAD-7)
**Time Frame:** Change from baseline to immediately post-intervention and 3-week follow-up
#### Secondary Outcomes
**Description:** The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances. 19 individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Higher scores indicate worse sleep quality where poor sleep will be a PSQI total score of \> 5.
**Measure:** The Pittsburgh Sleep Quality Index (PSQI)
**Time Frame:** Change from baseline to immediately post-intervention and 3-week follow-up
**Description:** The PSS is a 10-item scale designed to measure the perception of stress within the past month. Participants use a Likert scale with responses ranging from 0 = never to 4 = very often. PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. Additionally, scores can be categorized as low (0-13), moderate (14-26), and high (27-40) perceived stress.
**Measure:** Perceived Stress Scale (PSS-10)
**Time Frame:** Change from baseline to immediately post-intervention and 3-week follow-up
**Description:** Mindfulness will be measured by the MAAS. The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness. Each of the 15 items aims at measuring one's awareness of what is taking place at the present. The MAAS is answered on a five-point Likert scale. Higher scores reflect higher dispositional mindfulness.
**Measure:** Mindful Attention Awareness Scale (MAAS)
**Time Frame:** Change from baseline to immediately post-intervention and 3-week follow-up
**Description:** WEMWBS is a 14 item scale of mental well-being covering subjective well-being and psychological functioning, in which all items are worded positively and address aspects of positive mental health. The scale is scored by summing responses to each item answered on a 1 to 5 Likert scale. The minimum scale score is 14 and the maximum is 70.
**Measure:** Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
**Time Frame:** Change from baseline to immediately post-intervention and 3-week follow-up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Symptoms of anxiety (defined as a score of 10 or greater on the GAD-7) and/or depression (defined as a score of 10 or greater on the PHQ-8).
* Prescription medication for anxiety, depressive symptoms provided a stable dose for ≥4 weeks before baseline or no medication.
* 18+ years old.
* Based in the U.S.
* Access to a smartphone device, as the intervention will be delivered via a smartphone application.
Exclusion Criteria:
* A diagnosis of any of the following conditions: self-reported schizophrenia, psychosis, bipolar disorder, seizure disorder, substance use disorder, recent trauma to the head or brain damage, severe cognitive impairment, serious physical health concerns necessitating surgery or with a prognosis of less than 6 months, or pregnancy.
* Not being on a stable dose of anxiety or depression medication for ≥4 weeks.
* Risks associated with suicidal ideation and risk of self-harm.
* Two or more hospitalizations within the past 6 months for psychiatric reasons.
* Completed CBT (or another "active" form of psychotherapy that includes self-monitoring and cognitive and/or behavioral exercises) delivered by a licensed therapist in the past 6 months.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** ukirk@health.sdu.dk
**Name:** Ulrich Kirk, PhD
**Phone:** +4531328808
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Roanoke
**Contacts:**
***Contact 1:***
- **Email:** ukirk@health.sdu.dk
- **Name:** Ulrich Kirk, PhD
- **Role:** CONTACT
**Country:** United States
**Facility:** Fralin Biomedical Research Institute at VTC
**State:** Virginia
**Zip:** 24016
#### Overall Officials
**Official 1:**
**Affiliation:** University of Southern Denmark
**Name:** Ulrich Kirk, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Aggregated data collected in this project will be de-identified and made available on a shared secured data repository. Results from this project will be shared and disseminated, including manuscripts will be written and submitted for publication in peer-reviewed journals/conferences. All necessary ethical approvals will be obtained.
**IPD Sharing:** YES
**Time Frame:** Data will be made available upon request after dissemination of results.
### References Module
#### References
**Citation:** National Institute of Mental Health (2023). Any Anxiety Disorder. Retrieved April 25, 2023, from https://www.nimh.nih.gov/health/statistics/any-anxiety-disorder.
**Citation:** American Psychological Association (2022). Anxiety. Retrieved April 25, 2023, from https://www.apa.org/topics/anxiety.
**Citation:** Celano CM, Daunis DJ, Lokko HN, Campbell KA, Huffman JC. Anxiety Disorders and Cardiovascular Disease. Curr Psychiatry Rep. 2016 Nov;18(11):101. doi: 10.1007/s11920-016-0739-5.
**PMID:** 27671918
**Citation:** Lampl C, Thomas H, Tassorelli C, Katsarava Z, Lainez JM, Lanteri-Minet M, Rastenyte D, Ruiz de la Torre E, Stovner LJ, Andree C, Steiner TJ. Headache, depression and anxiety: associations in the Eurolight project. J Headache Pain. 2016;17:59. doi: 10.1186/s10194-016-0649-2. Epub 2016 Jun 1.
**PMID:** 27245683
**Citation:** Neuhauser HK. The epidemiology of dizziness and vertigo. Handb Clin Neurol. 2016;137:67-82. doi: 10.1016/B978-0-444-63437-5.00005-4.
**PMID:** 27638063
**Citation:** Leonard BE, Song C. Stress and the immune system in the etiology of anxiety and depression. Pharmacol Biochem Behav. 1996 May;54(1):299-303. doi: 10.1016/0091-3057(95)02158-2.
**PMID:** 8728571
**Citation:** Saha L. Irritable bowel syndrome: pathogenesis, diagnosis, treatment, and evidence-based medicine. World J Gastroenterol. 2014 Jun 14;20(22):6759-73. doi: 10.3748/wjg.v20.i22.6759.
**PMID:** 24944467
**Citation:** National Alliance on Mental Illness (2018). The Comorbidity of Anxiety and Depression. Retrieved April 25, 2023, from https://www.nami.org/blogs/nami-blog/january-2018/the-comorbidity-of-anxiety-and-depression.
**Citation:** Hirschfeld RM. The Comorbidity of Major Depression and Anxiety Disorders: Recognition and Management in Primary Care. Prim Care Companion J Clin Psychiatry. 2001 Dec;3(6):244-254. doi: 10.4088/pcc.v03n0609.
**PMID:** 15014592
**Citation:** Andrade LH, Alonso J, Mneimneh Z, Wells JE, Al-Hamzawi A, Borges G, Bromet E, Bruffaerts R, de Girolamo G, de Graaf R, Florescu S, Gureje O, Hinkov HR, Hu C, Huang Y, Hwang I, Jin R, Karam EG, Kovess-Masfety V, Levinson D, Matschinger H, O'Neill S, Posada-Villa J, Sagar R, Sampson NA, Sasu C, Stein DJ, Takeshima T, Viana MC, Xavier M, Kessler RC. Barriers to mental health treatment: results from the WHO World Mental Health surveys. Psychol Med. 2014 Apr;44(6):1303-17. doi: 10.1017/S0033291713001943. Epub 2013 Aug 9.
**PMID:** 23931656
**Citation:** Centers for Disease Control and Prevention (2018). Prevalence of Depression Among Adults Aged 20 and Over: United States, 2013-2016. Retrieved April 25, 2023, from https://www.cdc.gov/nchs/products/databriefs/db303.htm.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000019964
- Term: Mood Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M4324
- Name: Anxiety Disorders
- Relevance: HIGH
- As Found: Anxiety
- ID: M7061
- Name: Depressive Disorder
- Relevance: HIGH
- As Found: Depression
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M21835
- Name: Mood Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003863
- Term: Depression
- ID: D000003866
- Term: Depressive Disorder
- ID: D000001008
- Term: Anxiety Disorders
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434870
**Brief Title:** Effect of Spinal Anesthesia in Elective Cesarean Cases on Frontal QRS Angle in Anemic and Non-Anemic Patients
**Official Title:** Comparison of the Effect of Spinal Anesthesia Applied in Elective Cesarean Cases on Frontal QRS Angle in Anemic and Non-Anemic Patients
#### Organization Study ID Info
**ID:** MAIEAH630004
#### Organization
**Class:** OTHER
**Full Name:** Sanliurfa Mehmet Akif Inan Education and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-08-31
**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:** 2024-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sanliurfa Mehmet Akif Inan Education and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Sanliurfa Mehmet Akif Inan Education and Research Hospital
**Investigator Full Name:** ahmet kaya
**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 QRS-T angle represents a novel marker of myocardial repolarisation. It is defined as the angle difference between the direction of ventricular depolarisation (QRS wave) and the direction of ventricular repolarisation (T wave). It is an indicator of instability in the electrophysiological properties of the myocardium and is associated with arrhythmias. The frontal QRS-T angle is a straightforward, cost-effective parameter that can be readily obtained from 12-lead electrocardiography.
The most prevalent arrhythmias during pregnancy are atrial arrhythmias. However, ventricular tachyarrhythmias are exceedingly rare during pregnancy and may be life-threatening.
Caesarean section is one of the most common surgical procedures. General anaesthesia, spinal anaesthesia and epidural anaesthesia can be employed in these patients. Spinal anaesthesia is a frequently employed method in caesarean section operations due to its rapid onset of effect, technical simplicity of application and higher probability of success.
In pregnant women, anaemia is defined as a haemoglobin concentration below 11 mg/dL in the first trimester, 11 mg/dL in the second trimester and 10.5 mg/dL in the third trimester.
**Detailed Description:** The QRS-T angle represents a novel marker of myocardial repolarisation. It is defined as the angle difference between the direction of ventricular depolarisation (QRS wave) and the direction of ventricular repolarisation (T wave). It is an indicator of instability in the electrophysiological properties of the myocardium and is associated with arrhythmias. The frontal QRS-T angle is a straightforward, cost-effective parameter that can be readily derived from 12-lead electrocardiography. The angle between the QRS and T waves is a useful indicator of myocardial repolarisation. It is associated with arrhythmias and instability in the electrophysiological properties of the myocardium. The frontal QRS-T angle is a simple, inexpensive parameter that can be easily obtained from 12-lead electrocardiography.
Pregnancy has a profound effect on the cardiovascular system. It results in an increase in blood volume, heart rate, venous pressure in the lower extremities, and cardiac output. Furthermore, it can result in a reduction in peripheral resistance and pulmonary vascular resistance, as well as a decline in blood pressure. Furthermore, it affects the cardiac conduction system, rendering patients more susceptible to arrhythmias. The most prevalent arrhythmias during pregnancy are atrial arrhythmias. Ventricular tachyarrhythmias are relatively uncommon during pregnancy and can be life-threatening.
One of the most common surgical procedures is caesarean section. General anaesthesia, spinal anaesthesia and epidural anaesthesia can be employed in these patients. Spinal anaesthesia is a frequently employed method in caesarean section operations due to its rapid onset of effect, technical ease of application and higher chance of success. In addition to the beneficial effects, direct cardiac and indirect cardiac side effects may be observed, such as vasodilatation due to sympathetic denervation, decreased right heart pressure and reflex bradycardia, which depend on the level of block.
In pregnant women, haemoglobin values below 11 mg/dL in the first trimester, 11 mg/dL in the second trimester and 10.5 mg/dL in the third trimester are considered to indicate anaemia.
The objective of this study was to investigate the effects of spinal anaesthesia in elective caesarean section cases on frontal QRS angle in anaemic and non-anaemic patients.
### Conditions Module
**Conditions:**
- Pregnancy Anemia
- Electrocardiography
- Anesthesia, Spinal
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In pregnant women, haemoglobin values below 11 mg/dL in the first trimester, 11 mg/dL in the second trimester and 10.5 mg/dL in the third trimester indicate anaemia.
The group comprised patients with haemoglobin levels below 10.5 mg/dL.
**Label:** Patients who had undergone Elective Cesarean Surgery with anemia
#### Arm Group 2
**Description:** In pregnant women, haemoglobin values below 11 mg/dL in the first trimester, 11 mg/dL in the second trimester and 10.5 mg/dL in the third trimester indicate anaemia.
The group comprised patients with haemoglobin levels above 10.5 mg/dL.
**Label:** Patients who had undergone Elective Cesarean Surgery without anemia
### Outcomes Module
#### Primary Outcomes
**Measure:** The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval. (T1)
**Time Frame:** preoperatively
**Measure:** The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T2)
**Time Frame:** after spinal anaesthesia
**Measure:** The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T3)
**Time Frame:** 5 min after spinal anaesthesia
**Measure:** The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T4)
**Time Frame:** 5 min after spinal anaesthesia
**Measure:** The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T5)
**Time Frame:** 10 min after spinal anaesthesia
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged 18-45 years
* Patients with American Society of Anesthesiologists (ASA) II classification
Exclusion Criteria:
* Patients with rhythm disorders
* Patients with electrolyte disturbances
* Patients with liver and/or renal failure
* Obese patients (body mass index \> 30)
* Trauma patients
* Cancer patients
* ASA III-IV patients
* Patients who do not wish to participate in the study will be excluded.
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** The study will include 100 patients aged 18-45 years with an American Society of Anesthesiologists (ASA) II classification who will undergo elective caesarean section.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** ahmet.kaya@sbu.edu.tr
**Name:** ahmet kaya
**Phone:** 00905327010609
**Role:** CONTACT
**Contact 2:**
**Email:** mahmutalp_k@yahoo.com
**Name:** mahmut alp karahan
**Phone:** 00905327808997
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Şanlıurfa
**Contacts:**
***Contact 1:***
- **Email:** ahmet.kaya@sbu.edu.tr
- **Name:** ahmet kaya
- **Phone:** 00905327010609
- **Role:** CONTACT
***Contact 2:***
- **Email:** mahmutalp_k@yahoo.com
- **Name:** mahmut alp karahan
- **Phone:** 00905327808997
- **Role:** CONTACT
**Country:** Turkey
**Facility:** University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital
**Status:** RECRUITING
**Zip:** 63050
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4070
- Name: Anemia
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- 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: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M207501
- Name: Chrysarobin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434857
**Brief Title:** Effectiveness of a Strength Program Over Cognitive Functionality in Older Adults
**Official Title:** Effectiveness of a Strength Program Over Cognitive Functionality in Older Adults Undergoing an Occupational Therapy Program
#### Organization Study ID Info
**ID:** 16069701
#### Organization
**Class:** OTHER
**Full Name:** University of Salamanca
### Status Module
#### Completion Date
**Date:** 2026-02-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Salamanca
#### Responsible Party
**Investigator Affiliation:** University of Salamanca
**Investigator Full Name:** Arturo Dávila Marcos
**Investigator Title:** PhD student
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a randomized, parallel, double-blind clinical trial. The main objective is to compare the efficacy of strength training, multimodal exercise with non-specific exercises and a control group on cognitive functionality and physical composition in subjects over 65 years of age with mild or non existent cognitive impairment currently receiving occupational therapy.
The intervention in both groups will be carried out for 30 weeks, with three weekly sessions. Two evaluations will be performed, one pre-intervention and one post-intervention. Cognitive Functionality (Montreal Cognitive Assessment (MOCA) and Lawton and Brody Scale), Sleep quality (Athens insomnia scale and Pittsburgh sleep quality index), physical functionality (Timed up and go (TUG), chair stand test and hand grip test and Short Physical Performance Battery (SPPB)), body composition (Body fat %, skeletal muscle index (SMI), appendicular skeletal muscle (ASM), waist circumference, waist hip ratio, body weight, body mass index (BMI)) will be evaluated.
**Detailed Description:** Design: Randomized, controlled clinical trial with three parallel groups, in which subjects over 65 years of age will be recruited. Study participants will be assigned to one of the three intervention groups. The study will have a duration of 8 months. There will be 2 evaluation visits, an initial one, and a final one after 8 months. During 8 months there will be 3 weekly sessions lasting 50 minutes.
Scope: The study will be carried out in the Salamanca Health Area, in collaboration with the Research, Teaching and Assistance Unit of the Faculty of Nursing and Physiotherapy of the University of Salamanca and the Department of Elderly People of the Salamanca City Council.
Interventions: 1) Multimodal Exercise Group (GEM); 2) Strength Exercise Group (GES); 3) No Exercise Control Group (CG). The GEM and GES sessions follow the same structural pattern. They will be structured according to the recommendations of the American College of Sports Medicine (ACSM). In the main part of the GES, only strength exercises will be performed.
Study population: 90 subjects over 65 years of age from the city of Salamanca will be recruited, distributed in 3 groups at a 1:1:1 ratio. Randomization will be performed using the Epidat 4.2 program. The sample size was calculated using GRANMO Version 7. 12 April 2012.
The main study variables are: Cognitive functionality (Montreal Cognitive Assessment (MOCA) and Lawton and Brody Scale), Sleep quality (Athens insomnia scale and Pittsburgh sleep quality index), Physical Functionality (Timed Up \& Go test (TUG), chair stand test and hand grip test and Short Physical Performance Battery (SPPB)), body composition (Body fat %, skeletal muscle index (SMI), appendicular skeletal muscle (ASM), waist circumference, waist hip ratio, body weight, body mass index (BMI)), SARC-F Questionnaire, % RM estimated by force-velocity profile and Gait speed.
Population characteristics will be presented as mean and standard deviation for continuous variables and as frequency distribution for qualitative variables. Statistical analysis The effect of the intervention on the study variables if the variables are parametric, Student's t-test will be used, and if they are non-parametric, the Wilcoxon test will be used. An alpha risk of 0.05 is set as the limit of statistical significance. The statistical program to be used will be SPSS, v.26.0.
The study will be carried out with the authorization of the Ethics Committee on Drug Research (CEIm) of the Salamanca Health Area, and with the prior informed consent of the study subjects. The participants will be informed of the objectives of the project and of the risks and benefits of the examinations and interventions to be performed. The study has been designed and subsequently assessed in accordance with Law 14/2007 on Biomedical Research, the ethical principles of the Declaration of Helsinki of the World Medical Association on ethical principles for medical research involving human subjects, as well as the other ethical principles and legal regulations applicable according to the characteristics of the study.
### Conditions Module
**Conditions:**
- Cognitive Impairment
- Aging Problems
**Keywords:**
- Aging
- Cognitive impairment
- Older adult
- Strength training
- Therapeutic exercise
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized, controlled clinical trial
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The main part of the strength training program will have the following exercises: wall push-ups, arm raises, elbow push-ups and extensions, weighted pronosupination, hand press, knee and hip hinge squat, deadlifts, front and sagittal plan stride, and heel raises.
It will consist on different phases:
1. st phase: exercise adaptation: the correct execution of upper and lower limb exercises will be taught for one month.
2. nd phase: Resistance training: During the following seven months, strength exercises will be performed at slow and normal speed of the movement patterns learned in the training course, increasing load and volume according to each subject's individual progress.
**Intervention Names:**
- Procedure: Strength training in older adults with mild or non existent cognitive impairment
**Label:** Strength Training Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The main part of the multicomponent exercise program integrates different exercise modalities: Aerobic, mobility, strength, balance and coordination exercises. Playful activities or games are also included.
Exercises will be turned gradually more demanding along the duration of the program.
**Intervention Names:**
- Procedure: Multimodal excercise in older adults with mild or non existent cognitive impairment
**Label:** Multimodal Exercise Group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Participants in this group should continue with their usual dietary pattern and level of physical activity, without changing their lifestyle habits during the study period. They will not participate in the strength exercise program, nor will they perform systematic, programmed and supervised physical exercise in any other program.
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Strength Training Group
**Description:** Strength training program applied to strength training group
**Name:** Strength training in older adults with mild or non existent cognitive impairment
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Multimodal Exercise Group
**Description:** Multimodal exercise program applied to multimodal exercise group
**Name:** Multimodal excercise in older adults with mild or non existent cognitive impairment
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Cognitive functionality will be measured with the Montreal Scales Assessment (MOCA). Maximum score is 30, considering a punctuation ≥ 26 is considered normal.
**Measure:** Cognitive functionality
**Time Frame:** 8 months
#### Secondary Outcomes
**Description:** A questionaire consisting of 7 items to screen sleep quality: subjective sleep quality,sleep latency, sleep duration, usual sleep efficiency, sleep perturbations, use of medication and daytime disfunction. Each item is scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
**Measure:** Pittsburgh sleep quality index
**Time Frame:** 6 months
**Description:** A shorter and simpler questionaire to quickly screen sleep quality. It consists of 8 components, each one scored from 0 to 3. Higher scores indicate worse sleep quality.
**Measure:** Athens insomnia scale
**Time Frame:** 6 months
**Description:** It is a measure used to assess a person's body weight in relation to their height. It is calculated by dividing a person's weight in kilograms by their height in meters squared (BMI = kg/m²).
**Measure:** Body Mass Index (BMI)
**Time Frame:** 8 months
**Description:** Test battery to assess physical performance and frailty degree consisting of 3 tests: gait speed, balance, and lower limb strength. The maximum score is 12 points and a score ≤ 8 points indicates poor physical performance.
**Measure:** Short Physical Performance Battery (SPPB)
**Time Frame:** 8 months
**Description:** It is considered a fast, safe and very reliable test for sarcopenia, in a distance of 4 meters, values greater than 0.8 m/s are considered positive.
**Measure:** Gait speed
**Time Frame:** 8 months
**Description:** A predictive test for frailty and falls, where individuals are asked to get up from a standard chair, walk to a marker 3 m away, turn around, and sit down again. Times greater than 20 seconds are considered positive.
**Measure:** Timed Up and Go (TUG)
**Time Frame:** 8 months
**Description:** A scale to evaluate functionality and independence in daily activities. It screens 8 items, ranged from 0 to 1. For women, a score of 8 is considered autonomous while for men the score is 5.
**Measure:** Lawton & Brody Scale
**Time Frame:** 8 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects older than 65
Exclusion Criteria:
* Absolute contraindication for excersice
* Severe cognitive impairment or dementia
* Language barriers
* Pending litigation or legal claim
**Healthy Volunteers:** True
**Minimum Age:** 65 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** turitodavila@usal.es
**Name:** Arturo Dávila Marcos
**Phone:** +34605998329
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Salamanca
**Contacts:**
***Contact 1:***
- **Email:** turitodavila@usal.es
- **Name:** Arturo Dávila Marcos
- **Phone:** +34605998329
- **Role:** CONTACT
***Contact 2:***
- **Name:** Arturo Dávila Marcos
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** University of Salamanca
**Zip:** 37007
#### Overall Officials
**Official 1:**
**Affiliation:** University of Salamanca
**Name:** Arturo Dávila Marcos
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003072
- Term: Cognition Disorders
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M29705
- Name: Cognitive Dysfunction
- Relevance: HIGH
- As Found: Cognitive Impairment
- ID: M6301
- Name: Cognition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000060825
- Term: Cognitive Dysfunction
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434844
**Brief Title:** Effectiveness of Auricular Acupuncture in Reducing Dental Anxiety and Pain Perception During Orthodontic Extractions Among Adolescents
**Official Title:** Effectiveness of Auricular Acupuncture in Reducing Dental Anxiety and Pain Perception During Orthodontic Extractions Among Adolescents - A Crossover Double-Blinded Randomised Controlled Trial
#### Organization Study ID Info
**ID:** UW23-024
#### Organization
**Class:** OTHER
**Full Name:** The University of Hong Kong
### 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:** 2024-05-23
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The University of Hong Kong
#### 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 prospective, randomised, double-blinded cross-over study aims to compare the effectiveness of auricular acupuncture (AA) with placebo sham acupuncture (PSA) in reducing dental anxiety, pain perception and physiological responses to stress and anxiety among adolescents during orthodontic extractions.
