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## Protocol Section
### Identification Module
**NCT ID:** NCT06447168
**Acronym:** ELFINITY
**Brief Title:** A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
**Official Title:** Prospective Non-interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 mg/Day in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting.
#### Organization Study ID Info
**ID:** CLIN-60190-461
#### Organization
**Class:** INDUSTRY
**Full Name:** Ipsen
### Status Module
#### Completion Date
**Date:** 2029-07-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-07-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Ipsen
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting.
PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged.
The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms. Many participants with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.
In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 24 months.
### Conditions Module
**Conditions:**
- Primary Biliary Cholangitis
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 424
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Defined as alkaline phosphatase (ALP) \<1.67 x upper limit of normal (ULN) and total bilirubin (TB) ≤ULN and ALP decrease ≥15% from baseline.
**Measure:** Percentage of participants with response to treatment
**Time Frame:** At month 6
#### Secondary Outcomes
**Measure:** Percentage of participants with normalization of ALP levels
**Time Frame:** At months 3, 6, 12, 18 and 24
**Description:** Defined as ALP\<1.67 x ULN and TB≤ULN and ALP decrease ≥15% from baseline.
**Measure:** Percentage of participants with response to treatment
**Time Frame:** At months 3, 12, 18 and 24
**Measure:** Change from baseline in liver function parameters: Serum levels of alanine aminotransferase (ALT)
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Measure:** Change from baseline in liver function parameters: Serum levels of Aspartate aminotransferase (AST)
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Measure:** Change from baseline in liver function parameters: Serum levels of Gamma-glutamyl transferase (GGT)
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Measure:** Change from baseline in liver function parameters: Serum levels of TB
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Measure:** Change from baseline in liver function parameters: Conjugated (direct) bilirubin
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Measure:** Change from baseline in liver function parameters: Serum levels of creatinine
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Measure:** Change from baseline in liver function parameters: Serum levels of albumin
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Description:** The PBC Itch score is a simple, self-administered Patient Reported Outcome (PRO) questionnaire that measures itch intensity. It uses 7-day recall periods and asks participants to rate the intensity of their worst itch over the past 7-day period on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).
**Measure:** Change from baseline in pruritus based on PBC Itch score
**Time Frame:** Monthly during 24 months.
**Description:** The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function. It is a subset of the longer (47-item) Functional Assessment of Cancer Therapy - Anemia (FACT-An), which includes the 27-item FACT-G and a 20-item subscale addressing additional concerns associated with the anemia of cancer and its treatment. This 20-item subscale, referred to as the anemia subscale, is comprised of 13-items that assess fatigue and its impact (the FACIT-Fatigue) and, 7 additional symptoms associated with anemia (e.g. shortness of breath, headache). participants rate their symptoms over the preceding seven days on a verbal response scale, the options range from 'not at all' / 'a little bit' / 'somewhat quite a bit' / very much'.
**Measure:** Change from baseline in fatigue based on functional assessment of chronic illness therapy-fatigue (FACIT-Fatigue) scale
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Description:** The PSQI was designed to evaluate overall sleep quality in the psychiatric disorders associated with sleep disturbances. Each of the questionnaire's 19-self-reported items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Five additional questions rated by the respondent's roommate or bed partner are included for clinical purposes and are not scored.
**Measure:** Change from baseline in sleep based on Pittsburgh sleep quality index (PSQI)
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Description:** The PBC-40 is a validated, PBC-specific, health-related Quality Of Life (QoL) questionnaire with 40 questions that assesses symptoms across six domains: fatigue, emotional and social, cognitive function, general symptoms and itch. Participants respond on a verbal response scale, depending on the section options range from 'never' / 'not at all' / 'strongly disagree' to 'always' / 'very much'/ 'strongly agree'. Five items (3/3 in the itch domain and 2/10 in the social domain) also include a 'does not apply' option. A score for each domain is provided (but a total score is not calculated), with each verbal response scale correlating to a score of 1-5 per item (0-5 on items with a 'does not apply' option) with 5 being the most affected.
**Measure:** Change from baseline in Quality Of Life (QoL) based on PBC-40 questionnaire
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Description:** The 5-D Itch scale assesses symptoms in terms of five domains: degree, duration, direction, disability and distribution. It is a 1 to 5 scale, with 5 being the most affected.
**Measure:** Change from baseline in QoL based on 5-Dimensional Itch scale (5-D Itch, also known as 5-D pruritus scale)
**Time Frame:** At months 3, 6, 12, 18 and 24
**Description:** Measured by transient elastography (FibroScan®) and enhanced liver fibrosis (ELF) test
**Measure:** Change from baseline in liver stiffness
**Time Frame:** At months 12 and 24.
**Description:** An Adverse event (AE) is any untoward medical occurrence, temporally associated with the use of study intervention, whether or not related to the study intervention. AESIs are AEs that may not be serious but are of special importance to a particular drug or class of drugs.
**Measure:** Percentage of participants experiencing Adverse Events (AEs), Adverse Events of Special Interests (AESIs) and special situations (SS).
**Time Frame:** From baseline to up to 24 months.
**Description:** Measured by treatment satisfaction questionnaire for medication (TSQM). The TSQM (version 1.4) has 14 questions divided into 4 subscales: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14).
**Measure:** Participant's satisfaction on treatment
**Time Frame:** At months 3, 6, 12, 18 and 24.
**Description:** Adherence to the treatment will be measured based on the participant report of missed doses every month.
**Measure:** Participant's adherence to treatment
**Time Frame:** Every month during 24 months.
**Description:** Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be graded by the investigator.
**Measure:** Percentage of participants with clinically significant changes in laboratory parameters
**Time Frame:** From baseline to up to 24 months.
**Description:** Clinically significant changes in physical examination will be reported. The clinical significance will be graded by the investigator.
**Measure:** Percentage of participants with clinically significant changes in physical examination
**Time Frame:** From baseline to up to 24 months.
**Description:** Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
**Measure:** Percentage of participants developing clinically significant changes in vital signs
**Time Frame:** From baseline to up to 24 months.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participant has provided written informed consent and agrees to comply with the study protocol.
* Participant with PBC diagnosis.
* Participant naïve to elafibranor, for whom the treating physician has decided to start treatment with elafibranor.
* If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected.
Exclusion Criteria:
* Participant who started elafibranor treatment before baseline visit.
* Participant is currently participating in, plans to participate in or has participated in an investigational drug study or medical device study containing active substance within 30 days or five half-lives of the drug/active substance, whichever is longer, prior to baseline visit.
* Participant with known hypersensitivity to the product or to any of its excipients.
* Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Participants with PBC for whom the treating physician has decided to start treatment with elafibranor 80 mg/day, as recommended in the approved indication.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ipsen Clinical Study Enquiries
**Phone:** See e mail
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Ipsen
**Name:** Ipsen Medical Director
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
**Description:** Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
**IPD Sharing:** YES
**Time Frame:** Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
**URL:** https://vivli.org/members/ourmembers/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001649
- Term: Bile Duct Diseases
- ID: D000001660
- Term: Biliary Tract Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000002780
- Term: Cholestasis, Intrahepatic
- ID: D000002779
- Term: Cholestasis
- ID: D000008107
- Term: Liver Diseases
- ID: D000008103
- Term: Liver Cirrhosis
- ID: D000005355
- Term: Fibrosis
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M6002
- Name: Cholangitis
- Relevance: HIGH
- As Found: Cholangitis
- ID: M11105
- Name: Liver Cirrhosis, Biliary
- Relevance: HIGH
- As Found: Primary Biliary Cholangitis
- ID: M11103
- Name: Liver Cirrhosis
- Relevance: LOW
- As Found: Unknown
- ID: M4935
- Name: Bile Duct Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4946
- Name: Biliary Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6019
- Name: Cholestasis
- Relevance: LOW
- As Found: Unknown
- ID: M6020
- Name: Cholestasis, Intrahepatic
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8485
- Name: Fibrosis
- Relevance: LOW
- As Found: Unknown
- ID: T4683
- Name: Primary Biliary Cholangitis
- Relevance: HIGH
- As Found: Primary Biliary Cholangitis
### Condition Browse Module - Meshes
- ID: D000002761
- Term: Cholangitis
- ID: D000008105
- Term: Liver Cirrhosis, Biliary
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447155
**Brief Title:** Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy
**Official Title:** The Impact of Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
#### Organization Study ID Info
**ID:** IstanbulTRH-DArman-003
#### Organization
**Class:** OTHER_GOV
**Full Name:** Istanbul Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2026-06-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Istanbul Training and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Istanbul Training and Research Hospital
**Investigator Full Name:** DİDEM ARMAN
**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:** Therapeutic hypothermia (TH) is accepted worldwide as a standard of care for infants born at or beyond 36 weeks gestational age with moderate-to-severe hypoxic ischaemic encephalopathy (HIE).
While central nervous system is the most affected organ system , multiorgan dysfunction including renal, pulmonary, cardiac, and/or gastrointestinal (GI) compromise is not infrequent. Although the process of 'cooling' itself is well defined, based on high-quality randomized controlled trials, there are few data to inform the provision of nutrition to infants with HIE during and soon after TH.However, breastfeeding plays a beneficial role in maintaining the structural and functional integrity of the gut. It may help to reduce systemic inflammatory response and positively regulates the microbiota. In many studies it is stated that enteral feeding during TH appears to be safe and feasible. There is insufficient evidence to choose the type of enteral feeding either bolus or continuous during TH.
The present study aimed to compare the impact of different types of enteral feeding in infants with HIE receiving TH.
**Detailed Description:** Objectives: The investigators aimed to evaluate the clinical consequences of different types of enteral nutrition during TH in babies with HIE.
Methods: This single-center, prospective randomized controlled trial (RCT) was conducted between June 2024 to June 2026 in Istanbul Research and Training Hospital. A cohort of 60 infants with HIE, born at 35 0/7 to 42 6/7 weeks of gestation who received TH were enrolled.
The infants enterally fed with bolus feeding during hypothermia (n =20), those who were fed continuously (n=20) constituted the study groups. The control group (n =20) was composed of neonates who were not fed. Infants were monitored for clinical consequences such as feeding intolerance, time to full enteral feeding, duration of hospitalization, necrotizing enterocolitis and mortality.
### Conditions Module
**Conditions:**
- Hypoxic Ischemic Encephalopathy of Newborn
- Feeding Patterns
**Keywords:**
- Newborn
- Hypoxic ischemic encephalopathy
- Enteral feeding
- Bolus
- Continuous
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The babies were randomized into three groups; Group 1.The neonates who received bolus feeding,Group 2. The neonates who received continuous feeding Group 3. The control group who were not fed during TH. The control group was composed of historical newborns. Three groups were compared in terms of demographic characteristics and clinical outcomes.
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Care provider decides the type of feeding according to the randomization list which were prepared via a website (http://www.randomizer.org)
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The babies were randomized into three groups; Group 1.The neonates who received bolus feeding,Group 2. The neonates who received continuous feeding Group 3. The control group who were not fed during TH. The control group was composed of historical newborns. Three groups were compared in terms of demographic characteristics and clinical outcomes.
**Intervention Names:**
- Dietary Supplement: Bolus feeding
**Label:** The babies fed with bolus feeding during TH
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** The babies were randomized into three groups; Group 1.The neonates who received bolus feeding,Group 2. The neonates who received continuous feeding Group 3. The control group who were not fed during TH. The control group was composed of historical newborns.Three groups were compared in terms of demographic characteristics and clinical outcomes.
**Intervention Names:**
- Dietary Supplement: Continuous feeding
**Label:** The babies fed with continuous feeding during TH
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** The babies were randomized into three groups; Group 1.The neonates who received bolus feeding,Group 2. The neonates who received continuous feeding Group 3. The control group who were not fed during TH. The control group was composed of historical newborns.Three groups were compared in terms of demographic characteristics and clinical outcomes.
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** The babies who were not fed
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- The babies fed with bolus feeding during TH
**Description:** The babies fed with bolus feeding during TH composed this group
**Name:** Bolus feeding
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- The babies fed with continuous feeding during TH
**Description:** The babies fed with continuous feeding during TH composed this group
**Name:** Continuous feeding
**Type:** DIETARY_SUPPLEMENT
#### Intervention 3
**Arm Group Labels:**
- The babies who were not fed
**Description:** The babies who were not fed during TH composed this group
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** The infants will be monitorized for NEC development
**Measure:** Development of Necrotizing enterocolitis (NEC)
**Time Frame:** From admission to NICU till postnatal 15th day or hospital discharge whichever came first
#### Secondary Outcomes
**Description:** The infants will be monitorized for feeding intolerance
**Measure:** Feeding intolerance
**Time Frame:** From admission to NICU till postnatal 15th day or hospital discharge whichever came first
**Description:** The infants will be monitorized for feeding intolerance
**Measure:** Time to full enteral feeding
**Time Frame:** From admission to NICU till postnatal 15th day or hospital discharge whichever came first
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The neonates with evidence of encephalopathy de¬fined by seizures or abnormalities on a modified Sarnat exam were enrolled. The hypoxic-ischemic injury was defined by 1. a pH of ≤ 7.0 and/or 2. base deficit \&gt;-16 mmol/L recorded in cord blood or blood gas obtained within the first hour postnatally or a pH of 7.0 - 7.15 and/or base deficit (-10-15.9) mmol/L with the presence of an acute perinatal event (cord prolapse, placental abruption, heart rate decelerations, severe fetal bradycardia). In cases where criteria 1 or 2 are met, with the presence of seizures or a diagnosis of moderate to severe encephalopathy according to the Sarnat \&amp; Sarnat classification based on neurological examination were treated with TH.
Exclusion Criteria: Infants with congenital malformation or hereditary metabolic diseases, infants whose enteral feeding was initiated before randomization and infants without lack of parental consent were excluded. The maternal and neonatal demographic characteristics and clinical outcomes were collected from medical records.
-
**Maximum Age:** 1 Day
**Minimum Age:** 0 Days
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** DİDEM ARMAN
**Phone:** 05056211989
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** IstanbulTRH
### IPD Sharing Statement Module
**Description:** The data sets generated during and/or analyzed during current study may be available from the corresponding author on reasonable request.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Azzopardi DV, Strohm B, Edwards AD, Dyet L, Halliday HL, Juszczak E, Kapellou O, Levene M, Marlow N, Porter E, Thoresen M, Whitelaw A, Brocklehurst P; TOBY Study Group. Moderate hypothermia to treat perinatal asphyxial encephalopathy. N Engl J Med. 2009 Oct 1;361(14):1349-58. doi: 10.1056/NEJMoa0900854. Erratum In: N Engl J Med. 2010 Mar 18;362(11):1056.
**PMID:** 19797281
**Citation:** Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003311. doi: 10.1002/14651858.CD003311.pub3.
**PMID:** 23440789
**Citation:** Martin-Ancel A, Garcia-Alix A, Gaya F, Cabanas F, Burgueros M, Quero J. Multiple organ involvement in perinatal asphyxia. J Pediatr. 1995 Nov;127(5):786-93. doi: 10.1016/s0022-3476(95)70174-5.
**PMID:** 7472837
**Citation:** Sharma S, Kallesh A, Aradhya AS, Diggikar S, Veeraiah PS, Subbareddy NN, Walikar S, Reddy IV, Sarji D, Venkatagiri P. Feasibility of Minimal Enteral Nutrition During Therapeutic Hypothermia for Perinatal Asphyxia: A Five-Year Multicenter Experience from South India. Indian J Pediatr. 2023 May;90(5):513-515. doi: 10.1007/s12098-022-04456-x. Epub 2023 Jan 16.
**PMID:** 36642779
**Citation:** Kumar J, Anne RP, Meena J, Sundaram V, Dutta S, Kumar P. To feed or not to feed during therapeutic hypothermia in asphyxiated neonates: a systematic review and meta-analysis. Eur J Pediatr. 2023 Jun;182(6):2759-2773. doi: 10.1007/s00431-023-04950-0. Epub 2023 Apr 4.
**PMID:** 37014443
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000002534
- Term: Hypoxia, Brain
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M5794
- Name: Brain Ischemia
- Relevance: HIGH
- As Found: Ischemic Encephalopathy
- ID: M10543
- Name: Ischemia
- Relevance: HIGH
- As Found: Ischemic
- ID: M4185
- Name: Hypoxia
- Relevance: HIGH
- As Found: Hypoxic
- ID: M10085
- Name: Hypothermia
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: HIGH
- As Found: Encephalopathy
- ID: M22660
- Name: Hypoxia-Ischemia, Brain
- Relevance: HIGH
- As Found: Hypoxic Ischemic Encephalopathy
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5783
- Name: Hypoxia, Brain
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001927
- Term: Brain Diseases
- ID: D000002545
- Term: Brain Ischemia
- ID: D000020925
- Term: Hypoxia-Ischemia, Brain
- ID: D000007511
- Term: Ischemia
- ID: D000000860
- Term: Hypoxia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447142
**Brief Title:** The Open Kinetic Chain and Closed Kinetic Chain Strengthening Exercises in Degenerative Meniscus Tears
**Official Title:** Comparison of the Open Kinetic Chain and Closed Kinetic Chain Strengthening Exercises on Pain, Function, and Health-related Quality of Life in Degenerative Meniscus Tears
#### Organization Study ID Info
**ID:** 2133
#### Organization
**Class:** OTHER
**Full Name:** Istanbul University - Cerrahpasa (IUC)
### Status Module
#### Completion Date
**Date:** 2024-10-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istanbul University - Cerrahpasa (IUC)
#### Responsible Party
**Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC)
**Investigator Full Name:** Tansu Birinci
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This randomized-controlled trial aims to compare the effect of open kinetic chain and closed kinetic chain strengthening exercises on pain, function, and health-related quality of life in degenerative meniscus tears.
**Detailed Description:** Patients with degenerative meniscus tears between the ages of 40 and 65 will be randomly divided into two groups: Group 1 (open kinetic chain strengthening exercises) and Group 2 (closed kinetic chain strengthening exercises). Interventions will be applied for 16 sessions (twice a week for 8 weeks). The patients will be assessed at baseline and at the end of the 8-week intervention. The pain during activity, at rest, and at night will be assessed with the Visual Analog Scale (VAS). Active range of motion will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer. The functional status and symptoms will be evaluated by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Lysholm Knee Scoring Scale. Health-related quality of life will be assessed with the Short Form-12 (SF-12).
### Conditions Module
**Conditions:**
- Degenerative Disease
- Meniscus Tear
- Knee Pain Swelling
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Each subject in Group 1 will receive a treatment protocol consisting of stretching exercises, open kinetic chain strengthening exercises, and functional exercises for the knee and hip.
**Intervention Names:**
- Other: Open kinetic chain strengthening exercise
**Label:** Group 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Each subject in Group 2 will receive a treatment protocol consisting of stretching exercises, closed kinetic chain strengthening exercises, and functional exercises for the knee and hip.
**Intervention Names:**
- Other: Closed kinetic chain strengthening exercise
**Label:** Group 2
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 1
**Description:** A web-based 8-week exercise program consisting of stretching exercises, open kinetic chain strengthening exercises, and functional exercises for the knee and hip will be performed.
**Name:** Open kinetic chain strengthening exercise
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Group 2
**Description:** A web-based 8-week exercise program consisting of stretching exercises, closed kinetic chain strengthening exercises, and functional exercises for the knee and hip will be performed.
**Name:** Closed kinetic chain strengthening exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
**Measure:** Knee Injury and Osteoarthritis Outcome Score (KOOS)
**Time Frame:** Baseline
#### Secondary Outcomes
**Description:** Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
**Measure:** Knee Injury and Osteoarthritis Outcome Score (KOOS)
**Time Frame:** At the end of 8-week intervention
**Description:** Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
**Measure:** Visual Analogue Scale (VAS)
**Time Frame:** Baseline
**Description:** Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
**Measure:** Visual Analogue Scale (VAS)
**Time Frame:** At the end of 8-week intervention
**Description:** Active knee range of motion including flexion and extension will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer.
**Measure:** Active Range of Motion
**Time Frame:** Baseline
**Description:** Active knee range of motion including flexion and extension will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer.
**Measure:** Active Range of Motion
**Time Frame:** At the end of 8-week intervention
**Description:** Isometric muscle strength will be measured with a handheld dynamometer for knee flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
**Measure:** Muscle Strength
**Time Frame:** Baseline
**Description:** Isometric muscle strength will be measured with a handheld dynamometer for knee flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
**Measure:** Muscle Strength
**Time Frame:** At the end of the 8-week intervention
**Description:** Functional limitations related to degenerative meniscal tear will be used with the Lysholm Score that is one of the most frequently used functional questionnaires. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability.
**Measure:** Lysholm Score
**Time Frame:** Baseline
**Description:** Functional limitations related to degenerative meniscal tear will be used with the Lysholm Score that is one of the most frequently used functional questionnaires. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability.
**Measure:** Lysholm Score
**Time Frame:** At the end of the 8-week intervention
**Description:** Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12. Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.
**Measure:** Short Form-12 (SF-12)
**Time Frame:** Baseline
**Description:** Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12. Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.
**Measure:** Short Form-12 (SF-12)
**Time Frame:** At the end of the 8-week intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Being aged between 40 and 65 years Having the degenerative meniscus tear in at least one knee Having body mass index in the range of 18-30 kg/m2 Feeling the pain that lasts for at least 2 months Having grade 1 or grade 2 degenerative meniscal tear diagnosed by an orthopedic specialist according to the MRI results Having the ability to read and write Turkish
Exclusion Criteria:
Having undergone arthroscopic partial meniscectomy surgery due to degenerative meniscal tear Participating in a physiotherapy program for degenerative meniscal tear in the last 12 weeks Have received steroid injections in the last 6 months Accompanying conditions such as injury to the surrounding ligaments, congenital anomaly in the affected knee, coxarthrosis and spinal stenosis Presence of any systemic disorder that may affect assessment parameters Failure to cooperate with assessments
**Maximum Age:** 65 Years
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Tansu Birinci, PT, PhD
**Phone:** 02162803333
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Istanbul University-Cerrahpasa
**State:** Bakırkoy
**Zip:** 34147
#### Overall Officials
**Official 1:**
**Affiliation:** Istanbul University - Cerrahpasa (IUC)
**Name:** Tansu Birinci, PT, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M15241
- Name: Rupture
- Relevance: LOW
- As Found: Unknown
- ID: M22785
- Name: Lacerations
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447129
**Brief Title:** Effect of NMES as an Add-On to Exercise Program in Degenerative Meniscus Tears: A Randomized Controlled Trial
**Official Title:** Effect of NMES as an Add-On to Exercise Program in Degenerative Meniscus Tears: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 216
#### Organization
**Class:** OTHER
**Full Name:** Istanbul University - Cerrahpasa (IUC)
### Status Module
#### Completion Date
**Date:** 2024-10-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istanbul University - Cerrahpasa (IUC)
#### Responsible Party
**Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC)
**Investigator Full Name:** Tansu Birinci
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This randomized-controlled trial aims to investigate the effect of NMES as an add-on to an exercise program in patients with degenerative meniscus tears.
**Detailed Description:** To investigate the efficacy of NMES as an add-on to an exercise program, voluntary patients with degenerative meniscus tears, aged between 40 and 65 years, will be randomly divided into two groups: Group 1 (Exercise with NMES) and Group 2 (Exercise). Interventions will be applied for 16 sessions (twice a week for 8 weeks). The patients will be assessed at baseline and at the end of the 8-week intervention. The pain during activity, at rest, and at night will be assessed with the Visual Analog Scale (VAS). Active range of motion will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer. The functional status and symptoms will be evaluated by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Lysholm Knee Scoring Scale. Health-related quality of life will be assessed with the Short Form-12 (SF-12).
### Conditions Module
**Conditions:**
- Degenerative Disease
- Meniscus Tear
- Knee Pain Swelling
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Each subject in Group 2 will receive a treatment protocol consisting of stretching exercises, strengthening exercises, functional exercises for the knee and hip, and NMES application for the quadriceps femoris muscle.
**Intervention Names:**
- Other: Exercise
- Other: Neuromuscular electrical stimulation
**Label:** Group 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Each subject in Group 2 will receive a treatment protocol consisting of stretching exercises, strengthening exercises, functional exercises for the knee and hip.
**Intervention Names:**
- Other: Exercise
**Label:** Group 2
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 1
- Group 2
**Description:** An 8-week exercise program used in conservative treatment of degenerative meniscus tears will be performed.
The patients will do exercises under the control of the physiotherapist in the clinic.
The patient will perform the exercises with the verbal and visual commands of the physiotherapist.
**Name:** Exercise
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Group 1
**Description:** The Neuromuscular Electrical Stimulation (NMES) will be applied for 20 minutes. The patient will be seated with hips and knees flexed at 90°. Electrodes will be placed on the proximal and distal ends of the vastus medialis obliquus and vastus lateralis muscles. The intensity will be increased as much as the patient can tolerate, and the patient will be asked to relax and not make voluntary muscle contractions.
**Name:** Neuromuscular electrical stimulation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
**Measure:** Knee Injury and Osteoarthritis Outcome Score (KOOS)
**Time Frame:** Baseline
#### Secondary Outcomes
**Description:** Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
**Measure:** Knee Injury and Osteoarthritis Outcome Score (KOOS)
**Time Frame:** At the end of 8-week intervention
**Description:** Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
**Measure:** Visual Analogue Scale (VAS)
**Time Frame:** Baseline
**Description:** Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
**Measure:** Visual Analogue Scale (VAS)
**Time Frame:** At the end of 8-week intervention
**Description:** Active knee range of motion including flexion and extension will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer.
**Measure:** Active Range of Motion
**Time Frame:** Baseline
**Description:** Active knee range of motion including flexion and extension will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer.
**Measure:** Active Range of Motion
**Time Frame:** At the end of 8-week intervention
**Description:** Isometric muscle strength will be measured with a handheld dynamometer for knee flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
**Measure:** Muscle Strength
**Time Frame:** Baseline
**Description:** Isometric muscle strength will be measured with a handheld dynamometer for knee flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
**Measure:** Muscle Strength
**Time Frame:** At the end of the 8-week intervention
**Description:** Functional limitations related to degenerative meniscal tear will be used with the Lysholm Score that is one of the most frequently used functional questionnaires. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability.
**Measure:** Lysholm Score
**Time Frame:** Baseline
**Description:** Functional limitations related to degenerative meniscal tear will be used with the Lysholm Score that is one of the most frequently used functional questionnaires. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability.
**Measure:** Lysholm Score
**Time Frame:** At the end of the 8-week intervention
**Description:** Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12. Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.
**Measure:** Short Form-12 (SF-12)
**Time Frame:** Baseline
**Description:** Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12. Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.
**Measure:** Short Form-12 (SF-12)
**Time Frame:** At the end of the 8-week intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Being aged between 40 and 65 years Having the degenerative meniscus tear in at least one knee Having body mass index in the range of 18-30 kg/m2 Feeling the pain that lasts for at least 2 months Having grade 1 or grade 2 degenerative meniscal tear diagnosed by an orthopedic specialist according to the MRI results Having the ability to read and write Turkish
Exclusion Criteria:
Having undergone arthroscopic partial meniscectomy surgery due to degenerative meniscal tear Participating in a physiotherapy program for degenerative meniscal tear in the last 12 weeks Have received steroid injections in the last 6 months Accompanying conditions such as injury to the surrounding ligaments, congenital anomaly in the affected knee, coxarthrosis and spinal stenosis Presence of any systemic disorder that may affect assessment parameters Failure to cooperate with assessments
**Maximum Age:** 65 Years
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ebru Kaya Mutlu, PT, PhD
**Phone:** 0 266 717 0117
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Tansu Birinci, PT, PhD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Ebru Kaya Mutlu, PT, PhD
- **Phone:** 0 266 717 0117
- **Role:** CONTACT
***Contact 3:***
- **Name:** Abdullah Yahya Okur, PT, MSc
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Ebru Kaya Mutlu, PT, PhD
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Tansu Birinci, PT, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 6:***
- **Name:** Nezih Ziroğu, MD
- **Role:** SUB_INVESTIGATOR
**Country:** Turkey
**Facility:** Istanbul University-Cerrahpasa
**State:** Bakırkoy
**Zip:** 34147
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M15241
- Name: Rupture
- Relevance: LOW
- As Found: Unknown
- ID: M22785
- Name: Lacerations
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447116
**Brief Title:** An EFS to Evaluate the Safety and Preliminary Effectiveness of the CGuard Prime™ Carotid Stent Placement in Acute Ischemic Stroke.
**Official Title:** An EFS to Evaluate the Safety and Preliminary Effectiveness of the CGuard Prime™ Carotid Stent Placement in the Procedure Setting of Acute Ischemic Stroke.
#### Organization Study ID Info
**ID:** CIP 004
#### Organization
**Class:** OTHER
**Full Name:** Jacobs institute
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Jacobs institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is Unapproved Device:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The Jacobs Institute is conducting a Sponsor Investigator study of patients ≥ 18 years to establish safety and preliminary effectiveness in treating extracranial stenosis with the CGuard Prime™ Carotid Stent in the setting as an acute ischemic stroke.
**Detailed Description:** A prospective, single-arm, open-label, nonblinded EFS to assess the safety and preliminary effectiveness of the CGuard Prime™ Carotid Stent in adults (18 years of age or older) with extracranial stenosis in the setting as an acute ischemic stroke.
### Conditions Module
**Conditions:**
- Acute Ischemic Stroke
### 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
### Interventions
#### Intervention 1
**Description:** CGuard Prime™ Carotid Stent System
**Name:** CGuard Prime™ Carotid Stent System
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Proportion of subjects with mRS ≤ 2 at 90 days
**Measure:** Proportion of subjects with mRS ≤ 2 at 90 days
**Time Frame:** 90 days
#### Secondary Outcomes
**Description:** Rate of TICI 2b or greater; Proportion of subjects with sICH within 24 hours; and New stroke within the same territory within 7 days.
**Measure:** Rate of TICI 2b or greater; Proportion of subjects with sICH within 24 hours; and New stroke within the same territory within 7 days.
**Time Frame:** 7 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients ≥18-year-old; Carotid stenosis with at least ≥ 50% stenosis; National Institute of Health Stroke Scale (NIHSS) \>/=6; and evidence of large vessel occlusion (LVO) in the anterior circulation (i.e., intracranial internal carotid artery, M1 and proximal M2) by computed tomography angiography (CTA).
Exclusion Criteria:
* Cannot provide consent or legally authorized representative not available to provide consent. Evidence of intracranial hemorrhage on non-contrast CT or MRI; ASPECTS\<6; and any contraindication to dual antiplatelet therapy.
**Maximum Age:** 90 Years
**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: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020520
- Term: Brain Infarction
- ID: D000002545
- Term: Brain Ischemia
- ID: D000007238
- Term: Infarction
- ID: D000009336
- Term: Necrosis
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: HIGH
- As Found: Ischemic
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- ID: M2400
- Name: Ischemic Stroke
- Relevance: HIGH
- As Found: Ischemic Stroke
- ID: M5793
- Name: Cerebral Infarction
- Relevance: HIGH
- As Found: Ischemic Stroke
- ID: M10282
- Name: Infarction
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22305
- Name: Brain Infarction
- Relevance: LOW
- As Found: Unknown
- ID: M5794
- Name: Brain Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M12284
- Name: Necrosis
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
- ID: D000083242
- Term: Ischemic Stroke
- ID: D000002544
- Term: Cerebral Infarction
- ID: D000007511
- Term: Ischemia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447103
**Brief Title:** An Investigational Scan (89Zr-DFO-GmAb PET/CT) Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX (CAIX) PET CT to Conventional PET CT for Post-Op Staging in Kidney Cancer
**Official Title:** 89Zr-DFO-GmAb PET/CT vs Contrast-Enhanced CT for Detection of Recurrent Clear Cell Renal Cell Carcinoma After Surgery
#### Organization Study ID Info
**ID:** 23-001576
#### Organization
**Class:** OTHER
**Full Name:** Jonsson Comprehensive Cancer Center
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2024-01928
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2030-06-01
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Telix Pharmaceuticals (Innovations) Pty Limited
#### Lead Sponsor
**Class:** OTHER
**Name:** Jonsson Comprehensive Cancer Center
#### 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:** This phase II trial compares the safety and effectiveness of 89Zr-DFO-GmAb positron emission tomography (PET)/computed tomography (CT) compared to contrast-enhanced CT after surgery in detecting clear cell renal cell cancer that has come back (recurrent). For some patients, the risk of recurrence after surgery remains high. Conventional CT methods, such as contrast-enhanced CT, may not detect small volume or micrometastatic disease. PET/CT with radiotracers, such as 89Zr-DFO-GmAb, may improve detection of tumor cells. Girentuximab (GmAb), a monoclonal antibody, is tagged with zirconium-89, a radioactive atom (which is also known as an isotope). The zirconium-89 (89Zr) isotope is attached to girentuximab with desferrioxamine (DFO) and this combined product is called 89Zr-DFO-girentuximab. 89Zr-DFO-girentuximab attaches itself to a protein on the surface of clear cell renal cell tumor cells called CAIX. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 89Zr-DFO-GmAb. Because some cancers, including clear cell renal cell cancer, take up 89Zr-DFO-GmAb it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Using contrast agents with CT scan to enhance the images (contrast-enhanced CT) is standard of care imaging. 89Zr-DFO-GmAb PET/CT may be safe and effective compared to contrast-enhanced CT in detecting recurrent clear cell renal cell cancer after surgery.
**Detailed Description:** PRIMARY OBJECTIVE:
I. To compare the lesion detection rate (i.e., positivity rate per patient) of zirconium Zr 89 girentuximab (89Zr-DFO-GmAb) PET/CT compared to the standard of care diagnostic contrast-enhanced CT alone at 4-12 weeks from surgical resection based on blinded independent central review (BICR).
SECONDARY OBJECTIVES:
I. To establish safety of 89Zr-DFO-GmAb in patients with intermediate-high or high risk imaged in the post-nephrectomy or metastasectomy setting.
II. To compare the positive predictive value (PPV) of 89Zr-DFO-GmAb PET/CT in patients with available lesion validation by 1) histopathology (biopsy/resection), 2) evidence of growth under surveillance or 3) reduction of size under treatment, and 4) unequivocal confirmation of malignancy on a different imaging modality.
III. To assess the recurrence-free survival of individuals with/without evidence of disease based on 89Zr-DFO-GmAb PET/CT staging results (PET/CT designated M1 versus \[vs\] M0).
EXPLORATORY OBJECTIVES:
I. Correlate level of histological CAIX expression (H Score) from the primary tumor to 89Zr-TLX250 standardized uptake values (SUVs) in patients with visualized disease on 89Zr-DFO-GmAb PET/CT.
II. To identify the standardized uptake value (SUV) cut-off for 89Zr-DFO-GmAb suitable for the detection of metastatic lesions in the postoperative setting.
III. To evaluate the performance of established prognostic transcriptomic classifiers (from the nephrectomy specimen) on disease-free survival.
IV. To evaluate if circulating tumor DNA (ctDNA) for the detection of molecular residual disease (MRD) correlates with the presence of active disease seen on 89Zr-DFO-GmAb PET/CT or predicts disease-free survival.
OUTLINE:
Patients receive 89Zr-DFO-GmAb intravenously (IV) over 3 minutes on day 0 then undergo whole body PET/CT and standard of care (SOC) diagnostic contrast-enhanced CT scan on day 7. Patients also blood sample collection on study. In addition, patients may undergo bone scan and CT or magnetic resonance imaging (MRI) of the brain on study as clinically indicated.
After completion of study intervention, patients are followed up at 8, 16 and 24 months.
### Conditions Module
**Conditions:**
- Clear Cell Renal Cell Carcinoma
- Metastatic Clear Cell Renal Cell Carcinoma
- Recurrent Clear Cell Renal Cell Carcinoma
- Sarcomatoid Renal Cell Carcinoma
- Stage II Renal Cell Cancer American Joint Committee on Cancer (AJCC) v8
- Stage III Renal Cell Cancer AJCC v8
- Stage IV Renal Cell Cancer AJCC v8
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 91
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients receive 89Zr-DFO-GmAb IV over 3 minutes on day 0 then undergo whole body PET/CT and SOC diagnostic contrast-enhanced CT scan on day 7. Patients also blood sample collection on study. In addition, patients may undergo bone scan and CT or MRI of the brain on study as clinically indicated.
**Intervention Names:**
- Procedure: Biospecimen Collection
- Procedure: Bone Scan
- Procedure: Computed Tomography
- Procedure: Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
- Other: Questionnaire Administration
- Drug: Zirconium Zr 89 Girentuximab
**Label:** Diagnostic (89Zr-DFO-GmAb PET/CT)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Diagnostic (89Zr-DFO-GmAb PET/CT)
**Description:** Undergo blood sample collection
**Name:** Biospecimen Collection
**Other Names:**
- Biological Sample Collection
- Biospecimen Collected
- Specimen Collection
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Diagnostic (89Zr-DFO-GmAb PET/CT)
**Description:** Undergo bone scan
**Name:** Bone Scan
**Other Names:**
- Bone Scintigraphy
**Type:** PROCEDURE
#### Intervention 3
**Arm Group Labels:**
- Diagnostic (89Zr-DFO-GmAb PET/CT)
**Description:** Undergo CT, PET/CT, and CT of the brain
**Name:** Computed Tomography
**Other Names:**
- CAT
- CAT Scan
- Computed Axial Tomography
- Computerized Axial Tomography
- Computerized axial tomography (procedure)
- Computerized Tomography
- Computerized Tomography (CT) scan
- CT
- CT Scan
- tomography
**Type:** PROCEDURE
#### Intervention 4
**Arm Group Labels:**
- Diagnostic (89Zr-DFO-GmAb PET/CT)
**Description:** Undergo MRI of the brain
**Name:** Magnetic Resonance Imaging
**Other Names:**
- Magnetic Resonance
- Magnetic Resonance Imaging (MRI)
- Magnetic resonance imaging (procedure)
- Magnetic Resonance Imaging Scan
- Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
- MR
- MR Imaging
- MRI
- MRI Scan
- MRIs
- NMR Imaging
- NMRI
- Nuclear Magnetic Resonance Imaging
- sMRI
- Structural MRI
**Type:** PROCEDURE
#### Intervention 5
**Arm Group Labels:**
- Diagnostic (89Zr-DFO-GmAb PET/CT)
**Description:** Undergo PET/CT
**Name:** Positron Emission Tomography
**Other Names:**
- Medical Imaging, Positron Emission Tomography
- PET
- PET Scan
- Positron emission tomography (procedure)
- Positron Emission Tomography Scan
- Positron-Emission Tomography
- proton magnetic resonance spectroscopic imaging
- PT
**Type:** PROCEDURE
#### Intervention 6
**Arm Group Labels:**
- Diagnostic (89Zr-DFO-GmAb PET/CT)
**Description:** Ancillary studies
**Name:** Questionnaire Administration
**Type:** OTHER
#### Intervention 7
**Arm Group Labels:**
- Diagnostic (89Zr-DFO-GmAb PET/CT)
**Description:** Given IV
**Name:** Zirconium Zr 89 Girentuximab
**Other Names:**
- 89Zr-DFO-TFP-girentuximab
- 89Zr-girentuximab
- 89Zr-TLX250
- Zirconium Zr 89 cG250
- Zirconium Zr 89-TLX250
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Patients will be treated as binary categorization as follows: (i) Patients who have ≥ 1 lesion confirmed to be recurrent disease will be designated positive (recurrence). (ii) Patients with no lesions detected will be designated negative (no recurrence). The analysis of the primary objective will utilize McNemar's test to compare the detection rate between the imaging techniques.
**Measure:** Lesion detection rate
**Time Frame:** Up to 16 weeks from surgical resection
#### Secondary Outcomes
**Description:** The total number of AEs will be summarized with grade and attribution. The total number of significant AEs will be summarized with attribution if present. AEs will be descriptive in nature and only counts and percentage will be reported.
**Measure:** Incidence of adverse events (AEs)
**Time Frame:** Up to day 14
**Description:** Will compare PPV of 89Zr-DFO-GmAb PET/CT in subjects designated as having a suspicious lesion on the BICR PET/CT evaluation, will review follow up for available lesion validation by 1) histopathology (biopsy/resection), 2) evidence of growth under surveillance or 3) reduction of size under treatment, and 4) unequivocal confirmation of malignancy on a different imaging modality. As there are no firm estimates to the number of lesions that will be designated as suspicious, there are no planned statistical analyses planned. Would present the total number of cases and the frequency of validation with the 95% confidence interval.
**Measure:** Positive predictive value (PPV)
**Time Frame:** Up to 2 years
**Description:** Recurrence-free survival will be calculated using the Kaplan-Meier Method with date and evidence of recurrence based on either clinical annotation by the treating physician or documentation of recurrence by diagnostic imaging or histopathology. Analysis will be descriptive and provide an estimated 2-year recurrence-free survival with 95% confidence interval. A Log-rank test will compare the differences in recurrence-free survival between groups.
**Measure:** Recurrence-free survival
**Time Frame:** Up to 2 years
**Description:** Questionnaires using Likert scores will be used to determine changes. Analysis will be descriptive.
**Measure:** Change in management and perceived clinical utility of the unblinded read/report of positron emission tomography/ computed tomography (PET/CT)
**Time Frame:** At baseline and up to 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18
* Histologically confirmed clear cell renal cell carcinoma (RCC) (ccRCC) (based on partial/radical nephrectomy/metastasectomy)
* For tumors with extensive sarcomatoid features, if there is evidence of areas of clear cell and high CAIX expression throughout the tumor on immunohistochemistry, they will be allowed on study
* Subjects must have undergone definitive treatment of their primary tumor (partial/radical nephrectomy) +/- resection of metastatic disease to no evidence of disease (NED) with a prior nephrectomy \< 2 years)
* Surgery must have been performed between 4-16 weeks at the time of planned imaging
* Subjects are considered to have a high risk of recurrence based on the following criteria:
* Intermediate-high risk ccRCC:
* pathologic tumor stage 2 (pT2), grade 4, or sarcomatoid, N0, M0
* pathologic tumor stage 3 (pT3), any grade, N0, M0
* High risk ccRCC:
* pathologic tumor stage 4 (pT4), any grade, N0, M0
* pT any stage, any grade, number of positive nodes (pN+), M0
* M1 now NED: pathologically-confirmed ccRCC, undergoing a resection of a solitary, isolated soft tissue metastasis within two years from initial nephrectomy
* Negative serum pregnancy tests in female patients of childbearing potential. (Women of child bearing potential \[WOCBP\] require a negative pregnancy test within 24 hours (urine) prior to receiving investigational product)
* Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-DFO-GmAb administration
* Individual must be able to remain still and lie flat for duration of the diagnostic imaging procedure (less than 1 hour)
Exclusion Criteria:
* Inability to provide written informed consent
* Any evidence of residual disease or known metastasis at the time of planned 89Zr-DFO-GmAb administration
* Prior post-operative imaging for confirmation of disease status
* An untreated non-renal malignancy with the following exceptions:
* Low risk prostate cancer on active surveillance (National Comprehensive Cancer Network \[NCCN\] very low/low risk)
* Non-melanoma skin cancer
* Any prior treated malignancy meeting the following characteristics:
* Treated stage I or II cancer from which the patient is currently in complete remission
* A stage III cancer from which the patient is progressing or has been disease-free for and has required active treatment (e.g. adjuvant or maintenance therapy) within the past 3 years prior to enrollment
* A hematologic malignancy from which the patient is currently in complete remission
* Contraindication to the use of iodinated contrast-enhanced CT agents, based on:
* Severe allergy (for which pre-medication cannot limit adverse reactions) or
* Estimated glomerular filtration rate (GFR) ≤ 30 ml/min/1.73m\^2
* Prior use of systemic therapy treatment for kidney cancer (PD-1, PD-L1, tyrosine kinase or TOR inhibitor) or radiotherapy within 4 weeks of enrollment
* Exposure to experimental diagnostic or therapeutic drug within 14 days from date of planned administration
* Women who are pregnant or breastfeeding
* Known hypersensitivity to girentuximab
* Known inability to remain still and lie flat imaging procedure (about 30 minutes)
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Los Angeles
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Brian Shuch
- **Phone:** 310-794-0987
- **Role:** CONTACT
***Contact 2:***
- **Name:** Brian Shuch
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** UCLA / Jonsson Comprehensive Cancer Center
**State:** California
**Zip:** 90095
#### Overall Officials
**Official 1:**
**Affiliation:** UCLA / Jonsson Comprehensive Cancer Center
**Name:** Brian Shuch
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000000230
- Term: Adenocarcinoma
- ID: D000007680
- Term: Kidney Neoplasms
- ID: D000014571
- Term: Urologic Neoplasms
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000007674
- Term: Kidney Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5548
- Name: Carcinoma, Renal Cell
- Relevance: HIGH
- As Found: Clear Cell Renal Cell Carcinoma
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrent
- ID: M10703
- Name: Kidney Neoplasms
- 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: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M3585
- Name: Adenocarcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M17320
- Name: Urologic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M10698
- Name: Kidney Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4906
- Name: Renal Cell Carcinoma
- Relevance: HIGH
- As Found: Renal Cell Carcinoma
- ID: T1341
- Name: Clear Cell Renal Cell Carcinoma
- Relevance: HIGH
- As Found: Clear Cell Renal Cell Carcinoma
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000002292
- Term: Carcinoma, Renal Cell
- ID: D000012008
- Term: Recurrence
### Intervention Browse Module - Ancestors
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: HIGH
- As Found: Irreversible Pulpitis
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000911
- Term: Antibodies, Monoclonal
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447090
**Acronym:** VMAC+DLI
**Brief Title:** VMAC+DLI Treatment of Patients With Relapse of AML After Allo-HSCT
**Official Title:** Study on the Efficacy and Safety of VMAC Combined With Donor Lymphocyte Infusion (DLI) in the Treatment of Patients With Relapse of Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation
#### Organization Study ID Info
**ID:** IIT2024002
#### Organization
**Class:** OTHER
**Full Name:** Institute of Hematology & Blood Diseases Hospital, China
### Status Module
#### Completion Date
**Date:** 2027-10-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-12
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Institute of Hematology & Blood Diseases Hospital, China
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This clinical trial included 30 cases and aimed to understand the effectiveness and safety of the VMAC regimen combined with donor lymphocyte infusion (DLI) in the treatment of patients with acute myeloid leukemia who have relapsed after allogeneic hematopoietic stem cell transplantation.
The main questions it aims to answer are:
The safety and efficacy of VMAC combined with DLI in the treatment of allo HSCT recurrence in AML patients;
**Detailed Description:** venetoclax 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; liposomal mitoxantrone 30 mg/m2/d, d1; cytarabine (Ara-C) 100 mg/m2/d, d1-7; cyclophosphamide (CY) 400 mg/m2/d, d2, 5)，and then rest for 1 day before giving cryopreserved donor stem cells.MNC1-2X10\^8/kg infusion, low-dose (25 mg Bid), short-course treatment (2-3 weeks after DLI) oral cyclosporine (CSA) is added to prevent graft-versus-host disease starting 3 days before the infusion of cryopreserved stem cells.
Monitor the occurrence of serious infections, cardiac toxicity, GVHD and other adverse reactions during the medication process; Blood routine recovery or bone marrow re examination 4 weeks after DLI to evaluate the efficacy of one course of VMAC combined with DLI; The patient was followed up for 2 years to evaluate long-term efficacy.
### Conditions Module
**Conditions:**
- Relapse Acute Myeloid Leukemia
**Keywords:**
- Mitoxantrone liposome
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### 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:** VMAC regimen :
Veneclatra (VEN) 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; Mitoxantrone Liposomal 30 mg/m2, d1; Cytosine arabinoside(Ara-C) 100 mg/m2/d, d1-7; Cyclophosphamide (CTX) 400 mg/m2/d, d2, 5); After 1 day of rest, cryopreserved donor stem cells MNC1-2X10\^8 /kg infusion, add low-dose (25 mg Bid) and short-course treatment (stop 2-3 weeks after DLI) oral cyclosporine (CSA) to prevent graft-versus-host disease (GVHD) 3 days before cryopreserved stem cell infusion.
**Intervention Names:**
- Drug: Mitoxantrone hydrochloride liposome
**Label:** VMAC+DLI
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- VMAC+DLI
**Description:** Veneclatra (VEN) 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; Mitoxantrone Liposomal 30 mg/m2, d1; Cytosine arabinoside(Ara-C) 100 mg/m2/d, d1-7; Cyclophosphamide (CTX) 400 mg/m2/d, d2, 5); After 1 day of rest, cryopreserved donor stem cells MNC1-2X10\^8 /kg infusion, add low-dose (25 mg Bid) and short-course treatment (stop 2-3 weeks after DLI) oral cyclosporine (CSA) to prevent graft-versus-host disease (GVHD) 3 days before cryopreserved stem cell infusion.
**Name:** Mitoxantrone hydrochloride liposome
**Other Names:**
- Venetoclax
- Cytarabine,Cytosine arabinoside
- Cyclophosphamide
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** All tumor target lesions disappear, no new lesions appear, and tumor markers are normal, maintained for at least 4 weeks
**Measure:** CRR
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** The maximum sum of diameters of tumor lesions decrease≥ 30% and is maintained for at least 4 weeks
**Measure:** PR
**Time Frame:** 1 year
**Description:** CR+PR
**Measure:** ORR
**Time Frame:** 1year
**Description:** The time from the start of treatment to death due to any reason
**Measure:** 2-year OS
**Time Frame:** 2 years
**Description:** The time from the start of treatment to disease recurrence or death from any cause
**Measure:** DFS
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients with AML confirmed by bone marrow morphology and morphological recurrence after allo-HSCT (proportion of bone marrow morphological blast cells ≥5%);
2. Age ≥18 years and ≤65 years old, regardless of gender;
3. Eastern Oncology The evaluation of physical status of the cooperative group (ECOG-PS) is 0-2 points;
4. An informed consent form must be signed before the start of the research procedure, and the patient himself or his immediate family members must sign the informed consent form. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the legal guardian or the patient's immediate family member will sign the informed consent form.
Exclusion Criteria:
Subjects who meet any of the following criteria shall not be enrolled in this study:
* 1) Secondary transplant patients;
* 2) Have a history of tumor and have received any treatment for this tumor in the past 3 years, except for superficial bladder cancer , basal cell or squamous cell carcinoma of the skin, cervical intraepithelial carcinoma (CIN) or prostate intraepithelial carcinoma (PIN);
* 3) Serological reactions of known HIV, active hepatitis B, and active hepatitis C virus positive or syphilis positive;
* 4) Suffering from mental illness or other conditions and unable to cooperate with the requirements of research treatment and monitoring;
* 5) Pregnant patients or patients who cannot take appropriate contraceptive measures during treatment;
* 6) Active heart disease, definition One or more of the following:
1. Long QTc syndrome or QTc interval \>480ms;
2. Complete left bundle branch block, II or III degree atrioventricular block;
3. Need for drug treatment or History of severe arrhythmia with clinical symptoms;
4. New York Heart Association classification ≥ II;
5. Left ventricular ejection fraction less than 50%;
6. Myocardial infarction, unstable angina, severe myocardial infarction within 6 months before enrollment History of unstable ventricular arrhythmias or any other arrhythmias requiring treatment, clinically severe pericardial disease, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
* 7) Transplantation from an unrelated donor;
* 8) Those deemed not suitable for enrollment by the researcher.
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xin Chen, Doctor
**Phone:** 13920985705
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Xueou Liu, Doctor
**Phone:** 022-23909095
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Tianjin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xin Chen, Doctor
- **Phone:** 13920985705
- **Role:** CONTACT
**Country:** China
**Facility:** Institute of Hematology & Blood Diseases Hospital, China
**State:** Tianjin
**Status:** RECRUITING
**Zip:** 300000
#### Overall Officials
**Official 1:**
**Affiliation:** Institute of Hematology & Blood Diseases Hospital, China
**Name:** Xin Chen, Doctor
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10945
- Name: Leukemia
- Relevance: HIGH
- As Found: Leukemia
- ID: M10955
- Name: Leukemia, Myeloid
- Relevance: HIGH
- As Found: Myeloid Leukemia
- ID: M18127
- Name: Leukemia, Myeloid, Acute
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Relapse
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- 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: HIGH
- As Found: Acute Myeloid Leukemia
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007938
- Term: Leukemia
- ID: D000007951
- Term: Leukemia, Myeloid
- ID: D000015470
- Term: Leukemia, Myeloid, Acute
- ID: D000012008
- Term: Recurrence
### Intervention Browse Module - Ancestors
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000018906
- Term: Antineoplastic Agents, Alkylating
- ID: D000000477
- Term: Alkylating Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000019653
- Term: Myeloablative Agonists
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- ID: D000000998
- Term: Antiviral Agents
- ID: D000000890
- Term: Anti-Infective Agents
- 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: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: Derm
- Name: Dermatologic Agents
### Intervention Browse Module - Browse Leaves
- ID: M6766
- Name: Cytarabine
- Relevance: HIGH
- As Found: Multi-
- ID: M6727
- Name: Cyclophosphamide
- Relevance: HIGH
- As Found: Cycle
- ID: M249656
- Name: Venetoclax
- Relevance: HIGH
- As Found: 15 minutes
- ID: M11908
- Name: Mitoxantrone
- Relevance: HIGH
- As Found: Move
- ID: M18961
- Name: Cyclosporine
- Relevance: LOW
- As Found: Unknown
- ID: M6730
- Name: Cyclosporins
- 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: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M20942
- Name: Antineoplastic Agents, Alkylating
- Relevance: LOW
- As Found: Unknown
- ID: M3820
- Name: Alkylating Agents
- Relevance: LOW
- As Found: Unknown
- ID: 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: 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: D000003520
- Term: Cyclophosphamide
- ID: C000579720
- Term: Venetoclax
- ID: D000008942
- Term: Mitoxantrone
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447077
**Brief Title:** Impact of Predetermined Day 5 ET vs. Predetermined Day 6 ET on Clinical Pregnancy Rate After ICSI Treatment
**Official Title:** Impact of Predetermined Day 5 Embryo Transfer vs. Predetermined Day 6 Embryo Transfer on Clinical Pregnancy Rate After Intracytoplasmic Sperm Injection (ICSI) Treatment
#### Organization Study ID Info
**ID:** ET d5 vs d6
#### Organization
**Class:** OTHER
**Full Name:** Infertility Treatment Center Dortmund
### Status Module
#### Completion Date
**Date:** 2028-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Fertility Center Dortmund
**Class:** UNKNOWN
**Name:** novum - Center for Reproductive Medicine Essen - Duisburg
**Class:** UNKNOWN
**Name:** Deutsche Klinik Bad Münder
#### Lead Sponsor
**Class:** OTHER
**Name:** Infertility Treatment Center Dortmund
#### Responsible Party
**Investigator Affiliation:** University of Witten/Herdecke
**Investigator Full Name:** Prof. Dr. Stefan Dieterle
**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 aim of this prospective multicenter study is to investigate the influence of a predetermined embryo transfer on day 6 compared to a predetermined embryo transfer on day 5. The study population consists of the control group (predetermined embryo transfer on day 5) and the study group (predetermined embryo transfer on day 6). The primary endpoint is the clinical pregnancy rate (detection of a gestational sac) per embryo transfer, and the secondary endpoint is the abortion rate per clinical pregnancy. The data from the multicenter study are obtained at three test centers (Fertility Center Dortmund, Fertility Center Essen and Fertility Center Bad Münder).
**Detailed Description:** Since a predetermined embryo transfer on day 5 cannot be performed in some centers on every day (e.g. sunday), some IVF centers perform an predetermined embryo transfer on day 4 or day 6, respepectively. Data for a predetermined embryo transfer on day 4 vs. a predetermined embryo transfer on day 5 showed no significant differences. However, since a day 6 transfer offers some advantages in assessing the development stage, the prolonged culture and transfer on day 6 transfer offers also a very promising option.
However, there are no prospective studies in the current literature examining the equivalence of a predetermined embryo transfer on day 6 vs. a predetermined embryo transfer on day 5.
The aim of this prospective multicenter study is to investigate the influence of a predetermined embryo transfer on day 6 compared to a predetermined embryo transfer on day 5. The study population consists of the control group (predetermined embryo transfer on day 5) and the study group (predetermined embryo transfer on day 6). The primary endpoint is the clinical pregnancy rate (detection of a gestational sac) per embryo transfer, and the secondary endpoint is the abortion rate per clinical pregnancy. The data from the multicenter study are obtained at three test centers (Fertility Center Dortmund, Fertility Center Essen and Fertility Center Bad Münder).
### Conditions Module
**Conditions:**
- Infertility
- Reproductive Issues
**Keywords:**
- ICSI
- Predetermined Day 6 Embryo Transfer
- Predetermined Day 5 Embryo Transfer
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 2400
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 9 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** The control group will include patients who have their oocyte pick-up on a Monday (embryo transfer on Saturday, day 5), Wednesday (embryo transfer on Monday, day 5), Thursday (embryo transfer on Tuesday, day 5), Friday (embryo transfer on Wednesday, day 5) and Saturday (embryo transfer on Thursday, day 5).
**Label:** Predetermined embryo transfer on day 5
#### Arm Group 2
**Description:** The study group will include patients who have their oocyte pick-up on a Tuesday (embryo transfer on Monday, day 6).
**Label:** Predetermined embryo transfer on day 6
### Outcomes Module
#### Primary Outcomes
**Description:** Clinical pregnancy rate per embryo transfer (detection of a gestational sac)
**Measure:** Clinical pregnancy rate per embryo transfer
**Time Frame:** 4 weeks after embryo transfer
#### Secondary Outcomes
**Description:** Abortion rate per clinical pregnancy (termination of an ongoing clinical pregnancy)
**Measure:** Abortion rate per clinical pregnancy
**Time Frame:** During entire ongoing pregnancy
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
The patients to be included should be ≥18 years old; there is no upper age limit. Only ICSI treatments with a single embryo transfer (SET) should be included. Only the first cycle per patient pair should be evaluated.
Exclusion Criteria:
none
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Female patients seeking ICSI treatment because of male subfertilit
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Stefan Dieterle, MD
**Phone:** 00492315575450
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Tom Trapphoff, DR
**Phone:** 00492315575450
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Witten/Herdecke
**Name:** Stefan Dieterle, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M10290
- Name: Infertility
- Relevance: HIGH
- As Found: Infertility
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007246
- Term: Infertility
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447064
**Acronym:** (CLOCS-2)
**Brief Title:** Cancer Loyalty Card Study 2 (CLOCS-2)
**Official Title:** Cancer Loyalty Card Study 2: a Retrospective Observational Case-Control Study
#### Organization Study ID Info
**ID:** 324742
#### Organization
**Class:** OTHER
**Full Name:** Imperial College London
### Status Module
#### Completion Date
**Date:** 2027-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-04-29
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-29
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Birmingham
**Class:** OTHER
**Name:** University of Nottingham
**Class:** OTHER
**Name:** University of Central Lancashire
**Class:** OTHER
**Name:** Cancer Research UK
**Class:** OTHER
**Name:** Imperial College Healthcare NHS Trust
#### Lead Sponsor
**Class:** OTHER
**Name:** Imperial College London
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Cancer is one of the leading causes of mortality worldwide and is responsible for an estimated 9.6 million deaths yearly. Cancer-related deaths can be reduced if patients are diagnosed and treated early. Delay in cancer diagnosis can occur at any point along the diagnostic spectrum, from the first observation of symptoms to the start of treatment. Diagnosing cancer when it is still at an early stage, before it has spread, gives surgery, radiotherapy and other treatments the best chance of working.
Therefore, early diagnosis is the most important way to improve cancer outcomes.
Most of the cancers usually presents with vague and non-alarming symptoms. Most individuals are diagnosed late when the cancer has already spread, and the prognosis is poor. There are over 200 different types of cancer that can cause many different signs and symptoms. Sometimes symptoms affect specific body areas, such as abdomen or skin. But signs can also be more general, and include weight loss, tiredness (fatigue) or unexplained pain. The type of symptoms varies from person to person.
The major reasons for not presenting to the GP with symptoms such as these are "not wanting to waste the GP's time" and normalisation of these symptoms. The persistence of a symptom, social influence and awareness encourage help-seeking behaviours in primary care. However, few believe their symptom(s) might be a sign of cancer. Consequently, people might choose to self-manage their symptoms by using over-the-counter medication, and to seek advice from other sources, (pharmacists, family, internet), rather than a primary care physician.
RATIONALE FOR CURRENT STUDY An early cancer diagnosis is essential for receiving treatment as early as possible to have the best chance for successful treatment. Early diagnosis of cancer can be challenging. Sometimes, the cancer symptoms resemble common illnesses and could resolve with the use of over-the-counter medications and other remedies until they become persistent or debilitating. The present study focuses on ten cancer forms: colon, oesophageal, stomach, liver, bladder, uterine, vulval, ovarian, endometrial and pancreatic. Patients diagnosed with the cancers mentioned above often report experiencing vague symptoms (such as abdominal or back pain, indigestion, feeling full etc). They often use over-the-counter medication to manage their symptoms before seeing a doctor.
Information about how often and what products participants purchase (e.g. pain killers, digestive products and natural remedies) to care for these symptoms could help identify these cancers a few crucial weeks or months earlier and encourage people to seek help sooner from their doctors.
**Detailed Description:** Purpose and Design The Cancer Loyalty Card Study-2 (CLOCS-2) addresses whether or not data already collected by high street retailers can detect significant changes in cancer patients' purchase behaviours before their diagnosis. The aim is to conduct a case-control study of cancer patients matched with participants without these cancer types. At least 750 recently diagnosed cancer patients and at least 750 participants as controls will be recruited and up to six years of prior purchase data will be collated.
Recruitment Participants, 18 years or older, with any of the aforementioned cancer forms and having at least one of the participating high street retailer's loyalty cards from Tesco or Boots in their household, will be recruited through the GP invites. All participants registering in the study and not holding the primary ownership of the loyalty cards from Tesco or Boots must register in the study along with the primary owner of the loyalty card from the same household. All the collected data will be safeguarded in a secure enclave with limited access to the CLOCS-2 team.
Consent All participants will be given the information sheet and consent form through a REDCap link shared through GP messages. They can take as much time as they need to read through the information sheet. If they choose to participate, they can complete the consent form whenever convenient and fill it out online at REDCap.
Methods Loyalty card holders with primary ownership of at least one of the participating high street retailers loyalty cards from Tesco or Boots and their family members living in the same household are eligible to participate in CLOCS-2. All participants will be invited to join the study by GP invites through text messages and can choose to sign up via a link provided in invites, that leads to REDCap. People over 18 years of age and with any form of cancer as listed earlier and who use at least one of the participating high street retailer's loyalty cards in their household will be recruited as cases. Whereas people over 18 years of age, without the diagnosis of these cancer types and using at least one of the participating high street retailer's loyalty cards in their households will be recruited as control participants.
Consenting participants will complete a brief online questionnaire at REDCap about their health, clinical history and lifestyle choices. To adhere to participating high street retailers' policies, all participants will need to provide a photo ID and utility bill for ID verification. The tentative participant recruitment date is 01/09/2023. Once the participants are recruited in the study, their past six years of purchase history will be requested from Tesco/Boots from the recruitment date. This data received from these high street retailers will be non-identifiable pseudonymised data. Participant identity will be linked to the analysis datasets only through a unique barcode assigned when completing the recruitment questionnaire, meaning the data will be pseudonymised.
The only identifiable information will be on the consent form and the participant barcode. Retailer and questionnaire data will only be linked via the pseudonymised participant barcode.
If participants consent to be re-contacted by the CLOCS-2 team for future studies or loyalty card detail clarification, they can opt for it in their consent forms. No further action is needed from participants once they complete their consent form and questionnaire (and clarify loyalty card details if necessary). Participants will be provided with the study's website and encouraged to visit the study's website for updates.
### Conditions Module
**Conditions:**
- Pancreatic Cancer
- Colon Cancer
- Oesophageal Cancer
- Stomach Cancer
- Liver Cancer
- Bladder Cancer
- Uterine Cancer
- Vulvar Cancer
- Ovarian Cancer
- Endometrial Cancer
**Keywords:**
- Ovarian Cancer
- Epidemiology
- Observational Study
- Risk Assessment
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 1500
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants diagnosed with cancer.
**Intervention Names:**
- Other: Cases & Controls
**Label:** Cases
#### Arm Group 2
**Description:** Participants not diagnosed with cancer.
**Intervention Names:**
- Other: Cases & Controls
**Label:** Controls
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cases
- Controls
**Description:** Participants will complete a brief online questionnaire at REDCap about their health, clinical history and lifestyle choices. The participant will need to provide a photo ID and utility bill for ID verification. After recruitment the participants purchase history in the past 6 years will be requested from the retailers.
**Name:** Cases & Controls
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The primary outcome of the CLOCS-2 will be to define the time by which the cases and controls are statistically significantly (p≤0.05) different in their purchase behaviours leading up to a cancer diagnosis on a population level.
**Measure:** Purchase behaviours (purchase of pain relief medications) assessed by Statistical Model
**Time Frame:** 3 years
#### Secondary Outcomes
**Description:** Defining a purchase threshold as an 'alert' about cancer symptoms in individuals and determining the predictive utility of purchasing behaviours in the early detection of these cancer forms.
**Measure:** Alert about Cancer symptoms assessed by purchase behaviour
**Time Frame:** 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Individuals, at least 18 years old, recently diagnosed and living with any of the mentioned cancer forms (colon, oesophageal, stomach, liver, bladder, uterine, vulval, ovarian, endometrial and pancreatic), diagnosed up to 2 years prior, at the latest and having loyalty card of at least one participating high street retailer in their household, are eligible to join the CLOCS-2 as cases.
* Individuals, at least 18 years old, who have not been diagnosed with any of these cancer forms and having at least one participating high street retailer loyalty card in their household, are eligible to join the CLOCS-2 as controls
Exclusion Criteria:
* Individuals under the age of 18 years.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Adults aged ≥18 years old, who own at least one participating high street retailer loyalty cad in their household. Among these individuals, those who have been diagnosed with any form of cancer as mentioned above (can join the CLOCS-2 as cases, and those who have no prior cancer diagnosis from the list of cancers mentioned above are eligible to join as controls.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sima Toopchiani
**Phone:** 02075942127
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Dr James Flanagan
**Phone:** 02075942127
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** London
**Contacts:**
***Contact 1:***
- **Name:** Emily Pickford
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** Imperial College Healthcare NHS Trust
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Imperial College London
**Name:** Dr James Flanagan
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Only aggregated and anonymised survey data will be shared with other researchers after publication. No sensitive individual level data will be shared.
**IPD Sharing:** NO
## 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: D000004700
- Term: Endocrine System Diseases
- 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: D000006058
- Term: Gonadal Disorders
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000014591
- Term: Uterine Diseases
- ID: D000014845
- Term: Vulvar Diseases
- ID: D000013272
- Term: Stomach Diseases
### 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: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12974
- Name: Ovarian Neoplasms
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M17589
- Name: Vulvar Neoplasms
- Relevance: HIGH
- As Found: Vulvar Cancer
- ID: M16064
- Name: Stomach Neoplasms
- Relevance: HIGH
- As Found: Stomach Cancer
- ID: M17342
- Name: Uterine Neoplasms
- Relevance: HIGH
- As Found: Uterine Cancer
- ID: M1704
- Name: Carcinoma, Ovarian Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M5030
- Name: Urinary Bladder Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M13110
- Name: Pancreatic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11113
- Name: Liver Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M19235
- Name: Endometrial Neoplasms
- Relevance: HIGH
- As Found: Endometrial 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: M7862
- Name: Endocrine System Diseases
- 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: M9163
- Name: Gonadal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M17339
- Name: Uterine Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17588
- Name: Vulvar Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16062
- Name: Stomach Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4387
- Name: Pancreatic Cancer
- Relevance: HIGH
- As Found: Pancreatic Cancer
- ID: T4352
- Name: Ovarian Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: T5877
- Name: Vulvar Cancer
- Relevance: HIGH
- As Found: Vulvar Cancer
- ID: T5486
- Name: Stomach Cancer
- Relevance: HIGH
- As Found: Stomach Cancer
- ID: T2141
- Name: Esophageal Cancer
- Relevance: HIGH
- As Found: Oesophageal Cancer
- ID: T4354
- Name: Ovarian Epithelial Cancer
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010051
- Term: Ovarian Neoplasms
- ID: D000016889
- Term: Endometrial Neoplasms
- ID: D000014846
- Term: Vulvar Neoplasms
- ID: D000013274
- Term: Stomach Neoplasms
- ID: D000014594
- Term: Uterine Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447051
**Brief Title:** Efficacy of New Post Kasai ILBS Protocol in Biliary Atresia.
**Official Title:** Efficacy of New Post Kasai ILBS Protocol in BiliaryAtresia.
#### Organization Study ID Info
**ID:** ILBS-Biliary Atresia-01
#### Organization
**Class:** OTHER
**Full Name:** Institute of Liver and Biliary Sciences, India
### Status Module
#### Completion Date
**Date:** 2026-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Institute of Liver and Biliary Sciences, India
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Biliary atresia (BA) is a neonatal progressive fibrosing cholan- giopathy and the most frequent indication for pediatric liver trans- plantation \[1\]. Surgical removal of biliary remnants and Roux-en-Y hepatoportoenterostomy (HPE) aims to restore biliary drainage and suppress progression to cirrhosis. Successful HPE, defined as a serum total bilirubin level \<2 mg/dL at three months after surgery, occurs in ∼50% of patients in the United States \[2\]. Young age seems to be the best predictor of response to HPE, with limited data on the efficacy of adjuvant therapies such as corticosteroids, antibiotics, and choleretic agents \[3,4\]. Potential modes of action of these therapies are to increase bile flow as well as exert an anti- inflammatory effect \[5\].
In 2007, a double-blind randomized trial in the United Kingdom identified a beneficial effect on corticosteroid therapy on reduction of bilirubin level at one month post HPE without sig- nificant change in the need for liver transplantation \[6\]. Since then there have been multiple trial most prominent being, Kings hospital trial \[7\] and START trial \[8\] which demonstrated reduction in bilirubin levels; however both failed to demonstrate any effect on native liver survival.
However one study done by Bezerra et al \[9\] where they employed steroid in customised manner showed significant improvement in bile drainage in their subjects versus their historical cohort. Hence we propose to perform a prospective cohort study to assess the Efficacy of new post Kasai (steroid) ILBS protocol in Biliary Atresia.
**Detailed Description:** Study population : Subject undergoing Kasai Sx at Institute of Liver and Biliary Sciences would be enrolled and will include retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024).
Study design: Cohort study with historical control ( Jan 2015- Dec 2017) Sample size: Time bound. All cases presenting during the study period will be included in the study.
Monitoring and assessment: Liver function test, Hemogram and International Normalised Ratio (INR) would be done weekly for one month, twice weekly for 2nd month and monthly thereafter till 1 year.
Statistical Analysis: Appropriate statistical test for correlation analysis will be applied.
Adverse effects: As per previous studies done , no serious adverse effect has been noted in treatment group vs control group.
### Conditions Module
**Conditions:**
- Biliary Atresia
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subject undergoing Kasai Surgery at Institute of Liver and Biliary Sciences would be enrolled and will include retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024).
**Intervention Names:**
- Other: Kasai Surgery
**Label:** Biliary Atresia
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Biliary Atresia
**Description:** As per institute treatment protocol
**Name:** Kasai Surgery
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** We expect steroids used in customized manner to improve biliary drainage and thereby improve native liver survival in post kasai patients.
**Time Frame:** Within 6 months
#### Secondary Outcomes
**Measure:** Improved survival with native liver at 12 months of age.
**Time Frame:** 12 months
**Measure:** Reduced progression of portal Hypertension at 6 & 12 months
**Time Frame:** 6 & 12 months
**Measure:** Improved Growth parameters at 3, 6, 12 months
**Time Frame:** 3, 6, 12 months
**Measure:** Reduction in Bilirubin levels at 3, 6, 12 month
**Time Frame:** 3, 6, 12 months
**Measure:** Reduced PELD at 3, 6, 12 months
**Time Frame:** 3, 6, 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Post Kasai Biliary atresia operated at ILBS with retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024).
Exclusion Criteria:
1. Subjects having major surgical complications
2. Defaulters or Patient not following protocol/not giving consent
3. Biliary atresia splenic malformation
**Maximum Age:** 6 Months
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** Subject undergoing Kasai Sx at Institute of Liver and Biliary Sciences would be enrolled and will include retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024).
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Dr Anmol Anmol, MD
**Phone:** 01146300000
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** New Delhi
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dr Anmol, MD
- **Phone:** 01146300000
- **Role:** CONTACT
**Country:** India
**Facility:** Institute of Liver & Biliary Sciences
**State:** Delhi
**Zip:** 110070
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001649
- Term: Bile Duct Diseases
- ID: D000001660
- Term: Biliary Tract Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000004065
- Term: Digestive System Abnormalities
- ID: D000000013
- Term: Congenital Abnormalities
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4942
- Name: Biliary Atresia
- Relevance: HIGH
- As Found: Biliary Atresia
- ID: M4935
- Name: Bile Duct Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4946
- Name: Biliary Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M7254
- Name: Digestive System Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: T757
- Name: Biliary Atresia
- Relevance: HIGH
- As Found: Biliary Atresia
### Condition Browse Module - Meshes
- ID: D000001656
- Term: Biliary Atresia
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447038
**Acronym:** NDO
**Brief Title:** Pilot Study for the Early Detection of Chronic Kidney Disease, Non-Dialysis Objective (NDO).
**Official Title:** Pilot Study for the Early Detection of Chronic Kidney Disease, Non-Dialysis Objective (NDO).
#### Organization Study ID Info
**ID:** OND 01
#### Organization
**Class:** OTHER
**Full Name:** Hospital Universitario de Burgos
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-03
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospital Universitario de Burgos
#### Responsible Party
**Investigator Affiliation:** Hospital Universitario de Burgos
**Investigator Full Name:** Didier Sánchez OSpina
**Investigator Title:** Doctor investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Chronic kidney disease (CKD) is a significant public health problem worldwide, affecting more than 10% of the Spanish population. Early detection is considered a top healthcare priority to establish strategies for preventing progression to more advanced stages of the disease and its complications. Additionally, CKD is associated with high comorbidity, poor prognosis, and substantial resource consumption within the healthcare system. In this context, albuminuria may be a more sensitive marker of CKD than reduced glomerular filtration rate (GFR), and it is also considered an indicator of not only renal damage but also \"systemic damage\" (generalized endothelial dysfunction, arterial remodeling, and increased cardiovascular risk) beyond the kidney. Furthermore, the reduction of proteinuria/albuminuria is clearly associated with a slower progression of CKD, making its reduction a therapeutic goal as well. Given this importance, this protocol aims to determine the urine albumin/creatinine ratio in all patients over 18 years old who visit their primary care physician in the province of Burgos, Spain, and require a blood test related to their reason for consultation.
**Detailed Description:** This is a protocol in which we seek to identify those patients with alterations incipient renal failure by determining the albumin/creatinine ratio in urine, test that is currently performed routinely in different groups of patients. By For this reason, the implementation of the non-dialysis objective protocol hopes to be implemented standardized form in patients who go to their primary attention doctor in the province of Burgos to later be extended to the entire Castilla y Leon community.
.
### Conditions Module
**Conditions:**
- Chronic Kidney Disease (CKD)
**Keywords:**
- Epidemiology.
- Chronic kidney disease.
- Primary care.
- Cardiovascular risk factors.
### Design Module
#### Design Info
**Observational Model:** ECOLOGIC_OR_COMMUNITY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 10000
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 10 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** Population of the city of Burgos \> 18 years old.
**Intervention Names:**
- Diagnostic Test: albumin creatinine ratio
**Label:** Population
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Population
**Description:** Albumin creatinine ratio, this test is routinely performed in urine.
**Name:** albumin creatinine ratio
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Determination of albuminuria in urine.
**Measure:** Albumin creatinine ratio.
**Time Frame:** 01/02/2024 al 01/12/2024
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Minimum age 18 years
Exclusion Criteria:
* Age less than 18 years
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Population of the city of Burgos, Spain who go to their primary doctor.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Burgos
**Country:** Spain
**Facility:** Maria J Izquierdo
**Zip:** 09003
#### Overall Officials
**Official 1:**
**Affiliation:** HUBU
**Name:** Maria J Izquierdo Ortiz, Doctor
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** HUBU
**Name:** Emilio J Gonzalez Parra, Doctor
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** HUBU
**Name:** Sebastian Mas Fontao, Doctor
**Role:** PRINCIPAL_INVESTIGATOR
**Official 4:**
**Affiliation:** HUBU
**Name:** Maria Martin Palencia, Doctor
**Role:** PRINCIPAL_INVESTIGATOR
**Official 5:**
**Affiliation:** HUBU
**Name:** Didier Sanchez, Doctor
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney Disease. Lancet. 2017 Mar 25;389(10075):1238-1252. doi: 10.1016/S0140-6736(16)32064-5. Epub 2016 Nov 23.
**PMID:** 27887750
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000051437
- Term: Renal Insufficiency
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Kidney Disease
- ID: M26717
- Name: Renal Insufficiency, Chronic
- Relevance: HIGH
- As Found: Chronic Kidney Disease
- ID: M26718
- Name: Renal Insufficiency
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: HIGH
- As Found: Chronic
### Condition Browse Module - Meshes
- ID: D000007674
- Term: Kidney Diseases
- ID: D000051436
- Term: Renal Insufficiency, Chronic
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447025
**Acronym:** Jive
**Brief Title:** An Open Label Extension Study of CTI-1601 in Subjects With Friedreich's Ataxia
**Official Title:** Jive: An Open Label Extension Study to Assess the Long-term Safety, Efficacy, Pharmacodynamics, Pharmacokinetics, and Tolerability of Subcutaneous CTI-1601 in Subjects With Friedreich's Ataxia
#### Organization Study ID Info
**ID:** CLIN-1601-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Larimar Therapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2027-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2027-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-25
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-02-15
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Larimar Therapeutics, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is an open-label extension (OLE) study designed to evaluate the long-term safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and clinical effects of subcutaneous (SC) administration of CTI-1601, also known as nomlabofusp, in subjects with Friedreich's ataxia (FRDA).
The objectives of this OLE study are:
* To evaluate the safety of long-term subcutaneous (SC) administration of CTI-1601 in subjects with FRDA
* To evaluate the PK of long-term subcutaneous (SC) administration of CTI-1601 in subjects with FRDA
* To evaluate the effect of long-term subcutaneous (SC) administration of CTI-1601 in subjects with FRDA on:
* Tissue FXN concentrations
* Clinical evaluations of FRDA
* Gene Expression and select lipids
**Detailed Description:** This is an open label extension (OLE) study in patients with FRDA who participated in a prior clinical study of CTI-1601 to evaluate the safety, PK, PD, and clinical effects of long-term daily administration of CTI-1601.
### Conditions Module
**Conditions:**
- Friedreich Ataxia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 75
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** CTI-1601 will be administered daily
**Intervention Names:**
- Biological: CTI-1601
**Label:** CTI-1601
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CTI-1601
**Description:** CTI-1601 is a recombinant fusion protein and is intended to deliver human frataxin, the protein deficient in Friedreich's ataxia
**Name:** CTI-1601
**Other Names:**
- Nomlabofusp
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Measure:** Number of subjects with treatment-emergent adverse events (TEAEs) by System Organ Class (SOC), Preferred Term (PT) and Maximum Severity
**Time Frame:** Up to 24 months
**Measure:** Number of subjects with abnormal laboratory test results
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in electrocardiogram (ECG) parameters including, but not limited to, HR, RR interval, PR interval, QRS duration, QT interval, and QTcF interval
**Time Frame:** Up to 24 months
**Description:** LVEF indicates the percentage of change in LV volume from diastole to systole that measures how well the left ventricle of the heart pumps blood.
**Measure:** Change from baseline in left ventricular ejection fraction (LVEF)
**Time Frame:** Up to 24 months
**Description:** LVEDV is the amount of blood, measured in milliliters (mL), in the heart's left ventricle just before the heart contracts.
**Measure:** Change from baseline in left ventricular end-diastolic volume (LVEDV)
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in blood pressure (mmHg)
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in pulse (bpm)
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in temperature (°C)
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in respiration rate (breaths per minute)
**Time Frame:** Up to 24 months
**Description:** The Columbia Suicide Severity Rating Scale (C-SSRS) is a tool used to assess the occurrence, severity, and frequency of suicidal thoughts and behaviors. A higher score on the C-SSRS generally indicate a worse outcome, as they signify a higher level of suicidal ideation or behavior.
**Measure:** Number of subjects with any suicidal ideation or behavior (Categories 1-10) of the Columbia Suicide Severity Rating Scale (C-SSRS)
**Time Frame:** Up to 24 months
**Measure:** Change from baseline at each collection timepoint in tissue frataxin concentrations normalized to total protein observed in buccal cells collected from cheek swabs and skin cells collected from skin punch biopsies
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in motor function as assessed by 9-hole peg test (9-HPT)
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in motor function as assessed by the timed 25-foot walk test (T25-FW)
**Time Frame:** Up to 24 months
**Description:** The Modified Friedreich's Ataxia Rating Scale (mFARS) is a modified neurologic scale involving direct subject participation and targets specific areas impacted by Friedreich's ataxia (bulbar, upper limb, lower limb, and upright stability), with scores ranging from 0-67 points, with higher scores indicating a greater level of disability.
**Measure:** Change from baseline in neurologic function as assessed by the modified Friedreich's Ataxia Rating Scale (mFARS) total score
**Time Frame:** Up to 24 months
**Description:** The Upright Stability Subscale is an assessment of an individual's ability to maintain balance and stability while standing upright. It has a minimum value of 0 and a maximum value of 36. A higher score indicates a better outcome, reflecting greater stability and balance abilities while standing upright.
**Measure:** Change from baseline in neurologic function as assessed by the upright stability subscale examination of the mFARS
**Time Frame:** Through study completion, up to 24 months
**Description:** The FARS_ADL, scored 0 to 36, is a subscale of FARS assessing a subject's ability to complete activities of daily living. A higher score indicates a greater level of disability. The FARS_ADL questionnaire will be performed at the timepoints indicated in protocol.
**Measure:** Change in activities of daily living (ADLs) as assessed by the Friedreich's Ataxia Rating Scale Activities of Daily Living (FARS_ADL)
**Time Frame:** Up to 24 months
**Description:** The Modified Fatigue Impact Scale (MFIS) is a revised form of the Fatigue Impact Scale based on items derived from interviews with MS patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. Participants rate on a 5-point scale, with 0 = 'Never' to 4 = 'Almost always' their agreement with 21 statements. Total score (0-84) and subscales for physical (0-36), cognitive (0-40) and psychosocial functioning (0-8). The 5-item version is scored (0-20). Higher numbers indicate greater fatigue. The MFIS will be performed at the timepoints indicated in protocol.
**Measure:** Change from baseline in total fatigue score and all the subscale scores as assessed by the Fatigue Impact Scale (MFIS)
**Time Frame:** Up to 24 months
**Measure:** Change from baseline in the assessment of disease as assessed by the Functional Staging for Ataxia
**Time Frame:** Up to 24 months
**Description:** The Patient Global Impression of Change (PGI-C) reflects a patient's assessment about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." The PGI-C will be performed at the timepoints indicated in protocol.
**Measure:** Overall impression of change as assessed by the patient using the Patient Global Impression of Change (PGI-C) Scale
**Time Frame:** Up to 24 months
**Description:** The Clinical Global Impression of Change (CGI-C) is an assessment to measure change in clinical status (symptoms and functional ability) of the subject's condition from baseline with study drug. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). The CGI-C will be performed at the timepoints indicated in protocol.
**Measure:** Overall impression of change assessed by a clinician using the Clinical Global Impression of Change (CGI-C)
**Time Frame:** Up to 24 months
**Measure:** Area under the concentration-time curve for the dosing interval (AUC0-tau)
**Time Frame:** Days 1, 30, 60, 90: pre-dose, 5, 15, 30 minutes after the dose, and 1, 2, 4, 6, 8 hours after the dose; Day 180: pre-dose and 5, 15 minutes after the dose; Days 270, 360, Q3M thereafter: pre-dose; through study completion, up to 24 months
**Measure:** Area under the concentration-time curve from time 0 to the time of last quantifiable concentration (AUC0-t)
**Time Frame:** Days 1, 30, 60, 90: pre-dose, 5, 15, 30 minutes after the dose, and 1, 2, 4, 6, 8 hours after the dose; Day 180: pre-dose and 5, 15 minutes after the dose; Days 270, 360, Q3M thereafter: pre-dose; through study completion, up to 24 months
**Measure:** Mean maximum observed concentration (Cmax)
**Time Frame:** Days 1, 30, 60, 90: pre-dose, 5, 15, 30 minutes after the dose, and 1, 2, 4, 6, 8 hours after the dose; Day 180: pre-dose and 5, 15 minutes after the dose; Days 270, 360, Q3M thereafter: pre-dose; through study completion, up to 24 months
**Measure:** Mean time of maximum observed concentration (Tmax)
**Time Frame:** Days 1, 30, 60, 90: pre-dose, 5, 15, 30 minutes after the dose, and 1, 2, 4, 6, 8 hours after the dose; Day 180: pre-dose and 5, 15 minutes after the dose; Days 270, 360, Q3M thereafter: pre-dose; through study completion, up to 24 months
**Measure:** Concentration reached immediately before the next dose is administered (Ctrough)
**Time Frame:** Days 1, 30, 60, 90: pre-dose, 5, 15, 30 minutes after the dose, and 1, 2, 4, 6, 8 hours after the dose; Day 180: pre-dose and 5, 15 minutes after the dose; Days 270, 360, Q3M thereafter: pre-dose; through study completion, up to 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects with FRDA who previously completed participation in a study of CTI-1601 will be eligible to participate in this study unless the subject experienced one or more of the following in a previous CTI-1601 study: a) serious adverse event (SAE) related to study drug; b) significant AE, defined as Grade 3 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 (or higher), related to study drug; c) some other event, related to participation in a previous study with CTI-1601, that supports the exclusion of the subject from participating in this study as determined by the Sponsor (i.e., an AE considered clinically significant by the Sponsor regardless of whether it met SAE criteria and regardless of CTCAE grade); d) Withdraw from participation in a previous study of CTI-1601 for any reason.
* Subject has a HbA1c less than or equal to 7.0%.
* Subject must demonstrate sufficient dexterity and visual acuity to prepare and self-administer SC injections of CTI-1601 QD or is able to identify a caregiver who will be trained and committed to prepare and administer the daily injections.
Exclusion Criteria:
Subjects are excluded from the study if any of the following exclusion criteria are met:
* Subjects who are confirmed as compound heterozygous (GAA repeat expansion on only one allele) for FRDA.
* Subject has any condition, disease, or situation, including a cardiac condition or disease, that in the opinion of the PI, could confound the results of the study or put the subject at undue risk, making participation inadvisable.
* Subject used any investigational drug (other than CTI-1601) or device within 90 days prior to Screening.
* Subject requires use of amiodarone.
* Subject used erythropoietin, etravirine, or gamma interferon within 90 days prior to Screening.
* Subject use of biotin supplementation that exceeds 30 mcg/day, either as part of a multivitamin or as a standalone supplement, within 7 days prior to the first dose of study drug. Biotin supplementation ≤30 mcg/day is permitted if taken at a stable dose and frequency for at least 28 days prior to Screening and there is a commitment from the subject to maintain the biotin dose throughout the study (due to interference with assays).
* Subject uses more than 3 grams of acetaminophen daily.
* Subject receives medication that requires SC injection in the abdomen or thigh.
* Subject is unable to discontinue medications that have not been at a stable dose and frequency for at least 28 days prior to Screening.
* Subject has a Screening echocardiogram (ECHO) LVEF \< 45%.
* Male subject has a QTcF \> 450 milliseconds or female subject has a QTcF \> 470 milliseconds on an ECG.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Los Angeles
**Country:** United States
**Facility:** University of California Los Angeles
**State:** California
**Zip:** 90095
**Location 2:**
**City:** Gainesville
**Country:** United States
**Facility:** Fixel Institute for Neurological Disease, University of Florida Health
**State:** Florida
**Zip:** 32608
**Location 3:**
**City:** Tampa
**Country:** United States
**Facility:** Morsani Center for Advanced Health Care, University of South Florida Health
**State:** Florida
**Zip:** 33612
**Location 4:**
**City:** Iowa City
**Country:** United States
**Facility:** University of Iowa
**State:** Iowa
**Zip:** 52242
**Location 5:**
**City:** Eatontown
**Country:** United States
**Facility:** Clinilabs Drug Development, Corp.
**State:** New Jersey
**Zip:** 07724
**Location 6:**
**City:** Columbus
**Country:** United States
**Facility:** Ohio State University United States
**State:** Ohio
**Zip:** 43210
**Location 7:**
**City:** Philadelphia
**Country:** United States
**Facility:** Hospital of the University of Pennsylvania
**State:** Pennsylvania
**Zip:** 19104
#### Overall Officials
**Official 1:**
**Affiliation:** Larimar Therapeutics, Inc.
**Name:** Larimar Therapeutics, Inc.
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Delatycki MB, Corben LA. Clinical features of Friedreich ataxia. J Child Neurol. 2012 Sep;27(9):1133-7. doi: 10.1177/0883073812448230. Epub 2012 Jun 29.
**PMID:** 22752493
**Citation:** Deutsch EC, Santani AB, Perlman SL, Farmer JM, Stolle CA, Marusich MF, Lynch DR. A rapid, noninvasive immunoassay for frataxin: utility in assessment of Friedreich ataxia. Mol Genet Metab. 2010 Oct-Nov;101(2-3):238-45. doi: 10.1016/j.ymgme.2010.07.001. Epub 2010 Jul 8.
**PMID:** 20675166
**Citation:** Fahey MC, Corben L, Collins V, Churchyard AJ, Delatycki MB. How is disease progress in Friedreich's ataxia best measured? A study of four rating scales. J Neurol Neurosurg Psychiatry. 2007 Apr;78(4):411-3. doi: 10.1136/jnnp.2006.096008. Epub 2006 Oct 20.
**PMID:** 17056635
**Citation:** Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994 Jan;18 Suppl 1:S79-83. doi: 10.1093/clinids/18.supplement_1.s79.
**PMID:** 8148458
**Citation:** Goodkin DE, Hertsgaard D, Seminary J. Upper extremity function in multiple sclerosis: improving assessment sensitivity with box-and-block and nine-hole peg tests. Arch Phys Med Rehabil. 1988 Oct;69(10):850-4.
**PMID:** 3178453
**Citation:** Koeppen AH. Friedreich's ataxia: pathology, pathogenesis, and molecular genetics. J Neurol Sci. 2011 Apr 15;303(1-2):1-12. doi: 10.1016/j.jns.2011.01.010.
**PMID:** 21315377
**Citation:** Guidelines MSCfCP. Fatigue and multiple sclerosis: evidence-based management strategies for fatigue in multiple sclerosis. 1998.
**Citation:** Lazaropoulos M, Dong Y, Clark E, Greeley NR, Seyer LA, Brigatti KW, Christie C, Perlman SL, Wilmot GR, Gomez CM, Mathews KD, Yoon G, Zesiewicz T, Hoyle C, Subramony SH, Brocht AF, Farmer JM, Wilson RB, Deutsch EC, Lynch DR. Frataxin levels in peripheral tissue in Friedreich ataxia. Ann Clin Transl Neurol. 2015 Aug;2(8):831-42. doi: 10.1002/acn3.225. Epub 2015 Jul 1.
**PMID:** 26339677
**Citation:** Pandolfo M. Friedreich ataxia. Arch Neurol. 2008 Oct;65(10):1296-303. doi: 10.1001/archneur.65.10.1296.
**PMID:** 18852343
**Citation:** Rudick R, Antel J, Confavreux C, Cutter G, Ellison G, Fischer J, Lublin F, Miller A, Petkau J, Rao S, Reingold S, Syndulko K, Thompson A, Wallenberg J, Weinshenker B, Willoughby E. Clinical outcomes assessment in multiple sclerosis. Ann Neurol. 1996 Sep;40(3):469-79. doi: 10.1002/ana.410400321.
**PMID:** 8797541
**Citation:** Wang C, Lu N, Chen WC, Li H, Tiwari R, Xu Y, Yue LQ. Propensity score-integrated composite likelihood approach for incorporating real-world evidence in single-arm clinical studies. J Biopharm Stat. 2020 May 3;30(3):495-507. doi: 10.1080/10543406.2019.1684309. Epub 2019 Nov 10.
**PMID:** 31707908
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020820
- Term: Dyskinesias
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000002526
- Term: Cerebellar Diseases
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000013132
- Term: Spinocerebellar Degenerations
- ID: D000013118
- Term: Spinal Cord Diseases
- ID: D000020271
- Term: Heredodegenerative Disorders, Nervous System
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000028361
- Term: Mitochondrial Diseases
- ID: D000008659
- Term: Metabolic Diseases
### 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: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4565
- Name: Ataxia
- Relevance: HIGH
- As Found: Ataxia
- ID: M5773
- Name: Cerebellar Ataxia
- Relevance: HIGH
- As Found: Ataxia
- ID: M8741
- Name: Friedreich Ataxia
- Relevance: HIGH
- As Found: Friedreich's Ataxia
- ID: M22574
- Name: Dyskinesias
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M5775
- Name: Cerebellar 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: M22510
- Name: Spinocerebellar Ataxias
- Relevance: LOW
- As Found: Unknown
- ID: M15929
- Name: Spinocerebellar Degenerations
- Relevance: LOW
- As Found: Unknown
- ID: M15915
- Name: Spinal Cord Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22092
- Name: Heredodegenerative Disorders, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M23341
- Name: Mitochondrial Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2386
- Name: Friedreich Ataxia
- Relevance: HIGH
- As Found: Friedreich's Ataxia
- ID: T5352
- Name: Spinocerebellar Ataxia
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001259
- Term: Ataxia
- ID: D000002524
- Term: Cerebellar Ataxia
- ID: D000005621
- Term: Friedreich Ataxia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06447012
**Brief Title:** Artificial Intelligence Development for Colorectal Polyp Diagnosis
**Official Title:** Development of a Novel Real Time Computer Assisted Colonoscopy Diagnostic Tool for Colorectal Polyps: Lesion Diagnosis and Personalised Patient Management
#### Organization Study ID Info
**ID:** 323988
#### Organization
**Class:** OTHER
**Full Name:** King's College Hospital NHS Trust
### Status Module
#### Completion Date
**Date:** 2026-05-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-04
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** King's College Hospital NHS Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Accurate classification of growths in the large bowel (polyps) identified during colonoscopy is imperative to inform the risk of colorectal cancer. Reliable identification of the cancer risk of individual polyps helps determine the best treatment option for the detected polyp and determine the appropriate interval requirements for future colonoscopy to check the site of removal and for further polyps elsewhere in the bowel.
Current advanced endoscopic imaging techniques require specialist skills and expertise with an associated long learning curve and increased procedure time. It is for these reasons that despite being introduced in clinical practice, uptake of such techniques is limited and current methods of polyp risk stratification during colonoscopy without Artificial intelligence (AI) is suboptimal. Approximately 25% of bowel polyps that are removed by major surgery are analysed and later proved to be non-cancerous polyps that could have been removed via endoscopy thus avoiding anatomy altering surgery and the associated risks. With accurate polyp diagnosis and risk stratification in real time with AI, such polyps could have been removed non-surgically (endoscopically). Current Computer Assisted Diagnosis (CADx, a form of AI) platforms only differentiate between cancerous and non cancerous polyps which is of limited value in providing a personalised patient risk for colorectal cancer. The development of a multi-class algorithm is of greater complexity than a binary classification and requires larger training and validation datasets. A robust CADx algorithm should also involve global trainable data to minimise the introduction of bias. It is for these reasons that this is a planned international multicentre study.
The Investigators aim to develop a novel AI five class pathology prediction risk prediction tool that provides reliable information to identify cancer risk independent of the endoscopists skill.
These 5 categories are chosen because treatment options differ according to the polyp type and future check colonoscopy guidelines require these categories
**Detailed Description:** The use of artificial intelligence in computer-assisted detection (CADe) to detect polyps (pre-cancerous growths) during colonoscopy is gaining increasing interest and acceptance with multiple devices already in the mainstream market. The Investigator know already from work in other countries that detecting more polyps results in a reduced risk of bowel cancer for the patient having the procedure, in the years following their colonoscopy (ie. pre-cancerous growths were detected and removed). This has formed the basis of national bowel cancer screening programmes. With increased detection of colorectal polyps, there is a growing need to correctly identify the nature of the polyp to inform the risk of colorectal cancer with the polyp detected and also the potential future risk to the patient. Accurate polyp diagnosis is also required to determine the correct mode or removal-whether this does require removal at all (leading to conservation of costs and resources in a challenging current climate), whether endoscopic removal is possible and if so by what procedure, whether surgery is required.
Published data demonstrates that approximately one quarter of surgically removed colorectal polyps with patients undergoing major surgery were benign and therefore major surgery could have been avoided with these polyps removed endoscopically reducing the risk of complication and organ preservation for the patient.
Current polyp diagnosis techniques involve the use and interpretation of specialist dyes and magnification endoscopes which come with gaining expertise expertise with an associated learning curve and increased procedure time. It is for these reasons that despite being introduced in clinical practice, uptake of such techniques is limited and current methods of polyp risk stratification during colonoscopy without AI is suboptimal.
Current polyp diagnosis AI (CADx) algorithms are limited to smaller classification Current CADx platforms differentiate between cancerous and non-cancerous polyps which is of limited value in providing a personalised patient risk for colorectal cancer. The development of a multiclass algorithm is of greater complexity than a binary classification and requires larger training and validation datasets. A robust CADx algorithm should also involve global trainable data to minimise the introduction of bias. It is for these reasons that this is a planned international multicentre study
Prospective collection of data:
This study will be conducted alongside usual patient care, but will require research staff to enter data onto a secure web-based report form (REDCAP database). This means that participants will undergo exactly the same procedure, with no differences and no extra visits or data, than would have otherwise have occurred. Participants will be those patients that have been scheduled to have a colonoscopy for the standard reasons. Patients will be invited in the usual way for colonoscopy.
They may - where possible - be sent the PIS with their appointment letter (up to 6 weeks in advance). On arrival in the endoscopy unit, they will be approached by a member of the research team and given a copy of the PIS to read - up to an hour before their procedure. They will be provided face-to-face information and explanation, prior to written consent to allow their data to be collected in the database. As the study does not require any change or additional procedures, The investigator feel that an initial approach on arrival into the endoscopy unit will provide sufficient, appropriate time to consent, even if the PIS has not been read in advance (although it will be sent if possible). The only additional consideration will be the consent to recording of the video (no patient identifiable data will be transferred as part of this aspect).
Once the colonoscopy has been completed, there will be no additional visits.
### Conditions Module
**Conditions:**
- Polyp of Colon
- Colorectal Polyp
**Keywords:**
- Artificial Intelligence
- Computer assisted diagnosis (CADx)
- Colorectal cancer
- Colorectal polyp
- Machine learning
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 4000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** No intervention required from this study, however images will be obtained from patient presenting for colonoscopy
**Name:** Colonoscopy
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Sensitivity and Specificity
**Measure:** To achieve an overall accuracy of 85% for the five-classification lesion prediction algorithm.
**Time Frame:** 24 months
**Description:** Assess the accuracy to the trained device
**Measure:** Positive and negative predicted value
**Time Frame:** 24 months
#### Secondary Outcomes
**Description:** We will analyse the calculate the histology agreement between the advance endoscopist
**Measure:** Interobserver agreement of the endoscopists' prediction of histology of polyps during the annotation process.
**Time Frame:** 36 months
**Description:** To assess if the prediction of patient gender, ethnicity, and age is possible with use of the developed CADx model.
**Measure:** Sub-analysis of the polyp characteristics focused on different gender and ethnicity.
**Time Frame:** 36 months
**Description:** A qualitative analysis of CADx incorrect diagnoses will also be conducted by a multidisciplinary panel to evaluate potential impact
**Measure:** This will be a sub analysis of an AI algorithm that is trained to predict polyp histology using the prospective data cohort.
**Time Frame:** 36 months
**Description:** We will evaluate if the use of AI during colonoscopy can be a learning tools for endoscopist
**Measure:** Learned effects of AI augmented endoscopy on endoscopist optical diagnosis
**Time Frame:** 36 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
- Above 18 years at inclusion Symptomatic or screening colonoscopy
Exclusion Criteria:
* Unable to provide informed consent.
* Colitis Associated Dysplasia
* Polyps at surgical anastomosis sites
* Pregnancy
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** All adult (over 18 years) presenting for screening or symptomatic colonoscopy
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Shraddha B Gulati, MBBS PHD MRCP
**Phone:** +442032996044
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Olaolu Olabintan, MBBS MRCP
**Phone:** +447939056819
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** London
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Shraddha B Gulati, MBBS PHD MRCP
- **Phone:** +442032996044
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Olaolu Olabintan, MBBS MRCP
- **Phone:** +447939056819
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** King's College Hospital NHS Foundation Trust
**Status:** RECRUITING
**Zip:** SE5 9RS
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000007417
- Term: Intestinal Polyps
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14011
- Name: Polyps
- Relevance: HIGH
- As Found: Polyps
- ID: M6339
- Name: Colonic Polyps
- Relevance: HIGH
- As Found: Polyp of Colon
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M10451
- Name: Intestinal Polyps
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011127
- Term: Polyps
- ID: D000003111
- Term: Colonic Polyps
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446999
**Brief Title:** Yoga-Based Breathing Exercise, Colorectal Cancer Surgery
**Official Title:** The Effect of Yoga-Based Breathing Exercise on Pain, Fatigue, Insomnia, and Self-Efficacy in Individuals Undergoing Colorectal Cancer Surgery-Randomized Controlled Study
#### Organization Study ID Info
**ID:** KaratayFG
#### Organization
**Class:** OTHER
**Full Name:** KTO Karatay University
### Status Module
#### Completion Date
**Date:** 2024-07-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** KTO Karatay University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study was designed as a prospective, parallel two groups and randomized controlled study with an experimental-control group to evaluate the effect of yoga-based breathing exercise on pain, fatigue, insomnia and self-efficacy in individuals undergoing colorectal cancer surgery. The sample size of the study was conducted with 60 patients, 30 in the control group and 30 in the experimental group, according to the results of a similar study with the G\*Power 3.1., 9.7 program, with α = 0.05, 80% power and 0.648 effect, and taking into account possible losses. was planned. Research inclusion criteria; Patients who underwent colorectal cancer surgery for the first time were those who were 18 years of age or older, had a mobile phone suitable for downloading the yoga-based breathing exercise video, used the same type and dose of painkillers, and volunteered to participate in the study. "Personal Information Form", "VAS Pain Scale", "Brief Fatigue Inventory", "Richard Campbell Sleep Scale" and "Health Promotion Strategies Used by Patients Scale" will be used to collect data. Participants assigned to the experimental group will be provided with breathing exercises using a protocol containing Yoga-based breathing exercises. In order to conduct the research, approval will be obtained from KTO Karatay University Non-Drug and Medical Device Research Ethics Committee, ethics committee approval and permission will be obtained from the institution where the research will be conducted. Participation in the study is voluntary and written consent will be obtained from the participants. The data will be evaluated in the IBM SPSS Statistics Standard Concurrent User V 26 (IBM Corp., Armonk, New York, USA) statistical package program. A level of p\<0.05 will be considered statistically significant.
**Detailed Description:** Colorectal cancers are the third most common type of cancer in terms of incidence worldwide and the second leading cause of death. Surgical treatment, chemotherapy and radiotherapy are generally used in the treatment of colorectal cancers. Side effects such as pain, nausea-vomiting, intestinal problems, and fatigue may occur after colorectal cancer surgery (CRCS). In addition, in patients who subsequently receive chemotherapy or radiotherapy, these patients may experience symptom distress and their quality of life may be negatively affected due to side effects such as nausea, vomiting, diarrhea, malnutrition, peripheral neuropathy and fear of cancer recurrence. Pharmacological methods in the management of fatigue are quite limited, and the effect of non-pharmacological approaches such as cognitive behavioral therapies, relaxation, exercise, training of patients and their relatives for fatigue management, exercise, cognitive behavioral therapies, and meditation is effective. Studies evaluating it are increasing. However, it has been stated that very few (10%) of cancer patients experiencing severe fatigue do yoga to manage fatigue. This research was planned to evaluate the effect of yoga-based breathing exercise on pain, fatigue, insomnia and self-efficacy in individuals undergoing colorectal cancer surgery.
Type of Research: This study was designed as a prospective, parallel 3-group and randomized controlled study with an experimental-control group to evaluate the effect of yoga-based breathing exercise on pain, fatigue, insomnia and self-efficacy in individuals undergoing colorectal cancer surgery.
Place and Time of the Research: The research will be conducted at Necmettin Erbakan University Meram Medical Faculty General Surgery Clinic between 01 September 2023 and 30 July 2024.
Population and Sample of the Research: The research population will consist of patients who come for colorectal cancer surgery between 01 September 2023 and 30 July 2024 at Necmettin Erbakan University Meram Faculty of Medicine General Surgery Clinic, where the research will be conducted. The sample number of the study was determined according to the results of a similar study with the G\*Power 3.1., 9.7 program with α = 0.05 and 80% power and 0.648 effect. The sample was determined as 50 patients, 25 patients in the experimental group and 25 patients in the control group. Considering possible losses during the study, it was planned to include a total of 60 patients, 30 patients in the experimental group and 30 patients in the control group.
Data Collection Tools: "Personal Information Form", "VAS Pain Scale", "Brief Fatigue Inventory", "Richard Campbell Sleep Scale" and "Health Promotion Strategies Used by Patients Scale" will be used to collect data.
VAS Pain Scale: It is a scale used to evaluate pain by giving a value between 0 and 10. A score of 0 means no pain, and a score of 10 means unbearable pain. As the score increases, the severity of pain increases.
Brief Fatigue Inventory: The scale evaluates the level of fatigue in the last 24 hours and the reflection of this fatigue on activities in daily life (general activity, mood, walking ability, work life, relationships with other people, joy of life). KYE; It consists of a total of 9 items, 3 items assessing fatigue, general fatigue, and 6 items assessing the impact of fatigue on daily life. Individuals score all items between "0" (no fatigue at all) and "10" (the most severe fatigue you can experience), taking into account the last 24 hours.
Richard Campbell Sleep Scale: The scale developed to determine sleep quality consists of six items: depth of night sleep, time to fall asleep, frequency of waking up, time to fall asleep when woken up, quality of sleep and noise level in the environment. Visual analog scale technique was applied for all expressions. RCUÖ average value; Scale variables are calculated by adding the mean scores and dividing by five. There is only a total score in the scale and the evaluation is made on the average of this score. A total score of the scale between 0 and 25 indicates poor sleep, and a score between 76 and 100 indicates good sleep. An increase in the total score average defines a positive increase in sleep quality.
Health Promotion Strategies Used by Patients Scale: The health promotion strategies used by patients scale was developed. This scale is a 29-item self-report scale. The scale, which initially consisted of 36 items and 4 subscales, was rearranged in 2001. With the factor analysis study called "Confirmatory Factor Analysis", the number of scale items was reduced to 29 and 3 sub-dimensions were defined. These sub-dimensions are: coping with stress, decision making and positive behavior. 1st to 10th of the scale. item, coping with stress sub-dimension, 11th-13th. items decision-making sub-dimension, 14th-29th. The items are the positive behavior subdimension.
Implementation of the Research: Patients who will undergo CRC will be given verbal information about the research before surgery, and those who agree to participate in the research will be evaluated for compliance with the inclusion criteria. The purpose of the research and how it will be implemented will be explained to the patient who meets the criteria for inclusion in the research, and their written consent will be obtained. Initial assessments will be made regarding sociodemographic and health history, VAS Pain score, Fatigue, Insomnia and Self-Efficacy level before surgery/pre-intervention. After the initial evaluation, patients will be assigned according to randomization. For the second evaluation, the VAS Pain score, Fatigue, Insomnia and Self-Efficacy levels of the control and experimental groups will be evaluated on the 4th day after surgery.
Experimental group: A protocol containing yoga-based breathing exercises will be used. The audio recording of this breathing exercise protocol will be uploaded to the video. After verbal information is given about how to do the exercise, the patient will be listened to the audio recording video and will be explained how to do it in practice. Then, the patient will be placed in a comfortable position by wearing headphones and will be allowed to exercise. The patient will be asked to do yoga-based exercise twice a day, the night before the surgery, once in the morning and once in the evening before going to bed for 3 days after the surgery.
Control group: Continuity of routine treatment and care of the patients included in the control group will be ensured. The control group will be recruited before preoperative assignment to patients. After the final test of the patients, information will be given about breathing exercises, and patients who want to do breathing exercises will be provided with a video link uploaded to their mobile phones.
Ethical Dimension of the Research: In order to conduct the research, ethics committee approval was obtained from KTO Karatay University Non-Pharmaceutical and Non-Medical Device Research Ethics Committee and permission was obtained from the institution where the research will be conducted. Participation in the study is voluntary and written consent will be obtained from the participants. To avoid bias, Clinical Trials protocol registration will be made after obtaining permission from the ethics committee.
Statistical Evaluation of Research Data: The data will be evaluated in the IBM SPSS Statistics Standard Concurrent User V 26 (IBM Corp., Armonk, New York, USA) statistical package program. Descriptive statistics will be given as number of units (n), percentage (%), mean ± standard deviation, median (M), minimum (min) and maximum (max) values. The normal distribution of the data of numerical variables will be evaluated with the Shapiro Wilk normality test. Homogeneity of variances will be evaluated with the Levene test. To evaluate the differences between two independent groups, "Student's t Test" is used when parametric test prerequisites are met; When this could not be achieved, the "Mann Whitney-U test" was used. A level of p\<0.05 will be considered statistically significant.
### Conditions Module
**Conditions:**
- Symptoms and Signs
**Keywords:**
- Colorectal cancer surgery
- Yoga-Based Breathing Exercise
- Pain
- Fatigue
- İnsomnia
- Self Efficacy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** 1. Experimental group: A protocol containing yoga-based breathing exercises will be used. The audio recording of this breathing exercise protocol will be uploaded to the video. After verbal information is given about how to do the exercise, the patient will be listened to the audio recording video and will be explained how to do it in practice. Then, the patient will be placed in a comfortable position by wearing headphones and will be allowed to exercise. The patient will be asked to do yoga-based exercise twice a day, the night before the surgery, once in the morning and once in the evening before going to bed for 3 days after the surgery.
2. Control group: Continuity of routine treatment and care of the patients included in the control group will be ensured.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** The data obtained as a result of the research will be coded as 'A' and 'B' by the researcher and transferred to the computer. In order to prevent bias in the evaluation of the data, the analysis of the coded data will be carried out by an independent statistician, thus ensuring statistician blinding.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A protocol containing yoga-based breathing exercises will be used. The audio recording of this breathing exercise protocol will be uploaded to the video. After verbal information is given about how to do the exercise, the patient will be listened to the audio recording video and will be explained how to do it in practice. Then, the patient will be placed in a comfortable position by wearing headphones and will be allowed to exercise. The patient will be asked to do yoga-based exercise twice a day, the night before the surgery, once in the morning and once in the evening before going to bed for 3 days after the surgery.
**Intervention Names:**
- Other: Yoga-Based Breathing Exercise
**Label:** Yoga-Based Breathing Exercise
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Continuity of routine treatment and care of the patients included in the control group will be ensured.
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Yoga-Based Breathing Exercise
**Description:** Breathing Exercise Protocol Purpose: This protocol is a guide prepared for patients who agree to participate in the study within the scope of scientific research to do breathing exercises.
Materials Required: A comfortable chair/a comfortable bed to lie on and comfortable clothing.
Exercise Duration: Approximately 20 minutes Exercise Time and Frequency: It should be done twice a day, at the same time, in the morning and in the evening.
You can do the exercise before going for a walk in the corridor in the morning and before going to sleep in the evening.
Normal Breathing and Focusing on Breathing (3 minutes) Alternate Nose Breathing-Nadi Shodhana (15-20 times/6 minutes) Normal Breathing and Focusing on Breathing (3 minutes) Bhramari Pranayama-Bee Buzzing Sound(8-10 times/5 minutes) Normal Breathing and Focusing on Breathing (3 minutes)
**Name:** Yoga-Based Breathing Exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** A 10 cm ruler has been designed with painlessness on one side and the most severe pain possible on the other side. This ruler is known as the Visual Analog Scale (VAS) for visual comparison. In the evaluation of the scale, "0" indicates no pain, "1-3" indicates mild pain, "4-6" indicates moderate pain, and "7-10" indicates severe pain levels.
**Measure:** Visual Analog Scale (VAS) - Pain Scale
**Time Frame:** One minute
**Description:** In the evaluation of fatigue, 0 points; no fatigue, 1-3 points; low fatigue, 4-6 points moderate fatigue, 7-9 points; extreme fatigue, 10 points; Fatigue is rated at the highest level.
**Measure:** Brief Fatigue Inventory
**Time Frame:** Two minutes
**Description:** It is a scale consisting of 6 items that assess the depth of nighttime sleep, the time it takes to fall asleep, the frequency of awakenings, the duration of wakefulness upon awakening, the quality of sleep, and the level of noise in the environment. Scores on the scale range from "0-25" indicating very poor sleep to "76-100" indicating very good sleep. While evaluating the total score of the scale based on 5 items, the 6th item, which assesses the level of noise in the environment, is excluded from the total score assessment. As the score on the scale increases, the quality of patients' sleep also increases.
**Measure:** Richard Campbell Sleep Scale
**Time Frame:** Two minutes
**Description:** The minimum score obtained from the scale is 29 and the maximum score is 145. An increase in score indicates that the level of self-efficacy regarding self-care behaviors has increased.
**Measure:** A measure of self-care self-efficacy
**Time Frame:** Two minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Having colo-rectal surgery for the first time
* Have a mobile phone suitable for downloading the yoga-based breathing exercise video,
* Use the same type and dose of painkillers,
* No communication barrier
* Volunteer to participate in the study.
Exclusion Criteria:
* Using sleeping pills,
* Having a physical disability in doing breathing exercises,
* Being diagnosed with a psychiatric disease,
* Having been doing yoga breathing exercises for the last six month
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Fatma Gündogdu
**Phone:** 05303243824
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Karatay
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Fatma Gündogdu
- **Phone:** 05303243824
- **Role:** CONTACT
**Country:** Turkey
**Facility:** KTO Karatay University
**State:** Konya
**Status:** RECRUITING
**Zip:** 42020
#### Overall Officials
**Official 1:**
**Affiliation:** KTO Karatay University
**Name:** Fatma Gündogdu
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** It will be shared when necessary.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Ban KA, Gibbons MM, Ko CY, Wick EC, Cannesson M, Scott MJ, Grant MC, Wu CL. Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Colorectal Surgery. Anesth Analg. 2019 May;128(5):879-889. doi: 10.1213/ANE.0000000000003366.
**PMID:** 29649026
**Citation:** Jaya P, Thakur A. Effect of Progressive Muscle Relaxation Therapy on Fatigue and Psychological Distress of Cancer Patients during Radiotherapy: A Randomized Controlled Trial. Indian J Palliat Care. 2020 Oct-Dec;26(4):428-432. doi: 10.4103/IJPC.IJPC_236_19. Epub 2020 Nov 19.
**PMID:** 33623302
**Citation:** Kirca K, Kutluturkan S. The effect of progressive relaxation exercises on treatment-related symptoms and self-efficacy in patients with lung cancer receiving chemotherapy. Complement Ther Clin Pract. 2021 Nov;45:101488. doi: 10.1016/j.ctcp.2021.101488. Epub 2021 Oct 2.
**PMID:** 34619419
**Citation:** Lev EL, Owen SV. A measure of self-care self-efficacy. Res Nurs Health. 1996 Oct;19(5):421-9. doi: 10.1002/(SICI)1098-240X(199610)19:53.0.CO;2-S.
**PMID:** 8848626
**Citation:** Scheepers ERM, Vink GR, Schiphorst AHW, Emmelot-Vonk MH, van Huis-Tanja LH, Hamakerl ME. Health-related quality-of-life trajectories during/after surgery and adjuvant chemotherapy in patients with colon cancer. Eur Geriatr Med. 2023 Jun;14(3):565-572. doi: 10.1007/s41999-023-00750-9. Epub 2023 Mar 25. Erratum In: Eur Geriatr Med. 2023 May 3;:
**PMID:** 36964869
**Citation:** Schmidt ME, Bergbold S, Hermann S, Steindorf K. Knowledge, perceptions, and management of cancer-related fatigue: the patients' perspective. Support Care Cancer. 2021 Apr;29(4):2063-2071. doi: 10.1007/s00520-020-05686-5. Epub 2020 Aug 29.
**PMID:** 32860177
**Citation:** Yin L, Fan L, Tan R, Yang G, Jiang F, Zhang C, Ma J, Yan Y, Zou Y, Zhang Y, Wang Y, Zhang G. Bowel symptoms and self-care strategies of survivors in the process of restoration after low anterior resection of rectal cancer. BMC Surg. 2018 Jun 4;18(1):35. doi: 10.1186/s12893-018-0368-5.
**PMID:** 29866087
**Citation:** Akin S, Can G, Durna Z, Aydiner A. The quality of life and self-efficacy of Turkish breast cancer patients undergoing chemotherapy. Eur J Oncol Nurs. 2008 Dec;12(5):449-56. doi: 10.1016/j.ejon.2008.07.006. Epub 2008 Oct 7.
**PMID:** 18842460
## 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: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- 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: M27137
- Name: Respiratory Aspiration
- Relevance: LOW
- As Found: Unknown
- ID: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446986
**Brief Title:** Dual Tasking and Upper Extremity Disability in Adolescent Idiopathic Scoliosis
**Official Title:** Clinical and Radiological Markers of Dual Tasking and Upper Extremity Disability in Adolescent Idiopathic Scoliosis
#### Organization Study ID Info
**ID:** E-11095095-050.04-181580
#### Organization
**Class:** OTHER
**Full Name:** Karamanoğlu Mehmetbey University
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Karaman Training and Research Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Karamanoğlu Mehmetbey University
#### Responsible Party
**Investigator Affiliation:** Karamanoğlu Mehmetbey University
**Investigator Full Name:** Aynur Başaran
**Investigator Title:** Proffessor Dr, MD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The goal of this observational study is to evaluate the dual task and upper extremity disability in individuals with adolescent idiopathic scoliosis compared to healthy controls and to examine their relationship with clinical and radiological parameters in adolescent idiopathic scoliosis (AIS). The main questions it aims to answer are:
1. To compare dual task and upper extremity disability in individuals with AIS and healthy sex and age-matched healthy controls.
2. To analyze the relationship of dual-task and upper extremity disability in individuals with AIS with clinical and radiological parameters All participants' dual-task performance will be evaluated and they will answer the upper extremity disability survey. Besides, the study groups will be examined thoroughly and radiological parameters will be calculated to identify the clinical and radiological parameters that affect dual-task performance and upper extremity disability.
**Detailed Description:** Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity and sagittal plane changes are accompanied by coronal plane changes. As a result of spinal deformity, morphological changes occur in the trunk and rib cage, and the relationships between body parts are affected. Considering the anatomical proximity between the scapula and the rib cage, alteration of the shoulder and upper extremity functions as a consequence of the change in proximal orientation is expected.
On the other hand, maintaining postural control depends on the dynamic relationship between sensory information and motor output. Dual tasking is an experience-based neurophysiological process that requires a person to perform two tasks simultaneously. When a person has problems with the neurophysiological process, the performance of one or both functions is negatively affected.
This observational study aims to evaluate the dual task and upper extremity disability in individuals with adolescent idiopathic scoliosis compared to healthy controls and to examine their relationship with clinical and radiological parameters in AIS. All participants' dual-task performance will be evaluated and they will answer the upper extremity disability survey. Besides, the study groups will be examined thoroughly and radiological parameters will be calculated to identify the clinical and radiological parameters that affect dual-task performance and upper extremity disability.
### Conditions Module
**Conditions:**
- Scoliosis Idiopathic
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with adolescent idiopathic scoliosis
**Intervention Names:**
- Other: Single and Dual-Task Timed Up and Go Test
- Other: Single and Dual-Task Tandem Walking Test
- Other: Simple Shoulder Test
**Label:** Study group
#### Arm Group 2
**Description:** Age and sex matched healthy adolescent peers
**Intervention Names:**
- Other: Single and Dual-Task Timed Up and Go Test
- Other: Single and Dual-Task Tandem Walking Test
- Other: Simple Shoulder Test
**Label:** Control group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control group
- Study group
**Description:** Timed Up and Go Test will be conducted. Then, for motor-motor dual-task evaluation, the test will be repeated while the subjects carry a tray containing 4 glasses of water without spilling the water. The time required to complete each test will be recorded in seconds.
**Name:** Single and Dual-Task Timed Up and Go Test
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Control group
- Study group
**Description:** The tandem walking test will be performed. Then, for cognitive-motor dual-task tandem walking test assessment, the test will be repeated while the subject completes one of 3 different cognitive tasks. These cognitive tasks used during dual-task trials will be switched between trials in an attempt to avoid a practice effect. The time required to complete each test will be recorded in seconds.
The cognitive tasks are as follows:
1. Counting down by six or seven from a randomly presented 2-digit number
2. Counting backward the months starting from a randomly selected month
3. Spelling a five-letter word backwards
**Name:** Single and Dual-Task Tandem Walking Test
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Control group
- Study group
**Description:** Simple Shoulder Test contains 12 items and rates pain and function in patients with shoulder problems. Each item has two options and is scored either ''1 = yes'' or ''0 = no''. The total score ranges from 0 to 12. Higher scores indicate better physical functions.
**Name:** Simple Shoulder Test
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Univariate statistical analyses will be performed to calculate the differences in seconds between the study group and control group.
**Measure:** The difference in seconds of the Single and Dual-Task Timed Up and Go Test between study and control groups
**Time Frame:** baseline
**Description:** Univariate statistical analyses will be performed to calculate the differences in seconds between the study group and control group.
**Measure:** The difference in seconds of the Single and Dual-Task Tandem Walking Test between study and control groups
**Time Frame:** baseline
**Description:** Univariate statistical analyses will be performed to calculate the differences in the scores between the study group and control group.
**Measure:** The difference of the Simple Shoulder Test scores between study and control groups
**Time Frame:** baseline
#### Secondary Outcomes
**Description:** Significant primary outcome measures will be controlled with:
* Clinical parameters:
* Scapular dyskinesia evaluation (present/absent)
* Lateral scapular shift test (positive/negative)
* TRACE score (Trunk Aesthetic Clinical Evaluation) (score ranges from 0 to12)
* Thoracic expansion (cm)
* Radiological parameters: Coronal plan:
* Curve type (single, double major),
* Location of curvature (Thoracic, thoracolumbar, lumbar),
* Majör curve side (right/left),
* Major curve Cobb angle (degrees),
* Coronal balance (mm),
* Apical vertebrae translation (mm),
* Apical vertebrae rotation (Grade from 0 to 4),
* Pelvic obliquity (degrees),
* Radiographic shoulder height (mm),
* Radiological parameters: Sagital plan
* Torasik kyphosis Cobb angle (degrees),
* Lumbar lordosis Cobb angle (degrees),
* Sagittal balance (mm),
* Pelvic tilt (degrees),
* Sacral slope (degrees),
* Pelvic incidence (degrees).
**Measure:** Multivariate analyses will be carried out with control variables
**Time Frame:** baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients diagnosed with Adolescent Idiopathic Scoliosis
Exclusion Criteria:
* Patients with complaints of neck, back, and shoulder pain
* Having a known neurological or systemic disease
* Having cognitive dysfunction that cannot cooperate with evaluations
* Having undergone musculoskeletal surgery or injury
* Extremity length difference of more than 1 cm
* Regular repetitive overhead shoulder movements related to professional or sports activities
* BMI \>30 kg/m2
**Healthy Volunteers:** True
**Maximum Age:** 17 Years
**Minimum Age:** 10 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** Adolescent Idiopathic Scoliosis
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Aynur Basaran, MD, Prof
**Phone:** +90 338 226 3225
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Elif D Durmaz
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Karaman
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Aynur Basaran
- **Phone:** +90 338 226 3225
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Karaman Training and Research Hospital
**Zip:** 70200
#### Overall Officials
**Official 1:**
**Affiliation:** Karaman Training and Research Hospital
**Name:** Elif D Durmaz
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013121
- Term: Spinal Curvatures
- ID: D000013122
- Term: Spinal Diseases
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M15417
- Name: Scoliosis
- Relevance: HIGH
- As Found: Scoliosis
- ID: M15918
- Name: Spinal Curvatures
- Relevance: LOW
- As Found: Unknown
- ID: M15919
- Name: Spinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012600
- Term: Scoliosis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446973
**Brief Title:** Evaluation Of Pain, Balance, Functional Performance and Quality of Life in Patients With Meniscus Lesions
**Official Title:** Evaluation Of Pain, Balance, Functional Performance and Quality of Life in Patients With Meniscus Lesions
#### Organization Study ID Info
**ID:** Istanbula
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Aydın University
### Status Module
#### Completion Date
**Date:** 2023-12-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-11-30
**Type:** ACTUAL
#### Start Date
**Date:** 2022-06-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-01
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istanbul Aydın University
#### Responsible Party
**Investigator Affiliation:** Istanbul Aydın University
**Investigator Full Name:** Barış CELBEK
**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:** Meniscal tears are common knee injuries, affecting a wide demographic from young athletes to the elderly population, often resulting from traumatic sports-related incidents or degenerative processes associated with aging. The impact of meniscal injuries extends beyond the immediate physical damage, influencing pain perception, balance, functional performance, and ultimately, the quality of life. Despite advancements in diagnostic and therapeutic strategies, the comprehensive effects of meniscal tears on these domains remain inadequately explored, particularly regarding their correlation with objective measures of pain, balance, muscle strength and quality of life.
The meniscus plays a crucial role in knee joint stability, load distribution, and shock absorption. Damage to this fibrocartilaginous structure can significantly impair knee function, leading to altered biomechanics, decreased joint stability, and increased risk of osteoarthritis. Previous research has predominantly focused on the surgical and non-surgical management of meniscal tears, with less attention to the broader implications on patients' daily lives, particularly in terms of postural stability, risk of falls, and overall physical well-being.
This study aims to bridge this knowledge gap by quantitatively assessing the risk of meniscal tears on pain levels, balance, functional performance, and quality of life. By comparing objective measurements between individuals with meniscal tears and healthy controls, the investigators seek to elucidate the multifaceted impact of these injuries. Understanding these relationships is crucial for developing targeted rehabilitation strategies that address not only the mechanical aspects of the injury but also the associated functional and quality of life concerns.
Our hypothesis was that individuals with meniscal lesions have worse pain, functional performance and quality of life compared to those without such injuries and also pain directly influences balance, functional performance, and quality of life in patients with meniscal injuries.
**Detailed Description:** This study included a total of 70 participants, divided into two groups: 35 patients diagnosed with meniscus tear and 35 healthy individuals. The investigators determined this sample size using the G-Power software to ensure a 95% power level and an effect size of 0.8, following the methodology recommended by Faul et al.
The criteria for inclusion in the meniscopathy group;
* Volunteering to participate in the research,
* To be between ages of 18-60,
* Not having systemic or neurological issues interfering with assessment completion,
* Have meniscus pathologies in one or both knees confirmed by MRI.
The criteria for inclusion in the control group;
* To be between ages of 18-60,
* Not have any orthopedic, neurological, or systemic conditions, Volunteer to participate in the study. Exlusion criteria from the study;
* Having had additional knee surgery or fractures in the affected lower extremity within the last year
* Having had autoimmune or inflammatory diseases,
* Having had involved in a physiotherapy program for the knee in the past six months.
Physical Properties and Sociodemographic Assessment Age, sex, height, body weight, dominant lower extremity, occupation was recorded. In addition, the affected side, the duration of complaints, and insights into the participants' activity levels and habits were noted.
Pain Severity and Range of Motion Assessment Pain intensity was quantified using the Visual Analog Scale (VAS), during various states such as activity, rest, and nighttime. Joint Range of Motion (ROM) was evaluated with a goniometer, adhering to established protocols for knee flexion and extension, to increase reliability in our measurements.
Muscle Strength Assessment Hamstring muscle group and Quadriceps Femoris muscle were evaluated. The knee flexion and extension muscle strengths of the subjects were given a value between 0 and 5 according to the resistance applied to the muscle in standard positions
Balance Assessment Berg Balance Scale (BBS) was utilized to determine fall risk and postural control. This test has a 14-item test that is used to assess the self-perceived balance among individuals. The total score ranges between 0 and 56, with higher scores indicating a better balance. The validity and reliability study of the Turkish version of BBS has been studied
Physical Performance Assessment Physical performance was further assessed via the Timed Up and Go Test (TUG) and the Five Times Sit to Stand Test (5TSTS) , both of which measure balance, walking speed, and functional mobility by timing participants in task-specific movements. For the TUG test, a point 3 m away from the participant's chair was marked and the participant was asked to get up from the chair, walk 3 m, return and sit back down and the completion time of the test was measured with a stopwatch. Participants were instructed to wear comfortable shoes. 5TSTS ; In this test, the patient sat with arms crossed over the chest and back against the chair. Upon the command "Start," the patient was asked to quickly stand up and sit down from a standard chair five times. The elapsed time was measured with a stopwatch and recorded in seconds.
Quality of Life Assessment The quality of life for those with meniscus pathology was evaluated using the Western Ontario Meniscal Evaluation Tool (WOMET), a Turkish-validated questionnaire that segments 16 questions into physical symptoms, lifestyle/work, and emotional impact, providing a comprehensive view of the participants' well-being.
### Conditions Module
**Conditions:**
- Meniscus Tear
- Quality of Life
**Keywords:**
- Peniscus tear
- Pain
- Quality of Life
- Balance
- Muscle Strenght
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized controlled trial
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 70
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 35 healthy individuals
**Label:** Control group
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** 35 patients diagnosed with meniscus tear
**Intervention Names:**
- Other: 35 patients with meniscus tear
**Label:** Meniscus tear group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Meniscus tear group
**Description:** Have meniscus pathologies in one or both knees confirmed by MRI.
**Name:** 35 patients with meniscus tear
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Pain intensity was quantified using the Visual Analog Scale (VAS), during various states such as activity, rest, and nighttime. Joint Range of Motion (ROM) was evaluated with a goniometer, adhering to established protocols for knee flexion and extension, to increase reliability in our measurements.There are numbers from 0 to 10. 0 is classified as no pain and 10 as very severe.
**Measure:** Pain Severity and Range of Motion Assessment
**Time Frame:** through study completion, an average of 1 year
**Description:** Hamstring muscle group and Quadriceps Femoris muscle were evaluated.The knee flexion and extension muscle strengths of the subjects were given a value between 0 and 5 according to the resistance applied to the muscle in standard positions
**Measure:** Muscle Strength Assessment
**Time Frame:** through study completion, an average of 1 year
**Description:** Berg Balance Scale (BBS) was utilized to determine fall risk and postural control.This test has a 14-item test that is used to assess the self-perceived balance among individuals. The total score ranges between 0 and 56, with higher scores indicating a better balance.
**Measure:** Balance Assessment
**Time Frame:** through study completion, an average of 1 year
**Description:** Timed Up and Go Test (TUG ). For the TUG test, a point 3 m away from the participant's chair was marked and the participant was asked to get up from the chair, walk 3 m, return and sit back down and the completion time of the test was measured with a stopwatch
**Measure:** Physical Performance Assessment- TUG
**Time Frame:** through study completion, an average of 1 year
**Description:** Participants were instructed to wear comfortable shoes. 5TSTS ; In this test, the patient sat with arms crossed over the chest and back against the chair. Upon the command "Start," the patient was asked to quickly stand up and sit down from a standard chair five times. The elapsed time was measured with a stopwatch and recorded in seconds.
**Measure:** Physical Performance Assessment- 5TSTS
**Time Frame:** through study completion, an average of 1 year
**Description:** The quality of life for those with meniscus pathology was evaluated using the Western Ontario Meniscal Evaluation Tool (WOMET).a Turkish-validated questionnaire that segments 16 questions into physical symptoms, lifestyle/work, and emotional impact, providing a comprehensive view of the participants' well-being
**Measure:** Quality of Life Assessment
**Time Frame:** through study completion, an average of 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Volunteering to participate in the research,
* To be between ages of 18-60,
* Not having systemic or neurological issues interfering with assessment completion,
* Have meniscus pathologies in one or both knees confirmed by MRI.
The criteria for inclusion in the control group;
* To be between ages of 18-60,
* Not have any orthopedic, neurological, or systemic conditions,
* Volunteer to participate in the study.
Exclusion Criteria:
* - Having had additional knee surgery or fractures in the affected lower extremity within the last year
* Having had autoimmune or inflammatory diseases,
* Having had involved in a physiotherapy program for the knee in the past six months.
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** Barış CELBEK
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M15241
- Name: Rupture
- Relevance: LOW
- As Found: Unknown
- ID: M22785
- Name: Lacerations
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446960
**Acronym:** APEDOC
**Brief Title:** The Role of Peripheral Afferents in Modulating Post-stroke Central Pain
**Official Title:** The Role of Peripheral Afferents in Modulating Post-stroke Central Pain
#### Organization Study ID Info
**ID:** C23-05
#### Organization
**Class:** OTHER_GOV
**Full Name:** Institut National de la Santé Et de la Recherche Médicale, France
#### Secondary ID Infos
**Domain:** N° EU CT
**ID:** 2023-504676-17-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-02-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-02-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-12
**Type:** ACTUAL
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-01-30
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Institut National de la Santé Et de la Recherche Médicale, France
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Central post-stroke pain (CPP) is extremely difficult to relieve and responds very poorly to analgesics targeting neuropathic pain, probably because the mechanisms underlying this pain remain poorly understood.
Stroke pain is traditionally considered to be of central origin and related to changes in the spinal cord and/or brain nociceptive systems. However, a recent study in a small cohort of patients has suggested that the peripheral nervous system (PNS) may have a role in the initiation and persistence of APD.
The main objective of this prospective randomised controlled bicentric study (Raymond Poincaré and Ambroise Paré) in double blind and parallel groups against placebo (3 arms) will be to evaluate the efficacy of two peripheral nerve blocks performed 14 days apart on spontaneous neuropathic pain after stroke. The active treatments used for the blocks will be either lidocaine 20 mg/ml or levobupivacaine 1.25 mg/ml or placebo (saline)
**Detailed Description:** The primary endpoint will be the change in neuropathic pain intensity (assessed on an 11-point pain intensity scale), expressed as a difference in pain intensity between the value obtained before each block and that obtained 45 minutes after, corresponding to the maximum expected effect. Secondary endpoints will include exertional pain, pain quality, % relief, clinical global impression, pain assessment on a patient diary for a fortnight after each block and adverse events.
Patients will be randomised to receive one of 3 study treatments (lidocaine 2%, levobupivacaine 1.25 mg/ml or placebo). The treatment protocol will involve 2 perineural blocks performed 14 days apart. Assessment will continue for up to 2 weeks after each block, i.e. up to one month after the start of treatment. An evaluation of pain will be carried out before the block and after each block, at 45 minutes and at 5 hours, and then daily by the patient on a self-evaluation booklet for the 14 days following each block.
Randomisation will be centralised on a server from a list drawn up in advance by computer rogramme, balanced by blocks of variable size. Allocation between the 3 arms will be done according to a balanced 1:1:1 distribution. Treatments will be numbered from 1 to n, and allocated to patients in the chronological order of their inclusion in the trial.
Patients will be randomised on the day of treatment using a centralised computerised randomisation procedure to receive one of the 3 study treatments (lidocaine 20 mg/ml levobupivacaine 1.25 mg/ml or saline). No matching by age or duration of pain is planned, as randomisation usually results in groups matched at baseline on these criteria. The treatment will be administered over two visits performed 14 days apart by a qualified anaesthetist using the peri-nervous route according to current ecommendations (see above). Only one randomisation will be performed at baseline, so that a patient on active treatment cannot receive placebo at a later date and vice versa (see figure 1).
The investigators plan to randomise 10 patients per group and a total of 30 patients to achieve 90% power with a two sided α risk=0.05,. Given the estimated premature discontinuation rate, the investigators consider it necessary to include 12 patients per group for a total of 36 patients.
This study opens the way to new therapeutic avenues for these patients who often fail all treatments
### Conditions Module
**Conditions:**
- Stroke
**Keywords:**
- Ischemic Stroke
- Central Neuropathic Pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Patients will be randomised to receive one of 3 study treatments (lidocaine 20 mg/ml, levobupivacaine 1.25 mg/ml, or saline).
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** It is a randomised, double-blind study
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Name (INN and/or speciality) : Lidocaine 20 mg/ml Pharmaceutical form: Injectable Route of administration: Peri-Nervous Dosage for administration: 20ml Duration of treatment: 2 bolus administrations at 14 day intervals
**Intervention Names:**
- Drug: Lidocaine 20mg/ml
**Label:** lidocaine 20 mg/ml
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Name (INN and/or speciality) : Levobupivacaine (Chirocaine), 1.25 mg/ml Pharmaceutical form: Injectable Route of administration: Peri-Nervous Dosage for administration: 20ml Duration of treatment: 2 bolus administrations at 14 day intervals
**Intervention Names:**
- Drug: Levobupivacaine Hydrochloride 1.25 MG/ML
**Label:** levobupivacaine 1.25 mg/ml
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Name (INN and/or speciality) : Sodium chloride (NaCl) 0.9 Pharmaceutical form: Injectable Route of administration: Peri-Nervous Dosage for administration: 20ml Duration of treatment: 2 bolus administrations at 14 day intervals
**Intervention Names:**
- Drug: Sodium Chloride 0.9% Inj
**Label:** Sodium chloride (NaCl) 0.9
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- lidocaine 20 mg/ml
**Description:** 2 bolus administrations at 14 day intervals Route of administration: Peri-Nervous Dosage for administration: 20ml
**Name:** Lidocaine 20mg/ml
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- levobupivacaine 1.25 mg/ml
**Description:** 2 bolus administrations at 14 day intervals Route of administration: Peri-Nervous Dosage for administration: 20ml
**Name:** Levobupivacaine Hydrochloride 1.25 MG/ML
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Sodium chloride (NaCl) 0.9
**Description:** 2 bolus administrations at 14 day intervals Route of administration: Peri-Nervous Dosage for administration: 20ml
**Name:** Sodium Chloride 0.9% Inj
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The evolution in neuropathic pain intensity assessed on an 11-point pain intensity scale (0 = no pain: 10: maximum imaginable pain), expressed as a difference in pain intensity between the value obtained before each block and that obtained 45 minutes after, corresponding to the maximum expected effect. The values obtained before and after each block will first be analysed individually and then combined for the two successive blocks for each patient and the comparison will be between the three treatment arms, lidocaine 20mg/ml, levobupivacaine 1.25mg/ml or placebo
Rationale for the choice of the main criterion :
Pain intensity will be assessed on a numerical scale that corresponds to the usual validated measurement criterion and the choice of 45 minutes corresponds to the maximum effect of local anaesthetics
**Measure:** To evaluate the efficacy of two peripheral nerve blocks performed 14 days apart on spontaneous neuropathic pain after stroke. The active treatments used for the blocks will be either lidocaine 20mg/ml or levobupivacaine 1.25mg/ml or placebo (saline)
**Time Frame:** 24 months
#### Secondary Outcomes
**Description:** - Comparison of the duration (in days) of efficacy of lidocaine 20 mg/ml levobupivacaine 1.25 mg/ml and placebo blocks on spontaneous and exertional pain assessed by an 11-point pain intensity scale (0 to 10) completed daily by the patient on a self-report diary, up to 14 days after each block.
**Measure:** - To evaluate the time course and duration of the effectiveness of the nerve blocks on spontaneous pain on a pain intensity scale completed daily by the patient on a self-evaluation booklet up to 14 days after each block.
**Time Frame:** 24 months
**Description:** - Comparison of the efficacy of levobupicacaine 1.25 mg/ml, lidocaine 20 mg/ml and placebo on spontaneous and exertional pain assessed by an 11-point pain intensity scale (0 to 10) at 45 minutes and then at 5 hours after the block and then daily on a self-evaluation booklet, up to 14 days after each block
**Measure:** - Evaluate the effectiveness of blocks on exercise pain
**Time Frame:** 24 months
**Description:** * Comparison of the efficacy of lidocaine, levobupivacaine and placebo blocks on the intensity of rubbing pain if present (dynamic mechanical allodynia) assessed before treatment with a brush and then at 45 minutes and at 5 hours after each block.
* Comparison of the efficacy of lidocaine, levobupivacaine and placebo blocks on spontaneous and provoked pain area (mechanical allodynia if present) assessed by a tracing (and then plotted on a graph allowing measurement of area in cm2) before treatment and then at 45 minutes and at 5 hours after each block using a method used in our previous studies
**Measure:** - Directly compare the efficacy of active blocks, i.e. lidocaine and levobupivacaine, on spontaneous and provoked pain (allodynia)
**Time Frame:** 24 months
**Description:** - Comparison of the efficacy of lidocaine, levobupivacaine and placebo blocks on mechanical pain and detection thresholds assessed by Semmes Weinstein monofilaments (calibrated from 0.057 g to 300 g) as well as on thermal pain and detection thresholds assessed by a thermotest before the treatment and at 45 minutes and at 5 hours after each block
**Measure:** - Evaluate the effectiveness of each block on provoked pain (mechanical allodynia), mechanical, hot and cold pain thresholds and pain area
**Time Frame:** 24 months
**Description:** - Comparison of the efficacy of lidocaine, levobupivacaine and placebo blocks on dimensions of neuropathic pain assessed by the NPSI questionnaire before treatment and at 45 minutes, and at 5 hours and 2 weeks after each block
**Measure:** - Evaluate the effectiveness of each block on the dimensions of neuropathic pain assessed by the NPSI questionnaire
**Time Frame:** 24 months
**Description:** Evaluation of adverse effects of lidocaine, levobupivacaine and placebo blocks after the blocks and up to 14 days after each block.
* Efficacy of lidocaine, levobupivacaine and placebo blocks on patient (PGIC) and examiner (CGIC) clinical global impression at 45 minutes, and at 5 hours and 2 weeks after each block.
* Proportion of responders to lidocaine, levobupivicaine and placebo treatments assessed at 45 minutes, ad at 5 hours and 2 weeks after each block.
**Measure:** - To evaluate the effectiveness of the blocks on the overall clinical impression, the percentage of relief as well as the satisfaction with the treatment
**Time Frame:** 24 months
**Description:** - Evaluation of adverse effects of lidocaine, levobupivacaine and placebo blocks after the blocks and up to 14 days after each block
**Measure:** - Assessing the adverse effects of each treatment
**Time Frame:** 24 months
**Description:** - Blinding assessment by a blinding questionnaire at the end of the study for each patient
**Measure:** - Assessing the maintenance of blinding by a blinding questionnaire at the end of the study
**Time Frame:** 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients aged 18 years and over with no maximum age (blocks are generally very well tolerated in the very elderly)
2. Pain in the upper or lower limb distal enough to be completely covered by a peripheral nerve block
3. Chronic pain for at least 6 months
4. Ischaemic or haemorrhagic stroke for at least 6 months documented clinically and by appropriate imaging (MRI)
5. Post-stroke central neuropathic pain defined as pain occurring in the aftermath of stroke meeting the criteria for probable or defined neuropathic pain according to the NeuPSIG algorithm and with a DN4 screening questionnaire score of at least 4 out of 10.
6. Spontaneous pain intensity greater than or equal to 4 out of 10 on an 11-point numerical scale (EN) at inclusion and randomisation (i.e. just before each block)
7. Patients affiliated to a social security scheme or beneficiaries of such a scheme
8. Stable oral analgesic pharmacological treatment for at least 2 weeks prior to inclusion
9. Acceptance and signing of the informed consent
Exclusion Criteria:
1. Inability or unwillingness to sign an informed consent
2. Person subject to a legal protection measure (safeguard of justice, curatorship, guardianship)
3. Patients with ongoing psychiatric pathology (major depression, psychosis) or cognitive disorders that prevent a good understanding of the protocol and questionnaires
4. Pain that is too widespread in one hemicycle or limb and cannot be adequately covered by blocks
5. Ongoing drug or substance abuse
6. Language (aphasia) or comprehension disorders, illiteracy
7. Moderate to severe renal or hepatic impairment
8. Contraindication to local anaesthetics for use in perineural blocks (infection or acute inflammation in the injection area, known allergy).
9. Pregnancy or breastfeeding
10. Known hypersensitivity to lidocaine, levobupivacaine, amide-linked local anaesthetics or to any of the excipients contained in the specialities used in the study.
11. Patients with recurrent porphyria or severe hypotension contraindicating treatment with lidocaine and/or levobupivacaine
12. Current treatment with antiarrhythmic drugs causing torsades de pointes (amiodarone, disopyramide, quinidinics, sotalol...) or with antiarrhythmic drugs with local anaesthetic activity (mexiletine or class III antiarrhythmic drugs) and cannot be discontinued.
13. Too little pain at the time of the blocks (\< 4 out of 10)
14. Need to modify analgesic pharmacological treatment at the beginning or during the study
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** VALERIA MARTINEZ, MD
**Phone:** 01 47 10 76 22
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** NADINE ATTAL, MD
**Phone:** 0149095931
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Boulogne-Billancourt
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** NADINE ATTAL, MD
- **Phone:** 0149095931
- **Role:** CONTACT
**Country:** France
**Facility:** CHU Ambroise Paré
**Status:** RECRUITING
**Zip:** 92100
**Location 2:**
**City:** Garches
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** VALERIA MARTINEZ, MD
- **Phone:** 01 47 10 76 22
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Raymond Poincaré
**Status:** RECRUITING
**Zip:** 92380
## 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: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- ID: M2400
- Name: Ischemic Stroke
- Relevance: LOW
- As Found: Unknown
- ID: M12381
- Name: Neuralgia
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
### Intervention Browse Module - Ancestors
- ID: D000000779
- Term: Anesthetics, Local
- ID: D000000777
- Term: Anesthetics
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000000889
- Term: Anti-Arrhythmia Agents
- ID: D000061567
- Term: Voltage-Gated Sodium Channel Blockers
- ID: D000026941
- Term: Sodium Channel Blockers
- ID: D000049990
- Term: Membrane Transport Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: ChanBlk
- Name: Channel Blockers
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11014
- Name: Lidocaine
- Relevance: HIGH
- As Found: Solution
- ID: M1832
- Name: Levobupivacaine
- Relevance: HIGH
- As Found: Synovitis
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4109
- Name: Anesthetics, Local
- Relevance: LOW
- As Found: Unknown
- ID: M4213
- Name: Anti-Arrhythmia Agents
- Relevance: LOW
- As Found: Unknown
- ID: M23177
- Name: Sodium Channel Blockers
- Relevance: LOW
- As Found: Unknown
- ID: M30025
- Name: Diuretics, Potassium Sparing
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008012
- Term: Lidocaine
- ID: D000077554
- Term: Levobupivacaine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446947
**Acronym:** EPISEPSIS
**Brief Title:** Identification of Markers of Poor Clinical Prognosis in Sepsis by Epigenetic Analysis
**Official Title:** Identification de Marqueurs de Mauvais Pronostic Clinique du Sepsis Par Analyse épigénétique.
#### Organization Study ID Info
**ID:** RCAPHM23_0006
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique Hopitaux De Marseille
### Status Module
#### Completion Date
**Date:** 2026-01-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-01-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assistance Publique Hopitaux De Marseille
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Sepsis is a multifactorial syndrome characterized by a dynamic course and a clinical outcome dependent on several factors, and responsible for one in five deaths worldwide. The aim of this trial is to identify new prognostic markers for the progression of sepsis to septic shock, by comparing epigenetic markers between patients who have or have not developed severe forms of sepsis.
The main objective of this preliminary study is to identify prognostic markers for the progression of sepsis to septic shock, i.e. to compare targeted markers between subjects with sepsis who progress to septic shock versus subjects with sepsis who do not progress to septic shock.
### Conditions Module
**Conditions:**
- Sepsis Syndrome
- Septic Shock
- Sepsis
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 25
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with sepsis admitted to intensive care who developed septic shock.
**Intervention Names:**
- Other: blood sampling
**Label:** Septic shock
#### Arm Group 2
**Description:** Patients with sepsis admitted to critical care with a favorable outcome (no septic shock)
**Intervention Names:**
- Other: blood sampling
**Label:** No septic shock
### Interventions
#### Intervention 1
**Arm Group Labels:**
- No septic shock
- Septic shock
**Description:** Blood sampling (6ml) on admission and a second on discharge from intensive care.
**Name:** blood sampling
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Compare targeted markers between subjects with sepsis progressing to septic shock versus subjects with sepsis not progressing to septic shock.
**Measure:** Identify prognostic markers for the progression of sepsis to septic shock
**Time Frame:** 18 months
#### Secondary Outcomes
**Description:** Epigenetic markers and associated candidate genes identified in PBMC at the time of sepsis between the group of subjects progressing to septic shock and the group of subjects not progressing to septic shock.
**Measure:** Epigenetic markers comparaison
**Time Frame:** 18 months
**Description:** Compare differentials in epigenetic marks and associated candidate genes (sepsis, second sampling) between the group of subjects progressing to septic shock and the group of subjects not progressing to septic shock
**Measure:** Differentials in epigenetic marks and associated candidate genes
**Time Frame:** 18 months
**Description:** In both groups, compare the epigenetic marks and associated candidate genes identified in PBMC during sepsis with those identified in PBMC collected at the time of septic shock or discharge from critical care.
**Measure:** Epigenetic marks and associated candidate genes identified in PBMC
**Time Frame:** 18 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male patients,
* Patients between 45 and 75 years of age,
* Patients undergoing major esophageal or digestive carcinological surgery,
* Patients with post-operative gram-negative bacterial sepsis (proven or suspected in the context of organ failure).
Exclusion Criteria:
* patients under 45 and aged 76 and over,
* female patients,
* non-carcinological or minor surgery,
* non-esophageal or non-digestive surgery,
* Gram-positive bacterial or fungal infections in the absence of associated BGN,
* patients with hematological cancer,
* immunocompromised patients,
* septic surgery (surgical site infection),
* patients expressing opposition to data collection and analysis (clinical and/or biological) within the regulatory framework of the study,
* patients under guardianship or curatorship,
* patients not affiliated to a social security system or equivalent in France,
* patients deprived of their liberty.
**Maximum Age:** 75 Years
**Minimum Age:** 45 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Male patients admitted to critical care for sepsis after thoracic or chest surgery.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Marc LEONE, MD PHD
**Phone:** 0491968655
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Assistance Publique Hopitaux De Marseille
**Name:** François CREMIEUX
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007239
- Term: Infections
- ID: D000007249
- Term: Inflammation
- ID: D000010335
- Term: Pathologic Processes
- ID: D000012769
- Term: Shock
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M20864
- Name: Sepsis
- Relevance: HIGH
- As Found: Sepsis
- ID: M16869
- Name: Toxemia
- Relevance: HIGH
- As Found: Sepsis
- ID: M20818
- Name: Systemic Inflammatory Response Syndrome
- Relevance: HIGH
- As Found: Sepsis Syndrome
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M15577
- Name: Shock
- Relevance: LOW
- As Found: Unknown
- ID: M15580
- Name: Shock, Septic
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000018805
- Term: Sepsis
- ID: D000014115
- Term: Toxemia
- ID: D000018746
- Term: Systemic Inflammatory Response Syndrome
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446934
**Acronym:** AVLA1
**Brief Title:** AKTIIA OBPM to Assess CPAP Effect on Blood Pressure in Obstructive Sleep Apnea
**Official Title:** Continual Optical Cuffless Monitoring to Assess the CPAP Therapeutic Effect on Blood Pressure in Obstructive Sleep Apnea Patients
#### Organization Study ID Info
**ID:** PS2023034
#### Organization
**Class:** OTHER
**Full Name:** Hospital Universitario Araba
### Status Module
#### Completion Date
**Date:** 2026-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** NETWORK
**Name:** Bioaraba Health Research Institute
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospital Universitario Araba
#### Responsible Party
**Investigator Affiliation:** Hospital Universitario Araba
**Investigator Full Name:** Mikel Azpiazu
**Investigator Title:** Medical Doctor
**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 learn if positive airway pressure (CPAP) therapy works for blood pressure (BP) control in obstructive sleep apnea (OSA) adult patients plus undiagnosed hypertension (HBP), using a cuffless bracelet for continual optical BP monitoring (AKTIIA OBPM).
It will also learn if CPAP improves cardiac function in these patients using speckle tracking echocardiography (STE) and to learn about ease of use and patient experience with AKTIIA device and AKTIIA OBPM.
The main questions it aims to answer are:
* Does CPAP reduce systolic BP (and other BP metrics) in this population?
* Does CPAP improve cardiac function in the same population? Researchers will compare BP metrics derived from AKTIIA OBPM and STE metrics in a before and after CPAP therapy to evaluate its therapeutic effect.
Participants will:
* Take a CPAP titration and telemonitoring program for 12 weeks (from the titration date)
* Take an AKTIIA OBPM one week before CPAP and 12 weeks since CPAP titration date
* Take a STE test twice, before starting CPAP and 12 weeks after CPAP titration date
* Take an online survey about easy of use and patient experience with AKTIIA OBPM device
**Detailed Description:** Patients with moderate-severe OSA, indication for CPAP therapy and undiagnosed hypertension will be included. If the patient meets all the inclusion criteria and none of the exclusion criteria, he/she will be considered a candidate for the study. Once the informed consent has been signed, a visit will be made to initiate continuous blood pressure monitoring with the AKTIIA system (AKTIIA OBPM). The first week (week 0, preCPAP) serves to confirm the presence of HBP (average BP 130/80+ mmHg and/or average nocturnal BP 120/70+ mmHg).
If the participant has HBP criteria, an speckle tracking echocardiography (STE) will be performed (preCPAP) and then CPAP treatment will be initiated following the sleep unit´s telemonitoring care program with initial ambulatory pressure titration. If the participant do not have HBP criteria, only CPAP treatment will be started.
The CPAP titration date will be day 1 for AKTIIA OBPM and CPAP monitoring. At 12 weeks of monitoring, a second STE will be scheduled (post-CPAP) and the end-of-study on-site visit is performed to assess: efficacy and adherence to CPAP, clinical and BP control in the AKTIIA OBPM (week 12, post-CPAP).
Finally, an anonymous electronic survey on AKTIIA device usability and patient experience with AKTIIA OBPM and CPAP therapy will be conducted.
Withdrawal criteria are: ineffective CPAP titration, CPAP dropout, invalid AKTIIA OBPM or dropout, prescription of antihypertensive drug, patient decision or PI decision and loss of contact.
Researchers will compare pre-post CPAP blood pressure metrics (systolic BP as the main parameter), circadian profile, dynamic metrics, STE metrics, efficacy and CPAP adherence, symptoms (ESS, QOL own scales) and subgroup analysis by gender, age, OSA severity or CPAP adherence.
### Conditions Module
**Conditions:**
- Hypertension
- Cardiac Function and Hemodynamics
- Usability
- Patient Experience
**Keywords:**
- Hypertension
- Obstructive Sleep Apnea
- Blood Pressure Monitors
- Continuous Positive Airway Pressure
- Echocardiography
- Pulse Wave Analysis
- Photoplethysmography
- Telemedicine
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Single-center, single-arm, interventional pre-post design study
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Interventional pre-post CPAP therapy
**Intervention Names:**
- Device: CPAP
**Label:** CPAP
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CPAP
**Description:** Initial CPAP titration and subsequent CPAP therapy for 12 weeks
**Name:** CPAP
**Type:** DEVICE
### Outcomes Module
#### Other Outcomes
**Description:** Change in ESS scoring from OSA diagnosis (pre-CPAP) to ESS scoring at the end of 12 weeks (post-CPAP). The ESS score is based on 8 questions and a scale of 0 to 24. The scale estimates whether the participants are experiencing excessive sleepiness due to OSA and its improvement with CPAP therapy. A normal score (no diurnal sleepiness) is less than 11 points.
**Measure:** Change from OSA diagnosis in Epworth Sleepiness Scale scoring at 12 weeks
**Time Frame:** Baseline at OSA diagnosis (pre-CPAP) and at the end of 12 weeks AKTIIA OBPM (post-CPAP)
**Description:** Participants answer an anonymous survey of several questions about the usability of the AKTIIA system and their experience and opinion about continuous blood pressure monitoring for 12 weeks. The questions are asked on a Likert scale from 1 to 5, with 5 being the best satisfaction/opinion.
**Measure:** Usability of AKTIIA system and Patient Experience with AKTIIA OBPM at 12 weeks
**Time Frame:** At the end of 12 weeks AKTIIA OBPM
#### Primary Outcomes
**Description:** Change in 24h/7d average SBP from week 0 (pre-CPAP) to week 12 (post-CPAP). SBP expressed in mmHg (millimeters of mercury)
**Measure:** Change from baseline in the AKTIIA OBPM systolic blood pressure (SBP) at 12 weeks
**Time Frame:** 1 week pre-CPAP and 1 week post-CPAP at the end of 12 weeks AKTIIA OBPM
#### Secondary Outcomes
**Description:** Change in LV-GLS from pre-CPAP speckle tracking echocardiography (STE) to post-CPAP STE at week 12 (post-CPAP). LV-GLS values are reported as absolute numbers. By convention, GLS is expressed as a negative number (normal range, -19% to -20%), and more negative LV GLS values represent better systolic performance.
**Measure:** Change from baseline in the left ventricular global longitudinal strain (LV-GLS) at 12 weeks
**Time Frame:** Baseline prep-CPAP and at the end of 12 weeks AKTIIA OBPM
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults 25-70 years old
* Moderate-severe OSA (AHI 15+)
* First prescription of CPAP therapy
* Undiagnosed HBP
* Smartphone use and technological skills
* Informed consent
Exclusion Criteria:
* Antihypertensive drug
* Cardiovascular comorbidity: atrial fibrilation, heart failure, ischemic heart disease, stroke
* Reduced perfusion (e.g. Raynaud)
* Severe/Advanced chronic disease
* Central apnea
* Pregnancy
* Shift work
* Other social issues: misunderstanding/miscommunication
**Maximum Age:** 70 Years
**Minimum Age:** 25 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mikel Azpiazu, MD
**Phone:** 945 00 59 16
**Phone Ext:** +34
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Vitoria-Gasteiz
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mikel Azpiazu, MD
- **Phone:** 945 005 916
- **Phone Ext:** +34
- **Role:** CONTACT
***Contact 2:***
- **Name:** Mikel Azpiazu, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Fernando Ereño, MD, PhD
- **Role:** SUB_INVESTIGATOR
**Country:** Spain
**Facility:** Hospital Universitario Araba
**State:** Araba
**Zip:** 01004
#### Overall Officials
**Official 1:**
**Affiliation:** Hospital Universitario Araba
**Name:** Mikel Azpiazu, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Data obtained through this study may be provided to qualified researchers with academic interest in sleep apnea, HBP or AKTIIA OBPM. Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact to [email protected]
**Description:** All Individual Participant Data (IPD) that underlie results in a publication
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
**IPD Sharing:** YES
**Time Frame:** Data requests can be submitted starting 1 month after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
### References Module
#### References
**Citation:** Sola J, Cortes M, Perruchoud D, De Marco B, Lobo MD, Pellaton C, Wuerzner G, Fisher NDL, Shah J. Guidance for the Interpretation of Continual Cuffless Blood Pressure Data for the Diagnosis and Management of Hypertension. Front Med Technol. 2022 May 17;4:899143. doi: 10.3389/fmedt.2022.899143. eCollection 2022.
**PMID:** 35655524
**Citation:** Tadic M, Gherbesi E, Faggiano A, Sala C, Carugo S, Cuspidi C. The impact of continuous positive airway pressure on cardiac mechanics: Findings from a meta-analysis of echocardiographic studies. J Clin Hypertens (Greenwich). 2022 Jul;24(7):795-803. doi: 10.1111/jch.14488. Epub 2022 Jun 13.
**PMID:** 35695237
**Citation:** Bazzano LA, Khan Z, Reynolds K, He J. Effect of nocturnal nasal continuous positive airway pressure on blood pressure in obstructive sleep apnea. Hypertension. 2007 Aug;50(2):417-23. doi: 10.1161/HYPERTENSIONAHA.106.085175. Epub 2007 Jun 4.
**PMID:** 17548722
**Citation:** Bradley TD, Floras JS. Obstructive sleep apnoea and its cardiovascular consequences. Lancet. 2009 Jan 3;373(9657):82-93. doi: 10.1016/S0140-6736(08)61622-0. Epub 2008 Dec 26.
**PMID:** 19101028
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-05-19
- Filename: SAP_000.pdf
- Has ICF: False
- Has Protocol: False
- Has SAP: True
- Label: Statistical Analysis Plan
- Size: 109631
- Type Abbrev: SAP
- Upload Date: 2024-05-31T12:25
- Date: 2023-05-19
- Filename: ICF_001.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 121384
- Type Abbrev: ICF
- Upload Date: 2024-05-31T12:25
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000001049
- Term: Apnea
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000020919
- Term: Sleep Disorders, Intrinsic
- ID: D000020920
- Term: Dyssomnias
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M15694
- Name: Sleep Apnea Syndromes
- Relevance: HIGH
- As Found: Sleep Apnea
- ID: M22010
- Name: Sleep Apnea, Obstructive
- Relevance: HIGH
- As Found: Obstructive Sleep Apnea
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Hypertension
- ID: M4361
- Name: Apnea
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- 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: M22242
- Name: Parasomnias
- Relevance: LOW
- As Found: Unknown
- ID: M22654
- Name: Sleep Disorders, Intrinsic
- Relevance: LOW
- As Found: Unknown
- ID: M22655
- Name: Dyssomnias
- Relevance: LOW
- As Found: Unknown
- ID: M15696
- Name: Sleep Wake Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012891
- Term: Sleep Apnea Syndromes
- ID: D000020181
- Term: Sleep Apnea, Obstructive
- ID: D000006973
- Term: Hypertension
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446921
**Acronym:** GIGI
**Brief Title:** The Effect of a Ginger Supplement on Digestive Complaints in Healthy Adults Versus a Placebo
**Official Title:** The Effect of a Ginger Formulation Supplementation on Gastrointestinal Complaints in Healthy Adults: A Randomized, Doubleblind, Placebo Controlled Trial
#### Organization Study ID Info
**ID:** GIV/010123
#### Organization
**Class:** INDUSTRY
**Full Name:** Givaudan France Naturals
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**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:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** NETWORK
**Name:** Analyze & Realize
**Class:** OTHER
**Name:** University Hospital of Leuven Leuven
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Givaudan France Naturals
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** True
### Description Module
**Brief Summary:** The aim of this clinical study is to investigate the effect of a ginger formulation as a dietary supplement on gastrointestinal complaints in healthy adults.
The effect of this formula will be compared to a placebo after 8 weeks of consumption.
### Conditions Module
**Conditions:**
- Dyspepsia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** randomized placebo controlled double blind trial
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 116
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 100 mg of ginger formula per capsule 2 capsules per day during 8 weeks
**Intervention Names:**
- Dietary Supplement: Ginger formula
**Label:** Ginger formula
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** 2 capsules per day during 8 weeks
**Intervention Names:**
- Dietary Supplement: Placebo
**Label:** Placebo formula
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ginger formula
**Description:** supplement delivering a minimum of 20 mg of gingeroids / d
**Name:** Ginger formula
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Placebo formula
**Description:** arabic gum
**Name:** Placebo
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** The LPDS is a questionnaire consisting of eight items: early satiation, postprandial fullness, upper abdominal bloating, epigastric pain, epigastric burning, nausea, belching and heartburn. Each symptom will be rated on a 5-point Likert-type scale: absent=0, mild=1, moderate=2, severe=3 and very severe=4 over a period of one day.
**Measure:** Leuven Postprandial Distress scale (LPDS)
**Time Frame:** daily, up to 66 days after the day of inclusion. from the day after inclusion until 8 weeks after randomization visit
#### Secondary Outcomes
**Description:** The Short Form (SF) Nepean Dyspepsia Index is a 10-item questionnaire with 5 sub-scales each examining the influence of dyspepsia on domains of health in subjects, namely tension/anxiety, interference with daily activities, disruption to regular eating/drinking, knowledge towards/control over disease symptoms and interference with work/study, with each sub-scale containing two items. Each item is measured by a 5-point Likert scale ranging from 0 (not at all or not applicable), 1 (a little), 2 (moderately), 3 (quite a lot) to 4 (extremely) scores.
**Measure:** Short Form Nepean Dyspepsia Index (SF-NDI)
**Time Frame:** monthly, from the day of randomization visit (V1) till end of study visit (V3) after 2 months
**Description:** Subjects instructed to answer the question: "How were your gastric symptoms during the past week in comparison with the baseline period preceding the intake of the food supplement? " (7 point Likert scale)
**Measure:** Overall Treatment Effect (OTE)
**Time Frame:** monthly, from the day of randomization visit (V1) till end of study visit (V3) after 2 months
**Description:** The gastric emptying breath test is a standard tool to measure gastric emptying rate in subjects with dyspeptic symptoms. After eating, subjects will provide a breath sample and will score the severity (0: absent - 4: very severe) of 6 epigastric symptoms (fullness, bloating, nausea, epigastric pain, burning, and belching) every 15 minutes until 4 hours postprandially.
**Measure:** Gastric emptying
**Time Frame:** twice : basal at visit V1 (randomization) and after 2 months
**Description:** Each of the 11 items are answered on a 4-point scale ranging from asymptomatic to maximum symptomatology. Using the Likert scoring method, responses on the extreme left receive a score of 0, increasing to 1, 2 or 3 as they become more symptomatic. The respondent's global score can range from 0 to 33. The global score also spans two dimensions-physical fatigue (measured by items 1-7) and psychological fatigue (measured by items 8-11). The Likert scoring system allows for means and distributions to be calculated for both the global total as well as the two sub-scales.
**Measure:** Chalder fatigue scale
**Time Frame:** monthly, from the day of randomization visit (V1) till end of study visit (V3) after 8 weeks
**Description:** The PSS-10 is a self-questionnaire comprising 10 items and allowing each item to be evaluated on its frequency of occurrence during the previous month using a 5-point scale ranging from 0 = never to 4 = very often (Cohen \& Williamson, 1988; Bellinghausen, 2009). The PSS-10 consists of 10 items from the PSS-14 (items 1, 2, 3, 6, 7, 8, 9, 10, 11, and 14). The PSS-10 allows the assessment of perceived stress without any loss of psychometric quality.
PSS-10 scores are obtained by reversing responses (e.g., Never = 4, Almost Never = 3, Sometimes = 2, Fairly Often = 1, Very Often= 0) to the four positively stated items (items 4, 5, 7 and 8 from the PSS-10, corresponding to items 6, 7, 9 and 10 from the original PSS-14) and then summing across all scale items.
Individual scores on the PSS-10 can range from 0 to 40 with higher scores indicating higher perceived stress.
**Measure:** Perceived stress scale (PSS-10)
**Time Frame:** monthly, from the day of randomization visit (V1) till end of study visit (V3) after 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Men and women aged 18-65 years
* Body Mass Index (BMI) 18.5 - 30.0 kg/m2 (limits included)
* Otherwise healthy subjects with Postprandial Distress Syndrome (PDS) as defined by ROME IV criteria: Must include one or both of the following criteria\* at least 3 days a week: - Bothersome postprandial fullness (i.e. severe enough to impact on usual activities)
* Bothersome early satiation (i.e. severe enough to prevent finishing a regular size meal)
\*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis with no apparent evidence of organic, systemic or metabolic disease or structural disease by standard clinical examination by the investigator at V0 that is likely to explain the complaints
* Documented Helicobacter pylori negative subjects according to a validated previous test (histological, breath, stool antigen or serological test) in the last 5 years or if not, with a rapid assay realized during V0
* Negative urine pregnancy test for women in childbearing age at V0 At V1, after 1-week diary completion, mean "PDS score" on LPDS scale ≥ 1 and \<3 (mild and moderate) As per this randomization criterion, any subjects with a "PDS score" of ≥3 (severe or very severe) or \<1 (too low) at V1 will be withdrawn from the study.
For assessment of PDS, the last 7 consecutive days before V1 should be used to calculate the score.
Exclusion Criteria:
* Subjects with dominant Epigastric Pain Syndrome (EPS) (as per Rome IV criteria) as main complaints at V0 as per investigator's judgement
* Subject with a dominant Irritable Bowel Syndrome (IBS) as per Rome IV criteria at V0 as per investigator's judgement
* Subjects suffering from or with history of dominant gastroesophageal reflux disease (GERD)-like symptoms at V0 as per investigator's judgement
* Self-reported organic findings in endoscopy in the last 5 years (if any) likely to explain dyspeptic symptoms
* Subject with other chronic gastrointestinal (GI) disorders (e.g. inflammatory bowel disease, coeliac disease)
* History of major gastrointestinal surgery (except for appendectomy or cholecystectomy)
* Suffering from or history of severe chronic disease in the last 5 years (e.g. cancer, HIV, hepatic or biliary disorders ongoing, pancreatic disease, kidney disease, uncontrolled cardiovascular disease, or chronic respiratory diseases) (self-reported)
* Presence of an organic cause explaining the dyspeptic complaints (e.g. peptic ulcer disease or parasitic infection) (self-reported)
* Family history of oesophageal or gastric cancer
* Subjects with diabetes (self-reported)
* Subjects with PHQ-9 (PATIENT HEALTH QUESTIONNAIRE)(score over 15 at V0
* Subjects with GAD-7 (Generalized Anxiety Disorder 7-item) score over 15 at V0
* Active psychiatric conditions (stable dose of 1 antidepressant is allowed, no other medication for psychiatric conditions)
* Subjects under treatment for dyspepsia complaints such as Proton Pump Inhibitors (PPI), Histamine 2 receptor antagonists (H2RAs), prokinetics, within the last 6 weeks before V0 and during the study and not willing to refrain their use during the study
* Subjects under opioids or immunosuppressants (antihistaminics and topical corticosteroids (nasal sprays, cutaneous) are allowed) or Non-steroidal anti-inflammatory drugs (NSAIDS) within the last 2 weeks before V0 and during the study and not willing to refrain their use during the study
* Subjects under treatment of antibiotics within the last 2 months before V0
* Subjects accustomed to use an anti-acid more than 3 times a week and not willing to refrain any consumption of these during the study
* Subjects under treatment of systemic corticoids within the last 3 months before V0 and not willing to refrain their use during the study
* Recent gastroenteritis or food borne illness such as confirmed food poisoning within the last 1 month before V0
* Under dietary supplement or treatment which could significantly affect parameters followed during the study according to the investigator (i.e. with laxative effect, with antidiarrheal effect, containing plant extracts (including ginger extracts), any formulation for digestive health, probiotics, prebiotics, symbiotic, vitamins and minerals) within the last 6 weeks before V0 or not willing to refrain from their consumption during the study
* Subjects used to consume any food and/or drink and/or condiment containing ginger (gari, pickled ginger, Japanese food, tea or infusion...) defined as more than 4 times a week before the study
* Subjects who do not agree to limit any ginger consumption during the study to maximally 4 times a week during the study
* With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredients and/or for the subgroup (with the gastric emptying test) to any components of the standard meals
* Pregnant or breastfeeding females, or wishing to become pregnant during the study
* With significant change of dietary habits or trying to lose weight within the last 3 months before V0 or planning to change dietary habits during the study or with eating disorders as per investigator judgement
* Following any specific diet such as high-protein, vegan, hypocaloric, ketogenic diet low in FODMAPs (Fructo-, Oligo, Di-Monosaccharides, And Polyols) except for vegetarian which is allowed
* Any change in the physical activity within the last 3 months before V0 or planning to change during the study or participant near or in the peak of training for an athletic race or competition
* Ongoing abuse of drugs, alcohol and / or medication at V0 or history of substance abuse within the last 12 months before V0
* Drinking more than 2 glasses of alcohol per day, every day and without interruption
* Smoking \> 10 cigarettes per day
* Heavy caffeinated beverage consumption (\>400 mg caffeine/day, i.e. more than 3 mugs of filter coffee or 4 espressos) within the last 2 weeks before V0 and during the study
* Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements
* Participation in any other clinical trial within the last 30 days before V0 and during the study
* Clinically relevant deviations from safety laboratory parameters (see section 11.8.3)
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anne Gensch
**Phone:** 49 176 44435206
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Geraldine Krausz, phD
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** UZ Leuven
**Name:** Tim Vanuytsel, Pr
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012817
- Term: Signs and Symptoms, Digestive
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7589
- Name: Dyspepsia
- Relevance: HIGH
- As Found: Dyspepsia
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004415
- Term: Dyspepsia
### Intervention Browse Module - Browse Branches
- Abbrev: HB
- Name: Herbal and Botanical
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T166
- Name: Ginger
- Relevance: HIGH
- As Found: Liver resection
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446908
**Brief Title:** Acceptability and Feasibility of a New Approach to Engage Patients With Steatotic Liver Disease in Physical Activity
**Official Title:** Acceptability and Feasibility of a New Approach to Engage Patients With Steatotic Liver Disease in Physical Activity
#### Organization Study ID Info
**ID:** 2024-A06PHYSACTIV
#### Organization
**Class:** OTHER
**Full Name:** Hopital Montfort
### Status Module
#### Completion Date
**Date:** 2027-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hopital Montfort
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Steatosis is the building of fat in the liver. Steatotic liver disease (SLD) regroups MASLD (metabolic dysfunction-associated steatotic liver disease) and MASH (metabolic dysfunction-associated steatohepatitis) i.e. MASLD with inflammation. An estimated 30% of the population worldwide has MASLD and 5% of Canadians have MASH. MASH is a leading cause of liver transplantation in Canada. There is no cure for SLD, and the treatment relies on diet, weight loss, and physical activity (PA).
Is a counselling intervention to help patients progressively engage in more PA a feasible and acceptable approach? Objectives. This proposal has three primary objectives: 1) To assess the feasibility of our PA counselling intervention (to be delivered online) with SLD patients; 2) To evaluate the acceptability of our intervention; 3) To evaluate the feasibility of the study methods/procedures.
Methodology. This study is an open-label, mono-centred, single-case experimental design with multiple base levels. The study will comprise 3 phases, alternating periods of observation (A) and 1 period of counselling (B) with an A1-B-A2 design.
PA will be assessed continuously using an accelerometer for 7 to 14 days per (A) phase. During phase (B), participants will receive the intervention, i.e. 6 x 45-minute, real-time, face-to-face, virtual sessions with a PA counsellor.
Based on past studies, our sample size will be 12 participants. They will be recruited through the hepatology clinic at Hôpital Montfort.
The primary outcomes of the project are to evaluate the feasibility and acceptability of the trial and intervention. The secondary outcomes are Daily PA time and biological/imaging data evolution
**Detailed Description:** Background and rationale: This pilot trial aims to evaluate the feasibility and acceptability of a counselling intervention on physical activity in patients with liver steatosis (primary aim) and changes in molecular outcomes (exploratory aim).
Liver steatosis is the build-up of fat in the form of lipid droplets inside hepatocytes (liver cells). Although it is a form of energy storage, it is considered pathological when more than 5% of hepatocytes demonstrate fat infiltration on a liver biopsy or imaging (ultrasound, magnetic resonance, or computed tomography). Until recently, liver steatosis was described as two entities with a clinicopathological continuum: non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) i.e. NAFLD with inflammation. NAFLD/NASH is strongly associated with features of the metabolic syndrome: type 2 diabetes mellitus (DM), hyperlipidemia, and obesity. Insulin resistance is considered one of the first steps to developing fatty liver infiltration. Indeed, 70% to 80% of patients with diabetes have NASH. A recent change in nomenclature now accounts for the link with cardiometabolic criteria. NAFLD is now MASLD (metabolic dysfunction-associated steatotic liver disease) i.e. steatosis and at least 1 cardiometabolic factor and NASH is MASH (metabolic dysfunction-associated steatohepatitis) i.e. MASLD with inflammation, regrouped as steatotic liver disease (SLD).
SLD is a silent disease: patients have no symptoms, are not routinely screened for the disease, and SLD is often revealed through complications of cirrhosis, at a late stage for intervention. Inflammation is confirmed when liver function tests alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are elevated. It is recommended to assess the level of associated fibrosis through non-invasive tests such as elastography that evaluates liver stiffness that increases with fibrosis, or algorithms such as Fibrosis-4 (FIB-4) that combines age, ALT, AST, and platelets count to identify fibrosis in patients over 35 years old. The SLD burden is expected to increase. An estimated 30% of the population worldwide has MASLD and 5% of Canadians have MASH (2). A Canadian study concluded that the number of people with post-MASH decompensated cirrhosis will double by 2030 and cases of liver cancer will increase by 80 % (2). MASH is a leading cause of liver transplantation in Canada (2). Despite extensive research with currently over 1350 active clinical trials (clinicaltrials.gov, accessed 19/09/2023), there is no cure for SLD, and the treatment relies on diet, weight loss, and physical activity (PA). The current North American guidelines state that patients with NAFLD should be strongly encouraged to engage in PA to the extent possible.
The effects of PA on SLD have been studied extensively. A systematic review (3) showed personalized PA improved the quality of life for cirrhotic patients without significant side effects and may reduce the 90-day readmission rates for transplant patients at the end of the program. Henri et al. showed US NAFLD adults who engaged in vigorous PA have a lower risk of death from cancer and all causes than NAFLD adults who do not engage in any PA; benefits persisted for low PA and any PA versus no PA (4). Similarly, a US study showed PA is inversely associated with NALFD and associated with better survival for NALFD patients (5). PA is also successful in preventing DM, which is now included in the MASH definition (6). Moreover, meta-analyses have concluded that PA contributes to decreasing levels of various biological markers of SLD (7), (8) and inflammatory markers (9), thus reducing intra-hepatic fat (10), (11), (12), (13). PA is thus efficacious in reducing inflammation and fibrosis in patients with SLD. However, key knowledge gaps remain including (1) scarce data on the impact of sustained PA in MASH patients, especially post-participation in studies, (2) lack of consistency in terms of eligibility criteria that are often too narrow and exclude patients seen in practice, (3) heterogeneous PA parameters (e.g., dosage, type, duration), and (4) variability of biological data collected. It is thus difficult to precisely define through meta-analyses and/or systematic reviews the optimal program to help support PA or its duration. Another critical gap is what is the influence of interventions that aim to have patients initiate and maintain PA on their own. This is important because in reality, it is not possible (or sustainable) to offer patients supervised PA sessions in the amount that is commensurate with current PA guidelines, considering patients have their own barriers to PA and the lack of support to help them initiate and maintain PA in everyday life. Indeed, from discussions with patients during clinical evaluation with Dr. Fresne, some barriers are lack of time, insufficient knowledge, fear of injury, and lack of financial resources. In the literature, perceived lack of resources and education, physical discomfort or limitations or pain, lack of space, and time constraints have been identified as barriers for PA (13),(14), (15).
We believe individualized support and guidance to help patients progressively engage in more PA is a better results-oriented sustainable approach than delivering supervised PA training sessions and propose a personalized counselling intervention to engage patients with SLD in PA.
Additionally, whether having patients initiate and maintain PA in everyday life by providing them with support can contribute to reducing inflammation and/or fibrosis in the liver remains to be described. It is known that sarcopenia (loss of skeletal muscle mass and strength) is associated with cirrhosis/liver fibrosis and DM, suggesting communication between the liver and muscles. During PA, the muscle secretes small peptides called myokines that act on the skeletal muscle, but also on distant organs, to improve their function, including decreasing inflammation and liver lipid content, such as interleukin 6 (IL-6), IL-15, irisin (16). PA also modifies the secretion of hepatokines, peptides secreted by hepatocytes. It is therefore possible that levels of these proteins will be modified in our population if they can initiate and maintain PA during their participation in PA counselling compared to their baseline PA level. These proteins could therefore serve as biomarkers to determine the efficacy of the PA counselling in improving SLD and reducing inflammation.
Significance and Innovation:
Engaging SLD patients in PA is crucial and a matter of public health. The number of SLD patients will increase in the next 10 years and there is currently no medication to treat the condition nor prevent the evolution towards cirrhosis with the associated risk of liver transplant and cancer. PA has proven its efficacy in SLD. However, physicians may not know how to help their patients to practice PA as a treatment and SLD patients face barriers to PA that need better characterization. We believe our innovative PA intervention using personalized counselling could help patients to overcome their barriers to PA. To our knowledge, this would be the first study that would provide patients keys to successfully engage in PA and empower SLD patients with PA through counselling. We believe participants in our study will be more likely to maintain long-term PA and the project will help us understand the barriers and facilitators to PA behavior change faced by SLD patients. If this feasibility project proves successful, we will develop a larger trial to assess the long-term engagement of SLD patients in PA and study the effects of PA on the interaction between liver, fat, and muscle in SLD patients.
Population and recruitment: Based on past SCED studies, our sample size will be 12 participants. They will be recruited through the hepatology clinic at Hôpital Montfort.
Intervention: The intervention is informed by the Telehealth Bariatric Behavioral Intervention (TELE-BariACTIV) study led by Drs Baillot and Brunet (18). The TELE-BariACTIV has been developed to increase PA for patients awaiting bariatric surgery. It is based on the principles of the BariACTIV trials (19),(20) that demonstrated a 6-week period of personalized face-to-face counselling before surgery centered on behavioral strategies such as goal-setting and self-monitoring significantly increased pre-surgery moderate-to-vigourous PA. TELE-BariACTIV was designed to reinforce theory-based content and participant's perspective, and include telehealth to increase reach. It was successfully tested (article in preparation) using a SCED. The purpose of the intervention is to increase autonomy, motivation, and self-confidence so participants can autonomously engage in PA. The content of the TELE-BariACTIV counselling is meant to be adapted to reflect participants' conditions, and we will do so by working with a patient-partner. The intervention aims to increase motivation (via satisfaction of basic psychological needs) and self-efficacy, critical determinants of PA behavior change.
Data collection: We will collect sociodemographic data such as age, sex, gender, language, level of education, profession, and income. PA will be measured daily throughout the trial via an accelerometer (7-14 days in each (A) phase) mailed to the participants. They will be instructed to wear the accelerometer continuously, except during water-based activities, and to maintain a log of wear times with waking and bed times. Accelerometer data will be extracted and downloaded (10-second epochs) using the appropriate software and will be cleaned in accordance with the logbooks provided by the participants.
Qualitative data: We will collect data on (1) participants' opinions of the trial (assessments, timing, etc.) and intervention via with a semi-structured interview at the end of their participation, (2) onacceptability with a 7-item questionnaire developed and validated by the research team, and (3) on PA counsellor notes for each intervention session, for examples, duration, topics discussed, accomplishment of session objectives, participants' reactions to the content, next steps with the participants, and reflections as a PA counsellor (e.g., problems arising during the sessions, overall experience delivering the session, suggestion for intervention or personal improvements, and session deviations).
Quantitative data: We will collect/measure pre and post intervention data for : liver function tests (ALT, AST, Gamma Glutamyl Transferase, Alkaline Phosphatase, bilirubin, albumin), total/High Density Lipoprotein/Low Density Lipoprotein cholesterol levels, triglycerides levels, fasting glucose and insulin, HbA1c, fasting free fatty acids, Body Mass Index, waist circumference, IL-6, TNF-α, CReactive Protein, and leptin, and calculate composite scores such as FIB-4. We will also evaluate liver fibrosis with a liver elastography before screening and at the end of participation. Myokines and hepatokines will be measured using available kits.
Data analysis:
Quantitative data: Descriptive statistics will be computed for baseline sociodemographic, clinical, biological, feasibility, and acceptability data derived from the numerical responses and close-ended questions. All statistical analyses will be carried out using R and the appropriate packages. A Tau-U test for each participant and for the group will be performed to compare daily PA based on accelerometer data between phases A1 and B, as well as A1 and A2. Individual effect sizes will be aggregated in a meta-analysis to obtain a group-based effect size. A sensitivity analysis will also be performed with a randomization test.
Qualitative data: The content of the interviews and the PA counselors' notes completed after the sessions will be analyzed by two team members using content analysis after verbatim transcription, using the NVivo software.
Based on data from the TELE-bariACTIV study, our project will be deemed successful if the refusal rate is ≤25%, the retention rate after phase B (PA intervention) is ≥75%, the intervention attendance rate is ≥75%, and the intervention attrition rate ≤25%. The main objectives of our project are feasibility and acceptability: at this point, the evolution or lack of evolution of biological or imaging markers before and after participation will not be considered for the success of the project. It will, however, help define which markers should be used for a large-scale trial.
### Conditions Module
**Conditions:**
- Liver Steatosis
- MASH
- MASLD
**Keywords:**
- Physical activity
- coaching
- telehealth
- liver
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 12
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This study is an open-label, mono-centred, single-case experimental design with multiple base levels. The study will comprise 3 phases, alternating periods of observation (A) and 1 period of counselling (B) with an A1-B-A2 design.
PA will be assessed continuously using an accelerometer for 7 to 14 days per (A) phase. During phase (B), participants will receive the intervention, i.e. 6 x 45-minute, real-time, face-to-face, virtual sessions with a PA counsellor.
**Intervention Names:**
- Behavioral: Telehealth coaching for liver disease
**Label:** Coaching Intervention
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Coaching Intervention
**Description:** This study is an open-label, mono-centred, single-case experimental design with multiple base levels. The study will comprise 3 phases, alternating periods of observation (A) and 1 period of counselling (B) with an A1-B-A2 design.
PA will be assessed continuously using an accelerometer for 7 to 14 days per (A) phase. During phase (B), participants will receive the intervention, i.e. 6 x 45-minute, real-time, face-to-face, virtual sessions with a PA counsellor.
**Name:** Telehealth coaching for liver disease
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** to evaluate the feasibility of the intervention
**Measure:** attendance rate of participants
**Time Frame:** 1 year
**Description:** to evaluate the feasibility of the intervention
**Measure:** number of participants who completed the intervention
**Time Frame:** 1 year
**Description:** to evaluate the feasibility of the trial
**Measure:** refusal rates
**Time Frame:** 1 year
**Description:** to evaluate the feasibility of the trial
**Measure:** recruitment rates
**Time Frame:** 1 year
**Description:** to evaluate the feasibility of the trial
**Measure:** attrition rates
**Time Frame:** 1 year
**Description:** to evaluate the acceptability of the intervention
**Measure:** semi-structured interviews at the end of participation
**Time Frame:** 18 months
**Description:** to assess retrospective and prospective acceptability
**Measure:** 7-item questionnaire developed for the TELE-BariACTIV study with statements in the future tense for before phase B or past tense for after phase B
**Time Frame:** 18 months
#### Secondary Outcomes
**Description:** to evaluate the changes in daily PA before and after the coaching intervention
**Measure:** Measurement of daily PA time using a accelerometer during phases A
**Time Frame:** 18 months
**Description:** to evaluate the changes in biological variables before and after the coaching intervention
**Measure:** Measurement of liver function tests (ALT, AST, Gamma Glutamyl Transferase, Alkaline Phosphatase, bilirubin, albumin)
**Time Frame:** 18 months
**Description:** to evaluate the changes in biological variables before and after the coaching intervention
**Measure:** Measurement of lipids : fasting free fatty acids, total/High Density Lipoprotein/Low Density Lipoprotein cholesterol levels, triglycerides levels
**Time Frame:** 18 months
**Description:** to evaluate the changes in biological variables before and after the coaching intervention
**Measure:** Measurement of glucose levels: fasting glucose and insulin, HbA1clevels, triglycerides levels
**Time Frame:** 18 months
**Description:** to evaluate the changes in BMI before and after the coaching intervention
**Measure:** Measurement of weight
**Time Frame:** 18 months
**Description:** to evaluate the changes in BMI before and after the coaching intervention
**Measure:** Measurement of height
**Time Frame:** 18 months
**Description:** to evaluate the changes inflammation markers before and after the coaching intervention
**Measure:** Measurement of inflammation markers :IL-6, TNF-α, CReactive Protein, and leptin
**Time Frame:** 18 months
**Description:** to evaluate the changes liver fibrosis before and after the coaching intervention
**Measure:** Measurement of elastography
**Time Frame:** 18 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* \>18 years of age,
* confirmed MASLD or MASH without cirrhosis
* access to a computer with an internet connection
Exclusion Criteria:
* liver disease from another cause,
* the existence of cirrhosis on imaging or clinically,
* weekly alcohol consumption over 50g,
* having a contraindication to PA without medical clearance (the Get Active questionnaire from the Canadian Society for Exercise Physiology is used to determine if medical clearance is needed),
* being already enrolled in a supervised exercise intervention or PA behaviour change intervention or currently meeting PA guidelines of 150 mins/week
* the need for a wheelchair, cane, walker, or other support(s) to move
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Celine Fresne, MD
**Phone:** 6137464621
**Phone Ext:** 3588
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** H[opital Montfort
**Name:** Celine Fresne, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11107
- Name: Liver Diseases
- Relevance: HIGH
- As Found: Liver Disease
- ID: M8375
- Name: Fatty Liver
- Relevance: HIGH
- As Found: Liver Steatosis
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5868
- Name: Visceral Steatosis
- Relevance: HIGH
- As Found: Liver Steatosis
### Condition Browse Module - Meshes
- ID: D000008107
- Term: Liver Diseases
- ID: D000005234
- Term: Fatty Liver
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446895
**Acronym:** IMACORN-INFLI
**Brief Title:** Biomarkers of Inflammation and Endothelial Dysfunction in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries
**Official Title:** Biomarkers of Inflammation and Endothelial Dysfunction in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries
#### Organization Study ID Info
**ID:** IMACORN-INFLI
#### Organization
**Class:** OTHER
**Full Name:** Hospital Universitario Getafe
### Status Module
#### Completion Date
**Date:** 2025-05-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-22
**Type:** ACTUAL
#### Start Date
**Date:** 2020-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospital Universitario Getafe
#### Responsible Party
**Investigator Affiliation:** Hospital Universitario Getafe
**Investigator Full Name:** maria jesus espinosa pascual
**Investigator Title:** Cardiologist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Around 10% of patients with myocardial infarction (MI) present with nonobstructive coronary arteries (MINOCA) which pathophysiology is often uncertain. The aim of the study is to evaluate inflammation and endothelial dysfunction biomarkers in MINOCA patients during both acute and stable phases, comparing them with those with MI and obstructive coronary arteries (MICAD).
**Detailed Description:** Prospective observational study in patients with Myocardial Infarction (MI) divided into two groups: MI with obstructive coronary arteries (MICAD) and MI with non-obstructive coronary arteries (MINOCA). Levels of interleukin-6, tumor necrosis factor-alpha, high-sensitivity C- reactive protein, and asymmetric dimethylarginine will be determined at three time points: within the 24 hours from the onset of pain, discharge, and two months after MI. The association of biomarkers, normalized by peak troponin value, with the risk of MINOCA will be evaluated using logistic regression.
### Conditions Module
**Conditions:**
- Myocardial Infarction
- MINOCA
- Inflammation
- Biomarkers
- Endothelial Dysfunction
### Design Module
#### Bio Spec
**Description:** Serum, plasma, urine
**Retention:** SAMPLES_WITHOUT_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 400
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with Myocardial Infarction and Obstructive Coronary Arteries
**Intervention Names:**
- Diagnostic Test: Coronariography
**Label:** MICAD
#### Arm Group 2
**Description:** Patients with Myocardial Infarction and Non-obstructive Coronary Arteries
**Intervention Names:**
- Diagnostic Test: Coronariography
**Label:** MINOCA
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MICAD
- MINOCA
**Description:** Patients were classified as MICAD or MINOCA by the presence or absence of an epicardial vessel with ≥50% stenosis after performing a coronariography.
**Name:** Coronariography
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Levels of interleukin-6 (pg/ml) and tumor necrosis factor-alpha (pg/ml) will be determined.
**Measure:** Levels of interleukin-6 (pg/ml) and tumor necrosis factor-alpha (pg/ml)
**Time Frame:** At three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.
**Description:** Levels of asymmetric dimethylarginine will be determined
**Measure:** Levels of endhotelial disfunction biomarkers
**Time Frame:** At three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.
**Description:** Levels of high-sensitivity C-reactive protein (mg/L) will be determined.
**Measure:** Levels of high-sensitivity C-reactive protein (mg/L)
**Time Frame:** t three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients admitted with Myocardial Infarction and undergo a coronariography
* Patients must sign informed consent.
Exclusion Criteria:
* Patients who don´t sign informed consent
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients older than 18 years old admitted to our hospital with Myocardial Infarction and undergo a coronariography.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** MARIA JESUS ESPINOSA, MD
**Phone:** 636581691
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** JOAQUIN ALONSO, PHD
**Phone:** 609208299
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Getafe
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** MARIA JESUS ESPINOSA PASCUAL, MD
- **Phone:** 636581691
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** JOAQUIN ALONSO, PHD
- **Phone:** 609208299
- **Role:** CONTACT
**Country:** Spain
**Facility:** Hospital Universitario de Getafe
**State:** Madrid
**Status:** RECRUITING
**Zip:** 28905
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007511
- Term: Ischemia
- ID: D000009336
- Term: Necrosis
- ID: D000017202
- Term: Myocardial Ischemia
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000014652
- Term: Vascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M12155
- Name: Myocardial Infarction
- Relevance: HIGH
- As Found: Myocardial Infarction
- ID: M2656
- Name: MINOCA
- Relevance: HIGH
- As Found: Myocardial Infarction With Non-obstructive Coronary Arteries
- ID: M10293
- Name: Inflammation
- Relevance: HIGH
- As Found: Inflammation
- ID: M10282
- Name: Infarction
- Relevance: HIGH
- As Found: Infarction
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M12284
- Name: Necrosis
- Relevance: LOW
- As Found: Unknown
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: LOW
- As Found: Unknown
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009203
- Term: Myocardial Infarction
- ID: D000088442
- Term: MINOCA
- ID: D000007249
- Term: Inflammation
- ID: D000007238
- Term: Infarction
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446882
**Acronym:** DEFINITIVE
**Brief Title:** Diagnostic HER2DX-guided Treatment for patIents wIth Early-stage HER2-positive Breast Cancer
**Official Title:** Diagnostic HER2DX-guided Treatment for patIents wIth Early-stage HER2-positive Breast Cancer
#### Organization Study ID Info
**ID:** HCB-ONC002
#### Organization
**Class:** OTHER
**Full Name:** Fundacio Clinic Barcelona
### Status Module
#### Completion Date
**Date:** 2028-11
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** SOLTI Breast Cancer Research Group
**Class:** NETWORK
**Name:** Austrian Breast & Colorectal Cancer Study Group
**Class:** OTHER
**Name:** UNICANCER
**Class:** UNKNOWN
**Name:** Westdeutsche Studiengruppe GmbH (WSG)
**Class:** OTHER
**Name:** Istituto Oncologico Veneto IRCCS
**Class:** OTHER
**Name:** Istituto Europeo di Oncologia
**Class:** OTHER_GOV
**Name:** Sheba Medical Center
**Class:** OTHER
**Name:** University College Cork
**Class:** OTHER
**Name:** University of Padova
#### Lead Sponsor
**Class:** OTHER
**Name:** Fundacio Clinic Barcelona
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The primary goal of the DEFINITIVE trial is to demonstrate the effectiveness of the HER2DX diagnostic assay in enhancing the management of patients with early-stage HER2- positive breast cancer.
Patients randomized to arm A will receive adjuvant treatment by physician´s choice, blinded to the diagnostic HER2DX test results. Patients randomized to Arm B will receive personalized treatment according to HER2DX results.
**Detailed Description:** This is an international, multicenter, prospective, randomized, two-arm, open-label, phase III study to evaluate the HRQoL, safety, efficacy, and economical costs of using HER2DX in patients with stage II to IIIA HER2-positive breast cancer, suitable for neoadjuvant therapy.
A dual primary endpoint with an according multiple testing procedure is defined in this study. First, the study will evaluate superiority in quality of life using i) the GHS scale from the EORTC QLQ-C30 questionnaire version 3.0 and ii) the score from the FACIT Fatigue Scale.
### Conditions Module
**Conditions:**
- HER2-positive Breast Cancer
- Early-stage Breast Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 304
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Treatment by physician´s choice, blinded to the diagnostic HER2DX test results
**Intervention Names:**
- Other: Treatment by physician´s choice, blinded to the diagnostic HER2DX test results
**Label:** Arm A: Treatment by physician´s choice without the diagnostic test results
**Type:** OTHER
#### Arm Group 2
**Description:** Personalized treatment according to molecular diagnosis with non-blinded HER2DX results
**Intervention Names:**
- Device: Personalized treatment according to molecular diagnosis with HER2DX
**Label:** Arm B: Personalized treatment according to molecular diagnosis with HER2DX
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Arm B: Personalized treatment according to molecular diagnosis with HER2DX
**Description:** Patients with HER2DX high-risk disease:
* Neoadjuvant treatment:
* High HER2DX pCR score: paclitaxel per 12 weeks + trastuzumab +/- pertuzumab per 4-5 cycles.
* Medium HER2DX pCR score: carboplatin + paclitaxel per 12-18 (or docetaxel per 4-6 cycles) + trastuzumab +/- pertuzumab per 4-7 cycles.
* Low HER2DX pCR score: standard of care neoadjuvant CT regimens and HER2 blockade at the investigator's choice.
* Adjuvant treatment:
* pCR at surgery; Trastuzumab +/- pertuzumab up to a total of 18 cycles (including neoadjuvant and adjuvant therapy).
* No pCR at surgery: T-DM1 per 14 cycles.
Patients with HER2DX low-risk disease:
* Neoadjuvant treatment: paclitaxel per 12 weeks + trastuzumab +/- pertuzumab per 4-5 cycles.
* Adjuvant treatment will be according to the pCR status at surgery:
* pCR at surgery: trastuzumab or no adjuvant treatment.
* No pCR at surgery: trastuzumab or T-DM1.
**Name:** Personalized treatment according to molecular diagnosis with HER2DX
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Arm A: Treatment by physician´s choice without the diagnostic test results
**Description:** Patients randomized in ARM A will be treated with standard of care neoadjuvant CT regimens and HER2 blockade at the investigator's choice validated by national and/or international guidelines.
**Name:** Treatment by physician´s choice, blinded to the diagnostic HER2DX test results
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The GHS scale is based on two 7-point questions (from very poor to excellent, items 29-30 from EORTC QLQ-C30 questionnaire).
Following EORTC scoring manuals, a linear transformation will be used to standardize the GHS scale to a 0-100 scale.
**Measure:** Global health status (GHS) scale from the EORTC QLQ-C30 questionnaire
**Time Frame:** Up to 5 years
**Description:** The FACIT Fatigue Scale, version 4 will be used to evaluate PRO measures of quality-of-life concerns related to fatigue.
The FACIT Fatigue Scale is a 13-item questionnaire designed to measure fatigue and its impact on daily life in individuals with various health conditions. Respondents rate their fatigue experiences over the past week on a scale from 0 to 4, with higher scores indicating less fatigue. The total score ranges from 0 to 52.
**Measure:** Score from the FACIT Fatigue Scale
**Time Frame:** Up to 5 years
#### Secondary Outcomes
**Description:** Change from baseline in all other functional and symptom scales (items 1 to 28) from the EORTC QLQ-C30 questionnaire version 3.0 to assesses cancer-related symptoms, impacts, and treatment-related symptoms.
The items are rated on a 4-point rating scale ranging from 0 ("not at all") to 4 ("very much").
**Measure:** Functional and symptom scales from the EORTC QLQ-C30 questionnaire.
**Time Frame:** Up to 5 years
**Description:** Change from baseline in the score of the EuroQol-5D.
The 5-level version EQ-5D-5L is a 6-item generic patient-reported preference-based instrument designed to assess health status of patients. The EQ-5D-5L consists of 2 sections:
* the EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of severity: the dimensions of mobility, self-care, and usual activity are rated ranging from 1 (no problem completing task) to 5 (unable to complete task) while the dimensions of pain/discomfort and anxiety/depression are rated ranging 1 (no symptom) to 5 (extreme symptom).
* the EuroQoL visual analogue scale (EQ-VAS) is for patients to self-rate their (global) health state utilizing a vertically oriented visual analogue scale where 100 represents the "best possible health state" and 0 represents the "worst possible health state".
**Measure:** Score of the EuroQol-5D
**Time Frame:** Up to 5 years
**Description:** pCR rates between groups at randomization and according to the predefined HER2DX pCR score as a continuous variable and as group categories.
pCR will be defined as the complete absence of invasive carcinoma in the breast and axillary lymph nodes on histological examination at the time of definitive surgery, irrespective of in situ carcinoma in the breast.
**Measure:** pCR rates
**Time Frame:** Up to 5 years
**Description:** RCB between groups at randomization and according to HER2DX pCR score as a continuous variable and as group categories.
Residual cancer burden (RCB) is defined as classes 0, 1, 2 and 3, according to the MD Anderson Cancer Center recommendations by local evaluation.
**Measure:** Residual cancer burden (RCB)
**Time Frame:** Up to 5 years
**Description:** Invasive disease-free survival (iDFS) between groups at randomization and according to HER2DX pCR score in continuous variable and risk group.
iDFS is defined as the time from surgery until the date of the first occurrence of one of the following events: recurrence of ipsilateral invasive breast tumor, recurrence of ipsilateral locoregional invasive disease, a distant disease recurrence, contralateral invasive breast cancer, second primary or death from any cause.
**Measure:** Invasive disease-free survival (iDFS)
**Time Frame:** Up to 5 years
**Description:** Distant metastasis free survival (DMFS) between groups at randomization and according to HER2DX pCR score in continuous variable and risk group.
DMFS is defined as the time from surgery to date of first event of distant metastatic recurrence or death (any cause). Contralateral breast cancer and secondary cancers will not be considered. Patients who do not have a DMFS event will be censored at the last recurrence assessment. Patients alive with no evidence of metastasis at the time of their last visit are censored at the time of the last examination.
**Measure:** Distant metastasis free survival (DMFS)
**Time Frame:** Up to 5 years
**Description:** Recurrence-free interval (RFI) between groups at randomization and according to HER2DX pCR score in continuous variable and risk group.
RFI is defined as from surgery until the date of the first occurrence of one of the following events: recurrence of ipsilateral breast tumor (in situ or invasive), recurrence of ipsilateral locoregional invasive disease, a distant disease recurrence, contralateral invasive breast cancer or death from breast cancer.
**Measure:** Recurrence-free interval (RFI)
**Time Frame:** Up to 5 years
**Description:** Event free survival (EFS) between groups at randomization and according to HER2DX pCR score in continuous variable and risk group.
EFS is defined as the time from randomization to the first documented disease recurrence, unequivocal tumor progression determined by the treating investigator, or death from any cause, whichever occurs first.
**Measure:** Event free survival (EFS)
**Time Frame:** Up to 5 years
**Description:** Incidence, duration, and severity of adverse events (AEs) assessed by the NCI Common Terminology for Classification of AEs (CTCAE) version 5, including dose reductions, delays, and treatment discontinuations.
**Measure:** Incidence, duration, and severity of adverse events (safety and tolerability)
**Time Frame:** Up to 5 years
**Description:** Patient-reported Experience Measurement (PREM) data will be elicited from the patients in this study to fully understand the experience of patient.
Team accessibility, Communication, Information from care providers, Care continuum coordination, respect and courtesy, secondary effects management, shared-decision making, language barriers and overall care perception, will be evaluated using the Drug Therapy Team survey and the Supplementary Items survey from the CAHPS cancer care survey (AHQR).
The Drug Therapy Team Survey is a 56 items questionnaire designed to measure accessibility to the care team, quality of information provided, quality of the visit, management of the impact of the disease on daily life, quality of the administration staff support, and a global scale from 0 to 10 to rate the quality of the team.
The supplementary items survey is a 16 items questionnaire and measure three dimensions of experience: access, information and shared-decision making.
**Measure:** CAHPS cancer care survey (AHQR)
**Time Frame:** Up to 5 years
**Description:** Health economic evaluation to analyse the cost-effectiveness in patients with and without HER2DX test information, not only direct cost for hospitals/public health system, but also indirect cost from a societal perspective.
The EuroQol-5D-5L questionnaire will be used to calculate a health status utility score for use in health economic analyses.
**Measure:** Economic impact of the HER2DX test
**Time Frame:** Up to 5 years
**Description:** To evaluate whether the potential treatment de-escalation following tailored treatment by HER2DX could have impact in the work productivity using the Work Productivity and Activity Impairment Questionnaire (WPAI- GH).The WPAI-GH is a 6-item instrument that gauges absenteeism (missed work time due to the health issue), presenteeism (decreased productivity while working due to the health problem), overall work hindrance, and limitations in daily activities.
**Measure:** Work productivity
**Time Frame:** Up to 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Signed informed consent must be obtained prior to any trial-specific procedure. Note: Candidate patients in France must be affiliated to a Social Security System (or equivalent).
2. Male/female patients who are at least 18 years of age on the day of signing informed consent.
3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
4. Eligible for any of the following drugs: taxane, carboplatin, trastuzumab, pertuzumab and T-DM1 therapy.
5. Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast untreated and recently diagnosed.
6. Stage at presentation: cT1 cN1-2 or cT2-3 cN0-2 as determined by AJCC staging system, 8th edition (specifically in accordance with Anatomic Stage group rules).
Note: Axillary lymph node status must be assessed by fine needle biopsy or core biopsy. This procedure at screening will be omitted if there is no suspicion for positive axillary lymph node(s) radiographically or if a pathological report of suspicious lymph nodes of the results of a fine needle biopsy or core biopsy is available prior to the screening period.
7. Absence of distant metastasis (i.e., cM0).
8. Patients with multifocal tumors (more than one mass confined to the same quadrant as primary tumor) are eligible provided at least one focus is sampled and locally confirmed as HER2-positive.
9. Patients with multicentric tumors (multiple tumors involving more than one quadrant) are eligible provided all discrete lesions are sampled and locally confirmed as HER2-positive.
Note: In patients with multifocal or multicentric breast cancer, the largest lesion should be measured to determine T stage and to performe the HER2DX test.
10. HER2 positivity defined as either of the following: IHC 3+ or HER2 2+/ ISH positive as per most recent ASCO- CAP guideline according to the local laboratory as determined on the most recently analyzed tissue sample.
11. ER/PR status determined local based on pretreatment breast biopsy material according to the most recent ASCO/CAP guidelines.
12. Candidates for neoadjuvant treatment.
13. Patient agreement to undergo appropriate surgical management, including axillary lymph node surgery and partial or total mastectomy, after completion of neoadjuvant treatment
14. Baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans.
15. Availability of pre-treatment tumor tissue sample of FFPE tumor block from primary tumor in the breast for diagnostic HER2DX test. The tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for quality prior to enrollment. Archival tumor tissue or ex professo biopsy are acceptable.
16. Adequate hematologic and end-organ function.
17. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:
* Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period, 6 months after the final dose of doxorubicin, 12 months after the final dose of cyclophosphamide, 6 months after the final dose of paclitaxel, and 7 months after the final dose of trastuzumab, pertuzumab, or T-DM1, whichever occurs last. Women must refrain from donating eggs during this same period.
* A woman is of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\> 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.
* Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, copper intrauterine devices, hormonal contraceptives that inhibit ovulation, and hormone-releasing intrauterine devices in women with hormone receptor-negative tumors only; the use of hormonal contraceptives and hormone releasing intrauterine devices are prohibited in women with hormone receptor-positive tumors.
* The reliability of sexual abstinence should be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
18. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
* With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for 6 months after the final dose of doxorubicin and/or cyclophosphamide, 6 months after the final dose of paclitaxel, and 7 months after the final dose of trastuzumab, pertuzumab, or T-DM1, whichever occurs last. Men must refrain from donating sperm during this same period. Male patients are encouraged to seek advice regarding cryoconservation of sperm prior to commencing study treatment because of the possibility of infertility with CT.
* With a pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of doxorubicin and/or cyclophosphamide, 6 months after the final dose of paclitaxel, and 7 months after the final dose of trastuzumab, pertuzumab, or T-DM1, whichever occurs last to avoid exposing the embryo.
* The reliability of sexual abstinence should be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Exclusion Criteria:
1. Stage IV (metastatic) breast cancer.
2. Known hypersensitivity to any of the excipients of trastuzumab, pertuzumab, carboplatin, T-DM1, docetaxel or paclitaxel.
3. Patients with synchronous bilateral invasive breast cancer.
4. Prior systemic therapy for treatment of breast cancer.
5. Ulcerating or inflammatory breast cancer.
6. Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes.
7. Sentinel lymph node procedure or axillary lymph node dissection prior to initiation of neoadjuvant therapy.
8. Patients with a history of previous breast cancer are excluded. Patients with a history of any other cancers (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years are excluded. For patients with a history of other non-breast cancerscancerscancers within 3 years and considered of low risk of recurrence per investigator's judgment (for example, papillary thyroid cancer treated with surgery), eligibility is to be discussed with the Sponsor.
9. Cardiopulmonary dysfunction as defined by any of the following prior to randomization:
* History of congestive heart failure of any classification.
* Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease.
* High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate \> 100/min at rest, significant ventricular arrhythmia \[ventricular tachycardia\], or higher-grade atrioventricular \[AV\]-block \[second degree AV-block Type 2 \[Mobitz 2\] or third-degree AV-block\]).
* Significant symptoms (Grade \> 1) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia.
* Myocardial infarction within 12 months prior to randomization.
* Evidence of transmural infarction on ECG.
* Requirement for oxygen therapy.
* Dyspnea at rest.
10. Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the Study.
11. Severe infection within 4 weeks prior to initiation of Study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
12. History of significant co-morbidities that, in the judgment of the investigator, may interfere with the conduction of the Study, the evaluation of response, or with consent procedure.
13. Pregnancy or breastfeeding, or intention of becoming pregnant during Study treatment or within 6 months after the final dose of paclitaxel, or 7 months after the final dose of trastuzumab, pertuzumab, or T-DM1, whichever occurs last.
Note: Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of Study treatment.
14. Persons deprived of their liberty or under protective custody or guardianship.
15. Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: 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: M231
- Name: Albumin-Bound Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M1668
- Name: Docetaxel
- Relevance: LOW
- As Found: Unknown
- ID: M18650
- Name: Carboplatin
- Relevance: LOW
- As Found: Unknown
- ID: M289243
- Name: Pertuzumab
- Relevance: LOW
- As Found: Unknown
- ID: M325
- Name: Trastuzumab
- Relevance: LOW
- As Found: Unknown
- ID: M2102
- Name: Ado-Trastuzumab Emtansine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446869
**Brief Title:** Menopausal Symptoms Probiotic Study
**Official Title:** Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of the Combination of Levilactobacillus Brevis KABP-052, Lactiplantibacillus Plantarum KABP-051 and Pediococcus Acidilactici KABP-021 on Menopausal Symptoms and Quality of Life in Peri- and Post-menopausal Women
#### Organization Study ID Info
**ID:** KNK-DONACARE
#### Organization
**Class:** OTHER
**Full Name:** Community Pharmacology Services Ltd
### Status Module
#### Completion Date
**Date:** 2025-02-10
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Kaneka Americas Holding Inc.
#### Lead Sponsor
**Class:** OTHER
**Name:** Community Pharmacology Services 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:** In this study, we want to investigate if the active product consisting of a probiotic blend can potentiate the recirculation of active oestrogens into the bloodstream and help to mitigate menopause symptoms, which are closely related to oestrogens levels
### Conditions Module
**Conditions:**
- Menopause
**Keywords:**
- menopause
- menopausal symptoms
- hot flashes
- night sweats
- menopause treatment
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Study treatment vs Placebo
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Double-Blind
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 140
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Study treatment
**Intervention Names:**
- Dietary Supplement: Gyntima Menopause
**Label:** Gyntima Menopause
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo comparator arm
**Intervention Names:**
- Other: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Gyntima Menopause
**Description:** Combination of Levilactobacillus brevis KABP-052, Lactiplantibacillus plantarum KABP-051 and Pediococcus acidilactici KABP-021
**Name:** Gyntima Menopause
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Placebo comparator
**Name:** Placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** To assess the impact of the investigational product on the symptoms and quality of life (QoL) in menopausal women as assessed by Menopause Rating Score II (MRS-II) Each of the 11 symptoms contained in the scale can get 0 (no complaints) or up to 4 scoring points (severe symptoms) depending on the severity of the complaints perceived by the women completing the scale (an appropriate box is to be ticked). The score increases point by point with increasing severity of subjectively perceived symptoms in each of the 11 items.
**Measure:** Assess Impact
**Time Frame:** 120 days
#### Secondary Outcomes
**Description:** To assess the impact of the investigational product on the severity of symptoms as assessed by MRS-II
Each of the 11 symptoms contained in the scale can get 0 (no complaints) or up to 4 scoring points (severe symptoms) depending on the severity of the complaints perceived by the women completing the scale (an appropriate box is to be ticked). The score increases point by point with increasing severity of subjectively perceived symptoms in each of the 11 items.
**Measure:** Impact on Severity of Symptoms
**Time Frame:** 120 days
**Description:** To assess the impact of the investigational product on the number of hot flashes and night sweats.
All study participants will receive a diary where they will report their daily number of hot flashes and night sweats.
**Measure:** Impact on number of Hot Flashes / Night Sweats
**Time Frame:** 120 days
**Description:** To assess the impact of the investigational product on the intensity of hot flashes and night sweats
All study participants will receive a diary where they will report their daily number of hot flashes and night sweats.
**Measure:** Impact on Intensity of Hot Flashes / Night Sweats
**Time Frame:** 120 days
**Description:** To assess the impact of the investigational product on menopause-related QoL as assessed by the Greene Climacteric Scale (GCS) questionnaire
The Greene Climacteric Scale (GCS) is a standard list of 21 questions which women use to rate how much they are bothered by menopause symptoms such as hot flashes, night sweats, rapid heartbeat, and difficulty sleeping. Each symptom is rated on a 4-point Likert scale from 0 points (not at all) to 3 points (Extremely)
**Measure:** Impact on QoL
**Time Frame:** 120 days
**Description:** To assess the impact of the investigational product on Depress, Anxiety and Stress Scale-21 (DASS-21)
This scale form is a short form of the 42 item self reported questionnaire measuring depression, anxiety and stress. The 21 items on this questionnaire comprise a set of 3 self-reported scales designed to assess DASS. The 7 elements on the scales are graded on a Likert scale from 0 to 3.
**Measure:** Impact on Depression, Anxiety and Stress
**Time Frame:** 120 days
**Description:** To assess the impact of the investigational product on levels of relevant reproductive hormones during peri- and post-menopause
Efficacy laboratory tests are to be performed for all participants as indicated in the protocol's SoA. For Hormones - Oestrone, Oestradiol, FSH and progesterone.