Adolescents aged between 10-19 years old who are undergoing orthodontic treatments requiring bilateral premolar extractions will be invited to complete a validated questionnaire to record their dental anxiety level, oral health knowledge, attitudes, practices, demographic and socio-economic factors. During orthodontic extractions, physiological responses including heart rate and oxygen saturation will be measured with a fingertip pulse oximeter throughout the process.
The participants will be allocated randomly to one of the two groups in the study.
Group 1-- auricular acupuncture in their first orthodontic extraction visit and placebo sham acupuncture in their second orthodontic extraction visit.
Group 2-placebo sham acupuncture in their first orthodontic extraction visit and auricular acupuncture their second orthodontic extraction visit.
Both acupuncture interventions will be carried out by a Hong Kong registered Chinese medical practitioner. The acupuncture needles are kept in place for 20 minutes to exert its effect before the dental extraction. Placebo sham acupuncture will not cause any harm, but the acupuncture points have no reported effect on stress relief.
The extraction of premolars will be performed by a Hong Kong registered dentist. Local anesthesia is injected to numb the respective site, then the premolar will be removed with forceps, followed by stopping the bleeding by biting firmly on gauze.
### Conditions Module
**Conditions:**
- Dental Anxiety
**Keywords:**
- dental anxiety
- dental pain
- auricular acupunctures
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** TRIPLE
**Masking Description:** Both acupuncture interventions will be carried out by a Hong Kong licenced Chinese medical practitioner (CMP) with no involvement in data collection and assessment. A research assistant will be responsible for the randomisation and inform the CMP regarding the group allocation. The acupuncture needles are kept in place for 20 minutes before the dental treatment.
The extractions of premolars will be performed by a licenced general dental practitioner who is blinded towards the types of acupuncture received, so as the patient and their parents or caretakers.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The subjects will receive auricular acupuncture in the 1st visit and placebo sham acupuncture in the 2nd visit.
**Intervention Names:**
- Procedure: Auricular acupunctures
- Procedure: Sham acupunctures
**Label:** 1st visit Auricular acupuncture; 2nd visit Placebo sham acupuncture
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The subjects will receive placebo sham acupuncture in the 1st visit and auricular acupuncture in the 2nd visit.
**Intervention Names:**
- Procedure: Auricular acupunctures
- Procedure: Sham acupunctures
**Label:** 1st visit Placebo sham acupuncture; 2nd visit Auricular acupuncture
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 1st visit Auricular acupuncture; 2nd visit Placebo sham acupuncture
- 1st visit Placebo sham acupuncture; 2nd visit Auricular acupuncture
**Description:** After disinfection of the external ear with 75% alcohol wipes, 018x 13 filiform needles (Mocm International Limited) will be used to perform the auricular acupunctures at the relaxation point, tranquilizer point and master cerebral point at the left and right external ears.
**Name:** Auricular acupunctures
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- 1st visit Auricular acupuncture; 2nd visit Placebo sham acupuncture
- 1st visit Placebo sham acupuncture; 2nd visit Auricular acupuncture
**Description:** The auricular acupoints of finger, shoulder and tonsil will be targeted instead. These points are also located at the external ear and comparable to those in the intervention group. The external ear will be disinfected with 75% alcohol wipes. Auricular acupunctures with 018x 13 filiform needles (Mocm International Limited) will be carried out at the finger point, shoulder point and tonsil point of the left and right external ears.
**Name:** Sham acupunctures
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Self-reported dental fear measured by Spielberger State Trait Anxiety Inventory score, Scores range from 20 to 80, with higher scores correlating with greater anxiety
**Measure:** Dental fear
**Time Frame:** Baseline, immediately after the intervention. immediately after the surgery
#### Secondary Outcomes
**Description:** Pain measured by Visual Analog Scale. Scores range from 0-10, with her scores correlating with greater pain
**Measure:** Pain perceived
**Time Frame:** Immediately after the intervention. immediately after the surgery
**Description:** Heart rate
**Measure:** Psychological changes
**Time Frame:** Baseline, perioperatively, immediately after the surgery
**Description:** Saturation of peripheral oxygen (SpO2) measurement
**Measure:** Psychological changes
**Time Frame:** Baseline, perioperatively, immediately after the surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Undergoing orthodontic treatment and require bilateral extraction of premolars.
* Have parental consent signed by their parent or guardian.
* Medically fit with either ASA I or II status
* Have not taken any medications, especially anxiolytics and antidepressants
* The premolars to be extracted should be fully erupted and without any signs of ankylosis.
**Healthy Volunteers:** True
**Maximum Age:** 19 Years
**Minimum Age:** 10 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hong Kong
**Country:** Hong Kong
**Facility:** The University of Hong Kong
**State:** Hksar PRC
**Zip:** 999077
### IPD Sharing Statement Module
**Description:** Individual Participant Data (IPD) and other supporting materials will be made available to other researchers upon valid requests to the PI of the study.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: HIGH
- As Found: Anxiety
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M16853
- Name: Toothache
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001008
- Term: Anxiety Disorders
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
- ID: M10043
- Name: Hypnotics and Sedatives
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434831
**Acronym:** ESTIME
**Brief Title:** Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation
**Official Title:** Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation
#### Organization Study ID Info
**ID:** 2023_195
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Lille
### Status Module
#### Completion Date
**Date:** 2026-12-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-02
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-22
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Lille
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Overactive bladder syndrome (OAB) is defined by urgent and frequent urges to urinate associated with frequent night-time urination and sometimes urinary incontinence. Sacral neuromodulation (SNM) is now one of the second-line treatments for OAB.
The mode of action of SNM is still poorly understood but a number of data from recent scientific literature suggest that SNM may act, among other things, by altering the balance of the autonomic nervous system (ANS) - located at the interface between the urinary tract and the brain structures regulating the functioning of the urinary tract.
The aim of this study would therefore be to develop a predictive tool for the effectiveness of SNM.
### Conditions Module
**Conditions:**
- Bladder Hyperactivity
- Sacral Neuromodulation
**Keywords:**
- Bladder hyperactivity
- autonomic nervous system
- sacral neuromodulation
- urodynamic assessment
- heart rate variability
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Device: Medical device for SNM: Interstim II, Interstim micro
**Label:** ANI will be recorded during the SNM.
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ANI will be recorded during the SNM.
**Description:** ANI will be used during the SNM (2 hours)
**Name:** Medical device for SNM: Interstim II, Interstim micro
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Comparison of HFVI (high frequence variability index) analysed through heart rate variability (HRV) at baseline and during a standardized stimulation protocol (14 Hz, 210 mcs, amplitude to elicit anal motor response) randomly delivered at the level of the 4 contact points of the quadripolar lead at the time of lead implantation, between the effective and non-effective groups.
**Measure:** Comparison of HFVI analysed through HRV at baseline and during standardized stimulation protocol randomly delivered at the level of the 4contact points of the quadripolar lead at the time of lead implantation between the effective and noneffective groups
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Comparison of other HRV parameters (SDNN, RMSSD, HF, LF) at baseline and during a standardized stimulation protocol (14 Hz, 210 mcs, amplitude to elicit anal motor response) randomly delivered at the level of the 4 contact points of the quadripolar lead at the time of lead implantation,
**Measure:** Comparison of other HRV parameters at baseline and during a standardized stimulation protocol randomly delivered at the level of the 4 contact points of the quadripolar lead at the time of lead implantation
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male of female ≥ 18 years
* OAB syndrome
* Indication for a two-staged SNM
* Under general anaesthesia with Remifentanil and Propofol
* Patient who has given written consent to participate in the trial
* Patient willing to comply with all study procedures and duration
Exclusion Criteria:
* Tibial neuro-stimulation (last 3 months)
* Sacral neuromodulation (last 3 months)
* Botulinum toxin A intra-detrusor injection (last 9 months)
* Pregnancy in progress
* Administrative reasons
* Guardianship/curatorship
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020820
- Term: Dyskinesias
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000001745
- Term: Urinary Bladder Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000059411
- Term: Lower Urinary Tract Symptoms
- ID: D000020924
- Term: Urological Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- 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: M9999
- Name: Hyperkinesis
- Relevance: HIGH
- As Found: Hyperactivity
- ID: M27167
- Name: Urinary Bladder, Overactive
- Relevance: HIGH
- As Found: Bladder Hyperactivity
- ID: M22574
- Name: Dyskinesias
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M5026
- Name: Urinary Bladder Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M29464
- Name: Lower Urinary Tract Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M22659
- Name: Urological Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006948
- Term: Hyperkinesis
- ID: D000053201
- Term: Urinary Bladder, Overactive
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434818
**Acronym:** EDITOR
**Brief Title:** Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders
**Official Title:** Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)
#### Organization Study ID Info
**ID:** EDITDA056156
#### Organization
**Class:** INDUSTRY
**Full Name:** Evon Medics LLC
#### Secondary ID Infos
**ID:** 4R44DA056156-02
**Link:** https://reporter.nih.gov/quickSearch/4R44DA056156-02
**Type:** NIH
### 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:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-07-07
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Howard University
**Class:** UNKNOWN
**Name:** Maryland Treatment Center
**Class:** UNKNOWN
**Name:** Clinics of Dr. Edwin Chapman, MD, PC @ MHDG
**Class:** NIH
**Name:** National Institute on Drug Abuse (NIDA)
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Evon Medics LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD) clinics to demonstrate pilot effectiveness for SUD outcomes compared to treatment as usual (TAU) and Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) device as active control. The investigators will conduct a multi-site study of 300 adult patients with opiate use disorder (OUD), stimulant (i.e., cocaine, methamphetamine) and/or alcohol use disorder (AUD) from community and clinics to evaluate whether EDITOR is associated with better patient treatment outcomes (e.g., retention in treatment and abstinence). The pilot study will provide preliminary data needed for design of a Phase III trial, including estimates of effect size. The investigators will also explore development of machine learning/AI algorithms integrating clinical and physiological data into treatment decision guides for providers.
**Detailed Description:** The Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) is a project to develop a sustainable, scalable, and patient-centered mobile health platform, comprised of (1) a patient-facing culturally-adapted digital chemosensory therapeutic for stimulant, alcohol and opioid use disorders, sensors for acquisition of objective physiological measures of substance intoxication and withdrawal, and an application for running and interpreting the interventions and sensory acquisition programs; and (2) a provider-facing web portal, for substance use disorder treatment in socially disadvantaged and sexual minority populations.
The small business, Evon Medics implemented the use of the EDITOR device as a novel approach for remote management of substance use disorders (SUDs) amid the challenges of the COVID-19 pandemic. Management of SUD mostly involve direct contact between patients and providers, but the precedence of COVID-19 pandemic has elevated the need for patient-centered remote management of SUD. While digital therapeutics and mobile health platforms provide avenues for remote management, communities of African Americans (AA), Hispanic Americans (HA) and other socially disadvantaged populations lag in adoption of these mobile platforms, due to inability to read, digital illiteracy, lack of access to smartphones, absence of reliable Wi-Fi or internet, and financial constraints. Moreover, while interventions exist for OUD, there are no drugs for cocaine or stimulant use disorders. Underserved AA and HA communities with OUD, particularly marginalized men who have sex with men (MSM), have more severe co-existing cocaine, methamphetamine, and alcohol use disorders; and digital solutions for these populations are lacking. Providers on the other hand, lack well-adapted, intelligent-based physiological and psychophysical acquisition platforms to guide remote agonist management of opioid and alcohol withdrawal.
EVON Medics developed a combinatorial digital chemosensory-based orbitofrontal cortex training for Opioid Use Disorder (CBOT). Based on the limitations of CBOT for the socially disadvantaged AA, HA and MSM population, the investigators recently revised the platform for treatment of stimulant and alcohol use disorder, by including beta-caryophyllene chemosensory stimulation. Further product development, with innovative changes to the patient-facing platform and a new provider-facing platform to guide remote management of OUD, stimulant (cocaine and methamphetamine) use and alcohol use disorders were preliminary tested (Phase I) in affiliated substance use community programs and community populations in the under-served communities in Washington, DC and Maryland.
In this study phase, Phase II of this Fast-Track SBIR application, the investigators will conduct a pilot randomized trial of EDITOR compared to treatment as usual and CBOT for office-based treatment of SUDs in several federal funded programs associated with Evon Medics and Howard University, to assess EDITOR's effectiveness in improving treatment retention, reducing relapses, and mitigating SUD severity, and offering a promising solution for home-based SUD treatment.
### Conditions Module
**Conditions:**
- Substance Use Disorders
- Opioid Use Disorder
- Alcohol Use Disorder
- Cocaine Use Disorder
- Methamphetamine-dependence
**Keywords:**
- Substance Abuse
- Substance Use Disorder
- Retention
- Relapse
- Chemosensory-Based Olfactory Networks Training
- Remote Management
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The EDITOR device is designed to stimulate intensive neural activity in OFC over long periods of time. It consists of 40 daily cycles of intervention with a combination of olfactory stimulation and training tasks, lasting \~45 minutes, delivered once daily over three months. The device also includes 60% beta-caryophyllene chemosensory stimulation to target AUD and stimulant use disorder and 10 digital enhancements for the purpose of remote treatment, remote acquisition of behavioral and physiological data, and seamless data transmission to providers, through a HIPAA-compliant clinic end portal.
Participants assigned to this arm will receive their treatment-as-usual (TAU) alongside daily EDITOR therapy for three months. TAU will depend on the drug abused \[Buprenorphine with a median dose of 24 mg (range 16 - 32 mg) for Opioid use disorder and naltrexone (50-100 mg daily for Alcohol use disorder (AUD).
**Intervention Names:**
- Combination Product: EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance)
**Label:** Enhanced Digital-Chemosensory-Based Olfactory Training (EDITOR)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** CBOT with olfactory stimulants \& orbitofrontal (OFC) tasks
TAU same as above + CBOT (Chemosensory-Based Olfactory Training) therapy (40 cycles of olfactory stimulation and OFC training tasks, lasting \~45 minutes, once daily over three months) + use of their smartphone to communicate with their clinic provider/staff
**Intervention Names:**
- Combination Product: CBOT with olfactory stimulants & OFC tasks
**Label:** Chemosensory-Based Olfactory Training (CBOT)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Control Device (Sham) is CBOT device without olfactory stimulants and orbitofrontal tasks.
TAU same as above + CBOT sham + use of their smartphone to communicate with their clinic provider/staff. This CBOT device uses compressed room air scented with phenylethylamine (rose scent) instead of olfactory stimulants and has shape pattern matching tasks instead of cognitive tasks in order to blind users to their treatment assignment. Similar to the active arm, sham COT will be used daily for 45 minutes.
**Intervention Names:**
- Combination Product: CBOT Sham
**Label:** Chemosensory-Based Olfactory Training (CBOT) Sham
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Enhanced Digital-Chemosensory-Based Olfactory Training (EDITOR)
**Description:** EDITOR includes a user-friendly cloud portal synced with the main device, providing a comprehensive training program for the orbitofrontal cortex (OFC). The main device stimulates the orbitofrontal cortex intensely, preventing habituation to smells and improving adaptability. This enhances neurobehavioral plasticity, benefiting Substance Use Disorder (SUD) outcomes. The device also features a 60% beta-caryophyllene scent for addressing issues like Alcohol Use Disorder and stimulant use disorders. With ten digital enhancements, it enables remote treatment and data collection, seamlessly transmitting information to healthcare providers through a secure, HIPAA-compliant portal.
**Name:** EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance)
**Other Names:**
- EDITOR plus Treatment-As-Usual (TAU)
**Type:** COMBINATION_PRODUCT
#### Intervention 2
**Arm Group Labels:**
- Chemosensory-Based Olfactory Training (CBOT)
**Description:** The CBOT with proprietary odorant molecules is designed to stimulate olfactory neural activity over long periods of time combined with orbitofrontal cortex (OFC) dependent olfactory tasks.
**Name:** CBOT with olfactory stimulants & OFC tasks
**Other Names:**
- CBOT active plus TAU
**Type:** COMBINATION_PRODUCT
#### Intervention 3
**Arm Group Labels:**
- Chemosensory-Based Olfactory Training (CBOT) Sham
**Description:** CBOT Sham uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive olfactory tasks
**Name:** CBOT Sham
**Other Names:**
- CBOT passive plus TAU
**Type:** COMBINATION_PRODUCT
### Outcomes Module
#### Primary Outcomes
**Description:** 3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
**Measure:** Retention in SUD treatment
**Time Frame:** Baseline to day 14
**Description:** 3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
**Measure:** Retention in SUD treatment
**Time Frame:** Baseline to day 28
**Description:** 3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
**Measure:** Retention in SUD treatment
**Time Frame:** Baseline to 8 weeks
**Description:** 3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
**Measure:** Retention in SUD treatment
**Time Frame:** Baseline to three months
**Description:** Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through:
1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and
2. biochemical verification of drug use from urine samples collected and tested every two weeks.
**Measure:** SUD Relapse Rate
**Time Frame:** Baseline to day 7
**Description:** Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through:
1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and
2. biochemical verification of drug use from urine samples collected and tested every two weeks.
**Measure:** SUD Relapse Rate
**Time Frame:** Baseline to day 14
**Description:** Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through:
1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and
2. biochemical verification of drug use from urine samples collected and tested every two weeks.
**Measure:** SUD Relapse Rate
**Time Frame:** Baseline to day 28
**Description:** Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through:
1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and
2. biochemical verification of drug use from urine samples collected and tested every two weeks.
**Measure:** SUD Relapse Rate
**Time Frame:** Baseline to 8 weeks
**Description:** Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through:
1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and
2. biochemical verification of drug use from urine samples collected and tested every two weeks.
**Measure:** SUD Relapse Rate
**Time Frame:** Baseline to three months
**Description:** SUD engagement is the proportion of people treated at baseline who complete the first two weeks of treatment.
**Measure:** SUD engagement
**Time Frame:** Baseline to day 14
#### Secondary Outcomes
**Description:** Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates).
**Measure:** Opioid Craving Scale (OCS)
**Time Frame:** Baseline to Day 7
**Description:** Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving.
**Measure:** Cocaine Craving Questionnaire-Brief (CCQ-Brief)
**Time Frame:** Baseline to day 7
**Description:** Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?"
**Measure:** Self-report instruments for Alcohol Craving
**Time Frame:** Baseline to day 7
**Description:** Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).
**Measure:** Subjective Opioid Withdrawal Scale (SOWS)
**Time Frame:** Baseline to day 7
**Description:** Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
**Measure:** Positive and Negative Affect Scales (PANAS)
**Time Frame:** Baseline to day 7
**Description:** Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates).
**Measure:** Opioid Craving Scale (OCS)
**Time Frame:** Baseline to day 14
**Description:** Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving.
**Measure:** Cocaine Craving Questionnaire-Brief (CCQ-Brief)
**Time Frame:** Baseline to day 14
**Description:** Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?"
**Measure:** Self-report instruments for Alcohol Craving
**Time Frame:** Baseline to day 14
**Description:** Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).
**Measure:** Subjective Opioid Withdrawal Scale (SOWS)
**Time Frame:** Baseline to day 14
**Description:** Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
**Measure:** Positive and Negative Affect Scales (PANAS)
**Time Frame:** Baseline to day 14
**Description:** Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates).
**Measure:** Opioid Craving Scale (OCS)
**Time Frame:** Baseline to Day 28
**Description:** Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving.
**Measure:** Cocaine Craving Questionnaire-Brief (CCQ-Brief)
**Time Frame:** Baseline to day 28
**Description:** Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?"
**Measure:** Self-report instruments for Alcohol Craving
**Time Frame:** Baseline to day 28
**Description:** Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).
**Measure:** Subjective Opioid Withdrawal Scale (SOWS)
**Time Frame:** Baseline to day 28
**Description:** Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
**Measure:** Positive and Negative Affect Scales (PANAS)
**Time Frame:** Baseline to day 28
**Description:** Monthly severity of opioid, stimulants and alcohol use using the ASI-modified
The ASI is an assessment tool used to gauge the severity of a person's substance abuse and provides a comprehensive overview of a person's addiction-related issues. It addresses seven (7) main aspects of a person's behavior and environment. The areas assessed include medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status.
The ASI substance abuse assessment uses the composite score to assign a severity rating. The ratings are based on a scale of 0 to 9 as follows:
0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital.
**Measure:** Addiction Severity Index (ASI)
**Time Frame:** Baseline to day 28
**Description:** Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates).
**Measure:** Opioid Craving Scale (OCS)
**Time Frame:** Baseline to 8 weeks
**Description:** Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving.
**Measure:** Cocaine Craving Questionnaire-Brief (CCQ-Brief)
**Time Frame:** Baseline to 8 weeks
**Description:** Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?"
**Measure:** Self-report instruments for Alcohol Craving
**Time Frame:** Baseline to 8 weeks
**Description:** Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).
**Measure:** Subjective Opioid Withdrawal Scale (SOWS)
**Time Frame:** Baseline to 8 weeks
**Description:** Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
**Measure:** Positive and Negative Affect Scales (PANAS)
**Time Frame:** Baseline to 8 weeks
**Description:** Monthly severity of opioid, stimulants and alcohol use using the ASI-modified
The ASI is an assessment tool used to gauge the severity of a person's substance abuse and provides a comprehensive overview of a person's addiction-related issues. It addresses seven (7) main aspects of a person's behavior and environment. The areas assessed include medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status.
The ASI substance abuse assessment uses the composite score to assign a severity rating. The ratings are based on a scale of 0 to 9 as follows:
0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital.
**Measure:** Addiction Severity Index (ASI)
**Time Frame:** Baseline to 8 weeks
**Description:** Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates).
**Measure:** Opioid Craving Scale (OCS)
**Time Frame:** Baseline to three months
**Description:** Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving.
**Measure:** Cocaine Craving Questionnaire-Brief (CCQ-Brief)
**Time Frame:** Baseline to three months
**Description:** Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?"
**Measure:** Self-report instruments for Alcohol Craving
**Time Frame:** Baseline to three months
**Description:** Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).
**Measure:** Subjective Opioid Withdrawal Scale (SOWS)
**Time Frame:** Baseline to three months
**Description:** Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
**Measure:** Positive and Negative Affect Scales (PANAS)
**Time Frame:** Baseline to three months
**Description:** Monthly severity of opioid, stimulants and alcohol use using the ASI-modified
The ASI is an assessment tool used to gauge the severity of a person's substance abuse and provides a comprehensive overview of a person's addiction-related issues. It addresses seven (7) main aspects of a person's behavior and environment. The areas assessed include medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status.
The ASI substance abuse assessment uses the composite score to assign a severity rating. The ratings are based on a scale of 0 to 9 as follows:
0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital.