**Measure:** Impact on levels of reproductive hormones
**Time Frame:** 120 days
**Description:** To assess the impact of the investigational product on serum inflammation markers
Efficacy laboratory tests are to be performed for all participants, as indicated in the protocol's SoA. For Biomarkers - Interleukin (IL)-1β, IL-2, IL-4, IL-6, IL-8, tumour necrosis factor (TNF) and interferon). Note: Analysis of inflammation biomarkers will only be performed at the Sponsor's discretion after the results of hot flashes and QoL become available.
**Measure:** Impact on serum inflammation markers
**Time Frame:** 120 days
**Description:** To assess the impact of the investigational product on gut microbiota composition
The determination of the composition of the faecal microbiota will be carried out through a study of the V3-V4 hypervariable regions of the bacterial ribosomal 16S rRNA gene. Next, the libraries will be set up, and ultrasequencing, bioinformatics and statistical analysis will be carried out. The analysis will be performed in a specialised company called Microomics Systems S.L. located in Barcelona, Spain. Stool samples will be collected by study participants
**Measure:** Impact on gut microbiota composition
**Time Frame:** 120 days
**Description:** To assess the impact of the investigational product on digestive tolerance.
This will be assessedbased on documented gastrointestinal symptoms on the Gastrointestinal Symptom Rating Scale (GSRS)
**Measure:** Impact on digestive tolerance
**Time Frame:** 120 days
**Description:** To assess the safety of the investigational product Safety evaluation based on AE registry, Blood cell count and basic blood biochemistry
**Measure:** Safety of the IP
**Time Frame:** 120 days
**Description:** To assess the satisfaction with the use of the investigational product
Product satisfaction will be evaluated by using an ordinal 5-point Likert scale, where study participants will have to rate the degree to which they agree or disagree with the statement: "Please indicate the degree of satisfaction or dissatisfaction with the way the study product has relieved your symptoms associated to menopause"
**Measure:** Satisfaction of Use
**Time Frame:** 120 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Perimenopausal or post-menopausal women with spontaneous menopause and amenorrhoea for less than 2 years
* Self reported menopausal symptoms (5 or more hot flashes/night sweats per day or 35 or more per week recorded daily for 14 consecutive days)
* BMI between 18.5 and 34.9 kg/m2
* Menopause rating score II (MRS-II) total score of 9 or more at baseline visit
* Willing to sign Informed Consent Form
* Willing to not make relevant changes to their current dietary or lifestyle habits during study
* Able to follow study procedures
* If perimenopausal, agrees to use an accepted method of contraception for duration of study.
Exclusion Criteria:
* History of hysterectomy, oophorectomy, endometrial hyperplasia, uterine or endometrial cancer, breast cancer, or cancers associated with sex hormones
* Use of hormonal replacement therapy, hormone analogues, or oral contraceptives within 3 months prior to the start of the study
* Intake of herbal or food supplements with known effects on menopause symptoms within 1 month prior to the start of the study. Examples of prohibited substances are black cohosh, melatonin, ginseng, chasteberry, phytoestrogens (e.g., hop \[Humulus lupulus L.\], soy isoflavones, red clover) within 1 month prior to the start of the study
* Use of any food supplement containing probiotics or postbiotics or regular consumption (\>3 days/week) of foods containing probiotics (including yogurt with added probiotics or bifidus effect) within 1 month prior to the start of the study
* Use of oral (\>3 days) or parenteral antibiotics within 1 month prior to the start of the study
* Participants with a new diagnosis of mental health disorder in the last 12 months or with an unstable or uncontrolled mental health disorder in the opinion of the Investigator
* Diagnosis of type 1 or uncontrolled type 2 diabetes mellitus
* Diagnosis of chronic gastrointestinal disease, such as inflammatory bowel disease (Crohn's disease or ulcerative colitis), pancreatitis, or short bowel syndrome
* History of thyroid disorders (hypothyroidism or hyperthyroidism) which are untreated or unstable
* History of gastrointestinal surgery 6 months prior to the start of the study, with the exception of appendicectomy
* Regular intake (\>3 days/week) of medication that affects microbiota or bowel movements, namely laxatives like polyethylene glycol or stimulant laxatives (bisacodyl, sennosides, sodium pyrosulfate)
* History of coronary disease, myocardial infarction, unstable angina, or previous coronary angioplasty
* History of venous thromboembolism (VTE) or known to be high risk for VTE due to inherited or acquired thrombophilia (such as factor V Leiden, antiphospholipid syndrome)
* History of stroke or transient ischaemic attack
* History of severe renal dysfunction as defined by an estimated glomerular filtration rate \<30 mL/minute or severe liver dysfunction defined as established cirrhosis or active liver disease with alanine aminotransferase (ALT) \>3 × upper limit of normal at baseline
* Initiated for new diagnosis or changed dose of UK-approved therapeutic medication or nutraceuticals for a medical condition that can affect study outcomes according to the Investigator's judgement (i.e., statins, anti-hypertensives, etc.) within 90 days prior to study entry
* Diagnosis of primary or secondary immunodeficiency including acquired immunodeficiency syndrome, immunodeficiency, or active oncologic disease
* Known or suspected alcohol or drug abuse
* Any other surgical or medical condition, which in the opinion of the Investigator, may place the participant at higher risk from her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study
* Currently participating in another study or having participated in one within 3 months prior to the start of the study
* The participant is pregnant, planning a pregnancy, or breastfeeding
**Maximum Age:** 60 Years
**Minimum Age:** 42 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Karen Hopkins, MBChB
**Phone:** 0141 946 7888
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** David Cogan
**Phone:** 0141 946 7888
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Community Pharmacology Services Ltd
**Name:** Karen Hopkins, MBChB
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** No data will be shared
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M21519
- Name: Hot Flashes
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: LOW
- As Found: Unknown
- ID: T6036
- Name: Menopause
- Relevance: HIGH
- As Found: Menopause
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446856
**Acronym:** EVEN
**Brief Title:** EVEN - Effects of VR on Empathy for Nature in Patients With Psychosis and Depressive Disorders
**Official Title:** EVEN - Effects of VR on Empathy for Nature in Patients With Psychosis and Depressive Disorders / Effekte Von Virtueller Realität (VR) Auf Naturverbundenheit Und Empathie in Patient:Innen Mit Psychotischen Und Depressiven Erkrankungen
#### Organization Study ID Info
**ID:** EA2/046/24
#### Organization
**Class:** OTHER
**Full Name:** Charite University, Berlin, Germany
### Status Module
#### Completion Date
**Date:** 2024-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-27
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Universität Potsdam, Department Erziehungswissenschaft, Arbeitsbereich Schulbezogene Medienbildung
#### Lead Sponsor
**Class:** OTHER
**Name:** Charite University, Berlin, Germany
#### Responsible Party
**Investigator Affiliation:** Charite University, Berlin, Germany
**Investigator Full Name:** Alva Lütt
**Investigator Title:** Dr. med. Alva Lütt, MD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Study group: Experimental study to evaluate empathy, compassion, and nature connectedness before and after an immersive virtual reality experience in patients with depressive disorder, patients with psychotic disorder and healthy control subjects (subjects between 18 and 65 years of age).
Primary hypothesis: The increase in nature connectedness explored by virtual body ownership of a tree in VR differs depending on the health condition (schizophrenia, depression, healthy controls).
### Conditions Module
**Conditions:**
- Depressive Disorder
- Schizophrenia
- Healthy Control
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 20 patients with depressive disorder
**Intervention Names:**
- Device: VR application
**Label:** VR study group
#### Arm Group 2
**Description:** 20 patients with psychotic disorder.
**Intervention Names:**
- Device: VR application
**Label:** VR active control group
#### Arm Group 3
**Description:** 20 patients with no psychiatric disorder
**Intervention Names:**
- Device: VR application
**Label:** VR healthy control group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- VR active control group
- VR healthy control group
- VR study group
**Description:** The VR application consists of a software ("Tree") developed as part of a research project at MIT and legally acquired via the HTC store Viveport. Duration of the VR application: approx. 5 min.
**Name:** VR application
**Type:** DEVICE
### Outcomes Module
#### Other Outcomes
**Description:** acquisition of demographic data
**Measure:** demographic variables
**Time Frame:** pre VR exposure for all groups
**Description:** acquisition of psychiatric comorbidities and physical illnesses
**Measure:** comorbidities
**Time Frame:** pre VR exposure for all groups
**Description:** Assessment of symptom severity with the Positive and Negative Syndrome Scale (PANSS; Kay et al., 1987)
**Measure:** symptom severity - psychotic symptoms
**Time Frame:** For the VR study group (patients with depressive disorder) and VR active control group (patients with psychotic disorder) pre VR exposure (within the same session of 1 hour)
**Description:** Assessment of symptom severity with the Beck Depression Inventory (BDI; Beck et al., 1961)
**Measure:** symptom severity - depressive symptoms
**Time Frame:** For the VR study group (patients with depressive disorder) and VR active control group (patients with psychotic disorder) pre VR exposure (within the same session of 1 hour)
#### Primary Outcomes
**Description:** Measurement of Nature Connectedness as a state with the "Inclusion of Nature in Self" (INS)-Questionnaire (Kleespies et al., 2021), pre and post VR exposure.
**Measure:** Nature Connectedness
**Time Frame:** For all groups pre and directly post VR exposure
#### Secondary Outcomes
**Description:** Evaluation of empathy with the Multifaceted Empathy Test (MET; (Dziobek et al., 2008) pre and post VR exposure
**Measure:** Empathy
**Time Frame:** For all groups pre and directly post VR exposure (within the same session of 1 hour)
**Description:** Evaluation of Compassion (state compassion) pre and post VR exposure with the Positive and Negative Affect Schedule (PANAS) and five integrated items measuring compassion based on Pfattheicher et al., 2015.
**Measure:** Compassion
**Time Frame:** For all groups pre and directly post VR exposure (within the same session of 1 hour)
**Description:** Measured with the PANAS (see above) and with the Visual Analogue Scale (0-10) measuring the burden of the 3 main symptoms, previously specified during assessment of symptom severity (PANSS; (Kay et al., 1987) and Beck Depression Inventory (BDI, Beck et al., 1961))
**Measure:** symptom burden
**Time Frame:** For the VR study group (patients with depressive disorder) and VR active control group (patients with psychotic disorder) pre and post VR exposure (within the same session of 1 hour)
**Description:** Evaluation with a subscale of the Embodiment scale by Ahn et al. (2016) adapted from Slater et al. (2010)
**Measure:** Embodiment - Feeling of virtual body ownership
**Time Frame:** post VR exposure for all groups (within the same session of 1 hour)
**Description:** Evaluation of spirituality using the 4-item short version of the questionnaire "Transpersonales Vertrauen" (Hampel et al., 2019) pre VR exposure.
**Measure:** Spirituality
**Time Frame:** pre VR exposure for all groups
**Description:** Scale according to Ahn et al. (Ahn et al., 2016), adapted from the "Spatial Presence scale" by Bailenson et al. (2005) - own German translation adapted to the virtual Amazon forest area (Spangenberger et al., 2024)
**Measure:** Presence in VR
**Time Frame:** post VR exposure for all groups (within the same session of 1 hour)
**Description:** Cyber Sickness as a potential side effect of VR, measured with the Virtual Reality Sickness Questionnaire (Kim et al., 2018)
**Measure:** Virtual Reality Simulator Sickness
**Time Frame:** post VR exposure for all groups (within the same session of 1 hour)
**Description:** Explorative evaluation of electrodermal activity (EDA), e.g., skin conductance level (SCL) and skin conductance responses (SCR) in micro siemens during VR exposure
**Measure:** Explorative evaluation of electrodermal activity (EDA)
**Time Frame:** during (approx. 5 minutes) VR exposure
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* age: 18-65 years
* Inpatients and outpatients treated at the Psychiatric University Clinic of the Charité at St.
Hedwig Hospital
* diagnosis of depressive disorder (ICD-10: F32.X, F33.X) or diagnosis of schizophrenia (F20.X) or healthy controls without psychiatric diagnosis
* able to provide written informed consent
Exclusion Criteria:
* Acute suicidality or danger to others
* Primarily treatment-requiring eating disorder
* Acute dermatological condition affecting the hands that can distort skin conductivity measurements
* Control group: psychiatric or psychosomatic pre-diagnoses (except for the psychiatric active control group), other exclusion diagnoses corresponding to the patient 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:** Patients with depressive or psychotic disorder treated in the inpatient or outpatient psychiatric clinics or day clinics of the Psychiatric University Hospital Charité at St. Hedwig-Hospital
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Alva Lütt, Dr. med.
**Phone:** 03023110
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Berlin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Alva Lütt, Dr. med.
- **Role:** CONTACT
**Country:** Germany
**Facility:** Psychiatric University Hospital Charité at St. Hedwig Hospital
**Status:** RECRUITING
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019967
- Term: Schizophrenia Spectrum and Other Psychotic Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000019964
- Term: Mood Disorders
- ID: D000001526
- Term: Behavioral Symptoms
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M15376
- Name: Schizophrenia
- Relevance: HIGH
- As Found: Schizophrenia
- ID: M7061
- Name: Depressive Disorder
- Relevance: HIGH
- As Found: Depressive Disorder
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depressive Disorder
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21838
- Name: Schizophrenia Spectrum and Other Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21835
- Name: Mood Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012559
- Term: Schizophrenia
- ID: D000003866
- Term: Depressive Disorder
- ID: D000003863
- Term: Depression
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446843
**Acronym:** (RCT)
**Brief Title:** Comparing Platelet-Rich Fibrin + Hyaluronic Acid vs. Hyaluronic Acid for TMJ Internal Derangement
**Official Title:** Assessment of Injectable Platelet-rich Fibrin With Hyaluronic Acid Versus Hyaluronic Acid in Management of Temporomandibular Joint Internal Derangement
#### Organization Study ID Info
**ID:** CarioU
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-02
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Baghdad Mohammed abdo-alhage
#### Responsible Party
**Investigator Affiliation:** Cairo University
**Investigator Full Name:** Baghdad Mohammed abdo-alhage
**Investigator Title:** Assessment of injectable platelet-rich fibrin with hyaluronic acid versus Hyaluronic acid in management of temporomandibular joint internal derangement
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Injectable PRF technology, according to literature evidence, ensures the release of growth factors over time which play a major role in the release of regenerative factors for tissue repair after injection, while HA is an anti-inflammatory medication that can provide rapid relief from pain and inflammation in joints. It is a major natural component of synovial fluid that plays an important role in lubrication of synovial tissues However, its effect is typically temporary, and it doesn\'t promote tissue healing or regeneration.
For this reason, this protocol has been designed with the aim to investigate whether injection in the injection i- pRF with HA can achieve the same improvements of pain and function, compare this technique with arthrocentesis.
### Conditions Module
**Conditions:**
- Tmj Internal Derangment
**Keywords:**
- Hyaluronic acid ,Injectable PRF,TMJ ID
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 42
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** arthrocentesis with Ringer's lactate solution, of the superior joint compartment
**Intervention Names:**
- Combination Product: (Arthrocentesis following i-PRF +HA)
**Label:** (control group) will receive Arthrocentesis alone
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** arthrocentesis with Ringer's lactate solution, of the superior joint compartment then inject 1ml of HA following arthrocentesis.
**Intervention Names:**
- Combination Product: (Arthrocentesis following i-PRF +HA)
**Label:** (study group1) will receive (Arthrocentesis+HA)
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** arthrocentesis with Ringer's lactate solution, of the superior joint compartment then inject
1 ml of i- PRF then1ml of HA following arthrocentesis.
**Intervention Names:**
- Combination Product: (Arthrocentesis following i-PRF +HA)
**Label:** (study group2)(Arthrocentesis following i-PRF +HA)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- (control group) will receive Arthrocentesis alone
- (study group1) will receive (Arthrocentesis+HA)
- (study group2)(Arthrocentesis following i-PRF +HA)
**Description:** Intra-articular I-PRF with HA will be injected in the joint,1 ml of I-PRF will be injected inside the joint, Then from 25mg/ml of HA , 1ml will be injected into the superior joint space
**Name:** (Arthrocentesis following i-PRF +HA)
**Type:** COMBINATION_PRODUCT
### Outcomes Module
#### Primary Outcomes
**Description:** Pain measured through a 10 visual analogic scale (VAS)
**Measure:** pain at TMJ during spontaneous mouth opening and with articular palpation and forced opening
**Time Frame:** evaluated at the preoperative examination (baseline) and reassessed at follow-up evaluation at 1 month, 3, month, and 6 months after the procedure.
**Description:** mandibular mouth opening defined as MIO (maximum interincisal opening) \>/35
**Measure:** Maximum mouth opening
**Time Frame:** evaluated at the preoperative examination (baseline) and reassessed at follow-up evaluation at 1 month, 3, month, and 6 months after the procedure.
#### Secondary Outcomes
**Description:** MRI unit :degree of angle between the posterior margin of the disc and the vertical line drawn through the Centre of the condyle.
**Measure:** MRI evolution
**Time Frame:** preoperative examination (baseline) and 6 months after the procedure.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Presence of TMJ-ID related symptoms.
* Patients suffering from TMJ internal derangement (disc displacement with reduction).
* Age limit between 20 and 45years so Patient less than 21years will need assent form ...as well as written informed consent from the parents \\guardians.
* No previous TMJ surgical procedures
* Acquisition of informed consent.
* Cooperative patient
* Patients free from any systemic disease that may affect the procedure.
Exclusion Criteria:
* Previous malignant head and neck neoplasms.
* Patients suffering from inflammatory or connective tissue systemic diseases.
* Neurologic disorders.
* History of bony or fibrous adhesion
* Gross mechanical restrictions and condylar fractures, previous TMJ surgery, TMJ ankylosis, or acute infection.
* Patients maintained on anti-coagulants, muscle relaxants, non-steroidal anti-inflammatory drugs within 48 h preoperatively, corticosteroid injection at treatment site within one month or systemic use of corticosteroids within 2 weeks was also excluded in this study.
* Uncooperative patient
* Pregnant and lactating female.
* Patients with systemic diseases (e.g., rheumatoid arthritis, psoriatic arthritis, or juvenile arthritis), and those who had shown symptoms of hypersensitivity to the HA solution.
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Baghdad al-hage, MS
**Phone:** 01118074441
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Hassan Abd Elghany, prof
**Phone:** 01001545449
**Role:** CONTACT
### References Module
#### References
**Citation:** Yuce E, Komerik N. Comparison of the Efficiacy of Intra-Articular Injection of Liquid Platelet-Rich Fibrin and Hyaluronic Acid After in Conjunction With Arthrocentesis for the Treatment of Internal Temporomandibular Joint Derangements. J Craniofac Surg. 2020 Oct;31(7):1870-1874. doi: 10.1097/SCS.0000000000006545.
**PMID:** 32433129
**Citation:** Ghoneim NI, Mansour NA, Elmaghraby SA, Abdelsameaa SE. Treatment of temporomandibular joint disc displacement using arthrocentesis combined with injectable platelet rich fibrin versus arthrocentesis alone. J Dent Sci. 2022 Jan;17(1):468-475. doi: 10.1016/j.jds.2021.07.027. Epub 2021 Aug 21.
**PMID:** 35028072
**Citation:** Harba AN, Harfoush M. Evaluation of the participation of hyaluronic acid with platelet-rich plasma in the treatment of temporomandibular joint disorders. Dent Med Probl. 2021 Jan-Mar;58(1):81-88. doi: 10.17219/dmp/127446.
**PMID:** 33847473
**Citation:** Hegab AF, Hameed HIAA, Hassaneen AM, Hyder A. Synergistic effect of platelet rich plasma with hyaluronic acid injection following arthrocentesis to reduce pain and improve function in TMJ osteoarthritis. J Stomatol Oral Maxillofac Surg. 2023 Feb;124(1S):101340. doi: 10.1016/j.jormas.2022.11.016. Epub 2022 Nov 19.
**PMID:** 36414172
**Citation:** Isik G, Kenc S, Ozveri Koyuncu B, Gunbay S, Gunbay T. Does the Use of Injectable Platelet-Rich Fibrin After Arthrocentesis for Disc Displacement Without Reduction Improve Clinical Outcomes? J Oral Maxillofac Surg. 2023 Jun;81(6):689-697. doi: 10.1016/j.joms.2023.02.014. Epub 2023 Mar 13.
**PMID:** 36924792
**Citation:** Toameh MH, Alkhouri I, Karman MA. Management of patients with disk displacement without reduction of the temporomandibular joint by arthrocentesis alone, plus hyaluronic acid or plus platelet-rich plasma. Dent Med Probl. 2019 Jul-Sep;56(3):265-272. doi: 10.17219/dmp/109329.
**PMID:** 31577070
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M9878
- Name: Hyaluronic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446830
**Brief Title:** the Analgesic Efficacy of Vitamin B Complex in Critically Ill Obstetrics After Caesarean Section
**Official Title:** the Analgesic Efficacy of Vitamin B Complex With Paracetamol and Non-steroidal Antiinflammatory Medication in Critically Ill Obstetrics After Caesarian Section; A Prospective Randomized , Placebo-controlled and Double-blinded Study
#### Organization Study ID Info
**ID:** FMASU R370/2023
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-02
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-25
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-02
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Ain Shams University
#### 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:** We aim to investigate the value of vitamin B (B1, B6, B9, B12) on post-cesarean section analgesia in addition to the standard opioid-sparing multimodal regimen to achieve more robust analgesia with minimal side effects.
**Detailed Description:** Optimum analgesia is an essential component in enhanced recovery after elective and emergency Caesarean section. Opioid-based analgesia negatively affects maternal functional recovery. Unlike other types of surgeries, the performance and the quality of postoperative recovery in caesarean section affects two individuals: the patient and their infant, hence it is recommended to use Opioid-sparing medications post-caesarean section.
Multimodal analgesia is recommended for post-caesarean section pain control. The main properties of its components are to promote return of (i) Mobility (ii) Oral intake (iii) Normal bowel function (iv) Micturition: Trial without urinary catheter (v) Activities of daily living, with Few adverse effects: inactive metabolites (no nausea, vomiting, sedation, pruritus, constipation or respiratory depression), Readily available after discharge home, Little risk of dependency (especially long-term opioids), Minimal risk of hyperalgesia or chronic pain and cost-efficient with minimally invasive technique and no side-effects on the neonate.
The morbidity of critically ill obstetrics can increase due to inadequate control of pain and also due to the consumption of opioid analgesia due to associated respiratory depression, sedation, and nausea. Multimodal analgesia is strongly recommended.
An immune-histochemistry study found that B vitamins potentiate acute morphine antinociception. In other studies, the value of vitamin B complex on postoperative analgesia was discussed and investigated in different combinations Another study reported the value of folic acid in decreasing gastric hypersensitivity in maternal stress in rats. Other studies explained the benefit of folic acid in analgesia through modulating gut microbiota, reducing inflammation, modulating purinergic signaling, and promoting nerve repair (6)This is the first study to investigate the effect of vitamin B9 (folic acid ) and other vitamin B (B1, B6, B12) beside the standard opioid sparing analgesics on post-caesarean section pain in critically ill obstetrics.
### Conditions Module
**Conditions:**
- Analgesia
- Post Operative Pain
- Cesarean Section
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** two parallel-group, randomized, double-blinded
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** the candidate will be masked, and Assessments regarding the primary outcome will be conducted by an assessor blind to treatment allocation. The assessor will go through a profound assessment training program
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** oral vitamin B complex tablets preoperative and continue post-operative for 2 days One tablet oral once daily for 1- 2 days according to the length of stay; the tablet is a vitamin (B1, B6, B9, and B12).
Oral daily vitamin B concentration; Tablet is composed of ; B1= 250mg, B6= 150 mg, B12= 0,250 mg, B9= 0.5mgm, B2 15 mg standard analgesic ladder will be implemented in the form of; Paracetamol 1gram (2 tablets) / 8hr for 48 hours, Ketorolac 30 mg / 12 hour for 48 hours. Any pain will be treated appropriately with nalbuphine till the patient is comforted, and the total dose will be documented.
the routine ladder of paracetamol and ketorolac will be modified according to organ functions and the presence of any contraindication for usage
**Intervention Names:**
- Drug: multimodal analgesia and vitamin B
**Label:** vitamin B
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** patients will receive a preoperative; Oral placebo tablet (once/day) Post-operative and continue post-operative for 2 days; One placebo capsule oral once daily for 2 days. standard analgesic ladder will be implemented in the form of; Paracetamol 1 gram (2 tablets) / 8hr for 48 hours. Ketorolac / 12 hours for 48 hours. Any pain will be treated appropriately with nalbuphine till the patient is comforted, and the total dose will be documented.
the routine ladder of paracetamol and ketorolac will be modified according to organ functions and the presence of any contraindication for usage
**Intervention Names:**
- Drug: standard multimodal analgesia
**Label:** standard
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- vitamin B
**Description:** B1, B6 , B9 , B12 in addition to the routine paracetamol and NSAID
**Name:** multimodal analgesia and vitamin B
**Other Names:**
- neuroton tablets
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- standard
**Description:** Routine Paracetamol and NSAID
**Name:** standard multimodal analgesia
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** the difference in mean of the total amount consumed of paracetamol, ketorolac and nalbuphine
**Measure:** The total consumption of rescue analgesics in the first and second 24 hours after delivery
**Time Frame:** in the first 24 hours and in the second 24 hours (if stay is extended )
**Description:** Using the validated Arabic version; the score of the assessment will be done on 12 , 24 hours . the results will be compared among both groups
**Measure:** Pain score assessed by The Brief Pain Inventory (Short Form) after 12 -24 hours from delivery.
**Time Frame:** within 12 and 24 hours postoperative
#### Secondary Outcomes
**Description:** using The Obstetric Quality of Recovery-10 questionnaire
**Measure:** quality of recovery on discharge from ICU
**Time Frame:** on discharge from ICU ( or within 48 hours post operative ) which is shorter
**Description:** occurrences of any side effects as allergy
**Measure:** occurrence of any side effects
**Time Frame:** during ICU stay and no more than 48 hours post-caesarean section
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Critically ill -obstetric patients who will be delivered by cesarean section under neuraxial anesthesia.
Exclusion Criteria:
1. Patient's Refusal to participate
2. Known allergy to one or more of the given components.
3. Disturbed conscious level.
4. Prolonged or complicated surgery; defined by operative time of more than 90 min.
5. Severe liver dysfunction or failure
6. Severe renal dysfunction or failure.
7. Severe thrombocytopenia; platelets less than 50
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** wessam selima, MD
**Phone:** 01001958858
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** wessam Z mohamed
**Phone:** 01003069492
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cairo
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Anesthesia department
- **Phone:** 01009499962
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Ain shams university
**Status:** RECRUITING
**Zip:** 11591
#### Overall Officials
**Official 1:**
**Affiliation:** assistant professor (lecturer)- Ain shams university
**Name:** wessam selima, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Neall G, Bampoe S, Sultan P. Analgesia for Caesarean section. BJA Educ. 2022 May;22(5):197-203. doi: 10.1016/j.bjae.2021.12.008. Epub 2022 Mar 8. No abstract available. Erratum In: BJA Educ. 2022 Nov;22(11):448.
**PMID:** 35496649
**Citation:** Deng XT, Han Y, Liu WT, Song XJ. B Vitamins Potentiate Acute Morphine Antinociception and Attenuate the Development of Tolerance to Chronic Morphine in Mice. Pain Med. 2017 Oct 1;18(10):1961-1974. doi: 10.1093/pm/pnw358.
**PMID:** 28379583
**Citation:** Wang HJ, Zhang FC, Xu TW, Xu YC, Tian YQ, Wu YY, Xu JT, Hu S, Xu GY. DNMT1 involved in the analgesic effect of folic acid on gastric hypersensitivity through downregulating ASIC1 in adult offspring rats with prenatal maternal stress. CNS Neurosci Ther. 2023 Jun;29(6):1678-1689. doi: 10.1111/cns.14131. Epub 2023 Feb 27.
**PMID:** 36852448
**Citation:** Kang WB, Chen YJ, Lu DY, Yan JZ. Folic acid contributes to peripheral nerve injury repair by promoting Schwann cell proliferation, migration, and secretion of nerve growth factor. Neural Regen Res. 2019 Jan;14(1):132-139. doi: 10.4103/1673-5374.243718.
**PMID:** 30531087
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Post Operative Pain
- ID: M19010
- Name: Critical Illness
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010149
- Term: Pain, Postoperative
### Intervention Browse Module - Ancestors
- ID: D000018977
- Term: Micronutrients
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M17558
- Name: Vitamins
- Relevance: HIGH
- As Found: Period
- ID: M17546
- Name: Vitamin B Complex
- Relevance: HIGH
- As Found: Every 4 weeks
- ID: M9934
- Name: Hydroxocobalamin
- Relevance: LOW
- As Found: Unknown
- ID: M17548
- Name: Vitamin B 12
- Relevance: LOW
- As Found: Unknown
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M17544
- Name: Vitamin A
- Relevance: LOW
- As Found: Unknown
- ID: M302395
- Name: Retinol palmitate
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M8618
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M22645
- Name: Ketorolac
- Relevance: LOW
- As Found: Unknown
- ID: M12217
- Name: Nalbuphine
- 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: T441
- Name: Cobalamin
- Relevance: LOW
- As Found: Unknown
- ID: T444
- Name: Cyanocobalamin
- Relevance: LOW
- As Found: Unknown
- ID: T476
- Name: Vitamin B12
- Relevance: LOW
- As Found: Unknown
- ID: T468
- Name: Vitamin A
- Relevance: LOW
- As Found: Unknown
- ID: T462
- Name: Retinol
- 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
### Intervention Browse Module - Meshes
- ID: D000014815
- Term: Vitamins
- ID: D000014803
- Term: Vitamin B Complex
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446817
**Acronym:** HIGHADD
**Brief Title:** Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL
**Official Title:** Multicentric Clinical Investigation to Determine Safety and Efficacy of a Hydrophobic Acrylic Multifocal Intraocular Lens
#### Organization Study ID Info
**ID:** CE2301
#### Organization
**Class:** INDUSTRY
**Full Name:** Cutting Edge SAS
#### Secondary ID Infos
**Domain:** French BRC Identification number
**ID:** 2023-A01904-41
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Cutting Edge SAS
#### 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 purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.
**Detailed Description:** The study purpose is to demonstrate safety and performance after bilateral implantation of LuxHighAdd intraocular lenses.
The device under investigation is a hydrophobic acrylic multifocal intraocular lens (IOL) manufactured by the sponsor of this study.
### Conditions Module
**Conditions:**
- Cataract
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 57
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The experimental group will recieve the LuxHighAdd intraocular lens bilaterally.
**Intervention Names:**
- Device: LuxHighAdd IOL
**Label:** LuxHighAdd
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control group will recieve the LuxGood intraocular lens bilaterally.
**Intervention Names:**
- Device: LuxGood IOL
**Label:** LuxGood group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- LuxHighAdd
**Description:** Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
**Name:** LuxHighAdd IOL
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- LuxGood group
**Description:** Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.
**Name:** LuxGood IOL
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** To demonstrate the difference in monocular DCNVA between the High Add lens and the LuxGood monofocal lens by means of statistical significance.
**Measure:** Distance Corrected Near Visual Acuity (DCNVA)
**Time Frame:** 4/6 months after surgery
**Description:** To demonstrate the non-inferiority of the Lux High Add lens compared with the monofocal control LuxGood lens in terms of BCDVA by means of statistical significance.
**Measure:** Best corrected distance visual acuity (BCDVA)
**Time Frame:** 4/6 months after surgery
#### Secondary Outcomes
**Description:** Uncorrected photopic visual acuity at far in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.
**Measure:** Uncorrected Distance Visual Acuity (UDVA)
**Time Frame:** 4/6 months after surgery
**Description:** Uncorrected photopic visual acuity at intermediate distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.
**Measure:** Uncorrected Intermediate Visual Acuity (UIVA)
**Time Frame:** 4/6 months after surgery
**Description:** Uncorrected photopic visual acuity at near distance in monocular and binocular with LuxHighAdd lens compared to LuxGood lens.
**Measure:** Uncorrected Near Visual Acuity (UNVA)
**Time Frame:** 4/6 months after surgery
**Description:** Photopic visual acuity at intermediate distance in monocular and binocular with best distance correction with LuxHighAdd lens compared to LuxGood lens.
**Measure:** Distance Corrected Intermediate Visual Acuity (DCIVA)
**Time Frame:** 4/6 months after surgery
**Description:** Manifest subjective refraction
**Measure:** Manifest Refraction
**Time Frame:** 4/6 months after surgery
**Description:** Binocular defocus curve with the distance correction
**Measure:** Defocus curve
**Time Frame:** 4/6 months after surgery
**Description:** Adverse events rates
**Measure:** Adverse events rates
**Time Frame:** 4/6 months after surgery
**Description:** Contrast Sensitivity in binocular conditions with distance correction
**Measure:** Contrast Sensitivity
**Time Frame:** 4/6 months after surgery
**Description:** Halos and glare assessed with a simulator
**Measure:** Halo and glare scores
**Time Frame:** 4/6 months after surgery
**Description:** Assessment of quality of vision (CatQuest-9SF)
**Measure:** Patient-reported outcomes: Quality of vision Questionnaire
**Time Frame:** 4/6 months after surgery
**Description:** Assessment of spectacle independence (PRSIQ questionnaire )
**Measure:** Patient-reported outcomes: Spectacle independance Questionnaire
**Time Frame:** 4/6 months after surgery
**Description:** Frequency and proportion of eyes with ocular and visual symptoms (non-directed complaints) using an open-ended question
**Measure:** Patient-reported outcomes: open-ended question
**Time Frame:** 4/6 months after surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subject aged 50 or over on the day of inclusion, presenting a bilateral cataract, qualified for bilateral implantation
* No ocular comorbidity possibly affecting the study results
* Fit within the available IOL diopter range
* Have had no previous refractive surgery
* Regular corneal astigmatism ≤1.0 dioptres
* Clear intraocular media other than cataract
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Ability to attend all study follow-ups
* Signed informed consent.
Exclusion Criteria:
* Ocular surface disease potentially affecting study results
* Pre-existing ocular pathology or history of pathology potentially affecting the study results
* Acute or chronic disease or illness that would increase risk or confound study results
* Subjects who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than YAG capsulotomy)
* Axial lengths and keratometry such as the IOL spherical power is not in the range of 16 to 26 D
* Instability of keratometry or biometry measurements
* Traumatic cataract
* Amblyopia
* History of ocular trauma or any prior ocular surgery including refractive procedures
* Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens
* Pupil abnormalities
* Systemic or ocular medication that could modify pupil dynamics
* Expected complicated surgery or complicated surgery
* Concurrent participation in another drug or device investigation
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Line Bettinelli, OD
**Phone:** 0619530701
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Christophe Cesses
**Phone:** 0786991458
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Paris
**Contacts:**
***Contact 1:***
- **Name:** Alain Saad, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Alain Saad, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** Hôpital Fondation Adolphe de Rothschild
**Zip:** 75019
**Location 2:**
**City:** Rennes
**Contacts:**
***Contact 1:***
- **Name:** Pierre-Emmanuel Arcade, MD
- **Role:** CONTACT
***Contact 2:***
- **Name:** Pierre-Emmanuel Arcade, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** France
**Facility:** WestOphta
**Zip:** 35000
#### Overall Officials
**Official 1:**
**Affiliation:** Hôpital Fondation Adolphe de Rothschild
**Name:** Alain Saad, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007905
- Term: Lens Diseases
- ID: D000005128
- Term: Eye Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5638
- Name: Cataract
- Relevance: HIGH
- As Found: Cataract
- ID: M10917
- Name: Lens Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002386
- Term: Cataract
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446804
**Acronym:** EPTI-CO
**Brief Title:** Follow-up of Migraine Patients on Eptinezumab
**Official Title:** Feedback on the Use of Eptinezumab: Efficacy at 6 Months in Severe Migraine
#### Organization Study ID Info
**ID:** LOCAL/2024/AL-01
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Nīmes
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**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:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Centre Hospitalier Universitaire de Nīmes
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The October 2022 Transparency Commission considers that VYEPTI (eptinezumab) is a treatment option for patients suffering from severe migraine with at least 8 migraine days per month, who have failed at least two prophylactic treatments and have no cardiovascular impairment.
Since the beginning of 2023, eptinezumab has been available in France as an inpatient treatment prescribed by a migraine neurologist in a growing number of centres. The Saint-Denis Hospital and the Nîmes University Hospital are among the first centres to have started. The investigators from these 2 centres have therefore decided to pool their data to provide the first French feedback on its effectiveness.
### Conditions Module
**Conditions:**
- Migraine
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with severe migraine, with at least 8 migraine days per month and at least 2 failed background treatments.
**Intervention Names:**
- Other: None, pure observationnal study
**Label:** Migraine patients
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Migraine patients
**Description:** Pure observatonnal study
**Name:** None, pure observationnal study
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Number of headache and migraine days per month.
**Measure:** Headaches and migraines per month
**Time Frame:** 6 months
**Description:** Rate of responders (30%, 50% and super responders \> 75%)
**Measure:** Responders
**Time Frame:** 6 months
**Description:** Duration of effect of eptinezumab infusion (Numbers of weeks)
**Measure:** Duration
**Time Frame:** 6 months
**Description:** Evaluation of HIT6 scores (disability score),
≤ 49 headaches have little impact on daily life; between 50 and 55: headaches have some impact on daily life; 56 to 59: headaches have a significant impact on daily life; ≥ 60
**Measure:** HIT6 scores (disability score)
**Time Frame:** 6 months
**Description:** Evaluation of HAD score. From 0 to 7: absence of anxiety and/or depressive disorders, from 8 to 10: doubtful symptomatology, 11 to 21: proven anxiety and/or depression disorders of varying severity.
**Measure:** HAD (anxiety/depression score)
**Time Frame:** 6 months
**Description:** Use of concomitant crisis and background treatments (description)
**Measure:** Concomitant treatments
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adult patients suffering from severe migraine with at least 8 migraine days per month
* Patients who have failed at least 2 disease-modifying treatments,
* Patients treated with quarterly infusions of eptinezumab since March 2023 in a day hospital at Saint-Denis Hospital and Nîmes University Hospital.
Exclusion Criteria:
* Patient refusing to participate
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Consecutive patients with severe migraine with at least 8 migraine days per month and failure of at least 2 disease-modifying therapies, treated with quarterly infusions of eptinezumab since March 2023 in a day hospital at the Saint-Denis hospital and the Nîmes university hospital.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Anne LE FLOCH
**Phone:** 04 66 68 32 61
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nîmes
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Anne LE FLOCH
- **Phone:** 04 66 68 32 61
- **Role:** CONTACT
**Country:** France
**Facility:** CHU de Nîmes
**Zip:** 30900
**Location 2:**
**City:** Saint-Denis
**Contacts:**
***Contact 1:***
- **Name:** Guillaume BAILLE
- **Phone:** 01 42 35 60 00
- **Role:** CONTACT
**Country:** France
**Facility:** CH de Saint Denis
**Zip:** 93200
#### Overall Officials
**Official 1:**
**Affiliation:** Centre Hospitalier Universitaire de Nīmes
**Name:** Anissa MEGZARI
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000051270
- Term: Headache Disorders, Primary
- ID: D000020773
- Term: Headache Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M11852
- Name: Migraine Disorders
- Relevance: HIGH
- As Found: Migraine
- ID: M22529
- Name: Headache Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M9351
- Name: Headache
- Relevance: LOW
- As Found: Unknown
- ID: M26657
- Name: Headache Disorders, Primary
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008881
- Term: Migraine Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446791
**Brief Title:** Mehri Turki Surgical Technique of the Webbed Neck
**Official Title:** The Lateral Approach of the Webbed Neck: Mehri Turki Surgical Technique
#### Organization Study ID Info
**ID:** Hospital MT Maamouri
#### Organization
**Class:** OTHER
**Full Name:** Mohamed Tahar Maamouri University Hospital
### Status Module
#### Completion Date
**Date:** 2017-01-24
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2015-11-22
**Type:** ACTUAL
#### Start Date
**Date:** 2008-01-27
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Mohamed Tahar Maamouri University Hospital
#### Responsible Party
**Investigator Affiliation:** Mohamed Tahar Maamouri University Hospital
**Investigator Full Name:** Imen Turki Mehri, MD
**Investigator Title:** Maxillofacial and aesthetic surgeon
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The webbed neck is one of the conspicuous deformities of Turner syndrome that presents a surgical challenge. Despite the availability of surgical techniques, surgical outcomes are not always acceptable and recurrence occurs. Mehri Turki performed a surgical technique based on a latéral cervical approach allowing direct visual control to manage the fibrotic band. It provides a high level of visual control so that vulnerable anatomic structures are easily protected.
**Detailed Description:** Five girls between 17 and 19 years old, with Turner syndrome, had a webbed neck (pterygium colli) with low and laterally displaced nuchal hairline. The surgical technique aims to correct neck contour and hairline placement while concealing cervical scars. Thus, Preoperative drawing delimitated the harmful triangular hairy skin next to the fibrous band extending from the mastoid to the acromion. Besides, the predefined design drawings provide the exact placement of the future hairline. Choosing a prone position for bilateral and symmetrical repair, the surgical technique was as follows:
The incision was made at the junction of the hairless skin and the hairy skin from the mastoid up to the lower end of the webbing skin, in front of the acromion and completed by Z plasty to avoid scar contracture. The subcutaneous skin was undermined in the anterolateral direction, exposing the fibrous fascial band which must be excised to prevent recurrence. the harmful skin having a triangular shape was excised considering the future hairline. Skin closure was done after the superior traction of the posterior cervical advancement.
### Conditions Module
**Conditions:**
- Congenital Webbing of Neck
**Keywords:**
- Congenital abnormalities
- Webbed neck
- Surgical technique
- Turner syndrome
- Fetal cystic hygroma
- Nuchal fold
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Girls with congenital webbed neck deformity underwent the same surgical technique.
Outcomes were analysed with long-term follow-up.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 5
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A lateral approach surgical technique for the treatment of the webbed neck.
**Intervention Names:**
- Procedure: Mehri Turki Surgical Technique of the Webbed Neck
**Label:** Single arm interventionnal study
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Single arm interventionnal study
**Description:** The incision was made at the junction of the hairless skin and the hairy skin from the mastoid up to the acromion. A subcutaneous undermining allows direct visual control to excise the fibrotic band. Then the hairy skin with a triangular shape was excised. The closure of the defect was done after undermining an anterior cervical flap which was translated in a posterosuperior direction. Z plasty was performed in front of the acromion to prevent scar contracture. Surgical scars are concealed in the hairline which was well placed. The same procedure is done at the same surgical field on the other side to achieve perfect symmetry.
**Name:** Mehri Turki Surgical Technique of the Webbed Neck
**Other Names:**
- Mehri Turki Lateral approach Technique for the webbed beck
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Number of patient obtaining a normal neck contour without lateral fold
**Measure:** Neck contour
**Time Frame:** Just at the postoperative outcome up to 24 months of follow-up
**Description:** Number of patients with posterior hairline assent
**Measure:** Posterior hairline placement
**Time Frame:** Just at the postoperative outcome up to 24 months of follow-up
**Description:** Number of patients with a placement of scars at the level of the hairline
**Measure:** Scars placement
**Time Frame:** Just at the postoperative outcome up to 24 months of follow-up
#### Secondary Outcomes
**Description:** Scars evaluation according to Vancoover scare scale for all patients
**Measure:** Scars quality
**Time Frame:** from 8 months up to 24 months
**Description:** Number of patients in whom the fold of the neck recurred
**Measure:** Recurrece of the fold
**Time Frame:** 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* webbed neck with abnormal hairline
Exclusion Criteria:
* Surgical contraindication for any health concern
* Puberty age
**Maximum Age:** 19 Years
**Minimum Age:** 17 Years
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Overall Officials
**Official 1:**
**Affiliation:** University Hospital Mohamed Tahar Maamouri. Nabeul, Tunisia
**Name:** Imen Mehri Turki
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Mehri Turki I. Surgical correction of the webbed neck: an alternative lateral approach. GMS Interdiscip Plast Reconstr Surg DGPW. 2017 Mar 2;6:Doc04. doi: 10.3205/iprs000106. eCollection 2017.
**PMID:** 28275532
**Citation:** Turki IM. Surgical techniques for the webbed neck: a narrative review with a comparative study and surgical decision-making algorithm for an optimal aesthetic result. Oral Maxillofac Surg. 2023 Jun 20. doi: 10.1007/s10006-023-01166-2. Online ahead of print.
**PMID:** 37340235
#### See Also Links
**Label:** Turki IM. Surgical techniques for the webbed neck: a narrative review with a comparative study and surgical decision-making algorithm for an optimal aesthetic result. Oral Maxillofac Surg. 2023
**URL:** https://link.springer.com/article/10.1007/s10006-023-01166-2
**Label:** Mehri Turki I. Surgical correction of the webbed neck: an alternative lateral approach. GMS Interdiscip Plast Reconstr Surg DGPW. 2017
**URL:** https://www.egms.de/static/en/journals/iprs/2017-6/iprs000106.shtml
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M17174
- Name: Turner Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M9164
- Name: Gonadal Dysgenesis
- Relevance: LOW
- As Found: Unknown
- ID: T5765
- Name: Turner Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: T2589
- Name: Gonadal Dysgenesis
- Relevance: LOW
- As Found: Unknown
- ID: T1711
- Name: Cystic Hygroma
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446778
**Brief Title:** Haemodynamic Mechanisms and Multicentre Prospective Cohort Study of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms. Evaluation of the Safety and Efficacy of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms
**Official Title:** Haemodynamic Mechanisms and Multicentre Prospective Cohort Study of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms.
#### Organization Study ID Info
**ID:** LC2024ZD027
#### Organization
**Class:** OTHER
**Full Name:** Zhujiang Hospital
### Status Module
#### Completion Date
**Date:** 2025-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Zhujiang Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aims to collect clinical, laboratory, and imaging data from patients with unruptured intracranial aneurysms, and collect blood or urine samples for cotinine testing. The enrolled patients underwent Pipeline implantation. The purpose is to study the effect after Pipelineline implantation.
### Conditions Module
**Conditions:**
- Safety Issues
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 1000
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 2 Years
### Arms Interventions Module
#### Arm Group 1
**Label:** INCOMPLETE OCCLUSION
#### Arm Group 2
**Label:** IN-STENT STENOSIS
### Outcomes Module
#### Primary Outcomes
**Description:** incomplete occlusion
**Measure:** incomplete occlusion
**Time Frame:** 1 years
#### Secondary Outcomes
**Description:** in-stent stenosis
**Measure:** in-stent stenosis
**Time Frame:** 1 years
**Description:** perioperative complications
**Measure:** perioperative complications
**Time Frame:** 1 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* \>18years
Exclusion Criteria:
* with other cerebrovascular disease
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** patients undergoing Pipeline implantation
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Guangzhou
**Country:** China
**Facility:** Zhujiang hospital
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000020765
- Term: Intracranial Arterial Diseases
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5781
- Name: Intracranial Aneurysm
- Relevance: HIGH
- As Found: Intracranial Aneurysm
- ID: M4113
- Name: Aneurysm
- Relevance: HIGH
- As Found: Aneurysm
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22521
- Name: Intracranial Arterial Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002532
- Term: Intracranial Aneurysm
- ID: D000000783
- Term: Aneurysm
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446765
**Acronym:** MIND-BPD
**Brief Title:** Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
**Official Title:** Mindfulness-based Neurofeedback to Augment Dialectical Behavior Therapy (DBT) for Adults With Borderline Personality Disorder (Aim 1)
#### Organization Study ID Info
**ID:** 2000037582
#### Organization
**Class:** OTHER
**Full Name:** Yale University
#### Secondary ID Infos
**Domain:** NIH
**ID:** 1R61MH135009-01A1
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2026-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-02
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Connecticut Mental Health Center
**Class:** NIH
**Name:** National Institute of Mental Health (NIMH)
#### Lead Sponsor
**Class:** OTHER
**Name:** Yale University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The purpose of this study is to test the ability of mindfulness-based real time functional magnetic resonance imaging (fMRI) neurofeedback (mbNF) to increase the benefits of evidence-based psychotherapy for adults with Borderline Personality Disorder (BPD).
**Detailed Description:** The focus of this study is Aim 1.
### Conditions Module
**Conditions:**
- Borderline Personality Disorder
**Keywords:**
- fMRI neurofeedback
- mindfulness
### 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:** 150
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will participate in one session of mindfulness-based fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.
**Intervention Names:**
- Behavioral: mindfulness-based Neurofeedback
**Label:** mindfulness-based Neurofeedback
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will participate in one session of control fMRI neurofeedback followed by 20 weeks of remote online weekly Dialectical Behavior Therapy skills group.
**Intervention Names:**
- Other: control Neurofeedback
**Label:** control Neurofeedback
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- mindfulness-based Neurofeedback
**Description:** Participants will complete one session of mindfulness-based fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group.
**Name:** mindfulness-based Neurofeedback
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- control Neurofeedback
**Description:** Participants will complete one session of control fMRI neurofeedback prior to 20 weeks of remote online weekly DBT skills group.
**Name:** control Neurofeedback
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Defined as within-DMN connectivity as the resting state seed-based connectivity between core nodes of medial prefrontal cortex (mPFC) and posterior cingulate cortex (PCC). Change = post-NF within-DMN connectivity - pre-NF within-DMN connectivity.
**Measure:** Change in within-Default Mode Network (DMN) resting state functional connectivity after one session of neurofeedback (NF)
**Time Frame:** From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day
**Description:** Defined as DMN-FPCN anticorrelation as the fMRI seed-based connectivity from mPFC to dorsolateral prefrontal cortex (dlPFC)). Change = post-NF mPFC-dlPFC anticorrelation - pre-NF mPFC-dlPFC anticorrelation
**Measure:** Change in DMN-Frontoparietal Control Network (FPCN) anticorrelation in resting state functional connectivity data after one session of neurofeedback
**Time Frame:** From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day
#### Secondary Outcomes
**Description:** The State Mindfulness Scale (SMS) is a validated self-reported 21 item instrument assessing state mindfulness over the past 15 minutes. Possible scores range from 21 (not mindful) to 105 (very mindful).
**Measure:** Change from baseline in state mindfulness on State Mindfulness Scale (SMS) score on same day after neurofeedback.
**Time Frame:** From baseline (immediately before neurofeedback) to immediately after neurofeedback on the same day
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
* age 18-60,
* be able to provide written informed consent,
* meet criteria for BPD on semi-structured clinical interview,
* able to plan to keep any prescribed medications and psychotherapy constant during the study
* fluent in English.
Exclusion criteria:
* current DBT psychotherapy outside the study
* lifetime primary psychotic disorder or Bipolar I disorder
* developmental disorder (e.g. autism)
* history of learning disorder
* moderate or severe substance use disorder in the last 6 months
* active suicidal ideation with intent or plan in the past 3 months
* history of major medical or neurologic disorder
* MRI contraindications, including pregnancy
* poor performance on reading task (WRAT \> 11 errors)
* newly prescribed medications in the past 8 weeks
* daytime sedating medications (e.g. benzodiazepines, opiates, sedating neuroleptics)
* any scheduled daily benzodiazepines
* change in psychotherapy type or frequency in the past 12 weeks.
* At the discretion of the study PI
Eligibility will be determined by study personnel.
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sarah K Fineberg, MD PhD
**Phone:** 203-974-7265
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** New Haven
**Country:** United States
**Facility:** Connecticut Mental Health Center
**State:** Connecticut
**Zip:** 06519
#### Overall Officials
**Official 1:**
**Affiliation:** Yale University
**Name:** Sarah K Fineberg, MD PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Sharing will occur as required by NIMH through the National Data Archive.
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M13462
- Name: Personality Disorders
- Relevance: HIGH
- As Found: Personality Disorder
- ID: M5161
- Name: Borderline Personality Disorder
- Relevance: HIGH
- As Found: Borderline Personality Disorder
- 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: D000010554
- Term: Personality Disorders
- ID: D000001883
- Term: Borderline Personality Disorder
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446752
**Brief Title:** BIYELA - Bexsero Immunisation in Young Women in Africa
**Official Title:** A Phase 3 Randomized, Observer-Blind, Placebo-Controlled Study to Assess Efficacy of Meningococcal Group B (rMenB+OMV NZ (Bexsero)) in Preventing Gonococcal Infection Among South African Cis-Gender Women
#### Organization Study ID Info
**ID:** STUDY00019050
#### Organization
**Class:** OTHER
**Full Name:** University of Washington
### Status Module
#### Completion Date
**Date:** 2026-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-05-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Bill and Melinda Gates Foundation
**Class:** OTHER
**Name:** University of Witwatersrand, South Africa
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Washington
#### Responsible Party
**Investigator Affiliation:** University of Washington
**Investigator Full Name:** Connie Celum
**Investigator Title:** Professor, Department of Global Health
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This proposed 2-arm randomized evaluation of two doses of 4CMenB vaccine versus placebo at Enrollment and Month 2 is designed as a proof-of-concept study to inform potential use for dual meningococcal B and gonococcal prevention, and to inform Neisseria gonorrheae vaccine development.
**Detailed Description:** The World Health Organization (WHO) estimates that the global incidence of gonorrhea in 2020 was 82 million (CI: 48-130 million) among 15 to 49-year-olds, reflecting global incidence rates of 19/1000 women and 23/1000 men in that age group. Most gonococcal infections occur in LMICs. High rates of curable sexually transmitted infections (STIs) have been observed in pre-exposure prophylaxis (PrEP) demonstration projects conducted in adolescent girls and young women (AGYW) from eastern and southern Africa, with prevalences of Chlamydia trachomatis (CT) infection ranging from 24-30%, Neisseria gonorrheae (NG) infection from 7-10%, and syphilis seropositivity from 1-5%.
The consequences of bacterial STIs on AGYW's sexual and reproductive health can be substantial with long-term clinical repercussions: pelvic inflammatory disease (PID), chronic pelvic pain, tubal infertility, pregnancy complications, fetal and neonatal death, and increased susceptibility to HIV. Effective STI prevention interventions are needed to protect individuals, to prevent secondary transmission to partners, and to reduce the risk of long-term reproductive health consequences, particularly for women and their infants. STI prevention interventions could be integrated into PrEP programs, given the high prevalence and incidence of STIs in PrEP populations and the feasibility of providing integrated services in PrEP programs.
N.gonorrhoeae has been identified as a priority pathogen for the development of new vaccines and therapeutics given the current limited therapeutic options in the context of high rates of antimicrobial resistance. A vaccine for NG could mitigate the growing threat of antimicrobial resistance in NG, reduce the high NG prevalence and incidence among African women, and reduce the risk of reproductive morbidity from undiagnosed and untreated NG infection. Women have an increased risk of HIV due to bacterial STIs, both through direct mechanisms such as increased susceptibility due to genital inflammation, and indirectly through infertility, which is associated with increased condom-less sex as part of efforts to become pregnant. There are few other preventative bacterial STI interventions for women on the short-term horizon; unfortunately doxycycline post-exposure prophylaxis for STI prevention (doxy-PEP) was not effective for prevention of CT or NG among 449 Kenyan cis-gender women ages 18 to 30 who were taking HIV PrEP. This lack of efficacy appears to be in part due to adherence; doxycycline was detected in only 29% of 200 hair samples collected at follow-up visits from 50 randomly selected women in the doxy-PEP arm.
Gonorrhea may be vaccine-preventable. Several meningococcal outer membrane vesicle (OMV) proteins have \>90% sequence homology with gonococcal OMV proteins. The meningococcal 4CMenB (Bexsero) vaccine (rMenB+OMV NZ), that targets serogroup B N. meningitidis, is a licensed OMV vaccine that contains protein antigens commonly expressed on the surface of both N. meningitidis and N. gonorrhoeae. It induces bactericidal antibodies that mediate killing of the majority of epidemiologically relevant serogroup B N. meningitidis strains. Gonococcal proteins share a high level of identity with several antigens contained in the Bexsero rMenB+OMV NZ vaccine and vaccination with Bexsero induces antibodies in humans that recognize gonococcal proteins 22, 26, 27, 23, 24, 28. In addition to OMV, the vaccine includes three purified recombinant N. meningitidis serogroup B protein antigens (rMenB), two which are fused with accessory antigens: 1) neisserial heparin binding antigen (NHBA), fused with the accessory protein genome-derived neisserial antigen (GNA) 1030, 2) factor H-binding protein (fHbp), fused to GNA2091, and 3) neisserial adhesin A (NadA), presented as a single antigen. NHBA is present in virtually all N. gonorrhoeae strains and its nucleotide and amino acid sequences are highly conserved (96.9% sequence identity in N. gonorrhoeae strains, with 71.3% identity to the Bexsero antigens). Gonococcal fHbp is similar to meningococcal variant 3, which is included in the vaccine, but is not surface exposed and therefore is not expected to contribute to protection. Both GNA2091 and GNA1030 accessory antigens are highly conserved; although their potential contribution to protection is unknown, they could provide an added effect. NadA is absent in gonococcal strains. In a humanized mouse model, 4CMenB immunized mice had antibodies that showed functional activity against NG, clearance of NG was accelerated and bacterial load reduced, serum immunoglobin G (IgG) and IgG cross-reacted with NG OMV and there was a four-fold increase in serum bactericidal50 titres all suggestive of 4CMenB activity against NG28.
### Conditions Module
**Conditions:**
- Gonorrhea
- Gonorrhea of Pharynx
- Gonorrhea of Anus
- Gonorrhea of Cervix
**Keywords:**
- sexually transmitted infections
- STI
- Gonorrhea
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** 1:1 randomization to Bexsero vaccine or placebo injection, to be administered as two intramuscular (IM) doses, two months apart (at Enrollment/Visit 1 and Month 2/Visit 3). Assessment for safety events at one month following the IM doses (Visit 2 and Visit 4), followed by 5 in-clinic follow-up visits for safety, clinical, and laboratory assessments.
##### Masking Info
**Masking:** TRIPLE
**Masking Description:** Double-blind, Placebo-controlled
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 1100
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Meningococcal Serogroup B vaccine rMenB+OMV NZ (Bexsero) administered as an IM injection by 0.5-mL single-dose syringe at enrollment (Visit 1) and 2 months post-enrollment (Visit 3).
**Intervention Names:**
- Biological: Bexsero
**Label:** Bexsero
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Normal saline (placebo) administered as an IM injection by 0.5-mL single-dose syringe at enrollment (Visit 1) and 2 months post-enrollment (Visit 3).
**Intervention Names:**
- Biological: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Bexsero
**Description:** Administered as an IM injection by 0.5-mL single-dose syringe at enrollment (Visit 1) and 2 months post-enrollment (Visit 3).
**Name:** Bexsero
**Other Names:**
- 4MenB-4C
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Administered as an IM injection by 0.5-mL single-dose syringe at enrollment (Visit 1) and 2 months post-enrollment (Visit 3).
**Name:** Placebo
**Other Names:**
- Saline
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Assess efficacy of Bexsero in prevention of cervical and/or anorectal gonococcal infection
**Measure:** First diagnosis of gonorrhea at cervical or anorectal sites occurring greater than or equal to 1 month after the second vaccination with study product through to the study end
**Time Frame:** 18 months
#### Secondary Outcomes
**Description:** To assess efficacy of Bexsero in prevention of cervical and/or anorectal gonococcal infection by pre-specified subgroups, including HIV status, anatomical site (cervical compared to anorectal), and presence or absence of chlamydia
**Measure:** First diagnosis of gonorrhea at cervical or anorectal sites occurring >1 month after the second vaccination with study product through to study end, by specified subgroups
**Time Frame:** 18 months
**Description:** To estimate the efficacy of Bexsero in prevention of pharyngeal gonococcal infection
**Measure:** First diagnosis of pharyngeal gonorrhea occurring > 1 month after the second vaccination with study product through to study end, by study arm
**Time Frame:** 18 months
**Description:** To assess the durability of protection
**Measure:** Cumlative GC incidence in the first 9 months after receipt of the second dose of vaccine compared to cumlative GC incidence in the 10-16 months after receipt of the second dose
**Time Frame:** 18 months
**Description:** Proportion of participants with at least one serious adverse event (SAE), adverse event of special interest (AESI) or other reportable AE (adverse event)
**Measure:** To ascertain the safety of Bexsero
**Time Frame:** 18 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Individuals born female aged 18-45 years of age inclusive on the day of screening
* In good health as determined by past medical history, medication use, and targeted physical examination,
1. If not living with HIV, negative HIV test conducted at screening
2. If living with HIV, on an antiretroviral regimen for ≥3 months, with an undetectable HIV RNA of \<200 copies/ml and/or a CD4 count \>300 cells/cmm within 12 months of screening
* If of reproductive potential,
1. Willing to not become pregnant during vaccination period and
2. Have a negative pregnancy test prior to each vaccination and
3. Willing to use a reliable method of contraception until month 3 (i.e., after the second vaccination visit)
4. Not breastfeeding
* Sexually active in the past 3 months, defined as vaginal or anal sex
* At risk for gonorrhea based on sexual behaviour characteristics including
1. Previous PrEP use in the past 12 months, or
2. Past history of STIs in the past 12 months, or
3. 2 or more partners in the past 12 months
* Has provided signed informed consent, and is willing and likely to comply with the trial procedures and follow-up visit requirements
* Has a negative gonorrhea and chlamydia nucleic acid amplification test (NAAT) in the 14 days prior to the Enrollment Visit
Exclusion Criteria:
* Contra-indications to Bexsero
* Previous receipt of a Meningococcal Group B vaccine
* Receipt of antibiotics active against N. gonorrhoeae in the 14 days prior to the Enrollment Visit, including oral or parenteral antibiotics\*
* Participants with NG and/or CT detected at screening may re-screen after receiving appropriate antibiotic treatment
* Planned long-term (\> 4 weeks) antibiotic use for prophylaxis or treatment for acne or other bacterial condition(s)
* Use or planned use of a live vaccine within +/- 30 days, an inactive vaccine within +/- 14 days, or an influenza vaccine within +/- 7 days from receipt of study product. Authorized or approved, inactivated COVID-19 vaccines may be given more than 7 days +/- receipt of study product for all study participants
* Use of any investigational drug or vaccine within 30 days prior to enrollment, or planned/anticipated use during study participation
* Currently receiving immunosuppressive agent or systemic corticosteroids (dose \>5 mg/day of prednisone) for \>14 consecutive days within 90 days prior to enrollment. Topical or inhaled steroids are allowed. Topical steroids cannot be applied to study product injection site
* Has received antineoplastic (chemotherapy) or radiotherapy within 90 days prior to enrollment
* Has received immunoglobulins and/or any blood products within 180 days prior to enrollment
* Progressive, unstable, or uncontrolled disease including but not limited to cardiac, hepatic, renal, immunological, neurological or psychiatric conditions
* Has a condition which in the opinion of the investigator is not suitable for intramuscular vaccination, blood draws, or participation in the trial
* Pregnant or breastfeeding at enrollment
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Meighan Krows
**Phone:** 206-520-3833
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jason Caucutt
**Phone:** 206-520-3800
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cape Town
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Pippa Macdonald, MBChB
- **Phone:** +27 21 650 5869
- **Role:** CONTACT
***Contact 2:***
- **Name:** Pippa Macdonal, MBChB
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** South Africa
**Facility:** Desmond Tutu Health Foundation - Emavundleni Research Centre
**Location 2:**
**City:** Cape Town
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Rirhandzu Ndzhukule, MBChB
- **Phone:** +27 21 301 2068
- **Role:** CONTACT
***Contact 2:***
- **Name:** Rirhandzu Ndzhukule, MBChB
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Katherine Gill, MBChB
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** South Africa
**Facility:** Desmond Tutu Health Foundation - Masiphumulele Site
**Location 3:**
**City:** Cape Town
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Phillip du Preez, MBChB
- **Phone:** +27 21 650 1551
- **Role:** CONTACT
***Contact 2:***
- **Name:** Phillip du Preez, MBChB
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Amy Ward, MBBCh
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** South Africa
**Facility:** Khayelitsha Vuka Research Clinic
**Location 4:**
**City:** Johannesburg
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Nicole Poovan, MBChB
- **Phone:** +27 72 808 6113
- **Role:** CONTACT
***Contact 2:***
- **Name:** Sinead Delany-Moretlwe, MBBCh
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Nicole Poovan, MBChB
- **Role:** SUB_INVESTIGATOR
**Country:** South Africa
**Facility:** Wits RHI Ward 21 Clinical Research Site
**Location 5:**
**City:** Pietermaritzburg
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Shannon Bosman, MBChB
- **Phone:** +27 82 634 7680
- **Role:** CONTACT
***Contact 2:***
- **Name:** Alastair van Heerden, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Shannon Bosman, MBChB
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** South Africa
**Facility:** Center for Community Based Research (CCBR)
#### Overall Officials
**Official 1:**
**Affiliation:** University of Washington
**Name:** Connie Celum, MD, MPH
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Celum C, Hosek S, Tsholwana M, Kassim S, Mukaka S, Dye BJ, Pathak S, Mgodi N, Bekker LG, Donnell DJ, Wilson E, Yuha K, Anderson PL, Agyei Y, Noble H, Rose SM, Baeten JM, Fogel JM, Adeyeye A, Wiesner L, Rooney J, Delany-Moretlwe S. PrEP uptake, persistence, adherence, and effect of retrospective drug level feedback on PrEP adherence among young women in southern Africa: Results from HPTN 082, a randomized controlled trial. PLoS Med. 2021 Jun 18;18(6):e1003670. doi: 10.1371/journal.pmed.1003670. eCollection 2021 Jun.
**PMID:** 34143779
**Citation:** Celum CL, Bukusi EA, Bekker LG, Delany-Moretlwe S, Kidoguchi L, Omollo V, Rousseau E, Travill D, Morton JF, Mogaka F, O'Malley G, Barnabee G, van der Straten A, Donnell D, Parikh UM, Kudrick L, Anderson PL, Haberer JE, Wu L, Heffron R, Johnson R, Morrison S, Baeten JM; POWER Study Team. PrEP use and HIV seroconversion rates in adolescent girls and young women from Kenya and South Africa: the POWER demonstration project. J Int AIDS Soc. 2022 Jul;25(7):e25962. doi: 10.1002/jia2.25962.
**PMID:** 35822945
**Citation:** Celum CL, Gill K, Morton JF, Stein G, Myers L, Thomas KK, McConnell M, van der Straten A, Baeten JM, Duyver M, Mendel E, Naidoo K, Dallimore J, Wiesner L, Bekker LG. Incentives conditioned on tenofovir levels to support PrEP adherence among young South African women: a randomized trial. J Int AIDS Soc. 2020 Nov;23(11):e25636. doi: 10.1002/jia2.25636.
**PMID:** 33247553
**Citation:** Kennedy CE, Haberlen SA, Narasimhan M. Integration of sexually transmitted infection (STI) services into HIV care and treatment services for women living with HIV: a systematic review. BMJ Open. 2017 Jun 21;7(6):e015310. doi: 10.1136/bmjopen-2016-015310.
**PMID:** 28637733
**Citation:** Kakaire O, Byamugisha JK, Tumwesigye NM, Gamzell-Danielsson K. Prevalence and factors associated with sexually transmitted infections among HIV positive women opting for intrauterine contraception. PLoS One. 2015 Apr 10;10(4):e0122400. doi: 10.1371/journal.pone.0122400. eCollection 2015.
**PMID:** 25859659
**Citation:** Paavonen J, Eggert-Kruse W. Chlamydia trachomatis: impact on human reproduction. Hum Reprod Update. 1999 Sep-Oct;5(5):433-47. doi: 10.1093/humupd/5.5.433.
**PMID:** 10582782
**Citation:** Ville Y, Leruez M, Glowaczower E, Robertson JN, Ward ME. The role of Chlamydia trachomatis and Neisseria gonorrhoeae in the aetiology of ectopic pregnancy in Gabon. Br J Obstet Gynaecol. 1991 Dec;98(12):1260-6. doi: 10.1111/j.1471-0528.1991.tb15399.x.
**PMID:** 1777459
**Citation:** Stephens AJ, Aubuchon M, Schust DJ. Antichlamydial antibodies, human fertility, and pregnancy wastage. Infect Dis Obstet Gynecol. 2011;2011:525182. doi: 10.1155/2011/525182. Epub 2011 Sep 22.
**PMID:** 21949601
**Citation:** Amornkul PN, Vandenhoudt H, Nasokho P, Odhiambo F, Mwaengo D, Hightower A, Buve A, Misore A, Vulule J, Vitek C, Glynn J, Greenberg A, Slutsker L, De Cock KM. HIV prevalence and associated risk factors among individuals aged 13-34 years in Rural Western Kenya. PLoS One. 2009 Jul 31;4(7):e6470. doi: 10.1371/journal.pone.0006470.
**PMID:** 19649242
**Citation:** Masese L, Baeten JM, Richardson BA, Bukusi E, John-Stewart G, Graham SM, Shafi J, Kiarie J, Overbaugh J, McClelland RS. Changes in the contribution of genital tract infections to HIV acquisition among Kenyan high-risk women from 1993 to 2012. AIDS. 2015 Jun 1;29(9):1077-85. doi: 10.1097/QAD.0000000000000646.
**PMID:** 26125141
**Citation:** Steen R, Wi TE, Kamali A, Ndowa F. Control of sexually transmitted infections and prevention of HIV transmission: mending a fractured paradigm. Bull World Health Organ. 2009 Nov;87(11):858-65. doi: 10.2471/blt.08.059212.
**PMID:** 20072772
**Citation:** Naidoo S, Wand H, Abbai NS, Ramjee G. High prevalence and incidence of sexually transmitted infections among women living in Kwazulu-Natal, South Africa. AIDS Res Ther. 2014 Sep 15;11:31. doi: 10.1186/1742-6405-11-31. eCollection 2014.
**PMID:** 25243015
**Citation:** Ong JJ, Fu H, Baggaley RC, Wi TE, Tucker JD, Smith MK, Rafael S, Falconer J, Terris-Prestholt F, Mameletzis I, Mayaud P. Missed opportunities for sexually transmitted infections testing for HIV pre-exposure prophylaxis users: a systematic review. J Int AIDS Soc. 2021 Feb;24(2):e25673. doi: 10.1002/jia2.25673.
**PMID:** 33605081
**Citation:** Ong JJ, Baggaley RC, Wi TE, Tucker JD, Fu H, Smith MK, Rafael S, Anglade V, Falconer J, Ofori-Asenso R, Terris-Prestholt F, Hodges-Mameletzis I, Mayaud P. Global Epidemiologic Characteristics of Sexually Transmitted Infections Among Individuals Using Preexposure Prophylaxis for the Prevention of HIV Infection: A Systematic Review and Meta-analysis. JAMA Netw Open. 2019 Dec 2;2(12):e1917134. doi: 10.1001/jamanetworkopen.2019.17134.
**PMID:** 31825501
**Citation:** Tacconelli E, Carrara E, Savoldi A, Harbarth S, Mendelson M, Monnet DL, Pulcini C, Kahlmeter G, Kluytmans J, Carmeli Y, Ouellette M, Outterson K, Patel J, Cavaleri M, Cox EM, Houchens CR, Grayson ML, Hansen P, Singh N, Theuretzbacher U, Magrini N; WHO Pathogens Priority List Working Group. Discovery, research, and development of new antibiotics: the WHO priority list of antibiotic-resistant bacteria and tuberculosis. Lancet Infect Dis. 2018 Mar;18(3):318-327. doi: 10.1016/S1473-3099(17)30753-3. Epub 2017 Dec 21.
**PMID:** 29276051
**Citation:** Stewart J, Bukusi E, Sesay FA, Oware K, Donnell D, Soge OO, Celum C, Odoyo J, Kwena ZA, Scoville CW, Violette LR, Morrison S, Simoni J, McClelland RS, Barnabas R, Gandhi M, Baeten JM. Doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections among Kenyan women using HIV pre-exposure prophylaxis: study protocol for an open-label randomized trial. Trials. 2022 Jun 16;23(1):495. doi: 10.1186/s13063-022-06458-8.
**PMID:** 35710444
**Citation:** Petousis-Harris H, Radcliff FJ. Exploitation of Neisseria meningitidis Group B OMV Vaccines Against N. gonorrhoeae to Inform the Development and Deployment of Effective Gonorrhea Vaccines. Front Immunol. 2019 Apr 9;10:683. doi: 10.3389/fimmu.2019.00683. eCollection 2019.
**PMID:** 31024540
**Citation:** Semchenko EA, Tan A, Borrow R, Seib KL. The Serogroup B Meningococcal Vaccine Bexsero Elicits Antibodies to Neisseria gonorrhoeae. Clin Infect Dis. 2019 Sep 13;69(7):1101-1111. doi: 10.1093/cid/ciy1061.
**PMID:** 30551148
**Citation:** Hadad R, Jacobsson S, Pizza M, Rappuoli R, Fredlund H, Olcen P, Unemo M. Novel meningococcal 4CMenB vaccine antigens - prevalence and polymorphisms of the encoding genes in Neisseria gonorrhoeae. APMIS. 2012 Sep;120(9):750-60. doi: 10.1111/j.1600-0463.2012.02903.x. Epub 2012 Apr 28.
**PMID:** 22882265
#### See Also Links
**Label:** Global progress report on HIV, viral hepatitis and sexually transmitted infections, 2021
**URL:** https://iris.who.int/bitstream/handle/10665/342808/9789240030985-eng.pdf
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000016870
- Term: Neisseriaceae Infections
- ID: D000016905
- Term: Gram-Negative Bacterial Infections
- ID: D000001424
- Term: Bacterial Infections
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000007239
- Term: Infections
- ID: D000015231
- Term: Sexually Transmitted Diseases, Bacterial
- ID: D000012749
- Term: Sexually Transmitted Diseases
- ID: D000003141
- Term: Communicable Diseases
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M9174
- Name: Gonorrhea
- Relevance: HIGH
- As Found: Gonorrhea
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15558
- Name: Sexually Transmitted Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M19218
- Name: Neisseriaceae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M4722
- Name: Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M19249
- Name: Gram-Negative Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M12136
- Name: Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M17935
- Name: Sexually Transmitted Diseases, Bacterial
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006069
- Term: Gonorrhea
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17360
- Name: Vaccines
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446739
**Acronym:** WISDOM
**Brief Title:** LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)
**Official Title:** LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM): A Pilot Randomized Trial
#### Organization Study ID Info
**ID:** 00140224
#### Organization
**Class:** OTHER
**Full Name:** University of Alberta
### Status Module
#### Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-04-16
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Alberta
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** An estimated 10-15% of critically ill patients with acute kidney failure in the intensive care unit receive acute dialysis therapy. The majority of these patients initially receive continuous for of dialysis therapy call continuous renal replacement therapy (CRRT). Prior studies have suggested that higher CRRT dose-intensity improved health outcomes for these patients; however, this was not found in high-quality clinical trials. These more recent trials suggested a lower range of dose-intensity compared with the higher range as the new standard of care. This was incorporated into guidelines. To date, no clinical trials have evaluated this lower range and specifically, it is plausible that an even lower dose-intensity of CRRT may be well tolerated, safe, associated with similar outcomes and be more cost-effective. This is the objective of the WISDOM trial, to compare the guideline standard with lower dose-intensity among patients who are started on CRRT in the intensive care unit.
**Detailed Description:** Purpose: To primarily determine whether a lower CRRT dose-intensity in critically ill patients with acute kidney injury (AKI) is non-inferior to standard CRRT dose-intensity and to secondarily determined whether lower CRRT dose intensity will shorten total CRRT duration and improve kidney recovery compared with standard CRRT dose-intensity. This pilot trial will specifically evaluate the feasibility and tolerability of lower versus standard CRRT dose-intensity.
Hypothesis: The primary hypothesis of the WISDOM trial is that lower CRRT dose-intensity is non-inferior to current standard guideline-directed CRRT dose-intensity for critically ill patients with AKI with respect to duration of CRRT and successful liberation from RRT and kidney recovery. The secondary hypothesis of the WISDOM trial is that lower dose-intensity is superior to current standard guideline-directed CRRT dose-intensity for critically ill patients with AKI with respect to duration of CRRT and successful liberation from RRT and kidney recovery.
Justification: No randomized controlled trial (RCT) to date has specifically evaluated the lower dose-intensity threshold for critically ill patients receiving CRRT. Specifically, there has been no specific evidence or guidance on the minimum dose-intensity targets for patients receiving CRRT. This is important for several reasons. First, CRRT is an invasive, resource intensive and expensive therapy. As such, there should be a concerted effort to minimize time on RRT and facilitate early recovery and weaning. Second, abundant evidence derived from secondary analyses have suggested that higher CRRT dose-intensity can propagate oliguria, prolong CRRT therapy and delay kidney recovery. This would imply that lower dose-intensity may facilitate kidney recovery and earlier weaning from CRRT. Third, there may be added implications of higher dose-intensity, including prolongation of non-renal organ support, such as delay in weaning from invasive mechanical ventilation. Fourth, evidence derived from observational registries show that lower CRRT dose-intensity, in the range proposed in this trial, provides comparable efficacy in azotemic, metabolic and acid-base homeostasis with similar outcomes. Observational data have suggested a prescribed CRRT dose-intensity of 15 mL/kg/hr may be sufficient for metabolic and azotemic control and is not associated with worse outcomes compared with guideline directed dose-intensity. This is lower quality evidence, however, implies that lower dose-intensity may be acceptable and safe. Fifth, it is plausible that following a short period of metabolic stabilization with CRRT, the minimum recommended CRRT dose-intensity of 20-25 mL/kg/hr may be excessive and have unmeasurable harm (e.g., excessive clearance of electrolytes, micronutrients, and medications \[antimicrobials\]). Finally, the prescription of a lower CRRT dose-intensity may have meaningful impact on reducing bedside nursing workload (e.g., fewer replacement solution bag changes) and reducing costs attributable to CRRT (e.g., lower effluent rates will reduce total replacement solution utilized).
While this proposal outlines a pilot feasibility trial, it is aimed at performing a larger rigorous RCT that will generate generalizable and high-quality evidence to impact clinical practice. The findings of the main phase of the WISDOM trial will provide clearer evidence to guide the prescription of a minimal dose-intensity for patients receiving CRRT. While this may be an effluent dose of 20-25 mL/kg/hr, it is entirely plausible that this will be a lower dose-intensity.
Objectives: The overall WISDOM trial program will address whether a lower CRRT dose-intensity in critically ill patients with AKI is non-inferior to standard CRRT dose-intensity and will secondarily address whether lower CRRT dose intensity will shorten total CRRT duration and improve kidney recovery compared with standard CRRT dose-intensity.
### Conditions Module
**Conditions:**
- Acute Kidney Injury
- Dialysis; Complications
**Keywords:**
- acute kidney injury
- continuous renal replacement therapy
- dose-intensity
- randomized trial
- pilot feasibility
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The intervention arm will consist of low dose-intensity CRRT, defined as the hourly delivery of a total effluent of 10-15 mL/kg/hr while receiving CRRT. The intervention dose-intensity is based on the rationale that 10-15 mL/kg/hr is the lower threshold of dose-intensity currently provided in clinical practice and prior observational data showing this threshold is tolerated and safe.
**Intervention Names:**
- Device: Continuous Renal Replacement Therapy (CRRT)
**Label:** Low dose-intensity
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control arm will receive a dose-intensity CRRT of 25-30 mL/kg/hr while receiving CRRT, aligned with local practice and information by international clinical practice guidelines. The control dose-intensity is based on the rationale that this is currently recommended in clinical practice guidelines and is commonly applied in routine practice.
**Intervention Names:**
- Device: Continuous Renal Replacement Therapy (CRRT)
**Label:** Standard dose-intensity
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Low dose-intensity
- Standard dose-intensity
**Description:** Continuous Renal Replacement Therapy (CRRT) is a continuous form of acute renal replacement (hemofiltration/dialysis) therapy provided to critically ill patients with multi-organ dysfunction receiving life support in the intensive care unit (ICU).
**Name:** Continuous Renal Replacement Therapy (CRRT)
**Type:** DEVICE
### Outcomes Module
#### Other Outcomes
**Description:** Physiological and biochemical outcomes.
**Measure:** Daily bicarbonate while receiving CRRT, an average of 1 month.
**Time Frame:** Through study completion, at 90-days.
**Description:** Physiological and biochemical outcomes.
**Measure:** Daily serum phosphate while receiving CRRT, an average of 1 month
**Time Frame:** Through study completion, at 90-days.
**Description:** Physiological and biochemical outcomes.
**Measure:** Daily serum urea while receiving CRRT, an average of 1 month
**Time Frame:** Through study completion, at 90-days.
**Description:** Process of care measures.
**Measure:** The total treatment time per day while receiving CRRT following randomization.
**Time Frame:** Through study completion, at 90-days.
**Description:** Process of care measures.
**Measure:** The number of planned and unplanned hemofilter/circuit replacements while receiving CRRT following randomization.
**Time Frame:** Through study completion, at 90-days.
**Description:** Process of care measures.
**Measure:** The lowest and higher CRRT dose-intensity delivered for any given hour following randomization.
**Time Frame:** While receiving CRRT, an average of 1 month.
**Description:** Process of care measures.
**Measure:** The proportion of hours of CRRT when the dose-intensity is in the target range following randomization.
**Time Frame:** Through study completion, at 90-days.
**Description:** Safety measures.
**Measure:** Occurrence of adverse and serious adverse events.
**Time Frame:** Through study completion, at 90-days.
**Description:** Safety measures.
**Measure:** Occurrence of adverse events and serious adverse events leading to discontinuation of the trial intervention.
**Time Frame:** Through study completion, at 90-days.
**Description:** Clinical Outcomes.
**Measure:** RRT-free days at 90-days.
**Time Frame:** Through study completion, at 90-days.
#### Primary Outcomes
**Description:** This pilot trial will target detection of a minimum difference of 10 mL/kg/hr in delivered dose-intensity.
**Measure:** Difference in delivered CRRT dose-intensity
**Time Frame:** Through study completion, an average of 1 month.
#### Secondary Outcomes
**Description:** Consent rate for participation by patient or surrogate decision-maker (SDM).
**Measure:** Feasibility - consent rate
**Time Frame:** Through study completion, at 90-days.
**Description:** Time from eligibility (e.g., starting RRT) to randomization.
**Measure:** Feasibility - time to enrollment
**Time Frame:** During active recruitment into the trial, approximately 1 year.
**Description:** Protocol adherence for allocated CRRT dose-intensity.
**Measure:** Feasibility - adherence to prescribed CRRT dose-intensity
**Time Frame:** Through study completion, at 90-days.
**Description:** Ability to capture delivered CRRT dose-intensity measures.
**Measure:** Feasibility - ascertainment to delivered CRRT process measures
**Time Frame:** Through study completion, at 90-days.
**Description:** Ability to capture patient and kidney endpoints at 90-days.
**Measure:** Feasibility - outcome ascertainment
**Time Frame:** Through study completion, at 90-days.
**Description:** Ability to recruit 2 patients per site per month.
**Measure:** Feasibility - recruitment rate
**Time Frame:** During active recruitment into the trial, approximately 1 year.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* age \> 18 years
* clinical team decision to initiate CRRT associated with AKI
* within 18 hours of commencement of CRRT
* expected to receive CRRT for a duration of ≥ 48 hours
* able to provide informed consent or have an authorized representative provide consent after being informed on the details and risks of the trial unless a waiver of consent process is approved by local Research Ethics Board (REB).
Exclusion Criteria:
* absolute indication for higher dose-intensity CRRT
* end-stage kidney disease receiving maintenance dialysis
* inability to comply with the requirements of the study protocol.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sean M Bagshaw, MD
**Phone:** 780-248-1256
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Scott Jamieson
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Alberta
**Name:** Sean M Bagshaw, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** St. Michael's Hospital (Unity Health)
**Name:** Ron Wald
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000051437
- Term: Renal Insufficiency
- ID: D000007674
- Term: Kidney Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M28998
- Name: Acute Kidney Injury
- Relevance: HIGH
- As Found: Acute Kidney Injury
- ID: M19010
- Name: Critical Illness
- Relevance: LOW
- As Found: Unknown
- ID: M26718
- Name: Renal Insufficiency
- Relevance: LOW
- As Found: Unknown
- ID: M10698
- Name: Kidney Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000058186
- Term: Acute Kidney Injury
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446726
**Brief Title:** Low-dose Radiation Combined With Neoadjuvant Immunochemotherapy for Esophageal Squamous Cell Carcinoma
**Official Title:** Efficacy and Safety of Low-dose Radiation Combined With Neoadjuvant Chemotherapy and Immunotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma
#### Organization Study ID Info
**ID:** 18081312828
#### Organization
**Class:** OTHER
**Full Name:** Sichuan University
### Status Module
#### Completion Date
**Date:** 2026-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sichuan University
#### Responsible Party
**Investigator Affiliation:** Sichuan University
**Investigator Full Name:** Bo Zhang
**Investigator Title:** Principal investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study aims to investigate the efficacy and safety of low-dose radiation combined with neoadjuvant chemotherapy and immunotherapy in the treatment of locally advanced thoracic esophageal squamous cell carcinoma. By reducing the radiation dose from 40 Gy in 20 fractions to 4 Gy in 2 fractions, the goal is to lessen the adverse reactions caused by radiotherapy. Additionally, the study explores whether low-dose radiation therapy can promote the cross-presentation of tumor-specific antigens and increase lymphocyte infiltration into the tumor site. Study also examines whether this approach can enhance tumor-specific immune responses, thereby potentially improving the efficacy of immune checkpoint inhibitors.
**Detailed Description:** According to 2020 GLOBOCAN data, esophageal cancer ranks fifth in incidence among all malignant tumors in China, with new cases reaching 324,000 and annual deaths at 301,000. These figures indicate a significant burden of esophageal cancer in China, accounting for 55% of esophageal cancer cases globally. Unlike in Western countries, most esophageal cancer patients in China have squamous cell carcinoma, and 40% are diagnosed at an advanced stage. Surgery is a key treatment for locally advanced esophageal cancer, but patients may achieve better clinical outcomes if they receive neoadjuvant therapy before surgery. However, the prognosis for these patients remains relatively poor. From 2009 to 2015, the overall 5-year relative survival rate for esophageal cancer was 21.4%, with local tumors at 46.7%, regional metastasis at 25.1%, and distant metastasis at only 4.8%.
In recent years, immunotherapy has shown significant survival benefits in patients with advanced esophageal cancer. Immuno-chemotherapy has now become the standard first-line treatment for advanced esophageal cancer. Currently, the introduction of immunotherapy as neoadjuvant treatment in locally advanced esophageal cancer is a highly regarded research area. Many studies are underway involving the combined application of neoadjuvant chemotherapy and immunotherapy, as well as neoadjuvant chemoradiotherapy and immunotherapy. Regarding safety, tislelizumab is similar to foreign similar drugs, mostly causing grade 1-2 adverse reactions, and is within a controllable range. Our center's previous research results have shown that tislelizumab can be used as a neoadjuvant immunotherapy drug for esophageal squamous cell carcinoma, with good perioperative safety.
It is worth noting that recent study reports indicate that the pathological complete response (PCR) rate of neoadjuvant chemotherapy combined with immunotherapy in small sample studies ranges from 17% to 22%, showing significant heterogeneity. Recently, Chinese scholars published a study in the international authoritative academic journal "Nature Medicine," indicating that using a PD-L1 antibody for immunotherapy combined with surgery, although the PCR rate was only 8%, the long-term survival effect was comparable to traditional chemoradiotherapy. This further proves that compared to traditional neoadjuvant chemoradiotherapy, neoadjuvant immunotherapy has broad development potential. However, the local control effects of immunotherapy alone or combined with chemotherapy are still unsatisfactory, which may affect the radical outcome of surgery and the long-term survival of patients. Therefore, combining more effective local treatment methods with immunotherapy is undoubtedly a more promising treatment option.
Low-dose radiotherapy (LDRT) is generally defined as a treatment not exceeding 2 Gy per session, totaling no more than 10 Gy, and is considered a non-ablative treatment \[13\]. The low toxicity of low-dose radiotherapy makes it a treatment option for those not suitable for body-targeted radiation therapy. Furthermore, although low-dose radiotherapy does not directly kill cancer cells, it can promote tumor regression by readjusting the tumor immune microenvironment.
Low-dose radiotherapy damages cell DNA, causing previously hidden or difficult-to-recognize tumor antigens to be exposed on the cell surface. This change promotes the cross-presentation of tumor-specific antigens, increases lymphocyte infiltration into the tumor site, enhances tumor-specific immune responses, and further improves the efficacy of immune checkpoint inhibitors. Preoperative immunotherapy can activate the patient's immune system, enabling it to recognize tumor antigens and establish immune memory. This allows the immune system to continue to function in immune surveillance after the surgical removal of the tumor. Currently, the main focus of clinical research is on how to maximize the synergistic effects between different treatment modalities to achieve the best survival outcomes for patients with locally advanced esophageal cancer while minimizing treatment side effects.
This study is a Phase IIA clinical trial, a preliminary study of efficacy and safety. This study envisions a comprehensive treatment of neoadjuvant low-dose radiotherapy combined with chemotherapy and immunotherapy (chemo-immuno), which, by reducing the radiotherapy dose, can enhance local control efficacy and reduce adverse reactions caused by the combined treatment mode. Therefore, it is proposed to perform neoadjuvant low-dose radiotherapy combined with chemo-immuno treatment in patients with locally advanced esophageal squamous cell carcinoma, adjust the preoperative radiotherapy dose from 40 Gy/20f to 4 Gy/2f, evaluate the efficacy and safety of this treatment mode, and provide more evidence for the neoadjuvant treatment model for locally advanced esophageal cancer patients. Additionally, exploratory analyses of preoperative and postoperative tissue and blood samples will be conducted to understand the impact of preoperative low-dose radiotherapy combined with immunotherapy on the esophageal cancer immune microenvironment; suitable biological markers will be selected to identify the optimal beneficiary group.
### Conditions Module
**Conditions:**
- Esophageal Squamous Cell Carcinoma
**Keywords:**
- Esophageal squamous cell carcinoma
- low-dose radiation
- neoadjuvant immunochemotherapy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Cohort (30 cases): Patients receive neoadjuvant low-dose radiotherapy (4 Gy/2f) combined with a domestic PD-1 inhibitor (tislelizumab) and chemotherapy as neoadjuvant treatment.
##### 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:** During the neoadjuvant treatment phase, patients will undergo two cycles of low-dose radiotherapy, combined with chemotherapy and immunotherapy, each cycle lasting 21 days. The specific treatment protocol is as follows:
D1/2: Low-dose radiotherapy (4 Gy/2f) D3: Tislelizumab, fixed dose of 200 mg; Nab-paclitaxel 260 mg/m2; Cisplatin 75 mg/m2. The interval between radiotherapy and chemotherapy should not exceed 3 days. Drug infusions follow the sequence of tislelizumab → nab-paclitaxel → cisplatin/carboplatin, with at least a 30-minute interval between each infusion.
At the end of the neoadjuvant treatment, patients will undergo surgical treatment 6-8 weeks after the last treatment session.
**Intervention Names:**
- Drug: Tislelizumab
- Radiation: Low-dose radiotherapy
- Drug: Nab-paclitaxel
- Drug: Cisplatin
**Label:** neoadjuvant low-dose radiotherapy and immunochemotherapy group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- neoadjuvant low-dose radiotherapy and immunochemotherapy group
**Description:** Patients will undergo two cycles of immunotherapy, each cycle lasting 21 days. Day 3 and Day 24: Tislelizumab, fixed dose of 200 mg
**Name:** Tislelizumab
**Other Names:**
- Tislelizumab, fixed dose of 200 mg
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- neoadjuvant low-dose radiotherapy and immunochemotherapy group
**Description:** Patients will undergo two cycles of low-dose radiotherapy. Day 1/2 and Day 22/23: Low-dose radiotherapy (8 Gy/4f)
**Name:** Low-dose radiotherapy
**Other Names:**
- Low-dose radiotherapy (8 Gy/4f)
**Type:** RADIATION
#### Intervention 3
**Arm Group Labels:**
- neoadjuvant low-dose radiotherapy and immunochemotherapy group
**Description:** Patients will undergo two cycles of chemotherapy. Day 3 and Day 24: Nab-paclitaxel 260 mg/m2
**Name:** Nab-paclitaxel
**Other Names:**
- Nab-paclitaxel 260 mg/m2
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- neoadjuvant low-dose radiotherapy and immunochemotherapy group
**Description:** Patients will undergo two cycles of chemotherapy. Day 3 and Day 24: Cisplatin 75 mg/m2.
**Name:** Cisplatin
**Other Names:**
- Cisplatin 75 mg/m2
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The proportion of subjects with 0% of surviving tumor cells remaining in the primary tumor and in the sampled lymph nodes as evaluated by histology.
**Measure:** Pathologic complete response
**Time Frame:** Immediately after the surgery
#### Secondary Outcomes
**Description:** Complete response (CR) + partial response (PR) was evaluated by RECIST 1.1 criteria Complete response (CR) + partial response (PR) was evaluated by RECIST 1.1 criteria Complete response (CR) + partial response (PR) was evaluated by RECIST 1.1 criteria
**Measure:** Major pathological response
**Time Frame:** Immediately after the surgery
**Description:** Intraoperative evaluation
**Measure:** R0 rate
**Time Frame:** During the surgery
**Description:** The time of enrollment (i.e., signing the ICF) until the following events: any disease progression resulting in surgery not being performed, disease progression or recurrence after surgery, disease progression in patients without surgery, or death from any cause
**Measure:** 1/2 year event-free survival
**Time Frame:** 2 years
**Description:** Complete response (CR) + partial response (PR) was evaluated by RECIST 1.1 criteria
**Measure:** Overall Response Rate
**Time Frame:** Immediately after the surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Histologically confirmed thoracic esophageal squamous cell carcinoma with clinical staging of: cT1b-cT2 N1-2 M0 or cT3-cT4a N0-2 M0 (AJCC/UICC esophageal cancer staging, 8th edition)
2. Candidates eligible for an R0 curative resection
3. ECOG performance status of 0-1
4. Male or female patients aged ≥18 years and ≤75 years
5. Adequate major organ and bone marrow function (without transfusion or medication correction): Complete blood count: White blood cells ≥ 3.5×10\^9/L, Absolute Neutrophil Count (ANC) ≥1.5 ×10\^9/L, Platelets ≥100×10\^9/L, Hemoglobin ≥9g/dL
6. Radiation oncologist assessment confirms no severe pulmonary ventilatory dysfunction and no acute cardiac failure. (Pulmonary function: FEV1/FVC≥70%, FEV1≥50% of the normal value, DLCO (lung diffusion capacity) actual versus predicted value \>80%)
7. Liver function: Total bilirubin ≤1.5 times the upper limit of normal (ULN), Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) ≤2.5 times ULN, Serum albumin ≥3g/dL
8. Renal function: Serum creatinine ≤1.5×ULN, or creatinine clearance ≥ 60ml/min (calculated using the Cockcroft/Gault formula): Female: CrCl = (140 - age) x weight (kg) x 0.85 / 72 x serum creatinine (mg/dL) Male: CrCl = (140 - age) x weight (kg) x 1.00 / 72 x serum creatinine (mg/dL)
9. Study participants voluntarily join the study and sign a written informed consent form, and are able to comply with the protocol-specified visits and related procedures
10. Expected survival \>6 months
11. Patients agree to undergo surgical treatment as well as radiotherapy, chemotherapy, and immunotherapy
12. Women of childbearing potential must have a negative pregnancy test within 7 days prior to the initiation of treatment; all participants, regardless of gender, are willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last dose of study medication
13. No esophageal perforation or active esophageal bleeding, and no tracheal or major thoracic vascular invasion
14. According to the solid tumor response evaluation criteria (RECIST version 1.1), at least one measurable lesion by imaging
Exclusion Criteria:
1. Patients who are unsuitable for the immunotherapy and chemotherapy specified in the protocol
2. Patients with a history of treatment for ESCC, including experimental drugs, chemotherapy, radiotherapy, or therapies targeting T-cell co-stimulation checkpoint pathways such as anti-PD-1, anti-PD-L1, anti-PD-L2 antibodies or drugs
3. Patients with a history of primary tumor infiltration causing fistula
4. Patients assessed as having a high risk of fistula or signs of perforation
5. Patients who have required systemic corticosteroid treatment (prednisone \> 10 mg/day or equivalent dosage) or other immunosuppressive therapies within 14 days prior to the first administration. However, use of adrenocortical replacement steroids (prednisone ≤ 10 mg/day or equivalent) and minimal systemic absorption of topical, ocular, intra-articular, nasal, and inhaled corticosteroids, as well as short-term (≤ 7 days) use of corticosteroids for non-autoimmune conditions are allowed (dexamethasone can be used for paclitaxel pre-treatment)
6. Patients with active autoimmune diseases or a history of autoimmune diseases that might recur. However, participants with well-controlled type 1 diabetes, hypothyroidism requiring only hormone replacement, well-controlled celiac disease, and non-systemic treated skin conditions like vitiligo, psoriasis, or alopecia, or conditions not likely to recur without an external trigger are eligible
7. Patients with a history of interstitial lung disease, non-infectious pneumonia, or poorly controlled pulmonary diseases including pulmonary fibrosis or acute lung diseases
8. Patients needing systemic antibacterial, antifungal, or antiviral treatment for infections such as tuberculosis. Patients who have had a severe infection including but not limited to hospitalization-required complications, bacteremia, or severe infectious pneumonia within 4 weeks before the first administration, or those who have received therapeutic oral or intravenous antibiotics within 2 weeks before the first administration
9. Patients with a history of allogeneic organ transplant (excluding corneal transplant) or allogeneic hematopoietic stem cell transplant
10. Patients known to be allergic to the study drug tiragolumab, or to the active ingredients or excipients in the combined chemotherapy drugs
11. Patients with significant and severely symptomatic rhythm, conduction, or morphological abnormalities on a resting electrocardiogram, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, atrial fibrillation; unstable angina, congestive heart failure, or chronic heart failure with an NYHA classification of ≥ 2
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yong Yuan, Professor
**Phone:** +86 18980606739
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Xiaokun Li, Doctor
**Phone:** +86 18081312828
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** West China Hospital
**Name:** Jianxin Xue, professor
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Klug F, Prakash H, Huber PE, Seibel T, Bender N, Halama N, Pfirschke C, Voss RH, Timke C, Umansky L, Klapproth K, Schakel K, Garbi N, Jager D, Weitz J, Schmitz-Winnenthal H, Hammerling GJ, Beckhove P. Low-dose irradiation programs macrophage differentiation to an iNOS(+)/M1 phenotype that orchestrates effective T cell immunotherapy. Cancer Cell. 2013 Nov 11;24(5):589-602. doi: 10.1016/j.ccr.2013.09.014. Epub 2013 Oct 24.
**PMID:** 24209604
**Citation:** Herrera FG, Ronet C, Ochoa de Olza M, Barras D, Crespo I, Andreatta M, Corria-Osorio J, Spill A, Benedetti F, Genolet R, Orcurto A, Imbimbo M, Ghisoni E, Navarro Rodrigo B, Berthold DR, Sarivalasis A, Zaman K, Duran R, Dromain C, Prior J, Schaefer N, Bourhis J, Dimopoulou G, Tsourti Z, Messemaker M, Smith T, Warren SE, Foukas P, Rusakiewicz S, Pittet MJ, Zimmermann S, Sempoux C, Dafni U, Harari A, Kandalaft LE, Carmona SJ, Dangaj Laniti D, Irving M, Coukos G. Low-Dose Radiotherapy Reverses Tumor Immune Desertification and Resistance to Immunotherapy. Cancer Discov. 2022 Jan;12(1):108-133. doi: 10.1158/2159-8290.CD-21-0003. Epub 2021 Sep 3.
**PMID:** 34479871
**Citation:** Gupta A, Probst HC, Vuong V, Landshammer A, Muth S, Yagita H, Schwendener R, Pruschy M, Knuth A, van den Broek M. Radiotherapy promotes tumor-specific effector CD8+ T cells via dendritic cell activation. J Immunol. 2012 Jul 15;189(2):558-66. doi: 10.4049/jimmunol.1200563. Epub 2012 Jun 8.
**PMID:** 22685313
**Citation:** Barsoumian HB, Ramapriyan R, Younes AI, Caetano MS, Menon H, Comeaux NI, Cushman TR, Schoenhals JE, Cadena AP, Reilly TP, Chen D, Masrorpour F, Li A, Hong DS, Diab A, Nguyen QN, Glitza I, Ferrarotto R, Chun SG, Cortez MA, Welsh J. Low-dose radiation treatment enhances systemic antitumor immune responses by overcoming the inhibitory stroma. J Immunother Cancer. 2020 Oct;8(2):e000537. doi: 10.1136/jitc-2020-000537.
**PMID:** 33106386
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-04-15
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 606495
- Type Abbrev: Prot_SAP
- Upload Date: 2024-05-16T10:57
- Date: 2024-04-15
- Filename: ICF_001.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 185187
- Type Abbrev: ICF
- Upload Date: 2024-05-16T07:33
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000018307
- Term: Neoplasms, Squamous Cell
- ID: D000004938
- Term: Esophageal Neoplasms
- 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: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M5550
- Name: Carcinoma, Squamous Cell
- Relevance: HIGH
- As Found: Squamous Cell Carcinoma
- ID: M1733
- Name: Esophageal Squamous Cell Carcinoma
- Relevance: HIGH
- As Found: Esophageal Squamous Cell Carcinoma
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M20451
- Name: Neoplasms, Squamous Cell
- Relevance: LOW
- As Found: Unknown
- ID: M8088
- Name: Esophageal 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: 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: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000002294
- Term: Carcinoma, Squamous Cell
- ID: D000077277
- Term: Esophageal Squamous Cell Carcinoma
### 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
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
### 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: HIGH
- As Found: Strength
- ID: M6182
- Name: Cisplatin
- Relevance: HIGH
- As Found: Adults
- ID: M137899
- Name: Tislelizumab
- Relevance: HIGH
- As Found: Intensive Care
- ID: M18650
- Name: Carboplatin
- Relevance: LOW
- As Found: Unknown
- ID: M2853
- Name: Immunomodulating Agents
- 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
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000017239
- Term: Paclitaxel
- ID: D000068196
- Term: Albumin-Bound Paclitaxel
- ID: D000002945
- Term: Cisplatin
- ID: C000707970
- Term: Tislelizumab
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446713
**Acronym:** PIRATES
**Brief Title:** PIRATES Phase I Trial
**Official Title:** Proton Image-guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients
#### Organization Study ID Info
**ID:** 18646
#### Organization
**Class:** OTHER
**Full Name:** University Medical Center Groningen
### Status Module
#### Completion Date
**Date:** 2028-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-11
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Medical Center Groningen
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** In this study the safety \& feasibility of image-guided mid-treatment hyper-fractioned dose-escalation with proton therapy will be assessed for the treatment of locally advanced HPV-negative squamous cell oropharyngeal cancer
**Detailed Description:** For this study we propose a novel design to achieve tumor radiation dose-escalation with proton therapy plus standard of care concomitant chemotherapy, in combination with mid-treatment image-guided tumor boost dose adaptation, hybrid hyperfraction and selective critical structure sparing to prevent toxicities (arising from both the high- and intermediate- dose regions) and improve locoregional control.
### Conditions Module
**Conditions:**
- Head and Neck Cancer
- Oropharyngeal Cancer
**Keywords:**
- Proton therapy
- Hyperfractionation
- Dose-escalation
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Single arm Bayesian Phase I intervention study
##### Masking Info
**Masking:** NONE
**Masking Description:** All participants receive the experimental treatment
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 17
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The investigational radiation regime will be administered in a two-part schedule:
* The first 4 weeks (i.e. first 20 fractions) of the radiation treatment of the pathological tumor will be according to the conventional clinical standard: 20x 2 Gy to the CTV70 and 20 x 1.55 Gy to the CTV54.
* In week 4 (\~ fraction 16) GTV80 will be determined on conventional weekly CT and additional MR imaging (conventional clinical protocol). Only this adapted tumor volume, the so-called GTV80, will receive the dose escalation (i.e., 80.5 Gy).
* In the last 3 weeks (last 15 fractions) patients will be radiated twice per day (i.e. hyper-fractionation). The GTV80, CTV70 and CTV54 will receive 1.55 Gy in the morning, and the GTV80 and CTV70 will receive additional dose in the afternoon.
**Intervention Names:**
- Radiation: Proton therapy
**Label:** Hybrid hyper-fractioned dose escalation regimen
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Hybrid hyper-fractioned dose escalation regimen
**Description:** Hybrid hyper-fractioned dose escalation regimen
**Name:** Proton therapy
**Type:** RADIATION
### Outcomes Module
#### Other Outcomes
**Description:** All other physician rated toxicities (CTCAEv5), including all grades
**Measure:** Other physician rated toxicities
**Time Frame:** All SFP time points (baseline, weekly during RT, 6 weeks, 6, 12, 18, 24 months after treatment
**Description:** Patient-rated symptoms (EORTC QLQ-H\&N35)
**Measure:** Patient-rated symptoms
**Time Frame:** All SFP time points (baseline, weekly during RT, 6 weeks, 6, 12, 18, 24 months after treatment
**Description:** Quality of life (EORTC QLQ-C30)
**Measure:** Quality of life
**Time Frame:** All SFP time points (baseline, weekly during RT, 6 weeks, 6, 12, 18, 24 months after treatment
**Description:** WHO performance
**Measure:** WHO performance
**Time Frame:** All SFP time points (baseline, weekly during RT, 6 weeks, 6, 12, 18, 24 months after treatment
#### Primary Outcomes
**Description:** The number of dose limiting toxicity (DLT) events, defined as grade ≥4 mucositis, grade ≥4 ulceration, grade ≥4 dermatitis, grade ≥4 aspiration, grade ≥4 osteonecrosis and grade ≥3 myelopathy
**Measure:** Safety and feasibility
**Time Frame:** Within 6 months after radiotherapy
#### Secondary Outcomes
**Description:** Completion of treatment with a maximum of 2 fraction interruption
**Measure:** Completing radiotherapy regimen
**Time Frame:** During radiotherapy
**Description:** Percentage of patients completing the complete chemotherapy regimen
**Measure:** Completing radiotherapy regimen
**Time Frame:** During radiotherapy
**Description:** Rates of grade ≥3 mucositis, dermatitis, aspiration, dysphagia, hearing impaired, xerostomia, weight loss, trismus, hoarseness, oropharyngeal pain (according to CTCAEv5).
**Measure:** Toxicity
**Time Frame:** At 6 months after chemoradiation
**Description:** Preliminary tumor response rates measured on the standard follow-up MRI scan
**Measure:** Tumor response rate
**Time Frame:** All SFP time points (baseline, weekly during RT, 6 weeks, 6, 12, 18, 24 months after treatment
**Description:** Preliminary disease-free, overall survival and time-weighted locoregional control analyses
**Measure:** Disease-free, overall survival and time-weighted locoregional control
**Time Frame:** All SFP time points (baseline, weekly during RT, 6 weeks, 6, 12, 18, 24 months after treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Biopsy proven diagnosis of squamous cell carcinoma originating in the oropharynx.
* Routine staging procedures, including CT of the head and neck region and chest, head and neck FDG-PET/CT and MRI (treatment planning allowed), and endoscopic evaluation when indicated.
* Negative for p16
* Locally advanced disease, specifically meeting all following criteria:
* Stage III-IV
* T-stage 2-4
* All N-stages (N0-3)
* M0
* Eligible for primary concurrent chemoradiation using conventionally fractionated radiotherapy 70 Gy combined with weekly cisplatin
* Eastern Cooperative Oncology Group (ECOG) performance score ≥2
* Age ≥18 years
* Written informed consent
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study; patients that:
* underwent definitive resection of their primary tumor or nodal disease, except for incisional or excisional biopsies.
received radiation therapy in the head and neck area in the past
* have no detectable tumor anymore at both the primary site and lymph nodes at week 4 in treatment, because there will not be a volume to boost.
* are unable or unwilling to give written, informed consent
* have contra-indications for chemotherapy. This is at the discretion of the treating medical oncologist.
* are unable to tolerate intravenous contrast for both CT and MRI, having an estimated GFR \< 60 ml/min/1.73 m2 or any contraindications to gadolinium-based contrast agents.
* have any evidence of iron overload on pre-imaging laboratory studies.
* have other serious illnesses or medical conditions present at entry in the study, including (but not limited to): immunodeficiency virus (HIV) infection or other conditions of persistent immunodeficiency, neurologic or psychiatric disorders, active disseminated intravascular coagulation, unstable cardiac disease despite treatment or uncontrolled diabetes mellitus.
* Women who are pregnant or breast feeding
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Groningen
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** L.V. van Dijk, dr.
- **Phone:** 031655257381
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** UMC Groningen
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000010610
- Term: Pharyngeal Neoplasms
- ID: D000010039
- Term: Otorhinolaryngologic Neoplasms
- ID: D000010608
- Term: Pharyngeal Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
### Condition Browse Module - Browse Leaves
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: HIGH
- As Found: Head and Neck Cancer
- ID: M12885
- Name: Oropharyngeal Neoplasms
- Relevance: HIGH
- As Found: Oropharyngeal Cancer
- ID: M13517
- Name: Pharyngeal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12962
- Name: Otorhinolaryngologic Neoplasms
- 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
### Condition Browse Module - Meshes
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000009959
- Term: Oropharyngeal Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446700
**Brief Title:** Correlation Between Neck Pain and Visual Disturbances in Smartphone Users
**Official Title:** Correlation Between Neck Pain and Visual Disturbances in Smartphone Users
#### Organization Study ID Info
**ID:** neck pain and vision
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2024-06-01
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-05-25
**Type:** ACTUAL
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cairo University
#### Responsible Party
**Investigator Affiliation:** Cairo University
**Investigator Full Name:** Yasmin Saeed Atallah
**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 study is to Investigate the correlation between neck pain and visual disturbances in smartphone users.
**Detailed Description:** Study design:
Cross-sectional observational analytical study design conducted on smartphone users 2- Subject selection 141 subjects (who are smartphone users) according to sample size calculation will be selected randomly to complete the neck disability index and visual functional questionnaire 25 version 2000
### Conditions Module
**Conditions:**
- Neck Pain
- Visual Disturbances
**Keywords:**
- neck pain
- vision
- smartphone
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 141
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** participants complete the 2 questionnaire by an online form and paper
**Name:** neck disability index and visual functional questionnaire
**Other Names:**
- visual functional questionnaire
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'.
Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.
0 points or 0% means: no activity limitations, 50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability.
**Measure:** Neck disability index
**Time Frame:** 1 month
**Description:** The VFQ-25 consists of a base set of 25 vision targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question The VFQ-25 takes approximately 10 minutes on average to administer in the interviewer format. There is also a self-administered version of theSurvey.
**Measure:** Visual functional questionnare
**Time Frame:** 1 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 141 subjects who are smartphone users
* Age between 18 to 50 years
* Both genders are included
* Subjects Who put in more than 4 hours a day using smartphone
* Participants without systemic illnesses or physical deformities were also included
* Consent: Participants who provide informed consent to participate in the study.
* Neck disability index will be used to assess how your neck pain has affected your ability to manage in everyday life.
* Visual Functioning Questionnaire version 2000 will be used to assess vision-related quality of life
Exclusion Criteria:
* People with head and neck injuries
* eye diseases
* People with diabetic retinopathy
* who had refractive correction surgery
* psychiatric problems (depression)
* people with systemic illnesses or physical deformities
* people who have vision impairments and disabilities
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
**Study Population:** participants from universities and local population
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Yasmin Saeed Atallah
#### Overall Officials
**Official 1:**
**Affiliation:** Professor
**Name:** Mohamed H Elgendy
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: 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: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446687
**Brief Title:** Radiographic Assessment of Bone Gain Following Sinus Lifting With Simultaneous Implant Placement Using Crestal Approach With Membrane Control Technique for Bone Augmentation of Atrophied Maxillary Posterior Ridge
**Official Title:** Radiographic Assessment of Bone Gain Following Sinus Lifting With Simultaneous Implant Placement Using Crestal Approach With Membrane Control Technique for Bone Augmentation of Atrophied Maxillary Posterior Ridge
#### Organization Study ID Info
**ID:** 99522504
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2025-02-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Cairo University
#### Responsible Party
**Investigator Affiliation:** Cairo University
**Investigator Full Name:** Ali Hadi Homoud Radi
**Investigator Title:** Affiliation oral and maxillofacial surgery master candidate at cairo university
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study aims to evaluate the quantity and quality of the native and the newly bone around dental implants that's simultaneously installed with sinus lifting
### Conditions Module
**Conditions:**
- Implant Site Reaction
- Maxillary Deficiency
**Keywords:**
- Closed Sinus lifting
- Bone Gain
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### 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:** Sinus Lifting with simultaneously implant placement.
**Intervention Names:**
- Procedure: Dental implant with sinus lifting.
**Label:** Sinus Lifting by Using Crestal approach with membrane control technique.
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Sinus Lifting by Using Crestal approach with membrane control technique.
**Description:** Surgery will be performed under local infiltration anaesthesia. Flap will be done. For maxillary sinus lifting by using Crestal approach with Membrane Control Technique by Wang (Wang, 2017) will be employed. After reflecting on the flap, Magic Split will be used to confirm bone quality clinically. This will be followed by site preparation using Magic Marking Drill. Bone drilling will then be performed by Magic Drill shorter by 2 mm from the sinus floor. This will be followed by sinus lifting by using Magic Sinus Lifter (MSL). The 3mm space of the apex of the Sinus Lifter instrument enables direct control of the bone-block and consequently the membrane, which is connected to the bone-block. the fixture will be installed in the conventional method. Then cover the fixture with the cover screw. The flap will be sutured. An immediate CBCT will be requested to ensure the implant is in its proper position.
**Name:** Dental implant with sinus lifting.
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Calculate bone height and formation around dental implants.
**Measure:** Cone beam computed tomography (CBCT) bone height formation around dental implants
**Time Frame:** Patients will be evaluated after 3 days and weekly for the first month and then once monthly up to 4 months for signs of dehiscence. then cone-beam computed tomography 4 months postoperatively to calculate the amount of vertical bone gain.
#### Secondary Outcomes
**Description:** Calculate bone density formation around dental implants.
**Measure:** Cone beam computed tomography (CBCT) density formation around dental implants
**Time Frame:** Patients will be evaluated after 3 days and weekly for the first month and then once monthly up to 4 months for signs of dehiscence. then cone-beam computed tomography 4 months postoperatively to calculate the amount of vertical bone gain.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients required dental implant treatment in the posterior maxilla, in the premolar and molar regions ( both sexes).
2. Residual bone height 4-8mm in the estimated implant positions.
3. The bone width of the alveolar ridge is at least 5mm in estimated implant positions.
4. The edentulous ridges are covered with optimal thickness of mucoperiosteum.
Exclusion Criteria:
1. Patients with a systemically diseases or inflammation whether local or generalized.
2. Patients with bleeding disorders.
3. Subjected to irradiation in the head and neck area less than 1 year before implantation.
4. Poor oral hygiene and motivation.
5. Pregnant or nursing.
6. Severe bruxism or clenching.
7. Active infection or severe inflammation in the area intended for implant placement.
8. Unable to open mouth sufficiently to accommodate the surgical tooling.
**Healthy Volunteers:** True
**Maximum Age:** 90 Years
**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: D000020763
- Term: Pathological Conditions, Anatomical
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4589
- Name: Atrophy
- Relevance: HIGH
- As Found: Atrophied
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001284
- Term: Atrophy
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446674
**Brief Title:** Comparison Between Mini Monaka,Perforated Plugs and 3-Snip Punctoplasty in Punctal Stenosis
**Official Title:** Comparison Between Mini Monaka,Perforated Plugs and 3-Snip Punctoplasty in Punctal Stenosis.
#### Organization Study ID Info
**ID:** PS
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2025-04-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-25
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Almoatz bellah zohier Mohammed
**Investigator Title:** Ophthalmology Specialist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** To compare the result of mini monaka to perforated plug and 3 snip punctoplasty in management of punctal stenosis.
**Detailed Description:** Punctal stenosis is a common disorder of the punctum. It is an important cause of epiphora and accounted for 8% of all patients presenting with epiphora and 3% of all lacrimal drainage disorders. Although numerous factors have been implicated as causative agents, the exact pathogenesis is still elusive. The widely believed hypothesis that histological studies have supported is a common mechanism involving inflammation leading to fibrosis and subsequent stenosis .A stenotic punctum can be easily diagnosed by slit-lamp examination, while probing and irrigation of the lacrimal pathway is usually required to exclude a more distal obstruction There are no uniformly acceptable guidelines for the management of punctal stenosis. Several modalities described include punctal dilatation, 1-snip punctoplasty, 2-snip punctoplasty, 3-snip punctoplasty, rectangular 3-snip punctoplasty, 4-snip punctoplasty, punctal punching with Kelly's or Rsess punch, punctoplasty with mitomycin C, balloon punctoplasty, balloon puncta-canaliculoplasty, and inserting perforated punctal plugs, self-retaining bicanaliculata stents, or Mini-Monaka . The mini-monaka is a silicone post canalicular stent designed to repair canalicular lacerations. It is designed to fit snugly into the punctum and ampulla without any suturing .A perforated punctal plug can be put into the opening of the tear canal to allow drainage of tears. These are very small silicone arrowhead shaped tubes It is important to note that there is increasing evidence about the benefits of minimally invasive modalities like Mini-Monaka. the non-surgical dilation can be performed as an office procedure .
### Conditions Module
**Conditions:**
- Punctal Stenosis
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** mini monaka,perforated plugs
**Name:** mini monaka
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** correlation between mini monaka, perforated plugs and punctoplasty in punctal stenosis according to improvement in tear drainage by using slit lamp examination.
**Measure:** Comparison between mini monaka,perforated plugs and 3-Snip punctoplasty in punctal stenosis by using slit lamp examination
**Time Frame:** 1 year
**Description:** correlation between mini monaka, perforated plugs and punctoplasty in punctal stenosis according to improvement in tear drainage by using fluoresceine dilution test
**Measure:** Comparison between mini monaka,perforated plugs and 3-Snip punctoplasty in punctal stenosis by using fluoresceine dilution test
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* o Confirmed unilateral or bilateral cases of punctal stenosis based on slit-lamp examination.
Exclusion Criteria:
* o Epiphora due to distal obstruction
* Active ocular infection or inflammation.
* Anatomic abnormalities
* Ocular cicatricial pemphigoid
**Maximum Age:** 70 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients will be divided into 3 groups:
Group A: 7 patients with punctal stenosis will be treated with mini monoka. Group B: 7 patients with punctal stenosis will be treated with punctoplasty. Group C: 7 patients with punctal stenosis will be treated with perforated plug
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Assiut
**Country:** Egypt
**Facility:** Assiut university
**Zip:** 71515
#### Overall Officials
**Official 1:**
**Affiliation:** Assiut University
**Name:** mohamed shehata, prof
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Atkova EL, Maydanova AA, Krakhovetskiy NN, Reznikova LV. [Punctal stenosis: etiology, diagnosis, treatment]. Vestn Oftalmol. 2022;138(2):100-107. doi: 10.17116/oftalma2022138021100. Russian.
**PMID:** 35488568
**Citation:** Bukhari AA. Management options of acquired punctal stenosis. Saudi Med J. 2013 Aug;34(8):785-92.
**PMID:** 23974448
**Citation:** Tawfik HA, Ali MJ. A major review of punctal stenosis: Updated anatomy, epidemiology, etiology, and clinical presentation. Surv Ophthalmol. 2024 May-Jun;69(3):441-455. doi: 10.1016/j.survophthal.2024.02.001. Epub 2024 Feb 8.
**PMID:** 38336342
**Citation:** Mansur C, Pfeiffer ML, Esmaeli B. Evaluation and Management of Chemotherapy-Induced Epiphora, Punctal and Canalicular Stenosis, and Nasolacrimal Duct Obstruction. Ophthalmic Plast Reconstr Surg. 2017 Jan/Feb;33(1):9-12. doi: 10.1097/IOP.0000000000000745.
**PMID:** 27429222
**Citation:** Elbakary MA. Management of Bi-Punctal Stenosis by One-Snip Punctoplasty Combined with Silicone Intubation. Orbit. 2022 Jun;41(3):324-328. doi: 10.1080/01676830.2021.1904424. Epub 2021 Mar 29.
**PMID:** 33781149
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020763
- Term: Pathological Conditions, Anatomical
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6475
- Name: Constriction, Pathologic
- Relevance: HIGH
- As Found: Stenosis
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003251
- Term: Constriction, Pathologic
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446661
**Brief Title:** Using Text Messages to Improve Oral Chemotherapy for Adolescents and Young Adults With Acute Lymphoblastic Leukemia
**Official Title:** Improving Oral Chemotherapy Adherence in Maintenance for Adolescents and Young Adults With Acute Lymphoblastic Leukemia Using Text Messages
#### Organization Study ID Info
**ID:** IRB23-1519
#### Organization
**Class:** OTHER
**Full Name:** University of Chicago
### Status Module
#### Completion Date
**Date:** 2028-06-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Chicago
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this section is to learn how text message reminders might help with regularly taking chemotherapy medications for Adolescents and Young Adults (AYA) with Acute Lymphoblastic leukemia (ALL).
**Detailed Description:** This study aims to compare adherence to oral mercaptopurine and methotrexate during the first 84-day cycle of maintenance therapy for adolescent and young adult patients with Acute Lymphoblastic Leukemia on pediatric-based regimens between those who receive the high intensity text message intervention and those who receive standard-of-care. It is believed that high-intensity text messages will increase patient adherence within cycle 1.
### Conditions Module
**Conditions:**
- Acute Lymphoblastic Leukemia
**Keywords:**
- Oral Chemotherapy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 38
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Receives high-intensity text messaging for 2 cycles of treatment
**Intervention Names:**
- Other: High Intensity
**Label:** High Intensity
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Receives no texts for 1st cycle and low-intensity texts for 2nd cycle
**Intervention Names:**
- Other: No Text Messagings
- Other: Low Intensity Text Messaging
**Label:** Low Intensity
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- High Intensity
**Description:** Daily texts
**Name:** High Intensity
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Low Intensity
**Description:** Standard Care
**Name:** No Text Messagings
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Low Intensity
**Description:** Weekly Texts
**Name:** Low Intensity Text Messaging
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** ANC and platelet measurements are collected throughout maintenance to monitor for therapeutic goals and the potential need for dose changes as part of AYA Oncology pharmacist-led management program
**Measure:** To compare percentage of time during maintenance at goal absolute neutrophil count (ANC) and platelet count for AYA patients
**Time Frame:** 1 year
**Description:** Any changes in chemotherapy regimen or evidence of relapsed disease including new minimal residual disease (MRD) positivity within the first year of maintenance will be recorded.
**Measure:** To compare clinical outcomes during and after maintenance therapy for AYA patients
**Time Frame:** 1 year
#### Primary Outcomes
**Description:** To compare adherence to oral mercaptopurine and methotrexate during the first 84-day cycle of maintenance therapy for AYA patients with ALL on pediatric-based regimens between those who receive the high intensity text message intervention and those who receive standard of care.
**Measure:** To compare adherence to oral chemotherapy with mercaptopurine and methotrexate
**Time Frame:** 84 days
#### Secondary Outcomes
**Description:** At the start of cycle 1, Health Competence Beliefs Inventory (HCBI) scores will be collected as a baseline measurement of self-efficacy as measured in a prior AYA adherence study. Higher HCBI scores and lower ADI and SVM scores will be associated with higher adherence given prior associations with self-efficacy and family finances.
**Measure:** To describe the relationship between oral chemotherapy adherence and AYA patient factors
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age of 15-39 years-old at the time of initial ALL diagnosis
* Diagnosed with ALL
* Currently receiving treatment with pediatric-based regimen that includes maintenance with mercaptopurine and methotrexate (e.g., CALGB 10403). Study participation begins with the start of maintenance, so enrollment occurs prior to the start of maintenance.
Exclusion Criteria:
* Patient or caregiver who would receive text message reminders does not have a cell phone that receives text messages
* Patient does not wish to participate
**Maximum Age:** 39 Years
**Minimum Age:** 15 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Clinical Trials Intake
**Phone:** 1-855-702-8222
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Chicago
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Clinical Trials Intake
- **Phone:** 855-702-8222
- **Role:** CONTACT
***Contact 2:***
- **Name:** Wendy Stock
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Chicago Medicine Comprehensive Cancer Center
**State:** Illinois
**Zip:** 60637
#### Overall Officials
**Official 1:**
**Affiliation:** University of Chicago
**Name:** Wendy Stock
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Study results including PHI such as dates, assigned study ID, and initials may be shared with researchers and their teams at other sites as part of required safety reporting notifications (e.g. serious events/unanticipated problems, or other reportable events). Final reports (no PHI) may also be shared. Names and medical record numbers will not be shared externally.
Data will only be shared for analysis purposes.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000006402
- Term: Hematologic Diseases
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10945
- Name: Leukemia
- Relevance: HIGH
- As Found: Leukemia
- ID: M27585
- Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Relevance: HIGH
- As Found: Acute Lymphoblastic Leukemia
- ID: M10951
- Name: Leukemia, Lymphoid
- Relevance: HIGH
- As Found: Lymphoblastic Leukemia
- ID: M11220
- Name: Lymphoma
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T175
- Name: Acute Lymphoblastic Leukemia
- Relevance: HIGH
- As Found: Acute Lymphoblastic Leukemia
- ID: T3533
- Name: Lymphoblastic Lymphoma
- Relevance: HIGH
- As Found: Acute Lymphoblastic Leukemia
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T3543
- Name: Lymphosarcoma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007938
- Term: Leukemia
- ID: D000054198
- Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
- ID: D000007945
- Term: Leukemia, Lymphoid
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446648
**Brief Title:** Relationship bw Image-deriv Features of Intraoperative ICG Visualiz of NVBs During RARP & Functional Outcome
**Official Title:** Relationship Between Image-derived Features of Intraoperative ICG Visualization of Periprostatic Vasculature and NVBs During RARP and Functional Outcomes
#### Organization Study ID Info
**ID:** 4845
#### Organization
**Class:** OTHER
**Full Name:** University of California, Irvine
#### Secondary ID Infos
**Domain:** UCI CFCCC
**ID:** UCI 23-137
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of California, Irvine
#### Responsible Party
**Investigator Affiliation:** University of California, Irvine
**Investigator Full Name:** David Inkoo Lee
**Investigator Title:** Professor of Clinical Urology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a pilot, 3 phases open-label feasibility study with the 3rd phase consisting of randomized 2-arm intervention trial, to assess the systematic use of indocyanine green (ICG) in subjects with prostate adenocarcinoma during robot-assisted radical prostatectomy and its impact on sexual function outcomes at 12 months postoperatively.
**Detailed Description:** The first phase of this study will involve performing 50 cases of nerve-sparing RARP on patients who are good candidates for nerve sparing. During these procedures, we will record the location and size of arteries encountered to create a detailed 3D map of the surgical arterial vasculature.
In the second phase, we will recruit another 50 patients. These patients will receive an IV injection of ICG before encountering the arteries to visualize them prior to resection. This phase will determine the optimal dosage and timing for the IV ICG injection.
The third phase will utilize the dosage and timing defined in the second phase. This phase will be a randomized trial involving 300 patients.
### Conditions Module
**Conditions:**
- Prostate Adenocarcinoma
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 400
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Robot-Assisted Radical Prostatectomy will be performed as a standard procedure.
**Label:** SOC group
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Robot-Assisted Radical Prostatectomy using ICG
**Intervention Names:**
- Drug: ICG
**Label:** ICG group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ICG group
**Description:** Administer an IV ICG injection intraoperatively, using the optimal dosage and timing defined in the second phase of the study. Utilize the newly developed 3D vascular map for visualization of the arteries before and after prostate resection.
**Name:** ICG
**Other Names:**
- Indocyanine Green
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Number of patients who report using no pads or only 1 security pad per day at 3-month post-surgery.
**Measure:** Continence Rate at 3 month Post-surgery
**Time Frame:** 3 months
#### Secondary Outcomes
**Description:** Subjects will complete the investigator-developed, "Follow Up Continence And Sexual Function" questionnaires. This questionnaire includes questions typically asked in Sexual Health Inventory for Men (SHIM) and International Prostate Symptom Score (IPSS) surveys and assesses postoperative functional outcomes such as urinary continence/leakage, daily pad usage, sexual function such as percentage fullness of erection and postoperative
**Measure:** Patient Reported Continence and Sexual Functions
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. Patients must be ≥18 years old, male, and sexually active.
* 2. Histologically/pathologically confirmed localized prostate adenocarcinoma.
* 3. Adequate preoperative sexual defined as a score of ≥18 on the Sexual Health Inventory for Men (SHIM) questionnaire.
* 4. Patients who are candidates for good nerve sparing preoperatively determined by PI by assessing imaging findings.
* 5. Ability to read, write and understand and willingness to sign a written informed consent.
* 6. Patients must pass medical clearance from primary care provider and cardiologist, if applicable.
* 7. Patient must be determined to be medical fit for RARP by Investigator.
Exclusion Criteria:
* 1. No locally advanced or metastatic prostate adenocarcinoma.
* 2. Preoperative diagnosis of erectile dysfunction and with any history of intervention for sexual dysfunction such as intrapenile injections and intrapenile prosthesis implant.
* 3. Received neoadjuvant treatment for high-risk prostate cancer or received prior focal treatment of the prostate or prior definitive radiotherapy.
* 4. History of allergic reactions attributed to ICG.
* 5. Patients who are preoperatively not foreseen as ideal candidates for nerve sparing interventions by PI
* 6. Patients who are unable to comply with study and follow-up procedures as judged by the PI.
* 7. Patients who are illiterate.
* 8. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, or uncontrolled diabetes.
* 9. Any other disease, metabolic disorder, or abnormal finding upon physical examination or laboratory examination that makes the subject unsuitable for receiving the intervention, affects the interpretation of study outcomes, or poses risks to subject safety, as determined by the investigator.
**Gender Based:** True
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Chao Family Comprehensive Cancer Center University of California, Irvine
**Phone:** 1-877-827-8839
**Role:** CONTACT
**Contact 2:**
**Name:** University of California Irvine Medical
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Orange
**Country:** United States
**Facility:** Chao Family Comprehensive Cancer Center University of California, Irvine
**State:** California
**Zip:** 92868
#### Overall Officials
**Official 1:**
**Affiliation:** Chao Family Comprehensive Cancer Center
**Name:** David Lee, MD
**Role:** PRINCIPAL_INVESTIGATOR
## 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: 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
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446635
**Acronym:** Semiflex Pilot
**Brief Title:** Semiflex Assisted Vacuum Therapy for Perianal Abscesses/Sinuses and Fistula: a Pilot Study
**Official Title:** Semiflex Assisted Vacuum Therapy for Perianal Abscesses/Sinuses and Fistula: a Pilot Study
#### Organization Study ID Info
**ID:** 81105
#### Organization
**Class:** OTHER
**Full Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
### Status Module
#### Completion Date
**Date:** 2025-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-04-14
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
#### Responsible Party
**Investigator Affiliation:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
**Investigator Full Name:** Willem A. Bemelman
**Investigator Title:** Prof. Dr.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Rationale: Perianal fistulas are a common, invalidating problem for which a more effective and widely applicable treatment is necessary. Vacuum therapy has become one of the main pillars for management of a wide variety of (chronic) wound healing problems. A novel catheter set was developed for vacuum therapy of perianal abscesses/sinuses and fistulas: The Semiflex Dome System. This system will allow for a better and faster treatment and it will offer conformability with various fistula shapes and sizes.
Objective: With this pilot study, the investigators aim to test our novel catheter set for vacuum therapy of perianal abscesses/sinuses and fistulas for feasibility and efficacy.
Study design: The design of this prospective, multicentre study is a feasibility study.
Study population: Patients (≥ 18 years) with (Crohn's) perianal fistulas and patients with perianal abscesses/sinuses are eligible.
Intervention: A tailored (length and diameter) Semiflex dome catheter is inserted under general anaesthesia, after 6 weeks of seton drainage in patients with a perianal fistula and right away in patients with a perianal abscess/sinus. The catheter is fixed on a Renasys Adhesive gel patch (Smith and Nephew) and is connected with a tubing system to a vacuum pomp with an average vacuum pressure of 80 cm H2O. After two - three days the catheter will be exchanged by a shorter catheter in the outpatient setting. The therapy is continued for a maximum of four weeks in patients with a perianal abscess/sinus and two weeks in patients with perianal fistulas.
Main study parameters/endpoints: The primary objective of the study is the feasibility of the methodology with respect to smoothness of insertion and changing the semiflex catheters, capability of proper fixation of the catheter and maintaining vacuum for more than 48 hours, and compliance to the therapy in terms of pain and discomfort. Secondary objectives are efficacy of drainage of the perianal abscess/sinus, efficacy of curing the perianal abscess/sinus in terms of complete collapse of the sinus and disappearance of induration, efficacy of management of perianal fistula in terms of clinical and radiological healing, and safety in terms of complications.
Nature and extent of the burden and risks associated with participation: The Semiflex Dome Catheter System will be placed in patients with perianal fistulas and perianal abscess/sinus who would otherwise be treated using prior-art passive drainage catheters or repurposed vacuum-assisted closure therapy sponges. There are no known additional risks stemming from the proposed therapy. The Semiflex Dome Catheter System is made entirely of medical-grade silicone certified with ISO 10993- 05 and ISO 10993-10. The catheters will be connected with a tube configured to be connected to a CE certified vacuum generating system.
Sample size: Since this is a pilot study no sample size is required. The pilot study will consist of 2 parts. In the first part, 10 patients in each study group will be included and it will be assessed per study group if the catheter meets the proof of principle. After a positive result in one or both study groups, the second part of the study will start. 10 patients in each study group will be included. The proposed treatment protocol is considered feasible if at least 70% of the Semiflex dome catheter treatment per study group meets the four primary objectives.
### Conditions Module
**Conditions:**
- Perianal Fistula
- Perianal Fistula Due to Crohn's Disease
- Perianal Abscess
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Device: Semiflex Dome Catheter System
**Label:** Patients with a perianal abscess/sinus
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Device: Semiflex Dome Catheter System
**Label:** Patients with perianal fistula
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patients with a perianal abscess/sinus
- Patients with perianal fistula
**Description:** Abces: In patients that present with a perianal abscess/sinus the semiflex dome catheter is inserted under general anesthesia. A small cut is made to drain and irrigate the septic sinus.
Fistula: Under general anesthesia the seton is removed, the internal opening is excised and the internal opening is closed with a 2-0 Vicryl cross stitch.
Both: Before surgery, the length of the tract is measured on MRI or CT. A Semiflex Catheter with the appropriate length and a diameter is selected. If during surgery appears that this is not the appropriate size, a different size catheter can be used. The catheter is fixed on a Renasys Adhesive gel patch (Smith and Nephew). The catheter is connected with a tubing system to a vacuum pomp with an average vacuum pressure of 80 cm H2O. The tube will be taped on the patient. After every 2-3 days the catheter will be exchanged by a 3-6 mm shorter catheter.
**Name:** Semiflex Dome Catheter System
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The doctor will determine how easy the catheter is to insert on a scale of 0-10, with 0 being very difficult and 10 being very easy. A score \<5 is considered as not smooth. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
**Measure:** Smoothness of insertion and exchanging of the Semiflex catheter
**Time Frame:** 3 months
**Description:** The system is properly fixed if it has been in place for \>48 hours. If the system becomes loose before 48 hours, it is considered as not properly fixed. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
**Measure:** Proper fixation of the Semiflex catheter
**Time Frame:** 48 hours
**Description:** The system is properly vaccuum if it has been vacuum for \>48 hours. If the system looses vaccuum before 48 hours, it is considered as not properly vaccuum. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
**Measure:** Maintaining vacuum for more than 48 hours
**Time Frame:** 48 hours
**Description:** The patient gives a painscore after the Semiflex exchange on a scale of 0-10, with 0 being not painfull and 10 being very painfull. A score \>5 is considered as too painfull. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
**Measure:** Compliance to the therapy in terms of pain and discomfort
**Time Frame:** 3 months
#### Secondary Outcomes
**Description:** Is the Semiflex capable of draining the perianal abcess/sinus. 1 month after therapy a clinical evaluation will be done to see if the perianal abscess/ sinus is healed. Clinical closure is defined as closure of the external opening without discharge of pus on palpation. After three months a MRI is made to see if the perianal abscess/sinus is radiological healed. Radiological healing defined as complete fibrosis of the abscess/sinus on MRI.
**Measure:** Efficacy of drainage of the perianal abscess/sinus
**Time Frame:** 3 months
**Description:** Is the Semiflex capable of draining the perianal fistula. 1 month after therapy a clinical evaluation will be done to see if the perianal fistula is healed. Clinical closure is defined as closure of the external opening without discharge of pus or feaces on palpation. After three months a MRI is made to see if the perianal fistula is radiological healed. Radiological healing defined as complete fibrosis of the perianal fistual.
**Measure:** Efficacy of management of perianal fistula in terms of clinical and radiological healing
**Time Frame:** 3 months
**Description:** All complications related to the Semiflex treatment will be recorded during the follow-up of three months.
**Measure:** Safety in terms of complications
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria
* Perianal abscess/sinus or (Crohn's) perianal fistula
* ≥ 18 years and \< 80 years
* Written informed consent
Exclusion criteria
* Patients with more than 2 external perianal openings
* Rectovaginal fistula
* Life expectancy \< 2 years
* Dementia or altered mental status that would prohibit the understanding and giving of informed consent
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** AJM Pronk
**Phone:** +31642665328
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Amsterdam
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** AJM Pronk
- **Phone:** +31642665328
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Amsterdam UMC
**Status:** RECRUITING
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015212
- Term: Inflammatory Bowel Diseases
- ID: D000005759
- Term: Gastroenteritis
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000013492
- Term: Suppuration
- ID: D000007239
- Term: Infections
- ID: D000007249
- Term: Inflammation
- ID: D000010335
- Term: Pathologic Processes
- ID: D000007412
- Term: Intestinal Fistula
- ID: D000016154
- Term: Digestive System Fistula
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M37
- Name: Abscess
- Relevance: HIGH
- As Found: Abscess
- ID: M6638
- Name: Crohn Disease
- Relevance: HIGH
- As Found: Crohn's Disease
- ID: M8532
- Name: Fistula
- Relevance: HIGH
- As Found: Fistula
- ID: M14845
- Name: Rectal Fistula
- Relevance: HIGH
- As Found: Perianal Fistula
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17917
- Name: Inflammatory Bowel Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8875
- Name: Gastroenteritis
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M16273
- Name: Suppuration
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
- ID: M10446
- Name: Intestinal Fistula
- Relevance: LOW
- As Found: Unknown
- ID: M18616
- Name: Digestive System Fistula
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000038
- Term: Abscess
- ID: D000003424
- Term: Crohn Disease
- ID: D000012003
- Term: Rectal Fistula
- ID: D000005402
- Term: Fistula
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446622
**Brief Title:** Brain Blood Flow Responses During Exercise: Younger Cohort
**Official Title:** Influence of Biological Sex and Age on Cerebral Blood Flow and Vessel Function During Exercise: a Pilot Study
#### Organization Study ID Info
**ID:** 2022-0512: Younger Cohort
#### Organization
**Class:** OTHER
**Full Name:** University of Wisconsin, Madison
#### Secondary ID Infos
**Domain:** UW Madison
**ID:** Protocol Version 3/22/2023
**Type:** OTHER
**Domain:** UW Madison
**ID:** A176000
**Type:** OTHER
**Domain:** University of Wisconsin Foundation
**ID:** UWF
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-04-18
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Wisconsin, Madison
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Brain blood flow will be measured during exercise using magnetic resonance imaging.
**Detailed Description:** Over 6 million Americans are living with Alzheimer's disease and related dementias and this number is expected to reach over 13 million by 2060. Thus, there is an urgent need for interventions to prevent the development and progression of Alzheimer's disease and related dementias. Regular exercise is currently the most promising strategy as it is repeatedly shown to have neuroprotective benefits. Evidence suggests that the neuroprotective effects of exercise is the result of improved health of blood vessels. Despite the vast amount of evidence on the benefit of exercise on the peripheral vasculature, there is little information regarding brain vascular responses during exercise. This study will investigate the impact of exercise at varying intensities on brain blood flow during exercise, and will also examine the influence of age and sex.
This record represents a younger cohort for the study represented in NCT05864950.
### Conditions Module
**Conditions:**
- Cerebrovascular Circulation
- Magnetic Resonance Imaging
**Keywords:**
- Magnetic Resonance Imaging
- Exercise
- Brain Blood Flow
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 45
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Young Adults between 20-40 years of age.
**Intervention Names:**
- Device: MRI
**Label:** Young Adults
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Young Adults
**Description:** Participants will undergo an MRI scan while performing exercise at two intensities (light and moderate/vigorous) using an MRI-compatible stepper device.
**Name:** MRI
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The change in cross-sectional area of the cerebral arteries during exercise will be measured with MRI.
**Measure:** Cerebral Hemodynamics
**Time Frame:** One study visit, up to 120 minutes
**Description:** The change in intracranial blood flow during exercise will be measured with MRI.
**Measure:** Cerebral Blood Flow
**Time Frame:** One study visit, up to 120 minutes
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Healthy men or women between the ages of 20-40 years old
* Demonstrate an exercise history of engaging in aerobic physical activity at least 3 times per week for a minimum of 30 continuous minutes
* Have experience using cardiovascular exercise equipment (e.g., treadmill, elliptical, upright or recumbent bicycle, stair-stepper)
Exclusion Criteria:
* Outside of specified age range
* Do not have experience using cardiovascular exercise equipment
* Do not meet the physical activity criteria
* Present with a history or evidence of hepatic, renal, hematological disease, cardiovascular disease including uncontrolled hypertension, peripheral vascular disease, stroke/neurovascular disease, and diabetes
* have a body mass index ≥30 kg/m2
* are ≥ 71 inches (180 cm) in height
* have any contraindications to MRI
* currently use or have a history of use of tobacco or illegal substances
* have current and/or a history of depression or other mood related disorders (those with mild depression and/or anxiety that is controlled with medication and/or therapy will not be excluded)
* vulnerable populations (e.g., pregnant women, prisoners, individuals lacking capacity to consent)
* if the desired moderate/vigorous exercise intensity corresponds to \> 350 watts on the stepper device
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jill N Barnes, PhD
**Phone:** 608-262-1654
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Anna J Howery, MS
**Phone:** 608-262-9572
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Madison
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Anna J Howery, MS
- **Phone:** 608-262-9572
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Wisconsin-Madison
**State:** Wisconsin
**Status:** RECRUITING
**Zip:** 53706
#### Overall Officials
**Official 1:**
**Affiliation:** University of Wisconsin, Madison
**Name:** Jill N Barnes, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Matthews KA, Xu W, Gaglioti AH, Holt JB, Croft JB, Mack D, McGuire LC. Racial and ethnic estimates of Alzheimer's disease and related dementias in the United States (2015-2060) in adults aged >/=65 years. Alzheimers Dement. 2019 Jan;15(1):17-24. doi: 10.1016/j.jalz.2018.06.3063. Epub 2018 Sep 19.
**PMID:** 30243772
**Citation:** Barnes JN, Corkery AT. Exercise Improves Vascular Function, but does this Translate to the Brain? Brain Plast. 2018 Dec 12;4(1):65-79. doi: 10.3233/BPL-180075.
**PMID:** 30564547
**Citation:** Mitchell GF. Effects of central arterial aging on the structure and function of the peripheral vasculature: implications for end-organ damage. J Appl Physiol (1985). 2008 Nov;105(5):1652-60. doi: 10.1152/japplphysiol.90549.2008. Epub 2008 Sep 4.
**PMID:** 18772322
**Citation:** Silvestrini M, Pasqualetti P, Baruffaldi R, Bartolini M, Handouk Y, Matteis M, Moffa F, Provinciali L, Vernieri F. Cerebrovascular reactivity and cognitive decline in patients with Alzheimer disease. Stroke. 2006 Apr;37(4):1010-5. doi: 10.1161/01.STR.0000206439.62025.97. Epub 2006 Feb 23.
**PMID:** 16497984
**Citation:** Vicenzini E, Ricciardi MC, Altieri M, Puccinelli F, Bonaffini N, Di Piero V, Lenzi GL. Cerebrovascular reactivity in degenerative and vascular dementia: a transcranial Doppler study. Eur Neurol. 2007;58(2):84-9. doi: 10.1159/000103642. Epub 2007 Jun 12.
**PMID:** 17565221
**Citation:** Rubanyi GM, Romero JC, Vanhoutte PM. Flow-induced release of endothelium-derived relaxing factor. Am J Physiol. 1986 Jun;250(6 Pt 2):H1145-9. doi: 10.1152/ajpheart.1986.250.6.H1145.
**PMID:** 3487253
**Citation:** Harvey PJ, Picton PE, Su WS, Morris BL, Notarius CF, Floras JS. Exercise as an alternative to oral estrogen for amelioration of endothelial dysfunction in postmenopausal women. Am Heart J. 2005 Feb;149(2):291-7. doi: 10.1016/j.ahj.2004.08.036.
**PMID:** 15846267
**Citation:** Black MA, Cable NT, Thijssen DH, Green DJ. Impact of age, sex, and exercise on brachial artery flow-mediated dilatation. Am J Physiol Heart Circ Physiol. 2009 Sep;297(3):H1109-16. doi: 10.1152/ajpheart.00226.2009. Epub 2009 Jul 24.
**PMID:** 19633208
**Citation:** Duckles SP, Miller VM. Hormonal modulation of endothelial NO production. Pflugers Arch. 2010 May;459(6):841-51. doi: 10.1007/s00424-010-0797-1. Epub 2010 Mar 7.
**PMID:** 20213497
**Citation:** Moreau KL, Stauffer BL, Kohrt WM, Seals DR. Essential role of estrogen for improvements in vascular endothelial function with endurance exercise in postmenopausal women. J Clin Endocrinol Metab. 2013 Nov;98(11):4507-15. doi: 10.1210/jc.2013-2183. Epub 2013 Oct 3.
**PMID:** 24092827
**Citation:** Miller KB, Howery AJ, Rivera-Rivera LA, Johnson SC, Rowley HA, Wieben O, Barnes JN. Age-Related Reductions in Cerebrovascular Reactivity Using 4D Flow MRI. Front Aging Neurosci. 2019 Oct 17;11:281. doi: 10.3389/fnagi.2019.00281. eCollection 2019.
**PMID:** 31680935
**Citation:** Ogoh S, Ainslie PN. Cerebral blood flow during exercise: mechanisms of regulation. J Appl Physiol (1985). 2009 Nov;107(5):1370-80. doi: 10.1152/japplphysiol.00573.2009. Epub 2009 Sep 3.
**PMID:** 19729591
**Citation:** Soucy KG, Ryoo S, Benjo A, Lim HK, Gupta G, Sohi JS, Elser J, Aon MA, Nyhan D, Shoukas AA, Berkowitz DE. Impaired shear stress-induced nitric oxide production through decreased NOS phosphorylation contributes to age-related vascular stiffness. J Appl Physiol (1985). 2006 Dec;101(6):1751-9. doi: 10.1152/japplphysiol.00138.2006.
**PMID:** 17106067
**Citation:** Smith KJ, Ainslie PN. Regulation of cerebral blood flow and metabolism during exercise. Exp Physiol. 2017 Nov 1;102(11):1356-1371. doi: 10.1113/EP086249. Epub 2017 Sep 30.
**PMID:** 28786150
**Citation:** Smith KJ, Wong LE, Eves ND, Koelwyn GJ, Smirl JD, Willie CK, Ainslie PN. Regional cerebral blood flow distribution during exercise: influence of oxygen. Respir Physiol Neurobiol. 2012 Oct 15;184(1):97-105. doi: 10.1016/j.resp.2012.07.014. Epub 2012 Aug 16.
**PMID:** 22926137
**Citation:** Ogoh S, Tsukamoto H, Hirasawa A, Hasegawa H, Hirose N, Hashimoto T. The effect of changes in cerebral blood flow on cognitive function during exercise. Physiol Rep. 2014 Sep 28;2(9):e12163. doi: 10.14814/phy2.12163. Print 2014 Sep 1.
**PMID:** 25263210
**Citation:** Caldwell HG, Coombs GB, Howe CA, Hoiland RL, Patrician A, Lucas SJE, Ainslie PN. Evidence for temperature-mediated regional increases in cerebral blood flow during exercise. J Physiol. 2020 Apr;598(8):1459-1473. doi: 10.1113/JP278827. Epub 2020 Feb 6.
**PMID:** 31912506
**Citation:** Macdonald JA, Beshish AG, Corrado PA, Barton GP, Goss KN, Eldridge MW, Francois CJ, Wieben O. Feasibility of Cardiovascular Four-dimensional Flow MRI during Exercise in Healthy Participants. Radiol Cardiothorac Imaging. 2020 Jun 18;2(3):e190033. doi: 10.1148/ryct.2020190033.
**PMID:** 32734274
**Citation:** Macdonald JA, Roberts GS, Corrado PA, Beshish AG, Haraldsdottir K, Barton GP, Goss KN, Eldridge MW, Francois CJ, Wieben O. Exercise-induced irregular right heart flow dynamics in adolescents and young adults born preterm. J Cardiovasc Magn Reson. 2021 Oct 21;23(1):116. doi: 10.1186/s12968-021-00816-2.
**PMID:** 34670573
**Citation:** Miller KB, Gallo SJ, Rivera-Rivera LA, Corkery AT, Howery AJ, Johnson SC, Rowley HA, Wieben O, Barnes JN. Vertebral artery hypoplasia influences age-related differences in blood flow of the large intracranial arteries. Aging Brain. 2021 Jun 24;1:100019. doi: 10.1016/j.nbas.2021.100019. eCollection 2021.
**PMID:** 36911510
**Citation:** Barnes JN. Exercise, cognitive function, and aging. Adv Physiol Educ. 2015 Jun;39(2):55-62. doi: 10.1152/advan.00101.2014.
**PMID:** 26031719
**Citation:** Ferretti MT, Iulita MF, Cavedo E, Chiesa PA, Schumacher Dimech A, Santuccione Chadha A, Baracchi F, Girouard H, Misoch S, Giacobini E, Depypere H, Hampel H; Women's Brain Project and the Alzheimer Precision Medicine Initiative. Sex differences in Alzheimer disease - the gateway to precision medicine. Nat Rev Neurol. 2018 Aug;14(8):457-469. doi: 10.1038/s41582-018-0032-9.
**PMID:** 29985474
**Citation:** Beam CR, Kaneshiro C, Jang JY, Reynolds CA, Pedersen NL, Gatz M. Differences Between Women and Men in Incidence Rates of Dementia and Alzheimer's Disease. J Alzheimers Dis. 2018;64(4):1077-1083. doi: 10.3233/JAD-180141.
**PMID:** 30010124
#### See Also Links
**Label:** Brain Blood Flow Responses During Exercise - Older Cohort
**URL:** https://clinicaltrials.gov/study/NCT05864950
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446609
**Brief Title:** Drug-induced Liver Injury: Itching Study
**Official Title:** Understanding the Natural History and Impact of Itching (Pruritus) in Patients With Drug-induced Liver Injury (DILI)
#### Organization Study ID Info
**ID:** 23056
#### Organization
**Class:** OTHER
**Full Name:** University of Nottingham
### Status Module
#### Completion Date
**Date:** 2028-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-14
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Ipsen
**Class:** OTHER_GOV
**Name:** National Institute for Health Research, United Kingdom
**Class:** OTHER
**Name:** Nottingham University Hospitals NHS Trust
**Class:** UNKNOWN
**Name:** NIHR Nottingham Biomedical Research Centre
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Nottingham
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Idiosyncratic drug-induced liver injury (DILI) is an unpredictable adverse hepatic reaction to a medication used in its therapeutic dose. DILI is the second most common cause of itching in adult Hepatology after biliary obstruction. In particular cholestatic or mixed pattern types of DILI (in which bile flow from the liver is impaired) are associated with long-lasting effects as well as reduced quality of life. There is therefore an urgent need to determine the incidence and natural history of itching in DILI and establish a network of centres that will form a basis for a clinical trial to investigate a novel intervention to treat these.
**Detailed Description:** In Idiosyncratic drug-induced liver injury (DILI), the adverse effect is unexpected from the known pharmacological action of the agent. The incidence of DILI is estimated as between 14-19 per 100,000 inhabitants; a population-based study in Europe reported the annual incidence as 19.1 per 100,000. Despite its rarity, idiosyncratic DILI accounts for 7-15% of the cases of acute liver failure in Europe, although many cases resolve quickly. DILI is the most frequent reason for the market withdrawal of an approved drug. In addition, DILI occurs in association with many drugs and shows heterogeneity. There are no markers that can effectively pre-empt and prevent DILI or monitor the severity and course of the adverse event. It is also emerging that immunotherapy regimens devised for cancer treatment are associated with increased risk of DILI development.
Further characterisation and understanding of this is urgently needed to distinguish from other causes and develop more effective treatments. Age, smoking, metabolic syndrome, co-morbidity and other yet unidentified factors may generate an environment of oxidative stress that contributes to DILI. Therefore, 'in-depth phenotyping' is needed to develop a refined understanding of drug-related factors, host genetic and environmental risk factors linked to disease characteristics that would enable us to pre-empt and treat DILI. Further work is also needed to identify patients who may benefit from new treatments becoming available, so identification and analysis of certain sub-groups is of value.
Based on the pattern of liver biochemistry at the time of initial presentation, DILI is classified as cholestatic, hepatocellular or mixed type. Pruritus (itching) occurs in a proportion of patients with cholestatic and mixed pattern of DILI. Most DILI manifestations resolve within 3 months following the prompt withdrawal of the causative medication, but symptoms persist for 6 months in 18.8% and for 1 year in 12.4%; persistence of symptoms are more common in cholestatic pattern of DILI. Those with persistent DILI have significantly lower SF-36 quality of life scores at baseline and during follow-up.
Research is needed to identify patients who may benefit from new treatments becoming available, so identification and analysis of certain sub-groups is of value. DILI is the second most common cause of itching in adult Hepatology, after biliary obstruction. Cholestatic or mixed pattern of DILI is associated with chronicity as well as reduced quality of life.
There is currently limited data available on the incidence and impact of pruritus in DILI. Although therapeutics targeting bile acid pathways have been deployed to tackle cholestatic pruritus in primary biliary cholangitis (PBC), their application in cholestatic DILI requires investigation. Further, there is now also effective treatment that have been licensed to improve quality of life of patients with itching as well as potentially improving natural history of cholestatic conditions.
### Conditions Module
**Conditions:**
- Drug Induced Liver Injury
- Pruritus
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** To determine the number of participants who have diagnosis of DILI who report pruritus (itching) compared to the number with other acute non-DILI conditions (e.g. autoimmune hepatitis/viral hepatitis) who report itching within a cohort of patients presenting with acute liver injury.
**Measure:** Incidence of pruritus (itching) in patients with DILI
**Time Frame:** 2 years
#### Secondary Outcomes
**Description:** To determine the duration and re-occurrence of pruritus (itching) symptoms in patients who are diagnosed with DILI and in those with other acute non-DILI conditions. This will entail a repeated questionnaire at study visits and assessment of medical records to report a timescale of symptoms (weeks).
**Measure:** Duration of itching (pruritus) in patients who present with acute liver injury
**Time Frame:** 4 years
**Description:** To determine the severity of pruritus (itching) symptoms in patients who are diagnosed with DILI and in those with other acute non-DILI conditions. This will entail a repeated questionnaire at study visits to establish the level of itching.
**Measure:** Severity of itching (pruritus) in patients who present with acute liver injury
**Time Frame:** 4 years
**Description:** To determine whether any genetic variants of a 77 gene liver cholestasis panel (including causal variants of progressive familial intrahepatic cholestasis (PFIC)) are associated with pruritus in acute liver injury patients. We will report presence or absence of genetic markers
**Measure:** Genetic variants associated with itching (pruritus) in patients who present with acute liver injury
**Time Frame:** 2.5 years
**Description:** To determine the quality of life reported by patients who are diagnosed with DILI and in those with other acute non-DILI conditions. This will entail a repeated SF-36 questionnaire at study visits.
**Measure:** Quality of Life reported by patients who present with acute liver injury
**Time Frame:** 4 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥18 (no upper age limit) and able to give informed written consent
* Exposure to potential causal agent and diagnosed with suspected acute DILI defined as meeting one of the following analytical thresholds at enrolment (visit 1):
* alanine transaminase (ALT) ≥5 times upper limit of normal (ULN) or
* alkaline phosphatase ≥2 times ULN or
* ALT ≥3 times ULN plus total bilirubin \>2 times ULN
Results from clinical test samples collected within 36h of visit will be acceptable (as DILI is an acute event, patients are expected to recover or deteriorate quickly so enrolment aligned with diagnostic tests is necessary).
Exclusion Criteria:
* Patients with comorbidities of eczema and urticaria associated with pruritus
* Patients with existing diagnosis of blood-borne viral hepatitis infection (Hepatitis B/C/E)
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients recruited are those who meet the criteria for DILI, as defined by Aithal et al. (2011) and endorsed by the EASL DILI Guidelines.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Elinor Study Coordinator
**Phone:** 0115 7484390
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nottingham
**Contacts:**
***Contact 1:***
- **Name:** Sophie Cusick
- **Role:** CONTACT
**Country:** United Kingdom
**Facility:** Nottingham University Hospitals NHS Trust
**Status:** RECRUITING
### References Module
#### References
**Citation:** Aithal GP, Watkins PB, Andrade RJ, Larrey D, Molokhia M, Takikawa H, Hunt CM, Wilke RA, Avigan M, Kaplowitz N, Bjornsson E, Daly AK. Case definition and phenotype standardization in drug-induced liver injury. Clin Pharmacol Ther. 2011 Jun;89(6):806-15. doi: 10.1038/clpt.2011.58. Epub 2011 May 4.
**PMID:** 21544079
**Citation:** Andrade RJ, Chalasani N, Bjornsson ES, Suzuki A, Kullak-Ublick GA, Watkins PB, Devarbhavi H, Merz M, Lucena MI, Kaplowitz N, Aithal GP. Drug-induced liver injury. Nat Rev Dis Primers. 2019 Aug 22;5(1):58. doi: 10.1038/s41572-019-0105-0.
**PMID:** 31439850
**Citation:** Bjornsson ES, Bergmann OM, Bjornsson HK, Kvaran RB, Olafsson S. Incidence, presentation, and outcomes in patients with drug-induced liver injury in the general population of Iceland. Gastroenterology. 2013 Jun;144(7):1419-25, 1425.e1-3; quiz e19-20. doi: 10.1053/j.gastro.2013.02.006. Epub 2013 Feb 16.
**PMID:** 23419359
**Citation:** Bjornsson ES, Stephens C, Atallah E, Robles-Diaz M, Alvarez-Alvarez I, Gerbes A, Weber S, Stirnimann G, Kullak-Ublick G, Cortez-Pinto H, Grove JI, Lucena MI, Andrade RJ, Aithal GP. A new framework for advancing in drug-induced liver injury research. The Prospective European DILI Registry. Liver Int. 2023 Jan;43(1):115-126. doi: 10.1111/liv.15378. Epub 2022 Aug 15.
**PMID:** 35899490
**Citation:** Chen HL, Li HY, Wu JF, Wu SH, Chen HL, Yang YH, Hsu YH, Liou BY, Chang MH, Ni YH. Panel-Based Next-Generation Sequencing for the Diagnosis of Cholestatic Genetic Liver Diseases: Clinical Utility and Challenges. J Pediatr. 2019 Feb;205:153-159.e6. doi: 10.1016/j.jpeds.2018.09.028. Epub 2018 Oct 23.
**PMID:** 30366773
**Citation:** European Association for the Study of the Liver. Electronic address: [email protected]; Clinical Practice Guideline Panel: Chair:; Panel members; EASL Governing Board representative:. EASL Clinical Practice Guidelines: Drug-induced liver injury. J Hepatol. 2019 Jun;70(6):1222-1261. doi: 10.1016/j.jhep.2019.02.014. Epub 2019 Mar 27.
**PMID:** 30926241
**Citation:** Fontana RJ, Hayashi PH, Barnhart H, Kleiner DE, Reddy KR, Chalasani N, Lee WM, Stolz A, Phillips T, Serrano J, Watkins PB; DILIN Investigators. Persistent liver biochemistry abnormalities are more common in older patients and those with cholestatic drug induced liver injury. Am J Gastroenterol. 2015 Oct;110(10):1450-9. doi: 10.1038/ajg.2015.283. Epub 2015 Sep 8.
**PMID:** 26346867
#### See Also Links
**Label:** odevixibat description
**URL:** https://www.ema.europa.eu/en/documents/product-information/bylvay-epar-product-information_en.pdf
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012871
- Term: Skin Diseases
- ID: D000012877
- Term: Skin Manifestations
- ID: D000008107
- Term: Liver Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000064420
- Term: Drug-Related Side Effects and Adverse Reactions
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000011041
- Term: Poisoning
### 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
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M14396
- Name: Pruritus
- Relevance: HIGH
- As Found: Pruritus
- ID: M28486
- Name: Chemical and Drug Induced Liver Injury
- Relevance: HIGH
- As Found: Drug-induced Liver Injury
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Injury
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15680
- Name: Skin Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M30303
- Name: Drug-Related Side Effects and Adverse Reactions
- Relevance: LOW
- As Found: Unknown
- ID: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M13931
- Name: Poisoning
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000056486
- Term: Chemical and Drug Induced Liver Injury
- ID: D000011537
- Term: Pruritus
- ID: D000014947
- Term: Wounds and Injuries
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446596
**Brief Title:** TRAK vs Standard Home-based Exercise in Low Back Pain
**Official Title:** Effect of the Implementation of the TRAK Application Compared to the Standard Use of Exercise Dossier and Intervention Diary in a Home Therapeutic Exercise Intervention in Patients With Low Back Pain
#### Organization Study ID Info
**ID:** TRAK_Low_back_pain
#### Organization
**Class:** OTHER
**Full Name:** University of Valencia
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**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:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Valencia
#### Responsible Party
**Investigator Affiliation:** University of Valencia
**Investigator Full Name:** Rodrigo Martín-San-Agustin
**Investigator Title:** Assistant Professor of Physiotherapy
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The objective of the study is to compare the effect of a home therapeutic exercise intervention scheduled through the application of digital physiotherapy and telerehabilitation TRAK, versus a home therapeutic exercise program scheduled through a dossier and an exercise diary, with respect to disability (measured using the OSWESTRY questionnaire) and other variables (range of motion, strength, fatigue, histological changes, pain, medication intake, psychosocial factors and adherence), in patients with low back pain.
**Detailed Description:** The objective of the study is to compare the effect of a home therapeutic exercise intervention scheduled through the application of digital physiotherapy and telerehabilitation TRAK, versus a home therapeutic exercise program scheduled through a dossier and an exercise diary, with respect to disability (measured using the OSWESTRY questionnaire) and other variables (range of motion, strength, fatigue, histological changes, pain, medication intake, psychosocial factors and adherence), in patients with low back pain.
This randomized controlled trial has a parallel design, with two groups. Both groups will complete an 8-week home exercise program that includes flexibility and strength exercises. The program will be carried out with a frequency of 3 weekly sessions, preferably on alternate days. In the case of the experimental group, the program will be carried out with the support of the TRAK computer tool (https://www.trakphysio.com/es/), which allows the exercises to be carried out in front of a camera that, with the help of an artificial intelligence system, offers feedback to the participant and allows investigators/clinicians to keep a record of the sessions. In the case of the control group, the program will be carried out with the support of an information dossier of the exercises to be performed and a monitoring diary in which everything related to the sessions carried out will be noted. In both groups, as an addition to the home sessions, two face-to-face sessions will be held in the first and fifth weeks, respectively.
The exercise program includes flexibility and strength exercises, each made up of three levels of difficulty (easy, intermediate and difficult), with patients advancing to subsequent levels once each level is successfully overcome.
### Conditions Module
**Conditions:**
- Low Back Pain
**Keywords:**
- low back pain
- exercise
- telerehabilitation
### 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:** Home therapeutic exercise intervention scheduled through the software of digital physiotherapy and telerehabilitation TRAK
**Intervention Names:**
- Other: Exercise supported by the digital physiotherapy and telerehabilitation software TRAK
**Label:** Exercise supported by the digital physiotherapy and telerehabilitation software TRAK
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Home therapeutic exercise program scheduled through a dossier and an exercise diary
**Intervention Names:**
- Other: Standard home-based exercise
**Label:** Standard home-based exercise
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Exercise supported by the digital physiotherapy and telerehabilitation software TRAK
**Description:** 8 week home therapeutic exercise program that includes flexibility and strength exercises scheduled through the software of digital physiotherapy and telerehabilitation TRAK. The program will be carried out with a frequency of 3 weekly sessions, preferably on alternate days. The program will be carried out with the support of the TRAK software (https://www.trakphysio.com/es/), which allows the exercises to be carried out in front of a camera that, with the help of an artificial intelligence system, offers feedback to the participant and allows you to keep a record of the sessions. As an addition to the home sessions, two face-to-face sessions will be held in the first and fifth weeks, respectively. The exercise program includes three levels of difficulty (easy, intermediate and difficult), with patients advancing to subsequent levels once each level is successfully overcome.
**Name:** Exercise supported by the digital physiotherapy and telerehabilitation software TRAK
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Standard home-based exercise
**Description:** 8 week home therapeutic exercise program that includes flexibility and strength exercises scheduled through a dossier and an exercise diary. The program will be carried out with a frequency of 3 weekly sessions, preferably on alternate days. The program will be carried out with the support of an information dossier of the exercises to be performed and a monitoring diary in which everything related to the sessions carried out will be noted.. As an addition to the home sessions, two face-to-face sessions will be held in the first and fifth weeks, respectively. The exercise program includes three levels of difficulty (easy, intermediate and difficult), with patients advancing to subsequent levels once each level is successfully overcome.
**Name:** Standard home-based exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Disability measured using the Oswestry Disability Index
**Measure:** Disability
**Time Frame:** 8 weeks measurement (post intervention)
#### Secondary Outcomes
**Description:** Disability measured using the Oswestry Disability Index
**Measure:** Disability
**Time Frame:** Baseline; 32 weeks measurement (24 weeks post intervention)
**Description:** Range of movement measured using the modified Schober score
**Measure:** Range of movement (Schober score)
**Time Frame:** Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
**Description:** Range of movement measured using the Finger floor distance test
**Measure:** Range of movement (Finger floor distance test)
**Time Frame:** Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
**Description:** Extensor low back muscle strength measured using the Biering-Sorensen test
**Measure:** Extensor low back muscle strength
**Time Frame:** Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
**Description:** Muscle thickness (low back extensor muscles) measured using ultrasonography
**Measure:** Muscle thickness (low back extensor muscles)
**Time Frame:** Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
**Description:** Muscle thickness (transversus abdominis) measured using ultrasonography
**Measure:** Muscle thickness (transversus abdominis)
**Time Frame:** Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
**Description:** Mean pain during last week measured with a numerical pain rating scale
**Measure:** Low Back Pain
**Time Frame:** Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
**Description:** Medication intake registered using a diary
**Measure:** Medication intake
**Time Frame:** Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
**Description:** Kinesiofobia measured using the Tampa Scale of Kinesiofobia
**Measure:** Kinesiofobia
**Time Frame:** Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
**Description:** Depression measured using the Beck Depression Inventory
**Measure:** Depression
**Time Frame:** Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
**Description:** Fear Avoidance Beliefs measured using the Fear Avoidance Belief Questionnaire
**Measure:** Fear Avoidance Beliefs
**Time Frame:** Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
**Description:** Fear Avoidance Beliefs measured using the Fear Avoidance Components Scale
**Measure:** Fear Avoidance Components
**Time Frame:** Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
**Description:** Adherence measured using the TRAK application and an exercise diary
**Measure:** Adherence
**Time Frame:** Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Nonspecific subacute or chronic low back pain
Exclusion Criteria:
* Neuropathic pain
* Pain below the knees
* Pain in legs with tingling, sensation of current or sensory alterations
* Positive neurological tests. Lack of strength, sensitivity or altered reflexes
* Canal stenosis
* Nociplastic pain (fibromyalgia, generalized pain, emotional lability, affective and cognitive implications)
* Previous lumbar surgery
* Specific pathology (rheumatic, spondylolisthesis, oncological, fractures...)
* Pregnancy
* Performing medium-high intensity exercise of more than 100 minutes a week
* Pathology that prevents exercise (decompensated cardiac pathology, decompensated respiratory pathology, significant mobility difficulties...)
* Lack of digital skills
* Visual problems that prevent exercise with the phone screen
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rodrigo Martín-San Agustín, PhD
**Phone:** +34 963 983 853
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Valencia
**Name:** Rodrigo Martín-San Agustín, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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: M4714
- Name: Back Pain
- Relevance: HIGH
- As Found: Back Pain
- ID: M19433
- Name: Low Back Pain
- Relevance: HIGH
- As Found: Low Back 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: D000001416
- Term: Back Pain
- ID: D000017116
- Term: Low Back Pain
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446583
**Brief Title:** Preoperative Chewing Gum and Postoperative Nausea and Vomiting
**Official Title:** Study on the Impact of Preoperative Chewing Gum on Postoperative Nausea and Vomiting in Robotic Surgery
#### Organization Study ID Info
**ID:** KC24EISI0138
#### Organization
**Class:** OTHER
**Full Name:** Seoul St. Mary's Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**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:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Min Suk Chae
#### Responsible Party
**Investigator Affiliation:** Seoul St. Mary's Hospital
**Investigator Full Name:** Min Suk Chae
**Investigator Title:** Associate professor. CHAE, Min Suk
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** General anesthesia for surgery can often lead to postoperative nausea and vomiting (PONV). Additionally, decreased or paralyzed bowel movements are among the most common complications following abdominal surgery, causing pain, abdominal distension, nausea, and vomiting, which can delay patient recovery and extend hospital stays. Therefore, meticulous perioperative management is crucial.
In recent years, efforts have been made to reduce the burden of surgery, decrease postoperative complications, and promote rapid rehabilitation for a quicker return to daily life. These efforts also aim to reduce healthcare costs by shortening hospital stays and optimizing resources. Various interventions, such as early feeding, early removal of nasogastric tubes, and physical therapy, have been trialed in clinical settings to prevent prolonged bowel inactivity and paralysis. However, due to limited clinical efficacy, these methods are not routinely used.
Recently, many researchers have reported the benefits of chewing gum in enhancing bowel motility and reducing PONV. However, there is limited research on the impact of chewing gum on PONV in robotic surgeries, which are considered less invasive compared to open or laparoscopic surgeries. Furthermore, there is particularly scarce research on the effects of preoperative gum chewing.
### Conditions Module
**Conditions:**
- Gynecologic Disease
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 92
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Upon arrival at the preoperative preparation room, patients begin chewing sugar-free gum provided by the preoperative nurse. They continue chewing until they enter the operating room (for at least 15 minutes). Before entering the operating room, it is confirmed that the gum has been discarded.
**Intervention Names:**
- Other: Chewing sugar-free gum
**Label:** Preoperative chewing gum group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** After arriving at the preoperative preparation room, patients wait without chewing gum until they enter the operating room.
**Label:** No preoperative chewing gum group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Preoperative chewing gum group
**Description:** Upon arrival at the preoperative preparation room, patients begin chewing sugar-free gum provided by the preoperative nurse. They continue chewing until they enter the operating room (for at least 15 minutes). Before entering the operating room, it is confirmed that the gum has been discarded.
**Name:** Chewing sugar-free gum
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Incidence of nausea and vomiting in the post-anesthesia care unit
**Measure:** nausea and vomiting
**Time Frame:** One hour after surgery, referring to the period spent in the post-anesthesia care unit
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Adult patients aged 19 to under 70 years
2. Scheduled elective robotic surgery
3. American Society of Anesthesiologists (ASA) Physical Status Classification I or II
Exclusion Criteria:
1. Cases where robotic surgery was planned but suddenly converted to another type of surgery
2. Patients with a history of dental damage, dentures, loose or capped teeth, or other unstable dental conditions
3. Patients with a history of temporomandibular joint (TMJ) damage or surgery
4. Head and neck surgeries
5. Emergency surgeries
6. Refusal to participate in the study
**Maximum Age:** 70 Years
**Minimum Age:** 19 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Min Suk Chae, MD, PhD
**Phone:** 0222586150
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009325
- Term: Nausea
- ID: D000012817
- Term: Signs and Symptoms, Digestive
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000091662
- Term: Genital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: HIGH
- As Found: Gynecologic Disease
- ID: M17582
- Name: Vomiting
- Relevance: HIGH
- As Found: Vomiting
- ID: M22074
- Name: Postoperative Nausea and Vomiting
- Relevance: HIGH
- As Found: Postoperative Nausea and Vomiting
- ID: M12273
- Name: Nausea
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005831
- Term: Genital Diseases, Female
- ID: D000014839
- Term: Vomiting
- ID: D000020250
- Term: Postoperative Nausea and Vomiting
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446570
**Brief Title:** Phase II Study of Durvalumab(MEDI4736) + Tremelimumab in Pulmonary Sarcomatoid Carcinoma
**Official Title:** Phase II Study of Durvalumab +/- Tremelimumab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
#### Organization Study ID Info
**ID:** ESR-16-12012
#### Organization
**Class:** OTHER
**Full Name:** Seoul National University Hospital
### Status Module
#### Completion Date
**Date:** 2021-06-03
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2019-02-22
**Type:** ACTUAL
#### Start Date
**Date:** 2017-09-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Korean Cancer Study Group
#### Lead Sponsor
**Class:** OTHER
**Name:** Seoul National University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Phase II study of Durvalumab+/- Tremelimumab in patients with recurred metastatic head and neck squamous cell carcinoma
**Detailed Description:** Open, multicenter, single arm, phase II, biomarker driven umbrella trial for head and neck squamous cell carcinoma
### Conditions Module
**Conditions:**
- HNSCC
- Head and Neck Neoplasms
**Keywords:**
- biomarker driven umbrella trial
- Durvalumab + Tremelimumab Combination Treatment
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 18
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Durvalumab is a human immunoglobulin (Ig) G1 kappa (IgG1κ) monoclonal antibody (mAb) that blocks the interaction of PD-L1 with PD-1 on T-cells and CD80 on immune cells and is engineered to reduce antibody-dependent cell-mediated cytotoxicity.(IV class)
Tremelimumab is specific for human CTLA-4; cluster of differentiation a cell surface receptor that is expressed primarily on activated T cells and acts to inhibit their activation.(IV class)
**Intervention Names:**
- Drug: Durvalumab,Tremelimumab
**Label:** Durvalumab, tremelimumab
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Durvalumab, tremelimumab
**Description:** Durvalumab: 1.5g Q4W plusTremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.
**Name:** Durvalumab,Tremelimumab
**Other Names:**
- Experimental group
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** RECIST1.1
**Measure:** Response rate (RR)
**Time Frame:** 24months
#### Secondary Outcomes
**Description:** Disease progression is assessed by RECIST 1.1.
**Measure:** •Progression-Free Survival (PFS)
**Time Frame:** 24months
**Description:** Overall Survival is defined as the time from first dose to death due to any cause. Through the follow-up within 30 days after study completion or termination of the last subject, death and date of death will be checked for subject alive during treatment period
**Measure:** •Overall Survival (OS)
**Time Frame:** 24months
**Description:** number of patients with treatment-related AE as assessed by NCI CTCAE version 4.03
**Measure:** •Toxicity
**Time Frame:** 24months
**Description:** NGS, nanostring technology
**Measure:** •biomarker
**Time Frame:** 24months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. Recurrent or metastatic HNSCC, regardless of PD-L1 or HPV status 2. Age ≥20 3. ECOG PS 0-1 4. Ineligibility for local therapy (surgery or radiotherapy) 5. Prior palliative chemotherapy including platinum-based chemotherapy. When recurred within 6 months of definitive/neoadjuvant/adjuvant chemo- or chemoradiation, the chemotherapy is considered a line of therapy 6. At least one measurable lesion by RECIST ver 1.1 7. Adequate organ function for treatment
* Absolute neutrophil count (ANC) ≥1000 cells/mm3
* Hemoglobin: ≥ 9.0 g/dL
* Platelets ≥100,000 cells/mm3
* Estimated creatinine clearance ≥40 mL/min, or serum creatinine \<1.5 x institution upper limit of normal
* Bilirubin ≤1.5 x upper limit of normal (ULN)
* AST (SGOT) ≤2.5 x ULN (5.0 x ULN if hepatic metastases)
* ALT (SGPT) ≤2.5 x ULN (5.0 x ULN if hepatic metastases) 8. 12-Lead electrocardiogram (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention 9. The patient has provided signed informed consent
Exclusion Criteria:
* 1. Previous treatment with PD-1 or PDL-1 inhibitors 2. Nasopharyngeal carcinoma 3. Cytotoxic chemotherapy within 3 weeks of study entry; immunotherapy or investigational drug within 5 half-lives of study entry 4. Any major operation or irradiation within 4 weeks of baseline disease assessment. Palliative radiation is allowed 5. Symptomatic brain metastasis 6. Patients with known interstitial lung disease 7. Patients with uncontrolled or significant cardiovascular disease 8. Previous or concurrent malignancy (except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, thyroid cancer treated curatively) without evidence of recurrence for at least 3 years prior to study entry.
9. Pregnant or breast-feeding women 10. Systemic immunosuppressive therapy 11. Active autoimmune disease 12. Patient who have an active systemic fungal and/or known viral infection (for example, human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies) (inactive HBV carrier with adequate prophylactic antiviral agent can be enrolled) 13. Body weight \<30kg
14. Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Seoul
**Country:** Korea, Republic of
**Facility:** Seoul National University Hospital
**Zip:** 110-744
#### Overall Officials
**Official 1:**
**Affiliation:** Seoul National University Hospital
**Name:** Bhumsuk Keam
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** anticipated as research paper
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009369
- Term: Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M5550
- Name: Carcinoma, Squamous Cell
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: HIGH
- As Found: Head and Neck Neoplasms
### Condition Browse Module - Meshes
- ID: D000006258
- Term: Head and Neck Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000970
- Term: Antineoplastic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: LOW
- As Found: Unknown
- ID: M272500
- Name: Durvalumab
- Relevance: HIGH
- As Found: Docetaxel
- ID: M288326
- Name: Tremelimumab
- Relevance: HIGH
- As Found: Liver Disease
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M19117
- Name: Immunoglobulins, Intravenous
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000613593
- Term: Durvalumab
- ID: C000520704
- Term: Tremelimumab
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446557
**Acronym:** DIAMOND
**Brief Title:** De-scalation or swItch of Treatment According to Circulating tuMOr DNA Variation After 2 Cycles of Doublet Chemotherapy Plus Targeted Agent in Metastatic Unresectable Colorectal Cancer
**Official Title:** De-scalation or swItch of Treatment According to Circulating tuMOr DNA Variation After 2 Cycles of Doublet Chemotherapy Plus Targeted Agent in Metastatic Unresectable Colorectal Cancer (DIAMOND Study): A Randomized Phase III of PRODIGE Intergroup
#### Organization Study ID Info
**ID:** 2022/0343/HP
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Rouen
### Status Module
#### Completion Date
**Date:** 2031-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2031-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2025-01-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-02
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-02-26
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Rouen
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Background : In unresectable mCRC, a de-escalation strategy using maintenance or chemotherapy (CT) discontinuation in selected cases is considered as a valid option in non-progressive patients after a first-line induction of doublet CT + targeted agent (TA) (1-7).
In this context, circulating tumor DNA (ctDNA) is considered very promising to optimize decision making. Indeed, ctDNA harbour the same main alterations of the tumor and has been recognized as biologically relevant to reflect tumor dynamics and therapeutic efficacy (8).
As we and other groups reported in mCRC, that early variation of ctDNA during CT may be relevant to predict outcome (9-11). Indeed, patients with a ctDNA decrease from the first (C1) to the third (C3) cycles of CT (∆≥80% or ctDNA\<0.1 ng/ml at C3) or without ctDNA detectable at C1 and C3 have significant better survival as compared to patients with less decrease or with ctDNA increase (10). ctDNA monitoring had never been prospectively evaluated to guide early adaptation in the treatment strategy in mCRC.
Aim: A randomized phase III, open label, strategy trial of the superiority in overall survival (OS) adjusted on quality of life of an early treatment adaptation guided by ctDNA variation versus a standard management in unresectable left-side, MSS-BRAFV600E non-mutated mCRC treated by first-line doublet CT + TA.
Patients and methods :
-Main inclusion criteria will be (i) unresectable left-side and non-pre-treated mCRC (ii) MSS and non-mutated BRAFV600E tumor (iii) at least one measurable lesion (iv) ECOG 0-1 and adequate biological functions for first-line doublet CT + TA (antiEGFR if RAS WT, bevacizumab (BV) if RAS MUT).
Randomization (1:1) between an experimental strategy guided by ctDNA variation with de-escalation (Arm A1 or A2) or switch of treatment (Arm A3) versus standard strategy (Arm B). The analysis of variation of ctDNA from C1-C3 will be centralized and detected using Digital PCR targeting hypermethylation of WIF1/NPY genes (10) in real-time in arm A and in second step in arm B.
Randomization in Arm A: after 4 cycles of doublet + TA, non-progressive patients will be allocated to a strategy according to ctDNA value and variation from C1-C3:
Arm A1: CT discontinuation (ctDNA normalization \< 0.1 ng/ml or ctDNA not detectable) Arm A2 : maintenance with fluoropyrimidine + TA (ctDNA ≥ 0.1 ng/ml and ∆ctDNA≥ 80%).
Arm A3 : ctDNA non-responders (∆ctDNA \< 80% or increase) : switch of CT +/- TA.
Randomisation in Arm B: at least 8 cycles of doublet CT + TA before adaptation of sequence at physician choice.
Statistical considerations : with an expected median OS at 32 months (mean 37.6 months), a mean QoL at 70.0% in first-line mCRC, corresponding to 0.700 x 37.6 = 26.3 QALM or 2.19 QALY (SD 1.18 QALY), 408 patients are required (randomization 1:1) to show a gain of 4 months of quality-adjusted OS (4 QALM or 0.33 QALY) in experimental ctDNA strategy versus standard strategy (5% two-sided type I error rate, 81% power and 1.18 QALY SD).
The secondary objectives will be:
* To compare strategies (standard vs ctDNA guided) overall and in the subgroups of ctDNA response on 18, 24 and 36-months restricted mean of QoL-adjusted OS, OS, PFS, response rate, toxicity, Quality of Life and cost utility.
* Bio-collection for further ctDNA analysis. Only cost of samples collection and their transportation to the resource center is requested. Further ancillary analysis will be subject to independent funding requests to evaluate :
* ctDNA kinetics during the induction and its impact on outcome in overall population and in each arm
* ctDNA changes between time points during de-escalation arms to determine thresholds of variations predictive of clinical and/or radiological progression.
Conclusion: DIAMOND is a randomized phase III strategy trial to show the superiority in OS adjusted on quality of life of an early treatment adaptation guided by ctDNA versus a standard management in unresectable left-side, MSS-BRAFV600E non-mutated mCRC treated by first-line doublet CT + TA.
### Conditions Module
**Conditions:**
- Metastatic Colon Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 408
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** After 4 cycles of doublet + TA, non-progressive patients will be allocated to a strategy according to ctDNA value and variation from C1-C3
**Intervention Names:**
- Drug: treatment adaptation guided by ctDNA variation
**Label:** Arm A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** At least 8 cycles of doublet CT + TA before adaptation of sequence at physician choice.
**Intervention Names:**
- Drug: standard management
**Label:** Arm B
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Arm A
**Description:** after 4 cycles of doublet + TA, non-progressive patients will be allocated to a strategy according to ctDNA value and variation from C1-C3: Arm A1: CT discontinuation (ctDNA normalization \< 0.1 ng/ml or ctDNA not detectable) Arm A2 : maintenance with fluoropyrimidine + TA (ctDNA ≥ 0.1 ng/ml and ∆ctDNA≥ 80%).
Arm A3 : ctDNA non-responders (∆ctDNA \< 80% or increase) : switch of CT +/- TA.
**Name:** treatment adaptation guided by ctDNA variation
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Arm B
**Description:** At least 8 cycles of doublet CT + TA before adaptation of sequence at physician choice.
**Name:** standard management
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The primary endpoint is the superiority in overall survival (OS) adjusted on quality-adjusted life years (QALYs) for the experimental arm guided by ctDNA (Arm A1 + A2 + A3) as compared to the standard management (Arm B).
The follow-up will start from the date of randomization. Patients alive at last follow-up will have an extrapolation of their QALY, based on the OS curve and the patient QoL at last follow-up.
**Measure:** Evaluate the superiority in quality-adjusted OS of an early treatment adaptation guided by ctDNA variation
**Time Frame:** through study completion, an average of 7 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Histologically proven diagnosis of RAS WT or mutant, MSS, BRAFV600E non-mutated colorectal cancer.
* Left side or rectal cancer
* An unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.
* At least one measurable lesion according to RECIST criteria version 1.1.
* Age ≥ 18 years.
* ECOG PS ≤ 1
* Neutrophils ≥ 1.5 x 10\^9/L, Platelets ≥ 100 x 10\^9/L, Hb \> 9 g/dl.
* Total bilirubin ≤ 1.5 time the upper-normal limits (UNL) and ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 x UNL, or 5 x UNL in case of liver metastases, alkaline phosphatase ≤ 2.5 x UNL, or 5 x UNL in case of liver metastases.
* Creatinine clearance \> 50 mL/min or serum creatinine ≤ 1.5 x UNL.
* The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis.
* Adequate coagulation function \[International Normalized Ratio (INR) ≤1.5 and Partial. Thromboplastin Time (PTT) or activated PTT (aPTT) ≤1.5 x ULN.
* Written informed consent.
Exclusion Criteria:
* Right side colon cancer
* First-line chemotherapy +/- biologic agents for mCRC before C1
* Radiotherapy to any site within 4 weeks before C1
* Adjuvant oxaliplatin-based treatment completed less than 6 months before relapse.
* Treatment with any investigational drug within 30 days prior to C1
* Known allergy to any of the study treatment components.
* Dihydropyrimidine dehydrogenase (DPD) deficiency.
* Documented and/or symptomatic brain or leptomeningeal metastases.
* Patient with active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator.
* Uncontrolled or poorly controlled hypertension despite standard medical management.
* Severe renal or hepatic failure
* Serious or non-healing wound, ulcer, or bone fracture within 28 days prior to C1
* Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ.
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start.
* Infection with the human immunodeficiency virus.
* Symptomatic peripheral neuropathy grade 1 according the NCI CTC.
* Acute or subacute bowel obstruction or history of chronic diarrhea, which is considered clinically significant in the opinion of the investigator.
* Chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted.
* Pregnant or lactating women.
* Patient with active psychiatric illness or social situation that would severely limit compliance with study requirements.
**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: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446544
**Acronym:** OLVEELV
**Brief Title:** Functional Residual Capacity and Alveolar Recruitment in Single-lung Ventilation: a Randomized Study
**Official Title:** Functional Residual Capacity and Alveolar Recruitment in Single-lung Ventilation: a Randomized Study
#### Organization Study ID Info
**ID:** 2021/0383/HP
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Rouen
### Status Module
#### Completion Date
**Date:** 2026-03-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-02
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-02-26
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Rouen
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In thoracic surgery, the incidence of postoperative pulmonary complications is higher than for other surgeries. Indeed, thoracic surgery has the specificity of being carried out with single-lung ventilation and is thus a source of intraoperative atelectasis which persists postoperatively and gives rise to pulmonary complications, particularly infectious ones. During one-lung ventilation, mediastinal and abdominal compression on the ventilated lung leads to a drop in functional residual capacity (FRC) which will in turn lead to collapse of the small airways leading to the formation of atelectasis.
Strategies exist to limit the appearance of atelectasis. One of the intraoperative strategies is alveolar recruitment. Alveolar recruitment is a dynamic process that can be defined by a transient increase in transpulmonary pressure beyond the critical opening pressure. Physiologically, alveolar recruitment corresponds to the re-aeration of poorly or non-aerated lung areas. In single-lung ventilation, intraoperative alveolar recruitment maneuvers are not performed systematically to prevent the formation of atelectasis.
The General Electric Carescape R860 ventilator allows intraoperative monitoring of end-expiratory closing lung volume (EFVP), which corresponds to the CRF associated with positive expiratory pressure (PEEP). This spirometry incorporated in the ventilator continuously monitors the intraoperative variation of VPFE, thus making it possible to detect any significant decrease which would favor the formation of intraoperative atelectasis. Early detection of VPFE can therefore allow the anesthetist-resuscitator to initiate intraoperative alveolar recruitment maneuvers adapted to the patient. Alveolar recruitment maneuvers are then personalized and based on precise monitoring of the evolution of the VPFE.
The effectiveness of recruitment maneuvers can be evaluated and quantified (with the Lung Ultrasound Score (LUS)) postoperatively using pleuropulmonary ultrasound. Thus, early ultrasound detection, from the post-interventional monitoring room (SSPI), would make it possible to undertake rapid therapeutic maneuvers to combat the atelectasis observed. A patient could benefit, for example, from prophylactic NIV from the recovery room, from a stricter postural program in a seated position, or from an earlier and/or more intensive respiratory rehabilitation program with the physiotherapy team.
**Detailed Description:** In thoracic surgery, the incidence of postoperative pulmonary complications is higher than for other surgeries. Indeed, thoracic surgery has the specificity of being carried out with single-lung ventilation and is thus a source of intraoperative atelectasis which persists postoperatively and gives rise to pulmonary complications, particularly infectious ones. During one-lung ventilation, mediastinal and abdominal compression on the ventilated lung leads to a drop in functional residual capacity (FRC) which will in turn lead to collapse of the small airways leading to the formation of atelectasis.
Strategies exist to limit the appearance of atelectasis. One of the intraoperative strategies is alveolar recruitment. Alveolar recruitment is a dynamic process that can be defined by a transient increase in transpulmonary pressure beyond the critical opening pressure. Physiologically, alveolar recruitment corresponds to the re-aeration of poorly or non-aerated lung areas. In single-lung ventilation, intraoperative alveolar recruitment maneuvers are not performed systematically to prevent the formation of atelectasis.
The General Electric Carescape R860 ventilator allows intraoperative monitoring of end-expiratory closing lung volume (EFVP), which corresponds to the CRF associated with positive expiratory pressure (PEEP). This spirometry incorporated in the ventilator continuously monitors the intraoperative variation of VPFE, thus making it possible to detect any significant decrease which would favor the formation of intraoperative atelectasis. Early detection of VPFE can therefore allow the anesthetist-resuscitator to initiate intraoperative alveolar recruitment maneuvers adapted to the patient. Alveolar recruitment maneuvers are then personalized and based on precise monitoring of the evolution of the VPFE.
The effectiveness of recruitment maneuvers can be evaluated and quantified (with the Lung Ultrasound Score (LUS)) postoperatively using pleuropulmonary ultrasound. Thus, early ultrasound detection, from the post-interventional monitoring room (SSPI), would make it possible to undertake rapid therapeutic maneuvers to combat the atelectasis observed. A patient could benefit, for example, from prophylactic NIV from the recovery room, from a stricter postural program in a seated position, or from an earlier and/or more intensive respiratory rehabilitation program with the physiotherapy team.
### Conditions Module
**Conditions:**
- Lung Injury
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 44
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** arm monitoring of the VPFE with intraoperative alveolar recruitment maneuvers
**Intervention Names:**
- Procedure: VPFE monitoring with intraoperative alveolar recruitment maneuvers.
**Label:** arm monitoring of the VPFE with intraoperative alveolar recruitment maneuvers
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** VPFE monitoring arm without intraoperative alveolar recruitment maneuvers.
**Intervention Names:**
- Procedure: VPFE monitoring with intraoperative alveolar recruitment maneuvers.
**Label:** VPFE monitoring arm without intraoperative alveolar recruitment maneuvers.
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- arm monitoring of the VPFE with intraoperative alveolar recruitment maneuvers
**Description:** VPFE monitoring with intraoperative alveolar recruitment maneuvers.
**Name:** VPFE monitoring with intraoperative alveolar recruitment maneuvers.
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- VPFE monitoring arm without intraoperative alveolar recruitment maneuvers.
**Description:** VPFE monitoring with intraoperative alveolar recruitment maneuvers.
**Name:** VPFE monitoring with intraoperative alveolar recruitment maneuvers.
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** The primary endpoint will be the value of the LUS (Lung Ultrasound Score) score on the ventilated lung at the time of lung ultrasound in SSPI, 30 minutes after extubation (presence of atelectasis with a LUS score \> or = 10/18).
**Measure:** Evaluate the effect of VPFE monitoring with intraoperative alveolar recruitment maneuvers compared to VPFE monitoring without intraoperative alveolar recruitment maneuvers on pulmonary aeration of the ventilated lung
**Time Frame:** 30 min post-extubation
### Eligibility Module
**Eligibility Criteria:** * Adult patient aged 18 to 75 years inclusive
* Patient requiring lobectomy or segmentectomy by video or robot-thoracoscopy
* Patient having read and understood the information letter and signed the consent form
* Patient affiliated to a social security system
* Women :
* Of childbearing age (defined by the CTFG as a fertile woman, after menarche and until menopause, except in cases of permanent sterility (including hysterectomy, bilateral salpingectomy or bilateral oophorectomy))
* using effective contraception according to the WHO (combined hormonal contraception (containing estrogens and progestins), progestin-only contraception, intrauterine device (IUD), male or female condoms) for at least 4 weeks before inclusion and during the study And,
* Presenting a negative urine pregnancy test at inclusion;
* Menopause: menopause according to the CTFG is defined as the absence of periods for 12 months without any other medical cause. An elevated follicle-stimulating hormone (FSH) level in the postmenopausal interval can be used to confirm a postmenopausal state in women who are not using hormonal contraception or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
Exclusion Criteria:
* Patients aged 76 and over
* COPD patients (Gold stage 3 or 4 of the 2023 Gold classification)
* Patients with a history of ischemic coronary artery disease
* Patients with a history of pulmonary emphysema bubbles on the ventilated lung
* Tracheostomized patient
* Obese patients (\>30 kg/m²)
* Patients with a history of pulmonary resection
* ASA patients ≥4
* Patient benefiting from a pre-operative rehabilitation protocol with physiotherapy
* Pregnant or parturient or breastfeeding woman or proven absence of contraception
* Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/under guardianship or curatorship
* History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or preventing them from giving informed consent
* Patient refusing to give consent.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** David Mallet
**Phone:** 02 32 88 82 65
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000013898
- Term: Thoracic Injuries
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M28143
- Name: Lung Injury
- Relevance: HIGH
- As Found: Lung Injury
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16657
- Name: Thoracic Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000055370
- Term: Lung Injury
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446531
**Acronym:** Pre-DM
**Brief Title:** Prevention of Progression of Prediabetes, Obesity and CV Risk
**Official Title:** Pioneering and Affordable Strategies to Prevent Progression of Prediabetes, Obesity and CV Risk in Hispanics
#### Organization Study ID Info
**ID:** STUDY00000485 Pre-DM
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Health Science Center at San Antonio
### Status Module
#### Completion Date
**Date:** 2027-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2027-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Baptist Health Foundation of San Antonio
#### Lead Sponsor
**Class:** OTHER
**Name:** The University of Texas Health Science Center at San Antonio
#### 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 investigators are studying how to help people with prediabetes (Pre-DM) and obesity. The goal is to use new and affordable treatments to bring blood sugar levels back to normal and help participants to lose weight. The investigators also want to reduce participants risk of heart problems. The study team will look at how these treatments affect metabolism and other body functions to help find new ways to treat diabetes and obesity in the future.
**Detailed Description:** While taking part in this study, participants will be asked to attend approximately 16 visits with the researchers or study staff.
Study participants are assigned (single-blinded, only the study team will know the assigned group) to one of 4 study groups, receiving a 6-month treatment with Nutritional Consultation + either SGLT2 Inhibitor (Empagliflozin), Rybelsus (GLP1 Receptor Agonist), Metformin + Pioglitazone, or placebo. A placebo is an inactive, harmless substance that looks like the other study drugs. This study does not require overnight stays at the hospital in any of the study groups.
Duration of the Study will be about 6-7 months.
### Conditions Module
**Conditions:**
- Pre-Diabetes
- Weight, Body
- Cardiovascular Diseases
**Keywords:**
- Affordable strategies
- Prevention of progression
- Hispanic
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Single-blind Randomized, placebo-controlled trial.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** This will be single blind study, given all treatment arms being pills, once subjects are randomized, they will not be told which mediation they are taking, and treatment will be dispensed in unmarked bottles at each timepoint.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 64
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Randomization will occur 1:1:1:1 to this placebo group
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
#### Arm Group 2
**Description:** Randomization will occur 1:1:1:1 to this SGLT2 inhibitor group
**Intervention Names:**
- Drug: Jardiance 25Mg Tablet
**Label:** SGLT2 inhibitor Group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Randomization will occur 1:1:1:1 to this GLP-1 receptor agonist group
**Intervention Names:**
- Drug: Rybelsus Tablet
**Label:** GLP-1 Receptor Agonist Group
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Randomization will occur 1:1:1:1 to this metformin plus SGLT2 inhibitor group
**Intervention Names:**
- Drug: Metformin
- Drug: Actos
**Label:** Metformin with SGLT2 Inhibitor Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Placebo
**Description:** Oral tablet administered once daily
**Name:** Placebo
**Other Names:**
- Zebbo
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- GLP-1 Receptor Agonist Group
**Description:** Oral tablet started at a 3mg dose once daily and increased to 7mg once daily or maximum tolerable dose.
**Name:** Rybelsus Tablet
**Other Names:**
- Semaglutide
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- SGLT2 inhibitor Group
**Description:** Oral 25 mg Sodium-Glucose Co-Transporter (SGLT2) inhibitor administered once daily
**Name:** Jardiance 25Mg Tablet
**Other Names:**
- Empagliflozin
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Metformin with SGLT2 Inhibitor Group
**Description:** Oral tablet started at a dose of 500mg with an increase of 500mg weekly up to a maximum dose of 2000mg (4 tablets)
**Name:** Metformin
**Other Names:**
- Metformin Hydrochloride
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- Metformin with SGLT2 Inhibitor Group
**Description:** Oral tablet dosed at 15mg once daily
**Name:** Actos
**Other Names:**
- Pioglitazone
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of glycated hemoglobin level in blood
**Measure:** Hemoglobin A1c Level (HBA1c)
**Time Frame:** Baseline and 6 months
#### Secondary Outcomes
**Description:** Measure of body fat based on height and weight that applies to adult men and women
**Measure:** Body Mass Index (BMI)
**Time Frame:** Baseline and 6 months
**Description:** Measurement of body fat using a DEXA scan
**Measure:** Percentage of Body Fat Composition
**Time Frame:** Baseline and 6 months
**Description:** Cardiac function is measured by left-ventricular function measured using cardiac MRI and expressed as a percentage
**Measure:** Left Ventricular Function
**Time Frame:** Baseline and 6 months
**Description:** A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS
**Measure:** Measure of phosphocreatine k-value
**Time Frame:** Baseline and 6 months
**Description:** A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS
**Measure:** Measure of oxidative capacity
**Time Frame:** Baseline and 6 months
**Description:** A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS
**Measure:** Measure of intramyocellular lipids (IMCL)
**Time Frame:** Baseline and 6 months
**Description:** A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS
**Measure:** Measure of extramyocellular lipids (EMCL)
**Time Frame:** Baseline and 6 months
**Description:** A survey used to assess physical function. Subjects will rank 20 questions from a scale of 1 - 5, with 5 being the highest physical function and 1 being the lowest. The score will be added up, and the Raw score will be converted to T-Score using the PROMIS Adult v2.0 Physical Function 20a Short Form Conversion Table. The range of T-scores is 12.1-62.5. A higher score indicates higher physical function.
**Measure:** Patient Reported Outcomes (PROMIS)
**Time Frame:** Baseline and 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients will have an established diagnosis of pre-Diabetes Mellitus (DM) before the screening visit, documented by an acceptable modality in the last 6 months.
2. Age ≥ 18 years old
3. Body Mass Index (BMI)=25-40 kg/m2
4. Glycated Hemoglobin (HbA1c) = 5.7-6.4%
5. Blood Pressure (BP) \<160/100
6. Estimated Glomerular Filtration Rate (eGFR) ≥30 ml/min•1.73m2
7. Body weight must be stable (±5 pounds) over the last 3 months.
8. Oral diuretics, if prescribed to the patient according to local guidelines and discretion of the investigator, should be stable for at least 1 week prior to randomization.
9. Hispanic ethic group
10. Willing to adhere to medication regimen for up to 6 months.
11. Male or female, if female, met these criteria:
1. Not pregnant or breast-feeding
2. Negative pregnancy test result at visit 1 (screening)
3. During the entire study, women of childbearing potential (WOCBP) including peri-menopausal women who have a menstrual period within 1 year must practice appropriate, and effective birth control, either implants or pills, or a vasectomized partner prior to receiving the first dose of study medication
12. Does not suffer from severe claustrophobia
13. No contraindication for Magnetic Resonance Imaging (MRI) (metal plates, screws, shrapnel, pins, or cardiac pacemaker)
Exclusion Criteria:
1. Patients currently on one of the selected therapies
2. Extended diagnoses with Type 2 Diabetes
3. Pregnancy, lactation, women of childbearing age (WOCBA) unwilling to use contraception
4. Known allergy/sensitivity to study drugs or their ingredients
5. Major oncologic diagnosis in the last 5 years
6. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
7. Inability or unwillingness of individual or legal guardian/representative to give written informed consent
8. Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study
9. Myocardial infraction, coronary artery bypass graft surgery, or other major cardiovascular event in the past 60 days
10. Heart transplant recipient or listed for a heart transplant
11. Currently implanted left ventricular assist device
12. Cardiomyopathy based on infiltrative or cumulative hypertrophic obstructive cardiomyopathy or known pericardial constriction
13. Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period
14. Acute decompensated heart failure requiring intravenous diuretics, vasodilators, inotropic agents, or mechanical support within 1 week of screening and during the screening period prior to randomization
15. Implanted cardioverter defibrillator within 3 months prior to screening
16. Cardiac resynchronization therapy
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Carolina Solis-Herrera, MD
**Phone:** 210-567-4900
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Francisca Acosta, PhD
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** San Antonio
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Carolina Solis-Herrera, MD
- **Phone:** 210-567-4900
- **Role:** CONTACT
**Country:** United States
**Facility:** University of Texas Health Science Center at San Antonio
**State:** Texas
**Status:** RECRUITING
**Zip:** 78229
#### Overall Officials
**Official 1:**
**Affiliation:** The University of Texas Health Science Center at San Antonio
**Name:** Carolina Solis-Herrera, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** The Institution or respective designees may present or publish the results of a scientific investigation involving this Study in accordance with International Committee of Medical Journal Editors (ICMJE). The Sponsor Investigator, funding agency, or PI initiating the study will collaborate to determine who has publication rights for authorship upon review and approval of proposed manuscripts.
**Info Types:**
- STUDY_PROTOCOL
- SAP
**IPD Sharing:** YES
**Time Frame:** At the time of publication in a peer review journal
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000003920
- Term: Diabetes Mellitus
- 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
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M14117
- Name: Prediabetic State
- Relevance: HIGH
- As Found: Pre-diabetes
- ID: M20559
- Name: Disease Progression
- Relevance: HIGH
- As Found: Progression
- ID: M5114
- Name: Body Weight
- Relevance: HIGH
- As Found: Weight, Body
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M20295
- Name: Glucose Intolerance
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000011236
- Term: Prediabetic State
- ID: D000018450
- Term: Disease Progression
- ID: D000001835
- Term: Body Weight
### Intervention Browse Module - Ancestors
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000097789
- Term: Glucagon-Like Peptide-1 Receptor Agonists
- ID: D000077203
- Term: Sodium-Glucose Transporter 2 Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Gast
- Name: Gastrointestinal Agents
### Intervention Browse Module - Browse Leaves
- ID: M11667
- Name: Metformin
- Relevance: HIGH
- As Found: Assessment
- ID: M1693
- Name: Pioglitazone
- Relevance: HIGH
- As Found: Arthroplasty
- ID: M353561
- Name: Semaglutide
- Relevance: HIGH
- As Found: Carbohydrate
- ID: M258082
- Name: Empagliflozin
- Relevance: HIGH
- As Found: At home
- ID: M1691
- Name: Sodium-Glucose Transporter 2 Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M3401
- Name: Glucagon-Like Peptide-1 Receptor Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M26997
- Name: Glucagon-Like Peptide 1
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M9043
- Name: Glucagon
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008687
- Term: Metformin
- ID: D000077205
- Term: Pioglitazone
- ID: C000591245
- Term: Semaglutide
- ID: C000570240
- Term: Empagliflozin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446518
**Brief Title:** Assessing Virtual Reality for Perioperative Anxiolysis and Postoperative Pain Modulation in Adolescents Undergoing MIRPE Surgery
**Official Title:** A Randomized Control Trial for Assessing Virtual Reality for Perioperative Anxiolysis and Postoperative Pain Modulation in Adolescents Undergoing MIRPE Surgery
#### Organization Study ID Info
**ID:** NRG 2022/2
#### Organization
**Class:** OTHER
**Full Name:** Semmelweis University
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-08-17
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Új Nemzeti Kiválóság Program
#### Lead Sponsor
**Class:** OTHER
**Name:** Semmelweis University
#### Responsible Party
**Investigator Affiliation:** Semmelweis University
**Investigator Full Name:** Dr. Trinh Sarolta
**Investigator Title:** Dr
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to test virtual reality in adolescents undergoing minimally invasive repair of pectus excavatum surgery. The main questions it aims to answer are:
* Can virtual reality decrease anxiety in adolescents on the day of the surgery?
* Can virtual reality be used as a pain modulator in adolescents in postoperative care? Participants will be asked to wear a VR headset for a minimum of 1 hour before and after the surgery. Patients will be asked to fill out three anxiety tests: on admission, in the operating room and on the surgical ward on the day after surgery.
Researchers will compare VR group to control group to see if anxiety and pain was different among those who recieved the VR headset.
### Conditions Module
**Conditions:**
- Pectus Excavatum
- Pectus Deformity
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** On admission, patients are asked to fill out a STAI-T and-S anxiety inventory. Attending investigator will take vital parameters upon admission.
Patients are asked to use the VR headset a minimum of 1 hour before surgery. Participants are asked to fill out a STAI-S test in the operating room, where physiologic data is collected and timing and dose of medication administered. After surgery, during emergence physiologic data is collected, and attending anesthesiologist fills out the PAED score. Patients are encouraged to use the VR headset after surgery, any time when they feel comfortable.
Pain using an NRS scale, and vital parameters are monitored postoperative 1, 2, 3, 6, 12 hours (if patient is not sleeping) and in the morning following surgery at 6 and 9 am. A final STAI-S test is filled out by patients in the morning after surgery. Data regarding painkiller demand is collected after surgery.
**Intervention Names:**
- Device: Virtual reality exposure
**Label:** VR intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** On admission, patients are asked to fill out a STAI-T and-S anxiety inventory. Attending investigator will take vital parameters upon admission.
Participants are asked to fill out a STAI-S test in the operating room, where physiologic data is collected and timing and dose of medication administered. After surgery, during emergence physiologic data is collected, and attending anesthesiologist fills out the PAED score.
Pain using an NRS scale, and vital parameters are monitored postoperative 1, 2, 3, 6, 12 hours (if patient is not sleeping) and in the morning following surgery at 6 and 9 am. A final STAI-S test is filled out by patients in the morning after surgery. Data regarding painkiller demand is collected after surgery.
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- VR intervention group
**Description:** Assessing immersive virtual reality as a distraction tool in anxiolysis and pain modulation.
**Name:** Virtual reality exposure
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Anxiety assessed by STAI-S and STAI-T questionnaires level of anxiety will be assessed using the State Trait Anxiety-Inventory. The test is composed of 2 parts: STAI-S (How does the patient feel right now?) and STAI-T (How does the patient feel on average?). Both questionnaires contain 20 questions with answers rating from 1 to 4.
**Measure:** Decrease in anxiety
**Time Frame:** 1-2 days
#### Secondary Outcomes
**Description:** Pain assessed by Numerical Pain Rating Scale level of pain will be assessed using the Numerical Pain Rating Scale. The scale is composed of 0 (no pain) to 10 (worst pain imaginable)
**Measure:** Decrease in pain
**Time Frame:** 1-2 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient between 14-18 years old
* reported chest deformity (pectus excavatum/ carinatum)
* patients undergoing MIRPE surgery in general anesthesia
* Hungarian fluency
* willing to comply with study procedures.
Exclusion Criteria:
* gross cognitive impairment that would interfere with the ability to consent or complete study procedures.
* Head injury
* Head infection
* Altered mental status (independently from midazolam)
* Scabies or louse
* Dizziness or vertigo
* Blindness or severe vision loss
* Lack of parental/ guardian or patient consent
* Those, who has a head deformity, so VR headset does not fit well
**Healthy Volunteers:** True
**Maximum Age:** 18 Years
**Minimum Age:** 13 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Budapest
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sarolta Trinh, M.D.
- **Phone:** +36208038003
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Jermendy Agnes, M.D, Ph.D., M.P.H
- **Phone:** +36204600798
- **Role:** CONTACT
**Country:** Hungary
**Facility:** Department of Paediatrics, Semmelweis University
**Status:** RECRUITING
**Zip:** 1083
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000000013
- Term: Congenital Abnormalities
- ID: D000001848
- Term: Bone Diseases, Developmental
- ID: D000001847
- Term: Bone Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000009139
- Term: Musculoskeletal Abnormalities
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Postoperative Pain
- ID: M8779
- Name: Funnel Chest
- Relevance: HIGH
- As Found: Pectus Excavatum
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M5126
- Name: Bone Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5127
- Name: Bone Diseases, Developmental
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12096
- Name: Musculoskeletal Abnormalities
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005660
- Term: Funnel Chest
- ID: D000010149
- Term: Pain, Postoperative
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446505
**Brief Title:** Evaluation of a Decision Aid for Deep Brain Stimulation Surgery for Parkinson's Disease
**Official Title:** Feasibility, Acceptability, and Effectiveness of an Online Decision Aid for Patients With Parkinson's Disease Considering Deep Brain Stimulation Surgery Using a Pragmatic, Randomized Pilot Trial
#### Organization Study ID Info
**ID:** 23-2390
#### Organization
**Class:** OTHER
**Full Name:** University of Colorado, Denver
#### Secondary ID Infos
**ID:** K12AR084226
**Link:** https://reporter.nih.gov/quickSearch/K12AR084226
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2026-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-07
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Colorado, Denver
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to learn if a Decision Aid can help patients with Parkinson's disease make a decision about undergoing Deep Brain Stimulation surgery. The main questions it aims to answer are:
* Is the Decision Aid acceptable to patients with Parkinson's disease considering Deep Brain Stimulation surgery?
* Does the decision aid improve decision quality (informed, value-based decision) and uncertainty about the decision?
Researchers will compare immediate use of the decision aid during the evaluation process for deep brain stimulation surgery to delayed introduction of the decision aid.
Participants will:
* Receive the decision aid at the beginning of the evaluation process or towards the end
* Complete surveys at 5 visits (remote or in-person) over approximately 6 months
### Conditions Module
**Conditions:**
- Parkinson Disease
**Keywords:**
- Deep Brain Stimulation
- Decision Aid
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 42
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive the Decision Aid at baseline.
**Intervention Names:**
- Other: Deep Brain Stimulation Decision Aid
**Label:** Early Decision Aid
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process.
**Intervention Names:**
- Other: Deep Brain Stimulation Decision Aid
**Label:** Delayed Decision Aid
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Delayed Decision Aid
- Early Decision Aid
**Description:** An online decision support tool that provides education about deep brain stimulation and the alternatives, and includes value clarification exercise.
**Name:** Deep Brain Stimulation Decision Aid
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** This tool measures the comprehensibility of components of the decision aid including its length, amount of information, balance and suitability for decision-making. Higher scores indicate that the tool is more acceptable.
**Measure:** Acceptability tool from the Ottawa Hospital Research Institute
**Time Frame:** Baseline
**Description:** This tool measures the comprehensibility of components of the decision aid including its length, amount of information, balance and suitability for decision-making. Higher scores indicate that the tool is more acceptable.
**Measure:** Acceptability tool from the Ottawa Hospital Research Institute
**Time Frame:** 2 weeks after decision for deep brain stimulation surgery
**Description:** The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
**Measure:** Decisional Conflict Scale (DCS)
**Time Frame:** Baseline
**Description:** The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
**Measure:** Decisional Conflict Scale (DCS)
**Time Frame:** 1 Month
**Description:** The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
**Measure:** Decisional Conflict Scale (DCS)
**Time Frame:** 3 Months
**Description:** The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
**Measure:** Decisional Conflict Scale (DCS)
**Time Frame:** 2 weeks after decision for deep brain stimulation surgery
**Description:** The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.
**Measure:** Decisional Conflict Scale (DCS)
**Time Frame:** 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
#### Secondary Outcomes
**Description:** The worksheet measures how well participants understood the options and outcomes presented in the decision aid, as well as if their decision was consistent with their goals and values. For the knowledge portion of the worksheet, the scores range from 0 to 10, with higher scores indicating increased knowledge about DBS.
**Measure:** Decision Quality Worksheet
**Time Frame:** 2 weeks after decision for deep brain stimulation surgery
**Description:** The worksheet measures how well participants understood the options and outcomes presented in the decision aid, as well as if their decision was consistent with their goals and values. For the knowledge portion of the worksheet, the scores range from 0 to 10, with higher scores indicating increased knowledge about DBS.
**Measure:** Decision Quality Worksheet
**Time Frame:** 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
**Description:** This scale measures the participant's self-confidence in or belief in one's ability to make decisions and participate in shared decision-making. The scores range from 0 to 100. A score of 0 means "extremely low self efficacy" and a score of 100 means "extremely high self efficacy".
**Measure:** Decision Self-Efficacy scale
**Time Frame:** Baseline
**Description:** This scale measures the participant's self-confidence in or belief in one's ability to make decisions and participate in shared decision-making. The scores range from 0 to 100. A score of 0 means "extremely low self efficacy" and a score of 100 means "extremely high self efficacy".
**Measure:** Decision Self-Efficacy scale
**Time Frame:** 3 Months
**Description:** This scale measures the participant's self-confidence in or belief in one's ability to make decisions and participate in shared decision-making. The scores range from 0 to 100. A score of 0 means "extremely low self efficacy" and a score of 100 means "extremely high self efficacy".
**Measure:** Decision Self-Efficacy scale
**Time Frame:** 2 weeks after decision for deep brain stimulation surgery
**Description:** This validated, single-item instrument assesses how ready the participant is to make a decision about deep brain stimulation surgery. The scores vary from 0 "not at all ready" to 5 "completely ready".
**Measure:** Decision Readiness Instrument
**Time Frame:** Baseline
**Description:** This validated, single-item instrument assesses how ready the participant is to make a decision about deep brain stimulation surgery. The scores vary from 0 "not at all ready" to 5 "completely ready".