**Measure:** Addiction Severity Index (ASI)
**Time Frame:** Baseline to three months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age 18 - 80 years, inclusive at enrollment.
2. Diagnosis of current moderate or severe substance use disorders, opioid use disorders, stimulant (cocaine and methamphetamine) use, and alcohol use disorders in the past three months, including the past month.
3. Does not meet criteria for other current SUDs outside of the 3 above, except for mild or moderate use of cannabis
4. Willing to receive study interventions and buprenorphine (for OUD group) and naltrexone (for AUD group) during the study
5. Females must not be pregnant at enrollment and agree not to become pregnant during the trial, through scientifically valid ways of contraception
6. Willing to sign the informed consent form.
7. Have a stable place to stay and retain the EDITOR devices in a secure condition when receiving the intervention and during the entire duration of the study participation.
Exclusion Criteria:
1. Any significant neurological disease such as stroke, dementia, meningitis, neurosyphilis, cerebral palsy, encephalitis, epilepsy, or seizures.
2. Mental retardation.
3. Presence of serious mental illness, such as schizophrenia, bipolar disorders, and suicidal risk. Diagnosis of major depressive disorders, anxiety disorders, and post-traumatic stress disorders (PTSD), will be included if symptoms are stable, with no suicidal ideas or plans, and there are no recent changes in treatment of these conditions in the 6 weeks prior to enrollment.
4. Experiencing current suicide ideas or plans.
5. Any unstable medical condition such as uncontrolled hypertension, uncontrolled diabetes, or liver cirrhosis as determined by the site PI.
6. History of severe traumatic nose injury that affects the ability to smell or significant intranasal disease, as determined by the site PI.
7. Known allergies or intolerance to aromas from plant essential oils. E.g., orange and lemon.
8. Breastfeeding or pregnancy test positive or plans to get pregnant in the 6 months following enrollment.
9. Individuals who are on parole or probation.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** enwulia@evonmedics.org
**Name:** Evaristus Nwulia, MD
**Phone:** 410-227-2005
**Role:** CONTACT
**Contact 2:**
**Email:** oawofeso@evonmedics.org
**Name:** Opeyemi M Awofeso, MD
**Phone:** 410-891-4007
**Phone Ext:** 1
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Washington
**Contacts:**
***Contact 1:***
- **Name:** Edwin Chapman, MD
- **Role:** CONTACT
**Country:** United States
**Facility:** Clinics of Dr. Edwin Chapman @ MHDG
**State:** District of Columbia
**Status:** RECRUITING
**Zip:** 20002
**Location 2:**
**City:** Washington
**Contacts:**
***Contact 1:***
- **Name:** Tanya Alim, MD
- **Role:** CONTACT
**Country:** United States
**Facility:** Howard University
**State:** District of Columbia
**Status:** RECRUITING
**Zip:** 20060
**Location 3:**
**City:** Rockville
**Country:** United States
**Facility:** Maryland Treatment Center
**State:** Maryland
**Status:** ENROLLING_BY_INVITATION
**Zip:** 20853
#### Overall Officials
**Official 1:**
**Affiliation:** Evon Medics LLC
**Name:** Charles Nwaokobia
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Evon Medics LLC
**Name:** Evaristus Nwulia, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** Howard University
**Name:** Tanya Alim, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 4:**
**Affiliation:** Clinics of Dr. Edwin Chapman at MHDG
**Name:** Edwin Chapman, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 5:**
**Affiliation:** Maryland Treatment Center
**Name:** Marc Fishman, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000019973
- Term: Alcohol-Related Disorders
- ID: D000079524
- Term: Narcotic-Related Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC25
- Name: Substance Related Disorders
### Condition Browse Module - Browse Leaves
- ID: M3774
- Name: Alcohol Drinking
- Relevance: LOW
- As Found: Unknown
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: HIGH
- As Found: Substance Use Disorders
- ID: M3783
- Name: Alcoholism
- Relevance: HIGH
- As Found: Alcohol Use Disorder
- ID: M12244
- Name: Opioid-Related Disorders
- Relevance: HIGH
- As Found: Opioid Use Disorder
- ID: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21842
- Name: Alcohol-Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M2057
- Name: Narcotic-Related Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000000437
- Term: Alcoholism
- ID: D000009293
- Term: Opioid-Related Disorders
### Intervention Browse Module - Ancestors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: CNSSti
- Name: Central Nervous System Stimulants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: AlcDet
- Name: Alcohol Deterrents
- Abbrev: NarcAntag
- Name: Narcotic Antagonists
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
### Intervention Browse Module - Browse Leaves
- ID: M4029
- Name: Central Nervous System Stimulants
- Relevance: HIGH
- As Found: Reader
- ID: M12222
- Name: Naltrexone
- Relevance: LOW
- As Found: Unknown
- ID: M5317
- Name: Buprenorphine
- Relevance: LOW
- As Found: Unknown
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
- ID: M287684
- Name: Caryophyllene
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000697
- Term: Central Nervous System Stimulants
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434805
**Brief Title:** An Education Initiative to Reduce Stigma Towards Sex Workers and Sexual Minorities Among Nursing Students
**Official Title:** An Education Initiative to Reduce Stigma Towards Sex Workers and Sexual Minorities Among Nursing Students: a Pilot Study
#### Organization Study ID Info
**ID:** HE-NHS2024/02
#### Organization
**Class:** OTHER
**Full Name:** Hong Kong Metropolitan University
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hong Kong Metropolitan University
#### Responsible Party
**Investigator Affiliation:** Hong Kong Metropolitan University
**Investigator Full Name:** Dr Polly MA Haixia
**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:** Background: Sex workers and sexual minorities (SWSM) often encounter barriers when accessing healthcare services due to social stigma and discrimination. In Hong Kong, stigma and prejudice exist among nurses and nursing students toward SWSM.
Aims: This education initiative aims to improve the knowledge, attitudes, and clinical competence of nursing students in caring for SWSM.
Methods: This pilot study will employ a one-group pre-and post-test design. Convenience sampling will be used to recruit 52 nursing students from the clinical phase of the Bachelor of Nursing program at the School of Nursing and Health Studies of Hong Kong Metropolitan University, as well as nursing students from other local universities. The intervention will consist of a four-session one-day workshop based on social cognitive theory and interpersonal contact theory. The workshop will cover various topics, including terminologies, human rights, stigma and discrimination in healthcare settings, contact with SWSM, and skills building. The primary outcome measure will include participants' attitudes toward SWSM. Secondary outcome measures included their knowledge and clinical competence. These outcome measurements will be assessed at baseline (T0) and after the intervention (T1) and three months follow up (T2). Additionally, focus group discussions will be carried out to explore participants' experiences of the intervention.
Discussion: Findings from this study could contribute to the existing knowledge on stigma surrounding SWSM in Hong Kong and its impact on healthcare. The intervention is expected to increase the knowledge, attitudes, and skills of nursing students in providing care for SWSM. By promoting non-judgmental and equitable care, the research aims to contribute to the overall well-being and health outcomes of SWSM. These results will inform future nursing education curricula and clinical practice, facilitating the development of more inclusive and patient-centered care for marginalized populations in Hong Kong and beyond.
### Conditions Module
**Conditions:**
- Stigmatization
- Sex Work
- Homosexuality
- Transgenderism
**Keywords:**
- gender and sexual minority
- sex workers
- cultural competency
- nursing students
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** A single group with outcome assessments will be taken at baseline, post-intervention, and at 3-month follow-up.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 52
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This is a one-day workshop with four sessions.
**Intervention Names:**
- Other: sex workers and sexual minorities education workshop
**Label:** Education workshop
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Education workshop
**Description:** The participants will receive a one-day workshop (four sessions). The generic content aims at enhancing the understanding of sexual orientation, gender identities, social stigma, sex work and sexual orientation and human rights (session 1), the lived experience of SWSM (session 2), the content specifically related to the medical and healthcare field, including be familiar with the professional and ethical obligations (session 3), the skills that can be adopted when providing services to SWSM (session 4).
**Name:** sex workers and sexual minorities education workshop
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Attitudes Toward Lesbians and Gay Men Scale (ATLG) is an instrument designed to measure the attitudes of heterosexuals toward lesbians and gay men. It consists of 20 items, the first 10 about lesbians and the next 10 about gay men, and can be used as a single scale or two distinct subscales. Items are scored using a 4-point Likert scale, from 1 (strongly disagree) to 4 (strongly agree). The total score range for both the lesbian and gay subscale is from 10 to 40. The ATLG was validated in Hong Kong.
**Measure:** Attitudes toward lesbians and gay men scale (ATLG)
**Time Frame:** baseline, immediately after the intervention, 3-months post-intervention
**Description:** The Genderism and Transphobia Scale (GTS) is a questionnaire consisting of 32 items measuring cognitive, behavioral, and affective dimensions of genderism, transphobia, and gender-bashing. The statements are rated on a 7-point Likert scale (1 = strongly agree to 7 = strongly disagree), with higher scores denoting strong negative feelings and behaviors toward transgender individuals. The GTS was validated in Hong Kong and included an additional item 33, and the total score ranges from 33 to 231.
**Measure:** Genderism and Transphobia Scale (GTS)
**Time Frame:** baseline, immediately after the intervention, 3-months post-intervention
**Description:** The scale will measure nursing students' attitudes towards sex workers, which was adopted from a scale developed by Melby et al. (1992) to determine nurses' attitudes towards prostitutes (Melby et al., 1992). The scale on nursing students' attitudes was comprised of eight items on attitude, with three related to morals, two to control, and three to sympathy. A 5-point Likert-type scale was used, with 1 = strongly disagree, and 5 = strongly agree. Negative items (items 2 and 7) will be reversely coded, with higher score representing positive attitudes. The total score ranges from 8 to 40.
**Measure:** Attitudes Toward sex workers with HIV and sexually transmitted diseases (STDs)
**Time Frame:** baseline, immediately after the intervention, 3-months post-intervention
#### Secondary Outcomes
**Description:** LGBT-DOCSS will be used to assess nursing students' clinical skills in caring for sexual minorities. It includes 18 items crossing three domains: clinical preparedness, attitudinal attitudes, and basic knowledge. A 7-point Likert-type scale was used, with 1 = not at all true, 4 = somewhat true, and 7 = total true. The total score ranges from 18 to 126. Higher scores are indicative of higher levels of clinical preparedness and rudimentary knowledge and less prejudicial attitudinal awareness regarding LGBT clients/patients. LGBT-DOCSS was back-and-forth translated by the research team.
**Measure:** LGBT development of clinical skills scale (LGBT-DOCSS)
**Time Frame:** baseline, immediately after the intervention, 3-months post-intervention
**Description:** Sex worker development of clinical skills scale (SW-DOCSS) is developed based on LGBT-DOCSS. It will be used to assess nursing students' clinical skills in caring for sexual minorities. It includes 10 items crossing three domains: clinical preparedness, attitudinal attitudes, and basic knowledge. A 7-point Likert-type scale was used, with 1 = not at all true, 4 = somewhat true, and 7 = total true. The total score ranges from 10 to 70. Higher scores are indicative of higher levels of clinical preparedness and rudimentary knowledge and less prejudicial attitudinal awareness regarding sex worker clients/patients. A pilot test will be conducted to establish the reliability of the SW-DOCSS.
**Measure:** Sex worker development of clinical skills scale (SW-DOCSS)
**Time Frame:** baseline, immediately after the intervention, 3-months post-intervention
**Description:** The measurement of nursing students' knowledge of sex workers and sexual minorities is developed from previous studies. It includes 14 items, where students will be asked to rate each statement as either right or wrong. The total score ranges from 0 to 14, with a higher score indicating more accurate knowledge of sex workers and sexual minorities.
**Measure:** Self-developed questionnaire regarding knowledge of sex workers and sexual minorities
**Time Frame:** baseline, immediately after the intervention, 3-months post-intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* aged 18 years of age or above;
* studying in the clinical phase (i.e., year 3 to year 5);
* are able to speak, read, and write Cantonese or Putonghua;
* are willing to participate in the study and share their experience of the education initiative with the research group;
* have informed consent to participate in the study.
Exclusion Criteria:
* Those who have completed a similar workshop or discussion of sex workers and sexual minorities in previous nursing education will be excluded from this study.
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** phxma@hkmu.edu.hk
**Name:** Haixia Ma, PhD
**Phone:** 39702990
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** Participants' privacy, confidentiality, and voluntary participation of the study will be ensured. Participants' information will be kept in a password-protected computer. Only the research team could access the original data.
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434792
**Brief Title:** Study to Evaluate Efficacy and Safety of Bronpass Tab. in Patients With Chronic Obstructive Pulmonary Disease
**Official Title:** A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Dose-response Phase 2 Clinical Trial to Compare the Efficacy and Safety of Bronpass Tab. Versus Placebo in Patients With Stable COPD
#### Organization Study ID Info
**ID:** HL_HL301_204
#### Organization
**Class:** INDUSTRY
**Full Name:** Hanlim Pharm. Co., Ltd.
### 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:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-06-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-18
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Hanlim Pharm. Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group dose-response phase 2 clinical trial study to evaluate the efficacy and safety of Bronpass Tab. in 96 patients with chronic obstructive pulmonary disease.
**Detailed Description:** This study is to prove that Bronpass Tab. is superior in clinical efficacy and safety in improving COPD symptoms compared to placebo for 12 weeks in patients suffering from chronic obstructive pulmonary disease.
### Conditions Module
**Conditions:**
- Chronic Obstructive Pulmonary Disease
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 96
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Twice daily for 12 weeks
**Intervention Names:**
- Drug: Bronpass Tab.
**Label:** Bronpass Tab.
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Twice daily for 12 weeks
**Intervention Names:**
- Other: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Bronpass Tab.
**Description:** Twice daily for 12 weeks
**Name:** Bronpass Tab.
**Other Names:**
- HL301
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Twice daily for 12 weeks
**Name:** Placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Change from baseline in CAT(COPD Assessment Test) total score at Visit 5
**Time Frame:** Time frame: 3 months(Visit 5)
#### Secondary Outcomes
**Measure:** Change from baseline in CAT total score at Visit 3 and Visit 4
**Time Frame:** Time frame: 1 month(Visit 3), 2 months(Visit 4)
**Measure:** Change from baseline in CAT cough score at Visit 3, Visit 4, and Visit 5
**Time Frame:** Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
**Measure:** Change from baseline in CAT sputum score at Visit 3, Visit 4, and Visit 5
**Time Frame:** Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
**Measure:** Incidence of moderate and severe COPD exacerbations from baseline to Visit 5
**Time Frame:** Time frame: 3 months(Visit 5)
**Measure:** Change frome baseline in PFT(Pulmonary Function Test) such as FEV1(Forced Expiratory Volume in one second), FVC(Forced Vital Capacity), FEV1/FVC at Visit 5
**Time Frame:** Time frame: 3 months(Visit 5)
**Measure:** Change from baseline in SGRQ-C(St. George's Respiratory Questionnaire for COPD patients) Score at Visit 3, Visit 4, and Visit 5
**Time Frame:** Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
**Measure:** Change from baseline in COAT(Cough Assessment Test) Score at Visit 3, Visit 4, and Visit 5
**Time Frame:** Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. 40 years ≤ age
2. Patients who are diagnosed as COPD (based on the definition in the Korean Society of Tuberculosis and Respiratory Diseases COPD Guidelines)
3. Patients who meet all of the following criteria at the screening test
* FEV1/FVC \< 0.70 after bronchodilator administration
* 30% ≤ FEV1 \< 80% predicted after bronchodilator administration
* Cough or sputum-related score on the CAT ≥ 3
4. Current or former smokers with a smoking history of 10 pack-years or more at screening.
5. Patients who have listened to a detailed explanation of this clinical trial, fully understand it, and voluntarily provide written consent to participate.
Exclusion Criteria:
1. Patients with a current medical history of asthma (However, patients previously diagnosed as asthma who have recovered and currently have a diagnosis of COPD are eligible for participation.)
2. Patients with a medical history of respiratory diseases other than COPD
3. Patients who have undergone lung volume reduction surgery.
4. Patients with a history of lung transplantation.
5. Patients with a history of respiratory infections within 4 weeks prior to screening
6. Patients with a history of moderate or severe acute exacerbation within 4 weeks prior to screening.
7. Pregnant or lactating women.
8. Patients who are considered ineligible for this clinical trial due to other reasons as judged by the investigator.
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** 20130643@kuh.ac.kr
**Name:** Kwang Ha Yoo, MD, PhD
**Phone:** 82-2-2030-5114
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Email:** 20130643@kuh.ac.kr
- **Name:** Kwang Ha Yoo, MD, PhD
- **Phone:** 82-2-2030-5114
- **Role:** CONTACT
**Country:** Korea, Republic of
**Facility:** Konkuk University School of Medicine
**Status:** RECRUITING
**Zip:** 05030
#### Overall Officials
**Official 1:**
**Affiliation:** Konkuk University
**Name:** Kwang Ha Yoo, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## 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
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434779
**Acronym:** JETART
**Brief Title:** Investigating Efficacy and Safety of JETi® in Arterial Occlusions in FEM-POP and Prox BTK-Lesions (JETART)
**Official Title:** Single Arm, Multicenter, Prospective Registry Investigating Efficacy and Safety of Mechanical Thrombectomy (JETi®) in Acute and Acute-on-Chronic Arterial Occlusions in Femoro-popliteal and Proximal BTK-Lesions (JETART)
#### Organization Study ID Info
**ID:** iD320240306
#### Organization
**Class:** OTHER
**Full Name:** ID3 Medical
### Status Module
#### Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-05
**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:** 2024-03-06
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Vascular Science LP GmbH
**Class:** INDUSTRY
**Name:** Abbott
#### Lead Sponsor
**Class:** OTHER
**Name:** ID3 Medical
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To demonstrate the efficacy and safety of the mechanical thrombectomy device (JETi 6F and 8F) for treatment of patients with symptomatic peripheral artery disease (PAD) due to acute or acute on chronic occlusions of the femoral and/or popliteal arteries and the first 10 cm of the below-the -knee arteries.
### Conditions Module
**Conditions:**
- Peripheral Arterial Disease
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Device: JETi 6F and 8F Thrombectomy system
**Label:** Mechanical Thrombectomy (JETi®)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Mechanical Thrombectomy (JETi®)
**Description:** To demonstrate the efficacy and safety of the mechanical thrombectomy device (JETi 6F and 8F) for treatment of patients with symptomatic peripheral artery disease (PAD) due to acute or acute on chronic occlusions of the femoral and/or popliteal arteries and the first 10 cm of the below-the -knee arteries.
**Name:** JETi 6F and 8F Thrombectomy system
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The primary efficacy endpoint is technical procedural success (post Jeti) defined as restoration of impaired flow to a straight-line orthograde flow in the target vessel/bypass with near complete or complete recanalization of occluded vessel by using the JETI system prior to further additional endovascular therapy.
**Measure:** Primary Efficacy Endpoint
**Time Frame:** During index procedure
**Description:** The primary safety endpoint is a composite of
1. freedom from device- and procedure-related death through 30 days post-index procedure;
2. freedom from major target limb amputation (above-the-ankle (ATA)) through 30 days post-procedure and
3. freedom from clinically-driven target vessel revascularization (CD-TVR) through 30 days post-index procedure
**Measure:** Primary Safety Endpoint
**Time Frame:** Up to 30 days post-index procedure
#### Secondary Outcomes
**Description:** Defined as successful delivery of the device to the lesion
**Measure:** Acute device success
**Time Frame:** During index procedure
**Description:** Secondary safety endpoint is a composite of
1. freedom from Major Adverse Events (MAEs). MAEs are defined as: all-cause death; bleeding, hematoma and intracranial hemorrhage; major target limb amputation; thrombosis at the target lesion.
2. freedom from major target limb amputation and MALE
3. freedom from CD-TVR
**Measure:** Secondary safety endpoint at discharge up to 30 days post index procedure
**Time Frame:** Up to 30 days
**Description:** Clinical improvement is defined as a composite of
1. freedom from major target limb amputation,
2. freedom from TVR,
3. freedom from worsening target limb Rutherford class (compared to baseline)
4. freedom from decrease in target limb ankle brachial index (ABI) ≥0.15 (compared to baseline)
**Measure:** Sustained clinical improvement at discharge and at 30- days post-index procedure
**Time Frame:** Hospital admission to discharge up to 30 days and at 30 days
**Description:** The primary patency is defined as a composite of
1. freedom from clinically-driven target lesion revascularization (CD-TLR)
2. freedom from binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis) as confirmed by an independent Corelab
**Measure:** Primary Patency at discharge and at 30 days post-index procedure
**Time Frame:** Hospital admission to discharge up to 30 days and at 30 days
**Description:** TLR is defined as a reintervention to maintain or restore the patency in the target lesion. TLR is clinically-driven (CD) when the TLR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or \>0.15 when compared to post-procedure
**Measure:** Freedom from TLR at discharge and at 30 days post-index procedure
**Time Frame:** Hospital admission to discharge up to 30 days and at 30 days
**Description:** Change in target limb Rutherford Classification from baseline to 30 days post-index procedure
**Measure:** Change in target limb Rutherford Classification from baseline to 30 days post-index procedure
**Time Frame:** Up to 30 days
**Description:** Change in target limb resting ABI from baseline to discharge and at 30 days post-index procedure
**Measure:** Change in target limb resting ABI from baseline to discharge and at 30 days post-index procedure
**Time Frame:** Up to 30 days
**Description:** Change of life quality according to the Walking Impairment Questionnaire (WIQ) from baseline to 30 days post-index procedure
**Measure:** Change of life quality according to the Walking Impairment Questionnaire (WIQ) from baseline to 30 days post-index procedure
**Time Frame:** Up to 30 days
**Description:** Change of life quality according to the EQ-5D questionnaire from baseline to 30 days post-index procedure
**Measure:** Change of life quality according to the EQ-5D questionnaire from baseline to 30 days post-index procedure
**Time Frame:** Up to 30 days
**Description:** Duration of hospital stay
**Measure:** Duration of hospital stay
**Time Frame:** Hospital admission to discharge up to 30 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient is ≥18 years
* Patient has Rutherford Classification 2,3 or 4.
* Patient has provided written informed consent and is willing to comply with study follow-up requirements.
Angiographic inclusion criteria
* De novo thrombotic occlusive lesion(s) or thrombotic re-occlusion or in-stent thrombotic occlusive lesion(s) or thrombotic occlusion of a bypass (autolog or prosthetic) occurring acute or subacute with onset of complains within \<30 days prior to first seen by investigating physician.
* Target lesion is located between the ostium of the SFA and the end of the P3 segment of the popliteal artery, tibioperoneal trunk, respectively the first 10 cm of the below the knee vessels
* Target vessel diameter ≥ 3 mm and ≤ 8 mm and irrespective of lesion length
* Target lesion must be occlusive lesion Note: there is no limitation in lesion length
* Successful, uncomplicated crossing of the target lesion occurs when the tip of the guidewire is distal to the target lesion without the occurrence of flow-limiting dissection of perforation and is judged by visual inspection to be within the true lumen.