**Measure:** Decision Readiness Instrument
**Time Frame:** 1 Month
**Description:** This validated, single-item instrument assesses how ready the participant is to make a decision about deep brain stimulation surgery. The scores vary from 0 "not at all ready" to 5 "completely ready".
**Measure:** Decision Readiness Instrument
**Time Frame:** 3 Months
**Description:** This validated, single-item instrument assesses how ready the participant is to make a decision about deep brain stimulation surgery. The scores vary from 0 "not at all ready" to 5 "completely ready".
**Measure:** Decision Readiness Instrument
**Time Frame:** 2 weeks after decision for deep brain stimulation surgery
**Description:** This scale measures how satisfied the participant is with their decision about whether or not to undergo deep brain stimulation surgery. The areas of satisfaction include how informed they were, if the decision was the best for them, if the decision was consistent with their values and if they had as much input as they wanted. Scores range from 6 to 30. Higher scores indicate higher satisfaction with the decision.
**Measure:** Satisfaction with Decision Scale
**Time Frame:** 2 weeks after decision for deep brain stimulation surgery
**Description:** This scale measures how satisfied the participant is with their decision about whether or not to undergo deep brain stimulation surgery. The areas of satisfaction include how informed they were, if the decision was the best for them, if the decision was consistent with their values and if they had as much input as they wanted. Scores range from 6 to 30. Higher scores indicate higher satisfaction with the decision.
**Measure:** Satisfaction with Decision Scale
**Time Frame:** 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
**Description:** This questionnaire measures quality of life in Parkinson's disease related to the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. Scores range from 0 to 100 with higher scores indicating lower quality of life.
**Measure:** Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)
**Time Frame:** Baseline
**Description:** This questionnaire measures quality of life in Parkinson's disease related to the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. Scores range from 0 to 100 with higher scores indicating lower quality of life.
**Measure:** Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)
**Time Frame:** 2 weeks after decision for deep brain stimulation surgery
**Description:** This questionnaire measures quality of life in Parkinson's disease related to the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. Scores range from 0 to 100 with higher scores indicating lower quality of life.
**Measure:** Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)
**Time Frame:** 2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery
**Description:** Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
**Measure:** Expectations
**Time Frame:** Baseline
**Description:** Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
**Measure:** Expectations
**Time Frame:** 1 Month
**Description:** Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
**Measure:** Expectations
**Time Frame:** 3 Months
**Description:** Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery.
**Measure:** Expectations
**Time Frame:** 2 weeks after decision for deep brain stimulation surgery
**Description:** This questionnaire measures the degree of shared decision-making that took place in physician visits discussing deep brain stimulation surgery. The scores range from 0 (no perceived shared decision-making) to 100 (highest level of perceived shared decision-making).
**Measure:** Shared Decision-Making Questionnaire - 9
**Time Frame:** 1 Month
**Description:** This questionnaire measures the degree of shared decision-making that took place in physician visits discussing deep brain stimulation surgery. The scores range from 0 (no perceived shared decision-making) to 100 (highest level of perceived shared decision-making).
**Measure:** Shared Decision-Making Questionnaire - 9
**Time Frame:** 3 Months
**Description:** This questionnaire measures the degree of shared decision-making that took place in physician visits discussing deep brain stimulation surgery. The scores range from 0 (no perceived shared decision-making) to 100 (highest level of perceived shared decision-making).
**Measure:** Shared Decision-Making Questionnaire - 9
**Time Frame:** 2 weeks after decision for deep brain stimulation surgery
**Description:** This scale measures how much the participant trusts their surgeon. The scale ranges from 11 to 55, with higher scores indicating a higher level of trust.
**Measure:** Trust in the Surgeon Scale
**Time Frame:** 2 weeks after decision for deep brain stimulation surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Adults with a diagnosis of Parkinson's disease referred for deep brain stimulation surgery evaluation at the University of Colorado
Exclusion Criteria:
* Atypical Parkinsonism
* Diagnosis of Dementia
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Michelle E Fullard, MD
**Phone:** 3037242194
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Erika Shelton
**Phone:** 3037244644
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Aurora
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Michelle E Fullard
- **Phone:** 303-724-2194
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Erika Shelton
- **Phone:** 3037244644
- **Phone Ext:** Fullard
- **Role:** CONTACT
***Contact 3:***
- **Name:** Michelle E Fullard, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Colorado Anschutz
**State:** Colorado
**Status:** RECRUITING
**Zip:** 80045
#### Overall Officials
**Official 1:**
**Affiliation:** University of Colorado, Denver
**Name:** Michelle E Fullard, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** We plan to share the de-identified dataset after the primary results have been accepted for publication. No patient identifiers will be included in the shared data.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020734
- Term: Parkinsonian Disorders
- ID: D000001480
- Term: Basal Ganglia Diseases
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009069
- Term: Movement Disorders
- ID: D000080874
- Term: Synucleinopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M13213
- Name: Parkinson Disease
- Relevance: HIGH
- As Found: Parkinson's Disease
- ID: M22494
- Name: Parkinsonian Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M25603
- Name: Ganglion Cysts
- Relevance: LOW
- As Found: Unknown
- ID: M16358
- Name: Synovial Cyst
- Relevance: LOW
- As Found: Unknown
- ID: M4774
- Name: Basal Ganglia Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12029
- Name: Movement Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M2217
- Name: Synucleinopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010300
- Term: Parkinson Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446492
**Brief Title:** Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study
**Official Title:** Impact of Video-Enhanced Consent on Informed Decision-Making for Parents of Extremely Preterm Infants Eligible for the ViDES Study: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** HSC-MS-22-0563 (sub-study)
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Health Science Center, Houston
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The University of Texas Health Science Center, Houston
#### Responsible Party
**Investigator Affiliation:** The University of Texas Health Science Center, Houston
**Investigator Full Name:** Maria del Mar Romero López
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This pilot randomized controlled trial evaluates the impact of video-enhanced consent compared to the usual approach. The investigators aim to assess if video-enhanced consent empowers decision-making and improves understanding in parents considering participation in the ViDES study, which investigates the effectiveness of Vitamin D supplementation in extremely preterm infants (the ViDES study is separately registered as NCT05459298).
### Conditions Module
**Conditions:**
- Understanding of Consent in Clinical Research
- Implementation of Video-Consent in Clinical Research
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The research team will introduce themselves and ask the parents to watch an informational video explaining the ViDES study on an iPad while they stay in the room with the parents. After viewing the video, the team will answer any questions and provide written consent and enough time to decide whether to participate in the study. The research team will also provide a QR code that grants parents/guardians access to the video on their own device at any time. This allows them to pause, rewind, and revisit the information. A pamphlet will also be provided.
**Intervention Names:**
- Other: ViDEO explaining study
**Label:** Video-enhanced approach to consent
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The research team will present a detailed explanation of the ViDES study, answer questions, provide written consent, and provide enough time to decide on participation or not in the study.
**Intervention Names:**
- Other: Usual Care
**Label:** Usual care approach to consent
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Video-enhanced approach to consent
**Description:** The research team will introduce themselves and ask the parents to watch an informational video explaining the ViDES study on an iPad while they stay in the room with the parents. After viewing the video, the team will answer any questions and provide written consent and enough time to decide whether to participate in the study. The research team will also provide a QR code that grants parents/guardians access to the video on their own device at any time. This allows them to pause, rewind, and revisit the information.
**Name:** ViDEO explaining study
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Usual care approach to consent
**Description:** The research team will present a detailed explanation of the ViDES study, answer questions, provide written consent, and provide enough time to decide on participation or not in the study.
**Name:** Usual Care
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** ViDES trial consent rate
**Time Frame:** Within 1 week of the intervention
**Description:** The questionnaire assesses recall of possible benefits and risks of participation.
**Measure:** Participants' understanding of the ViDES study as assessed by a questionnaire
**Time Frame:** Within 48 hours of the intervention
**Description:** The questionnaire assesses satisfaction with ability to ask questions and decision time.
**Measure:** Participants' satisfaction with consent approach as assessed by a questionnaire
**Time Frame:** Within 48 hours of the intervention
**Description:** The questionnaire assesses participant's opinions related to participation in research and research being part of the care of infants.
**Measure:** Participant's opinions related to participation in research as assessed by a questionnaire
**Time Frame:** Within 48 hours of the intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Parents/legal guardians of extremely preterm infants (\<28 weeks gestational age or \<1000 g birth weight) admitted to the Neonatal Intensive Care Unit at Children's Memorial Hermann hospital that qualify for the ViDES study (ViDES study is separately registered as NCT05459298)
Exclusion Criteria:
* Parents/legal guardians deaf or blind
* Parents/legal guardians unable to consent for the VIDES study
**Healthy Volunteers:** True
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Maria del Mar Romero López, MD, MS, PhD
**Phone:** 713-500-7283
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Houston
**Country:** United States
**Facility:** McGovern Medical School at UTHealth Houston
**State:** Texas
**Zip:** 77030
#### Overall Officials
**Official 1:**
**Affiliation:** The University of Texas Health Science Center at Houston (UTHealth Houston)
**Name:** Maria del Mar Romero López, MD, MS, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M25869
- Name: Premature Birth
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446479
**Brief Title:** Effects of THC on Alcohol Consumption and Neural Correlates of Reward
**Official Title:** Effects of THC on Alcohol Consumption and Neural Correlates of Reward
#### Organization Study ID Info
**ID:** 22-1314
#### Organization
**Class:** OTHER
**Full Name:** University of Colorado, Denver
### Status Module
#### Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-02-13
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute on Alcohol Abuse and Alcoholism (NIAAA)
**Class:** OTHER
**Name:** Colorado State University
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Colorado, Denver
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
### Description Module
**Brief Summary:** Alcohol and cannabis are often used together such that their effects overlap, but little is known about the neural mechanisms that underlie simultaneous use. High doses of THC have not been well-studied in the laboratory, and it is unclear how high doses of THC may impact alcohol consumption patterns. The proposed study will explore the effects of oral THC (20mg dronabinol) vs. placebo on neural reward, alcohol self-administration and naturalistic co-use patterns.
**Detailed Description:** Participants will undergo a screening assessment, baseline session and two laboratory visits. The laboratory visits will involve an MRI scan and the opportunity to consume alcohol in our BAR lab. Prior to the MRI, participants will consume, a placebo (0mg) or high (20mg) dose of oral THC (dronabinol). Visits will be separated by 7 to 14 days. Dronabinol is an FDA-approved product that will be dispensed by our on-campus pharmacy
### Conditions Module
**Conditions:**
- Cannabis Use Disorder
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 28
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This arm will receive placebo on the first visit, and dronabinol on the second visit
**Intervention Names:**
- Drug: Dronabinol Pill
- Drug: Placebo
**Label:** Placebo first, Dronabinol second
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** This arm will receive dronabinol on the first visit, and placebo on the second visit.
**Intervention Names:**
- Drug: Dronabinol Pill
- Drug: Placebo
**Label:** Dronabinol first, Placebo second
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dronabinol first, Placebo second
- Placebo first, Dronabinol second
**Description:** Dronabinol 20 mg
**Name:** Dronabinol Pill
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Dronabinol first, Placebo second
- Placebo first, Dronabinol second
**Description:** placebo
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Alcohol cue reactivity task BOLD signal to alcohol cues, relative to neutral beverage cues
**Measure:** Change in alcohol cue-elicited brain activation (fMRI) between medication periods
**Time Frame:** 1 hour after administration of a single dose of study medication at 7 days, 14 days.
**Description:** Cannabis cue reactivity task BOLD signal to cannabis cues, relative to neutral cues
**Measure:** Change in cannabis cue-elicited brain activation (fMRI) between medication periods
**Time Frame:** 1 hour after administration of a single dose of study medication at 7 days, 14 days.
**Description:** Number of drinks self-administered
**Measure:** Alcohol self-administration
**Time Frame:** 3-4 hours after administration of a single dose of study medication at 7 days, 14 days.
**Description:** # of drinks consumed per day
**Measure:** Self-reported alcoholic drinks consumed
**Time Frame:** one report per day for the 14 days after the final laboratory visit on day 14.
**Description:** Amount of cannabis consumed per day
**Measure:** Self-reported cannabis use
**Time Frame:** One report per day for the 14 days after the final laboratory visit on day 14
**Description:** Number of days in which cannabis and alcohol were both used
**Measure:** Self-reported cannabis and alcohol co-use
**Time Frame:** One report per day for the 14 days after the final laboratory visit on day 14.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Drink alcohol
* Use cannabis
* Contact site for additional details
Exclusion Criteria:
* MRI contraindications (implanted metal, weight \> 315 lb, etc.).
* Contact site for additional details
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004327
- Term: Drinking Behavior
### 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: HIGH
- As Found: Alcohol Consumption
- ID: M5449
- Name: Marijuana Abuse
- Relevance: LOW
- As Found: Unknown
- ID: M7502
- Name: Drinking Behavior
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000428
- Term: Alcohol Drinking
### Intervention Browse Module - Ancestors
- ID: D000006213
- Term: Hallucinogens
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000011619
- Term: Psychotropic Drugs
- ID: D000018712
- Term: Analgesics, Non-Narcotic
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000063386
- Term: Cannabinoid Receptor Agonists
- ID: D000063385
- Term: Cannabinoid Receptor Modulators
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000006728
- Term: Hormones
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
### Intervention Browse Module - Browse Leaves
- ID: M16527
- Name: Dronabinol
- Relevance: HIGH
- As Found: Placenta
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
- ID: M9305
- Name: Hallucinogens
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- 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: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000013759
- Term: Dronabinol
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446466
**Brief Title:** PEMF Stimulation on Physical Exercise in Sedentary People
**Official Title:** Influence of Pulsed Electromagnetic Fields (PEMFs) Stimulation on Physical Exercise in Sedentary People
#### Organization Study ID Info
**ID:** PEMF on sedentary
#### Organization
**Class:** OTHER
**Full Name:** University of Bologna
### Status Module
#### Completion Date
**Date:** 2024-02-03
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-01-09
**Type:** ACTUAL
#### Start Date
**Date:** 2023-11-12
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Bologna
#### Responsible Party
**Investigator Affiliation:** University of Bologna
**Investigator Full Name:** Milena Raffi
**Investigator Title:** Associate professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The pulsed electromagnetic fields (PEMF) are a non-invasive therapy used for clinical treatments. Recent publications in exercise physiology showed that PEMF enhanced the velocity and the quantity of available muscle O2, and the rate of muscle oxygen extraction and utilization, in semi-professional cyclists during a heavy constant-load exercise. This study investigates the effect of stimulation on muscular activation in sedentary young people who perform a constant-load exercise at moderate intensity. The protocols foresees the enrollment of nine male sedentary young people. The response of the muscle activity will be recorded by surface electromyography (EMG) and assessed by measuring the root mean square normalized to the peak of the maximum voluntary contraction. Data will be collected in the vastus Medialis (RVM) and Biceps Femoris (RBF) of the right leg, at the baseline (standstill sitting), on warm-up (unloaded cy-cling) and during 30 minutes of constant-load exercise in two experimental conditions (PEMF ON vs PEMF OFF).
**Detailed Description:** The study design is single-blind with randomized controlled condition. Nine male sedentary young people will participate at this study. G∗power software version 3.1.9.2 (Kiel, Germany) predicted that a total sample size of 8 would give sufficient power (0.80) to detect a significant difference at alpha level of 0.05. One additional participant will be included to ensure the availability of data in case of missing or corrupted data. All participants will be volunteers, healthy, non-smokers, without muscular injury or physical deficit at the time of the experiment. Exclusion criteria are the use of supplements or medications. All participants will receive both a written and verbal explanation of the experimental procedure. The informed consent will be obtained before the beginning of recordings.
The experiments will be performed on the cycle-ergometer (H-300-R Lode, Exere Air Machine, Italy) under a standardized procedure in a quiet room with a temperature of 22°C. Recordings will be performed at the same time of the day (9:00-12:00 AM) to avoid circadian influence. Subjects will be instructed to avoid caffeine, alcohol and heavy physical activity in the 12h preceding the experiment. The surface EMG activity will be recorded from the right Vastus Medialis and right Biceps Femoris caput longum at a sampling rate of 1000 Hz by a Free-EMG 1000 (BTS Bioengineering, Inc.). Free-EMG is a device with wireless miniaturized probes for the dynamic analysis of muscle activity. For signal acquisition, the probes (41,5×24,8x14mm) are directly attached to the electrodes and signals are detected and captured. Each probe is equipped with internal memory to ensure uninterrupted recording in case of temporary connection loss. To stimulate the entire right thigh, 2 circular 20 cm PEMF loop-antenna devices (Torino II, Rio Grande Neurosciences, USA) will be placed at the beginning and at the end of the right leg. The PEMF waveform consists of a pulse-burst modulated 27.12 Mega-Hertz (MHz) sinusoidal carrier, with 2ms burst width repeated at 2 Hertz, with peak magnetic field at the center of the loop 5±1 microTesla.
Participants will come to the laboratory 5 times, with an interval of 3 days between each time. In each of these visits few recordings will be performed.
The first day foresees the recording of the maximum voluntary contraction (MVC) and an incremental test until exhaustion to find the individual maximum oxygen consumption (VO2max). Regarding MVC recording, each participant will perform, for five seconds, an isometric contraction against a maximum load using isotonic machines (Exere Air Machine, Italy). The participants will repeat the same procedure 3 times, separated by 2 minutes of rest. The MVC peak value of each investigated muscle will be used to normalize electromyographic data (procedure already used in previous studies). Regarding VO2max recording, each subject will perform an incremental test on a cycle-ergometer (H-300-R Lode) to find the maximum oxygen consumption (VO2max), in order to individualize the correct workload to be used for the exercise sessions. Gases will be analyzed using a Quark b2 breath-by-breath metabolic system (Cosmed, Italy). The system will be calibrated immediately before each test in accordance with the manufacturer's guidelines: volume calibration will be performed at different flow rates with a 3- L calibration syringe and calibration of gas analyzers will be performed with a tank of reference gas mixture (16.00% O2, 5.00% CO2) and ambient air (20.93% O2 and 0.03% CO2).
From day two to four, participants will come to the laboratory for the exercise sessions. The experimental conditions will be PEMF ON and PEMF OFF, in which the PEMF will be turned on and off respectively. When the trial will start with the PEMF in ON modality, the device will be turned off after 17 minutes and the participant will keep going cycling until the end of the trial. Otherwise, when the trial will start with the PEMF in OFF modality, the device will be turned on after 17 minutes and the participant will keep going cycling until the end of the trial. Each condition will be repeated twice in different days for a total of four recordings per subject. The two PEMF loops will be positioned on the right leg in both experimental conditions in order to avoid stimulation being perceived by the subjects at the skin level.
Data will be recorded in three epochs: 1) baseline, 2) warm-up, 3) constant-load exercise. To record the baseline values, the participants will sit for 1-minute with the right leg extended. The warm-up involves an unloaded cycling for 1-minute. Then, an instantaneous increase of the workload, which will be attained in \~3s, will be the onset for the constant-load exercise (physical effort). Participants will be instructed to keep cycling at a cadence of 70 revolutions per minute for the entire duration of the trial. Each trial will be ended after 30 minutes of exercise.
### Conditions Module
**Conditions:**
- PEMF Effect
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 9
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Two interventions will be performed on the same group of subjects
**Intervention Names:**
- Device: PEMF ON-OFF
- Device: PEMF OFF-ON
**Label:** Participants group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Participants group
**Description:** The experimental conditions PEMF ON-OFF foresees that PEMF will start in ON modality being turned off after 17 minutes. The participant will keep going cycling until the end of the trial.
**Name:** PEMF ON-OFF
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Participants group
**Description:** The experimental conditions PEMF OFF-ON foresees that PEMF will start in OFF modality being turned on after 17 minutes. The participant will keep going cycling until the end of the trial.
**Name:** PEMF OFF-ON
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The aim is to verify if PEMF stimulation can enhance muscle activity during cycling. Electromyographic recordings on both vastus Medialis (RVM) and Biceps Femoris (RBF) of the right leg will be performed. To verify the effect we will analyze the amplitude (in mV) of the muscle response.
**Measure:** PEMF effect on amplitude of muscle contraction
**Time Frame:** Two weeks recordings
**Description:** The aim is to verify if PEMF stimulation can enhance muscle activity during cycling. Electromyographic recordings on both vastus Medialis (RVM) and Biceps Femoris (RBF) of the right leg will be performed. To verify the effect we will analyze the duration (in msec) of the muscle response.
**Measure:** PEMF effect on duration of muscle contraction
**Time Frame:** Two weeks recordings
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
- healthy sedentary volunteers
Exclusion Criteria:
* smokers
* muscular injury or physical deficit at the time of the experiment
* use of supplements or medications
**Healthy Volunteers:** True
**Maximum Age:** 35 Years
**Minimum Age:** 23 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Bologna
**Country:** Italy
**Facility:** Record Sport - Via del Pilastro 8
**Zip:** 40126
#### Overall Officials
**Official 1:**
**Affiliation:** University of Bologna
**Name:** Milena Raffi, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Trofe A, Piras A, Muehsam D, Meoni A, Campa F, Toselli S, Raffi M. Effect of Pulsed Electromagnetic Fields (PEMFs) on Muscular Activation during Cycling: A Single-Blind Controlled Pilot Study. Healthcare (Basel). 2023 Mar 22;11(6):922. doi: 10.3390/healthcare11060922.
**PMID:** 36981580
**Citation:** Raffi M, Piras A, Persiani M, Perazzolo M, Squatrito S. Angle of gaze and optic flow direction modulate body sway. J Electromyogr Kinesiol. 2017 Aug;35:61-68. doi: 10.1016/j.jelekin.2017.05.008. Epub 2017 May 31.
**PMID:** 28601564
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446453
**Brief Title:** Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure
**Official Title:** Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure
#### Organization Study ID Info
**ID:** 24-005-CCMC
#### Organization
**Class:** OTHER
**Full Name:** Connecticut Children's Medical Center
### Status Module
#### Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-01
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Connecticut Children's Medical Center
#### Responsible Party
**Investigator Affiliation:** Connecticut Children's Medical Center
**Investigator Full Name:** Jacob
**Investigator Title:** Neonatal-Perinatal Fellow
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Point-of-care ultrasound (POCUS) is the use of ultrasound by the bedside provider in real time to answer a specific question and guide medical management. POCUS can be used to diagnose the severity of neonatal respiratory distress syndrome (RDS) through a lung ultrasound score. Lung ultrasound scores have also been shown to predict if an infant is treated with an initial dose of surfactant. Therefore, using lung ultrasound scores to guide surfactant therapy for RDS will likely lead to earlier surfactant therapy and may improve short-term respiratory outcomes. This study will test this theory by comparing lung ultrasound score-guided surfactant therapy for premature infants with RDS with our current surfactant administration guidelines.
### Conditions Module
**Conditions:**
- Respiratory Distress Syndrome, Newborn
- Pulmonary Surfactants
- Intensive Care Units, Neonatal
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 52
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The control group will receive surfactant therapy based on our unit's current surfactant guidelines, including but not limited to a FiO2 requirement ≥ 0.3 on non-invasive positive pressure ventilation.
**Label:** Control
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** The treatment group will receive surfactant therapy if the initial LUS at 1-2 hours of life is \> 9 or if they meet our unit's current surfactant therapy guidelines (irrespective of the LUS).
**Intervention Names:**
- Diagnostic Test: Echography-guided Surfactant THERapy (ESTHER)
**Label:** Treatment
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment
**Description:** Decision to administer surfactant therapy using a semi-quantitative lung ultrasound score.
**Name:** Echography-guided Surfactant THERapy (ESTHER)
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** (CPAP Level x FiO2)/(SpO2)
**Measure:** Oxygen Saturation Index
**Time Frame:** At 24 hours of life.
#### Secondary Outcomes
**Description:** (CPAP Level x FiO2)/(SpO2)
**Measure:** Oxygen Saturation Index
**Time Frame:** At 48 and 72 hours of life.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The infant's parent/legal guardian can understand and willingly sign a written informed consent document for this study
* Birth gestational age between 27w0d-36w6d
* Diagnosis of respiratory failure secondary to RDS requiring respiratory support with non-invasive positive pressure ventilation
Exclusion Criteria:
* Unable to obtain lung ultrasound between 1-2 hours of life
* Infants already intubated or received surfactant before the point of care lung ultrasound
* Infants born with congenital cardiac disease, congenital lung disease, or congenital facial/airway malformations
* Infants born with chromosomal abnormalities
* Infants with APGARs ≤ 5 at 10 minutes of life
* Infants requiring cardiopulmonary resuscitation or therapeutic hypothermia in the first 6 hours of life
**Maximum Age:** 2 Hours
**Minimum Age:** 0 Hours
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jacob Kelner
**Phone:** 860-545-9720
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Connecticut Children's
**Name:** Jacob Kelner
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000012120
- Term: Respiration Disorders
- ID: D000007235
- Term: Infant, Premature, Diseases
- ID: D000007232
- Term: Infant, Newborn, Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14965
- Name: Respiratory Distress Syndrome
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
- ID: M14964
- Name: Respiratory Distress Syndrome, Newborn
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome, Newborn
- ID: M14968
- Name: Respiratory Insufficiency
- Relevance: HIGH
- As Found: Respiratory Failure
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M25869
- Name: Premature Birth
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10279
- Name: Infant, Premature, Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10276
- Name: Infant, Newborn, Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4927
- Name: Respiratory Distress Syndrome, Infant
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome, Newborn
- ID: T192
- Name: Acute Respiratory Distress Syndrome
- Relevance: HIGH
- As Found: Respiratory Distress Syndrome
### Condition Browse Module - Meshes
- ID: D000012128
- Term: Respiratory Distress Syndrome
- ID: D000012127
- Term: Respiratory Distress Syndrome, Newborn
- ID: D000012131
- Term: Respiratory Insufficiency
### Intervention Browse Module - Ancestors
- ID: D000019141
- Term: Respiratory System Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M14517
- Name: Pulmonary Surfactants
- Relevance: HIGH
- As Found: DPP
- ID: M21137
- Name: Respiratory System Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000011663
- Term: Pulmonary Surfactants
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446440
**Brief Title:** Lap Adhesiolysis in Intestinal Obstruction
**Official Title:** Comperative Study Between Laparoscopic Adhesiolysis Vs Open Adhesiolysis in Adhesive Intestinal Obstruction
#### Organization Study ID Info
**ID:** Lap adhesiolysis
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-12-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-01
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Assiut University
#### Responsible Party
**Investigator Affiliation:** Assiut University
**Investigator Full Name:** Bemen Soliman Haroun Abdulla
**Investigator Title:** General Surgery department at assiut University hospitals
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Comparison between the results of laparotomy and laparoscopy in adhesive intestinal obstruction and introduce the use of laparoscopy to the emergency setting in Asyut University Hospital.
**Detailed Description:** Adhesive Intestinal obstruction is one of the most common complications after any abdominal surgery.
Adhesions account for 75% of causes of intestinal obstruction. laparoscopic adhesiolysis recently increase in frequency over open adhesiolysis but there is no definit evidence of its superiority. In term of length of hospital stay and morbidity.
adhesive bowel obstruction mainly managed by conservative treatment but some refractory cases needs surgical intervention In this study we will evaluate feasibility and efficacy of using laparoscop in adhesiolysis over open approach .
### Conditions Module
**Conditions:**
- Adhesions Bowel
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** These group will include cases underwent laparoscopic adhesiolysis
**Intervention Names:**
- Procedure: Laparoscopic adhesiolysis
**Label:** Group A
#### Arm Group 2
**Description:** These group will include cases underwent open adhesiolysis
**Intervention Names:**
- Procedure: Open adhesiolysis
**Label:** Group B
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A
**Description:** Laparoscopic adhesiolysis
**Name:** Laparoscopic adhesiolysis
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Group B
**Description:** Open adhesiolysis
**Name:** Open adhesiolysis
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Signs and symptoms of intestinal obstruction
**Measure:** Recurrence rate
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* any male or female above 18 years has adhesive Intestinal obstruction
* patient fulfilled the criteria to participate but operated before time of study if adequate data available
* patient in which conservative management is failed
Exclusion Criteria:
* othe casues of intestinal obstruction (other than adhsions)
* shocked patient
* cardiovascular diseases
* coagulopathy
* liver cirrhosis
* intracranial diseases
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Any case of intestinal obstruction and failed medical treatment and for surgery either open or laparoscopic adhesiolysis
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Assiut
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Assiut University Hospitals
- **Phone:** +2088241-1906
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Assiut University Hospital
**Status:** RECRUITING
### 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
### Condition Browse Module - Browse Leaves
- ID: M10449
- Name: Intestinal Obstruction
- Relevance: HIGH
- As Found: Intestinal Obstruction
- ID: M3620
- Name: Tissue Adhesions
- 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: D000007415
- Term: Intestinal Obstruction
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446427
**Brief Title:** The Effect of Acute High Altitude Exposure on Rescuer Performance and Patient Care
**Official Title:** The Effect of Acute High Altitude Exposure on Rescuer Performance and Patient Care
#### Organization Study ID Info
**ID:** 2024-00237
#### Organization
**Class:** OTHER
**Full Name:** Insel Gruppe AG, University Hospital Bern
### Status Module
#### Completion Date
**Date:** 2025-05-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Insel Gruppe AG, University Hospital Bern
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Rescue services in mountainous regions are frequently called to missions at altitudes \>3000 m. Under the difficult conditions of acute exposure to altitude, the crews then have to undertake demanding medical and rescue measures. Previous studies in non-medical personnel, such as astronauts, aircraft pilots, and military helicopter pilots have found that the lack of oxygen associated with acute exposure to altitude may impair cognitive functions. No data exists on the effect this may have on the performance of medical staff in terms of patient examination, communication, decision-making, planning, and overall patient care. This study aims to close this knowledge gap. The investigators of this study aim to make rescue missions to high altitude safer for both the patients and the rescuers.
To assess the effect of high altitude on patient care, the investigators recruit highly trained medical specialists who will perform patient care in simulated scenarios both at high altitude and at low altitude. These scenarios will be recorded and the performance of the medical specialists judged by independent reviewers.
The medical specialists will also perform in simulated scenarios at high altitude two more times: once with supplementary oxygen, and once after spending a night at high altitude. the investigators do this to evaluate whether supplementary oxygen improves their performance, and whether symptoms of acute mountain sickness (which usually develop after spending the first night at high altitude) decreases their performance further.
**Detailed Description:** Rescue services in mountainous regions are frequently called to missions at altitudes \>3000 m. Under the difficult conditions of acute exposure to altitude, the crews then have to undertake demanding medical and rescue measures, such as an emergency induction of anaesthesia, resuscitation, treatment of polytraumatized patients, or a winch manoeuvre by helicopter in exposed, fall-prone terrain.
The exponential decrease in barometric pressure at altitude results in hypobaric hypoxia (HH), leading to a reduction in the partial pressure of oxygen at every point along the oxygen transport chain from the ambient air to tissue mitochondria. If the body's adaptive mechanisms fail to compensate for the lack of oxygen, symptoms like headache, nausea, fatigue, and dizziness may occur. In addition, HH may impair higher cortical functions. Individuals affected by high altitude frequently do not recognise a decline in cognitive function and overall performance, which can lead to incidents and even fatal consequences.
Previous studies in non-medical personnel, such as astronauts, aircraft pilots, and military helicopter pilots have explored the influence of HH on multiple cognitive domains. Impairment of working memory was described during hypoxia awareness trainings and in pilots while others reported no effects. Some studies have reported reduced psychomotor vigilance, while others found no effects. To counteract these impairments, the European Union Aviation Safety Agency (EASA) mandates simulated hypoxia training for pilots flying rescue missions to above 4000 m.
Studies in medical personnel are few and mostly focused on the quality of cardiopulmonary resuscitation (CPR) at (simulated) high altitude. High-quality CPR, which can be physically demanding for rescuers even under normoxic conditions, leads to rescuer fatigue faster under HH. Two recent studies have shown that HH leads to a lower quality of CPR at simulated and natural high altitude. A smaller study found simulated altitude to have a negative effect on the quality of ventilation but not on chest compression. A recent study reported a slower reaction time in medical personnel at simulated high altitude. Particularly noteworthy is the fact that rescuers did neither notice the reduced cognitive function nor the decreased quality of CPR they provided under HH, even though they were highly trained helicopter emergency medical services personnel. To the investigators' knowledge, CPR at high altitude has only been studied as an isolated skill. No data exist on the performance of medical staff in terms of patient examination, communication, decision-making, planning, and overall patient care. This study aims to close this knowledge gap. The findings of this study may help to broaden the understanding of HH, and lay the ground for further research in high altitude rescue.
As the primary endpoint of this study, the investigators evaluate medical performance and patient care using validated scores for medical skills and non-technical skills (Modified Simulation Team Assessment Tool (STAT), Concise Assessment of Leader Management (CALM), Team Emergency Assessment Measure (TEAM). These three scores are averaged (25% STAT, 25% CALM, 50% TEAM) to form a composite score. Scores are assessed by an analysis of video recordings of the simulated scenarios by independent outside assessors.
Secondary endpoints are described in detail elsewhere. They involve the measurement of reaction speed, risk assessment ability, cognitive function, the presence/absence of acute mountain sickness (AMS), the self-assessment of cognitive capacity, and basic vital functions. The concrete tests and measurements the investigators imply are:
* Psychomotor Vigilance Test (PVT)
* Balloon Analogue Risk Task (BART)
* Digit Symbol Substitution Test (DSST)
* Lake Louis Score (LLS), AMS is present at a score of three or higher
* Self-Assessment of Cognitive Capacity on a scale of 1-10
* Heart rate, Blood-pressure, peripheral blood oxygen saturation (SpO2) as measured by non-invasive means
The investigators will assess medical performance (and all other tests and measurements mentioned above) at four time points (baseline, interventions 1-3).
Testing at 30 minutes after arrival by train at high altitude (the High Altitude Research Station Jungfraujoch, 3450 m, "intervention 1") and at low altitude (Bern, 540 m, "baseline") are performed to answer the main hypothesis; whether acute rescuer exposure to high altitude impairs patient care.
To answer the additional research questions, additional testing will be performed at high altitude 4 hours after arrival with supplemental oxygen (4 litres/min, nasal) ("intervention 2") and after spending the night at 3450 m ("intervention 4").
At the four time points of measurement, the participants will have to run through one of the following four scenarios of simulated patient care:
1. A polytraumatised 35 y.o. patient who fell 12 metres. Adequate treatment will entail: anamnesis, immobilisation of the cervical spine, treatment of a tension pneumothorax, installation of analgosedation.
2. A 64 y.o. patient with acute abdominal pain and nausea due to an acute myocardial infarction. Adequate treatment will entail: Anamnesis, performing and interpreting a 12-lead electrocardiogram, resuscitation.
3. A 35 y.o. mother with her 5 m.o. child who is experiencing a seizure. Adequate treatment will entail: Anamnesis, treatment of the epileptic seizure, recognition of impeding respiratory failure and consequent assisted ventilation.
4. A 19 y.o. hypothermic patient. Adequate treatment will entail: Anamnesis, recognition of likely hypothermia and taking measures to avoid afterdrop, resuscitation according to hypothermia protocols, adequate care after return of spontaneous circulation.
All four scenarios are designed to be of equal difficulty. However, the order of the scenarios is randomised electronically before the start of the study, so that different participants go through different scenarios at all points of measurements (baseline, interventions 1-3). This is done to avoid skewing of performance due to some scenarios being inadvertently more difficult or easier than others.
Before each scenario, the participants undergo all tests and measurements outlined above (PVT, BART, DSST, LLS, Self-Assessment of Cognitive Capacity on a scale of 1-10, Heart rate, Blood-pressure, peripheral blood oxygen saturation).
Supplemental application of oxygen during intervention 2 might bias the participants. Therefore, they will receive air via nasal cannula at the same flow rate during all other scenarios (baseline, interventions 1 and 3) in the sense of a "placebo administration".
### Conditions Module
**Conditions:**
- High Altitude
- Hypobaric Hypoxia
- Risk Reduction
**Keywords:**
- High Altitude
- Hypobaric Hypoxia
- Patient Care
- Patient Safety
- Rescuer Safety
- Emergency Medicine
- Anaesthesia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** The investigators imply a repeated measures design. A group of 20 participants will perform in simulated medical scenarios sequentially under four different circumstances (baseline, interventions 1-3)
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** Participants cannot be masked to whether they are at high or low altitude and whether they have spent a night at high altitude. However, they will not know whether they receive air (baseline, interventions 1 and 3) or supplementary oxygen nasally at the same flow rate (intervention 2).
Outcome Assessors will be fully blinded. They assess the medical performance on video recordings of the simulated scenarios, and will not know which time point a specific scenario has taken place (baseline, interventions 1-3) and whether participants receive air or supplementary oxygen.
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Thirty minutes after arrival at the Research Station Jungfraujoch by train, a simulated scenario of patient care ("intervention 1", high altitude at 3450 masl) is performed.
**Name:** Acute high altitude exposure
**Other Names:**
- Intervention 1
**Type:** OTHER
#### Intervention 2
**Description:** 4 hours after arrival at the Research Station Jungfraujoch by train, a simulated scenario of patient care ("intervention 2", high altitude at 3450 masl) is performed, while the participants receive 4 litres / minute of oxygen via nasal route.
**Name:** Acute high altitude exposure, with supplementary oxygen
**Other Names:**
- Intervention 2
**Type:** OTHER
#### Intervention 3
**Description:** After having spent a night at the Research Station Jungfraujoch, a simulated scenario of patient care ("Intervention 3", high altitude at 3450 masl) is performed.
**Name:** Subacute high altitude exposure, after having spent a night at high altitude
**Other Names:**
- Intervention 3
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The investigators asses the quality of patient care at low and high altitude exposure.
The primary outcome of the study - a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT) - will be analysed by means of a linear mixed-effect regression model to account for the longitudinal study design. In particular, each of the four time points represents a fixed effect (implemented with a factor variable) and a random offset for each participants is included in the model allowing to represent the repeated measurements and associated covariance structure.
The analysis of the primary endpoint - the difference in the composite score between baseline and after acute altitude exposure (intervention 1) - will be performed by assessing the pairwise contrast of the estimated marginal means of the linear mixed-effect regression model.
**Measure:** The effect of acute high altitude exposure on medical performance, measured by the STAT score
**Time Frame:** Baseline, intervention 1 (30 minutes after arriving at high altitude)
**Description:** The investigators asses the quality of patient care at low and high altitude exposure.
The primary outcome of the study - a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT) - will be analysed by means of a linear mixed-effect regression model to account for the longitudinal study design. In particular, each of the four time points represents a fixed effect (implemented with a factor variable) and a random offset for each participants is included in the model allowing to represent the repeated measurements and associated covariance structure.
The analysis of the primary endpoint - the difference in the composite score between baseline and after acute altitude exposure (intervention 1) - will be performed by assessing the pairwise contrast of the estimated marginal means of the linear mixed-effect regression model.
**Measure:** The effect of acute high altitude exposure on medical performance, measured by the CALM score
**Time Frame:** Baseline, intervention 1 (30 minutes after arriving at high altitude)
**Description:** The investigators asses the quality of patient care at low and high altitude exposure.
The primary outcome of the study - a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT) - will be analysed by means of a linear mixed-effect regression model to account for the longitudinal study design. In particular, each of the four time points represents a fixed effect (implemented with a factor variable) and a random offset for each participants is included in the model allowing to represent the repeated measurements and associated covariance structure.
The analysis of the primary endpoint - the difference in the composite score between baseline and after acute altitude exposure (intervention 1) - will be performed by assessing the pairwise contrast of the estimated marginal means of the linear mixed-effect regression model.
**Measure:** The effect of acute high altitude exposure on medical performance, measured by the TEAM score
**Time Frame:** Baseline, intervention 1 (30 minutes after arriving at high altitude)
#### Secondary Outcomes
**Description:** The investigators asses any changes to the quality of patient care when participants receive supplementary oxygen during acute high altitude exposure. Since acute effects of high altitude exposure are mainly due to hypobaric hypoxia, supplementary oxygen might improve patient care. Patient care is measured through a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT).
The investigators use the same linear mixed-effect regression model as described under the primary outcome for the assessment of this outcome, but comparing intervention 2 (4 hours after arrival at high altitude, with supplementary oxygen) to baseline) and intervention 1 (at 30 minutes after arrival at high altitude).
**Measure:** The effect of supplementary oxygen on medical performance during acute high altitude exposure, measured as a composite of STAT, CALM, and TEAM scores
**Time Frame:** Baseline, intervention 1 (30 minutes after arriving at high altitude), intervention 2 (4 hours after arriving at high altitude, with supplementary oxygen)
**Description:** The investigators asses the quality of patient care under subacute high altitude exposure, i.e. after having spent a night at high altitude. At the altitude at which the study takes place, 30-40% of participants are expected to develop mild to moderate symptoms of acute mountain sickness, which might impair the quality of patient care they provide. The presence and severity of AMS will be assessed by the Lake Louis Score. AMS is present at a score of 3 or higher. Patient care is measured through a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT).
The investigators use the same linear mixed-effect regression model as described under the primary outcome for the assessment of this outcome, but comparing intervention 3 (after having spent a night at high altitude, no supplementary oxygen) to baseline and intervention 1 (at 30 minutes after arrival at high altitude).
**Measure:** The effect of subacute high altitude exposure on medical performance, measured as a composite of STAT, CALM, and TEAM scores
**Time Frame:** Baseline, intervention 1 (30 minutes after arriving at high altitude), intervention 3 (after having spent a night at high altitude)
**Description:** The impact of age and sex on medical performance during all points of testing (baseline, interventions 1-3) will be analysed by including the interactions of two variables (age and sex) with the fixed effect (representing the four time points) in the linear mixed-effect regression model described under the primary outcome. The statistical significance of the interaction will be assessed with a likelihood ratio test.
Patient care is measured through a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT).
**Measure:** The effect of gender and age on medical performance during low altitude, acute and subacute high altitude exposure, measured as a composite of STAT, CALM, and TEAM scores
**Time Frame:** Baseline, intervention 1 (30 minutes after arriving at high altitude), intervention 2 (4 hours after arriving at high altitude, with supplementary oxygen), intervention 3 (after having spent a night at high altitude)
**Description:** Cognitive functions, such as measured by the psychomotor tests the investigators imply, can be impaired by high altitude exposure. The Psychomotor Vigilance Test (PVT) measures reaction speed in milliseconds. The Balloon Analogue Risk Task (BART) measures risk-taking behaviour in three numerical outcome variables. The Digit Symbol Substitution Test (DSST) measures cognitive performance and has a number of correct answers the participant found as its outcome. Participants will also self-assess their cognitive function on a scale of 1 to 10.
The investigators will look for statistical correlations between the results of psychomotor testing (PVT, BART, DSST) and the self-assessment of cognitive capacity, and the quality of patient care at all four time points (baseline, interventions 1-3). Patient care is measured through a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT).
**Measure:** The correlations between psychomotor test results (PVT, BART, DSST, self-assessment of cognitive function) and medical performance during low altitude, acute and subacute high altitude exposure, measured as a composite of STAT, CALM, and TEAM scores
**Time Frame:** Baseline, intervention 1 (30 minutes after arriving at high altitude), intervention 2 (4 hours after arriving at high altitude, with supplementary oxygen), intervention 3 (after having spent a night at high altitude)
**Description:** The investigators will measure basic vital parameters of participants (blood pressure, heart rate, and peripheral blood oxygen saturation) by non-invasive means at all time points of testing (baseline, interventions 1-3). They will look for correlations between those parameters and the medical performance. Patient care is measured through a composite score comprising three previously validated scores (25% CALM, 25% TEAM, 50% STAT).
**Measure:** The correlations between vital parameters (blood pressure, heart rate, peripheral blood oxygen saturation) and medical performance during low altitude, acute and subacute high altitude exposure, measured as a composite of STAT, CALM, and TEAM scores
**Time Frame:** Baseline, intervention 1 (30 minutes after arriving at high altitude), intervention 2 (4 hours after arriving at high altitude, with supplementary oxygen), intervention 3 (after having spent a night at high altitude)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Medical doctors with certification and experience in preclinical emergency medicine, defined as (all must apply):
* 2 or more years of training in anaesthesiology
* 3 or more months of preclinical work
* 50 or more cases as the lead preclinical physician with potential danger to the patient's life (with a National Advisory Committee for Aeronautics score (NACA) of 4 or more)
* A valid preclinical certification (Swiss "Notarztkurs" or similar)
* Written informed consent to participate in the study
Exclusion Criteria (none must apply):
* Any medical condition known to place the participant at higher risk for hypoxia-induced adverse events (cardiovascular, pulmonary, neurological, otherwise).
* Pre-acclimatisation to high altitude, defined as travel to above 2500 m in the 4 weeks previous to the study
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sven Straumann, MD
**Phone:** 316322111
**Phone Ext:** +41
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Juergen Knapp, PD, MD
**Phone:** 316322111
**Phone Ext:** +41
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bern
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sven Straumann, MD
- **Phone:** +41794622644
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Yves Balmer
- **Phone:** 031 632 27 22
- **Phone Ext:** +41
- **Role:** CONTACT
***Contact 3:***
- **Name:** Juergen Knapp, PD, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Sven Straumann, MD
- **Role:** SUB_INVESTIGATOR
**Country:** Switzerland
**Facility:** Berner Simulations- und CPR-Zentrum BeSiC
**Zip:** 3010
**Location 2:**
**City:** Bern
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Sven Straumann, MD
- **Phone:** 316322111
- **Phone Ext:** +41
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Claudine Frieden
- **Phone:** 31 684 40 52
- **Phone Ext:** +41
- **Role:** CONTACT
***Contact 3:***
- **Name:** Juergen Knapp, PD, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Sven Straumann, MD
- **Role:** SUB_INVESTIGATOR
**Country:** Switzerland
**Facility:** High Altitude Research Station Jungfraujoch
**Zip:** 3012
#### Overall Officials
**Official 1:**
**Affiliation:** University Hospital of Bern (Inselspital), Department of Anaesthesiology and Pain Medicine
**Name:** Juergen Knapp, PD, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** No individual participant data (IPD) will be shared in the primary publication(s). IPD can be made available at a reasonable request.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Luks AM, Beidleman BA, Freer L, Grissom CK, Keyes LE, McIntosh SE, Rodway GW, Schoene RB, Zafren K, Hackett PH. Wilderness Medical Society Clinical Practice Guidelines for the Prevention, Diagnosis, and Treatment of Acute Altitude Illness: 2024 Update. Wilderness Environ Med. 2024 Mar;35(1_suppl):2S-19S. doi: 10.1016/j.wem.2023.05.013. Epub 2023 Dec 27.
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**PMID:** 29352676
**Citation:** Suto T, Saito S, Tobe M, Kanamoto M, Matsui Y. Reduction of Arterial Oxygen Saturation Among Rescuers During Cardiopulmonary Resuscitation in a Hypobaric Hypoxic Environment. Wilderness Environ Med. 2020 Mar;31(1):97-100. doi: 10.1016/j.wem.2019.10.008. Epub 2020 Feb 7.
**PMID:** 32044210
**Citation:** Egger A, Niederer M, Tscherny K, Burger J, Fuhrmann V, Kienbacher C, Roth D, Schreiber W, Herkner H. Influence of physical strain at high altitude on the quality of cardiopulmonary resuscitation. Scand J Trauma Resusc Emerg Med. 2020 Mar 6;28(1):19. doi: 10.1186/s13049-020-0717-0.
**PMID:** 32143653
**Citation:** Vogele A, van Veelen MJ, Dal Cappello T, Falla M, Nicoletto G, Dejaco A, Palma M, Hufner K, Brugger H, Strapazzon G. Effect of Acute Exposure to Altitude on the Quality of Chest Compression-Only Cardiopulmonary Resuscitation in Helicopter Emergency Medical Services Personnel: A Randomized, Controlled, Single-Blind Crossover Trial. J Am Heart Assoc. 2021 Dec 7;10(23):e021090. doi: 10.1161/JAHA.121.021090. Epub 2021 Dec 2.
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**PMID:** 31911060
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**Citation:** Berger MM, Kohne H, Hotz L, Hammer M, Schommer K, Bartsch P, Mairbaurl H. Remote ischemic preconditioning delays the onset of acute mountain sickness in normobaric hypoxia. Physiol Rep. 2015 Mar;3(3):e12325. doi: 10.14814/phy2.12325.
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**Citation:** Luks AM, Swenson ER, Bartsch P. Acute high-altitude sickness. Eur Respir Rev. 2017 Jan 31;26(143):160096. doi: 10.1183/16000617.0096-2016. Print 2017 Jan.
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**Citation:** Kammerer T, Faihs V, Hulde N, Bayer A, Hubner M, Brettner F, Karlen W, Kropfl JM, Rehm M, Spengler C, Schafer ST. Changes of hemodynamic and cerebral oxygenation after exercise in normobaric and hypobaric hypoxia: associations with acute mountain sickness. Ann Occup Environ Med. 2018 Nov 19;30:66. doi: 10.1186/s40557-018-0276-2. eCollection 2018.
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**Citation:** Phillips L, Basnyat B, Chang Y, Swenson ER, Harris NS. Findings of Cognitive Impairment at High Altitude: Relationships to Acetazolamide Use and Acute Mountain Sickness. High Alt Med Biol. 2017 Jun;18(2):121-127. doi: 10.1089/ham.2016.0001. Epub 2017 May 16.
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**Citation:** Issa AN, Herman NM, Wentz RJ, Taylor BJ, Summerfield DC, Johnson BD. Association of Cognitive Performance with Time at Altitude, Sleep Quality, and Acute Mountain Sickness Symptoms. Wilderness Environ Med. 2016 Sep;27(3):371-8. doi: 10.1016/j.wem.2016.04.008. Epub 2016 Jul 22.
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**Citation:** Meier A, Yang J, Liu J, Beitler JR, Tu XM, Owens RL, Sundararajan RL, Malhotra A, Sell RE. Female Physician Leadership During Cardiopulmonary Resuscitation Is Associated With Improved Patient Outcomes. Crit Care Med. 2019 Jan;47(1):e8-e13. doi: 10.1097/CCM.0000000000003464.
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## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4185
- Name: Hypoxia
- Relevance: HIGH
- As Found: Hypoxia
- ID: M7796
- Name: Emergencies
- Relevance: LOW
- As Found: Unknown
- ID: M3873
- Name: Altitude Sickness
- Relevance: HIGH
- As Found: High Altitude
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- 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: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T179
- Name: Acute Mountain Sickness
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000532
- Term: Altitude Sickness
- ID: D000000860
- Term: Hypoxia
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446414
**Brief Title:** Evaluating Implementation and Impact of Provincial Scale-up of the Adapted Choose to Move (CTM) Program
**Official Title:** Provincial Scale-up of Choose to Move: Implementation and Impact Evaluation of an Adapted Health-Promoting Program for Equity-Deserving Older Adults
#### Organization Study ID Info
**ID:** H23-00199
#### Organization
**Class:** OTHER
**Full Name:** University of British Columbia
#### Secondary ID Infos
**Domain:** Public Health Agency of Canada
**ID:** 2223-HQ-000373
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2027-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2027-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Public Health Agency of Canada (PHAC)
#### Lead Sponsor
**Class:** OTHER
**Name:** University of British Columbia
#### Responsible Party
**Investigator Affiliation:** University of British Columbia
**Investigator Full Name:** Heather McKay
**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:** Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. In this project, the investigators will support community-based seniors' services (CBSS) organizations across BC through a readiness-building process so they can adapt CTM and deliver the program to more diverse groups of underserved older adults than have previously participated in CTM.
**Detailed Description:** Choose to Move (CTM) a 3-month, choice-based health-promoting program for low active older adults being scaled-up in phases across British Columbia (BC), Canada. To date (Phases 1-4), CTM participants have included mostly white older women living in large urban centres. In this project, the investigators aim to expand the reach of CTM to more diverse populations of underserved older adults across BC.
Within CTM (Phase 4), trained activity coaches support older adults in two ways. First, in a one-on-one consultation, activity coaches help participants to set goals and create action plans for physical activity tailored to each person's interests and abilities. Older adults can choose to participate in individual or group-based activities. Second, activity coaches facilitate 8 group meetings with small groups of participants.
In this study, the central support unit (CSU) will work with community-based seniors' services (CBSS) organizations across BC to adapt the CTM Phase 4 program to 'best fit' the population of underserved older adults they serve, and build capacity in these organizations to deliver CTM. The investigators will then evaluate the implementation of the adapted programs, and the impact of the adapted programs on older adults' physical and social health.
Objectives:
1. To assess whether CTM (adapted Phase 4) was implemented as planned (fidelity) and investigate factors that support or inhibit its implementation at scale across BC (Part I - Implementation Evaluation).
2. To assess the impact (effectiveness) of CTM (adapted Phase 4) on the physical activity, mobility, and social connectedness of older adult participants (Part II - Impact Evaluation).
Study Design:
The investigators use a hybrid type 2 effectiveness-implementation (Curran et al. 2012) pre-post study design to evaluate the adapted CTM Phase 4 program. The investigators use mixed methods (quantitative and qualitative) and collect data at 0 (baseline) and 3 (post-intervention) months to assess implementation and impact of CTM.
### Conditions Module
**Conditions:**
- Aging
- Mobility Limitation
- Physical Inactivity
- Loneliness
- Social Isolation
**Keywords:**
- Older adults
- Physical activity
- Mobility
- Social isolation
- Loneliness
- Social connectedness
- Behavior change
- Implementation
- Adaptation
- Scale-up
- Health equity
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** CTM (adapted Phase 4) is a 3-month, flexible, choice-based health-promoting program for low active older adults. CTM includes:
1-on-1 Consultation: Participants meet 1-on-1 with their activity coach at the start of the program to set goals and develop a physical activity action plan tailored to their abilities, interests and resources. Older adults can choose to participate in individual or group-based activities.
Group Meetings: Participants will attend eight, 1-hour group-based meetings (max of 15 participants) led by an activity coach. Meetings cover a health-related discussion topic and provide time for social connection among participants. Meetings can be held online or in-person.
Community-based seniors' services organizations that deliver CTM may adapt the program (e.g., deliver in a different language, adapt for cultural or geographical factors) to fit the needs of the older adults they serve but the two components listed above will be retained.
**Intervention Names:**
- Behavioral: Choose to Move
**Label:** Choose to Move
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Choose to Move
**Description:** As described under study arm description
**Name:** Choose to Move
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Number of organizations and older adults participating in adapted CTM programs will be obtained from program records.
**Measure:** Reach-individual
**Time Frame:** 3 months
**Description:** The neighbourhood characteristics of the regions where CTM programs were delivered will be determined using the Canadian Social Environment Topology (CanSET) tool.
**Measure:** Reach-regional
**Time Frame:** 0 months
**Description:** Number of activity coaches trained to deliver the CTM program will be obtained from program records.
**Measure:** Adoption - CTM program
**Time Frame:** 3 months
**Description:** Number of group meetings (0-8) delivered by activity coaches will be assessed by survey (developed in house).
**Measure:** Dose delivered - CTM program (survey)
**Time Frame:** 3 months
**Description:** Fidelity to planned delivery will be assessed via survey (designed in house) for activity coaches and older adult participants. Higher scores (1-5 Likert scale) indicate better adherence to planned delivery.
**Measure:** Fidelity - CTM program (survey)
**Time Frame:** 3 months
**Description:** Fidelity to planned delivery will be assessed via interview with activity coaches and older adult participants.
**Measure:** Fidelity - CTM program (interview)
**Time Frame:** 3 months
**Description:** Program satisfaction will be assessed via participant (older adults) survey (designed in house). Higher scores (1-5 Likert scale) indicate higher participant satisfaction with the intervention.
**Measure:** Participant Responsiveness - CTM program (survey)
**Time Frame:** 3 months
**Description:** Program satisfaction will be assessed via interview with older adult CTM participants.
**Measure:** Participant Responsiveness - CTM program (interview)
**Time Frame:** 3 months
**Description:** Program delivery costs will be recorded using a cost capture template developed in house.
**Measure:** Cost
**Time Frame:** 0, 3 months
**Description:** Extent to which the adapted CTM program can be adapted, tailored, refined, or reinvented to meet local needs will be assessed by survey (4 items each on a 1-5 Likert scale with 1 being completely disagree and 5 being completely agree; developed in house).
**Measure:** Adaptation - CTM program (survey)
**Time Frame:** 3 months
#### Primary Outcomes
**Description:** The single item physical activity questionnaire will be used to measure physical activity. Output variable is self-reported number of days/week ≥30 min physical activity in the past week (range 0-7).
**Measure:** Change in physical activity
**Time Frame:** 0, 3 months
#### Secondary Outcomes
**Description:** Two items will assess participants' ability to walk a quarter of a mile and up 10 steps. The output variable is self- reported presence of mobility-disability (no/any difficulty walking 400m or climbing one flight of stairs).
**Measure:** Change in capacity for mobility
**Time Frame:** 0, 3 months
**Description:** The Physical Functioning Subscale of the SF-36 will be used to assess the physical function aspect of mobility. The measure asks participants to rate if their health limits them in performing 10 different activities. The output variable is an average score (range 0-100) of physical functioning, where a higher score indicates a more favourable health state.
**Measure:** Change in physical functioning
**Time Frame:** 0, 3 months
**Description:** The three-item loneliness scale will be used to assess loneliness. Participants rate three aspects of loneliness. The output variable is loneliness score (range 3-9); lower scores indicate lower levels of loneliness.
**Measure:** Change in loneliness
**Time Frame:** 0, 3 months
**Description:** A four-item questionnaire adapted from two questions on social contact frequency will be used to assess social isolation. The output variable is social isolation score (range 0-20); higher scores indicate lower levels of social isolation.
**Measure:** Change in social isolation
**Time Frame:** 0, 3 months
**Description:** A six-item questionnaire will be used to assess social network. The output variable is an equally weighted sum (range 0-30) where higher scores indicate more social engagement.
**Measure:** Change in social network
**Time Frame:** 0, 3 months
**Description:** A single item will be used to assess sense of belonging as an indicator of social connectedness. The output variable is sense of belonging score (range 1-4) where lower scores indicate a stronger sense of belonging.
**Measure:** Change in social connectedness
**Time Frame:** 0, 3 months
**Description:** A single item will be used to assess frequency (days/week) of physical activity that strengthens bone and/or muscle.
**Measure:** Change in bone- and/or muscle-strengthening physical activity
**Time Frame:** 0, 3 months
**Description:** A single item will be used to assess frequency (days/week) of physical activity that improve balance.
**Measure:** Change in balance-enhancing physical activity
**Time Frame:** 0, 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
* Central support unit staff member
* Activity coach hired by delivery partner organization (activity coaches must speak English to participate in the evaluation);
* English-speaking older adults (aged \>=50 years) who participate in CTM (recruited by delivery partner organizations) will be invited to participate in the evaluation;
* Punjabi-speaking older adults will also be invited to participate in the evaluation if they can read English or Punjabi and/or if the activity coach or a member of the research team has the necessary language skills to ensure effective communication of the Punjabi language translated consent form and surveys.
Exclusion criteria:
* non-English speaking activity coaches
* CTM participants \< 50 years
* CTM participants who do not speak either English or Punjabi
**Healthy Volunteers:** True
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Vancouver
**Country:** Canada
**Facility:** Active Aging Research Team, Robert H. N. Ho Research Centre
**State:** British Columbia
**Zip:** V5Z 1M9
#### Overall Officials
**Official 1:**
**Affiliation:** University of British Columbia
**Name:** Heather McKay, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of British Columbia
**Name:** Joanie Sims Gould, MSW, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
**PMID:** 22310560
**Citation:** Milton K, Bull FC, Bauman A. Reliability and validity testing of a single-item physical activity measure. Br J Sports Med. 2011 Mar;45(3):203-8. doi: 10.1136/bjsm.2009.068395. Epub 2010 May 19.
**PMID:** 20484314
**Citation:** Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
**PMID:** 18504506
**Citation:** Macdonald HM, Nettlefold L, Bauman A, Sims-Gould J, McKay HA. Pragmatic Evaluation of Older Adults' Physical Activity in Scale-Up Studies: Is the Single-Item Measure a Reasonable Option? J Aging Phys Act. 2022 Feb 1;30(1):25-32. doi: 10.1123/japa.2020-0412. Epub 2021 Aug 4.
**PMID:** 34348228
**Citation:** Simonsick EM, Newman AB, Visser M, Goodpaster B, Kritchevsky SB, Rubin S, Nevitt MC, Harris TB; Health, Aging and Body Composition Study. Mobility limitation in self-described well-functioning older adults: importance of endurance walk testing. J Gerontol A Biol Sci Med Sci. 2008 Aug;63(8):841-7. doi: 10.1093/gerona/63.8.841.
**PMID:** 18772472
**Citation:** Veroff JB. The dynamics of help-seeking in men and women: a national survey study. Psychiatry. 1981 Aug;44(3):189-200.
**PMID:** 7267859
**Citation:** Bauer GR, Braimoh J, Scheim AI, Dharma C. Transgender-inclusive measures of sex/gender for population surveys: Mixed-methods evaluation and recommendations. PLoS One. 2017 May 25;12(5):e0178043. doi: 10.1371/journal.pone.0178043. eCollection 2017.
**PMID:** 28542498
**Citation:** Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
**PMID:** 1593914
**Citation:** Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
**PMID:** 20957426
**Citation:** McKay H, Naylor PJ, Lau E, Gray SM, Wolfenden L, Milat A, Bauman A, Race D, Nettlefold L, Sims-Gould J. Implementation and scale-up of physical activity and behavioural nutrition interventions: an evaluation roadmap. Int J Behav Nutr Phys Act. 2019 Nov 7;16(1):102. doi: 10.1186/s12966-019-0868-4.
**PMID:** 31699095
**Citation:** Durlak JA, DuPre EP. Implementation matters: a review of research on the influence of implementation on program outcomes and the factors affecting implementation. Am J Community Psychol. 2008 Jun;41(3-4):327-50. doi: 10.1007/s10464-008-9165-0.
**PMID:** 18322790
**Citation:** Weiner BJ. A theory of organizational readiness for change. Implement Sci. 2009 Oct 19;4:67. doi: 10.1186/1748-5908-4-67.
**PMID:** 19840381
**Citation:** Subedi R, Aitken N, Greenberg L. Canadian Social Environment Typology User Guide. Ottawa, ON: Statistics Canada; 2022.
**Citation:** Scaccia JP, Cook BS, Lamont A, Wandersman A, Castellow J, Katz J, Beidas RS. A practical implementation science heuristic for organizational readiness: R = MC2. J Community Psychol. 2015 Apr;43(4):484-501. doi: 10.1002/jcop.21698. Epub 2015 Apr 13.
**PMID:** 26668443
**Citation:** Miller CJ, Barnett ML, Baumann AA, Gutner CA, Wiltsey-Stirman S. The FRAME-IS: a framework for documenting modifications to implementation strategies in healthcare. Implement Sci. 2021 Apr 7;16(1):36. doi: 10.1186/s13012-021-01105-3.
**PMID:** 33827716
**Citation:** Wiltsey Stirman S, Baumann AA, Miller CJ. The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions. Implement Sci. 2019 Jun 6;14(1):58. doi: 10.1186/s13012-019-0898-y.
**PMID:** 31171014
#### See Also Links
**Label:** Choose to Move website
**URL:** http://choosetomove.ca
**Label:** Active Aging Research Team website
**URL:** http://activeagingrt.ca
## 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: M26689
- Name: Mobility Limitation
- Relevance: HIGH
- As Found: Mobility Limitation
### Condition Browse Module - Meshes
- ID: D000051346
- Term: Mobility Limitation
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446401
**Acronym:** Lead4Care
**Brief Title:** The Case of "Triple" Versus "Double" Therapy for Patients With High Volume Metastatic Hormone Sensitive Prostate Cancer
**Official Title:** Longitudinal Evaluation of Adding Docetaxel to ADT and Novel Hormone Treatment for Patients With High Volume Metastatic Hormone Sensitive Prostate Cancer in Order to Assess Relative Effectiveness: the Case of "Triple" Versus "Double" Therapy
#### Organization Study ID Info
**ID:** 2024-01881-02
#### Organization
**Class:** OTHER
**Full Name:** Uppsala University
### Status Module
#### Completion Date
**Date:** 2031-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-03
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Uppsala University Hospital
**Class:** OTHER
**Name:** University Hospital, Umeå
**Class:** OTHER
**Name:** Sahlgrenska University Hospital, Sweden
**Class:** UNKNOWN
**Name:** Saint Göran Hospital
**Class:** OTHER
**Name:** Swedish Cancer Society
#### Lead Sponsor
**Class:** OTHER
**Name:** Uppsala University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Lead4Care is an observational, open-label, multicenter study evaluating the effectiveness, tolerance, and cost-effectiveness of triple against double therapy in matched groups of mHSPC patients with high tumor burden. In addition to androgen deprivation therapy (ADT), the triple constitutes of docetaxel and novel hormonal therapy (NHT), and the double of NHT therapy in addition to ADT.
Their effectiveness is compared in terms of mortality and morbidity, which is captured by HRQoL, pain, fatigue. Potential side effects are captured by neuropathy, diarrhea, constipation, anxiety, sickness, and dyssomnia. The cost-effectiveness is evaluated within a Markov model from a societal perspective in which the main disease stages are mHSPC, mCRPC and death.
In connection with a regular visit in hospital care, prostate cancer patients who in addition to ADT will initiate double or triple therapy are offered participation in the study. If they consent on-line, they will receive 13 online surveys over a 60-month period. The surveys are sent with an interval of two months for the first six months, quarterly thereafter until two years, and thereafter yearly.
Once all participants have been recruited, the baseline data shared by healthcare personnel and patients will be enriched with registry data. This baseline and registry data involves information about the patients' historical and current health- and socioeconomic status. Thereby, Lead4Care will be able to identify comparable groups of patients on triple and double treatments by using advanced matching methods.
In order to assure an objective analysis, Lead4Care will not allow any data extraction until Lead4Care has predefined and published all details regarding the comparison. The existing protocol is then complemented with information on exactly which patients will be compared across triple and double therapy, and how outcomes will be compared.
For these treatments, the main objectives are to:
* Compare mortality and morbidity on triple and double therapy, and their relative side-effects.
* Capture patient preferences for these different treatment outcomes over time.
* Evaluate cost-effectiveness of triple versus double therapy from a societal perspective.
**Detailed Description:** Comprehensive evaluation:
The treatment landscape of metastatic hormone-sensitive prostate cancer (mHSPC) is evolving rapidly and treatment guidelines often need to be made before the effectiveness of available combinations have been compared. Such is the case for the current recommendation to combine androgen deprivation therapy (ADT) with new hormonal therapy (NHT) and docetaxel (DTX). This triple therapy has not yet been directly evaluated against the alternative of ADT and NHT, i.e., the double therapy. The therapies have only been evaluated indirectly in the trials PEACE-1 and ARASENS. Lead4Care will evaluate triple against double therapy with regard to potential differences in disease progression as well as tolerance. Thereby, Lead4Care will do a comprehensive comparative effectiveness (CE) evaluation which can contribute to the pool of evidence important for future guidelines.
Observational design:
Lead4Care leaves the treatment choice to the clinicians and the patients, and uses advanced matching methods to ensure comparability between patients receiving triple- and double therapy. As the groups are expected to differ in terms of their tolerance to DTX, and the doctors' valuation of tolerance differ, Lead4Care expect to be able to identify such matching groups on a subset of enrolled patients. The matched groups will be used for the CE evaluation. Patients will consequently be enrolled and followed prospectively irrespective of which therapy the clinicians will choose, and similar groups will be matched especially with regard to their tolerance to DTX as proxied by their age, comorbidity, ECOG collected within Lead4Care but also in terms of their health- and socioeconomic status (SES) in general requested from national registries. The matched groups will be as similar as expected in a randomized experiment in terms of tolerance in particular, but also in terms of health, and SES. Consequently, there is no need for randomization to ensure comparability, using this study design.
Lean observational design:
The additional data that prospective studies usually collect from healthcare, can pose an administrative burden on healthcare workers. Lead4Care has therefore invested considerable effort in developing the study design which leaves few tasks to healthcare workers, i.e., only screen the patient population and report the baseline data. Instead, Lead4Care will take responsibility for all future contact with the patients according to the study protocol. This involves supporting patients in consenting to the study and in reporting their symptoms, tolerance, and progressions in the 13 on-line questionnaires. The patients will hold a patient paper diary with such critical information that the study ask the patients to remember from healthcare visits, i.e., the date and levels for PSA:s, the date for castration resistant, and the date for next treatment. Lead4Care will therefore test a design that minimizes the burden on healthcare systems and which could remove some of the administrative barriers for CE evaluations.
Pain focus:
Recent research suggests that improved pain awareness could potentially reduce the risk of SREs and/or mortality. The rationale behind this is that pain seems to serve as an indicator of development of bone metastasis as the disease advances. Adequate disease management and properly pain control can help mitigate skeleton-related events (SRE), which, in turn, can impact mortality rates. For that reason, Lead4Care will evaluate pain differences across the treatments, and explore how these pain differences potentially can predict SRE and/or mortality.
Cost-effective care:
In Sweden, the cost for prostate cancer consumes a considerable part (12%) of our cancer related healthcare costs, which in in turn constitute 3% of the total healthcare costs. Choosing cost-effective prostate cancer treatments could consequently have a visible impact on Swedish healthcare costs. Lead4Care will therefore evaluate the triple- against the double therapy from a health-economic perspective. The additional cost for adding DTX and treating its potential complications (neurotoxicity, GI side-effects, osteoporosis etc.) will be compared against the difference in quality adjusted life years (QALY). This ratio is used within Sweden for prioritization of scarce resources. Lead4Care can therefore serve as a model for the health-economic (HE) evaluations, which becomes increasingly important as the availability of prostate cancer treatments is increasing.
Patient-centered care:
In healthcare, there is often a dilemma since treatments for prostate cancer can provide survival benefits for the patients but at potential HRQoL loss. For instance, patients who undergo surgery improve their survival but their HRQoL may worsen because of complications. Moreover, patients who receive DTX in the triple therapy may improve their survival but their HRQoL may worsen because of side-effects. Lead4Care has therefore developed an instrument together with patients which captures patients' treatment preferences. This instrument will ascertain patients' preferences for life prolonging or HRQoL improving treatments. Lead4Care will therefore help us better understand the population's treatment preferences. This information is important in order to better take the patients preferences into account in planning their care, just as is required in the Swedish Patient Act.
Objectives:
With the implementation of Lead4Care, the hope is to achieve the following objectives:
To evaluate the clinical effectiveness of triple- versus double therapy in matched groups of mHSPC patients with high tumour burden.
To evaluate the tolerance of triple- versus double therapy in matched groups of mHSPC patients with high tumour burden.
To describe the patients' treatment preferences (gain in survival against loss of HRQoL) for mHSPC patients with high tumour burden.
To describe the cost-effectiveness of adding DTX for mHSPC-patients with high tumour burden.
To evaluate the clinical effectiveness of triple- versus double therapy in matched sub-groups of mHSPC patients with high tumour burden (e,g, w/wo visceral metastases).
To explore the way pain proxy for or predict SRE and survival for mHSPCpatients with high tumour burden with baseline bone metastases.
### Conditions Module
**Conditions:**
- Prostate Cancer
**Keywords:**
- Prostate cancer, mHSPC, Comparative effectiveness evaluation,Triple therapy, Double therapy
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 1400
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with mHSPC and high tumour burden receiving treatment with androgen deprivation treatment, new hormone therapy (abiraterone, apalutamide, enzalutamide or darolutamide) and docetaxel.
**Intervention Names:**
- Drug: Prescription Docetaxel
**Label:** Triple therapy
#### Arm Group 2
**Description:** Patients with mHSPC and high tumour burden receiving treatment with androgen deprivation treatment and new hormone therapy (abiraterone, apalutamide, enzalutamide or darolutamide).
**Label:** Double therapy
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Triple therapy
**Description:** Lead4Care leaves the treatment choice to the clinicians and the patients, i.e., does not intervene in their choice of treatment. However, Lead4Care proxy a randomized controlled experiment in which the intervention would be to add docetaxel to androgen deprivation treatment, new hormone therapy (abiraterone, apalutamide, enzalutamide or darolutamide). This involves a comparison of triple and double therapies.
**Name:** Prescription Docetaxel
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** PC-HRQoL is a patient reported outcome measurement captured by FACT-F and 1 additional question in the patient reported survey data.
To understand whether the PC-HRQoL differences across the treatments are also clinically significant, we have included Patient Global Impression of HRQoL Change (PGI-C). Thereby, the Minimal Important Differences (MIDs) for the different HRQoL measurements can be derived.
**Measure:** Prostate cancer specific health-related quality of life (PC-HRQoL)
**Time Frame:** Measured at baseline and month 6, 12, 18, 24, 36, 48 and 60.
**Description:** HRQoL is a patient reported outcome measurement captured by EuroQol's 5Q-5D-5L and 1 additional question added by the researchers.
**Measure:** General Health-Related Quality of life (HRQoL)
**Time Frame:** Measured at baseline and month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48 and 60.
**Description:** Side effects is a patient reported outcome measurement captured by FACT-GOG-NTX and 7 additional questions developed by the researchers relating to GI-symptoms, sleep disturbances, nervous tensions (anxiety) and medical infections.
**Measure:** Side effects
**Time Frame:** Measured at baseline and month 2, 4, 6, 9, 12, 15, 18, 21, 24 36, 48 and 60.
**Description:** SRE measured through Swedish registers and is assumed to have occurred if the patient experiences a hospitalization due to a pathologic fracture (ICD codes M485, M495, M844 and M907) or spinal cord compression (ICD codes G550, G834, G952, G958, G959 and G992).
**Measure:** Skeleton Related Events (SRE)
**Time Frame:** Measured at month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48, 60 and thereafter annually until month 144 (12 years).
**Description:** We measure the patient tolerance for quality of life deterioration in order to gain length of life. The instrument has been developed in collaboration with patients along with input from researchers and healthcare professionals. The measurement is in captured by the patient reported survey data.
**Measure:** Treatment preferences trade-off
**Time Frame:** Measured at baseline and month 6, 12, 18, 24, 36, 48 and 60.
#### Primary Outcomes
**Description:** Death due to any causes, i.e., overall survival (OS). captured by the Swedish National Cause of Death Register.
**Measure:** Mortality
**Time Frame:** : Measured at month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48, 60 and thereafter annually until month 144 (12 years).
#### Secondary Outcomes
**Description:** Aspects of pain is a patient reported outcome measurement captured by both The McGill Pain Questionnaire and 4 additional questions related to different aspects of pain added by the researchers.
To understand whether the pain differences across the treatments are also clinically significant, we have included Patient Global Impression of Pain Change (PGI-C). Thereby, the Minimal Important Differences (MIDs) for the different pain measurements can be derived.
**Measure:** Pain intensity
**Time Frame:** Measured at baseline and month 6, 12, 18, 24, 36, 48, and 60.
**Description:** Aspects of fatigue is a patient reported outcome measurement captured by both the fatigue domain of FACIT-F and 4 additional questions related to different aspects of fatigue added by the researchers.
To understand whether the fatigue differences across the treatments are also clinically significant, we have included Patient Global Impression of Fatigue Change (PGI-C). Thereby, the Minimal Important Differences (MIDs) for the different fatigue measurements can be derived.
**Measure:** Fatigue
**Time Frame:** Measured at baseline and month 2, 4, 6, 12, 18, 24, 36, 48 and 60.
**Description:** Time until the patients' prostate cancer becomes castration resistant (mCRPC) is based on patient-reported survey data regarding the elevation of their PSA-levels.
**Measure:** Time to progression
**Time Frame:** Measured at month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48 and 60.
**Description:** Time until the patient receives first line treatment for mCRPC is captured by patient reported survey data regarding their start of new treatment for their prostate cancer.
**Measure:** Time to first line treatment of mCRPC
**Time Frame:** Measured at month 2, 4, 6, 9, 12, 15, 18, 21, 24, 36, 48, 60 and thereafter annually until month 144 (12 years).
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Patients eligible for inclusion in this study must meet all of the following criteria:
* Patients should have initiated triple or double therapy no longer than 3 months from the start of ADT,
* Patients must have mHSPC at the time of enrolment, and visceral metastases or four or more bone metastases (of which at least one is outside the axial skeleton.
* Patients must be ≥ 18 years old at the time of enrolment. Note: NHT could be abiraterone acetate, apalutamide, darolutamide or enzalutamide.
Exclusion Criteria:
Participants meeting any of the of the following criteria are not eligible for inclusion:
* Patients who do not understand written and/or oral instructions in Swedish.
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients with mHSPC and high tumor burden initiating treatment with triple or double therapy. High metastatic burden being defined as either visceral metastases or four or more bone metastases of which at least one outside the axial skeleton.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sophie Langenskiöld, SRLECT & PhD
**Phone:** +4673 469 77 64
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Vincent Nordgren, PhD-student
**Phone:** +4673 469 77 65
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Uppsala
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ingrida Verbiené, MD and PhD
- **Phone:** +4673 68 69 248
- **Role:** CONTACT
**Country:** Sweden
**Facility:** Uppsala University Hospital
**State:** Region Uppsala
**Zip:** 751 85
#### Overall Officials
**Official 1:**
**Affiliation:** Uppsala University
**Name:** Sophie Langenskiöld, SRLECT & PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## 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
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
### Intervention Browse Module - Ancestors
- 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: M1668
- Name: Docetaxel
- Relevance: HIGH
- As Found: Physical
- ID: M4059
- Name: Androgens
- Relevance: LOW
- As Found: Unknown
- ID: M9789
- Name: Hormones
- 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: D000077143
- Term: Docetaxel
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446388
**Brief Title:** Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors
**Official Title:** A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 and/or QL1706 Combination Chemotherapy for the Treatment of CLDN18.2-Positive Advanced Malignant Solid Tumors
#### Organization Study ID Info
**ID:** QLS31905-202
#### Organization
**Class:** INDUSTRY
**Full Name:** Qilu Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2027-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-01
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Qilu Pharmaceutical Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.
### Conditions Module
**Conditions:**
- Advanced Solid Tumor
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 360
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine.
**Intervention Names:**
- Drug: QLS31905
- Drug: Oxaliplatin
- Drug: Capecitabine
**Label:** QLS31905 + oxaliplatin + capecitabine
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Gastric/gastroesophageal junction cancer participants will be treated with QL1706 in combination with oxaliplatin and capecitabine.
**Intervention Names:**
- Drug: Oxaliplatin
- Drug: Capecitabine
- Drug: QL1706
**Label:** QL1706 + oxaliplatin + capecitabine
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Gastric/gastroesophageal junction cancer participants will be treated with QLS31905 at doses determined by the phase I study in combination with oxaliplatin and capecitabine+ QL1706.
**Intervention Names:**
- Drug: QLS31905
- Drug: Oxaliplatin
- Drug: Capecitabine
- Drug: QL1706
**Label:** QLS31905 + oxaliplatin + capecitabine + QL1706
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin.
**Intervention Names:**
- Drug: QLS31905
- Drug: Gemcitabine
- Drug: Cisplatin
**Label:** QLS31905 + gemcitabine+cisplatin
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** Biliary tract cancer will be treated with QL1706 in combination with gemcitabine and cisplatin.
**Intervention Names:**
- Drug: Gemcitabine
- Drug: Cisplatin
- Drug: QL1706
**Label:** QL1706 + gemcitabine+cisplatin
**Type:** EXPERIMENTAL
#### Arm Group 6
**Description:** Biliary tract cancer will be treated with QLS31905 at doses determined by the phase I study in combination with gemcitabine and cisplatin+ QL1706.
**Intervention Names:**
- Drug: QLS31905
- Drug: Gemcitabine
- Drug: Cisplatin
- Drug: QL1706
**Label:** QLS31905 + gemcitabine+cisplatin+ QL1706
**Type:** EXPERIMENTAL
#### Arm Group 7
**Description:** Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy recommended by guidelines.
**Intervention Names:**
- Drug: QLS31905
- Drug: Chemotherapy drug
**Label:** QLS31905 + standard chemotherapy
**Type:** EXPERIMENTAL
#### Arm Group 8
**Description:** Other solid tumor participants will be treated with QL1706 in combination with standard chemotherapy recommended by guidelines.
**Intervention Names:**
- Drug: QL1706
- Drug: Chemotherapy drug
**Label:** QL1706 + standard chemotherapy
**Type:** EXPERIMENTAL
#### Arm Group 9
**Description:** Other solid tumor participants will be treated with QLS31905 at doses determined by the phase I study in combination with standard chemotherapy and QL1706.
**Intervention Names:**
- Drug: QLS31905
- Drug: QL1706
- Drug: Chemotherapy drug
**Label:** QLS31905 + standard chemotherapy + QL1706
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- QLS31905 + gemcitabine+cisplatin
- QLS31905 + gemcitabine+cisplatin+ QL1706
- QLS31905 + oxaliplatin + capecitabine
- QLS31905 + oxaliplatin + capecitabine + QL1706
- QLS31905 + standard chemotherapy
- QLS31905 + standard chemotherapy + QL1706
**Description:** Administered as an intravenous infusion.
**Name:** QLS31905
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- QL1706 + oxaliplatin + capecitabine
- QLS31905 + oxaliplatin + capecitabine
- QLS31905 + oxaliplatin + capecitabine + QL1706
**Description:** 130 mg/m2, intravenous infusion, D1, up to 8 cycles.
**Name:** Oxaliplatin
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- QL1706 + oxaliplatin + capecitabine
- QLS31905 + oxaliplatin + capecitabine
- QLS31905 + oxaliplatin + capecitabine + QL1706
**Description:** 1000 mg/m2, oral, bid, D1-D14
**Name:** Capecitabine
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- QL1706 + gemcitabine+cisplatin
- QLS31905 + gemcitabine+cisplatin
- QLS31905 + gemcitabine+cisplatin+ QL1706
**Description:** 1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
**Name:** Gemcitabine
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- QL1706 + gemcitabine+cisplatin
- QLS31905 + gemcitabine+cisplatin
- QLS31905 + gemcitabine+cisplatin+ QL1706
**Description:** 25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
**Name:** Cisplatin
**Type:** DRUG
#### Intervention 6
**Arm Group Labels:**
- QL1706 + gemcitabine+cisplatin
- QL1706 + oxaliplatin + capecitabine
- QL1706 + standard chemotherapy
- QLS31905 + gemcitabine+cisplatin+ QL1706
- QLS31905 + oxaliplatin + capecitabine + QL1706
- QLS31905 + standard chemotherapy + QL1706
**Description:** 5 mg/kg, intravenous infusion,D1
**Name:** QL1706
**Type:** DRUG
#### Intervention 7
**Arm Group Labels:**
- QL1706 + standard chemotherapy
- QLS31905 + standard chemotherapy
- QLS31905 + standard chemotherapy + QL1706
**Description:** Standard chemotherapy recommended by guidelines.
**Name:** Chemotherapy drug
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR)
**Measure:** Objective response rate (ORR)
**Time Frame:** Approximately 24 months
#### Secondary Outcomes
**Description:** An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom,or disease (new or exacerbated) temporally associated with the use of a medicinal product.
**Measure:** Safety assessed by Adverse Events (AEs)
**Time Frame:** Approximately 24 months
**Description:** Adverse Event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect,hospitalization, or medically important event.
**Measure:** Safety assessed by incidence of serious adverse events (SAE)
**Time Frame:** Approximately 24 months
**Description:** Number of participants with potentially clinically significant laboratory values.
**Measure:** Number of participants with laboratory value abnormalities
**Time Frame:** Approximately 24 months
**Description:** DOR is defined as the time from the date of the first response (CR/PR) until the date of radiological progressive disease or death due to any cause (whichever occurs first).
**Measure:** Duration of Response (DOR)
**Time Frame:** Approximately 24 months
**Description:** PFS is defined as the duration from the subject's first dose of the investigational product to the first imaging confirmation of radiological progressive disease or death due to any cause (whichever occurs first).
**Measure:** Progression Free Survival(PFS)
**Time Frame:** Approximately 24 months
**Description:** OS is defined as the duration from the first dose of the investigational product to the time point when death occurs due to any cause.
**Measure:** Overall Survival (OS)
**Time Frame:** Approximately 24 months
**Description:** Cmax will be derived from the PK serum samples collected.
**Measure:** Maximum concentration (Cmax)
**Time Frame:** Approximately 24 months
**Description:** Tmax will be derived from the PK serum samples collected.
**Measure:** Time of the maximum concentration (Tmax)
**Time Frame:** Approximately 24 months
**Description:** T1/2 will be derived from the PK serum samples collected.
**Measure:** Terminal elimination half-life (T1/2)
**Time Frame:** Approximately 24 months
**Description:** CL will be derived from the PK serum samples collected.
**Measure:** Clearance (CL)
**Time Frame:** Approximately 24 months
**Description:** Vz will be derived from the PK serum samples collected.
**Measure:** Apparent volume of distribution during the terminal phase (Vz)
**Time Frame:** Approximately 24 months
**Description:** Immunogenicity will be measured by the number of participants that are ADA positive.
**Measure:** Number of anti-drug antibody (ADA) Positive Participants
**Time Frame:** Approximately 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects voluntarily participate in the study and sign the informed consent form;
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
* Expected survival time ≥ 3 months;
* Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors;
* No prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease;
* Tumor tissue samples determined to be positive for Claudin18.2 by immunohistochemistry (IHC);
* At least one measurable lesion per RECIST v1.1;
* Patients with adequate cardiac, liver, renal function, etc.
Exclusion Criteria:
* History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
* Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
* Known central nervous system metastases;
* Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test; Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse;
* Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lin Shen, M.D
- **Phone:** 010-881965671
- **Role:** CONTACT
**Country:** China
**Facility:** Beijing Cancer Hospital
**State:** Beijing
**Zip:** 100142
## Derived Section
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- 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: M6182
- Name: Cisplatin
- Relevance: LOW
- As Found: Unknown
- ID: M2985
- Name: Gemcitabine
- Relevance: HIGH
- As Found: Activity
- ID: M377
- Name: Capecitabine
- Relevance: HIGH
- As Found: Imaging
- ID: M1674
- Name: Oxaliplatin
- Relevance: HIGH
- As Found: Min
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000093542
- Term: Gemcitabine
- ID: D000069287
- Term: Capecitabine
- ID: D000077150
- Term: Oxaliplatin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446375
**Brief Title:** FIFA 11+ Kids Training Protocol and Physical Performance
**Official Title:** Effects of FIFA 11+ Kids Training Protocol on Motor Competence and Physical Performance in Youth Female Volleyball Players: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 2023.48.03.07
#### Organization
**Class:** OTHER
**Full Name:** Princess Nourah Bint Abdulrahman University
### Status Module
#### Completion Date
**Date:** 2023-12-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-08-10
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-01
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Namik Kemal University
#### Lead Sponsor
**Class:** OTHER
**Name:** Princess Nourah Bint Abdulrahman University
#### Responsible Party
**Investigator Affiliation:** Princess Nourah Bint Abdulrahman University
**Investigator Full Name:** Monira Aldhahi
**Investigator Title:** Associate professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study evaluates the FIFA 11+ Kids Training Protocol, specifically its application to young female volleyball players. It compares it against standard warm-up routines in terms of enhancing motor skills and physical performance. The research anticipates that the FIFA 11+ principles will yield positive outcomes when integrated with existing knowledge of volleyball performance metrics. The study involved 34 young female volleyball players divided into an exercise group (15 players) and a control group (19 players). Initial assessments included anthropometric measurements and motor competence tests such as balancing backward, jumping sideways, moving sideways, and eye-hand coordination (KTK3+ tests).
Subsequent sessions focused on physical and functional tests, including balance performance, agility (pro-agility test), vertical jump (countermovement jump test), and the functional movement screen (FMS) test. A two-way analysis of variance was used to compare the effects of the exercise versus the control group over time, revealing that the exercise group showed significant improvements in dynamic balance, KTK balancing backward, and KTK moving sideways. This study aims to provide innovative insights into the effectiveness of the FIFA 11+ Kids Training Protocol, highlighting its potential benefits in improving physical and motor competencies in young female volleyball players.
**Detailed Description:** Although direct studies on the FIFA 11+ Kids Training Protocol specifically for young female volleyball players are scarce, the program's principles are anticipated to enhance motor skills and physical performance. This study seeks to investigate the potential benefits of applying the FIFA 11+ principles, along with existing insights into motor skills and physical performance in volleyball, to young female players. The objective is to assess how the FIFA 11+ Kids Training Protocol affects motor competence and physical performance. This research aspect is expected to contribute innovative findings to existing literature. The study aimed to determine the effects of the FIFA 11+Kids warm-up program and standard warm-up program on motor competence and physical performance elements of young female volleyball players. A total of 34 volleyball players will complete all the measurement and exercise processes and participate in the post-tests. The experimental design involved participants being randomly assigned to exercise (EG; n=15) and control (CG; n=19) groups. In the first session, anthropometric measurements, including height and body weight, will be measured. Following that, motor competence tests, namely balancing backward, jumping sideways, moving sideways, and eye-hand coordination tests (KTK3+), were measured sequentially. On the second session, physical and functional tests were conducted. These included balance performance measurements, agility test (pro-agility), vertical jump test (countermovement jump test), and functional movement screen (FMS) test. The two-way analysis of variance will be conducted to determine whether being in the exercise group had a significant effect on test scores for mixed measurements, the group-time interaction showed that the exercise group's score increase was significantly higher than that of the control group in dynamic balance, KTK balancing backward and KTK movie sideways parameters
### Conditions Module
**Conditions:**
- Volleyball
- Balance
- Agility
- Functional Capacity
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 39
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** FIFA 11+ KIDS Training Protocol will be conducted by the experimental group twice a week for 8 weeks with 15-20-minute interventions. Volleyball players continued their standard volleyball training after the training protocol.
**Intervention Names:**
- Other: exercise
**Label:** The experimental Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control group will continue their regular volleyball training interventions. All tests were conducted at the same time of day (13:30-16:30) to minimize the impact of circadian rhythms on the results.
**Intervention Names:**
- Other: exercise
**Label:** Control Group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control Group
- The experimental Group
**Description:** FIFA 11+ KIDS Training Protocol .consists of seven different exercises: three for unilateral, dynamic stability of the lower limbs (hopping, jumping and landing); three for whole body and trunk strength/stability; and one exercise on falling technique.
**Name:** exercise
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Countermovement Jump (CMJ) values of all participants will be measured. Peak muscle power measures in watts (W) using the Accupeak power2.0 portable force platform system (Accupeak power2.0, USA). The measurement frequency of the device was set to 500 Hz. Participants will undrergo a 10-minute warm-up program before completing a CMJ. Participants will be asked to begin a downward movement and jump as high as possible after hearing a tone from the computer.
**Measure:** Peak power and jump height measurement
**Time Frame:** at baseline and end of 8 week
**Description:** The Body coordination test for children (KTK3+ test battery, supported by a hand-eye coordination task), will be used to assess children's motor competence. KTK3 measures general gross motor coordination . The test include backward balancing (BB), sideways movement (MS), sideways jumping (JS), and hand-eye coordination task (EHC).
**Measure:** The Body coordination test
**Time Frame:** at baseline and end of 8 week
**Description:** Static and dynamic balance parameters were assessed using a mobile platform that provides an interactive training tool (SensBalance Miniboard; Sensamove®, Utrecht, Netherlands).Participants performed measurements of static and dynamic balance parameters on the mobile platform for 30 seconds in two trials. The highest score from the two trials was used in the statistical analysis.
**Measure:** Balance tests
**Time Frame:** at baseline and end of 8 week
**Description:** The test course set with markers placed 5 yards (4.57m) to the left and right of the starting line, with indicators (motivational for the participants' age) placed accordingly. A photocell gate was placed at the starting line to record repeated passage times. Before the start of the application, the participant took their position at the starting line. When ready, they touched the marker on the right first, then the marker on the left, and finally crossed the starting line to finish the test. Measurements will be conducted in two trials.
**Measure:** Pro-agility test
**Time Frame:** at baseline and end of 8 week
**Description:** The Functional Movement Screening (FMS)™ system, developed by Gray Cook, Lee Burton and Keith Fields, is a system used to determine potential injury risk in athletes and the quality of individuals' movement patterns, to assess poor neuromuscular control and to improve athletic performance. The Functional Movement Screening test consists of 7 different basic movements (deep squat, hurdle step, single line step, shoulder mobility, active straight leg raise, trunk stability push-up, rotation stability). Scoring for FMS consists of four different possibilities. Scores range from zero to three, with three being the best possible score. The maximum score for the FMS test is 21.
**Measure:** Functional Movement Screen Test Protocol
**Time Frame:** at baseline and end of 8 week
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Children between age of 11 -13 years old
* typically developing children
* participants should not be using any medication
* Free of any history of cardiovascular disease
Exclusion Criteria:
* Intake of performance-enhancing drugs, anabolic steroids
* Any history of injury, or physiological or physical limitations that could affect the ability to perform training and physical testing in the last year.
**Healthy Volunteers:** True
**Maximum Age:** 13 Years
**Minimum Age:** 11 Years
**Sex:** FEMALE
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Riyadh
**Country:** Saudi Arabia
**Facility:** Monira Aldhahi
**Zip:** 12341
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446362
**Brief Title:** Client-Centered Breastfeeding Support: Effects on Primipara Mothers in a Randomized Trial Breastfeeding Self-Efficacy, Attitudes, and Problems in Primiparous Mothers: A Randomized Controlled Trial
**Official Title:** The Effect of an Interaction Model of a Client Health Behavior-Based Breastfeeding Support Program on Breastfeeding Self-Efficacy, Attitudes, and Problems in Primiparous Mothers: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 10.186.1.145 111 7.02.2024
#### Organization
**Class:** OTHER
**Full Name:** Pamukkale University
### Status Module
#### Completion Date
**Date:** 2026-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-01
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Pamukkale University
#### Responsible Party
**Investigator Affiliation:** Pamukkale University
**Investigator Full Name:** Muberra Altun
**Investigator Title:** ABD 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:** Study Description
The goal of this randomized controlled trial is to examine the effects of a client health behavior interaction model-based breastfeeding support program on breastfeeding self-efficacy, attitudes, and problems in primipara mothers. The main questions it aims to answer are:
1. How does the program influence mothers' self-efficacy in breastfeeding?
2. What impact does the program have on mothers' attitudes towards breastfeeding and the problems they encounter?
Participants will:
1. Receive breastfeeding support through an interactive health behavior model.
2. Participate in assessments of their breastfeeding self-efficacy and attitudes at designated intervals throughout the study duration.
There is a comparison group:
1. Researchers will compare the intervention group (mothers receiving the structured program) to a control group (mothers receiving standard care) to see if there is a significant difference in outcomes related to breastfeeding self-efficacy, attitudes, and encountered problems.
**Detailed Description:** Study Title:
The Effect of an Interaction Model of a Client Health Behavior-Based Breastfeeding Support Program on Breastfeeding Self-Efficacy, Attitudes, and Problems in Primiparous Mothers: A Randomized Controlled Trial
Objective:
The primary aim of this study is to investigate the impact of a breastfeeding support program, based on a client health behavior interaction model, on the breastfeeding self-efficacy, attitudes, and problems of first-time mothers.
Background:
Breastfeeding is recognized as the gold standard for infant nutrition, offering numerous health benefits to both infants and mothers. Despite its benefits, breastfeeding rates remain suboptimal globally, with many mothers encountering challenges that hinder breastfeeding practices. Innovative support programs are necessary to enhance breastfeeding self-efficacy and improve attitudes towards breastfeeding, especially among primipara mothers.
Study Design:
This study is a randomized controlled trial with a pretest-posttest design. The study will be conducted at Family Health Centers in Denizli, Turkey, from September 2024 to December 2026.
Population:
The study will include primipara mothers who are between 32 and 40 weeks of gestation at the time of recruitment. Participants will be randomly assigned to either the intervention group or the control group.
Intervention:
The intervention group will receive a structured breastfeeding support program based on the Interaction Model of Client Health Behavior (IMCHB). This program includes:
* Educational Sessions: In-person sessions and educational materials (brochures and videos) provided during the last trimester of pregnancy.
* Motivational Interviews: Five face-to-face motivational interviews conducted postpartum at specific intervals (1-3 days, 15 days, 30 days, 45 days, and 60 days after birth) to address individual challenges and provide tailored support.
* Follow-Up Support: Two additional follow-up sessions via WhatsApp video calls at 4 months and 5 months postpartum to reinforce the intervention and provide ongoing support.
Control Group:
The control group will receive the standard care provided at Family Health Centers, which includes routine breastfeeding education and support, without the additional structured program.
Data Collection:
Data will be collected at multiple time points:
* Baseline (32-36 weeks of gestation): Initial assessment of demographic information, breastfeeding self-efficacy, and attitudes.
* Postpartum Assessments: Data collection at 1-3 days, 15 days, 30 days, 45 days, 60 days, 3 months, and 6 months postpartum using structured questionnaires and scales.
Key Components of the Intervention:
* Educational Content: Development and dissemination of educational materials based on the IMCHB model, addressing common breastfeeding issues and techniques.
* Motivational Interviewing: Conducted by trained health professionals, focusing on enhancing motivation and addressing barriers to successful breastfeeding.
Support Tools: Use of mobile communication (WhatsApp) to provide additional support and ensure accessibility.
Outcomes:
The primary outcomes include changes in breastfeeding self-efficacy and attitudes, as measured by validated scales. Secondary outcomes involve the frequency and nature of breastfeeding problems reported by participants.
Hypotheses:
1. Mothers in the intervention group will demonstrate higher breastfeeding self-efficacy compared to the control group.
2. Mothers in the intervention group will have more positive attitudes towards breastfeeding compared to the control group.
3. Mothers in the intervention group will report fewer breastfeeding problems compared to the control group.
Statistical Analysis:
Data will be analyzed using the Statistical Package for the Social Sciences (SPSS). Descriptive statistics will summarize the demographic data. Comparative analyses (e.g., t-tests, ANOVA) will be conducted to evaluate differences between the intervention and control groups. Longitudinal data will be analyzed using repeated measures ANOVA to assess changes over time.
Ethical Considerations:
The study has received approval from the Pamukkale University Non-Interventional Clinical Research Ethics Committee. Informed consent will be obtained from all participants. Confidentiality and data security measures will be strictly followed throughout the study.
### Conditions Module
**Conditions:**
- This Study Evaluates the Impact of a Breastfeeding Support Program Based on the IMCHB on Primipara Focusing on Breastfeeding Self-efficacy and Attitudes
**Keywords:**
- Breastfeeding Self-Efficacy
- Breastfeeding Support
- Client Health Behavior
- Motivational Interviewing
- Breastfeeding Attitudes
- Breastfeeding Problems
- Infant Nutrition
- Maternal Confidence
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This randomized controlled trial (RCT) evaluates the impact of a client health behavior interaction model-based breastfeeding support program on primipara mothers. Participants are randomly assigned to either the intervention group, which receives structured support including educational sessions, motivational interviews, and follow-up via WhatsApp, or the control group, which receives standard care. The study focuses on measuring changes in breastfeeding self-efficacy, attitudes, and problems in the first six months postpartum.
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** This study employs a double-blind masking approach. Participants, care providers, and investigators are blinded to intervention allocation. The outcomes assessor, responsible for evaluating primary and secondary outcomes, is also blinded to group assignments. This minimizes bias and ensures objective assessment of breastfeeding self-efficacy, attitudes, and problems. Masking is maintained through coded intervention materials and separate teams for intervention delivery and outcome assessment.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 45
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in this arm will receive a structured breastfeeding support program based on the Interaction Model of Client Health Behavior (IMCHB). This program includes:
Educational Sessions: Conducted during the last trimester of pregnancy. Motivational Interviews: Conducted face-to-face postpartum at 1-3 days, 15 days, 30 days, 45 days, and 60 days.
Follow-Up Support: Two additional follow-up sessions via WhatsApp video calls at 4 and 5 months postpartum.
**Intervention Names:**
- Behavioral: IMCHB-Based Breastfeeding Support Program
**Label:** IMCHB-Based Support Program
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in this arm will receive the standard care provided at Family Health Centers, which includes routine breastfeeding education and support. This standard care does not include the structured and additional support interventions provided to the experimental group.
**Intervention Names:**
- Behavioral: Standard Breastfeeding Education
**Label:** Standard Care
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- IMCHB-Based Support Program
**Description:** This intervention includes a structured breastfeeding support program based on the Interaction Model of Client Health Behavior (IMCHB). It consists of:
Educational Sessions: Conducted during the last trimester of pregnancy to provide information and prepare mothers for breastfeeding.
Motivational Interviews: Conducted face-to-face at 1-3 days, 15 days, 30 days, 45 days, and 60 days postpartum to address individual challenges and provide personalized support.
Follow-Up Support: Two follow-up sessions via WhatsApp video calls at 4 and 5 months postpartum to reinforce the intervention and provide ongoing assistance.
**Name:** IMCHB-Based Breastfeeding Support Program
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Standard Care
**Description:** Participants receive the standard care provided at Family Health Centers, which includes routine breastfeeding education and support typically offered to new mothers. This standard care does not include the additional structured support interventions provided in the IMCHB-Based Breastfeeding Support Program.
**Name:** Standard Breastfeeding Education
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** The proportion of infants exclusively breastfed, defined as receiving only breast milk with no supplementary liquids or solids, except for vitamins, minerals, or medications.
**Measure:** Exclusive Breastfeeding Rate
**Time Frame:** Assessed at 1-3 days, 15 days, 30 days, 45 days, 60 days, 3 months, and 6 months postpartum.
#### Primary Outcomes
**Description:** The measurement of mothers' confidence in their ability to breastfeed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF). The scale consists of 14 items scored on a 5-point Likert scale, where higher scores indicate greater self-efficacy in breastfeeding.
**Measure:** Breastfeeding Self-Efficacy
**Time Frame:** Assessed at baseline (32-36 weeks of gestation), and postpartum at 1-3 days, 15 days, 30 days, 45 days, 60 days, 3 months, and 6 months.
#### Secondary Outcomes
**Description:** Assessment of mothers' attitudes towards breastfeeding using the Iowa Infant Feeding Attitude Scale (IIFAS). The scale includes 17 items rated on a 5-point Likert scale, with higher scores indicating more positive attitudes toward breastfeeding.
**Measure:** Breastfeeding Attitudes
**Time Frame:** Assessed at baseline (32-36 weeks of gestation), and postpartum at 1-3 days, 15 days, 30 days, 45 days, 60 days, 3 months, and 6 months.
**Description:** Measurement of the frequency and severity of breastfeeding problems using the Breastfeeding Experience Scale (BES). The scale evaluates issues such as latch difficulties, pain, and milk supply concerns.
**Measure:** Breastfeeding Problems
**Time Frame:** Assessed postpartum at 1-3 days, 15 days, 30 days, 45 days, 60 days, 3 months, and 6 months.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Primiparous mothers
* Gestational age between 32-40 weeks
* Ability to communicate effectively
* Ownership of a smartphone
* Minimum education level: primary school graduate
Exclusion Criteria:
* Infants with health issues
* Mothers with medical or pregnancy-related complications that hinder breastfeeding (e.g., heart disease, cancer, nephritis, active or untreated tuberculosis, HIV/AIDS, active herpes lesions on the breast, severe malnutrition)
* Participants undergoing infertility treatment with IVF
**Healthy Volunteers:** True
**Maximum Age:** 35 Years
**Minimum Age:** 15 Years
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Denizli
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Muberra NA Altun, PhD
- **Phone:** +905366407849
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Ilgun NA Ozen Cinar, PhD
- **Phone:** +905323556791
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Pamukkale University Family Health Center
**State:** Pamukkale
**Status:** RECRUITING
**Zip:** 20100
### IPD Sharing Statement Module
**Access Criteria:** PD will be shared with researchers who provide a methodologically sound proposal. Proposals will be reviewed by an independent review committee. Data will be available for analyses aimed at achieving the objectives in the approved proposal. Requests for IPD should be directed to the study principal investigator.
**Description:** All collected IPD that underlie the results in a publication will be shared.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
**IPD Sharing:** YES
**Time Frame:** Starting 6 months after publication and available for 5 years.
### References Module
#### References
**Citation:** World Health Organization (WHO). Exclusive breastfeeding for six months best for babies everywhere. Available at: https://www.who.int/news-room/detail/15-01-2024-exclusive-breastfeeding-for-six-months-best-for-babies-everywhere. 2024.
**Citation:** UNICEF. Breastfeeding. Available at: https://www.unicef.org/nutrition/index_24824.html. 2024.
**Citation:** Berwick DM, Jacques J. The future of primary care and breastfeeding support. Journal of Health Care Management. 2023; 68(4): 345-354.
**Citation:** Centers for Disease Control and Prevention (CDC). Breastfeeding Report Card: United States, 2022. Available at: https://www.cdc.gov/breastfeeding/data/reportcard.htm. 2022.
**Citation:** Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
**PMID:** 26869575
**Citation:** Gyamfi AA, Annan RA, Apprey C, Aduku L. Breastfeeding practices and determinants in Ghana: analysis of demographic and health survey data. International Breastfeeding Journal. 2022; 17(1): 32.
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**Citation:** Franco-Antonio C, Díaz-Gómez NM, Almeida-Pittito B, Cubas W, Monteiro N. Randomized controlled trials on breastfeeding education: a review of interventions. Clinical Lactation. 2019; 10(4): 156-165.
**Citation:** Akgün N, Taştekin T. Impact of educational interventions on breastfeeding knowledge and attitudes. Breastfeeding Medicine. 2020; 15(2): 103-110.
**Citation:** Wulandari D, Rachmawati PD, Rahayu DK. Postpartum educational package on breastfeeding self-efficacy and motivation. Maternal & Child Health Journal. 2022; 26(3): 319-327
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## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446349
**Acronym:** BENZ_HALTE
**Brief Title:** Brief Motivational Intervention (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users
**Official Title:** Impact of Identification and Brief Motivational Intervention in Dispensing Pharmacies (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users
#### Organization Study ID Info
**ID:** 38RC23.0198
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Grenoble
#### Secondary ID Infos
**Domain:** ID RCB
**ID:** 2023-A01747-38
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-02-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Grenoble
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** We hypothesise that a short-term intervention by dispensing pharmacists is feasible and relatively easy to implement, and that it could have an impact on the deprescribing of BZD/Z in adult patients.
Two primary objectives will be evaluated in a sequential hierarchical manner, with two primary endpoints analysed one after the other, without alpha risk adjustment, but the second can only be analysed if the null hypothesis is rejected for the first:
1. Evaluate the impact of brief motivational intervention (BMI) on reducing the daily dose of BZD/Z prescribed at 6 months (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies.
2. Evaluate the impact of BMI on clinical worsening at 6 months (non-inferiority hypothesis) in comparison with the usual practice of dispensing BZD/Z in pharmacies.
**Detailed Description:** In France, the prevalence of use of benzodiazepines (BZDs) and related drugs (Z-drugs: zolpidem, zopiclone) (BZD/Z) was estimated at 13.4% in 2015, and 15% of new users had a first prescription exceeding the legal duration. The increase in prescriptions has continued to grow: in the first 4 months of 2021, an increase of 1.3 million anxiolytic treatments and 580,000 hypnotic treatments was observed, with new prescriptions for these treatments increasing by 15% for anxiolytics and 26% for hypnotics over the same year. The prevalence of long-term (\>6 months) BZD prescriptions varies from country to country between 6% and 15% in the general population, and is estimated to reach 22% to 55% in people aged ≥ 65 years. In France, recommendations and good practice guidelines recommend prescriptions limited to 4 weeks for hypnotic BZD/Z and 12 weeks for anxiolytic BZD. However, a recent study focusing solely on anxiolytic BZDs, carried out in patients covered by the general social security system (excluding special schemes such as self-employed workers, farmers, etc.), showed that 12.2% of women and 9.3% of men aged over 50 were prescribed for longer than the legal duration.
All countries agree on the need to limit the length of time these drugs are prescribed because of the rapid inversion of the benefit/risk ratio in the case of prolonged and continuous prescribing (rapid loss of efficacy due to the tolerance effect associated with the occurrence of adverse effects.
A number of public health initiatives have been taken in France to reduce the initiation or continued use of long-term BZD/Z prescriptions, including information for healthcare professionals about the risks, pictograms on drug packaging, directives from the health authorities, incentives offered by the Assurance Maladie and regulatory measures to control prescribing. Alongside these measures, various types of psychosocial intervention are specifically aimed at deprescribing, defined as a clinically supervised process of stopping or reducing the dose of drugs when they cause harm or when the potential risks outweigh the benefits. These strategies have been evaluated for several years, ranging from brief interventions in the form of letters, self-support manuals and targeted consultations, to more complex psychotherapeutic interventions such as cognitive behavioural therapy (CBT) or pharmacological interventions.
Although complex interventions such as structured educational programmes or 3rd wave CBT have been shown to be effective in reducing long-term BZD/Z use, particularly in the elderly, they are often too long and complex to be implemented on a large scale, particularly in primary care, and all the more so in a context of increasing shortage of specialists. Brief interventions, which are both more realistic and functional, have been shown to be effective in reducing and stopping long-term use of BZD/Z at 6 and 12 months post-intervention. At the same time, very few studies have involved the active participation of pharmacy professionals. Yet the involvement of pharmacists would optimise prescribing, and a simple psychoeducation action carried out in pharmacies would have an economic impact. With a view to the shift to ambulatory care centred on the structuring of care pathways, increasing the skills of local pharmacists, as part of a multiprofessional coordination strategy, is a response to the requirements of the law modernising the French healthcare system, while offering a simple and pragmatic intervention model for patients whose prescriptions need to be optimised.
In this study, we propose to evaluate the impact of identification combined with a brief motivational intervention in pharmacies (BMI) targeting the deprescription of BZD/Z in adult patients with long-term prescriptions (≥ 6 months).
### Conditions Module
**Conditions:**
- Benzodiazepine Withdrawal
**Keywords:**
- substance use disorder
- community pharmacy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Brief motivational intervention in community pharmacy
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** identification followed by a brief motivational intervention in pharmacies (BMI) based on the mobilisation of patients' psychosocial skills and the integration of tools to help reduce consumption of BZD/Z prescribed over the long term (≥ 6 months).
**Intervention Names:**
- Other: Brief motivational intervention
**Label:** Brief motivational intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Standard of care in case of benzodiazepine prescription
**Label:** Control
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Brief motivational intervention
**Description:** identification followed by a brief motivational intervention in pharmacies (BMI) based on the mobilisation of patients' psychosocial skills and the integration of tools to help reduce consumption of BZD/Z prescribed over the long term (≥ 6 months).
**Name:** Brief motivational intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** reduction of at least 50% of the Defined Daily Dose (DDD) initially prescribed, 6 months after the BPMI (during the last 4 weeks prior to the assessment)
**Measure:** efficacy on reducing daily dose
**Time Frame:** 6 months
**Description:** Clinical worsening is defined as:
* An increase in anxiety ≥ 3 points of the HAD-A sub-score (the minimum clinically significant difference being estimated at 3.2 +/- 4.
* and/or an increase ≥ 8 points in the ISI (the minimum difference corresponding to a moderate improvement being estimated at \> 7 points.
**Measure:** efficacy on clinical worsening
**Time Frame:** 6 months
#### Secondary Outcomes
**Description:** 1. Proportion of patients with a reduction of at least 50% of the initially prescribed Defined Daily Dose (DDD), without clinical worsening, during the last 4 weeks prior to assessment.
**Measure:** reduction in the prescribed daily dose of BZD/Z without clinical worsening (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies
**Time Frame:** 12 months
**Description:** Proportion of patients whose BZD/Z prescription was stopped, without clinical worsening. Discontinuation is defined as no prescriptions or dispensing identified in the last 4 weeks prior to assessment.
**Measure:** complete cessation of BZD/Z prescriptions without clinical worsening (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies
**Time Frame:** 6 months and 12 months
**Description:** declared average daily dose consumed and the number of days without consumption during the 7 days preceding the patient's visit
**Measure:** declared consumption compared with the usual practice of dispensing BZD/Z in pharmacies
**Time Frame:** 6 months and 12 months
**Description:** Worsening of anxiety at 12 months is considered to be an increase in anxiety ≥ 3 points on the HAD-A sub-score.
**Measure:** anxiety symptoms
**Time Frame:** 12 months
**Description:** A worsening of depression is considered to be an increase in depression ≥ 4 points on the HAD-D sub-score.
**Measure:** depressive symptoms
**Time Frame:** 6 and 12 months
**Description:** A worsening of insomnia is considered to be an increase in insomnia ≥ 8 points on the ISI.
**Measure:** severity of insomnia
**Time Frame:** 12 months
**Description:** Evaluation of transfers to addictive products and/or behaviours on the "drugs" version of the Addictive Behaviour Intensity Questionnaire (QMICA)
**Measure:** transfers to other addictive products or behaviours
**Time Frame:** 6 and 12 months
**Description:** Assessment of misuse of BZD/Z. In the absence of a questionnaire specifically evaluating the misuse of benzodiazepine drugs, the evaluation is carried out in the form of open questions.
**Measure:** misuse of BZD/Z
**Time Frame:** 6 and 12 months
**Description:** Description of all adverse events reported by patients during study follow-up. Specific monitoring of known severe adverse events related to the reduction in BZD/Z consumption, as well as falls, is carried out.
**Measure:** Adverse events description
**Time Frame:** 3, 6, 9 and 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Continuous treatment (at least once daily) with BZD/Z for at least 6 months, after verification of 6 months' supply.
* Signed informed consent
* Patient able to understand the survey and complete a questionnaire in French.
* Affiliation with the French social security system
Exclusion Criteria:
* Concomitant treatment with:
* The following oral antipsychotics: risperidone, olanzapine, aripiprazole, quetiapine, clozapine, haloperidol, flupentixol, pimozide, chlorpromazine, sulpiride, zuclopenthixol, loxapine, cyamemazine (\>100mg/D), sulpiride (\>150mg/D),
* Injectable medium- and long-acting antipsychotics
* Thymoregulatory treatment with lithium
* Treatments for alcohol use disorders: baclofen, nalmefene, naltrexone, acamprosate, disulfiram
* Opiate substitution treatments: buprenorphine, methadone
* Anti-epileptic drugs
* History of convulsions or epilepsy
* History of gabaergic withdrawal accidents: delirium tremens, confusional syndrome requiring specialist treatment (hospitalisation, specialist consultation), epileptic seizures, etc.
* Patients suffering from cancer
* Persons referred to in articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to all protected persons: pregnant women, women in childbirth, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure).
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lucie Pennel, MD, PhD
**Phone:** +33 670 386 149
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Adeline PARIS, PharmD, PhD
**Phone:** +334 767 767 383
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Annonay
**Contacts:**
***Contact 1:***
- **Name:** Jean-Michel RIFFARD, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie Riffard Annonay
**Zip:** 07100
**Location 2:**
**City:** Auriol
**Contacts:**
***Contact 1:***
- **Name:** Morgane KERVEGANT, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie du Village
**Zip:** 13390
**Location 3:**
**City:** Beauvais
**Contacts:**
***Contact 1:***
- **Name:** Jean-Philippe EQUINET, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie des Champs Dolent
**Zip:** 60000
**Location 4:**
**City:** Cap-d'Ail
**Contacts:**
***Contact 1:***
- **Name:** Elisabeth TROISGROS, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie Troisgros
**Zip:** 06320
**Location 5:**
**City:** Castelnaudary
**Contacts:**
***Contact 1:***
- **Name:** Isabelle SIBRA, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie des Fontanilles
**Zip:** 11400
**Location 6:**
**City:** Dolus-d'Oléron
**Contacts:**
***Contact 1:***
- **Name:** Agnès LALIS, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie Dolus d'Oléron
**Zip:** 17550
**Location 7:**
**City:** Dommartin
**Contacts:**
***Contact 1:***
- **Name:** Luc MARCHAND, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie de Dommartin
**Zip:** 69380
**Location 8:**
**City:** Embrun
**Contacts:**
***Contact 1:***
- **Name:** Xavier BONO, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie du Mont Guillaume
**Zip:** 05200
**Location 9:**
**City:** Lavelanet
**Contacts:**
***Contact 1:***
- **Name:** Fabrice PERILHOU, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie du Pog
**Zip:** 09300
**Location 10:**
**City:** Lentilly
**Contacts:**
***Contact 1:***
- **Name:** Olivier DESCOUT, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie de Lentilly
**Zip:** 69210
**Location 11:**
**City:** Ludres
**Contacts:**
***Contact 1:***
- **Name:** Adrien Thomas, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie Thomas
**Zip:** 54710
**Location 12:**
**City:** Marignane
**Contacts:**
***Contact 1:***
- **Name:** Aurore ALLIONE, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie Saint Pierre Marignane
**Zip:** 13700
**Location 13:**
**City:** Marseille
**Contacts:**
***Contact 1:***
- **Name:** Virginie ZURECKI, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie Milan Saint-Giniez
**Zip:** 13008
**Location 14:**
**City:** Moncoutant
**Contacts:**
***Contact 1:***
- **Name:** Estelle DELABROYE, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie de la Sèvre
**Zip:** 79320
**Location 15:**
**City:** Saint-Omer
**Contacts:**
***Contact 1:***
- **Name:** Jean-Philippe SILVIE, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie du Théâtre
**Zip:** 62500
**Location 16:**
**City:** Saint-Porchaire
**Contacts:**
***Contact 1:***
- **Name:** Alexandre PEYRIDIEUX, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie du Château
**Zip:** 17250
**Location 17:**
**City:** Sanary-sur-Mer
**Contacts:**
***Contact 1:***
- **Name:** Virginie CLEMENT, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie Fleur de Mai
**Zip:** 83110
**Location 18:**
**City:** Savigné-l'Évêque
**Contacts:**
***Contact 1:***
- **Name:** Hervé LABARRIERE, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie Labarrière
**Zip:** 72460
**Location 19:**
**City:** Villemoisson-sur-Orge
**Contacts:**
***Contact 1:***
- **Name:** Mélanie SAROT, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Pharmacie de l'Ermitage
**Zip:** 91360
**Location 20:**
**City:** Évenos
**Contacts:**
***Contact 1:***
- **Name:** Nathalie DEBORD, PharmD
- **Role:** CONTACT
**Country:** France
**Facility:** Ma Pharmacie Evenos
**Zip:** 83330
#### Overall Officials
**Official 1:**
**Affiliation:** University Hospital, Grenoble
**Name:** Lucie PENNEL, MD,PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
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**PMID:** 29760269
**Citation:** Cloatre E. Regulating Alternative Healing in France, And the Problem of 'Non-Medicine'. Med Law Rev. 2019 May 1;27(2):189-214. doi: 10.1093/medlaw/fwy024.
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**Citation:** Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.
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**Citation:** Ohayon MM, Caulet M, Priest RG, Guilleminault C. Psychotropic medication consumption patterns in the UK general population. J Clin Epidemiol. 1998 Mar;51(3):273-83. doi: 10.1016/s0895-4356(97)00238-2.
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**Citation:** Neutel CI. The epidemiology of long-term benzodiazepine use. Int Rev Psychiatry. 2005 Jun;17(3):189-97. doi: 10.1080/09540260500071863.
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**Citation:** Lagnaoui R, Depont F, Fourrier A, Abouelfath A, Begaud B, Verdoux H, Moore N. Patterns and correlates of benzodiazepine use in the French general population. Eur J Clin Pharmacol. 2004 Sep;60(7):523-9. doi: 10.1007/s00228-004-0808-2.
**PMID:** 15338086
**Citation:** Olfson M, King M, Schoenbaum M. Benzodiazepine use in the United States. JAMA Psychiatry. 2015 Feb;72(2):136-42. doi: 10.1001/jamapsychiatry.2014.1763.
**PMID:** 25517224
**Citation:** Clay E, Falissard B, Moore N, Toumi M. Contribution of prolonged-release melatonin and anti-benzodiazepine campaigns to the reduction of benzodiazepine and Z-drugs consumption in nine European countries. Eur J Clin Pharmacol. 2013 Apr;69(4):1-10. doi: 10.1007/s00228-012-1424-1. Epub 2012 Nov 1.
**PMID:** 23114457
**Citation:** Schonfeld L, Hazlett RW, Hedgecock DK, Duchene DM, Burns LV, Gum AM. Screening, Brief Intervention, and Referral to Treatment for Older Adults With Substance Misuse. Am J Public Health. 2015 Jan;105(1):205-211. doi: 10.2105/AJPH.2013.301859.
**PMID:** 24832147
**Citation:** Vicens C, Bejarano F, Sempere E, Mateu C, Fiol F, Socias I, Aragones E, Palop V, Beltran JL, Pinol JL, Lera G, Folch S, Mengual M, Basora J, Esteva M, Llobera J, Roca M, Gili M, Leiva A. Comparative efficacy of two interventions to discontinue long-term benzodiazepine use: cluster randomised controlled trial in primary care. Br J Psychiatry. 2014 Jun;204(6):471-9. doi: 10.1192/bjp.bp.113.134650. Epub 2014 Feb 13.
**PMID:** 24526745
**Citation:** Ng BJ, Le Couteur DG, Hilmer SN. Deprescribing Benzodiazepines in Older Patients: Impact of Interventions Targeting Physicians, Pharmacists, and Patients. Drugs Aging. 2018 Jun;35(6):493-521. doi: 10.1007/s40266-018-0544-4.
**PMID:** 29705831
**Citation:** Tannenbaum C, Martin P, Tamblyn R, Benedetti A, Ahmed S. Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial. JAMA Intern Med. 2014 Jun;174(6):890-8. doi: 10.1001/jamainternmed.2014.949.
**PMID:** 24733354
**Citation:** Westbury J, Jackson S, Gee P, Peterson G. An effective approach to decrease antipsychotic and benzodiazepine use in nursing homes: the RedUSe project. Int Psychogeriatr. 2010 Feb;22(1):26-36. doi: 10.1017/S1041610209991128. Epub 2009 Oct 9.
**PMID:** 19814843
**Citation:** Faure G, Letoublon C, Clouye G, Guignier M, Marty F. [Value of arteriography in injuries of the kidney. The surgeon's viewpoint]. J Radiol Electrol Med Nucl. 1976 Aug-Sep;57(8-9):669-72. No abstract available. French.
**PMID:** 978637
**Citation:** Navy HJ, Weffald L, Delate T, Patel RJ, Dugan JP. Clinical Pharmacist Intervention to Engage Older Adults in Reducing Use of Alprazolam. Consult Pharm. 2018 Dec 1;33(12):711-722. doi: 10.4140/TCP.n.2018.711..
**PMID:** 30545435
**Citation:** Kreek MJ, LaForge KS, Butelman E. Pharmacotherapy of addictions. Nat Rev Drug Discov. 2002 Sep;1(9):710-26. doi: 10.1038/nrd897. Erratum In: Nat Rev Drug Discov 2002 Nov;1(11):920.
**PMID:** 12209151
**Citation:** Miller WR, Rollnick S. Ten things that motivational interviewing is not. Behav Cogn Psychother. 2009 Mar;37(2):129-40. doi: 10.1017/S1352465809005128.
**PMID:** 19364414
**Citation:** Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012 Apr 24;7:37. doi: 10.1186/1748-5908-7-37.
**PMID:** 22530986
**Citation:** Atkins L, Francis J, Islam R, O'Connor D, Patey A, Ivers N, Foy R, Duncan EM, Colquhoun H, Grimshaw JM, Lawton R, Michie S. A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems. Implement Sci. 2017 Jun 21;12(1):77. doi: 10.1186/s13012-017-0605-9.
**PMID:** 28637486
**Citation:** Yang M, Morin CM, Schaefer K, Wallenstein GV. Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference. Curr Med Res Opin. 2009 Oct;25(10):2487-94. doi: 10.1185/03007990903167415.
**PMID:** 19689221
**Citation:** Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
**PMID:** 11438246
**Citation:** Knisely JS, Wunsch MJ, Cropsey KL, Campbell ED. Prescription Opioid Misuse Index: a brief questionnaire to assess misuse. J Subst Abuse Treat. 2008 Dec;35(4):380-6. doi: 10.1016/j.jsat.2008.02.001. Epub 2008 Jul 26.
**PMID:** 18657935
**Citation:** Seppala LJ, Wermelink AMAT, de Vries M, Ploegmakers KJ, van de Glind EMM, Daams JG, van der Velde N; EUGMS task and Finish group on fall-risk-increasing drugs. Fall-Risk-Increasing Drugs: A Systematic Review and Meta-Analysis: II. Psychotropics. J Am Med Dir Assoc. 2018 Apr;19(4):371.e11-371.e17. doi: 10.1016/j.jamda.2017.12.098.
**PMID:** 29402652
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**URL:** https://www.alcoologie-et-addictologie.fr/index.php/aa/article/view/674
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**URL:** https://www.has-sante.fr/jcms/c_2038262/fr/arret-des-benzodiazepines-et-medicaments-apparentes-demarche-du-medecin-traitant-en-ambulatoire
**Label:** Related Info
**URL:** https://www.equator-network.org/wp-content/uploads/2014/03/TIDieR-Checklist-Word_translation-FRENCH_Dec-2017.pdf
**Label:** Related Info
**URL:** https://solidarites-sante.gouv.fr/soins-et-maladies/medicaments/professionnels-de-sante/bon-usage-par-les-professionnels/article/le-bon-usage-des-benzodiazepines-par-les-professionnels-de-sante#:~:text=Syndrome%20de%20sevrage,-Apparition%20de%20signes&text=Signes%20g%C3%A9n%C3%A9raux%20fr%C3%A9quents%20%3A%20anxi%C3%A9t%C3%A9%2C%20insomnie,convulsions%2C%20incoordination%20motrice%2C%20coma
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**URL:** https://www.has-sante.fr/jcms/c_601509/fr/modalites-d-arret-des-benzodiazepines-et-medicaments-apparentes-chez-le-patient-age
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M1557
- Name: Drug Misuse
- Relevance: HIGH
- As Found: Drug Users
- 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: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000076064
- Term: Drug Misuse
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446336
**Acronym:** HASS
**Brief Title:** Creation of a Pre-operative Score, the HASS Score, for Injuries Reliable Diagnosis of Long Biceps Tendon
**Official Title:** Creation of a Pre-operative Score, the HASS Score, for Injuries Reliable Diagnosis of Long Biceps Tendon
#### Organization Study ID Info
**ID:** RGDS-2023-12-010
#### Organization
**Class:** OTHER
**Full Name:** GCS Ramsay Santé pour l'Enseignement et la Recherche
### Status Module
#### Completion Date
**Date:** 2026-04-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-04-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** GCS Ramsay Santé pour l'Enseignement et la Recherche
#### 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 long biceps tendon (LBT) has a particular anatomical pathway, making it fragile due to repeated microtrauma or trauma which can lead to chronic lesions of LBT.
Current issue with this pathology is the absence of preoperative effective clinical and paraclinical tools, allowing confirmed diagnosis, in particular because of its entanglement with other pathologies.
This diagnostic uncertainty generates an approximation for LBT therapeutic indications so that therapeutic indications are frequently finalized during glenohumeral arthroscopy.
Having a reliable and reproducible diagnostic tool for LBT pathologies would allow an improvement in their surgical load management .
In this context, this research is based on the hypothesis that the construction of a pre-operative score, the HASS score, combining pre-operative clinical and paraclinical data would allow to obtain a reliable diagnosis of LBT injuries.
**Detailed Description:** The long biceps tendon (LBT) has a particular anatomical pathway, making it fragile due to repeated microtrauma or trauma which can lead to chronic lesions of LBT. Aging can also worsen damage to this tendon. LBT lesions are frequently associated with other pathologies of glenohumeral complex, particularly damage to the rotators' cuff or subacromial impingements.
Current issue with this pathology is the absence of preoperative effective clinical and paraclinical tools, allowing confirmed diagnosis, in particular because of its entanglement with other pathologies.
Isolated clinical tests are numerous and ineffective. Ultrasound is a reliable examination for taking LBT volumetric measurements or to diagnose instability but it fails in the diagnosis of cracks and tendinopathy. CT scan, CT arthrography, MRI and MRI arthrography, except a few characteristic signs of LBT lesions, ignore most of lesions and their analysis is difficult and little reproducible.
This diagnostic uncertainty generates an approximation for LBT therapeutic indications so that therapeutic indications are frequently finalized during glenohumeral arthroscopy. However, more distal lesions, in or under the bicipital groove, not accessible in arthroscopy, are described in the literature.
Having a reliable and reproducible diagnostic tool for LBT pathologies would allow an improvement in their surgical load management . It would then be possible not to ignore a lesion which is not visible on arthroscopy or conversely not to perform excess gestures on healthy LBT. It would allow also to provide clear preoperative information to patient on planned surgical procedures and their consequences.
In this context, this research is based on the hypothesis that the construction of a pre-operative score, the HASS score, combining pre-operative clinical and paraclinical data would allow to obtain a reliable diagnosis of LBT injuries.
### Conditions Module
**Conditions:**
- Biceps Tendon Disorder
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Creation of a pre-operative score
**Name:** HASS Score
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** HASS score will rely on clinical data (Speed test, O'Brien test, palpation of the bicipital groove, Yergason test, Uppercut test, Throwing test and Hourglass test) and imaging data (Scan or CT scan, MRI or arthro-MRI)
**Measure:** HASS score
**Time Frame:** 1 day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient with operative indication for tenodesis tenotomy, represented by persistence of clinical signs after medical treatment for more than 6 months
* Patient with shoulder pain lasting more than 6 months
Exclusion Criteria:
* Patient with a ruptured LBT on the pre-operative imaging assessment
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients who fulfill eligibility criteria
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Olivier COURAGE, MD
**Phone:** + 33 2 76 89 97 93
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Le Havre
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Olivier COURAGE, MD
- **Phone:** + 33 2 76 89 97 93
- **Role:** CONTACT
**Country:** France
**Facility:** Hôpital Privé de l'Estuaire
**Status:** RECRUITING
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000013708
- Term: Tendon Injuries
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M27013
- Name: Tendinopathy
- Relevance: HIGH
- As Found: Tendon Disorder
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16479
- Name: Tendon Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000052256
- Term: Tendinopathy
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446323
**Brief Title:** Comparison of Minimal Effective Dose of Sucrose for Pain Relief in Neonates After Minor Procedure
**Official Title:** Comparison of Minimal Effective Dose of Sucrose for Pain Relief in Neonates After Minor Procedure
#### Organization Study ID Info
**ID:** Rawalpindi MU
#### Organization
**Class:** OTHER
**Full Name:** Rawalpindi Medical College
### Status Module
#### Completion Date
**Date:** 2024-02-29
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-02-29
**Type:** ACTUAL
#### Start Date
**Date:** 2023-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Rawalpindi Medical College
#### Responsible Party
**Investigator Affiliation:** Rawalpindi Medical College
**Investigator Full Name:** Mehak Fatima
**Investigator Title:** Mehak Fatima
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Type of Study: Randomized Controlled Trial Aim: To compare the effectiveness of two doses of sucrose solution for pain relief in neonates after minor procedures.
Participants' Tasks:
Receive either 0.2 ml or 0.5 ml of sucrose solution. Undergo minor procedures. Pain intensity assessment using the Premature Infant Pain Profile (PIPP).
Comparison Groups:
Researchers compared the effects of administering 0.2 ml and 0.5 ml doses of sucrose solution on post-procedural pain in neonates.
**Detailed Description:** This study is a randomized controlled trial conducted at the Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi, from March 2023 to February 2024. It aims to compare the effectiveness of two different doses of sucrose solution (0.2 ml versus 0.5 ml) for pain relief in neonates after minor procedures.
Objective:
To compare the outcome of 0.2 ml versus 0.5 ml sucrose solution for pain relief in neonates after minor procedures.
Study Design:
Randomized Controlled Trial
Study Place and Duration:
Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi, March 2023 to February 2024.
Participants and Methods:
Total of 148 neonates enrolled who underwent minor procedures and were admitted to the neonatal intensive care unit.
Randomly divided into two groups:
Group I: Administered 0.2 ml of sucrose solution Group II: Administered 0.5 ml of sucrose solution Pain intensity measured using the Premature Infant Pain Profile (PIPP). Data analyzed using SPSS version 25.0.
### Conditions Module
**Conditions:**
- Post Procedural Pain Management in Neonates
**Keywords:**
- sucrose solution, pain relief, neonates, minor procedure, Premature Infant Pain Profile
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** In this parallel interventional study, neonates who have undergone minor procedures and are admitted to the neonatal intensive care unit are randomly assigned to one of two groups: Group I or Group II. Group I receives a 0.2 ml dose of sucrose solution, while Group II receives a 0.5 ml dose.
The study follows a parallel design, where each group receives a different intervention (different doses of sucrose solution) simultaneously. This design allows for a direct comparison between the two interventions while minimizing potential biases.
After administration of the respective doses, the neonates are monitored for pain intensity using the Premature Infant Pain Profile (PIPP). Data on pain scores are collected and analyzed using statistical methods, such as those performed with SPSS version 25.0.
The primary objective of this parallel interventional study is to determine which dose of sucrose solution (0.2 ml or 0.5 ml) is more effective in reducing post-procedural pain in neonates.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** The investigators responsible for assessing the primary outcome measure, pain intensity using the Premature Infant Pain Profile (PIPP), are blinded to the treatment allocation. While neonates and healthcare providers administering the interventions are aware of the treatment groups, the investigators conducting the outcome assessments remain unaware of which dose of sucrose solution each neonate received. This masking of the investigators helps mitigate potential bias in the assessment of pain relief efficacy. However, it is acknowledged that complete masking of all parties involved is not feasible due to the nature of the interventions
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 148
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in this arm receive a 0.2 ml dose of sucrose solution. Care providers administer the specified dose of sucrose solution to neonates who have undergone minor procedures and are experiencing post-procedural pain. The dose is administered orally, following standardized protocols. Participants in this group are monitored for pain intensity using the Premature Infant Pain Profile (PIPP) by investigators who are masked to the treatment allocation. Data on pain scores and any adverse events are recorded and analyzed as part of the study.
**Intervention Names:**
- Drug: 0.2 ml dose of sucrose
**Label:** Group I: Neonates receiving a 0.2 ml dose of sucrose solution
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Participants in this arm receive a 0.5 ml dose of sucrose solution. Similar to Arm 1, care providers administer the specified dose orally to neonates following minor procedures. The administration is conducted according to standardized protocols. Pain intensity in this group is also monitored using the Premature Infant Pain Profile (PIPP) by investigators who remain masked to the treatment allocation. Data collected includes pain scores and any adverse events experienced by participants.
**Intervention Names:**
- Drug: 0.2 ml dose of sucrose
**Label:** Group II: Neonates receiving a 0.5 ml dose of sucrose solution.
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group I: Neonates receiving a 0.2 ml dose of sucrose solution
- Group II: Neonates receiving a 0.5 ml dose of sucrose solution.
**Description:** Both interventions aim to provide pain relief to neonates following minor procedures by administering sucrose solution orally. The study evaluates the efficacy of each dose (0.2 ml vs. 0.5 ml) in reducing post-procedural pain intensity, as measured by the Premature Infant Pain Profile (PIPP). Additionally, any adverse events associated with the administration of sucrose solution are documented and analyzed as part of the study.
**Name:** 0.2 ml dose of sucrose
**Other Names:**
- 0.5 ml dose of sucrose
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The primary outcome of this study is the measurement of pain intensity in neonates following minor procedures, assessed using the Premature Infant Pain Profile (PIPP). The PIPP is a validated tool used to evaluate pain in preterm and term neonates based on behavioral and physiological indicators.
**Measure:** pain intensity in neonates
**Time Frame:** immediately after administrating the sucrose
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Healthy term neonates admitted to the neonatal intensive care unit (NICU) and high dependency unit (HDU) at the Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi.
Exclusion Criteria:
* Neonates with contraindications for sucrose administration, including:
Inability to swallow. Pharmacological muscle relaxation. Heavy sedation. Neonates who are unable to clearly view the infant's face, hindering accurate pain assessment
**Healthy Volunteers:** True
**Maximum Age:** 30 Days
**Minimum Age:** 1 Day
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Rawalpindi
**Country:** Pakistan
**Facility:** Mehak Fatima
**State:** Punjab
**Zip:** 00042
### IPD Sharing Statement Module
**Info Types:**
- STUDY_PROTOCOL
- ICF
- CSR
**IPD Sharing:** YES
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M1219
- Name: Pain, Procedural
- Relevance: HIGH
- As Found: Procedural Pain
- ID: M25869
- Name: Premature Birth
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000073818
- Term: Pain, Procedural
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446310
**Brief Title:** Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
**Official Title:** A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase 3, Clinical Study of QLG2198 in Haemodialysis Adult Subjects With Moderate-to-Severe Pruritus
#### Organization Study ID Info
**ID:** QLG2198-301
#### Organization
**Class:** INDUSTRY
**Full Name:** Qilu Pharmaceutical (Hainan) Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-08-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-02-21
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-27
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Qilu Pharmaceutical (Hainan) 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 a multicentre study that consists of a 12-week double-blind period, and a 14-week open-label extension period and a 1-week follow-up period.
**Detailed Description:** Total study duration for a single subject is 31 to 32 weeks with a 4-week screening period, a 12-week double-blind period, a 14-week open-label extension period, and a 1-week follow-up period.
QLG2198 will be administered in the double-blind and open-label period 3 times a week at the end of each dialysis session. The total dose of the investigational product will be determined based on the subject's prescription dry body weight.
The primary objective of the study is:
To evaluate the efficacy and safety of QLG2198 0.5 μg/kg compared to placebo in reducing the intensity of itch in HD subjects with moderate-to-severe pruritus.
### Conditions Module
**Conditions:**
- Uremic Pruritus
### 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:** 194
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Interventions:
Drug: QLG2198 Injection
**Intervention Names:**
- Drug: QLG2198
**Label:** 12-weeks double-blind period-QLG2198
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Interventions:
Drug: Placebo Injection
**Intervention Names:**
- Drug: Placebo
**Label:** 12-weeks double-blind period- placebo
**Type:** PLACEBO_COMPARATOR
#### Arm Group 3
**Description:** Interventions:
Drug: QLG2198 Injection
**Intervention Names:**
- Drug: QLG2198
**Label:** 14-weeks open-label period following the double-blind period- QLG2198
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 12-weeks double-blind period-QLG2198
- 14-weeks open-label period following the double-blind period- QLG2198
**Description:** Participants receive QLG2198 three times a week (0,5 micrograms/kg dry body weight). QLG21988 is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis.
**Name:** QLG2198
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- 12-weeks double-blind period- placebo
**Description:** Participants receive Placebo three times a week (0,5 micrograms/kg dry body weight). Placebo is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores.
**Measure:** Change from baseline in the weekly mean of the WI-NRS score
**Time Frame:** Week 4 of double-blind period
#### Secondary Outcomes
**Description:** The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores.
**Measure:** Proportion of subjects achieving ≥3-point improvement from baseline with respect to the weekly mean of the WI-NRS
**Time Frame:** Week 4 、Week 8、 Week 12 of double-blind period
**Description:** The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores.
**Measure:** Proportion of subjects achieving ≥4-point improvement from baseline with respect to the weekly mean of the WI-NRS
**Time Frame:** Week 4 、Week 8、 Week 12 of double-blind period
**Description:** The 5-D itch scale is a questionnaire where patients assess the 5 dimensions of itch (degree, duration, direction, disability, and distribution).
**Measure:** Change from baseline in itch-related Quality of Life (QoL) assessed by the 5-D itch scale total score
**Time Frame:** Week 4 、Week 8、Week 12 of double-blind period,Week 4 、Week 8、Week 12 、Week 15 of open-label extension period
**Description:** The Skindex-10 scale is a questionnaire that measures QoL in relationship to the itch intensity
**Measure:** Change from baseline in itch-related QoL assessed by the Skindex-10 scale total score
**Time Frame:** Week 4 、Week 8、 Week 12 of double-blind period,Week 4 、Week 8、Week 12 、Week 15 of open-label extension period
**Description:** The Patient Global Impression of Change is a questionnaire that assesses the change in itch compared to the itch at the start of the study
**Measure:** Patient Global Impression of Change
**Time Frame:** End of double-blind period, week 12
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects with chronic kidney disease (CKD) on HD 3 times weekly for ≥12 weeks prior to screening who can continue HD without changing its frequency or method
* If female, is not pregnant, or nursing.
* agrees not to donate sperm or egg after the first dose of investigational product administration until 7 days after the last dose of investigational product, and agrees to use contraceptive method from heterosexual intercourse during the study until 7 days after the last dose of investigational product.
* Subjects with a prescription dry body weight between 40 and 100 kg
Exclusion Criteria:
* Planned to receive a kidney transplant during the study.
* Has localised itch restricted to the palms of the hands.
* Has pruritus only during the dialysis session
* Subjects with severe hepatic impairment (Child-Pugh Class C) or concurrent hepatic cirrhosis.
* Subject is receiving ongoing ultraviolet treatment .
* Subjects with concurrent malignancy except excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ that has been excised or resected completely.
* Known or suspected history of alcohol or drug abuse/dependence within 12 months prior to screening.
* New or change of treatment received for itch within 2 weeks prior to screening.
**Maximum Age:** 85 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Wu Yidi, M.M
**Phone:** 16653176910
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jiang xiaoning, P.M
**Phone:** 13791914950
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zuo LI
- **Role:** CONTACT
**Country:** China
**Facility:** Peking University People's Hospital
**State:** Beijing
**Status:** NOT_YET_RECRUITING
**Location 2:**
**City:** Jieyang
**Contacts:**
***Contact 1:***
- **Name:** Liu Qinghua
- **Role:** CONTACT
**Country:** China
**Facility:** Jieyang People's Hospital
**State:** Guangdong
**Status:** RECRUITING
**Location 3:**
**City:** Jinan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Wang Rong
- **Role:** CONTACT
**Country:** China
**Facility:** Shandong Provincial Hospital
**State:** Shandong
**Status:** NOT_YET_RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** Peking University People's Hospital
**Name:** Zuo Li
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Shandong Provincial Hospital
**Name:** Wang Rong
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## 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
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446297
**Brief Title:** Generational Diversity in the Medical Profession
**Official Title:** Investigating the Experiences of Generational Diversity Within the Medical Profession of the National Health Service: An Exploratory Study Amongst Post-Graduate Doctors in Training
#### Organization Study ID Info
**ID:** 330463
#### Organization
**Class:** OTHER
**Full Name:** University Hospital Plymouth NHS Trust
### Status Module
#### Completion Date
**Date:** 2025-02-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Plymouth
**Class:** UNKNOWN
**Name:** Health Education England
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital Plymouth NHS Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of our work is to investigate how post-graduate doctors in training (PGDiTs) experience generational diversity with their colleagues in the workplace. We want to explore and understand how PGDiTs perceive and experience generational diversity in the workplace and look into where these differences between generations could come from.
Our research team wants to do this by running focus groups. These focus groups would be made up of PGDiTs that are working within one hospital. The doctors will be split into the different generations (i.e. generation X, Y and Z). A set list of questions will be used to prompt and guide the focus group conversations. Each focus group will be audio-recorded using an electronic device and then analysed with the aid of computer software. We will then generate themes from the data and use this to create an overall story of the data.
We hope this research can help inform supervisors and employers of the impact of generational diversity on on PGDiTs. This may be used to help develop ways of improving working relationships for PGDiTs with their supervisors and employers.
**Detailed Description:** The different generations and the differences between them has provided considerable interest within the media, organisations and academia. A new generation entering the workforce often prompts new conversations about the differences between all generations. Investigating these generational differences has been attempted with mixed levels of success. Some organisations have made suggestions to overcome these generational differences and improve the workplace environment. The National Health Service (NHS) is one of the largest organisations in England, but very limited research investigating generational differences in the NHS has been done.
Post-graduate doctors in training (PGDiTs) are doctors working in recognised training schemes in the NHS. These doctors range from newly qualified doctors working in the Foundation Year training scheme to doctors with over a decade of experience working in their specialist areas. The last two decades have witnessed a number of changes to these doctors' working lives, some positive and some negative. The impact of generational diversity amongst these doctors has not been looked at. These doctors are likely to experience generational diversity with their supervisors, who may have completed training several years previously.
Research Question and Objectives:
We want to answer the question: how do PGDiTs experiences generational diversity in an NHS hospital? Our objectives are to explore and understand the concept, perceptions, experiences and sources of generational diversity of PGDiTs working in the NHS.
Study Design:
This study will involve the use of qualitative semi-structured face-to-face focus groups to explore and understand the concept, perceptions, experiences and sources of generational differences amongst PGDiTs. The focus groups will be stratified according to the generational cohorts of the participants. The study methodology supporting our study design is pragmatic with components of grounded theory and interpretative phenomenological analysis being used. Inductive thematic analysis will be used as our method of data analysis.
Contingency arrangements are also available for certain situations. In the event that face-to-face group meetings are not practically possible due to logistical reasons then virtual meetings will be arranged. If insufficient numbers of participants are recruited to conduct focus groups then semi-structured interviews will be conducted.
The consent process has been directed by the HRA's consent and participation guidance. Prior to participating in the study, all participants must electronically agree via email. All potential participants will receive an electronic copy of the informed consent form and participant information sheet (PIS) and be provided with an opportunity to ask any question of the research team. This opportunity for questions can occur via phone call, email or as a face-to-face meeting. Participants will be asked via email to confirm their participation in the research study and willingness to complete the consent form. On the day of the focus group, each participant will be provided with a printed version of the informed consent form and asked to complete it.
Data analysis:
Each focus group will be directed primarily by the interview schedule. Each focus group will be electronically audio-recorded and subsequently transcribed. Data analysis will be conducted using thematic analysis with the generation of codes and themes. Data analysis software will be used for thematic analysis.
### Conditions Module
**Conditions:**
- Generation Gap
- Generations
- Intergenerational Relations
**Keywords:**
- Generation
- Generation Gap
- Generational Diversity
- Intergenerational workforce
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Date of Birth (DOB) categorisation of Generation X: 1st January 1965 - 31st December 1980.
PGDiTs recruited from the local hospital will be stratified into generational groups according to their date of birth. We anticipate on having approximately two focus groups per generation.
**Intervention Names:**
- Other: Focus Group.
**Label:** Generational X
#### Arm Group 2
**Description:** DOB categorisation of Generation Y: 1st January 1981 - 31st December 1995. PGDiTs recruited from the local hospital will be stratified into generational groups according to their date of birth. We anticipate on having approximately two focus groups per generation.
**Intervention Names:**
- Other: Focus Group.
**Label:** Generation Y
#### Arm Group 3
**Description:** DOB categorisation of Generation Z: 1st January 1996 - 31st December 2010. PGDiTs recruited from the local hospital will be stratified into generational groups according to their date of birth. We anticipate on having approximately two focus groups per generation.
**Intervention Names:**
- Other: Focus Group.
**Label:** Generation Z
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Generation Y
- Generation Z
- Generational X
**Description:** Participants in each focus group will attend a face-to-face (or virtual) meeting that lasts approximately 90 minutes. This will be composed of a briefing period, interview period supported and guided by an interview schedule and finishing with a debrief period. The same process will be followed if individual semi-structured interviews are undertaken.
**Name:** Focus Group.
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Qualitative data analysis will be conducted using thematic analysis to generate a number of codes and themes from the transcripts generated from focus groups and semi-structured interviews.
**Measure:** Thematic Analysis
**Time Frame:** 4 months.
### Eligibility Module
**Eligibility Criteria:** The following criteria must all be met to permit inclusion in the research study:
* Any medically qualified healthcare professional with a General Medical Council (GMC) registration number, AND
* Currently working in a recognised training programme in the Southwest (i.e. foundation year training, integrated medical training, core surgical training, acute care common stem training, higher specialty training), AND
* Currently based at University Hospitals Plymouth (UHP), AND
* Consents to being interviewed and recorded for the purposes of the study.
An individual will be excluded from the study if any of the following criteria are met:
* Any medically qualified professional with a GMC registration number that is not currently enrolled within a recognised training programme at UHP, OR
* any medical professional working outside of UHP, OR
* employed as an Allied Health Professional, Advanced Clinical Practitioner, Advanced Critical Care Practitioner or Physician Associate will not be eligible for inclusion in the study, OR
* any individual eligible for inclusion into the study that does NOT consent to being interviewed OR recorded.
**Healthy Volunteers:** True
**Maximum Age:** 100 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study participants must a postgraduate doctor-in-training working within a recognised training programme in the Southwest of England and currently based at University Hospitals Plymouth NHS Trust. This will range from newly qualified doctors that are working within the foundation programme to doctors that are working in higher specialty training programmes.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Matthew A Boissaud-Cooke, MBChB MRCS
**Phone:** 01752437339
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jane Thurlow, MBChB FRCA
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** NHS England South West, University Hospitals Plymouth NHS Trust
**Name:** Matthew A Boissaud-Cooke, MBChB MRCS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Data will be collected and retained in accordance with the United Kingdom Data Protection Act (2018) and the General Data Protection Regulation (GDPR, 2016).
Given the nature of the data that is collected, we do not plan on making individual participant data available to other researchers. The final data set will be anonymised and shared with the relevant members of the study research team only. The anonymised data (i.e. anonymised transcripts and the thematically analysed data) will be archived by the Research and Development Department of University Hospitals Plymouth NHS Trust (Plymouth, United Kingdom).
We will only report or publish non-identifiable and anonymised sections of individuals' transcripts.
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446284
**Brief Title:** Target ADHD Executive Working Memory Replication Study
**Official Title:** Behavioral and Neural Target Engagement for ADHD Executive Working Memory Training
#### Organization Study ID Info
**ID:** HHC-2023-0178
#### Organization
**Class:** OTHER
**Full Name:** Hartford Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-12-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-02-26
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hartford 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 proposed study will replicate target engagement as assessed in the first phase while also determining if it correlates with clinically meaningful improvements in ADHD dysfunction
**Detailed Description:** This proposal is a 3-year clinical trial study replicating an R61 study that targeted brain engagement in 62 ADHD diagnosed adolescents. This study will recruit n=130 adolescents, n=90 ADHD, 40 non-ADHD. The ADHD group will be randomized to a 'sham training' placebo or to train 4 times each week using 4 different EWM exercises that have been combined into the format of a typical cognitive training intervention. Exercise difficulty levels in the active intervention will increase across 5 weeks to continually challenge EWM ability. EWM training will use a novel, remotely-supervised 'at home' computerized training approach that was developed in the Phase I study. This study will attempt to establish a convincing link between the hypothesized targets found in Phase I and ADHD symptom expression. It also will characterize ADHD brain activity or EWM ability changes relative to typical levels seen in the n=40 non-ADHD control group.
### Conditions Module
**Conditions:**
- ADHD
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 130
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive EWM training sessions.
**Intervention Names:**
- Behavioral: EWM Training
**Label:** ADHD EWM
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive placebo training sessions.
**Intervention Names:**
- Behavioral: Placebo Training
**Label:** ADHD Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ADHD EWM
**Description:** Training tasks will target Executive Working Memory areas of the brain. Task difficulty will be adaptively increased across the 5 weeks of training based on session-to-session performance.
**Name:** EWM Training
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- ADHD Placebo
**Description:** Computerized tasks with comparable engagement that do not tap executive working memory processes
**Name:** Placebo Training
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** fMRI measures of brain activation and functional connectivity - Conventional measures of 'brain activation' are estimated using GLM regression models that fit the fMRI BOLD timeseries data to a model of expected hemodynamic change as elicited by fMRI versions of the executive working memory training task trials. Functional connectivity is assessed using a form of cross-correlation analysis that quantifies how much the entire BOLD timeseries in different brain regions are similar to one another. Our a priori treatment target brain regions are the superior frontal sulcus and mid-lateral prefrontal cortex region of interest. Brain activity and functional connectivity specifically to these regions represent the primary outcome measures of the study.
**Measure:** Magnetic Resonance Imaging Functional Brain Scan using a Seimens 3T Skyra.
**Time Frame:** Change in fMRI measurements from baseline assessment versus 5 weeks at the conclusion of training
**Description:** Reaction time (RT) from training tasks of executive working memory. These are experimental, non-published tasks that were tested in this project for the first time in Phase I: Updating (removal then replacement of stimuli by new information to be maintained in working memory), Shifting (refocusing selective attention on different stimuli held concurrent in working memory without altering contents), distractor Filtering (inhibiting irrelevant information) and Suppression (resolution of proactive interference from initial stimuli to be able to respond optimally to control trials). Trial structure and duration are similar across these tasks. The tasks record RT in milliseconds. Data from active experimental conditions will be log-transformed prior to statistical testing.
**Measure:** Experimental executive working memory training tasks - Reaction Time
**Time Frame:** Change in scores from baseline assessment versus 5 weeks at the conclusion of training
**Description:** Accuracy (defined as percentage of correct answers from the pool of available items) from training tasks of executive working memory. These are experimental, non-published tasks that were tested in this project for the first time in Phase I: Updating (removal then replacement of stimuli by new information to be maintained in working memory), Shifting (refocusing selective attention on different stimuli held concurrent in working memory without altering contents), distractor Filtering (inhibiting irrelevant information) and Suppression (resolution of proactive interference from initial stimuli to be able to respond optimally to control trials). Trial structure and duration are similar across these tasks. Data from active experimental conditions will be arcsine-transformed prior to statistical testing.
**Measure:** Experimental executive working memory training tasks - Performance Accuracy
**Time Frame:** Change in scores from baseline assessment versus 5 weeks at the conclusion of training
#### Secondary Outcomes
**Description:** The parent and self-report short forms of the Conners' Rating Scales were designed for repeated and/or brief assessment of symptoms relevant to ADHD and related disorders.
Items are measured on a likert scale from 0-3. There are 39 items with total raw scores ranging from 0-117. Higher scores indicate greater severity in ADHD sympotms. This instrument will be used as confirmation of significant association between symptom severity and evidence of target engagement in brain regions.
**Measure:** Conners Rating Scales 3rd Edition
**Time Frame:** Change in scores from baseline assessment versus 5 weeks at the conclusion of training
**Description:** The Near/Far transfer tasks are computer tasks designed by the Principal Investigator to detail common Working Memory processes. They are programmed and adminstered utilizing E-Prime software. The Near Transfer tasks will test the generalizability of Executive Working Memory training outside of trained tasks, and the Far Transfer tasks will test the training effects to other abilities often impaired in ADHD. They are comprised of four categories: Shifting - Refresh/Repeat Task, Updating - Spatial Updating Task, Filtering - Attend-Ignore Task, and Suppression - Introducing Resistance Task
**Measure:** Near/Far transfer tasks
**Time Frame:** Change in measurements from baseline assessment versus 5 weeks at the conclusion of training.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteriia:
* Diagnosis of ADHD
* English speaking
* Right-handed
* \>5th grade reading level
* \>80 IQ level
Exclusion Criteria:
* Braces, metal or implant devices
* Brain abnormality, neurological disorder
* TBI or loss of consciousness\>30 minutes
* Diagnosis of Psychosis, Bipolar Disorder, ASD, PTSD, OCD, SUD, Tourette's Disorder
**Healthy Volunteers:** True
**Maximum Age:** 18 Years
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Karen L Kesten, MS
**Phone:** 8605457776
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Abigail Sullivan, MS
**Phone:** 8605457363
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hartford
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Karen L Kesten, MS
- **Phone:** 860-545-7776
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Abigail Sullivan, MS
- **Phone:** (860) 545-7363
- **Role:** CONTACT
***Contact 3:***
- **Name:** Michael C Stevens, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Institute of Living/Hartford Hospital
**State:** Connecticut
**Status:** RECRUITING
**Zip:** 06106
#### Overall Officials
**Official 1:**
**Affiliation:** Institute of Living/Hartford Hospital
**Name:** Michael C Stevens, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-09-22
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 1055598
- Type Abbrev: Prot_SAP
- Upload Date: 2024-03-26T11:53
- Date: 2024-02-13
- Filename: ICF_001.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 241274
- Type Abbrev: ICF
- Upload Date: 2024-02-19T15:14
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446271
**Brief Title:** Biomarkers in SCOTland CardiomyopatHy Registry (Bio-SCOTCH)
**Official Title:** Biomarkers in SCOTland CardiomyopatHy Registry
#### Organization Study ID Info
**ID:** GN23CA296
#### Organization
**Class:** OTHER
**Full Name:** NHS Greater Glasgow and Clyde
### Status Module
#### Completion Date
**Date:** 2027-03-19
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-03-19
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-11
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Glasgow
**Class:** INDUSTRY
**Name:** Roche Diagnostics GmbH
#### Lead Sponsor
**Class:** OTHER
**Name:** NHS Greater Glasgow and Clyde
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Genetic cardiomyopathy is increasingly recognised and can lead to heart failure, arrhythmia and sudden cardiac death. Some gene positive patients have rapidly progressive disease with high rates of heart failure and cardiac transplantation, while others present with SCD. Other gene positive patients will never develop cardiomyopathy. At present, we cannot distinguish between these groups and rely on expensive and labour-intensive surveillance by electrocardiography, echocardiography and sometimes cardiac magnetic resonance imaging.
This study will investigate existing and novel biomarkers (including blood, urine electrocardiographic and imaging) at various stages of disease in patients with a personal or family history of TTN, MYBPC3, LMNA, FLNC or DSP gene variant, which are known to cause cardiomyopathy.
**Detailed Description:** There is a growing appreciation for the role that genetics play in the development of cardiomyopathy, which can lead to heart failure, arrhythmia and sudden cardiac death.
Increased use of genetic testing has identified numerous gene variants, which cause cardiomyopathy with dilated, hypertrophic, restrictive, non-dilated left ventricular and arrhythmogenic right ventricular phenotypes described.
Some gene variants cause a rapidly progressive cardiomyopathy with high rates of heart failure and cardiac transplantation, while others present with SCD, meaning that genotype-specific risk stratification and clinical surveillance is urgently needed. Some gene-positive individuals will never develop cardiomyopathy due to variable penetrance. At present, we cannot distinguish between these patients and therefore rely on expensive and labour-intensive surveillance by electrocardiography, echocardiography and sometimes cardiac magnetic resonance imaging. For every gene-positive affected individual with cardiomyopathy, cascade genetic testing will identify other gene-positive family members who are often asymptomatic and may not yet be affected.
A blood or urine-based biomarker that identifies pre-clinical disease or cardiomyopathy would allow for more efficient monitoring of gene positive people and could replace multiple, repeated electrocardiograms, echocardiograms and cardiac magnetic resonance imaging scans. A biomarker that accurately identifies pre-clinical cardiomyopathy could enable targeted early treatment. A biomarker that predicts future disease progression would be of high clinical value.
### Conditions Module
**Conditions:**
- Cardiomyopathies
- Genetic Predisposition
- Cardiomyopathy, Primary
**Keywords:**
- Cardiomyopathy
- Genetic
- Biomarkers
### Design Module
#### Bio Spec
**Description:** Plasma RNA
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 750
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Pathogenic and likely pathogenic variants defined by American College of Medical Genetics guidelines.
Expected recruitment of: 300 TTN, 300 MYBPC3, up to 50 LMNA, up to 50 FLNC and up to 50 DSP
**Intervention Names:**
- Diagnostic Test: Plasma biomarker levels
**Label:** Gene positive participants (personal history of TTN, MYBPC3, LMNA, FLNC or DSP gene variant)
#### Arm Group 2
**Description:** Expected recruitment of 50 patients.
**Intervention Names:**
- Diagnostic Test: Plasma biomarker levels
**Label:** Gene negative controls (family history of TTN, MYBPC3, LMNA, FLNC or DSP gene variant)
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Gene negative controls (family history of TTN, MYBPC3, LMNA, FLNC or DSP gene variant)
- Gene positive participants (personal history of TTN, MYBPC3, LMNA, FLNC or DSP gene variant)
**Description:** This study will investigate existing and novel biomarkers (including blood, urine electrocardiographic and imaging) at various stages of disease in patients with a personal or family history of TTN, MYBPC3, LMNA, FLNC or DSP gene variant, which are known to cause cardiomyopathy.
Cardiomyopathy will be defined per European Society of Cardiology cardiomyopathy guidelines and heart failure stage will be defined per American Heart Associate guidelines.
**Name:** Plasma biomarker levels
**Other Names:**
- Electrocardiogram
- Echocardiogram
- Cardiac magnetic resonance imaging
- 24-hour Holter monitor
- Questionnaires (Kansas City Cardiomyopathy Questionnaire & General Practice Physical Activity Questionnaire)
- Urine biomarker levels
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** Diagnostic performance of existing and novel biomarkers across the spectrum of disease in patients with pathogenic/ likely pathogenic TTN, MYBPC3, LMNA, FLNC or DSP gene variants.
**Measure:** Biomarker performance
**Time Frame:** 3 years
#### Secondary Outcomes
**Description:** Correlation of biomarkers with cardiac imaging measures of inflammation and myocardial fibrosis in genetic cardiomyopathies.
**Measure:** Biomarker correlation
**Time Frame:** 3 years
**Description:** Investigation of biomarkers that can predict which patients (who are gene positive without cardiomyopathy) will develop cardiomyopathy, heart failure, arrhythmia, or die
**Measure:** Prediction of cardiomyopathy development
**Time Frame:** 3 years with long-term data linkage
**Description:** Investigation of biomarkers that can predict which patients (who are gene positive with cardiomyopathy) will have progressive cardiomyopathy, heart failure, arrhythmia, or die.
**Measure:** Prediction of cardiomyopathy progression
**Time Frame:** 3 years with long-term data linkage
**Description:** Investigate the natural history of genetic cardiomyopathy due to variants in TTN, MYBPC3, LMNA, FLNC and DSP genes.
**Measure:** Natural history of genetic cardiomyopathies
**Time Frame:** 3 years with long-term data linkage
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male or female ≥10 years of age
* Written informed consent / assent
* Pathogenic or likely pathogenic variant in a cardiomyopathy gene (TTN, LMNA, MYBPC3, DSP, FLNC) or undergoing predictive genetic testing (if negative these people would be invited to enter the control arm)
Exclusion Criteria:
* Unable to consent.
* Geographical / social reasons preventing attending study centre
* Unable to complete study assessments.
* Severe non-cardiac disease expected to reduce life expectancy \< 5 years
* Current participation in a blinded drug interventional trial (or treatment within 4 weeks)
**Minimum Age:** 10 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** People with a personal or family history of TTN, LMNA, MYBPC3, DSP, or FLNC gene variant who have been referred to the West of Scotland Inherited Cardiac Conditions Service clinic.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Caroline J Coats, MBBS, PhD
**Phone:** 0141 451 6121
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Rachel C Myles, MBBS, PhD
**Phone:** 0141 451 6121
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000004198
- Term: Disease Susceptibility
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### 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: M12154
- Name: Cardiomyopathies
- Relevance: HIGH
- As Found: Cardiomyopathy
- ID: M21875
- Name: Genetic Predisposition to Disease
- Relevance: HIGH
- As Found: Genetic Predisposition
- ID: M7380
- Name: Disease Susceptibility
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009202
- Term: Cardiomyopathies
- ID: D000020022
- Term: Genetic Predisposition to Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446258
**Brief Title:** Assessment of the Impact of Soft Tissue Mobilization on the Scar in Patients After Cesarean Section
**Official Title:** Assessment of the Impact of Soft Tissue Mobilization on the Scar in Patients After Cesarean Section
#### Organization Study ID Info
**ID:** CMUMKscarmobilisation
#### Organization
**Class:** OTHER
**Full Name:** Nicolaus Copernicus University
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Nicolaus Copernicus University
#### Responsible Party
**Investigator Affiliation:** Nicolaus Copernicus University
**Investigator Full Name:** Piotr Ożóg
**Investigator Title:** dr n. med. i n. o zdr.
**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 assess the impact of soft tissue mobilization on the scar in patients after cesarean section. Two physiotherapeutic interventions will be performed in the form of mobilization of the soft tissues (myofascial release techniques) of the lower abdominal area and the cesarean section scar, two weeks apart. The researchers will perform an assessment before and after each therapeutic session, as well as 2 weeks after the last therapy (follow-up). The level of satisfaction with life (Satisfaction with Life Scale (SWLS)) as well as the area of the cesarean section scar (Vancouver Scar Scale (VSS), scar assessment according to the Mustoe classification) will be analyzed. Researchers will also assess the sequence of abdominal muscle contractions during activation of the pelvic floor muscles (ultrasound examination) and quantify the state of soft tissue tension using the MyotonPro measuring device.
### Conditions Module
**Conditions:**
- Cesarean Section Complications
**Keywords:**
- Soft tissue mobilization, scar, cesarean section
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_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:** Two manual therapy treatments (myofascial release, soft tissue mobilization) in the lower abdominal area and the cesarean section scar, two weeks apart.
**Intervention Names:**
- Other: Manual therapy (myofascial release, soft tissue mobilization)
**Label:** Experimental Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental Group
**Description:** Soft tissue mobilization will be performed by a team of experienced manual therapists.
**Name:** Manual therapy (myofascial release, soft tissue mobilization)
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Vancouver Scar Scale (VSS) rating the scars according to four parameters: vascularity, pigmentation, pliability, and height. Each parameter contains ranked subscales that may be summed to obtain a total score ranging from 0 (representing normal skin) to 13 (representing worst scar imaginable)
**Measure:** Vancouver Scar Scale (VSS)
**Time Frame:** 1. Before first intervention (baseline); 2. Before the second intervention (two weeks after the first intervention); 3. Two weeks after the second intervention (follow-up)
**Description:** 6-stage scar classification taking into account its shape, size, color, as well as symptoms such as pain and itching.
**Measure:** Scar assessment according to the Mustoe classification
**Time Frame:** 1. Before first intervention (baseline); 2. Before the second intervention (two weeks after the first intervention); 3. Two weeks after the second intervention (follow-up)
**Description:** The Satisfaction with Life Scale (SWLS) is used to measure the feeling of satisfaction with life. This tool consists of five statements that the respondent evaluates on a seven-point scale. The respondent assesses the extent to which each statement applies to his or her life so far. The result obtained is the overall degree of satisfaction with life. The results range from 5 to 35 points. The higher the score, the higher the sense of life satisfaction.
**Measure:** Satisfaction With Life Scale (SWLS)
**Time Frame:** 1. Before first intervention (baseline); 2. Before the second intervention (two weeks after the first intervention); 3. Two weeks after the second intervention (follow-up)
**Description:** Sonoscape E2 device
**Measure:** Assessment of the sequence of abdominal muscle contraction during activation of the pelvic floor muscles - ultrasound examination
**Time Frame:** 1. Before first intervention (baseline); 2. After first intervention; 3. Before the second intervention (two weeks after the first intervention); 4. After the second intervention; 5. Two weeks after the second intervention (follow-up)
**Description:** Objective parameter \[N/m\] quantifying the state of soft tissue tension using the MyotonPro device. Determines the force generated by the myometer's measuring tip needed to deform the tissue being examined to a specified depth. During the planned examination, the area of the cesarean section scar and the erector spinae muscle in the lumbar section will be assessed.
**Measure:** Quantitative assessment of soft tissue tension - Stiffness (S)
**Time Frame:** 1. Before first intervention (baseline); 2. After first intervention; 3. Before the second intervention (two weeks after the first intervention); 4. After the second intervention; 5. Two weeks after the second intervention (follow-up)
**Description:** An objective parameter that quantifies the state of soft tissue tension using the MyotonPro device. It determines a property of tissue called elasticity. It is the ability of muscle tissue to return to its original shape after the deforming force ceases. During the planned examination, the area of the cesarean section scar and the erector spinae muscle in the lumbar section will be assessed.
**Measure:** Quantitative assessment of soft tissue tension - Decrement (D)
**Time Frame:** 1. Before first intervention (baseline); 2. After first intervention; 3. Before the second intervention (two weeks after the first intervention); 4. After the second intervention; 5. Two weeks after the second intervention (follow-up)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* women aged 18-45,
* undergone at least 1 cesarean section in a period of not less than 6 months,
* not using physiotherapy for a cesarean section scar
Exclusion Criteria:
* women under 18 and over 45,
* pregnant women,
* presence of abdominal mesh,
* condition after abdominoplasty; nephrectomy; hysterectomy; cystectomy,
* uterine fibroids,
* stoma,
* occurrence of neurological symptoms (exclusion based on a functional test including the following elements: trunk flexion test in a sitting position (Slump test), Babinski test and clonic reflex test, tension tests for the sciatic nerve (passive straight leg raise test) and bowstring test and femoral nerve test (in lying on the front and on the side), examination of knee and ankle reflexes, as well as assessment of superficial sensation and strength of indicator muscles in the innervation of the lumbar-sacral spine),
* positive result of pain provocation tests: axial compression of the spine and maximum compression of the intervertebral foramen in the lumbosacral spine area,
* presence of contraindications to myofascial release therapy (active cancer, deep vein thrombosis, aneurysms, infectious diseases, viral and bacterial infections, acute inflammation and fever),
* women who underwent CC surgery in less than 6 months,
* previous surgical treatment and spine injury,
* vertical scar after cesarean section,
* use of physiotherapy treatments in the last six months,
* additionally the following comorbid conditions: cancer, diabetes, osteoporosis, diseases of the digestive system, circulatory system, rheumatic, mental and gynecological diseases, pregnancy
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Katarzyna Strojek, PhD
**Phone:** +48668124555
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Physiotherapy, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toruń
**Name:** Katarzyna Strojek, PhD
**Role:** STUDY_CHAIR
### References Module
#### References
**Citation:** Stupak A, Kondracka A, Fronczek A, Kwasniewska A. Scar Tissue after a Cesarean Section-The Management of Different Complications in Pregnant Women. Int J Environ Res Public Health. 2021 Nov 15;18(22):11998. doi: 10.3390/ijerph182211998.
**PMID:** 34831752
**Citation:** Gilbert I, Gaudreault N, Gaboury I. Exploring the Effects of Standardized Soft Tissue Mobilization on the Viscoelastic Properties, Pressure Pain Thresholds, and Tactile Pressure Thresholds of the Cesarean Section Scar. J Integr Complement Med. 2022 Apr;28(4):355-362. doi: 10.1089/jicm.2021.0178. Epub 2022 Jan 13.
**PMID:** 35426735
**Citation:** Li YP, Liu CL, Zhang ZJ. Feasibility of Using a Portable MyotonPRO Device to Quantify the Elastic Properties of Skeletal Muscle. Med Sci Monit. 2022 Jan 28;28:e934121. doi: 10.12659/MSM.934121.
**PMID:** 35087016
**Citation:** Gilbert I, Gaudreault N, Gaboury I. Intra- and inter-evaluator reliability of the MyotonPRO for the assessment of the viscoelastic properties of caesarean section scar and unscarred skin. Skin Res Technol. 2021 May;27(3):370-375. doi: 10.1111/srt.12956. Epub 2020 Oct 21.
**PMID:** 33084197
## 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: M6160
- Name: Cicatrix
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446245
**Acronym:** DIRECT
**Brief Title:** Adjunctive Doxycycline for Central Nervous System Tuberculosis
**Official Title:** DIRECT: Doxycycline Adjunctive Therapy to Reduce Excess Mortality and Complications From Central Nervous System Tuberculosis - Phase II Randomized Clinical Trial
#### Organization Study ID Info
**ID:** 2024/00039
#### Organization
**Class:** OTHER
**Full Name:** National University Hospital, Singapore
### Status Module
#### Completion Date
**Date:** 2027-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-28
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** National Medical Research Council (NMRC), Singapore
#### Lead Sponsor
**Class:** OTHER
**Name:** National University Hospital, Singapore
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Although tuberculosis is now considered a treatable disease, central nervous system tuberculosis (CNS-TB) when managed with the current standard-of-care (SOC), still has mortality rates ranging from 30-50% even in tertiary hospital centers. At present, the SOC for the management of CNS-TB is anti-tuberculous therapy with adjunctive corticosteroids. In CNS-TB, the activity of pathogenic host matrix metalloproteinases (MMPs) is unopposed to tissue inhibitors of metalloproteinases (TIMPs), resulting in a matrix-degrading phenotype which may drive worse outcomes in CNS-TB. In a prior established CNS-TB murine model, the investigators have demonstrated that adjunctive MMP inhibition using doxycycline, a widely available and cheap drug, in addition to standard TB treatment, compared with standard TB treatment alone, improved murine survival (Manuscript in preparation). The investigators previously showed that in humans with pulmonary TB, doxycycline with anti-TB treatment is safe, accelerates the resolution of inflammation, and suppresses systemic and respiratory MMPs. Hence, the investigators are now ideally positioned to determine if adjunctive doxycycline in patients with CNS-TB can improve clinical outcomes. The investigators will perform a Phase 2 double-blind randomized-controlled trial (RCT) of adjunctive doxycycline versus placebo with standard TB treatment and steroids for 8 weeks, with the primary outcome of 8-week mortality or severe neurological deficits.
**Detailed Description:** The investigators hypothesize that in patients with CNS-TB, the addition of doxycycline to SOC improves clinical outcomes.
The specific aims are to determine:
1. Whether the primary outcome of mortality rates or severe neurological deficits in CNS-TB patients in the doxycycline arm improves at 8 weeks. Neurological deficits will be defined using a modified Rankin scale score of 3 or higher to measure the degree of disability or dependence in the daily activities of people who have suffered from neurological disability.
2. Whether MMPs and inflammatory gene transcriptomics in the doxycycline arm are reduced. Plasma and cerebrospinal fluid (CSF) MMPs and TIMPs will be measured by luminex bead array technology. The functional activity of CSF MMPs will be assessed using Dye-quenched (DQ) Gelatin degradation. Inflammatory gene transcripts will be measured using whole-blood bulk RNA sequencing and single-cell RNA sequencing. CSF will also be profiled using single-cell RNA sequencing.
3. Whether concurrent SOC treatment and doxycycline for CNS-TB are safe. The investigators will monitor patients for side effects including liver function tests to evaluate any significant change in the safety profile of the patients after administration of adjunctive doxycycline, in comparison to the placebo arm. Standard measures such as grade 3 or 4 adverse events or serious adverse events will be determined.
These specific aims will determine if doxycycline will improve clinical outcomes in the management of CNS-TB, reduce long-term neurological deficits whilst demonstrating a comparable safety profile. These aims are critical to form the basis of a large-scale Phase 3 randomised-controlled trial of CNS-TB which will positively impact clinical practice and international guidelines.
Background and Clinical Significance
The global burden of tuberculosis and TB sequelae
Despite being declared an emergency by the World Health Organisation (WHO) in 1993, tuberculosis (TB) remains a global health epidemic. A significant proportion of the global population is infected with TB, particularly in lower- to middle-income countries in resource-limited settings. Despite strategies directed towards infection control and TB management, worldwide annual TB deaths are estimated to be 1.3 million. Furthermore, the coronavirus disease 2019 (COVID-19) pandemic has also impacted TB, and TB incidence is expected to rise substantially. In Singapore, TB incidence has stagnated after some significant improvements with an annual incidence of approximately 39 TB infections per 100,000 people, which translates to under 3,000 TB patients per year. Additionally, there are rising multi-drug-resistant (MDR) and extensively drug-resistant (XDR) TB regionally and in the world, which pose clinical challenges. MDR and XDR TB often require prolonged treatment courses with medications that are often unavailable in resource-limited settings. Singapore is not exempted from the scourge of MDR and XDR TB cases, which have been described in prisons, gaming arcades and even housing estates. Global and local epidemiology indicates that TB remains an infectious disease threat.
One of the most severe forms of TB is CNS-TB which can lead to significant morbidity and mortality. In CNS-TB, tissue destruction can result in long-term neurological sequelae with permanent neurological deficits. Even with appropriate treatment for CNS-TB and microbiological cure, mortality rates for CNS-TB remain high at up to 30-50%; CNS-TB may still leave behind residual neurological deficits. Patients can become bed-bound and dependent on activities of daily living. Even with good standard-of-care, there still is cognitive impairment in up to 55% of patients and motor deficits in up to 40% of patients, with significant residual neurological deficits. Adjunctive steroids significantly reduce mortality (41.3% placebo vs 31.8% in the steroid arm), but death rates remain unacceptably high. Critically, steroids did not show a significant improvement in severe disability from neurological deficits. TB sequelae cause substantial morbidity long after TB itself is treated, as currently there is no treatment to prevent severe neurological disability.
Host immunopathology and TB tissue destruction
Prior published work has shown that the cause of tissue destruction in TB resulting in sequelae is excessive host inflammatory and adaptive immune response. Although the immunopathology in TB is not fully understood, it has been shown that pro-inflammatory cytokines such as tumour necrosis factor-alpha (TNF-α) may play a key role. Proteases result in tissue destruction in TB patients, with MMPs having a unique ability to collectively degrade all extracellular matrix fibrils at a neutral power of hydrogen (pH), of which the secretion of MMPs in TB is excessive. MMP activity is dysregulated in TB, which is the key in the pathophysiology. The secretion of multiple MMPs are up-regulated, arising from human macrophages, epithelial cells and neutrophils which we showed. The upregulation of MMPs with tissue destruction has been shown in several TB animal models, which provides further evidence on the role of pathogenic MMPs in vivo.
Doxycycline is the only MMP inhibitor licensed by the U.S. Food and Drug Administration which has both anti-bacterial and immunomodulatory properties. It is an antibiotic that is used for decades for a range of clinical indications, including periodontal disease (gum disease), acting on periodontal clefts by reducing the concentration of collagenases. Doxycycline has also been shown to be bacteriostatic to Mycobacterium tuberculosis (Mtb). It has an excellent safety profile, even when given for prolonged durations. It may also be administered by nasogastric tube for individuals with swallowing disability. Furthermore, it is a drug that is widely available and cheap, making it highly accessible even in resource-limited settings. The addition of doxycycline adjunctive therapy to corticosteroids and standard TB therapy may decrease host MMP expression and inflammatory gene responses in human CNS-TB, hence improving clinical outcomes and neurological sequelae.
Doxycycline modulates TB tissue destruction
The first doxycycline pulmonary TB trial worldwide was conducted by us. In a Phase 2 double-blind randomised-controlled trial of 30 pulmonary TB patients, investigating doxycycline host-directed therapy funded by the National Medical Research Council, the investigators showed that 2 weeks of doxycycline improved pulmonary cavity resolution as indicated by the patients exhibiting significantly smaller cavities. In addition, there was also a beneficial host immunological effect that persisted 6 weeks post-discontinuation of the doxycycline, accelerating a return to healthy gene expression of the host transcriptome. MMPs were also down-regulated with suppression of plasma MMP-1 and further reduction of collagenase and gelatinase MMPs in the sputum. However, the effects of doxycycline on mortality or neurological outcomes in CNS-TB are unknown. This Phase 2 randomised-controlled-trial determines if adjunctive doxycycline treatment can be extended to CNS-TB to improve clinical outcomes and neurological sequelae. Reducing neurological disability would alleviate burden on healthcare facilities and maximise an individual's economically productive life. If positive, these findings will provide preliminary data for a Phase 3 RCT. Findings will be rapidly conveyed to the WHO with whom the investigators closely collaborate, to impact international guidelines and clinical practice.
Specific Aims and Hypothesis
The investigators hypothesize that in patients with CNS-TB, the addition of doxycycline to SOC improves clinical outcomes.
The specific aims are to determine:
1. Whether the primary outcome of mortality rates or severe neurological deficits in CNS-TB patients in the doxycycline arm improves at 8 weeks. Neurological deficits will be defined using a modified Rankin scale score of 3 or higher to measure the degree of disability or dependence in the daily activities of people who have suffered from neurological disability.
2. Whether MMPs and inflammatory gene transcriptomics in the doxycycline arm are reduced. Plasma and cerebrospinal fluid (CSF) MMPs and TIMPs will be measured by luminex bead array technology. The functional activity of CSF MMPs will be assessed using Dye-quenched (DQ) Gelatin degradation. Inflammatory gene transcripts will be measured using whole-blood bulk RNA sequencing and single-cell RNA sequencing. CSF will also be profiled using single-cell RNA sequencing.
3. Whether concurrent SOC treatment and doxycycline for CNS-TB are safe. The investigators will monitor patients for side effects including liver function tests to evaluate any significant change in the safety profile of the patients after administration of adjunctive doxycycline, in comparison to the placebo arm. Standard measures such as grade 3 or 4 adverse events or serious adverse events will be determined.
These specific aims will determine if doxycycline will improve clinical outcomes in the management of CNS-TB, reduce long-term neurological deficits whilst demonstrating a comparable safety profile. These aims are critical to form the basis of a large-scale Phase 3 randomised-controlled trial of CNS-TB which will positively impact clinical practice and international guidelines.
### Conditions Module
**Conditions:**
- Tuberculosis, Meningeal
- Tuberculosis; Meningitis (Etiology)
- Tuberculosis, Central Nervous System
- Tuberculosis; Meningoencephalitis (Etiology)
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Phase II, multi-center randomised controlled trial, parallel design of intervention versus placebo
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Double-blinded
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Doxycycline 100 mg twice daily with once daily anti-tuberculous treatment comprising of at least three agents, including rifampicin 10 mg/kg, isoniazid 5 mg/kg, ethambutol 15 - 20 mg/kg, ± pyrazinamide 25 mg/kg and pyridoxine 10-50 mg per day, or aminoglycosides or quinolones according to managing physicians' discretion. Adjunctive corticosteroids to be dosed at 0.4mg/kg/day of dexamethasone or equivalent for week 1, then 0.3mg/kg/day for week 2, 0.2mg/kg/day for week 3, 0.1mg/kg/day for week 4, then tapered to stop over the next 4 weeks. Other forms of corticosteroids are also acceptable e.g. hydrocortisone, methylprednisolone at the equivalent dosage. Where needed, the drugs will be adjusted according to renal function. These will be given daily for 8 weeks. Subsequently doxycycline will be ceased and patients are to continue with their standard anti-tuberculous treatment and duration according to their managing physician.
**Intervention Names:**
- Drug: Doxycycline
- Drug: Anti Tuberculosis Drug
- Drug: Adjunctive corticosteroid
**Label:** Doxycycline + standard anti-tuberculous treatment + corticosteroid therapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo twice daily with once daily anti-tuberculous treatment comprising of at least three agents, including rifampicin 10 mg/kg, isoniazid 5 mg/kg, ethambutol 15-20 mg/kg, ± pyrazinamide 25 mg/kg and pyridoxine 10-50 mg per day, or aminoglycosides or quinolones according to managing physicians' discretion. Adjunctive corticosteroids to be dosed at 0.4mg/kg/day of dexamethasone or equivalent for week 1, then 0.3mg/kg/day for week 2, 0.2mg/kg/day for week 3, 0.1mg/kg/day for week 4, then tapered to stop over the next 4 weeks. Other forms of corticosteroids are also acceptable e.g. hydrocortisone, methylprednisolone at the equivalent dosage. Where needed, the drugs will be adjusted according to renal function. These will be given daily for 8 weeks. Subsequently placebo will be ceased and patients are to continue with their standard anti-tuberculous treatment and duration according to their managing physician.
**Intervention Names:**
- Drug: Placebo
- Drug: Anti Tuberculosis Drug
- Drug: Adjunctive corticosteroid
**Label:** Placebo + standard anti-tuberculous treatment + corticosteroid therapy
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Doxycycline + standard anti-tuberculous treatment + corticosteroid therapy
**Description:** adjunctive doxycycline to standard anti-tuberculous treatment and corticosteroid therapy
**Name:** Doxycycline
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo + standard anti-tuberculous treatment + corticosteroid therapy
**Description:** Placebo
**Name:** Placebo
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Doxycycline + standard anti-tuberculous treatment + corticosteroid therapy
- Placebo + standard anti-tuberculous treatment + corticosteroid therapy
**Description:** Standard anti-tuberculous therapy
**Name:** Anti Tuberculosis Drug
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Doxycycline + standard anti-tuberculous treatment + corticosteroid therapy
- Placebo + standard anti-tuberculous treatment + corticosteroid therapy
**Description:** Adjunctive corticosteroids to be dosed at 0.4mg/kg/day of dexamethasone or equivalent for week 1, then 0.3mg/kg/day for week 2, 0.2mg/kg/day for week 3, 0.1mg/kg/day for week 4, then tapered to stop over the next 4 weeks. Other forms of corticosteroids are also acceptable eg. hydrocortisone, methylprednisolone at the equivalent dosage
**Name:** Adjunctive corticosteroid
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Patients who survived 8 weeks from the diagnosis of CNS-TB, OR Persistent neurological disability at 8 weeks defined as a modified Rankin score of 3 or greater.
**Measure:** Mortality or severe neurological deficits (modified Rankin scale of 3 or more) within 8 weeks.
**Time Frame:** 8 weeks
#### Secondary Outcomes
**Description:** Mortality at 8 weeks from diagnosis of CNS-TB
**Measure:** Mortality at 8 weeks from diagnosis of CNS-TB
**Time Frame:** 8 weeks
**Description:** Persistent neurological disability at 8 weeks of diagnosis of CNS-TB
**Measure:** Persistent neurological disability at 8 weeks of diagnosis of CNS-TB
**Time Frame:** 8 weeks
**Description:** Magnetic resonance imaging or Computed tomography brain at 8 weeks showing persistent changes associated with CNS-TB from the time of diagnosis
**Measure:** Magnetic resonance imaging or Computed tomography brain at 8 weeks showing persistent changes associated with CNS-TB from the time of diagnosis
**Time Frame:** 8 weeks
**Description:** Whole blood will be collected in Tempus tubes and processed in a biosafety level-3 laboratory. Library preparation and bulk RNA sequencing will be performed as previously described. In addition, in the subset of patients recruited from Singapore, single-cell RNA sequencing (scRNAseq) will be performed from the doxycycline and placebo arm, analysing 10,000 cells per sample. In this subset of patients, blood for bulk RNAseq will also be stored as a backup. Single-cell RNAsequencing from the CSF will also be performed. Bioinformatic analyses will be performed to evaluate the pattern of change of host transcriptome at week 8, in established pipelines.
**Measure:** The pattern of change of host transcriptome at week 8
**Time Frame:** 8 weeks
**Description:** Whole blood will be spun down, plasma collected and sterile filtered in a biosafety level-3 laboratory before transferring to a biosafety level-2 laboratory. MMP Luminex bead array will be performed which has been established in Dr Catherine Ong's laboratory. The pattern of change of host plasma MMPs at week 8.
**Measure:** The pattern of change of host plasma MMPs at week 8
**Time Frame:** 8 weeks
**Description:** CSF will be collected and sterile filtered in a biosafety level-3 laboratory before transferring to a biosafety level-2 laboratory. MMP Luminex bead array will be performed which has been established in Dr Catherine Ong's laboratory. The host CSF MMPs at week 2 shall be evaluated.
**Measure:** The pattern of change of host CSF MMPs at week 2
**Time Frame:** 2 weeks
**Description:** These will be recorded using the Division of AIDS table for Grading the Severity of Adult and Paediatric adverse events (December 2004)
**Measure:** Adverse events and serious adverse events
**Time Frame:** 8 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Aged 21 years and above.
2. Patients receiving ≤ 7 days of TB treatment or about to start combination TB treatment, including injectable agents, where required.
3. Patients with clinical evidence of meningitis (combination of nuchal rigidity and cerebrospinal fluid abnormalities), defined as either confirmed, probable or possible CNS-TB:
1. "Definite" CNS-TB would be defined if acid-fast bacilli (AFB) or a positive nucleic acid amplification test for M. tuberculosis in the cerebrospinal fluid of patients.
2. "Probable" CNS-TB would be defined if the patient exhibit one or more of the following: suspected pulmonary tuberculosis on chest radiography, acid-fast bacilli found in any specimen other than the cerebrospinal fluid or clinical evidence of other extrapulmonary tuberculosis.
3. "Possible" CNS-TB would be defined if the patients exhibit at least four of the following: a history of tuberculosis, predominance of lymphocytes in the cerebrospinal fluid, a duration of illness of more than five days, a ratio of cerebrospinal fluid glucose to plasma glucose of less than 0.5, altered consciousness, yellow cerebrospinal fluid, or focal neurologic signs.
4. Alanine aminotransferase (ALT) level \< 3 times the upper limit of normal.
5. Able to provide informed consent. If the patient has no mental capacity to give consent, then consent may be provided for by the patient's next of kin.
6. Lumbar puncture and brain imaging (either computed tomography or magnetic resonance imaging, with or without contrast) is required at baseline for enrolment
Exclusion Criteria:
1. Cancer
2. Pregnant or breastfeeding
3. Allergies to tetracyclines
4. Patients on retinoic acid, neuromuscular blocking agents or pimozide which may increase the risk of drug toxicity.
5. Autoimmune disease and/or on systemic immunosuppressants.
6. Use of any investigational or non-registered drug, vaccine or medical device other than the study drug within 182 days preceding dosing of the study drug or planned use during the study period.
7. Enrolment in any other clinical trial involving a systemic drug or intervention involving the CNS.
8. Evidence of severe depression, schizophrenia or mania.
9. Contraindications to the use of steroids.
10. Investigators' assessment of lack of willingness to participate and comply with all requirements including follow-up of the protocol or identification of any factor presumed to significantly increase the participant's risk of suffering an adverse outcome.
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Singapore
**Country:** Singapore
**Facility:** National University Hospital
**Zip:** 119228
### IPD Sharing Statement Module
**Description:** Data may be made available on reasonable request
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Ong CW, Elkington PT, Friedland JS. Tuberculosis, pulmonary cavitation, and matrix metalloproteinases. Am J Respir Crit Care Med. 2014 Jul 1;190(1):9-18. doi: 10.1164/rccm.201311-2106PP.
**PMID:** 24713029
**Citation:** Poh XY, Hong JM, Bai C, Miow QH, Thong PM, Wang Y, Rajarethinam R, Ding CSL, Ong CWM. Nos2-/- mice infected with M. tuberculosis develop neurobehavioral changes and immunopathology mimicking human central nervous system tuberculosis. J Neuroinflammation. 2022 Jan 24;19(1):21. doi: 10.1186/s12974-022-02387-0. Erratum In: J Neuroinflammation. 2022 Aug 1;19(1):197.
**PMID:** 35073927
**Citation:** Miow QH, Vallejo AF, Wang Y, Hong JM, Bai C, Teo FS, Wang AD, Loh HR, Tan TZ, Ding Y, She HW, Gan SH, Paton NI, Lum J, Tay A, Chee CB, Tambyah PA, Polak ME, Wang YT, Singhal A, Elkington PT, Friedland JS, Ong CW. Doxycycline host-directed therapy in human pulmonary tuberculosis. J Clin Invest. 2021 Aug 2;131(15):e141895. doi: 10.1172/JCI141895.
**PMID:** 34128838
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009164
- Term: Mycobacterium Infections
- ID: D000000193
- Term: Actinomycetales Infections
- ID: D000016908
- Term: Gram-Positive Bacterial Infections
- ID: D000001424
- Term: Bacterial Infections
- ID: D000001423
- Term: Bacterial Infections and Mycoses
- ID: D000007239
- Term: Infections
- ID: D000090862
- Term: Neuroinflammatory Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000020805
- Term: Central Nervous System Viral Diseases
- ID: D000002494
- Term: Central Nervous System Infections
- ID: D000004660
- Term: Encephalitis
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000020806
- Term: Central Nervous System Bacterial Infections
- ID: D000092225
- Term: Tuberculosis, Extrapulmonary
- ID: D000016920
- Term: Meningitis, Bacterial
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M17127
- Name: Tuberculosis
- Relevance: HIGH
- As Found: Tuberculosis
- ID: M11573
- Name: Meningoencephalitis
- Relevance: HIGH
- As Found: Meningoencephalitis
- ID: M22119
- Name: Tuberculosis, Central Nervous System
- Relevance: HIGH
- As Found: Tuberculosis, Central Nervous System
- ID: M17140
- Name: Tuberculosis, Meningeal
- Relevance: HIGH
- As Found: Tuberculosis, Meningeal
- ID: M11564
- Name: Meningitis
- Relevance: HIGH
- As Found: Meningitis
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12119
- Name: Mycobacterium Infections
- Relevance: LOW
- As Found: Unknown
- ID: M4722
- Name: Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M19252
- Name: Gram-Positive Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M12136
- Name: Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M4721
- Name: Bacterial Infections and Mycoses
- Relevance: LOW
- As Found: Unknown
- ID: M2803
- Name: Neuroinflammatory Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22560
- Name: Central Nervous System Viral Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5743
- Name: Central Nervous System Infections
- Relevance: LOW
- As Found: Unknown
- ID: M7825
- Name: Encephalitis
- 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: M22561
- Name: Central Nervous System Bacterial Infections
- Relevance: LOW
- As Found: Unknown
- ID: M2910
- Name: Tuberculosis, Extrapulmonary
- Relevance: LOW
- As Found: Unknown
- ID: M19264
- Name: Meningitis, Bacterial
- Relevance: LOW
- As Found: Unknown
- ID: T644
- Name: Bacterial Meningitis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000014376
- Term: Tuberculosis
- ID: D000008590
- Term: Meningoencephalitis
- ID: D000020306
- Term: Tuberculosis, Central Nervous System
- ID: D000014390
- Term: Tuberculosis, Meningeal
- ID: D000008581
- Term: Meningitis
### Intervention Browse Module - Ancestors
- ID: D000000900
- Term: Anti-Bacterial Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000000962
- Term: Antimalarials
- ID: D000000981
- Term: Antiprotozoal Agents
- ID: D000000977
- Term: Antiparasitic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: AnEm
- Name: Antiemetics
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: Lipd
- Name: Lipid Regulating Agents
- Abbrev: NeuroAg
- Name: Neuroprotective Agents
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M7493
- Name: Doxycycline
- Relevance: HIGH
- As Found: Signs
- ID: M4311
- Name: Antitubercular Agents
- Relevance: HIGH
- As Found: Azacytidine, 5-
- ID: M23026
- Name: Vitamin B 6
- Relevance: LOW
- As Found: Unknown
- ID: M14583
- Name: Pyridoxal
- Relevance: LOW
- As Found: Unknown
- ID: M14589
- Name: Pyridoxine
- Relevance: LOW
- As Found: Unknown
- ID: M7102
- Name: Dexamethasone
- Relevance: LOW
- As Found: Unknown
- ID: M235549
- Name: Dexamethasone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M9912
- Name: Hydrocortisone
- Relevance: LOW
- As Found: Unknown
- ID: M155245
- Name: Hydrocortisone 17-butyrate 21-propionate
- Relevance: LOW
- As Found: Unknown
- ID: M228609
- Name: Hydrocortisone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M263259
- Name: Hydrocortisone hemisuccinate
- Relevance: LOW
- As Found: Unknown
- ID: M14120
- Name: Prednisolone
- Relevance: LOW
- As Found: Unknown
- ID: M10570
- Name: Isoniazid
- Relevance: LOW
- As Found: Unknown
- ID: M14571
- Name: Pyrazinamide
- Relevance: LOW
- As Found: Unknown
- ID: M8125
- Name: Ethambutol
- Relevance: LOW
- As Found: Unknown
- ID: M11749
- Name: Methylprednisolone
- Relevance: LOW
- As Found: Unknown
- ID: M1833
- Name: Methylprednisolone Acetate
- Relevance: LOW
- As Found: Unknown
- ID: M11750
- Name: Methylprednisolone Hemisuccinate
- Relevance: LOW
- As Found: Unknown
- ID: M229449
- Name: Prednisolone acetate
- Relevance: LOW
- As Found: Unknown
- ID: M211887
- Name: Prednisolone hemisuccinate
- Relevance: LOW
- As Found: Unknown
- ID: M248881
- Name: Prednisolone phosphate
- Relevance: LOW
- As Found: Unknown
- ID: M15118
- Name: Rifampin
- Relevance: LOW
- As Found: Unknown
- ID: M4222
- Name: Anti-Bacterial Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4280
- Name: Antimalarials
- Relevance: LOW
- As Found: Unknown
- ID: M4298
- Name: Antiprotozoal Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4294
- Name: Antiparasitic Agents
- Relevance: LOW
- As Found: Unknown
- ID: T474
- Name: Vitamin B6
- Relevance: LOW
- As Found: Unknown
- ID: T459
- Name: Pyridoxal
- Relevance: LOW
- As Found: Unknown
- ID: T461
- Name: Pyridoxine
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000004318
- Term: Doxycycline
- ID: D000000995
- Term: Antitubercular Agents
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446232
**Brief Title:** Influenza Vaccine Effectiveness in Among Young Children in Taiwan
**Official Title:** Influenza Vaccine Effectiveness in Inpatient and Outpatient Settings Among Young Children in Taiwan
#### Organization Study ID Info
**ID:** 202304120RINC
#### Organization
**Class:** OTHER
**Full Name:** National Taiwan University Hospital
### Status Module
#### Completion Date
**Date:** 2029-08-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-05
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2028-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2023-06-27
**Study First Submit QC Date:** 2024-06-05
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** National Taiwan University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This project uses questionnaires to statistically analyze whether influenza vaccination is protective for young children.
**Detailed Description:** This plan is expected to admit 350 children who are admitted to the emergency department or hospitalized due to influenza and are aged from 6 months (inclusive) to under 18 years old. Vaccine status, statistical analysis of whether the flu vaccine is protective.
### Conditions Module
**Conditions:**
- Influenza Vaccine Allergy
**Keywords:**
- Influenza Vaccine
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 1
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** This project uses questionnaires to statistically analyze whether the flu vaccine is protective for young children. Researchers collect flu rapid test results and invite subjects to write questionnaires. Data collectors administered a standardised questionnaire that included information on demographics, medical history (including flu vaccination status and self-reported prior flu infection).
**Measure:** Questionnaires
**Time Frame:** 12 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Clinical diagnosis of influenza by Flu A+B rapid antigen test
* Known vaccination status
Exclusion Criteria:
* Unknown vaccination status
**Maximum Age:** 18 Years
**Minimum Age:** 6 Months
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
**Study Population:** Those who have performed a rapid influenza screening test, regardless of whether the result is negative or positive
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yi Jen Liau
**Phone:** 02-23123456
**Phone Ext:** 271729
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Taipei
**Country:** Taiwan
**Facility:** National Taiwan University Hospital
**Status:** RECRUITING
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000009976
- Term: Orthomyxoviridae Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M10295
- Name: Influenza, Human
- Relevance: HIGH
- As Found: Influenza
- ID: M10018
- Name: Hypersensitivity
- 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: M12902
- Name: Orthomyxoviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007251
- Term: Influenza, Human
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17360
- Name: Vaccines
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446219
**Brief Title:** Efficacy and Safety Comparison of Upadacitinib and Vedolizumab in Second-line Treatment for Crohn's Disease
**Official Title:** A Retrospective Analysis of the Efficacy and Safety Comparison of Upadacitinib and Vedolizumab in Second-line Treatment for Crohn's Disease
#### Organization Study ID Info
**ID:** 2024ZSLYEC-257
#### Organization
**Class:** OTHER
**Full Name:** Sixth Affiliated Hospital, Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2024-03-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-31
**Type:** ACTUAL
#### Start Date
**Date:** 2020-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-01
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sixth Affiliated Hospital, Sun Yat-sen University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study focuses on Upadacitinib, a new oral and small-molecular medication that inhibits specific enzymes involved in inflammation. The goal is to determine efficacy and safety of Upadacitinib for Crohn's Disease patients in China compared with Vedolizumab, which is used to inhibit recruitment of inflammatory cells. Crohn's Disease significantly affects individuals' quality of life and imposes a high burden on society and healthcare systems. Current treatments don't work for everyone, and some patients may need surgery. Upadacitinib has shown promise in other countries for treating Crohn's Disease and related conditions, and has been approved by the US FDA for such use.
Our retrospective and multicenter study looks back at patient records from multiple hospitals to analyze the outcomes of those who have received Upadacitinib and Vedolizumab. Investigators aim to enroll patients treated between January 2020 and March 2024, who received follow-up for more than 12 weeks. For patients, families, and healthcare providers, this research could provide a potential new treatment option for Crohn's Disease. Better efficacy and safety of Upadacitinib than Vedolizumab could lead to better management of the disease, possibly reducing the need for surgery and improving the quality of life. The ultimate goal is to provide more personalized and effective treatment strategies for Crohn's Disease patients in China.
**Detailed Description:** This retrospective, multicenter study is designed to compare the efficacy and safety of Upadacitinib and Vedolizumab in second-line treatment for Crohn's Disease, the former is an oral selective enzyme inhibitor, and the latter is a monoclonal antibody targeting integrin α4β7. Crohn's Disease poses a significant impact on the quality of life for individuals and presents a considerable challenge to healthcare systems due to the societal burdens it incurs. While current therapeutic interventions offer relief, they fail to suffice for all patients, with some requiring surgical intervention. Despite the approval of Upadacitinib by the US FDA and its promising application in other nations for Crohn's Disease management, there is a scarcity of data on its effectiveness and safety among Chinese patients. Our research aims to fill this knowledge gap by retrospectively analyzing patient records from multiple hospitals across China. The study targets the adult patients that has received follow-up for more than 12 weeks between January 2020 and March 2024. By assessing the outcomes of these patients, our objective is to ascertain the potential of Upadacitinib as a viable treatment alternative, which may revolutionize the current Crohn's Disease treatment paradigm in China.The implications of this study are significant for patients, their families, and healthcare providers, as it could herald a new therapeutic avenue for Crohn's Disease management. A clearer understanding of Upadacitinib's role in disease control could enhance patient care by decreasing the necessity for surgical procedures and ameliorating life quality for Crohn's Disease sufferers. The overarching ambition of this research is to pave the way for more individualized and efficacious treatment methodologies for the Crohn's Disease patient populace in China.
### Conditions Module
**Conditions:**
- Crohn Disease
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 172
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Upadacitinib, a selective Janus kinase (JAK) inhibitor taken orally, is being assessed for its unique capacity to attenuate inflammatory pathways in Crohn's Disease at a cellular level by selectively inhibiting JAK1, a pathway integral to inflammatory cytokine production. This study focuses on its use as main therapy for Chinese patients unresponsive to conventional Crohn's Disease treatments, such as tumor necrosis factor-α inhibitor. Rinvoq is the marketed drugs for clinical use, whose oral dosage is 45 mg per day during the induction period and 15 mg/30 mg per day during maintenance period, and the induction period would last for 8 weeks.
**Label:** Upadacitinib
#### Arm Group 2
**Description:** Vedolizumab, a monoclonal antibody targeting integrin α4β7, is used to inhibit recruitment of inflammatory cells. This drug is always used as second-line treatment for patients with moderate-to-severe active stage Crohn's Disease who fail to respond to conventional treatments such as tumor necrosis factor-α inhibitor. This study uses Vedolizumab as control group to illustrate the efficacy and safety of Upadacitinib in second-line treatment for Crohn's Disease. Entyvio is the marketed drugs for clinical use, should be given intra-arterially in week 0, 2, 6 and every subsequent 8 weeks.
**Label:** Vedolizumab
### Outcomes Module
#### Primary Outcomes
**Description:** Steroid-Free Clinical Remission in Crohn's Disease is defined as a CDAI score of less than 150, achieved without the use of corticosteroids.
**Measure:** Steroid-Free Clinical Remission
**Time Frame:** Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
#### Secondary Outcomes
**Description:** Clinical Remission in Crohn's Disease is defined as a CDAI score of less than 150
**Measure:** Clinical Remission
**Time Frame:** Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
**Description:** Clinical Response in Crohn's Disease is a decrease in CDAI score by 70 points or more from baseline.
**Measure:** Clinical Response
**Time Frame:** Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
**Description:** An SES-CD score of 2 or less indicates endoscopic remission
**Measure:** Endoscopic Remission
**Time Frame:** Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
**Description:** Endoscopic Response in Crohn's Disease is a decrease in SES-CD score by 50 percent or more from baseline.
**Measure:** Endoscopic Response
**Time Frame:** Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
**Description:** An SES-CD score of 0 is indicative of mucosal healing
**Measure:** Mucosal Healing
**Time Frame:** Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
**Description:** Defined as the complete disappearance or minimization of intestinal inflammation on imaging studies, signifying no visible lesions, normalized wall thickness, absence of strictures or obstructions, and no new areas of disease. Radiographic remission is an important indicator of deep remission in disease treatment goals.
**Measure:** Radiological Remission
**Time Frame:** Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
**Description:** Typically defined as a significant reduction in the size of affected areas, decreased wall thickness, and decreased markers of inflammation observed through imaging methods such as MRI or CT scans. A radiographic response indicates a reduction in disease activity but may not represent complete disease remission.
**Measure:** Radiological Response
**Time Frame:** Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients who were hospitalized in our institution or its branches between January 2020 and March 2024.
* Patients aged 18 years or older.
* Confirmed as moderately-to-severely active Crohn's disease according to Chinese clinical practice guideline on the management of Crohn's disease (2023,Guangzhou).
* Failure to respond to or tolerate anti-tumor necrosis factor-α inhibitors (Infliximab, Adalimumab).
* Follow-up time for no less than 12 weeks.
Exclusion Criteria:
* Patients who have previously used Upadacitinib and Vedolizumab.
* With insufficient clinical data at baseline, 12 weeks in the UPA group and 14 weeks in the VDZ group to evaluate the efficacy.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study population comprises patients aged 18 and older who were hospitalized for Crohn's Disease between January 2020 and March 2024 at our institution or its branches, and who have been received follow-up for no less than 12 weeks prior to March 2024. The study population should also failure to respond to or tolerate anti-tumor necrosis factor-α inhibitors (Infliximab, Adalimumab). The focus is on adults with a confirmed diagnosis to assess the efficacy in inducing clinical remission and altering disease progression. Exclusion criteria include unclear diagnosis, patients under 18, previously using Upadacitinib/Vedolizumab and absence of clinical data, ensuring a uniform group for valid results.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Guangzhou
**Country:** China
**Facility:** the Sixth Affiliated Hospital of Sun Yat-Sen University
**State:** Guangdong
**Zip:** 510655
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015212
- Term: Inflammatory Bowel Diseases
- ID: D000005759
- Term: Gastroenteritis
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000007410
- Term: Intestinal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6638
- Name: Crohn Disease
- Relevance: HIGH
- As Found: Crohn's Disease
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17917
- Name: Inflammatory Bowel Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8875
- Name: Gastroenteritis
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003424
- Term: Crohn Disease
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
### Intervention Browse Module - Browse Leaves
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: LOW
- As Found: Unknown
- ID: M288641
- Name: Vedolizumab
- Relevance: LOW
- As Found: Unknown
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M275493
- Name: Upadacitinib
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446206
**Brief Title:** Adebrelimab Plus Chemotherapy, Bevacizumab and Fluzoparib in Platinum-Sensitive Relapsed Ovarian Cancer
**Official Title:** Adebrelimab Plus Chemotherapy and Bevacizumab Induction Therapy Followed by Maintenance Therapy With Adebrelimab Plus Fluzoparib and Bevacizumab in Platinum-Sensitive Relapsed Ovarian Cancer (CHANGCHUN): A Single-Arm, Exploratory Study
#### Organization Study ID Info
**ID:** 2024-HS-022
#### Organization
**Class:** OTHER
**Full Name:** The First Hospital of Jilin University
### Status Module
#### Completion Date
**Date:** 2028-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The First Hospital of Jilin University
#### Responsible Party
**Investigator Affiliation:** The First Hospital of Jilin University
**Investigator Full Name:** Ziling Liu
**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 investigators explore the efficacy and safety of adebrelimab (PD-L1 inhibitor) plus chemotherapy and bevacizumab induction therapy followed by maintenance therapy with adebrelimab plus fluzoparib (PARP inhibitor)and bevacizumab in platinum-sensitive relapsed ovarian cancer.
### Conditions Module
**Conditions:**
- Platinum-sensitive Relapsed Ovarian Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 22
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Adebrelimab, paclitaxel, carboplatin, bevacizumab, fluzoparib
**Label:** Experimental arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental arm
**Description:** Adebrelimab plus paclitaxel, carboplatin and bevacizumab induction therapy followed by maintenance therapy with adebrelimab plus fluzoparib and bevacizumab.
**Name:** Adebrelimab, paclitaxel, carboplatin, bevacizumab, fluzoparib
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** Classification per Common Terminology Criteria for Adverse Events (CTC-AE) version 5.0.
**Measure:** All grades adverse event (AE)
**Time Frame:** Through study completion, an average of 2 year.
**Description:** ≥ grade 3 per CTC-AE version 5.0.
**Measure:** Serious adverse events
**Time Frame:** Through study completion, an average of 2 year.
**Measure:** Immune checkpoint inhibitor-related adverse events（irAEs）
**Time Frame:** Through study completion, an average of 2 year.
#### Primary Outcomes
**Measure:** 12-month progression-free survival rate
**Time Frame:** Twelve months after patients received their first antitumor drug therapy.
#### Secondary Outcomes
**Measure:** Objective Response Rate (ORR)
**Time Frame:** The radiological evaluations will be performed once at the end of every 2 cycles within 6 cycles and once every 4 cycles after Cycle 6(each cycle is 21 days).
**Description:** Progress Free Survival (PFS) in patients with complete response (CR)/partial response (PR) after induction chemotherapy.
**Measure:** Progression-free survival of CR/PR
**Time Frame:** The time from the first dose of investigational product to the first progression of disease (PD) in radiological evaluation or death for any reason (whichever comes first), assessed up to 2 years .
**Description:** Progress Free Survival (PFS) in patients with stable disease (SD) after induction chemotherapy.
**Measure:** Progression-free survival of SD
**Time Frame:** The time from the first dose of investigational product to the first progression of disease (PD) in radiological evaluation or death for any reason (whichever comes first), assessed up to 2 years .
**Measure:** Overall Survival（OS）
**Time Frame:** The time from the first dose of investigational product to the death for any reason, assessed up to 2 years.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients volunteered to participate in this study after full informed consent and signed a written informed consent form;
2. Aged 18-75 years old;
3. Pathologically confirmed ovarian epithelial cancer, epithelial fallopian tube cancer, or primary peritoneal cancer;
4. International Federation of Gynecology and Obstetrics (FIGO) 2018 edition staging III-IV;
5. Having received no more than 2 prior lines of platinum-containing chemotherapy and ≥ 6 months between the time of last chemotherapy and tumor recurrence;
6. No more than 1 prior PARP inhibitor;
7. Negative for germline breast cancer susceptibility gene(BRCA) mutations;
8. At least 1 measurable lesion according to RECIST 1.1 evaluation criteria;
9. Patients with expected survival of ≥12 weeks;
10. Have an Eastern Cooperative Oncology Group(ECOG) Performance Status(PS) score of 0-1;
11. The patient has good organ function: without having received transfusions of blood products, granulocyte colony-stimulating factor, interleukin 11, thrombopoietin, or thrombopoietin receptor agonists within 14 days prior to the first receipt of therapeutic agents in this regimen：
* Neutrophil count ≥1.5 x 10\^9/L.
* platelet count ≥ 80 × 10\^9/ L.
* hemoglobin ≥75 g/L.
* albumin ≥30 g/L.
* Albumin ≥30 g/L
* Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
* Alanine amino transferase(ALT), Aspartate amino transferase(AST) ≤ 3 times ULN (without liver metastases) or ≤ 5 times ULN (if liver metastases occur)
* Serum creatinine ≤1.5 times upper limit of normal (ULN)
* Requirements for coagulation: international normalized ratio (INR) ≤1.5 times ULN, prothrombin time (PT) ≤1.5 times ULN, activated partial thromboplastin time (APTT) ≤1.5 times ULN.
* Corrected serum electrolytes within normal range;
12. Women of childbearing potential must have had a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use an appropriate method of contraception for the duration of the trial and for 8 weeks after the last administration of the test drug.
Exclusion Criteria:
1. Known hypersensitivity or severe allergic reactions to the study drug or any of its excipients;
2. Concurrent other incurable malignancies;
3. The presence of uncontrolled or symptomatic active central nervous system (CNS) metastases;
4. Pregnancy or confirmed by blood or urine Human Chorionic Gonadotropin(HCG) test or lactation, or subjects of childbearing potential who are unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last trial treatment;
5. Difficult-to-control diabetes mellitus (defined as high fluctuations in blood glucose that interfere with the patient's life as well as frequent hypotension despite standard insulin therapy and frequent blood glucose monitoring);
6. Myocardial infarction, severe/unstable angina pectoris, New York Heart Association(NYHA) class 2 or greater cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias and symptomatic congestive heart failure, uncontrolled hypertension of moderate or greater severity (Systolic Blood Pressure \>160 mm Hg or Diastolic Blood Pressure \>100 mm Hg) within 4 weeks prior to the first study dose, known coronary artery disease, congestive heart failure that does not meet the above criteria congestive heart failure or left ventricular ejection fraction \<50% that meets the above criteria must be treated with an optimally stabilized medical regimen as determined by the treating physician and, if appropriate, in consultation with a cardiologist;
7. Patients with a history of neurologic autoimmune disease, or moderate to severe autoimmune disease, or high doses of immunosuppressive agents for symptom control
8. History of known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
9. Receipt of any of the following medications or treatments prior to the first study drug treatment
1. major surgery within 6 weeks (tissue biopsies and Peripherally Inserted Central Catheter or infusion port implantation via peripheral venous puncture for diagnostic purposes are permitted)
2. Requires ongoing high-dose systemic corticosteroids (\>10 mg/day prednisone or equivalent dose of other medications) or other systemic immunosuppressants (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, tacrolimus, cyclosporine, meclofenamic acid esters, anti-thymocyte globulin, and anti-tumor necrosis factor medications), and continues to be required after enrollment; \[Note\]: Topical skin, ocular, intra-articular, intranasal, and inhaled corticosteroids are permitted .