* A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmed by angiography.
* At least one patent native distal outflow artery to the ankle or foot, free from significant stenosis (≥ 50 % stenosis) as confirmed by angiography.
Exclusion Criteria:
* Patients meets any contraindication for JETi mechanical thrombectomy use per IFU
* Lesion crossing is difficult and the lesion is not suspicious for fresh thrombus containment
* Pregnant women or female patients of childbearing potential that do not use adequate contraceptive methods
* Patient has a life expectancy of less than 1 year
* Patient has a known allergy to contrast medium that cannot be adequately pre-medicated.
* Patient is allergic to all anti-platelet treatments
* Patient has platelet count \<100.000/mm3 or \>700.000/mm
* Patient has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the study procedure
* Patient is diagnosed with coagulopathy that bares the risk of increased bleeding risk
* Patient has history of stroke within past 90 days
* Patient is participating in an investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study.
* Patient has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure
* Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol
* Patient suffering from HIT II
Angiographic Exclusion Criteria:
* Target lesion is larger than 8 mm, respectively smaller than 3 mm
* Significant target vessel tortuosity or other parameters prohibiting access to the target lesion
* Absence of thrombus in the target vessel
* Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤ 30 % residual diameter stenosis without death or major complications.
* No patent outflow vessels on the level of 10 cm below the origin of below the-knee arteries to the level of the foot or ankle.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### IPD Sharing Statement Module
**Description:** No IPD sharing plan
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000050197
- Term: Atherosclerosis
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M29213
- Name: Peripheral Arterial Disease
- Relevance: HIGH
- As Found: Peripheral Arterial Disease
- ID: M18894
- Name: Peripheral Vascular Diseases
- Relevance: HIGH
- As Found: Peripheral Arterial Disease
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: HIGH
- As Found: Arterial Occlusion
- ID: M26188
- Name: Atherosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4469
- Name: Arteriosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000058729
- Term: Peripheral Arterial Disease
- ID: D000016491
- Term: Peripheral Vascular Diseases
- ID: D000001157
- Term: Arterial Occlusive Diseases
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434766
**Acronym:** TMCP
**Brief Title:** Multicenter iTBS Neuromodulation for PTSD Treatment
**Official Title:** A Multicenter Clinical Study on Transcranial Magnetic Stimulation of the Primary Motor Cortex for PTSD Treatment
#### Organization Study ID Info
**ID:** yan2024-0108
#### Organization
**Class:** OTHER
**Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
### Status Module
#### Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**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:** 2024-05-15
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Shanghai Mental Health Center
**Class:** UNKNOWN
**Name:** The Affiliated Kangning Hospital of Ningbo University
**Class:** OTHER
**Name:** The First Affiliated Hospital of Anhui Medical University
#### Lead Sponsor
**Class:** OTHER
**Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex (M1) as adjunct treatment for PTSD patients. The primary outcome measure includes changes in PTSD symptom severity, with secondary outcome measures focusing on negative moods improvements, quality of life and social/occupation functioning and functional connectivity of the brain.
**Detailed Description:** The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex as adjunct treatment for PTSD patients.
Compared to traditional repetitive transcranial magnetic stimulation (rTMS), iTBS strategy usually delivers large amounts of pulses in a shorter time period, and its equal efficiency has been demonstrated in several psychiatric disorders such as major depressive disorder (MDD). Through this adequately randomized and sham-controlled study of iTBS for PTSD, this work will provide an alternative and potentially more potent stimulation target for clinical PTSD treatment. This study will also provide a comprehensive assessment of this treatment strategy towards improvements in symptoms, quality of life and brain functioning in PTSD.
The ultimate goal of this study is to develop a non-invasive brain stimulation approach targeting a novel site for alleviating symptoms and improving life quality for PTSD patients.
### Conditions Module
**Conditions:**
- Posttraumatic Stress Disorder
**Keywords:**
- iTBS
- PTSD
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Sham stimulation is used as a parallel control group for iTBS group.
##### Masking Info
**Masking:** TRIPLE
**Masking Description:** Participants, investigators and outcomes assessors are all blind to the group assignments.
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 140
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A sham coil with exactly the same appearance of active coil is used to compare with active coil. Stimulation dose and frequency is the same as active stimulation.
**Intervention Names:**
- Device: sham stimulation
**Label:** Sham stimulation
**Type:** SHAM_COMPARATOR
#### Arm Group 2
**Description:** An active coil is used to deliver iTBS. The stimulation dose is 20 sessions (1800 pulses per session; 2 sessions a day, at least 1 hour apart) over the course of 2 weeks (10 days to 14 days, allow at most three breaks and only once of the longest interval of 2 days).
**Intervention Names:**
- Device: intermittent theta-burst stimulation (iTBS)
**Label:** Active stimulation
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Sham stimulation
**Description:** sham theta-burst transcranial magnetic stimulation
**Name:** sham stimulation
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Active stimulation
**Description:** intermittent theta-burst transcranial magnetic stimulation
**Name:** intermittent theta-burst stimulation (iTBS)
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Change in PTSD symptom severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).
The CAPS-5 is a structured interview designed to make a categorical PTSD diagnosis, as well as to provide a measure of PTSD symptom severity. The structure corresponds to the DSM-5 criteria, with B, C, D and E symptoms rated for both frequency and intensity which are summed to provide severity ratings. Items rated '0' means 'absent' and item rated '4' means 'extreme/incapacitating'. Higher scores indicate more severe PTSD symptoms.
**Measure:** Change in PTSD Symptom Severity
**Time Frame:** Baseline and 4 weeks after finishing treatment
#### Secondary Outcomes
**Description:** Change in PTSD symptom severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).
**Measure:** Change in PTSD Symptom Severity
**Time Frame:** Baseline, 10 times treatment, 20 times treatment, 2 weeks after finishing treatment and 8 weeks after finishing treatment
**Description:** The PCL-5 is a 20-item self-report checklist of PTSD symptoms based closely on the DSM-5 criteria. Respondents rate each item from 0 ("not at all") to 4 ("extremely") to indicate the degree to which they have been bothered by that particular symptom over the past month (or past week if using the PCL-5 weekly). A total symptom severity score (range: 0-80) can be obtained by summing the scores for each of the 20 items, with higher scores indicating more severe PTSD symptoms.
**Measure:** Change in Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score
**Time Frame:** Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
**Description:** The IDS-SR is a 30-item questionnaire measuring depressive symptoms. Each item has four statements that reflect various degrees of symptom severity, scored on a four-point scale from 0 to 3. The 16-item Quick Inventory of Depressive Symptomatology (QIDS) is a new measure of depressive symptom severity derived from the 30-item IDS-SR and has highly acceptable psychometric properties.
**Measure:** Change in The Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR) Score
**Time Frame:** Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
**Description:** The Personal and Social Performance Scale (PSP) is a 100-point single-item rating scale that assesses four important domains of patients with mental disorders. The four main areas include (a) socially useful activities, including work and study; (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors.
**Measure:** Change in The Personal Social Performance (PSP) scale
**Time Frame:** Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
**Description:** Q-LES-Q-SF is a patient-reported 16-item instrument that measures the degree of enjoyment and satisfaction in daily life over the past week. Individual items are rated on a scale from 1-5 ('very poor', 'poor', 'fair', 'good', or 'very good'). The Q-LES-Q-SF total score is the sum of the first 14 item scores (i.e. excluding medication satisfaction and overall life satisfaction and contentment) with a higher score indicating greater satisfaction (range = 14-70).
**Measure:** change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
**Time Frame:** Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
**Description:** Structural, resting-state and task-based fMRI will be performed if the participant agree. During task-fMRI, the participant will listen to a script around one minute recorded during his/her first interview, describing the traumatic experience in details. The participant will be instructed to recall the traumatic experience vividly during the task-fMRI. Brain activity patterns and connectivity network will be presented and analyzed.
**Measure:** Change in neural activity pattern and functional connectivity of the brain based on fMRI
**Time Frame:** Baseline, 20 times treatment, 4 weeks after finishing treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged between 18 to 65 years old
* Right handedness
* Have a diagnosis of PTSD meeting DSM-5 criteria
* CAPS-5 score\>35
* Under stable medication for at least four weeks
* Capable of independently reading and understanding study materials and providing informed consent.
Exclusion Criteria:
* Current (or past if appropriate) significant neurological or medical disorder, or lifetime history of 1) seizure disorder; 2) primary or secondary CNS tumors; 3) stroke; or 4) cerebral aneurysm.
* Primary psychotic disorder, bipolar I disorder, major depressive disorder, or personality disorders
* Lifetime history of attempted suicide or HAMD-17 suicide item (item 3) ≥ 3 points
* Implanted device (deep brain stimulation) or metal in the brain; a pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos if choose to do fMRI
* Previous experience of rTMS
* Pregnancy/lactation, or planning to become pregnant during the study
* Current under psychological or other physical treatments
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** hhq0301@zju.edu.cn
**Name:** Huiqian Huang, Ph.D.
**Phone:** (+86)18757143725
**Role:** CONTACT
**Contact 2:**
**Email:** 1252037349@qq.com
**Name:** Shanshan Li, Bachelor
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Shanghai Mental Health Center
**Name:** Yuan Shen, M.D., Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** The Affiliated Kangning Hospital of Ningbo University
**Name:** Chang Yu, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** The First Affiliated Hospital of Anhui Medical University
**Name:** Kai Wang, M.D., Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 4:**
**Affiliation:** Second Affiliated Hospital, School of Medicine, Zhejiang University
**Name:** Xiaoming Li, M.D., Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000040921
- Term: Stress Disorders, Traumatic
- ID: D000068099
- Term: Trauma and Stressor Related Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M24916
- Name: Stress Disorders, Traumatic
- Relevance: LOW
- As Found: Unknown
- ID: M16103
- Name: Stress Disorders, Post-Traumatic
- Relevance: HIGH
- As Found: Posttraumatic Stress Disorder
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M222
- Name: Trauma and Stressor Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013313
- Term: Stress Disorders, Post-Traumatic
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434753
**Brief Title:** Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease.
**Official Title:** Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease: A Multicenter, Randomized, Double-blind, Placebo Controlled Clinical Trial
#### Organization Study ID Info
**ID:** IC/LV/ACZ/PCHC
#### Organization
**Class:** OTHER
**Full Name:** Hospital Universitari Vall d'Hebron Research Institute
### Status Module
#### Completion Date
**Date:** 2026-03-02
**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:** 2026-03-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-10-02
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Hospital General Universitario Gregorio Marañon
**Class:** OTHER
**Name:** Hospital Vall d'Hebron
**Class:** UNKNOWN
**Name:** Hospital Universitario Puerta del Hierro
**Class:** OTHER
**Name:** Hospital Clinic of Barcelona
**Class:** OTHER
**Name:** Hospital Universitario Central de Asturias
**Class:** OTHER
**Name:** Complejo Hospitalario de Toledo
**Class:** OTHER
**Name:** Germans Trias i Pujol Hospital
**Class:** OTHER
**Name:** Hospital Universitario Marqués de Valdecilla
**Class:** OTHER
**Name:** Hospital Miguel Servet
**Class:** OTHER
**Name:** Parc Taulí Hospital Universitari
**Class:** OTHER
**Name:** Hospital de la Santa creu i Sant Pau - Barcelona
**Class:** OTHER
**Name:** Hospital Universitari de Bellvitge
**Class:** OTHER
**Name:** Hospital del Mar
**Class:** NETWORK
**Name:** University Hospital of Girona Dr.Josep Trueta
#### 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:** Zinc homeostasis could play a role in advanced chronic liver disease (cACLD) and its supplementation has been linked with improvement in liver function, decrease of hepatic complications and reduction in hepatocellular carcinoma (HCC) incidence. cACLD encompasses a heterogeneous group of patients with a variable risk of clinically significant portal hypertension (CSPH) and clinical events. The ANTICIPATE model is a validated model for stratifying these risks. Our aim is to demonstrate that the administration of zinc can reduce the rate and risk of presenting clinical events (first decompensation, HCC, death and liver transplantation). This study protocol describes an ongoing phase III, national, multicentre, randomized, double-blind clinical trial that will enroll 300 patients to receive either the trial treatment (zinc acexamate) or placebo. An inclusion period of 42 months is planned, with a minimal duration of follow up of 2 years. Our principal hypothesis is that zinc could modify the natural history of cACLD patients, with an overall improvement in prognosis
### Conditions Module
**Conditions:**
- Advanced Chronic Liver Disease
- Portal Hypertension
- Hepatocellular Carcinoma
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Phase III, randomized, double-blind clinical trial with two parallel groups, controlled with placebo. This is a low-level intervention clinical trial since the experimental drug is an authorized medication. This is a multicenter national study with fifteen Spanish centers recruiting patients
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The experimental group will receive ACZ at a daily dose of 600 mg, equivalent to 100mg of elemental zinc (one hard gelatin capsule of 300 mg of ACZ twice a day). Treatment will be stopped when the patient presents any of the events that define the main endpoint of the study.
**Intervention Names:**
- Drug: Zinc Acexamate
**Label:** Zinc Acexamate
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control group will receive twice a day orally hard gelatin capsules, identical to those of ACZ, in color, weight and nature, but containing an inert preparation (isomaltose).
**Intervention Names:**
- Drug: Zinc Acexamate
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Placebo
- Zinc Acexamate
**Description:** The experimental group will receive ACZ at a daily dose of 600 mg, equivalent to 100mg of elemental zinc (one hard gelatin capsule of 300 mg of ACZ twice a day). Treatment will be stopped when the patient presents any of the events that define the main endpoint of the study.
The control group will receive twice a day orally hard gelatin capsules, identical to those of ACZ, in color, weight and nature, but containing an inert preparation (isomaltose).
**Name:** Zinc Acexamate
**Other Names:**
- Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Ordinal scale to assess efficacy of the intervention, with the expected distribution of patients on each study arm at the 2- year mark, based on an effect size of an OR of 0.55.
The primary endpoint will be assessed at the two-year mark as the distribution of patients in a 6-value ordinal scale. The most severe category (Value 6) will be the development of clinical events: First descompensation, hepatocellular carcinoma, liver related-death, liver transplantation.
This ordinal scale captures both the development of clinical events (level 6), and the risk of presenting them, based on the ANTICIPATE model. Considering the sum of expected clinical events at 24 months of follow-up according to the PREDESCI study and other studies on the natural history of liver cirrhosis with the added effect of decompensation, HCC and death, a total of 20% of clinical events are expected at two years of follow-up (16% decompensations, 2% hepatocellular carcinomas and 2% deaths).
**Measure:** Values 1-6. Ordinal scale to assess efficacy of the intervention.
**Time Frame:** 24 months
#### Secondary Outcomes
**Description:** Number of descompensations: First descompensation, hepatocellular carcinoma, liver related-death, liver transplantation.
**Measure:** Evaluate if the administration of zinc decreases the risk of having the first decompensation and what type.
**Time Frame:** 24 months
**Description:** Odds Ratio
**Measure:** Evaluate if the administration of zinc decreases the risk of CSPH estimated by the ANTICIPATE model.
**Time Frame:** 24 months
**Description:** Odds Ratio
**Measure:** Evaluate if the administration of zinc reduces the risk of hepatocellular carcinoma.
**Time Frame:** 24 months
**Description:** Odds Ratio
**Measure:** Evaluate if the administration of zinc reduces the risk of bacterial infections.
**Time Frame:** 24 months
**Description:** Odds Ratio
**Measure:** Evaluate if the administration of zinc improves overall transplant-free survival and the risk of liver-related death.
**Time Frame:** 24 months
**Description:** Score (Child-Pugh and MELD)
**Measure:** Evaluate if the administration of zinc improves liver function as measured by Child-Pugh and MELD score.
**Time Frame:** 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients of both sexes with diagnosed compensated advanced chronic liver disease (cACLD) determined by hepatic stiffness on transient elastography \>15 kPa.
* Age between 18 and 80 years, inclusive.
* Absence of prior or current decompensation.
* For women of childbearing age, a possible pregnancy will be ruled out by a pregnancy test prior to the start of the study. Following the test, the woman must use an effective contraceptive method during sexual intercourse (see Appendix I) in the days leading up to the start of treatment, and continue to use it throughout the treatment period, as well as for several days after its completion.
* Signing of informed consent.
Exclusion Criteria:
* History or current presence of hepatocellular carcinoma.
* Concomitant systemic disease with a short-term poor prognosis.
* Pregnancy, breastfeeding, or refusal to use contraceptive measures during participation in the study.
* Patients with compensated advanced chronic liver disease (cACLD) due to hepatitis B virus (HBV) under antiviral treatment, and those with cACLD due to hepatitis C virus (HCV) cured with antiviral treatment.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** joan.genesca@vallhebron.cat
**Name:** Joan Genescá, MD, PhD
**Phone:** 934 89 30 00
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Name:** Joan Genescá, MD, PhD
- **Role:** CONTACT
**Country:** Spain
**Facility:** Hospital Universitari Vall d'Hebron
**Status:** RECRUITING
**Zip:** 08035
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M9613
- Name: Carcinoma, Hepatocellular
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: HIGH
- As Found: Liver Disease
- ID: M10026
- Name: Hypertension, Portal
- Relevance: HIGH
- As Found: Portal Hypertension
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008107
- Term: Liver Diseases
- ID: D000006975
- Term: Hypertension, Portal
### Intervention Browse Module - Ancestors
- ID: D000000894
- Term: Anti-Inflammatory Agents, Non-Steroidal
- ID: D000018712
- Term: Analgesics, Non-Narcotic
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000018501
- Term: Antirheumatic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: Micro
- Name: Micronutrients
### Intervention Browse Module - Browse Leaves
- ID: M164210
- Name: 6-acetylaminocaproic acid
- Relevance: HIGH
- As Found: Fagerström Test for Nicotine Dependence
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M17768
- Name: Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4218
- Name: Anti-Inflammatory Agents, Non-Steroidal
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M20786
- Name: Analgesics, Non-Narcotic
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000018802
- Term: 6-acetylaminocaproic acid
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434740
**Brief Title:** A Study of SBRT Combined With Puterizumab in Intrapulmonary Metastasis From NSCLC
**Official Title:** The Efficacy and Safety of Stereotactic Radiotherapy Combined With Puterizumab in Non Small Cell Lung Cancer With Intrapulmonary Metastasis：A Phase II Prospective Single Arm Clinical Study
#### Organization Study ID Info
**ID:** SRRS-LCsbrt
#### Organization
**Class:** OTHER
**Full Name:** Sir Run Run Shaw Hospital
### Status Module
#### Completion Date
**Date:** 2027-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sir Run Run Shaw Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study aims to evaluate the efficacy and safety of SBRT combined with Puterizumab immunotherapy for non-small cell lung cancer with pulmonary metastases, and to determine the correlation between MRD and treatment efficacy. Through single-cell sequencing and spatial transcriptome information analysis, the underlying mechanisms will be analyzed to provide a basis for improving the new precision treatment methods for tumor immunotherapy resistance.
### Conditions Module
**Conditions:**
- Non-Small-Cell Lung Cancer
**Keywords:**
- lung cancer
- radiotherapy
- immunotherapy
- single-cell sequencing
- SBRT
- peripheral blood mononuclear cell
- minimalResidual disease
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 37
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The enrolled subjects will receive SBRT treatment combined with Puterizumab.
**Intervention Names:**
- Radiation: Stereotactic Body Radiation Therapy，SBRT
- Drug: Puterizumab
**Label:** experimental group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- experimental group
**Description:** The enrolled subjects will receive SBRT treatment for lung metastases.The dose segmentation is 10Gy/f, with a total dose of 50Gy/5f, once every other day.
**Name:** Stereotactic Body Radiation Therapy，SBRT
**Type:** RADIATION
#### Intervention 2
**Arm Group Labels:**
- experimental group
**Description:** Within 7-14 days after SBRT, Puterizumab should be used (dosage: recommended dosage of 200mg, intravenous infusion, infusion time of 60 minutes (± 15 minutes), once every 3 weeks (Q3W), for 6-8 months or intolerable toxicity).
**Name:** Puterizumab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The tumor response rate will evaluate the local control of lung metastases，referring to the evaluation criteria for solid tumor efficacy RECIST 1.1
**Measure:** tumor response rate
**Time Frame:** From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
#### Secondary Outcomes
**Description:** Using the minimal residual disease (MRD) panel for ctDNA molecular residual detection, and through ctDNA multi-node assessment, we can dynamically monitor the therapeutic efficacy and disease recurrence.
**Measure:** Minor Residual Lesions
**Time Frame:** From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
**Description:** PFS is the time from enrollment to tumor progression or death.
**Measure:** progression-free survival
**Time Frame:** From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
**Description:** OS is the time from enrollment to death due to any reason.
**Measure:** overall survival
**Time Frame:** From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
**Description:** Refer to the acute radiation injury grading standards of the United States Collaborative Group on Tumor Radiotherapy (RTOG)
**Measure:** RTOG acute radiation injury grading
**Time Frame:** From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted during the entire SBRT process and monthly after SBRT for up to 12 months.
**Description:** The quality of life will be evaluated using the QLQ-30 score.
**Measure:** QLQ-30 score
**Time Frame:** From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
**Description:** Using flow cytometry to detect the count and percentage of lymphocytes, including CD3+, CD3+, CD4+, CD3+, CD8+, CD4+/CD8+, and CD3-CD56+.
**Measure:** Lymphocyte subpopulation analysis
**Time Frame:** From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. age≥18
2. Non small cell lung cancer patients who have experienced pulmonary metastasis after PD-1 immunotherapy in the past
3. Voluntarily participate in this study and sign an informed consent form
4. The presence of evaluable size and number of pulmonary metastases on chest CT
5. There are indications for lung puncture biopsy
6. General physical condition (ECOG) 0-1
7. The laboratory test meets the following standards: white blood cell count\>3.5 × 109/L, absolute value of neutrophils\>1.8 × 109/L, platelet count ≥ 75 × 109/L, hemoglobin ≥ 100g/L; NR ≤ 1.5, and APTT ≤ 1.5 times the upper limit of normal value or partial prothrombin time (PT) ≤ 1.5 times the upper limit of normal value; Total bilirubin ≤ 1.25 times the upper limit of normal value; ALT and AST\<5 times the upper limit of normal values; 24-hour creatinine clearance rate\>50mL/min or blood creatinine\<1.5 times the upper limit of normal value.
Exclusion Criteria:
1. Unable to tolerate or refuse further immunotherapy
2. Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiteracy, etc
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** sunxiaonan@zju.edu.cn
**Name:** Xiaonan Sun, Ph D
**Phone:** 8613606618387
**Role:** CONTACT
**Contact 2:**
**Email:** 3413007@zju.edu.cn
**Name:** Xuyun Xie, MD
**Phone:** 8613989882983
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Sir Runrun Shaw Hospital
**Name:** Xiaonan Sun, Ph D
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Description:** After the research is completed, the statistical results will be published as an article.
**IPD Sharing:** NO
## 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
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: HIGH
- As Found: Non-Small Cell Lung Cancer
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: LOW
- As Found: Unknown
- ID: M11172
- Name: Lung Neoplasms
- Relevance: HIGH
- As Found: 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 - 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: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434727
**Acronym:** ISI-I3DM-01
**Brief Title:** Evaluating Intuitive 3D Models in Preoperative Surgical Planning for Thoracic and Colorectal Procedures.
**Official Title:** A Retrospective Multicenter Study for Intuitive 3D Models (I3DM), During Simulated Preoperative Surgical Planning for Anatomic Lung Resection and Lower Anterior Resection Procedures
#### Organization Study ID Info
**ID:** ISI-I3DM-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Intuitive Surgical
### 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:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Intuitive Surgical
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The Study Objective: To evaluate the clinical utility of a 3D model with 2D CT/MRI scans during simulated preoperative surgical planning of open, laparoscopic, or robotic-assisted anatomic lung resection (segmentectomy, lobectomy) or Lower Anterior Resection (LAR) procedures.
**Detailed Description:** This is a Retrospective study evaluating the clinical utility of a 3D model with 2D CT/MRI scans during simulated preoperative surgical planning of open, laparoscopic, or robotic-assisted anatomic lung resection (segmentectomy, lobectomy) or Lower Anterior Resection (LAR) procedures.
### Conditions Module
**Conditions:**
- Thoracic
- Colorectal Disorders
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Anatomic Lung Resection (Segmentectomy or Lobectomy) Procedures
**Label:** Thoracic Group
#### Arm Group 2
**Description:** Lower Anterior Resection Procedures
**Label:** Colorectal Group
### Outcomes Module
#### Primary Outcomes
**Description:** Surgeon questionnaires evaluating their preoperative surgical plan
**Measure:** Clinical Utility of 3D Model vs standard 2D in Preoperative Surgcial Planning
**Time Frame:** 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
DICOM inages from Subjects 18 years or older who have undergone either anatomic lung resection (segmentectomy, lobectomy) or a Lower Anterior Resection procedure will be .
Exclusion Criteria:
* N/A
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Subjects 18 years or older who have undergone anatomic lung resection (segmentectomy, lobectomy) or a Lower Anterior Resection procedure will be considered for this study.
## Derived Section
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434714
**Brief Title:** Management of Postoperative Pain After Cesarean Delivery Using Bridge Auricular Percutaneous Nerve Field Stimulator
**Official Title:** Management of Postoperative Pain After Cesarean Delivery Using Bridge Auricular Percutaneous Nerve Field Stimulator
#### Organization Study ID Info
**ID:** INOVA-2023-131
#### Organization
**Class:** OTHER
**Full Name:** Inova Fairfax Hospital
### Status Module
#### Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-08
**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:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Inova Fairfax Hospital
#### Responsible Party
**Investigator Affiliation:** Inova Fairfax Hospital
**Investigator Full Name:** Antonio Saad
**Investigator Title:** Director of Perinatal Research Unit
**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:** Post-cesarean section (CS) pain is commonly treated with acetaminophen, ibuprofen, and opioid medications as needed following delivery. About 300,000 women annually who were exposed to opioids after CS will go on to use opioids chronically. Reducing the quantity of post-CS opioids has been shown to decrease the amount of opioids used without compromising pain control. Bridge is a small device that sits on the outer ear and works similarly to a transcutaneous electrical nerve stimulation (TENS) unit to decrease pain sensation without medications. It has been shown to effectively reduce pain to decrease medication requirements after surgeries. This study aims to see if women receiving the Bridge device use need less pain medication than those without the device.
**Detailed Description:** Cesarean delivery is one of the most performed surgeries in the U.S. with approximately 1.15 million surgeries performed annually. Despite this, postoperative pain management remains a challenge. Prescribed total milligram morphine equivalents (MMEs) can range from 25 MMEs (equivalent to 3.3 oxycodone 5-mg tablets) to 1,950 MMEs (equivalent to 260 oxycodone 5-mg tablets). Additionally, the post discharge analgesia prescription is not correlated with the 24-hour predischarge opioid use or pain score. Most U.S. women who are prescribed opioids after a cesarean delivery receive at least 10 more tablets than necessary. A study looking at individualizing opioid prescriptions based on inpatient requirements found that women used about 60% of their prescription, regardless of the amount of opioids prescribed. Decreasing opioid requirement after cesarean delivery, can decrease women's exposure to opioids, reduce the risk of neonatal central nervous system depression due to exposure in breastmilk, and limit the potential for extra opioids from unused, filled prescriptions to fall into the wrong hands. Post-cesarean mothers use opioids for a median of 8 days after delivery. Bridge is a minimally invasive device shown in previous studies to reduce pain medication requirements in the post-operative acute recovery period. The device is a auricular percutaneous electrical nerve stimulator that modulates pain receptors leading to reduced pain sensation. This trial study to examine the utility of the Bridge device as an adjunct to standard of care post-cesarean pain regimens (acetaminophen, ibuprofen or ketorolac, and oxycodone or other similar opioid). Post-cesarean patients will be randomized in a 1:1:1 ratio to Bridge device, sham device, or standard of care treatment and followed through the postpartum period.
### Conditions Module
**Conditions:**
- Post-operative Pain, Acute
- Cesarean Section
- Opioid Use Disorder
- Opioids; Harmful Use
**Keywords:**
- cesarean section
- post-operative pain
- opioid abuse
- non-pharmacologic therapy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Double-blinded, placebo-controlled, 3 arm randomized controlled trial
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Participants will be randomized to either active Bridge device, sham (non-functional) device, or standard of care post-operative pain regimen. Participants, care providers, and investigators will be blinded to those in active or sham device groups.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 159
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Bridge device placed in post-anesthesia care unit (PACU) and worn until end-of-life of the device (at 5 days) in addition to standard of care pain medications as per institutional policy
**Intervention Names:**
- Device: Auricular percutaneous nerve field stimulator
**Label:** Bridge device
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Sham (non-functional) Bridge device placed in post-anesthesia care unit (PACU) and worn until 5 days post-delivery in addition to standard of care pain medications as per institutional policy
**Intervention Names:**
- Device: Sham auricular percutaneous nerve field stimulator
**Label:** Sham device
**Type:** SHAM_COMPARATOR
#### Arm Group 3
**Description:** Standard of care pain medications only as per institutional policy
**Label:** Standard of care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Bridge device
**Description:** Percutaneous nerve field stimulator device placed on the ear for 5 days
**Name:** Auricular percutaneous nerve field stimulator
**Other Names:**
- Bridge
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Sham device
**Description:** Non-functioning percutaneous nerve field stimulator device placed on the ear for 5 days
**Name:** Sham auricular percutaneous nerve field stimulator
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Total opioid intake in morphine milligram equivalents (MME) on post-operative day 4
**Measure:** Total opioid intake on post-operative day 4
**Time Frame:** Four days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Female 18 years or older able to provide informed consent in English or Spanish.
* Scheduled for cesarean delivery under neuraxial anesthesia.
* Intact skin surface behind and around the ear at the site of electrode application.
Exclusion Criteria:
* Active drug abuse.
* Chronic opioid user.
* Severe chronic pain.
* Hemophilia.
* Cardiac pacemaker or implantable electronic devices.
* Psoriasis vulgaris or other skin conditions precluding safe device application.
* Previous history of sensitivity to compound benzoin tincture.
* Hearing aid precluding proper placement of the device or removing which interferes with their hearing ability.
* Subject is concurrently participating in another research study with an investigational drug or medical device that in the Investigator's opinion could impact subject safety or study results.
* Subject with reasons to maintain an epidural beyond operative room.
* Subject with complex surgery or subject who may need more than a cesarean surgery with possible tubal sterilization procedure.
* Subject is deemed not suitable for the study at the discretion of the principal Investigator.
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** antonio.saad@inova.org
**Name:** Antonio Saad, MD
**Phone:** 7037766040
**Role:** CONTACT
**Contact 2:**
**Email:** ellen.murrin@inova.org
**Name:** Ellen M Murrin, DO
**Phone:** 7037766040
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Falls Church
**Contacts:**
***Contact 1:***
- **Name:** Antonio Saad, MD
- **Phone:** 703-776-6040
- **Role:** CONTACT
***Contact 2:***
- **Name:** Antonio Saad, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Ellen M Murrin, DO
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Inova Fairfax Medical Campus
**State:** Virginia
**Zip:** 22042
#### Overall Officials
**Official 1:**
**Affiliation:** Inova Health Systems
**Name:** Antonio Saad, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Inova Health Systems
**Name:** Ellen M Murrin, DO
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Osmundson SS, Min JY, Grijalva CG. Opioid prescribing after childbirth: overprescribing and chronic use. Curr Opin Obstet Gynecol. 2019 Apr;31(2):83-89. doi: 10.1097/GCO.0000000000000527.
**PMID:** 30789842
**Citation:** Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
**PMID:** 26996986
**Citation:** Chelly JE, Monroe AL, Planinsic RM, Tevar A, Norton BE. Auricular field nerve stimulation using the NSS-2 BRIDGE(R) device as an alternative to opioids following kidney donor surgery. J Complement Integr Med. 2021 Nov 1;19(2):449-454. doi: 10.1515/jcim-2021-0208. eCollection 2022 Jun 1.
**PMID:** 34714990
**Citation:** Lim G, LaSorda KR, Monroe AL, Chelly JE. Auricular percutaneous nerve field stimulator device as alternative therapy for Cesarean delivery analgesia: proof of concept. Can J Anaesth. 2019 Dec;66(12):1522-1523. doi: 10.1007/s12630-019-01465-x. Epub 2019 Aug 20. No abstract available.
**PMID:** 31432323
## 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
- ID: D000079524
- Term: Narcotic-Related Disorders
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Post Operative Pain, Acute
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12244
- Name: Opioid-Related Disorders
- Relevance: HIGH
- As Found: Opioid Use Disorder
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M2057
- Name: Narcotic-Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010149
- Term: Pain, Postoperative
- ID: D000009293
- Term: Opioid-Related Disorders
### 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: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434701
**Acronym:** SPICE
**Brief Title:** Severe COVID-19 Infection in Children Presenting to EDs in Israel and England
**Official Title:** Severe COVID-19 Infection in Children Presenting to Emergency Departments in Israel and England: A Prospective Multicenter Study
#### Organization Study ID Info
**ID:** SPICE-HMO-CTIL
#### Organization
**Class:** OTHER
**Full Name:** Hadassah Medical Organization
### Status Module
#### Completion Date
**Date:** 2026-08-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-30
**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:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** London North West Healthcare NHS Trust
#### Lead Sponsor
**Class:** OTHER
**Name:** Hadassah Medical Organization
#### Responsible Party
**Investigator Affiliation:** Hadassah Medical Organization
**Investigator Full Name:** Itai Shavit
**Investigator Title:** Chair, Division of Pediatrics, Hadassah Medical Center
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Even though the COVID-19 pandemic is no longer at its peak, the threat still lingers. Engaging in prospective surveillance studies will enable us to monitor the disease and prepare for any potential resurgence. COVID-19 surveillance studies are essential tools for policymakers to make informed decisions, allocate resources, and develop strategies to control the spread of the virus and protect public health.
The objective of this surveillance study is to prospectively assess in-hospital severe morbidity related to COVID-19 infection in children who present to the Pediatric Emergency Department (ED).
A prospective multicenter study will be conducted across eight EDs in Israel and five EDs in the United Kingdom. The study population will include children aged 16 years or younger with a severe acute COVID-19 infection. Confirmation of acute COVID-19 infection will be based on polymerase chain reaction nasopharyngeal swab testing. The study will also include patients diagnosed with multisystem inflammatory syndrome in children (MIS-C), as defined by the CDC.
### Conditions Module
**Conditions:**
- COVID-19
- Inflammatory Response
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 500
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Nasopharyngeal swab sampling for COVID-19
**Intervention Names:**
- Diagnostic Test: Nasopharyngeal swab sampling for COVID-19
**Label:** Severe acute COVID-19 infection
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Severe acute COVID-19 infection
**Description:** The healthcare provider will gently insert the swab a short distance (1-1.5 cm for young children) into one nostril, reaching the back of the nasal cavity. The swab will then be gently rotated and rubbed for a few seconds to collect a sample of mucus. The same process may be repeated in the other nostril.
**Name:** Nasopharyngeal swab sampling for COVID-19
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The percentage of patients diagnosed with SACI among all patients admitted to the Emergency Department
**Measure:** Severe acute COVID-19 infection (SACI)
**Time Frame:** Up to 16 weeks
#### Secondary Outcomes
**Description:** The percentage of COVID-19 patients treated with low-flow oxygen among all patients admitted to the Emergency Department
**Measure:** Administration of low-flow oxygen therapy via nasal cannula or face mask
**Time Frame:** Up to 12 weeks
**Description:** The percentage of COVID-19 patients treated with HFNC or CPAP among all patients admitted to the Emergency Department
**Measure:** Administration of high-flow oxygen via nasal cannula (HFNC), or administration of oxygen via bilevel or continuous positive airway pressure (CPAP) machine
**Time Frame:** Up to 12 weeks
**Description:** The percentage of COVID-19 patients treated with mechanical ventilation among all patients admitted to the Emergency Department
**Measure:** Treatment with mechanical ventilation
**Time Frame:** Up to 12 weeks
**Description:** The percentage of COVID-19 patients treated with ECMO among all patients admitted to the Emergency Department
**Measure:** Treatment with extracorporeal membrane oxygenation (ECMO)
**Time Frame:** Up to 8 weeks
**Description:** The percentage of COVID-19 patients treated with vasopressor support among all patients admitted to the Emergency Department
**Measure:** Treatment with vasopressor support
**Time Frame:** Up to 8 weeks
**Description:** Mean duration of ICU stay for patients admitted with COVID-19
**Measure:** Length of ICU stay
**Time Frame:** Up to 16 weeks
**Description:** Mean duration of hospital stay for patients admitted with COVID-19
**Measure:** Length of hospital stay
**Time Frame:** Up to 24 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. SACI
Patients aged 16 years or younger with a positive COVID-19 PCR nasopharyngeal swab testing or bronchoalveolar sample who meet the definition of SACI:
* Receive oxygen via low-flow nasal cannula or oxygen mask, high-flow nasal cannula, bilevel or continuous positive airway pressure machine, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) Or
* Admitted to ICU
2. MIS-C Patients aged 16 years or younger diagnosed with MIS-C
**Maximum Age:** 16 Years
**Minimum Age:** 0 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** shavit1@hadassah.org.il
**Name:** Itai Shavit, MD
**Phone:** 00 972 50 2063239
**Role:** CONTACT
**Contact 2:**
**Email:** lhadas@hadassah.org.il
**Name:** Hadas Lamberg, PhD
**Phone:** 00 972 2 6777572
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007239
- Term: Infections
- ID: D000011024
- Term: Pneumonia, Viral
- ID: D000011014
- Term: Pneumonia
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000018352
- Term: Coronavirus Infections
- ID: D000003333
- Term: Coronaviridae Infections
- ID: D000030341
- Term: Nidovirales Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M7796
- Name: Emergencies
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M2561
- Name: COVID-19
- Relevance: HIGH
- As Found: COVID-19
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13904
- Name: Pneumonia
- Relevance: LOW
- As Found: Unknown
- ID: M13914
- Name: Pneumonia, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20490
- Name: Coronavirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6555
- Name: Coronaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M23685
- Name: Nidovirales Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000086382
- Term: COVID-19
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434688
**Brief Title:** Body Awareness and Mental Fatigue in Neck Pain
**Official Title:** Examining Mental Fatigue, Body Awareness, and Mindfulness in People With Chronic Neck Pain
#### Organization Study ID Info
**ID:** 10557444
#### Organization
**Class:** OTHER
**Full Name:** Hacettepe University
### 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:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-29
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-27
**Type:** ESTIMATED
**Status Verified Date:** 2024-02
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hacettepe University
#### Responsible Party
**Investigator Affiliation:** Hacettepe University
**Investigator Full Name:** Selenay Aydogdu
**Investigator Title:** principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The primary aim of the study was to examine the difference between mental fatigue, in-body, out-of-body and mindfulness parameters in people with chronic neck pain compared to a healthy control group, and to analyze the relationships between mental fatigue and neck disability level and awareness levels, and between awareness levels and neck disability level and quality of life.
The secondary aim was to examine the relationships between pain intensity, frequency, duration, pain self-efficacy, physical condition, anxiety and depression, mental fatigue and awareness levels in people with chronic neck pain.
**Detailed Description:** Neck pain is a prevalent musculoskeletal issue that can cause significant disability. Individuals with neck pain may experience changes in muscle structure and behavior, as well as sensory-perceptual-motor issues such as decreased proprioception and related neuromuscular changes. Additionally, neck pain can lead to psychological problems such as anxiety and depression.Although some awareness parameters have been evaluated in studies on neck pain in the literature and it has been shown that chronic pain is associated with impaired body awareness and that this impairment contributes to and/or maintains chronic pain, no study has been found to examine all awareness parameters in detail. Another cause that compromises the accuracy of information contributing to body awareness is mental fatigue. Mental fatigue can negatively affect a person's level of perception. In one study, it was stated that mental fatigue was a determinant of neck disability, but studies on this subject were found to be very insufficient. Therefore, the aim of this study was to examine the sub-parameters of awareness and mental fatigue in people with chronic neck pain, to compare them with healthy people and to examine the relationship between the parameters evaluated.
### Conditions Module
**Conditions:**
- Neck Pain
- Mental Fatigue
- Mindfulness
- Awareness
**Keywords:**
- mental fatigue
- Mindfulness
- Interoception
- Proprioception
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 66
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Study Group Inclusion Criteria:
* Having chronic neck pain for at least 3 months.
* Being between 18 and 65 years of age.
* Scoring 5 and above on the Neck Disability Questionnaire.
* Scoring 24 and above on the Mini Mental Status Examination.
* Being able to read and write.
* Being willing to participate in the study.
Study Group Exclusion Criteria:
* Participation in any physical therapy program in the last 3 months.
* Having the following problems:
* Radiculopathy, myleopathy (motor and sensory loss) and other neurologic diseases.
* Inflammatory diseases
* History of malignancy.
* Congenital spinal cord anomaly and congenital spinal deformities
* Spinal pathologies, traumatic medulla spinalis injury and other medulla spinalis pathologies.
* Vestibular disorders.
* Diagnosed psychiatric disorders such as bipolar disorder and panic attacks.
* Vision problems that do not improve despite vision aids.
* Pregnancy
**Intervention Names:**
- Other: Mental Fatigue:
- Other: Body Awareness:
- Other: Neck Disability Level
- Other: Quality Of Life
- Other: Pain Assessment:
- Other: Physical Condition:
- Other: Anxiety and Depression:
**Label:** Individuals experiencing neck pain
#### Arm Group 2
**Description:** Control Group Inclusion Criteria:
* Age between 18 and 65 years.
* Scoring 24 and above on the Mini Mental State Examination.
* To be able to read and write.
* Volunteering to participate in the study.
Control Group Exclusion Criteria:
* Having chronic pain in the spine, especially in the neck.
* Exclusion criteria for the study group
**Intervention Names:**
- Other: Mental Fatigue:
- Other: Body Awareness:
- Other: Quality Of Life
- Other: Physical Condition:
- Other: Anxiety and Depression:
**Label:** Healthy individuals without neck pain
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Healthy individuals without neck pain
- Individuals experiencing neck pain
**Description:** The Mental Fatigue Scale (MFS) will be used to assess mental fatigue.
**Name:** Mental Fatigue:
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Healthy individuals without neck pain
- Individuals experiencing neck pain
**Description:** Individuals' general body awareness will be assessed with the Body Awareness Questionnaire (BAQ).
Neck awareness of individuals will be assessed with the Fremantle Neck Awareness Questionnaire (FreBFA).
Short Form of the Five Facet Mindfulness Questionnaire (FFMQ - Short Form) will be used to assess people's mindfulness.
- In-body awareness:
For the sense of interoception, the Multidimensional Assessment of Interoceptive Awareness Scale, which assesses interoceptive body awareness, will be used.
To evaluate proprioception, a Cervical Range of Motion (CROM) device is used.
The bucket test will be used to assess subjective visual verticality, which is one of the sub-dimensions of verticality perception.
Two scales will be used to assess people's awareness of weight transfer symmetry.
- Out of Body Awareness:
"Right-Left Confusion Hand Test" will be used to evaluate the mental rotation skill within the scope of the sense of extroception.
**Name:** Body Awareness:
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Individuals experiencing neck pain
**Description:** Neck disability index will be used to assess this parameter.
**Name:** Neck Disability Level
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- Healthy individuals without neck pain
- Individuals experiencing neck pain
**Description:** SF-12 will be used to assess quality of life.
**Name:** Quality Of Life
**Type:** OTHER
#### Intervention 5
**Arm Group Labels:**
- Individuals experiencing neck pain
**Description:** Pain intensity will be assessed by Visual Analog Scale (VAS). In addition, pain duration and pain frequency will be questioned. The Pain Self-Efficacy Questionnaire will be used to assess the confidence of people with chronic pain to perform certain tasks and behaviors despite their pain.
**Name:** Pain Assessment:
**Type:** OTHER
#### Intervention 6
**Arm Group Labels:**
- Healthy individuals without neck pain
- Individuals experiencing neck pain
**Description:** Normal range of motion of the cervical region will be evaluated with the "Cervical Range of Motion" device.
New York Posture Rating Scale will be used to evaluate posture.
Symmetry of weight transfer to both lower extremities of the individuals in standing upright position will be evaluated.
**Name:** Physical Condition:
**Type:** OTHER
#### Intervention 7
**Arm Group Labels:**
- Healthy individuals without neck pain
- Individuals experiencing neck pain
**Description:** Beck Depression and Beck Anxiety scales will be used to assess depression and anxiety.
**Name:** Anxiety and Depression:
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Mental Fatigue Scale (MFS) will be used to assess mental fatigue. It includes questions about general fatigue, lack of initiative, mental fatigue, concentration difficulties, memory problems, slowness of thinking, sensitivity to stress, increased tendency to be emotional, irritability, sensitivity to light and noise, decreased or increased sleep. It has a 7-point Likert-type scale and is scored from 0 to 3. A rating of 0 indicates normal functioning, 1 indicates mild problem, 2 indicates significant problem and 3 indicates maximum problem. According to the total score, 0-10= no mental fatigue problem, 10.5-14.5= mild mental fatigue, 15-20= quite serious mental fatigue, ≥ 20.5= serious mental fatigue.
**Measure:** Mental Fatigue
**Time Frame:** 2024 may- 2024 July
**Description:** General body awareness of individuals will be assessed with the Body Awareness Questionnaire (BAQ).
**Measure:** General Body Awareness
**Time Frame:** 2024 may- 2024 July
**Description:** Neck disability index will be used to assess this parameter. The questionnaire contains 10 questions related to different activities. Each question is scored between 0 and 5. The level of disability is determined according to the total score obtained from the questionnaire. 0-4 = no disability, 5-14 = mild disability, 15-24 = moderate disability, 25- 34 = severe disability, 35 and above = total disability.
**Measure:** Neck Disability
**Time Frame:** 2024 may- 2024 July
**Description:** The SF-12, which is more practical and shorter than the SF-36 but contains the same sub-dimensions as the SF-36, will be used to assess quality of life. SF-12 consists of 8 sub-dimensions and 12 items including physical functioning (2 items), physical role, body pain, general health, energy, social functioning, emotional role and mental health. The questionnaire scoring is calculated under the headings of physical and mental health, which are the two main components of general health.
**Measure:** General health questionnaire
**Time Frame:** 2024 may - 2024 July
**Description:** Two scales were used to assess weight transfer awareness. Results will be recorded in kg.
**Measure:** weight transfer awareness
**Time Frame:** 2024 may- 2024 July
**Description:** Individuals' neck awareness will be assessed with the Fremantle Neck Awareness Questionnaire (FreBFA).
**Measure:** neck awareness
**Time Frame:** 2024 may- 2024 July
**Description:** Short Form of the Five Facet Mindfulness Questionnaire (FFMQ - Short Form) will be used to assess people's mindfulness
**Measure:** mindfulness
**Time Frame:** 2024 may- 2024 July
**Description:** For the sense of interoception, the Multidimensional Assessment of Interoceptive Awareness Scale, which assesses interoceptive body awareness, will be used.
**Measure:** interoception
**Time Frame:** 2024 may- 2024 July
**Description:** The Cervical Range of Motion (CROM) device is used to assess proprioception. The device assesses proprioception in 6 different directions of the neck.
**Measure:** proprioception
**Time Frame:** 2024 may- 2024 July
**Description:** The bucket test will be used to assess subjective visual verticality, which is one of the sub-dimensions of verticality perception.
**Measure:** verticality
**Time Frame:** 2024 may- 2024 July
**Description:** The sense of extroception will be evaluated with the right-left hand confusion test.
**Measure:** extroception
**Time Frame:** 2024 may- 2024 July
#### Secondary Outcomes
**Description:** Pain intensity will be assessed by Visual Analog Scale (VAS).0: I have no pain 10: I have unbearable pain In addition, pain duration and pain frequency will be questioned.
**Measure:** Pain Assessment
**Time Frame:** 2024 may- 2024 July
**Description:** The Pain Self-Efficacy Questionnaire will be used to assess the confidence of people with chronic pain to perform certain tasks and behaviors despite their pain. Each item is rated on a 7-point Likert-type scale (0=not at all confident, 6=fully confident). The total score ranges from 0 to 60, with higher scores indicating greater self-efficacy for functioning despite pain.
**Measure:** Pain self efficacy
**Time Frame:** 2024 may- 2024 July
**Description:** Beck Depression and Beck Anxiety scales will be used to assess depression and anxiety. Both questionnaires have 21 questions and are scored between 0-3. According to the total scores, 0-9 points in the Beck Depression Scale indicates normal level, 10-16 points indicates mild depression, 17-29 points indicates moderate depression and 30-63 points indicates severe depression. On the Beck Anxiety Scale, 0-17 points are classified as low anxiety, 18-24 points as moderate anxiety, and 25 and above points as high anxiety.
**Measure:** Anxiety and Depression
**Time Frame:** 2024 may- 2024 July
**Description:** Normal range of motion of the cervical region will be evaluated with the "Cervical Range of Motion" device. Active ranges of motion in flexion-extension, lateral flexion and rotation directions will be recorded with the subjec
**Measure:** Range of motion
**Time Frame:** 2024 may- 2024 July
**Description:** New York Posture Rating Scale will be used to evaluate posture. Posture changes that may occur in 13 different parts of the body including head, neck, shoulders, shoulders, back, waist, hip and ankle are observed. According to the results of the observation, five (5) points are given if the person has proper posture, three (3) points if the posture is moderately impaired, and one (1) point if there is a serious impairment. A high score means that the posture is good.
**Measure:** Posture Assesment
**Time Frame:** 2024 may- 2024 July
**Description:** Symmetry of weight transfer to both lower extremities of the individuals in a standing upright position will be evaluated. It will be recorded in kg.
**Measure:** Weight transfer
**Time Frame:** 2024 may- 2024 July
### Eligibility Module
**Eligibility Criteria:** Study Group Inclusion Criteria:
* Having chronic neck pain for at least 3 months.
* Being between 18 and 65 years of age.
* Scoring 5 and above on the Neck Disability Questionnaire.
* Scoring 24 and above on the Mini Mental State Examination.
* To be able to read and write.
* Being volunteer to participate in the study.
Study Group Exclusion Criteria:
* Participation in any physical therapy program in the last 3 months.
* Having the following problems:
* Radiculopathy, myleopathy (motor and sensory loss) and other neurological diseases.
* Inflammatory diseases (rheumatoid arthritis, etc.).
* History of malignancy.
* Congenital spinal cord anomaly and congenital spinal deformities.
* Spinal pathologies, traumatic medulla spinalis injury and other medulla spinalis pathologies.
* Vestibular disorders.
* Diagnosed psychiatric illnesses such as bipolar disorder, psychotic illnesses and panic attacks.
* Vision problems that do not fully recover despite vision aids (glasses, etc.).
* Pregnancy status
Control Group Inclusion Criteria:
* Age between 18 and 65 years.
* Scoring 24 and above on the Mini Mental State Examination.
* To be able to read and write.
* Volunteering to participate in the study.
Control Group Exclusion Criteria:
* Having chronic pain in the spine, especially in the neck.
* Exclusion criteria for the study group
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** individuals with neck pain and healthy individuals without neck pain
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ankara
**Contacts:**
***Contact 1:***
- **Email:** selenay.aydgd@gmail.com
- **Name:** Selenay Aydoğdu, 1
- **Phone:** 5312723599
- **Phone Ext:** +90
- **Role:** CONTACT
***Contact 2:***
- **Email:** nkose@hacettepe.edu.tr
- **Name:** Nezire Köse, 2
- **Phone:** 3052525
- **Phone Ext:** 0312
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Hacettepe University
**State:** Sıhhiye
**Zip:** 06100
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Amiri Arimi S, Ghamkhar L, Kahlaee AH. The Relevance of Proprioception to Chronic Neck Pain: A Correlational Analysis of Flexor Muscle Size and Endurance, Clinical Neck Pain Characteristics, and Proprioception. Pain Med. 2018 Oct 1;19(10):2077-2088. doi: 10.1093/pm/pnx331.
**PMID:** 29304254
**Citation:** Dere T, Alemdaroglu-Gurbuz I. Muscular endurance and its association with neck pain, disability, neck awareness, and kinesiophobia in patients with chronic neck pain. Somatosens Mot Res. 2023 Mar 10:1-8. doi: 10.1080/08990220.2023.2186390. Online ahead of print.
**PMID:** 36897182
#### See Also Links
**Label:** The Relevance of Proprioception to Chronic Neck Pain: A Correlational Analysis of Flexor Muscle Size and Endurance, Clinical Neck Pain Characteristics, and Proprioception
**URL:** https://pubmed.ncbi.nlm.nih.gov/29304254/
**Label:** Muscular endurance and its association with neck pain, disability, neck awareness, and kinesiophobia in patients with chronic neck pain
**URL:** https://pubmed.ncbi.nlm.nih.gov/36897182/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000001526
- Term: Behavioral Symptoms
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M21485
- Name: Neck Pain
- Relevance: HIGH
- As Found: Neck Pain
- ID: M8364
- Name: Fatigue
- Relevance: HIGH
- As Found: Fatigue
- ID: M8365
- Name: Mental Fatigue
- Relevance: HIGH
- As Found: Mental Fatigue
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005221
- Term: Fatigue
- ID: D000019547
- Term: Neck Pain
- ID: D000005222
- Term: Mental Fatigue
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434675
**Brief Title:** Prevalence of Variants of Nasal Cavity and Nasal Septum in Nepalese
**Official Title:** Anatomical Variants of Nasal Cavities and Nasal Septum in Nepalese Patients: A Retrospective Cross-Sectional Study at a Tertiary Care Center
#### Organization Study ID Info
**ID:** 15/2023
#### Organization
**Class:** OTHER
**Full Name:** Grande International Hospital, Nepal
### Status Module
#### Completion Date
**Date:** 2024-05-05
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-09-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Grande International Hospital, Nepal
#### Responsible Party
**Investigator Affiliation:** Grande International Hospital, Nepal
**Investigator Full Name:** PRAJWAL DAHAL
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** A retrospective study was conducted on 343 patients. CT PNS and head of the patients were evaluated for variants of nasal septum and nasal cavity.
**Detailed Description:** A retrospective study was conducted on 343 patients aged 13 years and above. Two investigators, each with 3 to 4 years of experience in the field of radiology, evaluated computed tomography scans of the paranasal sinuses and the head of these patients. The nasal septum was evaluated for degree and types of variants. Various variants of nasal cavities and nasal septum were also evaluated.
### Conditions Module
**Conditions:**
- Nasal Septum; Deviation, Congenital
**Keywords:**
- Nasal Septum
- Nasal Cavity
- Turbinate
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 343
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients evaluated for nasal polyps
**Intervention Names:**
- Other: No intervention done
**Label:** Polyps
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Polyps
**Description:** No intervention done
**Name:** No intervention done
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Prevalence of deviated nasal septum will be calculated. Among those with nasal septum deviation, frequency of deviation to right, left and S shaped nasal septum will be evaluated. Nasal septal deviation angle will be measured and grading will be done.
**Measure:** Prevalence of variants of Nasal septum
**Time Frame:** 6 months
**Description:** Prevalence of variants of nasal cavities like hypertrophied turbinate, paradoxical turbinate, concha bullosa, lamellar concha will be obtained.
**Measure:** Prevalence of variants of nasal cavity
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1)Patients undergoing NCCT PNS and Head for chronic rhinosinusitis, headache and vertigo
Exclusion Criteria:
1. Patient less than 13 years age
2. Patients with recent trauma
3. Patient with large mass/ extensive polyposis
**Healthy Volunteers:** True
**Maximum Age:** 91 Years
**Minimum Age:** 13 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Patient of age 13 years and more undergoing NCCT PNS and Head for chronic rhinosinusitis , headache and vertigo
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kathmandu
**Country:** Nepal
**Facility:** Prajwal Dahal
**State:** Bagmati
**Zip:** Nepal
#### Overall Officials
**Official 1:**
**Affiliation:** Grande International Hospital
**Name:** PRAJWAL DAHAL
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: Rare
- Name: Rare Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434662
**Brief Title:** Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML
**Official Title:** A Phase II Study of the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection, Cytarabine and Venetoclax in Patients With Relapsed/Refractory AML
#### Organization Study ID Info
**ID:** CSPC-DED-AML-K13
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital of Zhejiang University
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-29
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
#### Lead Sponsor
**Class:** OTHER
**Name:** First Affiliated Hospital of Zhejiang University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. It will also tentatively explore the correlation between different biological characteristics and therapeutic efficacy. The main questions it aims to answer are:Dose the combination regimen of MAV enhanced the composite complete remission in R/R AML? Participants will receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.
**Detailed Description:** Acute myeloid leukemia (AML) is a highly aggressive hematologic malignancy with a poor prognosis. The "3+7" regimen, combining anthracyclines with cytarabine, remains the standard treatment for first line treatment. However, about 20% of patients will develop into primary refractory disease, and more than 50% of patients who achieved complete remission will eventually relapse. For patients with R/R AML, there is currently no established standard treatment. Combining the third drugs with "3+7" regimen is one of the clinical exploration directions.
The purpose of this prospective, single-center, single-arm, pahse II study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax in the treatment of R/R AML. All participants will receive MAV treatment including 24 mg/m2 mitoxantrone hydrochloride liposome on day 1, 1.0 g/m2 q12h cytarabine on day 1,3,5 and 400 mg venetoclax on day 2-10 with a dose escalation on day 2-4. Each cycle consists of 4 weeks. A maximum of 2 cycles of therapy are planned.
### Conditions Module
**Conditions:**
- Relapsed/Refractory Acute Myeloid Leukaemia
- Myeloid Malignancy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 34
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** mitoxantrone hydrochloride liposome injection, cytarabine combined with venetoclax
**Intervention Names:**
- Drug: mitoxantrone hydrochloride liposome
- Drug: Cytarabine
- Drug: Venetoclax
**Label:** MAV regimen
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MAV regimen
**Description:** Mitoxantrone hydrochloride liposome (24 mg/m\^2) on day 1, every 4 weeks
**Name:** mitoxantrone hydrochloride liposome
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- MAV regimen
**Description:** Cytarabine (1.0 g/m\^2, q12h ) on day 1,3,5, every 4 weeks
**Name:** Cytarabine
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- MAV regimen
**Description:** Venetoclax 100 mg on day 2，200 mg on day 3，400 mg on day 4-10, every 4 weeks
**Name:** Venetoclax
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Blast rate lower than 5% with or without peripheral blood cell recover
**Measure:** Composite complete remission (CRc) rate
**Time Frame:** At the end of each cycle (each cycle is 28 days), up to 2 cycles
#### Secondary Outcomes
**Description:** Response is assessed according to the the European LeukemiaNet (ELN) 2022 criteria
**Measure:** Overall response rate (ORR)
**Time Frame:** At the end of each cycle (each cycle is 28 days), up to 2 cycles
**Description:** Defined only for patients achieving CR or CRi; measured from the date of achievement of remission until the date of hematologic relapse or death from any cause;
**Measure:** Relapsed free survival (RFS)
**Time Frame:** up to 12 months
**Description:** Defined for all patients in a trial; measured from day 1 of treatment to the date of treatment failure, hematologic relapse from CR/CRi or death from any cause, whichever occurs first;
**Measure:** Event free survival (EFS)
**Time Frame:** up to 12 months
**Description:** Defined for all patients in a trial; measured from day 1 of treatment to the date of death from any cause;
**Measure:** overall survival (OS)
**Time Frame:** up to 12 months
**Description:** Percentage of participants who achieve a CR MRD- as defined by investigators based on ELN 2022 criteria; MRD level is detected by flow cytometry which value \<0.1% is defined as negtive;
**Measure:** Rate of CR without minimal residual disease (CR MRD-)
**Time Frame:** At the end of each cycle (each cycle is 28 days), up to 2 cycles
**Description:** The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.Hematologic and non-hematologic toxicity.
**Measure:** Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
**Time Frame:** From day 1 of treatment to 28 days after the last dose
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
2. Age ≥18.
3. Clinically diagnosed relapsed/refractory AML, excluding acute promyelocytic leukemia.
1. Initial treatment patients who failed after 2 courses of treatment with standard regimen.
2. Bone marrow blasts≥5% after the first CR/CRi, or reappearance of blasts in the blood in at least 2 peripheral blood samples at least one week apart, or leukemia cell infiltration appeared in extramedullary without treatment.
3. First conversion from MRD negativity to MRD positivity without treatment.
4. Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2.
5. Researchers determined that the patients could tolerate intensive chemotherapy.
6. Life expectancy \> 3 months.
7. AST/ALT≤2.5 ULN (for subjects with hepatic infiltration≤5 ULN); Total bilirubin≤1.5 ULN (for subjects with hepatic infiltration≤3 ULN); Serum creatinine≤1.5 ULN.
Exclusion Criteria:
1. Previous anti-tumor therapy meets one of the following criteria:
1. Prior therapy with mitoxantrone or mitoxantrone liposome;
2. Prior therapy with doxorubicin or anthracyclines, and the cumulative dose of doxorubicin \> 360 mg/m\^2 (1 mg doxorubicin was equivalent to 2 mg daunorubicin or 0.5 mg idarubicin);
3. Have received other anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, Chinese medicines with anti-tumor activity, except those that do not affect the efficacy of the study as determined by the investigator) or participated in other clinical trials and received clinical trial drugs within 4 weeks or 5 half-lives of the drug before the study;
2. Cardiovascular diseases, including but not limited to:
1. QTc interval \>480 ms or long QTc syndrome in screening;
2. Complete left bundle branch block, 2 or 3 grade atrioventricular block;
3. Requiring treatment of serious and uncontrolled arrhythmia;
4. New York Heart Association（NYHA≥3;
5. Cardiac ejection fraction (EF) was less than 50%;
6. Myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other history of arrhythmia or clinically serious pericardial disease that requires treatment within the first 6 months of enrollment, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
3. Central nervous system leukemia;
4. Previous or current occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years).
5. Subjects are suffering from any other uncontrollable disease (including but not limited to: uncontrolled diabetes and hypertension, and advanced infection);
6. HIV infection.
7. HBsAg or HBcAb positive, with HBV-DNA≥1x10\^3 copies/mL; or HCV-RNA≥1x10\^3 copies/mL;
8. A history of immediate or delayed allergy to similar drug and excipients of the investigate drug.
9. Pregnant, lactating female or subjects who refuse to use effective contraception during the study.
10. With a history of severe neurological or psychiatric illness.
11. Not suitable for this study as decided by the investigator.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** jiej0503@163.com
**Name:** Jie Jin, M.D.
**Phone:** +86 571-87236896
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Email:** jiej0503@163.com
- **Name:** Jie Jin, M.D.
- **Phone:** +86 571-87236896
- **Role:** CONTACT
**Country:** China
**Facility:** The First Affiliated Hospital, Zhejiang University School of Medicine
**State:** Zhejiang
**Status:** RECRUITING
**Zip:** 310003
#### Overall Officials
**Official 1:**
**Affiliation:** Zhejiang University
**Name:** Jie Jin, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10945
- Name: Leukemia
- Relevance: LOW
- As Found: Unknown
- ID: M10955
- Name: Leukemia, Myeloid
- Relevance: LOW
- As Found: Unknown
- ID: M18127
- Name: Leukemia, Myeloid, Acute
- Relevance: LOW
- As Found: Unknown
- ID: T3995
- Name: Myeloid Leukemia
- Relevance: HIGH
- As Found: Myeloid Leukemia
- ID: T182
- Name: Acute Myeloid Leukemia
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: T188
- Name: Acute Non Lymphoblastic Leukemia
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Ancestors
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000000998
- Term: Antiviral Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- 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: D000059005
- Term: Topoisomerase II Inhibitors
- ID: D000059003
- Term: Topoisomerase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M6766
- Name: Cytarabine
- Relevance: HIGH
- As Found: Multi-
- ID: M249656
- Name: Venetoclax
- Relevance: HIGH
- As Found: Extended
- ID: M11908
- Name: Mitoxantrone
- Relevance: HIGH
- As Found: Ask
- ID: M4281
- Name: Antimetabolites
- 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: M10212
- Name: Immunosuppressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000003561
- Term: Cytarabine
- ID: C000579720
- Term: Venetoclax
- ID: D000008942
- Term: Mitoxantrone
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434649
**Brief Title:** Posterior Extra-fascial RARP in Intermediate or High Risk Prostate Cancer
**Official Title:** Application of the Extra-fascial Robot Assisted Radical Prostatectomy Via the Posterior Approach in Intermediate or High Risk Patients: a Prospective, Multicenter, Double-blind, Randomized Controlled Study
#### Organization Study ID Info
**ID:** FirstAHFujian-Ning Xu
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital of Fujian Medical University
### Status Module
#### Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**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:** 2024-05-10
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Fujian Cancer Hospital
**Class:** OTHER
**Name:** Zhongshan Hospital Xiamen University
**Class:** OTHER
**Name:** Fuzhou General Hospital
**Class:** OTHER
**Name:** Longyan City First Hospital
**Class:** OTHER
**Name:** The First Hospital of Jilin University
**Class:** OTHER
**Name:** The First Affiliated Hospital of Nanchang University
**Class:** OTHER
**Name:** Ningbo No. 1 Hospital
**Class:** OTHER
**Name:** Hainan People's Hospital
**Class:** OTHER
**Name:** Second Affiliated Hospital of Third Military Medical University
**Class:** OTHER
**Name:** Zhejiang University
**Class:** OTHER
**Name:** Huashan Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Ning Xu
#### Responsible Party
**Investigator Affiliation:** First Affiliated Hospital of Fujian Medical University
**Investigator Full Name:** Ning Xu
**Investigator Title:** Head of Urology
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study was designed as a prospective, multicentre, double-blind, randomised controlled clinical trial. It aims to investigate the feasibility and safety of the posterior approach extrafascial technique and the anterior approach extrafascial technique in robot-assisted radical prostatectomy (RARP) for intermediate- and high-risk prostate cancer patients, to compare the oncological prognosis, functional prognosis, and safety of the two techniques in intermediate- and high-risk prostate cancer patients, and to provide evidence-based medical evidence for the choice of surgical treatment modality for intermediate- and high-risk prostate cancer patients.
**Detailed Description:** This study was designed as a prospective, multicentre, double-blind, randomised controlled clinical trial. It aims to investigate the feasibility and safety of the posterior approach extrafascial technique and the anterior approach extrafascial technique in robot-assisted radical prostatectomy (RARP) for intermediate- and high-risk prostate cancer patients, to compare the oncological prognosis, functional prognosis, and safety of the two techniques in intermediate- and high-risk prostate cancer patients, and to provide evidence-based medical evidence for the choice of surgical treatment modality for intermediate- and high-risk prostate cancer patients.
About 118 subjects will be enrolled in this study in a total of 12 research centres across the country, and eligible subjects will be randomly assigned to the posterior approach extrafascial technique group and the anterior approach extrafascial technique group in a 1:1 ratio. All subjects routinely underwent comprehensive and systematic physical examination, laboratory tests and imaging examinations before surgery. After surgery, subjects were followed up at 1 week (visit 2, day 14±2), 1 month (visit 3, day 28±5), 3 months (visit 4, day 90±7), 6 months (visit 5, day 180±7), and 12 months (visit 6, day 360±14) after removal of the urinary catheter after the surgery, and then annually thereafter (visit 7), with urine control rate (defined as 0/ 1 pad) and 24-h pad weight questionnaires, PSA examination, International Prostate Symptom Score (IPSS), International Consultation on Incontinence Questionnaire Short Form (ICI-QSF), International Index of Erectile Function (IIEF), and related scores such as General Health-Related Quality of Life (EORTC QLQ-C30) and Prostate Cancer-Specific Quality of Life (QLQ-PR25). ) and other relevant scores; in case of clinical suspicion of local recurrence, imaging (pelvic MRI), whole-body bone imaging in patients with bone pain, and whole-body PET/CT if necessary. Subjects will be monitored and evaluated for adverse events (AE) throughout the trial. Subjects will participate in the clinical trial for an expected duration of approximately 1 year, after which they will be followed up periodically according to the usual follow-up strategy.
### Conditions Module
**Conditions:**
- Surgical Procedure, Unspecified
- Prostate Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Double-blind technique will be used in this study. The blinding process will be done by a statistician unrelated to this clinical trial. Treatment group assignment will not be known to the subject or to the study followers or to the investigator who clinically evaluates the subject for the entire duration of the trial. Allocation concealment was achieved in this study through an interactive response system. In the absence of serious complications or other emergencies in the subjects during the study period, normal procedures were followed for revealing blinding, this study provides for the use of secondary blinding.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 118
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In 2010, Italian urologist Dr Bocciardi carried out the first clinical practice of separation and resection of the prostate via the vesicorectal fossa, and this new surgical procedure was called Retzius-sparing Robotic Assisted Radical Prostatectomy (RS-RARP). In recent years, the posterior approach extrafascial technique of RS-RARP which has been used to widely resect the prostate and its surrounding fascia and neurovascular bundles, compared with RS-RARP, has been proposed to provide more complete resection of the tumour and reduce the rate of positive margins. The patients are included into the posterior approach extrafascial technique group who undergo the posterior approach extrafascial technique of RS-RARP.
**Intervention Names:**
- Procedure: Extrafascial robotic assisted radical prostatectomy via posterior approach
**Label:** the posterior approach extrafascial technique group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Anterior approach extrafascial technique is the most traditional method of radical prostatectomy for prostate cancer, in which the prostate is tied ventrally to expose the prostate by cutting the deep dorsal penile vein complex and the surrounding ligaments and fascia, and intraoperatively extensive resection is required to remove the prostate and its surrounding fascia and neurovascular bundles. The patients are included into the anterior approach extrafascial technique group who undergo the anterior approach extrafascial technique robotic assisted radical prostatectomy.
**Intervention Names:**
- Procedure: Extrafascial robotic assisted radical prostatectomy via anterior approach
**Label:** the anterior approach extrafascial technique group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- the posterior approach extrafascial technique group
**Description:** Extrafascial robotic assisted radical prostatectomy via posterior approach will be applied in the intermediate or high risk patients.
**Name:** Extrafascial robotic assisted radical prostatectomy via posterior approach
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- the anterior approach extrafascial technique group
**Description:** Extrafascial robotic assisted radical prostatectomy via anterior approach will be applied in the intermediate or high risk patients.
**Name:** Extrafascial robotic assisted radical prostatectomy via anterior approach
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** rate of the preservation of urinary control function at 1 week after postoperative removal of the urinary catheter status
**Measure:** rate of continence
**Time Frame:** 1 week after postoperative removal of the urinary catheter
**Description:** according to International Consultation on Incontinence Questionnaire Short Form, change in voiding score from baseline period at each visit viewpoint
**Measure:** voiding score
**Time Frame:** through study completion, an average of 1 year
**Description:** according to International Index of Erectile Function, change in erectile function score from baseline period at each visit viewpoint
**Measure:** erectile function score
**Time Frame:** through study completion, an average of 1 year
#### Secondary Outcomes
**Description:** the rate of positive specimen margins after surgery
**Measure:** the rate of positive specimen margins
**Time Frame:** after surgery, , an average of 1 year
**Description:** according to EORTC QLQ-C30, quality of life scores at each visit
**Measure:** quality of life scores
**Time Frame:** through study completion, an average of 1 year
**Description:** biochemical recurrence or imaging recurrence/progression at each visit
**Measure:** biochemical recurrence or imaging recurrence/progression
**Time Frame:** through study completion, an average of 1 year
**Description:** deaths (overall survival time) at each visit
**Measure:** overall survival time
**Time Frame:** From date of randomization until date of death from any cause, an average of 5 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. intermediate- and high-risk prostate cancer patients assessed by comprehensive clinical evaluation;
2. prostate volume \<80 ml;
3. life expectancy of patients \>10 years;
4. patients sign the "informed consent";
5. Routine preoperative examination has been improved (chest CT, electrocardiogram, and color Doppler echocardiography), and there is no serious basic disease. After clinical evaluation, it can tolerance robot-assisted radical prostatectomy (RARP).
Exclusion Criteria:
1. life expectancy \<10 years;
2. comorbidities with other malignancies;
3. uncorrected coagulation dysfunctions;
4. patients with severe underlying diseases such as severe pulmonary insufficiency who could not tolerate the surgery;
5. patients or family members who did not accept radical prostatectomy.
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** drxun@fjmu.edu.cn
**Name:** Ning Xu, Dr.
**Phone:** 13235907575
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** the First Affiliated Hospital, Fujian Medical University
**Name:** Xue-Yi Xue
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005834
- Term: Genital Neoplasms, Male
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000011469
- Term: Prostatic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434636
**Brief Title:** The Effect of Tranexamic Acid in Endoscopic and Microscopic Ear Surgery Cases on Surgeon Satisfaction
**Official Title:** The Effect of The Use of Low Dose Tranexamic Acid on Surgeon Satisfaction, Side Effects and Complications in Endoscopic and Microscopic Ear Surgery Cases Which Are Used With Controlled Hypotension
#### Organization Study ID Info
**ID:** 2024/88
#### Organization
**Class:** OTHER
**Full Name:** TC Erciyes University
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05
**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:** 2024-05-19
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** TC Erciyes University
#### Responsible Party
**Investigator Affiliation:** TC Erciyes University
**Investigator Full Name:** Talha Ersoy
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** By using tranexamic acid, an antifibrinolytic drug, the aim is to prevent the restriction of the field of view of the surgical field due to bleeding in middle ear microscopic and endoscopic surgery operations in which controlled hypotension is applied, and therefore the prolongation of the surgical time, and to increase surgeon satisfaction.
**Detailed Description:** After obtaining approval from our university and the Turkish Ministry of Health's pharmaceutical and medical device agency and written consent from the patients, 100 patients who underwent middle ear surgery using controlled hypotension under general anesthesia will be included in the study.
The study will be conducted in a randomized controlled, double-blind manner. Patients between the ages of 18-65 and with American Society of Anesthesiologists (ASA) Scores I and II will be included in the study. Patients will be divided into two groups: Intervention (M) and Control (C). Just before the operation begins, 10 mg/kg tranexamic acid (TXA) will be administered to the intervention group in 100 mL of 0.9% physiological saline (SF) solution in 15 minutes. 100 mL of 0.9% SF solution will be sent to the control group in 15 minutes. At the end of the operation, the operator's quality of vision of the surgical field will be recorded by questioning the surgeon's satisfaction with the Boezaart Score and the Surgeon Satisfaction Score.
### Conditions Module
**Conditions:**
- Middle Ear Disease
**Keywords:**
- tranexamic acid
- controlled hypotension
- middle ear surgery
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Patients will be divided into two groups: Intervention (M) and Control (C). Just before the operation begins, 10 mg/kg tranexamic acid (TXA) will be administered to the intervention group in 100 mL of 0.9% physiological saline (SF) solution in 15 minutes. 100 mL of 0.9% SF solution will be sent to the control group in 15 minutes.
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients' vital values will be recorded before surgery.10 mg/kg tranexamic acid (Transamine 10% IV/IM Solution for Injection) is added into 100 cc serum through the appropriate vascular access and injected for 15 minutes.The amount of bleeding in the surgical field will be evaluated by the surgeon using the Boezaart Scale.Intraoperatively, hemodynamic changes such as bradycardia, tachycardia, arrhythmia and agents used such as vasopressors, antiarrhythmics and vagolytics will be recorded in the patient.Post-Operatively the surgeon's quality of vision will be questioned with the Surgeon Satisfaction Scale.Postoperative 0th, 12th, and 24th developments - the presence of vomiting and postoperative complaints will be questioned.The presence of bleeding or complications in the first 2 weeks after surgery will be questioned.The presence of thromboembolic events and other services will be questioned within 12 weeks after surgery.
**Intervention Names:**
- Drug: Transamine 10% IV/IM Solution for Injection
**Label:** Intervention Group (I)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Preoperative vital values of the patients will be recorded.100 cc of physiological saline will be sent through the appropriate vascular access in 15 minutes.
The amount of bleeding in the surgical field will be evaluated by the surgeon using the Boezaart Scale. Intraoperatively, hemodynamic changes such as bradycardia, tachycardia, arrhythmia that develop in the patient, and agents such as vasopressors, antiarrhythmics, and vagolytics used will be recorded.
Postoperatively the surgeon's quality of vision will be questioned with the Surgeon Satisfaction Scale. The presence of nausea and vomiting and postoperative complaints will be questioned at the 0th, 12th, and 24th postoperative hours. The presence of surgical bleeding or complications that occur in the first 2 weeks of surgery will be questioned. The presence of thromboembolic events and other complications will be questioned within 12 weeks postoperatively.
**Intervention Names:**
- Drug: %0.9 Saline
**Label:** Control Group (C)
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention Group (I)
**Description:** 10 mg/kg tranexamic acid (Transamine 10% IV/IM Injectable Solution) will be placed into 100 cc physiological saline through the appropriate vascular access and injected within 15 minutes.
**Name:** Transamine 10% IV/IM Solution for Injection
**Other Names:**
- tranexamic acid
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Control Group (C)
**Description:** 100 cc %0.9 Normal Saline will be injected through the appropriate vascular access within 15 minutes
**Name:** %0.9 Saline
**Other Names:**
- Physiological Saline
- %0.9 NaCl
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** At the end of a surgery, the surgical field was graded in terms of bleeding by the surgeon using the scale used by Boezaart et al in 1995;
0 : No bleeding (cadaveric conditions).
1. : Slight bleeding: no suctioning required.
2. : Slight bleeding: occasional suctioning required.
3. : Slight bleeding: frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.
4. : Moderate bleeding: frequent suctioning required and bleeding threatens surgical field directly after suction is removed.
5. : Severe bleeding: constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible.
**Measure:** Boezaart et al grading scale
**Time Frame:** 2-3 hours
**Description:** At the and of surgery , surgeon's satisfaction with surgical field quality was also graded in a 5-item Likert scale, where 1 = poor and 5 = excellent
**Measure:** Surgeon Satisfaction Score
**Time Frame:** 2-3 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Individuals between the ages of 18-65
* Individuals with ASA I (no additional disease) or ASA II (mild systemic disease)
* Those who do not have a disease such as thrombophilia or bleeding diathesis will be included in the study
Exclusion Criteria:
* Patients with ASA III (those with uncontrolled chronic disease) or above
* Patients with cardiovascular disease, congestive heart failure, coronary artery disease, cerebrovascular insufficiency, renal or hepatic failure
* Patients with thrombophilia, bleeding diathesis, coagulation defects
* Pregnant patients
* Those with a history of any allergic reaction to tranexamic acid and its derivatives will be excluded from the study
**Gender Based:** True
**Gender Description:** All genders will be included this study
**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:** drdrtalhaersoy@gmail.com
**Name:** Talha ERSOY, MD
**Phone:** +905316682730
**Role:** CONTACT
**Contact 2:**
**Email:** nesibeknr@gmail.com
**Name:** Nesibe ERSOY, MD
**Phone:** +905079157672
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** TC Erciyes University
**Name:** Talha ERSOY, MD
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M7601
- Name: Ear Diseases
- Relevance: HIGH
- As Found: Ear Disease
- ID: M10072
- Name: Hypotension
- Relevance: LOW
- As Found: Unknown
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004427
- Term: Ear Diseases
### Intervention Browse Module - Ancestors
- 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
- ID: D000000928
- Term: Antidepressive Agents
- ID: D000011619
- Term: Psychotropic Drugs
- ID: D000008996
- Term: Monoamine Oxidase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000014151
- Term: Anti-Anxiety Agents
- ID: D000014149
- Term: Tranquilizing Agents
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Coag
- Name: Coagulants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: VaCoAg
- Name: Vasoconstrictor Agents
### Intervention Browse Module - Browse Leaves
- ID: M16902
- Name: Tranexamic Acid
- Relevance: HIGH
- As Found: Stage IV
- ID: M16945
- Name: Tranylcypromine
- Relevance: HIGH
- As Found: Subpopulations
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M4213
- Name: Anti-Arrhythmia Agents
- Relevance: LOW
- As Found: Unknown
- ID: M17409
- Name: Vasoconstrictor Agents
- 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
- ID: M4247
- Name: Antidepressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
- ID: M11960
- Name: Monoamine Oxidase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M16905
- Name: Anti-Anxiety Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000014191
- Term: Tranylcypromine
- ID: D000014148
- Term: Tranexamic Acid
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434623
**Brief Title:** Federal Learning Algorithm for an Intelligent Insulin Decision System for Dynamic Glucose Control in Type 2 Diabetic Patients
**Official Title:** A Multicenter Federal Learning Algorithm to Build an Intelligent Insulin Decision System for Dynamic Glucose Control in Type 2 Diabetic Patients
#### Organization Study ID Info
**ID:** 20240324025304420
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Zhongshan 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:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-01
**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:** 2024-05-23
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shanghai Zhongshan Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Constructing an intelligent insulin decision-making system for dynamic glucose control in type 2 diabetes mellitus via a multicentre federated learning algorithm, comparing the performance of the federated learning model, the local model and the initial model, and evaluating their feasibility and safety.
**Detailed Description:** Constructing an intelligent insulin decision-making system for dynamic glucose control in type 2 diabetes mellitus via a multicentre federated learning algorithm, comparing the performance of the federated learning model, the local model and the initial model, and evaluating their feasibility and safety.
### Conditions Module
**Conditions:**
- Diabetes
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 30100
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: patient record
**Label:** patients record
### Interventions
#### Intervention 1
**Arm Group Labels:**
- patients record
**Description:** using patient record to construct AI models
**Name:** patient record
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** the accuracy of AI models
**Time Frame:** up to 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* type 2 diabetes inpatients receiving insulin therapy
Exclusion Criteria:
* use of insulin pumps or glucocorticoids during hospitalisation
* less than two days of insulin therapy
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** type 2 diabetes who
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** li.xiaoying@zs-hospital.sh.cn
**Name:** Xiaoying Li, PhD.
**Phone:** 02164041990
**Role:** CONTACT
**Contact 2:**
**Email:** chen.ying4@zs-hospital.sh.cn
**Name:** Ying Chen
**Phone:** 13482
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Fudan University
**Name:** Xiaoying Li, Professor
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### 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: LOW
- As Found: Unknown
### 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: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434610
**Brief Title:** A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.
**Official Title:** A Multicenter, Randomized, Double-blind, Parallel-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of B013 Combined With Paclitaxel in the Treatment of Platinum-resistant Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer.
#### Organization Study ID Info
**ID:** SPH-B013-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Shanghai Jiaolian Drug Research and Development Co., Ltd
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Shanghai Pharmaceuticals Holding Co., Ltd
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Shanghai Jiaolian Drug Research and Development Co., Ltd
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
### Conditions Module
**Conditions:**
- Platinum-resistant Recurrent Ovarian Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: B013
- Drug: Paclitaxel
**Label:** B013
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Paclitaxel
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- B013
**Description:** B013: The subjects will receive IV dose of B013 600 mg on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
**Name:** B013
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- B013
- Placebo
**Description:** Paclitaxel: 80 mg/m\^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.
**Name:** Paclitaxel
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Placebo
**Description:** Placebo: The subjects will receive IV dose of placebo matched to B013 on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** From the date of randomization to the date of progression disease or death , whichever occurred first.
**Measure:** Progression-free survival (PFS)
**Time Frame:** Approximately 2 years
#### Secondary Outcomes
**Description:** Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
**Measure:** Objective response rate (ORR)
**Time Frame:** Approximately 2 years
**Description:** DCR was defined as the percentage of participants who have achieved complete response, partial response and stable disease.
**Measure:** Disease control rate (DCR)
**Time Frame:** Approximately 2 years
**Description:** DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause.
**Measure:** Duration of remission (DOR)
**Time Frame:** Approximately 5 years
**Description:** Determination of the overall survival times of all participants.
**Measure:** Overall Survival (OS)
**Time Frame:** Approximately 2 years
**Description:** The incidence of adverse event (regardless of its relationship to study drug) will be classified using MedDRA and the severity of each adverse event will be graded using NCI CTCAE v5.0.
**Measure:** Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
**Time Frame:** Approximately 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Subjects who voluntarily participate in this study and sign informed consent form;
2. Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence;
3. ECOG performance status of 0 or 1；
4. Expected survival \> 12 weeks;
5. The subject has at least one measurable lesion;
6. Normal function of major organs;
7. The fertile subjects agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose.
Exclusion Criteria:
1. Subjects who have received prescribed treatment previously;
2. Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
3. Subjects with known central nervous system metastasis and multiple bone metastasis;
4. Subjects who had clinical symptoms of pleural effusion, pericardial effusion or ascites before randomization and needed puncture drainage, or had received puncture drainage within the previous 2 weeks;
5. Have a history of other malignant tumors within 5 years before signing the informed consent;
6. Subjects with prescribed cardiovascular diseases;
7. Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;
8. Had severe lung disease before randomization;
9. Before randomization, the peripheral nerve toxicity of previous anti-tumor treatment was \> grade 2, and other reversible toxicity was \> grade 1;
10. Subjects who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery;
11. Subjects who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs;
12. Subjects who are known to be allergic to any component of B013 or paclitaxel.
13. Subjects with a known history of substance abuse, alcohol or drug use; Subjects with a known history of neurological or psychiatric disorders;
14. Female subjects who are pregnant or breastfeeding;
15. Other situations determined by the researchers and/or sponsors as unsuitable for participation in this trial.
**Gender Based:** True
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** JJYIN555@163.com
**Name:** Xiaohua Wu
**Phone:** 0086-021-64175590
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Name:** Xiaohua Wu
- **Role:** CONTACT
**Country:** China
**Facility:** Fudan University Shanghai Cancer center
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000010049
- Term: Ovarian Diseases
- ID: D000000291
- Term: Adnexal Diseases
- ID: D000005831
- Term: Genital Diseases, Female
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000005833
- Term: Genital Neoplasms, Female
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000091662
- Term: Genital Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000006058
- Term: Gonadal Disorders
- ID: D000002277
- Term: Carcinoma
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: 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: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrent
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12972
- Name: Ovarian Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3643
- Name: Adnexal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8945
- Name: Genital Neoplasms, Female
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9163
- Name: Gonadal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: T4352
- Name: Ovarian Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: T4354
- Name: Ovarian Epithelial Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: T2189
- Name: Fallopian Tube Cancer
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010051
- Term: Ovarian Neoplasms
- ID: D000077216
- Term: Carcinoma, Ovarian Epithelial
- ID: D000012008
- Term: Recurrence
### Intervention Browse Module - Ancestors
- ID: D000000972
- Term: Antineoplastic Agents, Phytogenic
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000050257
- Term: Tubulin Modulators
- ID: D000050256
- Term: Antimitotic Agents
- ID: D000050258
- Term: Mitosis Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M19537
- Name: Paclitaxel
- Relevance: HIGH
- As Found: Surgery
- ID: M231
- Name: Albumin-Bound Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M26197
- Name: Tubulin Modulators
- Relevance: LOW
- As Found: Unknown
- ID: M26196
- Name: Antimitotic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000017239
- Term: Paclitaxel
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434597
**Brief Title:** A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.
**Official Title:** A Multicenter, Open, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH5030 Tablets in Subjects With Her2-positive/Mutated Biliary Tract OR Colorectal Cancer.
#### Organization Study ID Info
**ID:** SPH5030-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Shanghai Pharmaceuticals Holding Co., Ltd
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Shanghai Pharmaceuticals Holding Co., Ltd
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.
### Conditions Module
**Conditions:**
- Biliary Tract or Colorectal Cancer With Her2-positive/Mutated
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: SPH5030
**Label:** SPH5030
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SPH5030
**Description:** SPH5030：Oral, QD, 600mg
**Name:** SPH5030
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
**Measure:** Objective response rate (ORR)
**Time Frame:** Approximately 2 years
#### Secondary Outcomes
**Description:** DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause.
**Measure:** Duration of remission (DOR)
**Time Frame:** Approximately 2 years
**Description:** DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.
**Measure:** Disease control rate (DCR)
**Time Frame:** Approximately 2 years
**Description:** From the start date of study treatment to the date of progression disease or death , whichever occurred first.
**Measure:** Progression-free survival (PFS)
**Time Frame:** Approximately 2 years
**Description:** Determination of the overall survival times of all patients
**Measure:** Overall Survival (OS)
**Time Frame:** Approximately 2 years
**Description:** Adverse event type, incidence, duration
**Measure:** Incidence of Treatment-Emergent Adverse Events
**Time Frame:** Approximately 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Metastatic and/or unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and/or unresectable advanced biliary tract carcinoma
2. HER2 positive or HER2 gene mutation;
3. Meet the requirements of previous treatment;
4. ECOG performance status of 0 or 1；
5. Expected survival ≥ 3 months;
6. No serious abnormalities in hematopoietic function, liver or kidney function;
7. Females who are not pregnant, non-lactating.. Subjects who complied with the contraceptive requirements of the protocol.;
8. Fully informed subjects who voluntarily sign the ICF.
Exclusion Criteria:
1. Subjects who have previously received anti-HER2 molecular targeted therapy;
2. Subjects who have been treated with any other clinical trial drug within 4 weeks prior to the first dose;
3. Subjects with uncontrolled or severe cardiovascular and cerebrovascular diseases; Subjects with severe lung disease; 4. Subjects who may have conditions that affect the absorption, distribution, metabolism, or excretion of the study drug determined by the investigator;
5 Subjects who are taking potent CYP3A4 or CYP2C8 inhibitors or inducers; 6 Subjects with other malignancies in the past 5 years; 7 Subjects with CNS system metastasis with clinical symptoms; 8 Subjects who do not meet the protocol requirements for hepatitis B and C at screening, have a history of immunodeficiency, or other acquired、congenital immunodeficiency diseases, or have a history of organ transplantation; 9. Other situations that do not meet the requirements of the protolol.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** jfjzyygw@163.com
**Name:** Jianming Xu
**Phone:** 0086-010-66937166
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Name:** Jianming Xu
- **Role:** CONTACT
**Country:** China
**Facility:** Chinese PLA General hospital
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434584
**Brief Title:** Explainable Insulin Decision-making System to Assist Physicians in Diabetes Management
**Official Title:** Explainable Insulin Decision-making System to Assist Physicians in Diabetes Management
#### Organization Study ID Info
**ID:** 20240218043800077
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Zhongshan Hospital
### Status Module
#### Completion Date
**Date:** 2023-06-10
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-03-20
**Type:** ACTUAL
#### Start Date
**Date:** 2022-12-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shanghai Zhongshan 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 investigators plan to conduct a multi-case, multi-reader observational study with the primary objective of exploring the effects of an interpretable insulin-assisted decision-making system on physicians' (1) decision accuracy and (2) decision confidence.
### Conditions Module
**Conditions:**
- Diabetes
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 48
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: without AI assistance
- Other: with AI dosage assistance
- Other: with explainable AI assistance
- Other: with faulty explainable AI assistance
**Label:** senior doctor group
#### Arm Group 2
**Intervention Names:**
- Other: without AI assistance
- Other: with AI dosage assistance
- Other: with explainable AI assistance
- Other: with faulty explainable AI assistance
**Label:** junior doctor group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- junior doctor group
- senior doctor group
**Description:** provide insulin dosage and confidence score without AI assistance
**Name:** without AI assistance
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- junior doctor group
- senior doctor group
**Description:** provide insulin dosage and confidence score with AI dosage assistance
**Name:** with AI dosage assistance
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- junior doctor group
- senior doctor group
**Description:** provide insulin dosage and confidence score with explainable AI assistance
**Name:** with explainable AI assistance
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- junior doctor group
- senior doctor group
**Description:** provide insulin dosage and confidence score with faulty explainable AI assistance
**Name:** with faulty explainable AI assistance
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The investigators used MAE and clinical agreement to quantitatively assess the accuracy of clinician-recommended insulin doses.
1. Mean Absolute Error (MAE) represents the error between the clinician-recommended value and the expert-recommended value (gold standard).
2. Clinical agreement: Clinical agreement is calculated as the proportion of clinically consistent insulin doses (clinician-given adjustments in the same direction as the expert's protocol and within 20% of the dose difference) to the total insulin dose.
**Measure:** Doctors' decision-making accuracy
**Time Frame:** up to 2 months
**Description:** Clinicians' confidence in decision-making was assessed using a 10-point Likert scale from 1 (not at all confident) to 10 (completely confident).
**Measure:** Doctors' decision-making confidence
**Time Frame:** up to 2 months
### Eligibility Module
**Eligibility Criteria:** Case:
Inclusion Criteria:
* Patients with T2DM who were admitted to Zhongshan Hospital of Fudan University from 2022.12 to 2023.3.
* Insulin regimen is one of the following: a. Basal regimen: once a day subcutaneous injection of long-acting or ultra-long-acting insulin; b. Premixed regimen: two/three times a day subcutaneous injection of premixed insulin; c. Basal mealtime regimen: three times a day before meals subcutaneous injection of short-acting or rapid-acting insulin, plus once a day injection of long-acting or ultra-long-acting insulin.
Exclusion Criteria:
- Cases will be excluded if there is insufficient information for a valid assessment (missing data on insulin or blood glucose \>40%).
Doctor
Inclusion Criteria:
licensed medical practitioner.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** include 40 patient cases and 8 doctors (4 senior and 4 junior)
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Shanghai
**Country:** China
**Facility:** Xiaoying Li
**State:** Shanghai
**Zip:** 200032
#### Overall Officials
**Official 1:**
**Affiliation:** Fudan University
**Name:** Xiaoying Li, Professor
**Role:** STUDY_CHAIR
## 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
- 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: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434571
**Acronym:** CLEAR
**Brief Title:** Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
**Official Title:** Comparing Telehealth-Delivered Cognitive Behavioral Therapy for Insomnia to Web-Based to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
#### Organization Study ID Info
**ID:** STUDY00160591
#### Organization
**Class:** OTHER
**Full Name:** University of Kansas Medical Center
### Status Module
#### Completion Date
**Date:** 2028-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Kansas Medical Center
#### Responsible Party
**Investigator Affiliation:** University of Kansas Medical Center
**Investigator Full Name:** Catherine Siengsukon, PT, PhD
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.
### Conditions Module
**Conditions:**
- Multiple Sclerosis
- Insomnia
**Keywords:**
- Cognitive behavioral therapy for insomnia
- CBT-I
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 1x/week, 6-week 45-60 min one-one-one manualized program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes time in bed restriction, stimulus control, relaxation strategies, cognitive restructuring, and sleep health promotion education.
**Intervention Names:**
- Behavioral: Telehealth cognitive behavioral therapy for insomnia (tCBT-I)
**Label:** Telehealth cognitive behavioral therapy for insomnia (tCBT-I)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The Go!ToSleep online program is a 6-week interactive, web-based program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, relaxation techniques and cognitive restructuring with daily lessons (41 lessons in total)
**Intervention Names:**
- Behavioral: Web-based cognitive behavioral therapy for insomnia (wCBT-I)
**Label:** Web-based cognitive behavioral therapy for insomnia (wCBT-I)
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** The treatment as usual comparison group will be encouraged to continue with their usual care recommended by their physician and their usual activities and sleep habits during the period between baseline and 6-month reassessment.
**Intervention Names:**
- Behavioral: Treatment as usual (TAU)
**Label:** Treatment as usual (TAU)
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Telehealth cognitive behavioral therapy for insomnia (tCBT-I)
**Description:** The general sessions outlines are as follows with each session:
Session 1: determine treatment plan, set up sleep schedule and stimulus control, discuss strategies for how to stay awake to prescribed hour and what to do if wake up in middle of night, sleep hygiene education Session 2: continue upward titration of total sleep time, review sleep hygiene; introduce diaphragmatic breathing Session 3: continue upward titration of total sleep time, introduce mindfulness Session 4: continue upward titration of total sleep time, introduce progressive muscle relaxation Session 5: continue upward titration of total sleep time, discuss negative sleep beliefs Session 6: assess global treatment gains, discuss relapse prevention
**Name:** Telehealth cognitive behavioral therapy for insomnia (tCBT-I)
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Web-based cognitive behavioral therapy for insomnia (wCBT-I)
**Description:** Participants receive a daily e-mail reminder to access the program and to complete a sleep log for the prior night's sleep. After completing the sleep log, the daily lesson is made available. Each participant will be provided with a unique password to access the online program.
**Name:** Web-based cognitive behavioral therapy for insomnia (wCBT-I)
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- Treatment as usual (TAU)
**Description:** They will be encouraged to avoid starting any new treatment for their sleep unless recommended by their physician. They will be offered access to the web-based CBT-I program following the 6-month reassessment to complete if they wish.
**Name:** Treatment as usual (TAU)
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Disability will be assessed using the PDDS scale which is a single-item 9 point scale ranging from "normal" (score of 0) to "bedridden" (score of 8).
**Measure:** Patient-Determined Disability Steps (PDDS)
**Time Frame:** baseline
**Description:** Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9), with a score of ≥20 suggesting severe depression. It consists of 9 items with a score ranging from 0-27.
**Measure:** Patient Health Questionnaire (PHQ-9)
**Time Frame:** baseline, Week 6, Month 6
**Description:** Anxiety symptoms will be assessed using the 7-item GAD-7, with a score of ≥15 indicating severe anxiety. This questionnaire consists of 7 items, and the score from each item is summed for an overall score ranging from 0-21 with a higher score indicating a higher level of anxiety
**Measure:** Generalized Anxiety Disorder Assessment (GAD-7)
**Time Frame:** baseline, Week 6, Month 6
**Description:** To assess adherence to the CBT-I intervention, the sleep log will be used to assess number of mornings/week got out of bed at agreed upon time and the number of times got out of bed if unable to sleep. A total percentage will be calculated and used as the outcome of interest.
**Measure:** Adherence to CBT-I intervention
**Time Frame:** Each CBT-I session Week 1-6
**Description:** Participants will be asked "In general, how healthy is your overall diet?" and will rate on a 5-point Likert scale (5 = "excellent", 4 = "very good", 3 = "good", 2 = "fair", 1 = "poor")
**Measure:** Diet quality
**Time Frame:** baseline
**Description:** Participants will mark on the sleep log at each assessment period the time period for eating breakfast, lunch, and dinner. Variability in mealtime will be quantified as the standard deviation from the individual's mean meal start time.
**Measure:** Eating regularity
**Time Frame:** baseline, Week 6, Month 6
**Description:** Participants will mark on the sleep log the number of times they wake up to void their bladder during the sleep opportunity window.
**Measure:** Nighttime urination frequency
**Time Frame:** baseline, Week 6, Month 6
**Description:** PainDetect includes 13 items that assesses neuropathic pain. A total score ranges from -1 to 38, with higher scores indicating higher levels of neuropathic pain.
**Measure:** PainDetect
**Time Frame:** baseline, Week 6, Month 6
**Description:** Fibromyalgia Survey Questionnaire includes the assessment of the number of painful body regions. Scores ranges from 0-31. A higher score indicates worse symptoms.
**Measure:** Fibromyalgia Survey Questionnaire
**Time Frame:** baseline, Week 6, Month 6
**Description:** Measures max and average pain intensity during past 7 days. The T-score value, with a mean of 50 and standard deviation of 10 representing the rescaled raw score, will be reported.
**Measure:** PROMIS SF v.1.0 - Pain Intensity
**Time Frame:** baseline, Week 6, Month 6
#### Primary Outcomes
**Description:** The ISI consists of 7 questions, each rated on a 0-4 scale. The range of scores on the ISI is 0-28, with a score of ≥ 10 suggesting clinical insomnia. The lower the score the less severe insomnia.
**Measure:** Insomnia Severity Index (ISI)
**Time Frame:** baseline, Week 6, Week 12
#### Secondary Outcomes
**Description:** The PSQI consists of 9 items within 7 sleep categories. The 7 sleep category scores are summed to form a single global score ranging from 0-21. A global score of \>5 reflects poor sleep quality.
**Measure:** Pittsburgh Sleep Quality Index (PSQI)
**Time Frame:** baseline, Week 6, Month 6
**Description:** Consists of eight scenarios of daily activity, and participants use a four-point Likert scale to rate how likely they are to doze. Score ranges 0-24 with a higher score indicating daytime sleepiness.
**Measure:** Epworth Sleepiness Scale (ESS)
**Time Frame:** baseline, Week 6, Month 6
**Description:** This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs.
**Measure:** Dysfunctional Beliefs About Sleep
**Time Frame:** baseline, Week 6, Month 6
**Description:** The PANAS is a 20-item self-report questionnaire used to measure positive and negative emotions. There are two subscales (Positive Affect and Negative Affect) with 10 items each. The respondent scores how applicable a list of emotions are on a 5-point Likert scale with 1 = "Very slightly or not at all" to 5 = "Extremely". A higher score on the Positive Affect subscale indicates greater intensity of positive emotions, and a high score on Negative Affect indicate greater intensity of negative emotions.
**Measure:** Positive Affect and Negative Affect Schedule (PANAS)
**Time Frame:** baseline, Week 6, Month 6
**Description:** The SESS is a 9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy. Scores range from 0-45 and a higher score indicates higher sleep self-efficacy.
**Measure:** Sleep Self-Efficacy Scale (SESS)
**Time Frame:** baseline, Week 6, Month 6
**Description:** Participants will wear an actigraph on their non-dominant wrist for 7 nights to assess sleep/wake cycle. Mains variables of interest are sleep regularity, timing, efficiency, and duration
**Measure:** Actigraphy
**Time Frame:** baseline, Week 6, Month 6
**Description:** The MFIS assesses the impact of fatigue on daily activities for the month prior. The MFIS consists of 21 items with 3 subscales: physical, cognitive, and psychosocial. The score on the 21 items are scored with a range of 0-84 with a higher score indicating a greater impact of fatigue.
**Measure:** Modified Fatigue Impact Scale (MFIS)
**Time Frame:** baseline, Week 6, Month 6
**Description:** The FSS assesses the impact of fatigue on activities for the week prior and consists of 9 questions. The mean of the 9 scores is calculated with a range of 0-7.
**Measure:** Fatigue Severity Scale (FSS)
**Time Frame:** 'baseline, Week 6, Month 6
**Description:** Quality of life will be assessed using the Multiple Sclerosis Impact Scale (MSIS-29). MSIS-29 is total of 29 items scale, with subscales of physical (20 items) and psychological (9 items). Responses computed in a range from 0-100, and higher scores indicating a worse quality of life due to physical and physiological impacts of MS
**Measure:** Multiple Sclerosis Impact Scale (MSIS-29)
**Time Frame:** baseline, Week 6, Month 6
**Description:** The CFQ assesses perception of cognitive abilities over the past 6 months. consists of 25 items that the individual rates on a 5-point Likert scale with 0 = "never" and 4 = "Very Often" with a summary score of 0-100 with a higher score indicating poorer perceived cognitive abilities.
**Measure:** Cognitive Failures Questionnaire (CFQ)
**Time Frame:** baseline, Week 6, Month 6
**Description:** blood marker of axonal damage
**Measure:** plasma neurofilament light (NfL)
**Time Frame:** baseline, Week 6, Month 6
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18-65 years old
* Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines21 and verified by their neurologist
* Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale)
* Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5
* ≥10 on Insomnia Severity Index
* English speaking
* ≥31 on Telephone Interview of Cognitive Status
* Has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study
* Report having access to internet service or a data plan and access to a computer, tablet, or smart phone
Exclusion Criteria:
* Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
* \>3 on STOP BANG indicating increased risk of sleep apnea
* Restless legs syndrome as determined by RLS-Diagnosis Index
* Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised
* Parasomnia as determined by the Sleep Disorders-Revised
* If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking \< 3 months or dose has changed in past 3 months
* Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
* Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety
* Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by DSM-5 criteria
* History of other nervous system disorder such as stroke or Parkinson's disease
* Currently pregnant or intending to become pregnant in the next 6 months
* Severe mental illness such as schizophrenia or bipolar disorder
* Severe neurological or sensory impairments that would interfere significantly with testing
* Relapse and/or corticosteroid use in the past 8 weeks
* History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am
* Currently receiving a behavioral sleep health intervention
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** enelson5@kumc.edu
**Name:** Eryen Nelson, MPH
**Phone:** 913-945-7349
**Role:** CONTACT
**Contact 2:**
**Email:** csiengsukon@kumc.edu
**Name:** Catherine Siengsukon, PhD
**Phone:** 913-588-6913
**Role:** CONTACT
## 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
- ID: D000020919
- Term: Sleep Disorders, Intrinsic
- ID: D000020920
- Term: Dyssomnias
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
- ID: M15415
- Name: Sclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M12060
- Name: Multiple Sclerosis
- Relevance: HIGH
- As Found: Multiple Sclerosis
- ID: M10356
- Name: Sleep Initiation and Maintenance Disorders
- Relevance: HIGH
- As Found: Insomnia
- 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: 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: D000009103
- Term: Multiple Sclerosis
- ID: D000007319
- Term: Sleep Initiation and Maintenance Disorders
### Intervention Browse Module - Browse Branches
- Abbrev: CNSSti
- Name: Central Nervous System Stimulants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M5373
- Name: Caffeine
- Relevance: LOW
- As Found: Unknown
- ID: T370
- Name: Caffeine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-05-31
|
## Protocol Section
### Identification Module
**NCT ID:** NCT06434558
**Acronym:** ICE-OSA
**Brief Title:** Imaging Predictors of Cryolysis Efficacy for Treatment of Obstructive Sleep Apnea
**Official Title:** Imaging Predictors of Cryolysis Efficacy for Treatment of Obstructive Sleep Apnea
#### Organization Study ID Info
**ID:** 855200
#### Organization
**Class:** OTHER
**Full Name:** University of Pennsylvania
### Status Module
#### Completion Date
**Date:** 2030-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Pennsylvania
#### Responsible Party
**Investigator Affiliation:** University of Pennsylvania
**Investigator Full Name:** Raj Dedhia, MD
**Investigator Title:** Associate Professor of Otorhinolaryngology & Medicine | Director, Division of Sleep Surgery & CPAP Alternatives Clinic
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this observational study is to further evaluate the efficacy and mechanism of action of the Cryosa Procedure, a novel procedure intended to treat obstructive sleep apnea (OSA). The patient population includes participants with OSA who are enrolled in the ARCTIC-3 study and are undergoing the Cryosa Procedure. The main questions we aim to answer are:
(1) evaluate predictors of successful treatment with the Cryosa Procedure, which is described in more detail in the ARCTIC-3 protocol (IRB #854182), and (2) evaluate a potential mechanism of action of this novel therapy.
We hypothesize that higher baseline quantities of oropharyngeal fat and higher baseline upper airway neurotonic activity will be correlated with a successful reduction in OSA symptom severity as measured by a change in apnea-hypopnea index values. We also hypothesize that responders will have a decrease in oropharyngeal fat, which would indicate the mechanism of action of this novel therapy is a loss in oropharyngeal fat.
Participants will be asked to:
1. have an MRI before undergoing the Cryosa Procedure
2. have an ultrasound before the Cryosa Procedure
3. permit the use of pressure-sensing catheters and ultrasound during their drug-induced sleep endoscopy, which is part of the ARCTIC-3 protocol
4. have an MRI after the Cryosa Procedure
5. have an ultrasound after the Cryosa Procedure.
**Detailed Description:** Previous research has shown there is increased fat at the base of the tongue and other locations of the oropharynx in patients with Obstructive Sleep Apnea (OSA) compared to match control non-OSA patients. Subsequently, Cryosa developed the Cryosa Procedure, which is further detailed in the ARCTIC-3 protocol (IRB #854182). This procedure involves the Cryosa System, a device intended to induce adipose cryolysis, a non-surgical removal of by inducing cell death (apoptosis) with a controlled freezing of the soft tissue, in the upper airway.
Whereas the objective of the ARCTIC-3 study is to determine the efficacy and safety of the Cryosa Procedure, the co-primary aims of the ICE-OSA study are to (1) evaluate predictors of successful treatment with the Cryosa Procedure and (2) evaluate a potential mechanism of action of this novel therapy. We hypothesize that (1) higher baseline quantity of oropharyngeal fat and higher baseline upper airway neurotonic activity are correlated with a successful reduction in OSA severity, and (2) responders will have a decrease in quantity of oropharyngeal fat (as measured by post-operation magnetic resonance imaging, MRI). Investigating the mechanisms and predictors of this novel therapy is necessary to inform future clinical trials and patient selection for the Cryosa Procedure. To assess these metrics, the ICE-OSA study utilizes MRI, point-of-care ultrasound (POCUS), and the addition of pharyngeal manometry and ultrasound (US) during drug-induced sleep endoscopy (DISE) for ARCTIC-3 participants.
Study Statistics:
These prognostic data are going to be collected as part of a small pilot study to inform the upcoming pivotal trial. For this reason, we seek independent variables with large effect sizes to update and enhance patient selection criteria for the future trial.
We propose use of Student's t-test for responders/non-responders (responder defined as reduction of AHI by \>50%) for the surgical intervention. Our expected ratio of responders to non-responders is 1:1 based on data provided by the study sponsor (unpublished).
Our previous data examining tongue fat in MRI demonstrated values of quantity of fat tissue in fatty tongues to be roughly 14,000 mm3 and fat tissue in non-fatty tongues to be roughly 7,000 mm3. Using these parameters, we calculated that 10 subjects total would be required (assuming a standard deviation of 4,000 mm3) to detect significant differences between responders/non-responders with an alpha of 0.05 and a power of 80%.
### Conditions Module
**Conditions:**
- Obstructive Sleep Apnea of Adult
**Keywords:**
- Obstructive Sleep Apnea
- ultrasound
- MRI
- cryotherapy
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** The Cryosa Procedure is part of the ARCTIC-3 protocol (IRB #854182). Therefore, all patients enrolled in this study are expected to undergo the Cryosa Procedure. Undergoing the Cryosa Procedure is not a part of this protocol.
**Name:** Cryosa Procedure
**Other Names:**
- Cryotherapy
- OSA Cryotreatment
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Quantity of oropharyngeal fat will be measured with magnetic resonance imaging (MRI) before the Cryosa Procedure and 6 months after the Cryosa Procedure in all subject participants.
**Measure:** Change from Baseline in Oropharyngeal Fat at 6 Months
**Time Frame:** Baseline and 6 months
**Description:** All participants in this study, who are also enrolled in the ARCTIC-3 study, are undergoing a polysomnogram as part of the ARCTIC-3 study at baseline and at 6 months. AHI is measured during these sleep studies in every patient at both timepoints.
**Measure:** Change in Baseline Apnea Hypopnea Index at 6 Months
**Time Frame:** Baseline and 6 Months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Enrolled in the ARCTIC-3 clinical trial at the University of Pennsylvania\*
* Provision of signed and dated informed consent form for ICE-OSA
Exclusion Criteria:
* MRI contraindications (claustrophobia, ferromagnetic implants/foreign bodies, etc.)
* Patient is pregnant or becomes pregnant during their enrollment
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** This study enrolls only participants that are previously enrolled in the ARCTIC-3 trial and are subsequently undergoing the Cryosa Procedure as part of the ARCTIC-3 protocol. As required by the eligibility criteria in the ARCTIC-3 study, these patients have a BMI less than or equal to 40 kg/m2, are 22 to 70 years old, and have moderate to severe obstructive sleep apnea (OSA).
Additionally, eligibility requirements from the ARCTIC-3 trial include having never previously undergone uvulopalatopharyngoplasty or tongue base reduction for the treatment of OSA. Patients are also excluded for any other reasons the principal investigator would deem a contraindication to undergoing procedures outlined by the ARCTIC-3 protocol.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** erica.kent1@pennmedicine.upenn.edu
**Name:** Erica R Kent, BS
**Phone:** 215-615-8777
**Role:** CONTACT
**Contact 2:**
**Email:** everett.seay@pennmedicine.upenn.edu
**Name:** Everett Seay, BS,, RPSGT
**Phone:** 215-615-8777
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Philadelphia
**Country:** United States
**Facility:** University of Pennsylvania
**State:** Pennsylvania
**Zip:** 19104
#### Overall Officials
**Official 1:**
**Affiliation:** University of Pennsylvania
**Name:** Raj Dedhia, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-05-15
- Filename: ICF_000.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 454764
- Type Abbrev: ICF
- Upload Date: 2024-05-23T16:06
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
- ID: D000020919
- Term: Sleep Disorders, Intrinsic
- ID: D000020920
- Term: Dyssomnias
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M4361
- Name: Apnea
- Relevance: HIGH
- As Found: Apnea
- ID: M15694
- Name: Sleep Apnea Syndromes
- Relevance: HIGH
- As Found: Sleep Apnea
- ID: M22010
- Name: Sleep Apnea, Obstructive
- Relevance: HIGH
- As Found: Obstructive Sleep Apnea
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
- ID: M22242
- Name: Parasomnias
- Relevance: LOW
- As Found: Unknown
- ID: M22654
- Name: Sleep Disorders, Intrinsic
- Relevance: LOW
- As Found: Unknown
- ID: M22655
- Name: Dyssomnias
- Relevance: LOW
- As Found: Unknown
- ID: M15696
- Name: Sleep Wake Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001049
- Term: Apnea
- ID: D000012891
- Term: Sleep Apnea Syndromes
- ID: D000020181
- Term: Sleep Apnea, Obstructive
### Misc Info Module
- Version Holder: 2024-05-31
|