10. Serious infections within 90 days, such as severe pneumonia requiring hospitalization, bacteremia, and co-infections; active tuberculosis; \[Note 1\] Hepatitis B Surface Antigen Positive (HBsAg+) and/or Hepatitis B Core Antibody Positive (HBcAb+) patients will be required to undergo a Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) test, if the HBV DNA copy number \<1000 cps/mL, or less than the lower limit of detectable value of the research center, can participate in this study and regulate the use of anti-hepatitis B virus medication; \[Note 2\] patients with hepatitis C antibody positive (HCV Ab+) need to undergo HCV RNA testing, and HCV RNA negative (defined as less than the lower limit of detectable value of the research center) can participate in this study;
11. Psychiatric disorders that interfere with informed consent and/or protocol adherence;
12. Other conditions that, in the judgment of the investigator, make participation in this study inappropriate.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000010049
- Term: Ovarian Diseases
- ID: D000000291
- Term: Adnexal Diseases
- ID: D000005831
- Term: Genital Diseases, Female
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000005833
- Term: Genital Neoplasms, Female
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000091662
- Term: Genital Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000006058
- Term: Gonadal Disorders
- ID: D000002277
- Term: Carcinoma
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000007154
- Term: Immune System Diseases
### 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: BC20
- Name: Immune System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12974
- Name: Ovarian Neoplasms
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M1704
- Name: Carcinoma, Ovarian Epithelial
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M10018
- Name: Hypersensitivity
- Relevance: HIGH
- As Found: Sensitive
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12972
- Name: Ovarian Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3643
- Name: Adnexal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8945
- Name: Genital Neoplasms, Female
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9163
- Name: Gonadal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4352
- Name: Ovarian Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: T4354
- Name: Ovarian Epithelial Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
### Condition Browse Module - Meshes
- ID: D000010051
- Term: Ovarian Neoplasms
- ID: D000077216
- Term: Carcinoma, Ovarian Epithelial
- ID: D000006967
- Term: Hypersensitivity
### 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
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000020533
- Term: Angiogenesis Inhibitors
- ID: D000043924
- Term: Angiogenesis Modulating Agents
- ID: D000006133
- Term: Growth Substances
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000006131
- Term: Growth Inhibitors
- ID: D000067856
- Term: Poly(ADP-ribose) Polymerase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
### 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: M246
- Name: Bevacizumab
- Relevance: HIGH
- As Found: Non-
- ID: M18650
- Name: Carboplatin
- Relevance: HIGH
- As Found: System
- ID: M242260
- Name: Fluzoparib
- Relevance: HIGH
- As Found: Emptying
- ID: M26197
- Name: Tubulin Modulators
- Relevance: LOW
- As Found: Unknown
- ID: M26196
- Name: Antimitotic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- ID: M22318
- Name: Angiogenesis Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M9231
- Name: Growth Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M205
- Name: Poly(ADP-ribose) Polymerase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000017239
- Term: Paclitaxel
- ID: D000068258
- Term: Bevacizumab
- ID: D000016190
- Term: Carboplatin
- ID: C000722917
- Term: Fluzoparib
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446193
**Brief Title:** To Evaluate the Efficacy and Safety of 'NDTx-01' in Patients With ASD or SCD
**Official Title:** A Multi-center, Randomized, Assessor-blind, Superiority, Confirmatory Clinical Trial to Assess Safety and Efficacy of Cognitive Therapy Software 'NDTx-01' for Improving Social Awareness and Interaction in Children and Adolescents With Autism Spectrum Disorder (ASD) or Social Communication Disorder (SCD)
#### Organization Study ID Info
**ID:** ND-02
#### Organization
**Class:** INDUSTRY
**Full Name:** Neudive Inc.
#### Secondary ID Infos
**Domain:** Ministry of Health and Welfare, Republic of Korea
**ID:** RS-2023-00265178
**Type:** OTHER_GRANT
**Domain:** Daegu-Gyueongbuk Medical Innovation Foundation (KMEDI hub)
**ID:** B0081112000610
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2025-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Neudive Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to demonstrate the superiority of the treatment of cognitive therapy software 'NDTx-01' compared to TAU (Treatment-As-Usual).
**Detailed Description:** This confirmatory clinical trial aims to demonstrate the superiority of 'NDTx-01' by comparing and evaluating the efficacy and safety of the experimental group applying 'NDTx-01' with TAU (Treatment-As-Usual) and the control group applying TAU only.
The study participants will be randomized in a 1:1 as experimental group and control group. The experimental group applies 'NDTx-01' 30 times for 6 weeks (5 times a week) with TAU and the control group gets TAU only. For the primary purpose, the change in the adaptive behavior combination (ABC) score of the Korean version of the Vineland Adaptive Behavior Scale-II (K-VABS-II) at 42 days compared to the baseline will be evaluated.
### Conditions Module
**Conditions:**
- Autism Spectrum Disorder
- Social Communication Disorder
**Keywords:**
- autism spectrum disorder
- social communication disorder
- digital therapeutics
- adolescents
- social communication
- social skills
- social adaptation
- autistic
- cognitive behavior therapy
- social stories
- peer relationship
- intervention
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** NDTx-01 + TAU (Treatment-As-Usual)
**Intervention Names:**
- Device: NDTx-01
- Behavioral: TAU
**Label:** The experimental group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** TAU (Treatment-As-Usual)
**Intervention Names:**
- Behavioral: TAU
**Label:** The control group
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- The experimental group
**Description:** NDTx-01 intervention: Run 'NDTx-01' application on a smartphone 5 times a week, for 6 weeks, 30 sessions in total.
**Name:** NDTx-01
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- The control group
- The experimental group
**Description:** TAU: Autism Spectrum Disorders(ASD) or Social Communication Disorders(SCD)-related treatment/rehabilitation/education
**Name:** TAU
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The K-VABS-II is a tool used to assess adaptive behavior and functioning in individuals from birth to 99 years old. It evaluates personal and social skills necessary for everyday living.
**Measure:** Adaptive Behavior Composite score of K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ)
**Time Frame:** Baseline, Day 28, Day 42
#### Secondary Outcomes
**Description:** The K-VABS-II is a tool used to assess adaptive behavior and functioning in individuals from birth to 99 years old. It evaluates personal and social skills necessary for everyday living.
**Measure:** K-VABS-II (Korean Vineland Adaptive Behavior Scales-Ⅱ)
**Time Frame:** Baseline, Day 28, Day 42
**Description:** The SRS-2 consists of a series of questions answered by parents or caregivers who observe the individual's behavior. It is a tool used to assess social skills, social cognition, and behaviors associated with autism spectrum disorders (ASD) in children and adolescents. It's designed to help clinicians, educators, and researchers identify and understand social impairments commonly seen in individuals with ASD or other developmental disorders.
**Measure:** SRS-2 (Korean Social Responsiveness Scale-2)
**Time Frame:** Baseline, Day 28, Day 42
**Description:** The K-PRQ-CA is a tool designed to assess the quality of the relationship between parents and their children or adolescents. It's used to evaluate various aspects of the parent-child relationship, including communication, support, discipline, and overall satisfaction.
**Measure:** K-PRQ-CA (Korean Parenting Relationship Questionnaire - Child & Adolescent)
**Time Frame:** Baseline, Day 28, Day 42
**Description:** The KIPR is a tool used to assess peer relationships among Korean children and adolescents. It's designed to measure various aspects of peer interactions, including social skills, peer acceptance, peer rejection, and the quality of friendships.
**Measure:** KIPR (Korean Inventory of Peer Relationships)
**Time Frame:** Baseline, Day 28, Day 42
**Description:** The EQ-5D-5L is a standardized measure of health-related quality of life developed by the EuroQol Group. It's used to assess a person's health status and well-being across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The "5L" in EQ-5D-5L stands for "five levels," indicating that each dimension has five response levels ranging from no problems to extreme problems.
**Measure:** EQ-5D-5L (EuroQol Five Dimension Five Level Scale)
**Time Frame:** Baseline, Day 42
**Description:** The CGI-S is a widely used clinician-rated scale designed to assess the overall severity of a patient's condition in clinical trials. Clinicians typically rate the CGI-S on a seven-point scale, where each point represents a different level of severity.
**Measure:** CGI-S (Clinical Global Impression-Severity)
**Time Frame:** Baseline, Day 28, Day 42
**Description:** The CGI-I is a clinician-rated scale used to assess changes in a patient's overall clinical condition or improvement over time, particularly in clinical trials. Clinicians typically rate the CGI-I on a seven-point scale, where each point represents a different level of improvement compared to baseline.
**Measure:** CGI-I (Clinical Global Impression-Improvement)
**Time Frame:** Day 28, Day 42
**Description:** The 'NDTx-01 Satisfaction Questionnaire' includes 4 questions related to satisfaction with the experience of using the investigational device.
**Measure:** NDTx-01 Satisfaction Questionnaire
**Time Frame:** Day 42
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Children and adolescents between the ages of 10 and 18
* Diagnosed with autism spectrum disorder (ASD) or social communication disorder (SCD) based on the clinical judgment of a psychiatrist according to DSM-5 diagnostic criteria
* Participants who are able to install 'NDTx-01' on an Android smartphone and use it alone or with the help of their guardian
* Participants who are able to comply with the recommended application time for the investigational medical device (6 weeks, 30 times, 5 times a week)
* Participants who have agreed not to use any other medical devices besides the investigational medical device during the clinical trial
* Participants who agree that there should be no change in the use of drugs which can significantly affect one's sociality during the clinical trial (If there is a drug being taken during screening, it can be taken continuously, but the total daily dose, ingredients, etc., should remain unchanged until the end of the study visit.)
* Participants who agree not to participate in other Applied Behavior Analysis (ABA) treatment/rehabilitation/education, social treatment/rehabilitation/education program (If there is treatment/rehabilitation/education being received during screening, it can be received continuously, but the number of applications and treatment methods should remain unchanged until the end of the study visit.)
* Participants who and whose parents (legal guardians) have volunteered to participate in this clinical trial and have given written consent to the subject description and consent form
* Participants willing to comply with the clinical trial procedures
Exclusion Criteria:
* A risk of clinically significant behavioral problems, emotion regulation problems, psychotic symptoms, self-harm, or other harm at a level that affects the treatment process
* Severe acute/chronic medical or mental illness
* Serious trauma or surgery performed within 4 weeks before the screening date
* Participants with other disabilities such as severe neurological diseases (e.g. brain lesions, mental disorders, etc.)
* Participants who are currently participating in another clinical trial or have participated in another clinical trial within 30 days before the screening date
* Participants with a previous history of using NDTx-01, the investigational device
* Participants who have a change in the usage or dosage of drugs which can significantly affect one's sociality, or a change in participation in treatment/rehabilitation/education programs that can significantly affect one's sociality within 8 weeks before the baseline date of the clinical trial
* In other cases where the investigator determines that participation in the clinical trial is inappropriate due to ethical reasons or the possibility of influencing the results of the clinical trial
**Maximum Age:** 18 Years
**Minimum Age:** 10 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kate Kim
**Phone:** +82-10-4524-9860
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Samsung Medical Center
**Name:** Yoo Sook Joung, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000065886
- Term: Neurodevelopmental Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6374
- Name: Communication Disorders
- Relevance: HIGH
- As Found: Communication Disorders
- ID: M4623
- Name: Autistic Disorder
- Relevance: HIGH
- As Found: Autism
- ID: M206
- Name: Autism Spectrum Disorder
- Relevance: HIGH
- As Found: Autism Spectrum Disorder
- ID: M141
- Name: Social Communication Disorder
- Relevance: HIGH
- As Found: Social Communication Disorder
- ID: M5903
- Name: Child Development Disorders, Pervasive
- Relevance: HIGH
- As Found: Autism Spectrum Disorder
- ID: M5902
- Name: Developmental Disabilities
- Relevance: LOW
- As Found: Unknown
- ID: M30644
- Name: Neurodevelopmental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21826
- Name: Neurobehavioral Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003147
- Term: Communication Disorders
- ID: D000001321
- Term: Autistic Disorder
- ID: D000067877
- Term: Autism Spectrum Disorder
- ID: D000002659
- Term: Child Development Disorders, Pervasive
- ID: D000067404
- Term: Social Communication Disorder
### Intervention Browse Module - Browse Branches
- Abbrev: Derm
- Name: Dermatologic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M6263
- Name: Coal Tar
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446180
**Brief Title:** Streptococcus Salivarius K12@Lip@GSH Alleviates Oral Mucositis in Patients Undergoing Radiotherapy
**Official Title:** Streptococcus Salivarius K12@Lip@GSH preventsOral Mucositis in Patients Undergoingintensity Modulated Radiotherapy for Malignant Head and Neck Tumors(Including Nasopharyngeal Carcinoma) : A Single, Single Arm Prospective Trial
#### Organization Study ID Info
**ID:** 2024-002
#### Organization
**Class:** OTHER
**Full Name:** The General Hospital of Western Theater Command
### Status Module
#### Completion Date
**Date:** 2024-05-20
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-21
**Type:** ACTUAL
#### Start Date
**Date:** 2024-01-31
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The General Hospital of Western Theater Command
#### Responsible Party
**Investigator Affiliation:** The General Hospital of Western Theater Command
**Investigator Full Name:** Zhihui Li
**Investigator Title:** PhD,Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Radiation-induced oral mucositis (RIOM) is the most common oral complication of cancer patients receiving radiotherapy and/or chemotherapy, leading to poor quality of life. the investigators previous studies that have reported the use of single SSK12 probiotics in RIOM. However, SSK12 probiotics alone may lack stability, free radical scavenging activity and oral local targeting.Here, the investigators designed a new oral probiotic K12@Lip@GSH that SSK12 is encapsulated in liposomes(Lip) to enhance its stability and free radical scavenging ability, and glutathione (GSH) transporter-mediated oral targeting agent based on the over-expression of GSH transporters at the RIOM. The investigators have complete evaluated the treatment outcome of SSK12@Lip@GSH on RIOM mice.
The investigators designed a single-center, single-arm prospective clinical study to evaluate the efficacy and safety of SsK12@Lip@GSH in the treatment of radioactive oral mucositis in patients with head and neck malignancies
**Detailed Description:** Radiotherapy (RT) is an important method of treatment for malignant tumors of the head and neck and can be used alone or in combination with chemotherapy as a radical or adjuvant therapy. Despite improvements in RT equipment and techniques, various acute oral complications persist, including oral mucositis (OM), dry mouth, taste dysfunction, and oral infections. OM is one of the most common acute radiation-related toxicities, and approximately 50%-70% of patients experience severe OM (SOM) defined by the WHO scale as grade 3 to 4. The painful inflammation and ulceration associated with OM not only profoundly affect patients' ability to eat, swallow, and speak, but also decrease their tolerance to anti-cancer treatment, thereby, impairing their quality of life (QoL) significantly and causing interruptions in their cancer treatment. Although some clinical strategies for radiation-induced OM have been recommended by the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology (MASCC/ISOO) , their efficacy and safety still need further clinical validation. Recent evidence suggests the involvement of oral microbiota in radiationinduced OM, and modulation of oral microbiota is promising for the management of OM. Streptococcus salivarius K12 is a commercially available oral probiotic with strong oral colonization ability, bacteriocin-like inhibitory substance (BLIS)-producing capability, and immunomodulatory properties, and has been used to treat oral candidiasis, pharyngitis, tonsillitishalitosis, and otitis media. More importantly, data from our recent animal study demonstrated that topical use of S. salivarius K12 ameliorates radiationinduced OM in mice by modulating the oral microbiota, mainly by suppressing oral anaerobes.
the investigatorsprevious studies that have reported the use of single SSK12 probiotics in RIOM. In 2024, the applicant team published a randomized controlled trial as the first author in the top journal in the field of oncology, Journal o f Clinical Oncology, which found that Streptococcus salivarius K12 (SSK12) can effectively alleviate RIOM in radiotherapy patients with malignant head and neck tumors.
However, SSK12 probiotics alone may lack stability, free radical scavenging activity and oral local targeting.Here, the investigators designed a new oral probiotic K12@Lip@GSH that SSK12 is encapsulated in liposomes(Lip) to enhance its stability and free radical scavenging ability, and glutathione (GSH) transporter-mediated oral targeting agent based on the over-expression of GSH transporters at the RIOM. the investigators evaluated the treatment outcome of SSK12@Lip@GSH on RIOM mice .
In vitro studies showed that SSK12@Lip@GSH treatment was beneficial for the healing of RIOM mice, as reflected by reduced ulcer size, increased basal layer epithelial cellularity and mucosal thickness, and elevated epithelial proliferation and attenuated apoptosis. Genomic results showed that the SSK12@Lip@GSH could improve relevant mRNA pathways to promote RIOM healing. In addition, SSK12@Lip@GSH treatment reconstituted the oral microbiota and decreased the abundance of oral anaerobes of RIOM mice.Therefore, the SSK12@Lip@GSH holds promise as a potential approach for preventing and treating radiation-induced oral mucositis.
### Conditions Module
**Conditions:**
- Oral Mucositis
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 20
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** SsK12@Lip@GSH
**Intervention Names:**
- Dietary Supplement: SsK12@Lip@GSH
**Label:** Experimental group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental group
**Description:** SsK12@Lip@GSH powder contained no less than 5×10\^8 CFU viable cells of SsK12@Lip@GSH as the active ingredient.
**Name:** SsK12@Lip@GSH
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.The WHO Oral Toxicity Scale categorizes oral mucositis into grades 0-4, with the higher the grade the more severe the patient's oral mucositis. Grade 0 means that the oral mucosa is normal and the patient has no symptoms or signs; grade 1 means that the mucosa is erythematous with or without pain and does not interfere with eating; grade 2 means that the mucosa is erythematous and ulcerated, but still able to eat solid food; grade 3 means that the mucosa is severely ulcerated with extensive erythema and unable to eat solid food; and grade 4 means that the ulcers of the mucosa are fused together into a sheet, and their severity is so severe that it is not possible to eat.
**Measure:** The incidence of Severe Oral mucositis (WHO grade ≥3)
**Time Frame:** From the start of radiotherapy to 4 weeks after completion of radiotherapy
#### Secondary Outcomes
**Description:** Time from the first day of radiotherapy to the first determination of SOM. Patients without observed SOM were assigned onset days of 6 or 6.5 weeks
**Measure:** The time to onset of Severe Oral mucositis (WHO grade ≥3)
**Time Frame:** From the start of radiotherapy to 4 weeks after completion of radiotherapy
**Description:** The first determination of SOM to the first instance of non-severe OM (WHO grade \<3), without a subsequent instance of SOM. Patients without observed SOM were assigned a duration of 0 days
**Measure:** The duration of Severe Oral mucositis (WHO grade ≥3)
**Time Frame:** From the start of radiotherapy to 4 weeks after completion of radiotherapy
**Description:** Patients report mouth and throat soreness (MTS) scores (Likert scale 1 to 5) via the oral mucositis weekly questionnaire （OMWQ）. Higher score indicates more severe symptoms
**Measure:** Mouth and throat soreness (MTS) scores
**Time Frame:** From the start of radiotherapy to 4 weeks after completion of radiotherapy
**Description:** Xerostomia is subjectively assessed on the Summated Xerostomia Inventory (SXI). The SXI is categorized according to score as 0 no dry mouth (5), 1 mild dry mouth (6-8), 2 moderate dry mouth (9-12), and 3 severe (13-15).
**Measure:** Xerostomia summated xerostomia inventory (SXI)
**Time Frame:** From the start of radiotherapy to 4 weeks after completion of radiotherapy
**Description:** FACT- H\&N quality of life questionnaire 4.0 is a scale used to assess quality of life in
**Measure:** Functional assessment of cancer therapy-head and neck (FACT- H&N) quality of life questionnaire
**Time Frame:** From the start of radiotherapy to 4 weeks after completion of radiotherapy
**Description:** Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version
**Measure:** Adverse events
**Time Frame:** From the start of radiotherapy to 4 weeks after completion of radiotherapy
**Description:** Patients report the degree to the impact of MTS on oral activities (including swallowing, drinking, eating, talking, sleeping) (Likert scale 1 to 5) via the oral mucositis weekly questionnaire （OMWQ）. Higher score indicates more severe symptoms
**Measure:** Oral activities scores
**Time Frame:** From the start of radiotherapy to 4 weeks after completion of radiotherapy
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
* 2. Aged 18-80 years;
* 3. Eastern Cooperative Oncology Group performance status of ≤2;
* 4. Planning to receive definitive RT or postoperative adjuvant RT;
* 5. Normal liver, kidney and bone marrow function;
* 6. Sign informed consent.
Exclusion Criteria:
* 1.Known hypersensitivity or more severe allergies to Lactobacillus Reuteri components;
* 2.Those with poor compliance;
* 3.Pregnancy or breastfeeding;
* 4.History of head and neck radiotherapy;
* 5.Taking antifungal or viral medications one week prior to the start of radiation therapy.
* 6.Other patients (with any other serious other medical condition) who, in the opinion of the investigator, are not suitable for participation in this study.
**Healthy Volunteers:** True
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Chengdu
**Country:** China
**Facility:** Department of Oncology，The General Hospital of Western Theater Command
**State:** Sichuan
**Zip:** 610083
#### Overall Officials
**Official 1:**
**Affiliation:** The General Hospital of Western Theater Command
**Name:** zhihui li
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005759
- Term: Gastroenteritis
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M26955
- Name: Mucositis
- Relevance: HIGH
- As Found: Mucositis
- ID: M16070
- Name: Stomatitis
- Relevance: HIGH
- As Found: Oral Mucositis
- ID: M1730
- Name: Nasopharyngeal Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M8875
- Name: Gastroenteritis
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4047
- Name: Nasopharyngeal Carcinoma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000052016
- Term: Mucositis
- ID: D000013280
- Term: Stomatitis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446167
**Brief Title:** Comparative Efficacy of Laser, Extracorporeal Shockwave Therapy and Exercise Therapy on Plantar Fasciitis Outcomes
**Official Title:** Comparative Efficacy of Multiwave Locked System Laser, Extracorporeal Shockwave Therapy and Exercise Therapy on Plantar Fasciitis Outcomes: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** İstanbulSBÜ-FTR-IEK-01
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Saglik Bilimleri University
### Status Module
#### Completion Date
**Date:** 2022-04-29
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-04-29
**Type:** ACTUAL
#### Start Date
**Date:** 2021-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-01
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istanbul Saglik Bilimleri University
#### Responsible Party
**Investigator Affiliation:** Istanbul Saglik Bilimleri University
**Investigator Full Name:** Ibrahim Ethem Kirez
**Investigator Title:** Specialist Doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study aims to evaluate the effectiveness of exercise combined with ESWT (Extracorporeal Shockwave Therapy), exercise combined with MLS (Multiwave Locked System) laser therapy, and exercise alone in female patients diagnosed with unilateral plantar fasciitis, using Visual Analog Scale (VAS), Heel Tenderness Index (HTI), Foot and Ankle Outcome Score (FAOS), Foot Function Index (FFI) and fall risk, as clinical parameters to assess any differences in effectiveness levels among these treatments.
**Detailed Description:** Plantar fasciitis (PF) is a prevalent condition characterized by the degeneration of the plantar fascia, a band of connective tissue that originates from the calcaneus to the proximal phalanges and the skin of the foot's anterior part. Despite common misconceptions, plantar fasciitis is not primarily an inflammatory process but results from repetitive microtears leading to a secondary inflammatory reaction of the plantar fascia.
Despite the condition's self-limiting nature, with 70% to 80% of patients experiencing symptom relief through conservative treatment alone, a combination of treatments is often necessary for many. Conservative interventions include rest, cold application, stretching and strengthening exercises, orthotic devices, lifestyle modifications, weight loss, and night splints. Additionally, non-invasive physical therapy modalities such as Extracorporeal Shock Wave Therapy (ESWT), laser, and ultrasound have shown to be cost-effective and accessible treatment options. Invasive treatments, including injections and surgery, are considered for resistant cases
Previous studies have examined the effectiveness of ESWT, Low level laser therapy, High intensity laser therapy, and exercise treatments in patients with PF, demonstrating their efficacy. Although there are studies investigating the effectiveness of MLS laser therapy on various musculoskeletal pathologies, to our knowledge, there is no study specifically examining its efficacy on PF
### Conditions Module
**Conditions:**
- Plantar Fascitis
**Keywords:**
- Plantar Fasciitis
- Exercise
- Lasers
- Extracorporeal Shockwave Therapy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** 60 patients met the eligibility criteria and were enrolled in the study. The eligible participants were randomized into three distinct groups each comprising 20 individuals: an exercise alone group (Exercise group), an exercise combined with MLS laser therapy group (Laser group), and an exercise combined with ESWT group (ESWT group). Randomization was conducted using a computer-assisted program
##### Masking Info
**Masking:** SINGLE
**Masking Description:** The evaluation of outcomes was performed by an assessor blinded to the treatment allocation.
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All groups received a regimen of daily exercises, including stretches for the plantar fascia and Achilles tendon, and strengthening exercises for the calf muscles and foot intrinsic muscles. Each type of exercise was demonstrated to the participants by the same physiotherapist at the beginning of the treatment process, to be performed twice a day with 10 repetitions each time.
**Intervention Names:**
- Other: Exercises
**Label:** Exercise group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** The MLS Laser applied to the treatment group was administered using an ASA brand Mphi model device. Patients in the Laser group were positioned in a prone position. Treatment was applied continuously for 7 minutes along the plantar fascia, sole of the foot, heel area, and Achilles tendon in accordance with the plantar fasciitis treatment program on the device, at a dose of 1.73 J/cm2 and a frequency of 700 Hz. A treatment program was established with 3 sessions per week, totaling 10 sessions. Patients receiving laser therapy also continued with their exercise programs.
**Intervention Names:**
- Other: Exercises
- Other: MLS Laser Treatment
**Label:** Laser group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** The treatment group was administered with the Swiss DolorClast Master ESWT device, which produces radial shock waves. Patients in the ESWT group were positioned in a prone position. The most painful point in the heel area was identified through palpation. Gel was applied to this area, followed by the surrounding soft tissues, towards the plantar fascia and the attachment area of the Achilles tendon at the dorsal aspect of the heel. Radial ESWT treatment was applied at a frequency of 10 Hz, pressure of 2.5 bars, and 2000 impulses per session, once a week for a total of 4 sessions. Patients receiving ESWT therapy also continued with their exercise programs.
**Intervention Names:**
- Other: Exercises
- Other: ESWT treatment
**Label:** ESWT group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ESWT group
- Exercise group
- Laser group
**Description:** All groups received a regimen of daily exercises, including stretches for the plantar fascia and Achilles tendon, and strengthening exercises for the calf muscles and foot intrinsic muscles. Each type of exercise was demonstrated to the participants by the same physiotherapist at the beginning of the treatment process, to be performed twice a day with 10 repetitions each time.
**Name:** Exercises
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Laser group
**Description:** The MLS Laser applied to the treatment group was administered using an ASA brand Mphi model device. Patients in the Laser group were positioned in a prone position. Treatment was applied continuously for 7 minutes along the plantar fascia, sole of the foot, heel area, and Achilles tendon in accordance with the plantar fasciitis treatment program on the device, at a dose of 1.73 J/cm2 and a frequency of 700 Hz. A treatment program was established with 3 sessions per week, totaling 10 sessions
**Name:** MLS Laser Treatment
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- ESWT group
**Description:** The treatment group was administered with the Swiss DolorClast Master ESWT device, which produces radial shock waves. Patients in the ESWT group were positioned in a prone position. The most painful point in the heel area was identified through palpation. Gel was applied to this area, followed by the surrounding soft tissues, towards the plantar fascia and the attachment area of the Achilles tendon at the dorsal aspect of the heel. Radial ESWT treatment was applied at a frequency of 10 Hz, pressure of 2.5 bars, and 2000 impulses per session, once a week for a total of 4 sessions
**Name:** ESWT treatment
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** VAS is a scale 10 cm in length, starting from "no pain" and ending with "unbearable pain" (0: no pain, 10: unbearable pain). Patients indicate the severity of their pain by marking the appropriate point on this scale. The distance between "no pain" and this marked point is measured and recorded in centimeters
**Measure:** Visual Analog Scale (VAS)
**Time Frame:** one month
#### Secondary Outcomes
**Description:** The FFI is a self-reported questionnaire designed to assess the impact of foot pathology on three domains: pain (9 items), disability (9 items), and activity limitation (5 items). Each item is rated on a scale from 0 (no issue) to 10 (severe issue). The scores are normalized to a 100-point scale for each domain, offering a detailed metric for functional impairment. To calculate the Total FFI score, the average of the scores from the three subheadings is taken. Higher scores are associated with more severe illness. The Turkish adaptation of the FFI was conducted by Yalıman et al.
**Measure:** Foot Function Index (FFI)
**Time Frame:** one month
**Description:** Adapted from the knee injury and osteoarthritis outcome score, the FAOS is a detailed tool that evaluates five domains: symptoms and stiffness (7 items), pain (9 items), daily living activities (17 items), sports and recreational activities (5 items), and quality of life (4 items). Each question has 5 different responses that can be scored from 0 for the best condition to 4 for the worst condition, based on the intensity of the complaint. The result ranges from 0 to 100. A score of 0 indicates the worst possible foot and ankle symptoms, while a score of 100 indicates no foot and ankle symptoms. The Total FAOS score is calculated by taking the percentage of responses given to all 42 questions, regardless of the subheadings. The Turkish adaptation of the FAOS was conducted by Karatepe et al. in 2009.
**Measure:** Foot and Ankle Outcome Score (FAOS)
**Time Frame:** one month
**Description:** The HTI quantifies pain sensitivity in the heel through clinical palpation. It is scored from 0 (no pain) to 3 (severe pain with withdrawal reflex), enabling objective assessment of localized tenderness.
**Measure:** Heel Tenderness Index (HTI)
**Time Frame:** one month
**Description:** The Biodex balance system SD-2014 is a robotic device equipped with computer software that allows tilting up to 20° in all directions, enabling objective assessment of balance and fall risk. High scores indicate impaired balance and increased risk of falling. During measurement, patients are asked to remove their shoes and step onto the platform, maintaining a comfortable position while visually monitoring themselves on the screen to stay centered. Patients are instructed to maintain this position throughout the measurements. Subsequently, according to the fall risk measurement protocol of the device, fall risk calculations are performed at levels 12-8, with 20-second test durations repeated 3 times. The fall risk resulting from these 3 measurements is provided as the overall stability index (OSI) score.
**Measure:** Biodex Fall Risk Assessment
**Time Frame:** one month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age between 18-65 years
* Female gender
* Symptoms persisting for at least 6 weeks
* Unilateral plantar fasciitis
* Consent to participate in the study
Exclusion Criteria:
* Male gender
* Bilateral plantar fasciitis
* Treatment with ESWT, laser or injection therapy for plantar fasciitis in the previous year
* Participation in a physical therapy program for plantar fasciitis in the last six months
* History of systemic inflammatory disease
* History of lower extremity fracture or surgery
* Pregnancy
* History of epilepsy
* Malignancy
* Active infection
* Coagulation disorders
* Severe cardiac disease or history of pacemaker
* History of neuromuscular disease affecting balance parameters
* Regular use of nonsteroidal antiinflammatory drugs
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Istanbul
**Country:** Turkey
**Facility:** İstanbul Medipol University
**Zip:** 34200
#### Overall Officials
**Official 1:**
**Affiliation:** İstanbulSBÜ
**Name:** İbrahim Ethem Kirez
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000005534
- Term: Foot Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M8351
- Name: Fasciitis
- Relevance: HIGH
- As Found: Fasciitis
- ID: M24656
- Name: Fasciitis, Plantar
- Relevance: HIGH
- As Found: Plantar Fasciitis
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8658
- Name: Foot Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005208
- Term: Fasciitis
- ID: D000036981
- Term: Fasciitis, Plantar
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446154
**Acronym:** FOLFOX
**Brief Title:** FOLFOX Chemotherapy Plus Fruquintinib and Sintilimab After First-line Treatment in Unresectable Hepatocellular Carcinoma
**Official Title:** FOLFOX Chemotherapy (Oxaliplatin, Fluorouracil, and Leucovorin), Fruquintinib and Sintilimab After First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma: A Single-arm, Single-center, Phase II Study
#### Organization Study ID Info
**ID:** FOLFRUS-001
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-06-04
### 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:** Clinical Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Nowadays, there are few second-line treatment options for advanced hepatocellular carcinoma (HCC). In order to further improve the efficacy of second-line treatment for advanced HCC, we plan to conduct a single-arm, single-center and phase II clinical study to explore the efficacy and safety of the new second-line treatment for advanced HCC.
Previous studies had shown that FOLFOX systemic chemotherapy tended to increase the median survival time of patients with advanced HCC, and significantly improved the progression-free survival and tumor response rate. Therefore, FOLFOX systemic chemotherapy has become one of the recommended treatments for advanced HCC in Chinese guidelines.
A phase II clinical study had showed that sintilimab combined with fruquintinib was with a promising anti-tumor activity in patients with advanced HCC who had received standard treatment, with a median progression-free survival of 7.4 months and a tumor response rate of 31.6%. Furthermore, there was a synergistic effect among chemotherapy, immunotherapy and anti-angiogenic therapy. Our previous phase II study showed that the median progression-free survival was 9.73 months, the median overall survival time was 14.63 months, and the tumor response rate was 43.3% in HCC patients extrahepatic metastasis who received FOLFOX systemic chemotherapy combined with targeted and immunotherapy. The results from our study suggested that the combination therapy had excellent anti-tumor efficacy and safety profile.
Therefore. We intend to conduct this clinical study to explore the efficacy and safety of FOLFOX systemic chemotherapy combined with fruquintinib and sintilimab in second-line treatment for patients with unresectable HCC after first-line treatment.
### Conditions Module
**Conditions:**
- Hepatocellular Carcinoma
- Immunotherapy
- Anti-angiogenic Therapy
- FOLFOX Systemic Chemotherapy
- Second-line Treatment
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** FOLFOX systemic chemotherapy plus fruquintinib and sintilimab
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** FOLFOX systemic chemotherapy plus fruquintinib and sintilimab
**Intervention Names:**
- Drug: FOLFOX systemic chemotherapy plus fruquintinib and sintilimab
**Label:** FOLFRUS
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- FOLFRUS
**Description:** The current PICC catheterization was unified for patients undergoing FOLFOX systemic chemotherapy. After catheterization, the catheter was connected to the injection pump in the ward and was continuously pumped into the following chemotherapeutic drugs. The chemotherapy was repeated every 3 weeks for a total of 8 courses.
Oxaliplatin, 85mg/m2，IV (intra venous)，Day 1. Calcium folinate, 400mg/m2，IV，Day1. 5FU, 400mg/m2, IV, Day1, sequentially 2400mg/m2, IV, lasting for 46 hours. Fruquintinib was given orally for 5mg/ days. After 3 weeks, the drug was stopped for 1 week.
Sintilimab was infused intravenously 200mg each time, repeated every three weeks.
**Name:** FOLFOX systemic chemotherapy plus fruquintinib and sintilimab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Objective response rate
**Measure:** ORR
**Time Frame:** Two years
#### Secondary Outcomes
**Description:** Median overall survival
**Measure:** OS
**Time Frame:** Two years
**Description:** Median progression-free survival
**Measure:** PFS
**Time Frame:** Two years
### 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
* who had received previously atezolizumab/sintilimab plus bevacizumab, lenvatinib, sorafenib or camrelizumab plus rivoceranib
* had at least on measurable disease, as defined by Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) criteria
* 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
* 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
* allergy to the investigational agents or any agent given in association with this trial
* incomplete medical information.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ming Shi
**Phone:** 020-87343115
**Role:** CONTACT
### 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 - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M1674
- Name: Oxaliplatin
- Relevance: LOW
- As Found: Unknown
- ID: M8600
- Name: Fluorouracil
- Relevance: LOW
- As Found: Unknown
- ID: M6191
- Name: Leucovorin
- Relevance: LOW
- As Found: Unknown
- ID: M29233
- Name: Levoleucovorin
- 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: T447
- Name: Folinic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446141
**Brief Title:** Effect of Osteopathic Technique on Respiratory Parameters and Pain in Thoracic Outlet Syndrome
**Official Title:** Effect of Osteopathic Technique on Respiratory Parameters and Pain in Thoracic Outlet Syndrome
#### Organization Study ID Info
**ID:** HorusU1
#### Organization
**Class:** OTHER
**Full Name:** Horus University
### Status Module
#### Completion Date
**Date:** 2024-05-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-05-31
**Type:** ACTUAL
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-01
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Horus University
#### Responsible Party
**Investigator Affiliation:** Horus University
**Investigator Full Name:** Ahmed Metwally Mohamed Elshinnawy
**Investigator Title:** Assistant Professor, Department of Physical Therapy for Neuromuscular Disorders and Its Surgery, Faculty of Physical Therapy, Horus University, New Damietta, Egypt
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Background: With regard to patients with thoracic outlet syndrome (GBS), it is important to improve inspiratory muscle strength and endurance, and pain perception in patients with TOS, so that patients are able to regain pulmonary function and endurance. Objective: To investigate the impact of osteopathic interventions on respiratory parameters and pain levels in individuals diagnosed with thoracic outlet syndrome (TOS). Subjects and methods: forty adults after the onset of TOS will be assigned randomly into two equal groups. In Group A will be allocated to traditional physical therapy program, three sessions/week in addition to 60-minute sessions of Osteopathic technique, one session/week for 3 months, group B will receive traditional physical therapy program, three sessions/week for 3 months. Selected respiratory parameters by spirometer, maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) and a visual analogue scale of pain severity, measured at baseline and after 3 months.
**Detailed Description:** Method Design This parallel, two-group, randomized controlled trial will use concealed allocation, blinding of outcome assessors and intention-to- treat analysis. People with TOS will enroll to 3-month, osteopathic technique (Group A) or traditional physical therapy program (Group B). The allocation order will be concealed by placing each random allocation in a sealed opaque envelope, which will be opened after the participant enrolled in the study. Thus, researchers and therapists will not know or decide which enrolling participant would receive which therapy. After an envelope was opened, the participant and the therapists who administered the interventions will became aware of that participant's allocated intervention. Outcomes were measured at baseline and after 3 months. In addition to ethics approval \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*.
Participants The study was conducted in Outpatient clinics of Faculty of physical therapy, Horus University. The study population will be consisted of patients diagnosed, by physicians or neurologists, as previous cases of 'definite' TOS. To be eligible to participate, patients with TOS were required to be aged 30-35 years, be in a stable clinical condition and have a physical disability based on assessment. The exclusion criteria were Patients with surgery plan for TOS, those who underwent TOS surgeries, those with smoking history, traumatic cervical injuries, diabetes mellitus and/or malignancies.
Measurement procedures:
1. Spirometer:
2. Micro Respiratory Pressure Meter:
3. Visual Analogue Scale:
Interventions Group A In addition to usual care from the treating physician or neurologist, participants will be prescribed a 3 months program. It will consist a 60 minute of traditional physical therapy program, three sessions/week in addition to 60-minute of Osteopathic technique, once per week.
The program included:
I- Postural correction through correction of:
* Forward head
* Protracted shoulders
* Depressed shoulder.
II- Strengthen ex to:
* Shoulder girdle elevators and retractors.
* Cervical and dorsal extensors
* raising arms to reach full flexion and elevation.
III- Restoration of normal mobility o Inhibition of muscle spasm especially scaleni and pectoral ms. by source of heat\& slow, sustain and self-stretching ex.
IV- Breathing ex: diaphragmatic breathing.
The Osteopathic technique included:
Patients will be positioned in a supine position. Osteopathic technique will consist of supoccibital release, soft tissue release of thoracic outlet, mobilization of cervical facet joints, stretching of scalene anterior, scalene medius, upper trapezius, and levator scapula, pectorals major and minor. Subsequently, cost vertebral and cost transverse joint mobilizations will be applied using rib elevation. Then, manipulation of the vertebrae the levels between C6 and T1 will be applied using thrust mobilization technique. Afterwards, mobilization of the first rib will be applied. Finally, mobilization of the upper cervical spine will be performed.
Group B In addition to usual care from the treating physician or neurologist, participants were prescribed a 60 minute, three times per week of traditional physical therapy program.
The program included:
I- Postural correction through correction of:
* Forward head
* Protracted shoulders
* Depressed shoulder.
II- Strengthen ex to:
* Shoulder girdle elevators and retractors.
* Cervical and dorsal extensors
* raising arms to reach full flexion and elevation. III- Restoration of normal mobility o Inhibition of muscle spasm especially scaleni and pectoral ms. by source of heat\& slow, sustain and self-stretching ex.
IV- Breathing ex: diaphragmatic breathing,.
### Conditions Module
**Conditions:**
- Thoracic Outlet Syndrome
**Keywords:**
- Osteopathic Technique - Respiratory Parameters - Pain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The Osteopathic technique included:
Patients will be positioned in a supine position. Osteopathic technique will consist of supoccibital release, soft tissue release of thoracic outlet, mobilization of cervical facet joints, stretching of scalene anterior, scalene medius, upper trapezius, and levator scapula, pectorals major and minor. Subsequently, cost vertebral and cost transverse joint mobilizations will be applied using rib elevation. Then, manipulation of the vertebrae the levels between C6 and T1 will be applied using thrust mobilization technique. Afterwards, mobilization of the first rib will be applied. Finally, mobilization of the upper cervical spine will be performed.
##### Masking Info
**Masking:** SINGLE
**Masking Description:** I- Postural correction through correction of:
* Forward head
* Protracted shoulders
* Depressed shoulder.
II- Strengthen ex to:
* Shoulder girdle elevators and retractors.
* Cervical and dorsal extensors
* raising arms to reach full flexion and elevation.
III- Restoration of normal mobility
o Inhibition of muscle spasm especially scaleni and pectoral ms. by source of heat\& slow, sustain and self-stretching ex.
IV- Breathing ex: diaphragmatic breathing.
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The Osteopathic technique included:
Patients will be positioned in a supine position. Osteopathic technique will consist of supoccibital release, soft tissue release of thoracic outlet, mobilization of cervical facet joints, stretching of scalene anterior, scalene medius, upper trapezius, and levator scapula, pectorals major and minor. Subsequently, cost vertebral and cost transverse joint mobilizations will be applied using rib elevation. Then, manipulation of the vertebrae the levels between C6 and T1 will be applied using thrust mobilization technique. Afterwards, mobilization of the first rib will be applied. Finally, mobilization of the upper cervical spine will be performed.
**Intervention Names:**
- Other: Osteopathic technique
**Label:** Group A
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** I- Postural correction through correction of:
* Forward head
* Protracted shoulders
* Depressed shoulder.
II- Strengthen ex to:
* Shoulder girdle elevators and retractors.
* Cervical and dorsal extensors
* raising arms to reach full flexion and elevation. III- Restoration of normal mobility o Inhibition of muscle spasm especially scaleni and pectoral ms. by source of heat\& slow, sustain and self-stretching ex.
IV- Breathing ex: diaphragmatic breathing,.
**Intervention Names:**
- Other: Osteopathic technique
**Label:** Group B
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A
- Group B
**Description:** Patients will be positioned in a supine position. Osteopathic technique will consist of supoccibital release, soft tissue release of thoracic outlet, mobilization of cervical facet joints, stretching of scalene anterior, scalene medius, upper trapezius, and levator scapula, pectorals major and minor. Subsequently, cost vertebral and cost transverse joint mobilizations will be applied using rib elevation. Then, manipulation of the vertebrae the levels between C6 and T1 will be applied using thrust mobilization technique. Afterwards, mobilization of the first rib will be applied. Finally, mobilization of the upper cervical spine will be performed.
**Name:** Osteopathic technique
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** (MIR Spirolab®) was used to measure pulmonary function test; forced vital capacity (FVC), forced expiratory volume in 1st second (FEV1), and Tiffeneau index (Forced expiratory volume in the one second/Forced vital capacity) (FEV1/FVC).
**Measure:** (a) A portable spirometer:
**Time Frame:** 3 month
**Description:** (MicroRPMTM made in USA). It was a handheld manometer with a disposal mouth-piece and used to calculate maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
**Measure:** (b) Micro Respiratory Pressure Meter:
**Time Frame:** 3 month
**Description:** This scale was utilized to measure the pain intensity before and after treatment. The pain test was 10 cm (100 mm) length with two endpoints labeled (0=no pain) and (10=most pain ever).
**Measure:** (c) Visual Analogue Scale:
**Time Frame:** 3 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The study population consisted of patients diagnosed, by physicians or neurologists, as previous cases of 'definite' TOS.
* To be eligible to participate, patients with TOS were required to be aged 30-35 years, be in a stable clinical condition and have a physical disability based on assessment.
Exclusion Criteria:
* Patients with surgery plan for TOS, those who underwent TOS surgeries, those with smoking history, traumatic cervical injuries, diabetes mellitus and/or malignancies.
**Maximum Age:** 35 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Damietta
**Country:** Egypt
**Facility:** Horus University
**State:** International Coastal Road New Damietta
**Zip:** 17611
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Physical Therapy for Internal Medicine and Elderly
**Name:** Zeezy S. Eraky, Lecturer
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Department of Orthopedic Physical Therapy
**Name:** Ehab A. Abdallah, Lecturer
**Role:** STUDY_CHAIR
**Official 3:**
**Affiliation:** Department of Basic science
**Name:** Haitham M. Elmasry, Lecturer
**Role:** STUDY_CHAIR
**Official 4:**
**Affiliation:** faculty of medicine
**Name:** Hatem M. El-Samouly, Asst Prof
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Description:** All IPD will be shared through the corresponding author after acceptance of all authors
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000009408
- Term: Nerve Compression Syndromes
- ID: D000010523
- Term: Peripheral Nervous System Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16660
- Name: Thoracic Outlet Syndrome
- Relevance: HIGH
- As Found: Thoracic Outlet Syndrome
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular 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: M13432
- Name: Peripheral Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- 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: D000013901
- Term: Thoracic Outlet Syndrome
- ID: D000013577
- Term: Syndrome
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M16204
- Name: Sulfamethazine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446128
**Brief Title:** A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)
**Official Title:** A Dose Escalating Study of CD19/CD22/BCMA Three Targets Autologous Chimeric Antigen Receptor T (CAR-T) Cell Therapy in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)
#### Organization Study ID Info
**ID:** BZE2204-A-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Shanghai Cell Therapy Group Co.,Ltd
### Status Module
#### Completion Date
**Date:** 2025-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Shanghai Cell Therapy Group 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 single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed or refractory B cell non-Hodgkin lymphoma.
**Detailed Description:** This is a single arm, open-label, dose escalation investigator initiated (IIT) study, the primary objective is to evaluate the safety and tolerability of CD19/CD22/BCMA CAR-T therapy in patients with B cell non-Hodgkin lymphoma, and determine the maximum tolerated dose (MTD). For the secondary objectives, pharmacokinetics(PK), survival of CAR-T cells in vivo, pharmacodynamics (PD) and efficacy in R/R B cell NHL will be evaluated.
This study flow comprises of a screening phase( ≤28 days prior to apheresis), apheresis phase (occur upon enrollment, ≤10 days prior to infusion), lymphodepletion phase (from Day -5 to Day -3) ,infusion of CD19/CD22/BCMA CAR-T cells on Day0, DLT assessments phase from Day1 to Day 28 and post-treatment follow-up phase (Day 29 and up to end of the study).
### Conditions Module
**Conditions:**
- Non-Hodgkin Lymphoma, B-cell
**Keywords:**
- B cell non-hodgkin lymphoma
- CAR-T
- CD19
- CD22
- BCMA
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The safety and tolerability of BZE2204 will be assessed in a "1+1+1+3" and "3+3" dose escalation approach in different B-cell non-hodgkin lymphoma
**Intervention Names:**
- Biological: CD19/CD20/BCMA CAR T cells
**Label:** CD19/CD20/BCMA CAR T therapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- CD19/CD20/BCMA CAR T therapy
**Description:** Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CD19/CD20/BCMA CAR T cells.
Cyclophosphamide and fludarabine will be given from day-5 to day-3 before the infusion for lymphodepletion. On day0 subjects will receive one dose treatment with CD19/CD20/BCMA CAR T cells by intravenous (IV) injection
**Name:** CD19/CD20/BCMA CAR T cells
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Safety
**Measure:** Dose-limiting toxicity(DLT)
**Time Frame:** Day0-Day28
**Description:** Tolerability
**Measure:** Maximum tolerated dose (MTD)
**Time Frame:** Day0-Day28
#### Secondary Outcomes
**Description:** Pharmacokinetics (PK)
**Measure:** Maximum Plasma Concentration(Cmax)
**Time Frame:** Day0-Day28，Day0-undetectable for CAR positive T cells
**Description:** Pharmacokinetics (PK)
**Measure:** Maximum Plasma Concentration Time (Tmax)
**Time Frame:** Day0-Day28，Day0-undetectable for CAR positive T cells
**Description:** Pharmacokinetics(PK)
**Measure:** Area Under Curve (AUC)
**Time Frame:** Day0-Day28，Day0-undetectable for CAR positive T cells
**Description:** Pharmacokinetics(PK)
**Measure:** CAR positive T cells
**Time Frame:** Day0-Day28，Day0-undetectable for CAR positive T cells
**Description:** Pharmacodynamics (PD)
**Measure:** Cytokines ( IL(interleukin)-2, IL-4, IL-6, IL-8, IL-10, IL-15, IFN(interferon)-γ, TNF(tumor necrosis factor)-α and MCP( monocyte chemoattractant protein)-1)
**Time Frame:** Day0-Day28
**Description:** Clinical response assessed by Lugano Response Criteria for non-Hodgkin Lymphoma
**Measure:** Overall survival (OS)
**Time Frame:** Day28,Month2,Month3,Month6,Month9,Month12,Month18,Month24
**Description:** Clinical response assessed by Lugano Response Criteria for non-Hodgkin Lymphoma
**Measure:** Progression-free survival (PFS)
**Time Frame:** Day28,Month2,Month3,Month6,Month9,Month12,Month18,Month24
### Eligibility Module
**Eligibility Criteria:** Key Inclusion Criteria:
* Patients who are diagnosed with relapsed/refractory B cell non-Hodgkin lymphoma , especially
* Diffuse Large B Cell Lymphoma, not other specified (DLBCL,NOS),
* Primary Mediastinal Large B Cell Lymphoma (PMBCL)
* Transformation Follicular Lymphoma (TFL)
* High grade B-cell lymphoma(HGBCL)
* High grade B-cell lymphoma (HGBCL) with MYC(myelocytomatosis oncogene) and BCL2(B-cell lymphoma2) /BCL6 (B-cell lymphoma6) rearrangement
* Refractory diseases are defined as one of the following
* No response to last line of therapy: i. Progressive disease (PD) as best response to most recent therapy regimen; ii. Stable disease (SD) as best response to most recent therapy regimen
* Not candidate for autologous stem cell transplant (ASCT) or refractory post-ASCT: i. Disease progression (PD) or relapsed ≤12 months of ASCT (must have biopsy proven recurrence in relapsed individuals) ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy
* Individuals must have received adequate prior therapy including at a minimum:
* anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative and
* an anthracycline containing chemotherapy regimen
* Immunohistochemical staining shows at least two of B cell surface receptor antigen CD19,CD20, BCMA are positive(including weak, medium and strong positive)
* At least one measurable lesion during the screening based on the recommendation for initial evaluation, staging and response assessment of Hodgkin and non-Hodgkin lymphoma.
* Life expectancy ≥ 12 weeks
* Eastern cooperative oncology group (ECOG) performance status of 0 or 1
* Adequate renal, hepatic, pulmonary and cardiac function defined as:
* Renal function: Serum creatinine ≤ 1.5 upper limit of normal(ULN), or eGFR ≥ 60 mL/min/1.73m2 \[eGFR(estimated glomerular filtration rate)=186×age\^-0.203×SCr\^-1.154（mg/dl）,female×0.742\]
* Hepatic function: i: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 ULN and ii: total bilirubin ≤ 2 ULN, except in individuals with Gilbert syndrome (in Gilbert's syndrome patients, those with total bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN can be enrolled).iii: International normalized ratio (INR) or prothrombin time (PT) ≤1.5 ULN Pulmonary: Have the minimum level of pulmonary reserve, defined as ≤ CTCAE (Common Terminology Criteria for Adverse Events) grade 1 dyspnea and the SaO2(oxygen saturation)≥ 91% on room air
* Cardiac: left ventricular ejection fraction (LVEF) ≥50% determined by echocardiogram(ECG) or multigated acquisition scan (MUGA)
* Adequate bone marrow function, define as:
* absolute neutrophil count (ANC) ≥1 ×10\^9/L
* absolute lymphocyte count (ALC)≥ 0.5 ×10\^9/L
* Platelets ≥50 ×109/L；
* Hemoglobulin ≥80 g/L; patients with bone marrow involvement can be enrolled if globulin\>60 g/L
* Female of child-bearing age and male participants must agree to use effective contraceptive methods until no CAR-T cells can be detected by PCR(polymerase chain reaction) test.
Key Exclusion Criteria:
* Individuals who have antiCD45 or antiCD3 therapy
* Individuals with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of primary or secondary CNS (central nervous system) lymphoma, cerebrospinal fluid malignant cells or brain metastases
* Presence or history of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
* History of allogeneic stem cell transplantation
* Any of the following situations:
• HBsAg/ HBeAg positive; HBeAb/HBcAb positive and HBV(hepatitis B virus) DNA copies above the lower test limit;
* HCV(hepatitis C virus) RNA positive
* HIV(human immunodeficiency virus) positive or treponema pallidum positive
* Presence of active or life-threatening fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
* Individuals presence of unstable angina or myocardial infarction within 6 months of screening, or other severe/uncontrolled diseases during the screening (eg. Unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
* Presence of uncontrolled arrhythmia with treatment
* Pregnancy or breastfeeding women
Other protocol defined inclusion/exclusion criteria may apply.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Shanghai
**Country:** China
**Facility:** Mengchao Cancer Hospital
**State:** Shanghai
**Zip:** 201800
#### Overall Officials
**Official 1:**
**Affiliation:** Shanghai Mengchao Cancer Hospital
**Name:** Jinxing Lou
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11220
- Name: Lymphoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: M18828
- Name: Lymphoma, B-Cell
- Relevance: HIGH
- As Found: Lymphoma, B-Cell
- ID: M11222
- Name: Lymphoma, Non-Hodgkin
- Relevance: HIGH
- As Found: Non-Hodgkin Lymphoma
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M11225
- Name: Lymphoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M11203
- Name: Lymphatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10206
- Name: Immunoproliferative Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3543
- Name: Lymphosarcoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: T640
- Name: B-cell Lymphoma
- Relevance: HIGH
- As Found: B-Cell Non-Hodgkin Lymphoma
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
- ID: D000008228
- Term: Lymphoma, Non-Hodgkin
- ID: D000016393
- Term: Lymphoma, B-Cell
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M6727
- Name: Cyclophosphamide
- Relevance: LOW
- As Found: Unknown
- ID: M283230
- Name: Fludarabine
- Relevance: LOW
- As Found: Unknown
- ID: M225513
- Name: Fludarabine phosphate
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446115
**Brief Title:** Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer
**Official Title:** Decreasing Chemotherapy Induced Distress Using Immersive Virtual Reality in Patients With Cancer
#### Organization Study ID Info
**ID:** CASE3124
#### Organization
**Class:** OTHER
**Full Name:** Case Comprehensive Cancer Center
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-11
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Case Comprehensive Cancer Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this clinical trial is to learn if the use of virtual reality during chemotherapy treatment helps participants achieve an improvement in distress, which may include unpleasant experience, anxiety, depression and/or pain.
Participants will:
* Be randomly assigned to one of two available groups (virtual reality or standard of care)
* Participations will only be during one chemotherapy session.
* Those assigned to virtual reality:
* The research team will provide a virtual reality
* The research team will provide guidance on how the headset works and will be available to assist with any questions or concerns.
* Participants will also be able to choose different relaxing backgrounds depending on their preference. headset during the chemotherapy session for 15 to 30 minutes
* Those assigned to the standard of care:
* The research team will provide the participants with the opportunity to choose a preferred activity such as reading a book, watching television, etc.
**Detailed Description:** In recent decades, new cancer cases have consistently risen. Participants diagnosed with cancer commonly face psychological symptoms including distress, anxiety, and depression in addition to physical symptoms (i.e., pain). Importantly, these symptoms might be exacerbated during chemotherapy sessions. New innovative technological strategies have been under development to control the symptoms and improve quality of life. Immersive virtual reality (VR) is a simulated experience that enables participants to interact with an artificial three-dimensional visual and auditory environment. VR could be an innovative intervention to relieve psychological symptoms associated with chemotherapy.
### Conditions Module
**Conditions:**
- Malignant Neoplasm
- Cancer
**Keywords:**
- Virtual Reality
- Chemotherapy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This is a two-arm, randomized 1:1, pilot study.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 70
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will be asked to use a headset device during 15 to 30 minutes while receiving a chemotherapy infusion. Participants have the option to choose from different virtual reality setting depending on their preference (i.e., nature videos, meditations, interactive applications, among others).
**Intervention Names:**
- Device: Virtual Reality
- Other: Questionnaires
**Label:** Virtual reality
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will be asked to choose any activity of your preference during the chemotherapy session (i.e., watching tv, reading a book, listening to music or a podcast, etc.)
**Intervention Names:**
- Other: Preferred activity
- Other: Questionnaires
**Label:** Standard of care
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Virtual reality
**Description:** Virtual Reality Headset applied to the participants during chemotherapy session. Participants select their preferred virtual reality experience (i.e., nature videos, meditations, interactive applications, etc). Virtual reality (VR) by definition, is a simulated experience consisting of an experiential environment created by hardware and software technology capable of provoking sensations of real experiences. It can be further divided into 1) immersive; 2) semi-immersive; and 3) non-immersive. Immersive VR employs head-mounted display (HMD) system technology to separate users from their surroundings and engage in real-time with a three-dimensional environment generated by a computer.
**Name:** Virtual Reality
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Standard of care
**Description:** Participants will engage in a preferred activity such as reading, watching television, coloring, etc. during chemotherapy.
**Name:** Preferred activity
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Standard of care
- Virtual reality
**Description:** Participants will be administered multiple pre and post intervention questionnaires including NCCN Distress thermometer, GAD-7 and CCVA.
**Name:** Questionnaires
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The primary endpoint is the distress score change between pre- and post-intervention to evaluate the effectiveness of immersive virtual reality during chemotherapy sessions in reducing distress in participants with high levels of distress from baseline diagnosed with any type of Cancer, using The NCCN Distress Thermometer. This is a single-item questionnaire used to screen for psychological distress in participants. It consists of a simple scale ranging from 0 to 10, where participants rate their level of distress. A score of 5 or more on the NCCN Distress Thermometer indicates moderate to severe psychological distress
**Measure:** Change in distress scores between pre- and post-intervention
**Time Frame:** Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention
#### Secondary Outcomes
**Description:** A secondary endpoint is the change in pain scores between pre- and post-intervention to evaluate the effectiveness of immersive virtual reality in reducing pain using the Universal Pain Assessment Tool. The Universal Pain Assessment Tool is a widely used instrument that consists of a visual analogue scale used to assess pain intensity. It includes a pain intensity scale that ranges from 0 to 10.
**Measure:** Changes in pain scores between pre- and post-intervention
**Time Frame:** Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention
**Description:** A secondary endpoint is the change in anxiety scores pre- and post-intervention to evaluate the effectiveness of immersive virtual reality in reducing anxiety using the Generalized Anxiety Disorder-7 item (GAD-7). The Generalized Anxiety Disorder-7 item (GAD-7) questionnaires will be used to assess self-reported anxiety. The GAD-7 questionnaire will be interpreted as follows: minimal anxiety (0-4 points); mild anxiety (5-9 points); moderate anxiety (10-14 points) and severe anxiety (15-21 points).
**Measure:** Changes in GAD-7 scores between pre- and post-intervention
**Time Frame:** Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention
**Description:** A secondary endpoint is the change in depression scores pre- and post-intervention to evaluate the effectiveness of immersive virtual reality in reducing depression symptoms. The Cleveland Clinic Analog Scale (CCVAS) for depressive symptoms questionnaire will be used to assess self-reported depression. The CCVAS uses a 0-10 Likert scale, where 10 means feeling very depressed and 0 means not feeling any depression.
**Measure:** Changes in CCVAS scores between pre- and post-intervention
**Time Frame:** Pre-intervention window of +/- 1 hours before intervention; post-intervention window of +/-1 hours post intervention
**Description:** A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Age will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.
**Measure:** Predictor of intervention efficacy: Age
**Time Frame:** Day 1
**Description:** A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Race will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.
**Measure:** Predictor of intervention efficacy: Race
**Time Frame:** Day 1
**Description:** A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Ethnicity will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.
**Measure:** Predictor of intervention efficacy: Ethnicity
**Time Frame:** Day 1
**Description:** A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Marital status will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.
**Measure:** Predictor of intervention efficacy: Martial Status
**Time Frame:** Day 1
**Description:** A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Occupation will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.
**Measure:** Predictor of intervention efficacy: Occupation
**Time Frame:** Day 1
**Description:** A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Time-to-diagnosis will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.
**Measure:** Predictor of intervention efficacy: Time since diagnosis
**Time Frame:** Day 1
**Description:** A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Participants' current chemotherapy regimen will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.
**Measure:** Predictor of intervention efficacy: Current chemotherapy regimen
**Time Frame:** Day 1
**Description:** A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. The "time since therapy was initiated" will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.
**Measure:** Predictor of intervention efficacy: Time since therapy initiated
**Time Frame:** Day 1
**Description:** A secondary goal is to determine participants' clinical and sociodemographic characteristics associated with significant changes after the immersive virtual reality intervention. Participant attitudes toward the use of virtual reality will be collected as a variable to assess whether this factor is a significant predictor of intervention efficacy.
**Measure:** Predictor of intervention efficacy: Attitudes towards use of virtual reality
**Time Frame:** Day 1
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 years.
* Biopsy proven diagnosis of Cancer (any stage or type).
* Must have a National Comprehensive Cancer Network Distress Thermometer Score ≥ 5 any time since diagnosis.
* Must have the ability to understand and the willingness to sign a written informed consent document
* Followed by a medical oncologist, radiation oncologist, and/or breast surgeon at Cleveland Clinic.
* Ability to read and write in English or Spanish.
Exclusion Criteria:
* Age \<18 years.
* No prior history of Cancer.
* Prior medical history of severe motion sickness.
* Prior medical history of seizures
* Pregnancy.
* Unable or unwilling to participate in the immersive Virtual Reality study at the Maroone Cancer Center
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Zeina Nahleh, MD FACP
**Phone:** (954) 659-5840
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Weston
**Contacts:**
***Contact 1:***
- **Name:** Zeina Nahleh, MD, FACP
- **Role:** CONTACT
***Contact 2:***
- **Name:** Zeina Nahleh, MD FACP
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Cleveland Clinic Florida, Maroone Cancer Center
**State:** Florida
**Zip:** 33331
#### Overall Officials
**Official 1:**
**Affiliation:** Cleveland Clinic Florida, Maroone Cancer Center
**Name:** Zeina Nahleh, MD FACP
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Individual participant data will not be shared as this is a minimally invasive pilot study.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446102
**Brief Title:** Bifurcation Coronary Lesion 0-0-1
**Official Title:** Bifurcation Coronary Lesion 0-0-1
#### Organization Study ID Info
**ID:** 23.02718.000229
#### Organization
**Class:** OTHER
**Full Name:** RCF@ICPS
### Status Module
#### Completion Date
**Date:** 2023-12-29
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-12-29
**Type:** ACTUAL
#### Start Date
**Date:** 2023-12-11
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** RCF@ICPS
#### Responsible Party
**Investigator Affiliation:** GCS Ramsay Santé pour l'Enseignement et la Recherche
**Investigator Full Name:** Francesca SANGUINETI
**Investigator Title:** MD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Research Involving Human Persons (RIHP 3) focusing on the treatment of type 0-0-1 bifurcation lesions in routine practice. Multicenter Study.
To retrieve and analyze the details of different angioplasty techniques used in this type of bifurcation lesion (Medina 0-0-1) in order to describe current practice and search for predictors of clinical events.
**Detailed Description:** The primary objective of the trial is to estimate the frequency of Major Adverse Cardiac Events (MACE), including cardiac death, myocardial infarction within the territory of the treated lesion, and revascularization of the target lesion in a representative population of patients treated by coronary angioplasty of type 0-0-1 bifurcation lesions.
The sample size will be determined by the number of angioplasties of type 0-0-1 bifurcation lesions performed at each center between 2016 and 2022.
Since the trial is observational in nature and there are no previously published studies, the sample size cannot be calculated based on the desired precision of the estimation.
Furthermore, the purpose of the study is also to assess the techniques used to treat this type of coronary bifurcation and to highlight any differences between different centers and with other types of coronary bifurcation lesions described in the literature.
### Conditions Module
**Conditions:**
- Coronary Bifurcation Stenosis
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 273
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Composite of cardiovascular death rate, myocardial infarction rate and target vessel revascularization rate.
**Measure:** Major Adverse Cardiovascular Events
**Time Frame:** 3 years
#### Secondary Outcomes
**Description:** Target lesion revascularization rate
**Measure:** Target lesion revascularization
**Time Frame:** 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male or female aged 18 years and older,
* Who underwent angioplasty for a coronary bifurcation lesion of type 0-0-1 between 2016 and 2022.
Exclusion Criteria:
- Opposing the collection and processing of necessary data and refusing additional telephone follow-up
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** In this trial, approximately 300 patients will be recruited from the Hôpital Privé Jacques Cartier in Massy, Clinique Pasteur in Toulouse, and Maasstad Hospital in Rotterdam between 2016 and 2022.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Massy
**Country:** France
**Facility:** Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier
**Zip:** 91300
**Location 2:**
**City:** Toulouse
**Country:** France
**Facility:** Clinique Pasteur
**Zip:** 31076
**Location 3:**
**City:** Rotterdam
**Country:** Netherlands
**Facility:** Maasstad Ziekenhuis
**Zip:** 3079 DZ
#### Overall Officials
**Official 1:**
**Affiliation:** ICPS
**Name:** Francesca SANGUINETI, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-10-16
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 397342
- Type Abbrev: Prot
- Upload Date: 2024-05-17T16:26
## 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: M6475
- Name: Constriction, Pathologic
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446089
**Brief Title:** A Chinese Version of the Thinking Health Program for East Asian Pregnant Immigrant People in Canada
**Official Title:** The Feasibility of a Culturally Tailored Mobile App-based Thinking Healthy Program for Mental Health Support of East Asian Pregnant Immigrants in Canada
#### Organization Study ID Info
**ID:** 6041350
#### Organization
**Class:** OTHER
**Full Name:** Queen's University
#### Secondary ID Infos
**Domain:** Canadian Institutes of Health Research
**ID:** FRN 154988
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**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:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Canadian Institutes of Health Research (CIHR)
#### Lead Sponsor
**Class:** OTHER
**Name:** Shahirose Sadrudin Premji
#### Responsible Party
**Investigator Affiliation:** Queen's University
**Investigator Full Name:** Shahirose Sadrudin Premji
**Investigator Title:** Professor and Sally Smith Chair in Nursing, School of Nursing
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this study is to determine the feasibility of using a psychosocial intervention culturally adapted in China to support perinatal mental well-being of Chinese immigrant pregnant women in Canada. The intervention is adapted from the Thinking Healthy Program (THP), available through a mobile application, and will be offered to Chinese immigrant pregnant women (22 weeks' gestation or greater) residing in Canada, who are over the age of 18, and speak Mandarin. The main questions this study aims to answer are:
* Will the Chinese version of the THP be acceptable to Chinese immigrant pregnant women residing in Canada and will they use the program which is delivered through a mobile App?
* How well does the process of recruiting, keeping participants in the study and helping them complete the activities work, so it can be used for a future larger study?
Women interested in the study and who meet the study criteria will complete a questionnaire at the start of the study, then use the THP for three weeks, complete questionnaires 3-4 weeks after completing the intervention and 6-8 weeks after having their baby(ies). Some may be asked to participate in an individual interview.
**Detailed Description:** Common mental health conditions during pregnancy include depression and anxiety. Having an immigrant status and belonging to an ethnic minority group is linked to an increased likelihood of perinatal mental health problems. The lack of culturally tailored and innovative intervention is a predominant factor affecting mental health outcomes for immigrant women. Psychological and psychosocial interventions have been reported to significantly improve non-migrant women's mental health. The Thinking Healthy Program (THP), a low-intensity, low-cost, psychosocial intervention ("talking therapies") based on cognitive behavioural therapy, is comprised of 12, 1-hour sessions with content organized in modules (e.g., preparing for the baby, baby's arrival) that have associated activities (e.g., mood chart). In China, the THP has been culturally and linguistically adapted using rigorous processes and delivered to support women in the management of perinatal depression. To improve access and ensure a more impactful outcome to the culturally adapted THP, a mobile App was created in China with a brief Chinese version of the culturally adapted THP.
The primary objective of this study is to (1) assess the feasibility (acceptability and usability) of the linguistically and culturally adapted THP delivered through a mobile App to Chinese immigrant pregnant women residing in Canada; and (2) examine the process of recruitment, retention, and adherence to intervention to inform a future trial. The secondary objective is to produce preliminary evidence on the effectiveness of the brief Chinese version of THP on immigrant women's mental well-being, specifically depression.
A sequential explanatory mixed-method feasibility study involving a pre-post design in which a single group will be assembled and assessed quantitatively at baseline, 3-4 weeks post completion of brief Chinese version of the THP intervention and again at 6-8 weeks following the birth of their baby. A subset of participants that have engaged with the intervention (n=up to 15) will be invited to individual semi-structured telephone interview to share their experience with the intervention.
A convenience sample of 50 participants will be recruited for the intervention, with a subset of 15 participants to be individually interviewed via the telephone.
Participants will be recruited through social media (WeChat and Xiaohongshu), research team members' University mailing list, dissemination to professional colleagues (e.g., Obstetrics and Gynecologists), and collaboration with social and health-based organizations that serve the East Asian community in Canada.
At baseline, the sociodemographic characteristics, immigrant characteristics, health/obstetric history, and history of psychological well-being will be assessed. Potential covariates that will be assessed once include acculturation (baseline; Vancouver Index of Acculturation) and preterm birth (at 6 to 8 weeks postpartum) while all others including pregnancy-related anxiety (Pregnancy-Related Anxiety Scale), somatic symptoms (Patient Health Questionnaire-15), psychological stress (Perceived Stress Scale-10), resilience (Connor-Davidson Resilience Scale-10), social support (Multidimensional Scale of Perceived Social Support), mother-infant relationship (prenatal section of the Pre- and Postnatal Bonding Scale), and patient activation (Behavioural Activation for Depression Scale) will be assessed at baseline and follow-up (after intervention and/or 6 to 8 weeks postpartum), using the scales and instruments listed above.
### Conditions Module
**Conditions:**
- Perinatal Depression
**Keywords:**
- immigrant women
- East-Asian immigrants
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will be invited to complete three modules relevant to the health and well-being of mothers and fetus/infants during the perinatal period, through an Android based app on their mobile device.
In addition, each section incorporates the three healthy thinking steps to help the mother negotiate each of the three areas.
After the introductory session, each session involves four tasks that mothers are required to complete. The tasks include 1) a review of the key message from the previous section, 2) a review of the mood chart, 3) engaging in the three steps to thinking healthy on the designated area for the section, and 4) practicing suggested activities between sessions.
**Intervention Names:**
- Behavioral: THP: cognitive behavior therapy and behavioral activation
**Label:** Adapted THP group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Adapted THP group
**Description:** The adapted THP takes into account cultural and linguistic characteristics of the participants. Participants will be invited to complete three modules on an Android based app on their mobile, populated with information and activities from the adapted THP.
**Name:** THP: cognitive behavior therapy and behavioral activation
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Pregnancy-Related Anxiety Scale (10 items)
**Measure:** Pregnancy-related anxiety
**Time Frame:** Baseline, at 3-4 weeks
**Description:** PHQ-15 (14 items)
**Measure:** Somatic symptoms
**Time Frame:** Baseline, at 3-4 weeks, and 6-8 weeks post-partum
**Description:** Perceived Stress Scale (10 items)
**Measure:** Psychological stress
**Time Frame:** Baseline, at 3-4 weeks, and 6-8 weeks post-partum
**Description:** Connor-Davidson Resilience Scale (10 items)
**Measure:** Resilience
**Time Frame:** Baseline, at 3-4 weeks, and 6-8 weeks post-partum
**Description:** Multidimensional Scale of Perceived Social Support (12 items)
**Measure:** Social support
**Time Frame:** Baseline, at 3-4 weeks, and 6-8 weeks post-partum
**Description:** Pre- and Postnatal Bonding Scale (5 items)
**Measure:** Mother-infant relationship
**Time Frame:** Baseline, at 3-4 weeks, and 6-8 weeks post-partum
**Description:** PREMIUM Abbreviated activation scale (5 items)
**Measure:** Patient activation
**Time Frame:** Baseline, at 3-4 weeks
**Description:** Pregnancy/Delivery/Puerperium Outcome questions (5 items)
**Measure:** Preterm birth
**Time Frame:** 6-8 weeks post-partum
**Description:** Vancouver Index of Acculturation (18 items)
**Measure:** Acculturation
**Time Frame:** Baseline
#### Primary Outcomes
**Description:** Objective measurement of usability of internet-based cognitive behavioural therapy
**Measure:** Score on the System Usability Scale (SUS) 10 points
**Time Frame:** At 3-4 weeks
**Description:** Structured questions based on seven domains of Sekhon's Theoretical Framework of Acceptability
**Measure:** Acceptability of app-based THP
**Time Frame:** At 3-4 weeks
**Description:** Through RedCap-captured data and study intervention App-derived user data. Number of participants approached and recruited to the study will be tracked, and reported in a participant flow diagram.
**Measure:** Recruitment to study
**Time Frame:** During recruitment to study, expected 4 months
**Description:** Number of participants lost to follow-up (i.e., these may include dropouts who use the brief Chinese version of the THP mobile App but fail to complete the follow-up assessments), as well as number of participants with partial or complete data for analysis will be tracked.
**Measure:** Retention in study
**Time Frame:** Through study completion, an average of 12 months.
**Description:** Defined as the extent to which individuals experience the content of the brief Chinese version of the THP mobile App (i.e., average amount of time participants spend on the modules, average amount of time participants use of the health assistants and tools within the app). Measured through App-derived user data.
**Measure:** Adherence to intervention
**Time Frame:** Through intervention duration, an average of 3-4 weeks.
#### Secondary Outcomes
**Description:** Edinburgh Postnatal depression scale (EPDS; 10 items). Assess change of mean scores from baseline to treatment completion (at 3-4 weeks), and 6-8 weeks after the birth of the baby, adjusting for significant predictors (e.g. social support, mother-infant bonding).
**Measure:** Effectiveness of app-based THP
**Time Frame:** Baseline, at 3-4 weeks, and 6-8 weeks post-partum
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* pregnant women at ≥ 22 weeks of gestation AND
* ≥ 18 years old AND
* are first or second-generation Chinese immigrants residing in Canada (who identify as someone with East Asian cultural and ethnic background born outside of Canada or have at least one parent born outside of Canada) AND
* who screen positive for depression with Patient Health Questionnaire-9 (PHQ-9) score \> 5; AND
* understand both spoken and written Mandarin language; AND
* have access to internet and a smartphone with android operating system; AND
* are willing to download and use the study mobile App with brief Chinese version of THP for "talking therapy" with accompanying activities.
Exclusion Criteria:
* Women currently being treated for mental conditions, including depression
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Shahirose Premji, PhD, NP
**Phone:** 613-533-6000
**Phone Ext:** 79885
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Kingston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Shahirose S Premji, NP, PhD
- **Phone:** 1-613-533-6000
- **Phone Ext:** 79885
- **Role:** CONTACT
**Country:** Canada
**Facility:** Queen's University
**State:** Ontario
**Zip:** K7L 3N6
#### Overall Officials
**Official 1:**
**Affiliation:** Queen's University
**Name:** Shahirose Premji, PhD, NP
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003863
- Term: Depression
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446076
**Acronym:** FOOTSTEPS
**Brief Title:** Feedback Using behaviOral econOmic Theories on STEP countS in Cardiovascular Disease Patients: RCT
**Official Title:** Feedback Using behaviOral econOmic Theories on STEP countS in Cardiovascular Disease Patients: A Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 23-RCK043
#### Organization
**Class:** OTHER
**Full Name:** St. Luke's International Hospital, Japan
### Status Module
#### Completion Date
**Date:** 2026-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-12
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-30
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Trigen
#### Lead Sponsor
**Class:** OTHER
**Name:** St. Luke's International Hospital, Japan
#### Responsible Party
**Investigator Affiliation:** St. Luke's International Hospital, Japan
**Investigator Full Name:** Atsushi Mizuno
**Investigator Title:** Director, Medical quality management office
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a prospective, randomized controlled trial. The aim of the study is to verify the effectiveness of interventions using gamification with social incentives and social support to increase physical activity in patients with CVD through randomized controlled trials.
**Detailed Description:** The three aims of this randomized controlled trials;
1. To demonstrate the effectiveness of loss framing in gamification for achieving increased physical activity in patients with CVD.
2. To demonstrate the effectiveness of social support in gamification for achieving increased physical activity in patients with CVD.
3. To evaluate the impact of the intervention using social incentives and social support through gamification on changes in participants\' subjective assessment of physical activity levels, body mass index (BMI), and lipid panel in blood tests.
Secondary Objective:
1. To assess whether the differences between study groups in achieving the goal of increased physical activity during the 6-week intervention period persist during the 6-week follow-up period.
2. To investigate how the increase in physical activity through gamification in patients with CVD is influenced by patients\' behavioral characteristics and environmental factors.
This trial will be a five-group, randomized controlled trial (RCT) with an intervention period of 6 weeks and a follow-up period of additional 6 weeks.
### Conditions Module
**Conditions:**
- Cardiovascular Diseases
- Rehabilitation
- Behavioral Economics
**Keywords:**
- Cardiovascular diseases
- Rehabilitation
- Behavioral Economics
- Health Services
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 550
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in this group will not receive goal-setting or gamification interventions during the 6-week intervention period and the additional 6-week follow-up period. As an "active control" during the 12-week trial period, participants will be able to check their daily step counts using an application with the same specifications.
**Label:** Control group
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** This group will receive a gamification intervention with loss framing.
**Intervention Names:**
- Behavioral: Gamification (Gain/Loss framing)
**Label:** Gamification (Loss framing)
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** This group will receive a gamification intervention with gain framing.
**Intervention Names:**
- Behavioral: Gamification (Gain/Loss framing)
**Label:** Gamification (Gain framing)
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** This group will receive a gamification intervention with loss framing and a social support intervention.
**Intervention Names:**
- Behavioral: Gamification (Gain/Loss framing)
- Behavioral: Social support
**Label:** Gamification (Loss framing) + Social support
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** This group will receive a gamification intervention with gain framing and a social support intervention.
**Intervention Names:**
- Behavioral: Gamification (Gain/Loss framing)
- Behavioral: Social support
**Label:** Gamification (Gain framing) + Social support
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Gamification (Gain framing)
- Gamification (Gain framing) + Social support
- Gamification (Loss framing)
- Gamification (Loss framing) + Social support
**Description:** Participants will take part in a 6-week game-based program designed to help them reach their daily step goals. They are encouraged to maintain their daily step counts to achieve their daily step target over the 6-week intervention period. The gamification design incorporates two theoretically effective behavioral economics principles, "Fresh Start" and "Loss Aversion". All participants start from the Silver rank (middle rank), and their rank changes based on each final point of the week. The ranks are set from top to bottom as Platinum, Gold, Silver, Bronze, and Blue. In loss framing, if the daily step target is 6000 steps, maintaining 70 points for achieving 6000 steps on day 1, and a deduction of 10 points for not achieving it. In gain framing, achieving 6000 steps on day 1 results in an addition of 10 points, with no increase for not achieving it. After one week, ranks increase if the points at midnight on Sunday are 40 or above, and decrease if below this threshold.
**Name:** Gamification (Gain/Loss framing)
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Gamification (Gain framing) + Social support
- Gamification (Loss framing) + Social support
**Description:** Participants in this group are asked to designate a family member or friend to provide social support. This supporter is encouraged to check the participant's progress and provide support during the interventional period. The supporter will also receive weekly emails throughout the period, informing them about the participant's daily step counts, achievement status, points, levels, and other relevant information.
**Name:** Social support
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Change in the participant's subjective assessment of physical activity level measured using the International Physical Activity Questionnaire (IPAQ) Short Form
**Measure:** Exploratory outcome 1
**Time Frame:** From enrollment to the end of follow-up period at 14 weeks
**Description:** Change in body weight (BMI) (kg/m\^2)
**Measure:** Exploratory outcome 2
**Time Frame:** From enrollment to the end of follow-up period at 14 weeks
**Description:** Change in LDL/HDL cholesterol (mg/dL)
**Measure:** Exploratory outcome 3
**Time Frame:** From enrollment to the end of follow-up period at 14 weeks
#### Primary Outcomes
**Description:** The primary outcome is change in mean daily step counts from baseline to the 6-week intervention period.
**Measure:** Change in mean daily step counts
**Time Frame:** From enrollment to the end of intervention period at 8 weeks (2-weeks run-in and 6-weeks intervention period)
#### Secondary Outcomes
**Description:** Secondary outcomes include the percentage of days achieving their step goals during the intervention and follow-up periods and the change in daily step counts from baseline to follow-up period.
**Measure:** Percentage of days achieving their step goals
**Time Frame:** From enrollment to the end of follow-up period at 14 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 18 years or older
* History of old myocardial infarction or chronic heart failure
* Ability to read and provide informed consent to participate in this trial
* Owning a smartphone capable of installing this application
Exclusion Criteria:
* Having difficulty using smartphones (due to vision problems or IT literacy issues)
* Exercise therapy is contraindicated (in accordance with the 2021 revised guidelines on rehabilitation in cardiovascular diseases)
* Ability to read and provide informed consent to participate in this trial
* Owning a smartphone capable of installing this application
* Participating in other studies related to physical activity
* Being pregnant
* Any other medical conditions or reasons they are unable to participate in a physical activity study for 12 weeks
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Takahiro Suzuki, MD, MPH
**Phone:** 810335415151
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Cardiovascular Medicine, St. Luke's International Hospital
**Name:** Atsushi Mizuno, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Meshes
- ID: D000002318
- Term: Cardiovascular Diseases
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M4854
- Name: Benzocaine
- Relevance: LOW
- As Found: Unknown
- ID: T433
- Name: Tannic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446063
**Brief Title:** Efficacy & Tolerance of Cosmetic Product RV5098A on Face Pigmentation Maintenance in Adult Vitiligo Patients.
**Official Title:** Efficacy and Tolerance of the Cosmetic Care Product RV5098A on the Maintenance of Pigmentation on Face in Adult Patients With Vitiligo.
#### Organization Study ID Info
**ID:** RV5098A20230158
#### Organization
**Class:** INDUSTRY
**Full Name:** Pierre Fabre Dermo Cosmetique
### Status Module
#### Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Pierre Fabre Dermo Cosmetique
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Vitiligo is an autoimmune depigmentation disorder affecting 0.5 to 1% of the population worldwide. Vitiligo lesions are characterized by a progressive loss of pigmentation caused by the disappearance of functioning melanocytes in the epidermis, mainly resulting from the activation of immune cells in a genetically predisposed patient.
Despite major advances in the understanding of the mechanisms of the disease, the treatment remains challenging. Different treatment strategies could lead to cosmetically acceptable repigmentation (\>75%), particularly on face and neck. However, after repigmentation, the risk of relapse is estimated at nearly 40% during the first year after stopping treatment.
To date, long-term management remains a challenge. With their topical product RV5098A adapted for patients with vitiligo, Pierre Fabre Laboratories hypothesize that it could be effective in maintaining pigmentation of previously repigmented lesions in adults with facial vitiligo.
### Conditions Module
**Conditions:**
- Vitiligo
**Keywords:**
- Vitiligo
- Adults
- Face
- Repigmented
- Maintenance of repigmentation
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: Test product
**Label:** Treated group
#### Arm Group 2
**Intervention Names:**
- Other: Control Product
**Label:** Control group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treated group
**Description:** Twice daily applications The product is applied to the entire face.
**Name:** Test product
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Control group
**Description:** Twice daily applications The product is applied to the entire face.
**Name:** Control Product
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** assessed by the investigator on the face on a 7-point scale (from significant worsening to significant improvement)
**Measure:** Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo
**Time Frame:** assessed after 24 weeks of use
#### Secondary Outcomes
**Description:** assessed by the investigator on the face on a 7-point scale (from significant worsening to significant improvement)
**Measure:** Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo assessed by the investigator
**Time Frame:** assessed after 12 weeks of use
**Description:** assessed by the subject on the face on a 7-point scale (from very much worse to very much improved)
**Measure:** Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo assessed by the subject
**Time Frame:** assessed after 12 and 24 weeks of use and monthly at home
**Description:** assessed by the investigator on the face on a vitiligo severity scale from 0 (absent) to 3 (complete depigmentation)
**Measure:** Efficacy of the test product RV5098A on the maintenance of pigmentation by the severity of facial vitiligo by the investigator
**Time Frame:** assessed at baseline and after 12 and 24 weeks of use.
**Description:** assessed by the investigator on the face with score of extent of vitiligo
**Measure:** Efficacy of the test product RV5098A on the maintenance of pigmentation by the extent of facial vitiligo
**Time Frame:** assessed at baseline and after 12 and 24 weeks of use.
**Description:** assessed by the subject on the face on a 5-point scale (from no vitiligo to very severe)
**Measure:** Efficacy of the test product RV5098A on the maintenance of pigmentation by the severity of facial vitiligo by the subject
**Time Frame:** assessed at baseline, after 12 and 24 weeks of use and monthly at home
**Description:** assessed by the subject with quality-of-life questionnaire
**Measure:** Efficacy of the test product RV5098A on the maintenance of pigmentation by the impact on quality of life assessed by the patient
**Time Frame:** assessed at baseline, after 12 and 24 weeks of use
**Description:** Measurement of depigmentation surface on a target lesion of the face by the investigator.
**Measure:** Efficacy of the test product RV5098A on the maintenance of pigmentation by imaging quantification.
**Time Frame:** assessed at baseline, after 12 and 24 weeks of use.
**Description:** A questionnaire with a scale from 0 to 10 responding to statements about the sensorial experience and effect of the product (0=not at all agree, 10=completely agree).
**Measure:** Cosmetic satisfaction and perceived effects as regards to the use of the test product RV5098A by Cosmetic acceptability questionnaire assessed by the patient
**Time Frame:** assessed after 12 and 24 weeks of use.
**Description:** assessed by the investigator with 5-point scale (from bad to excellent)
**Measure:** Global tolerance of the test product RV5098A assessed by the investigator.
**Time Frame:** assessed after 24 weeks of use.
**Description:** The subject will report his/her compliance in a subject's diary
**Measure:** Compliance of the subjects to the test product RV5098A
**Time Frame:** through study completion, 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Criteria related to the population:
- Subject aged between 18 and 75 years included.
Criteria related to the disease:
* Subject with facial vitiligo, regardless of its duration.
* having a sufficient repigmentation rate of the vitiligo after repigmenting treatment
Criteria related to treatments and/or products:
- Subject responder to a repigmenting treatment
Non-inclusion Criteria:
Criteria related to the diseases / skin condition:
* Subject with active vitiligo.
* Subject with spontaneous repigmentation without treatment.
* Subject having other dermatological condition, an acute, chronic, or progressive disease or history of disease liable to interfere with the study assessments or considered by the Investigator hazardous for the subject or incompatible with the study requirements.
Criteria related to treatments and/or products:
* Systemic immunomodulatory treatment taken for another pathology, before inclusion, on-going or planned to be established during the study.
* Any topical immunomodulatory treatment applied on the face for another pathology, on-going or planned to be established during the study.
* Any other topical or systemic treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy according to the investigator's assessment.
* Any dietary supplement for vitiligo within 4 weeks before the inclusion visit or planned to be established during the study.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Subjects will be enrolled from the investigator's outpatient's reception and/or from the database of the centre. The subjects corresponding to eligibility criteria may receive a phone call, a letter or an e-mail proposing to participate to the clinical study.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Christophe CHAMARD
**Phone:** +335.34.50.65.88
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Adeline BACQUEY
**Phone:** +335.34.50.65.33
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Bordeaux
**Contacts:**
***Contact 1:***
- **Name:** Julien SENESCHAL, Pr
- **Role:** CONTACT
**Country:** France
**Facility:** COSDERMA
**State:** Gironde
**Status:** RECRUITING
**Zip:** 33000
#### Overall Officials
**Official 1:**
**Affiliation:** CHU Bordeaux
**Name:** Julien SENESCHAL, Pr
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000017496
- Term: Hypopigmentation
- ID: D000010859
- Term: Pigmentation Disorders
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- 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: M17563
- Name: Vitiligo
- Relevance: HIGH
- As Found: Vitiligo
- ID: M21089
- Name: Facies
- Relevance: LOW
- As Found: Unknown
- ID: M19761
- Name: Hypopigmentation
- Relevance: LOW
- As Found: Unknown
- ID: M13754
- Name: Pigmentation Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2945
- Name: Hypomelanotic Disorder
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000014820
- Term: Vitiligo
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446050
**Brief Title:** Chemokine and Co-stimulatory Molecule-modified Mesenchymal Stem Cells for the Treatment of Advanced Colorectal Cancer
**Official Title:** CXCL Chemokine and TNF Superfamily Co-stimulatory Molecule-modified Mesenchymal Stem Cells for the Treatment of Advanced Colorectal Cancer
#### Organization Study ID Info
**ID:** 2022TILINSHEN002
#### Organization
**Class:** OTHER
**Full Name:** Shanghai East Hospital
### Status Module
#### Completion Date
**Date:** 2027-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-06-21
**Type:** ACTUAL
**Status Verified Date:** 2023-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-29
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shanghai East Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The aim of this study is to assess the safety and efficacy of human umbilical cord-derived allogenic mesenchymal stem cells (MSCs) engineered to express antitumor chemokine and co-stimulatory molecule. Following systemic administration, these cells are able to migrate into solid tumors such as colorectal tumors. Once enriched in the tumor, they will attract peripheral lymphocytes consisting of T and natural killer (NK) cells, and simultaneously stimulate the infiltrated lymphocytes for persistent and enhanced antitumor immunity. Thus, this MSC-based treatment provides a potentially effective and targeted immunotherapeutic strategy for tumors with unfavorable immune microenvironment and possibly poor response to immune checkpoint blockade (ICB).
During this investigator-initiated trial (IIT), colorectal cancer patients will receive modified MSCs every 21 days via intravenous infusion. Increasing does will be tested in the initial cohort and an optimal dose will be chosen for the remaining patients.
### Conditions Module
**Conditions:**
- Advanced Colorectal Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Patients will receive infusion of MSC-L every 21 days.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Mesenchymal Stem Cells mobilizing Lymphocytes (MSC-L)
**Intervention Names:**
- Biological: MSC-L
**Label:** MSC-L
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MSC-L
**Description:** Human umbilical cord-derived mesenchymal stem cells (MSCs) genetically modified to express antitumor chemokine and co-stimulatory molecule will be administered intravenously at a dose of 1/2/3 x 10\^6 cells/kg, every 21 days for at least 6 cycles of treatment.
**Name:** MSC-L
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Proportion of patients who has experienced a DLT
**Measure:** Dose-Limiting Toxicities rate (DLT)
**Time Frame:** 4 months
**Description:** Proportion of patients who has experienced an AE
**Measure:** Adverse Event (AE)
**Time Frame:** 4 months
**Description:** The largest dose that has an estimated risk of causing DLT (defined as MSC-L related adverse event of grade 3 or higher) equal or closest to the target level of 35% (the target toxicity level).
**Measure:** Determination of optimal dose of MSC-L
**Time Frame:** 4 months
#### Secondary Outcomes
**Description:** Percentage of patients cancer whose MSC-L treatment has led to a complete response, partial response, or stable disease.
**Measure:** Disease Control Rate (DCR)
**Time Frame:** 24 months
**Description:** Time from the date of first dose of study treatment to the date of progression or death from any cause.
**Measure:** Progression-free survival (PFS)
**Time Frame:** 24 months
**Description:** Time from the date of first dose of study treatment to the date of death.
**Measure:** Overall Survival (OS)
**Time Frame:** 24 months
**Description:** Quantification of circulating MSC-L in the blood.
**Measure:** MSC-L kinetics in peripheral blood
**Time Frame:** 21 days post first infusion
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria (Participants must meet all of the following selection criteria in order to participate in this study):
1. Age less than 18 years old (including 18 years old), regardless of gender;
2. Patients with metastatic or locally advanced colorectal cancer confirmed by pathological histology or cytology;
3. According to the Efficacy Evaluation Criteria for Solid Tumors (RECIST) version 1.1, there are very few measurable tumor lesions;
4. Individuals who have progressed or are intolerant to standard treatment in the past, or patients who refuse standard treatment;
5. Severe abnormalities in the fluid system, liver and kidney function: lymphocyte count ≥ 0.8 × 10\^9/L, absolute neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 9g/dL, platelet count ≥ 75 × 10\^9/L; Alanine aminotransferase (ALT) ≤ 3 times upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 3 times ULN, creatinine ≤ 1.5 times ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN, prothrombin time (PT) ≤ 1.5 times ULN, international standardized mean value (INR) ≤ 1.5 times ULN;
6. Eastern Cooperative Oncology Group (ECOG) score 0-2;
7. Patients with fertility must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) during the trial period and at least 12 weeks after the last treatment;
8. Patients who have not undergone any other adoptive immune cell therapy or stem cell therapy within two years;
9. The patient is willing to participate and sign an informed consent form in writing.
Exclusion Criteria (Subjects with any of the following characteristics are not eligible to participate in this study):
1. Individuals with a history of allergies to biological agents or allergies to any ingredients used for cell culture;
2. Pregnant or lactating individuals;
3. Expected shelf life of more than 3 months;
4. Active infections that require systemic treatment or uncontrollable infections;
5. The adverse reactions of previous anti-tumor treatments have not yet recovered to Common Terminology Criteria for Adverse Events 4.03 (CTCAE4.03) level evaluation ≤ 1 level (excluding hair loss);
6. Have a history of severe cerebrovascular diseases, including but not limited to ventricular arrhythmias that require clinical intervention; Within 6 months, there have been acute coronary syndrome, myocardial infarction, congestive heart failure, stroke, or other Grade III or higher cardiovascular events; The New York Heart Association (NYHA) Heart Function Rating ≥ Grade II or Left Ventricular Ejection Score (LVEF) \<50%; Poor control of hypertension despite standard treatment (systolic blood pressure \>150mmHg, diastolic blood pressure \>90mmHg);
7. A history of severe pulmonary parenchyma or pulmonary vascular related diseases, including but not limited to high-risk individuals for venous thromboembolism (VTE) (Padua score ≥ 4), as outlined in the Chinese Consensus of Cardiopulmonary Resuscitation Experts on Venous Thromboembolism Cardiac Arrest (CA) Guidelines; Or oxygen may be needed to maintain sufficient blood oxygen saturation (≥ 95%);
8. Patients with clinical symptoms of central nervous system metastasis and/or cancerous meningitis (patients with stable brain metastasis can be grouped), and those suspected of central nervous system or leptomeningeal metastasis need CT/MRI examination to rule them out;
9. Individuals with clinically confirmed autoimmune diseases (excluding thyroiditis);
10. Individuals with HIV infection; Individuals with acute Epstein-Barr virus (EBV) or cytomegalovirus (CMV) virus infection;
11. Patients with active replication of hepatitis B virus (DNA \> 1000 cps/mL), hepatitis C patients;
12. Individuals who have received allogeneic bone marrow transplantation in the past;
13. Immunosuppressive subjects, including known immunodeficiencies; Within 14 days before the first dose of cell therapy and during the study period, those who require systemic use of steroid drugs (prednisone \>10mg/day or equivalent doses of similar drugs) or other immunosuppressants (excluding those who have recently or recently used systemic steroids, or short-term use of steroid drugs for preventive treatment);
14. Known to have alcohol or drug dependence;
15. The researcher assessed that there may be medical history or disease, treatment or abnormal experimental values that may hinder the full participation of the subjects in this clinical study, or other situations that are not suitable for participation in this clinical study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yanan Hai, MD
**Phone:** +86-18817821998
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dr. Hai
- **Phone:** +86-18817821998
- **Role:** CONTACT
***Contact 2:***
- **Name:** Yong Gao, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Shanghai East Hospital (South Division)
**State:** Shanghai
**Status:** RECRUITING
**Zip:** 200123
#### Overall Officials
**Official 1:**
**Affiliation:** Shanghai East Hospital
**Name:** Yong Gao, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446037
**Acronym:** ASCENT
**Brief Title:** Assessment of Gesture Accuracy of a Prosthesis Control System
**Official Title:** Assessment of Gesture Accuracy for a Multi-electrode EMG Sensor Array Based Prosthesis Control System
#### Organization Study ID Info
**ID:** PN01
#### Organization
**Class:** INDUSTRY
**Full Name:** Phantom Neuro Inc.
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-10
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-28
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Phantom Neuro Inc.
#### 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 is evaluating the performance of prosthesis control system, referred to as Phantom X, in able bodied individuals and individuals with upper limb amputation at the forearm level.
**Detailed Description:** The study will characterize the performance of Phantom X system and associated algorithms in decoding EMG signals for various hand gesture control. The EMG signals will be sensed using a non-invasive multi-electrode array applied to subjects' forearms.
### Conditions Module
**Conditions:**
- Upper Limb Amputation Below Elbow (Injury)
**Keywords:**
- Prosthesis
- Upper limb amputee
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 25
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All subjects will be instrumented with an electrode array on their forearms. The EMG signals detected by the electrodes will be fed into Phantom X hardware running the Phantom X algorithms. The algorithms will decode the EMGs signals and drive a desk mounted hand prosthesis.
**Intervention Names:**
- Device: Non-invasive EMG band instrumentation
**Label:** Interventional arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Interventional arm
**Description:** The sensed EMG signals from the subjects will be decoded by Phantom X algorithm and used to drive various gestures in a desk-mounted hand prosthesis
**Name:** Non-invasive EMG band instrumentation
**Other Names:**
- EMG prosthesis control
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Percentage of hand gestures accurately decoded by Phantom X algorithm
**Measure:** Gesture accuracy
**Time Frame:** Acute visit (at most 3 hours)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Individuals 21 years in age and older
2. Individuals with amputation of one or both arms at transradial level (applies to amputees only)
3. Ability to follow study directions
4. Willingness and ability to sign Informed Consent
Exclusion Criteria:
1. Individuals with previously diagnosed muscle pathologies
2. Individuals with impaired muscle function and/or impaired ability to perform normal hand movements (normal participants) or ability to perform normal phantom hand movements (amputees)
3. Individuals with transhumeral or higher amputation of both arms (applies to amputees only)
4. Cognitively impaired to follow study instructions
5. Allergies to skin adhesive materials necessary for cutaneous electrode placement
6. Excessive hair growth on arms and inability to shave off the hair for electrode placement
7. Pregnant woman
8. Arms or residual limbs with insufficient diameter to accommodate the wearing of two cutaneous sensor arrays
9. Injuries, bruises, or open wounds on the arm that needs to be instrumented for the study
**Healthy Volunteers:** True
**Minimum Age:** 21 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Vinod Sharma, PhD
**Phone:** 763-350-2091
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446024
**Acronym:** JapanIndigoPMS
**Brief Title:** Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
**Official Title:** Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
#### Organization Study ID Info
**ID:** 27548
#### Organization
**Class:** INDUSTRY
**Full Name:** Penumbra Inc.
### Status Module
#### Completion Date
**Date:** 2025-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-12-07
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Penumbra Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study aims to confirm the safety and effectiveness of the INDIGO Aspiration System in patients requiring immediate treatment for acute lower extremity artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis. Primary objective of the study is to collect predetermined data on use, safety and effectiveness, including clinical and technical performance of the INDIGO System in Japan.
### Conditions Module
**Conditions:**
- Acute Limb Ischemia
- Arterial Occlusion Mesenteric Artery Superior
- Acute DVT of Lower Extremity
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 500
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 6 Months
### Arms Interventions Module
#### Arm Group 1
**Description:** Mechanical aspiration thrombectomy
**Intervention Names:**
- Device: Mechanical aspiration thrombectomy
**Label:** Group 1: Indigo Aspiration System treatment
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group 1: Indigo Aspiration System treatment
**Description:** Mechanical thrombectomy is an endovascular technique for removing blood clots from vessels. Penumbra's Indigo system actively extracts thrombus using a continuous vacuum pump, enabling aspiration of thrombus of various sizes and lengths.
**Name:** Mechanical aspiration thrombectomy
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Target lower extremity salvage rate at (defined as: freedom from major amputation at or proximal to the ankle)
**Measure:** ALI: Target Limb Salvage
**Time Frame:** 30 days post-treatment and 6 months post-treatment
**Description:** Primary technical success should be defined per vessel treated on an intent-to-treat basis and applies only to segment treated with Indigo. Defined as successful use of the device to re-establish any antegrade flow and complete or near complete (95% by volume) removal of thrombus as assessed by visual analysis of angiographic images or by other objective imaging such as DUS, CTA, or MRA.
**Measure:** ALI: Technical Success
**Time Frame:** Intraoperative
**Description:** Major bleeding events as defined by ISTH
**Measure:** ALI: Major device-related bleeding in ALI patients
**Time Frame:** Periprocedural
**Description:** Restoration of antegrade blood flow without the need for other revascularization procedures such as vascular surgery or bypass.
**Measure:** SMA: Technical success
**Time Frame:** Intraoperative
**Description:** A distal filling defect with an abrupt cut-off, determined to be new since the pre-procedure angiogram, present at the end of the procedure, and clinically significant requiring intervention other than Indigo use. If the area in question was not clearly visualized, filling defects distal to the target lesion cannot be categorized as emboli.
**Measure:** SMA: Device-related Distal Embolization
**Time Frame:** Intraoperative
**Description:** Complete or near complete (75% or more) reduction in venous thrombosis, as assessed by visual evaluation of intraoperative venography
**Measure:** DVT: Technical success
**Time Frame:** Intraoperative
**Description:** Major device-related bleeding as defined by ISTH
**Measure:** DVT: Major Device-Related Bleeding
**Time Frame:** Periprocedural
**Description:** Symptomatic new PE objectively confirmed on Computed Tomographic Pulmonary Angiography (CTPA), echocardiography, MRI, or invasive contrast pulmonary angiography.
**Measure:** DVT: New Symptomatic Pulmonary Embolism (PE)
**Time Frame:** 30 days post-treatment
**Description:** Re-thrombosis of target vein segment requiring re-intervention within 30 days
**Measure:** DVT: Clinically significant re-thrombosis of the target venous segment
**Time Frame:** 30 days post-treatment
**Description:** Device related SAE and all-cause mortality
**Measure:** All Disease States: Device-related Serious adverse effects (SAE) and mortality
**Time Frame:** 6 months post-treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Patients who meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.
Exclusion Criteria:
Patients who do not meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** The INDIGO System is intended for use in patients with acute lower limb artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis who require immediate treatment and for whom it is difficult to perform surgical thrombectomy or who are expected to have no effective therapeutic effect.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mikiharu Morita
**Phone:** +1-510-440-5612
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Alameda
**Country:** United States
**Facility:** Sponsor Penumbra, Inc.
**State:** California
**Status:** RECRUITING
**Zip:** 94502
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: HIGH
- As Found: Arterial Occlusion
- 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: D000001157
- Term: Arterial Occlusive Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06446011
**Brief Title:** Effects of RCT on Periapical Healing, Inflammatory Markers, and Kidney Function Indicators in CKD Patients With AP
**Official Title:** Potential Effects of Non-surgical Endodontic Treatment on Periapical Healing, Inflammatory Markers, and Kidney Function Indicators in Chronic Kidney Disease Patients With Apical Periodontitis- Interventional Study.
#### Organization Study ID Info
**ID:** Himanshi Verma
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2024-08-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-07-12
**Type:** ACTUAL
**Status Verified Date:** 2023-11
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2023-12-07
**Study First Submit QC Date:** 2024-05-31
### 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
### Description Module
**Brief Summary:** The purpose of this prospective study is to determine the effect of non-surgical root canal treatment in chronic kidney disease patients and healthy patients with apical periodontitis.
**Detailed Description:** It has been found that there is an association between prevalence of odontogenic infection and systemic diseases. An elevated level of systemic cytokines has been observed in conjunction with both AP and CKD . The proinflammatory status and impaired immune response associated with systemic diseases (chronic kidney disease ) can affect the reparative response of the dental pulp and periapical healing. One study observed significant positive relation between number of diagnosed AP and urea serum level . A 4.35-mg/dL increase in the urea serum level could be expected per 1-unit increase in the number of teeth with AP. Improving oral health care through nonsurgical endodontic treatment(NSET) may improve the systemic inflammatory status and improve renal function.
The aim of this prospective study is to determine the effect of non-surgical root canal treatment in chronic kidney disease patients and healthy patients with apical periodontitis
1. Clinical and radiographic success rate will be considered as primary outcome, will be checked at baseline,6months,12months follow up.Periapical status will be checked according to periapical index given by Orstavik
2. Reduction in inflammatory(hsCRP) and kidney makers(serum urea , creatinine , eGFR) will be considered as secondary outcome, will be checked at baseline,3months,6months follow up.
### Conditions Module
**Conditions:**
- Apical Periodontitis
- Chronic Kidney Diseases
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 74
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Root canal treatment will be performed in teeth with apical periodontitis in chronic kidney disease patients and change in PAI score, eGFR and systemic markers will be checked.
**Intervention Names:**
- Procedure: root canal treatment in Ckd patients
**Label:** Chronic kidney disease group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Root canal treatment will be performed in teeth with apical periodontitis in healthy patients and change in PAI score and systemic markers will be checked
**Intervention Names:**
- Procedure: root canal treatment in healthy patients
**Label:** Healthy group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Chronic kidney disease group
**Description:** root canal treatment in teeth with apical periodontitis to observe periapical healing , and change in eGFR ,blood urea and creatinine and HSCRP
**Name:** root canal treatment in Ckd patients
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Healthy group
**Description:** root canal treatment in teeth with apical periodontitis to observe periapical healing and change in HSCRP
**Name:** root canal treatment in healthy patients
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Periodical status will be assessed in periodical radiograph and scoring of periapical index will be done according to size and periphery of peri-apical radiolucency with coding 1 to 5
**Measure:** Periapical Index(PAI)
**Time Frame:** 12MONTHS
#### Secondary Outcomes
**Description:** BY BLOOD SAMPLE measured in mL/min/1.73m2
**Measure:** eGFR
**Time Frame:** 3-6MONTHS
**Description:** BY BLOOD SAMPLE measured in mg/dL
**Measure:** serum creatinine
**Time Frame:** 3-6MONTHS
**Description:** HIGH SENSITIVE C-reactive protein measured by ELISA kit in mg/L
**Measure:** hs-CRP
**Time Frame:** 3-6MONTHS
**Description:** measured by collecting blood sample in mg/dL
**Measure:** Blood urea
**Time Frame:** 3-6MONTHS
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1- Known patient of Chronic Kidney Disease \[CKD Stages 1,2,3,4,5 with mature permanent teeth.
2. Age18year or older . 3. ≥ to 12 natural teeth (excluding 3rd molars) 4 The periapical index (PAI) was used to evaluate the periapical status patients with PAI ≥3 are included in the study.
Exclusion Criteria:
1. Patients having systemic disorders other than chronic kidney disease (e.g HIV; Diabetes mellitus; Coronary heart disease; no history of secondary hyperparathyroidism)
2. Patients with periodontitis , pocket depth and CAL\>5mm( stage 3 ,4) will be excluded.
3. Pregnancy; lactation \& contraceptives.
4. Patients taking antibiotics, statins, corticosteroids and aspirin which can affect the level of inflammatory markers in past one month.
**Gender Based:** True
**Gender Description:** Gender matched healthy control participants to the same gender chronic kidney disease individuals will be analyzed.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** SHWETA MITTAL, MDS
**Phone:** 9255596960
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** SANJAY TEWARI, MDS
**Phone:** 01262-283876
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rohtak
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** HIMANSHI VERMA, MDS
- **Phone:** 7042836872
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** SHWETA MITTAL, MDS
- **Phone:** 9255596960
- **Role:** CONTACT
**Country:** India
**Facility:** PGIDS
**State:** Haryana
**Status:** RECRUITING
**Zip:** 121004
#### Overall Officials
**Official 1:**
**Affiliation:** PGIDS,ROHTAK
**Name:** HIMANSHI VERMA, MDS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000051437
- Term: Renal Insufficiency
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000010483
- Term: Periapical Diseases
- ID: D000007571
- Term: Jaw Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10698
- Name: Kidney Diseases
- Relevance: HIGH
- As Found: Kidney Disease
- ID: M13427
- Name: Periodontitis
- Relevance: HIGH
- As Found: Periodontitis
- ID: M13395
- Name: Periapical Periodontitis
- Relevance: HIGH
- As Found: Apical Periodontitis
- ID: M26717
- Name: Renal Insufficiency, Chronic
- Relevance: HIGH
- As Found: Chronic Kidney Disease
- ID: M26718
- Name: Renal Insufficiency
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M13419
- Name: Periodontal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13393
- Name: Periapical Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10601
- Name: Jaw Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010518
- Term: Periodontitis
- ID: D000010485
- Term: Periapical Periodontitis
- ID: D000007674
- Term: Kidney Diseases
- ID: D000051436
- Term: Renal Insufficiency, Chronic
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M1804
- Name: Carbamide Peroxide
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445998
**Brief Title:** Effect of Task Oriented Training on Cognitive Function in Elderly Stroke Patients
**Official Title:** Effect of Task Oriented Training on Cognitive Function in Elderly Stroke Patients
#### Organization Study ID Info
**ID:** HorusU
#### Organization
**Class:** OTHER
**Full Name:** Horus University
### Status Module
#### Completion Date
**Date:** 2024-05-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-01
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-05-31
**Type:** ACTUAL
#### Start Date
**Date:** 2024-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-01
**Study First Submit QC Date:** 2024-06-01
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Horus University
#### Responsible Party
**Investigator Affiliation:** Horus University
**Investigator Full Name:** Ahmed Metwally Mohamed Elshinnawy
**Investigator Title:** Assistant Professor, Department of Physical Therapy for Neuromuscular Disorders and Its Surgery, Faculty of Physical Therapy, Horus University, New Damietta, Egypt
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Background: The impact of stroke at the time of diagnosis is on the attention and executive functions, which may be impaired at various post-stroke intervals. Objective: To improve Cognitive Function in Elderly Stroke Patients through Task Oriented Training. Subjects and methods: Forty Elderly stroke patients from both sexes assigned randomly into two equal groups. In Group A were allocated to task oriented training in addition to traditional physical therapy program, group B received traditional physical therapy program, three sessions/week for 3 months. Cognitive Function assessed by Reha-com device, Addenbrooke's Cognitive Examination Revised (ACE-R) test and Montreal Cognitive Assessment Scale (MoCA), measured at baseline and after 3 months.
**Detailed Description:** Methods The current study was conducted to examine the influence of task oriented training on cognitive functions in post Elderly stroke patients. All patients were diagnosed clinically and radiologically and referred from their neurological consultants as having post stroke cognitive impairment (PSCI). The patients were chosen, and the study was carried- out in outpatient clinics of Faculty of physical therapy, Horus University, this study was conducted at the period from ============== to==============.
True experimental research design study (one factorial RCT, pre-test and post-test control group design) was utilized. One trained research assistant assessed all patients and collected all data to reduce inter-investigator error. Patients were randomized according to the treatment procedure into two equal groups.
Randomization method: Patients who met the study's inclusion criteria were randomized into two groups (A and B) utilizing a secure opaque closed envelope allocation mechanism. Group A (study group): consisted of twenty hemiparetic patients received task oriented training in addition to traditional physical therapy program, 3 times per week for 3 month, every session for 1 hour (30 minutes task oriented training followed by 30 minutes traditional physical therapy program). Group B (control group): consisted of twenty hemiparetic patients received the traditional physical therapy program, 3 sessions/week for 3 month, each session for 1hour.
Blinding: All patients were assessed and referred by the same physician and physical therapy evaluation before beginning and at the end of the treatment program. Treatment allocations were kept secret from both the researcher and the participants.
Inclusion criteria: Forty right-handed hemiparetic patients from both genders aged from 60 to 70 years old. They are complaining from a single ischemic stroke diagnosed by Neurologist and confirmed radiologically by MRI of the brain. Duration of illness ranged from three to twelve months. Spasticity grade (1 to 1+) based on the Modified Ashworth Scale (MAS). Medically as well as psychologically stable patients. All patients had normal and stable vital signs (heart rate, blood pressure, temperature as well as respiratory rate). All patients had a good educational level and the body mass index ranged from 20-30 Kg/m2.
Exclusion criteria: Patients with Recurrent stroke or hemiparesis due to other neurological causes rather than stroke. Patients with severe cardiovascular issues that have not been adequately treated. Visual, auditory and other neurological disorders. Patients receiving medications that may affect cognition.
Data collection and intervention Assessment methods After being informed of the study's goals, methods, potential benefits, privacy, as well as data use, all participants signed a written consent form. Pre-treatment and post-treatment assessments were conducted on all patients.
Measurement procedures:
1. Assessment of cognitive function by Reha-com device The computerized Reha-Com device containing the (attention and concentration) program was utilized as the patient is asked to concentrate on every detail in the separately presented picture and select the one that resembles it in every detail from the matrix, as the assessment screen is splitted into two parts. One portion represents the matrix that involves: according to (24) levels of difficulty: 3 pictures (1 by 3 matrix), 6 pictures (2 by 3 matrix) as well as 9 pictures (3 by 3 matrix), and the other part represents the separated picture.
2. Addenbrooke's Cognitive Examination Revised (ACE-R) test It consists of 26 tasks, divided into five domains. It takes about 15 minutes to administer. The maximum possible score is 100, and questions are asked in the sequence stated, with scores calculated immediately based on the addition of point values for each correctly answered question (10).
3. Montreal Cognitive Assessment Scale (MoCA):
The test is commonly used to screen for cognitive impairment. It was designed to detect mild cognitive Impairment. It takes approximately 10 minutes to complete, 30-point cognitive screening instrument. It is utilized to evaluate multiple aspects of cognition, including: short-term memory; visual-spatial skills; executive function; concentration; attention; memory for work; language; as well as time-and-place awareness. The possible range of MoCA scores is 0-30. If you scored 26 or more, you're in the normal range. Scores below 25 indicate mild cognitive impairment (MCI) in individuals who have suffered a stroke, and the score has a high sensitivity (77%) as well as specificity (83%) (11).
Intervention methods Task-oriented training program: \[For study group\] Rocker board training The subject was asked to control anteroposterior then mediolateral rolling movement of the rocking board, first placing both feet then one foot, first with eyes opened then with eyes closed, from sitting then standing position.
Wobble board training The subject was asked to try to stop the multidirectional rolling wobble board movement, first with eyes opened then with eyes closed, from sitting then standing position, repeat 10 times.
Sit to stand The patient was instructed to lean forward then press on heel then stand up. Both hands should be on the thigh and push against it to stand. This progress to be performed with opened eyes then with closed eyes firstly on a firm surface then on foam surface with repetitions 10 times.
Walk five steps forward From standing position, the patient was asked to walk five steps forward firstly on a firm surface, then on foam surface and repeat 10 times.
Upstairs and downstairs three steps The patient was asked to perform upstairs five steps and downstairs with hand supported then without hand supported, repeat 10 times.
Traditional physical therapy program: \[For both groups\] Range of motion exercises Range of motion exercises was performed for the foot. The patient was asked to sit in a chair, lift the affected foot and circle in a clockwise, then a counterclockwise motion. Repeat this cycling five and ten times in each direction.
Strengthing exercises:
Graduate active exercise was used through strengthing of ankle dorsiflexors, planterflexor, invertors and evertors. Proprioceptive neuromuscular facilitation was also applied to strength distal muscles in the form of repeated contraction for dorsiflexors of ankle joint for ten minutes.
Sensory re-education:
Tactile stimulation for both superficial and deep sensation was applied. Gait Training Walking within parallel bar with hand supported then without hand support was participated for ten minutes. Obstacles also were used with hand support then without hand support.
### Conditions Module
**Conditions:**
- Stroke
**Keywords:**
- Task Oriented Training - Cognitive Function
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** task oriented training
##### Masking Info
**Masking:** SINGLE
**Masking Description:** traditional physical therapy
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** consisted of twenty hemiparetic patients received task oriented training in addition to traditional physical therapy program, 3 times per week for 3 month, every session for 1 hour (30 minutes task oriented training followed by 30 minutes traditional physical therapy program).
**Intervention Names:**
- Other: task oriented training
**Label:** Group A (study group)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** consisted of twenty hemiparetic patients received the traditional physical therapy program, 3 sessions/week for 3 month, each session for 1hour.
**Intervention Names:**
- Other: task oriented training
**Label:** Group B (control group)
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Group A (study group)
- Group B (control group)
**Description:** Task-oriented training program: \[For study group\] Rocker board training Wobble board training Sit to stand Walk five steps forward Upstairs and downstairs three steps
**Name:** task oriented training
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The computerized Reha-Com device containing the (attention and concentration) program was utilized as the patient is asked to concentrate on every detail in the separately presented picture and select the one that resembles it in every detail from the matrix, as the assessment screen is splitted into two parts. One portion represents the matrix that involves: according to (24) levels of difficulty: 3 pictures (1 by 3 matrix), 6 pictures (2 by 3 matrix) as well as 9 pictures (3 by 3 matrix), and the other part represents the separated picture.
**Measure:** 1- Assessment of cognitive function by Reha-com device
**Time Frame:** 3 month
**Description:** It consists of 26 tasks, divided into five domains. It takes about 15 minutes to administer. The maximum possible score is 100, and questions are asked in the sequence stated, with scores calculated immediately based on the addition of point values for each correctly answered question (10).
**Measure:** 2- Addenbrooke's Cognitive Examination Revised (ACE-R) test
**Time Frame:** 3 month
**Description:** The test is commonly used to screen for cognitive impairment. It was designed to detect mild cognitive Impairment. It takes approximately 10 minutes to complete, 30-point cognitive screening instrument. It is utilized to evaluate multiple aspects of cognition, including: short-term memory; visual-spatial skills; executive function; concentration; attention; memory for work; language; as well as time-and-place awareness. The possible range of MoCA scores is 0-30. If you scored 26 or more, you're in the normal range. Scores below 25 indicate mild cognitive impairment (MCI) in individuals who have suffered a stroke, and the score has a high sensitivity (77%) as well as specificity (83%) (11).
**Measure:** 3- Montreal Cognitive Assessment Scale (MoCA):
**Time Frame:** 3 month
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
* Forty right-handed hemiparetic patients from both genders aged from 60 to 70 years old.
* They are complaining from a single ischemic stroke diagnosed by Neurologist and confirmed radiologically by MRI of the brain. Duration of illness ranged from three to twelve months. Spasticity grade (1 to 1+) based on the Modified Ashworth Scale (MAS).
* Medically as well as psychologically stable patients. All patients had normal and stable vital signs (heart rate, blood pressure, temperature as well as respiratory rate).
* All patients had a good educational level and the body mass index ranged from 20-30 Kg/m2.
Exclusion criteria:
* Patients with Recurrent stroke or hemiparesis due to other neurological causes rather than stroke.
* Patients with severe cardiovascular issues that have not been adequately treated. Visual, auditory and other neurological disorders.
* Patients receiving medications that may affect cognition.
**Maximum Age:** 70 Years
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Damietta
**Country:** Egypt
**Facility:** Horus University
**State:** New Damietta
**Zip:** 17611
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Physical Therapy for Internal Medicine and Elderly
**Name:** Zeezy S Eraky, Lecturer
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** Department of Basic Science
**Name:** Haitham M. Elmasry, Lecturer
**Role:** STUDY_CHAIR
**Official 3:**
**Affiliation:** Department of Physical Therapy for Neuromuscular Disorders and its Surgery
**Name:** Ibrahim M. Hamoda, Asst Prof
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Description:** All the IPD will be shared Through the Corresponding author after acceptance of all authors
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002561
- Term: Cerebrovascular Disorders
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M22306
- Name: Stroke
- Relevance: HIGH
- As Found: Stroke
- ID: M5810
- Name: Cerebrovascular Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000020521
- Term: Stroke
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445985
**Brief Title:** Hydrotherapy in Duchenne Muscular Dystrophy (DMD)
**Official Title:** Hydrotherapy for Health in Boys and Adolescents With Duchenne Muscular Dystrophy
#### Organization Study ID Info
**ID:** 304633
#### Organization
**Class:** OTHER
**Full Name:** Lancashire Teaching Hospitals NHS Foundation Trust
#### Secondary ID Infos
**Domain:** Health Research Authority
**ID:** 21/PR/1748
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-12-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-11-02
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-02-14
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Duchenne UK
#### Lead Sponsor
**Class:** OTHER
**Name:** Lancashire Teaching Hospitals NHS Foundation Trust
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this clinical trial aims to establish if there are meaningful benefits to providing a hydrotherapy service for young people with Duchenne muscular dystrophy (DMD). The main aims are to: 1. to allocate a clinical physiotherapist to a project implementing hydrotherapy in young patients with DMD to establish whether there are meaningful benefits to their daily life. 2. to conduct patient and parent interviews to understand the barriers to completing a hydrotherapy intervention and ensure future research addresses meaningful outcomes for those with DMD.
**Detailed Description:** The quality of life in young males with Duchenne muscular dystrophy (DMD) is negatively impacted by daily pain, changes in body composition and a lack of support to undertake physical activity. Hydrotherapy represents a potential means of involving boys and adolescents with DMD in activity that could benefit the negative factors influencing their quality of life. There are presently no guidelines or evidence for the benefits of hydrotherapy with the standards of care for young males with DMD.
This trial will provide evidence that will allow care providers to advocate the use of hydrotherapy within the management of DMD, as an inclusive activity, that can be adopted by those with DMD who are either ambulatory, or non-ambulatory. Through 12-weeks of hydrotherapy, the trial will investigate whether there are benefits to physical function, pain and quality of life. These measures represent meaningful outcomes in the progression of DMD, and have direct patient impact for those affected by DMD. On completion of the hydrotherapy, there will be a series of interviews with some of the participants and their parents. The aim of these interviews is to understand participant and parent barriers to hydrotherapy, and uncover whether hydrotherapy improves the lives of the participants beyond simple clinical measures and questionnaires.
The study aims recruit 44 boys and young men with Duchenne muscular dystrophy. Patients will be recruited from NHS neuromuscular services and through families who attend the local hospice.
Following an informed consent process they will enter the first 12 week stage, as a control to observe and measure their habitual physical activity, along with monitoring their diet. They will then enter the intervention stage where they will have a weekly physiotherapy led pool session with a number of physical activities. During the hydrotherapy period, participants will access the hydrotherapy pool once a week for 12 weeks. Sessions are supervised by an experienced physiotherapist, who will guide the exercise for a session lasting 30 to 60 minutes.
The exercises, intensity and specific hydrotherapy plan will be derived from consultation with the participants and their parents. Due to the variance within the presentation of the condition, and the inclusive age range within the study, an externally valid approach to exercise prescription will be utilised. Diet and physical function will be measured during this stage.
There will be a number of assessments to be completed at 3 time points. As much as possible these will be arranged as single visits. The first before the control period, the second after the control period, and the third after the hydrotherapy period. The assessments include a number of physical assessments, including assessments of function and ability, body mass and quality of life. After completion, all participants will be invited to complete a qualitative interview, in particular enquiring about the experience and logistics of hydrotherapy.
### Conditions Module
**Conditions:**
- Duchenne Muscular Dystrophy
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Patients with DMD, show great variability in age and speed of deterioration. As such it is difficult to find matched controls for a short randomised intervention study. Instead, due to the progressive nature of DMD and the inherent variance within a mixed age and ability population, the participants will act as their own controls. This single-arm, non-crossover design where the participant acts as his own control, although not as robust as randomized control exercise trials, is advocated for longitudinal interventions in populations such as the present one.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 44
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will have a 12 week period where they will continue with their habitual physical activity behaviour. Diet and physical activity will be monitored
**Label:** Control
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Participants will complete 12-weeks of hydrotherapy, involving up to 60 mins of hydrotherapy once a week. Diet and physical activity will be monitored.
**Intervention Names:**
- Other: Hydrotherapy
**Label:** Hydrotherapy
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Hydrotherapy
**Description:** Physiotherapy led pool session
**Name:** Hydrotherapy
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Fat mass, body fat percentage and fat free mass will be measured using BIA (bioelectrical impedance). BIA has been validated in DMD and is accurate enough to measure longitudinal changes in body composition and muscle mass in this population
**Measure:** Body Mass via Bioelectrical impedance (BIA)
**Time Frame:** 24 weeks
**Description:** A pain map assessment of the topographic distribution of daily pain will also be competed, consistent with our previous work in DMD. Scale of 1-10
**Measure:** Pain Scale
**Time Frame:** 24 weeks
**Description:** PedsQL QoL - Quality of Life for both participants, and the DMD-QoL Proxy for parents - Scale of 0-4
**Measure:** PedsQL QoL / DMD QoL - Quality of Life
**Time Frame:** 24 weeks
#### Secondary Outcomes
**Description:** Upper limb strength using grip and pinch measure using digital, handheld dynamometers North-Star
**Measure:** Upper Limb Strength
**Time Frame:** 24 weeks
**Description:** Limited ankle range of motion (ROM) Ankle plantarflexion-dorsiflexion (PF-DF ROM) will be assessed through a goniometer
**Measure:** Range of Motion
**Time Frame:** 24 weeks
**Description:** Pulmonary function will be assessed using digital spirometry
**Measure:** Pulmonary function
**Time Frame:** 24 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Established diagnosis of Duchenne Muscular Dystrophy (either by genetics or muscle biopsy)
* Between 6 and 25 years of age
* On stable dose of steroids or not on steroids
Exclusion Criteria:
* Younger than 6 years, older than 25 years
* Recent change in steroid dose, less than 3 months prior
* Undertaking formal hydrotherapy supervised by physiotherapist on a regular basis (weekly or more frequent)
**Gender Based:** True
**Gender Description:** DMD affects those born male.
**Maximum Age:** 25 Years
**Minimum Age:** 6 Years
**Sex:** MALE
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kina Dr Bennett
**Phone:** 441772522031
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Research Access
**Phone:** 441772522031
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Preston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kina Bennett
- **Phone:** +44177252
- **Phone Ext:** 2031
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Research Access
- **Phone:** +44177252
- **Phone Ext:** 2031
- **Role:** CONTACT
***Contact 3:***
- **Name:** Christian De Goede
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United Kingdom
**Facility:** Lancashire Teaching Hospitals NHS Foundation Trust
**State:** Lancashire
**Status:** RECRUITING
**Zip:** PR2 9HT
#### Overall Officials
**Official 1:**
**Affiliation:** Lancashire Teaching Hospitals NHS Foundation Trust
**Name:** Christian De Goede
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** The results of this study will be used to inform the neuromuscular service in Preston and at other sites in the UK. The results will also be shared more widely by presenting them at regional and or national meetings. The results may be published in a scientific journal and presented at scientific medical conferences and through publications and meetings organised by Duchenne UK.
**IPD Sharing:** NO
## Document Section
### Large Document Module
#### Large Docs
- Date: 2023-08-22
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 772877
- Type Abbrev: Prot
- Upload Date: 2024-02-14T07:26
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020966
- Term: Muscular Disorders, Atrophic
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000030342
- Term: Genetic Diseases, Inborn
- ID: D000040181
- Term: Genetic Diseases, X-Linked
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC10
- Name: Nervous System 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: M12093
- Name: Muscular Dystrophies
- Relevance: HIGH
- As Found: Muscular Dystrophy
- ID: M22185
- Name: Muscular Dystrophy, Duchenne
- Relevance: HIGH
- As Found: Duchenne Muscular Dystrophy
- ID: M4589
- Name: Atrophy
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22697
- Name: Muscular Disorders, Atrophic
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: M24877
- Name: Genetic Diseases, X-Linked
- Relevance: LOW
- As Found: Unknown
- ID: T3963
- Name: Muscular Dystrophy
- Relevance: HIGH
- As Found: Muscular Dystrophy
- ID: T698
- Name: Becker Muscular Dystrophy
- Relevance: HIGH
- As Found: Duchenne Muscular Dystrophy
- ID: T1945
- Name: Duchenne Muscular Dystrophy
- Relevance: HIGH
- As Found: Duchenne Muscular Dystrophy
### Condition Browse Module - Meshes
- ID: D000009136
- Term: Muscular Dystrophies
- ID: D000020388
- Term: Muscular Dystrophy, Duchenne
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445972
**Brief Title:** Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)
**Official Title:** A Phase 1/2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of MK-2870 Plus Paclitaxel as the Second-Line Treatment of Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma: Substudy 06D
#### Organization Study ID Info
**ID:** 3475-06D
#### Organization
**Class:** INDUSTRY
**Full Name:** Merck Sharp & Dohme LLC
#### Secondary ID Infos
**Domain:** EU CT
**ID:** 2023-509306-29
**Type:** OTHER
**Domain:** UTN
**ID:** U1111-1299-8160
**Type:** OTHER
**Domain:** Merck ID
**ID:** MK-3475-06D
**Type:** OTHER
**Domain:** Merck ID
**ID:** Keymaker-U06
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-10-27
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Merck Sharp & Dohme LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a phase 1/2 multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of MK-2870 plus paclitaxel versus Ramucirumab plus paclitaxel, for the treatment of participants with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma who have failed 1 prior line of therapy. This is an estimation study, and no formal hypothesis testing will be performed.
**Detailed Description:** The master protocol is MK-3475-U06.
### Conditions Module
**Conditions:**
- Gastroesophageal Junction
- Gastroesophageal Adenocarcinoma
- Esophageal Neoplasms
- Esophageal Cancer
**Keywords:**
- Programmed Cell Death-1 (PD1, PD-1)
- Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
- Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive ramucirumab at 8mg/kg via intravenous (IV) infusion on days 1 and 15 of each 4-week cycle for up to \~60 weeks plus paclitaxel at 80 mg/M\^2 via IV infusion on Days 1, 8, and 15 of each 4-week cycle (3 weeks on and 1 week off) for up to \~60 weeks.
**Intervention Names:**
- Biological: Ramucirumab
- Drug: Paclitaxel
**Label:** Ramucirumab + Paclitaxel
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Following a 28-day run-in with MK-2870 at 3 mg/kg and 4 mg/kg IV infusion on Days 1 and 15 of a 6-week cycle plus paclitaxel at 80 mg/M\^2 IV infusion on days 1, 8 and 15 of a 4-week cycle, participants will receive paclitaxel at 80 mg/M\^2 IV infusion on days 1, 8, 15 of each 4-week cycle (3 weeks on and 1 week off) up to \~60 weeks plus MK-2870 at selected dose IV infusion on days 1, 15, 29 of every 6-week cycle until discontinuation.
**Intervention Names:**
- Drug: Paclitaxel
- Biological: MK-2870
**Label:** MK-2870 + Paclitaxel
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Ramucirumab + Paclitaxel
**Description:** 8 mg/kg IV Infusion
**Name:** Ramucirumab
**Type:** BIOLOGICAL
#### Intervention 2
**Arm Group Labels:**
- MK-2870 + Paclitaxel
- Ramucirumab + Paclitaxel
**Description:** 80 mg/M\^2 IV infusion
**Name:** Paclitaxel
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- MK-2870 + Paclitaxel
**Description:** 3 mg/kg or 4 mg/kg IV Infusion
**Name:** MK-2870
**Other Names:**
- SKB264
- sacituzumab tirumotecan
- sac-TMT
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** DLTs are defined as any drug-related adverse event (AE) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The percentage of participants who experience at least one DLT will be presented.
**Measure:** Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase
**Time Frame:** Up to ~28 days
**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE will be presented.
**Measure:** Percentage of Particiapants who Experience an Adverse Event (AE) During the Safety Lead-In Phase
**Time Frame:** Up to ~60 days
**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE will be presented.
**Measure:** Percentage of Participants who Discontinue Study Intervention Due to an AE During the Safety Lead-In Phase
**Time Frame:** Up to ~28 days
**Description:** ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
**Measure:** Objective Response Rate (ORR)
**Time Frame:** Up to ~30 months
#### Secondary Outcomes
**Description:** PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
**Measure:** Progression Free Survival (PFS)
**Time Frame:** Up to ~52 months
**Description:** For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
**Measure:** Duration of Response (DOR)
**Time Frame:** Up to ~52 months
**Description:** OS is defined as the time from the date of randomization to the date of death from any cause. OS will be presented.
**Measure:** Overall Survival (OS)
**Time Frame:** Up to ~52 months
**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE will be presented.
**Measure:** Percentage of Particiapants who Experience an AE During the Efficacy Phase
**Time Frame:** Up to ~52 months
**Description:** An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE will be presented.
**Measure:** Percentage of Participants who Discontinue Study Intervention Due to an AE During the Efficacy Phase
**Time Frame:** Up to ~52 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has histologically and/or cytologically confirmed diagnosis of previously treated, 2L (received first line (1L) treatment) gastric adenocarcinoma, GEJ adenocarcinoma, or esophageal adenocarcinoma
* Has metastatic disease or locally advanced, unresectable disease
* Has experienced documented objective radiographic or clinical disease progression during or after 1L therapy containing any platinum/fluoropyrimidine doublet with or without immunotherapy
* Has gastroesophageal adenocarcinoma that is not human epidermal growth factor receptor 2 (HER2)/neu positive
* Can provide an archival tumor tissue sample or most recently obtained core, incisional, or excisional biopsy of a tumor lesion
* AEs due to previous anticancer therapies must be ≤Grade 1 or baseline (except alopecia and vitiligo). Endocrine-related AEs adequately treated with hormone replacement are acceptable.
* Has Eastern Cooperative Oncology Group performance status of 0 or 1
* Has a life expectancy of at least 3 months
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has squamous cell or undifferentiated esophageal gastric cancer
* Has experienced weight loss \>20% over 3 months before the first dose of study intervention
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
* Has Grade ≥2 peripheral neuropathy
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
* Has a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days prior to randomization
* Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
* Has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization
* Has uncontrolled arterial hypertension ≥150/≥90 mm Hg
* Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment
* Has undergone major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to randomization or planned major surgery following initiation of study treatment
* Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents
* Is receiving chronic therapy with nonsteroidal anti-inflammatory agents (NSAIDs) or other antiplatelet agents
* Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") during the 3 months prior to randomization
* Has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to study entry
* Has history of GI perforation and/or fistulae within 6 months prior to randomization
* Has a history of human immunodeficiency virus (HIV) infection
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study drug intervention
* Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has an active infection requiring systemic therapy
* Has a concurrent active Hepatitis B (defined as hepatitis B surface antigen (HBsAg) positive and/or detectable hepatitis B virus deoxyribonucleic acid (HBV DNA)) and Hepatitis C virus (defined as anti-hepatitis C virus antibody (HCV Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
* Has severe hypersensitivity (Grade ≥3) to MK-2870, any of its excipients and/or to another biologic therapy
* Has not adequately recovered from major surgery or have ongoing surgical complications
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Overall Officials
**Official 1:**
**Affiliation:** Merck Sharp & Dohme LLC
**Name:** Medical Director
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Description:** http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
**IPD Sharing:** YES
**URL:** http://engagezone.msd.com/ds_documentation.php
### References Module
#### See Also Links
**Label:** Merck Clinical Trials Information
**URL:** https://www.merckclinicaltrials.com
## 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
- 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: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3585
- Name: Adenocarcinoma
- Relevance: HIGH
- As Found: Adenocarcinoma
- ID: M8088
- Name: Esophageal Neoplasms
- Relevance: HIGH
- As Found: Esophageal Neoplasms
- ID: M6845
- Name: Death
- Relevance: LOW
- As Found: Unknown
- 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
- 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: D000000230
- Term: Adenocarcinoma
- ID: D000004938
- Term: Esophageal Neoplasms
### 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
- ID: D000020533
- Term: Angiogenesis Inhibitors
- ID: D000043924
- Term: Angiogenesis Modulating Agents
- ID: D000006133
- Term: Growth Substances
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000006131
- Term: Growth Inhibitors
### 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: M3246
- Name: Ramucirumab
- Relevance: HIGH
- As Found: Adjuvant therapy
- ID: M349416
- Name: Pembrolizumab
- 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
- ID: M22318
- Name: Angiogenesis Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M9231
- Name: Growth Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000017239
- Term: Paclitaxel
- ID: D000096662
- Term: Ramucirumab
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445959
**Brief Title:** Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib
**Official Title:** Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib
#### Organization Study ID Info
**ID:** 2024-0180
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**Domain:** NCI-CTRP Clinical Registry
**ID:** NCI-2024-04807
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2029-06-30
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-11-29
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Rigel Pharmaceuticals,Inc.
#### Lead Sponsor
**Class:** OTHER
**Name:** M.D. Anderson Cancer Center
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To find a recommended combination dose of decitabine and venetoclax that can be given in combination with olutasidenib to participants with AML.
**Detailed Description:** Primary Objectives
* Phase 1b: To determine the safety and tolerability and recommended phase 2 dose (RP2D) of decitabine (either IV or oral decitabine/cedazuridine (ASTX727, Inqovi)) and venetoclax in combination with olutasidenib.
* Phase 2: To determine the composite remission rate (CR, CRh and CRi) of decitabine (IV or oral decitabine/cedazuridine (ASTX727, Inqovi)) and venetoclax in combination with olutasidenib for newly diagnosed (Arm A) or relapsed/refractory (Arm B) participants with IDH1-mutated myeloid malignancy.
Secondary Objectives
* To determine duration of response (DOR), event-free survival (EFS), and overall survival (OS)
* To evaluate occurrence of minimal residual disease (MRD) negative status by multiparameter flow cytometry and molecular evaluation.
* To determine the overall response rate (CR, CRh, CRi, MLFS, and PR)
* To characterize the pharmacokinetic (PK) profiles of venetoclax and olutasidenib in plasma samples (Phase 1b only).
Exploratory Objectives
- To investigate global gene expression profiles, DNA methylation profiles, BH3 profiling and other potential prognostic markers to explore predictors of antitumor activity and/or resistance to treatment.
### Conditions Module
**Conditions:**
- Mutant IDH1 Inhibitor Olutasidenib
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 78
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants enrolled in Part 1, the dose of venetoclax/decitabine you receive will depend on when you join this study. Up to 3 dose levels will be tested. Up to 6 participants will be enrolled at each dose level.
- All participants will receive the same dose level of olutasidenib.
**Intervention Names:**
- Drug: Olutasidenib
- Drug: Venetoclax
- Drug: Decitabine
**Label:** Part 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants enrolled in Part 2, you will receive venetoclax/decitabine at the recommended dose that was found in Part 1.
- All participants will receive the same dose level of olutasidenib.
**Intervention Names:**
- Drug: Olutasidenib
- Drug: Venetoclax
- Drug: Decitabine
**Label:** Part 2
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Part 1
- Part 2
**Description:** Given by PO
**Name:** Olutasidenib
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Part 1
- Part 2
**Description:** Given by PO
**Name:** Venetoclax
**Other Names:**
- ABT-199
- GDC-0199
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Part 1
- Part 2
**Description:** Given by IV
**Name:** Decitabine
**Other Names:**
- Dacogen
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
**Measure:** Safety and adverse events (AEs)
**Time Frame:** Through study completion; an average of 1 year.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age \> 18 years
2. Participants must have a documented IDH1 gene mutation
3. Participants with a diagnosis of relapsed or refractory AML (including biphenotypic or bilineage leukemia including a myeloid component or isolated extramedullary AML), high-risk MDS by IPSS-R or IPSS-M; OR
4. Participants with newly diagnosed AML not eligible or appropriate for intensive chemotherapy are also eligible. (Phase 2 portion only)
5. To be considered not eligible for intensive chemotherapy, participants must be defined by the following: Age 75 years or older, or Age 18 to 74 years with at least one of the following comorbidities:
1. Severe cardiac disorder (eg, congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina).
2. Severe pulmonary disorder (eg, DLCO ≤65% or forced expiratory volume in 1 second \[FEV1\] ≤65%).
3. Creatinine clearance ≥30 mL/min to \<45 mL/min.
4. Moderate hepatic impairment with total bilirubin \>1.5 to .3.0 x upper limit of normal (ULN)
5. ECOG performance status of 2 or 3
6. Any other comorbidity that per the investigator renders a patient inappropriate for intensive chemotherapy
6. Eastern Cooperative Oncology Group (ECOG) Performance Status \</=2 (unless age 18 to 74 years of age with newly diagnosed AML not eligible for intensive chemotherapy as per 5e above)
7. Adequate renal function including creatinine \< 1.5, unless related to the disease or unless age 18 to 74 years of age with newly diagnosed AML not eligible for intensive chemotherapy as per 5c above.
8. Adequate hepatic function (direct bilirubin \< 2x upper limit of normal (ULN) unless increase is due to Gilbert fs disease or leukemic involvement, and AST and/or ALT \< 3x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and/or ALT \< 5x ULN will be considered eligible, or unless age 18 to 74 years of age with newly diagnosed AML not eligible for intensive chemotherapy as per 5d above)
9. In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 14 days for cytotoxic or non-cytotoxic (immunotherapy agent(s), or an interval of 5 half-lives of the prior therapy. Oral hydroxyurea and/or cytarabine (up to 2 g/m2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the PI. Concurrent intrathecal therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted.
10. Male participants who are sexually active with a women of childbearing potential (WOCBP) and who have not had vasectomies must be willing to use a barrier method of contraception and refrain from sperm donation from initial study drug until 90 days after last dose of study drug.
11. Willing and able to provide informed consent.
Exclusion Criteria:
1. Participants with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British \[FAB\] class M3-AML).
2. Participants with any concurrent uncontrolled clinically significant medical condition including life-threatening severe infection, or psychiatric illness, which could place the participants at unacceptable risk of study treatment.
3. Participants with active, uncontrolled leukemia involvement of the CNS
4. Participants with active graft-versus-host-disease (GVHD) status post stem cell transplant (patients without active GVHD on chronic suppressive immunosuppression and/or phototherapy for chronic skin GVHD are permitted after discussion with the PI).
5. Participants with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
6. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.
7. Participant has a white blood cell count \> 25 x 10\^9/L. (Note: Hydroxyurea and cytarabine is permitted to meet this criterion.)
8. Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception.
A) Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, IUD, and double barrier methods (for example a condom in combination with a spermicide).
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Courtney DiNardo, MD
**Phone:** (713) 794-1141
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Courtney DiNardo, MD
- **Phone:** 713-794-1141
- **Role:** CONTACT
***Contact 2:***
- **Name:** Courtney DiNardo, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** MD Anderson Cancer Center
**State:** Texas
**Zip:** 77030
#### Overall Officials
**Official 1:**
**Affiliation:** M.D. Anderson Cancer Center
**Name:** Courtney DiNardo, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### See Also Links
**Label:** MD Anderson Cancer Center
**URL:** http://www.mdanderson.org
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000004791
- Term: Enzyme Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M249656
- Name: Venetoclax
- Relevance: HIGH
- As Found: 15 minutes
- ID: M1697
- Name: Decitabine
- Relevance: HIGH
- As Found: Marrow
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000579720
- Term: Venetoclax
- ID: D000077209
- Term: Decitabine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445946
**Acronym:** DECIDE
**Brief Title:** DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
**Official Title:** DECIDE: A Comparative Effectiveness Trial of Oral Metformin Versus Injectable Insulin for the Treatment of Gestational Diabetes
#### Organization Study ID Info
**ID:** 2024H0193
#### Organization
**Class:** OTHER
**Full Name:** Ohio State University
### Status Module
#### Completion Date
**Date:** 2030-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2029-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-06-04
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Patient-Centered Outcomes Research Institute
**Class:** OTHER
**Name:** The George Washington University Biostatistics Center
#### Lead Sponsor
**Class:** OTHER
**Name:** Ohio State University
#### Responsible Party
**Investigator Affiliation:** Ohio State University
**Investigator Full Name:** Kartik K Venkatesh
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin.
This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.
**Detailed Description:** Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. Glycemic control decreases the risk of adverse pregnancy outcomes for the pregnant individual with GDM and the infant exposed in utero (1). One in four individuals with GDM will require pharmacotherapy to achieve glycemic control. Insulin has been the mainstay of pharmacotherapy. Metformin is an alternative option increasingly used in clinical practice (2). Both insulin and metformin reduce the risk of adverse pregnancy outcomes, but comparative effectiveness data from a well-characterized, adequately powered, and diverse U.S. population remain lacking (3). Because metformin crosses the placenta, long-term safety data, in particular the risk of childhood obesity, from exposed children are also needed. In addition, the patient-reported experiences of individuals with GDM requiring pharmacotherapy remains to be characterized, including barriers for and facilitators of metformin versus insulin use.
In a two-arm open-label, pragmatic comparative effectiveness randomized controlled trial (RCT), the DECIDE Study will examine whether metformin is not inferior to insulin in reducing adverse pregnancy outcomes and is comparably safe for exposed mothers and children, and whether patient-reported factors, including facilitators of and barriers to use, differ between metformin versus insulin use. The DECIDE Study Consortium will recruit and retain 1,572 pregnant individuals with GDM who need pharmacotherapy at 20 U.S. sites to metformin versus insulin and follow them and their children through delivery and then to 2-years
Primary aim:
To evaluate whether outcomes in pregnant individuals randomized to metformin are not inferior to those in pregnant individuals randomized to insulin for the composite adverse neonatal outcome defined as large-for-gestational-age birthweight (LGA), hypoglycemia, hyperbilirubinemia, or death.
Secondary aims:
1. To evaluate whether mean child body mass index (BMI) at 2 years of age is higher in the offspring of pregnant individuals randomized to metformin.
2. To conduct a qualitative or mixed-methods analyses on a subgroup of participants to understand facilitators and barriers associated with metformin versus insulin use and heterogeneity of treatment effects (HTE) to facilitate evidence-based pharmacotherapy.
3. To evaluate whether pregnant individuals randomized to metformin have equivalent maternal (hypertensive disorder of pregnancy, gestational weight gain, mode of delivery, and obstetric anal sphincter injuries) and neonatal (preterm birth, mechanical ventilation, NICU admission, oxygen support, and respiratory distress syndrome) outcomes.
4. To evaluate whether pregnant individuals randomized to metformin have equivalent maternal (obesity, anthropometry, adiposity, diabetes, hypertension, cholesterol, and metabolic profile) and child (obesity, anthropometry, and adiposity) outcomes at 2-years postpartum.
5. To evaluate whether pregnant individuals randomized to metformin have equivalent patient-reported outcomes (PROs), as measured at 6 weeks postpartum and at 2 years postpartum.
### Conditions Module
**Conditions:**
- Gestational Diabetes Mellitus
- Pregnancy, High Risk
**Keywords:**
- Insulin
- Pregnancy
- Glycemic control
- Metformin
- Gestational diabetes
- Diabetes
- Adverse pregnancy outcomes
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 1572
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Metformin as either immediate- or extended-release formulations can be utilized, and titrated to a maximum daily dose of 2,500 mg. Participants receiving metformin will have insulin added only if they have not achieved euglycemia for at least 30% of glucose values after generally receiving the maximum daily dose of metformin of 2,500 mg, or in select situations in the setting of participant intolerance due to mild gastrointestinal symptoms. Participants will be asked to continue taking metformin after treatment supplementation with insulin.
**Intervention Names:**
- Drug: Metformin
**Label:** Metformin
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Insulin will be initiated utilizing clinical standards using trimester-specific weight-based dosing criteria, including both basal and prandial insulins for up to a total of 4 daily injections. Consistent with clinical practice, some people may be managed with a single dose of intermediate- or long-acting insulin at night to treat isolated fasting hyperglycemia, while others may require additional treatment of postprandial hyperglycemia with shorter-acting insulin. The sites' insulin formularies include rapid- (Novolog and Humalog), intermediate- (Humulin N, Novolin N, and NPH), and long-acting insulins (Detemir and Lantus).
**Intervention Names:**
- Drug: Insulin
**Label:** Insulin
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Metformin
**Description:** Individuals randomized to this arm will receive oral metformin tablets for their Gestational diabetes mellitus treatment.
**Name:** Metformin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Insulin
**Description:** Individuals randomized to this arm will receive injectable insulin for their Gestational diabetes mellitus treatment.
**Name:** Insulin
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** LGA will be defined as a birthweight ≥90th%tile for gestational age based on a US birth certificate reference adjusted for parity and/or fetal sex. Neonatal hypoglycemia will be defined as a blood glucose \<35 mg/dL or treatment \<24 hours after birth with either IV, PO, or gel glucose therapy. Neonatal hyperbilirubinemia will be defined as treated with phototherapy or exchange transfusion in the first postnatal week and either treatment in the first postnatal week or kernicterus. Fetal or neonatal death can be due to any indication between randomization to hospital discharge or 30 days postnatal if still hospitalized (excluding voluntary pregnancy termination).
**Measure:** A neonatal composite adverse outcome of large-for-gestational-age (LGA) birthweight, hypoglycemia, hyperbilirubinemia, and/or death.
**Time Frame:** LGA at birth. Hypoglycemia <24 hours after birth. Hyperbilirubinemia within the first week after birth. Death between randomization to hospital discharge or 30 days postnatal.
**Description:** Child BMI measured in kg/m2 as a continuous measure standardized using U.S. CDC reference adjusted for child sex
**Measure:** Child body mass index (BMI) at 2 years of age
**Time Frame:** 2 years of age.
#### Secondary Outcomes
**Description:** HDP will include either gestational hypertension or preeclampsia. Gestational hypertension will be defined as: systolic blood pressure of 140 mm Hg or more or diastolic blood pressure of 90 mm Hg or more on two occasions at least 4 hours apart after 20 weeks of gestation in a woman with a previously normal blood pressure. Preeclampsia will be defined as: above blood pressure criteria AND proteinuria (300 mg or more per 24 hour urine collection, protein/creatinine ratio of 0.3 mg/dL or more, or dipstick reading of 2+) OR thrombocytopenia (platelet count less than 100 109/L), renal insufficiency (serum creatinine greater than 1.1 mg/dL or a doubling of the serum creatinine concentration in the absence of other renal disease), impaired liver function (elevated blood concentrations of liver transaminases to twice normal concentration), pulmonary edema, new-onset headache or visual symptoms not attributed to other diagnoses.
**Measure:** Hypertensive disorder of pregnancy, HDP (maternal)
**Time Frame:** Randomization to delivery
**Description:** Gestational weight gain between weight at first prenatal visit and weight at delivery based on z-score and defined as excess versus within Institute of Medicine (IOM) recommendations based on first pregnancy BMI.
**Measure:** Gestational weight gain (maternal)
**Time Frame:** Initiation of prenatal care to delivery
**Description:** Cesarean delivery or vaginal delivery
**Measure:** Mode of delivery (maternal)
**Time Frame:** At birth
**Description:** First degree: Injury to perineal skin only; Second degree: Injury to perineum involving perineal muscles but not involving anal sphincter; Third degree: Injury to perineum involving anal sphincter complex, including 3a: Less than 50% of external anal sphincter thickness torn; 3b: More than 50% external anal sphincter thickness torn; and 3c: Both external anal sphincter and internal anal sphincter torn; and Fourth degree: Injury to perineum involving anal sphincter complex (external anal sphincter and internal anal sphincter) and anal epithelium.
**Measure:** Obstetric perineal/anal sphincter injuries (maternal)
**Time Frame:** At birth
**Description:** Preterm birth \<37 weeks and \<34 weeks based on project gestational age
**Measure:** Preterm birth (child)
**Time Frame:** At birth
**Description:** Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation within first 72 hours of birth
**Measure:** Requiring mechanical ventilation (child)
**Time Frame:** <72 hours after birth
**Description:** Admitted to NICU or intermediate nursery ≥72 hours, any indication
**Measure:** NICU admission (child)
**Time Frame:** Birth to delivery discharge.
**Description:** Requiring oxygen support
**Measure:** Oxygen support (child)
**Time Frame:** <72 hours after birth
**Description:** Signs of respiratory distress with oxygen requirement and confirmed by chest x-ray.
**Measure:** Respiratory distress syndrome (child)
**Time Frame:** Anytime during the first 72 hours after birth
**Description:** Continuous measure, using standardized protocol as kg/m2.
**Measure:** Body mass index (BMI) (maternal)
**Time Frame:** 2-year follow-up
**Description:** BMI per the following classifications: Normal or underweight: \< 25 kg/m2; Overweight: 25 to \< 30 kg/m2; Class 1: 30 to \< 35 kg/m2; Class 2: 35 to \< 40 kg/m2; and Class 3: 40 kg/m2 or greater.
**Measure:** Obesity overall and by class (maternal)
**Time Frame:** 2-year follow-up
**Description:** Waist circumference, continuous measures in cm
**Measure:** Anthropometry (maternal)
**Time Frame:** 2-year follow-up
**Description:** Hip circumference, continuous measures in cm
**Measure:** Anthropometry (maternal)
**Time Frame:** 2-year follow-up
**Description:** Waist - to - hip ratio, continuous measure
**Measure:** Anthropometry (maternal)
**Time Frame:** 2-year follow-up
**Description:** Triceps, subscapular, suprailiac skinfolds, continuous measures in cm
**Measure:** Adiposity (maternal)
**Time Frame:** 2 year follow-up
**Description:** A1c \> 6.5% OR fasting plasma glucose \> 126 mg/dL OR OGTT \> 200 mg/dL OR prior diagnosis per patient report
**Measure:** Type 2 diabetes (maternal)
**Time Frame:** 2-year follow-up.
**Description:** A1c 5.7% to 6.4% OR fasting plasma glucose 100 mg/dl to 125 mg/dL OR OGTT 140 to 199 mg/dL
**Measure:** Prediabetes (maternal)
**Time Frame:** 2-year follow-up.
**Description:** Per American Heart Association criteria as below and/or antihypertensive medication or prior diagnosis per patient report, and defined as: Elevated: Systolic between 120-129 and diastolic less than 80 mm Hg; Stage 1: Systolic between 130-139 or diastolic between 80-89 mm Hg; and Stage 2: Systolic at least 140 or diastolic at least 90 mm Hg.
**Measure:** Hypertension (maternal)
**Time Frame:** 2-year follow-up.
**Description:** Fasting state, defined as a continuous measure and dichotomous at the following thresholds for each component: Total cholesterol: \> 200 mg/dL; LDL cholesterol: \> mg/dL; HDL cholesterol: \< 40 mg/dL; Triglycerides: \> 200 mg/dL.
**Measure:** Cholesterol (maternal)
**Time Frame:** 2-year follow-up.
**Description:** Continuous measure, percentage.
**Measure:** Hemoglobin A1c (maternal)
**Time Frame:** 2-year follow-up.
**Description:** BMI ≥85th%tile for age and sex.
**Measure:** Overweight (child)
**Time Frame:** 2-year follow-up.
**Description:** BMI ≥95th%tile for age and sex.
**Measure:** Obesity (child)
**Time Frame:** 2-year follow-up.
**Description:** Abdominal circumference; age- and sex-adjusted per WHO z-scores for arm circumference.
**Measure:** Anthropometry (child)
**Time Frame:** 2-year follow-up.
**Description:** Triceps/subscapular skinfold thickness \> 90th%tile for age and sex; individual and sum of measures.
**Measure:** Adiposity (child)
**Time Frame:** 2-year follow-up.
**Description:** The TSQM (version 1.4) comprises 14 items across four domains focusing on effectiveness (three items), side effects (five items), convenience (three items), and global satisfaction (three items) of the medication over the previous 2-3 weeks. With the exception of item 4 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied). Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Item 4 was not included for scoring.
**Measure:** Treatment Satisfaction Questionnaire for Medication (TSQM)
**Time Frame:** 6-weeks postpartum.
**Description:** A set of 5 questions developed in the Rowan et al. RCT assessing patient adherence, preferences, and experiences with metformin versus insulin for GDM (Rowan et al., NEJM, 2008).
**Measure:** Questionnaire on Acceptability of Treatment
**Time Frame:** 6-weeks postpartum.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Singleton gestation. Twin reduction to singleton, either spontaneously or therapeutically, is eligible if it occurred before 14 weeks gestational age.
* Age 18 years or older
* Gestational age at randomization between 20 0/7 - 31 6/7 weeks based on project gestational age.
* GDM diagnosis between 20 0/7 - 31 6/7 weeks based on project gestational age.
* Requires medication for glucose control defined as ≥ 30% elevated glucose values (either fasting or postprandial or both) in the week prior to randomization per determination of the provider or documented in the medical record.
* Patient willingness and ability to attend 2-year follow-up visit.
Exclusion criteria:
* Renal disease (serum creatinine \>1.3 mg/dL) due to the potential impact of metformin on renal function.
* Major structural malformation of the fetus.
* Known fetal aneuploidy based on invasive testing or positive for aneuploidy on cell-free fetal DNA screening.
* Contraindication to metformin or insulin, including: history of lactic acidosis, intractable nausea and vomiting, prior documented allergy and/or anaphylaxis.
* Pregestational diabetes documented in the medical record, GDM diagnosis \<20 weeks, or prior A1c\>6.5%
* Fasting hyperglycemia \>115 mg/dl for ≥ 50% of fasting glucose values in the past week (due to the high risk of metformin failure with fasting hyperglycemia).
* Enrolled in a trial that influences primary study outcomes (composite neonatal outcome at delivery or childhood body mass index at 2 years).
* Prenatal care or delivery planned at a location where access to the complete electronic medical record will not be available to research staff.
* Language barrier (appropriate translation resources unavailable at the site)
* Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.
**Gender Based:** True
**Gender Description:** This study is restricted to pregnant individuals.
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kartik Venkatesh, MD, PhD
**Phone:** 614-293-2222
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Anna Bartholomew, MPH, BS, RN
**Phone:** 614-685-3229
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Tuscaloosa
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ashley Battarbee, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Michael Jordan
- **Role:** CONTACT
***Contact 3:***
- **Name:** Ashley Battarbee, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Alabama
**State:** Alabama
**Zip:** 35487
**Location 2:**
**City:** Los Angeles
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Tania Esakoff, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Marla Sharp
- **Role:** CONTACT
***Contact 3:***
- **Name:** Tania Esakoff, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Cedars Sinai Medical Center
**State:** California
**Zip:** 90048
**Location 3:**
**City:** San Francisco
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Nasim Sobhani, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Magie Fong
- **Role:** CONTACT
***Contact 3:***
- **Name:** Nasim Sobhani, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of California San Francisco
**State:** California
**Zip:** 94143
**Location 4:**
**City:** Newark
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Matthew Hoffman, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Carrie Kitto
- **Role:** CONTACT
***Contact 3:***
- **Name:** Matthew Hoffman, MD
- **Role:** SUB_INVESTIGATOR
***Contact 4:***
- **Name:** Anthony Sciscione, MD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Christiana Care
**State:** Delaware
**Zip:** 19718
**Location 5:**
**City:** Tampa
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Anjali Kaimal Kaimal, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Maha Jumaily
- **Role:** CONTACT
***Contact 3:***
- **Name:** Anjali Kaimal, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of South Florida
**State:** Florida
**Zip:** 33620
**Location 6:**
**City:** Boston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Erika Werner, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Beth Marsh
- **Role:** CONTACT
***Contact 3:***
- **Name:** Erika Werner, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Patrick Catalano, MD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Tufts University
**State:** Massachusetts
**Zip:** 02111
**Location 7:**
**City:** Boston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lydia Shook, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Nancy Kingori
- **Role:** CONTACT
***Contact 3:***
- **Name:** Lydia Shook, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Camille Powe, MD
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Lauren Fiechtner, MD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Massachusetts General Hospital
**State:** Massachusetts
**Zip:** 02114
**Location 8:**
**City:** Boston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Chloe Zera, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Andy Ngyuen
- **Role:** CONTACT
***Contact 3:***
- **Name:** Chloe Zera, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Beth Israel Deaconess Medical Center
**State:** Massachusetts
**Zip:** 02215
**Location 9:**
**City:** Albuquerque
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Vivek Katukuri, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Karen Taylor
- **Role:** CONTACT
***Contact 3:***
- **Name:** Vivek Katukuri, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of New Mexico
**State:** New Mexico
**Zip:** 87131
**Location 10:**
**City:** New York
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Natalia Zork, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Joseph Celentano
- **Role:** CONTACT
***Contact 3:***
- **Name:** Natalia Zork, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Columbia University Irving Medical Center
**State:** New York
**Zip:** 10032
**Location 11:**
**City:** Chapel Hill
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kim Boggess, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Amber Ivins
- **Role:** CONTACT
***Contact 3:***
- **Name:** Kim Boggess, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of North Carolina Chapel Hill
**State:** North Carolina
**Zip:** 27514
**Location 12:**
**City:** Winston-Salem
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** David Stamilio, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Christina Tulbert
- **Role:** CONTACT
***Contact 3:***
- **Name:** David Stamilio, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Wake Forest University
**State:** North Carolina
**Zip:** 27106
**Location 13:**
**City:** Columbus
**Country:** United States
**Facility:** The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
**State:** Ohio
**Zip:** 43210
**Location 14:**
**City:** Dayton
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Samantha Wiegand, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Emily Reynolds
- **Role:** CONTACT
***Contact 3:***
- **Name:** Samantha Wiegand, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Premier Health - Miami Valley Hospital
**State:** Ohio
**Zip:** 45409
**Location 15:**
**City:** Pittsburgh
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Maisa Feghali, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** John Collins
- **Role:** CONTACT
***Contact 3:***
- **Name:** Maisa Feghali, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Pittsburgh
**State:** Pennsylvania
**Zip:** 15213
**Location 16:**
**City:** Providence
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Martha Kole-White, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Kelsey Inglesby
- **Role:** CONTACT
***Contact 3:***
- **Name:** Martha Kole-White, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Brown University
**State:** Rhode Island
**Zip:** 02912
**Location 17:**
**City:** Greenville
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kacey Eichelberger, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Patti Parker
- **Role:** CONTACT
***Contact 3:***
- **Name:** Kacey Eichelberger, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of South Carolina Greenville
**State:** South Carolina
**Zip:** 29605
**Location 18:**
**City:** Austin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Lorie Harper, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Mickey Roberts
- **Role:** CONTACT
***Contact 3:***
- **Name:** Lorie Harper, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Texas Austin
**State:** Texas
**Zip:** 78705
**Location 19:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hector Mendez-Figueroa, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Laura Nixon
- **Role:** CONTACT
***Contact 3:***
- **Name:** Hector Mendez-Figueroa, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** University of Texas Health Science Center
**State:** Texas
**Zip:** 77030
**Location 20:**
**City:** Norfolk
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Malgorzata Mlynarczyk, MD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Cheryl Sparrer
- **Role:** CONTACT
***Contact 3:***
- **Name:** Malgorzata Mlynarczyk, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** George Saade, MD
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Eastern Virginia Medical School
**State:** Virginia
**Zip:** 23501
#### Overall Officials
**Official 1:**
**Affiliation:** Ohio State University
**Name:** Kartik Venkatesh, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Users interested in obtaining these data must complete a Restricted Data Use Agreement, specify the reason for the request, and obtain IRB approval or notice of exemption for their research.
**Description:** PCORI guidelines for data sharing will be followed, including the release of the Analyzable Data Set. This is the final cleaned and locked data set that contains all the data used in conducting the analyses reported in the PCORI Final Research Report and is de-identified in accordance with the HIPAA Privacy Rule.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Data will be available on website in March 2030.
**URL:** https://www.icpsr.umich.edu/web/pages/pcodr/
### References Module
#### References
**Citation:** Venkatesh KK, Chiang CW, Castillo WC, Battarbee AN, Donneyong M, Harper LM, Costantine M, Saade G, Werner EF, Boggess KA, Landon MB. Changing patterns in medication prescription for gestational diabetes during a time of guideline change in the USA: a cross-sectional study. BJOG. 2022 Feb;129(3):473-483. doi: 10.1111/1471-0528.16960. Epub 2021 Nov 8.
**PMID:** 34605130
**Citation:** Venkatesh KK, Wu J, Trinh A, Cross S, Rice D, Powe CE, Brindle S, Andreatta S, Bartholomew A, MacPherson C, Costantine MM, Saade G, McAlearney AS, Grobman WA, Landon MB. Patient Priorities, Decisional Comfort, and Satisfaction with Metformin versus Insulin for the Treatment of Gestational Diabetes Mellitus. Am J Perinatol. 2023 Dec 4. doi: 10.1055/s-0043-1777334. Online ahead of print.
**PMID:** 38049101
**Citation:** Venkatesh KK, Lynch CD, Powe CE, Costantine MM, Thung SF, Gabbe SG, Grobman WA, Landon MB. Risk of Adverse Pregnancy Outcomes Among Pregnant Individuals With Gestational Diabetes by Race and Ethnicity in the United States, 2014-2020. JAMA. 2022 Apr 12;327(14):1356-1367. doi: 10.1001/jama.2022.3189.
**PMID:** 35412565
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M19012
- Name: Diabetes, Gestational
- Relevance: HIGH
- As Found: Gestational Diabetes
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000016640
- Term: Diabetes, Gestational
- ID: D000003920
- Term: Diabetes Mellitus
### Intervention Browse Module - Ancestors
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M11667
- Name: Metformin
- Relevance: HIGH
- As Found: Assessment
- ID: M10365
- Name: Insulin
- Relevance: LOW
- As Found: Unknown
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M29802
- Name: Insulin Lispro
- Relevance: LOW
- As Found: Unknown
- ID: M349
- Name: Insulin Detemir
- Relevance: LOW
- As Found: Unknown
- ID: M29801
- Name: Insulin Aspart
- Relevance: LOW
- As Found: Unknown
- ID: M347
- Name: Insulin Glargine
- Relevance: LOW
- As Found: Unknown
- ID: M327
- Name: Isophane Insulin, Human
- Relevance: LOW
- As Found: Unknown
- ID: M10373
- Name: Insulin, Isophane
- Relevance: LOW
- As Found: Unknown
- ID: M173174
- Name: Isophane insulin, beef
- Relevance: LOW
- As Found: Unknown
- ID: M26073
- Name: Insulin, Long-Acting
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000008687
- Term: Metformin
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445933
**Brief Title:** Vitamin B6 and Depression in Pregnant and Peri-partum Women
**Official Title:** The Correlation Between Vitamin B6 and Avoiding Depression in Pregnant and Peri-partum Women
#### Organization Study ID Info
**ID:** 202309090RIPA
#### Organization
**Class:** OTHER
**Full Name:** National Taiwan University Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-27
**Study First Submit QC Date:** 2024-06-03
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** National Taiwan University Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Perinatal depression is a highly prevalent and serious health issue during pregnancy. According to statistics, approximately one out of every ten postpartum women experiences this condition. Symptoms can manifest as mood fluctuations or emotional lows. Unfortunately, these symptoms are often overlooked by patients themselves or misinterpreted by others as normal adjustments to the new role of motherhood. Consequently, timely assistance and support are frequently lacking.
To address this, the investigators urgently need effective preventive measures for perinatal depression before it escalates. Recent research suggests that simple oral supplementation of vitamin B6 may help prevent and alleviate perinatal depression to some extent. Vitamin B6 plays several crucial roles in the body, including regulating neurotransmission and mental health. Therefore, it could contribute to maintaining emotional stability and psychological balance.
In contemporary times, numerous screening methods for perinatal depression involve questionnaires. However, these methods presuppose an awareness of the possibility of perinatal depression. Individuals who are unaware of these questionnaires may go undetected. Hence, our aim is to investigate whether cardiac electrophysiology results obtained through a wearable device could offer a more objective evaluation of the status of perinatal depression.
Our plan involves conducting a prospective study to delve deeper into the preventive and therapeutic effects of vitamin B6 on perinatal depression in pregnant women. Through systematic experiments and data analysis, the investigators aim to explore the impact of vitamin B6 dosage, duration, and timing of administration. Ultimately, the investigators hope to provide evidence-based recommendations and guidance for clinical practice. The investigators' goal is to offer new insights and methods to protect the mental health of expectant mothers, ensuring a pleasant and healthy pregnancy journey for each one.
**Detailed Description:** The total expected number of participants is 120, with 60 in the experimental group and 60 in the control group. Participants in the experimental group will take Vitamin B6, while those in the control group will take a placebo that looks similar. To ensure the credibility of the study and reduce bias, the investigators will adopt a randomized double-blind design. The target population is pregnant women aged 20-50 years, in their 28th-30th week of pregnancy. Vitamin B6 is an FDA-approved Class A drug in the United States, with no evidence of any side effects on the fetus. A baseline blood sample to measure Vitamin B6 concentration will be taken during the 28th-30th week of pregnancy, and another sample will be taken upon admission for delivery for follow-up. To avoid blood glucose affecting Vitamin B6 levels, both blood samples will be taken after an 8-hour fast. The experimental group will take three 25mg Vitamin B6 tablets daily (75mg/day) from the 28th-30th week until the end of pregnancy, and two 25mg Vitamin B6 tablets daily (50mg/day) for one month after delivery. The control group will take three placebo tablets daily from the 28th week until the end of pregnancy, and two placebo tablets daily for one month after delivery. The placebo tablets contain starch and resemble the shape of the Vitamin B6 tablets. During each prenatal visit from the 28th week until the end of pregnancy, doctors will remind participants to take their medication. An electronic system at NTU Hospital will also remind participants weekly to take their medication. Postpartum, study staff will remind participants every two weeks by phone to continue taking Vitamin B6 or placebo. Participants will complete a postpartum depression questionnaire at the 6-week follow-up visit. The results of the postpartum depression questionnaire will be analyzed in relation to Vitamin B6 intake. The investigators currently plan to use linear and logistic regression analysis to examine the association between depression scores and Vitamin B6 concentration. Other possible statistical methods include: Chi-square, independent t-test, Mann-Whitney U test, and Fisher's exact test. A p-value below 5% will be considered statistically significant. Data will be analyzed using SPSS 20.
### Conditions Module
**Conditions:**
- Postpartum Depression
- Heart Rate Variability
**Keywords:**
- Vitamins
- Wearable devices
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** After recruitment during 24-28 weeks of gestation, women would be given Vitamin B6 tablets (25mg/tablet, 75mg/day) until delivery. After delivery of the baby, the participants would be asked to take tablets(25mg/tablet, 50mg/day) up to six weeks postpartum.
**Intervention Names:**
- Combination Product: Vitamin B6
**Label:** Experimental arm
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** After recruitment during 24-28 weeks of gestation, women would be given three placebo tablets per day until delivery. After delivery of the baby, the participants would be asked to take two placebo tablets per day up to six weeks postpartum.
**Intervention Names:**
- Combination Product: Placebo
**Label:** Placebo arm
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental arm
**Description:** The intervention is taking Vitamin B6 orally from recruitment around 24-28 gestational weeks to 6 weeks post-partum. 75mg/ day before delivery and 50mg/ day after delivery.
**Name:** Vitamin B6
**Type:** COMBINATION_PRODUCT
#### Intervention 2
**Arm Group Labels:**
- Placebo arm
**Description:** Placebo
**Name:** Placebo
**Type:** COMBINATION_PRODUCT
### Outcomes Module
#### Primary Outcomes
**Description:** We would like to see if women taken Vitamin B6 would have lowered incidence of having General Anxiety Disorder score≥3 or Edinburgh Postnatal Depression Scale≥10.
**Measure:** Number of people with General Anxiety Disorder score≥3 and Edinburgh Postnatal Depression Scale≥10
**Time Frame:** 22 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Pregnant women at 24-28 weeks of gestation
* Without a personal history of depression, bipolar disorder, schizophrenia, or other mental health conditions.
Exclusion Criteria:
* Allergic to Vitamin B6
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 20 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** HanYing Chen
**Phone:** 886-930078287
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Attending physician
**Name:** HanYing Chen
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Khodadad M, Bahadoran P, Kheirabadi GR, Sabzghabaee AM. Can Vitamin B6 Help to Prevent Postpartum Depression? A Randomized Controlled Trial. Int J Prev Med. 2021 Oct 19;12:136. doi: 10.4103/ijpvm.IJPVM_240_19. eCollection 2021.
**PMID:** 34912512
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000019964
- Term: Mood Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000011644
- Term: Puerperal Disorders
- ID: D000011248
- Term: Pregnancy Complications
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: HIGH
- As Found: Depression
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M21076
- Name: Depression, Postpartum
- Relevance: HIGH
- As Found: Postpartum Depression
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M21835
- Name: Mood Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14499
- Name: Puerperal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019052
- Term: Depression, Postpartum
- ID: D000003863
- Term: Depression
- ID: D000003866
- Term: Depressive Disorder
### Intervention Browse Module - Ancestors
- ID: D000014815
- Term: Vitamins
- ID: D000018977
- Term: Micronutrients
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000014803
- Term: Vitamin B Complex
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: Vi
- Name: Vitamins
### Intervention Browse Module - Browse Leaves
- ID: M17558
- Name: Vitamins
- Relevance: LOW
- As Found: Unknown
- ID: M17546
- Name: Vitamin B Complex
- Relevance: LOW
- As Found: Unknown
- ID: M23026
- Name: Vitamin B 6
- Relevance: HIGH
- As Found: TAS-
- ID: M14583
- Name: Pyridoxal
- Relevance: HIGH
- As Found: TAS-
- ID: M14589
- Name: Pyridoxine
- Relevance: HIGH
- As Found: TAS-
- ID: M21009
- Name: Micronutrients
- Relevance: LOW
- As Found: Unknown
- ID: M16885
- Name: Trace Elements
- Relevance: LOW
- As Found: Unknown
- ID: M8618
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T474
- Name: Vitamin B6
- Relevance: HIGH
- As Found: TAS-
- ID: T459
- Name: Pyridoxal
- Relevance: HIGH
- As Found: TAS-
- ID: T461
- Name: Pyridoxine
- Relevance: HIGH
- As Found: TAS-
- ID: T446
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T448
- Name: Folate
- Relevance: LOW
- As Found: Unknown
- ID: T475
- Name: Vitamin B9
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000025101
- Term: Vitamin B 6
- ID: D000011730
- Term: Pyridoxal
- ID: D000011736
- Term: Pyridoxine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445920
**Brief Title:** Risk Factors Analysis for Clinical Important Postoperative Nausea and Vomiting
**Official Title:** Risk Factors Analysis for Clinical Important Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastrointestinal Surgery Based on LASSO and Stepwise Regression
#### Organization Study ID Info
**ID:** 2024ZSLYEC-201
#### Organization
**Class:** OTHER
**Full Name:** Sixth Affiliated Hospital, Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2024-06-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-02
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-02
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sixth Affiliated Hospital, Sun Yat-sen University
#### Responsible Party
**Investigator Affiliation:** Sixth Affiliated Hospital, Sun Yat-sen University
**Investigator Full Name:** Zhi-Nan Zheng
**Investigator Title:** Attending doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Postoperative nausea and vomiting (PONV) is a distressing and common complication after surgery. The concept of clinical important PONV (CI-PONV) assesses the impact of PONV on patient-reported outcomes. This research aims to conduct an analysis of the risk factors contributing to CI-PONV utilizing the least absolute shrinkage and selection operator (LASSO) and stepwise regression techniques. All 1154 patients participating in the FDP-PONV trial are included in this study and categorized into two groups: the CI-PONV group and the non-CI-PONV group. CI-PONV is defined as the occurrence of PONV with a simplified PONV impact scale score of 5 or higher within 24 hours after surgery. The LASSO method is employed to identify the most relevant variables from an initial set of 56 related variables and stepwise regression is used to further refine the selection of the ultimate predictors.
**Detailed Description:** Drawing from prior studies, we conducted a sample size calculation for a predictive model using the website https://mvansmeden.shinyapps.io/BeyondEPV/. By setting the number of candidate predictors to 9, the events fraction to 0.14, and the criterion value for rMPSE to 0.04, we determined that a minimum total sample size of 900 is required, with a minimally expected event per variable of 13.9. All patients were classified into either the CI-PONV group or the non-CI-PONV group. All 56 perioperative clinical features, encompassing baseline characteristics, preoperative conditions, and intraoperative information, were considered as potential predictive factors. In the quest to uncover potential predictive factors associated with CI-PONV, we employed the least absolute shrinkage and selection operator (LASSO) to sift through clinically significant variables. Subsequently, we utilized stepwise regression based on the Akaike Information Criterion (AIC) to further refine the selection of the ultimate predictors.
### Conditions Module
**Conditions:**
- Postoperative Nausea and Vomiting
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 1154
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** No Intervention
**Name:** No Intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The occurrence of PONV with the simplified PONV impact scale score of 5 or more. PONV is defined as PONV as the experience of nausea, retching, or vomiting during the first 24 hours following surgery.
**Measure:** Clinically important postoperative nausea and vomiting (CI-PONV)
**Time Frame:** The first 24 hours after surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
a) age between 18 and 75 years, b) having 3 or 4 Apfel risk factors, and c) scheduled to undergo laparoscopic gastrointestinal surgical procedures under general anesthesia.
Exclusion Criteria:
a) American Society of Anesthesiologists (ASA) physical status greater than 3, b) severe hepatic dysfunction, c) contraindications to fosaprepitant, 5-HT3 receptor antagonist, or dexamethasone, d) preoperative use of medications known to have antiemetic properties, e) presence of mental disorders or inability to communicate, and f) pregnant or nursing women.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** All 1154 patients in the FDP-PONV trial will be enrolled in this study. The FDP-PONV trial was a randomized, controlled, double-blind trial that aimed to evaluate the effectiveness and safety of fosaprepitant in managing PONV in patients undergoing laparoscopic gastrointestinal surgery. The FDP-PONV trial was approved by the Ethics Committee of the Sixth Affiliated Hospital of Sun Yat-sen University (2021ZSLYEC-78), and registered at Clinicaltrials.gov (NCT04853147).
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Zhinan Zheng, MD
**Phone:** 0086-15915734893
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zhinan Zheng, MD
- **Phone:** 0086-15915734893
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Yang Zhao, MD
- **Phone:** 0086-13802435520
- **Role:** CONTACT
**Country:** China
**Facility:** Department of Anesthesia, The Sixth Affiliated Hospital, Sun Yat-sen University
**State:** Guangdong
**Status:** RECRUITING
**Zip:** 510655
#### Overall Officials
**Official 1:**
**Affiliation:** The Sixth Affiliated Hospital, Sun Yat-sen University
**Name:** Zhinan Zheng
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833. Erratum In: Anesth Analg. 2020 Nov;131(5):e241.
**PMID:** 32467512
**Citation:** Eberhart LH, Mauch M, Morin AM, Wulf H, Geldner G. Impact of a multimodal anti-emetic prophylaxis on patient satisfaction in high-risk patients for postoperative nausea and vomiting. Anaesthesia. 2002 Oct;57(10):1022-7. doi: 10.1046/j.1365-2044.2002.02822.x.
**PMID:** 12358962
**Citation:** Myles PS, Williams DL, Hendrata M, Anderson H, Weeks AM. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10,811 patients. Br J Anaesth. 2000 Jan;84(1):6-10. doi: 10.1093/oxfordjournals.bja.a013383.
**PMID:** 10740539
**Citation:** Shaikh SI, Nagarekha D, Hegade G, Marutheesh M. Postoperative nausea and vomiting: A simple yet complex problem. Anesth Essays Res. 2016 Sep-Dec;10(3):388-396. doi: 10.4103/0259-1162.179310.
**PMID:** 27746521
**Citation:** Habib AS, Chen YT, Taguchi A, Hu XH, Gan TJ. Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: a retrospective database analysis. Curr Med Res Opin. 2006 Jun;22(6):1093-9. doi: 10.1185/030079906X104830.
**PMID:** 16846542
**Citation:** Parra-Sanchez I, Abdallah R, You J, Fu AZ, Grady M, Cummings K 3rd, Apfel C, Sessler DI. A time-motion economic analysis of postoperative nausea and vomiting in ambulatory surgery. Can J Anaesth. 2012 Apr;59(4):366-75. doi: 10.1007/s12630-011-9660-x. Epub 2012 Jan 6.
**PMID:** 22223185
**Citation:** Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
**PMID:** 10485781
**Citation:** Zhou CM, Wang Y, Xue Q, Yang JJ, Zhu Y. Predicting early postoperative PONV using multiple machine-learning- and deep-learning-algorithms. BMC Med Res Methodol. 2023 May 31;23(1):133. doi: 10.1186/s12874-023-01955-z.
**PMID:** 37259031
**Citation:** Kim JH, Cheon BR, Kim MG, Hwang SM, Lim SY, Lee JJ, Kwon YS. Postoperative Nausea and Vomiting Prediction: Machine Learning Insights from a Comprehensive Analysis of Perioperative Data. Bioengineering (Basel). 2023 Oct 1;10(10):1152. doi: 10.3390/bioengineering10101152.
**PMID:** 37892882
**Citation:** Edgman-Levitan S, Schoenbaum SC. Patient-centered care: achieving higher quality by designing care through the patient's eyes. Isr J Health Policy Res. 2021 Mar 5;10(1):21. doi: 10.1186/s13584-021-00459-9.
**PMID:** 33673875
**Citation:** Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.
**PMID:** 22290456
**Citation:** Hubbard RA, Su YR, Bowles EJ, Ichikawa L, Kerlikowske K, Lowry KP, Miglioretti DL, Tosteson ANA, Wernli KJ, Lee JM. Predicting five-year interval second breast cancer risk in women with prior breast cancer. J Natl Cancer Inst. 2024 Mar 11:djae063. doi: 10.1093/jnci/djae063. Online ahead of print.
**PMID:** 38466940
**Citation:** Liu J, Yu Y, Qi W, Ma X, Han Y. Innovation and entrepreneurship of Chinese returning migrant workers in their home region. Heliyon. 2024 Apr 26;10(9):e30296. doi: 10.1016/j.heliyon.2024.e30296. eCollection 2024 May 15.
**PMID:** 38694132
**Citation:** Portet S. A primer on model selection using the Akaike Information Criterion. Infect Dis Model. 2020 Jan 7;5:111-128. doi: 10.1016/j.idm.2019.12.010. eCollection 2020.
**PMID:** 31956740
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012817
- Term: Signs and Symptoms, Digestive
- ID: D000011183
- Term: Postoperative Complications
- 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: M17582
- Name: Vomiting
- Relevance: HIGH
- As Found: Vomiting
- ID: M22074
- Name: Postoperative Nausea and Vomiting
- Relevance: HIGH
- As Found: Postoperative Nausea and Vomiting
- ID: M12273
- Name: Nausea
- Relevance: HIGH
- As Found: Nausea
- ID: M15622
- Name: Signs and Symptoms, Digestive
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009325
- Term: Nausea
- ID: D000014839
- Term: Vomiting
- ID: D000020250
- Term: Postoperative Nausea and Vomiting
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445907
**Brief Title:** Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia
**Official Title:** Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia
#### Organization Study ID Info
**ID:** 2024-0178
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**Domain:** NCI-CTRP Clinical Registry
**ID:** NCI-2024-04788
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-07-01
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-11-29
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Qurient Co., Ltd.
#### Lead Sponsor
**Class:** OTHER
**Name:** M.D. Anderson Cancer Center
#### 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:** To learn about the safety and tolerability of the drug combination of Q702, azacitidine, and venetoclax when given to participants with relapsed/refractory AML.
**Detailed Description:** Primary Objective:
- To evaluate safety of single agent Q702 and the combination of azacitidine, venetoclax and Q702.
Secondary Objectives:
* To estimate rate of CR/CRh/CRi by 4 treatment cycles
* To estimate overall response rate (ORR)
* To estimate rate of MRD negative by 4 treatment cycles
* To estimate overall survival (OS)
* To estimate relapse-free survival (RFS)
Exploratory Objectives:
* To determine the plasma concentration and pharmacokinetic (PK) parameters of Q702 when dosed in combination with azole antifungals in AML patients
* To estimate duration of response (DOR)
* To estimate median time to blood count recovery
* To estimate median time to first response
* To estimate median time to negative MRD
* To study drug-drug interactions with CYP3A4 inhibitor azole antifungals
* Additional response and survival endpoints
* To explore biomarkers of response, pathway engagement, and resistance
### Conditions Module
**Conditions:**
- Acute Myeloid Leukemia
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** SINGLE_GROUP
##### 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 enrolled in Part 1, the dose of Q702 a participant receives will depend on when the participant joins this study. Up to 2 dose levels of Q702 will be tested.
All participants will receive the same dose level of azacitidine. Participants dose of venetoclax will be based on other medications the participant may be receiving, such as CYP3A inhibitors.
**Intervention Names:**
- Drug: Azacitidine
- Drug: Venetoclax
- Drug: Q702
**Label:** Part 1 (Dose Escalation)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants enrolled in Part 2, will receive Q702 at the recommended dose that was found in Part 1.
All participants will receive the same dose level of azacitidine. Participants dose of venetoclax will be based on other medications participant may be receiving, such as CYP3A inhibitors.
**Intervention Names:**
- Drug: Azacitidine
- Drug: Venetoclax
- Drug: Q702
**Label:** Part 2 (Dose Expansion)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Part 1 (Dose Escalation)
- Part 2 (Dose Expansion)
**Description:** Given by IV
**Name:** Azacitidine
**Other Names:**
- 5-azacytidine
- 5-aza
- Vidaza™
- 5-AZC
- AZA-CR
- Ladakamycin
- NSC-102816
- Azacytidine
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Part 1 (Dose Escalation)
- Part 2 (Dose Expansion)
**Description:** Given by PO
**Name:** Venetoclax
**Other Names:**
- ABT-199
- GDC-0199
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Part 1 (Dose Escalation)
- Part 2 (Dose Expansion)
**Description:** Given by PO
**Name:** Q702
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
**Measure:** Safety and adverse events (AEs)
**Time Frame:** Through study completion; an average of 1 year.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Participants need to have a confirmed diagnosis of AML, or MDS/AML with 10% to 19% blasts, per the International Consensus Classification 2022 or the WHO 2022 classification.23,24
2. Participants ≥18 years with R/R AML or R/R MDS/AML, other than acute promyelocytic leukemia (APL), with no available standard treatment options.
3. Relapsed or refractory disease defined by standard criteria as follows:
a. Relapsed: Bone marrow blasts ≥5%, reappearance of blasts in the blood, or development of extramedullary disease following achievement of CR/CRi/MLFS b. Refractory: Failure to achieve CR/CRi/MLFS following initial treatment, with evidence of persistent leukemia by blood and/or bone marrow evaluation with blasts ≥5% c. Appropriate prior therapy in order for patient to be deemed relapsed or refractory include any of the following: i. At least 1 cycle of purine analogue containing intensive induction chemotherapy regimen, e.g., FLAG-Ida, CLIA or CLAG-M or similar regimens with or without venetoclax.25,26 ii. At least 1 cycle of intensive induction chemotherapy with venetoclax, e.g., 7
+ 3 or CPX-351 with venetoclax or similar regimens iii. At least 2 cycles of intensive induction chemotherapy such as 7 + 3 or 5 + 2 or similar regimens without venetoclax iv. 2 cycles of venetoclax with HMA/LDAC +/- other agents
* 4 cycles of HMA alone
* Younger/fit patients (\<60 years) in first relapse following intensive chemotherapy, will only be eligible if the first remission (CR1) duration was ≤12 months. d. Patients relapsing with persistent or new TP53 mutation will be eligible irrespective of CR1 duration. e. Older/unfit patients who relapse on HMA + venetoclax based maintenance regimen will be eligible irrespective of CR1 duration.
4. ECOG PS 0 to 1
5. Participants relapsing after allo-SCT may be eligible if they have recovered from all transplant-related toxicities and are off all immunosuppression, with no more than grade 1 chronic GVHD.
Physiologic ("replacement") dose of steroids (≤10 mg prednisone or equivalent) may be acceptable. Patients must be off all immunosuppression, including calcineurin inhibitors, for at least 2 weeks or 5 half-lives, whichever is longer, prior to enrollment on study.
6. Participants with actionable mutations with available FDA-approved therapies, e.g., FLT3, IDH1/2 inhibitors may be enrolled after they have exhausted appropriate lines of FDA approved treatment options.
7. Participants with antecedent hematological disorder (AHD), e.g., aplastic anemia, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) or myeloproliferative disorder or neoplasm (MPD or MPN) who have previously received a regimen appropriate for AML for the antecedent hematological disorder, as described above, and have progressed to AML, will be eligible for the dose escalation and salvage dose expansion cohorts. This is due to recognized poor outcomes in such patients with "treated secondary AML".27,28
8. Adequate hepatic function (total bilirubin ≤ 1.5 x upper limit of normal (ULN) unless increase is due to Gilbert's disease, and AST and/or ALT ≤ 2 x ULN).
9. Adequate renal function with creatinine clearance ≥ 45 mL/min calculated by the Cockcroft-Gault formula or MDRD equation or measured by 24-hour urine collection.
10. The effects of these agents on the developing human fetus are unknown. For this reason, and because other therapeutic agents used in this trial may be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 90 days after last treatment.
a. This includes all female patients between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: i. Postmenopausal (no menses in greater than or equal to 12 consecutive months). ii. History of hysterectomy or bilateral salpingo-oophorectomy. iii. Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range, who have received whole pelvic radiation therapy). iv. History of bilateral tubal ligation or another surgical sterilization procedure.
b. Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), tubal ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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. c. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of treatment.
11. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
1. Participants with t(15;17) karyotypic abnormality.
2. Participant has a white blood cell count \> 15 x 10⁹/L. Hydroxyurea, and/or cytarabine (up to 2 g/m2 total) used as supportive care is permitted to meet this criterion prior to enrollment.
3. Prior use of any cytotoxic chemotherapy, targeted therapy, radiation therapy, immunotherapy, or other clinical trial therapies within 2 weeks, prior to first dose of study treatment. Participants should have recovered from all prior therapy related toxicities. Participants may receive hydroxyurea or cytarabine for control of WBC count during this washout period.
4. Participants with known symptomatic or uncontrolled CNS leukemia.
5. Participant has systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
6. Active ophthalmological disorders, e.g., retinal pigment epithelium (RPE)/photoreceptor disorders such as retinitis pigmentosa, cone-rod dystrophies, Bests dystrophy, Stargardt disease (STGD), macular degeneration. Exceptions:
1. Mild blurry vision, either age-related or due to ocular or systemic disorder (e.g., diabetes, dry eyes, cataracts, uncorrected refraction abnormality) may be allowed at the discretion of an ophthalmologist if deemed as not constituting evidence of pre-existing retinopathy or a condition with the potential to cause a predisposition to drug-induced retinopathy.
2. Participants with only one assessable eye and no evidence of pre-existing retinopathy may be allowed at the discretion of the principal investigator.
7. Participants with known acute or chronic liver disease, cirrhosis, hepatic steatosis with elevated liver function tests or elevated LFTs of unknown etiology.
8. Active and uncontrolled comorbidities including decompensated congestive heart failure NYHA class III/IV, clinically significant, uncontrolled arrhythmia, acute respiratory failure, unstable or decompensated pulmonary disease, as judged by the treating physician.
9. Decompensated congestive heart failure, hypokalemia, prolonged QT interval corrected for heart rate (QTc) (as calculated using Fridericia's formula) to greater than 450 msec for males, or to greater than 470 msec for females or long QT syndrome, or history of Torsades de pointes.
10. Participants with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications as determined by the investigator.
11. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection with detectable viral DNA or RNA, respectively, or known HIV or HTLV-1 infection.
12. Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator.
13. Any previous malignancy, except when the patient has completed definitive curative-intent treatment with chemotherapy and/or surgery and/or radiotherapy at least 1 month prior to enrollment. Participants having completed definitive treatment for the following conditions may be eligible immediately after completion of definitive curative-intent therapy, after healing of wounds, and no evidence of residual disease by examination or imaging or cytology/pathology, e.g., non-melanoma skin cancers, or any carcinoma in-situ, e.g., ductal carcinoma in situ, urothelial cancer, cervical cancer, localized prostate cancer, pre-cancerous colon polyp, etc.
14. Major surgery within 4 weeks prior to screening or a major wound that has not fully healed.
- Participants under legal protection measure (guardianship, trusteeship or safeguard of justice) and/or uncontrolled psychiatric comorbidities, ongoing illicit substance abuse, any impairment or unwillingness to comply with the treatments, follow-up, requirements and procedures of this clinical trial.
15. A known hypersensitivity or severe allergy to study drug components or diluents
16. Nursing women, women of childbearing potential (WOCBP) with positive urine or serum pregnancy test, or WOCBP who are not willing to maintain adequate contraception.
17. Pregnant women are excluded from this study because study agents may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated on this study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Abhishek Maiti, MBBS
**Phone:** (713) 745-3228
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Abhishek Maiti, MBBS
- **Phone:** 713-745-3228
- **Role:** CONTACT
***Contact 2:***
- **Name:** Abhishek Maiti, MBBS
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** MD Anderson Cancer Center
**State:** Texas
**Zip:** 77030
#### Overall Officials
**Official 1:**
**Affiliation:** M.D. Anderson Cancer Center
**Name:** Abhishek Maiti, MBBS
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### See Also Links
**Label:** MD Anderson Cancer Center
**URL:** http://www.mdanderson.org
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000006402
- Term: Hematologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10945
- Name: Leukemia
- Relevance: HIGH
- As Found: Leukemia
- ID: M10955
- Name: Leukemia, Myeloid
- Relevance: HIGH
- As Found: Myeloid Leukemia
- ID: M18127
- Name: Leukemia, Myeloid, Acute
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M9490
- Name: Hematologic Diseases
- 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: HIGH
- As Found: Acute Myeloid Leukemia
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007938
- Term: Leukemia
- ID: D000007951
- Term: Leukemia, Myeloid
- ID: D000015470
- Term: Leukemia, Myeloid, Acute
### 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: D000004791
- Term: Enzyme Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M249656
- Name: Venetoclax
- Relevance: HIGH
- As Found: 15 minutes
- ID: M1697
- Name: Decitabine
- Relevance: LOW
- As Found: Unknown
- ID: M4673
- Name: Azacitidine
- Relevance: HIGH
- As Found: Frequency
- ID: M30564
- Name: Cytochrome P-450 CYP3A Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000001374
- Term: Azacitidine
- ID: C000579720
- Term: Venetoclax
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445894
**Brief Title:** Accelerated Intermittent Theta-burst Stimulation to Modify Cognitive Function and Balance in Dementia and Memory Loss
**Official Title:** Accelerated Intermittent Theta-burst Stimulation to Modify Cognitive Function and Balance in Dementia and Memory Loss
#### Organization Study ID Info
**ID:** 17300
#### Organization
**Class:** OTHER
**Full Name:** McMaster University
### Status Module
#### Completion Date
**Date:** 2025-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-05-31
**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:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-31
**Study First Submit QC Date:** 2024-05-31
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** McMaster University
#### Responsible Party
**Investigator Affiliation:** McMaster University
**Investigator Full Name:** Aimee Nelson
**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 process of aging is accompanied by normal deterioration of body systems, leading to a decline in various functional domains including cognitive, visual, vestibular, somatosensory, and motor function. With this functional decline, there is an increasing burden of care due to the rise of injury, direct and indirect healthcare costs, and the loss of independence in performing daily activities. Notably, falls in the older population represents one of the greatest costs incurred by Canadians annually.
The study investigates whether rTMS delivered to M1 will lead to greater improvement in balance compared to rTMS delivered to DLPFC. Determining this answer will allow greater success in TMS target refinement. Given the profound burden that geriatric medicine has on the Canadian healthcare system, understanding the link between balance and cognition can significantly impact the approach to management of this population.
**Detailed Description:** Approximately 20-30% of Canadian adults \>65 years old experience falls each year, and this rate drastically increases for those \>85 years of age \[2\]. With the aging population, the number of annual reported falls has increased by 47% from 2008 to 2020 \[3\]. Individuals with cognitive impairment exhibit an 8x higher risk of falls compared to those without \[4\]. Balance is a key risk factor for falls \[5-7\], and there is evidence suggesting that balance control is a marker of cognitive decline \[8\]. For example, cognitive function is significantly correlated with postural control \[9\] and postural sway \[10\]. In Parkinson's disease, balance has been linked to greater executive dysfunction and slower processing speed \[11\].
Synaptic plasticity induced via neuromodulatory techniques can lead to improvements in motor and cognitive function. One such technique is Transcranial magnetic stimulation (TMS), a non-invasive form of neuromodulation. To induce synaptic plasticity, magnetic stimuli are delivered via TMS in theta-burst patterns. This includes continuous theta burst stimulation (cTBS) that induces long term depression (LTD)-like changes in neuronal excitability and intermittent theta burst stimulation (iTBS) that induces long term potentiation (LTP)-like changes in neuronal excitability \[12\]. Previous literature suggests that iTBS may be an effective tool for modulating cognition and motor function.
Wu et al. (2022) found an improvement in memory function of Alzheimer disease patients following a 14-day course of iTBS delivered to the dorsolateral prefrontal cortex (DLPFC) \[13\]. Trung et al. (2019) showed that 3 days of iTBS delivered to the DLPFC led to cognitive improvements in a sample of Parkinson's disease patients with mild cognitive impairment (MCI) \[14\]. Regarding balance, iTBS has been shown to be an effective intervention for balance recovery when delivered to the cerebellum \[16,17\] or the primary motor cortex (M1) \[16\]. Improvements in gait performance have also been seen following other patterns of stimulation including repetitive TMS (rTMS) in the post-stroke population \[18-20\]. These improvements in cognition and balance following iTBS may be linked to plastic changes in neuronal structure, as seen in animal models \[21\].
Accelerated intermittent theta-burst stimulation (iTBS) encompass multiple sessions of iTBS administered within a singular day over the course of several days, consequently diminishing the duration of the treatment regimen. aiTBS has been shown to be a tolerable and safe form of non-invasive brain stimulation with rapid antidepressant efficacy and anti-suicidal effects in patients with major depressive disorder \[22-27\]. Previous studies have demonstrated aiTBS paradigm which consisted of iTBS delivered 3 times per day separated by 15 min intervals, over the course of 14 days, resulted in an improvement in memory function in individuals with Alzheimer disease \[13, 27\].
For this study question we have chosen two different stimulation sites. DLFPC is known for its contributions to learning and memory. Individuals with dementia typically receive rTMS stimulation to DLPFC to explore whether cognitive function can be improved (Wu et al., 2020). It has been seen that individuals with dementia suffer from a greater number of falls, it is unclear whether rTMS to DLPFC will improve balance performance and risk of falls better than rTMS delivered to M1, a typical site of stimulation for balance related studies. iTBS has been shown to be an effective intervention for balance recovery when delivered to the primary motor cortex (M1) (Liao et al., 2024). Improvements in gait performance have also been seen following other patterns of stimulation including repetitive TMS (rTMS) in the post-stroke population when delivered to M1 (Wang et al., 2012; Wang et al., 2019; Rastgoo et al., 2016). These improvements in cognition and balance following iTBS may be linked to plastic changes in neuronal structure, as seen in animal models (Tsang et al., 2021).
We there ask the study question whether rTMS delivered to M1 will lead to greater improvement in balance compared to rTMS delivered to DLPFC. Determining this answer will allow greater success in TMS target refinement. Given the profound burden that geriatric medicine has on the Canadian healthcare system, understanding the link between balance and cognition can significantly impact the approach to management of this population
### Conditions Module
**Conditions:**
- Dementia Alzheimers
**Keywords:**
- neuroplasticity
- transcranial magnetic stimulation
- dementia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 36
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** iTBS will be delivered using a Magstim Rapid 2 stimulator (Magstim, Whitland, UK) guided with neuronavigation (Brainsight, Rogue Research, Montreal, QC, Canada) to target M1. Participants will receive 14 days of stimulation. During each treatment day, three iTBS sessions separated by 15-minute intervals will be delivered. Each iTBS session consists of 600 stimuli delivered in 50 Hz bursts of 3 pulses at 70% of the resting motor threshold. In total, individuals will receive 1800 stimuli delivered each day as performed elsewhere . Following iTBS individuals will participate in 10 minutes of balance training performed on balance board (BTracks https://balancetrackingsystems.com).
**Intervention Names:**
- Device: Active Repetitive Transcranial Magnetic Stimulation
**Label:** Active rTMS to M1
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** iTBS will be delivered using a Magstim Rapid 2 stimulator (Magstim, Whitland, UK) guided with neuronavigation (Brainsight, Rogue Research, Montreal, QC, Canada) to target DLPFC. Participants will receive 14 days of stimulation. During each treatment day, three iTBS sessions separated by 15-minute intervals will be delivered \[13,22\]. Each iTBS session consists of 600 stimuli delivered in 50 Hz bursts of 3 pulses at 70% of the resting motor threshold. In total, individuals will receive 1800 stimuli delivered each day as performed elsewhere \[13,23,27\]. Following iTBS individuals will participate in 10 minutes of balance training performed on balance board (BTracks https://balancetrackingsystems.com).
**Intervention Names:**
- Device: Active Repetitive Transcranial Magnetic Stimulation
**Label:** Active rTMS to DLPFC
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** sham iTBS will be delivered using a Magstim Rapid 2 stimulator (Magstim, Whitland, UK) guided with neuronavigation (Brainsight, Rogue Research, Montreal, QC, Canada) to target M1. Participants will receive 14 days of placebo stimulation. Following sham iTBS individuals will participate in 10 minutes of balance training performed on balance board (BTracks https://balancetrackingsystems.com).
**Intervention Names:**
- Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
**Label:** Placebo rTMS to M1
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Active rTMS to DLPFC
- Active rTMS to M1
**Description:** rTMS is a non-invasive, non-painful procedure used to relieve chronic pain and promote short-term changes. The first dorsal interossesous (FDI) muscle of the left motor cortex will be targeted using neuronavigation software.
**Name:** Active Repetitive Transcranial Magnetic Stimulation
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Placebo rTMS to M1
**Description:** A sham coil will be utilized for the sham rTMS condition. It is important to note that from the participant perspective, the sham stimulation will feel and sound identical to active. The location and all other parameters of Sham rTMS will be identical to Active rTMS.
**Name:** Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Patients wear their regular footwear and can use a walking aid, if needed. It will begin by having the patient sit back in a standard armchair and identify a line 3 meters, or 10 feet away, on the floor. The participant will be instructed "When I say "Go," I want you to: 1. Stand up from the chair. 2. Walk to the line on the floor at your normal pace. 3. Turn. 4. Walk back to the chair at your normal pace. 5. Sit down again." During this task, IMU will be worn on the ankle to collect movement kinematics relating to balance. During this task two research personnel, one positioned on either side of the participant, will be present in order to stabilize the participant in the case of a loss of balance. In addition, foam padding will be positioned surrounding the patient during standing assessments and moved alongside the patient in walking assessments
**Measure:** Time Up & Go (TUG) task
**Time Frame:** At baseline 1-2 days pre-intervention, and 1-2 days post-intervention
#### Secondary Outcomes
**Description:** A patient-reported questionnaire regarding balance confidence during 16 everyday activities. The ABC scale is quick and easy to administer and has demonstrated good reliability, validity, and sensitivity
**Measure:** Activities-Specified Balance Confidence (ABC) scale
**Time Frame:** At baseline 1-2 days pre-intervention, and 1-2 days post-intervention
**Description:** A sensitive, reliable, valid, and sensitive 14-item scale that assesses dynamic balance \[30\]. It includes components evaluating anticipatory postural adjustments, responses to perturbation, sensory orientation and dynamic stability during gait. The total score ranges from 0 ("no balance") to 28 ("complete balance"). Each task on the M-BESTest will be scored from 0-2, which correspond to normal, moderate or severe inability to perform the task. In order to complete this test Temper® foam (4 inches thick, medium density T41 firmness rating), chair without arm rests or wheels, incline ramp, stopwatch, a box (9" height) and a 3-meter distance measured out and marked on the floor with tape \[from chair\] will be required.
**Measure:** Mini-Balance Evaluation Systems Test (M-BESTest)
**Time Frame:** At baseline 1-2 days pre-intervention, and 1-2 days post-intervention
**Description:** Assesses the capacity of an individual to control center of gravity (COG) within their base of support. While standing on a force platform, subjects are asked to move a cursor indicating their COG from a center target to a peripheral target and back as quickly as possible while minimizing deviation. The process is repeated three times for each of nine peripheral targets in a random order with 30 second rests between each target presentation. Outcome measures derived from the test include movement reaction time (RT) movement velocity (MV), maximum COG excursion (ME), end point COG excursion (EE), and directional control (DC). These LS measures are all impaired in fallers compared to non-fallers \[32\].
**Measure:** Balance Assessment test
**Time Frame:** At baseline 1-2 days pre-intervention, and 1-2 days post-intervention
**Description:** The GAI is a 20-item scale that screens for anxiety symptoms in adults aged 50 and over. It is designed to assess anxiety symptoms over the past week.
**Measure:** Geriatric Anxiety Inventory (GAI)
**Time Frame:** At baseline 1-2 days pre-intervention, and 1-2 days post-intervention
**Description:** The CSDD is a valid screening tool for depression in elderly individuals with and without dementia \[34\]. This is a 19-item scale that it's designed to assess depressive symptoms over the past week and is completed by the individual's appointed caregiver.
**Measure:** Cornell Scale for Depression in Dementia (CSDD)
**Time Frame:** At baseline 1-2 days pre-intervention, and 1-2 days post-intervention
**Description:** Associative memory will be assessed using a face-word association task adapted from Wu et al. \[13\]. In this task, participants will be presented with 12 different pictures of human faces for 12s each. With each face, a common word will be presented, making a face-word pair. The participants will be instructed to memorize the face-word pairs. After a one-minute break, participants were again showed the same faces in a randomized order without the associated word. Participants were asked to recall the unique common word that was presented with each face. The number of successful answers will be summed as the associative memory score. Participants repeated this task twice, with a three-minute interval between each attempt. The average score of the two trials was used as the final associative memory score.
**Measure:** Associative memory
**Time Frame:** At baseline 1-2 days pre-intervention, and 1-2 days post-intervention
**Description:** The MOCA is a tool used to assess cognitive impairment \[35\]. It assesses various aspects of cognition including executive function, memory, language, attention, and orientation. A score less than 25 out of 30 is considered significant for MCI.
**Measure:** Montreal Cognitive Assessment (MOCA)
**Time Frame:** At baseline 1-2 days pre-intervention, and 1-2 days post-intervention
**Description:** Frequency of Falls: This questionnaire is composed of a single question that asks the number of falls experienced in the past 6 months. In the event that the SDM provides consent, they will be asked for a response to this questionnaire. In the event that the participant provides direct consent they will be asked to answer the question posed on the questionnaire. The researcher will additionally reach out to the family member/caregiver identified on the assent form to acquire this information. In the case of discrepant responses between the participant and the family member/caregiver we will use the response provided by the latter.
**Measure:** Frequency of Falls
**Time Frame:** At baseline 1-2 days pre-intervention, 6 months post-intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Individuals must be diagnosed with Dementia and/or memory loss by a clinician.
2. Individuals must exhibit adequate oral communication skills and cognitive function sufficient to obtain a score ranging between 10-27 on the Mini-Mental State Exam (Wu et al., 2022).
3. Instructions will be delivered in English; therefore participants must demonstrate an understanding of instruction provided in English or have a caregiver present who can translate and be presented during all study sessions.
4. Individuals must be able to walk or stand with or without personnel or assistive devices.
5. Individuals must be greater than or equal to 50 years of age.
Exclusion Criteria:
* 1. Contraindications to rTMS; presence of a pacemaker, metal/electrical/magnetic implants not including titanium, known history of untreated or uncontrolled psychological disorders, pregnancy, history of seizure or diagnoses of epilepsy, are taking any prescription medications that increase the risk of seizure.
**Minimum Age:** 50 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Aimee J Nelson, PhD
**Phone:** 9055259140
**Phone Ext:** 28053
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hamilton
**Country:** Canada
**Facility:** McMaster Unviersity
**State:** Ontario
**Zip:** L8S 4K1
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000024801
- Term: Tauopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
### 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
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M6904
- Name: Dementia
- Relevance: HIGH
- As Found: Dementia
- ID: M3885
- Name: Alzheimer Disease
- Relevance: HIGH
- As Found: Dementia Alzheimers
- ID: M3985
- Name: Amnesia
- Relevance: LOW
- As Found: Unknown
- ID: M11552
- Name: Memory Disorders
- Relevance: HIGH
- As Found: Memory Loss
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System 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: M23002
- Name: Tauopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- 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: T2192
- Name: Familial Alzheimer Disease
- Relevance: HIGH
- As Found: Dementia Alzheimers
### Condition Browse Module - Meshes
- ID: D000003704
- Term: Dementia
- ID: D000000544
- Term: Alzheimer Disease
- ID: D000008569
- Term: Memory Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06445881
**Acronym:** MSJZT-NSCLC
**Brief Title:** Efficacy and Safety of Modified Si Jun Zi Tang in Perioperative NSCLC Treatment
**Official Title:** A Multi-center, Prospective, Exploratory Study Evaluating the Efficacy and Safety of a Modified Si Jun Zi Tang Formula in the Perioperative Treatment of Non-small Cell Lung Cancer
#### Organization Study ID Info
**ID:** IIT20240018C-R1
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital of Zhejiang University
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-02
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Study First Submit Date:** 2024-06-02
**Study First Submit QC Date:** 2024-06-02
### Sponsor Collaborators Module
#### 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
### Description Module
**Brief Summary:** Chemotherapy combined with immunotherapy is the current standard perioperative treatment for non-small cell lung cancer (NSCLC). However, this regimen has multiple side effects and shows variable efficacy among individuals. In China, adjunctive traditional Chinese medicine is widely accepted by lung cancer patients. Modified Si Jun Zi Tang, a classic formula in traditional Chinese medicine, is known for its benefits in unifying and strengthening the spleen. This study aims to evaluate whether the addition of Modified Si Jun Zi Tang to chemotherapy and immunotherapy during the neoadjuvant phase can improve the R0 resection rate, objective response rate (ORR), and safety in patients with resectable and potentially resectable NSCLC. Secondary objectives include assessing whether this combination can improve 1-year and 2-year disease-free survival (DFS) post-surgery. Additionally, we will collect relevant biological samples to identify tumor markers associated with efficacy, prognosis, and side effects, providing a theoretical basis for modernizing and standardizing traditional Chinese medicine.
### Conditions Module
**Conditions:**
- Non Small Cell Lung Cancer
- Perioperative Complication
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive Modified Si Jun Zi Tang combined with chemotherapy (albumin-bound paclitaxel or pemetrexed + carboplatin) and PD1 monoclonal antibody, followed by surgery if feasible. Postoperatively, they will continue with Modified Si Jun Zi Tang and PD1 monoclonal antibody for up to one year.
**Intervention Names:**
- Drug: Modified Si Jun Zi Tang
**Label:** Modified Si Jun Zi Tang Combined with Chemotherapy and Immunotherapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive standard chemotherapy (albumin-bound paclitaxel or pemetrexed + carboplatin) and PD1 monoclonal antibody, followed by surgery if feasible. Postoperatively, they will continue with PD1 monoclonal antibody for up to one year.
**Label:** Standard Chemotherapy and Immunotherapy
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Modified Si Jun Zi Tang Combined with Chemotherapy and Immunotherapy
**Description:** Modified Si Jun Zi Tang is a classic formula in traditional Chinese medicine, known for its benefits in unifying and strengthening the spleen.
**Name:** Modified Si Jun Zi Tang
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The proportion of patients achieving complete surgical resection with negative margins (R0 resection) after neoadjuvant therapy.
**Measure:** R0 Resection Rate
**Time Frame:** Assessed at the time of surgery, approximately 2-4 months after starting treatment.
**Description:** The proportion of patients achieving partial or complete response as defined by RECIST v1.1 criteria.
**Measure:** Objective Response Rate (ORR)
**Time Frame:** Assessed after 2 cycles of treatment (approximately 6 weeks) and before surgery, if applicable.
**Description:** The proportion of patients experiencing treatment-related adverse reactions, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
**Measure:** Incidence of Adverse Reactions
**Time Frame:** Assessed throughout the treatment period, from the start of treatment up to one year post-surgery.
#### Secondary Outcomes
**Description:** The proportion of patients who remain free of disease recurrence or progression one year after surgery.
**Measure:** 1-Year Disease-Free Survival (DFS)
**Time Frame:** Assessed one year post-surgery.
**Description:** The proportion of patients who remain free of disease recurrence or progression two years after surgery.
**Measure:** 2-Year Disease-Free Survival (DFS)
**Time Frame:** Assessed two years post-surgery.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age ≥ 18 and ≤ 75 years.
2. Pathologically confirmed non-small cell lung cancer (NSCLC) with no prior treatment for this tumor.
3. Clinical stage II-IIIB (N2) tumors assessed as resectable or potentially resectable by a multidisciplinary team (MDT).
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 - 1.
5. Adequate organ function, including:
Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, platelets ≥ 80 x 10\^9/L, hemoglobin ≥ 90 g/L.
Liver: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤ 3 times ULN.
Kidneys: Creatinine clearance rate ≥ 45 mL/min (using the standard Cockcroft-Gault formula) or ≤ 1.5 times ULN.
6. At least one measurable lesion according to RECIST v1.1 criteria.
7. For women: Must be surgically sterilized, postmenopausal, or use highly effective contraception during and for 3 months after treatment; must not be pregnant or breastfeeding during the treatment period.
8. Patients must have compliance and geographic proximity to ensure adequate follow-up.
Exclusion Criteria:
1. Patients with a history of autoimmune diseases, active tuberculosis, active hepatitis (HBV DNA \<2000 IU), or HIV infection.
2. Patients expected to be unable to tolerate surgery, such as those with severe cardiopulmonary insufficiency or coagulation disorders (APTT \<1.5 times ULN, INR \>2.0, PT \>16 seconds).
3. History of other malignancies within the past 2 years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, superficial bladder cancer \[Ta, Tis \& T1\], or papillary thyroid carcinoma.
4. Any unstable systemic disease (including active systemic infections requiring systemic treatment, liver disease, kidney disease, or metabolic disorders, acute cerebral infarction or cerebral hemorrhage, etc.).
5. Significant cardiovascular events: congestive heart failure \> NYHA Class 2; unstable angina, active coronary artery disease (CAD) (myocardial infarction over 1 year before study entry is allowed); severe arrhythmias requiring treatment (use of beta-blockers or digoxin is allowed) or uncontrolled hypertension.
6. Significant neurological or psychiatric disorders, including epilepsy, dementia, etc.
7. Patients with interstitial lung disease or a history of interstitial pneumonia.
8. Participation in other anti-tumor drug clinical trials within 4 weeks prior to enrollment.
9. Previous use of PD-1/PD-L1 inhibitors or other anti-tumor immunotherapy drugs.
10. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation.
11. Known allergy to the drugs or drug excipients used in the study or severe allergic reactions to other monoclonal antibodies.
12. Presence of other severe physical or laboratory abnormalities that may increase the risk of participating in the study, interfere with study results, or any other condition that, in the investigator's judgment, may affect the conduct or results of the clinical study.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jianzhen Shan, MD
**Phone:** +86-571-87235409
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Zhen Liu, MD
**Phone:** +86-571-87235409
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jianzhen Shan, MD
- **Phone:** +86-571-87235409
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Zhen Liu, MD
- **Phone:** +86-571-87235407
- **Role:** CONTACT
**Country:** China
**Facility:** the First Affilated Hospital of Zhejiang University
**State:** Zhejiang
**Status:** RECRUITING
**Zip:** 310000
#### Overall Officials
**Official 1:**
**Affiliation:** the First Affiliated Hospital of Zhejiang Universtiy
**Name:** Jianzhen Shan, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000002283
- Term: Carcinoma, Bronchogenic
- ID: D000001984
- Term: Bronchial Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M11172
- Name: Lung Neoplasms
- Relevance: HIGH
- As Found: Lung Cancer
- ID: M5546
- Name: Carcinoma, Non-Small-Cell Lung
- Relevance: HIGH
- As Found: Non-Small Cell Lung Cancer
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5540
- Name: Carcinoma, Bronchogenic
- Relevance: LOW
- As Found: Unknown
- ID: M5260
- Name: Bronchial Neoplasms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008175
- Term: Lung Neoplasms
- ID: D000002289
- Term: Carcinoma, Non-Small-Cell Lung
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M4230
- Name: Antibodies, Monoclonal
- Relevance: LOW
- As Found: Unknown
- ID: M19537
- Name: Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M231
- Name: Albumin-Bound Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M18650
- Name: Carboplatin
- Relevance: LOW
- As Found: Unknown
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M264
- Name: Pemetrexed
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |