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## Protocol Section
### Identification Module
**NCT ID:** NCT06435455
**Brief Title:** GH21 Combined With D-1553 With Advanced Solid Tumors
**Official Title:** A Multicenter, Open-label Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GH21 Combined With D-1553 in Patients With Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation
#### Organization Study ID Info
**ID:** GH21C203
#### Organization
**Class:** OTHER
**Full Name:** Suzhou Genhouse Bio Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2027-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Zhejiang Cancer Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Suzhou Genhouse Bio Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This s a multi-center, open-label phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GH21 combined with D-1553 in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation.
**Detailed Description:** This study includes 2 parts: dose escalation(Phase Ib) and dose expansion (Phase II). The objective of the dose escalation part is to evaluate the safety, tolerability and pharmacokinetics of GH21 in combination with D-1553 in patients with advanced solid tumors harboring KRAS G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion part, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS G12C mutation.
### Conditions Module
**Conditions:**
- KRAS G12C Mutant Solid Tumors
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 126
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** GH21 capsules combined with D-1553 tablets were administrated orally
**Intervention Names:**
- Drug: GH21+D-1553
**Label:** "GH21 + D-1553" Group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- "GH21 + D-1553" Group
**Description:** The combination of GH21 and D-1553 is expected to benefit solid tumors harboring the KRASG12C mutation.
**Name:** GH21+D-1553
**Other Names:**
- GH21 capsules combined with D-1553 tablets
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Incidence of dose limiting toxicities (DLTs) in the dose escalation phase.
**Measure:** Number of participants with dose limiting toxicities
**Time Frame:** 2 years
**Description:** All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs , etc
**Measure:** Number of participants with adverse events
**Time Frame:** 2 years
#### Secondary Outcomes
**Description:** ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
**Measure:** Objective response rate (ORR)
**Time Frame:** 2 years
**Description:** DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.
**Measure:** Duration of response (DOR)
**Time Frame:** 2 years
**Description:** DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD).
**Measure:** Disease Control Rate (DCR)
**Time Frame:** 2 years
**Description:** PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first.
**Measure:** Progression-free survival (PFS)
**Time Frame:** 2 years
**Description:** OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor
**Measure:** Overall survival (OS)
**Time Frame:** 2 years
**Description:** Peak Plasma concentration
**Measure:** Cmax
**Time Frame:** 2 years
**Description:** Time to achieve Cmax
**Measure:** Tmax
**Time Frame:** 2 years
**Description:** Area under the plasma concentration-time curve
**Measure:** AUC
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The patient or his legal representative is able to understand and voluntarily sign a written informed consent (before commencing this study and any research procedure);
* Age ≥18 years old, male or female;
* Dose escalation stage (Stage Ib) : advanced solid tumors with KRAS G12C mutation in patients who have previously failed standard therapy or have no standard therapy or are intolerant to standard therapy.
* Dose Expansion Phase (Phase II) :
Cohort 1: advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation; .
Cohort 2: G12Ci naïve advanced solid tumors with KRAS G12C mutation. Cohort 3: G12Ci treated advanced solid tumors with KRAS G12C.
* The patient must have at least one measurable lesion that meets the RECIST v1.1 definition (tumor lesion located in the area of prior radiotherapy or other local regional treatment site is generally not considered as a measurable lesion unless there is definite progression of the lesion);
* Expected survival ≥3 months;
* ECOG Physical strength score: 0-1;
* The patient must have adequate organ function, defined as follows:
blood Absolute neutrophil count (ANC) ≥1.5×109/L within 14 days without the support of granulocyte colony-stimulating factor; No blood transfusion within 14 days, platelets ≥100×109/L without the use of thrombopoietin (TPO) and interleukin-11 (IL-11); Hemoglobin ≥90 g/L without blood transfusion within 14 days, without erythropoietin (EPO); kidney Serum creatinine ≤1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60ml/min calculated using the modified Cockcroft-Gault equation or eGFR≥ 60ml/min estimated by the MDRD equation; liver albumin ≥3.0 g/dL; Total bilirubin ≤1.5×ULN; In patients with liver metastasis, total bilirubin ≤2.5×ULN; AST/ALT≤2.5 x ULN; In patients with liver metastasis, AST/ALT≤5×ULN; Coagulation function International Normalized ratio (INR) and prothrombin time (PT) ≤1.5×ULN, unless the patient is being treated with anticoagulants (INR\<2.5×ULN) and PT or PTT is within the therapeutic range for which the anticoagulant is intended to be used; Activated partial thromboplastin time (APTT) ≤1.5×ULN, unless the patient is being treated with an anticoagulant (APTT\<2.5×ULN) and PT or PTT is within the therapeutic range for which the anticoagulant is intended to be used.
* Fertile men and women of childbearing age must agree to use reliable contraception (hormonal or barrier or abstinence) from the time they sign an informed consent until 6 months after the final administration of the investigational drug. Pregnancy test results for women of reproductive age must be negative within ≤7 days before the first study drug administration.
Exclusion Criteria:
* Received biological agents of chemotherapy and anti-tumor therapy within 3 weeks before the first administration, and received anti-tumor drugs such as radiotherapy and endocrine therapy within 4 weeks before the first administration, except for the following:
nitrosourea or mitomycin C within 6 weeks prior to first use of the study drug; Oral fluorouracil, small molecule targeted drugs, and Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 5 half-lives or 2 weeks prior to the first use of the study drug (whichever is shorter); local palliative radiotherapy within 2 weeks prior to the first use of the study drug;
* Received other investigational drugs or treatments that are not on the market within 5 half-lives or 4 weeks (whichever is shorter) prior to initial administration;
* Had major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose, or required elective surgery during the trial;
* Use of CYP3A4 or P-gp suppressor or strong inducer within 2 weeks or 5 half-lives prior to initial administration;
* There is evidence of the following heart diseases:
acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months before first administration; Grade III-IV heart failure based on the New York Heart Association Cardiac Function Scale at screening; During screening, echocardiography (ECHO) showed left ventricular ejection fraction (LVEF) ≤50%.
Fridericia adjusted QT interval (QTcF) ≥450ms (male), ≥470ms (female) at screening; The presence of poorly controlled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) after medication at screening;
* Has difficulty swallowing or has a gastrointestinal disease or other malabsorption condition that affects drug absorption, such as intestinal obstruction, Crohn's disease, ulcerative colitis, short bowel syndrome, gastric emptying disorder, or has severe gastrointestinal related toxicity before first administration and does not recover below grade 2; Or confirmed clinically significant or acute gastrointestinal disease;
* Uncontrolled pleural effusion, pericardial effusion, or pleural effusion requiring repeated drainage (once a month or more frequently);
* Patients with active brain metastases or with symptoms of active central nervous system metastases, including headache, vomiting, and vertigo, are eligible only if they meet all of the following criteria and are asymptomatic and have treated or untreated CNS lesions:
The presence of measurable lesions outside the CNS as determined by RECIST v1.1; Stable brain metastases after treatment, defined as no evidence of disease progression or bleeding during the 28 days prior to initiation of treatment and discontinuation of steroid hormones and other therapeutic agents for at least 14 days prior to enrollment;
* Patients with interstitial pneumonia, or any evidence of clinically active interstitial lung disease, within 6 months prior to first dosing;
* Arteriovenous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, occurred within 6 months prior to initial administration;
* Have a history of other malignancies (except skin squamous cell carcinoma in situ that has been cured and has not recurred for 5 years, basal cell carcinoma and cervical carcinoma in situ, etc., which are considered by researchers to be eligible for inclusion; Dose escalation phase, except for those deemed acceptable by the investigator);
* Patients who have a history of severe allergy, or have a history of allergy to the experimental drug/any excipient/combination drug, or have a history of allergy to multiple drugs;
* Hepatitis B virus infection (HBsAg positive and DNA copy number \>1000 IU/ml); Or infected with hepatitis C virus (HCV antibody positive and HCV RNA \> the upper limit of normal); Or infected with human immunodeficiency virus (HIV antibody positive); Or infected with treponema pallidum (defined as TP-Ab positive);
* There is an active infection (≥ grade 2) requiring anti-infective treatment or an unexplained fever exceeding 38 ° C within 28 days before the first dose;
* Active stage of autoimmune disease as determined by the investigator within 28 days before the first dose;
* Any toxicity from previous antitumor therapy prior to initial administration has not returned to CTCAE 5.0 rating ≤ Class 1 (unless hair loss, grade 2 peripheral neuropathy, and/or other grade ≤2 adverse events that do not pose a safety risk);
* Pregnant and lactating women;
* The investigator considers that there are any clinical or laboratory abnormalities or other reasons to be unsuitable for participating in this clinical study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jieqi Tang, bachelor
**Phone:** +8613311557758
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Zhengbo Song, Doctorate
**Phone:** +8613857153345
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Meshes
- ID: D000009369
- Term: Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435442
**Brief Title:** PK,PD and DDI of Epaminurad and Naproxen in Healthy Volunteers
**Official Title:** A Phase 1 Study to Evaluate the Safety and PK/PD Drug-drug Interaction Between Epaminurad and Naproxen or to Assess the Safety and Multiple-Dose PK/PD Characteristics of Epaminurad in Healthy Volunteers
#### Organization Study ID Info
**ID:** JW23103
#### Organization
**Class:** INDUSTRY
**Full Name:** JW Pharmaceutical
### Status Module
#### Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** JW Pharmaceutical
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** A Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and Naproxen in Healthy Volunteers
**Detailed Description:** Part 1: to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and Naproxen in Healthy Koreans/ Part 2: to evaluate the safety, PK/PD of Epaminurad in Healthy Caucasians
### Conditions Module
**Conditions:**
- Healthy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** PART 1: A open-label, multiple-dose, single group/ PART 2: A placebo-controlled, randomized, double-blind, multiple-dose, parallel group
##### Masking Info
**Masking:** DOUBLE
**Masking Description:** PART 1: None (Open Label)/ PART 2: Double (Participant, Investigator)
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 28
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Epaminurad 9 mg, Naproxen 500 mg
**Intervention Names:**
- Drug: Epaminurad, Naproxen
**Label:** Part 1
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Epaminurad 9 mg
**Intervention Names:**
- Drug: Epaminurad
**Label:** Part 2(Test group)
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Epaminurad 9 mg placebo
**Intervention Names:**
- Drug: Epaminurad placebo
**Label:** Part 2(Control group)
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Part 1
**Description:** Period 1: Epaminurad/ Period 2: Naproxen -\> Epaminurad+Naproxen
**Name:** Epaminurad, Naproxen
**Other Names:**
- URC102, Naxen
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Part 2(Test group)
**Description:** Epaminurad
**Name:** Epaminurad
**Other Names:**
- URC102
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Part 2(Control group)
**Description:** Epaminurad placebo
**Name:** Epaminurad placebo
**Other Names:**
- URC102 placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** To evaluate the AUC of Epaminurad and Naproxen
**Measure:** Area under the plasma concentration versus time curve (AUC)
**Time Frame:** 7 days
**Description:** To evaluate the Cmax of Epaminurad and Naproxen
**Measure:** Peak plasma concentrations (Cmax)
**Time Frame:** 7 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age: 19\~50
2. Weight: between 50.0 kg\~90.0 kg, Body Mass Index(BMI): 18.0 kg/m\^2 or heavier and below 30.0 kg/m\^2
3. Part 1: Korean/ Part 2: Caucasian
Exclusion Criteria:
1. Medical history- chronic liver disease, acute gout attack, uric acid stone, diabetes, hypertension, hyperlipidemia or lipid abnormality
2. Clinical examination- eGFR (CKD-EPI) \< 90mL/min/1.73m\^2, Serum uric acid \< 3 mg/dL or \> 7 mg/dL, AST (SGOT), ALT (SGPT) \> upper limit of normal ranges X 1.5, Total bilirubin, γ-GTP \> upper limit of normal ranges X 1.5, CK \> upper limit of normal ranges X 2, Positive serologic results
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 19 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** JW Pharmaceutical
**Phone:** +82-2-840-6852
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Name:** Kyung-sang Yu
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Korea, Republic of
**Facility:** Seoul National University Hospital
#### Overall Officials
**Official 1:**
**Affiliation:** Seoul National University Hospital
**Name:** Kyung-sang Yu, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Intervention Browse Module - Ancestors
- ID: D000000894
- Term: Anti-Inflammatory Agents, Non-Steroidal
- ID: D000018712
- Term: Analgesics, Non-Narcotic
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000006074
- Term: Gout Suppressants
- ID: D000016861
- Term: Cyclooxygenase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M12239
- Name: Naproxen
- Relevance: HIGH
- As Found: Cross-over
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4218
- Name: Anti-Inflammatory Agents, Non-Steroidal
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M20786
- Name: Analgesics, Non-Narcotic
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M19209
- Name: Cyclooxygenase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000009288
- Term: Naproxen
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435429
**Brief Title:** A Phase 3, Randomized, Open-label, Controlled Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer
**Official Title:** A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to Trastuzumab in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, or Are Intolerant to, Previous Trastuzumab Deruxtecan Treatment
#### Organization Study ID Info
**ID:** JZP598-303
#### Organization
**Class:** INDUSTRY
**Full Name:** Jazz Pharmaceuticals
#### Secondary ID Infos
**Domain:** EU CTR
**ID:** 2023-508960-31-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2031-04-25
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2031-04-25
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-16
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Jazz Pharmaceuticals
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The efficacy and safety of zanidatamab in combination with physician's choice of chemotherapy compared with trastuzumab in combination with physician's choice of chemotherapy will be evaluated for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.
**Detailed Description:** Zanidatamab, as a monotherapy or in combination with other antineoplastic agents, has shown clinically meaningful efficacy against multiple HER2-positive advanced/metastatic tumors, including in patients with metastatic breast cancer (mBC). Zanidatamab may offer a viable treatment option for patients with metastatic HER2-positive breast cancer.
The primary objective of the study is to compare the efficacy of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy. The secondary objectives of the study will include further comparing the efficacy, safety and tolerability, patient-reported tolerability, and patient-reported physical functioning of zanidatamab plus chemotherapy versus trastuzumab plus chemotherapy. The pharmacokinetics and immunogenicity of zanidatamab in combination with chemotherapy will also be evaluated.
### Conditions Module
**Conditions:**
- Metastatic HER2-positive Breast Cancer
**Keywords:**
- Zanidatamab
- Trastuzumab
- Metastatic HER2-positive breast cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 550
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants with HER2-positive metastatic breast cancer (mBC) who have progressed on, or are intolerant to, previous T-DXd treatment will be randomized to receive intravenous infusion of zanidatamab plus physician's choice of chemotherapy (eribulin, or vinorelbine, or gemcitabine, or capecitabine).
**Intervention Names:**
- Drug: Zanidatamab
- Drug: Eribulin
- Drug: Vinorelbine
- Drug: Gemcitabine
- Drug: Capecitabine
**Label:** Zanidatamab plus physician's choice of chemotherapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants with HER2-positive metastatic breast cancer (mBC) who have progressed on, or are intolerant to, previous T-DXd treatment will be randomized to receive intravenous infusion of trastuzumab plus physician's choice of chemotherapy (eribulin, or gemcitabine, or vinorelbine, or capecitabine).
**Intervention Names:**
- Drug: Trastuzumab
- Drug: Eribulin
- Drug: Vinorelbine
- Drug: Gemcitabine
- Drug: Capecitabine
**Label:** Trastuzumab plus physician's choice of chemotherapy
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Zanidatamab plus physician's choice of chemotherapy
**Description:** Administered by intravenous infusion
**Name:** Zanidatamab
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Trastuzumab plus physician's choice of chemotherapy
**Description:** Administered by intravenous infusion
**Name:** Trastuzumab
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Trastuzumab plus physician's choice of chemotherapy
- Zanidatamab plus physician's choice of chemotherapy
**Description:** Administered by intravenous infusion
**Name:** Eribulin
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Trastuzumab plus physician's choice of chemotherapy
- Zanidatamab plus physician's choice of chemotherapy
**Description:** Administered by intravenous infusion
**Name:** Vinorelbine
**Type:** DRUG
#### Intervention 5
**Arm Group Labels:**
- Trastuzumab plus physician's choice of chemotherapy
- Zanidatamab plus physician's choice of chemotherapy
**Description:** Administered by intravenous infusion
**Name:** Gemcitabine
**Type:** DRUG
#### Intervention 6
**Arm Group Labels:**
- Trastuzumab plus physician's choice of chemotherapy
- Zanidatamab plus physician's choice of chemotherapy
**Description:** Given orally
**Name:** Capecitabine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** PFS is defined as the time in months from randomization to the date of first documented disease progression (as assessed by BICR according to RECIST v1.1) or death from any cause, whichever occurs first.
**Measure:** Progression-free Survival (PFS) Per RECIST Version 1.1 As Assessed by Blinded Independent Central Review (BICR)
**Time Frame:** Until disease progression or death, up to approximately 44 months
#### Secondary Outcomes
**Description:** OS is defined as the time in months from randomization to the date of death due to any cause.
**Measure:** Overall Survival (OS)
**Time Frame:** Until death, up to approximately 80 months
**Description:** The BICR-assessed confirmed ORR is defined as the proportion of participants who had a best overall response of BICR-assessed Complete Response (CR) or Partial Response (PR) after randomization.
**Measure:** Confirmed Objective Response Rate (ORR) Per RECIST Version 1.1, As Assessed by BICR
**Time Frame:** Until disease progression or death, up to approximately 44 months
**Description:** BICR-assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) as assessed by BICR per RECIST v1.1 or death from any cause.
**Measure:** Duration of Response (DOR) Per RECIST Version 1.1, As Assessed by BICR
**Time Frame:** Until disease progression or death, up to approximately 44 months
**Description:** Investigator-assessed PFS is defined as the time in months from randomization to the date of first documented disease progression (as assessed by investigator according to RECIST v1.1) or death from any cause, whichever occurs first
**Measure:** PFS Per RECIST Version 1.1, As Assessed By Investigator
**Time Frame:** Until disease progression or death, up to approximately 44 months
**Description:** The investigator-assessed confirmed ORR is defined as the proportion of participants who had a best overall response of investigator-assessed confirmed CR or PR after randomization.
**Measure:** Confirmed ORR Per RECIST Version 1.1, As Assessed By Investigator
**Time Frame:** Until disease progression or death, up to approximately 44 months
**Description:** Investigator-assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented PD as assessed by the investigator per RECIST v1.1 or death from any cause.
**Measure:** DOR Per RECIST Version 1.1, As Assessed By Investigator
**Time Frame:** Until disease progression or death, up to approximately 44 months
**Measure:** Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events As Graded by NCI CTCAE Version 5.0
**Time Frame:** Up to approximately 44 months
**Measure:** Number of Participants With Dose Reductions
**Time Frame:** Up to approximately 44 months
**Measure:** Number of Participants Discontinuing Study Treatment Due to TEAEs
**Time Frame:** Up to approximately 44 months
**Measure:** Serum Concentrations of Zanidatamab
**Time Frame:** Up to approximately 44 months
**Measure:** Number of Participants Positive for Anti-drug Antibodies to Zanidatamab
**Time Frame:** Up to approximately 44 months
**Measure:** Proportion of All Treated Participants, As Treated, Reporting Symptomatic Adverse Events While On Treatment Based on PRO-CTCAE and EORTC Item Library
**Time Frame:** Up to approximately 44 months
**Measure:** Proportion of All Treated Participants, As Treated, Reporting Overall Side-effect Bother on the FACIT-GP5
**Time Frame:** Up to approximately 44 months
**Measure:** Proportion of Treated Participants, As Treated, With Maintained or Improved Physical Function While On Treatment Based On The Physical Functioning Subscale of the EORTC QLQ-C30
**Time Frame:** Up to approximately 44 months
### Eligibility Module
**Eligibility Criteria:** Participants are eligible to be included in the study only if all of the following criteria apply:
1. Is 18 years of age or of the legal adult age per local standard at the time of signing the informed consent.
2. Has histologically confirmed HER2-positive breast cancer according to ASCO-CAP Guidelines as evaluated by a central laboratory
3. Participants with unresectable or metastatic HER2 positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.
4. Has measurable disease per RECIST version 1.1.
5. Is eligible to receive one of the chemotherapy options listed in the physician's choice of chemotherapy (eribulin, gemcitabine, vinorelbine, or capecitabine).
6. Participants with history of treated or clinically inactive CNS metastases are eligible as specified in the protocol.
7. Has a life expectancy of at least 6 months, in the opinion of the investigator.
8. Has adequate hematologic parameters as defined in the protocol.
9. Has adequate hepatic function as specified in the protocol.
10. Has creatinine clearance ≥ 30 mL/minute as calculated per local institutional guidelines.
11. Has LVEF ≥ 50% as determined by either echocardiogram or MUGA obtained within 4 weeks before the first dose of study intervention.
12. Has ECOG performance status of 0 or 1.
13. Participant agrees to the following based on sex assigned at birth.
1. Male participants:
Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 5 months after the last dose of study intervention or the contraception period for the combination chemotherapy of choice per local guidance/standard practice, whichever is longer:
* Refrain from donating fresh unwashed semen.
* Use contraception as follows as specified in the protocol
2. Female participants:
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
* Is a women of nonchildbearing potential OR
* Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of \< 1% per year), with low user dependency during the study intervention period and for at least 5 months after the last dose of study intervention or the contraception period for the combination chemotherapy of choice per local guidance/standard practice, whichever is longer.
* A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 3 days before the first dose of study intervention.
* Additional requirements for pregnancy testing during and after study intervention are provided in the protocol.
* The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
14. Is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol.
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. Has known or suspected leptomeningeal disease.
2. Has uncontrolled or significant cardiovascular disease.
3. Has toxicity related to prior cancer therapy that has not resolved to ≤ Grade 1, with exceptions as stated in the protocol.
4. Has uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
5. Has known HIV infection.
6. Has active hepatitis B or C infection.
7. Has an active SARS-CoV-2 infection. Participants with prior infection that has resolved per local institutions' requirements and screening guidance are eligible.
8. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab.
9. Is unable to receive trastuzumab treatment due to medical contraindications.
10. Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site.
11. Has any condition that would prevent treatment with the physician's choice of chemotherapy.
12. Has any issue or condition that in the opinion of the investigator would contraindicate the participant's participation in the study or confound the results of the study.
Prior/Concomitant Therapy
13. Has a history of prior allogeneic bone marrow, stem cell, or solid organ transplantation.
14. Was treated with any local or systemic antineoplastic therapy (including hormonal therapies for breast cancer) or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to randomization.
15. Has a history of trauma or major surgery within 4 weeks prior to randomization.
Other Exclusions
16. Has a known hypersensitivity to any components of the study drugs, including chemotherapy.
17. Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Clinical Trial Disclosure & Transparency
**Phone:** 215-832-3750
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000074322
- Term: Antineoplastic Agents, Immunological
- ID: D000000972
- Term: Antineoplastic Agents, Phytogenic
- ID: D000050257
- Term: Tubulin Modulators
- ID: D000050256
- Term: Antimitotic Agents
- ID: D000050258
- Term: Mitosis Modulators
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M2985
- Name: Gemcitabine
- Relevance: HIGH
- As Found: Activity
- ID: M377
- Name: Capecitabine
- Relevance: HIGH
- As Found: Imaging
- ID: M325
- Name: Trastuzumab
- Relevance: HIGH
- As Found: Quality
- ID: M233243
- Name: Trastuzumab deruxtecan
- Relevance: LOW
- As Found: Unknown
- ID: M1710
- Name: Vinorelbine
- Relevance: HIGH
- As Found: CSF
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M1346
- Name: Antineoplastic Agents, Immunological
- Relevance: LOW
- As Found: Unknown
- ID: M26197
- Name: Tubulin Modulators
- Relevance: LOW
- As Found: Unknown
- ID: M26196
- Name: Antimitotic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000093542
- Term: Gemcitabine
- ID: D000069287
- Term: Capecitabine
- ID: D000068878
- Term: Trastuzumab
- ID: D000077235
- Term: Vinorelbine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435416
**Brief Title:** Predictive Value of Postoperative Prognostic Nutritional Index Trajectory on 1-year Mortality After Off-pump Coronary Artery Bypass Surgery
**Official Title:** Predictive Value of Postoperative Prognostic Nutritional Index Trajectory on 1-year Mortality After Off-pump Coronary Artery Bypass Surgery
#### Organization Study ID Info
**ID:** 3-2023-0184
#### Organization
**Class:** OTHER
**Full Name:** Gangnam Severance Hospital
### Status Module
#### Completion Date
**Date:** 2025-07-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-07-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-07-12
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Gangnam Severance Hospital
#### Responsible Party
**Investigator Affiliation:** Gangnam Severance Hospital
**Investigator Full Name:** Myung Il Bae
**Investigator Title:** Clinical Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study investigated the changing pattern of postoperative Prognostic Nutritional Index (PNI) after off-pump coronary artery bypass surgery using a trajectory analysis. The investigators aimed to investigate the correlation between postoperative PNI recovery patterns and mortality in patients undergoing off-pump coronary artery bypass surgery.
### Conditions Module
**Conditions:**
- Patients Undergoing Off-pump Coronary Artery by Pass Surgery
**Keywords:**
- Prognostic Nutritional Index (PNI)
- Off-pump coronary artery bypass (OPCAB),
- Coronary artery bypass graft surgery (CABG)
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 983
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: No intervention
**Label:** PNI trajectory group 1
#### Arm Group 2
**Intervention Names:**
- Other: No intervention
**Label:** PNI trajectory group 2
### Interventions
#### Intervention 1
**Arm Group Labels:**
- PNI trajectory group 1
- PNI trajectory group 2
**Description:** No intervention
**Name:** No intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** 1 year after surgery
**Measure:** one-year mortality
**Time Frame:** one-year mortality after surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
• Patients aged ≥ 18 years who underwent off-pump coronary artery bypass surgery
Exclusion Criteria:
* Patients without PNI value between 1 and 3 days after surgery
* Patients without PNI value between 20 and 60 days after surgery
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients undergoing off-pump coronary artery bypass surgery
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Myung Il Bae
**Phone:** 82-2-2019-6611
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Myung Il Bae
- **Phone:** 82-2-2019-6611
- **Role:** CONTACT
**Country:** Korea, Republic of
**Facility:** Gangnam Severnace Hospital
**State:** GangnamGu
**Status:** RECRUITING
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435403
**Acronym:** CoVICIS
**Brief Title:** SARS-CoV-2 Specific Antibody Responses and Impact for COVID-19 Disease in Ethiopia
**Official Title:** SARS-CoV-2 Specific Antibody Responses and Impact for COVID-19 Disease in Health Care Worker and Community Members From Ethiopian Related to Natural SARS CoV-2 Infection and COVID-19 Vaccination
#### Organization Study ID Info
**ID:** ETH-02
#### Organization
**Class:** OTHER
**Full Name:** Ludwig-Maximilians - University of Munich
### Status Module
#### Completion Date
**Date:** 2025-02-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-02-28
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-11-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** St. Paul's Hospital Millennium Medical College, Ethiopia
**Class:** OTHER
**Name:** Jimma University
#### Lead Sponsor
**Class:** OTHER
**Name:** Michael Hoelscher
#### Responsible Party
**Investigator Affiliation:** Ludwig-Maximilians - University of Munich
**Investigator Full Name:** Michael Hoelscher
**Investigator Title:** Director, Division of Infectious Diseases and Tropical Medicine, LMU Munich
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** In this study we aim to characterize SARS CoV-2 strain specific immune response (SARS-CoV-2 Spike IgG) in health care workers and general populations at the Jimma Medical Center and the St. Paul Hospital in Addis Ababa in association to clinical immune protection and Covid-19 disease. Participants, stratified by SARS-CoV-2 infection and vaccination status, will be followed at 3-month intervals for a maximum of 2 years. Prevalence, incidence, and dynamics of SARS-CoV-2 specific antibodies as well as clinical assessments especially related to COVID-19 breakthrough disease in previously exposed/vaccinated participants will be performed. From a subset of selected participant blood sample, more in depth immunological analysis will be performed that include virus culture-based neutralization assays, antibody avidity assays, SARS-CoV-2 specific antibody epitope recognition using peptide arrays, and T-cell immunity assays (IGRA).
We also plan to analyze and model cost-effectiveness considerations related to adapted COVID-19 vaccine strategies, specifically if SARS-CoV-2 the costs for routine sero-diagnosis in high SARS-CoV-2 prevalent population prior to vaccination will impact the decision to vaccinate (no vaccination for low-risk populations or reduced vaccine dosing) and is cost-efficient. The study is largely exploratory, providing deeper insights in SARS-CoV-2 specific immune responses and interaction with SARS-CoV-2 viral variants.
**Detailed Description:** The COVID-19 pandemic has severely impacted health systems, interventions for infection control and resulting preventive public life restrictions. In a recent study, we determined high rates of previous SARS-CoV-2 infection in health care worker (over 70%) and communities in Ethiopia (up to 60%), with resulting potential natural acquired SARS-CoV-2 specific immunity. In contrast to the situation in Europe, the scale out of COVID-19 vaccination is however very low, and currently there is a scarcity of COVID-19 vaccines available all over Africa. Naturally acquired or vaccine induced SARS-CoV-2 immune responses have shown to protect against (severe) COVID-19 disease. However, immune responses are waning over time and new SARS-CoV-2 viral variants increasingly demonstrate immune escape properties. Correlates of clinical immune protections are currently investigated including binding SARS-CoV-2 spike IgG or neutralizing antibody levels, as well as cellular immune responses. However, threshold of immune protection are not yet defined that would guide the need of booster vaccinations, including for individuals with natural acquired immunity. There is evidence, that vaccination regimens in those individuals could be abbreviated to single shot booster, that would greatly economize challenged COVID-19 strategies in Africa.
The CoVICIS is a network of European and African researcher who collaborate on the overall objective to investigate SARS-CoV-2 specific immune response and correlates of immune protection in the context of circulating SARS-CoV-2 viral variants. In this affiliated study, we aim to investigate these outcomes in Ethiopian health care worker and community members throughout a longitudinal, prospective cohort study. Participants, stratified according to their SARS-CoV-2 infection and vaccination status, will be followed-up in 3-monthly intervals To characterize SARS CoV-2 strain specific immune response (SARS-CoV-2 Spike IgG) in health care workers and general populations stratified by previous (1) SARS CoV-2 exposure (SARS-CoV-2 anti-nucleocapsid antibody positive versus negative) and (2) vaccination status at the Jimma Medical Center (JMC) and the St. Paul Hospital in Addis Ababa in association to clinical immune protection and Covid-19 disease. Prevalence, incidence, and dynamics of SARS-CoV-2 specific antibodies as well as clinical assessments will be performed in 3-monthly intervals over a maximum period of 24 months.
At each study visits, immune responses including SARS-CoV-2 spike IgG and neutralizing antibody will be measured. In addition, SARS CoV-2-specific T cell responses will be studied in each of the study groups. COVID-19 disease or SARS-CoV-2 infections will be assessed throughout the study by clinical history, SARS-CoV-2 PCR diagnostics, and seroconversion of SARS-CoV-2 anti-nucleocapsid antibody testing as appropriate. In addition, more in-depth analysis will be performed in a subset of stored blood samples at collaborating specialized laboratories in Germany and Switzerland, including peptide array mapping, T-cell assays and affinity/avidity analysis against the ACE-II receptor. We further aim to characterize circulating SARS CoV-2 strains from PCR isolates in the context of investigated immune responses. Outcome results will be provided for computational analysis, integrating models for immune protection. Finally, we will explore the feasibility and cost-effectiveness of abbreviated single shot COVID-19 vaccination for individuals with pre-existing natural immunity to assess COVID-19 vaccine strategies that are especially applicable in African settings.
Findings from this study aim to help in guiding the current Covid-19 control strategy in Ethiopia. It might also give the first insight about the dynamics and level of antibodies produced against SARS-CoV-2 in the Ethiopian population.
### Conditions Module
**Conditions:**
- SARS CoV 2 Infection
- COVID-19 Breakthrough
- COVID-19 Recurrent
**Keywords:**
- COVID-19
- Seroepidemiologic Studies
- Longitudinal Studies
- Ethiopia / epidemiology
- SARS-CoV-2
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 1000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** SARS-CoV-2 anti-nucleocapsid positive, vaccinated
**Label:** Group 1 (N=300)
#### Arm Group 2
**Description:** SARS-CoV-2 anti-nucleocapsid positive, not vaccinated
**Label:** Group 2 (N=300)
#### Arm Group 3
**Description:** SARS-CoV-2 anti-nucleocapsid negative, vaccinated
**Label:** Group 3 (N=300)
#### Arm Group 4
**Description:** SARS-CoV-2 anti-nucleocapsid negative, not vaccinated
**Label:** Group 4 (N=100)
### Outcomes Module
#### Other Outcomes
**Measure:** Difference of extended humoral (e.g. neutralizing antibodies) and cellular immune responses in a subset of participants by study groups at different time points
**Time Frame:** 24 months
**Measure:** Recognition of SARS-CoV-2 specific peptide in a subset of participants by study groups at different time points
**Time Frame:** 24 months
**Measure:** Detection and description of COVID19 and determination of upper respiratory viral load in subjects with (re)infection
**Time Frame:** 24 months
#### Primary Outcomes
**Measure:** Difference of antibody levels between study groups by month 12
**Time Frame:** 12 months
**Measure:** Proportion of participants with suspected clinically reported severe COVID-19 disease or evidence of SARS-CoV-2 exposure between study groups by month 12
**Time Frame:** 12 months
**Measure:** Proportion of SARS-CoV-2 breakthrough infections in previously exposed/vaccinated participants
**Time Frame:** 24 months
#### Secondary Outcomes
**Measure:** Difference of antibody levels between groups by month 6, 18 and 24
**Time Frame:** 24 months
**Measure:** Antibody levels after single 1st vaccination in previously infected persons
**Time Frame:** 24 months
**Measure:** Proportion of participants with suspected clinically reported severe COVID-19 disease or evidence of SARS-CoV-2 exposure between study groups by month 6, 18 and 24
**Time Frame:** 24 months
**Measure:** Prevalence and distribution of circulating SARS-CoV-2 variants around baseline and during the study period
**Time Frame:** 24 months
**Measure:** Costs related to SARS-CoV-2 anti-nucleocapsid diagnostics in relation to spared costs by abbreviated/not performed COVID-19 vaccine regimen
**Time Frame:** 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
1. Adults, 18 years of above
2. Provision of oral as well as written informed consent
3. Available estimation of the period or the time-point when SARS-CoV-2 infection occurred (e.g. confirmed or highly suspected COVID-19 disease, SARS-CoV-2 anti-nucleocapsid seroconversion) (only applicable for participants included in group 1 and 2).
4. Employed/working in hospital (medical doctors, nurses/midwives, students, auxiliary personnel such as cleaner, runner, social worker) for HCW
5. Willingness to provide blood samples by venipuncture for serology and immunological characterization
6. Willingness to provide health information, report medical events and to performed SARS-CoV-2 diagnostics (swabs for PCR) in the case of suspected COVID-19 disease
Exclusion criteria:
1. Prisoners
2. Mentally disturbed persons
3. Persons for whom study participation will induce an unacceptable risk or burden as judged by the investigator (e.g. seriously sick persons)
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Healthcare workers (clinical staff, practicing medical interns, cleaners, guards, food handlers, and receptionists) at the two hospitals and potentially participants from the general urban population in Jimma and Addis Ababa will be included. N=500 participants at each site (N=1000 in total) will be stratified according to their SARS CoV-2 sero-s and Covid-19 vaccination status at inclusion into 4 groups. We aim to target at least 30% representation of HCW's, respectively community participants for each study group.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Arne Kroidl, MD
**Phone:** +49-89-4400
**Phone Ext:** 59816
**Role:** CONTACT
**Contact 2:**
**Name:** Rebecca Kisch
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Addis Ababa
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Solomon Ali, PhD
- **Phone:** +251911488680
- **Role:** CONTACT
**Country:** Ethiopia
**Facility:** Department of Microbiology Immunology and Parasitology
**Status:** RECRUITING
**Location 2:**
**City:** Jimma
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Esayas K Gudina, MD, PhD
- **Phone:** +251917550576
- **Role:** CONTACT
**Country:** Ethiopia
**Facility:** Jimma University
**Status:** RECRUITING
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011024
- Term: Pneumonia, Viral
- ID: D000011014
- Term: Pneumonia
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000018352
- Term: Coronavirus Infections
- ID: D000003333
- Term: Coronaviridae Infections
- ID: D000030341
- Term: Nidovirales Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M2561
- Name: COVID-19
- Relevance: HIGH
- As Found: COVID-19
- ID: M10283
- Name: Infections
- Relevance: HIGH
- As Found: Infection
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13904
- Name: Pneumonia
- Relevance: LOW
- As Found: Unknown
- ID: M13914
- Name: Pneumonia, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20490
- Name: Coronavirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6555
- Name: Coronaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M23685
- Name: Nidovirales Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000007239
- Term: Infections
- ID: D000086382
- Term: COVID-19
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435390
**Brief Title:** Coronavirus Disease 2019 (COVID-19) Pandemic on the Oral Hygiene Status of Children
**Official Title:** The Impact of the COVID-19 Pandemic on the Oral Hygiene Status of Children With High Caries Risk and Their Parents
#### Organization Study ID Info
**ID:** E.630276
#### Organization
**Class:** OTHER
**Full Name:** Gazi University
### Status Module
#### Completion Date
**Date:** 2022-05-15
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-03-15
**Type:** ACTUAL
#### Start Date
**Date:** 2019-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-28
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Gazi University
#### Responsible Party
**Investigator Affiliation:** Gazi University
**Investigator Full Name:** Hanife ALTINIŞIK
**Investigator Title:** Doç. Dr.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The purpose of this study is to compare oral hygiene status and dietary habits of 3-5 years old children and their parents with a questionnaire and clinic examination between pre- and post-COVID-19 period.
**Detailed Description:** Study Rationale and Objectives:
The primary motivation behind this study lies in understanding the impact of the COVID-19 pandemic on oral health behaviors, specifically focusing on children at high risk for dental caries.
Objectives include assessing changes in tooth brushing habits and dietary patterns among both children and their parents.
Study Design:
The study employs a prospective observational design. Participants are parents of 155 children aged 3-5 years. Data collection occurs at two time points: before and after the COVID-19 pandemic.
Data Collection Instruments:
A structured questionnaire is administered to parents. It covers:
Children's and parents' dietary habits (frequency of sugary food consumption). Oral hygiene practices (tooth brushing frequency). The index of decayed-missing-filled deciduous teeth (dmft) is used to assess dental caries status in children.
The COVID-19 pandemic had a limited impact on high-caries-risk children's tooth brushing habits.
However, increased sugary food consumption by both children and parents exacerbated caries risk.
Collaborative efforts between healthcare professionals and parents are crucial to mitigate negative oral health effects during such challenging times.
### Conditions Module
**Conditions:**
- COVID-19 Pandemic
**Keywords:**
- COVID-19
- oral hygiene
- dietary habits
- parents
- pediatric dentistry
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 155
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 3-5 year old 155 children with high caries risk and their parents before and after COVID-19
**Label:** 3-5 year old 155 children with high caries risk and their parents
### Outcomes Module
#### Primary Outcomes
**Description:** Changing tooth brushing and diet habits of 155 children aged 3-5 with high risk of caries during the COVID-19 pandemic period
**Measure:** Changing tooth brushing and diet habits during the COVID-19 pandemic
**Time Frame:** from 15 March to 15 May 2022
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 3-5 year old children with high caries risk. To identify high caries-risk children, the criteria used by the the American Academy of Pediatric Dentistry (AAPD) for assessing a child's dental caries risk were applied.
Exclusion Criteria:
* Childrens with systemic health problems and childrens with any space maintainers.
**Healthy Volunteers:** True
**Maximum Age:** 5 Years
**Minimum Age:** 3 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** This study used retrospective information for healthy 3-5 year old children with high caries risk and their parents who applied to the our University Pediatric Dentistry clinic between September 2019 and March 2020 (in the last six months before COVID-19)
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ankara
**Country:** Turkey
**Facility:** Zeliha Hatipoğlu Palaz
**State:** Biskek Street/ Emek
**Zip:** 06490
#### Overall Officials
**Official 1:**
**Affiliation:** Gazi University
**Name:** ZELIHA HATİPOĞLU PALAZ
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Gazi University
**Name:** NAGEHAN AKTAŞ
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Docimo R, Costacurta M, Gualtieri P, Pujia A, Leggeri C, Attina A, Cinelli G, Giannattasio S, Rampello T, Di Renzo L. Cariogenic Risk and COVID-19 Lockdown in a Paediatric Population. Int J Environ Res Public Health. 2021 Jul 15;18(14):7558. doi: 10.3390/ijerph18147558.
**PMID:** 34300008
**Citation:** Gotler M, Oren L, Spierer S, Yarom N, Ashkenazi M. The impact of COVID-19 lockdown on maintenance of children's dental health: A questionnaire-based survey. J Am Dent Assoc. 2022 May;153(5):440-449. doi: 10.1016/j.adaj.2021.10.004. Epub 2021 Oct 19.
**PMID:** 35221097
**Citation:** Mohapatra RK, Pintilie L, Kandi V, Sarangi AK, Das D, Sahu R, Perekhoda L. The recent challenges of highly contagious COVID-19, causing respiratory infections: Symptoms, diagnosis, transmission, possible vaccines, animal models, and immunotherapy. Chem Biol Drug Des. 2020 Nov;96(5):1187-1208. doi: 10.1111/cbdd.13761. Epub 2020 Jul 26.
**PMID:** 32654267
**Citation:** Daly J, Black EAM. The impact of COVID-19 on population oral health. Community Dent Health. 2020 Nov 30;37(4):236-238. doi: 10.1922/CDH_Dec20editorialDalyBlack03.
**PMID:** 33269826
**Citation:** Greuter W. [Practical industrial medicine in Switzerland]. Soz Praventivmed. 1981 Jul;26(3):126-9. doi: 10.1007/BF02081368. German.
**PMID:** 7293495
**Citation:** Bonneau JC. [Contact allergy to sulfites: contact allergens, sources of exposure, and clinical profile]. Allerg Immunol (Paris). 1994 Nov;26(9):324-6. French.
**PMID:** 7865116
**Citation:** Blumer S, Dagon N, Peretz B, Ratson T, Kharouba J. Function of the Family Unit, Oral Hygiene Rules and Attitudes to Dental Health in Children During First-Wave 2020 COVID-19 Lockdown. J Clin Pediatr Dent. 2021 Jan 1;45(1):1-7. doi: 10.17796/1053-4625-45.1.1.
**PMID:** 33690823
**Citation:** Angelopoulou MV, Seremidi K, Papaioannou W, Gizani S. Impact of the COVID-19 lockdown on the oral health status of paediatric dental patients in Greece. Int J Paediatr Dent. 2023 May;33(3):246-253. doi: 10.1111/ipd.13048. Epub 2023 Mar 13.
**PMID:** 36680387
**Citation:** Goswami M, Grewal M, Garg A. Attitude and practices of parents toward their children's oral health care during COVID-19 pandemic. J Indian Soc Pedod Prev Dent. 2021 Jan-Mar;39(1):22-28. doi: 10.4103/jisppd.jisppd_478_20.
**PMID:** 33885383
**Citation:** Mahagna M, Nir I, Larbier M, Nitsan Z. Effect of age and exogenous amylase and protease on development of the digestive tract, pancreatic enzyme activities and digestibility of nutrients in young meat-type chicks. Reprod Nutr Dev. 1995;35(2):201-12. doi: 10.1051/rnd:19950208.
**PMID:** 7537505
**Citation:** Dickson-Swift V, Kangutkar T, Knevel R, Down S. The impact of COVID-19 on individual oral health: a scoping review. BMC Oral Health. 2022 Sep 22;22(1):422. doi: 10.1186/s12903-022-02463-0.
**PMID:** 36138456
**Citation:** Navarro-Perez CF, Fernandez-Aparicio A, Gonzalez-Jimenez E, Montero-Alonso MA, Schmidt-RioValle J. Effects of COVID-19 lockdown on the dietary habits and lifestyle in a population in southern Spain: a cross-sectional questionnaire. Eur J Clin Nutr. 2022 Jun;76(6):883-890. doi: 10.1038/s41430-021-01034-w. Epub 2021 Oct 28.
**PMID:** 34711931
**Citation:** Olszewska A, Paszynska E, Roszak M, Czajka-Jakubowska A. Management of the Oral Health of Children During the COVID-19 Pandemic in Poland. Front Public Health. 2021 Jul 29;9:635081. doi: 10.3389/fpubh.2021.635081. eCollection 2021.
**PMID:** 34395353
**Citation:** Tellez M, Gomez J, Pretty I, Ellwood R, Ismail AI. Evidence on existing caries risk assessment systems: are they predictive of future caries? Community Dent Oral Epidemiol. 2013 Feb;41(1):67-78. doi: 10.1111/cdoe.12003.
**PMID:** 22978796
**Citation:** Costa AL, Pereira JL, Franco L, Guinot F. COVID-19 Lockdown: Impact on Oral Health-Related Behaviors and Practices of Portuguese and Spanish Children. Int J Environ Res Public Health. 2022 Nov 30;19(23):16004. doi: 10.3390/ijerph192316004.
**PMID:** 36498079
**Citation:** Caramida M, Dumitrache MA, Tancu AMC, Ilici RR, Ilinca R, Sfeatcu R. Oral Habits during the Lockdown from the SARS-CoV-2 Pandemic in the Romanian Population. Medicina (Kaunas). 2022 Mar 5;58(3):387. doi: 10.3390/medicina58030387.
**PMID:** 35334563
**Citation:** Ruiz-Roso MB, de Carvalho Padilha P, Mantilla-Escalante DC, Ulloa N, Brun P, Acevedo-Correa D, Arantes Ferreira Peres W, Martorell M, Aires MT, de Oliveira Cardoso L, Carrasco-Marin F, Paternina-Sierra K, Rodriguez-Meza JE, Montero PM, Bernabe G, Pauletto A, Taci X, Visioli F, Davalos A. Covid-19 Confinement and Changes of Adolescent's Dietary Trends in Italy, Spain, Chile, Colombia and Brazil. Nutrients. 2020 Jun 17;12(6):1807. doi: 10.3390/nu12061807.
**PMID:** 32560550
**Citation:** Hamilton K, Cornish S, Kirkpatrick A, Kroon J, Schwarzer R. Parental supervision for their children's toothbrushing: Mediating effects of planning, self-efficacy, and action control. Br J Health Psychol. 2018 May;23(2):387-406. doi: 10.1111/bjhp.12294. Epub 2018 Jan 18.
**PMID:** 29349924
**Citation:** Kotha SB, AlFaraj NSM, Ramdan TH, Alsalam MA, Al Ameer MJ, Almuzin ZM. Associations between Diet, Dietary and Oral Hygiene Habits with Caries Occurrence and Severity in Children with Autism at Dammam City, Saudi Arabia. Open Access Maced J Med Sci. 2018 Jun 6;6(6):1104-1110. doi: 10.3889/oamjms.2018.245. eCollection 2018 Jun 20.
**PMID:** 29983812
#### See Also Links
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/34300008/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/35221097/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/32654267/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/33269826/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/32569870/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/33549091/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/33690823/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/36680387/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/33885383/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/32978848/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/36138456/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/34711931/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/34395353/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/22978796/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/36498079/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/35334563/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/32560550/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/29349924/
**Label:** COVID-19 Pandemic
**URL:** http://pubmed.ncbi.nlm.nih.gov/29983812/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011024
- Term: Pneumonia, Viral
- ID: D000011014
- Term: Pneumonia
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000007239
- Term: Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000018352
- Term: Coronavirus Infections
- ID: D000003333
- Term: Coronaviridae Infections
- ID: D000030341
- Term: Nidovirales Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M2561
- Name: COVID-19
- Relevance: HIGH
- As Found: COVID-19
- ID: M20490
- Name: Coronavirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M13904
- Name: Pneumonia
- Relevance: LOW
- As Found: Unknown
- ID: M13914
- Name: Pneumonia, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6555
- Name: Coronaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M23685
- Name: Nidovirales Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000086382
- Term: COVID-19
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435377
**Acronym:** EMR+APC
**Brief Title:** Efficacy, Safety and Recurrence After Cold-EMR Plus APC for Large Colonic Lesions
**Official Title:** Prospective Observational Study APC AND BIOPSY POST COLD-EMR IN COLONIC LESIONS
#### Organization Study ID Info
**ID:** Cold-EMR plus APC
#### Organization
**Class:** OTHER
**Full Name:** Istituto Clinico Humanitas
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istituto Clinico Humanitas
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This prospective observational study aims to evaluate the efficacy, safety and recurrence of cold-snaring for large colonic lesions combined with argon plasma coagulation of the resection bed.
### Conditions Module
**Conditions:**
- Colonic Disease
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** * Initial submucosal injection of saline solution and methylene blue, followed by 'piece-meal' resection using a dedicated cold snare
* Biopsy of the resection bed
* Ablation of the defect using argon plasma coagulation (APC).
**Name:** Procedure: Cold EMR + APC
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Evaluation of residual in the biopsy of the defect after the cold-EMR. The specimen will be evaluated independently from the polyp sample.
**Measure:** Residual
**Time Frame:** 1 day
**Description:** The recurrence rate of adenomas at the site of any qualifying, previously resected lesions is measured after 3-6 and 12 months.
**Measure:** Recurrence
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Complete resection of polyp
**Measure:** Efficacy of procedure
**Time Frame:** 1 day
**Description:** Delayed-bleeding, defined was defined as clinical evidence of bleeding (hematemesis, hematochezia or melena or a decrease of hemoglobin concentration \> 2g/dL, which required transfusion or endoscopic reintervention with hemostasis within 30 days of hospital discharge)
**Measure:** Rate of delayed bleeding of the patient
**Time Frame:** 1 day
**Description:** The post-polipectomy syndrome is defined by the presence of fever or abdominal pain
**Measure:** Rate of post-polipectomy syndrome
**Time Frame:** 1 day
**Description:** Rate of perforation and delayed perforation
**Measure:** perforation
**Time Frame:** 1 day
**Description:** Average time of procedure and polyp resection time
**Measure:** Time
**Time Frame:** 1 day
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All patients aged ≧ 18 years undergoing colonoscopy for any indication (screening, anemia, surveillance, or scheduled to undergo endoscopic mucosal resection)
* Lesions of 20 mm and larger.
* All colonic lesions removed using COLD-EMR technique, presenting both adenomatous (Kudo IIIL/IIIS pit pattern)
* Patients who were able to provide written informed consent
Exclusion Criteria:
* Suspected lesions for submucosal invasion (e.g., Kudo V or Paris 0-IIa-IIc with non-granular surface)
* Lesions with a wide Paris 0-Is component (\>10mm) that could increase the risk of submucosal invasion and could limit the mechanical cutting of the snare
* Pedunculated polyps
* Active/quiescent colitis
* Rectal lesions
* Residual or recurrent adenoma after endoscopic mucosal resection
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** All subjects will be evaluated for post-procedural pain (using a VAS scale) and need for pain-killers. As part of the standard care, the patient will receive a 30-day post procedure follow-up phone call or an ambulatory evaluation will be arranged 30-days after the endoscopic procedure, to discuss the histologic results and schedule a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the post procedural pain in the first four weeks after treatment, the need for pain-killers and, should these occur, the adverse events (included fever, hematochezia, need for hospital admission). The rate of recurrence will be calculated by endoscopic visualization of the EMR site at the follow-up (T1:3-6 months; T2 11-13Months) using endoscopic magnification and electronic chromoendoscopy.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Rozzano
**Country:** Italy
**Facility:** Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
**State:** Milano
**Zip:** 20089
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: HIGH
- As Found: Colonic Diseases
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003108
- Term: Colonic Diseases
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M11726
- Name: Methylene Blue
- Relevance: LOW
- As Found: Unknown
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435364
**Brief Title:** Cervical Manual Therapy and Vagus Nerve Stimulation in Patients With Nonspecific Neck Pain
**Official Title:** Investigation of the Effect of Instrument Supported Cervical Manual Therapy Methods and Vagus Nerve Stimulation in Patients With Nonspecific Neck Pain
#### Organization Study ID Info
**ID:** E-10840098-202.3.02-2983
#### Organization
**Class:** OTHER
**Full Name:** Istanbul Medipol University Hospital
### Status Module
#### Completion Date
**Date:** 2024-08-21
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Istanbul Medipol University Hospital
#### Responsible Party
**Investigator Affiliation:** Istanbul Medipol University Hospital
**Investigator Full Name:** hazal genc
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** People with chronic neck pain are becoming more and more common in society every day.
**Detailed Description:** In chronic neck pain investigations, it is generally reported that all people experience neck pain once in my life and more than half of the developed societies experience this problem. It has been stated that 48% of these continue as chronic neck pain, which significantly affects the quality of life due to the postponement of treatment due to its cost.
### Conditions Module
**Conditions:**
- Pain Syndrome
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 50
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This non-invasive system is activated by the cutaneous distribution of vagus nerve afferents via the external ear.
**Intervention Names:**
- Other: Vagus nerve stimilation
**Label:** Vagus nerve
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Manual therapy is effective in the treatment of musculoskeletal pain.
**Intervention Names:**
- Other: Manual therapy
**Label:** Manual therapy
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Vagus nerve
**Description:** This non-invasive system is activated by the cutaneous distribution of vagus nerve afferents through the external ear. Somatosensory innervation is provided by the auricular branch.
**Name:** Vagus nerve stimilation
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Manual therapy
**Description:** Manual therapy is mostly defined by the tissue targeted by the practitioner; it can be joint biased, muscle and connective tissue biased and/or neurovascular system biased techniques.
**Name:** Manual therapy
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Device is a heart rate sensor with the gold standard in high precision and accuracy that comes with a wearable chest strap. It can be connected to multiple training devices via Bluetooth and ANT+. The device features a soft, adjustable sensor that contacts the chest to capture heart rate in real time.
**Measure:** Autonomic nervous system device
**Time Frame:** 4 weeks
**Description:** The neck disability index is the most commonly used functional outcome tool for disabilities in the cervical region. This outcome assessment tool was created by modifying the Oswestry Disability Index and is highly reliable (Chad E. Cook, Amy E. Cook 2011).
Scoring is given for each question as A: 0 points, B: 1 point, C: 2 points, D: 3 points, E: 4 points, F: 5 points. The total score gives the test score. According to the test result 0-4=No disability 5-14= Mild disability 15-24= Moderate disability 25-34 = Severe disability
**Measure:** Neck disability index:
**Time Frame:** 4 weeks
**Description:** Range of motion is the ability of a joint to go through the full range of motion. The range of motion of a joint can be passive or active. Passive ROM - The maximum range of motion through which the joint can move with the aid of external force. Active ROM - the range of motion achieved by contracting and relaxing opposing muscles
**Measure:** Joint Range of Motion
**Time Frame:** 4 weeks
**Description:** The visual analogue scale (VAS) is a validated, subjective measure of acute and chronic pain. Scores are recorded by placing a handwritten mark on a 10 cm line representing the continuum between "no pain" and "worst pain"
**Measure:** The visual analogue scale (VAS)
**Time Frame:** 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria for volunteers and/or study participants;
* Presence of neck pain for at least three months
* Non-specific neck pain
* To have signed the voluntary consent form
Exclusion criteria for volunteers and/or participants;
* Having undergone surgery for the cervical region
* Rehabilitation of the neck area at least three months prior to treatment
* Traumatic medulla spinalis injury
* Neurological deficit
* Rheumatological disease
* Structural spinal disorders
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Hazal GENÇ, PhD
**Phone:** 05413204291
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hazal GENÇ, phd
- **Phone:** +905413204291
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Bahçehir University
**Status:** RECRUITING
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M21485
- Name: Neck Pain
- Relevance: HIGH
- As Found: Neck Pain
- ID: M16355
- Name: Syndrome
- 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: D000019547
- Term: Neck Pain
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435351
**Brief Title:** Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy
**Official Title:** Precision DC: Personalized Neoantigen Dendritic Cell Vaccine Pilot Trial for High Risk Triple Negative Breast Cancer After Neoadjuvant Therapy
#### Organization Study ID Info
**ID:** MCC-23142
#### Organization
**Class:** OTHER
**Full Name:** H. Lee Moffitt Cancer Center and Research Institute
### Status Module
#### Completion Date
**Date:** 2029-05
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2029-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** H. Lee Moffitt Cancer Center and Research Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This is a pilot protocol to evaluate the safety, feasibility, and immunogenicity of a personalized breast cancer vaccine based utilizing whole exome sequencing data of a patient's residual breast tumor following neoadjuvant chemotherapy.
### Conditions Module
**Conditions:**
- Breast Cancer
- Triple Negative Breast Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 16
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The tumor specimen collected from the primary tumor will undergo whole exome sequencing (WES). The WES data will be analyzed to select up to 20 neoantigens. From this screen up to 10 peptides will be selected to be synthesized for testing and use on the DC pheresis product that will be collected.
The ready vaccine product will be cryopreserved and then thawed once the patient is ready to under the vaccination sequence.
**Intervention Names:**
- Procedure: Leukapheresis
- Biological: Dendritic Cell (DC) Vaccine
**Label:** Dendritic Cell (DC) Vaccine
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dendritic Cell (DC) Vaccine
**Description:** Removal of white blood cells (leukocytes) from the blood. The dendritic cells are harvested from the white blood cells that are collected and trained to recognize the specific abnormal proteins found in the tumor sample.
One needle is inserted in each arm. An apheresis machine removes blood from the vein in one arm, separates and retains the leukocytes from the blood, and then returns the rest of the blood to the other arm.
**Name:** Leukapheresis
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Dendritic Cell (DC) Vaccine
**Description:** The vaccine will be given intranodally (inguinal or axillary) under ultrasound guidance using a dose of 40-50 million cells three times spaced 2 weeks apart for the initial priming sequence.
3 doses of the priming vaccines are given once every 2 weeks. 2 booster shots (if available) will be given 6 months and 12 months following completion of initial priming vaccines.
**Name:** Dendritic Cell (DC) Vaccine
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Successful production and administration of DC1 priming vaccination sequence in greater than 60% of patients enrolled.
**Measure:** Percentage of patients enrolled who successfully undergo at least one vaccination.
**Time Frame:** Up to 3 Years
#### Secondary Outcomes
**Description:** Immunogenicity will be determined by ELISpot and reactive T-Cell Receptor (TCR) expansion.
ELISPot is an enzyme-linked immunospot assay. It is a highly sensitive immunoassay that measures the frequency of cytokine-secreting cells at the single-cell level.
**Measure:** Number of participants who achieve Immunogenicity after administration of vaccine
**Time Frame:** Up to 3 Years
**Description:** Disease Free Survival will be measured as the length of time after treatment to cancer recurrence or death from any cause.
**Measure:** Disease Free Survival (DFS)
**Time Frame:** Up to 3 Years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient has stage II-III ER/PR less than or equal to 10% HER2 negative by FISH and/or IHC breast cancer treated with standard of care neoadjuvant systemic chemotherapy and surgical resection with significant residual breast tumor (equivalent to RCB II or III) disease.
* Patient has sufficient residual viable primary breast tumor or ipsilateral breast axillary nodal metastatic cancer tissue accessible to Moffitt for whole exome sequencing.
* Patient is 18 years of age or older.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Patients must have adequate organ and marrow function.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Patients without radiologic evidence of active metastatic disease and who are within 18 months of their last dose curative intent chemotherapy and/or radiotherapy (whichever is later) for the purposes of study enrollment.
* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients with known active locally advanced unresectable or metastatic cancer.
* Patients with significant uncontrolled intercurrent illness or autoimmune disease requiring systemic immunosuppressants that would be deemed unsuitable to participate in the study by the Principal Investigator (PI).
* Patients who have a medical issue in the opinion of the treating physician and/or PI that would make them unsuitable for pheresis.
* Patients who are currently receiving any other investigational agents.
* Patients with psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Neveen Abdo
**Phone:** 813-745-4412
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Tampa
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Neveen Abdo
- **Phone:** 813-745-4412
- **Role:** CONTACT
***Contact 2:***
- **Name:** Hatem Soliman, MD
- **Role:** CONTACT
***Contact 3:***
- **Name:** Hatem Soliman, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Mohammed Al-Jumayl
- **Role:** SUB_INVESTIGATOR
***Contact 5:***
- **Name:** Avan Armaghani
- **Role:** SUB_INVESTIGATOR
***Contact 6:***
- **Name:** Ricardo Costa
- **Role:** SUB_INVESTIGATOR
***Contact 7:***
- **Name:** Martine Extermann
- **Role:** SUB_INVESTIGATOR
***Contact 8:***
- **Name:** Heather Han
- **Role:** SUB_INVESTIGATOR
***Contact 9:***
- **Name:** Susan Hoover
- **Role:** SUB_INVESTIGATOR
***Contact 10:***
- **Name:** Nazanin Khakpour
- **Role:** SUB_INVESTIGATOR
***Contact 11:***
- **Name:** John Kiluk
- **Role:** SUB_INVESTIGATOR
***Contact 12:***
- **Name:** Laura Kruper
- **Role:** SUB_INVESTIGATOR
***Contact 13:***
- **Name:** Marie Lee
- **Role:** SUB_INVESTIGATOR
***Contact 14:***
- **Name:** Loretta Loftus
- **Role:** SUB_INVESTIGATOR
***Contact 15:***
- **Name:** Tracey O'Connor
- **Role:** SUB_INVESTIGATOR
***Contact 16:***
- **Name:** Christine Sam
- **Role:** SUB_INVESTIGATOR
***Contact 17:***
- **Name:** Aixa Soyano Muller
- **Role:** SUB_INVESTIGATOR
***Contact 18:***
- **Name:** Brian Czerniecki
- **Role:** SUB_INVESTIGATOR
***Contact 19:***
- **Name:** Kimberly Lee
- **Role:** SUB_INVESTIGATOR
**Country:** United States
**Facility:** Moffitt Cancer Center
**State:** Florida
**Status:** RECRUITING
**Zip:** 33612
#### Overall Officials
**Official 1:**
**Affiliation:** Moffitt Cancer Center
**Name:** Hatem Soliman, MD
**Role:** STUDY_DIRECTOR
### References Module
#### See Also Links
**Label:** Moffitt Cancer Center Clinical Trials Website
**URL:** http://www.moffitt.org/clinical-trials-research/clinical-trials/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M30373
- Name: Triple Negative Breast Neoplasms
- Relevance: HIGH
- As Found: Triple Negative Breast Cancer
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
- ID: D000064726
- Term: Triple Negative Breast Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17360
- Name: Vaccines
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435338
**Acronym:** HPV Decide
**Brief Title:** Patient Decision Aid Tool for HPV Vaccination Among Adults Ages 27-45 Years Old
**Official Title:** Patient Decision Aid Tool for HPV Vaccination Among Adults Ages 27-45 Years Old
#### Organization Study ID Info
**ID:** 100257
#### Organization
**Class:** OTHER
**Full Name:** The University of Texas Health Science Center at San Antonio
### Status Module
#### Completion Date
**Date:** 2024-01-18
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-01-18
**Type:** ACTUAL
#### Start Date
**Date:** 2023-12-13
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of North Texas Health Science Center
**Class:** OTHER
**Name:** University of South Florida
**Class:** OTHER
**Name:** Temple University
**Class:** OTHER
**Name:** Indiana University School of Medicine
**Class:** INDUSTRY
**Name:** Merck Sharp & Dohme LLC
#### Lead Sponsor
**Class:** OTHER
**Name:** The University of Texas Health Science Center at San Antonio
#### Responsible Party
**Investigator Affiliation:** The University of Texas Health Science Center at San Antonio
**Investigator Full Name:** Erika L. Thompson
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this study is to learn if a patient decision tool for HPV vaccination works for decision-making among adults ages 27-45. Researchers will compare a web-based patient decision tool to an information sheet to see if the tool works for decision-making. Participants will take a baseline survey, view the intervention or control condition, and then take a follow-up survey.
### Conditions Module
**Conditions:**
- Decision Aid
- Hpv
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 632
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patient decision aid on HPV vaccination on webpage.
**Intervention Names:**
- Behavioral: Patient decision aid
**Label:** Patient decision aid
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Vaccine information sheet on HPV vaccination view on webpage.
**Intervention Names:**
- Behavioral: Control
**Label:** Control
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patient decision aid
**Description:** The patient decision aid for HPV vaccination among mid-adults, named HPV Decide. It is delivered online on a website.
**Name:** Patient decision aid
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Control
**Description:** Vaccine information sheet on HPV vaccination. Attention control condition.
**Name:** Control
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** This scale has 16 items and 5 response categories. The decisional conflict scale (DCS) measures personal perceptions of: uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making (in full version) such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. The scores ranged from 0 "no conflict" to 100 "extreme decisional conflict."
**Measure:** Decisional conflict - 16 item scale
**Time Frame:** Immediate post-test
**Description:** Decision conflict scale recommended for every day clinical practice. It has 4 items and two response categories. Scores range from 0 \[extremely high decisional conflict\] to 4 \[no decisional conflict\].
**Measure:** Decisional conflict - 4 item scale
**Time Frame:** Immediate post-test
#### Secondary Outcomes
**Description:** 16-item knowledge item related to human papillomavirus and human papillomavirus vaccination. Scale from 0 \[low knowledge\] to 16 \[high knowledge\].
**Measure:** Knowledge
**Time Frame:** Immediate post-test
**Description:** Intentions for information seeking, talking to a healthcare provider, and getting vaccinated
**Measure:** Intentions
**Time Frame:** Immediate post-test
**Description:** Vaccine decision, including decide to get vaccinated, unsure, and decided not to get vaccinated
**Measure:** Decision
**Time Frame:** Immediate post-test
**Description:** Perceived expectation was assessed by asking participant agreement on a 5-point Likert scale to the following statement, "The effectiveness of the HPV vaccine will vary from person to person." Higher score indicates higher perceived effectiveness.
**Measure:** Perceived expectation
**Time Frame:** Immediate post-test
**Description:** Perceived risks of HPV infection were also assessed, including participants' perceptions of getting an HPV-associated infection genital/anal warts, or cancer in their lifetime. Response options ranged from very unlikely (lower score) to very likely (higher score).
How likely are you to get an HPV related cancer, like cervical, oral, or anal cancer, in your lifetime? How likely are you to get an HPV infection in your lifetime? How likely are you to get anal or genital warts in your lifetime?
**Measure:** Perceived risk
**Time Frame:** Immediate post-test
**Description:** The Decision Self-Efficacy Scale evaluates an individual's self-confidence to make decisions on their own or with support from other sources. Scores range from 0 \[extremely low self-efficacy\] to 100 \[extremely high self efficacy\].
**Measure:** Decision self-efficacy
**Time Frame:** Immediate post-test
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Unvaccinated for HPV
* 27-45 years
* Resides in the United States
* Reads English
* Consents to participate
Exclusion Criteria:
* none
**Gender Based:** True
**Gender Description:** Cis-gender male or female only due to randomization stratification
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 27 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** San Antonio
**Country:** United States
**Facility:** UT School of Public Health San Antonio
**State:** Texas
**Zip:** 78229
### IPD Sharing Statement Module
**Description:** Upon reasonable request to the PI, study materials will be shared.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** O'Connor AM. User Manual - Decisional Conflict Scale (16 item question format). Ottawa: Ottawa Hospital Research Institute. 1993. http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf
**Citation:** Legare F, Kearing S, Clay K, Gagnon S, D'Amours D, Rousseau M, O'Connor A. Are you SURE?: Assessing patient decisional conflict with a 4-item screening test. Can Fam Physician. 2010 Aug;56(8):e308-14.
**PMID:** 20705870
**Citation:** O'Connor AM. User Manual - Decision Self-Efficacy Scale. Ottawa: Ottawa Hospital Research Institute. 1993. http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf
**Citation:** Garg A, Wheldon CW, Galvin AM, Moore JD, Griner SB, Thompson EL. The Development and Psychometric Evaluation of the Mid-adult Human Papillomavirus Vaccine Knowledge Scale in the United States. Sex Transm Dis. 2022 Jun 1;49(6):423-428. doi: 10.1097/OLQ.0000000000001615. Epub 2022 Feb 8.
**PMID:** 35608097
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M17360
- Name: Vaccines
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435325
**Brief Title:** Effectiveness of a Precision Diet Based on Gene Expression Versus a Personalized Mediterranean-Style Diet in Weight Loss
**Official Title:** Effectiveness of a Precision Diet Based on Gene Expression Versus a Personalized Mediterranean-Style Diet in Weight Loss
#### Organization Study ID Info
**ID:** IIBSP-SOB-2022-109
#### Organization
**Class:** OTHER
**Full Name:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-31
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-03
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University of Barcelona
#### Lead Sponsor
**Class:** OTHER
**Name:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
#### Responsible Party
**Investigator Affiliation:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
**Investigator Full Name:** Jose Manuel Soria
**Investigator Title:** Director of the Genomics Unit in Complex Diseases
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The present randomized controlled trial aims to evaluate the relationship between gene expression profiling and the response to a precision diet compared to a personalized Mediterranean-style diet (control diet) in metabolically healthy individuals with overweight and obesity.
Compared to the control diet, the precision diet is expected to increase adherence to dietary recommendations (resulting in weight loss and maintenance). In addition, we postulate that the precision diet will lead to greater lifestyle changes, improving long-term well-being and health in people with overweight and obesity.
**Detailed Description:** The study aims to evaluate the effectiveness of a precision diet based on gene expression versus a personalized Mediterranean-style diet. For this purpose, a 24-week parallel randomized controlled trial will be conducted. Once eligible participants are recruited, each volunteer will attend three clinical visits (at baseline-week 0 \[T0\], week 12 \[T1\], and week 24 \[T2\]), a study initiation visit (at week 1), and five online follow-up visits (at weeks 3, 6, 9, 16 and 20).
First, the participants will come to the baseline visit \[T0\] in which, we will collect data related to health status, body composition, lifestyle, and well-being. In addition, a registered nurse will collect a blood sample for gene expression profiling, along with other biochemical parameters, such as glycemic and lipid markers.
In the following days, the biochemical results from the baseline visit will be evaluated to confirm that the volunteers are metabolically healthy. For this reason, it will not be until seven days after the baseline visit that the eligibility of the participants will be confirmed. After this confirmation, participants will be scheduled for the study initiation visit.
At this visit, the volunteers will be randomly assigned to one of the two study arms, intervention (precision diet) or control diet. Those assigned to the intervention arm will follow the precision diet (a hypocaloric Mediterranean-style diet based on gene expression), while those assigned to the control arm will follow the control diet (a personalized hypocaloric Mediterranean-style diet without considering gene expression).
Then, 12 weeks after the start of the intervention we will schedule the second study visit \[T1\] in which we will evaluate the same variables as in the baseline visit \[T0\]. Likewise, at the end of the intervention (week 24), we will schedule the third study visit \[T2\] in which we will evaluate the same variables as in the baseline visit \[T0\].
In addition, during the 24 weeks of the study, both groups will attend five online follow-up visits (every 3 to 4 weeks) to ensure adherence to the intervention, as well as continuous care and to adapt dietary recommendations when needed.
### Conditions Module
**Conditions:**
- Overweight and Obesity
**Keywords:**
- Personalized nutrition
- Epigenetics
- Metabotype
- Weight Loss
- Well-being
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 61
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The intervention arm will receive a hypocaloric Mediterranean-style diet (TEE - 500kcal, macronutrient distribution: 45 - 55% carbohydrates, 15 - 25% protein, and 25 - 35% fat) with dietary recommendations based on the participant's gene expression profile.
**Intervention Names:**
- Behavioral: Precision diet
**Label:** Intervention arm
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control arm will receive a hypocaloric Mediterranean-style diet (TEE - 500kcal, macronutrient distribution: 45 - 55% carbohydrates, 15 - 25% protein, and 25 - 35% fat) personalized to the participant's dietary and lifestyle habits.
**Intervention Names:**
- Behavioral: Control diet
**Label:** Control arm
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention arm
**Description:** After the recruitment and randomization, the participants will follow the assigned diet and recommendations for 6-months.
**Name:** Precision diet
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Control arm
**Description:** After the recruitment and randomization, the participants will follow the assigned diet and recommendations for 6-months.
**Name:** Control diet
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Calculated as weight (kg) divided by height (in squared meters), BMI= kg/m\^2.
**Measure:** Changes in body mass index (BMI) from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Measured as the percentage of body fat with a body composition analyzer (Inbody 120, Korea).
**Measure:** Changes in body fat from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
#### Secondary Outcomes
**Description:** The RNA from fasting blood samples will be sequenced using Illumina technology and then the Limma software package will be used to analyze gene expression data from the RNA sequence.
**Measure:** Changes in gene expression profiling from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Fasting measurement of triglycerides, total cholesterol, LDL-cholesterol and HDL-cholesterol (mmol/L) will be measured in venous blood with the standard methodology of the clinical analysis laboratory of the Hospital de Sant Pau.
**Measure:** Changes in fasting blood lipids from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Fasting measurement of glucose, insulin, and glycated hemoglobin (mmol/L) will be measured in venous blood with the standard methodology of the clinical analysis laboratory of the Hospital de Sant Pau.
**Measure:** Changes in glycemic markers from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Fasting measurement of CRP will be measured in venous blood with the standard methodology of the clinical analysis laboratory of the Hospital de Sant Pau.
**Measure:** Changes in C-Reactive Protein (CRP) levels from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Measured to the nearest 0.1 cm using a flexible steel anthropometric tape (CESCORF, Brazil) calibrated in centimeters.
**Measure:** Changes in waist and hip circumference from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Measured as the kilograms of muscle mass with a body composition analyzer (Inbody 120, Korea).
**Measure:** Changes in muscle mass from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Measured in Metabolic Equivalents of Task (MET) per minute and week, using the short version of the International Physical Activity Questionnaire (IPAQ). The IPAQ consists of 7 questions that assess the frequency, duration, and intensity of physical activity (moderate and vigorous) performed in the last seven days, as well as walking and sitting time on a workday. The minimum value is 0 MET-minutes/week, indicating no physical activity. Higher scores represent a higher amount of physical activity, while lower scores indicate lower levels of physical activity.
**Measure:** Changes in physical activity from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Energy and nutrient intake will be assessed with a 151-item semi-quantitative food frequency questionnaire (FFQ) (Fernández-Ballart et al., 2010) and a 3-day dietary record (DR), in which participants will record their food intake for three days. The frequency of consumption for each food item is reported on a nine-level incremental scale (never or almost never, 1-3 times per month, once per week, 2-4 times per week, 5-6 times per week, once per day, 2-3 times per day, 4-6 times per day and more than six times per day). To calculate energy and nutrient intake from both methods (FFQ and DR), the Spanish food composition tables will be used.
**Measure:** Changes in energy and nutrient intake from baseline to week 24
**Time Frame:** Week 0, week 12, and 24
**Description:** Diet quality will be evaluated through the 17-item Mediterranean Diet Adherence Screener (MEDAS) (Schröder et al. 2021). Score ranges from 0 to 17, where higher scores indicate greater adherence to the Mediterranean Diet.
**Measure:** Changes in diet quality from baseline to week 24
**Time Frame:** Week 0, week 12 and 24
**Description:** Eating behaviors will be measured with the Spanish version of the Three Factor Eating Questionnaire (TFEQ-R21) (Martín-García et al. 2016). It consists of three subscales: Cognitive Restraint (CR), Uncontrolled Eating (UE), and Emotional Eating (EE). Scores range from 0 to 21 for CR and UE, and from 0 to 15 for EE. Higher scores on each subscale indicate higher levels of the corresponding eating behavior.
**Measure:** Changes in eating behavior from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Well-being will be measured with the Spanish version of the World Health Organization (WHO-5) Well-being Index (Lucas-Carrasco et. al. 2012). Scores range from 0 to 25, where higher scores indicate higher well-being.
**Measure:** Changes in well-being from baseline to weeks 12 and 24.
**Time Frame:** Week 0, 12 and 24
**Description:** Stress will be evaluated through the Perceived Stress Scale (PSS-10), validated for Spanish population (Remor et al. 2006). Scores range from 0 to 40, where higher scores indicate a higher level of perceived stress.
**Measure:** Changes in stress levels from baseline to week 24.
**Time Frame:** Week 0 and 24
**Description:** Anxiety and depression state will be measured by the Hospital Anxiety and Depression Scale (HADS), validated for Spanish population (Herrero et al. 2003). It consists of two subscales: HADS-A, designed to detect anxious states, and HADS-D, designed to detect depressive states. Scores range from o to 21, where higher scores indicate greater levels of anxiety or depression.
**Measure:** Changes in depression and anxiety degree from baseline to week 24.
**Time Frame:** Week 0 and 24
**Description:** Satiety will be evaluated using the Visual Analogue Scale (VAS) after each meal. Scores range from 0 to 100 mm, where higher scores indicate greater levels of satiety.
**Measure:** Changes in satiety from baseline to weeks 9, 16 and 24.
**Time Frame:** Week 1, 9, 16 and 24 .
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* BMI 26-35 Kg/m\^2.
* Metabolically healthy.
Exclusion Criteria:
* Any comorbidity associated with obesity (such as type 2 diabetes mellitus, hypertension, dyslipidemia).
* Medications (Antidepressants; Antipsychotics; Anxiolytic; Statins; Antihypertensives; Insulin or anti-diabetics).
* Intragastric balloon or Bariatric surgery.
* History of weight loss treatment within the previous 3 months.
* Women with menopause, pregnancy, or breastfeeding.
* Smokers.
* Food allergies or intolerances.
* Eating disorders.
* Shift work.
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Maria Izquiero-Pulido, Phd
**Phone:** +34934037293
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Isabella Parilli-Moser, Phd
**Phone:** +34638793344
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Maria Izquierdo Pulido, Phd
- **Phone:** +34934037293
- **Role:** CONTACT
**Country:** Spain
**Facility:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
**Status:** RECRUITING
**Zip:** 08041
#### Overall Officials
**Official 1:**
**Affiliation:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
**Name:** Jose Manuel Soria, Phd
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of Barcelona
**Name:** Maria Izquierdo-Pulido, Phd
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
- ID: D000001836
- Term: Body Weight Changes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
- ID: M26186
- Name: Overweight
- Relevance: HIGH
- As Found: Overweight
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M18102
- Name: Weight Loss
- Relevance: HIGH
- As Found: Weight Loss
- ID: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5115
- Name: Body Weight Changes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000050177
- Term: Overweight
- ID: D000015431
- Term: Weight Loss
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435312
**Acronym:** ziMyG+
**Brief Title:** An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
**Official Title:** An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Zilucoplan in Pediatric Study Participants With Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis
#### Organization Study ID Info
**ID:** MG0015
#### Organization
**Class:** INDUSTRY
**Full Name:** UCB Pharma
#### Secondary ID Infos
**Domain:** EU CT Number
**ID:** 2022-502073-42-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-12-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-10-26
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-13
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** UCB Biopharma SRL
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to assess the long-term safety and tolerability of an additional 52 weeks of Zilucoplan treatment administered by subcutaneous injection once daily in pediatric study participants
### Conditions Module
**Conditions:**
- Generalized Myasthenia Gravis
**Keywords:**
- generalized Myasthenia Gravis
- gMG
- RA101495
- Zilucoplan
- pediatric
- MG0015
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 8
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Study participants will receive Zilucoplan at a pre-defined dose based on their weight.
**Intervention Names:**
- Drug: Zilucoplan
**Label:** Zilucoplan Arm
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Zilucoplan Arm
**Description:** Zilucoplan will be administered subcutaneously to pediatric study participants
**Name:** Zilucoplan
**Other Names:**
- RA101495
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** An adverse event (AE) is any untoward medical occurence in a patient or clinical investigation where the study participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
**Measure:** Occurence of treatment emergent adverse events during the course of the study
**Time Frame:** Baseline (Day 1) to Safety Follow-up (up to Week 60)
**Description:** A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
Results in death Is life-threatening Requires inpatient hospitalization Results in persistent disability/incapacity Is a congenital anomaly/birth defect Important medical event.
**Measure:** Occurence of treatment-emergent serious adverse events (TESAEs)
**Time Frame:** Baseline (Day 1) to Safety Follow-up (up to Week 60)
**Description:** An adverse event (AE) is any untoward medical occurence in a participant or clinical investigation administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to permanent withdrawal of study medication.
**Measure:** Occurence of treatment-emergent advserse events leading to permanent withdrawal of investigational medicinal product
**Time Frame:** Baseline (Day 1) to Safety Follow-up (up to Week 60)
**Description:** Percentage of participants who experienced treatment-emergent infections as adverse events.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
**Measure:** Occurence of treatment-emergent infections
**Time Frame:** Baseline (Day 1) to Safety Follow-up (up to Week 60)
#### Secondary Outcomes
**Description:** Blood samples for the measurement of plasma concentrations of Zilucoplan will be collected at Week 52.
**Measure:** Plasma concentration of Zilucoplan at Week 52
**Time Frame:** Week 52
**Description:** Blood samples for measurement of sRBC lysis will be collected at Week 52.
**Measure:** Sheep red blood cell (sRBC) lysis activity at Week 52
**Time Frame:** Week 52
**Description:** Blood samples for measurement of C5 will be collected at Week 52.
**Measure:** Blood complement component 5 (C5) levels at Week 52
**Time Frame:** Week 52
**Description:** The MG-ADL score is an 8-item patient-reported outcome (PRO) instrument. The MG-ADL targets symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The item responses are scored from 0 to 3, and the total score of MG-ADL is the sum of the 8 items and ranges from 0 to 24, with a higher score indicating more disability.
**Measure:** Myasthenia Gravis Activity of Daily Living (MG-ADL) score at Week 52
**Time Frame:** Week 52
**Description:** QMG score is a standardized and validated quantitative strength scoring system that was developed specifically for MG. The QMG total score is obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3). The score ranges from 0 to 39, with lower scores indicating lower disease activity.
**Measure:** Quantitative Myasthenia Gravis (QMG) score at Week 52
**Time Frame:** Week 52
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
United States of America (USA) specific inclusion criterion:
- Participant must be ≥ 12 years of age at the time of signing the Informed Consent/Assent according to local regulation.
Rest of World (ROW) specific inclusion criterion:
- Participant must be ≥ 2 years of age at the time of signing the Informed Consent/Assent according to local regulation.
Global specific inclusion criteria:
* Participant has completed the MG0014 according to the protocol, and further treatment with zilucoplan is in the interest of the participant in the investigator´s opinion
* Participant agrees to receive booster vaccinations against meningococcal infections during the study, if clinically indicated according to the local standard of care
Exclusion Criteria:
* Study participant met any mandatory investigational medicinal product (IMP) withdrawal or mandatory permanent discontinuation criteria in MG0014 or permanently discontinued IMP
* Participant has known positive serology for muscle-specific kinase
* Participant has known hypersensitivity to any components of the IMP
* Participant has a prior history of meningococcal disease
**Minimum Age:** 12 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** UCB Cares
**Phone:** +18445992273
**Phone Ext:** (USA)
**Role:** CONTACT
**Contact 2:**
**Name:** UCB Cares
**Phone:** 001 844 599 2273
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** 001 844 599 2273 (UCB)
**Name:** UCB Cares
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
**Description:** Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- CSR
**IPD Sharing:** YES
**Time Frame:** Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
**URL:** https://www.Vivli.org
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009135
- Term: Muscular Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000020879
- Term: Neuromuscular Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020361
- Term: Paraneoplastic Syndromes, Nervous System
- ID: D000009423
- Term: Nervous System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000010257
- Term: Paraneoplastic Syndromes
- ID: D000020274
- Term: Autoimmune Diseases of the Nervous System
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000020511
- Term: Neuromuscular Junction Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12112
- Name: Myasthenia Gravis
- Relevance: HIGH
- As Found: Myasthenia Gravis
- ID: M20944
- Name: Muscle Weakness
- Relevance: HIGH
- As Found: Myasthenia
- ID: M4554
- Name: Asthenia
- Relevance: LOW
- As Found: Unknown
- ID: M13204
- Name: Paresis
- Relevance: LOW
- As Found: Unknown
- ID: M12092
- Name: Muscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22619
- Name: Neuromuscular Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M13170
- Name: Paraneoplastic Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M22160
- Name: Paraneoplastic Syndromes, Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M12367
- Name: Nervous System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22297
- Name: Neuromuscular Junction Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T3973
- Name: Myasthenia Gravis
- Relevance: HIGH
- As Found: Myasthenia Gravis
### Condition Browse Module - Meshes
- ID: D000009157
- Term: Myasthenia Gravis
- ID: D000018908
- Term: Muscle Weakness
### Intervention Browse Module - Browse Branches
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M3473
- Name: Acetylcholine
- Relevance: LOW
- As Found: Unknown
- ID: M4225
- Name: Antibodies
- Relevance: LOW
- As Found: Unknown
- ID: M10184
- Name: Immunoglobulins
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435299
**Acronym:** CANNABITCH
**Brief Title:** Efficacy and Tolerance of Cannabidiol in Patients With Severe Pruritus: a Multicenter, Double-blind, Randomized, Placebo-controlled Study
**Official Title:** Efficacy and Tolerance of Cannabidiol in Patients With Severe Pruritus: a Multicenter, Double-blind, Randomized, Placebo-controlled Study
#### Organization Study ID Info
**ID:** 29BRC23.0164
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Brest
### Status Module
#### Completion Date
**Date:** 2024-09-28
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-14
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-27
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Brest
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Pruritus is defined as an unpleasant sensation leading to the need to scratch. Medications for pruritus are much less effective than those used for pain and it is imperative to find new therapeutic options.
Over the last 20 years, the understanding of the pathophysiology of pruritus has progressed significantly, opening new possible therapeutic fields. Among these, cannabinoids seem very promising because the physiological inhibitory role of endocannabinoids, mainly produced by neurons, has been well demonstrated. Data from the literature suggest that the antipruritic effects of cannabinoids are due to a combination of effects on neuronal activation, transmission along the afferent pathway, and local modulation of keratinocytes and mast cells. The antipruritic effect is peripheral and central, through modulation of CB1, CB2 or TRPV1 channels. CB1 and CB2 receptors are specific cannabinoid receptors, CB1 being present at the central and peripheral level while CB2 is only peripheral and very present in the skin. Cannabinoids can also bind to TRPV1, and thus inhibit neurogenic inflammation by antagonizing or stabilizing this ion channel, which prevents neuronal activation by pruritogenic mediators. Phytocannabinoids are derived from cannabis and are used for a variety of purposes, with their development for medical purposes expanding rapidly. The two best known are tetrahydrocannabinol (THC) and cannabidiol (CBD). THC binds to TRPV1, CB2 and CB1, the activation of the latter being at the origin of parallel psychotropic effects. CBD binds mainly to TRPV1, which allows us to expect very favorable effects on pruritus, neurogenic inflammation and skin pain, without fearing side effects of this type.
A limited number of studies suggest that cannabinoids may be useful topically or systemically, in humans or animals, but no comparative study with placebo has been performed. These encouraging results have been observed in cases of induced pruritus, idiopathic pruritus, eczema, uremic pruritus, cholestatic pruritus, prurigo, sensitive skin or even epidermolysis bullosa.
Currently, the ANSM is conducting an evaluation of the effects of medical cannabis on severe pain. We propose to evaluate the effects on severe pruritus in a randomized placebo-controlled study one of the products chosen by the ANSM in this context, the oil LITTLE GREEN PHARMA, which we choose for its dominant CBD ratio (THC \< 5 mg/ml, CBD \> 5 mg/ml).
### Conditions Module
**Conditions:**
- Pruritus
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 218
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Cannabis oil 50mg/mL arm :
An auto-titration phase will take place during the first 14 days of treatment: 0.2 ml on the first day then increase of 0.2 ml every 2 days in 2 daily doses, that is to say 1.4 ml/day maximum.
If any tolerable side-effects occurred, patients were advised not to increase the dose; if intolerable side-effects occurred, dose reduction was advised.
After initial titration, the dose will then be maintained for 4 consecutive weeks.
**Intervention Names:**
- Drug: Cannabis oil
**Label:** Cannabis oil
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo arm :
An auto-titration phase will take place during the first 14 days of treatment: 0.2 ml on the first day then increase of 0.2 ml every 2 days in 2 daily doses, that is to say 1.4 ml/day maximum.
If any tolerable side-effects occurred, patients were advised not to increase the dose; if intolerable side-effects occurred, dose reduction was advised.
After initial titration, the dose will then be maintained for 4 consecutive weeks.
**Intervention Names:**
- Drug: Placebo
**Label:** PLACEBO
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cannabis oil
**Description:** Patients in this arm will have to take Cannabis oil (50mg/mL) twice a day with the daily dose estimated during auto titration phase (from W0 to W2)
**Name:** Cannabis oil
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- PLACEBO
**Description:** Patients in this arm will have to take Placebo oil twice a day with the daily dose estimated during auto titration phase (from W0 to W2)
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6.
**Measure:** WI-NRS change
**Time Frame:** Week 0
**Description:** Binary outcome (success or failure). Success is defined by a reduction of 30% in WINRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) from the inclusion visit to week 6.
**Measure:** WI-NRS change
**Time Frame:** Week 6
#### Secondary Outcomes
**Description:** - Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from inclusion visit to week 2.
**Measure:** WI-NRS change from W0 to W2
**Time Frame:** Week 0
**Description:** - Proportion of patients achieving at least a weekly mean reduction of 4 points in WI-NRS (Worst Itching Intensity Numerical Rating Scale - On a scale of 0 (no itch) to 10 (worst itch imaginable)) score from inclusion (= Week 0) visit to week 2.
**Measure:** WI-NRS change from W0 to W2
**Time Frame:** Week 2
**Description:** - Change in ItchyQoL score from inclusion (= Week 0) visit to week 2 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W2
**Time Frame:** Week 0
**Description:** - Change in ItchyQoL score from inclusion (= Week 0) visit to week 2 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W2
**Time Frame:** Week 2
**Description:** - Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 2 (The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W2
**Time Frame:** Week 0
**Description:** - Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 2(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W2
**Time Frame:** Week 2
**Description:** - Change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W6
**Time Frame:** Week 0
**Description:** - Change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W6
**Time Frame:** Week 2
**Description:** - Change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W6
**Time Frame:** Week 4
**Description:** - Change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL change from W0 to W6
**Time Frame:** Week 6
**Description:** - Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL percent change from W0 to W6
**Time Frame:** Week 0
**Description:** - Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL percent change from W0 to W6
**Time Frame:** Week 2
**Description:** - Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL percent change from W0 to W6
**Time Frame:** Week 4
**Description:** - Percent change in ItchyQoL score from inclusion (= Week 0) visit to week 6.(The ItchyQoL questionnaire contains 22 items, and each item is rated on a 5-point scale, ranging from 1 = never to 5 = all the time)
**Measure:** ItchyQoL percent change from W0 to W6
**Time Frame:** Week 6
**Description:** - Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W2
**Time Frame:** Week 0
**Description:** - Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W2
**Time Frame:** Week 2
**Description:** - Percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W2
**Time Frame:** Week 0
**Description:** - Percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 2 (10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W2
**Time Frame:** Week 2
**Description:** - Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W6
**Time Frame:** Week 0
**Description:** - Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W6
**Time Frame:** Week 2
**Description:** - Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W6
**Time Frame:** Week 4
**Description:** - Change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6. (10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale evolution from W0 to W6
**Time Frame:** Week 6
**Description:** - Percent change and percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W6
**Time Frame:** Week 0
**Description:** - Percent change and percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W6
**Time Frame:** Week 2
**Description:** - Percent change and percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W6
**Time Frame:** Week 4
**Description:** - Percent change and percent change in Chronic Itch Burden Scale - 10 from inclusion (= Week 0) visit to week 6.(10 questions rated from "Not at all" to "Very much" on patient itching)
**Measure:** Chronic Itch Burden Scale change from W0 to W6
**Time Frame:** Week 6
**Description:** - Incidence and severity of treatment-emergent adverse events.
**Measure:** Treatment adverse events
**Time Frame:** Week 0
**Description:** - Incidence and severity of treatment-emergent adverse events.
**Measure:** Treatment adverse events
**Time Frame:** Week 2
**Description:** - Incidence and severity of treatment-emergent adverse events.
**Measure:** Treatment adverse events
**Time Frame:** Week 4
**Description:** - Incidence and severity of treatment-emergent adverse events.
**Measure:** Treatment adverse events
**Time Frame:** Week 6
**Description:** - Incidence and severity of treatment-emergent adverse events.
**Measure:** Treatment adverse events
**Time Frame:** Week 8
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 years
* Severe pruritus, defined by a mean WI-NRS score ≥7/10 (evaluated on one week before inclusion, regardless of the cause of the pruritus
* Insufficient relief (WI-NRS ≥7/10 ) or poor tolerance (adverse effects) of accessible drug and non-drug therapies
* Stable treatment (for treatment of the prurit) for at least 6 weeks
Exclusion Criteria:
* Inability of the patient to give free and informed consent
* Personal history of psychotic disorders
* Severe hepatic impairment (prothrombin level \<50%)
* Moderate to severe renal impairment (estimated glomerular filtration rate ≤ 44 mL/min/1.73 m2 ?)
* Disease or history of severe cardiovascular or cerebrovascular disorders (myocardial infraction, stroke)
* Pregnant or breastfeeding woman
* Lack of understanding of questionnaires or inability to follow up - Inability of the patient to give free and informed consent
* Personal history of psychotic disorders
* Severe hepatic impairment (prothrombin level \>50%) or predictive biological impairment
* Severe renal impairment (Estimated glomerular filtration rate ≤ 44 mL/min/1.73 m2 ? )
* Severe cardiovascular (myocardial infarction, cardiovascular accident) or cerebrovascular disease or history of such disease
* Pregnant or breastfeeding woman
* Lack of understanding of questionnaires or inability to follow up
* Cannabinoid use outside the clinical trial
* Use of cannabis or its derivatives less than one week before inclusion
* History of hypersensitivity or allergy to any cannabinoid product
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Laurent MISERY, PU-PH
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012871
- Term: Skin Diseases
- ID: D000012877
- Term: Skin Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14396
- Name: Pruritus
- Relevance: HIGH
- As Found: Pruritus
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15680
- Name: Skin Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011537
- Term: Pruritus
### Intervention Browse Module - Browse Branches
- Abbrev: AntiConv
- Name: Anticonvulsants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M5445
- Name: Cannabidiol
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435286
**Brief Title:** Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States
**Official Title:** Effectiveness and Performance of a Mobile, Automated, Optical Biopsy Technology for Esophageal Cancer Screening: A Clinical Study in Brazil and the United States
#### Organization Study ID Info
**ID:** H-53483
#### Organization
**Class:** OTHER
**Full Name:** Baylor College of Medicine
### Status Module
#### Completion Date
**Date:** 2026-08-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** William Marsh Rice University
**Class:** OTHER
**Name:** M.D. Anderson Cancer Center
**Class:** OTHER
**Name:** Instituto do Cancer do Estado de São Paulo
**Class:** OTHER
**Name:** Hospital de Cancer de Barretos - Fundacao Pio XII
#### Lead Sponsor
**Class:** OTHER
**Name:** Baylor College of Medicine
#### Responsible Party
**Investigator Affiliation:** Baylor College of Medicine
**Investigator Full Name:** Sharmila Anandasabapathy
**Investigator Title:** Professor of Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** In a previous clinical trial in China and the United States (US), the investigators developed and validated a mobile, high-resolution microendoscope (mHRME) for screening and surveillance of esophageal squamous cell neoplasia (ESCN). The trial revealed higher specificity for qualitative (visual) interpretation by experts but not the novice and in the surveillance arm (100% vs. 19%, p \<0.05). In the screening arm, diagnostic yield (neoplastic biopsies/total biopsies) increased 3.6 times (8 to 29%); 16% of patients were correctly spared any biopsy, and 18% had a change in clinical plan. In a pilot study in Brazil, the investigators tested a software-assisted mHRME with deep-learning software algorithms to aid in the detection of neoplastic images and determine the performance, efficiency, and impact of the AI-mHRME when to Lugol's chromoendoscopy (LCE) alone and when using AI-mHRME with LCE. In this clinical trial, the investigators will build on the Brazil pilot trial data to optimize an artificial intelligence (AI) mHRME and evaluate its clinical impact and implementation potential in ethnically and socioeconomically diverse populations in the US and Brazil.
**Detailed Description:** The investigators' hypothesis is that the artificial intelligence (AI) mobile, high-resolution microendoscope (mHRME) will increase the accuracy of Lugol's chromoendoscopy (LCE) in endoscopic cancer detection in low- and middle-income countries (LMICs) and high-income countries (HICs).
Objective 1: The investigators' first objective is to evaluate the diagnostic performance, efficiency, and impact of this automated optical biopsy device. In a single-arm study (n=200) of high-risk subjects undergoing LCE followed by AI-mHRME for ESCN screening in Brazil and the US, the investigators will evaluate the diagnostic performance and efficiency of this automated optical biopsy device.
The investigators' other hypotheses are that the AI-mHRME will:
1. increase the mHRME accuracy in novices and be non-inferior to experts,
2. increase user confidence among experts and novices, and
3. increase the LCE efficiency and impact byreducing biopsies and second procedures.
The investigators will compare the accuracy of the AI-mHRME software read to novice and expert clinicians' subjective reading to gold-standard histopathology by an expert gastrointestinal (GI) pathologist. For clinician confidence and clinical impact, they will determine the clinician's confidence level in the software diagnosis and the potential clinical impact of this diagnosis among novice and expert endoscopists using AI-mHRME. The clinician reads will be part of the mHRME procedure and treatment "plan" (biopsy vs. not biopsy vs. treat). Clinicians are not considered study subjects in objective 1. The clinical impact will be determined by the change in the clinician's decision in the treatment "plan" before and after the AI-mHRME read. For efficiency (biopsy saving and diagnostic yield), they will determine the number of patients spared any biopsy due to AI-mHRME. The investigators will compare the diagnostic yield of AI-mHRME and LCE vs. LCE alone (diagnostic yield = neoplastic biopsies/total number of biopsies obtained in biopsied patients).
Objective 2: This objective will have three study populations, with a total sample size of n=50 subjects. To determine barriers and facilitators to implementing AI-mHRME, the team will form Health Sector Stakeholder Advisory Boards (HS-SAB) in the US and Brazil as the first study population. The HS-SABs will include academic partners, primary care providers referring patients, doctors performing esophageal cancer screening, hospital administrators, and patient and caregiver representatives. The HS-SAB sample size will be 6-10 members in the US and Brazil each, a standard number of participants for research advisory boards. The team will collect feedback and input through focus group discussions (FGDs) at 6 time points across the project period per HS-SAB. FGD objectives will match the research stage: clinical trial planning (recruitment and retention plan refinement), data collection (stakeholders identification), result interpretation, and dissemination.
For the second study population, the team will conduct semi-structured individual interviews with implementers to assess barriers and facilitators to implementing AI-assisted cancer technologies (n=40). Interviews will be with patients and caregivers(n=10), GI clinicians (n=10), primary care physicians (n=10), and hospital and health leadership (n=10).
There will be surveys with endoscopists (n=40) at the participating sites to understand their thoughts on HRME.
### Conditions Module
**Conditions:**
- Suspected or Known Squamous Cell Neoplasia
- Prior History of Squamous Cell Dysplasia and /or Neoplasia
**Keywords:**
- Squamous cell neoplasia
- Proflavine
- Lugol's chromoendoscopy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** Participants will be enrolled based on criteria for surveillance or screening for esophageal squamous cell carcinoma. They will receive standard-of-care endoscopy and the artificial intelligence mobile high-resolution microendoscopy procedures.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All subjects will receive White Light Imaging (WLI) and Lugol's Chromoendoscopy (LCE), the current standard of care (SOC) procedure. Following LCE, all subjects will receive the artificial intelligence (AI) mobile high-resolution microendoscopy (mHRME) imaging with Proflavine Hemisulfate of any LCE abnormal and LCE normal areas (4:1 ratio). For both WLI and LCE, we will record the subjective clinician read (neoplastic, non-neoplastic), the confidence level in their diagnoses (high, low), and the action plan (biopsy vs. no biopsy vs. treat). With the AI-mHRME, we will image the same LCE abnormal and normal areas and record the software read, the clinician confidence level, and action plan. Finally, the imaged LCE abnormal areas will be biopsied or resected, and evaluated by a pathologist.
**Intervention Names:**
- Drug: Proflavine Hemisulfate
- Device: Artificial Intelligence Mobile High-Resolution Microendoscope
**Label:** Artificial Intelligence Mobile High Resolution Microendoscope (AI-mHRME) imaging
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Artificial Intelligence Mobile High Resolution Microendoscope (AI-mHRME) imaging
**Description:** Approximately 5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa.
**Name:** Proflavine Hemisulfate
**Other Names:**
- Proflavine
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Artificial Intelligence Mobile High Resolution Microendoscope (AI-mHRME) imaging
**Description:** The AI-mHRME will be inserted through the endoscope biopsy channel and gently placed against the mucosa where proflavine was sprayed. The probe will transmit images to the computer/laptop for the clinician to observe any abnormal tissues and save photos of these tissues.
**Name:** Artificial Intelligence Mobile High-Resolution Microendoscope
**Other Names:**
- AI-mHRME
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Change in clinical plan ('biopsy vs. no biopsy vs. treat') following AI-mHRME.
**Measure:** Clinical Impact
**Time Frame:** 18 months
**Description:** Sensitivity, specificity, positive and negative predictive values of AI-mHRME.
**Measure:** Performance Characteristics
**Time Frame:** 18 months
**Description:** Efficiency in the number of biopsies saved, procedures saved.
**Measure:** Procedure Efficiency
**Time Frame:** 18 months
**Description:** Confidence of expert and novice clinicians in clinically interpreting mHRME (pre- and post-use of AI-mHRME).
**Measure:** Clinician Confidence
**Time Frame:** 18 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Outpatients undergoing routine (standard of care) Lugol's chromoendoscopic screening for squamous cell neoplasia will be eligible for enrollment, including patients with a known history of head/neck squamous cell cancer; heavy smoking and alcohol, other dietary or geographic risk factors or prior dysplasia
* Patients \>18 years old.
* Patients of any sex or gender.
* Patients who are willing and able to give informed consent.
Exclusion Criteria:
* Allergy or prior reaction to the fluorescent contrast agent proflavine hemisulfate.
* Patients who are unable to give informed consent.
* Known advanced squamous cell carcinoma of the distal esophagus or dysplastic/suspected malignant esophageal lesion greater than or equal to 2 cm in size not amenable to endoscopic therapy.
* Patient unable to undergo routine endoscopy with biopsy:
* Women who are pregnant or breast feeding,
* Prothrombin time greater than 50% of control; PTT greater than 50 sec, or INR greater than 2.0,
* Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sharmila Anandasabapathy, MD
**Phone:** 7137980950
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Adrianna O Maliga, MPH
**Phone:** (713) 798-5987
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Adrianna O Maliga, MPH
- **Phone:** 713-798-5987
- **Role:** CONTACT
***Contact 2:***
- **Name:** Sharmila Anandasabapathy, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Baylor St. Luke's Medical Center
**State:** Texas
**Zip:** 77030
**Location 2:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Adrianna O Maliga, MPH
- **Phone:** 713-798-5987
- **Role:** CONTACT
***Contact 2:***
- **Name:** Mimi C Tan, MD, MPH
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Ben Taub Hospital (Harris Health Systems)
**State:** Texas
**Zip:** 77030
**Location 3:**
**City:** Barretos
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Elisa R Baba, MD, PhD
- **Phone:** +55-11-98501-9190
- **Role:** CONTACT
***Contact 2:***
- **Name:** Elisa R Baba, MD, PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Claudio Hashimoto, MD, MBA
- **Role:** SUB_INVESTIGATOR
**Country:** Brazil
**Facility:** Hospital de Cancer de Barretos - Fundacao Pio XII
**State:** São Paulo
**Zip:** 14784-400
**Location 4:**
**City:** São Paulo
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Fauze Maluf-Filho, MD
- **Phone:** +55-11-9919-19014
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Elaine U Uehara, MS
- **Phone:** +55-11-3893-3535
- **Role:** CONTACT
***Contact 3:***
- **Name:** Fauze Maluf-Filho, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** Evandro Sobroza de Mello, MD
- **Role:** SUB_INVESTIGATOR
**Country:** Brazil
**Facility:** Instituto do Câncer do Estado de São Paulo
**Zip:** 01246-000
#### Overall Officials
**Official 1:**
**Affiliation:** Baylor College of Medicine
**Name:** Sharmila Anandasabapathy, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-05-07
- Filename: Prot_SAP_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: True
- Label: Study Protocol and Statistical Analysis Plan
- Size: 315623
- Type Abbrev: Prot_SAP
- Upload Date: 2024-05-23T16:17
- Date: 2024-05-07
- Filename: ICF_001.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 107478
- Type Abbrev: ICF
- Upload Date: 2024-05-23T16:17
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000006258
- Term: Head and Neck Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000004935
- Term: Esophageal Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M8088
- Name: Esophageal Neoplasms
- Relevance: HIGH
- As Found: Esophageal Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M9348
- Name: Head and Neck Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8085
- Name: Esophageal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T2141
- Name: Esophageal Cancer
- Relevance: HIGH
- As Found: Esophageal Cancer
### Condition Browse Module - Meshes
- ID: D000004938
- Term: Esophageal Neoplasms
- ID: D000009369
- Term: Neoplasms
### Intervention Browse Module - Ancestors
- ID: D000000891
- Term: Anti-Infective Agents, Local
- ID: D000000890
- Term: Anti-Infective Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Coag
- Name: Coagulants
### Intervention Browse Module - Browse Leaves
- ID: M14242
- Name: Proflavine
- Relevance: HIGH
- As Found: Alternating with
- ID: M193072
- Name: Lugol's solution
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4215
- Name: Anti-Infective Agents, Local
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000011370
- Term: Proflavine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435273
**Acronym:** ARTEMISIA
**Brief Title:** A Randomised, Double-blind, Parallel Group, Placebo Controlled, 4-Week, Phase II Study to Evaluate the Effect of AZD4604 on Airway Inflammation and Biomarkers in Adults With Asthma
**Official Title:** A Randomised, Double-blind, Parallel Group, Placebo Controlled, 4-Week, Phase II Study to Evaluate the Effect of AZD4604 on Airway Inflammation and Biomarkers in Adults With Asthma
#### Organization Study ID Info
**ID:** D8210C00005
#### Organization
**Class:** INDUSTRY
**Full Name:** AstraZeneca
#### Secondary ID Infos
**Domain:** EMA
**ID:** 2023-510291-32-00
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-08-12
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-08-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-31
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** AstraZeneca
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of this study is to investigate the effect on airway inflammation and JAK1-associated signalling pathways of AZD4604 compared with placebo in participants with moderate-to-severe asthma.
Study details include:
* The study duration for each participant will be approximately 10 weeks.
* The duration of IMP administration will be approximately 4 weeks.
**Detailed Description:** This is a multicentre, randomised, placebo-controlled, double-blind study to investigate the effect on airway inflammation and JAK1-associated signalling pathways of AZD4604, administered over a 4-week treatment period to adult patients with moderate-to-severe asthma. The study will recruit patients receiving treatment with medium-to-high dose inhaled corticosteroid-long-acting beta-agonist (ICS-LABA) at screening and having a history of at least one severe asthma exacerbation within the year prior to Visit 1 or have an Asthma control questionnaire-6 (ACQ-6) score ≥ 1.5 at Visit 1. Enrolled participants will be randomised into the study to either AZD4604 or placebo. Participants discontinuing the study before the completion of Visit 6a (including the second bronchoscopy) will be replaced. Participants will be randomised using an interactive response technology/randomisation and trial supply management system at a ratio of 2:1 to AZD4604 or placebo, respectively. Randomisation will be stratified based on fractional exhaled nitric oxide (FeNO) levels to ensure a similar proportion of participants with FeNO above and below 25 parts per billion (ppb) in the 2 treatment arms. The study will be conducted at approximately 28 sites in approximately 5 countries.
### Conditions Module
**Conditions:**
- Asthma
**Keywords:**
- Asthma, Mechanistic Study, Bronchoscopy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 48
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** AZD4604
**Intervention Names:**
- Drug: AZD4604
**Label:** AZD4604
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo to AZD4604
**Intervention Names:**
- Drug: Placebo to AZD4604
**Label:** Placebo to AZD4604
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- AZD4604
**Description:** Janus kinase 1 (JAK1) inhibitor
**Name:** AZD4604
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo to AZD4604
**Description:** Placebo to AZD4604
**Name:** Placebo to AZD4604
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Gene expression in airway epithelial cells
**Measure:** Change from baseline to end of investigational medicinal product (IMP) administration in expression of T2 and non-T2, and JAK1-related genes and gene signatures in bronchial brushings
**Time Frame:** 4 weeks
#### Secondary Outcomes
**Description:** To evaluate the effect of AZD4604 as compared to placebo on STAT phosphorylation in the airways
**Measure:** Change from baseline to end of IMP administration in STAT phosphorylation in bronchial biopsies
**Time Frame:** 4 weeks
**Description:** To explore the effect of AZD4604 on cellular pathology in the airways as compared to placebo
**Measure:** Change in number of airway cells, including but not limited to inflammatory cells, airway smooth muscle cells, and goblet cells from baseline to end of IMP administration in bronchial biopsies (cells per mm² determined by microscopic evaluation)
**Time Frame:** 4 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Documented physician-diagnosed asthma ≥ 12 months prior to screening (Visit 1).
* Participants treated with medium-to-high dose ICS in combination with LABA at a stable dose for at least 2 months prior to Visit 1 (the ICS can be contained within an ICS-LABA fixed dose combination product or as separate inhaled products regularly taken together). Treatment with additional asthma controller therapies (eg, long-acting muscarinic antagonist, leukotriene receptor antagonist) at a stable dose ≥ 2 months prior to Visit 1 is allowed. Treatment with maintenance systemic corticosteroids (oral or injectable) is not allowed.
* A documented history of ≥ 1 severe asthma exacerbation within 1 year prior to Visit 1 or ACQ-6 ≥ 1.5 at Visit 1. A severe asthma exacerbation is defined as a worsening of asthma that leads to an inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥ 24 hours) due to asthma.
* Morning pre-BD FEV1 ≥ 60% predicted at Visit 1.
* Able to perform acceptable lung function testing for FEV1 according to American Thoracic Society/ European Respiratory Society (ATS/ERS) 2019 acceptability criteria.
* Able and willing to undertake bronchoscopy. There should be no absolute contra-indications to bronchoscopy as outlined in the bronchoscopy manual.
* Documented evidence of asthma in the 5 years up to or including Visit 1.
* Able and willing to comply with the requirements of the protocol including ability to read, write, be fluent in the translated language of all participant-facing questionnaires used at the study site, and use electronic devices, eg, electronic patient reported outcomes (ePRO) device and spirometer.
* Body weight ≥ 40 kg and body mass index \< 35 kg/m2.
* All females must have a negative serum pregnancy test result at Visit 1.
* Females not of childbearing potential are defined as females who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
* All FOCBP who are sexually active with a non-sterilised male partner must agree to use one highly effective method of birth control.
Exclusion Criteria:
* A severe asthma exacerbation within 8 weeks prior to Visit 1.
* History of herpes zoster reactivation (shingles).
* Clinically important pulmonary disease other than asthma, eg, active lung infection, chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, history or planned lung lobectomy, alpha-1 anti-trypsin deficiency, primary ciliary dyskinesia, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, and hyper-eosinophilic syndrome.
* Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator.
* Any clinically significant cardiac or cerebrovascular disease.
* History of venous thromboembolism.
* Participants with a recent history of, or who have a positive test for, infective hepatitis or unexplained jaundice, or participants who have been treated for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Positivity for hepatitis B virus (HBV) surface antigen is a reason for exclusion.
* Current or prior history of alcohol or drug abuse (including marijuana), as judged by the investigator. Positive drug screening result that cannot be justified by participant's medical history and its relevant treatment (over-the-counter product or a valid prescription), or history of or current alcohol or drug abuse (including marijuana and marijuana-containing valid prescriptions), as judged by the investigator.
* History of malignancy other than superficial basal cell carcinoma.
* Treatment with systemic corticosteroid (short-term or maintenance) use within 8 weeks (oral) or 12 weeks (intramuscular) before Visit 1.
* Any immunosuppressive therapy (including hydroxychloroquine, methotrexate, cyclosporine, and tacrolimus) within 12 weeks prior to Visit 1.
* Treatment with marketed biologics including benralizumab, mepolizumab, reslizumab, omalizumab, dupilumab, and tezepelumab within 6 months or 5 half-lives of Visit 1, whichever is longer.
* Inhaled corticosteroid plus fast-acting β2 agonist as a rescue medication (eg, Symbicort, Fostair, or Airsupra Maintenance and Reliever Treatment) is not allowed 30 days prior to Visit 1, during screening, run-in and baseline periods, throughout the treatment period, and preferably until 1 week after the last administration of the IMP.
* Live, attenuated, or mRNA vaccines within 4 weeks of Visit 1.
* Immunoglobulin therapy or blood products within 4 weeks of Visit 1.
* Any immunotherapy within 6 months of Visit 1, except for stable maintenance dose allergen-specific immunotherapy started at least 4 weeks prior to Visit 1 and expected to continue through to the end of the follow-up period.
* Anticoagulants (including vitamin K antagonists and Factor Xa inhibitors). Antiplatelet agents are allowable if in the opinion of the investigator they can be safely withheld for 7 days prior to the procedure.
* Participants with a known hypersensitivity to AZD4604 or any of the excipients of the product.
* Abnormal findings identified on physical examination, ECG, or laboratory testing include, but not limited to: Alanine aminotransferase/transaminase (ALT) or aspartate aminotransferase/transaminase AST ≥ 1.5 × upper limit of normal (ULN), Total bilirubin (TBL) ≥ ULN (unless due to known Gilbert's disease), Evidence of chronic liver disease, International Normalised Ratio (INR) \> 1.5, Platelet count \< 150,000 per microliter, Abnormal vital signs, after 5 minutes of supine or sitting rest (confirmed by 1 controlled measurement), defined as any of the following: Systolic blood pressure (BP) \< 80 mmHg or ≥ 150 mmHg, Diastolic BP \< 50 mmHg or ≥ 95 mmHg, Pulse \< 50 bpm or \> 100 bpm, Signs of pulmonary oedema or volume overload, Any clinically significant rhythm, conduction, or morphology abnormalities in the ECG including but not limited to QT interval corrected using Fridericia's formula (QTcF) \> 450 ms.
For female participants only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
* Current smokers or participants with smoking history ≥ 10 pack-years.
* Participants with a known long-term exposure to occupational asbestos, silica, radon, heavy metals, and polycyclic aromatic hydrocarbons.
* Positive, first-degree family history of primary lung cancer.
* Positive urine cotinine test at Visit 1 and at any timepoint throughout the study.
* Major surgery within 8 weeks prior to Visit 1, or planned inpatient surgery, major dental procedure or hospitalisation during screening, treatment, or follow-up periods.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** AstraZeneca Clinical Study Information Center
**Phone:** 1-877-240-9479
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Calgary
**Country:** Canada
**Facility:** Research Site
**State:** Alberta
**Zip:** T2N 4Z6
**Location 2:**
**City:** North Vancouver
**Country:** Canada
**Facility:** Research Site
**State:** British Columbia
**Zip:** V7L 2L7
**Location 3:**
**City:** Montreal
**Country:** Canada
**Facility:** Research Site
**State:** Quebec
**Zip:** H4A 3J1
**Location 4:**
**City:** Quebec
**Country:** Canada
**Facility:** Research Site
**Zip:** G1V 4G5
**Location 5:**
**City:** Aalborg
**Country:** Denmark
**Facility:** Research Site
**Zip:** 9100
**Location 6:**
**City:** Hvidovre
**Country:** Denmark
**Facility:** Research Site
**Zip:** 2650
**Location 7:**
**City:** Vejle
**Country:** Denmark
**Facility:** Research Site
**Zip:** 7100
**Location 8:**
**City:** Essen
**Country:** Germany
**Facility:** Research Site
**Zip:** 45239
**Location 9:**
**City:** Frankfurt/Main
**Country:** Germany
**Facility:** Research Site
**Zip:** 60389
**Location 10:**
**City:** Frankfurt
**Country:** Germany
**Facility:** Research Site
**Zip:** 60596
**Location 11:**
**City:** Grosshansdorf
**Country:** Germany
**Facility:** Research Site
**Zip:** 22927
**Location 12:**
**City:** Peine
**Country:** Germany
**Facility:** Research Site
**Zip:** 31224
**Location 13:**
**City:** Barcelona
**Country:** Spain
**Facility:** Research Site
**Zip:** 08035
**Location 14:**
**City:** Santander
**Country:** Spain
**Facility:** Research Site
**Zip:** 39008
**Location 15:**
**City:** Birmingham
**Country:** United Kingdom
**Facility:** Research Site
**Zip:** B9 5SS
**Location 16:**
**City:** Leicester
**Country:** United Kingdom
**Facility:** Research Site
**Zip:** LE3 9QP
**Location 17:**
**City:** Liverpool
**Country:** United Kingdom
**Facility:** Research Site
**Zip:** L7 8YE
**Location 18:**
**City:** London
**Country:** United Kingdom
**Facility:** Research Site
**Zip:** W12 0HS
**Location 19:**
**City:** Manchester
**Country:** United Kingdom
**Facility:** Research Site
**Zip:** M23 9QZ
**Location 20:**
**City:** Oxford
**Country:** United Kingdom
**Facility:** Research Site
**Zip:** OX3 7LE
**Location 21:**
**City:** Southampton
**Country:** United Kingdom
**Facility:** Research Site
**Zip:** SO9 4XY
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001982
- Term: Bronchial Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000008171
- Term: Lung Diseases
- ID: D000012130
- Term: Respiratory Hypersensitivity
- ID: D000006969
- Term: Hypersensitivity, Immediate
- ID: D000006967
- Term: Hypersensitivity
- ID: D000007154
- Term: Immune System Diseases
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC20
- Name: Immune System Diseases
### Condition Browse Module - Browse Leaves
- ID: M10293
- Name: Inflammation
- Relevance: HIGH
- As Found: Inflammation
- ID: M4556
- Name: Asthma
- Relevance: HIGH
- As Found: Asthma
- ID: M5258
- Name: Bronchial Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11170
- Name: Lung Diseases, Obstructive
- Relevance: LOW
- As Found: Unknown
- ID: M10018
- Name: Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M14967
- Name: Respiratory Hypersensitivity
- Relevance: LOW
- As Found: Unknown
- ID: M10020
- Name: Hypersensitivity, Immediate
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001249
- Term: Asthma
- ID: D000007249
- Term: Inflammation
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435260
**Brief Title:** To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Locally Advanced Pancreatic Cancer
**Official Title:** To Explore the Efficacy of Hypofractionated Radiotherapy Followed by AG Regimen Chemotherapy Plus Camrelizumab Immunotherapy as Neoadjuvant Therapy for Locally Advanced Pancreatic Cancer
#### Organization Study ID Info
**ID:** ARK-pancreatic-001
#### Organization
**Class:** OTHER
**Full Name:** Hebei Medical University Fourth Hospital
### Status Module
#### Completion Date
**Date:** 2027-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hebei Medical University Fourth Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** The purpose of this study is to assess surgical conversion rate and the immediate and long-term outcomes to patients who receive hypofractionated radiotherapy and AG combined with camrelizumab immunotherapy of locally advanced pancreatic cancer.
### Conditions Module
**Conditions:**
- Pancreatic Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Efficacy evaluation was performed within 2 weeks after the end of neoadjuvant therapy, surgical treatment was performed in patients assessed as operable and in those with a clear intention to undergo surgery, postoperative adjuvant chemotherapy and ICIs were determined according to the patient's tolerance and independent will, and enter the follow-up period.
**Intervention Names:**
- Drug: Camrelizumab+chemotherapy
- Radiation: hypofractionated radiotherapy
**Label:** Hypofractionated radiotherapy+Camrelizumab+chemotherapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Hypofractionated radiotherapy+Camrelizumab+chemotherapy
**Description:** Chemotherapy combined with ICIs was started 5-7 days after the completion of radiotherapy:
AG: intravenous nab-paclitaxel 125 mg/m2 and gemcitabine 1000mg/m2 d1,8, q3w, 4 cycles.
Camrelizumab: 200mg, iv, 30min, q3w, 4 cycles.
**Name:** Camrelizumab+chemotherapy
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Hypofractionated radiotherapy+Camrelizumab+chemotherapy
**Description:** Hypofractionated radiotherapy: pGTV:40Gy/5F, PTV≥25Gy/5F.
**Name:** hypofractionated radiotherapy
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Description:** There was no residual by the microscope
**Measure:** a.R0-resection rate
**Time Frame:** within 3 weeks after surgery
#### Secondary Outcomes
**Description:** The proportion of tumor markers in turned negative
**Measure:** Conversion to negative rate
**Time Frame:** up to 23 weeks
**Description:** Baseline to measured stable disease
**Measure:** Objective response rate (ORR)
**Time Frame:** tumor assessment every 6 weeks since the treatment began, up to 24 months
**Description:** Baseline to measured progressive disease
**Measure:** Disease control rate (DCR)
**Time Frame:** tumor assessment every 6 weeks since the treatment began, up to 24 months
**Description:** Baseline to measured date of death from any cause
**Measure:** 3-year Overall survival (OS)
**Time Frame:** 3 years
**Description:** DFS is defined as the time from registration to the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause. Patients without an event are censored at the date of last evaluation.
**Measure:** 3-year Disease Free Survival (DFS)
**Time Frame:** 3 years
**Description:** Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of participants with adverse events will be recorded at each treatment visit.
**Measure:** Adverse events
**Time Frame:** 3 years
**Description:** Evaluate the quality of life according to QOL-BREF. The number of participants with quality of life will be recorded at each treatment visit.
**Measure:** Quality of life
**Time Frame:** 1 years after therapy
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age:18 to 75 years old, male or female;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
3. Tumor was located in the pancreas;
4. Pathological diagnosis was pancreatic ductal adenocarcinoma or acinar cell carcinoma;
5. No distant metastasis;
6. Clinical assessment was locally advanced (at least qualified one of the following criteria:①Lymph node metastasis outside the surgical area;②tumor surrounded more than half of the superior mesenteric vein;③tumor was adjacent to or wrapped more than half of the celiac artery;④Superior mesenteric vein or portal vein occlusion is not suitable for revascularization;⑤Invasion or wrapping of the aorta).
7. There was no history of immune system diseases, other malignant tumors, myocarditis, coronary heart disease, other cardiovascular and cerebrovascular diseases, thyroid dysfunction, liver and kidney diseases, psychiatric diseases, infectious diseases, or systemic diseases other than those mentioned above.
Participants were willing to join in this study, good adherence and written informed consent.
Exclusion Criteria:
1. Patients who did not meet these inclusion criteria;
2. Poor cognitive ability, inability to answer questions, inability to fill out questionnaires, or mental disorders;
3. The investigators think inappropriate.
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Li Peng
**Phone:** 13933868818
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shijiazhuang
**Country:** China
**Facility:** Fourth Hospital of Hebei Medical University
**State:** Hebei
**Zip:** 050011
#### Overall Officials
**Official 1:**
**Affiliation:** Fourth Hospital of Hebei Medical
**Name:** Li Peng
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Fourth Hospital of Hebei Medical
**Name:** Fengpeng Wu
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000010182
- Term: Pancreatic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13110
- Name: Pancreatic Neoplasms
- Relevance: HIGH
- As Found: Pancreatic Cancer
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13102
- Name: Pancreatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T4387
- Name: Pancreatic Cancer
- Relevance: HIGH
- As Found: Pancreatic Cancer
### Condition Browse Module - Meshes
- ID: D000010190
- Term: Pancreatic Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M19537
- Name: Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M231
- Name: Albumin-Bound Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M2985
- Name: Gemcitabine
- 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 |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435247
**Acronym:** AAR
**Brief Title:** The Effect of Accompainment by Older Adults on Anesthetic Recovery
**Official Title:** The Effect of Accompainment by Older Adults on Anaesthetic Recovery
#### Organization Study ID Info
**ID:** CMABC-24-18
#### Organization
**Class:** OTHER
**Full Name:** American British Cowdray Medical Center
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** American British Cowdray Medical Center
#### Responsible Party
**Investigator Affiliation:** American British Cowdray Medical Center
**Investigator Full Name:** Mariana Guadalupe García Hernandez
**Investigator Title:** Physician investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Summary:
In 2022, Mexico estimated a population of 17,958,707 older adults. With increased life expectancy, it is essential to seek strategies that improve the health of this population, as they are more vulnerable compared to other age groups due to functional and cognitive decline, along with an increase in chronic diseases and medication intake. During this stage of life, there is a possibility of requiring surgical treatment, which is the focus of this protocol proposing a maneuver that impacts patients' health without requiring economic costs. The proposal suggests the accompaniment of older adults by a family member during the immediate post-anesthetic period. Hypothesis: Accompaniment of older adults during the immediate postoperative period improves the quality of anesthetic recovery by 60%. This value is based on a study by Shem, where accompanying older adults prior to anesthetic induction resulted in a 61% reduction in anxiety among older adults. Anesthesiologists have expanded their role in perioperative medicine alongside geriatric medicine services for older surgical patients.
An experimental study will be conducted with two randomly divided groups: one group with accompaniment and one group without accompaniment in the recovery area. Both groups will be assessed using different questionnaires: 1. Pfeiffer Test for cognitive impairment diagnosis, 2. QoR-15 to assess the quality of anesthetic recovery, 3. Beck Anxiety Questionnaire, all of which will be administered 24 hours after surgery. Delirium will also be assessed using NuDESC at 24 hours, day 5, and 30 days after surgery. General data prior to surgery will be recorded, and vital signs such as heart rate, blood pressure, and pain on a verbal scale from 0 to 10 will be monitored during the postoperative period.
Statistical analysis will involve representing baseline characteristics of the population using mean and standard deviation or median and interquartile range, depending on the distribution type. X2 will be used to compare both groups in terms of outcomes. Finally, a multivariate analysis will be conducted using logistic regression to adjust for confounding variables.
**Detailed Description:** Justification:
Due to the increase in life expectancy and the growing number of older adults worldwide and in our country, it is important to search for and implement feasible and cost-free measures to improve the quality of medical care, specifically in surgical treatments that impact the reduction of complications, shorten recovery time, and indirectly improve the quality of life for these patients.
Feasibility and relevance:
* The research question aims to improve the quality of medical care for older adults with a humanistic approach.
* In a group of people that will continue to grow, with a longer life expectancy, they will require surgical treatments.
* There are no articles evaluating the quality of anesthetic recovery or its impact on their health with accompaniment.
* Approximately 222 surgeries are performed in this population every month, making it a frequent occurrence.
* It is a measure that does not incur any cost.
* It can be applied in any hospital setting.
Problem statement:
The increase in life expectancy worldwide has led to a larger population of older adults, and Mexico is no exception. Therefore, it is important to establish measures that improve the quality of medical care and reduce complications in this age group, using measures that do not incur any economic costs. Specifically, in the perioperative period, proposing the accompaniment of older adults in the anesthetic recovery area.
Research question:
Does the accompaniment of older adults improve the quality of anesthetic recovery with a score higher than 122 on the QoR15 scale?
Hypotheses:
Null hypothesis:
The accompaniment of older adults in the immediate postoperative period does not improve the quality of anesthetic recovery with a score lower than 121 on the QoR15 scale.
Alternative hypothesis:
The accompaniment of older adults in the immediate postoperative period improves the quality of anesthetic recovery with a score higher than 122 on the QoR15 scale.
Overall objective:
- Determine if the accompaniment of older adults improves the quality of anesthetic recovery, classified as good or excellent according to the QoR15 scale with a score of 122 to 150.
Specific objectives:
* Determine the incidence of anxiety in older adults in the anesthetic recovery area, considering anxiety with a score higher than 22 on the Beck scale.
* Determine the presence or absence of delirium in older adults in the perioperative period.
* Assess if the accompaniment of older adults reduces the length of stay in the anesthetic recovery area, aiming for a stay of no more than 60 minutes.
### Conditions Module
**Conditions:**
- Old Age; Debility
**Keywords:**
- ederly, quality of anesthetic recovery, accompaniment
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** This is a randomized clinical trial design with two groups
* One group will have family accompaniment in the recovery area, the other will not
* The QoR-15 scale will be used to measure the quality of anesthetic recovery
* The randomization was done using the OpenEpi software
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 240
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The first group will have a family member accompany them in the recovery area
**Intervention Names:**
- Behavioral: With or without accompainment in the recovery anaesthetic area
**Label:** Accompainment in the recovery area
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The second group will not have accompainment as is currently standard practice
**Label:** without accompainment
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Accompainment in the recovery area
**Description:** one grup will have family accompainment in the recovery area and the other group will not in both groups the QoR15 scale will be used to measure the quality of anesthetic recovery
**Name:** With or without accompainment in the recovery anaesthetic area
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** The goal is to evaluate the impact of this accompainment on enhancing the quality of patients anesthetic recovery, as measured by the QoR15 scale
**Measure:** The best score in the QoR15 scale
**Time Frame:** Within 24 hours followin the surgical procedure
#### Secondary Outcomes
**Description:** Anxiety will be measured in both groups: the intervetion grup and the control grup. This assessment will occur at two time points
**Measure:** Anxiety in both groups measured using the Beck Anxiety Scale
**Time Frame:** Before the surgical procedure and 24 hors after the surgical event
**Description:** Delirium will be measured in the two grups at 3 times points post surgery
**Measure:** Delirium
**Time Frame:** 24 hours, day 5 and day 30.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria: Scheduled for elective surgery under balanced anesthesia with a hospital stay not exceeding 48 hours.
* ASA I y II
* Education level Hight school or higher
Exclusion Criteria:
* History of diseasses associated with dementia
* Emergency surgery.
* Regional anesthesia or sedation
* Moderate to severe cognitive impairment
* History of smoking or drugs
* Surgerios with risk of major bleeding more or equal 1000ml
* Hip or long bone surgeries
**Healthy Volunteers:** True
**Minimum Age:** 60 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Mariana Garcia, investigator
**Phone:** +525541922325
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Juan Talavera, consultant
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Mexico City
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mariana Garcia, Investigator
- **Phone:** +525541922325
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Juan Talavera, consultor
- **Role:** CONTACT
**Country:** Mexico
**Facility:** The American Brithish Cowdray Medical Center, I.A.P
**Zip:** 01120
#### Overall Officials
**Official 1:**
**Affiliation:** American British Cowdray Medical Center
**Name:** Mariana Garcia, investigator
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M1175
- Name: Frailty
- Relevance: HIGH
- As Found: Debility
### Condition Browse Module - Meshes
- ID: D000073496
- Term: Frailty
### Intervention Browse Module - Ancestors
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: HIGH
- As Found: Provider
### Intervention Browse Module - Meshes
- ID: D000000777
- Term: Anesthetics
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435234
**Brief Title:** Construction of a Risky Sexual Behaviour Intervention Programme for College Students Based on BCW Theory
**Official Title:** Construction of a Risky Sexual Behaviour Intervention Programme for College Students Based on BCW Theory
#### Organization Study ID Info
**ID:** HMUDQ20231116201
#### Organization
**Class:** OTHER
**Full Name:** Harbin Medical University
### Status Module
#### Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Rong Zhang
#### Responsible Party
**Investigator Affiliation:** Harbin Medical University
**Investigator Full Name:** Rong Zhang
**Investigator Title:** Principal Investigator
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Using the intervention functions of Behavior Change Wheel (BCW) and BCTs, we constructed an intervention program for college students' risky sexual behaviors by combining literature analysis, qualitative research, Delphi's expert correspondence, and pre-experiment (20 students in the test group and 20 students in the control group). Before the intervention (T0) and at the end of the intervention (12 weeks, T1), we measured students' psychosexual health, social support, and sexual self-efficacy using relevant scales to ensure the effectiveness of the intervention. By clarifying the influencing factors of college students' risky sexual behaviors, the proposed intervention program for college students' risky sexual behaviors can effectively reduce the incidence of college students' risky sexual behaviors, improve the level of college students' psychosexual health, increase the level of social support, improve the sense of sexual self-efficacy, improve the level of risk perception, enhance the ability of risky decision-making, reduce the risky behaviors, and reduce the occurrence of adverse outcomes, thus providing a reference and reference for the prevention and control of college students' risky sexual behaviors. This will provide reference for the prevention and control of risky sexual behaviors among college students.
### Conditions Module
**Conditions:**
- Unsafe Sex
**Keywords:**
- Risky sexual behavior
- BCW
- college students
- intervention program
- unsafe sex
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: risky sexual behavior intervention
**Label:** intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Label:** control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- intervention group
**Description:** Intervening in risky sexual behaviors among college students
**Name:** risky sexual behavior intervention
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Questionnaire on Sexual Mental Health of College Students.A total of 31 entries were made, each of which was scored using a Likert 5 scale (1=completely disagree, 5=completely agree), with 25 items scored positively and 6 items scored negatively.
Total scores ranged from 31-155, with higher scores indicating lower levels of psychosexual health
**Measure:** Sexual mental health
**Time Frame:** pre-intervention(T0); At the end of the intervention(12 weeks, T1)
**Description:** Social Support Rating Scale for College Students.There are 17 entries in total. Each entry was scored on a Likert 5-point scale (1=very non-compliant, 5=very compliant), with a total score range of 17-85, with higher scores indicating that 5-point Likert scale (1=very poorly met, 5=very well met), with a total score ranging from 17-85, with higher scores indicating that college students received more social support
**Measure:** Social Support
**Time Frame:** pre-intervention(T0); At the end of the intervention(12 weeks, T1)
**Description:** Sexual Self-Efficacy Scale.There are a total of 34 entries. The first five dimensions were each scored on a 5-point Likert scale (1=strongly disagree, 5=strongly agree), and the last two dimensions were each scored on a scale of 0 (never) to -4 (more than 5 times), for a total score of 130, with higher scores indicating higher sexual self-efficacy
**Measure:** Sexual self-efficacy
**Time Frame:** pre-intervention(T0); At the end of the intervention(12 weeks, T1)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. aged ≥16 years;
2. full-time undergraduate college students;
3. engaged in risky sexual behaviors (including multiple sexual partners, unprotected sex, and casual sex, and one of them is considered to have engaged in risky sexual behaviors) during their college years;
4. able to clearly recall and describe the incident;
5. signed an informed consent form
Exclusion Criteria:
1. not wanting to be asked sex-related questions;
2. being screened at the beginning of the semester using the Mental Health Survey and diagnosed by a psychiatrist as having a mental illness (schizophrenia, major depressive disorder, bipolar disorder)
**Healthy Volunteers:** True
**Maximum Age:** 24 Years
**Minimum Age:** 16 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### IPD Sharing Statement Module
**Description:** Non-disclosure of study data due to ethical requirements and protection of subjects' privacy
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435221
**Acronym:** ORCA-OL
**Brief Title:** Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers
**Official Title:** A Multicenter, Open-Label Study Assessing Long-Term Exposure With Cytisinicline 3 mg TID
#### Organization Study ID Info
**ID:** ACH-CYT-13
#### Organization
**Class:** INDUSTRY
**Full Name:** Achieve Life Sciences
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-24
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Achieve Life Sciences
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Safety assessment of long-term 3 mg cytisinicline three times daily (TID) exposure for 52 weeks is the main purpose of this study, conducted in the United States.
### Conditions Module
**Conditions:**
- Smoking Cessation
- Vaping Cessation
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 650
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Cytisinicline 3 mg TID for 52 weeks.
**Intervention Names:**
- Drug: Cytisinicline
**Label:** Cytisinicline 3 mg TID
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cytisinicline 3 mg TID
**Description:** film-coated oral tablets containing 3 mg cytisinicline
**Name:** Cytisinicline
**Other Names:**
- Cytisine
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Incidence Rate of Treatment Emergent Serious Adverse Events (SAEs)
**Time Frame:** up to Week 52
#### Secondary Outcomes
**Measure:** Incidence Rate of Related Treatment Emergent SAEs
**Time Frame:** up to Week 52
**Measure:** Incidence Rate of Treatment Emergent Adverse Events (TEAEs)
**Time Frame:** up to Week 52
**Measure:** Incidence Rate of Related TEAEs
**Time Frame:** up to Week 52
**Measure:** Number of Participants With Clinically Significant Abnormal Hematology and Chemistry Parameters
**Time Frame:** up to Week 52
**Measure:** Percentage of Participants With Clinically Significant Abnormal Hematology and Chemistry Parameters
**Time Frame:** up to Week 52
**Measure:** Number of Participants With Potentially Clinically Significant Abnormal Vital Signs
**Time Frame:** up to Week 52
**Measure:** Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs
**Time Frame:** up to Week 52
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Prior participation in the ORCA-2, ORCA-3 or ORCA-V1 clinical studies.
2. Former ORCA-2/ORCA-3 and ORCA-V1 subjects who are current daily cigarette smokers and/or daily nicotine-containing electronic cigarette users. Amount of daily combustible and/or nicotine containing electronic cigarette use at baseline is determined by subject self-report.
3. At Screening, subjects must have expired carbon monoxide (CO) ≥10 ppm if self-reporting as smokers or ≥30 ng/mL cotinine using a point-of-care cotinine oral fluid screening device if self-reporting as users of nicotine containing electronic cigarettes.
4. Willing to initiate cytisinicline treatment on the day after enrollment and set a quit date within 14 days of starting treatment.
5. Willing to actively participate in the study's cessation behavioral support provided throughout the study.
6. Able to fully understand study requirements, willing to participate, and comply with dosing schedule.
7. Sign the Informed Consent Form.
Exclusion Criteria:
1. Known hypersensitivity to cytisinicline or any of the excipients.
2. Clinically significant abnormal screening serum chemistry or hematology values.
3. Clinically significant abnormal screening 12-lead ECG determined after minimum of 5 minutes in supine position (ie, requiring treatment or further assessment).
4. Recent history (within 3 months prior to screening) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.
5. Current uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).
6. Currently psychotic or having had a psychotic event within 3 months prior to screening; currently having suicidal ideation or risk for suicide (corresponding to question 4 or 5 on the screening C-SSRS OR "Yes" to any suicidal behavior question on the screening C-SSRS with clear suicidal intent or previous attempt); or current symptoms of moderate to severe depression (depression score ≥11 on the HADS) at screening. If any subject becomes psychotic during the study, they must be removed from cytisinicline treatment and/or additional study visits.
7. Severe renal impairment defined as a creatinine clearance (CrCl) \<60 mL/min on screening lab (estimated with the Cockroft-Gault equation).
8. Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.0 x the upper limit of normal (ULN) on screening lab.
9. Women who are pregnant or breast-feeding.
10. Female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study. Acceptable methods of birth control include:
* True abstinence: When this is in line with the preferred and usual lifestyle of the subject. \[Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\].
* Barrier methods:
* diaphragm
* cervical cap
* contraceptive sponge
* Hormonal methods:
* Oral contraceptives
* Vaginal ring such as NuvaRing
* Skin patch such as Xulane
* Injection such as Depro-Provera
* Implantable rod such as Nexplanon
11. Participation in a clinical study with an investigational drug in the 4 weeks prior to enrollment.
12. Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Julie Ball
**Phone:** 425.686.1540
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Roxann Becco
**Phone:** 425.686.1500
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Kansas City
**Contacts:**
***Contact 1:***
- **Name:** Martha S Fanning, ME
- **Role:** CONTACT
**Country:** United States
**Facility:** Alliance for Multispecialty Research, LLC
**State:** Missouri
**Zip:** 64114
#### Overall Officials
**Official 1:**
**Affiliation:** Achieve Life Sciences, Inc.
**Name:** Julie Ball
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435208
**Brief Title:** Impact of Subgingival Instrumentation on Psychological Distress and Mental Health Status in Bruxers With Periodontitis
**Official Title:** Impact of Subgingival Instrumentation on Psychological Distress and Mental Health Status in Bruxers With Periodontitis
#### Organization Study ID Info
**ID:** PRIYANKAPERIO2024
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2025-02-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Postgraduate Institute of Dental Sciences Rohtak
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Bruxism is a non-functional repetitive jaw-muscle activity characterized by grinding or clenching the teeth. Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism.
**Detailed Description:** Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Although the etiology is not known exactly, it has been suggested that bruxism is a multifactorial disorder. Periodontitis, a prevalent inflammatory condition affecting the periodontium, has been linked to bruxism in several studies. The coexistence of bruxism and periodontitis poses unique challenges in clinical management of periodontitis. Also, as periodontitis became chronic, the occurrence of depression increased. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism. Therefore, this study aims to investigate impact of subgingival instrumentation on psychological distress and mental health status in bruxers with periodontitis.
### Conditions Module
**Conditions:**
- Periodontal Diseases
- Bruxism
- Periodontitis
- Distress, Emotional
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 45
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** subgingival instrumentation will be done in all participants
**Intervention Names:**
- Other: Subgingival instrumentation
**Label:** PERIODONTITIS BRUXISM
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- PERIODONTITIS BRUXISM
**Description:** All the participants will undergo scaling and root planning with hand scalers, curettes and ultrasonic scaler.
**Name:** Subgingival instrumentation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Assessment of psychological distress will be done by using Kessler Psychological distress(K10)
**Measure:** Psychological distress
**Time Frame:** BASELINE,2 MONTHS ,3 MONTHS
**Description:** Assessment of mental health status will be done by using mental health inventory 38
**Measure:** Mental Health Status
**Time Frame:** Baseline, 2 months, 3 months
#### Secondary Outcomes
**Description:** periodontal probing depth
**Measure:** periodontal parameter
**Time Frame:** Baseline, 2 month, 3 month
**Description:** bleeding on probing
**Measure:** periodontal inflammation
**Time Frame:** Baseline, 2 month, 3 month
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Systemically healthy patients
* Patient having periodontitis with bruxism
* Age between 30-50 years
Exclusion Criteria:
* History of mental health disorder
* History of systemic disease
* History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs
* Pregnant or lactating females
**Healthy Volunteers:** True
**Maximum Age:** 50 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** RAJINDER KR SHARMA, MDS
**Phone:** 9416358222
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Priyanka Chandela, BDS
**Phone:** +917027019277
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Rohtak
**Country:** India
**Facility:** Post Graduate Institute of Dental Sciences
**State:** Haryana
**Zip:** 124001
#### Overall Officials
**Official 1:**
**Affiliation:** PGIDS , ROHTAK
**Name:** Priyanka Chandela, BDS
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009059
- Term: Mouth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
- ID: D000014076
- Term: Tooth Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M13427
- Name: Periodontitis
- Relevance: HIGH
- As Found: Periodontitis
- ID: M13419
- Name: Periodontal Diseases
- Relevance: HIGH
- As Found: Periodontal Diseases
- ID: M5286
- Name: Bruxism
- Relevance: HIGH
- As Found: Bruxism
- ID: M12019
- Name: Mouth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010518
- Term: Periodontitis
- ID: D000010510
- Term: Periodontal Diseases
- ID: D000002012
- Term: Bruxism
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435195
**Brief Title:** Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases
**Official Title:** Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases
#### Organization Study ID Info
**ID:** K5112
#### Organization
**Class:** OTHER
**Full Name:** Peking Union Medical College Hospital
### Status Module
#### Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Peking Union Medical College Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this observational study is to systematically describe the clinical characteristics and outcomes of patients with pituitary complex and rare diseases at Peking Union Medical College Hospital. The main questions it aims to answer are:
* What are the influencing factors and rates of remission?
* What are the comorbidities associated with these diseases?
* What are the perioperative events, radiological findings, and pathological features?
Researchers will compare different patient groups to see if there are significant differences in these outcomes.
Participants will:
* Undergo detailed clinical evaluations.
* Provide medical history and data for analysis.
* Participate in follow-up assessments to monitor disease progression and treatment outcomes.
**Detailed Description:** The study aims to provide a comprehensive analysis of pituitary complex and rare diseases at Peking Union Medical College Hospital. By leveraging a large cohort, the research will explore various clinical characteristics and outcomes. Specifically, the study will examine influencing factors and rates of remission, the presence of comorbidities, and perioperative events. Additionally, it will evaluate radiological findings and pathological features to better understand these conditions. Through this detailed investigation, the study seeks to enhance knowledge and inform clinical practice regarding the management and prognosis of pituitary complex and rare diseases.
### Conditions Module
**Conditions:**
- Pituitary Diseases
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 3000
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The Pituitary Complex and Rare Diseases cohort consists of patients diagnosed with various pituitary disorders, including but not limited to pituitary adenomas, craniopharyngiomas, Rathke's cleft cysts, sellar region germ cell tumors, cavernous sinus syndrome, and other diseases. Patients requiring surgical resection or biopsy of pituitary pathologies will undergo transsphenoidal surgery or craniotomy.
**Intervention Names:**
- Procedure: Surgical Removal
- Procedure: Biopsy
**Label:** Pituitary Complex and Rare Diseases
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Pituitary Complex and Rare Diseases
**Description:** Resection of pituitary pathologies.
**Name:** Surgical Removal
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Pituitary Complex and Rare Diseases
**Description:** Taking a small tissue or liquid sample from the pituitary pathologies and the affected area for examination and diagnosis
**Name:** Biopsy
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Hormonal normalization and free of pathologies
**Measure:** Remission
**Time Frame:** Postoperative one week and extends to the latest follow-up, estimated at up to 3 years
#### Secondary Outcomes
**Description:** Systemic changes accompanied with Pituitary Complex and Rare Diseases
**Measure:** Disease Comorbidities
**Time Frame:** From patient admission to an evaluation period extending up to the latest follow-up, estimately up to 3 years
**Description:** adverse events or medical issues that arise after a surgical procedure on the pituitary diseases.These complications can include various problems such as bleeding, infection, hormonal imbalances, cerebrospinal fluid leaks, vision changes, or neurological deficits
**Measure:** Postoperative complications
**Time Frame:** Postoperative one week and extends to the latest follow-up, estimated at up to 3 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Diagnosed with rare sellar diseases including but not limited to pituitary adenomas (such as Thyrotropin-secreting pituitary adenomas, GH-secreting adenomas), craniopharyngiomas, Rathke's cleft cysts, sellar region germ cell tumors, cavernous sinus syndrome, and other diseases
* Detailed medical history, including clinical symptoms, treatment plans and follow-up outcomes
Exclusion Criteria:
* Incomplete medical records, especially missing key imaging diagnostic results
* Patients with coexisting primary central nervous system diseases unrelated to sellar region diseases (such as severe traumatic brain injury)
* Patients whose sellar region pathological diagnosis was changed or overturned during the follow-up period
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Patients who are diagnosed with Pituitary Complex and Rare Diseases at Peking Union Medical College Hospital
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Yong Yao, MD
**Phone:** +8669152530
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yong Yao, MD
- **Phone:** +8669152530
- **Role:** CONTACT
**Country:** China
**Facility:** Peking Union Medical College Hospital
**State:** Beijing
**Status:** RECRUITING
**Zip:** 100730
#### Overall Officials
**Official 1:**
**Affiliation:** Department of Neurosurgery, Peking Union Medical College Hospital
**Name:** Yong Yao, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007027
- Term: Hypothalamic Diseases
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M13791
- Name: Pituitary Diseases
- Relevance: HIGH
- As Found: Pituitary
- ID: M24518
- Name: Rare Diseases
- Relevance: HIGH
- As Found: Rare disease
- ID: M10077
- Name: Hypothalamic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010900
- Term: Pituitary Diseases
- ID: D000035583
- Term: Rare Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435182
**Brief Title:** Study of OT202 in Treating Moderate to Severe Dry Eye
**Official Title:** A Phase II, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of OT202 Eye Drops in the Treatment of Moderate to Severe Dry Eye
#### Organization Study ID Info
**ID:** OT202-02-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Ocumension Therapeutics (Shanghai) Co., Ltd
### Status Module
#### Completion Date
**Date:** 2024-01-26
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-01-26
**Type:** ACTUAL
#### Start Date
**Date:** 2023-04-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Ocumension Therapeutics (Shanghai) Co., Ltd
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a phase II study to explore the optimal dosage of OT202 in treating dry eye.
**Detailed Description:** Subjects successfully enrolled will enter a 2-week induction period of OT202 solvent eye drops, treated with OT202 three times daily (morning, afternoon, and evening), with 1-2 drops each time. On the day of the baseline visit (Visit 2), subjects will be assessed again to meet the inclusion and exclusion criteria. Subjects remain in the study are then randomized with a 1:1:1 ratio to 3 groups, the 0.5% OT202 eye drop group, 1% OT202 eye drop group, or OT202 solvent eye drop group, for an 8-week treatment period. Safety visits will be conducted 2 weeks after completion of the respective treatment.
### Conditions Module
**Conditions:**
- Dry Eye
**Keywords:**
- Moderate dry eye
- Severe dry eye
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Parallel assignment: 0.5% OT202 eye drop group;1% OT202 eye drop group;OT202 solvent eye drop group with a 1:1:1 ratio.
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 213
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Administered three times daily (morning, afternoon, and evening), with 1-2 drops each time, instilled into the conjunctival sac.
**Intervention Names:**
- Drug: OT202 conc 0.5%
**Label:** OT202 conc.0.5% group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Administered three times daily (morning, afternoon, and evening), with 1-2 drops each time, instilled into the conjunctival sac.
**Intervention Names:**
- Drug: OT202 conc 0.1%
**Label:** OT202 conc. 0.1% group
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Administered three times daily (morning, afternoon, and evening), with 1-2 drops each time, instilled into the conjunctival sac.
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- OT202 conc.0.5% group
**Description:** Apply 1-2 drops of OT202 0.5% solution into the conjunctival sac. three times daily
**Name:** OT202 conc 0.5%
**Other Names:**
- Investigational product
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- OT202 conc. 0.1% group
**Description:** Apply 1-2 drops of OT202 0.1% solution into the conjunctival sac. three times daily
**Name:** OT202 conc 0.1%
**Other Names:**
- Investigational product
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Placebo group
**Description:** Apply 1-2 drops of placebo solution into the conjunctival sac. three times daily
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Compare the difference of changes in TCSS relative to baseline of three study groups on day 56.
**Measure:** Total Corneal Fluorescein Staining (TCSS) score
**Time Frame:** Day 56
#### Secondary Outcomes
**Description:** Compare the difference of changes in VAS scale relative to baseline of three study groups on day 28 \& 56.
**Measure:** Visual Analogue Scale (VAS) Score
**Time Frame:** DAY 28 & 56
**Description:** Compare the DAY 28 \& 56 OSDI scale results of the subjects with the baseline results.
**Measure:** Ocular Surface Disease Index (OSDI) Score
**Time Frame:** Day 28 & 56
**Description:** Compare the DAY 28 \& 56 Conjunctive Hyperemia data of the subjects with the baseline data.
**Measure:** Conjunctive Hyperemia
**Time Frame:** Day 28 & 56
**Description:** Compare the DAY 28 \& 56 Corneal Staining data of the subjects with the baseline data.
**Measure:** Corneal Staining
**Time Frame:** Day 28 & 56
**Description:** Compare the DAY 28 \& 56 SANDE scale results of the subjects with baseline .
**Measure:** A dry eye syndrome questionnaire - Symptom Assessment iN Dry Eye(SANDE)
**Time Frame:** Day 28 & 56
**Description:** Compare the DAY 28 \& 56 TFBUT scale results of the subjects with baseline .
**Measure:** Tear Film Breakup-time (TFBUT)
**Time Frame:** Day 28 & 56
**Description:** Compare the DAY 28 \& 56 Schirmer I Test scale results of the subjects with baseline .
**Measure:** Schirmer I Test
**Time Frame:** Day 28 & 56
### Eligibility Module
**Eligibility Criteria:** ---Inclusion Criteria ---
1. 18 to 75 years of age (inclusive) at the time of signing the ICF, either sex or ethnic group.
2. With history of dry eye for at least 6 months prior to screening, and history of use or willingness to use eye drops for the treatment of dry eye within 6 months prior to screening
.
3. Binocular BCVA ≥ 0.25 decimals (standard logarithmic visual acuity chart) at Screening and Baseline.
4. At least one eye (the same eye) meets all the following criteria at screening and baseline:
* TCSS ≥ 2 points
* Eye dryness score (EDS) ≥ 40 points in VAS
* Conjunctival hyperemia score ≥ 1 point
* TFBUT ≤ 5 seconds
* 1 mm/5 min ≤ Schirmer I test (without surface anesthesia) ≤ 10 mm/5 min
5. Must be able to understand and sign the ICF approved by Independent Ethics Committee (EC).
6. Willing and able to conduct protocol-required study visits, follow study guidelines, and take study drug as instructed.
---Exclusion Criteria ---
1. With contraindication or hypersensitivity to the study drug (OT202 and excipients) or diagnostic reagents (fluorescein sodium, lissamine green, etc.).
2. During the screening period and baseline period, any eye with ocular active inflammation or structural abnormalities that may affect the trial assessment, including but not limited to trichiasis, blepharospasm, blepharitis, meibomitis, severe meibomian gland dysfunction, bulbar conjunctival laxity, keratitis, recurrent corneal erosion, allergic conjunctivitis, iritis, anterior chamber inflammation, known retinal detachment, diabetic retinopathy, or history of any progressive retinal disease.
3. With history of possible or confirmed ocular infection (bacterial, viral, or fungal) or ocular herpes (simple or zoster) in either eye, as determined by the patient's medical history and/or at the screening and baseline examinations.
4. Those with intraocular pressure (non-contact tonometry) greater than 21 mmHg or less than 8 mmHg or diagnosed with glaucoma at screening and baseline, or those with ocular hypertension who underwent intraocular pressure reduction therapy, and those with a history or suspicion of glaucoma.
5. Those with any systemic disease expected to potentially affect the study results. It include but is not limited to Sjögren syndrome, Stevens-Johnson syndrome, rheumatoid arthritis, graft versus host disease, systemic lupus erythematosus, scleroderma, sarcoidosis, herpes, acne, rosacea, etc.
6. Those who cannot stop using any ocular medication or treatment during the clinical trial.
7. Those with recent clinically relevant history (e.g., hepatic, renal impairment) within 6 months prior to screening or current severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, autoimmune, and other relevant systemic diseases (e.g., severe chronic obstructive pulmonary disease, arrhythmia, significant heart failure, uncontrolled hypertension, type 2 diabetes mellitus), as assessed by the investigator.
8. Those on a chronic, systemic medication regimen used for less than 1 month at screening and baseline or with dose changed within 1 month (including initiation of new medication and discontinuation).
9. Those who have used any prohibited medications (topical ocular, systemic, and/or injectable medications) during the specified period prior to screening. These medications are also prohibited during the study. However, if a subject has a prohibited medication at screening, it needs to be stopped and washed out according to the washout period specified below, which can be included in the wash-out period. The minimum reasonable washout period for prohibited medications is as follows:
* Systemic and local immunosuppressant and immunotherapy (such as cyclosporine eye drops, tacrolimus eye drops, etc.): 60 days;
* Corticosteroids (any route): 14 days;
* Systemic or ocular topical mast cell stabilizers, antihistamines, antihistamines/mast cell stabilizer combination, vasoconstrictors, monoamine oxidase inhibitors: 7 days;
* Other topical ophthalmic preparations (including artificial tears): 3 days;
* Medications known to cause ocular dryness (e.g., anticholinergics, serotonin reuptake inhibitors, beta-blockers, diuretics, etc.): 14 days.
Note:Non-periocular, low-potency, over-the-counter corticosteroid topical skin creams are allowed for use in the study (e.g., hydrocortisone butyrate cream/ointment).
10. Previous use of spleen tyrosine kinase (Syk) inhibitors or eye drop products targeting the same as anti-vascular endothelial growth factor (VEGF).
11. Those who wore corneal contact lenses within 7 days prior to screening or required them during the study.
12. Those who underwent meibomian gland massage or moist chamber therapy within 7 days prior to screening, or non-drug therapies for dry eye such as intense pulsed light therapy, thermal pulsation therapy, etc., within the previous 6 months before screening.
13. Those who previously underwent dry eye surgery such as tear duct embolization (current tear duct embolization status or punctal plug use in the past 6 months) or amniotic membrane transplantation.
14. Those who underwent ocular surface surgery (e.g., LASIK excimer laser in situ keratomileusis) within 12 months prior to screening or intraocular surgery within 6 months prior to screening in either eye, as determined by the subject's medical history and/or examination, or anticipated ocular surgery during the study.
15. Those who use other investigational products or devices within 3 months prior to screening or concurrently during the study.
16. Non-compliance with drug administration (\< 80% or \> 120%) during the introduction period.
17. Females of childbearing potential who are currently pregnant, or have a positive pregnancy test result, or plan to get pregnant during the study, or are currently breastfeeding, or do not agree to use appropriate contraception methods to avoid pregnancy during the study period up to 1 month after the last dose of study drug.
18. Males who do not agree to use one or more acceptable effective contraception methods during the study period up to 1 month after the last dose of study drug.
19. Any condition or situation that, in the opinion of the investigator, may pose a safety risk to the subject in the trial or may interfere with the conduct of the study, or the investigator believes that the subject may not be able to complete or comply with the requirements of the study (due to administrative reasons or otherwise).
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Changsha
**Country:** China
**Facility:** The Third Xiangya Hospital Of Central South University
**Location 2:**
**City:** Hangzhou
**Country:** China
**Facility:** The Second Affiliated Hospital Zhejiang University School of Medicine
**Location 3:**
**City:** Kunming
**Country:** China
**Facility:** Then Second People's Hospital of Yunnan Province
**Location 4:**
**City:** Ningbo
**Country:** China
**Facility:** Ning Bo Eye Hospital
**Location 5:**
**City:** Tianjin
**Country:** China
**Facility:** Tianjin Eye Hospital
**Location 6:**
**City:** Tianjin
**Country:** China
**Facility:** Tianjin Medical University Eye Hospital
**Location 7:**
**City:** Wenzhou
**Country:** China
**Facility:** Eye Hospital, WMU
**Location 8:**
**City:** Wuhan
**Country:** China
**Facility:** Renmin Hospital of Wuhan University
**Location 9:**
**City:** Wuhan
**Country:** China
**Facility:** Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
**Location 10:**
**City:** Xi'an
**Country:** China
**Facility:** The First Affiliated Hospital of Xi'an Jiaotong University
#### Overall Officials
**Official 1:**
**Affiliation:** Eye Hospital, WMU
**Name:** Wei Chen
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Sponsor GmbH
**Name:** Jialu Xia
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007766
- Term: Lacrimal Apparatus Diseases
- ID: D000005128
- Term: Eye Diseases
- ID: D000007637
- Term: Keratoconjunctivitis
- ID: D000003231
- Term: Conjunctivitis
- ID: D000003229
- Term: Conjunctival Diseases
- ID: D000007634
- Term: Keratitis
- ID: D000003316
- Term: Corneal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M18040
- Name: Dry Eye Syndromes
- Relevance: HIGH
- As Found: Dry Eye
- ID: M10664
- Name: Keratoconjunctivitis Sicca
- Relevance: HIGH
- As Found: Dry Eye
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M10663
- Name: Keratoconjunctivitis
- Relevance: LOW
- As Found: Unknown
- ID: M10786
- Name: Lacrimal Apparatus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6455
- Name: Conjunctivitis
- Relevance: LOW
- As Found: Unknown
- ID: M6453
- Name: Conjunctival Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10660
- Name: Keratitis
- Relevance: LOW
- As Found: Unknown
- ID: M6539
- Name: Corneal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015352
- Term: Dry Eye Syndromes
- ID: D000007638
- Term: Keratoconjunctivitis Sicca
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M12814
- Name: Ophthalmic Solutions
- Relevance: LOW
- As Found: Unknown
- 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:** NCT06435169
**Brief Title:** Comparative Presence of Piriformis Syndrome in Patients With Lumbar Disc Bulging and Protrusion
**Official Title:** Comparative Presence of Piriformis Syndrome in Patients With Lumbar Disc Bulging and Protrusion
#### Organization Study ID Info
**ID:** Yuzuncu Yil University Türkiye
#### Organization
**Class:** OTHER
**Full Name:** Yuzuncu Yıl University
### Status Module
#### Completion Date
**Date:** 2024-05-20
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-04-01
**Type:** ACTUAL
#### Start Date
**Date:** 2024-03-04
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Yuzuncu Yıl University
#### Responsible Party
**Investigator Affiliation:** Yuzuncu Yıl University
**Investigator Full Name:** Volkan Şah
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Clinicians consider lumbar disc herniation more prominently in the differential diagnosis than piriformis syndrome, as it is the most common cause of sciatica, and this canalizes them to overlook that the sciatic nerve may be compressed by the piriformis muscle, below the L4-L5-S1 intervertebral disc levels.
As far as is known, there are no 'patient series' in the literature regarding the incidence of Piriformis syndrome in Lumbar Disc Herniation, only one case report has been found. This clinical study aims to reveal that Piriformis syndrome may also be present in patients with disc herniation on Magnetic Resonance Imaging (MRI), and that sometimes it may even be the main cause of sciatic nerve pain.
**Detailed Description:** In this study, the participants between the ages of 18-65, who were diagnosed with L4-L5 and/or L5-S1 Lumbar Disc Herniation (bulging and protrusion) by having a Lumbar MRI at the Faculty of Medicine Sports Medicine outpatient clinic, were reached through their contact numbers, and those who had not previously undergone waist/hip surgery and those who described unilateral sciatica complaints (hip-leg-foot pain and numbness) during the interview were invited to Yüzüncü Yıl University Faculty of Medicine Sports Medicine polyclinic and Lasegue's, Flexion Adduction Internal Rotation (FAIR) and Freiberg's tests were performed.
### Conditions Module
**Conditions:**
- Piriformis Syndrome
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 76
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Lasegue's test, FAIR (Flexion Adduction Internal Rotation) test and, Freiberg's test will be performed in a single check-up for patients diagnosed with L4-L5 and/or L5-S1 Lumbar Disc Herniation (bulging) by lumbar Magnetic Resonance Imaging (MRI). The presence of Piriformis syndrome was investigated in these patients with Freiberg and FAIR tests.
**Intervention Names:**
- Diagnostic Test: Lasegue's, Freiberg's and, FAIR (Flexion Adduction Internal Rotation) tests.
**Label:** 38 patients with lumbar disc bulging
#### Arm Group 2
**Description:** Lasegue's, FAIR (Flexion Adduction Internal Rotation) and, Freiberg's test will be performed in a single check-up for patients diagnosed with L4-L5 and/or L5-S1 Lumbar Disc Herniation (protrusion) by lumbar Magnetic Resonance Imaging (MRI). The presence of Piriformis syndrome was investigated in these patients with Freiberg and FAIR tests.
**Intervention Names:**
- Diagnostic Test: Lasegue's, Freiberg's and, FAIR (Flexion Adduction Internal Rotation) tests.
**Label:** 38 patients with lumbar disc protrusion
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 38 patients with lumbar disc bulging
- 38 patients with lumbar disc protrusion
**Description:** The Straight Leg Raise test or Lasegue test, is also crucial in detecting disc herniation and neural compression. Lasègue's sign is said to be positive if the angle to which the leg can be raised (upon straight leg raising) before eliciting pain is \<45°.The presence of Piriformis syndrome was investigated in these patients with Freiberg and FAIR tests. Freiberg's test elicits pain by passively internal rotation of the extended hip, when the patient is in supine. The purpose of this test is on the one hand stretching of the irritated Piriformis Muscle (PM), on the other hand provoking sciatic nerve compression. The FAIR test is a sensitive and specific test for detection if irritation of the sciatic nerve by the piriformis. FAIR stands for flexion, adduction and internal rotation. Also known as piriformis test.
**Name:** Lasegue's, Freiberg's and, FAIR (Flexion Adduction Internal Rotation) tests.
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The Straight Leg Raise test or Lasegue test, is also crucial in detecting disc herniation and neural compression. Lasègue's sign is said to be positive if the angle to which the leg can be raised (upon straight leg raising) before eliciting pain is \<45°.
**Measure:** Lasegue's Test
**Time Frame:** Baseline
**Description:** Freiberg's test elicits pain by passively internal rotation of the extended hip, when the patient is in supine. The purpose of this test is on the one hand stretching of the irritated piriformis muscle, on the other hand provoking sciatic nerve compression.
**Measure:** Freiberg's Test
**Time Frame:** Baseline
**Description:** The FAIR test is a sensitive and specific test for detection if irritation of the sciatic nerve by the piriformis. FAIR stands for flexion, adduction and internal rotation. Also known as piriformis test.
**Measure:** FAIR (Flexion Adduction Internal Rotation) test
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Being between the ages of 18-65
* Having unilateral sciatica
* Having disk herniation in the form of bulging or protrusion in a previous Lumbar Magnetic Resonance Imaging (MRI)
Exclusion Criteria:
* Having bilateral sciatica
* Having disc herniation in the form of extrusion or sequestration in a previous Lumbar Magnetic Resonance Imaging (MRI)
* Previous back and/or hip surgery
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Patients of both genders between the ages of 18-65 with lumbar disc bulging or protrusion
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Van
**Country:** Turkey
**Facility:** Volkan Şah
**Zip:** 65080
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004194
- Term: Disease
- ID: D000010335
- Term: Pathologic Processes
- ID: D000020426
- Term: Sciatic Neuropathy
- ID: D000020422
- Term: Mononeuropathies
- ID: D000010523
- Term: Peripheral Nervous System Diseases
- ID: D000009468
- Term: Neuromuscular Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000009408
- Term: Nerve Compression Syndromes
- ID: D000009437
- Term: Neuralgia
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000017699
- Term: Pelvic Pain
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: HIGH
- As Found: Syndrome
- ID: M28404
- Name: Piriformis Muscle Syndrome
- Relevance: HIGH
- As Found: Piriformis Syndrome
- ID: M22222
- Name: Sciatic Neuropathy
- Relevance: LOW
- As Found: Unknown
- ID: M22218
- Name: Mononeuropathies
- Relevance: LOW
- As Found: Unknown
- ID: M13432
- Name: Peripheral Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12411
- Name: Neuromuscular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12352
- Name: Nerve Compression Syndromes
- Relevance: LOW
- As Found: Unknown
- ID: M5853
- Name: Charcot-Marie-Tooth Disease
- Relevance: LOW
- As Found: Unknown
- ID: M18092
- Name: Hereditary Sensory and Motor Neuropathy
- Relevance: LOW
- As Found: Unknown
- ID: M12381
- Name: Neuralgia
- Relevance: LOW
- As Found: Unknown
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M19918
- Name: Pelvic Pain
- Relevance: LOW
- As Found: Unknown
- ID: T4568
- Name: Piriformis Syndrome
- Relevance: HIGH
- As Found: Piriformis Syndrome
- ID: T1081
- Name: Charcot-Marie-Tooth Disease
- Relevance: LOW
- As Found: Unknown
- ID: T2761
- Name: Hereditary Motor and Sensory Neuropathy
- Relevance: LOW
- As Found: Unknown
- ID: T2766
- Name: Hereditary Neuropathy With Liability to Pressure Palsies
- Relevance: LOW
- As Found: Unknown
- ID: T5067
- Name: Roussy Levy Syndrome
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000055958
- Term: Piriformis Muscle Syndrome
- ID: D000013577
- Term: Syndrome
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435156
**Acronym:** SOPHIST
**Brief Title:** Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes
**Official Title:** A Phase 2 Double-blind Randomised Controlled Trial Studying the Effect of Sotagliflozin Versus Placebo in Individuals With Heart Failure and Type 1 Diabetes.
#### Organization Study ID Info
**ID:** 01-50-23
#### Organization
**Class:** OTHER
**Full Name:** University of Dundee
#### Secondary ID Infos
**Domain:** Juvenile Diabetes Research Foundation
**ID:** 3-SRA-2023-1376-M-B
**Type:** OTHER_GRANT
**Domain:** IRAS
**ID:** 1007807
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Lexicon Pharmaceuticals
**Class:** OTHER
**Name:** Juvenile Diabetes Research Foundation
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Dundee
#### Responsible Party
**Investigator Affiliation:** University of Dundee
**Investigator Full Name:** Ify Mordi, MD
**Investigator Title:** Clinical Senior Lecturer and Honorary Consultant Cardiologist
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** People with type 1 diabetes sometimes develop heart failure which can cause symptoms like breathlessness, tiredness or ankle swelling, reduced quality of life and lead to being admitted to hospital or suffering potential fatal consequences. This trial is investigating if a tablet called sotagliflozin, can improve quality of life in people with type 1 diabetes and heart failure. In addition, this trial will also assess the safety and tolerability of sotagliflozin in this population.
In previous trials that included people with type 2 diabetes and heart failure sotagliflozin was shown to improve patients' symptoms of heart failure, quality of life and reduce the chance of people with heart failure being admitted to hospital or dying. However, people with type 1 diabetes and heart failure were not included in these trials meaning that it is not known if these benefits also apply to this population.
This trial aims to recruit 320 people with type 1 diabetes and heart failure symptoms in multiple sites in the United Kingdom (UK). This trial will compare the health and quality of life of participants who take sotagliflozin tablets with participants who take placebo tablets, which is a dummy tablet that looks the same as sotagliflozin. Participants will be randomly allocated to one of two groups (i.e. one taking sotagliflozin and the other the placebo) and both the medical team and participants will not know in which group each participant is until the end of the study. Participants will be in the trial for approximately 6 months and will be given sotagliflozin or placebo tablets to take 1 per day for 4 months. The trial is expected to run for a total of 26 months.
**Detailed Description:** BACKGROUND Intensive insulin therapy designed to near-normalize glucose levels in people with type 1 diabetes significantly reduces an individual's risk of long-term micro- and macrovascular complications. Unfortunately, glycaemic targets are not achieved by the majority of people with type 1 diabetes and as such overall life expectancy remains reduced compared to those without type 1 diabetes. Cardiovascular disease remains a major cause of morbidity and mortality in type 1 diabetes. There is growing recognition that heart failure (HF) is an increasing problem in type 1 diabetes. Diabetes itself is an independent risk factor for HF, causing structural and functional cardiac changes that predispose to HF (known as diabetic cardiomyopathy). HF is the end result of many cardiovascular diseases such as hypertension and myocardial infarction, and improved treatments for these conditions and changing demographic trends mean that many more people are surviving longer and developing HF.
HF has a substantial healthcare burden. In the United States (US) and Europe, the prevalence of HF in the general population is around 1-2% - around 6 million adults in the US are estimated to be living with HF currently. In 2014 in the US there were \~1.1 million emergency department visits, 980 000 hospitalizations, and 84 000 deaths with HF as the primary cause, with an estimated cost of \~$11.3 billion (\~$11,500/per patient for each hospitalisation). Despite advances in management of HF over the past 30 years, the incidence of mortality and HF hospitalisation in recent HF clinical trials remained high at \~20-30% over 2 years.
The burden of HF in type 1 diabetes is less well characterised compared to HF in those with type 2 diabetes (and individuals without diabetes), however the data still indicate the substantial nature of this growing problem. One of the largest epidemiological studies was a Scottish national data study of 3.25 million individuals \>30 years old, where the crude incidence of HF hospitalisation was over twice that of the population without diabetes. While the crude incidence was less than in type 2 diabetes, type 1 diabetes patients were on average 20 years younger. Despite their younger age, 30-day mortality following HF hospitalisation was higher in individuals with type 1 diabetes after adjustment for age, sex and socioeconomic status, indicating that outcomes are worse in HF patients with type 1 diabetes compared to those with either type 2 diabetes or without diabetes. Data from Scandinavia supports this finding and suggests that the risk of both incident HF and cardiovascular mortality was higher for individuals with type 1 diabetes compared to type 2 diabetes after adjustment for age. The overall prevalence of HF in this study at baseline was 3.1% - extrapolated to the US this would equate to 57,000 of the 1.9 million individuals with type 1 diabetes. A recent meta-analysis of all available data suggested that the incidence of HF was 3.1 times higher in individuals with type 1 diabetes compared to controls (typically the general population). Assuming a 5% incidence of HF hospitalisation/year, HF hospitalizations cost the US healthcare system \~$29 million per year. In summary, these data suggest that not only is HF a significant problem in individuals with type 1 diabetes, but there is evidence of an outcome disparity compared to individuals with type 2 diabetes or those without diabetes.
Although there are some differences (e.g. presentation at a younger age), the pathophysiology of HF in type 1 diabetes is similar to type 2 diabetes. Risk factors are similar (e.g. glycaemic control, coronary artery disease and hypertension), leading to inflammation, endothelial dysfunction, fibrosis, and subsequent diastolic and systolic dysfunction. Given the pathophysiological similarities, there is little to suggest that HF therapies that have shown benefit in individuals with type 2 diabetes (or individuals without diabetes) would not also be efficacious in type 1 diabetes. In all current HF guidelines mainstay HF treatments (renin-angiotensin system blockers, beta-blockers, and mineralocorticoid receptor antagonists) are recommended for all patients with HF regardless of diabetes status.
Sodium-glucose co-transporter inhibitors (SGLTi) were initially developed as oral add-on treatments for glycaemic control in type 2 diabetes. A consistent finding in large cardiovascular outcome trials was a significant \~30% risk reduction in hospitalisation for HF, as well as overall reductions in cardiovascular mortality. Subsequently, SGLTi in addition to guideline-directed HF therapy have been studied in HF patients either with type 2 diabetes or without diabetes and have again shown a consistent benefit compared to placebo, with significant reductions in mortality and HF hospitalisation irrespective of cardiac function left ventricular ejection fraction (LVEF) at baseline without any concerning safety signals. SGLTi also improve HF-related quality of life (QoL) and renal outcomes. This has led to the inclusion of SGLTi in the most recent HF treatment guidelines as a cornerstone of therapy in addition to established pharmacological agents (e.g., renin-angiotensin system inhibitors, beta-blockers and mineralocorticoid receptor antagonists). However, there is one key issue - individuals with type 1 diabetes have been excluded from these HF trials, in part due to concerns around safety. At present there is no evidence to support the use of these life-saving therapies in this population that already has worse outcomes than other groups with HF.
In adult type 1 diabetes, Phase III trials with dapagliflozin, empagliflozin and sotagliflozin have been completed, collectively showing modest benefits of SGLT inhibition in terms of Haemoglobin A1c (HbA1c) reduction, increased time in range, reduced body weight and total insulin dose. However, SGLTi use in type 1 diabetes was also associated with an increased risk of diabetic ketoacidosis (DKA), which has limited their more widespread use in type 1 diabetes.
Sotagliflozin is a dual SGLT1 and 2 inhibitor that is currently approved in the United Kingdom for use in individuals with type 1 diabetes with a body mass index (BMI) of ≥27kg/m2 and taking insulin doses of at least 0.5 units/kg of body weight in patients with inadequate glycaemic control. As with selective SGLT2i, sotagliflozin also improves HF-related outcomes. The key evidence for this comes from two clinical trials. In the Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease (SCORED) trial including 10,584 patients with type 2 diabetes, chronic kidney disease and cardiovascular risk factors, sotagliflozin caused a 26% relative risk reduction in the primary endpoint of cardiovascular death, HF hospitalisation or urgent HF visit compared to placebo. There was also a 33% relative risk reduction in HF hospitalisation or urgent HF visits, figures consistent with other SGLT2i trials.
The second key trial was the Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure (SOLOIST-WHF) trial. In this trial 1,222 patients with type 2 diabetes and a recent HF hospitalisation were randomised to sotagliflozin 200mg once daily (with uptitration to 400mg once daily) or placebo. Patients were included regardless of left ventricular ejection fraction (LVEF) at baseline. The median follow-up duration was 9 months.
Sotagliflozin caused a 33% relative risk reduction in the primary outcome of cardiovascular death, HF hospitalisation or urgent HF visit, with a 36% reduction in HF hospitalisation or urgent HF visits that met statistical significance. Sotagliflozin also significantly improved QoL at 4 months measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Rates of serious adverse events (SAEs) leading to study drug withdrawal were similar in both sotagliflozin and placebo groups, though severe hypoglycaemia was more common with sotagliflozin than placebo (9 individuals vs. 2). There was no significant increase in incidence of DKA with sotagliflozin compared to placebo (2 vs. 4). Taken together, these two trials confirm the benefit of sotagliflozin on HF related outcomes, consistent with selective SGLT2i. Again, individuals with type 1 diabetes were excluded from both of these trials.
In summary, there is significant HF related morbidity and mortality in type 1 diabetes, and outcomes are worse than in HF patients with type 2 diabetes or without diabetes. Oral sotagliflozin 200mg daily is licensed for improving glycaemic control in type 1 diabetes in the UK. Although sotagliflozin improves HF related outcomes and QoL in patients with type 2 diabetes and patients with HF who do not have diabetes, studies are needed to determine whether these benefits might extend to patients with type 1 diabetes and heart failure.
RATIONALE As outlined above, HF is a significant problem in type 1 diabetes, with an estimated prevalence of 3-5%. Outcomes for individuals with type 1 diabetes and HF are worse than in those with type 2 diabetes or without diabetes, with increased mortality and hospitalisation rates. Critically, patients with type 1 diabetes have been excluded from pivotal trials of the latest advance in HF treatment (SGLT2i), potentially exacerbating these outcome disparities further.
The proposed trial will be the first to provide data on the efficacy and safety of sotagliflozin, in patients with type 1 diabetes and HF (regardless of LVEF). If a beneficial signal is found, this would provide strong support for extending the use of sotagliflozin in this group of patients with type 1 diabetes and adoption into clinical guidelines. A multi-centre, double-blind, randomised controlled trial to provide the strongest level of evidence for previous findings of the researchers will be conducted. Importantly, by choosing QoL measured using the KCCQ as the primary endpoint, an outcome that not only correlates strongly with mortality and hospitalisation but is also accepted by the US Food and Drug Administration (FDA) as a valid endpoint for regulatory approval has been selected. The KCCQ is a 23- item self-administered questionnaire that measures the patient's perception of their health status, including HF symptoms, impact on physical and social function, and how their HF impacts their QOL within the preceding 2 weeks. Improvements in KCCQ score map very well to reductions in mortality and hospitalisation and SGLT2i have consistently improved KCCQ scores. A 5-point increase in KCCQ score is traditionally considered clinically meaningful and is associated with a 7% reduction in mortality and HF hospitalisation. Given the prohibitive size of trial that would be required to demonstrate an improvement in mortality or HF hospitalizations with sotagliflozin in type 1 diabetes, the KCCQ represents an ideal endpoint for the trial. The proposed trial has the potential to be a high-impact, practice-changing trial.
### Conditions Module
**Conditions:**
- Type 1 Diabetes
- Heart Failure
**Keywords:**
- Type 1 Diabetes
- heart failure
- Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
- sotagliflozin
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 320
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Sotagliflozin oral tablet, 200mg once per day for 16 weeks.
**Intervention Names:**
- Drug: Sotagliflozin
**Label:** Sotagliflozin
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Placebo oral tablet, 200mg once per day for 16 weeks.
**Intervention Names:**
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Sotagliflozin
**Description:** Sodium-glucose Co-transporter inhibitor
**Name:** Sotagliflozin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Matched placebo
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Other Outcomes
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes
**Measure:** Change in New York Heart Association (NYHA) class
**Time Frame:** From baseline to weeks 16 and 20
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes
**Measure:** Change in daily loop diuretic dose
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes
**Measure:** Change in systolic and diastolic blood pressure.
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes
**Measure:** Number of hospitalizations and deaths (first and total number) due to heart failure
**Time Frame:** From baseline to weeks 16 and 20
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on renal parameters
**Measure:** Change in estimated glomerular filtration rate (eGFR)
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on renal parameters
**Measure:** Change in serum creatinine
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on renal parameters
**Measure:** Change in urine albumin to creatinine ratio
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on diabetes-related parameters
**Measure:** Change in total, basal and bolus insulin doses
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on diabetes-related parameters
**Measure:** Change in in body weight
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics
**Measure:** Mean blood glucose level over preceding 14 days
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics
**Measure:** Blood glucose percentage time in range (3.9-10.0 mmol/L) over preceding 14 days
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics
**Measure:** Blood glucose percentage time below range (3.0-3.8 mmol/L and <3.0 mmol/L) over preceding 14 days
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics
**Measure:** Blood glucose percentage time above range (10.1-13.9mmol/L and >13.9 mmol/L) over preceding 14 days
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics
**Measure:** Glycaemic variability index
**Time Frame:** From baseline to week 16
**Description:** To investigate if trial outcomes are associated with baseline c-peptide levels
**Measure:** C-peptide level
**Time Frame:** At baseline
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on ketone levels
**Measure:** Proportion of participants with non-acidotic ketosis
**Time Frame:** From baseline to week 16
#### Primary Outcomes
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on quality of life (QoL).
KCCQ clinical summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).
**Measure:** Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score
**Time Frame:** From baseline to week 16
#### Secondary Outcomes
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL.
KCCQ clinical summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).
**Measure:** Change in KCCQ clinical summary score
**Time Frame:** From baseline to week 4
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL.
KCCQ overall summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).
**Measure:** Change in KCCQ overall summary score
**Time Frame:** From baseline to weeks 4 and 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL.
KCCQ clinical summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).
KCCQ overall summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).
**Measure:** Proportion of participants with a ≥5, ≥10 and ≥15 point increase in KCCQ clinical and overall summary scores
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL.
Treatment satisfaction status score (no unit, ranges from 0 to 36, with higher scores reflecting greater treatment satisfaction).
Treatment satisfaction change score (no unit, designed to overcome ceiling effects and to detect changes in treatment satisfaction on a scale from -18 to 18 with negative scores reflecting decreased treatment satisfaction, 0 reflecting no change and positive scores reflecting increased treatment satisfaction).
**Measure:** Change in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc)
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL.
The instrument consists of two components: the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ-VAS).The first part consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels (level 1 "no problems", level 2 "slight problems", level 3 "moderate problems", level 4 "severe problems", and level 5 "extreme problems"), from which a single EQ-5D index score can be calculated ranging from 0 to 1 where higher scores indicate higher health utility. The EQ-VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health.
**Measure:** Change in EQ-5D-5L questionnaire score
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on walking distance
**Measure:** Change in distance covered during 6-minute walk test
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on NT-proBNP
**Measure:** Change in N-terminal pro b-type natriuretic peptide (NT-proBNP)
**Time Frame:** From baseline to week 16
**Description:** To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on glycaemic control
**Measure:** Change in Haemoglobin A1c (HbA1c)
**Time Frame:** From baseline to week 16
**Description:** To provide information on safety and tolerability of sotagliflozin 200mg once daily in addition to standard of care compared to placebo
**Measure:** Proportion of participants with level 2 or level 3 hypoglycaemia
**Time Frame:** From baseline to weeks 16 and 20
**Description:** To provide information on safety and tolerability of sotagliflozin 200mg once daily in addition to standard of care compared to placebo
**Measure:** Proportion of participants with diabetic ketoacidosis (DKA)
**Time Frame:** From baseline to weeks 16 and 20
**Description:** To provide information on safety and tolerability of sotagliflozin 200mg once daily in addition to standard of care compared to placebo
**Measure:** Proportion of participants requiring hospitalisation due to heart failure (HF)
**Time Frame:** From baseline to weeks 16 and 20
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age 18 years to \<85 years.
* Type 1 diabetes.
* Insulin dose ≥0.5 units/kg body weight at screening or body mass index (BMI) ≥25kg/m2 at screening
* Using continuous glucose monitor at screening or willing to use one for the duration of the trial.
* Diagnosis of heart failure (HF) regardless of left ventricular ejection fraction (LVEF), defined as one or more of the following:
Previous HF hospitalisation where HF was documented as the primary cause of hospitalisation and there was a requirement for loop diuretics
OR
Impaired left ventricular (LV) function (i.e. LVEF \<50% by any imaging modality) at any time
OR
Preserved LV systolic function (LVEF ≥50%) with left atrial enlargement (2-dimensional echocardiographic measurement of left atrial width ≥3.8cm or left atrial length ≥5.0 cm or left atrial area ≥20cm2 or left atrial volume index \>29 ml/m2) within the last 24 months.
OR
Preserved LV systolic function (LVEF ≥50%) with left ventricular hypertrophy (2-dimensional echocardiographic measurement of end-diastolic interventricular septal diameter ≥1.2cm or end-diastolic left ventricular posterior wall diameter ≥1.2cm) within the last 24 months.
OR
Preserved LV systolic function (LVEF ≥50%) with echocardiographic diastolic dysfunction (septal e' \<7cm/sec or lateral e' \<10cm/sec or average E/e' ≥15) within the last 24 months.
* New York Heart Association Class II-IV at screening.
* Elevated N-terminal pro-B-type natriuretic peptide (≥250 ng/L for those in sinus rhythm, ≥400 ng/L if in atrial fibrillation) or B-type natriuretic peptide (≥75 ng/L for those in sinus rhythm, ≥100 ng/L if in atrial fibrillation) within 12 months of screening.
* Kansas City Cardiomyopathy clinical summary score \<85 at screening.
Exclusion Criteria:
* Cardiac surgery (coronary artery bypass graft or valve replacement), type 1 myocardial infarction, implantation of cardiac device (including biventricular pacemaker) or cardiac mechanical support implantation within 1 month of screening, or between screening and randomisation, or planned during the trial.
* End-stage heart failure requiring left ventricular assist devices, intra-aortic balloon pump, or any type of mechanical support at the time of randomisation.
* Documented primary severe valvular heart disease, amyloidosis or hypertrophic cardiomyopathy as principal cause of heart failure as judged by the local investigator.
* Respiratory disease thought to be the primary cause of dyspnoea as assessed by the local investigator.
* Chronic kidney disease with estimated glomerular filtration rate \<25ml/min/1.73m2 at screening.
* Moderate or severe hepatic impairment (e.g. Child-Pugh B and C) at screening as judged by the local investigator.
* Use of sotagliflozin or any sodium-glucose co-transporter-2 inhibitors (SGLT2i) within 1 month of screening or between screening and randomisation.
* Previous hypersensitivity/intolerance to SGLT2i.
* Presence of malignancy with expected life expectancy \<1 year at screening.
* Severe hypoglycaemia (hospitalisation for hypoglycaemia or episode requiring external assistance to treat) within 1 month prior to screening or between screening and randomisation.
* One episode of diabetic ketoacidosis or nonketotic hyperosmolar state within 1 month of screening or between screening and randomisation, or ≥2 diabetic ketoacidosis or nonketotic hyperosmolar state events within 6 months of screening.
* Pregnant or lactating women.
* Women of childbearing age or male partners of women of childbearing age and not practicing an acceptable method of birth control
* On a ketogenic diet.
* Unwilling/unable to share glucose and ketone monitoring data.
* Unwilling to wear continuous glucose monitoring during the trial.
* Use of any investigational drugs within five times of the elimination half-life after the last dose or within 30 days, whichever is longer. Current enrolment in non-interventional, observational studies will be allowed.
**Maximum Age:** 84 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ify Mordi, MBChB, MD
**Phone:** +44 1382 385591
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Dundee
**Name:** Ify Mordi, MBChB, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes
- ID: M7117
- Name: Diabetes Mellitus, Type 1
- Relevance: HIGH
- As Found: Type 1 Diabetes
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000003922
- Term: Diabetes Mellitus, Type 1
### Intervention Browse Module - Ancestors
- ID: D000077203
- Term: Sodium-Glucose Transporter 2 Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000007004
- Term: Hypoglycemic Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M254783
- Name: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
- Relevance: HIGH
- As Found: Videoconferencing
- ID: M1691
- Name: Sodium-Glucose Transporter 2 Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M10054
- Name: Hypoglycemic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000575681
- Term: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435143
**Acronym:** IESPI
**Brief Title:** Validation and Usability Study of Intermittent Electrical Simulation in Management of Pressure Injuries Stages 1 and 2
**Official Title:** Validation and Usability Study of Intermittent Electrical Simulation (Prelivia) IES in the Management of Pressure Injuries Stage 1 and Stage 2
#### Organization Study ID Info
**ID:** H24-00304
#### Organization
**Class:** OTHER
**Full Name:** University of British Columbia
### Status Module
#### Completion Date
**Date:** 2024-11-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Providence Health & Services
#### Lead Sponsor
**Class:** OTHER
**Name:** University of British Columbia
#### Responsible Party
**Investigator Affiliation:** University of British Columbia
**Investigator Full Name:** Lisa Maks
**Investigator Title:** Diabetes Clinical Nurse Specialist, Adjunct Professor UBC School of Nursing
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The focus of this study will be early stage pressure ulcers, which can quickly progress to stage 3, 4 or deep tissue injury The proposed study explores the feasibility of intermittent electrical stimulation (IES),Prelivia, a novel, non-invasive technology in the management of stage 1 and 2 pressure ulcers.
**Detailed Description:** Pressure ulcers (also known as pressure injuries or bedsores) constitute a major morbidity in critically ill patients due to immobilization, deranged tissue perfusion, and poor nutrition. It is estimated that the prevalence of pressure injuries is 2.2 to 23.9 percent or higher, depending on the hospital environment, significantly contributing to nosocomial risk and healthcare costs.
Particularly, they are one of the most common complications among people with limited mobility is increased pressure on certain areas of the body causing reduced blood flow and damage to the skin.
There has been extensive research that shows electrical stimulation can be useful in pressure ulcer treatment. (Arora et al, 2020) (5) Electrical stimulation is provided by an electrical current, which can be applied in many ways.
The study intervention applies Intermittent Electrical Stimulation (IES) to the affected area through surface electrodes. The device invokes muscle contractions for 10 seconds every 10 minutes, emulating the subconscious adjustments performed by able- bodied individuals in response to discomfort when seated or lying down. Animal studies demonstrate that IES reduces internal pressure at bone-muscle interfaces (the hypothesized mechanism for injury development), increases tissue oxygenation in surrounding areas, and reduces or eliminates deep tissue injury in muscles subjected to prolonged loading (Appendix A). (6) (L. Solis et al., 2008) (7) Clinical studies support the safety, feasibility, and general acceptability of gluteal IES in human participants. (Appendix B) (Ahmetovic et al., 2015) (8) (Kane et al., 2017) (9) This technology has been studied and has shown, with strong evidence, the capacity of IES to prevent sacral and ischial pressure injuries.
Prelivia uses RHT's patented Intermittent Electrical Stimulation (IES) technology which counteracts damaging tissue compression and increases blood flow to parts of the body that are at risk. Prelivia acts by mimicking the physiological micro-contractions that normally occur in mobile individuals when they fidget or shift their weight. Prelivia works by restoring subconscious muscle contractions and movements, or a 'fidgeting' movement that able-bodied individuals are able do. These muscle contractions increase tissue perfusion - the process in which metabolic waste is removed and fresh blood, oxygen, and nutrients are brought into the tissue. The target muscles(such as the glutei maximi) are electrically stimulated for 10 seconds every 10 minutes to restore adequate tissue perfusion to the surrounding tissue.
The system consists of a battery-powered stimulator (Prelivia Stimulator) and disposable hydrogel electrodes. Prelivia's streamlined design, simple application, and low cost make it the ideal addition to existing standard of care procedures.
Prelivia is the only device on the market that addresses poor circulation and low oxygenation in compressed areas. Current pressure injury preventative interventions rely on either temporarily relieving pressure (nurses turn patients every 2 hrs) , creams, or redistributing pressure (specialized mattresses, cushions, etc.). However, neither of these interventions restore blood circulation, tissue oxygenation, or tissue perfusion.
Primary objective: To evaluate users' interaction with the device, safety and tolerability by patients when wearing Prelivia IES during management of pressure injuries stage 1 and 2 during their stay in the hospital, up to 30 days, until patient death or discharge whatever comes first.
Secondary objective : Compare the status and healing time of stage 1 and 2 pressure injuries matched with the historic controls, via retrospective data review. Historic controls will involve consideration of various factors:
Patients with documented stage 1 and 2 pressure injuries matched according to the age range, gender, location of pressure injury(ies), Body mass Index and comorbidities.
Data will be requested from the Providence Healthcare Integrated Health informatics Datalab.
Exploratory objective: Develop high level health economic model for pressure injury cost savings.
### Conditions Module
**Conditions:**
- Pressure Injury
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** This is a feasibility study of testing Prelivia in an in-patient setting
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patient admitted to hospital with a confirmed stage 1 and 2 pressure injuries. Prelivia device will be applied to skin around pressure injury. Intermittent electrical stimulation will be administered for 10 seconds every 10 minutes to improve blood flow and muscle contraction to the area, simulating movement
**Intervention Names:**
- Device: Prelivia
**Label:** Patient with pressure injury stage 1 and stage 2
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Patient with pressure injury stage 1 and stage 2
**Description:** Pad applied to skin provide electrical stimulation for 10 seconds every 10 minutes
**Name:** Prelivia
**Other Names:**
- Intermittent electrical stimulation
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Will assess using qualitative questionnaire for both nursing staff and patient as to comfort and ease of use.
**Measure:** To evaluate users' interaction with the device, safety and tolerability by patients when wearing Prelivia IES during management of pressure injuries stage 1 and 2 during their stay in the hospital
**Time Frame:** 30 days
**Description:** Will perform an initial assessment of the wound (e.g. size, narrative description) and compare this pre-intervention with post-intervention after a maximum of 30 days of wear time.
**Measure:** Compare the status and healing time of stage 1 and 2 pressure injuries matched with historical controls via retrospective data review. Historic controls will involve consideration of a various factors:
**Time Frame:** 30 days
**Description:** Measurement of cost to treat patients that developed a severe pressure ulcer compared to those that did not.
**Measure:** Exploratory objective: to develop high level health economic model for pressure injury cost savings
**Time Frame:** 120 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria: Willing and able to provide written informed consent to participate and wear Prelivia for the duration of the study but not longer than 30 days Patients with new or already established stage 1 and 2 pressure injuries BMI \<40 Pressure injury location sacral/ischial region
-
Exclusion Criteria:
* existing pressure injury above stage 2 and injuries classified as DTI or unstageable continuous neuromuscular blocking drugs \& myasthenia gravis: may prevent the ability of IES to induce muscular contraction
* electrical stimulation to induce muscular contraction
* presence of permanent pacemaker or AICD, and for those with external wires after cardiac surgery, those who are using or at high risk for the development of a requirement for an external pacemaker
* unstable spinal, pelvic, or hop fractures that may be displaced by a forced contraction (for sacral and ischial ulcers)
* rhabdomyolysis
* skin breakdown or malignant skin involvement over the effected regions that would preclude the use of surface electrodes
* any implantable electrostimulation device
* have pacemaker or any other implantable neurostimulation devices,
* if your pressure injury is above stage 2, or
* if you are receiving neuromuscular blocking drugs,
* if you have myasthenia gravis,
* if you have unstable spinal, pelvic, or hip fractures that may be displaced by a forced contraction or
* if you are wearing an incontinence brief and have frequently loose bowel movements
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Lisa J Maks, MN
**Phone:** 604-816-6523
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Melodee Dayrit, BScN
**Phone:** 604-682-2344
**Phone Ext:** 62711
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** Unidentifyable research data will be shared with other team members
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012883
- Term: Skin Ulcer
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M834
- Name: Crush Injuries
- Relevance: HIGH
- As Found: Pressure Injury
- ID: M6870
- Name: Pressure Ulcer
- Relevance: HIGH
- As Found: Pressure Injury
- ID: M17206
- Name: Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: HIGH
- As Found: Injury
- ID: M15686
- Name: Skin Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003668
- Term: Pressure Ulcer
- ID: D000014947
- Term: Wounds and Injuries
- ID: D000071576
- Term: Crush Injuries
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435130
**Brief Title:** The Impact of Chokeberry Bioproducts on Metabolic Parameters and Antioxidant Potential
**Official Title:** The Impact of Chokeberry Bioproducts Consumption on Metabolic Parameters and the Antioxidant Potential of Serum
#### Organization Study ID Info
**ID:** MUBialystok2
#### Organization
**Class:** OTHER
**Full Name:** Medical University of Bialystok
### Status Module
#### Completion Date
**Date:** 2022-08-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-08-30
**Type:** ACTUAL
#### Start Date
**Date:** 2022-05-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Medical University of Bialystok
#### Responsible Party
**Investigator Affiliation:** Medical University of Bialystok
**Investigator Full Name:** Małgorzata Zujko
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Chokeberry can be used both in the prevention and treatment of various metabolic disorders due to its high antioxidant properties. The study assessed for the first time the synergistic effect of chokeberry juice and chokeberry fiber on selected metabolic and anthropometric parameters. 102 people (67 women and 35 men) took part in the intervention study. After 8 weeks of intervention with chokeberry juice and another 4 weeks of intervention with chokeberry juice and fiber, a change in waist circumference, blood pressure, glucose, glycated hemoglobin, LDL cholesterol, aspartate transaminase (AST) and the level of antioxidant potential was observed.
### Conditions Module
**Conditions:**
- Diet, Healthy
- Diabetes Mellitus
- Hypertension
- Obesity
- Hypercholesterolemia
**Keywords:**
- chokeberry
- juice
- fiber
- diet
- intervention
- diabetes
- obesity
- hypertension
- hypercholesterolemia
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** 102 people (67 women and 35 men) with metabolic disorders were included in the interventional study
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 102
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Study participants consumed 100 mL of chokeberry juice daily for 8 weeks. After 8 weeks, participants consumed 100 ml of chokeberry juice and 10 g of chokeberry fiber daily for 4 weeks.
**Intervention Names:**
- Other: Dietary intervention with chokeberry juices
- Other: Dietary intervention with chokeberry juices and fibers
**Label:** Dietary intervention with chokeberry juice and fibre
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dietary intervention with chokeberry juice and fibre
**Description:** The first stage of the dietary intervention lasted 8 weeks. Study participants consumed 100 ml of chokeberry juice daily. Chokeberry juice came from ecological cultivation (Poland). Participants qualified for the study had specific biochemical parameters tested: fasting glucose and insulin level, lipid profile (triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol), glycated hemoglobin, uric acid, C-reactive protein (CRP), creatinine, liver enzymes: alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamylotranspeptydase (GGTP), homocysteine and antioxidant potential. Blood tests were performed in a certified external laboratory before and after 8 weeks of intervention. In addition, blood pressure and waist circumference were tested.
**Name:** Dietary intervention with chokeberry juices
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Dietary intervention with chokeberry juice and fibre
**Description:** The second stage of the dietary intervention lasted 4 weeks. Study participants consumed 100 ml of chokeberry juice daily and 10 g chokeberry fiber daily (from ecological cultivation, Poland). Blood tests were performed in a certified external laboratory after 4 weeks of intervention. The following blood tests were performed: fasting glucose and insulin level, lipid profile (triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol), glycated hemoglobin, uric acid, C-reactive protein (CRP), creatinine, liver enzymes: alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamylotranspeptydase (GGTP), homocysteine and antioxidant potential. In addition, blood pressure and waist circumference were tested.
**Name:** Dietary intervention with chokeberry juices and fibers
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in waist circumference was observed.
**Measure:** Change in waist circumference
**Time Frame:** 12 weeks
**Description:** After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in systolic and diastolic blood pressure was observed.
**Measure:** Change in blood pressure
**Time Frame:** 12 weeks
**Description:** After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in glycated hemoglobin was observed.
**Measure:** Change in glycated hemoglobin
**Time Frame:** 12 weeks
**Description:** After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in glucose level was observed.
**Measure:** Change in glucose level
**Time Frame:** 12 weeks
**Description:** After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in LDL-cholesterol level was observed.
**Measure:** Change in LDL-cholesterol
**Time Frame:** 12 weeks
**Description:** After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in aspartate transaminase (AST) level was observed.
**Measure:** Change in aspartate transaminase (AST) level
**Time Frame:** 12 weeks
**Description:** After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in antioxidant potential of serum was observed.
**Measure:** Change in antioxidant potential of serum
**Time Frame:** 12 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* age 30-65 years,
* low or moderate physical activity.
Exclusion Criteria:
* age \<30 and \>65 years,
* high physical activity,
* obesity (class II),
* diabetes (all types),
* gastric ulcer,
* acute or chronic gastritis,
* intestinal diseases, including inflammatory bowel diseases and functional intestinal disorders,
* taking hypoglycemic, lipid-lowering, immunosuppressive, anticoagulant and antihypertensive drugs, use of steroid therapy,
* high physical activity,
* pregnancy,
* breastfeeding.
**Maximum Age:** 65 Years
**Minimum Age:** 30 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Białystok
**Country:** Poland
**Facility:** Medical University of Bialystok
**Zip:** 15-089
#### Overall Officials
**Official 1:**
**Affiliation:** Medical University of Bialystok
**Name:** Malgorzata E. Zujko, Dr.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000006949
- Term: Hyperlipidemias
- ID: D000050171
- Term: Dyslipidemias
- ID: D000052439
- Term: Lipid Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M10024
- Name: Hypertension
- Relevance: HIGH
- As Found: Hypertension
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
- ID: M12701
- Name: Obesity
- Relevance: LOW
- As Found: Unknown
- ID: M9988
- Name: Hypercholesterolemia
- Relevance: HIGH
- As Found: Hypercholesterolemia
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10002
- Name: Hyperlipoproteinemias
- Relevance: LOW
- As Found: Unknown
- ID: M10000
- Name: Hyperlipidemias
- Relevance: LOW
- As Found: Unknown
- ID: M26181
- Name: Dyslipidemias
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27029
- Name: Lipid Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006973
- Term: Hypertension
- ID: D000006937
- Term: Hypercholesterolemia
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: AA
- Name: Amino Acids
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: LOW
- As Found: Unknown
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M4292
- Name: Antioxidants
- Relevance: LOW
- As Found: Unknown
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M207501
- Name: Chrysarobin
- Relevance: LOW
- As Found: Unknown
- ID: M17277
- Name: Uric Acid
- Relevance: LOW
- As Found: Unknown
- ID: M18659
- Name: N-Methylaspartate
- Relevance: LOW
- As Found: Unknown
- ID: T0
- Name: Alanine
- Relevance: LOW
- As Found: Unknown
- ID: T3
- Name: Aspartic Acid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435117
**Acronym:** CO-CAPTAIN
**Brief Title:** Cancer Prevention Among Individuals With Mental Ill-health: Patient Navigation for Primary Cancer Prevention
**Official Title:** Cancer Prevention Among Individuals With Mental Ill-health: Co-adapting and Implementing Patient Navigation for Primary Cancer Prevention
#### Organization Study ID Info
**ID:** 101104784
#### Organization
**Class:** OTHER
**Full Name:** Medical University of Vienna
### Status Module
#### Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-28
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Senior Europa Sociedad Limitada
**Class:** OTHER
**Name:** Prolepsis Institute for Preventive, Environmental and Occupational Medicine
**Class:** OTHER
**Name:** Universitat Politècnica de València
**Class:** UNKNOWN
**Name:** STICHTING INTERNATIONAL FOUNDATION FOR INTEGRATED CARE
**Class:** OTHER
**Name:** Medical University of Lodz
**Class:** UNKNOWN
**Name:** Consejería de Familia, Juventud y Política Social, Comunidad de Madrid
**Class:** OTHER
**Name:** Servicio Madrileño de Salud, Madrid, Spain
**Class:** UNKNOWN
**Name:** Fundacion para la Investigacion e Innovacion Biosanitaria de Atencion Primaria
**Class:** UNKNOWN
**Name:** Mental Health Europe - Sante Mentale Europe
**Class:** OTHER
**Name:** University Mental Health Research Institute, Athens, Greece
**Class:** UNKNOWN
**Name:** Fundacion para el Fomento en Asturias de la Investigacion Cientifica Aplicada y Tecnologia
**Class:** UNKNOWN
**Name:** Consejeria de Salud - Principado de Asturias
**Class:** UNKNOWN
**Name:** Servicio de Salud del Principado de Asturias
#### Lead Sponsor
**Class:** OTHER
**Name:** Medical University of Vienna
#### Responsible Party
**Investigator Affiliation:** Medical University of Vienna
**Investigator Full Name:** Igor Grabovac
**Investigator Title:** Project coordinator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Prevention is essential for reducing cancer-related mortality. However, people with mental ill-health often face difficulties in accessing cancer prevention services. The EU-funded CO-CAPTAIN project aims to co-adapt and implement the Patient Navigation Model for primary cancer prevention in this underserved population. This evidence-based and patient-centred intervention aims to support patient empowerment through removal of systemic barriers, provide social support and promote timely access to primary prevention services.
**Detailed Description:** Cancer and mental ill-health constitute leading public health problems in Europe. More than 84 million people in the European Union (EU) report living with an on-going mental ill-health condition. While issues concerning mental health are of great importance, they often overshadow physical problems that people with mental ill-health face. Such is cancer, which is more prevalent in people with mental ill-health and is also the second most common cause of death in this population. People with mental ill-health often have difficulties in accessing quality cancer prevention services, but are also additionally overlooked in research which makes them overall an underserved population. What data is available, shows that potential reasons for these higher cancer morbidity and mortality rates are linked to more engagement in risky health behaviour (especially higher prevalence of smoking as well as overweight and obesity) but also experiences of significant barriers when accessing the highly fragmented heath care systems.
Timely and evidence-based preventive strategies including optimizing health care pathways provide a solution to the high cancer morbidity and could improve overall health outcomes in this disadvantaged population. One such mixed-skill strategy is Patient Navigation. Therefore, the overall goal of the CO-CAPTAIN project is to co-adapt the Patient Navigation (PN) model focusing on primary cancer prevention and to see if this model can prove to be beneficial in supporting individuals with mental ill-health through care services to reduce cancer risk factors by increasing knowledge, health literacy and empowerment. The Patient Navigation Model is an innovative, evidence-based and patient-centred intervention, which supports patient empowerment through removal of systemic barriers, providing social support and promoting timely access to primary prevention services. Based on implementation science and utilizing the Consolidated Framework for Implementation (CFIR) as well as the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks, the CO-CAPTAIN project aims to reduce the gap in health inequalities for people with mental ill-health by reducing cancer burden and improving overall health, which will, in turn, reduce associated costs across health and social care systems in Europe. Moreover, the CO-CAPTAIN project aims to harness the transformative potential of the integrated care pathways in cancer as well as provide health and social care policy recommendations for the adoption and implementation of the Patient Navigation Model across Europe.
The adapted Patient Navigation Model will be implemented in four European countries (Austria, Greece, Poland, Spain) and its potential to enable and improve access and utilization of primary cancer prevention measures for people with mental ill-health will be evaluated. The study will employ a mixed-methods design allowing for both exploratory and confirmatory research.
The project has been funded by the HORIZON EUROPE Framework Program (Call: Research and Innovation actions supporting the implementation of the Mission on Cancer (HORIZON-MISS-2022-CANCER-01-01) - Improving and upscaling primary prevention of cancer through implementation research) and is coordinated by the Medical University of Vienna.
### Conditions Module
**Conditions:**
- Cancer
**Keywords:**
- Europe
- Prevention
- Cancer
- Cancer prevention
- Primary prevention
- Mental health
- Mental health problems
- Patient Navigation
- Implementation science
- Co-design
- Longitudinal
- Person-centered
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 1240
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** All people with mental ill-health aged 18 or older who visit one of the recruitment sites will be asked to participate. Further participants will be recruited through partner organizations (non-governmental organisations, patient groups and professional organisations) involved in care for individuals with mental ill-health, as well as personal contacts. Additionally, healthcare professionals involved in care of people with mental ill-health will be asked to participate in the qualitative part of the study.
**Intervention Names:**
- Other: Patient Navigation
**Label:** People with mental ill-health
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- People with mental ill-health
**Description:** CO-CAPTAIN focuses on co-designing and piloting and evaluating the implementation of patient navigation (PN) for primary cancer prevention in people with mental ill-health. Patient Navigators, trained professionals with experience working with people with mental ill-health, will assist people with mental ill-health in gaining access to and utilizing appropriate primary cancer prevention measures offered within the respective healthcare and social system (including smoking cessation and physical activity and nutritional interventions). For this purpose, Patient Navigators will offer regular appointment with participants, apply motivational interviewing and aid in accessing appropriate materials while aiming at empowering participants in taking an active role and making better and more informed decisions regarding their health.
**Name:** Patient Navigation
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in health outcomes and socio-economic risk factors in the course of study participation. Next to socio-demographic data, participants will indicate their health status, alcohol consumption, sexual risk behavior, sun exposure, and vaccination status by self-report or electronic health reports.
**Measure:** Health data of participants as assessed by self-report or electronic health reports
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome nutritional intake. Nutritional intake will be assessed by the Rapid Prime Diet Quality Score Screener (rPDQS; range: 0-52, where higher values indicate healthier nutritional intake).
**Measure:** Nutritional intake of participants as assessed by the Rapid Prime Diet Quality Score Screener (rPDQS)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome smoking behavior. Smoking behavior will be assessed by the Fagerström Test for Nicotine Dependence (FND; range: 0-10, where higher values indicate higher nicotine dependence).
**Measure:** Smoking behavior of participants as assessed by the Fagerström Test for Nicotine Dependence (FND)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome physical activity. Physical activity will be assessed by the International Physical Activity Questionnaire (IPAQ; range: 0-19278 MET minutes per week, where higher values indicate more time spent on physical activity).
**Measure:** Physical activity of participants as assessed by the International Physical Activity Questionnaire (IPAQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome depressive symptoms. Depressive symptoms will be assessed by the Patient Health Questionnaire (PHQ-9; range: 0-27, where a higher score indicates more severe depressive symptoms).
**Measure:** Depressive symptoms of participants as assessed by the Patient Health Questionnaire (PHQ-9)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome generalized anxiety. Generalized anxiety will be assessed by the 7-item anxiety scale (GAD-7; range: 0-21, where higher values indicate more severe anxiety symptoms).
**Measure:** Generalized anxiety of participants as assessed by the 7-item anxiety scale (GAD-7)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the health outcome health-related anxiety. Health-related anxiety will be assessed by items from the Whiteley Index (Whiteley-6-R; range: 0-24, where higher values indicate more health anxiety symptoms).
**Measure:** Health-related anxiety of participants as assessed by the Whiteley Index (Whiteley-6-R)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in (health-related) quality of life. (Health-related) Quality of life will be assessed by items from the World Health Organization Quality of Life Brief Version (WHO-QOL-BREF; range: 4-20, where higher values indicate higher quality of life).
**Measure:** (Health-related) Quality of life of participants as assessed by the World Health Organization Quality of Life Brief Version (WHO-QOL-BREF)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in (health-related) quality of life. (Health-related) Quality of life will be assessed by items from the descriptive system of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L, where each dimension has a range from 1-5, where a higher value indicates more severe problems).
**Measure:** (Health-related) Quality of life of participants as assessed by the descriptive system of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in (health-related) quality of life. (Health-related) Quality of life will be assessed by items from the EQ visual analogue scale of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L, range: 0-100, where higher values indicate better subjective health).
**Measure:** (Health-related) Quality of life of participants as assessed by the EQ visual analogue scale of the EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in self-efficacy. Self-efficacy will be assessed by items from the General Self-Efficacy Scale (GSES; range: 10-40, where higher values indicate higher perceived self-efficacy).
**Measure:** Self-efficacy of participants as assessed by the General Self-Efficacy Scale (GSES)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in feeling understood and supported by healthcare providers (HPS) as part of health literacy. HPS as part of health literacy will be assessed by items of the HPS scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived HPS).
**Measure:** Feeling understood and supported by healthcare providers as part of health literacy of participants as assessed by the Feeling understood and supported by healthcare providers (HPS) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in having sufficient information to manage one's own health as part of health literacy. Having sufficient information to manage my health (HSI) as part of health literacy will be assessed by items of the HSI scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived HSI).
**Measure:** Having sufficient information to manage one's own health as part of health literacy of participants as assessed by the Having sufficient information to manage my health (HSI) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in actively managing one's own health as part of health literacy. Actively managing my health (AMH) as part of health literacy will be assessed by items of the AMH scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived AMH).
**Measure:** Actively managing one's own health as part of health literacy of participants as assessed by the Actively managing my health (AMH) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in social support as part of health literacy. Social support as part of health literacy will be assessed by items of the social support of health scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived social support for health).
**Measure:** Social support as part of health literacy of participants as assessed by the Social support of health scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in appraisal of health information as part of health literacy. Appraisal of health information (CA) as part of health literacy will be assessed by items of the CA scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-4, where higher values indicate higher perceived CA).
**Measure:** Appraisal of health information as part of health literacy of participants as assessed by the Appraisal of health information (CA) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to actively engage with healthcare providers as part of health literacy. Ability to actively engage with healthcare providers (AE) as part of health literacy will be assessed by items of the AE scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived AE).
**Measure:** Ability to actively engage with healthcare providers as part of health literacy of participants as assessed by the Ability to actively engage with healthcare providers (AE) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to navigate the healthcare system as part of health literacy. Navigating the healthcare system (NHS) as part of health literacy will be assessed by items of the NHS scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived NHS).
**Measure:** Navigating the healthcare system as part of health literacy of participants as assessed by the Navigating the healthcare system (NHS) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to find good health information as part of health literacy. Ability to find good health information (FHI) as part of health literacy will be assessed by items of the FHI scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived FHI).
**Measure:** Ability to find good health information as part of health literacy of participants as assessed by the Ability to find good health information (FHI) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in the ability to understand health information well enough to know what to do as part of health literacy. Understanding health information well enough to know what to do as part of health literacy will be assessed by items of the Understand health information well enough to know what to do (UHI) scale from the Health Literacy Questionnaire (HLQ, range of the mean score: 1-5, where higher values indicate higher perceived UHI).
**Measure:** Understand health information well enough to know what to do as part of health literacy of participants as assessed by the Understand health information well enough to know what to do (UHI) scale of the Health Literacy Questionnaire (HLQ)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in use of healthcare services. Use of healthcare services will be assessed by self-reports.
**Measure:** Use of healthcare services of participants as assessed by self-reports
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by evaluating cost-effectiveness and cost-utility. To assess cost-effectiveness and cost-utility of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, an economic evaluation will be carried out by analyzing health outcomes and costs (healthcare costs, cancer costs, burden).
**Measure:** Cost-effectiveness and cost-utility of the Patient Navigation Model for primary cancer prevention in people with mental ill-health as assessed by an economic evaluation
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in satisfaction with care. Satisfaction with care will be assessed by self-reports and items from the Patient Satisfaction Questionnaire Short Form (PSQ-18, range of the mean score: 1-5, where higher scores indicate higher satisfaction with medical care).
**Measure:** Satisfaction with care of participants as assessed by self-reports and items from the Patient Satisfaction Questionnaire Short Form (PSQ-18)
**Time Frame:** 18 months
**Description:** To evaluate the clinical utility/effectiveness of the Patient Navigation Model for primary cancer prevention in people with mental ill-health, the extent to which people with mental ill-health benefitted from the intervention will be assessed by investigating changes in discrimination experiences. Discrimination experiences will be assessed by self-reports.
**Measure:** Discrimination experiences of participants as assessed by self-reports
**Time Frame:** 18 months
**Description:** The co-adapted Patient Navigation Model will be evaluated by assessing facilitators of the intervention to determine its effectiveness. Experiences of people with mental ill-health, navigators, and healthcare professionals involved in care of people with mental ill-health will be considered. Qualitative data will be gathered using semi-structured interviews.
**Measure:** Facilitators of the Patient Navigation Model as experienced by participants and assessed by qualitative semi-structured interviews
**Time Frame:** 18 months
**Description:** The co-adapted Patient Navigation Model will be evaluated by assessing barriers of the intervention to determine its effectiveness. Experiences of people with mental ill-health, navigators, and healthcare professionals involved in care of people with mental ill-health will be considered. Qualitative data will be gathered using semi-structured interviews.
**Measure:** Barriers of the Patient Navigation Model as experienced by participants and assessed by qualitative semi-structured interviews
**Time Frame:** 18 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18 years of age or older
* Individuals who have been diagnosed with one or more mental disorders OR healthcare professionals involved in care of individuals with mental ill-health
* Sufficient knowledge of language
Exclusion Criteria:
* Individuals unable to give consent due to diminished capacity
* Individuals who do not provide consent
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Igor Grabovac, MD, PhD
**Phone:** +43 1 40160 34897
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Hanna M. Mües, MSc
**Phone:** +43 1 40160 34662
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Vienna
**Contacts:**
***Contact 1:***
- **Name:** Hietzing Hospital
- **Role:** CONTACT
**Country:** Austria
**Facility:** Hietzing Hospital
**Location 2:**
**City:** Vienna
**Contacts:**
***Contact 1:***
- **Name:** Medical University of Vienna
- **Role:** CONTACT
**Country:** Austria
**Facility:** Medical University of Vienna
**Location 3:**
**City:** Athens
**Contacts:**
***Contact 1:***
- **Name:** Mental Health Clinic
- **Role:** CONTACT
**Country:** Greece
**Facility:** Mental Health Clinic
**Location 4:**
**City:** Athens
**Contacts:**
***Contact 1:***
- **Name:** The Day Hospital
- **Role:** CONTACT
**Country:** Greece
**Facility:** The Day Hospital
**Location 5:**
**City:** Athens
**Contacts:**
***Contact 1:***
- **Name:** The Guest House / Protected apartments
- **Role:** CONTACT
**Country:** Greece
**Facility:** The Guest House / Protected apartments
**Location 6:**
**City:** Łódź
**Contacts:**
***Contact 1:***
- **Name:** POMOST
- **Role:** CONTACT
**Country:** Poland
**Facility:** The Association of Youth and People with Mental Problems, Their Families and Friends POMOST
**Location 7:**
**City:** Madrid
**Country:** Spain
**Facility:** Servicio Madrileño de Salud (SERMAS)
#### Overall Officials
**Official 1:**
**Affiliation:** Medical University of Vienna
**Name:** Igor Grabovac, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Upon request
**Description:** Upon request from other researchers, the principal investigator may provide study materials and data in an anonymised and limited form, while adhering to the Data Security Department of the Medical University of Vienna.
**Info Types:**
- STUDY_PROTOCOL
- ICF
**IPD Sharing:** YES
**Time Frame:** Accessibility is expected after completion of the study as well as of related publications. Only data that does not allow identification of participants will be made available.
### References Module
#### See Also Links
**Label:** HORIZON EUROPE
**URL:** https://cordis.europa.eu/project/id/101104784
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435104
**Brief Title:** Aromatherapy in the Treatment of Early Breast Cancer
**Official Title:** Effects of Aromatherapy on Anxiety and Tumor Immunity of Early Breast Cancer Patients,a Pilot Study
#### Organization Study ID Info
**ID:** SYSKY-2024-063-02
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
### Status Module
#### Completion Date
**Date:** 2027-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-13
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Breast cancer is a major threat to women's health, and chemotherapy is one of the most important treatment method. Chemotherapy is cytotoxic , and has a positive tumor immune effect. However, it is worth noting that anxiety caused by breast cancer itself and adverse reactions of chemotherapy not only affects the patients' quality of life, but also reduces the treatment compliance and even survival benefits of patients. Previous literatures have shown that aromatherapy may improve chemotherapy-induced anxiety and even affect anti-tumor immunity.
Therefore,we envisage that aromatherapy conbimed with chemotherapy in the treatment of breast cancer in clinical practice has the advantages of improving efficacy and survival.
However, there is still a lack of relevant clinical studies. We planned to design a prospective clinical trial to evaluate the efficacy and safety of aromatherapy combined with chemotherapy on anxiety, relevant sympathetic neurotransmitters and tumor immunity in breast cancer patients.
**Detailed Description:** Breast cancer is the most common malignant tumor in women all over the world. In China, the incidence of breast cancer is increasing, especially in the economically developed cities. Studies have shown that the breast cancer patients have a higher incidence of anxiety and depression to the general population. Tumor burden is an important chronic stressor that can cause a wide range of negative emotions, such as anxiety and depression. According to the data published by the World Health Organization, the incidence of depression in cancer patients is between 20% to 45%, which is far more than the incidence of 6.1% to 9.5% in the general population.Among them, the depression tendency of breast cancer patients is particularly obvious, and up to 80% of breast cancer patients suffer from different degrees of depression. Depression and anxiety have a crucial influence on the physiological and psychological function, treatment compliance and the quality of life of breast cancer patients, and may even be an important factor affecting the mortality of breast cancer patients.
Therefore, how to improve the anxiety of breast cancer patients to improve the quality of life and even the survival time of patients has vital clinical value. Considering the adverse reactions and tolerance of current anti-anxiety drugs, more mild and effective anti-anxiety methods are expected in clinical practice. Among them, as an important means of rehabilitation treatment, aromatherapy has obtained surprising data in the prevention of adverse reactions of chemotherapy and the improvement of insomnia, so the value of aromatherapy in the improvement of anxiety is also expected.
In conclusion, Breast cancer is a major threat to women's health, and chemotherapy is one of the most important treatment method. Chemotherapy is cytotoxic , and has a positive tumor immune effect. However, it is worth noting that anxiety and depression caused by breast cancer disease itself and adverse reactions of chemotherapy not only affects the quality of life of patients, but also reduces the treatment compliance and even survival benefits of patients. Previous literatures have shown that aromatherapy may improve chemotherapy-induced anxiety and even have influence on tumor immunity. However, there is still lack of relevant clinical researches. Therefore, we plan to design a prospective clinical study to evaluate the effect of aromatherapy combined with neoadjuvant chemotherapy on anxiety, sympathetic neurotransmitters and tumor immunity in early breast cancer patients.
### Conditions Module
**Conditions:**
- Early Breast Cancer
**Keywords:**
- Early breast Cancer
- Anxiety
- Aromatherapy
- Neoadjuvant chemotherapy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The research model consists of two arms#
1. armA:neoadjuvant chemotherapy
2. armB:neoadjuvant chemotherapy+aromatherapy
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will receive effective neoadjuvant chemotherapy for at least 2 courses.
**Intervention Names:**
- Other: neoadjuvant chemotherapy
**Label:** neoadjuvant chemotherapy
**Type:** OTHER
#### Arm Group 2
**Description:** Patients will receive effective neoadjuvant chemotherapy for at least 2 courses, and the aromatherapy is recommended to continue throughout neoadjuvant chemotherapy.
**Intervention Names:**
- Other: neoadjuvant chemotherapy
- Other: aromatherapy
**Label:** neoadjuvant chemotherapy+aromatherapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- neoadjuvant chemotherapy
- neoadjuvant chemotherapy+aromatherapy
**Description:** The neoadjuvant chemotherapy plan will be selected according to the recommendations of the NCCN guidelines and the Chinese CSCO guidelines for early breast cancer.The neoadjuvant chemotherapy plans include:AC-T(HP),TCb(HP),AC-TCb, in which A represents anthracycline, C represents cyclophosphamide, T represents taxane, Cb represents carboplatin, H represents trastuzumab, and P represents pertuzumab.
**Name:** neoadjuvant chemotherapy
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- neoadjuvant chemotherapy+aromatherapy
**Description:** Patients will inhale essential oils during the neoadjuvant chemotherapy courses.
**Name:** aromatherapy
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Changes of anxiety scores (Hamilton Anxiety Scale and State-trait anxiety inventory scale) before and after two neoadjuvant chemotherapy courses.
**Measure:** Change in anxiety score
**Time Frame:** before neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy course 2 (each course is 21 days)
#### Secondary Outcomes
**Description:** The time from the start of randomization to death due to any cause
**Measure:** Overall Survival, OS
**Time Frame:** 2 years
**Description:** The function or quality of a patient's physical, psychological, and social adaptability is also known as quality, which is assessed according to the EROTC C30 scale.
**Measure:** Quality of life scale score,QoL
**Time Frame:** before neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy course 2 (each course is 21 days)
**Description:** Proportion of patients with pathologic complete response after neoadjuvant chemotherapy
**Measure:** Pathologic complete response,pCR
**Time Frame:** 2 years
**Description:** The time from diagnosis to first recurrence or death of the patient
**Measure:** Disease-free survival,DFS
**Time Frame:** 2 years
**Description:** All target lesions disappeared, no new lesions appeared, and tumor markers remained normal for at least 4 weeks.
**Measure:** Complete response,CR
**Time Frame:** 2 years
**Description:** The sum of the maximum diameters of the target lesions is reduced by≥30%,maintained for at least 4 weeks.
**Measure:** Partial response,PR
**Time Frame:** 2 years
**Description:** The sum of the maximum diameters of the target lesions is within the prescribed range of partial response and progressive disease.
**Measure:** Stable disease,SD
**Time Frame:** 2 years
**Description:** The sum of the maximum diameters of the target lesions increases by at least 20%, and their absolute value of diameters increases by at least 5mm, or new lesions appear.
**Measure:** Progressive disease,PD
**Time Frame:** 2 years
**Description:** The proportion of patients with a tumor volume reduction of ≥30% and a minimum timeframe according to accepted response evaluation criteria (e.g., RECIST version 1.1 in solid tumors), including cases of complete response (CR) and partial response (PR).
**Measure:** Objective Response Rate, ORR
**Time Frame:** 2 years
**Description:** Proportion of confirmed complete response, partial response, or stable disease ≥ 24 weeks.
**Measure:** Clinical Benefit Rate, CBR
**Time Frame:** 24 weeks after enrollment
**Description:** The scores of self-rating anxiety scale (SAS) before treatment, after each treatment and 3 months after the last treatment.
**Measure:** Anxiety rating scale
**Time Frame:** before treatment and 3 months after the last treatment
**Description:** The scores of Pittsburgh sleep quality index(PSQI) before treatment, after each treatment and 3 months after the last treatment.
**Measure:** Sleep rating scale
**Time Frame:** before treatment and 3 months after the last treatment
**Description:** The scores of Hamilton Depression Scale(HAMD) before treatment and after 2 times of treatment.
**Measure:** Depression scale
**Time Frame:** before neoadjuvant chemotherapy and at the end of neoadjuvant chemotherapy course 2 (each course is 21 days)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Adult female patients (age 18-80 years) with early breast cancer confirmed by pathology.
2. Patients have not received any anti-tumor treatment,and are planning to receive neoadjuvant chemotherapy.
3. Patients with mild anxiety scored 50 in Self-Rating Anxiety Scale.
4. ECOG physical status score ≤ 2 and expected survival of not less than 3 months.
5. At least one measurable lesion should be present in the imaging examination within 2 weeks prior to enrollment.
6. Adequate reserve of bone marrow function: white blood cell count ≥ 3.0×10\^9/L, neutrophil count ≥ 1.5 × 10\^9/L; Platelet count ≥ 70 × 10\^9/L.
7. Basically normal liver, kidney and cardiac function:total bilirubin≤3 times the upper limit of normal value,Alanine Transaminase/Aspartate Aminotransferase≤2.5 times the upper limit of normal value(patients with liver metastases≤5 times the upper limit of normal value),serum creatinine≤1.5 times the upper limit of normal value or creatinine clearance rate≥60mL/min, left ventricular ejection fraction (LVEF) ≥ 55%,QTcF(Fridericia correction) ≤ 470 ms.
8. Be able to understand the research process, volunteer to participate in the study, and sign informed consent.
Exclusion Criteria:
1. Patients who are not able to receive aromatherapy:be allergic to aromatherapy materials or suffer from heterosmia.
2. Received surgery within 2 weeks prior to enrollment.
3. Patients with severe cardiovascular and cerebrovascular events within 12 months, including but not limited to unstable angina, myocardial infarction, cerebral hemorrhage, and cerebral infarction (except asymptomatic lacunar infarction requiring no treatment)
4. Patients with active autoimmune diseases requiring treatment (e.g., corticosteroids or immunosuppressive drugs) within the past 2 years. Patients who need corticosteroid replacement therapy for adrenal insufficiency were excluded.
5. Patients with a definite past medical history or present medical history of neurological or mental disorders, including epilepsy or dementia.
6. The researchers believe that patients are not suitable to participate in any other circumstances of this study, which may interfere with the accompanying diseases or conditions of the study, or have any serious medical obstacles that may affect the safety of the subjects.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jianli J Zhao, doctorate
**Phone:** 15920589334
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Erwei E Song, doctorate
**Phone:** 13926477694
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Country:** China
**Facility:** Sun Yat-sen Memorial Hospital, Sun Yat-sen University
**State:** Guangdong
**Zip:** 510120
#### Overall Officials
**Official 1:**
**Affiliation:** Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
**Name:** Jianli J Zhao, doctorate
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** As personal information of patients is involved, we decided not to share individual participant data of patients.
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Harbeck N, Penault-Llorca F, Cortes J, Gnant M, Houssami N, Poortmans P, Ruddy K, Tsang J, Cardoso F. Breast cancer. Nat Rev Dis Primers. 2019 Sep 23;5(1):66. doi: 10.1038/s41572-019-0111-2.
**PMID:** 31548545
**Citation:** Xiong SY, Wen HZ, Dai LM, Lou YX, Wang ZQ, Yi YL, Yan XJ, Wu YR, Sun W, Chen PH, Yang SZ, Qi XW, Zhang Y, Wu GY. A brain-tumor neural circuit controls breast cancer progression in mice. J Clin Invest. 2023 Dec 15;133(24):e167725. doi: 10.1172/JCI167725.
**PMID:** 37847562
**Citation:** Wang X, Wang N, Zhong L, Wang S, Zheng Y, Yang B, Zhang J, Lin Y, Wang Z. Prognostic value of depression and anxiety on breast cancer recurrence and mortality: a systematic review and meta-analysis of 282,203 patients. Mol Psychiatry. 2020 Dec;25(12):3186-3197. doi: 10.1038/s41380-020-00865-6. Epub 2020 Aug 20.
**PMID:** 32820237
**Citation:** Carreira H, Williams R, Funston G, Stanway S, Bhaskaran K. Associations between breast cancer survivorship and adverse mental health outcomes: A matched population-based cohort study in the United Kingdom. PLoS Med. 2021 Jan 7;18(1):e1003504. doi: 10.1371/journal.pmed.1003504. eCollection 2021 Jan.
**PMID:** 33411711
**Citation:** Sharma M, Grewal K, Jandrotia R, Batish DR, Singh HP, Kohli RK. Essential oils as anticancer agents: Potential role in malignancies, drug delivery mechanisms, and immune system enhancement. Biomed Pharmacother. 2022 Feb;146:112514. doi: 10.1016/j.biopha.2021.112514. Epub 2021 Dec 25.
**PMID:** 34963087
**Citation:** Bayala B, Bassole IH, Gnoula C, Nebie R, Yonli A, Morel L, Figueredo G, Nikiema JB, Lobaccaro JM, Simpore J. Chemical composition, antioxidant, anti-inflammatory and anti-proliferative activities of essential oils of plants from Burkina Faso. PLoS One. 2014 Mar 24;9(3):e92122. doi: 10.1371/journal.pone.0092122. eCollection 2014.
**PMID:** 24662935
**Citation:** Peterfalvi A, Miko E, Nagy T, Reger B, Simon D, Miseta A, Czeh B, Szereday L. Much More Than a Pleasant Scent: A Review on Essential Oils Supporting the Immune System. Molecules. 2019 Dec 11;24(24):4530. doi: 10.3390/molecules24244530.
**PMID:** 31835699
**Citation:** Zhao ZJ, Sun YL, Ruan XF. Bornyl acetate: A promising agent in phytomedicine for inflammation and immune modulation. Phytomedicine. 2023 Jun;114:154781. doi: 10.1016/j.phymed.2023.154781. Epub 2023 Mar 22.
**PMID:** 37028250
**Citation:** Zhang Z, Liu Q, Wen P, Zhang J, Rao X, Zhou Z, Zhang H, He X, Li J, Zhou Z, Xu X, Zhang X, Luo R, Lv G, Li H, Cao P, Wang L, Xu F. Activation of the dopaminergic pathway from VTA to the medial olfactory tubercle generates odor-preference and reward. Elife. 2017 Dec 18;6:e25423. doi: 10.7554/eLife.25423.
**PMID:** 29251597
**Citation:** Bhimani RV, Yates R, Bass CE, Park J. Distinct limbic dopamine regulation across olfactory-tubercle subregions through integration of in vivo fast-scan cyclic voltammetry and optogenetics. J Neurochem. 2022 Apr;161(1):53-68. doi: 10.1111/jnc.15577. Epub 2022 Feb 5.
**PMID:** 35061915
**Citation:** Ben-Shaanan TL, Schiller M, Azulay-Debby H, Korin B, Boshnak N, Koren T, Krot M, Shakya J, Rahat MA, Hakim F, Rolls A. Modulation of anti-tumor immunity by the brain's reward system. Nat Commun. 2018 Jul 13;9(1):2723. doi: 10.1038/s41467-018-05283-5.
**PMID:** 30006573
**Citation:** Kite SM, Maher EJ, Anderson K, Young T, Young J, Wood J, Howells N, Bradburn J. Development of an aromatherapy service at a Cancer Centre. Palliat Med. 1998 May;12(3):171-80. doi: 10.1191/026921698671135743.
**PMID:** 9743836
**Citation:** Deng C, Xie Y, Liu Y, Li Y, Xiao Y. Aromatherapy Plus Music Therapy Improve Pain Intensity and Anxiety Scores in Patients With Breast Cancer During Perioperative Periods: A Randomized Controlled Trial. Clin Breast Cancer. 2022 Feb;22(2):115-120. doi: 10.1016/j.clbc.2021.05.006. Epub 2021 May 20.
**PMID:** 34134947
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000001941
- Term: Breast Diseases
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: HIGH
- As Found: Breast Cancer
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M5218
- Name: Breast Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001943
- Term: Breast Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: 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: 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: M147959
- Name: Taxane
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435091
**Acronym:** REBECCA-3
**Brief Title:** REBECCA-3 Study, Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
**Official Title:** REBECCA-3 Study, Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
#### Organization Study ID Info
**ID:** REBECCA3SUH
#### Organization
**Class:** OTHER_GOV
**Full Name:** Helse Stavanger HF
### Status Module
#### Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-14
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER_GOV
**Name:** Helse Stavanger HF
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The overall aim of the REBECCA project is to exploit the potential of "real-world data" to support clinical research and improve existing clinical workflow. The primary aim of the REBECCA-3 study is to use multi-source "real-world data" to monitor the quality of life (QoL) of prostate cancer patients who are affected by cancer-related fatigue during and after treatment. This is to investigate whether the REBECCA monitoring is accepted by male patients and can be used within various forms of cancer.
Study design: 40 prostate cancer patients that undergo radiology and/or chemotherapy treatment will be included at the time of diagnosis. After end of primary treatment, the patients will receive a smartwatch, and have to download a REBECCA patient app on their mobile and a PC plug-in on their PC so that we can monitor their QoL for 4 months. In addition to collecting digital QoL parameters through the REBECCA-system, patient-reported QoL measures will also be collected through standardized PROMs and self-evaluation forms. Further, biological samples (blood, urine, and faeces) are collected at three time points of the study (i.e., at the time of: diagnosis, completed treatment, and 4 months post treatment), to investigate immunologic biomarkers, DNA methylation patterns and microbiota for assessment of new biological and prognostic information related to the development of cancer-related fatigue in prostate cancer patients.
### Conditions Module
**Conditions:**
- Cancer Related Fatigue
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Description:** Daily and weekly frequency of participant interactions with the REBECCA system.
**Measure:** Evaluation of the average REBECCA system usage rate throughout the monitoring period.
**Time Frame:** From the end of treatment to the 4-month post-treatment follow-up.
#### Secondary Outcomes
**Description:** The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ) C30 scores patients QoL on a scale of 0-100, where higher values indicate higher QoL.
**Measure:** Quality of life (QoL) measured by the EORTC-QLQ-C30.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** The SF36 scores the patients physical and mental health on a scale of 0-100, where higher values indicate better health.
**Measure:** Quality of life (QoL) measured by the SF36-questionnaire.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** The Expanded Prostate Cancer Index Composite short form 26 (EPIC-26) scores the patients QoL on a scale of 0-100, where higher values indicate better health.
**Measure:** Quality of life (QoL) measured by the EPIC-26-questionnaire.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** The fatigue Visual Analog Scale (fVAS) scores fatigue on a scale of 0-100, where lower values indicate less fatigue, thus a reduction in fVAS score between timepoints indicates a reduction of fatigue.
**Measure:** Fatigue in primary prostate cancer patients measured by the fVAS questionnaire.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** The Fatigue Severity Scale (FSS) scores fatigue on a scale of 1-7, where lower values indicate less fatigue, thus a reduction in FSS score between timepoints indicates a reduction of fatigue.
**Measure:** Fatigue in primary prostate cancer patients measured by the FSS questionnaire.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** The Fatigue Questionnaire (FQ) scores fatigue on a scale of 0-33, where lower values indicate less fatigue, thus a reduction in FQ score between timepoints indicates a reduction of fatigue.
**Measure:** Fatigue in primary prostate cancer patients measured by the FQ questionnaire.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** The REBECCA system index score is given as values between 0 and 100, where higher values indicate higher QoL.
**Measure:** REBECCA system index score
**Time Frame:** At the 4-month post-treatment follow-up.
**Description:** Weekly measurements over a 4-month period.
**Measure:** Longitudinal analysis of the effect of the use of REBECCA using Generalized Estimating Equation (GEE)
**Time Frame:** From the end of treatment to the 4-month post-treatment follow-up.
**Description:** Measure levels of fatigue biomarkers: HSP90, IL1β, IL6, IL10, IL1βRa, and DNA methylation.
**Measure:** Fatigue biomarkers in plasma of primary prostate cancer patients.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** Long-read 16S rRNA sequencing of faecal samples to characterize the gut microbiota composition.
**Measure:** Gut microbiota composition in primary prostate cancer patients.
**Time Frame:** At the time of inclusion, at the end of treatment (3-6 months from time of inclusion) and at the 4-month post-treatment follow-up
**Description:** REBECCA score (scale 0-100) correlation to the EORTC-QLQ-C30 (scale 0-100), SF36 (scale 0-100), and EPIC-26 (scale 0-100).
**Measure:** Correlation between the REBECCA system index score and QoL questionnaire scores.
**Time Frame:** At the 4-month post-treatment follow-up.
**Description:** REBECCA score (scale 0-100) correlation to the fVAS (scale 0-100), FSS (scale 0-7) and FQ (scale 0-33).
**Measure:** Correlation between the REBECCA system index score and fatigue questionnaire scores.
**Time Frame:** At the 4-month post-treatment follow-up.
**Description:** REBECCA score (scale 0-100) correlation to fatigue biomarker levels of HSP90, IL1β, IL6, IL10, IL1βRa and DNA methylation in plasma.
**Measure:** Correlation between the REBECCA system index score and fatigue biomarker levels in plasma
**Time Frame:** At the 4-month post-treatment follow-up.
**Description:** REBECCA score (scale 0-100) correlation to fatigue biomarker levels of pro-inflammatory and anti-inflammatory microbes in feces.
**Measure:** Correlation between the REBECCA system index score and fatigue biomarker levels in feces.
**Time Frame:** At the 4-month post-treatment follow-up.
**Description:** The System Usability Scale measures user satisfaction on a scale from 0-100, where a score \>75 indicate system use satisfaction.
**Measure:** Subjective assessments of system usability measured by the System Usability Scale questionnaire.
**Time Frame:** At the 4-month post-treatment follow-up.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Prostate cancer patients with histologically detectable M0 prostate cancer requiring primary surgery or primary radiation therapy followed by hormone therapy at least and no more than 3 months of initiation prior to study start
* Male prostate cancer patients under 80 years of age.
* Patients who have an increased life expectancy beyond the first 3 months after starting treatment.
* Patients who have the ability to understand the protocol and can participate in the follow-up plan.
* Patients who have the absence of psychological, familial, sociological, or geographic condition potentially hindering compliance with the study protocol and follow-up schedule.
* Patients who have a smart phone.
Exclusion Criteria:
* Patients who do not consent to the study protocol.
* Patients with a previous cancer diagnosis (except skin cancer treated only by surgery).
* Patients who have previously been treated with any form of chemotherapy/radiotherapy.
* Foreign-language patients without sufficient Norwegian understanding
* Patients who do not have a smartphone
**Gender Based:** True
**Maximum Age:** 80 Years
**Minimum Age:** 19 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Prostate cancer patients at Stavanger University Hospital, Norway
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kjersti Tjensvoll, PhD
**Phone:** 004747809206
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Marius Stensland, MD
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Stavanger
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kjersti Tjensvoll, PhD
- **Phone:** 004747809206
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Marius Stensland, MD
- **Role:** CONTACT
**Country:** Norway
**Facility:** Stavanger University Hospital
**Status:** RECRUITING
**Zip:** 4067
#### Overall Officials
**Official 1:**
**Affiliation:** Helse Stavanger HF
**Name:** Svein Skeie, PhD
**Role:** STUDY_DIRECTOR
### References Module
#### See Also Links
**Label:** REBECCA Project Site
**URL:** https://rebeccaproject.eu/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5220
- Name: Breast Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: HIGH
- As Found: Chronic Conditions
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002908
- Term: Chronic Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435078
**Brief Title:** Developments of Novel Virtual Visual and Haptic Stimulation Systems for the Elderly
**Official Title:** Developments of Novel Virtual Visual and Haptic Stimulation Systems for the Elderly
#### Organization Study ID Info
**ID:** B-ER-105-238
#### Organization
**Class:** OTHER
**Full Name:** National Cheng-Kung University Hospital
### Status Module
#### Completion Date
**Date:** 2017-08-21
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2017-08-21
**Type:** ACTUAL
#### Start Date
**Date:** 2017-03-06
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** National Cheng-Kung University Hospital
#### Responsible Party
**Investigator Affiliation:** National Cheng-Kung University Hospital
**Investigator Full Name:** Fong Chin Su
**Investigator Title:** Chair Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** previous studies indicated that sensory input can have positive impacts on finger force control in the elderly. Additionally, according to previous reports, apart from pharmacotherapy, nonpharmacologic interventions, such as psychosocial-environmental treatments, are emerging for the behavior and affective symptoms in AD . Moreover, enhanced finger force control and coordination lead to better hand dexterity and is believed to eventually improve life independence in the healthy elderly and the elderly with AD. Therefore, this study aims to develop novel virtual visual and haptic stimulation systems for the elderly to enhance their finger force control.
### Conditions Module
**Conditions:**
- Healthy Elderly
- Alzheimer Disease
**Keywords:**
- Pressing Evaluation and Training System
- Virtual Reality
- Augmented Reality
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 40
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** subjects will be instructed to execute simulated piano playing tasks with Augmented Reality.
**Intervention Names:**
- Device: mPETS(modified-PETS system)
**Label:** AR-mPETS
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** subjects will be instructed to execute simulated piano playing tasks with Virtual Reality.
**Intervention Names:**
- Device: mPETS(modified-PETS system)
**Label:** VR-mPETS
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- AR-mPETS
- VR-mPETS
**Description:** The pressing evaluation and training system (PETS) consists of five force transducers, a pad position-adjustable frame, and biofeedback system. Five force transducers are used to collect the applied normal force from five digits.
**Name:** mPETS(modified-PETS system)
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Subjects will be asked to track the target force and presses task digit to fit the target line until finish.
**Measure:** Force-track testing
**Time Frame:** Before and after intervention (4 weeks)
#### Secondary Outcomes
**Description:** In sequential testing, subjects will be asked to follow the pressing guide. The reaction time of sequential movements will be recorded and calculated.
**Measure:** Sequential testing( reaction time)
**Time Frame:** Before and after intervention (4 weeks)
**Description:** In sequential testing, subjects will be asked to follow the pressing guide. The correct ratio of sequential movements will be recorded and calculated.
**Measure:** Sequential testing( correct ratio )
**Time Frame:** Before and after intervention (4 weeks)
### Eligibility Module
**Eligibility Criteria:** Healthy elderly
Inclusion Criteria:
* Aged ≥ 65
* Healthy adult (no skeletal muscle, neurological disease that will affect training).
Exclusion Criteria:
* Neurological disorders
* Musculoskeletal problems
* History of surgery Patients with Alzheimer's disease
Inclusion Criteria:
* Diagnosed with Alzheimer's disease.
* No skeletal muscle, neurological disease that will affect training.
**Healthy Volunteers:** True
**Maximum Age:** 85 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Tainan
**Country:** Taiwan
**Facility:** National Cheng Kung University
**Zip:** 701
#### Overall Officials
**Official 1:**
**Affiliation:** Chair Professor
**Name:** Fong-Chin Su
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Organization, W.H., Global health and aging. Acedido março, 2011. 5: p. 2015.
**Citation:** Grabiner MD, Enoka RM. Changes in movement capabilities with aging. Exerc Sport Sci Rev. 1995;23:65-104. No abstract available.
**PMID:** 7556361
**Citation:** Ranganathan VK, Siemionow V, Sahgal V, Liu JZ, Yue GH. Skilled finger movement exercise improves hand function. J Gerontol A Biol Sci Med Sci. 2001 Aug;56(8):M518-22. doi: 10.1093/gerona/56.8.m518.
**PMID:** 11487606
**Citation:** Olafsdottir HB, Zatsiorsky VM, Latash ML. The effects of strength training on finger strength and hand dexterity in healthy elderly individuals. J Appl Physiol (1985). 2008 Oct;105(4):1166-78. doi: 10.1152/japplphysiol.00054.2008. Epub 2008 Aug 7.
**PMID:** 18687981
**Citation:** Keogh JW, Morrison S, Barrett R. Strength training improves the tri-digit finger-pinch force control of older adults. Arch Phys Med Rehabil. 2007 Aug;88(8):1055-63. doi: 10.1016/j.apmr.2007.05.014.
**PMID:** 17678670
**Citation:** Kwok TC, Lam KC, Wong PS, Chau WW, Yuen KS, Ting KT, Chung EW, Li JC, Ho FK. Effectiveness of coordination exercise in improving cognitive function in older adults: a prospective study. Clin Interv Aging. 2011;6:261-7. doi: 10.2147/CIA.S19883. Epub 2011 Sep 29.
**PMID:** 22087065
**Citation:** Zhang W, Scholz JP, Zatsiorsky VM, Latash ML. What do synergies do? Effects of secondary constraints on multidigit synergies in accurate force-production tasks. J Neurophysiol. 2008 Feb;99(2):500-13. doi: 10.1152/jn.01029.2007. Epub 2007 Nov 28.
**PMID:** 18046000
**Citation:** Kim SW, Shim JK, Zatsiorsky VM, Latash ML. Finger inter-dependence: linking the kinetic and kinematic variables. Hum Mov Sci. 2008 Jun;27(3):408-22. doi: 10.1016/j.humov.2007.08.005. Epub 2008 Feb 5.
**PMID:** 18255182
**Citation:** Shim JK, Lay BS, Zatsiorsky VM, Latash ML. Age-related changes in finger coordination in static prehension tasks. J Appl Physiol (1985). 2004 Jul;97(1):213-24. doi: 10.1152/japplphysiol.00045.2004. Epub 2004 Mar 5.
**PMID:** 15003998
**Citation:** Parikh PJ, Cole KJ. Handling objects in old age: forces and moments acting on the object. J Appl Physiol (1985). 2012 Apr;112(7):1095-104. doi: 10.1152/japplphysiol.01385.2011. Epub 2012 Jan 12.
**PMID:** 22241054
**Citation:** Shinohara M, Scholz JP, Zatsiorsky VM, Latash ML. Finger interaction during accurate multi-finger force production tasks in young and elderly persons. Exp Brain Res. 2004 Jun;156(3):282-92. doi: 10.1007/s00221-003-1786-9. Epub 2004 Feb 19.
**PMID:** 14985892
**Citation:** Shinohara M, Li S, Kang N, Zatsiorsky VM, Latash ML. Effects of age and gender on finger coordination in MVC and submaximal force-matching tasks. J Appl Physiol (1985). 2003 Jan;94(1):259-70. doi: 10.1152/japplphysiol.00643.2002. Epub 2002 Sep 13.
**PMID:** 12391031
**Citation:** Olafsdottir H, Zhang W, Zatsiorsky VM, Latash ML. Age-related changes in multifinger synergies in accurate moment of force production tasks. J Appl Physiol (1985). 2007 Apr;102(4):1490-501. doi: 10.1152/japplphysiol.00966.2006. Epub 2007 Jan 4.
**PMID:** 17204576
**Citation:** Cobos, F.J.M. and M.d.M.M. Rodríguez, A Review of psychological intervention in Alzheimer s disease. International Journal of Psychology and Psychological Therapy, 2012. 12(3): p. 373-388.
**Citation:** Franssen EH, Souren LE, Torossian CL, Reisberg B. Equilibrium and limb coordination in mild cognitive impairment and mild Alzheimer's disease. J Am Geriatr Soc. 1999 Apr;47(4):463-9. doi: 10.1111/j.1532-5415.1999.tb07240.x.
**PMID:** 10203123
**Citation:** Verheij S, Muilwijk D, Pel JJ, van der Cammen TJ, Mattace-Raso FU, van der Steen J. Visuomotor impairment in early-stage Alzheimer's disease: changes in relative timing of eye and hand movements. J Alzheimers Dis. 2012;30(1):131-43. doi: 10.3233/JAD-2012-111883.
**PMID:** 22377783
**Citation:** Wu YH, Pazin N, Zatsiorsky VM, Latash ML. Improving finger coordination in young and elderly persons. Exp Brain Res. 2013 Apr;226(2):273-83. doi: 10.1007/s00221-013-3433-4. Epub 2013 Feb 15.
**PMID:** 23411675
**Citation:** Langlois F, Vu TT, Chasse K, Dupuis G, Kergoat MJ, Bherer L. Benefits of physical exercise training on cognition and quality of life in frail older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):400-4. doi: 10.1093/geronb/gbs069. Epub 2012 Aug 28.
**PMID:** 22929394
**Citation:** Shim JK, Karol S, Kim YS, Seo NJ, Kim YH, Kim Y, Yoon BC. Tactile feedback plays a critical role in maximum finger force production. J Biomech. 2012 Feb 2;45(3):415-20. doi: 10.1016/j.jbiomech.2011.12.001. Epub 2012 Jan 4.
**PMID:** 22222494
**Citation:** Kim Y, Shim JK, Hong YK, Lee SH, Yoon BC. Cutaneous sensory feedback plays a critical role in agonist-antagonist co-activation. Exp Brain Res. 2013 Aug;229(2):149-56. doi: 10.1007/s00221-013-3601-6. Epub 2013 Jul 9.
**PMID:** 23836110
**Citation:** Li K, Marquardt TL, Li ZM. Removal of visual feedback lowers structural variability of inter-digit force coordination during sustained precision pinch. Neurosci Lett. 2013 Jun 17;545:1-5. doi: 10.1016/j.neulet.2013.04.011. Epub 2013 Apr 24.
**PMID:** 23624025
**Citation:** Ambike S, Zatsiorsky VM, Latash ML. Processes underlying unintentional finger-force changes in the absence of visual feedback. Exp Brain Res. 2015 Mar;233(3):711-21. doi: 10.1007/s00221-014-4148-x. Epub 2014 Nov 23.
**PMID:** 25417192
**Citation:** Hu X, Newell KM. Aging, visual information, and adaptation to task asymmetry in bimanual force coordination. J Appl Physiol (1985). 2011 Dec;111(6):1671-80. doi: 10.1152/japplphysiol.00760.2011. Epub 2011 Sep 29.
**PMID:** 21960656
**Citation:** Seo NJ, Fischer HW, Bogey RA, Rymer WZ, Kamper DG. Use of visual force feedback to improve digit force direction during pinch grip in persons with stroke: a pilot study. Arch Phys Med Rehabil. 2011 Jan;92(1):24-30. doi: 10.1016/j.apmr.2010.08.016. Epub 2010 Nov 18.
**PMID:** 21092931
**Citation:** Hu X, Loncharich M, Newell KM. Visual information interacts with neuromuscular factors in the coordination of bimanual isometric force. Exp Brain Res. 2011 Mar;209(1):129-38. doi: 10.1007/s00221-010-2528-4. Epub 2010 Dec 28.
**PMID:** 21188355
**Citation:** Loucks TM, Ofori E, Sosnoff JJ. Force control under auditory feedback: effector differences and audiomotor memory. Percept Mot Skills. 2012 Jun;114(3):915-35. doi: 10.2466/24.25.27.PMS.114.3.915-935.
**PMID:** 22913030
**Citation:** Jo HJ, Ambike S, Lewis MM, Huang X, Latash ML. Finger force changes in the absence of visual feedback in patients with Parkinson's disease. Clin Neurophysiol. 2016 Jan;127(1):684-692. doi: 10.1016/j.clinph.2015.05.023. Epub 2015 Jun 3.
**PMID:** 26072437
**Citation:** Stein J, Bishop J, Gillen G, Helbok R. A pilot study of robotic-assisted exercise for hand weakness after stroke. IEEE Int Conf Rehabil Robot. 2011;2011:5975426. doi: 10.1109/ICORR.2011.5975426.
**PMID:** 22275627
**Citation:** Wu YH, Truglio TS, Zatsiorsky VM, Latash ML. Learning to combine high variability with high precision: lack of transfer to a different task. J Mot Behav. 2015;47(2):153-65. doi: 10.1080/00222895.2014.961892. Epub 2014 Nov 3.
**PMID:** 25365477
**Citation:** Friedman N, Chan V, Reinkensmeyer AN, Beroukhim A, Zambrano GJ, Bachman M, Reinkensmeyer DJ. Retraining and assessing hand movement after stroke using the MusicGlove: comparison with conventional hand therapy and isometric grip training. J Neuroeng Rehabil. 2014 Apr 30;11:76. doi: 10.1186/1743-0003-11-76.
**PMID:** 24885076
**Citation:** Tsai, M.-F., 中風病人手指創新復健器. 成功大學生物醫學工程學系學位論文, 2016: p. 1-94.
**Citation:** Levanon Y. The advantages and disadvantages of using high technology in hand rehabilitation. J Hand Ther. 2013 Apr-Jun;26(2):179-83. doi: 10.1016/j.jht.2013.02.002.
**PMID:** 23598084
**Citation:** Manepalli, J., A. Desai, and P. Sharma, Psychosocial-environmental treatments for Alzheimer's disease. Primary Psychiatry, 2009. 16(6): p. 39.
**Citation:** Chiu HY, Hsu HY, Kuo LC, Chang JH, Su FC. Functional sensibility assessment. Part I: develop a reliable apparatus to assess momentary pinch force control. J Orthop Res. 2009 Aug;27(8):1116-21. doi: 10.1002/jor.20859.
**PMID:** 19195027
**Citation:** Hsu HY, Kuo LC, Chiu HY, Jou IM, Su FC. Functional sensibility assessment. Part II: Effects of sensory improvement on precise pinch force modulation after transverse carpal tunnel release. J Orthop Res. 2009 Nov;27(11):1534-9. doi: 10.1002/jor.20903.
**PMID:** 19402148
**Citation:** Shieh SJ, Hsu HY, Kuo LC, Su FC, Chiu HY. Correlation of digital sensibility and precision of pinch force modulation in patients with nerve repair. J Orthop Res. 2011 Aug;29(8):1210-5. doi: 10.1002/jor.21365. Epub 2011 Mar 4.
**PMID:** 21374708
**Citation:** Hsu HY, Kuo LC, Kuo YL, Chiu HY, Jou IM, Wu PT, Su FC. Feasibility of a novel functional sensibility test as an assisted examination for determining precision pinch performance in patients with carpal tunnel syndrome. PLoS One. 2013 Aug 20;8(8):e72064. doi: 10.1371/journal.pone.0072064. eCollection 2013.
**PMID:** 23977209
**Citation:** Yen WJ, Kuo YL, Kuo LC, Chen SM, Kuan TS, Hsu HY. Precision pinch performance in patients with sensory deficits of the median nerve at the carpal tunnel. Motor Control. 2014 Jan;18(1):29-43. doi: 10.1123/mc.2013-0004.
**PMID:** 24496877
**Citation:** Chiu HY, Hsu HY, Su FC, Jou IM, Lin CF, Kuo LC. Setup of a novel biofeedback prototype for sensorimotor control of the hand and preliminary application in patients with peripheral nerve injuries. Phys Ther. 2013 Feb;93(2):168-78. doi: 10.2522/ptj.20120050. Epub 2012 Sep 27.
**PMID:** 23023814
**Citation:** Hsu HY, Lin CF, Su FC, Kuo HT, Chiu HY, Kuo LC. Clinical application of computerized evaluation and re-education biofeedback prototype for sensorimotor control of the hand in stroke patients. J Neuroeng Rehabil. 2012 May 9;9:26. doi: 10.1186/1743-0003-9-26.
**PMID:** 22571177
**Citation:** Hsu HY, Kuo LC, Jou IM, Chen SM, Chiu HY, Su FC. Establishment of a proper manual tactile test for hands with sensory deficits. Arch Phys Med Rehabil. 2013 Mar;94(3):451-8. doi: 10.1016/j.apmr.2012.07.024. Epub 2012 Aug 9.
**PMID:** 22885285
**Citation:** Hsu HY, Kuo YL, Jou IM, Su FC, Chiu HY, Kuo LC. Diagnosis from functional perspectives: usefulness of a manual tactile test for predicting precision pinch performance and disease severity in subjects with carpal tunnel syndrome. Arch Phys Med Rehabil. 2014 Apr;95(4):717-25. doi: 10.1016/j.apmr.2013.11.017. Epub 2013 Dec 16.
**PMID:** 24355426
**Citation:** Hsu HY, Shieh SJ, Kuan TS, Yang HC, Su FC, Chiu HY, Kuo LC. Manual Tactile Test Predicts Sensorimotor Control Capability of Hands for Patients With Peripheral Nerve Injury. Arch Phys Med Rehabil. 2016 Jun;97(6):983-90. doi: 10.1016/j.apmr.2016.01.008. Epub 2016 Jan 30.
**PMID:** 26829761
**Citation:** Chiu HY, Hsu HY, Kuo LC, Su FC, Yu HI, Hua SC, Lu CH. How the impact of median neuropathy on sensorimotor control capability of hands for diabetes: an achievable assessment from functional perspectives. PLoS One. 2014 Apr 10;9(4):e94452. doi: 10.1371/journal.pone.0094452. eCollection 2014.
**PMID:** 24722361
**Citation:** Hsu HY, Chiu HY, Lin HT, Su FC, Lu CH, Kuo LC. Impacts of elevated glycaemic haemoglobin and disease duration on the sensorimotor control of hands in diabetes patients. Diabetes Metab Res Rev. 2015 May;31(4):385-94. doi: 10.1002/dmrr.2623. Epub 2015 Feb 3.
**PMID:** 25417846
**Citation:** Yang CJ, Hsu HY, Lu CH, Chao YL, Chiu HY, Kuo LC. The associations among hand dexterity, functional performance, and quality of life in diabetic patients with neuropathic hand from objective- and patient-perceived measurements. Qual Life Res. 2015 Jan;24(1):213-21. doi: 10.1007/s11136-014-0748-y. Epub 2014 Jul 14.
**PMID:** 25017499
**Citation:** Chen PT, Jou IM, Lin CJ, Chieh HF, Kuo LC, Su FC. Is the Control of Applied Digital Forces During Natural Five-digit Grasping Affected by Carpal Tunnel Syndrome? Clin Orthop Relat Res. 2015 Jul;473(7):2371-82. doi: 10.1007/s11999-015-4189-x. Epub 2015 Feb 18.
**PMID:** 25690168
**Citation:** Chen PT, Lin CJ, Jou IM, Chieh HF, Su FC, Kuo LC. One digit interruption: the altered force patterns during functionally cylindrical grasping tasks in patients with trigger digits. PLoS One. 2013 Dec 31;8(12):e83632. doi: 10.1371/journal.pone.0083632. eCollection 2013.
**PMID:** 24391799
**Citation:** Kuo LC, Chen SW, Lin CJ, Lin WJ, Lin SC, Su FC. The force synergy of human digits in static and dynamic cylindrical grasps. PLoS One. 2013;8(3):e60509. doi: 10.1371/journal.pone.0060509. Epub 2013 Mar 27.
**PMID:** 23544151
**Citation:** Kuo LC, Hsu HM, Wu PT, Lin SC, Hsu HY, Jou IM. Impact of distal median neuropathy on handwriting performance for patients with carpal tunnel syndrome in office and administrative support occupations. J Occup Rehabil. 2014 Jun;24(2):332-43. doi: 10.1007/s10926-013-9471-8.
**PMID:** 23934582
**Citation:** Hsu, H.-M., et al., Quantification of handwriting performance: Development of a force acquisition pen for measuring hand-grip and pen tip forces. Measurement, 2013. 46(1): p. 506-513.
**Citation:** Lai, K.-Y., et al., Effects of hand span size and right-left hand side on the piano playing performances: Exploration of the potential risk factors with regard to piano-related musculoskeletal disorders. International Journal of Industrial Ergonomics, 2015. 50: p. 97-104.
**Citation:** Park J, Wu YH, Lewis MM, Huang X, Latash ML. Changes in multifinger interaction and coordination in Parkinson's disease. J Neurophysiol. 2012 Aug 1;108(3):915-24. doi: 10.1152/jn.00043.2012. Epub 2012 May 2.
**PMID:** 22552184
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003704
- Term: Dementia
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000024801
- Term: Tauopathies
- ID: D000019636
- Term: Neurodegenerative Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M3885
- Name: Alzheimer Disease
- Relevance: HIGH
- As Found: Alzheimer's Disease
- ID: M6904
- Name: Dementia
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23002
- Name: Tauopathies
- Relevance: LOW
- As Found: Unknown
- ID: M21558
- Name: Neurodegenerative Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T2192
- Name: Familial Alzheimer Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000544
- Term: Alzheimer Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435065
**Brief Title:** Direct Pulp Capping Agent on Human Pulp Tissue
**Official Title:** Histological and Radiographic Evaluation of the Effects of Direct Pulp Capping Agent on Human Pulp Tissue
#### Organization Study ID Info
**ID:** 2264
#### Organization
**Class:** OTHER
**Full Name:** Maharishi Markendeswar University (Deemed to be University)
### Status Module
#### Completion Date
**Date:** 2024-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** DR SURINDER SACHDEVA
#### Responsible Party
**Investigator Affiliation:** Maharishi Markendeswar University (Deemed to be University)
**Investigator Full Name:** DR SURINDER SACHDEVA
**Investigator Title:** periodontist
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This in- vivo study was conducted to evaluate the response of human pulp tissue following direct pulp capping using four different pulp capping agents in premolars scheduled for extraction in patients undergoing orthodontic treatment.
**Detailed Description:** For the study 40 premolars from patients in the age group of 15-25 years, undergoing orthodontic treatment, in the Department of Orthodontics, MMCDSR, Mullana, Ambala, who had to get their premolars extracted as per their orthodontic treatment plan will be selected.
Only healthy premolars, with no caries, showing no signs and symptoms of pulpitis or periodontal diseases were selected. Medically compromised patients, or teeth with radiographic findings of external/internal resorption, bone loss, or calcifications in the pulp chamber will be excluded from the study. The selected premolars were then randomly divided into four equal groups namely: GROUP I - Direct pulp capping procedure performed using Biodentine. GROUP II - Direct pulp capping procedure performed using MTA. GROUP III - Direct pulp capping procedure performed using TheraCal LC. GROUP IV - Direct pulp capping procedure performed using Tristrontium aluminate.
The direct pulp capping procedure was carried out under rubber dam. The study protocol included class I cavity preparations on the premolars, followed by iatrogenic exposure of the pulp (0.5mm) using a sterile round bur, placement of the direct pulp capping agent according to the material of allotted to the study group. The teeth were permanently restored on the same visit, except for MTA group were the teeth were temporarily restored using Cavit G, and recalled after 1 day for permanent restoration. The patients were then enquired for any 94 SUMMARY 95 symptoms at 1 day and 7 days post operatively. The teeth were then, atraumatically extracted 3 months after the procedure. The extracted teeth were then put to CBCT as well as histopathological examination. Through CBCT evaluation, the completeness of the dentine bridge was evaluated. Histopathological examination was done to examine the pulpal response and the quality of the dentine bridge formed
### Conditions Module
**Conditions:**
- Reversible Pulpitis
**Keywords:**
- DIRCT PULP CAPPING
- Biodentine
- MTA
- TheraCal LC
- Tristrontium Aluminate
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- PHASE4
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** DIRECT PULP CAPPING WILL BE DONE USING BIODENTINE AS DIRECT PULP CAPPING AGENT
**Intervention Names:**
- Drug: Biodentine
**Label:** BIODENTINE
**Type:** SHAM_COMPARATOR
#### Arm Group 2
**Description:** DIRECT PULP CAPPING WILL BE DONE USING MTA AS DIRECT PULP CAPPING AGENT
**Intervention Names:**
- Drug: Mineral Tri-Oxide Aggregate
**Label:** MINERAL TRIOXIDE AGGREGATE
**Type:** SHAM_COMPARATOR
#### Arm Group 3
**Description:** DIRECT PULP CAPPING WILL BE DONE USING THERACAL LC AS DIRECT PULP CAPPING AGENT
**Intervention Names:**
- Drug: THERACAL LC
**Label:** THERACAL LC
**Type:** SHAM_COMPARATOR
#### Arm Group 4
**Description:** DIRECT PULP CAPPING WILL BE DONE USING TRISTRONTIUM ALUMINATE AS DIRECT PULP CAPPING AGENT
**Intervention Names:**
- Drug: TRISTRONTIUM ALUMINATE
**Label:** TRISTRONTIUM ALUMINATE
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- BIODENTINE
**Description:** DIRECT PULP CAPPINGWILL BE DONE USING BIODENTINE
**Name:** Biodentine
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- MINERAL TRIOXIDE AGGREGATE
**Description:** DIRECT PULP CAPPINGWILL BE DONE USING MTA
**Name:** Mineral Tri-Oxide Aggregate
**Other Names:**
- MTA
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- THERACAL LC
**Description:** DIRECT PULP CAPPINGWILL BE DONE USING THERACAL LC
**Name:** THERACAL LC
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- TRISTRONTIUM ALUMINATE
**Description:** DIRECT PULP CAPPINGWILL BE DONE USING TRISTRONTIUM ALUMINATE
**Name:** TRISTRONTIUM ALUMINATE
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** radiographic examination will be done after 90 days and presence or absence of secondary dentin formation and completeness of the dentinal bride formed will be evaluated by CBCT
**Measure:** RADIOGRAPHIC EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE
**Time Frame:** 90 DAYS
**Description:** Histological examination of the extracted teeth will be done after 90 days and evidence of dentinal bridge formation will be evaluated microscopically
**Measure:** HISTOLOGICAL EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE
**Time Frame:** 90 DAYS
### Eligibility Module
**Eligibility Criteria:** INCLUSION CRITERIA:
* CARIES-free, undamaged mature maxillary and mandibular premolars that were planned for extraction for orthodontic reasons.
* Teeth that show no reaction to percussion.
* Teeth with no previous restorations.
* Teeth that show vitality, when checked with an electric pulp tester.
* Teeth that show no signs of caries or periapical pathology when examined
* radiographically.
* Fully erupted teeth, that allowed proper application of rubber dam.
EXCLUSION CRITERIA:
* caries are present
* Teeth with signs and symptoms of irreversible pulpitis, such as nighttime severe pain
* or spontaneous pain.
* Teeth that show sensitivity to hot and/or cold.
* Radiographic examination reveals any signs of caries, periapical pathology,
* internal/external root resorption, furcal radiolucency/ inter-radicular bone destruction
* and/or calcifications in the pulp chamber or canals.
* Medically compromised patient.
* Pregnant patient.
**Healthy Volunteers:** True
**Maximum Age:** 25 Years
**Minimum Age:** 15 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** swati chhabra, MDS
**Phone:** 7015070095
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** navneet kukreja, MDS
**Phone:** 9416028633
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Ambāla
**Contacts:**
***Contact 1:***
- **Name:** swati chhabra
- **Role:** CONTACT
**Country:** India
**Facility:** Swati
**State:** Haryana
**Status:** RECRUITING
**Zip:** 133207
#### Overall Officials
**Official 1:**
**Affiliation:** professor
**Name:** surinder sachdeva, mds
**Role:** STUDY_DIRECTOR
### References Module
#### References
**Citation:** Parolia A, Kundabala M, Rao NN, Acharya SR, Agrawal P, Mohan M, Thomas M. A comparative histological analysis of human pulp following direct pulp capping with Propolis, mineral trioxide aggregate and Dycal. Aust Dent J. 2010 Mar;55(1):59-64. doi: 10.1111/j.1834-7819.2009.01179.x.
**PMID:** 20415913
**Citation:** Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlinska J. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7. doi: 10.1016/j.joen.2013.01.005. Epub 2013 Apr 10.
**PMID:** 23683272
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003788
- Term: Dental Pulp Diseases
- ID: D000014076
- Term: Tooth Diseases
- ID: D000009057
- Term: Stomatognathic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14525
- Name: Pulpitis
- Relevance: HIGH
- As Found: Pulpitis
- ID: M6984
- Name: Dental Pulp Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16831
- Name: Tooth Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12017
- Name: Stomatognathic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011671
- Term: Pulpitis
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435052
**Brief Title:** Efficacy of Eye Movement Desensitization & Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan
**Official Title:** Efficacy of Eye Movement Desensitization & Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan: A Full-fledged Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 111
#### Organization
**Class:** OTHER
**Full Name:** Khushal Khan Khattak Univeristy, Karak, Pakistan
### Status Module
#### Completion Date
**Date:** 2025-08-15
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08-15
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-08-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-02-01
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Khushal Khan Khattak Univeristy, Karak, Pakistan
#### Responsible Party
**Investigator Affiliation:** Khushal Khan Khattak Univeristy, Karak, Pakistan
**Investigator Full Name:** Dr. Anwar Khan
**Investigator Title:** Dr. Anwar Khan, Assistant Professor of Organizational Psychology
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This Randomized Controlled Trial will check the efficacy of Eye Movement Desensitization \& Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan
**Detailed Description:** This Randomized Controlled Trial will check the efficacy of Eye Movement Desensitization \& Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan.
It will be a single blind multi-center RCT with two arms (EMDR and CBT). This study will broadly work on following aims:
1. Initially the comparative efficacy of EMDR and CBT (i.e., standard face-to-face protcols) will be determined on large scale in Pakistan by:
1. Examining whether EMDR is non-inferior to CBT in the treatment of PTSD and its two comorbidities in Pakistan.
2. Studying changes in the symptoms (i.e., reduction in the PTSD and comorbid symptoms with the passage of time) after administering EMDR and CBT. The level of change in the symptoms will ultimately help in determining the extent of effectiveness of both therapies.
3. Examine the reciprocal relationship between PTSD and comorbid symptoms for knowing whether any reduction in the PTSD symptoms can help in reducing the comorbid symptoms after administering EMDR and CBT.
2. At the mean time work on the design and development of virtual EMDR and CBT therapies (i.e., Web-based and Mobile Applications) will also be started. The initial prototypes will be tested for its comparative efficacy. Later once the final versions will be developed then it will be also tested for its comparative efficacy on large scale in Pakistan.
### Conditions Module
**Conditions:**
- Post Traumatic Stress Disorder
- Depression, Anxiety
**Keywords:**
- Post Traumatic Stress Disorder
- EMDR
- CBT
- Pakistan
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Eye Movement Desensitization and Reprocessing (EMDR) therapy will be administered face-to-face by a psychotherapist in a total of 12 sessions, with one session per week. The efficacy of EMDR therapy will be compared with Cognitive Behavioral Therapy (CBT) in the treatment of Post-Traumatic Stress Disorder (PTSD) in Pakistan.
**Intervention Names:**
- Behavioral: Eye Movement Desensitization & Reprocessing Therapy
**Label:** Eye Movement Desensitization & Reprocessing Therapy
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Cognitive Behavioral Therapy (CBT) will be delivered face-to-face by a psychotherapist in a total of 14 sessions, with one session per week. The efficacy of CBT will be compared with Eye Movement Desensitization and Reprocessing therapy in the treatment of Post-Traumatic Stress Disorder in Pakistan.
**Intervention Names:**
- Behavioral: Cognitive Behavioral Therapy
**Label:** Cognitive Behavioral Therapy
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Eye Movement Desensitization & Reprocessing Therapy
**Description:** Eye Movement Desensitization and Reprocessing (EMDR) therapy will be administered face-to-face by a psychotherapist in a total of 12 sessions, with one session per week. The efficacy of EMDR therapy will be compared with Cognitive Behavioral Therapy in the treatment of Post-Traumatic Stress Disorder in Pakistan.
**Name:** Eye Movement Desensitization & Reprocessing Therapy
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Cognitive Behavioral Therapy
**Description:** Cognitive Behavioral Therapy will be comparatively checked with Eye Movement Desensitization \& Reprocessing Therapy for its efficacy. It will be administered by psychotherapist in 14 sessions (each session per week)
**Name:** Cognitive Behavioral Therapy
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Post-traumatic stress disorder (PTSD) will be assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 scores will be utilized to determine the severity of PTSD symptoms. Typically, a CAPS-5 score of 40 or above will serve as the cutoff point for diagnosing PTSD.
**Measure:** Post-traumatic stress disorder
**Time Frame:** 2 years
#### Secondary Outcomes
**Description:** Depressive and anxiety symptoms will be measured using the Hamilton Depression Rating Scale and the State-Trait Anxiety Inventory, respectively. A Hamilton Depression Rating Scale score of 20 or above, and a State-Trait Anxiety Inventory score of 40 or above, will serve as the cutoff points.
**Measure:** Depressive and Anxiety Symptoms
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
reverse of the exclusion critera
Exclusion Criteria:
The following patients will be excluded:
1. Patients below the age of 15 years and above 60 years, since this study is neither on children nor on old aged patients;
2. Patients who can't move their hands and eyes/or can't perform basic movements;
3. Patients who are unconscious for longer periods and unable to recover consciousness;
4. Patients not meeting the basic screening criteria of PTSD/ PTSD is not the main problem;
5. Patients with severe intellectual impairments, since such patients are difficult to communicate
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Karak
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Anwar Khan
- **Phone:** 03345606406
- **Role:** CONTACT
**Country:** Pakistan
**Facility:** Anwar Khan
**Status:** RECRUITING
**Zip:** 27200
### IPD Sharing Statement Module
**Description:** can be shared on request
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000068099
- Term: Trauma and Stressor Related Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: LOW
- As Found: Unknown
- ID: M7058
- Name: Depression
- Relevance: LOW
- As Found: Unknown
- ID: M4324
- Name: Anxiety Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M16103
- Name: Stress Disorders, Post-Traumatic
- Relevance: HIGH
- As Found: Post Traumatic Stress Disorder
- ID: M24916
- Name: Stress Disorders, Traumatic
- Relevance: HIGH
- As Found: Traumatic Stress Disorder
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M222
- Name: Trauma and Stressor Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000040921
- Term: Stress Disorders, Traumatic
- ID: D000013313
- Term: Stress Disorders, Post-Traumatic
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435039
**Brief Title:** A Study of APL-1501 Extended Release Capsules Compared to APL-1202 Immediate Release Tablets in Healthy Volunteers
**Official Title:** A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of APL-1501 ER Capsules Compared to APL-1202 IR Tablets in Healthy Volunteers
#### Organization Study ID Info
**ID:** YHGT-APL1501-NHS-103
#### Organization
**Class:** OTHER
**Full Name:** Syneos Health
### Status Module
#### Completion Date
**Date:** 2024-10-22
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-21
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-26
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Asieris Pharmaceuticals (AUS) Pty Ltd.
#### Lead Sponsor
**Class:** OTHER
**Name:** Syneos Health
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The primary objective of the study is to assess safety and tolerability following administration of single doses of APL-1202 (immediate release) IR tablets and APL-1501 extended release (ER) capsules in healthy participants.
### Conditions Module
**Conditions:**
- Healthy Volunteers
**Keywords:**
- Bladder Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 32
**Type:** ESTIMATED
**Phases:**
- PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will receive APL-1202 375 milligram (mg) IR tablets, orally, once on Day 1 of Period 1 (Treatment R1), followed by T1 APL-1501 764 mg ER capsules, orally, once, on Day 4 of Period 2 (Treatment T1). A washout period of more than or equal to (\>=) 72 hours will be maintained in between Period 1 and 2.
**Intervention Names:**
- Drug: APL-1202
- Drug: APL-1501
**Label:** Cohort 1, Sequence 1, R1T1: APL-1202 IR 375 mg + APL-1501 ER 764 mg
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will receive APL-1501 764 mg ER capsules, orally, once on Day 1 of Period 1 (Treatment T1), followed by APL-1202 375 mg IR tablets, orally, once, on Day 4 of Period 2 (Treatment R1). A washout period of \>=72 hours will be maintained in between Period 1 and 2.
**Intervention Names:**
- Drug: APL-1202
- Drug: APL-1501
**Label:** Cohort 1, Sequence 2, T1R1: APL-1501 ER 764 mg + APL-1202 IR 375 mg
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Participants will receive APL-1202 375 mg IR tablets, orally, once on Day 1 of Period 1 (Treatment R1), followed by APL-1501 1146 mg ER capsules, orally, once, on Day 4 of Period 2 (Treatment T2). A washout period of \>=72 hours will be maintained in between Period 1 and 2.
**Intervention Names:**
- Drug: APL-1202
- Drug: APL-1501
**Label:** Cohort 2, Sequence 1, R1T2: APL-1202 IR 375 mg + APL-1501 ER 1146 mg
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Participants will receive APL-1501 1146 mg ER capsules, orally, once on Day 1 of Period 1 (Treatment T2), followed by APL-1202 375 mg IR tablets, orally, once, on Day 4 of Period 2 (Treatment R1). A washout period of \>=72 hours will be maintained in between Period 1 and 2.
**Intervention Names:**
- Drug: APL-1202
- Drug: APL-1501
**Label:** Cohort 2, Sequence 2, T2R1: APL-1501 ER 1146 mg + APL-1202 IR 375 mg
**Type:** EXPERIMENTAL
#### Arm Group 5
**Description:** Participants will receive APL-1501 1528 mg ER capsules, orally, once on Day 1.
**Intervention Names:**
- Drug: APL-1501
**Label:** Cohort 3: APL-1501 ER 1528 mg
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Cohort 1, Sequence 1, R1T1: APL-1202 IR 375 mg + APL-1501 ER 764 mg
- Cohort 1, Sequence 2, T1R1: APL-1501 ER 764 mg + APL-1202 IR 375 mg
- Cohort 2, Sequence 1, R1T2: APL-1202 IR 375 mg + APL-1501 ER 1146 mg
- Cohort 2, Sequence 2, T2R1: APL-1501 ER 1146 mg + APL-1202 IR 375 mg
**Description:** APL-1202 IR tablets.
**Name:** APL-1202
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Cohort 1, Sequence 1, R1T1: APL-1202 IR 375 mg + APL-1501 ER 764 mg
- Cohort 1, Sequence 2, T1R1: APL-1501 ER 764 mg + APL-1202 IR 375 mg
- Cohort 2, Sequence 1, R1T2: APL-1202 IR 375 mg + APL-1501 ER 1146 mg
- Cohort 2, Sequence 2, T2R1: APL-1501 ER 1146 mg + APL-1202 IR 375 mg
- Cohort 3: APL-1501 ER 1528 mg
**Description:** APL-1501 ER capsules.
**Name:** APL-1501
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** Number of Participants With Adverse Events (AEs)
**Time Frame:** From Baseline up to Day 9
**Measure:** Number of Participants With Abnormal Vital Sign Measurements
**Time Frame:** From Baseline up to Day 9
**Measure:** Number of Participants With Abnormal 12-Lead Electrocardiogram (ECGs) Recordings
**Time Frame:** From Baseline up to Day 9
**Measure:** Number of Participants With Abnormal Physical Examinations
**Time Frame:** From Baseline up to Day 9
**Measure:** Number of Participants With Abnormal Clinical Laboratory Values
**Time Frame:** From Baseline up to Day 9
#### Secondary Outcomes
**Measure:** AUC0-t: Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** AUC0-inf: Area Under the Concentration-time Curve From Time Zero to Infinity of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Cmax: Maximal Observed Concentration of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Tlast: Time When the Last Concentration is Observed of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Tmax: Time When the Cmax is Observed of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Description:** Residual area is defined as percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity and is calculated as, \[1-(AUC0-t/AUC0-inf)\]\*100.
**Measure:** Residual Area of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** T½ el: Terminal Elimination Half-life of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Kel: Terminal Elimination Rate Constant of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Cl/F: Apparent Clearance of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Vz/F: Apparent Volume of Distribution of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** DNAUC0-inf: Dose Normalized AUC0-inf of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** DNCmax: Dose Normalized Cmax of APL-1202, and ASN-1651 (Metabolite) Following APL-1501 ER Capsules
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Geometric Mean Ratio of Cmax of APL-1501 ER Capsules in Reference to APL-1202 IR Tablets
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Geometric Mean Ratio of AUC0-t of APL-1501 ER Capsules in Reference to APL-1202 IR Tablets
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Measure:** Geometric Mean Ratio of AUC0-inf of APL-1501 ER Capsules in Reference to APL-1202 IR Tablets
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Description:** The relative bioavailability of APL-1501 versus APL-1202 will be assessed through linear mixed modelling.
**Measure:** Frel: Relative Bioavailability of APL-1501 ER Capsules and APL-1202 IR Tablets
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Description:** Dose proportionality will be assessed by visual inspection of dose normalised Cmax values versus dose.
**Measure:** Dose Proportionality of Cmax
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Description:** Dose proportionality will be assessed by visual inspection of dose normalised AUC0-t values versus dose.
**Measure:** Dose Proportionality of AUC0-t
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
**Description:** Dose proportionality will be assessed by visual inspection of dose normalised AUC0-inf values versus dose.
**Measure:** Dose Proportionality of AUC0-inf
**Time Frame:** Cohorts 1 and 2 - Days 1 and 4: Pre-dose and up to 24 hours post-dose; Cohort 3 - Day 1: Pre-dose and up to 24 hours post-dose
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Participants must meet all of the following criteria to be included in the study:
1. Male, \>=18 and less than or equal to (\<=) 65 years of age, with body mass index (BMI) greater than (\>) 18.5 and less than (\<) 32.0 kilogram per square meter (kg/m\^2) and body weight \>=50.0 kilogram (kg).
2. Non-smoker (no use of tobacco or nicotine products, example, snuff, chewing tobacco, cigars, cigarettes, pipes, e-cigarettes \[vaping\] etc. within 3 months prior to screening).
3. Healthy as defined by:
1. the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
2. the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
4. Sexually active non-sterile males must be willing to use an acceptable contraceptive method throughout the study.
5. Able to understand the study procedures and provide signed informed consent to participate in the study.
Exclusion Criteria:
Participants to whom any of the following applies will be excluded from the study:
1. Any clinically significant abnormal finding at physical examination.
2. Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV) antibody, or Human immunodeficiency virus (HIV) antigen and antibody.
3. Positive urine drug screen, cotinine test, or alcohol breath test.
4. History of significant allergic reactions (example, anaphylactic reaction, hypersensitivity, angioedema) to any drug.
5. Clinically significant Electrocardiograms (ECG) abnormalities or vital signs abnormalities (systolic blood pressure \[BP\] lower than 90 or over 140 millimeters of mercury \[mmHg\], diastolic BP lower than 50 or over 90 mmHg, heart rate \[HR\] less than 40 or over 100 beats per minute \[bpm\], or RR less than 10 or over 25 bpm) at screening.
6. History of drug abuse within 1 year prior to screening or recreational use of marijuana within 1 month or other illegal drugs such as cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives within 3 months prior to screening.
7. History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units of alcohol per week (1 unit = 375 milliliter \[mL\] of beer 3.5 percent (%), or 100 mL of wine 13.5%, or 30 mL of distilled alcohol 40%).
8. Use of medications within the timeframes specified in section.
9. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
10. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
11. Optic nerve disease, cataracts, or a history of related conditions.
12. Any reason which, in the opinion of the Investigator, would prevent the participant from participating in the study.
**Gender Based:** True
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Dr Christopher Argent
**Phone:** +61 2 9382 5800
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Asieris Pharmaceuticals (AUS) Pty Ltd.
**Name:** Dr Christopher Argent
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5030
- Name: Urinary Bladder Neoplasms
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435026
**Brief Title:** Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1
**Official Title:** Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1
#### Organization Study ID Info
**ID:** 22-2056
#### Organization
**Class:** OTHER
**Full Name:** University of North Carolina, Chapel Hill
#### Secondary ID Infos
**ID:** R01AI157859
**Link:** https://reporter.nih.gov/quickSearch/R01AI157859
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Institute of Allergy and Infectious Diseases (NIAID)
#### Lead Sponsor
**Class:** OTHER
**Name:** University of North Carolina, Chapel Hill
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study aims: (1) to determine the optimal dose of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for daily oral pre-exposure prophylaxis (PrEP) during pregnancy based on drug pharmacokinetics, and (2) evaluate the maternal and infant safety of increased FTC/TDF doses during these periods.
**Detailed Description:** This is a staged study to assess the pharmacokinetics (PK) and safety of increased FTC/TDF doses for PrEP during pregnancy:
STAGE 1-Dose Identification: Phase 2a pharmacokinetic (PK) study. Using an intensive sampling approach, the following detailed PK information about three doses of daily oral PrEP in pregnancy will be collected: standard FTC/TDF dose (200mg/300mg, n=18), 150% standard dose (300mg/450mg, n=18), and 200% standard dose (400mg/600mg, n=18). Following a lead-in period-where participants receive PrEP for 14 days under direct observation to reach steady state concentrations-plasma, peripheral blood mononuclear cells (PBMC), and other specimens are collected over a 24-hour period to characterize key PK parameters. During pregnancy, two cycles will be performed (i.e., during the second and third trimester) at the assigned FTC/TDF dose. For all participants, this cycle will be repeated at 12 weeks postpartum using the standard FTC/TDF dose, providing a within-person non-pregnant comparator in the longitudinal assessment of bioequivalence. Standard dose FTC/TDF will be offered between periods of direct observation.
INTERMEDIARY STEP-Independent Review: Findings from the initial dose identification stage will be independently reviewed by the Study Monitoring Committee. Based on assessments of the PK, tolerability and preliminary safety data, the committee is expected to recommend an increased dosage of FTC/TDF (150% vs. 200% standard dose) for further investigation in Stage 2.
STAGE 2-Extended Safety Assessment: Phase 2b open-label randomized trial. In the second stage, the extended safety of increased dose PrEP that was identified via independent review will be assessed. Comparison of standard vs. increased FTC/TDF dosages via an open-label randomized trial of 112 pregnant women, allocated 1:1 will be done. Because safety is inextricably linked to adherence, direct observation will be used to confirm adherence, but extend the exposure period through the remainder of pregnancy. Maternal safety will be assessed using detailed medical histories, symptoms diaries, and routine laboratory screening. Information about fetal growth, birth outcomes, and infant growth will be collected; and assessment of maternal and infant bone mineral density will be done twice in the early postpartum period. Embedded in this second stage is population PK sampling (i.e., in plasma, PBMCs, dried blood spot (DBS), and cervicovaginal fluid) to inform models of FTC/TDF concentrations over the course of pregnancy, to be developed as part of this study (Aim 3). Again, following the period of directly observed PrEP at the assigned dose in pregnancy, standard dose FTC/TDF will be self-administered postpartum, in accordance with local HIV guidelines.
\*\* In this record, only activities related to Stage 1 of the study are described. When this advances to Stage 2, a separate entry record in clinicaltrials.gov will be created. \*\*
### Conditions Module
**Conditions:**
- HIV
- Prevention
- Pregnancy
**Keywords:**
- HIV
- PrEP
- Pregnancy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized controlled trial
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 54
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** daily oral FTC/TDF standard dose (200mg/300mg, n=18)
**Intervention Names:**
- Drug: FTC/TDF 200mg/300mg
**Label:** Standard Dose
**Type:** OTHER
#### Arm Group 2
**Description:** daily oral FTC/TDF dose (300mg/450mg, n=18),
**Intervention Names:**
- Drug: FTC/TDF 300mg/450mg
**Label:** 150% standard dose
**Type:** OTHER
#### Arm Group 3
**Description:** daily oral FTC/TDF (400mg/600mg, n=18)
**Intervention Names:**
- Drug: FTC/TDF 400mg/600mg
**Label:** 200% standard dose
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Standard Dose
**Description:** Standard Dose
**Name:** FTC/TDF 200mg/300mg
**Other Names:**
- PrEP
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- 150% standard dose
**Description:** 150% Standard Dose
**Name:** FTC/TDF 300mg/450mg
**Other Names:**
- PrEP
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- 200% standard dose
**Description:** 200% Standard Dose
**Name:** FTC/TDF 400mg/600mg
**Other Names:**
- PrEP
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** AUC of TFV-DP
**Measure:** Tenofovir diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs)
**Time Frame:** Up to 20 weeks after delivery
#### Secondary Outcomes
**Description:** The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS Adverse Event Grading Table), will be used to measure safety.
These include grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening) events. Relatedness of adverse events will be assessed by site teams as defined in the protocol.
**Measure:** Maternal grade >/= 2 adverse events
**Time Frame:** Up to 20 weeks after delivery
**Description:** This is a composite outcome that includes fetal death (spontaneous abortion or stillbirth), preterm birth (\<37 weeks gestation), and small for gestational age (\<10%tile birthweight for gestational age according to INTERGROWTH 21st standards)
**Measure:** Adverse pregnancy outcomes
**Time Frame:** At time of delivery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
Maternal participants:
* Aged 16 years or older
* PrEP-eligible by local guidelines
* Pregnant with a viable singleton pregnancy of between 14 and 23 completed weeks of gestation (from 14 weeks + 0 days to 23 weeks + 6 days) by ultrasonography at study entry
* HIV-negative based on the study-specific screening algorithm
* Hepatitis B surface antigen (HBsAg)-negative
* Weight \>35 kg
* Provided informed consent and expressed willingness to participate in study activities with their infants, including daily administration of oral PrEP under direct observation
Infant participants:
Infant participants enter the study with their mother as unborn infants. There are no specific eligibility criteria for infant participation otherwise. If an infant is deemed too ill to undergo study procedures, procedures necessary for clinical management may be prioritized.
Exclusion Criteria:
Maternal participants will not enter the study if any of the following conditions are identified during the screening process:
* Grade 2 or greater laboratory parameters for alanine transaminase (ALT) or aspartate aminotransferase (AST), hemoglobin (HB), and absolute neutrophil count (ANC).
* Estimated creatinine clearance (CrCl) 90 mL/min or below, using the Cockcroft-Gault formula.
* Known history or evidence of current significant disease process, including: hematological conditions, renal disease, unexplained bone fractures, environmental enteric dysfunction, or allergies/sensitivities to FTC/TDF.
* Other current significant or uncontrolled disease process (active or chronic), substance use, or social circumstances that, in the judgment of the site investigator, would make participation in the study inappropriate or unsafe.
* Fetuses with known or suspected major fetal anomaly, either from screening ultrasound or via medical record
* Intention to leave the study site's catchment area before scheduled study exit.
* Current use of prohibited medications
* Concurrent use of other biomedical HIV prevention interventions (vaginal ring, injectable PrEP, any investigational prevention product).
**Gender Based:** True
**Gender Description:** Pregnant women
**Healthy Volunteers:** True
**Minimum Age:** 16 Years
**Sex:** FEMALE
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rassil Barada, MPH
**Phone:** 9194452864
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Lilongwe
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Friday Saidi, MBBS, MMed
- **Role:** CONTACT
**Country:** Malawi
**Facility:** Bwaila District Hospital
**Location 2:**
**City:** Harare
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Teacler Nematadzira, MBChB, MSc
- **Role:** CONTACT
**Country:** Zimbabwe
**Facility:** Seke North CRS
#### Overall Officials
**Official 1:**
**Affiliation:** University of North Carolina, Chapel Hill
**Name:** Benjamin Chi, MD, MSc
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of Zimbabwe
**Name:** Lynda Stranix-Chibanda, MBChB, MMed
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** University of Colorado - Anschutz Medical Campus
**Name:** Peter Anderson, PharmD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
**Description:** Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina (UNC).
**Info Types:**
- ICF
**IPD Sharing:** YES
**Time Frame:** Beginning 9 and continuing for 36 months following publication
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M18250
- Name: HIV Infections
- Relevance: LOW
- As Found: Unknown
- ID: M3522
- Name: Acquired Immunodeficiency Syndrome
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435013
**Brief Title:** Lenvatinib vs Bevacizumab Plus ICIs and HAIC in Unresectable HCC
**Official Title:** Lenvatinib Versus Bevacizumab Combined With Immune Checkpoint Inhibitors and Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: A Retrospective, Multi-center, and Propensity Score Matching Study
#### Organization Study ID Info
**ID:** LenBev-001
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2024-05-20
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-03-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-12-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sun Yat-sen University
#### Responsible Party
**Investigator Affiliation:** Sun Yat-sen University
**Investigator Full Name:** Shi Ming
**Investigator Title:** Ming Shi
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Previous studies had suggested hepatic arterial infusion chemotherapy (HAIC) combined with immune checkpoint inhibitors (ICIs) and anti-angiogenic drugs had promising anti-tumor activity in unresectable hepatocellular carcinoma (HCC). Two kinds of anti-angiogenic drugs (tyrosine kinase inhibitors \[lenvatinib\] and anti-VEGF antibody \[bevacizumab\]) were applied in first-line treatment of unresectable HCC. However, little is known about the difference of efficacy and safety between lenvatinib (LenHAP) or bevacizumab (BevHAP) combined with ICIs and HAIC in unresectable HCC.
### Conditions Module
**Conditions:**
- Hepatocellular Carcinoma
- Lenvatinib
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 208
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Lenvatinib combined with hepatic arterial infusion chemotherapy and PD-1/PD-L1;
**Intervention Names:**
- Drug: Lenvatinib
**Label:** LenHAP
#### Arm Group 2
**Description:** Bevacizumab combined with hepatic arterial infusion chemotherapy and PD-1/PD-L1;
**Label:** BevHAP
### Interventions
#### Intervention 1
**Arm Group Labels:**
- LenHAP
**Description:** Lenvatinib combined with hepatic arterial infusion chemotherapy and PD-1/PD-L1;
**Name:** Lenvatinib
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Measure:** progression-free survival
**Time Frame:** 2015-1 to 2023-4
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:patients aged 18 years or older, with unresectable, locally advanced, or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Disease criteria(15), who had received no previous treatment, had at least on measurable disease, as defined by Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) criteria(16), had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, had a Child-Pugh liver function score of 7 or less and had adequate hematologic and organ function (absolute neutrophil count ≥1.2×109/l, platelet count ≥60×109/l, total bilirubin \<30μmol/l, albumin ≥30g/l, aspartate transaminase and alanine transaminase ≤5×upper limit of the normal, creatinine clearance rate of ≤1.5×upper limit of the normal, and left ventricular ejection ≥45%) -
Exclusion Criteria:history of HIV, organ allograft, combined with other malignant tumors, evidence of hepatic decompensation, bleeding diathesis or event, and allergy to the investigational agents or any agent given in association with this trial and incomplete medical information.
-
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** patients with received the combination therapy of lenvatinib/bevacizumab, hepatic arterial infusion chemotherapy and PD-1/L1
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Guangzhou
**Country:** China
**Facility:** Cancer Center Sun Yat-sen University
**State:** Guangdong
**Zip:** 510060
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000000230
- Term: Adenocarcinoma
- ID: D000008113
- Term: Liver Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000008107
- Term: Liver Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: HIGH
- As Found: Carcinoma
- ID: M9613
- Name: Carcinoma, Hepatocellular
- Relevance: HIGH
- As Found: Hepatocellular Carcinoma
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: M3585
- Name: Adenocarcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M11113
- Name: Liver Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002277
- Term: Carcinoma
- ID: D000006528
- Term: Carcinoma, Hepatocellular
### Intervention Browse Module - Ancestors
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000047428
- Term: Protein Kinase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M246
- Name: Bevacizumab
- Relevance: LOW
- As Found: Unknown
- ID: M353738
- Name: Lenvatinib
- Relevance: HIGH
- As Found: Infected
- ID: M2342
- Name: Immune Checkpoint Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M25820
- Name: Protein Kinase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000531958
- Term: Lenvatinib
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06435000
**Acronym:** POLARIS
**Brief Title:** An Observational Study in Subjects to Follow the Progression of Stargardt Disease Type 1 (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ABCA4 Gene
**Official Title:** An Observational Study in Subjects to Follow the Progression of Stargardt Disease Type 1 (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ATP Binding Cassette Subfamily a Member 4 (ABCA4) Gene
#### Organization Study ID Info
**ID:** SB-CS-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Splice Bio
### Status Module
#### Completion Date
**Date:** 2027-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-29
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Splice Bio
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is an Observational Study to Follow the Progression of Stargardt Disease Type 1 (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ABCA4 Gene
This is a multicenter study which will enroll approximately 75 subjects
**Detailed Description:** Comprehensive knowledge of a disease is essential to the design and conduct of well-controlled, interventional clinical trials. Understanding of the disease state is important for identifying the patient population for a clinical trial, study duration, and selection of clinically meaningful endpoints.
Observational studies play an important role in the understanding of rare diseases and facilitating effective development of potential therapies. To support clinical research, observational studies can help define the clinical features of a rare disease, rate of progression, pathophysiology, and other important factors. Further, following the course of a disease over time allows investigators to identify demographic variables, genotypic and phenotypic features, and other characteristics that may correlate with disease and outcomes in the absence of treatment. Thus, observational studies are useful in guiding the design of therapeutic studies, including selection of the patient population, trial duration, and the types of outcome measures to evaluate efficacy and safety.
Results of a natural history study evaluating the progression of atrophy secondary to Stargardt Disease have been published using retrospective and prospective cohorts of patients (ProgStar, Strauss et al., 2016).
In summary, the current study is a prospective observational study of patients with STGD1, the aim of which is to further enhance understanding of disease progression and structural and functional markers that can be used to evaluate the efficacy and safety of therapeutic interventions, especially in light of advancements in imaging technology.
### Conditions Module
**Conditions:**
- Stargardt
- Stargardt's Disease
- Stargardt Disease
- STGD1
**Keywords:**
- POLARIS
- Splicebio
- STGD1
- ABCA4
### Design Module
#### Bio Spec
**Description:** Buccal saliva swab to determine a minimum of two pathogenic or likely pathogenic mutations in the ABCA4 gene to genetically confirm the disease, as per eligibility criteria
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 75
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Outcomes Module
#### Primary Outcomes
**Measure:** Document disease progression based on change from baseline in lesion size as measured by DDAF on FAF imaging
**Time Frame:** 96 weeks
#### Secondary Outcomes
**Measure:** Change from baseline in ellipsoid zone (EZ) area as measured by SD-OCT
**Time Frame:** 96 weeks
**Measure:** Change from baseline in BCVA using ETDRS
**Time Frame:** 96 weeks
**Measure:** Change from baseline in LLVA using ETDRS
**Time Frame:** 96 weeks
**Measure:** Change from baseline in retinal sensitivity based on macular microperimetry
**Time Frame:** 96 weeks
**Measure:** Change from baseline in contrast sensitivity scores
**Time Frame:** 96 weeks
**Measure:** Change from baseline using Patient Reported Outcome Questionnaires
**Time Frame:** 96 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Provide written consent
2. Are male or female aged 12-65 years old
3. Have a diagnosis of STGD1 caused by bi-allelic likely pathogenic or pathogenic variants in the ABCA4 gene confirmed genotypically by an accredited genotyping laboratory
4. Have a history of STGD1 progression within the last 2 years, in the opinion of the investigator.
5. Eligible eye(s) must have:
1. BCVA of between 24-88 ETDRS letters, inclusive (20/20 - 20/320 Snellen equivalent, 0.0-1.2 logMAR) at the Screening Visit.
2. Clinical evidence of a macular lesion phenotypically consistent with Stargardt Disease.
3. Fundus autofluorescence (FAF) measurement of definitely decreased autofluorescence (DDAF) as measured by the Central Reading Center (CRC).
4. Total lesion must be imaged in its entirety.
5. All total lesion borders must be ≥300 microns from all image edges.
6. Eligible eye(s) must have clear ocular media and adequate pupillary dilation, including no allergy to dilating eyedrops, to permit good quality retinal imaging.
Exclusion Criteria:
1. Are an immediate family member (e.g., child, sibling) of the Sponsor or study site personnel.
2. Have any concurrent ocular disease that would affect study procedures or outcomes (e.g., cataracts; subjects can be enrolled 90 days after successful cataract surgery) in eligible eyes.
3. Have two likely pathogenic or pathogenic variants (not STGD1) in autosomal recessive inherited retinal dystrophy (IRD) genes or a single likely pathogenic or pathogenic variant in autosomal dominant or X-linked IRD genes.
4. Have had any intraocular surgery or thermal laser within 90 days of study entry or any prior thermal laser in the macular region within the eligible eye(s).
5. Have any major surgical procedure within 30 days of the Screening Visit or planned or anticipated major surgery during the study period.
6. Are unwilling to stop taking the following products at Screening and throughout the study:
1. Supplements containing vitamin A or beta-carotene, liver-based products.
2. Prescription oral retinoids.
7. Have actively participated in an investigational therapy study or have received any investigational therapy within 90 days of the Screening Visit or 5 half-lives, whichever is longer. Note: any ophthalmic history of gene therapy, stem cell therapy, surgical implantation of prosthetic retinal chips, or intravitreal or sub-retinal injections exclude the subject from study participation.
8. Have known serious allergies to the fluorescein dye that might be used to measure intraocular pressure (IOP), ocular dilating drops, topical ocular anesthetic, or any history of anaphylaxis reaction.
9. Have a history of amblyopia in the eligible eye(s).
10. Have any significant ocular or non-ocular disease/disorder (or medication and/or laboratory test abnormalities) which, in the opinion of the investigator and with concurrence of the Medical Monitor, may either put the subject at risk because of participation in the study, may influence the results of the study, or affect the subject's ability to participate in the study.
**Maximum Age:** 65 Years
**Minimum Age:** 12 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Participants will be selected that have a genetic and clinical diagnosis of STGD1 and fulfil all other entry criteria.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** SpliceBio SpliceBio
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** Sponsor will wait until data fully analyzed and published before considering sharing
**IPD Sharing:** NO
### References Module
#### See Also Links
**Label:** SpliceBio
**URL:** https://splice.bio/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015785
- Term: Eye Diseases, Hereditary
- ID: D000005128
- Term: Eye Diseases
- ID: D000012162
- Term: Retinal Degeneration
- ID: D000012164
- Term: Retinal Diseases
- ID: D000030342
- Term: Genetic Diseases, Inborn
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC11
- Name: Eye Diseases
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M20559
- Name: Disease Progression
- Relevance: LOW
- As Found: Unknown
- ID: M2147
- Name: Stargardt Disease
- Relevance: HIGH
- As Found: Stargardt Disease
- ID: M11260
- Name: Macular Degeneration
- Relevance: HIGH
- As Found: Stargardt Disease
- ID: M8271
- Name: Eye Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M18339
- Name: Eye Diseases, Hereditary
- Relevance: LOW
- As Found: Unknown
- ID: M14997
- Name: Retinal Degeneration
- Relevance: LOW
- As Found: Unknown
- ID: M14999
- Name: Retinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M23686
- Name: Genetic Diseases, Inborn
- Relevance: LOW
- As Found: Unknown
- ID: T5470
- Name: Stargardt Disease
- Relevance: HIGH
- As Found: Stargardt Disease
### Condition Browse Module - Meshes
- ID: D000080362
- Term: Stargardt Disease
- ID: D000008268
- Term: Macular Degeneration
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434987
**Brief Title:** Impact of RIVP on GI Function in Patients Undergoing Surgical Repair for ATAAD
**Official Title:** Impact of Retrograde Inferior Vena Cava Perfusion on Gastrointestinal Function in Patients Undergoing Surgical Repair for Acute Type A Aortic Dissection: A Study Protocol and Prospective Evaluation.
#### Organization Study ID Info
**ID:** 2023-KY-215-01
#### Organization
**Class:** OTHER
**Full Name:** The Second Hospital of Nanjing Medical University
### Status Module
#### Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-12-25
**Type:** ACTUAL
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The Second Hospital of Nanjing Medical University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Acute Type A Aortic Dissection (ATAAD) is a serious medical condition that requires immediate surgical intervention. The repair of Acute Type A Aortic Dissection (ATAAD) combines different surgical procedures, including the use of Cardiopulmonary Bypass (CPB). This study focuses on the gastrointestinal (GI) system and the complications arising in the gastrointestinal (GI) system as a result of this procedure. Retrograde Inferior Vena Cava Perfusion (RIVP) is a technique used during Cardiopulmonary Bypass (CPB) that could show potential in mitigating latent gastrointestinal (GI) complications. The study aims to evaluate the effectiveness of Retrograde Inferior Vena Cava Perfusion (RIVP) in patients receiving Acute Type A Aortic Dissection (ATAAD) repair with Cardiopulmonary Bypass (CPB) in reducing Ischemic Reperfusion (IR) injury and inflammatory responses that affect gastrointestinal (GI) integrity. It intends to compare the postoperative gastrointestinal (GI) complications and long-term gastrointestinal (GI) function between patients treated with Antegrade Cerebral Perfusion (ACP) and Retrograde Inferior Vena Cava Perfusion (RIVP), and those treated with Antegrade Cerebral Perfusion (ACP) alone. The patients will be placed in their respective groups as per the decision of the surgeons, perfusionists, and the condition of the patient. Data collection will be facilitated by a comprehensive Case Report Form (CRF). This pilot study, guided by established methodologies, places the study's sample size at 30 to ensure statistical reliability and prevent resource wastage. Through this approach of sample collection, baseline data collection, peri-operative data recording, and follow-up assessments, the study aims to shed light on the impact of Retrograde Inferior Vena Cava Perfusion (RIVP) during Acute Type A Aortic Dissection (ATAAD) repair on gastrointestinal (GI) complications and systemic/intestinal inflammation. The integration of specialized Case Report Forms (CRFs) and structured questionnaires ensures standardized data collection and management, while prioritizing patient confidentiality. The study's data analysis, powered by R software, will provide valuable insights into the efficacy of Retrograde Inferior Vena Cava Perfusion (RIVP) in enhancing clinical outcomes and improving patient's prognosis in the surgical treatment of Acute Type A Aortic Dissection (ATAAD).
**Detailed Description:** Retrograde Inferior Vena Cava Perfusion ( RIVP) is a adjunct technique used in surgery during the repair of Acute Type A Aortic Dissection (ATAAD). This procedure generally involves perfusing oxygenated blood into the inferior vena cava, directing it toward the visceral organs and lower extremities. This technique plays an important role in reducing the risk of ischemic injury to these vital regions during deep hypothermic circulatory arrest (DHCA) when combined with Antegrade Cerebral Perfusion (ACP).
Recent study showed that the use of Retrograde Inferior Vena Cava Perfusion (RIVP), in conjunction with Antegrade Cerebral Perfusion (ACP), may lead to lower rates of organ dysfunction in the lower body, reduced mortality and shorter Cardiopulmonary Bypass (CPB) duration. It has also been associated with maintaining higher higher body temperature during circulatory arrest which may be beneficial for the overall patient well-being.
However, despite these promising results , there is a need for further research to explore the scientific impact of Retrograde Inferior Vena Cava Perfusion (RIVP) on gastrointestinal function during and after Acute Type A Aortic Dissection (ATAAD) repair. Gastrointestinal complications are a crucial aspect of a patients outcomes, and more often neglected. Understanding the relationship between Retrograde Inferior Vena Cava Perfusion (RIVP) and these complications may be essential and have the potential to lead better prognosis among patients, resulting in improved outcomes.
In summary, Retrograde Inferior Vena Cava Perfusion (RIVP) is a valuable technique that helps protect abdominal organs and lower extremities during Acute Type A Aortic Dissection (ATAAD) surgery. While it shows promise in improving patient outcomes, ongoing research is necessary to comprehensively assess its effect on gastrointestinal function, thus optimizing its use in the surgical management of Acute Type A Aortic Dissection (ATAAD).
This study is designed as a single centered, prospective, cohort study with an exploratory framework. The study will be conducted at the Second Affiliated Hospital of Nanjing Medical University Cardiovascular Center. This study will focus on patients undergoing Acute Type A Aortic Dissection (ATAAD) repair with or without Retrograde Inferior Vena Cava Perfusion (RIVP). Patients will be assigned to these groups based on surgical and patient specific criteria in the ratio 1:1 and will follow patients in the Cardiovascular Critical Care Unit ( CCU) pre-operatively. Group A will receive selective ACP+RIVP, while group B will receive ACP alone under mild to moderate hypothermia. As per the general rule of thumb, the study anticipates to recruit up to 30 patients for the pilot study in total. 15 in each group.
Patients will undergo diagnostic assessments to confirm diagnosis of Acute Type A Aortic Dissection (ATAAD) and depending on urgency they will proceed either to surgery or Cardiovascular Critical Care Unit (CCU). Informed consent will be obtained, but this will in no way delay the treatment protocol for the patients. In case of urgent surgery, a surgical fellow will obtain the consent. Patients can withdraw without repercussions and no replacements will be sought.
All data will be collected and recorded systematically in a well drafted case report form. A protocol has been written to conduct this study and we have followed the SPIRITS guidelines. Any changes in the protocol will be timely reported and adjusted.
We will collect blood samples at specific time intervals, pre operatively (PO1), post operatively day 1 (PO2), day 3 (PO3), day 7 (PO4). The study will include biomarker evaluation: CRP, intestinal barrier indicators ( D-amine oxidase(DAO), Fatty Acid Binding Protein 2 (FABP2), D-Lactate, Endotoxins) and 12 cytokine panel.
All baseline data ranging from clinical parameters, anthropometric data, baseline gastrointestinal (GI) assessment and clinical data will be obtained before surgery and recorded in the case report form.
Peri operative data, duration of Cardiopulmonary Bypass (CPB), duration of deep hypothermic circulatory arrest (DHCA), cross clamp time, surgery time, number of units of whole blood, fresh frozen plasma, pooled platelets and cryoprecipitate administered will be collected within the surgical room by the perfusionist and the anesthesiologist.
A prospective longitudinal study will assess long term gastrointestinal (GI) dysfunction post surgery through follow up methods such as outpatient, Wechat application, in hospital or telephone based follow up evaluation at specified intervals (1,3,6,12 months) post hospital discharge. A meticulously drafted questionnaire will be used as a tool for assessment.
To establish presence of gut barrier dysfunction, the investigators will look at the specific patterns or deviation in values of the biomarkers from the normal or baseline levels. An increase in pro-inflammatory cytokines may suggest an inflammatory response associated with gut barrier dysfunction. Elevated levels of D- Lactate, Fatty Acid Binding Protein 2 (FABP2) and endotoxins and decreased activity levels of D-amine oxidase (DAO) could suggest gut barrier dysfunction.
The investigators will perform comprehensive statistical analysis to evaluate continuous variables, like inflammatory markers. This includes calculating the mean, standard deviation and interquartile range for values related to C- reactive protein (CRP), cytokines and intestinal barrier markers. The investigators will use the t-test to analyze differences in these variables. For ordinal data from the Case Report Form (CRF) and follow up questionnaire, wilcoxon rank sun test for hypothesis testing will be used. Categorical data will be presented as percentages , and the differences in these categories will be assessed using the chi-squared test. To handle data at multiple time points, ANOVA will be used to assess variance. When dealing with multiple dependant variables like various cytokine levels simultaneously , the investigators will employ a multivariate analysis of variance. We will consider results statistically significant if the p value is \<0.05, in lone with established research and data analysis practices.
### Conditions Module
**Conditions:**
- Type A Aortic Dissection
**Keywords:**
- Acute Type A Aortic Dissection
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** ACP+RIVP under mild to moderate hypothermia
**Intervention Names:**
- Procedure: Retrograde Inferior Vena Cava Perfusion
**Label:** ATAAD patients undergoing Cardiopulmonary Bypass (CPB) with RIVP
#### Arm Group 2
**Description:** ACP only under mild to moderate hypothermia.
**Intervention Names:**
- Procedure: Antegrade cerebral perfusion
**Label:** ATAAD patients undergoing Cardiopulmonary Bypass (CPB) without RIVP
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ATAAD patients undergoing Cardiopulmonary Bypass (CPB) with RIVP
**Description:** Retrograde inferior vena cava (RIVP) involves perfusing oxygenated blood into the inferior vena cava, which then flows towards the viscera, abdominal organs and lower extremities. By maintaining perfusion to these regions during cardiopulmonary bypass (CPB) and induced hypothermia, Retrograde inferior vena cava (RIVP) helps mitigate the risk of ischemic injury to the abdominal organs. Following the initiation of total cardiopulmonary bypass, the body temperature will be gradually lowered to achieve deep-moderate hypothermia ( 24-38°C). This procedure will involve the combination of selective antegrade cerebral perfusion and retrograde inferior vena cava perfusion. Antegrade perfusion will be maintained at a flow rate of 5-7mL/min/kg, while retrograde perfusion will be regulated to sustain the required pumm pressure and blood flow.
**Name:** Retrograde Inferior Vena Cava Perfusion
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- ATAAD patients undergoing Cardiopulmonary Bypass (CPB) without RIVP
**Description:** After mild to moderate hypothermia is achieved, a cannula will be inserted into the right axillary artery, brachiocephalic or innominate artery to provide continuous flow to the brain. A flow rate of 5-7mL/min/kg will be maintained.
**Name:** Antegrade cerebral perfusion
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Patients undergoing CPB with RIVP may have a better prognosis and less incidence of long term GI disturbance as compared to those patients undergoing CPB without RIVP. Measurement tools: 1. Biomarkers; levels of D-Lactate, FABP2 ( Fatty Acid Binding Protein 2), endotoxins and DAO (Diamine Oxidase). Measurement method: Samples of blood will be analyzed using ELISA ( Enzyme Linked Immunosorbent Assay)
**Measure:** RIVP will reduce post operative GI disturbances and gut barrier dysfunction.
**Time Frame:** Pre operatively, Post -operative day 1 ,day 2, day 3 and day 7
**Description:** Measurements: C-Reactive protein (CRP) and 12 cytokine panel. Method: blood samples will be analyzed using immunoassays
**Measure:** Inflammatory response will be possibly reduced in those undergoing RIVP
**Time Frame:** Pre operatively, Post -operative day 1 ,day 2, day 3 and day 7
**Description:** Measurement tools: clinical assessment for gastrointestinal function and questionnaire. Special formulated case report forms will contain a detailed questionnaire assessing the quality of life and gastrointestinal function. Method: Baseline gastrointestinal function will be assessed pre opratively and follow up questionnaire post operatively.
**Measure:** Gastrointestinal assessment and long term gastrointestinal dysfunction.
**Time Frame:** Follow up questionaires will be addressed at 1,3,6 and 12 months post hospital discharge. Follow up will be outpatient visits, telephone based calls and interviews, wechat application at the specified intervals
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients undergoing ATAAD repair under CPB.
2. Age: 18-70 years
3. Give consent
Exclusion Criteria:
1. Variables that can influence gut microbiome like antibiotics or probiotics 2 weeks prior to surgery
2. On chemotherapy
3. Evidence of pre-operative malperfusion of the GI system
4. Presence of GI any pathology (IBD,GERD,PU)
5. Continuous enteral feeding prior to surgery
6. Refuse to participate in the study
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** The study groups with be patients undergoing ATAAD repair under CPB with and without RIVP. This is a cohort study and the patients will not be assigned any specific group randomly or by a computer. The patients will be placed in their respective groups as per the decision of the surgeons, perfusionist and the condition of the patient. Patients admitted through the emergency department will be initially enrolled into the cardiovascular department and subsequently invited to participate in this study.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Sanaa Azim
**Phone:** +8615679202116
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Xun Zhang
**Phone:** +8618502522060
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Nanjing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Qing Guo Li
- **Phone:** +86 139 1389 9923
- **Role:** CONTACT
**Country:** China
**Facility:** The Second Affiliated Hospital of Nanjing Medical University
**State:** Jiangsu
**Status:** RECRUITING
**Zip:** 210011
#### Overall Officials
**Official 1:**
**Affiliation:** The Second Hospital of Nanjing Medical University
**Name:** Qing Guo Li
**Role:** STUDY_CHAIR
**Official 2:**
**Affiliation:** The Second Affiliate Hospital of Nanjing Medical University
**Name:** Sanaa Azim
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
### References Module
#### References
**Citation:** Harris KM, Nienaber CA, Peterson MD, Woznicki EM, Braverman AC, Trimarchi S, Myrmel T, Pyeritz R, Hutchison S, Strauss C, Ehrlich MP, Gleason TG, Korach A, Montgomery DG, Isselbacher EM, Eagle KA. Early Mortality in Type A Acute Aortic Dissection: Insights From the International Registry of Acute Aortic Dissection. JAMA Cardiol. 2022 Oct 1;7(10):1009-1015. doi: 10.1001/jamacardio.2022.2718.
**PMID:** 36001309
**Citation:** Salomon J, Ericsson A, Price A, Manithody C, Murry DJ, Chhonker YS, Buchanan P, Lindsey ML, Singh AB, Jain AK. Dysbiosis and Intestinal Barrier Dysfunction in Pediatric Congenital Heart Disease Is Exacerbated Following Cardiopulmonary Bypass. JACC Basic Transl Sci. 2021 Mar 3;6(4):311-327. doi: 10.1016/j.jacbts.2020.12.012. eCollection 2021 Apr.
**PMID:** 33997519
**Citation:** Cheng LK, O'Grady G, Du P, Egbuji JU, Windsor JA, Pullan AJ. Gastrointestinal system. Wiley Interdiscip Rev Syst Biol Med. 2010 Jan-Feb;2(1):65-79. doi: 10.1002/wsbm.19.
**PMID:** 20836011
**Citation:** Sarkar M, Prabhu V. Basics of cardiopulmonary bypass. Indian J Anaesth. 2017 Sep;61(9):760-767. doi: 10.4103/ija.IJA_379_17.
**PMID:** 28970635
**Citation:** Halter J, Steinberg J, Fink G, Lutz C, Picone A, Maybury R, Fedors N, DiRocco J, Lee HM, Nieman G. Evidence of systemic cytokine release in patients undergoing cardiopulmonary bypass. J Extra Corpor Technol. 2005 Sep;37(3):272-7.
**PMID:** 16350379
**Citation:** Typpo KV, Larmonier CB, Deschenes J, Redford D, Kiela PR, Ghishan FK. Clinical characteristics associated with postoperative intestinal epithelial barrier dysfunction in children with congenital heart disease. Pediatr Crit Care Med. 2015 Jan;16(1):37-44. doi: 10.1097/PCC.0000000000000256.
**PMID:** 25162512
**Citation:** Yan TD, Bannon PG, Bavaria J, Coselli JS, Elefteriades JA, Griepp RB, Hughes GC, LeMaire SA, Kazui T, Kouchoukos NT, Misfeld M, Mohr FW, Oo A, Svensson LG, Tian DH. Consensus on hypothermia in aortic arch surgery. Ann Cardiothorac Surg. 2013 Mar;2(2):163-8. doi: 10.3978/j.issn.2225-319X.2013.03.03.
**PMID:** 23977577
**Citation:** Safi HJ, Miller CC 3rd, Lee TY, Estrera AL. Repair of ascending and transverse aortic arch. J Thorac Cardiovasc Surg. 2011 Sep;142(3):630-3. doi: 10.1016/j.jtcvs.2010.11.015. Epub 2011 Jan 26.
**PMID:** 21269650
**Citation:** Ehrlich M, Fang WC, Grabenwoger M, Cartes-Zumelzu F, Wolner E, Havel M. Perioperative risk factors for mortality in patients with acute type A aortic dissection. Circulation. 1998 Nov 10;98(19 Suppl):II294-8.
**PMID:** 9852917
**Citation:** Ziyaeifard M, Alizadehasl A, Massoumi G. Modified ultrafiltration during cardiopulmonary bypass and postoperative course of pediatric cardiac surgery. Res Cardiovasc Med. 2014 May;3(2):e17830. doi: 10.5812/cardiovascmed.17830. Epub 2014 Apr 1.
**PMID:** 25478538
**Citation:** Lin J, Qin Z, Liu X, Xiong J, Wu Z, Guo Y, Kang D, Du L. Retrograde inferior vena caval perfusion for total aortic arch replacement surgery: a randomized pilot study. BMC Cardiovasc Disord. 2021 Apr 20;21(1):193. doi: 10.1186/s12872-021-02002-9.
**PMID:** 33879045
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000094665
- Term: Dissection, Blood Vessel
- ID: D000000783
- Term: Aneurysm
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000094683
- Term: Acute Aortic Syndrome
- ID: D000001018
- Term: Aortic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4114
- Name: Aortic Dissection
- Relevance: HIGH
- As Found: Aortic Dissection
- ID: M3081
- Name: Dissection, Blood Vessel
- Relevance: LOW
- As Found: Unknown
- ID: M4113
- Name: Aneurysm
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M3085
- Name: Acute Aortic Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M4334
- Name: Aortic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000784
- Term: Aortic Dissection
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: HB
- Name: Herbal and Botanical
### Intervention Browse Module - Browse Leaves
- ID: M16204
- Name: Sulfamethazine
- Relevance: LOW
- As Found: Unknown
- ID: T204
- Name: Kava
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434974
**Brief Title:** Prevalence of Birth Before Arrival and Associated Factors Among Postpartum Women in Southern Ethiopia
**Official Title:** Prevalence of Birth Before Arrival and Associated Factors Among Postpartum Women in Southern Ethiopia: Community-Based Cross-Sectional Study
#### Organization Study ID Info
**ID:** LMHB
#### Organization
**Class:** OTHER
**Full Name:** Wachemo University
### Status Module
#### Completion Date
**Date:** 2023-05-20
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-05-20
**Type:** ACTUAL
#### Start Date
**Date:** 2023-04-05
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Wachemo University
#### Responsible Party
**Investigator Affiliation:** Wachemo University
**Investigator Full Name:** Mitiku Desalegn
**Investigator Title:** Lecturer
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Background: Birth before arrival is defined as unplanned deliveries without the attendance of skilled personnel just before arrival to a health facility. It constitutes a high-risk newborn population and has high perinatal morbidity and mortality. In Ethiopia, most studies and health surveys done, only look at home and hospital deliveries but do not consider deliveries taking place between the house and health facility. The aim of this study is to assess the prevalence of birth before arrival and its associated factors among postpartum women in Lemo woreda, Hadiya zone, SNNPR Ethiopia, 2023.
Methods: Community-based cross-sectional study was conducted among postpartum women in Lemo woreda, Hadiya zone, SNNPR Ethiopia from April, 05 to May 20, 2023. Three hundred eighty-two postpartum women who gave birth six months preceding this study were included. Twelve out of 36 kebeles were selected randomly and simple random sampling was employed for the selection of participant women. Interviewer-administered questionnaire was used for data collection. A binary logistic regression analysis was computed and variables with a p-value of \< 0.25 were recruited to the final multivariable logistic regression analysis. Model fitness was checked using Hosmer and Lemeshow goodness of fit test (x2 = 16.04, p-value = 0.250). Statistical significance was declared using odds ratios and 95% confidence intervals at p-value \< 0.05.
Result: The prevalence of birth before arrival among women who gave birth in the last six months preceding this study in the study area was 15.2% (95%CI: 11.8%, 19.1%). In the multi-variable analysis, the variables found to have an association with birth before arrival in the final model were having no antenatal care (AOR = 2.63; 95%CI: 1.23, 5.63), dependent women autonomy status (AOR = 3.32; 95%CI: 1.12, 9.89), being not knowledgeable about labor symptoms (AOR = 2.15; 95%CI: 1.11, 4.18), and having birth preparedness towards index birth (AOR = 0.13; 95%CI: 0.05, 0.35).
Conclusion: The prevalence of birth before arrival in the study area was unacceptably high. A statistically significant association was seen between birth before arrival and having no antenatal care, dependent women's autonomy status, being not knowledgeable about labor symptoms, and having birth preparedness towards index birth. Intervening to avert birth before arrival through effective antenatal care programs and enhancing women's autonomy may help to reduce birth before arrival and its adverse perinatal outcomes.
**Detailed Description:** Results Socio-demographic characteristics A total of 382 study participants were included in the analysis with a 100% response rate. The mean age of participant women was 30.3 years + 4.4 SD. The majority of participant women were in the age group 23-26 years (28.3%), but women in the age category of 27-30 were the most experienced birth before arrival (34.6%) and three fourth of them were rural residents (76.2%). Nearly half of women (45.5%) attained secondary education (grades 9-12). The majority of the participant mothers (83.8%) were housewives in their occupation whereas 68.0% of their husbands were farmers. The mean estimated monthly income of the family was 7,216 birr + 3,073.4 SD. The majority of participants (95.0%) had media exposure and radio was the commonest media (Table 2).
Table 2: Socio-demographic characteristics of women who gave birth in the last six months in Lemo district, Hadiya zone, Southern Ethiopia (n = 382).
Variables Category Frequency (percentage) Total
No BBA BBA Mother's age in years Range (23-38) 23-26 27-30 31-34 35-38 105 (97.2%) 70 (65.4%) 78 (88.6%) 71 (88.9%) 3 (2.8%) 37 (34.6%) 10 (11.4%) 8 (10.1%) 108 (28.3%) 107 (28.0%) 88 (23.0%) 79 (20.7%) Residence Urban Rural 74 (81.3%) 250 (85.9%) 17 (18.7%) 41 (14.1%) 91 (23.8%) 291 (76.2%) Women's educational status No formal education Primary Secondary Higher education 31 (60.8%) 154 (88.5%) 126 (89.4%) 13 (81.3%) 20 (39.2%) 20 (11.5%) 15 (10.6%) 3 (18.7%) 51 (13.4%) 174 (45.5%) 141 (36.9%) 16 (4.2%) Husband's educational status No formal education Primary Secondary Higher education 5 (41.7%) 132 (89.8%) 160 (86.5%) 27 (71.1%) 7 (58.3%) 15 (10.2%) 25 (13.5%) 11 (28.9%) 12 (3.1%) 147 (38.5%) 185 (48.4%) 38 (10.0%) Women's occupation Housewife Maid Civil servant 272 (85.0%) 38 (86.4%) 14 (77.8%) 48 (15.0%) 6 (13.6%) 4 (22.2%) 320 (83.8%) 44 (11.5%) 18 (4.7%) Husband's occupation Farmer Merchant Civil servant 229 (88.1%) 80 (77.7%) 15 (78.9%) 31 (11.9%) 23 (22.3%) 4 (21.1%) 260 (68.0%) 103 (27.0%) 19 (5.0%) Housing characteristics Private Rented 295 (85.3%) 29 (80.6%) 51 (14.7%) 7 (19.4%) 346 (90.6%) 36 (9.4%) The average estimated monthly income of the family in Birr 2,000-6,000 6,001-11,000 11,001-15,000 162 (89.0%) 126 (78.7%) 36 (90.0%) 20 (11.0%) 34 (21.3%) 4 (10.0%) 182 (47.6%) 160 (41.9%) 40 (10.5%) Media exposure Yes No 310 (85.4%) 14 (73.7%) 53 (14.6%) 5 (26.3%) 363 (95.0%) 19 (5.0%) Type of media (n = 363) Radio Television Social media 277 (88.8%) 28 (65.1%) 5 (62.5%) 35 (11.2%) 15 (34.9%) 3 (37.5%) 312 (81.7%) 43 (11.2%) 8 (2.1%) BBA: Birth Before Arrival; birr: Ethiopian currency Reproductive Health and Obstetric Characteristics The majority of participant women (76.7%) of them had antenatal care (ANC) follow-up for their last pregnancy. Two-thirds of women had 1-3 ANC contacts for their last delivery with a mean of 1.2 + 0.4 SD. The proportion of women who used contraceptives before their last pregnancy was 26.4%. Two-thirds of the participant women (71.7%) had postnatal care (PNC) follow-up for their last birth and 76.2% of women had planned and wanted the type of last pregnancy. The average value of the women's autonomy index was 0.68 and 26.7% of participant women were autonomous. The proportion of women with grand multigravida was 21.0%, the duration of labor of index birth \> 12 hours was 54.7%, birth preparedness towards index birth of 86.1%, women with knowledge of the expected date of delivery (EDD) of the index birth were 66.7%, and 66.1% of women know labor symptoms. The mean number of pregnancies was 3.0 + 1.6 SD and the median duration of labor of the last birth was 14 (IQR 12-24) (Table 3).
Table 3: Reproductive health and obstetric characteristics of participant women by birth before arrival in Lemo district, Hadiya zone, Southern Ethiopia (n = 382).
Variables Category Frequency (percentage) Total
No BBA BBA ANC for the last delivery Yes No 254 (86.7%) 70 (78.7%) 39 (13.3%) 19 (21.3%) 293 (76.7%) 89 (23.3%) Number of ANC contacts (n = 293) 1-3 contacts \> 4 contacts 178 (86.0%) 76 (88.4%) 29 (14.0%) 10 (11.6%) 207 (70.6%) 86 (29.4%) Type of health facility for ANC (n = 293) At hospital At health centre At health post 14 (82.4%) 177 (87.2%) 63 (86.3%) 3 (17.6%) 26 (12.8%) 10 (13.7%) 17 (5.8%) 203 (69.3%) 73 (24.9%) Used contraceptive before last pregnancy Yes No 83 (82.2%) 241 (85.8%) 18 (17.8%) 40 (14.2%) 101 (26.4%) 281 (73.6%) PNC for the last delivery Yes No 233 (85.0%) 91 (84.3%) 41 (15.0%) 17 (15.7%) 274 (71.7%) 108 (28.3%) Type of pregnancy Planned and wanted Unplanned but wanted Unplanned \& unwanted 249 (85.6%) 68 (91.9%) 7 (41.2%) 42 (14.4%) 6 (8.1%) 10 (58.8%) 291 (76.2%) 74 (19.4%) 17 (4.4%) Women autonomy Non-autonomous Autonomous 231 (82.5%) 93 (91.2%) 49 (17.5%) 9 (8.8%) 280 (73.3%) 102 (26.7%) Gravidity Multigravidae Grand multigravidae 259 (85.8%) 65 (81.3%) 43 (14.2%) 15 (18.7%) 302 (79.0%) 80 (21.0%) Duration of labor of index birth \< 12 hours \> 12 hours 155 (89.6%) 169 (80.9%) 18 (10.4%) 40 (19.1%) 173 (45.3%) 209 (54.7%) Know the EDD of the index birth Yes No 226 (88.6%) 98 (77.2%) 29 (11.4%) 29 (22.8%) 255 (66.7%) 127 (33.3%) Birth preparedness towards index birth Yes No 285 (86.6%) 39 (73.6%) 44 (13.4%) 14 (26.4%) 329 (86.1%) 53 (13.9%) Knowledge of labor symptoms (n=350) Not knowledgeable Knowledgeable 89 (74.8%) 205 (88.7%) 30 (25.2%) 26 (11.3%) 119 (34.0%) 231 (66.0%) Mode of previous delivery SVD Instrumental delivery SVD with episiotomy Cesarean section 217 (85.1%) 34 (94.4%) 72 (80.9%) 1 (50.0%) 38 (14.9%) 2 (5.6%) 17 (19.1%)
1 (50.0%) 255 (66.7%) 36 (9.4%) 89 (23.3%) 2 (0.6%) ANC: Antenatal Care; BBA: Birth Before Arrival; EDD: Expected Date of Delivery; PNC: Postnatal Care; SVD: Spontaneous Vaginal Delivery Access to a healthcare facility The median time of the delay to seek health care was 14 hours (IQR 12-24) and the mean duration of the second delay was 1.3 hours + 0.6 SD. One-fourth (25.9%) of women delayed \> 24 hours in deciding to seek health care and one-third (33.8%) travelled \> 2 hours to reach a health care facility. The major reason for the first delay was not realising the problem (28.8%) for women with birth before arrival and lack of transport (62.3%) was the major reason for the second delay. About means of transport, 35.8% of women used Horse/Donkey carts. Regarding the condition of the road, 29.3% of women replied that it is a wide road. More than half of women (51.6%) delivered their index birth at night (Table 4).
Table 4: Access to health care facility among women who gave birth in the last six months in Lemo district, Hadiya zone, Southern Ethiopia (n=382).
Variables Category Frequency (percentage) Total
No BBA BBA First delay Delayed \< 24 hours Delayed \> 24 hours 246 (86.9%) 78 (78.8%) 37 (13.1%) 21 (21.2%) 283 (74.1%) 99 (25.9%) Second delay (n = 317) Traveled \< 2 hours Traveled \> 2 hours 171 (81.4%) 88 (82.2%) 39 (18.6%) 19 (17.8%) 210 (66.2%) 107 (33.8%) Reasons for 1st delay Underestimate severity Did not realize the problem Essential person for decision making not around 195 (86.7%) 116 (71.2%) 78 (86.7%) 30 (13.3%) 47 (28.8%) 12 (13.3%) 225 (100%) 163 (100%) 90 (100%) Reasons for 2nd delay (n = 317) Lack of money Lack of transport Distant health facility 61 (87.1%) 159 (80.7%) 38 (77.6%) 9 (12.9%) 38 (19.3%) 11 (22.4%) 70 (22.1%) 197 (62.3%) 49 (15.6%) Means of transport (n = 317) Motorbike Ambulance Public transport Horse/Donkey cart On foot Carried by other people 39 (100.0%) 16 (48.5%) 62 (100.0%) 83 (73.5%) 14 (58.3%) 44 (97.8%) 0 (0.0%) 17 (51.5%) 0 (0.0%) 30 (26.5%) 10 (41.3%)
1 (2.2%) 39 (12.3%) 33 (10.4%) 62 (19.6%) 113 (35.8%) 24 (7.6%) 45 (14.2%) Status of the roadroad All weather road Weather raod 225 (83.3%) 99 (88.4%) 45 (16.7%) 13 (11.6%) 270 (70.7%) 112 (29.3%) Time of delivery of index birth Night Day 150 (76.1%) 174 (94.1%) 47 (23.9%) 11 (5.9%) 197 (51.6%) 185 (48.4%) Women who delivered their last birth at home were not asked for the second delay and its reasons.
Birth before arrival The prevalence of birth before arrival among women who gave birth in the last six months preceding this study in the study area was 15.2% (95%CI: 11.8%, 19.1%). Among them, 84.5% of women gave birth on the route to a health care facility (Table 5).
Table 5: Profile of birth before arrival among women who gave birth in the last six months in Lemo district, Hadiya zone, Southern Ethiopia (n = 382).
Variables Frequency Percentage Place of last delivery Home Before arrival to a health care facility Health care facility 67 58 257 17.5 15.2 67.3 The specific place of BBA to health care facility (n=58) On the route to health care facility In ambulance 49 9 84.5 15.5 BBA: Birth before Arrival. Factors associated with birth before arrival Using bivariate binary logistic regression analyses, variables with a p-value of \< 0.25 were recruited to be included in the final model. Thus, in the multi-variable analysis, the variables found to have an association with birth before arrival in the final model were having no antenatal care (AOR = 2.63; 95%CI: 1.23, 5.63), dependent women autonomy status (AOR = 3.32; 95%CI: 1.12, 9.89), being not knowledgeable about labor symptoms (AOR = 2.15; 95%CI: 1.11, 4.18), and having birth preparedness towards index birth (AOR = 0.13; 95%CI: 0.05, 0.35).
Therefore, this study found that women, who have no antenatal care visits during the index pregnancy, had three times higher odds of birth before arrival compared to women with antenatal care. The probability of having birth before arrival to a health care facility was three times higher for women who were dependent on their autonomy status compared with those who were autonomous. Moreover, those women who were not knowledgeable about labor symptoms had two times more likely to experience birth before arrival compared to those who were knowledgeable. Women who have birth preparedness towards index pregnancy were 87% less likely to experience birth before arrival compared to women with no birth preparedness plan. Having first and second delay, status of the road, time of delivery, and income were unrelated to the probability of birth before arrival (Table 6).
Table 6: Multivariate logistic regression showing factors associated with birth before arrival among women who gave birth in the last six months in Lemo district, Hadiya zone, Southern Ethiopia.
Variables Category COR (95% CI) AOR (95% CI) P-value Media exposure Yes No 1.00 2.09 (0.72, 6.04) 1.00 2.74 (0.82, 9.18) 0.103 Receive ANC in last pregnancy Yes No 1.00 1.77 (0.96, 3.25) 1.00 2.63 (1.23, 5.63) 0.013 Women autonomy Unautonomous Autonomous 2.19 (1.04, 4.64) 1.00 3.32 (1.12, 9.89) 1.00 0.031 Knowledge of labor symptoms Not knowledgeable Knowledgeable 2.66 (1.49, 4.75) 1.00 2.15 (1.11, 4.18) 1.00 0.023 Birth preparedness for the last birth Yes No 0.43 (0.22, 0.86) 1.00 0.13 (0.05, 0.35) 1.00 \< 0.001 Used contraceptive before last pregnancy Yes No 1.31 (0.71, 2.40) 1.00 1.70 (0.78, 3.69) 1.00 0.181 First delay Delayed \< 24 hours Delayed \> 24 hours 1.00 1.79 (1.00, 3.24) 1.00 1.86 (0.92, 3.76) 0.082 ANC: Antenatal Care; AOR: Adjusted Odds Ratio; CI: Confidence Interval; COR: Crude Odds Ratio Discussion The prevalence of birth before arrival among women who gave birth in the last six months preceding this study in the study area was unacceptably high. In the current study, the variables associated with birth before arrival in the Lemo district of Hadiya zone were having no antenatal care, dependent women's autonomy status, being not knowledgeable about labor symptoms, and having birth preparedness towards index birth.
Globally, the prevalence of birth before arrival to a healthcare facility is estimated to be less than 1% of all deliveries in developed countries (1,5,10,14,15). But the prevalence of BBA rises exponentially in low-income countries to greater than 50% (1,7). In the current study, the prevalence of birth before arrival is 15.2%. This is a high prevalence in the study area, as the rate of BBA is used as an index of accessibility to perinatal care and a rate greater than 1.5% signals challenges in health care provision where appropriate interventions are praiseworthy (9). Births occurred between home and health care facilities either en route to health care facilities or in ambulances were given less attention and no recent evidence was found in Ethiopia that indicated its prevalence. However, according to the mini EDHS 2019 report, 40% of the total live births were delivered in health facilities in rural areas and 58.7% were delivered at home and the gap 1.2% reported as other might be taken as the prevalence of BBA to health facility even though it was not reported (7).
The current study's finding was higher than EDHS's report and this difference might be due to the misclassification bias. Accordingly, in the EDHS questionnaire, there was no option indicated for BBA, so the BBA prevalence might be misclassified to home or health facility delivery prevalence; but in the current study option for birth before arrival to health facility was indicated in the questionnaire. Yet the prevalence of BBA in South Africa is 5.4%, and in rural Malawi was 9% (4,19). As per the current study's finding, the prevalence of BBA in Lemo district was higher than the prevalence in South Africa and rural Malawi. The difference might be due to the variation of level of socio-economic status across countries.
This study established that women, who have no antenatal care visits during the index pregnancy, had three times higher odds of birth before arrival compared to women with antenatal care. Similarly, a national register study in Finland documented that one of the predictors for deliveries before arrival to health care facility was fewer prenatal visits (26). Another study from Tharaka Nithi County of Kenya documented that the obstetric risk factors associated with BBA were; ANC attendance, timing of ANC attendance and number of ANC visits (20). A prospective case control study from Nkangala District, South Africa concluded that being unbooked was found to predict the occurrence of BBAs (4). The findings of these studies were concurrent to the current study's finding. Even though there is no similar evidence from Ethiopia, our finding was supported by the 2019's mini EDHS report that showed seventy-four percent of births to mothers who attended four or more ANC visits were delivered in a health facility, as compared with 14% of births to mothers with no ANC visits (7). This signals that the ANC program if properly delivered will be important for reducing birth before arrival to health care facilities and subsequently its adverse perinatal outcomes.
Dependent women in their autonomy status compared with those who were autonomous had three times higher odds of giving birth before arrival to a health care facility as per the current study. Similarly, one study shows that women's autonomy was positively associated with health facility delivery in Ethiopia (27). Another study revealed the strongest association between delivery at healthcare facilities attended by skilled birth attendants in the Southern African region among women who made decisions on household income solely (28). Women's autonomy can influence their decision to seek health care and could result in delays in reaching as early as possible to a health care facility to give birth if she is not adequately autonomous. So this results in birth before arrival. We required policy actions that increase women's autonomy at home and this could be effective in helping assure women's delivery at health care facilites.
Furthermore, the current study reveals that those women who were not knowledgeable about labor symptoms had two times more likely to experience birth before arrival compared to those who were knowledgeable. Our finding was supported by one study from Tharaka Nithi County of Kenya which documented that the obstetric risk factors associated with BBA were recognition of the onset of labor and knowledge of signs and symptoms of labor (20). The finding implies that having poor knowledge of labor symptoms could affect women in early and properly recognizing the onset of labor and seek for healthcare facility delivery in the early hours. Therefore, standard guidelines for ANC in Ethiopia were required and emphasised that every pregnant woman should receive ANC from a skilled provider(7), which must include counselling and enter-personal education with women concerning labor symptoms.
Additionally, women who have birth preparedness towards index pregnancy were less likely to experience birth before arrival compared to women with no birth preparedness plan as per the current study. Similarly, one study from Tharaka Nithi County of Kenya documented that the obstetric risk factors associated with BBA were the identification of healthcare facility for delivery, identification of means of transport, financial preparation for hospital delivery, and basic supplies for birth (20). These are the components of the birth preparedness plan that were revealed by the Kenya study and these were used in our study as constructs to measure and compute variables for birth preparedness. As Ethiopia has adopted the WHO's goal-oriented focused antenatal care for promoting the health and survival of mothers and babies; one of its basic components that's individualized birth plan, complication readiness and emergency preparedness' is expected to alleviate the problem of BBA if properly performed. Having first and second delay, status of the raod, time of delivery, and income were unrelated to the probability of birth before arrival.
Strengths and limitations of the study Our study revealed the delivery of babies occurred between home and health care facilities and came up with the prevalence of BBA and its associated factors as this issue was given less attention by literature in Ethiopia. The study has a limitation in that it was based on a cross-sectional design due to its unclearly indicated prevalence of BBA, but we recommend it be based on a community-based case-control study. The results obtained from the current study were based on women's interviews and cannot be free from recall and social desirability biases.
Conclusion The prevalence of birth before arrival among women who gave birth in the last six months preceding this study in the study area was unacceptably high. Statistically significant association was seen between birth before arrival and having no antenatal care, dependent women autonomy status, being not knowledgeable about labor symptoms, and having birth preparedness towards index birth. Intervening to avert birth before arrival through an effective antenatal acre program especially focusing on individualized counselling concerning knowledge of labor symptoms and birth preparedness plan and providing extra vigilant attention for enhancing women's autonomy in the community may help to reduce birth before arrival and its adverse perinatal outcomes.
Data-Sharing Statement All data generated or analyzed during this study are included in the manuscript and are also available from the corresponding author upon request.
Ethical Approval and Consent to Participate Ethical clearance was obtained from Wachemo University, the faculty of medicine and the public health institution review board with reference no (WCU/NEMMCSH/182/2023). Permission was granted from the concerned bodies of Lemo woreda and selected kebele administrators. Moreover, written informed consent was obtained from each woman. Confidentiality of the information was assured. Moreover, this study was conducted in compliance with the Declaration of Helsinki. Anonymous data were taken and the confidentiality of participant's information was secured.
Acknowledgment We would like to forward our appreciations to health office and health extension workers of study area for their kind cooperation. We are also thankful to data collectors and the study participants.
Author Contributions All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work. All authors reviewed the manuscript.
Funding No funding was received for this work Disclosure The authors declare that they have no competing interests.
### Conditions Module
**Conditions:**
- Safe Delivery of Baby
### Design Module
#### Design Info
**Observational Model:** ECOLOGIC_OR_COMMUNITY
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 382
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Interviewer administered questionnaire
**Name:** Interview
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Prevalence of Birth before Arrival
**Time Frame:** May, 2023
#### Secondary Outcomes
**Measure:** Associated Factors of Birth Before Arrival among Postpartum Women
**Time Frame:** May, 2023
### Eligibility Module
**Eligibility Criteria:** Postpartum women who were in a state of not being able to respond to the study questionnaires due to their health status were excluded from the study.
**Gender Based:** True
**Healthy Volunteers:** True
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** A community-based cross-sectional study was conducted among 382 postpartum women who gave birth in the last six months before the current study and reside in Lemo Woredas.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hosa'ina
**Country:** Ethiopia
**Facility:** Wachemo University
**Zip:** 667
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: Rare
- Name: Rare Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434961
**Brief Title:** The Trial of SHR6508 in Secondary Hyperparathyroidism
**Official Title:** A Multicenter, Randomised, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism
#### Organization Study ID Info
**ID:** SHR6508-301
#### Organization
**Class:** INDUSTRY
**Full Name:** Shanghai Hengrui Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-07
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-24
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Shanghai Hengrui Pharmaceutical Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** The study is being conducted to evaluate the efficacy and safety of SHR6508 among Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.
### Conditions Module
**Conditions:**
- Secondary Hyperparathyroidism
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 486
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: SHR6508 plus oral placebo tablets
**Label:** Treatment group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Cinacalcet plus intravenous placebo
**Label:** Active Control group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Treatment group
**Description:** SHR6508 plus oral placebo tablets
**Name:** SHR6508 plus oral placebo tablets
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Active Control group
**Description:** Cinacalcet plus intravenous placebo
**Name:** Cinacalcet plus intravenous placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** iPTH was tested at a central laboratory.
**Measure:** Proportion of Participants to End of Study whose iPTH decreased by>30% from baseline
**Time Frame:** efficacy assessment period, defined as Week 20-27
#### Secondary Outcomes
**Description:** iPTH was tested at a central laboratory.
**Measure:** Proportion of Participants to End of Study whose iPTH decreased by>50% from baseline
**Time Frame:** efficacy assessment period, defined as Week 20-27
**Description:** Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
**Measure:** Incidence of nausea and vomiting events
**Time Frame:** Day1 to End of Treatment, End of Treatment is about Week 27
**Description:** iPTH was tested at a central laboratory.
**Measure:** Proportion of Participants to End of Treatment whose iPTH decreased to 300 pg/mL from baseline
**Time Frame:** efficacy assessment period, defined as Week 20-27
**Description:** cCa and P were tested at a central laboratory.
**Measure:** Change From Baseline in serum cCa and P
**Time Frame:** efficacy assessment period, defined as Week 20-27
**Description:** Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
**Measure:** Participants With Treatment-Emergent Adverse Events (TEAEs)
**Time Frame:** Day1 to End of Study, End of Study is about Week 31
**Description:** Anti-SHR6508 Antibody was measured in patient serum samples using a validated enzyme-linked immunosorbent assay (ELISA) method.
**Measure:** Participants with Anti-SHR6508 Antibody at baseline and postbaseline
**Time Frame:** Day1 to End of Study, End of Study is about Week 31
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Able and willing to provide a written informed consent
2. Diagnosed with end stage renal disease receiving maintenance hemodialysis
3. Male or female
4. Meet the Body Mass Index standard
5. Stably use of concomitant medication of other therapies of SHPT
6. Meet the standard of iPTH level, cCa
Exclusion Criteria:
1. Subjects with a history of malignant tumor
2. Subjects with neuropsychiatric diseases
3. Subjects with a history of cardiovascular diseases
4. Subjects with gastrointestinal diseases
5. Subjects with a history of surgery
6. Subjects with a history of blood loss
7. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin
8. Subjects with a treatment history of similar drugs
9. Allergic to a drug ingredient or component
10. Pregnant or nursing women
11. No birth control during the specified period of time
12. Subject with a history of alcohol abuse and drug abuse
13. Participated in clinical trials of other drugs
14. The investigators determined that other conditions were inappropriate for participation in this clinical trial
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kunming Li
**Phone:** 0518-82342973
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Name:** Xueqing Yu
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** China
**Facility:** Guangdong Provincial People's Hospital
**State:** Guangdong
**Zip:** 510000
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009385
- Term: Neoplastic Processes
- ID: D000009369
- Term: Neoplasms
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010279
- Term: Parathyroid Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
### Condition Browse Module - Browse Leaves
- ID: M12307
- Name: Neoplasm Metastasis
- Relevance: HIGH
- As Found: Secondary
- ID: M10012
- Name: Hyperparathyroidism
- Relevance: HIGH
- As Found: Hyperparathyroidism
- ID: M10013
- Name: Hyperparathyroidism, Secondary
- Relevance: HIGH
- As Found: Secondary Hyperparathyroidism
- ID: M12330
- Name: Neoplastic Processes
- Relevance: LOW
- As Found: Unknown
- ID: M13192
- Name: Parathyroid Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009362
- Term: Neoplasm Metastasis
- ID: D000006961
- Term: Hyperparathyroidism
- ID: D000006962
- Term: Hyperparathyroidism, Secondary
### Intervention Browse Module - Ancestors
- ID: D000077264
- Term: Calcium-Regulating Hormones and Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000057966
- Term: Calcimimetic Agents
- ID: D000006727
- Term: Hormone Antagonists
- ID: D000006730
- Term: Hormones, Hormone Substitutes, and Hormone Antagonists
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: BDCA
- Name: Bone Density Conservation Agents
### Intervention Browse Module - Browse Leaves
- ID: M418
- Name: Cinacalcet
- Relevance: HIGH
- As Found: Degarelix
- ID: M9789
- Name: Hormones
- Relevance: LOW
- As Found: Unknown
- ID: M5381
- Name: Calcium
- Relevance: LOW
- As Found: Unknown
- ID: M5398
- Name: Calcium, Dietary
- Relevance: LOW
- As Found: Unknown
- ID: M9788
- Name: Hormone Antagonists
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000069449
- Term: Cinacalcet
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434948
**Brief Title:** The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery
**Official Title:** The Effect of Omega 3 Supplementation on Postoperative Delirium in Elderly Patients Undergoing Major Cardiac Surgery: a Prospective, Randomized, Controlled Trial
#### Organization Study ID Info
**ID:** 2099184
#### Organization
**Class:** OTHER
**Full Name:** University of Missouri-Columbia
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Missouri-Columbia
#### Responsible Party
**Investigator Affiliation:** University of Missouri-Columbia
**Investigator Full Name:** Quinn Johnson
**Investigator Title:** Department Chair of Anesthesiology and Perioperative Medicine
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of this study is to determine whether giving omega-3 fatty acids prior to and after cardiac bypass surgeries decreases the incidence of postoperative delirium in patients aged 65 and over.
**Detailed Description:** Patients aged 65 years and over requiring elective cardiac bypass surgeries will receive either 0, 2, or 4 grams of omega-3 ethyl esters before their surgery and for 3 days postoperatively to determine whether there is an affect on the incidence of postoperative delirium. All patients will receive hospital standard of care therapy for their surgery and hospital stay.
### Conditions Module
**Conditions:**
- Postoperative Delirium
**Keywords:**
- postoperative delirium
- delirium
- fish oil
- omega 3
- Lovaza
- cardiac bypass
- omega 3 ethyl esters
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Arm 1: 4 grams of Omega-3 Ethyl Esters Arm 2: 2 grams of Omega-3 Ethyl Esters Arm 3: Standard of care
##### Masking Info
**Masking:** NONE
**Masking Description:** This study will not be blinded as there is no suitable placebo for omega-3 ethyl esters available at this time.
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will be given 4 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively.
**Intervention Names:**
- Drug: Omega-3 Ethyl Esters 4 g
**Label:** Omega-3 Ethyl Esters 4 g
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Patients will be given 2 grams of omega-3 ethyl esters orally before surgery and for 3 days postoperatively.
**Intervention Names:**
- Drug: Omega-3 Ethyl Esters 2 g
**Label:** Omega-3 Ethyl Esters 2 g
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Patients will not receive any study drug.
**Label:** Standard of Care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Omega-3 Ethyl Esters 4 g
**Description:** 4 grams = 4 capsules, once daily
**Name:** Omega-3 Ethyl Esters 4 g
**Other Names:**
- Omega-3 ethyl esters
- Lovaza
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Omega-3 Ethyl Esters 2 g
**Description:** 2 grams = 2 capsules, once daily
**Name:** Omega-3 Ethyl Esters 2 g
**Other Names:**
- Lovaza
- Omega-3 ethyl esters
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Number of patients that experienced postoperative delirium during the study.
**Measure:** Presence of Postoperative Delirium
**Time Frame:** From the date of surgery until the patient is discharged, up to 30 days.
#### Secondary Outcomes
**Description:** Concentrations of cytokines in blood collected before patient is put on cardiac bypass, immediately after bypass, and 1, 2, and 3 days postoperative.
**Measure:** Cytokine Concentrations
**Time Frame:** 0, 1, 2, 3 days postoperatively
**Description:** Concentrations of polyunsaturated fatty acids in blood collected before patient is put on cardiac bypass, immediately after bypass, and 1, 2, and 3 days postoperative.
**Measure:** Polyunsaturated Fatty Acid Concentrations
**Time Frame:** 0, 1, 2, 3 days postoperatively
**Description:** Presence of any postoperative delirium symptoms during patient's hospital stay.
**Measure:** Postoperative Delirium Symptoms
**Time Frame:** From the date of surgery until the patient is discharged, up to 30 days.
**Description:** Number of days patient stayed in hospital from the time of admission to discharge.
**Measure:** Length of Stay
**Time Frame:** From the date of surgery until the patient is discharged, up to 30 days.
**Description:** Number of patients administered anesthesia using mainly propofol or sevoflurane.
**Measure:** Type of Anesthesia Used
**Time Frame:** Day of surgery
**Description:** Average morphine milligram equivalents given to patients postoperatively until their discharge from the hospital.
**Measure:** Amount of Pain Medication Given Postoperatively
**Time Frame:** From the date of surgery until the patient is discharged, up to 30 days.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 65 years
* American Society of Anesthesiologists (ASA) Class Physical Status I-IV
Exclusion Criteria:
* Inability to obtain written informed consent.
* Inability to take study drug due to intubation or other reason.
* Delirium present at screening.
* Known hypersensitivity (e.g. anaphylactic reaction) to omega-3 ethyl esters or any of its components
* Allergy to fish or shellfish
* Currently taking warfarin (Coumadin), apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa/Lixiana), rivaroxaban (Xarelto), or other anticoagulant drugs.
* Currently taking omega-3, omega-6, vitamin E, or fish oil supplements.
* Significant renal disease with a serum creatinine ≥ 2 mg/dL.
* Significant liver disease with alanine aminotransferase (ALT) levels 1.5 times the normal range of 6-45 units/liter and aspartate transferase (AST) levels 1.5 times the normal range of 10-42 units/liter.
* History or diagnosis of diabetes.
* History or diagnosis of neurodegenerative disease such as Parkinson's, Alzheimer's, or dementia.
* History or diagnosis of bleeding disorder.
* History or diagnosis of metabolic syndrome or disorder.
* History or diagnosis of thyroid problems such as hyperthyroidism or hypothyroidism.
**Minimum Age:** 65 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Antoinette Burger, PhD
**Phone:** 5738843740
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Paige Spencer, BS
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Missouri-Columbia
**Name:** Quinn Johnson, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003221
- Term: Confusion
- ID: D000019954
- Term: Neurobehavioral Manifestations
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M6894
- Name: Delirium
- Relevance: HIGH
- As Found: Delirium
- ID: M772
- Name: Emergence Delirium
- Relevance: HIGH
- As Found: Postoperative Delirium
- ID: M6446
- Name: Confusion
- Relevance: LOW
- As Found: Unknown
- ID: M21826
- Name: Neurobehavioral Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003693
- Term: Delirium
- ID: D000071257
- Term: Emergence Delirium
### Intervention Browse Module - Browse Branches
- Abbrev: Ot
- Name: Other Dietary Supplements
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T415
- Name: Omega 3 Fatty Acid
- Relevance: HIGH
- As Found: Unacceptable
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434935
**Acronym:** VCAB-1
**Brief Title:** Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit
**Official Title:** Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit
#### Organization Study ID Info
**ID:** CIP-003
#### Organization
**Class:** INDUSTRY
**Full Name:** Vascudyne, Inc.
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2025-07-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-11-07
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Vascudyne, Inc.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The Vascudyne Coronary Artery Bypass Study (VCAB-1) is an initial safety and feasibility study of the Vascudyne, Inc. Coronary Artery Bypass Conduit (CAB A) for bypass of stenosed native coronary arteries in patients undergoing coronary artery bypass surgery.
**Detailed Description:** Prospective, non-randomized, initial evaluation clinical study to assess the feasibility of TRUE CAB for secondary coronary targets in patients needing multiple coronary artery bypass.
Patients will be implanted with a single TRUE CAB bypass (single proximal and distal anastomoses) to the second or third CA bypass target.
The primary target CA shall be bypassed using an arterial graft. The left anterior descending (LAD) CA bypass, if needed, shall be bypassed using the left internal mammary artery (LIMA). A saphenous vein shall be used for any additional targets as needed.
Estimated enrollment for first three patients (2 weeks), followed by enrollment over 4 months. Follow up through 24 months.
### Conditions Module
**Conditions:**
- Coronary Artery Disease
**Keywords:**
- CABG
- Coronary bypass
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients will be implanted with a single TRUE CAB bypass (single proximal and distal anastomoses) to the second or third CA bypass target
**Intervention Names:**
- Combination Product: CABA
**Label:** True CABA
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- True CABA
**Description:** Coronary Bypass
**Name:** CABA
**Type:** COMBINATION_PRODUCT
### Outcomes Module
#### Primary Outcomes
**Description:** Intervention-free angiographic patency \[failure defined as \>50% stenosis or occlusion\].
**Measure:** Patency
**Time Frame:** 6 months
**Description:** Major Adverse Cardiac and Cerebrovascular events (MACCE)
**Measure:** MACE
**Time Frame:** 30 days
#### Secondary Outcomes
**Description:** Intervention-free angiographic patency \[failure defined as \>50% stenosis or occlusion\].
**Measure:** Patency
**Time Frame:** 30 days
**Description:** Intervention-free angiographic patency \[failure defined as \>50% stenosis or occlusion\].
**Measure:** Patency
**Time Frame:** 12 months
**Description:** Intervention-free angiographic patency \[failure defined as \>50% stenosis or occlusion\].
**Measure:** Patency
**Time Frame:** 18 months
**Description:** Fitzgibbon classification
**Measure:** Fitzgibbon classification
**Time Frame:** 30 days, 6 months and 12 months
**Description:** Freedom from MACCE
**Measure:** MACCE
**Time Frame:** 6, 12, 18 and 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients needing isolated coronary artery bypass grafting to multiple coronary arteries (CA) in which the first target CA must be an arterial bypass and the TRUE CAB target CA must be at least 2mm in diameter, have at least 75% stenosis (\>90% ideal) proximal to the bypass, have at least TIMI II flow (in non-100% stenosis), shall be among the following options: proximal right coronary artery (RCA), Ramus intermedius, left marginal arteries (M1, M2), or diagonal branches (D1, D2). In case of diagonal selection, ensure it will not impact LIMA patency.
2. Male or female patients between the ages of 45 and 75 years inclusive.
3. Elective patient, selected and accepted by the local Heart Team and confirmed by the Sponsor's Screening Committee for an on-pump full sternotomy CABG surgery.
4. Life expectancy of at least 4 years.
5. Female subjects must be of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening).
6. Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
7. Patient has been informed and agrees to pre- and post-procedure follow-up, including follow-up cardiac ultrasound and coronary angiogram or CT.
8. Patient is willing to be compliant with prescribed anticoagulant therapy (critical to preventing thrombus in the investigational device).
Exclusion Criteria:
1. Patients with left ventricular ejection fraction \< 35%.
2. Patients with diffusive coronary artery disease.
3. Patients requiring emergency surgery.
4. Patients with cardiogenic shock.
5. Patients undergoing repeat CABG.
6. Previous, concomitant, and/or planned cardiac procedure including:
1. heart valve surgery
2. Percutaneous Coronary Intervention (PCI)
3. Ablation
4. Patent Foramen Ovale (PFO) repair
5. Dor or Maze procedure
7. History of cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation.
8. Myocardial infarction (MI) within 21 days or cerebral vascular accident (CVA) within 90 days of the CABG procedure.
9. Patients with Type 1 Diabetes and Patients with Type II Diabetes having A1C\>8.
10. Abnormal platelet level defined as Plt Count \>400,000.
11. Severe kidney disease, Glomerular Filtration Rate (GFR) \< 50mL/min, or active dialysis patients
12. Moderate to severe chronic obstructive pulmonary disease (COPD) with a forced expiratory volume (FEV) \<1.5 lit/sec or 45% predicted FEV1.
13. Patient with underlying interstitial lung disease. Can be assessed via imaging or test like DLCO
14. Endocarditis, pericarditis, or any other active systemic infection that would interfere with patient safety.
15. Patient on preoperative anticoagulant (i.e. Warfarin).
16. Abnormal blood values (e.g. leukopenia, anemia, or thrombocytopenia) that could influence graft hemostasis or patient recovery.
17. Known allergies to study device components: Nitinol, Nickel, Titanium, or agents/medication such as contrast agents, antiplatelet therapy, beta-blocker, or statins required for study assessment or optimal post-CABG medical treatment (hospital standard of care).
18. Known need for emergency surgery for any reason and/or intervention/surgery prior to and within 12 months after the CABG surgery that requires antiplatelet therapy discontinuation.
19. History of heparin-induced thrombocytopenia.
20. Contraindication to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet and factor Xa inhibitor therapy.
21. Immunodeficiency including AIDS / HIV, active autoimmune disease, or on immunosuppressant therapy.
22. Treatment with any investigational drug or device within 60 days prior to study entry or ongoing participation in another clinical study of an investigational product.
23. Subject has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance.
24. Has any other condition, in the opinion of the principal investigator, which would put the patient at increased risk from participating in the study or otherwise prevent participation.
**Maximum Age:** 75 Years
**Minimum Age:** 45 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Asunción
**Country:** Paraguay
**Facility:** Sanatario Italiano
#### Overall Officials
**Official 1:**
**Affiliation:** Italian Hospital Asuncion Paraguay
**Name:** Adrian Ebner, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003327
- Term: Coronary Disease
- ID: D000017202
- Term: Myocardial Ischemia
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
- ID: D000014652
- Term: Vascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M6546
- Name: Coronary Artery Disease
- Relevance: HIGH
- As Found: Coronary Artery Disease
- ID: M19506
- Name: Myocardial Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M6549
- Name: Coronary Disease
- Relevance: LOW
- As Found: Unknown
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4469
- Name: Arteriosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003324
- Term: Coronary Artery Disease
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434922
**Brief Title:** Prevention and Early Detection of Ulcer Recurrence in Patients With Type II Diabetes Mellitus
**Official Title:** A Randomized Clinical Trial Study on the Prevention Strategy and Early Detection of Ulcer Recurrence in Patients With Type II Diabetes Mellitus Using the Risk of Recurrence Ulcer Tool
#### Organization Study ID Info
**ID:** ID01
#### Organization
**Class:** OTHER
**Full Name:** Institute Technology and Health Muhammadiyah West Kalimantan
### Status Module
#### Completion Date
**Date:** 2023-06-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-06-30
**Type:** ACTUAL
#### Start Date
**Date:** 2023-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Institute Technology and Health Muhammadiyah West Kalimantan
#### Responsible Party
**Investigator Affiliation:** Institute Technology and Health Muhammadiyah West Kalimantan
**Investigator Full Name:** Haryanto Haryanto
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this clinical trial is to to evaluate the effectiveness of prevention strategies of recurrence in DFU's. It will also to detect the risk level of recurrence. The main question it aims to answer are:
* Does intervention of prevention strategies effective to prevent the recurrence of DFU's?
* How the risk level of the recurrence on DFU's patients?
* How the impact of quality of life on DFU's patients?
Researchers will compare intervention groups (receiving education covered various aspects, including they received guidance on foot examination, foot care, dietary habits, physical exercise, and stress management), and control groups (received standards follow-up care provided by healthcare providers, including pamphlets outlining care for DM patients based on the five pillars, including DM management, medication adherence, dietary practices, physical exercise routines, and foot care).
Participants will:
* For intervention group will be educated every month
* Data for both intervention and control groups were collected monthly until three months.
**Detailed Description:** 1. Introduction
A recurrence of a diabetic foot ulcer refers to the emergence of a new foot ulcer in individuals with a prior history of foot ulceration, irrespective of the specific location or duration since the occurrence of the previous ulcer. Even after the resolution of a foot ulcer, recurrence remains a common problem. In Indonesia, studies have indicated a recurrence rate of diabetic foot ulcers ranging from 13.30% to 35%, while global recurrence rates vary significantly among different countries. Thus, implementing prevention strategies is crucial in averting recurrence. These strategies, such as proper foot care, glycemic control, and early detection and management of risk factors, can significantly reduce the occurrence and recurrence of diabetic foot ulcers.
Several studies have highlighted various preventive treatments aimed at decreasing the likelihood of diabetic foot ulcer recurrence. These treatments include integrated foot care, self-management techniques, patient education, therapeutic footwear utilization, and surgical intervention. Recent research has also explored the potential of thermography in detecting foot ulcer risk among patients with diabetes mellitus. While numerous original studies and systematic reviews have reported prevention strategies for preventing diabetic foot recurrence, there is limited research on the combined approach of early detection and prevention of foot ulcer recurrence.
In Indonesia, preventive strategies for diabetes mellitus patients have been implemented through the PROLANIS program, a chronic disease management initiative launched in 2010 in community health centers. PROLANIS focuses on diabetes self-management and follows the five-pillar method established by the Indonesian Society of Endocrinology (PERKENI), encompassing dietary practices, physical activity, pharmaceutical interventions, glucose monitoring, and educational initiatives. Despite the nationwide adoption of these pillars since 2011, the prevalence of recurrence remains significant in Indonesia. Prevention strategies, carried out by healthcare provider teams, including nursing staff, are vital in addressing this challenge. Nurses are involved in physical assessment, early detection, foot care, and education, making their role crucial in implementing prevention strategies.
Early detection is integral to preventing ulcer recurrence. A systematic review identified three main types of interventions used in early ulcer recurrence detection: conventional physical assessment, 3D thermal camera assessment systems, and diabetic foot screening instruments. Hence, further development of early detection methods for recurrence risk is necessary.
The study utilized a multifaceted approach incorporating four techniques to reduce the risk of ulcer recurrence in patients with DM. These strategies included:1) conducting a thorough physical examination and assessing the foot, which involved utilizing a thermograph to identify variations in skin temperature; 2) implementing appropriate foot care practices; 3) providing patients with educational resources and guidance; and 4) promptly identifying and addressing factors that may increase the likelihood of ulcer recurrence.
1.1. Objective The primary objective of this study is to assess the efficacy of preventive measures while ascertaining the degree of risk associated with potential recurrences using the risk of recurrence ulcer tool. Additionally, an assessment was conducted to evaluate the impact on the quality of life.
2. Methods and Materials 2.1. Study Design and Participants This study is prospective clinical trial design to evaluate the effectiveness of prevention strategies utilizing an early detection tool for ulcer recurrence. The study had approved by the ethics committee of the Institute of Technology and Health Muhamamdiyah West Kalimantan. Conducted between January and July 2023 at two community health centers in Pontianak and Kubu Raya, West Kalimantan, Indonesia, the study followed the Consolidated Standards of Reporting Trials (CONSORT); randomized controlled trial (RCT) guidelines principles. Sixty participants were recruited using simple random allocation sampling, with 30 individuals assigned to each group based on calculated sample size requirements. G Power software was utilized to determine sample size, considering a significance level (α) of 0.05, power (β) of 0.95, proportion (p1) of 0.12 in group 1, and proportion (p2) of 0.54 in group 2. Inclusion criteria included the ability to perform everyday tasks, cooperation, and ulcer recovery for at least two weeks, while exclusion criteria comprised serious illnesses or sequelae, active foot ulcers, Charcot neuro-osteoarthropathy, persistent limb-threatening ischemia, and foot infections.
Participants who had received care at the community health centers and had recovered from their wounds constituted the intervention and control groups. Recruitment involved searching medical records and contacting eligible individuals. Written informed consent was obtained before enrollment. The 60 participants were divided into intervention and control groups. Both groups were encouraged to visit the community health centers, with researchers conducting home visits if necessary. The intervention group received the study's treatment, while the control group received standard follow-up care provided by healthcare providers, including pamphlets outlining care for DM patients based on the five pillars, including ulcer prevention.
2.2. Data Collection In this investigation, four research assistants underwent training following the study protocol to conduct examinations on diabetic feet, which included utilizing tools such as the thermograph, monofilament test, vascular Doppler ultrasound, conventional foot plantar scan, and diabetic foot and nail care. Additionally, they were trained in collecting demographic data, assessing diabetic wounds, and educating patients. Patient education covered various aspects, including regular monitoring of blood glucose levels, effective dietary management, consistent physical activity, routine foot inspections, adherence to prescribed medications, and appropriate footwear selection based on plantar foot pressure measurements. Following plantar foot pressure measurement, patients were educated on maintaining regular blood sugar control, dietary management, exercise routines, foot inspection practices, medication adherence, and proper footwear selection.
During the intervention procedure, data collection sessions lasted approximately 1 to 1.50 hours, with education and foot care provided once a month. Subsequently, patients underwent monthly follow-ups for three months, during which they received guidance on foot examination, foot care, dietary habits, physical exercise, and stress management.
For the control group, a comprehensive foot examination was conducted at the initial assessment to evaluate the overall foot health of participants. Patients in the control group were educated about DM management, medication adherence, dietary practices, physical exercise routines, and foot care through pamphlets. Data for both intervention and control groups were collected monthly through examinations and inspections, each conducted by two nurses who had completed preventive foot care training.
Throughout the study, data collection included vascular Doppler ultrasonography (BT-200 V, 8 MHz; Bistos Co., Ltd., Seongna, Korea) for assessing the ankle-brachial index (ABI) and the monofilament test using a 10-g (5.7) Semmes-Weinstein monofilament to evaluate neuropathic status. Additionally, plantar pressure distribution data were collected using a foot printer (Bauerfeind AG, Thuringia, Germany) and a callus removal device. Clinical examinations were conducted to assess structural and functional foot deformities, including claw/hammer toe, hallux rigidus, hallux valgus, bony prominences, pes cavus, pes planus, and metatarsal head abnormalities.
The risk level recurrence ulcer tool, INDIFURUTO (Indonesian Diabetic Foot Ulcer Recurrence Assessment Tool), was utilized to assess the risk level. INDIFURUTO considers factors such as history of amputation, smoking, serum glucose levels, ankle-brachial index, monofilament test results, and differences in foot skin temperature. Skin temperature measurements were obtained using smartphone-based thermography (FLIR ONE Gen 3, Teledyne FLIR LLC, Wilsonville, OR, USA). Subjects were categorized as high risk if they scored less than or equal to 22 points, medium risk if they scored between 23 and 45, and low risk if they scored more than or equal to 46. Previous studies have demonstrated high sensitivity (100%) and specificity (90%) of this tool. INDIFURUTO assessments were conducted at baseline, and at the second and third follow-up assessments for both groups.
The European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) version was utilized to evaluate participants' quality of life, a measure that has demonstrated reliability with a Cronbach's alpha coefficient of 0.79. Quality of life assessments were conducted at baseline, as well as at the second and third follow-up assessments for both intervention and control groups. Participants self-assessed their level of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression, with responses ranging from level 1 (indicating the best state) to level 3 (indicating the worst state). Additionally, participants reported their current health status using a visual analog scale (EQ-VAS) that ranged from 0 (indicating the lowest health status) to 100 (indicating the highest health status) points.
Demographic data were also collected, including information on gender, age, BMI, duration of diabetes mellitus (DM), fasting blood sugar value, ethnicity, occupation status, education level, religion, smoking status, type of diabetes, diabetes treatment, presence of DM complications, foot deformities, history of previous amputation, and time elapsed since the last ulcer healed.
2.3. Data Analysis All data were analyzed using SPSS software (version 26.0; IBM Corp., Armonk, NY, USA). The demographic variables were assessed using descriptive statistics (means, standard deviation, frequencies). A mixed model for repeated measures analysis was used to test the differences in quality of life and high-risk level on baseline and the third follow-ups between the two groups. p \< 0.05 was chosen as the level of significance
### Conditions Module
**Conditions:**
- Recurrence
- Diabetic Foot
- Thermography
- Quality of Life
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Intervention group: patient education covered various aspects, including regular monitoring of blood glucose levels, effective dietary management, consistent physical activity, routine foot inspections, adherence to prescribed medications, and appropriate footwear selection based on plantar foot pressure measurements.
During the intervention procedure, data collection sessions lasted approximately 1 to 1.50 hours, with education and foot care provided once a month. Subsequently, patients underwent monthly follow-ups for three months, during which they received guidance on foot examination, foot care, dietary habits, physical exercise, and stress management.
Control group: Patients were educated about DM management, medication adherence, dietary practices, physical exercise routines, and foot care through pamphlets.
##### Masking Info
**Masking:** NONE
**Masking Description:** The investigators known the groups.
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 60
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Groups received the prevention strategies to prevent the recurrence of DFU's
**Intervention Names:**
- Device: Prevention Strategies
**Label:** Prevention Strategies
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Groups received the standard strategies to prevent the recurrence of DFU's
**Intervention Names:**
- Device: Standard Strategiies
**Label:** Standard Strategies
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Prevention Strategies
**Description:** Data collection sessions lasted approximately 1 to 1.50 hours, with education and foot care provided once a month. Subsequently, patients underwent monthly follow-ups for three months, during which they received guidance on foot examination, foot care, dietary habits, physical exercise, and stress management.
**Name:** Prevention Strategies
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Standard Strategies
**Description:** Group were educated about DM management, medication adherence, dietary practices, physical exercise routines, and foot care through pamphlets
**Name:** Standard Strategiies
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The risk level recurrence ulcer tool, INDIFURUTO (Indonesian Diabetic Foot Ulcer Recurrence Assessment Tool), was used to assess the risk level. Subjects were categorized as high risk if they scored less than or equal to 22 points, medium risk if they scored between 23 and 45, and low risk if they scored more than or equal to 46.
**Measure:** The degree of risk of recurrence
**Time Frame:** up to three months
**Description:** Prevention stratagies is evaluated using INDIFURUTO tool (history of amputation, smoking, serum glucose levels, ankle-brachial index, monofilament test results, and differences in foot skin temperature). Good=INDIFURUTO total score increase than baseline and Poor=INDIFURUTO total score decrease than baseline
**Measure:** Efficacy of prevention strategies
**Time Frame:** up to three months
#### Secondary Outcomes
**Description:** The European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) version was used to evaluate participants' quality of life. Level 1 (indicating the best state) to Level 3 (indicating the worst state).
**Measure:** Quality of life of DFU's
**Time Frame:** up to three months
**Description:** Health status using a visual analog scale (EQ-VAS) that ranged from 0 (indicating the lowest health status) to 100 (indicating the highest health status).
**Measure:** Health status of DFU's
**Time Frame:** up to three months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Participants have a history of diabetic foot ulcers.
* signed an informed consent
Exclusion Criteria:
* Declined to participate
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Pontianak
**Country:** Indonesia
**Facility:** Haryanto Haryanto
**State:** Kalimantan Barat
**Zip:** 78164
#### Overall Officials
**Official 1:**
**Affiliation:** ITEKES Muhammadiyah Kalimantan Barat
**Name:** Haryanto Haryanto
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000003925
- Term: Diabetic Angiopathies
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000016523
- Term: Foot Ulcer
- ID: D000007871
- Term: Leg Ulcer
- ID: D000012883
- Term: Skin Ulcer
- ID: D000012871
- Term: Skin Diseases
- ID: D000048909
- Term: Diabetes Complications
- ID: D000003929
- Term: Diabetic Neuropathies
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrence
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes Mellitus
- ID: M7119
- Name: Diabetes Mellitus, Type 2
- Relevance: HIGH
- As Found: Type II Diabetes Mellitus
- ID: M19933
- Name: Diabetic Foot
- Relevance: HIGH
- As Found: Diabetic Foot
- ID: M17206
- Name: Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M7120
- Name: Diabetic Angiopathies
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M18919
- Name: Foot Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M10883
- Name: Leg Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15686
- Name: Skin Ulcer
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M26004
- Name: Diabetes Complications
- Relevance: LOW
- As Found: Unknown
- ID: M7124
- Name: Diabetic Neuropathies
- Relevance: LOW
- As Found: Unknown
- ID: T6034
- Name: Quality of Life
- Relevance: HIGH
- As Found: Quality of Life
### Condition Browse Module - Meshes
- ID: D000017719
- Term: Diabetic Foot
- ID: D000003920
- Term: Diabetes Mellitus
- ID: D000003924
- Term: Diabetes Mellitus, Type 2
- ID: D000012008
- Term: Recurrence
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434909
**Brief Title:** CYTALUX™for the Intraoperative Imaging of Prostate Cancer
**Official Title:** An Investigator Sponsored Study to Investigate the Safety and Efficacy of CYTALUX™ (PAFOLACIANINE) INJECTION for the Intraoperative Imaging of Prostate Cancer
#### Organization Study ID Info
**ID:** IUSCCC-0890
#### Organization
**Class:** OTHER
**Full Name:** Indiana University
### Status Module
#### Completion Date
**Date:** 2025-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** On Target Laboratories
#### Lead Sponsor
**Class:** OTHER
**Name:** Clinton Bahler
#### Responsible Party
**Investigator Affiliation:** Indiana University
**Investigator Full Name:** Clinton Bahler
**Investigator Title:** Principal investigator
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** True
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** This study is being done to compare how much using Cytalux™ (pafolacianine) with NIR (Near InfraRed) fluorescent imaging improves the detection of malignant (growing in an uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node dissection for biopsy confirmed prostate cancer.
The U.S. Food and Drug Administration (FDA) has approved the targeted imaging agent pafolacianine (Cytalux) for use in ovarian cancer (2021) and lung cancer surgery (2022.)
**Detailed Description:** This is an open label trial in up to 15 subjects with biopsy confirmed prostate cancer (PCa) who have been scheduled to undergo a laparoscopic radical prostatectomy with or without robotic assistance, with pelvic lymph node dissection. This is a non-intervention trial to assess the accuracy of an imaging agent, folate targeted fluorescent dye (pafolacianine), during a standard of care radical prostatectomy.
Qualifying subjects will be Grade Group 3 to 5 (\>/= cT3) with either suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and/or seminal vesicle infiltration (SVI)), or suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission tomography (PSMA PET+).
Whether using an anterior or a posterior approach, the tissues planned for removal will be visualized first under normal light, and their locations marked on a provided template. All additional suspicious tissue or nodes will be similarly marked, whether removed or not. Prior to removal, the field must be illuminated with Near Infrared light (NIR) and fluorescent tissues must be marked on the template. This may proceed in an iterative fashion, switching from first normal light to NIR as the surgical field expands.
NIR imaging must be conducted in the timeframe of one hour to twenty-four hours following IV infusion of pafolacianine. Lymphatics to be examined are, at a minimum, the external iliac, internal iliac and obturator fossa, and common iliac. Fluorescence positive nodules and nodes will be removed at the surgeon's discretion and sent as labeled (specimen number, tissue, location) specimens to pathology without designation of florescence. Ink dots should ideally be applied to the spot suspected of being cancerous.
### Conditions Module
**Conditions:**
- Prostate Cancer
**Keywords:**
- fluorescent
- image guided intervention
- folate
- prostate cancer
- laparoscopic prostatectomy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 15
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients with risk of EPE and having robotic prostatectomy for prostate cancer.
**Intervention Names:**
- Diagnostic Test: Cytalux™ (pafolacianine) for fluorescent imaging
**Label:** Fluorescent guided surgery
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Fluorescent guided surgery
**Description:** Cytalux™ (pafolacianine) injection: folate analog ligand conjugated with an indole cyanine green-like dye for real-time cancer margin status.
This is used in conjunction with appropriate imaging system.
**Name:** Cytalux™ (pafolacianine) for fluorescent imaging
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The proportion of subjects who have a Clinically Significant Event (CSE). A CSE is a composite endpoint defined as at least one of the following outcomes:
1. One or more resected "NIR only" positive lymph nodes that contain metastatic disease as confirmed by pathology.
2. Histologically confirmed cancer in resected "NIR only" residual non-nodal soft tissue following prostatectomy.
**Measure:** Detection of residual cancer
**Time Frame:** Day of surgery (visit 2)
#### Secondary Outcomes
**Description:** To evaluate the proportion of subjects whose surgical procedure changed in scope from the planned surgery based on the use of
**Measure:** Treatment change
**Time Frame:** Day of surgery (visit 2)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Signed and dated informed consent form
2. Male subjects 18 years of age and older
3. Known primary prostate cancer
4. Grade Group 3 to 5 with either:
1. suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and/or seminal vesicle infiltration (SVI)), or 3 or more biopsy cores of grade group 3-5;
2. suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission tomography (PSMA PET+));
3. or both.
5. Planned to undergo a laparoscopic prostatectomy with or without robotic assistance, and lymph node dissection
6. Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
7. Agree to stop folate or folic acid supplements at least 48 hours prior to injection of study agent
Exclusion Criteria:
1. The surgeon plans to perform an extraperitoneal approach
2. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
3. History of anaphylactic reactions to products containing indocyanine green
4. History of allergy to any of the components of PAFOLACIANINE
**Maximum Age:** 90 Years
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jennifer Lehman, RN
**Phone:** 317-278-0340
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Carmel
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jennifer Lehman
- **Phone:** 317-278-0340
- **Role:** CONTACT
***Contact 2:***
- **Name:** Clinton Bahler, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** IU Health Joe and Shelly Schwarz Cancer Center
**State:** Indiana
**Zip:** 46032
**Location 2:**
**City:** Indianapolis
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jennifer Lehman
- **Phone:** 317-278-0340
- **Role:** CONTACT
***Contact 2:***
- **Name:** Clinton Bahler, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center
**State:** Indiana
**Zip:** 46202
**Location 3:**
**City:** Indianapolis
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jennifer Lehman
- **Phone:** 317-278-0340
- **Role:** CONTACT
***Contact 2:***
- **Name:** Clinton Bahler, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Indiana University Health Methodist Hospital
**State:** Indiana
**Zip:** 46202
#### Overall Officials
**Official 1:**
**Affiliation:** Indiana University
**Name:** Clinton Bahler, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005834
- Term: Genital Neoplasms, Male
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000011469
- Term: Prostatic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: Micro
- Name: Micronutrients
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: Vi
- Name: Vitamins
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M17546
- Name: Vitamin B Complex
- Relevance: LOW
- As Found: Unknown
- ID: M8618
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M8619
- Name: Folic Acid Antagonists
- Relevance: LOW
- As Found: Unknown
- ID: T447
- Name: Folinic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T446
- Name: Folic Acid
- Relevance: LOW
- As Found: Unknown
- ID: T448
- Name: Folate
- Relevance: LOW
- As Found: Unknown
- ID: T475
- Name: Vitamin B9
- Relevance: LOW
- As Found: Unknown
- ID: T399
- Name: Indole
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434896
**Acronym:** CrEATE
**Brief Title:** Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
**Official Title:** Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial
#### Organization Study ID Info
**ID:** NL71881.041.19
#### Organization
**Class:** OTHER
**Full Name:** UMC Utrecht
### Status Module
#### Completion Date
**Date:** 2035-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2035-03
**Type:** ESTIMATED
#### Start Date
**Date:** 2020-03-05
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Personal Genome Diagnostics (PGDx)
**Class:** OTHER
**Name:** The Netherlands Cancer Institute
#### Lead Sponsor
**Class:** OTHER
**Name:** UMC Utrecht
#### Responsible Party
**Investigator Affiliation:** UMC Utrecht
**Investigator Full Name:** Miriam Koopman
**Investigator Title:** Prof. dr.
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design).
Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.
### Conditions Module
**Conditions:**
- Circulating Tumor DNA
- Recurrence
- Colon Cancer Stage II
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized controlled trial
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 1320
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. Results are reported to the treating physician and patients. All patients with detectable ctDNA are considered high risk stage 2 patients and will be offered adjuvant chemotherapy for 3 months (4 cycles CAPOX) according to routine clinical practice. Patients with undetectable ctDNA will receive routine follow-up at the surgical department.
**Intervention Names:**
- Other: ctDNA analysis after surgery
**Label:** ctDNA-based treatment group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The treating physician and patient are not informed about the ctDNA result and these patients will receive routine follow-up at the surgical department.
**Label:** Standard of care group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ctDNA-based treatment group
**Description:** ctDNA analysis of post-surgery blood samples will be performed directly after informed consent for MEDOCC-CrEATE.
**Name:** ctDNA analysis after surgery
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Proportion of patients starting with adjuvant chemotherapy after detection of ctDNA in their blood.
**Time Frame:** 8-12 weeks after surgery
#### Secondary Outcomes
**Description:** Proportion of patients that will experience disease recurrence
**Measure:** Recurrence Rate
**Time Frame:** 2 and 5 years after surgery
**Description:** Proportion of patients that are alive and free of disease
**Measure:** Disease Free Survival rate
**Time Frame:** 2 and 5 years after surgery
**Description:** Proportion of patients that are alive
**Measure:** Disease-related Overall Survival rate
**Time Frame:** 5 years after surgery
**Measure:** Time to Recurrence
**Time Frame:** From date of randomization until the date of recurrence, assessed up to 5 years.
**Description:** Quality of Life will be measured using questionnaires that are provided to patients who have given informed consent for the collection of questionnaires within PLCRC.
**Measure:** Quality of Life after treatment
**Time Frame:** 10 years
**Measure:** Cost-effectiveness of the ctDNA-based treatment
**Time Frame:** 5 years after diagnosis
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Age ≥ 18 years
* Informed consent for PLCRC with specific consent for:
* additional blood withdrawals
* collection and use of tissue for scientific research
* invitation for future (experimental) research within the cohort, including TwiCs studies
* Inclusion in observational PLCRC -MEDOCC substudy
* Histological confirmed stage II colon cancer
* Fit enough to receive treatment with combination chemotherapy (fluoropyrimidine and oxaliplatin) according to the treating physician
Exclusion Criteria:
* Indication for adjuvant chemotherapy according to treating physician
* Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma
* Incomplete primary tumor resection (R1 or R2 resection)
* Contra-indication for fluoropyrimidines or oxaliplatin
* Pregnancy
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Miriam Koopman, Prof. dr.
**Phone:** +316 46 91 95 66
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** 's Hertogenbosch
**Contacts:**
***Contact 1:***
- **Name:** J.F.M. Pruijt
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Jeroen Bosch Ziekenhuis
**Status:** RECRUITING
**Location 2:**
**City:** Alkmaar
**Contacts:**
***Contact 1:***
- **Name:** M.P. Hendriks
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Noordwest Ziekenhuisgroep
**Status:** RECRUITING
**Location 3:**
**City:** Almelo
**Contacts:**
***Contact 1:***
- **Name:** R. Hoekstra
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Ziekenhuisgroep Twente
**Status:** RECRUITING
**Location 4:**
**City:** Almere
**Contacts:**
***Contact 1:***
- **Name:** J.D.W. van der Bilt
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Flevoziekenhuis
**Status:** RECRUITING
**Location 5:**
**City:** Amersfoort
**Contacts:**
***Contact 1:***
- **Name:** J.M. van Dodewaard
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Meander Medisch Centrum
**Status:** RECRUITING
**Location 6:**
**City:** Arnhem
**Contacts:**
***Contact 1:***
- **Name:** I. Werter
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Rijnstate
**Status:** RECRUITING
**Location 7:**
**City:** Breda
**Contacts:**
***Contact 1:***
- **Name:** M. Streppel
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Amphia Ziekenhuis
**Status:** RECRUITING
**Location 8:**
**City:** Delft
**Contacts:**
***Contact 1:***
- **Name:** A.J. Verschoor
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Reinier de Graaf Gasthuis
**Status:** RECRUITING
**Location 9:**
**City:** Den Haag
**Contacts:**
***Contact 1:***
- **Name:** F.J.F. Jeurissen
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Haaglanden MC
**Status:** RECRUITING
**Location 10:**
**City:** Deventer
**Contacts:**
***Contact 1:***
- **Name:** L.W. Kessels
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Deventer Ziekenhuis
**Status:** RECRUITING
**Location 11:**
**City:** Dordrecht
**Contacts:**
***Contact 1:***
- **Name:** M. Vidakovic
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Albert Schweizer Ziekenhuis
**Status:** RECRUITING
**Location 12:**
**City:** Ede
**Contacts:**
***Contact 1:***
- **Name:** M. Verstappen
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Ziekenhuis Gelderse Vallei
**Status:** RECRUITING
**Location 13:**
**City:** Goes
**Contacts:**
***Contact 1:***
- **Name:** H.K. van Halteren
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Admiraal de Ruyter Ziekenhuis
**Status:** RECRUITING
**Location 14:**
**City:** Gorinchem
**Contacts:**
***Contact 1:***
- **Name:** M.A. Davidis
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Rivas
**Status:** RECRUITING
**Location 15:**
**City:** Haarlem
**Contacts:**
***Contact 1:***
- **Name:** H.B.A.C. Stockmann
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Spaarne Gasthuis
**Status:** RECRUITING
**Location 16:**
**City:** Harderwijk
**Contacts:**
***Contact 1:***
- **Name:** A.P. Schouten van der Velden
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Ziekenhuis St. Jansdal
**Status:** RECRUITING
**Location 17:**
**City:** Maastricht
**Contacts:**
***Contact 1:***
- **Name:** L.B.J. Valkenburg
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Maastricht UMC
**Status:** RECRUITING
**Location 18:**
**City:** Middelharnis
**Contacts:**
***Contact 1:***
- **Name:** A.I. de Vos
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Van Weel-Bethesda Ziekenhuis
**Status:** RECRUITING
**Location 19:**
**City:** Nieuwegein
**Contacts:**
***Contact 1:***
- **Name:** M. Los
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** St. Antonius Ziekenhuis
**Status:** RECRUITING
**Location 20:**
**City:** Nijmegen
**Contacts:**
***Contact 1:***
- **Name:** J. Janssen
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Canisius Wilhelmina Ziekenhuis
**Status:** RECRUITING
**Location 21:**
**City:** Roosendaal
**Contacts:**
***Contact 1:***
- **Name:** S. Boudewijns
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Bravis Ziekenhuis
**Status:** RECRUITING
**Location 22:**
**City:** Rotterdam
**Contacts:**
***Contact 1:***
- **Name:** F.E. de Jongh
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Ikazia Ziekenhuis
**Status:** RECRUITING
**Location 23:**
**City:** Uden
**Contacts:**
***Contact 1:***
- **Name:** J. van Extel
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Bernhoven
**Status:** RECRUITING
**Location 24:**
**City:** Utrecht
**Contacts:**
***Contact 1:***
- **Name:** L. van Leeuwen
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Diakonessenhuis
**Status:** RECRUITING
**Location 25:**
**City:** Utrecht
**Contacts:**
***Contact 1:***
- **Name:** Miriam Koopman
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** UMC Utrecht
**Status:** RECRUITING
**Location 26:**
**City:** Veldhoven
**Contacts:**
***Contact 1:***
- **Name:** L.H.J Simkens
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** Maxima Medisch Centrum
**Status:** RECRUITING
**Location 27:**
**City:** Venlo
**Country:** Netherlands
**Facility:** VieCuri Medisch Centrum
**Status:** RECRUITING
**Location 28:**
**City:** Weert
**Contacts:**
***Contact 1:***
- **Name:** N.A.J.B. Peters
- **Role:** CONTACT
**Country:** Netherlands
**Facility:** St. Jans Gasthuis
**Status:** RECRUITING
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000015179
- Term: Colorectal Neoplasms
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrence
- ID: M6338
- Name: Colonic Neoplasms
- Relevance: HIGH
- As Found: Colon Cancer
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003110
- Term: Colonic Neoplasms
- ID: D000012008
- Term: Recurrence
### Intervention Browse Module - Browse Branches
- Abbrev: HB
- Name: Herbal and Botanical
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: T120
- Name: Cola
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434883
**Brief Title:** Assessment of an App-based Anxiety/Depression Program in a Population With Elevated Anxiety/Depression
**Official Title:** Assessment of an App-based Anxiety/Depression Program in a Population With Elevated Anxiety/Depression A Clinical Randomized Controlled Trial
#### Organization Study ID Info
**ID:** 434587
#### Organization
**Class:** OTHER
**Full Name:** University of Southern Denmark
### Status Module
#### Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-05
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-03-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Virginia Polytechnic Institute and State University
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Southern Denmark
#### Responsible Party
**Investigator Affiliation:** University of Southern Denmark
**Investigator Full Name:** Ulrich Kirk
**Investigator Title:** Associate Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Generalized anxiety disorder is a mental health disorder characterized by feelings of tension and worry with physical symptoms including increased blood pressure. Approximately 20% of US adults reported an anxiety disorder in the past year and an estimated 31% of US adults reported anxiety at some time in their lives. Anxiety can be experienced throughout one's life and levels of anxiety can increase with stressful life events, physical health conditions, and medication use. Chronic, untreated anxiety has been linked to headaches, dizziness, depression, high blood pressure, heart disease, digestive disorders, and a worsened immune system - greatly impacting one's overall quality of life (QOL).
Anxiety and depression are highly comorbid, with approximately 50-60% of those with anxiety symptoms also experiencing depression symptoms. Experiencing these disorders and symptoms comorbidly may further worsen one's mental health and overall QOL. Untreated, chronic depression can heighten symptoms of depression leading to increased risk of heart disease, sleep disruptions, weight gain/loss, a weakened immune system, physical pains, and suicide attempts.
Anxiety and depression are commonly treated using various psychotherapeutic techniques including cognitive behavioral therapy (CBT) and acceptance and commitment therapy techniques administered by a licensed therapist. However, therapy has many barriers to treatment including insurance not covering treatments, overall treatment cost, unsure where to seek treatment/no access to a therapist, and therapy being unavailable and inconvenient due to scheduling during the workday. As such, app-based mental health tools have increased in popularity to improve access and affordability to effective mental health treatments.
The purpose of the study is to examine the effectiveness of a guided anxiety/depression app-based program by Headspace, which uses CBT with mindfulness to improve anxiety and depression symptoms in a population with elevated baseline anxiety and/or depression. The study will employ a 2-arm app-based intervention involving 1 active intervention and a waitlist control for a duration of 3 weeks, followed by a 3-week follow-up assessment.
**Detailed Description:** Participants who meet the inclusion criteria will complete the informed consent procedure and the baseline assessment consisting of the study's primary outcomes of anxiety (GAD-7) and depression (PHQ-8) and the secondary outcome measures including sleep quality using the PSQI, perceived stress using the PSS-10, mindfulness using the MAAS, well-being using the WEMWBS, and report use of prescription medication. After the baseline assessment, participants will be randomized into one of two groups (Headspace Anxiety/Depression Program or waitlist control). Participants will participate in the intervention/waitlist control group for 3 weeks. Having completed the 3 week intervention, participants will complete the post-intervention assessment consisting of the primary and secondary outcome measures. Finally, participants will complete the follow-up assessment 3 weeks after post-intervention with a questionnaire to assess changes in routines (including physical activity, prescription medication use or treatments), and the primary and secondary outcome measures.
### Conditions Module
**Conditions:**
- Depression Anxiety Disorder
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 168
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: Anxiety/Depression Program
**Label:** Anxiety/Depression Program
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Intervention Names:**
- Other: Waitlist
**Label:** Waitlist
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Anxiety/Depression Program
**Description:** Participants will complete the Headspace Anxiety/Depression Program, which is a 21 day program based on CBT, combined with mindfulness. The program is trans-diagnostic in nature (i.e. addresses both anxiety and depression symptoms).
**Name:** Anxiety/Depression Program
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Waitlist
**Description:** Participants will continue their regular routines for an 21 day period and will not be assigned to an intervention.
**Name:** Waitlist
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The PHQ-8 is used to measure depression symptoms. The PHQ-8 consists of 8 items. Participants use a Likert scale ranging from 0 = not at all to 3 = nearly every day. The range of PHQ-8 scores is 0-24.
**Measure:** Patient Health Questionnaire-8 (PHQ8)
**Time Frame:** Change from baseline to immediately post-intervention and 3-week follow-up
**Description:** The GAD-7 is a 7-item self-report scale based on the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for generalized anxiety disorder, with items scored from 0 (not at all) to 3 (nearly every day).
**Measure:** General Anxiety Disorder-7 (GAD-7)
**Time Frame:** Change from baseline to immediately post-intervention and 3-week follow-up
#### Secondary Outcomes
**Description:** The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances. 19 individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Higher scores indicate worse sleep quality where poor sleep will be a PSQI total score of \> 5.
**Measure:** The Pittsburgh Sleep Quality Index (PSQI)
**Time Frame:** Change from baseline to immediately post-intervention and 3-week follow-up
**Description:** The PSS is a 10-item scale designed to measure the perception of stress within the past month. Participants use a Likert scale with responses ranging from 0 = never to 4 = very often. PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. Additionally, scores can be categorized as low (0-13), moderate (14-26), and high (27-40) perceived stress.
**Measure:** Perceived Stress Scale (PSS-10)
**Time Frame:** Change from baseline to immediately post-intervention and 3-week follow-up
**Description:** Mindfulness will be measured by the MAAS. The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness. Each of the 15 items aims at measuring one's awareness of what is taking place at the present. The MAAS is answered on a five-point Likert scale. Higher scores reflect higher dispositional mindfulness.
**Measure:** Mindful Attention Awareness Scale (MAAS)
**Time Frame:** Change from baseline to immediately post-intervention and 3-week follow-up
**Description:** WEMWBS is a 14 item scale of mental well-being covering subjective well-being and psychological functioning, in which all items are worded positively and address aspects of positive mental health. The scale is scored by summing responses to each item answered on a 1 to 5 Likert scale. The minimum scale score is 14 and the maximum is 70.
**Measure:** Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
**Time Frame:** Change from baseline to immediately post-intervention and 3-week follow-up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Symptoms of anxiety (defined as a score of 10 or greater on the GAD-7) and/or depression (defined as a score of 10 or greater on the PHQ-8).
* Prescription medication for anxiety, depressive symptoms provided a stable dose for ≥4 weeks before baseline or no medication.
* 18+ years old.
* Based in the U.S.
* Access to a smartphone device, as the intervention will be delivered via a smartphone application.
Exclusion Criteria:
* A diagnosis of any of the following conditions: self-reported schizophrenia, psychosis, bipolar disorder, seizure disorder, substance use disorder, recent trauma to the head or brain damage, severe cognitive impairment, serious physical health concerns necessitating surgery or with a prognosis of less than 6 months, or pregnancy.
* Not being on a stable dose of anxiety or depression medication for ≥4 weeks.
* Risks associated with suicidal ideation and risk of self-harm.
* Two or more hospitalizations within the past 6 months for psychiatric reasons.
* Completed CBT (or another "active" form of psychotherapy that includes self-monitoring and cognitive and/or behavioral exercises) delivered by a licensed therapist in the past 6 months.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ulrich Kirk, PhD
**Phone:** +4531328808
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Roanoke
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Ulrich Kirk, PhD
- **Role:** CONTACT
**Country:** United States
**Facility:** Fralin Biomedical Research Institute at VTC
**State:** Virginia
**Zip:** 24016
#### Overall Officials
**Official 1:**
**Affiliation:** University of Southern Denmark
**Name:** Ulrich Kirk, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Description:** Aggregated data collected in this project will be de-identified and made available on a shared secured data repository. Results from this project will be shared and disseminated, including manuscripts will be written and submitted for publication in peer-reviewed journals/conferences. All necessary ethical approvals will be obtained.
**IPD Sharing:** YES
**Time Frame:** Data will be made available upon request after dissemination of results.
### References Module
#### References
**Citation:** National Institute of Mental Health (2023). Any Anxiety Disorder. Retrieved April 25, 2023, from https://www.nimh.nih.gov/health/statistics/any-anxiety-disorder.
**Citation:** American Psychological Association (2022). Anxiety. Retrieved April 25, 2023, from https://www.apa.org/topics/anxiety.
**Citation:** Celano CM, Daunis DJ, Lokko HN, Campbell KA, Huffman JC. Anxiety Disorders and Cardiovascular Disease. Curr Psychiatry Rep. 2016 Nov;18(11):101. doi: 10.1007/s11920-016-0739-5.
**PMID:** 27671918
**Citation:** Lampl C, Thomas H, Tassorelli C, Katsarava Z, Lainez JM, Lanteri-Minet M, Rastenyte D, Ruiz de la Torre E, Stovner LJ, Andree C, Steiner TJ. Headache, depression and anxiety: associations in the Eurolight project. J Headache Pain. 2016;17:59. doi: 10.1186/s10194-016-0649-2. Epub 2016 Jun 1.
**PMID:** 27245683
**Citation:** Neuhauser HK. The epidemiology of dizziness and vertigo. Handb Clin Neurol. 2016;137:67-82. doi: 10.1016/B978-0-444-63437-5.00005-4.
**PMID:** 27638063
**Citation:** Leonard BE, Song C. Stress and the immune system in the etiology of anxiety and depression. Pharmacol Biochem Behav. 1996 May;54(1):299-303. doi: 10.1016/0091-3057(95)02158-2.
**PMID:** 8728571
**Citation:** Saha L. Irritable bowel syndrome: pathogenesis, diagnosis, treatment, and evidence-based medicine. World J Gastroenterol. 2014 Jun 14;20(22):6759-73. doi: 10.3748/wjg.v20.i22.6759.
**PMID:** 24944467
**Citation:** National Alliance on Mental Illness (2018). The Comorbidity of Anxiety and Depression. Retrieved April 25, 2023, from https://www.nami.org/blogs/nami-blog/january-2018/the-comorbidity-of-anxiety-and-depression.
**Citation:** Hirschfeld RM. The Comorbidity of Major Depression and Anxiety Disorders: Recognition and Management in Primary Care. Prim Care Companion J Clin Psychiatry. 2001 Dec;3(6):244-254. doi: 10.4088/pcc.v03n0609.
**PMID:** 15014592
**Citation:** Andrade LH, Alonso J, Mneimneh Z, Wells JE, Al-Hamzawi A, Borges G, Bromet E, Bruffaerts R, de Girolamo G, de Graaf R, Florescu S, Gureje O, Hinkov HR, Hu C, Huang Y, Hwang I, Jin R, Karam EG, Kovess-Masfety V, Levinson D, Matschinger H, O'Neill S, Posada-Villa J, Sagar R, Sampson NA, Sasu C, Stein DJ, Takeshima T, Viana MC, Xavier M, Kessler RC. Barriers to mental health treatment: results from the WHO World Mental Health surveys. Psychol Med. 2014 Apr;44(6):1303-17. doi: 10.1017/S0033291713001943. Epub 2013 Aug 9.
**PMID:** 23931656
**Citation:** Centers for Disease Control and Prevention (2018). Prevalence of Depression Among Adults Aged 20 and Over: United States, 2013-2016. Retrieved April 25, 2023, from https://www.cdc.gov/nchs/products/databriefs/db303.htm.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001526
- Term: Behavioral Symptoms
- ID: D000019964
- Term: Mood Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7061
- Name: Depressive Disorder
- Relevance: HIGH
- As Found: Depression
- ID: M7058
- Name: Depression
- Relevance: HIGH
- As Found: Depression
- ID: M4324
- Name: Anxiety Disorders
- Relevance: HIGH
- As Found: Anxiety
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M21835
- Name: Mood Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003863
- Term: Depression
- ID: D000003866
- Term: Depressive Disorder
- ID: D000001008
- Term: Anxiety Disorders
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434870
**Brief Title:** Effect of Spinal Anesthesia in Elective Cesarean Cases on Frontal QRS Angle in Anemic and Non-Anemic Patients
**Official Title:** Comparison of the Effect of Spinal Anesthesia Applied in Elective Cesarean Cases on Frontal QRS Angle in Anemic and Non-Anemic Patients
#### Organization Study ID Info
**ID:** MAIEAH630004
#### Organization
**Class:** OTHER
**Full Name:** Sanliurfa Mehmet Akif Inan Education and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-20
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sanliurfa Mehmet Akif Inan Education and Research Hospital
#### Responsible Party
**Investigator Affiliation:** Sanliurfa Mehmet Akif Inan Education and Research Hospital
**Investigator Full Name:** ahmet kaya
**Investigator Title:** assistant professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The QRS-T angle represents a novel marker of myocardial repolarisation. It is defined as the angle difference between the direction of ventricular depolarisation (QRS wave) and the direction of ventricular repolarisation (T wave). It is an indicator of instability in the electrophysiological properties of the myocardium and is associated with arrhythmias. The frontal QRS-T angle is a straightforward, cost-effective parameter that can be readily obtained from 12-lead electrocardiography.
The most prevalent arrhythmias during pregnancy are atrial arrhythmias. However, ventricular tachyarrhythmias are exceedingly rare during pregnancy and may be life-threatening.
Caesarean section is one of the most common surgical procedures. General anaesthesia, spinal anaesthesia and epidural anaesthesia can be employed in these patients. Spinal anaesthesia is a frequently employed method in caesarean section operations due to its rapid onset of effect, technical simplicity of application and higher probability of success.
In pregnant women, anaemia is defined as a haemoglobin concentration below 11 mg/dL in the first trimester, 11 mg/dL in the second trimester and 10.5 mg/dL in the third trimester.
**Detailed Description:** The QRS-T angle represents a novel marker of myocardial repolarisation. It is defined as the angle difference between the direction of ventricular depolarisation (QRS wave) and the direction of ventricular repolarisation (T wave). It is an indicator of instability in the electrophysiological properties of the myocardium and is associated with arrhythmias. The frontal QRS-T angle is a straightforward, cost-effective parameter that can be readily derived from 12-lead electrocardiography. The angle between the QRS and T waves is a useful indicator of myocardial repolarisation. It is associated with arrhythmias and instability in the electrophysiological properties of the myocardium. The frontal QRS-T angle is a simple, inexpensive parameter that can be easily obtained from 12-lead electrocardiography.
Pregnancy has a profound effect on the cardiovascular system. It results in an increase in blood volume, heart rate, venous pressure in the lower extremities, and cardiac output. Furthermore, it can result in a reduction in peripheral resistance and pulmonary vascular resistance, as well as a decline in blood pressure. Furthermore, it affects the cardiac conduction system, rendering patients more susceptible to arrhythmias. The most prevalent arrhythmias during pregnancy are atrial arrhythmias. Ventricular tachyarrhythmias are relatively uncommon during pregnancy and can be life-threatening.
One of the most common surgical procedures is caesarean section. General anaesthesia, spinal anaesthesia and epidural anaesthesia can be employed in these patients. Spinal anaesthesia is a frequently employed method in caesarean section operations due to its rapid onset of effect, technical ease of application and higher chance of success. In addition to the beneficial effects, direct cardiac and indirect cardiac side effects may be observed, such as vasodilatation due to sympathetic denervation, decreased right heart pressure and reflex bradycardia, which depend on the level of block.
In pregnant women, haemoglobin values below 11 mg/dL in the first trimester, 11 mg/dL in the second trimester and 10.5 mg/dL in the third trimester are considered to indicate anaemia.
The objective of this study was to investigate the effects of spinal anaesthesia in elective caesarean section cases on frontal QRS angle in anaemic and non-anaemic patients.
### Conditions Module
**Conditions:**
- Pregnancy Anemia
- Electrocardiography
- Anesthesia, Spinal
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In pregnant women, haemoglobin values below 11 mg/dL in the first trimester, 11 mg/dL in the second trimester and 10.5 mg/dL in the third trimester indicate anaemia.
The group comprised patients with haemoglobin levels below 10.5 mg/dL.
**Label:** Patients who had undergone Elective Cesarean Surgery with anemia
#### Arm Group 2
**Description:** In pregnant women, haemoglobin values below 11 mg/dL in the first trimester, 11 mg/dL in the second trimester and 10.5 mg/dL in the third trimester indicate anaemia.
The group comprised patients with haemoglobin levels above 10.5 mg/dL.
**Label:** Patients who had undergone Elective Cesarean Surgery without anemia
### Outcomes Module
#### Primary Outcomes
**Measure:** The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval. (T1)
**Time Frame:** preoperatively
**Measure:** The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T2)
**Time Frame:** after spinal anaesthesia
**Measure:** The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T3)
**Time Frame:** 5 min after spinal anaesthesia
**Measure:** The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T4)
**Time Frame:** 5 min after spinal anaesthesia
**Measure:** The measurements to be taken include QRS, frontal QRS, QRS angle and Tp-e interval.(T5)
**Time Frame:** 10 min after spinal anaesthesia
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged 18-45 years
* Patients with American Society of Anesthesiologists (ASA) II classification
Exclusion Criteria:
* Patients with rhythm disorders
* Patients with electrolyte disturbances
* Patients with liver and/or renal failure
* Obese patients (body mass index \> 30)
* Trauma patients
* Cancer patients
* ASA III-IV patients
* Patients who do not wish to participate in the study will be excluded.
**Maximum Age:** 45 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
**Study Population:** The study will include 100 patients aged 18-45 years with an American Society of Anesthesiologists (ASA) II classification who will undergo elective caesarean section.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** ahmet kaya
**Phone:** 00905327010609
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** mahmut alp karahan
**Phone:** 00905327808997
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Şanlıurfa
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** ahmet kaya
- **Phone:** 00905327010609
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** mahmut alp karahan
- **Phone:** 00905327808997
- **Role:** CONTACT
**Country:** Turkey
**Facility:** University of Health Science Turkey Sanliurfa Mehmet Akif Inan Training and Research Hospital
**Status:** RECRUITING
**Zip:** 63050
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4070
- Name: Anemia
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M207501
- Name: Chrysarobin
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434857
**Brief Title:** Effectiveness of a Strength Program Over Cognitive Functionality in Older Adults
**Official Title:** Effectiveness of a Strength Program Over Cognitive Functionality in Older Adults Undergoing an Occupational Therapy Program
#### Organization Study ID Info
**ID:** 16069701
#### Organization
**Class:** OTHER
**Full Name:** University of Salamanca
### Status Module
#### Completion Date
**Date:** 2026-02-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-15
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Salamanca
#### Responsible Party
**Investigator Affiliation:** University of Salamanca
**Investigator Full Name:** Arturo Dávila Marcos
**Investigator Title:** PhD student
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This is a randomized, parallel, double-blind clinical trial. The main objective is to compare the efficacy of strength training, multimodal exercise with non-specific exercises and a control group on cognitive functionality and physical composition in subjects over 65 years of age with mild or non existent cognitive impairment currently receiving occupational therapy.
The intervention in both groups will be carried out for 30 weeks, with three weekly sessions. Two evaluations will be performed, one pre-intervention and one post-intervention. Cognitive Functionality (Montreal Cognitive Assessment (MOCA) and Lawton and Brody Scale), Sleep quality (Athens insomnia scale and Pittsburgh sleep quality index), physical functionality (Timed up and go (TUG), chair stand test and hand grip test and Short Physical Performance Battery (SPPB)), body composition (Body fat %, skeletal muscle index (SMI), appendicular skeletal muscle (ASM), waist circumference, waist hip ratio, body weight, body mass index (BMI)) will be evaluated.
**Detailed Description:** Design: Randomized, controlled clinical trial with three parallel groups, in which subjects over 65 years of age will be recruited. Study participants will be assigned to one of the three intervention groups. The study will have a duration of 8 months. There will be 2 evaluation visits, an initial one, and a final one after 8 months. During 8 months there will be 3 weekly sessions lasting 50 minutes.
Scope: The study will be carried out in the Salamanca Health Area, in collaboration with the Research, Teaching and Assistance Unit of the Faculty of Nursing and Physiotherapy of the University of Salamanca and the Department of Elderly People of the Salamanca City Council.
Interventions: 1) Multimodal Exercise Group (GEM); 2) Strength Exercise Group (GES); 3) No Exercise Control Group (CG). The GEM and GES sessions follow the same structural pattern. They will be structured according to the recommendations of the American College of Sports Medicine (ACSM). In the main part of the GES, only strength exercises will be performed.
Study population: 90 subjects over 65 years of age from the city of Salamanca will be recruited, distributed in 3 groups at a 1:1:1 ratio. Randomization will be performed using the Epidat 4.2 program. The sample size was calculated using GRANMO Version 7. 12 April 2012.
The main study variables are: Cognitive functionality (Montreal Cognitive Assessment (MOCA) and Lawton and Brody Scale), Sleep quality (Athens insomnia scale and Pittsburgh sleep quality index), Physical Functionality (Timed Up \& Go test (TUG), chair stand test and hand grip test and Short Physical Performance Battery (SPPB)), body composition (Body fat %, skeletal muscle index (SMI), appendicular skeletal muscle (ASM), waist circumference, waist hip ratio, body weight, body mass index (BMI)), SARC-F Questionnaire, % RM estimated by force-velocity profile and Gait speed.
Population characteristics will be presented as mean and standard deviation for continuous variables and as frequency distribution for qualitative variables. Statistical analysis The effect of the intervention on the study variables if the variables are parametric, Student's t-test will be used, and if they are non-parametric, the Wilcoxon test will be used. An alpha risk of 0.05 is set as the limit of statistical significance. The statistical program to be used will be SPSS, v.26.0.
The study will be carried out with the authorization of the Ethics Committee on Drug Research (CEIm) of the Salamanca Health Area, and with the prior informed consent of the study subjects. The participants will be informed of the objectives of the project and of the risks and benefits of the examinations and interventions to be performed. The study has been designed and subsequently assessed in accordance with Law 14/2007 on Biomedical Research, the ethical principles of the Declaration of Helsinki of the World Medical Association on ethical principles for medical research involving human subjects, as well as the other ethical principles and legal regulations applicable according to the characteristics of the study.
### Conditions Module
**Conditions:**
- Cognitive Impairment
- Aging Problems
**Keywords:**
- Aging
- Cognitive impairment
- Older adult
- Strength training
- Therapeutic exercise
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Randomized, controlled clinical trial
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The main part of the strength training program will have the following exercises: wall push-ups, arm raises, elbow push-ups and extensions, weighted pronosupination, hand press, knee and hip hinge squat, deadlifts, front and sagittal plan stride, and heel raises.
It will consist on different phases:
1. st phase: exercise adaptation: the correct execution of upper and lower limb exercises will be taught for one month.
2. nd phase: Resistance training: During the following seven months, strength exercises will be performed at slow and normal speed of the movement patterns learned in the training course, increasing load and volume according to each subject's individual progress.
**Intervention Names:**
- Procedure: Strength training in older adults with mild or non existent cognitive impairment
**Label:** Strength Training Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The main part of the multicomponent exercise program integrates different exercise modalities: Aerobic, mobility, strength, balance and coordination exercises. Playful activities or games are also included.
Exercises will be turned gradually more demanding along the duration of the program.
**Intervention Names:**
- Procedure: Multimodal excercise in older adults with mild or non existent cognitive impairment
**Label:** Multimodal Exercise Group
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Participants in this group should continue with their usual dietary pattern and level of physical activity, without changing their lifestyle habits during the study period. They will not participate in the strength exercise program, nor will they perform systematic, programmed and supervised physical exercise in any other program.
**Label:** Control Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Strength Training Group
**Description:** Strength training program applied to strength training group
**Name:** Strength training in older adults with mild or non existent cognitive impairment
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- Multimodal Exercise Group
**Description:** Multimodal exercise program applied to multimodal exercise group
**Name:** Multimodal excercise in older adults with mild or non existent cognitive impairment
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Cognitive functionality will be measured with the Montreal Scales Assessment (MOCA). Maximum score is 30, considering a punctuation ≥ 26 is considered normal.
**Measure:** Cognitive functionality
**Time Frame:** 8 months
#### Secondary Outcomes
**Description:** A questionaire consisting of 7 items to screen sleep quality: subjective sleep quality,sleep latency, sleep duration, usual sleep efficiency, sleep perturbations, use of medication and daytime disfunction. Each item is scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
**Measure:** Pittsburgh sleep quality index
**Time Frame:** 6 months
**Description:** A shorter and simpler questionaire to quickly screen sleep quality. It consists of 8 components, each one scored from 0 to 3. Higher scores indicate worse sleep quality.
**Measure:** Athens insomnia scale
**Time Frame:** 6 months
**Description:** It is a measure used to assess a person's body weight in relation to their height. It is calculated by dividing a person's weight in kilograms by their height in meters squared (BMI = kg/m²).
**Measure:** Body Mass Index (BMI)
**Time Frame:** 8 months
**Description:** Test battery to assess physical performance and frailty degree consisting of 3 tests: gait speed, balance, and lower limb strength. The maximum score is 12 points and a score ≤ 8 points indicates poor physical performance.
**Measure:** Short Physical Performance Battery (SPPB)
**Time Frame:** 8 months
**Description:** It is considered a fast, safe and very reliable test for sarcopenia, in a distance of 4 meters, values greater than 0.8 m/s are considered positive.
**Measure:** Gait speed
**Time Frame:** 8 months
**Description:** A predictive test for frailty and falls, where individuals are asked to get up from a standard chair, walk to a marker 3 m away, turn around, and sit down again. Times greater than 20 seconds are considered positive.
**Measure:** Timed Up and Go (TUG)
**Time Frame:** 8 months
**Description:** A scale to evaluate functionality and independence in daily activities. It screens 8 items, ranged from 0 to 1. For women, a score of 8 is considered autonomous while for men the score is 5.
**Measure:** Lawton & Brody Scale
**Time Frame:** 8 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Subjects older than 65
Exclusion Criteria:
* Absolute contraindication for excersice
* Severe cognitive impairment or dementia
* Language barriers
* Pending litigation or legal claim
**Healthy Volunteers:** True
**Minimum Age:** 65 Years
**Sex:** ALL
**Standard Ages:**
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Arturo Dávila Marcos
**Phone:** +34605998329
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Salamanca
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Arturo Dávila Marcos
- **Phone:** +34605998329
- **Role:** CONTACT
***Contact 2:***
- **Name:** Arturo Dávila Marcos
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** Spain
**Facility:** University of Salamanca
**Zip:** 37007
#### Overall Officials
**Official 1:**
**Affiliation:** University of Salamanca
**Name:** Arturo Dávila Marcos
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003072
- Term: Cognition Disorders
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M29705
- Name: Cognitive Dysfunction
- Relevance: HIGH
- As Found: Cognitive Impairment
- ID: M6301
- Name: Cognition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000060825
- Term: Cognitive Dysfunction
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434844
**Brief Title:** Effectiveness of Auricular Acupuncture in Reducing Dental Anxiety and Pain Perception During Orthodontic Extractions Among Adolescents
**Official Title:** Effectiveness of Auricular Acupuncture in Reducing Dental Anxiety and Pain Perception During Orthodontic Extractions Among Adolescents - A Crossover Double-Blinded Randomised Controlled Trial
#### Organization Study ID Info
**ID:** UW23-024
#### Organization
**Class:** OTHER
**Full Name:** The University of Hong Kong
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-10-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The University of Hong Kong
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This prospective, randomised, double-blinded cross-over study aims to compare the effectiveness of auricular acupuncture (AA) with placebo sham acupuncture (PSA) in reducing dental anxiety, pain perception and physiological responses to stress and anxiety among adolescents during orthodontic extractions.
Adolescents aged between 10-19 years old who are undergoing orthodontic treatments requiring bilateral premolar extractions will be invited to complete a validated questionnaire to record their dental anxiety level, oral health knowledge, attitudes, practices, demographic and socio-economic factors. During orthodontic extractions, physiological responses including heart rate and oxygen saturation will be measured with a fingertip pulse oximeter throughout the process.
The participants will be allocated randomly to one of the two groups in the study.
Group 1-- auricular acupuncture in their first orthodontic extraction visit and placebo sham acupuncture in their second orthodontic extraction visit.
Group 2-placebo sham acupuncture in their first orthodontic extraction visit and auricular acupuncture their second orthodontic extraction visit.
Both acupuncture interventions will be carried out by a Hong Kong registered Chinese medical practitioner. The acupuncture needles are kept in place for 20 minutes to exert its effect before the dental extraction. Placebo sham acupuncture will not cause any harm, but the acupuncture points have no reported effect on stress relief.
The extraction of premolars will be performed by a Hong Kong registered dentist. Local anesthesia is injected to numb the respective site, then the premolar will be removed with forceps, followed by stopping the bleeding by biting firmly on gauze.
### Conditions Module
**Conditions:**
- Dental Anxiety
**Keywords:**
- dental anxiety
- dental pain
- auricular acupunctures
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** CROSSOVER
##### Masking Info
**Masking:** TRIPLE
**Masking Description:** Both acupuncture interventions will be carried out by a Hong Kong licenced Chinese medical practitioner (CMP) with no involvement in data collection and assessment. A research assistant will be responsible for the randomisation and inform the CMP regarding the group allocation. The acupuncture needles are kept in place for 20 minutes before the dental treatment.
The extractions of premolars will be performed by a licenced general dental practitioner who is blinded towards the types of acupuncture received, so as the patient and their parents or caretakers.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 30
**Type:** ACTUAL
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The subjects will receive auricular acupuncture in the 1st visit and placebo sham acupuncture in the 2nd visit.
**Intervention Names:**
- Procedure: Auricular acupunctures
- Procedure: Sham acupunctures
**Label:** 1st visit Auricular acupuncture; 2nd visit Placebo sham acupuncture
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The subjects will receive placebo sham acupuncture in the 1st visit and auricular acupuncture in the 2nd visit.
**Intervention Names:**
- Procedure: Auricular acupunctures
- Procedure: Sham acupunctures
**Label:** 1st visit Placebo sham acupuncture; 2nd visit Auricular acupuncture
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- 1st visit Auricular acupuncture; 2nd visit Placebo sham acupuncture
- 1st visit Placebo sham acupuncture; 2nd visit Auricular acupuncture
**Description:** After disinfection of the external ear with 75% alcohol wipes, 018x 13 filiform needles (Mocm International Limited) will be used to perform the auricular acupunctures at the relaxation point, tranquilizer point and master cerebral point at the left and right external ears.
**Name:** Auricular acupunctures
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- 1st visit Auricular acupuncture; 2nd visit Placebo sham acupuncture
- 1st visit Placebo sham acupuncture; 2nd visit Auricular acupuncture
**Description:** The auricular acupoints of finger, shoulder and tonsil will be targeted instead. These points are also located at the external ear and comparable to those in the intervention group. The external ear will be disinfected with 75% alcohol wipes. Auricular acupunctures with 018x 13 filiform needles (Mocm International Limited) will be carried out at the finger point, shoulder point and tonsil point of the left and right external ears.
**Name:** Sham acupunctures
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Self-reported dental fear measured by Spielberger State Trait Anxiety Inventory score, Scores range from 20 to 80, with higher scores correlating with greater anxiety
**Measure:** Dental fear
**Time Frame:** Baseline, immediately after the intervention. immediately after the surgery
#### Secondary Outcomes
**Description:** Pain measured by Visual Analog Scale. Scores range from 0-10, with her scores correlating with greater pain
**Measure:** Pain perceived
**Time Frame:** Immediately after the intervention. immediately after the surgery
**Description:** Heart rate
**Measure:** Psychological changes
**Time Frame:** Baseline, perioperatively, immediately after the surgery
**Description:** Saturation of peripheral oxygen (SpO2) measurement
**Measure:** Psychological changes
**Time Frame:** Baseline, perioperatively, immediately after the surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Undergoing orthodontic treatment and require bilateral extraction of premolars.
* Have parental consent signed by their parent or guardian.
* Medically fit with either ASA I or II status
* Have not taken any medications, especially anxiolytics and antidepressants
* The premolars to be extracted should be fully erupted and without any signs of ankylosis.
**Healthy Volunteers:** True
**Maximum Age:** 19 Years
**Minimum Age:** 10 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Hong Kong
**Country:** Hong Kong
**Facility:** The University of Hong Kong
**State:** Hksar PRC
**Zip:** 999077
### IPD Sharing Statement Module
**Description:** Individual Participant Data (IPD) and other supporting materials will be made available to other researchers upon valid requests to the PI of the study.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC07
- Name: Mouth and Tooth Diseases
### Condition Browse Module - Browse Leaves
- ID: M4324
- Name: Anxiety Disorders
- Relevance: HIGH
- As Found: Anxiety
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M16853
- Name: Toothache
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001008
- Term: Anxiety Disorders
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
- ID: M10043
- Name: Hypnotics and Sedatives
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434831
**Acronym:** ESTIME
**Brief Title:** Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation
**Official Title:** Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation
#### Organization Study ID Info
**ID:** 2023_195
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Lille
### Status Module
#### Completion Date
**Date:** 2026-12-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-02
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-22
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University Hospital, Lille
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Overactive bladder syndrome (OAB) is defined by urgent and frequent urges to urinate associated with frequent night-time urination and sometimes urinary incontinence. Sacral neuromodulation (SNM) is now one of the second-line treatments for OAB.
The mode of action of SNM is still poorly understood but a number of data from recent scientific literature suggest that SNM may act, among other things, by altering the balance of the autonomic nervous system (ANS) - located at the interface between the urinary tract and the brain structures regulating the functioning of the urinary tract.
The aim of this study would therefore be to develop a predictive tool for the effectiveness of SNM.
### Conditions Module
**Conditions:**
- Bladder Hyperactivity
- Sacral Neuromodulation
**Keywords:**
- Bladder hyperactivity
- autonomic nervous system
- sacral neuromodulation
- urodynamic assessment
- heart rate variability
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** DIAGNOSTIC
#### Enrollment Info
**Count:** 40
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Device: Medical device for SNM: Interstim II, Interstim micro
**Label:** ANI will be recorded during the SNM.
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- ANI will be recorded during the SNM.
**Description:** ANI will be used during the SNM (2 hours)
**Name:** Medical device for SNM: Interstim II, Interstim micro
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Comparison of HFVI (high frequence variability index) analysed through heart rate variability (HRV) at baseline and during a standardized stimulation protocol (14 Hz, 210 mcs, amplitude to elicit anal motor response) randomly delivered at the level of the 4 contact points of the quadripolar lead at the time of lead implantation, between the effective and non-effective groups.
**Measure:** Comparison of HFVI analysed through HRV at baseline and during standardized stimulation protocol randomly delivered at the level of the 4contact points of the quadripolar lead at the time of lead implantation between the effective and noneffective groups
**Time Frame:** 1 year
#### Secondary Outcomes
**Description:** Comparison of other HRV parameters (SDNN, RMSSD, HF, LF) at baseline and during a standardized stimulation protocol (14 Hz, 210 mcs, amplitude to elicit anal motor response) randomly delivered at the level of the 4 contact points of the quadripolar lead at the time of lead implantation,
**Measure:** Comparison of other HRV parameters at baseline and during a standardized stimulation protocol randomly delivered at the level of the 4 contact points of the quadripolar lead at the time of lead implantation
**Time Frame:** 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Male of female ≥ 18 years
* OAB syndrome
* Indication for a two-staged SNM
* Under general anaesthesia with Remifentanil and Propofol
* Patient who has given written consent to participate in the trial
* Patient willing to comply with all study procedures and duration
Exclusion Criteria:
* Tibial neuro-stimulation (last 3 months)
* Sacral neuromodulation (last 3 months)
* Botulinum toxin A intra-detrusor injection (last 9 months)
* Pregnancy in progress
* Administrative reasons
* Guardianship/curatorship
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020820
- Term: Dyskinesias
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000001745
- Term: Urinary Bladder Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
- ID: D000059411
- Term: Lower Urinary Tract Symptoms
- ID: D000020924
- Term: Urological Manifestations
### Condition Browse Module - Browse Branches
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M27167
- Name: Urinary Bladder, Overactive
- Relevance: HIGH
- As Found: Bladder Hyperactivity
- ID: M9999
- Name: Hyperkinesis
- Relevance: HIGH
- As Found: Hyperactivity
- ID: M22574
- Name: Dyskinesias
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M5026
- Name: Urinary Bladder Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17319
- Name: Urologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M29464
- Name: Lower Urinary Tract Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: M22659
- Name: Urological Manifestations
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006948
- Term: Hyperkinesis
- ID: D000053201
- Term: Urinary Bladder, Overactive
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434818
**Acronym:** EDITOR
**Brief Title:** Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders
**Official Title:** Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)
#### Organization Study ID Info
**ID:** EDITDA056156
#### Organization
**Class:** INDUSTRY
**Full Name:** Evon Medics LLC
#### Secondary ID Infos
**ID:** 4R44DA056156-02
**Link:** https://reporter.nih.gov/quickSearch/4R44DA056156-02
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-22
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-07-07
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Howard University
**Class:** UNKNOWN
**Name:** Maryland Treatment Center
**Class:** UNKNOWN
**Name:** Clinics of Dr. Edwin Chapman, MD, PC @ MHDG
**Class:** NIH
**Name:** National Institute on Drug Abuse (NIDA)
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Evon Medics LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD) clinics to demonstrate pilot effectiveness for SUD outcomes compared to treatment as usual (TAU) and Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) device as active control. The investigators will conduct a multi-site study of 300 adult patients with opiate use disorder (OUD), stimulant (i.e., cocaine, methamphetamine) and/or alcohol use disorder (AUD) from community and clinics to evaluate whether EDITOR is associated with better patient treatment outcomes (e.g., retention in treatment and abstinence). The pilot study will provide preliminary data needed for design of a Phase III trial, including estimates of effect size. The investigators will also explore development of machine learning/AI algorithms integrating clinical and physiological data into treatment decision guides for providers.
**Detailed Description:** The Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) is a project to develop a sustainable, scalable, and patient-centered mobile health platform, comprised of (1) a patient-facing culturally-adapted digital chemosensory therapeutic for stimulant, alcohol and opioid use disorders, sensors for acquisition of objective physiological measures of substance intoxication and withdrawal, and an application for running and interpreting the interventions and sensory acquisition programs; and (2) a provider-facing web portal, for substance use disorder treatment in socially disadvantaged and sexual minority populations.
The small business, Evon Medics implemented the use of the EDITOR device as a novel approach for remote management of substance use disorders (SUDs) amid the challenges of the COVID-19 pandemic. Management of SUD mostly involve direct contact between patients and providers, but the precedence of COVID-19 pandemic has elevated the need for patient-centered remote management of SUD. While digital therapeutics and mobile health platforms provide avenues for remote management, communities of African Americans (AA), Hispanic Americans (HA) and other socially disadvantaged populations lag in adoption of these mobile platforms, due to inability to read, digital illiteracy, lack of access to smartphones, absence of reliable Wi-Fi or internet, and financial constraints. Moreover, while interventions exist for OUD, there are no drugs for cocaine or stimulant use disorders. Underserved AA and HA communities with OUD, particularly marginalized men who have sex with men (MSM), have more severe co-existing cocaine, methamphetamine, and alcohol use disorders; and digital solutions for these populations are lacking. Providers on the other hand, lack well-adapted, intelligent-based physiological and psychophysical acquisition platforms to guide remote agonist management of opioid and alcohol withdrawal.
EVON Medics developed a combinatorial digital chemosensory-based orbitofrontal cortex training for Opioid Use Disorder (CBOT). Based on the limitations of CBOT for the socially disadvantaged AA, HA and MSM population, the investigators recently revised the platform for treatment of stimulant and alcohol use disorder, by including beta-caryophyllene chemosensory stimulation. Further product development, with innovative changes to the patient-facing platform and a new provider-facing platform to guide remote management of OUD, stimulant (cocaine and methamphetamine) use and alcohol use disorders were preliminary tested (Phase I) in affiliated substance use community programs and community populations in the under-served communities in Washington, DC and Maryland.
In this study phase, Phase II of this Fast-Track SBIR application, the investigators will conduct a pilot randomized trial of EDITOR compared to treatment as usual and CBOT for office-based treatment of SUDs in several federal funded programs associated with Evon Medics and Howard University, to assess EDITOR's effectiveness in improving treatment retention, reducing relapses, and mitigating SUD severity, and offering a promising solution for home-based SUD treatment.
### Conditions Module
**Conditions:**
- Substance Use Disorders
- Opioid Use Disorder
- Alcohol Use Disorder
- Cocaine Use Disorder
- Methamphetamine-dependence
**Keywords:**
- Substance Abuse
- Substance Use Disorder
- Retention
- Relapse
- Chemosensory-Based Olfactory Networks Training
- Remote Management
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The EDITOR device is designed to stimulate intensive neural activity in OFC over long periods of time. It consists of 40 daily cycles of intervention with a combination of olfactory stimulation and training tasks, lasting \~45 minutes, delivered once daily over three months. The device also includes 60% beta-caryophyllene chemosensory stimulation to target AUD and stimulant use disorder and 10 digital enhancements for the purpose of remote treatment, remote acquisition of behavioral and physiological data, and seamless data transmission to providers, through a HIPAA-compliant clinic end portal.
Participants assigned to this arm will receive their treatment-as-usual (TAU) alongside daily EDITOR therapy for three months. TAU will depend on the drug abused \[Buprenorphine with a median dose of 24 mg (range 16 - 32 mg) for Opioid use disorder and naltrexone (50-100 mg daily for Alcohol use disorder (AUD).
**Intervention Names:**
- Combination Product: EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance)
**Label:** Enhanced Digital-Chemosensory-Based Olfactory Training (EDITOR)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** CBOT with olfactory stimulants \& orbitofrontal (OFC) tasks
TAU same as above + CBOT (Chemosensory-Based Olfactory Training) therapy (40 cycles of olfactory stimulation and OFC training tasks, lasting \~45 minutes, once daily over three months) + use of their smartphone to communicate with their clinic provider/staff
**Intervention Names:**
- Combination Product: CBOT with olfactory stimulants & OFC tasks
**Label:** Chemosensory-Based Olfactory Training (CBOT)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Control Device (Sham) is CBOT device without olfactory stimulants and orbitofrontal tasks.
TAU same as above + CBOT sham + use of their smartphone to communicate with their clinic provider/staff. This CBOT device uses compressed room air scented with phenylethylamine (rose scent) instead of olfactory stimulants and has shape pattern matching tasks instead of cognitive tasks in order to blind users to their treatment assignment. Similar to the active arm, sham COT will be used daily for 45 minutes.
**Intervention Names:**
- Combination Product: CBOT Sham
**Label:** Chemosensory-Based Olfactory Training (CBOT) Sham
**Type:** SHAM_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Enhanced Digital-Chemosensory-Based Olfactory Training (EDITOR)
**Description:** EDITOR includes a user-friendly cloud portal synced with the main device, providing a comprehensive training program for the orbitofrontal cortex (OFC). The main device stimulates the orbitofrontal cortex intensely, preventing habituation to smells and improving adaptability. This enhances neurobehavioral plasticity, benefiting Substance Use Disorder (SUD) outcomes. The device also features a 60% beta-caryophyllene scent for addressing issues like Alcohol Use Disorder and stimulant use disorders. With ten digital enhancements, it enables remote treatment and data collection, seamlessly transmitting information to healthcare providers through a secure, HIPAA-compliant portal.
**Name:** EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance)
**Other Names:**
- EDITOR plus Treatment-As-Usual (TAU)
**Type:** COMBINATION_PRODUCT
#### Intervention 2
**Arm Group Labels:**
- Chemosensory-Based Olfactory Training (CBOT)
**Description:** The CBOT with proprietary odorant molecules is designed to stimulate olfactory neural activity over long periods of time combined with orbitofrontal cortex (OFC) dependent olfactory tasks.
**Name:** CBOT with olfactory stimulants & OFC tasks
**Other Names:**
- CBOT active plus TAU
**Type:** COMBINATION_PRODUCT
#### Intervention 3
**Arm Group Labels:**
- Chemosensory-Based Olfactory Training (CBOT) Sham
**Description:** CBOT Sham uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive olfactory tasks
**Name:** CBOT Sham
**Other Names:**
- CBOT passive plus TAU
**Type:** COMBINATION_PRODUCT
### Outcomes Module
#### Primary Outcomes
**Description:** 3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
**Measure:** Retention in SUD treatment
**Time Frame:** Baseline to day 14
**Description:** 3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
**Measure:** Retention in SUD treatment
**Time Frame:** Baseline to day 28
**Description:** 3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
**Measure:** Retention in SUD treatment
**Time Frame:** Baseline to 8 weeks
**Description:** 3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
**Measure:** Retention in SUD treatment
**Time Frame:** Baseline to three months
**Description:** Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through:
1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and
2. biochemical verification of drug use from urine samples collected and tested every two weeks.
**Measure:** SUD Relapse Rate
**Time Frame:** Baseline to day 7
**Description:** Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through:
1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and
2. biochemical verification of drug use from urine samples collected and tested every two weeks.
**Measure:** SUD Relapse Rate
**Time Frame:** Baseline to day 14
**Description:** Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through:
1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and
2. biochemical verification of drug use from urine samples collected and tested every two weeks.
**Measure:** SUD Relapse Rate
**Time Frame:** Baseline to day 28
**Description:** Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through:
1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and
2. biochemical verification of drug use from urine samples collected and tested every two weeks.
**Measure:** SUD Relapse Rate
**Time Frame:** Baseline to 8 weeks
**Description:** Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through:
1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and
2. biochemical verification of drug use from urine samples collected and tested every two weeks.
**Measure:** SUD Relapse Rate
**Time Frame:** Baseline to three months
**Description:** SUD engagement is the proportion of people treated at baseline who complete the first two weeks of treatment.
**Measure:** SUD engagement
**Time Frame:** Baseline to day 14
#### Secondary Outcomes
**Description:** Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates).
**Measure:** Opioid Craving Scale (OCS)
**Time Frame:** Baseline to Day 7
**Description:** Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving.
**Measure:** Cocaine Craving Questionnaire-Brief (CCQ-Brief)
**Time Frame:** Baseline to day 7
**Description:** Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?"
**Measure:** Self-report instruments for Alcohol Craving
**Time Frame:** Baseline to day 7
**Description:** Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).
**Measure:** Subjective Opioid Withdrawal Scale (SOWS)
**Time Frame:** Baseline to day 7
**Description:** Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
**Measure:** Positive and Negative Affect Scales (PANAS)
**Time Frame:** Baseline to day 7
**Description:** Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates).
**Measure:** Opioid Craving Scale (OCS)
**Time Frame:** Baseline to day 14
**Description:** Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving.
**Measure:** Cocaine Craving Questionnaire-Brief (CCQ-Brief)
**Time Frame:** Baseline to day 14
**Description:** Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?"
**Measure:** Self-report instruments for Alcohol Craving
**Time Frame:** Baseline to day 14
**Description:** Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).
**Measure:** Subjective Opioid Withdrawal Scale (SOWS)
**Time Frame:** Baseline to day 14
**Description:** Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
**Measure:** Positive and Negative Affect Scales (PANAS)
**Time Frame:** Baseline to day 14
**Description:** Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates).
**Measure:** Opioid Craving Scale (OCS)
**Time Frame:** Baseline to Day 28
**Description:** Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving.
**Measure:** Cocaine Craving Questionnaire-Brief (CCQ-Brief)
**Time Frame:** Baseline to day 28
**Description:** Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?"
**Measure:** Self-report instruments for Alcohol Craving
**Time Frame:** Baseline to day 28
**Description:** Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).
**Measure:** Subjective Opioid Withdrawal Scale (SOWS)
**Time Frame:** Baseline to day 28
**Description:** Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
**Measure:** Positive and Negative Affect Scales (PANAS)
**Time Frame:** Baseline to day 28
**Description:** Monthly severity of opioid, stimulants and alcohol use using the ASI-modified
The ASI is an assessment tool used to gauge the severity of a person's substance abuse and provides a comprehensive overview of a person's addiction-related issues. It addresses seven (7) main aspects of a person's behavior and environment. The areas assessed include medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status.
The ASI substance abuse assessment uses the composite score to assign a severity rating. The ratings are based on a scale of 0 to 9 as follows:
0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital.
**Measure:** Addiction Severity Index (ASI)
**Time Frame:** Baseline to day 28
**Description:** Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates).
**Measure:** Opioid Craving Scale (OCS)
**Time Frame:** Baseline to 8 weeks
**Description:** Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving.
**Measure:** Cocaine Craving Questionnaire-Brief (CCQ-Brief)
**Time Frame:** Baseline to 8 weeks
**Description:** Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?"
**Measure:** Self-report instruments for Alcohol Craving
**Time Frame:** Baseline to 8 weeks
**Description:** Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).
**Measure:** Subjective Opioid Withdrawal Scale (SOWS)
**Time Frame:** Baseline to 8 weeks
**Description:** Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
**Measure:** Positive and Negative Affect Scales (PANAS)
**Time Frame:** Baseline to 8 weeks
**Description:** Monthly severity of opioid, stimulants and alcohol use using the ASI-modified
The ASI is an assessment tool used to gauge the severity of a person's substance abuse and provides a comprehensive overview of a person's addiction-related issues. It addresses seven (7) main aspects of a person's behavior and environment. The areas assessed include medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status.
The ASI substance abuse assessment uses the composite score to assign a severity rating. The ratings are based on a scale of 0 to 9 as follows:
0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital.
**Measure:** Addiction Severity Index (ASI)
**Time Frame:** Baseline to 8 weeks
**Description:** Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates).
**Measure:** Opioid Craving Scale (OCS)
**Time Frame:** Baseline to three months
**Description:** Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving.
**Measure:** Cocaine Craving Questionnaire-Brief (CCQ-Brief)
**Time Frame:** Baseline to three months
**Description:** Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?"
**Measure:** Self-report instruments for Alcohol Craving
**Time Frame:** Baseline to three months
**Description:** Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).
**Measure:** Subjective Opioid Withdrawal Scale (SOWS)
**Time Frame:** Baseline to three months
**Description:** Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
**Measure:** Positive and Negative Affect Scales (PANAS)
**Time Frame:** Baseline to three months
**Description:** Monthly severity of opioid, stimulants and alcohol use using the ASI-modified
The ASI is an assessment tool used to gauge the severity of a person's substance abuse and provides a comprehensive overview of a person's addiction-related issues. It addresses seven (7) main aspects of a person's behavior and environment. The areas assessed include medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status.
The ASI substance abuse assessment uses the composite score to assign a severity rating. The ratings are based on a scale of 0 to 9 as follows:
0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital.
**Measure:** Addiction Severity Index (ASI)
**Time Frame:** Baseline to three months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Age 18 - 80 years, inclusive at enrollment.
2. Diagnosis of current moderate or severe substance use disorders, opioid use disorders, stimulant (cocaine and methamphetamine) use, and alcohol use disorders in the past three months, including the past month.
3. Does not meet criteria for other current SUDs outside of the 3 above, except for mild or moderate use of cannabis
4. Willing to receive study interventions and buprenorphine (for OUD group) and naltrexone (for AUD group) during the study
5. Females must not be pregnant at enrollment and agree not to become pregnant during the trial, through scientifically valid ways of contraception
6. Willing to sign the informed consent form.
7. Have a stable place to stay and retain the EDITOR devices in a secure condition when receiving the intervention and during the entire duration of the study participation.
Exclusion Criteria:
1. Any significant neurological disease such as stroke, dementia, meningitis, neurosyphilis, cerebral palsy, encephalitis, epilepsy, or seizures.
2. Mental retardation.
3. Presence of serious mental illness, such as schizophrenia, bipolar disorders, and suicidal risk. Diagnosis of major depressive disorders, anxiety disorders, and post-traumatic stress disorders (PTSD), will be included if symptoms are stable, with no suicidal ideas or plans, and there are no recent changes in treatment of these conditions in the 6 weeks prior to enrollment.
4. Experiencing current suicide ideas or plans.
5. Any unstable medical condition such as uncontrolled hypertension, uncontrolled diabetes, or liver cirrhosis as determined by the site PI.
6. History of severe traumatic nose injury that affects the ability to smell or significant intranasal disease, as determined by the site PI.
7. Known allergies or intolerance to aromas from plant essential oils. E.g., orange and lemon.
8. Breastfeeding or pregnancy test positive or plans to get pregnant in the 6 months following enrollment.
9. Individuals who are on parole or probation.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Evaristus Nwulia, MD
**Phone:** 410-227-2005
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Opeyemi M Awofeso, MD
**Phone:** 410-891-4007
**Phone Ext:** 1
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Washington
**Contacts:**
***Contact 1:***
- **Name:** Edwin Chapman, MD
- **Role:** CONTACT
**Country:** United States
**Facility:** Clinics of Dr. Edwin Chapman @ MHDG
**State:** District of Columbia
**Status:** RECRUITING
**Zip:** 20002
**Location 2:**
**City:** Washington
**Contacts:**
***Contact 1:***
- **Name:** Tanya Alim, MD
- **Role:** CONTACT
**Country:** United States
**Facility:** Howard University
**State:** District of Columbia
**Status:** RECRUITING
**Zip:** 20060
**Location 3:**
**City:** Rockville
**Country:** United States
**Facility:** Maryland Treatment Center
**State:** Maryland
**Status:** ENROLLING_BY_INVITATION
**Zip:** 20853
#### Overall Officials
**Official 1:**
**Affiliation:** Evon Medics LLC
**Name:** Charles Nwaokobia
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Evon Medics LLC
**Name:** Evaristus Nwulia, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** Howard University
**Name:** Tanya Alim, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 4:**
**Affiliation:** Clinics of Dr. Edwin Chapman at MHDG
**Name:** Edwin Chapman, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 5:**
**Affiliation:** Maryland Treatment Center
**Name:** Marc Fishman, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
- ID: D000019973
- Term: Alcohol-Related Disorders
- ID: D000079524
- Term: Narcotic-Related Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC25
- Name: Substance Related Disorders
### Condition Browse Module - Browse Leaves
- ID: M3774
- Name: Alcohol Drinking
- Relevance: LOW
- As Found: Unknown
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: HIGH
- As Found: Substance Use Disorders
- ID: M3783
- Name: Alcoholism
- Relevance: HIGH
- As Found: Alcohol Use Disorder
- ID: M12244
- Name: Opioid-Related Disorders
- Relevance: HIGH
- As Found: Opioid Use Disorder
- ID: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21842
- Name: Alcohol-Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M2057
- Name: Narcotic-Related Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000000437
- Term: Alcoholism
- ID: D000009293
- Term: Opioid-Related Disorders
### Intervention Browse Module - Ancestors
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: NarcAntag
- Name: Narcotic Antagonists
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: CNSSti
- Name: Central Nervous System Stimulants
- Abbrev: AlcDet
- Name: Alcohol Deterrents
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
### Intervention Browse Module - Browse Leaves
- ID: M5317
- Name: Buprenorphine
- Relevance: LOW
- As Found: Unknown
- ID: M3777
- Name: Ethanol
- Relevance: LOW
- As Found: Unknown
- ID: M4029
- Name: Central Nervous System Stimulants
- Relevance: HIGH
- As Found: Cleanser
- ID: M12222
- Name: Naltrexone
- Relevance: LOW
- As Found: Unknown
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M287684
- Name: Caryophyllene
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000697
- Term: Central Nervous System Stimulants
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434805
**Brief Title:** An Education Initiative to Reduce Stigma Towards Sex Workers and Sexual Minorities Among Nursing Students
**Official Title:** An Education Initiative to Reduce Stigma Towards Sex Workers and Sexual Minorities Among Nursing Students: a Pilot Study
#### Organization Study ID Info
**ID:** HE-NHS2024/02
#### Organization
**Class:** OTHER
**Full Name:** Hong Kong Metropolitan University
### Status Module
#### Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hong Kong Metropolitan University
#### Responsible Party
**Investigator Affiliation:** Hong Kong Metropolitan University
**Investigator Full Name:** Dr Polly MA Haixia
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Background: Sex workers and sexual minorities (SWSM) often encounter barriers when accessing healthcare services due to social stigma and discrimination. In Hong Kong, stigma and prejudice exist among nurses and nursing students toward SWSM.
Aims: This education initiative aims to improve the knowledge, attitudes, and clinical competence of nursing students in caring for SWSM.
Methods: This pilot study will employ a one-group pre-and post-test design. Convenience sampling will be used to recruit 52 nursing students from the clinical phase of the Bachelor of Nursing program at the School of Nursing and Health Studies of Hong Kong Metropolitan University, as well as nursing students from other local universities. The intervention will consist of a four-session one-day workshop based on social cognitive theory and interpersonal contact theory. The workshop will cover various topics, including terminologies, human rights, stigma and discrimination in healthcare settings, contact with SWSM, and skills building. The primary outcome measure will include participants' attitudes toward SWSM. Secondary outcome measures included their knowledge and clinical competence. These outcome measurements will be assessed at baseline (T0) and after the intervention (T1) and three months follow up (T2). Additionally, focus group discussions will be carried out to explore participants' experiences of the intervention.
Discussion: Findings from this study could contribute to the existing knowledge on stigma surrounding SWSM in Hong Kong and its impact on healthcare. The intervention is expected to increase the knowledge, attitudes, and skills of nursing students in providing care for SWSM. By promoting non-judgmental and equitable care, the research aims to contribute to the overall well-being and health outcomes of SWSM. These results will inform future nursing education curricula and clinical practice, facilitating the development of more inclusive and patient-centered care for marginalized populations in Hong Kong and beyond.
### Conditions Module
**Conditions:**
- Stigmatization
- Sex Work
- Homosexuality
- Transgenderism
**Keywords:**
- gender and sexual minority
- sex workers
- cultural competency
- nursing students
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
**Intervention Model Description:** A single group with outcome assessments will be taken at baseline, post-intervention, and at 3-month follow-up.
##### Masking Info
**Masking:** NONE
**Primary Purpose:** HEALTH_SERVICES_RESEARCH
#### Enrollment Info
**Count:** 52
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** This is a one-day workshop with four sessions.
**Intervention Names:**
- Other: sex workers and sexual minorities education workshop
**Label:** Education workshop
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Education workshop
**Description:** The participants will receive a one-day workshop (four sessions). The generic content aims at enhancing the understanding of sexual orientation, gender identities, social stigma, sex work and sexual orientation and human rights (session 1), the lived experience of SWSM (session 2), the content specifically related to the medical and healthcare field, including be familiar with the professional and ethical obligations (session 3), the skills that can be adopted when providing services to SWSM (session 4).
**Name:** sex workers and sexual minorities education workshop
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Attitudes Toward Lesbians and Gay Men Scale (ATLG) is an instrument designed to measure the attitudes of heterosexuals toward lesbians and gay men. It consists of 20 items, the first 10 about lesbians and the next 10 about gay men, and can be used as a single scale or two distinct subscales. Items are scored using a 4-point Likert scale, from 1 (strongly disagree) to 4 (strongly agree). The total score range for both the lesbian and gay subscale is from 10 to 40. The ATLG was validated in Hong Kong.
**Measure:** Attitudes toward lesbians and gay men scale (ATLG)
**Time Frame:** baseline, immediately after the intervention, 3-months post-intervention
**Description:** The Genderism and Transphobia Scale (GTS) is a questionnaire consisting of 32 items measuring cognitive, behavioral, and affective dimensions of genderism, transphobia, and gender-bashing. The statements are rated on a 7-point Likert scale (1 = strongly agree to 7 = strongly disagree), with higher scores denoting strong negative feelings and behaviors toward transgender individuals. The GTS was validated in Hong Kong and included an additional item 33, and the total score ranges from 33 to 231.
**Measure:** Genderism and Transphobia Scale (GTS)
**Time Frame:** baseline, immediately after the intervention, 3-months post-intervention
**Description:** The scale will measure nursing students' attitudes towards sex workers, which was adopted from a scale developed by Melby et al. (1992) to determine nurses' attitudes towards prostitutes (Melby et al., 1992). The scale on nursing students' attitudes was comprised of eight items on attitude, with three related to morals, two to control, and three to sympathy. A 5-point Likert-type scale was used, with 1 = strongly disagree, and 5 = strongly agree. Negative items (items 2 and 7) will be reversely coded, with higher score representing positive attitudes. The total score ranges from 8 to 40.
**Measure:** Attitudes Toward sex workers with HIV and sexually transmitted diseases (STDs)
**Time Frame:** baseline, immediately after the intervention, 3-months post-intervention
#### Secondary Outcomes
**Description:** LGBT-DOCSS will be used to assess nursing students' clinical skills in caring for sexual minorities. It includes 18 items crossing three domains: clinical preparedness, attitudinal attitudes, and basic knowledge. A 7-point Likert-type scale was used, with 1 = not at all true, 4 = somewhat true, and 7 = total true. The total score ranges from 18 to 126. Higher scores are indicative of higher levels of clinical preparedness and rudimentary knowledge and less prejudicial attitudinal awareness regarding LGBT clients/patients. LGBT-DOCSS was back-and-forth translated by the research team.
**Measure:** LGBT development of clinical skills scale (LGBT-DOCSS)
**Time Frame:** baseline, immediately after the intervention, 3-months post-intervention
**Description:** Sex worker development of clinical skills scale (SW-DOCSS) is developed based on LGBT-DOCSS. It will be used to assess nursing students' clinical skills in caring for sexual minorities. It includes 10 items crossing three domains: clinical preparedness, attitudinal attitudes, and basic knowledge. A 7-point Likert-type scale was used, with 1 = not at all true, 4 = somewhat true, and 7 = total true. The total score ranges from 10 to 70. Higher scores are indicative of higher levels of clinical preparedness and rudimentary knowledge and less prejudicial attitudinal awareness regarding sex worker clients/patients. A pilot test will be conducted to establish the reliability of the SW-DOCSS.
**Measure:** Sex worker development of clinical skills scale (SW-DOCSS)
**Time Frame:** baseline, immediately after the intervention, 3-months post-intervention
**Description:** The measurement of nursing students' knowledge of sex workers and sexual minorities is developed from previous studies. It includes 14 items, where students will be asked to rate each statement as either right or wrong. The total score ranges from 0 to 14, with a higher score indicating more accurate knowledge of sex workers and sexual minorities.
**Measure:** Self-developed questionnaire regarding knowledge of sex workers and sexual minorities
**Time Frame:** baseline, immediately after the intervention, 3-months post-intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* aged 18 years of age or above;
* studying in the clinical phase (i.e., year 3 to year 5);
* are able to speak, read, and write Cantonese or Putonghua;
* are willing to participate in the study and share their experience of the education initiative with the research group;
* have informed consent to participate in the study.
Exclusion Criteria:
* Those who have completed a similar workshop or discussion of sex workers and sexual minorities in previous nursing education will be excluded from this study.
**Maximum Age:** 50 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Haixia Ma, PhD
**Phone:** 39702990
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** Participants' privacy, confidentiality, and voluntary participation of the study will be ensured. Participants' information will be kept in a password-protected computer. Only the research team could access the original data.
**IPD Sharing:** NO
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434792
**Brief Title:** Study to Evaluate Efficacy and Safety of Bronpass Tab. in Patients With Chronic Obstructive Pulmonary Disease
**Official Title:** A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Dose-response Phase 2 Clinical Trial to Compare the Efficacy and Safety of Bronpass Tab. Versus Placebo in Patients With Stable COPD
#### Organization Study ID Info
**ID:** HL_HL301_204
#### Organization
**Class:** INDUSTRY
**Full Name:** Hanlim Pharm. Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-03
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-06-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-18
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Hanlim Pharm. Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group dose-response phase 2 clinical trial study to evaluate the efficacy and safety of Bronpass Tab. in 96 patients with chronic obstructive pulmonary disease.
**Detailed Description:** This study is to prove that Bronpass Tab. is superior in clinical efficacy and safety in improving COPD symptoms compared to placebo for 12 weeks in patients suffering from chronic obstructive pulmonary disease.
### Conditions Module
**Conditions:**
- Chronic Obstructive Pulmonary Disease
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 96
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Twice daily for 12 weeks
**Intervention Names:**
- Drug: Bronpass Tab.
**Label:** Bronpass Tab.
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Twice daily for 12 weeks
**Intervention Names:**
- Other: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Bronpass Tab.
**Description:** Twice daily for 12 weeks
**Name:** Bronpass Tab.
**Other Names:**
- HL301
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Placebo
**Description:** Twice daily for 12 weeks
**Name:** Placebo
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Change from baseline in CAT(COPD Assessment Test) total score at Visit 5
**Time Frame:** Time frame: 3 months(Visit 5)
#### Secondary Outcomes
**Measure:** Change from baseline in CAT total score at Visit 3 and Visit 4
**Time Frame:** Time frame: 1 month(Visit 3), 2 months(Visit 4)
**Measure:** Change from baseline in CAT cough score at Visit 3, Visit 4, and Visit 5
**Time Frame:** Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
**Measure:** Change from baseline in CAT sputum score at Visit 3, Visit 4, and Visit 5
**Time Frame:** Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
**Measure:** Incidence of moderate and severe COPD exacerbations from baseline to Visit 5
**Time Frame:** Time frame: 3 months(Visit 5)
**Measure:** Change frome baseline in PFT(Pulmonary Function Test) such as FEV1(Forced Expiratory Volume in one second), FVC(Forced Vital Capacity), FEV1/FVC at Visit 5
**Time Frame:** Time frame: 3 months(Visit 5)
**Measure:** Change from baseline in SGRQ-C(St. George's Respiratory Questionnaire for COPD patients) Score at Visit 3, Visit 4, and Visit 5
**Time Frame:** Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
**Measure:** Change from baseline in COAT(Cough Assessment Test) Score at Visit 3, Visit 4, and Visit 5
**Time Frame:** Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. 40 years ≤ age
2. Patients who are diagnosed as COPD (based on the definition in the Korean Society of Tuberculosis and Respiratory Diseases COPD Guidelines)
3. Patients who meet all of the following criteria at the screening test
* FEV1/FVC \< 0.70 after bronchodilator administration
* 30% ≤ FEV1 \< 80% predicted after bronchodilator administration
* Cough or sputum-related score on the CAT ≥ 3
4. Current or former smokers with a smoking history of 10 pack-years or more at screening.
5. Patients who have listened to a detailed explanation of this clinical trial, fully understand it, and voluntarily provide written consent to participate.
Exclusion Criteria:
1. Patients with a current medical history of asthma (However, patients previously diagnosed as asthma who have recovered and currently have a diagnosis of COPD are eligible for participation.)
2. Patients with a medical history of respiratory diseases other than COPD
3. Patients who have undergone lung volume reduction surgery.
4. Patients with a history of lung transplantation.
5. Patients with a history of respiratory infections within 4 weeks prior to screening
6. Patients with a history of moderate or severe acute exacerbation within 4 weeks prior to screening.
7. Pregnant or lactating women.
8. Patients who are considered ineligible for this clinical trial due to other reasons as judged by the investigator.
**Minimum Age:** 40 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kwang Ha Yoo, MD, PhD
**Phone:** 82-2-2030-5114
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Seoul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kwang Ha Yoo, MD, PhD
- **Phone:** 82-2-2030-5114
- **Role:** CONTACT
**Country:** Korea, Republic of
**Facility:** Konkuk University School of Medicine
**Status:** RECRUITING
**Zip:** 05030
#### Overall Officials
**Official 1:**
**Affiliation:** Konkuk University
**Name:** Kwang Ha Yoo, MD, PhD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M11168
- Name: Lung Diseases
- Relevance: HIGH
- As Found: Pulmonary Disease
- ID: M11170
- Name: Lung Diseases, Obstructive
- Relevance: HIGH
- As Found: Obstructive Pulmonary Disease
- ID: M23449
- Name: Pulmonary Disease, Chronic Obstructive
- Relevance: HIGH
- As Found: Chronic Obstructive Pulmonary Disease
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008171
- Term: Lung Diseases
- ID: D000008173
- Term: Lung Diseases, Obstructive
- ID: D000029424
- Term: Pulmonary Disease, Chronic Obstructive
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434779
**Acronym:** JETART
**Brief Title:** Investigating Efficacy and Safety of JETi® in Arterial Occlusions in FEM-POP and Prox BTK-Lesions (JETART)
**Official Title:** Single Arm, Multicenter, Prospective Registry Investigating Efficacy and Safety of Mechanical Thrombectomy (JETi®) in Acute and Acute-on-Chronic Arterial Occlusions in Femoro-popliteal and Proximal BTK-Lesions (JETART)
#### Organization Study ID Info
**ID:** iD320240306
#### Organization
**Class:** OTHER
**Full Name:** ID3 Medical
### Status Module
#### Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-06
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Vascular Science LP GmbH
**Class:** INDUSTRY
**Name:** Abbott
#### Lead Sponsor
**Class:** OTHER
**Name:** ID3 Medical
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** To demonstrate the efficacy and safety of the mechanical thrombectomy device (JETi 6F and 8F) for treatment of patients with symptomatic peripheral artery disease (PAD) due to acute or acute on chronic occlusions of the femoral and/or popliteal arteries and the first 10 cm of the below-the -knee arteries.
### Conditions Module
**Conditions:**
- Peripheral Arterial Disease
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 200
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Device: JETi 6F and 8F Thrombectomy system
**Label:** Mechanical Thrombectomy (JETi®)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Mechanical Thrombectomy (JETi®)
**Description:** To demonstrate the efficacy and safety of the mechanical thrombectomy device (JETi 6F and 8F) for treatment of patients with symptomatic peripheral artery disease (PAD) due to acute or acute on chronic occlusions of the femoral and/or popliteal arteries and the first 10 cm of the below-the -knee arteries.
**Name:** JETi 6F and 8F Thrombectomy system
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** The primary efficacy endpoint is technical procedural success (post Jeti) defined as restoration of impaired flow to a straight-line orthograde flow in the target vessel/bypass with near complete or complete recanalization of occluded vessel by using the JETI system prior to further additional endovascular therapy.
**Measure:** Primary Efficacy Endpoint
**Time Frame:** During index procedure
**Description:** The primary safety endpoint is a composite of
1. freedom from device- and procedure-related death through 30 days post-index procedure;
2. freedom from major target limb amputation (above-the-ankle (ATA)) through 30 days post-procedure and
3. freedom from clinically-driven target vessel revascularization (CD-TVR) through 30 days post-index procedure
**Measure:** Primary Safety Endpoint
**Time Frame:** Up to 30 days post-index procedure
#### Secondary Outcomes
**Description:** Defined as successful delivery of the device to the lesion
**Measure:** Acute device success
**Time Frame:** During index procedure
**Description:** Secondary safety endpoint is a composite of
1. freedom from Major Adverse Events (MAEs). MAEs are defined as: all-cause death; bleeding, hematoma and intracranial hemorrhage; major target limb amputation; thrombosis at the target lesion.
2. freedom from major target limb amputation and MALE
3. freedom from CD-TVR
**Measure:** Secondary safety endpoint at discharge up to 30 days post index procedure
**Time Frame:** Up to 30 days
**Description:** Clinical improvement is defined as a composite of
1. freedom from major target limb amputation,
2. freedom from TVR,
3. freedom from worsening target limb Rutherford class (compared to baseline)
4. freedom from decrease in target limb ankle brachial index (ABI) ≥0.15 (compared to baseline)
**Measure:** Sustained clinical improvement at discharge and at 30- days post-index procedure
**Time Frame:** Hospital admission to discharge up to 30 days and at 30 days
**Description:** The primary patency is defined as a composite of
1. freedom from clinically-driven target lesion revascularization (CD-TLR)
2. freedom from binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis) as confirmed by an independent Corelab
**Measure:** Primary Patency at discharge and at 30 days post-index procedure
**Time Frame:** Hospital admission to discharge up to 30 days and at 30 days
**Description:** TLR is defined as a reintervention to maintain or restore the patency in the target lesion. TLR is clinically-driven (CD) when the TLR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or \>0.15 when compared to post-procedure
**Measure:** Freedom from TLR at discharge and at 30 days post-index procedure
**Time Frame:** Hospital admission to discharge up to 30 days and at 30 days
**Description:** Change in target limb Rutherford Classification from baseline to 30 days post-index procedure
**Measure:** Change in target limb Rutherford Classification from baseline to 30 days post-index procedure
**Time Frame:** Up to 30 days
**Description:** Change in target limb resting ABI from baseline to discharge and at 30 days post-index procedure
**Measure:** Change in target limb resting ABI from baseline to discharge and at 30 days post-index procedure
**Time Frame:** Up to 30 days
**Description:** Change of life quality according to the Walking Impairment Questionnaire (WIQ) from baseline to 30 days post-index procedure
**Measure:** Change of life quality according to the Walking Impairment Questionnaire (WIQ) from baseline to 30 days post-index procedure
**Time Frame:** Up to 30 days
**Description:** Change of life quality according to the EQ-5D questionnaire from baseline to 30 days post-index procedure
**Measure:** Change of life quality according to the EQ-5D questionnaire from baseline to 30 days post-index procedure
**Time Frame:** Up to 30 days
**Description:** Duration of hospital stay
**Measure:** Duration of hospital stay
**Time Frame:** Hospital admission to discharge up to 30 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patient is ≥18 years
* Patient has Rutherford Classification 2,3 or 4.
* Patient has provided written informed consent and is willing to comply with study follow-up requirements.
Angiographic inclusion criteria
* De novo thrombotic occlusive lesion(s) or thrombotic re-occlusion or in-stent thrombotic occlusive lesion(s) or thrombotic occlusion of a bypass (autolog or prosthetic) occurring acute or subacute with onset of complains within \<30 days prior to first seen by investigating physician.
* Target lesion is located between the ostium of the SFA and the end of the P3 segment of the popliteal artery, tibioperoneal trunk, respectively the first 10 cm of the below the knee vessels
* Target vessel diameter ≥ 3 mm and ≤ 8 mm and irrespective of lesion length
* Target lesion must be occlusive lesion Note: there is no limitation in lesion length
* Successful, uncomplicated crossing of the target lesion occurs when the tip of the guidewire is distal to the target lesion without the occurrence of flow-limiting dissection of perforation and is judged by visual inspection to be within the true lumen.
* A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmed by angiography.
* At least one patent native distal outflow artery to the ankle or foot, free from significant stenosis (≥ 50 % stenosis) as confirmed by angiography.
Exclusion Criteria:
* Patients meets any contraindication for JETi mechanical thrombectomy use per IFU
* Lesion crossing is difficult and the lesion is not suspicious for fresh thrombus containment
* Pregnant women or female patients of childbearing potential that do not use adequate contraceptive methods
* Patient has a life expectancy of less than 1 year
* Patient has a known allergy to contrast medium that cannot be adequately pre-medicated.
* Patient is allergic to all anti-platelet treatments
* Patient has platelet count \<100.000/mm3 or \>700.000/mm
* Patient has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the study procedure
* Patient is diagnosed with coagulopathy that bares the risk of increased bleeding risk
* Patient has history of stroke within past 90 days
* Patient is participating in an investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study.
* Patient has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure
* Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol
* Patient suffering from HIT II
Angiographic Exclusion Criteria:
* Target lesion is larger than 8 mm, respectively smaller than 3 mm
* Significant target vessel tortuosity or other parameters prohibiting access to the target lesion
* Absence of thrombus in the target vessel
* Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤ 30 % residual diameter stenosis without death or major complications.
* No patent outflow vessels on the level of 10 cm below the origin of below the-knee arteries to the level of the foot or ankle.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### IPD Sharing Statement Module
**Description:** No IPD sharing plan
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000050197
- Term: Atherosclerosis
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M29213
- Name: Peripheral Arterial Disease
- Relevance: HIGH
- As Found: Peripheral Arterial Disease
- ID: M18894
- Name: Peripheral Vascular Diseases
- Relevance: HIGH
- As Found: Peripheral Arterial Disease
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: HIGH
- As Found: Arterial Occlusion
- ID: M26188
- Name: Atherosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4469
- Name: Arteriosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000058729
- Term: Peripheral Arterial Disease
- ID: D000016491
- Term: Peripheral Vascular Diseases
- ID: D000001157
- Term: Arterial Occlusive Diseases
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434766
**Acronym:** TMCP
**Brief Title:** Multicenter iTBS Neuromodulation for PTSD Treatment
**Official Title:** A Multicenter Clinical Study on Transcranial Magnetic Stimulation of the Primary Motor Cortex for PTSD Treatment
#### Organization Study ID Info
**ID:** yan2024-0108
#### Organization
**Class:** OTHER
**Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
### Status Module
#### Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Shanghai Mental Health Center
**Class:** UNKNOWN
**Name:** The Affiliated Kangning Hospital of Ningbo University
**Class:** OTHER
**Name:** The First Affiliated Hospital of Anhui Medical University
#### Lead Sponsor
**Class:** OTHER
**Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex (M1) as adjunct treatment for PTSD patients. The primary outcome measure includes changes in PTSD symptom severity, with secondary outcome measures focusing on negative moods improvements, quality of life and social/occupation functioning and functional connectivity of the brain.
**Detailed Description:** The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex as adjunct treatment for PTSD patients.
Compared to traditional repetitive transcranial magnetic stimulation (rTMS), iTBS strategy usually delivers large amounts of pulses in a shorter time period, and its equal efficiency has been demonstrated in several psychiatric disorders such as major depressive disorder (MDD). Through this adequately randomized and sham-controlled study of iTBS for PTSD, this work will provide an alternative and potentially more potent stimulation target for clinical PTSD treatment. This study will also provide a comprehensive assessment of this treatment strategy towards improvements in symptoms, quality of life and brain functioning in PTSD.
The ultimate goal of this study is to develop a non-invasive brain stimulation approach targeting a novel site for alleviating symptoms and improving life quality for PTSD patients.
### Conditions Module
**Conditions:**
- Posttraumatic Stress Disorder
**Keywords:**
- iTBS
- PTSD
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Sham stimulation is used as a parallel control group for iTBS group.
##### Masking Info
**Masking:** TRIPLE
**Masking Description:** Participants, investigators and outcomes assessors are all blind to the group assignments.
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 140
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** A sham coil with exactly the same appearance of active coil is used to compare with active coil. Stimulation dose and frequency is the same as active stimulation.
**Intervention Names:**
- Device: sham stimulation
**Label:** Sham stimulation
**Type:** SHAM_COMPARATOR
#### Arm Group 2
**Description:** An active coil is used to deliver iTBS. The stimulation dose is 20 sessions (1800 pulses per session; 2 sessions a day, at least 1 hour apart) over the course of 2 weeks (10 days to 14 days, allow at most three breaks and only once of the longest interval of 2 days).
**Intervention Names:**
- Device: intermittent theta-burst stimulation (iTBS)
**Label:** Active stimulation
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Sham stimulation
**Description:** sham theta-burst transcranial magnetic stimulation
**Name:** sham stimulation
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Active stimulation
**Description:** intermittent theta-burst transcranial magnetic stimulation
**Name:** intermittent theta-burst stimulation (iTBS)
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Change in PTSD symptom severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).
The CAPS-5 is a structured interview designed to make a categorical PTSD diagnosis, as well as to provide a measure of PTSD symptom severity. The structure corresponds to the DSM-5 criteria, with B, C, D and E symptoms rated for both frequency and intensity which are summed to provide severity ratings. Items rated '0' means 'absent' and item rated '4' means 'extreme/incapacitating'. Higher scores indicate more severe PTSD symptoms.
**Measure:** Change in PTSD Symptom Severity
**Time Frame:** Baseline and 4 weeks after finishing treatment
#### Secondary Outcomes
**Description:** Change in PTSD symptom severity measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).
**Measure:** Change in PTSD Symptom Severity
**Time Frame:** Baseline, 10 times treatment, 20 times treatment, 2 weeks after finishing treatment and 8 weeks after finishing treatment
**Description:** The PCL-5 is a 20-item self-report checklist of PTSD symptoms based closely on the DSM-5 criteria. Respondents rate each item from 0 ("not at all") to 4 ("extremely") to indicate the degree to which they have been bothered by that particular symptom over the past month (or past week if using the PCL-5 weekly). A total symptom severity score (range: 0-80) can be obtained by summing the scores for each of the 20 items, with higher scores indicating more severe PTSD symptoms.
**Measure:** Change in Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) Total Score
**Time Frame:** Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
**Description:** The IDS-SR is a 30-item questionnaire measuring depressive symptoms. Each item has four statements that reflect various degrees of symptom severity, scored on a four-point scale from 0 to 3. The 16-item Quick Inventory of Depressive Symptomatology (QIDS) is a new measure of depressive symptom severity derived from the 30-item IDS-SR and has highly acceptable psychometric properties.
**Measure:** Change in The Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR) Score
**Time Frame:** Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
**Description:** The Personal and Social Performance Scale (PSP) is a 100-point single-item rating scale that assesses four important domains of patients with mental disorders. The four main areas include (a) socially useful activities, including work and study; (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors.
**Measure:** Change in The Personal Social Performance (PSP) scale
**Time Frame:** Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
**Description:** Q-LES-Q-SF is a patient-reported 16-item instrument that measures the degree of enjoyment and satisfaction in daily life over the past week. Individual items are rated on a scale from 1-5 ('very poor', 'poor', 'fair', 'good', or 'very good'). The Q-LES-Q-SF total score is the sum of the first 14 item scores (i.e. excluding medication satisfaction and overall life satisfaction and contentment) with a higher score indicating greater satisfaction (range = 14-70).
**Measure:** change in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)
**Time Frame:** Baseline, 10 times treatment, 20 times treatment, 2, 4 and 8 weeks after finishing treatment
**Description:** Structural, resting-state and task-based fMRI will be performed if the participant agree. During task-fMRI, the participant will listen to a script around one minute recorded during his/her first interview, describing the traumatic experience in details. The participant will be instructed to recall the traumatic experience vividly during the task-fMRI. Brain activity patterns and connectivity network will be presented and analyzed.
**Measure:** Change in neural activity pattern and functional connectivity of the brain based on fMRI
**Time Frame:** Baseline, 20 times treatment, 4 weeks after finishing treatment
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged between 18 to 65 years old
* Right handedness
* Have a diagnosis of PTSD meeting DSM-5 criteria
* CAPS-5 score\>35
* Under stable medication for at least four weeks
* Capable of independently reading and understanding study materials and providing informed consent.
Exclusion Criteria:
* Current (or past if appropriate) significant neurological or medical disorder, or lifetime history of 1) seizure disorder; 2) primary or secondary CNS tumors; 3) stroke; or 4) cerebral aneurysm.
* Primary psychotic disorder, bipolar I disorder, major depressive disorder, or personality disorders
* Lifetime history of attempted suicide or HAMD-17 suicide item (item 3) ≥ 3 points
* Implanted device (deep brain stimulation) or metal in the brain; a pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos if choose to do fMRI
* Previous experience of rTMS
* Pregnancy/lactation, or planning to become pregnant during the study
* Current under psychological or other physical treatments
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Huiqian Huang, Ph.D.
**Phone:** (+86)18757143725
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Shanshan Li, Bachelor
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Shanghai Mental Health Center
**Name:** Yuan Shen, M.D., Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** The Affiliated Kangning Hospital of Ningbo University
**Name:** Chang Yu, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 3:**
**Affiliation:** The First Affiliated Hospital of Anhui Medical University
**Name:** Kai Wang, M.D., Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
**Official 4:**
**Affiliation:** Second Affiliated Hospital, School of Medicine, Zhejiang University
**Name:** Xiaoming Li, M.D., Ph.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000040921
- Term: Stress Disorders, Traumatic
- ID: D000068099
- Term: Trauma and Stressor Related Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
- Abbrev: BC26
- Name: Wounds and Injuries
### Condition Browse Module - Browse Leaves
- ID: M16103
- Name: Stress Disorders, Post-Traumatic
- Relevance: HIGH
- As Found: Posttraumatic Stress Disorder
- ID: M24916
- Name: Stress Disorders, Traumatic
- Relevance: LOW
- As Found: Unknown
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M222
- Name: Trauma and Stressor Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000013313
- Term: Stress Disorders, Post-Traumatic
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434753
**Brief Title:** Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease.
**Official Title:** Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease: A Multicenter, Randomized, Double-blind, Placebo Controlled Clinical Trial
#### Organization Study ID Info
**ID:** IC/LV/ACZ/PCHC
#### Organization
**Class:** OTHER
**Full Name:** Hospital Universitari Vall d'Hebron Research Institute
### Status Module
#### Completion Date
**Date:** 2026-03-02
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-04
**Type:** ACTUAL
**Last Update Submit Date:** 2024-06-03
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-03-02
**Type:** ESTIMATED
#### Start Date
**Date:** 2022-10-02
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Hospital General Universitario Gregorio Marañon
**Class:** OTHER
**Name:** Hospital Vall d'Hebron
**Class:** UNKNOWN
**Name:** Hospital Universitario Puerta del Hierro
**Class:** OTHER
**Name:** Hospital Clinic of Barcelona
**Class:** OTHER
**Name:** Hospital Universitario Central de Asturias
**Class:** OTHER
**Name:** Complejo Hospitalario de Toledo
**Class:** OTHER
**Name:** Germans Trias i Pujol Hospital
**Class:** OTHER
**Name:** Hospital Universitario Marqués de Valdecilla
**Class:** OTHER
**Name:** Hospital Miguel Servet
**Class:** OTHER
**Name:** Parc Taulí Hospital Universitari
**Class:** OTHER
**Name:** Hospital de la Santa creu i Sant Pau - Barcelona
**Class:** OTHER
**Name:** Hospital Universitari de Bellvitge
**Class:** OTHER
**Name:** Hospital del Mar
**Class:** NETWORK
**Name:** University Hospital of Girona Dr.Josep Trueta
#### Lead Sponsor
**Class:** OTHER
**Name:** Hospital Universitari Vall d'Hebron Research Institute
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Zinc homeostasis could play a role in advanced chronic liver disease (cACLD) and its supplementation has been linked with improvement in liver function, decrease of hepatic complications and reduction in hepatocellular carcinoma (HCC) incidence. cACLD encompasses a heterogeneous group of patients with a variable risk of clinically significant portal hypertension (CSPH) and clinical events. The ANTICIPATE model is a validated model for stratifying these risks. Our aim is to demonstrate that the administration of zinc can reduce the rate and risk of presenting clinical events (first decompensation, HCC, death and liver transplantation). This study protocol describes an ongoing phase III, national, multicentre, randomized, double-blind clinical trial that will enroll 300 patients to receive either the trial treatment (zinc acexamate) or placebo. An inclusion period of 42 months is planned, with a minimal duration of follow up of 2 years. Our principal hypothesis is that zinc could modify the natural history of cACLD patients, with an overall improvement in prognosis
### Conditions Module
**Conditions:**
- Advanced Chronic Liver Disease
- Portal Hypertension
- Hepatocellular Carcinoma
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Phase III, randomized, double-blind clinical trial with two parallel groups, controlled with placebo. This is a low-level intervention clinical trial since the experimental drug is an authorized medication. This is a multicenter national study with fifteen Spanish centers recruiting patients
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 300
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The experimental group will receive ACZ at a daily dose of 600 mg, equivalent to 100mg of elemental zinc (one hard gelatin capsule of 300 mg of ACZ twice a day). Treatment will be stopped when the patient presents any of the events that define the main endpoint of the study.
**Intervention Names:**
- Drug: Zinc Acexamate
**Label:** Zinc Acexamate
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control group will receive twice a day orally hard gelatin capsules, identical to those of ACZ, in color, weight and nature, but containing an inert preparation (isomaltose).
**Intervention Names:**
- Drug: Zinc Acexamate
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Placebo
- Zinc Acexamate
**Description:** The experimental group will receive ACZ at a daily dose of 600 mg, equivalent to 100mg of elemental zinc (one hard gelatin capsule of 300 mg of ACZ twice a day). Treatment will be stopped when the patient presents any of the events that define the main endpoint of the study.
The control group will receive twice a day orally hard gelatin capsules, identical to those of ACZ, in color, weight and nature, but containing an inert preparation (isomaltose).
**Name:** Zinc Acexamate
**Other Names:**
- Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Ordinal scale to assess efficacy of the intervention, with expected distribution of patients on each study arm at the 2-year mark, based on an effect size of an OR of 0.55.The most severe category (Value 6) will be the development of clinical events:First decompensation,hepatocellular carcinoma, liver related-death (non-liver-related deaths as competing events), and liver transplantation.Those patients free of a liver-related event at 2 years,will be classified according to the risk of CSPH (ANTICIPATE model value), distributing patients in the ordinal scale with ascending hierarchy of CSPH risk: Level 1,\<0.30 risk;Level 2,0.30-0.45 risk;Level 3, 0.45-0.60 risk;Level 4, 0.60-0.85 risk;and Level 5, \>0.85 risk.
Expected clinical events at 2 years of follow-up (PREDESCI study and others on natural history of liver cirrhosis) with added effect of decompensation, HCC and death:20% of clinical events at 2 years (16% decompensations,2% hepatocellular carcinomas and 2% deaths).
**Measure:** Values 1-6. Ordinal scale to assess efficacy of the intervention.
**Time Frame:** 24 months
**Description:** Time to occurrence of the composite endpoint of only clinical events until study termination.
**Measure:** Time-dependent composite clinical endpoint
**Time Frame:** End of Follow-up
#### Secondary Outcomes
**Description:** Number of descompensations: First descompensation, hepatocellular carcinoma, liver related-death, liver transplantation.
**Measure:** Evaluate if the administration of zinc decreases the risk of having the first decompensation and what type.
**Time Frame:** 24 months
**Description:** Odds Ratio
**Measure:** Evaluate if the administration of zinc decreases the risk of CSPH estimated by the ANTICIPATE model.
**Time Frame:** 24 months
**Description:** Odds Ratio
**Measure:** Evaluate if the administration of zinc reduces the risk of hepatocellular carcinoma.
**Time Frame:** 24 months
**Description:** Odds Ratio
**Measure:** Evaluate if the administration of zinc reduces the risk of bacterial infections.
**Time Frame:** 24 months
**Description:** Odds Ratio
**Measure:** Evaluate if the administration of zinc improves overall transplant-free survival and the risk of liver-related death.
**Time Frame:** 24 months
**Description:** Child-Pugh: 5 (better outcome) to 15 (worse outcome). Child- Pugh has not an unabbreviated title. MELD: 6 (better outcome) to 40 (worse outcome)
**Measure:** Evaluate if the administration of zinc improves liver function as measured by Child-Pugh and End-stage Liver Disease (MELD) score.
**Time Frame:** 24 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients of both sexes with diagnosed compensated advanced chronic liver disease (cACLD) determined by hepatic stiffness on transient elastography \>15 kPa.
* Age between 18 and 80 years, inclusive.
* Absence of prior or current decompensation.
* For women of childbearing age, a possible pregnancy will be ruled out by a pregnancy test prior to the start of the study. Following the test, the woman must use an effective contraceptive method during sexual intercourse (see Appendix I) in the days leading up to the start of treatment, and continue to use it throughout the treatment period, as well as for several days after its completion.
* Signing of informed consent.
Exclusion Criteria:
* History or current presence of hepatocellular carcinoma.
* Concomitant systemic disease with a short-term poor prognosis.
* Pregnancy, breastfeeding, or refusal to use contraceptive measures during participation in the study.
* Patients with compensated advanced chronic liver disease (cACLD) due to hepatitis B virus (HBV) under antiviral treatment, and those with cACLD due to hepatitis C virus (HCV) cured with antiviral treatment.
**Maximum Age:** 80 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Joan Genescá, MD, PhD
**Phone:** 934 89 30 00
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Barcelona
**Contacts:**
***Contact 1:***
- **Name:** Joan Genescá, MD, PhD
- **Role:** CONTACT
**Country:** Spain
**Facility:** Hospital Universitari Vall d'Hebron
**Status:** RECRUITING
**Zip:** 08035
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000004066
- Term: Digestive System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M10024
- Name: Hypertension
- Relevance: LOW
- As Found: Unknown
- ID: M11107
- Name: Liver Diseases
- Relevance: HIGH
- As Found: Liver Disease
- ID: M9613
- Name: Carcinoma, Hepatocellular
- Relevance: LOW
- As Found: Unknown
- ID: M10026
- Name: Hypertension, Portal
- Relevance: HIGH
- As Found: Portal Hypertension
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008107
- Term: Liver Diseases
- ID: D000006975
- Term: Hypertension, Portal
### Intervention Browse Module - Ancestors
- ID: D000000894
- Term: Anti-Inflammatory Agents, Non-Steroidal
- ID: D000018712
- Term: Analgesics, Non-Narcotic
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000018501
- Term: Antirheumatic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: Hemat
- Name: Hematinics
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: Micro
- Name: Micronutrients
### Intervention Browse Module - Browse Leaves
- ID: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M164210
- Name: 6-acetylaminocaproic acid
- Relevance: HIGH
- As Found: Colloidal silica
- ID: M17768
- Name: Zinc
- Relevance: LOW
- As Found: Unknown
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4218
- Name: Anti-Inflammatory Agents, Non-Steroidal
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M20786
- Name: Analgesics, Non-Narcotic
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: C000018802
- Term: 6-acetylaminocaproic acid
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434740
**Brief Title:** A Study of SBRT Combined With Puterizumab in Intrapulmonary Metastasis From NSCLC
**Official Title:** The Efficacy and Safety of Stereotactic Radiotherapy Combined With Puterizumab in Non Small Cell Lung Cancer With Intrapulmonary Metastasis:A Phase II Prospective Single Arm Clinical Study
#### Organization Study ID Info
**ID:** SRRS-LCsbrt
#### Organization
**Class:** OTHER
**Full Name:** Sir Run Run Shaw Hospital
### Status Module
#### Completion Date
**Date:** 2027-12-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Sir Run Run Shaw Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study aims to evaluate the efficacy and safety of SBRT combined with Puterizumab immunotherapy for non-small cell lung cancer with pulmonary metastases, and to determine the correlation between MRD and treatment efficacy. Through single-cell sequencing and spatial transcriptome information analysis, the underlying mechanisms will be analyzed to provide a basis for improving the new precision treatment methods for tumor immunotherapy resistance.
### Conditions Module
**Conditions:**
- Non-Small-Cell Lung Cancer
**Keywords:**
- lung cancer
- radiotherapy
- immunotherapy
- single-cell sequencing
- SBRT
- peripheral blood mononuclear cell
- minimalResidual disease
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 37
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The enrolled subjects will receive SBRT treatment combined with Puterizumab.
**Intervention Names:**
- Radiation: Stereotactic Body Radiation Therapy,SBRT
- Drug: Puterizumab
**Label:** experimental group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- experimental group
**Description:** The enrolled subjects will receive SBRT treatment for lung metastases.The dose segmentation is 10Gy/f, with a total dose of 50Gy/5f, once every other day.
**Name:** Stereotactic Body Radiation Therapy,SBRT
**Type:** RADIATION
#### Intervention 2
**Arm Group Labels:**
- experimental group
**Description:** Within 7-14 days after SBRT, Puterizumab should be used (dosage: recommended dosage of 200mg, intravenous infusion, infusion time of 60 minutes (± 15 minutes), once every 3 weeks (Q3W), for 6-8 months or intolerable toxicity).
**Name:** Puterizumab
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** The tumor response rate will evaluate the local control of lung metastases,referring to the evaluation criteria for solid tumor efficacy RECIST 1.1
**Measure:** tumor response rate
**Time Frame:** From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
#### Secondary Outcomes
**Description:** Using the minimal residual disease (MRD) panel for ctDNA molecular residual detection, and through ctDNA multi-node assessment, we can dynamically monitor the therapeutic efficacy and disease recurrence.
**Measure:** Minor Residual Lesions
**Time Frame:** From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
**Description:** PFS is the time from enrollment to tumor progression or death.
**Measure:** progression-free survival
**Time Frame:** From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
**Description:** OS is the time from enrollment to death due to any reason.
**Measure:** overall survival
**Time Frame:** From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
**Description:** Refer to the acute radiation injury grading standards of the United States Collaborative Group on Tumor Radiotherapy (RTOG)
**Measure:** RTOG acute radiation injury grading
**Time Frame:** From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted during the entire SBRT process and monthly after SBRT for up to 12 months.
**Description:** The quality of life will be evaluated using the QLQ-30 score.
**Measure:** QLQ-30 score
**Time Frame:** From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
**Description:** Using flow cytometry to detect the count and percentage of lymphocytes, including CD3+, CD3+, CD4+, CD3+, CD8+, CD4+/CD8+, and CD3-CD56+.
**Measure:** Lymphocyte subpopulation analysis
**Time Frame:** From the date of enrollment until the first record of tumor progression or any cause of death (whichever comes first), evaluations will be conducted 3 weeks and every 3 months after SBRT for up to 48 months.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. age≥18
2. Non small cell lung cancer patients who have experienced pulmonary metastasis after PD-1 immunotherapy in the past
3. Voluntarily participate in this study and sign an informed consent form
4. The presence of evaluable size and number of pulmonary metastases on chest CT
5. There are indications for lung puncture biopsy
6. General physical condition (ECOG) 0-1
7. The laboratory test meets the following standards: white blood cell count\>3.5 × 109/L, absolute value of neutrophils\>1.8 × 109/L, platelet count ≥ 75 × 109/L, hemoglobin ≥ 100g/L; NR ≤ 1.5, and APTT ≤ 1.5 times the upper limit of normal value or partial prothrombin time (PT) ≤ 1.5 times the upper limit of normal value; Total bilirubin ≤ 1.25 times the upper limit of normal value; ALT and AST\<5 times the upper limit of normal values; 24-hour creatinine clearance rate\>50mL/min or blood creatinine\<1.5 times the upper limit of normal value.
Exclusion Criteria:
1. Unable to tolerate or refuse further immunotherapy
2. Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiteracy, etc
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xiaonan Sun, Ph D
**Phone:** 8613606618387
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Xuyun Xie, MD
**Phone:** 8613989882983
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Sir Runrun Shaw Hospital
**Name:** Xiaonan Sun, Ph D
**Role:** STUDY_CHAIR
### IPD Sharing Statement Module
**Description:** After the research is completed, the statistical results will be published as an article.
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012142
- Term: Respiratory Tract Neoplasms
- ID: D000013899
- Term: Thoracic Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000002283
- Term: Carcinoma, Bronchogenic
- ID: D000001984
- Term: Bronchial Neoplasms
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: 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: M12307
- Name: Neoplasm Metastasis
- Relevance: LOW
- As Found: Unknown
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M14979
- Name: Respiratory Tract Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M16658
- Name: Thoracic Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5540
- Name: Carcinoma, Bronchogenic
- Relevance: LOW
- As Found: Unknown
- ID: M5260
- Name: Bronchial Neoplasms
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008175
- Term: Lung Neoplasms
- ID: D000002289
- Term: Carcinoma, Non-Small-Cell Lung
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434727
**Acronym:** ISI-I3DM-01
**Brief Title:** Evaluating Intuitive 3D Models in Preoperative Surgical Planning for Thoracic and Colorectal Procedures.
**Official Title:** A Retrospective Multicenter Study for Intuitive 3D Models (I3DM), During Simulated Preoperative Surgical Planning for Anatomic Lung Resection and Lower Anterior Resection Procedures
#### Organization Study ID Info
**ID:** ISI-I3DM-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Intuitive Surgical
### Status Module
#### Completion Date
**Date:** 2024-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-11
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Intuitive Surgical
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The Study Objective: To evaluate the clinical utility of a 3D model with 2D CT/MRI scans during simulated preoperative surgical planning of open, laparoscopic, or robotic-assisted anatomic lung resection (segmentectomy, lobectomy) or Lower Anterior Resection (LAR) procedures.
**Detailed Description:** This is a Retrospective study evaluating the clinical utility of a 3D model with 2D CT/MRI scans during simulated preoperative surgical planning of open, laparoscopic, or robotic-assisted anatomic lung resection (segmentectomy, lobectomy) or Lower Anterior Resection (LAR) procedures.
### Conditions Module
**Conditions:**
- Thoracic
- Colorectal Disorders
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 80
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Anatomic Lung Resection (Segmentectomy or Lobectomy) Procedures
**Label:** Thoracic Group
#### Arm Group 2
**Description:** Lower Anterior Resection Procedures
**Label:** Colorectal Group
### Outcomes Module
#### Primary Outcomes
**Description:** Surgeon questionnaires evaluating their preoperative surgical plan
**Measure:** Clinical Utility of 3D Model vs standard 2D in Preoperative Surgcial Planning
**Time Frame:** 2 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
DICOM inages from Subjects 18 years or older who have undergone either anatomic lung resection (segmentectomy, lobectomy) or a Lower Anterior Resection procedure will be .
Exclusion Criteria:
* N/A
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Subjects 18 years or older who have undergone anatomic lung resection (segmentectomy, lobectomy) or a Lower Anterior Resection procedure will be considered for this study.
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434714
**Brief Title:** Management of Postoperative Pain After Cesarean Delivery Using Bridge Auricular Percutaneous Nerve Field Stimulator
**Official Title:** Management of Postoperative Pain After Cesarean Delivery Using Bridge Auricular Percutaneous Nerve Field Stimulator
#### Organization Study ID Info
**ID:** INOVA-2023-131
#### Organization
**Class:** OTHER
**Full Name:** Inova Fairfax Hospital
### Status Module
#### Completion Date
**Date:** 2025-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-08
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Inova Fairfax Hospital
#### Responsible Party
**Investigator Affiliation:** Inova Fairfax Hospital
**Investigator Full Name:** Antonio Saad
**Investigator Title:** Director of Perinatal Research Unit
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Post-cesarean section (CS) pain is commonly treated with acetaminophen, ibuprofen, and opioid medications as needed following delivery. About 300,000 women annually who were exposed to opioids after CS will go on to use opioids chronically. Reducing the quantity of post-CS opioids has been shown to decrease the amount of opioids used without compromising pain control. Bridge is a small device that sits on the outer ear and works similarly to a transcutaneous electrical nerve stimulation (TENS) unit to decrease pain sensation without medications. It has been shown to effectively reduce pain to decrease medication requirements after surgeries. This study aims to see if women receiving the Bridge device use need less pain medication than those without the device.
**Detailed Description:** Cesarean delivery is one of the most performed surgeries in the U.S. with approximately 1.15 million surgeries performed annually. Despite this, postoperative pain management remains a challenge. Prescribed total milligram morphine equivalents (MMEs) can range from 25 MMEs (equivalent to 3.3 oxycodone 5-mg tablets) to 1,950 MMEs (equivalent to 260 oxycodone 5-mg tablets). Additionally, the post discharge analgesia prescription is not correlated with the 24-hour predischarge opioid use or pain score. Most U.S. women who are prescribed opioids after a cesarean delivery receive at least 10 more tablets than necessary. A study looking at individualizing opioid prescriptions based on inpatient requirements found that women used about 60% of their prescription, regardless of the amount of opioids prescribed. Decreasing opioid requirement after cesarean delivery, can decrease women's exposure to opioids, reduce the risk of neonatal central nervous system depression due to exposure in breastmilk, and limit the potential for extra opioids from unused, filled prescriptions to fall into the wrong hands. Post-cesarean mothers use opioids for a median of 8 days after delivery. Bridge is a minimally invasive device shown in previous studies to reduce pain medication requirements in the post-operative acute recovery period. The device is a auricular percutaneous electrical nerve stimulator that modulates pain receptors leading to reduced pain sensation. This trial study to examine the utility of the Bridge device as an adjunct to standard of care post-cesarean pain regimens (acetaminophen, ibuprofen or ketorolac, and oxycodone or other similar opioid). Post-cesarean patients will be randomized in a 1:1:1 ratio to Bridge device, sham device, or standard of care treatment and followed through the postpartum period.
### Conditions Module
**Conditions:**
- Post-operative Pain, Acute
- Cesarean Section
- Opioid Use Disorder
- Opioids; Harmful Use
**Keywords:**
- cesarean section
- post-operative pain
- opioid abuse
- non-pharmacologic therapy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Double-blinded, placebo-controlled, 3 arm randomized controlled trial
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Participants will be randomized to either active Bridge device, sham (non-functional) device, or standard of care post-operative pain regimen. Participants, care providers, and investigators will be blinded to those in active or sham device groups.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 159
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Bridge device placed in post-anesthesia care unit (PACU) and worn until end-of-life of the device (at 5 days) in addition to standard of care pain medications as per institutional policy
**Intervention Names:**
- Device: Auricular percutaneous nerve field stimulator
**Label:** Bridge device
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Sham (non-functional) Bridge device placed in post-anesthesia care unit (PACU) and worn until 5 days post-delivery in addition to standard of care pain medications as per institutional policy
**Intervention Names:**
- Device: Sham auricular percutaneous nerve field stimulator
**Label:** Sham device
**Type:** SHAM_COMPARATOR
#### Arm Group 3
**Description:** Standard of care pain medications only as per institutional policy
**Label:** Standard of care
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Bridge device
**Description:** Percutaneous nerve field stimulator device placed on the ear for 5 days
**Name:** Auricular percutaneous nerve field stimulator
**Other Names:**
- Bridge
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- Sham device
**Description:** Non-functioning percutaneous nerve field stimulator device placed on the ear for 5 days
**Name:** Sham auricular percutaneous nerve field stimulator
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Total opioid intake in morphine milligram equivalents (MME) on post-operative day 4
**Measure:** Total opioid intake on post-operative day 4
**Time Frame:** Four days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Female 18 years or older able to provide informed consent in English or Spanish.
* Scheduled for cesarean delivery under neuraxial anesthesia.
* Intact skin surface behind and around the ear at the site of electrode application.
Exclusion Criteria:
* Active drug abuse.
* Chronic opioid user.
* Severe chronic pain.
* Hemophilia.
* Cardiac pacemaker or implantable electronic devices.
* Psoriasis vulgaris or other skin conditions precluding safe device application.
* Previous history of sensitivity to compound benzoin tincture.
* Hearing aid precluding proper placement of the device or removing which interferes with their hearing ability.
* Subject is concurrently participating in another research study with an investigational drug or medical device that in the Investigator's opinion could impact subject safety or study results.
* Subject with reasons to maintain an epidural beyond operative room.
* Subject with complex surgery or subject who may need more than a cesarean surgery with possible tubal sterilization procedure.
* Subject is deemed not suitable for the study at the discretion of the principal Investigator.
**Healthy Volunteers:** True
**Maximum Age:** 55 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Antonio Saad, MD
**Phone:** 7037766040
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ellen M Murrin, DO
**Phone:** 7037766040
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Falls Church
**Contacts:**
***Contact 1:***
- **Name:** Antonio Saad, MD
- **Phone:** 703-776-6040
- **Role:** CONTACT
***Contact 2:***
- **Name:** Antonio Saad, MD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 3:***
- **Name:** Ellen M Murrin, DO
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Inova Fairfax Medical Campus
**State:** Virginia
**Zip:** 22042
#### Overall Officials
**Official 1:**
**Affiliation:** Inova Health Systems
**Name:** Antonio Saad, MD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Inova Health Systems
**Name:** Ellen M Murrin, DO
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Osmundson SS, Min JY, Grijalva CG. Opioid prescribing after childbirth: overprescribing and chronic use. Curr Opin Obstet Gynecol. 2019 Apr;31(2):83-89. doi: 10.1097/GCO.0000000000000527.
**PMID:** 30789842
**Citation:** Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
**PMID:** 26996986
**Citation:** Chelly JE, Monroe AL, Planinsic RM, Tevar A, Norton BE. Auricular field nerve stimulation using the NSS-2 BRIDGE(R) device as an alternative to opioids following kidney donor surgery. J Complement Integr Med. 2021 Nov 1;19(2):449-454. doi: 10.1515/jcim-2021-0208. eCollection 2022 Jun 1.
**PMID:** 34714990
**Citation:** Lim G, LaSorda KR, Monroe AL, Chelly JE. Auricular percutaneous nerve field stimulator device as alternative therapy for Cesarean delivery analgesia: proof of concept. Can J Anaesth. 2019 Dec;66(12):1522-1523. doi: 10.1007/s12630-019-01465-x. Epub 2019 Aug 20. No abstract available.
**PMID:** 31432323
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000079524
- Term: Narcotic-Related Disorders
- ID: D000019966
- Term: Substance-Related Disorders
- ID: D000064419
- Term: Chemically-Induced Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC25
- Name: Substance Related Disorders
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Post Operative Pain, Acute
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12244
- Name: Opioid-Related Disorders
- Relevance: HIGH
- As Found: Opioid Use Disorder
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M2057
- Name: Narcotic-Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21837
- Name: Substance-Related Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M30302
- Name: Chemically-Induced Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010149
- Term: Pain, Postoperative
- ID: D000009293
- Term: Opioid-Related Disorders
### Intervention Browse Module - Browse Branches
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M4107
- Name: Anesthetics
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434701
**Acronym:** SPICE
**Brief Title:** Severe COVID-19 Infection in Children Presenting to EDs in Israel and England
**Official Title:** Severe COVID-19 Infection in Children Presenting to Emergency Departments in Israel and England: A Prospective Multicenter Study
#### Organization Study ID Info
**ID:** SPICE-HMO-CTIL
#### Organization
**Class:** OTHER
**Full Name:** Hadassah Medical Organization
### Status Module
#### Completion Date
**Date:** 2026-08-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** London North West Healthcare NHS Trust
#### Lead Sponsor
**Class:** OTHER
**Name:** Hadassah Medical Organization
#### Responsible Party
**Investigator Affiliation:** Hadassah Medical Organization
**Investigator Full Name:** Itai Shavit
**Investigator Title:** Chair, Division of Pediatrics, Hadassah Medical Center
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** Even though the COVID-19 pandemic is no longer at its peak, the threat still lingers. Engaging in prospective surveillance studies will enable us to monitor the disease and prepare for any potential resurgence. COVID-19 surveillance studies are essential tools for policymakers to make informed decisions, allocate resources, and develop strategies to control the spread of the virus and protect public health.
The objective of this surveillance study is to prospectively assess in-hospital severe morbidity related to COVID-19 infection in children who present to the Pediatric Emergency Department (ED).
A prospective multicenter study will be conducted across eight EDs in Israel and five EDs in the United Kingdom. The study population will include children aged 16 years or younger with a severe acute COVID-19 infection. Confirmation of acute COVID-19 infection will be based on polymerase chain reaction nasopharyngeal swab testing. The study will also include patients diagnosed with multisystem inflammatory syndrome in children (MIS-C), as defined by the CDC.
### Conditions Module
**Conditions:**
- COVID-19
- Inflammatory Response
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SCREENING
#### Enrollment Info
**Count:** 500
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Nasopharyngeal swab sampling for COVID-19
**Intervention Names:**
- Diagnostic Test: Nasopharyngeal swab sampling for COVID-19
**Label:** Severe acute COVID-19 infection
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Severe acute COVID-19 infection
**Description:** The healthcare provider will gently insert the swab a short distance (1-1.5 cm for young children) into one nostril, reaching the back of the nasal cavity. The swab will then be gently rotated and rubbed for a few seconds to collect a sample of mucus. The same process may be repeated in the other nostril.
**Name:** Nasopharyngeal swab sampling for COVID-19
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The percentage of patients diagnosed with SACI among all patients admitted to the Emergency Department
**Measure:** Severe acute COVID-19 infection (SACI)
**Time Frame:** Up to 16 weeks
#### Secondary Outcomes
**Description:** The percentage of COVID-19 patients treated with low-flow oxygen among all patients admitted to the Emergency Department
**Measure:** Administration of low-flow oxygen therapy via nasal cannula or face mask
**Time Frame:** Up to 12 weeks
**Description:** The percentage of COVID-19 patients treated with HFNC or CPAP among all patients admitted to the Emergency Department
**Measure:** Administration of high-flow oxygen via nasal cannula (HFNC), or administration of oxygen via bilevel or continuous positive airway pressure (CPAP) machine
**Time Frame:** Up to 12 weeks
**Description:** The percentage of COVID-19 patients treated with mechanical ventilation among all patients admitted to the Emergency Department
**Measure:** Treatment with mechanical ventilation
**Time Frame:** Up to 12 weeks
**Description:** The percentage of COVID-19 patients treated with ECMO among all patients admitted to the Emergency Department
**Measure:** Treatment with extracorporeal membrane oxygenation (ECMO)
**Time Frame:** Up to 8 weeks
**Description:** The percentage of COVID-19 patients treated with vasopressor support among all patients admitted to the Emergency Department
**Measure:** Treatment with vasopressor support
**Time Frame:** Up to 8 weeks
**Description:** Mean duration of ICU stay for patients admitted with COVID-19
**Measure:** Length of ICU stay
**Time Frame:** Up to 16 weeks
**Description:** Mean duration of hospital stay for patients admitted with COVID-19
**Measure:** Length of hospital stay
**Time Frame:** Up to 24 weeks
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. SACI
Patients aged 16 years or younger with a positive COVID-19 PCR nasopharyngeal swab testing or bronchoalveolar sample who meet the definition of SACI:
* Receive oxygen via low-flow nasal cannula or oxygen mask, high-flow nasal cannula, bilevel or continuous positive airway pressure machine, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) Or
* Admitted to ICU
2. MIS-C Patients aged 16 years or younger diagnosed with MIS-C
**Maximum Age:** 16 Years
**Minimum Age:** 0 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Itai Shavit, MD
**Phone:** 00 972 50 2063239
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Hadas Lamberg, PhD
**Phone:** 00 972 2 6777572
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007239
- Term: Infections
- ID: D000011024
- Term: Pneumonia, Viral
- ID: D000011014
- Term: Pneumonia
- ID: D000012141
- Term: Respiratory Tract Infections
- ID: D000014777
- Term: Virus Diseases
- ID: D000018352
- Term: Coronavirus Infections
- ID: D000003333
- Term: Coronaviridae Infections
- ID: D000030341
- Term: Nidovirales Infections
- ID: D000012327
- Term: RNA Virus Infections
- ID: D000008171
- Term: Lung Diseases
- ID: D000012140
- Term: Respiratory Tract Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC01
- Name: Infections
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
### Condition Browse Module - Browse Leaves
- ID: M7796
- Name: Emergencies
- Relevance: LOW
- As Found: Unknown
- ID: M2561
- Name: COVID-19
- Relevance: HIGH
- As Found: COVID-19
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M13904
- Name: Pneumonia
- Relevance: LOW
- As Found: Unknown
- ID: M13914
- Name: Pneumonia, Viral
- Relevance: LOW
- As Found: Unknown
- ID: M14978
- Name: Respiratory Tract Infections
- Relevance: LOW
- As Found: Unknown
- ID: M17522
- Name: Virus Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M20490
- Name: Coronavirus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6555
- Name: Coronaviridae Infections
- Relevance: LOW
- As Found: Unknown
- ID: M23685
- Name: Nidovirales Infections
- Relevance: LOW
- As Found: Unknown
- ID: M15149
- Name: RNA Virus Infections
- Relevance: LOW
- As Found: Unknown
- ID: M11168
- Name: Lung Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000086382
- Term: COVID-19
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434688
**Brief Title:** Body Awareness and Mental Fatigue in Neck Pain
**Official Title:** Examining Mental Fatigue, Body Awareness, and Mindfulness in People With Chronic Neck Pain
#### Organization Study ID Info
**ID:** 10557444
#### Organization
**Class:** OTHER
**Full Name:** Hacettepe University
### Status Module
#### Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-29
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-27
**Type:** ESTIMATED
**Status Verified Date:** 2024-02
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Hacettepe University
#### Responsible Party
**Investigator Affiliation:** Hacettepe University
**Investigator Full Name:** Selenay Aydogdu
**Investigator Title:** principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The primary aim of the study was to examine the difference between mental fatigue, in-body, out-of-body and mindfulness parameters in people with chronic neck pain compared to a healthy control group, and to analyze the relationships between mental fatigue and neck disability level and awareness levels, and between awareness levels and neck disability level and quality of life.
The secondary aim was to examine the relationships between pain intensity, frequency, duration, pain self-efficacy, physical condition, anxiety and depression, mental fatigue and awareness levels in people with chronic neck pain.
**Detailed Description:** Neck pain is a prevalent musculoskeletal issue that can cause significant disability. Individuals with neck pain may experience changes in muscle structure and behavior, as well as sensory-perceptual-motor issues such as decreased proprioception and related neuromuscular changes. Additionally, neck pain can lead to psychological problems such as anxiety and depression.Although some awareness parameters have been evaluated in studies on neck pain in the literature and it has been shown that chronic pain is associated with impaired body awareness and that this impairment contributes to and/or maintains chronic pain, no study has been found to examine all awareness parameters in detail. Another cause that compromises the accuracy of information contributing to body awareness is mental fatigue. Mental fatigue can negatively affect a person's level of perception. In one study, it was stated that mental fatigue was a determinant of neck disability, but studies on this subject were found to be very insufficient. Therefore, the aim of this study was to examine the sub-parameters of awareness and mental fatigue in people with chronic neck pain, to compare them with healthy people and to examine the relationship between the parameters evaluated.
### Conditions Module
**Conditions:**
- Neck Pain
- Mental Fatigue
- Mindfulness
- Awareness
**Keywords:**
- mental fatigue
- Mindfulness
- Interoception
- Proprioception
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 66
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Study Group Inclusion Criteria:
* Having chronic neck pain for at least 3 months.
* Being between 18 and 65 years of age.
* Scoring 5 and above on the Neck Disability Questionnaire.
* Scoring 24 and above on the Mini Mental Status Examination.
* Being able to read and write.
* Being willing to participate in the study.
Study Group Exclusion Criteria:
* Participation in any physical therapy program in the last 3 months.
* Having the following problems:
* Radiculopathy, myleopathy (motor and sensory loss) and other neurologic diseases.
* Inflammatory diseases
* History of malignancy.
* Congenital spinal cord anomaly and congenital spinal deformities
* Spinal pathologies, traumatic medulla spinalis injury and other medulla spinalis pathologies.
* Vestibular disorders.
* Diagnosed psychiatric disorders such as bipolar disorder and panic attacks.
* Vision problems that do not improve despite vision aids.
* Pregnancy
**Intervention Names:**
- Other: Mental Fatigue:
- Other: Body Awareness:
- Other: Neck Disability Level
- Other: Quality Of Life
- Other: Pain Assessment:
- Other: Physical Condition:
- Other: Anxiety and Depression:
**Label:** Individuals experiencing neck pain
#### Arm Group 2
**Description:** Control Group Inclusion Criteria:
* Age between 18 and 65 years.
* Scoring 24 and above on the Mini Mental State Examination.
* To be able to read and write.
* Volunteering to participate in the study.
Control Group Exclusion Criteria:
* Having chronic pain in the spine, especially in the neck.
* Exclusion criteria for the study group
**Intervention Names:**
- Other: Mental Fatigue:
- Other: Body Awareness:
- Other: Quality Of Life
- Other: Physical Condition:
- Other: Anxiety and Depression:
**Label:** Healthy individuals without neck pain
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Healthy individuals without neck pain
- Individuals experiencing neck pain
**Description:** The Mental Fatigue Scale (MFS) will be used to assess mental fatigue.
**Name:** Mental Fatigue:
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Healthy individuals without neck pain
- Individuals experiencing neck pain
**Description:** Individuals' general body awareness will be assessed with the Body Awareness Questionnaire (BAQ).
Neck awareness of individuals will be assessed with the Fremantle Neck Awareness Questionnaire (FreBFA).
Short Form of the Five Facet Mindfulness Questionnaire (FFMQ - Short Form) will be used to assess people's mindfulness.
- In-body awareness:
For the sense of interoception, the Multidimensional Assessment of Interoceptive Awareness Scale, which assesses interoceptive body awareness, will be used.
To evaluate proprioception, a Cervical Range of Motion (CROM) device is used.
The bucket test will be used to assess subjective visual verticality, which is one of the sub-dimensions of verticality perception.
Two scales will be used to assess people's awareness of weight transfer symmetry.
- Out of Body Awareness:
"Right-Left Confusion Hand Test" will be used to evaluate the mental rotation skill within the scope of the sense of extroception.
**Name:** Body Awareness:
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Individuals experiencing neck pain
**Description:** Neck disability index will be used to assess this parameter.
**Name:** Neck Disability Level
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- Healthy individuals without neck pain
- Individuals experiencing neck pain
**Description:** SF-12 will be used to assess quality of life.
**Name:** Quality Of Life
**Type:** OTHER
#### Intervention 5
**Arm Group Labels:**
- Individuals experiencing neck pain
**Description:** Pain intensity will be assessed by Visual Analog Scale (VAS). In addition, pain duration and pain frequency will be questioned. The Pain Self-Efficacy Questionnaire will be used to assess the confidence of people with chronic pain to perform certain tasks and behaviors despite their pain.
**Name:** Pain Assessment:
**Type:** OTHER
#### Intervention 6
**Arm Group Labels:**
- Healthy individuals without neck pain
- Individuals experiencing neck pain
**Description:** Normal range of motion of the cervical region will be evaluated with the "Cervical Range of Motion" device.
New York Posture Rating Scale will be used to evaluate posture.
Symmetry of weight transfer to both lower extremities of the individuals in standing upright position will be evaluated.
**Name:** Physical Condition:
**Type:** OTHER
#### Intervention 7
**Arm Group Labels:**
- Healthy individuals without neck pain
- Individuals experiencing neck pain
**Description:** Beck Depression and Beck Anxiety scales will be used to assess depression and anxiety.
**Name:** Anxiety and Depression:
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The Mental Fatigue Scale (MFS) will be used to assess mental fatigue. It includes questions about general fatigue, lack of initiative, mental fatigue, concentration difficulties, memory problems, slowness of thinking, sensitivity to stress, increased tendency to be emotional, irritability, sensitivity to light and noise, decreased or increased sleep. It has a 7-point Likert-type scale and is scored from 0 to 3. A rating of 0 indicates normal functioning, 1 indicates mild problem, 2 indicates significant problem and 3 indicates maximum problem. According to the total score, 0-10= no mental fatigue problem, 10.5-14.5= mild mental fatigue, 15-20= quite serious mental fatigue, ≥ 20.5= serious mental fatigue.
**Measure:** Mental Fatigue
**Time Frame:** 2024 may- 2024 July
**Description:** General body awareness of individuals will be assessed with the Body Awareness Questionnaire (BAQ).
**Measure:** General Body Awareness
**Time Frame:** 2024 may- 2024 July
**Description:** Neck disability index will be used to assess this parameter. The questionnaire contains 10 questions related to different activities. Each question is scored between 0 and 5. The level of disability is determined according to the total score obtained from the questionnaire. 0-4 = no disability, 5-14 = mild disability, 15-24 = moderate disability, 25- 34 = severe disability, 35 and above = total disability.
**Measure:** Neck Disability
**Time Frame:** 2024 may- 2024 July
**Description:** The SF-12, which is more practical and shorter than the SF-36 but contains the same sub-dimensions as the SF-36, will be used to assess quality of life. SF-12 consists of 8 sub-dimensions and 12 items including physical functioning (2 items), physical role, body pain, general health, energy, social functioning, emotional role and mental health. The questionnaire scoring is calculated under the headings of physical and mental health, which are the two main components of general health.
**Measure:** General health questionnaire
**Time Frame:** 2024 may - 2024 July
**Description:** Two scales were used to assess weight transfer awareness. Results will be recorded in kg.
**Measure:** weight transfer awareness
**Time Frame:** 2024 may- 2024 July
**Description:** Individuals' neck awareness will be assessed with the Fremantle Neck Awareness Questionnaire (FreBFA).
**Measure:** neck awareness
**Time Frame:** 2024 may- 2024 July
**Description:** Short Form of the Five Facet Mindfulness Questionnaire (FFMQ - Short Form) will be used to assess people's mindfulness
**Measure:** mindfulness
**Time Frame:** 2024 may- 2024 July
**Description:** For the sense of interoception, the Multidimensional Assessment of Interoceptive Awareness Scale, which assesses interoceptive body awareness, will be used.
**Measure:** interoception
**Time Frame:** 2024 may- 2024 July
**Description:** The Cervical Range of Motion (CROM) device is used to assess proprioception. The device assesses proprioception in 6 different directions of the neck.
**Measure:** proprioception
**Time Frame:** 2024 may- 2024 July
**Description:** The bucket test will be used to assess subjective visual verticality, which is one of the sub-dimensions of verticality perception.
**Measure:** verticality
**Time Frame:** 2024 may- 2024 July
**Description:** The sense of extroception will be evaluated with the right-left hand confusion test.
**Measure:** extroception
**Time Frame:** 2024 may- 2024 July
#### Secondary Outcomes
**Description:** Pain intensity will be assessed by Visual Analog Scale (VAS).0: I have no pain 10: I have unbearable pain In addition, pain duration and pain frequency will be questioned.
**Measure:** Pain Assessment
**Time Frame:** 2024 may- 2024 July
**Description:** The Pain Self-Efficacy Questionnaire will be used to assess the confidence of people with chronic pain to perform certain tasks and behaviors despite their pain. Each item is rated on a 7-point Likert-type scale (0=not at all confident, 6=fully confident). The total score ranges from 0 to 60, with higher scores indicating greater self-efficacy for functioning despite pain.
**Measure:** Pain self efficacy
**Time Frame:** 2024 may- 2024 July
**Description:** Beck Depression and Beck Anxiety scales will be used to assess depression and anxiety. Both questionnaires have 21 questions and are scored between 0-3. According to the total scores, 0-9 points in the Beck Depression Scale indicates normal level, 10-16 points indicates mild depression, 17-29 points indicates moderate depression and 30-63 points indicates severe depression. On the Beck Anxiety Scale, 0-17 points are classified as low anxiety, 18-24 points as moderate anxiety, and 25 and above points as high anxiety.
**Measure:** Anxiety and Depression
**Time Frame:** 2024 may- 2024 July
**Description:** Normal range of motion of the cervical region will be evaluated with the "Cervical Range of Motion" device. Active ranges of motion in flexion-extension, lateral flexion and rotation directions will be recorded with the subjec
**Measure:** Range of motion
**Time Frame:** 2024 may- 2024 July
**Description:** New York Posture Rating Scale will be used to evaluate posture. Posture changes that may occur in 13 different parts of the body including head, neck, shoulders, shoulders, back, waist, hip and ankle are observed. According to the results of the observation, five (5) points are given if the person has proper posture, three (3) points if the posture is moderately impaired, and one (1) point if there is a serious impairment. A high score means that the posture is good.
**Measure:** Posture Assesment
**Time Frame:** 2024 may- 2024 July
**Description:** Symmetry of weight transfer to both lower extremities of the individuals in a standing upright position will be evaluated. It will be recorded in kg.
**Measure:** Weight transfer
**Time Frame:** 2024 may- 2024 July
### Eligibility Module
**Eligibility Criteria:** Study Group Inclusion Criteria:
* Having chronic neck pain for at least 3 months.
* Being between 18 and 65 years of age.
* Scoring 5 and above on the Neck Disability Questionnaire.
* Scoring 24 and above on the Mini Mental State Examination.
* To be able to read and write.
* Being volunteer to participate in the study.
Study Group Exclusion Criteria:
* Participation in any physical therapy program in the last 3 months.
* Having the following problems:
* Radiculopathy, myleopathy (motor and sensory loss) and other neurological diseases.
* Inflammatory diseases (rheumatoid arthritis, etc.).
* History of malignancy.
* Congenital spinal cord anomaly and congenital spinal deformities.
* Spinal pathologies, traumatic medulla spinalis injury and other medulla spinalis pathologies.
* Vestibular disorders.
* Diagnosed psychiatric illnesses such as bipolar disorder, psychotic illnesses and panic attacks.
* Vision problems that do not fully recover despite vision aids (glasses, etc.).
* Pregnancy status
Control Group Inclusion Criteria:
* Age between 18 and 65 years.
* Scoring 24 and above on the Mini Mental State Examination.
* To be able to read and write.
* Volunteering to participate in the study.
Control Group Exclusion Criteria:
* Having chronic pain in the spine, especially in the neck.
* Exclusion criteria for the study group
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** individuals with neck pain and healthy individuals without neck pain
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Ankara
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Selenay Aydoğdu, 1
- **Phone:** 5312723599
- **Phone Ext:** +90
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Nezire Köse, 2
- **Phone:** 3052525
- **Phone Ext:** 0312
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Hacettepe University
**State:** Sıhhiye
**Zip:** 06100
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Amiri Arimi S, Ghamkhar L, Kahlaee AH. The Relevance of Proprioception to Chronic Neck Pain: A Correlational Analysis of Flexor Muscle Size and Endurance, Clinical Neck Pain Characteristics, and Proprioception. Pain Med. 2018 Oct 1;19(10):2077-2088. doi: 10.1093/pm/pnx331.
**PMID:** 29304254
**Citation:** Dere T, Alemdaroglu-Gurbuz I. Muscular endurance and its association with neck pain, disability, neck awareness, and kinesiophobia in patients with chronic neck pain. Somatosens Mot Res. 2023 Mar 10:1-8. doi: 10.1080/08990220.2023.2186390. Online ahead of print.
**PMID:** 36897182
#### See Also Links
**Label:** The Relevance of Proprioception to Chronic Neck Pain: A Correlational Analysis of Flexor Muscle Size and Endurance, Clinical Neck Pain Characteristics, and Proprioception
**URL:** https://pubmed.ncbi.nlm.nih.gov/29304254/
**Label:** Muscular endurance and its association with neck pain, disability, neck awareness, and kinesiophobia in patients with chronic neck pain
**URL:** https://pubmed.ncbi.nlm.nih.gov/36897182/
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000001526
- Term: Behavioral Symptoms
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M21485
- Name: Neck Pain
- Relevance: HIGH
- As Found: Neck Pain
- ID: M8364
- Name: Fatigue
- Relevance: HIGH
- As Found: Fatigue
- ID: M8365
- Name: Mental Fatigue
- Relevance: HIGH
- As Found: Mental Fatigue
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- Relevance: LOW
- As Found: Unknown
- ID: M4818
- Name: Behavioral Symptoms
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000005221
- Term: Fatigue
- ID: D000019547
- Term: Neck Pain
- ID: D000005222
- Term: Mental Fatigue
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434675
**Brief Title:** Prevalence of Variants of Nasal Cavity and Nasal Septum in Nepalese
**Official Title:** Anatomical Variants of Nasal Cavities and Nasal Septum in Nepalese Patients: A Retrospective Cross-Sectional Study at a Tertiary Care Center
#### Organization Study ID Info
**ID:** 15/2023
#### Organization
**Class:** OTHER
**Full Name:** Grande International Hospital, Nepal
### Status Module
#### Completion Date
**Date:** 2024-05-05
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2024-05-01
**Type:** ACTUAL
#### Start Date
**Date:** 2023-09-15
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Grande International Hospital, Nepal
#### Responsible Party
**Investigator Affiliation:** Grande International Hospital, Nepal
**Investigator Full Name:** PRAJWAL DAHAL
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** A retrospective study was conducted on 343 patients. CT PNS and head of the patients were evaluated for variants of nasal septum and nasal cavity.
**Detailed Description:** A retrospective study was conducted on 343 patients aged 13 years and above. Two investigators, each with 3 to 4 years of experience in the field of radiology, evaluated computed tomography scans of the paranasal sinuses and the head of these patients. The nasal septum was evaluated for degree and types of variants. Various variants of nasal cavities and nasal septum were also evaluated.
### Conditions Module
**Conditions:**
- Nasal Septum; Deviation, Congenital
**Keywords:**
- Nasal Septum
- Nasal Cavity
- Turbinate
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 343
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients evaluated for nasal polyps
**Intervention Names:**
- Other: No intervention done
**Label:** Polyps
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Polyps
**Description:** No intervention done
**Name:** No intervention done
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Prevalence of deviated nasal septum will be calculated. Among those with nasal septum deviation, frequency of deviation to right, left and S shaped nasal septum will be evaluated. Nasal septal deviation angle will be measured and grading will be done.
**Measure:** Prevalence of variants of Nasal septum
**Time Frame:** 6 months
**Description:** Prevalence of variants of nasal cavities like hypertrophied turbinate, paradoxical turbinate, concha bullosa, lamellar concha will be obtained.
**Measure:** Prevalence of variants of nasal cavity
**Time Frame:** 6 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1)Patients undergoing NCCT PNS and Head for chronic rhinosinusitis, headache and vertigo
Exclusion Criteria:
1. Patient less than 13 years age
2. Patients with recent trauma
3. Patient with large mass/ extensive polyposis
**Healthy Volunteers:** True
**Maximum Age:** 91 Years
**Minimum Age:** 13 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** Patient of age 13 years and more undergoing NCCT PNS and Head for chronic rhinosinusitis , headache and vertigo
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Kathmandu
**Country:** Nepal
**Facility:** Prajwal Dahal
**State:** Bagmati
**Zip:** Nepal
#### Overall Officials
**Official 1:**
**Affiliation:** Grande International Hospital
**Name:** PRAJWAL DAHAL
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: Rare
- Name: Rare Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: T4202
- Name: Oculocerebral Syndrome With Hypopigmentation
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434662
**Brief Title:** Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML
**Official Title:** A Phase II Study of the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection, Cytarabine and Venetoclax in Patients With Relapsed/Refractory AML
#### Organization Study ID Info
**ID:** CSPC-DED-AML-K13
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital of Zhejiang University
### Status Module
#### Completion Date
**Date:** 2026-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-02-29
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
#### Lead Sponsor
**Class:** OTHER
**Name:** First Affiliated Hospital of Zhejiang University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. It will also tentatively explore the correlation between different biological characteristics and therapeutic efficacy. The main questions it aims to answer are:Dose the combination regimen of MAV enhanced the composite complete remission in R/R AML? Participants will receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.
**Detailed Description:** Acute myeloid leukemia (AML) is a highly aggressive hematologic malignancy with a poor prognosis. The "3+7" regimen, combining anthracyclines with cytarabine, remains the standard treatment for first line treatment. However, about 20% of patients will develop into primary refractory disease, and more than 50% of patients who achieved complete remission will eventually relapse. For patients with R/R AML, there is currently no established standard treatment. Combining the third drugs with "3+7" regimen is one of the clinical exploration directions.
The purpose of this prospective, single-center, single-arm, pahse II study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax in the treatment of R/R AML. All participants will receive MAV treatment including 24 mg/m2 mitoxantrone hydrochloride liposome on day 1, 1.0 g/m2 q12h cytarabine on day 1,3,5 and 400 mg venetoclax on day 2-10 with a dose escalation on day 2-4. Each cycle consists of 4 weeks. A maximum of 2 cycles of therapy are planned.
### Conditions Module
**Conditions:**
- Relapsed/Refractory Acute Myeloid Leukaemia
- Myeloid Malignancy
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 34
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** mitoxantrone hydrochloride liposome injection, cytarabine combined with venetoclax
**Intervention Names:**
- Drug: mitoxantrone hydrochloride liposome
- Drug: Cytarabine
- Drug: Venetoclax
**Label:** MAV regimen
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- MAV regimen
**Description:** Mitoxantrone hydrochloride liposome (24 mg/m\^2) on day 1, every 4 weeks
**Name:** mitoxantrone hydrochloride liposome
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- MAV regimen
**Description:** Cytarabine (1.0 g/m\^2, q12h ) on day 1,3,5, every 4 weeks
**Name:** Cytarabine
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- MAV regimen
**Description:** Venetoclax 100 mg on day 2,200 mg on day 3,400 mg on day 4-10, every 4 weeks
**Name:** Venetoclax
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Blast rate lower than 5% with or without peripheral blood cell recover
**Measure:** Composite complete remission (CRc) rate
**Time Frame:** At the end of each cycle (each cycle is 28 days), up to 2 cycles
#### Secondary Outcomes
**Description:** Response is assessed according to the the European LeukemiaNet (ELN) 2022 criteria
**Measure:** Overall response rate (ORR)
**Time Frame:** At the end of each cycle (each cycle is 28 days), up to 2 cycles
**Description:** Defined only for patients achieving CR or CRi; measured from the date of achievement of remission until the date of hematologic relapse or death from any cause;
**Measure:** Relapsed free survival (RFS)
**Time Frame:** up to 12 months
**Description:** Defined for all patients in a trial; measured from day 1 of treatment to the date of treatment failure, hematologic relapse from CR/CRi or death from any cause, whichever occurs first;
**Measure:** Event free survival (EFS)
**Time Frame:** up to 12 months
**Description:** Defined for all patients in a trial; measured from day 1 of treatment to the date of death from any cause;
**Measure:** overall survival (OS)
**Time Frame:** up to 12 months
**Description:** Percentage of participants who achieve a CR MRD- as defined by investigators based on ELN 2022 criteria; MRD level is detected by flow cytometry which value \<0.1% is defined as negtive;
**Measure:** Rate of CR without minimal residual disease (CR MRD-)
**Time Frame:** At the end of each cycle (each cycle is 28 days), up to 2 cycles
**Description:** The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.Hematologic and non-hematologic toxicity.
**Measure:** Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
**Time Frame:** From day 1 of treatment to 28 days after the last dose
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
2. Age ≥18.
3. Clinically diagnosed relapsed/refractory AML, excluding acute promyelocytic leukemia.
1. Initial treatment patients who failed after 2 courses of treatment with standard regimen.
2. Bone marrow blasts≥5% after the first CR/CRi, or reappearance of blasts in the blood in at least 2 peripheral blood samples at least one week apart, or leukemia cell infiltration appeared in extramedullary without treatment.
3. First conversion from MRD negativity to MRD positivity without treatment.
4. Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2.
5. Researchers determined that the patients could tolerate intensive chemotherapy.
6. Life expectancy \> 3 months.
7. AST/ALT≤2.5 ULN (for subjects with hepatic infiltration≤5 ULN); Total bilirubin≤1.5 ULN (for subjects with hepatic infiltration≤3 ULN); Serum creatinine≤1.5 ULN.
Exclusion Criteria:
1. Previous anti-tumor therapy meets one of the following criteria:
1. Prior therapy with mitoxantrone or mitoxantrone liposome;
2. Prior therapy with doxorubicin or anthracyclines, and the cumulative dose of doxorubicin \> 360 mg/m\^2 (1 mg doxorubicin was equivalent to 2 mg daunorubicin or 0.5 mg idarubicin);
3. Have received other anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, Chinese medicines with anti-tumor activity, except those that do not affect the efficacy of the study as determined by the investigator) or participated in other clinical trials and received clinical trial drugs within 4 weeks or 5 half-lives of the drug before the study;
2. Cardiovascular diseases, including but not limited to:
1. QTc interval \>480 ms or long QTc syndrome in screening;
2. Complete left bundle branch block, 2 or 3 grade atrioventricular block;
3. Requiring treatment of serious and uncontrolled arrhythmia;
4. New York Heart Association(NYHA≥3;
5. Cardiac ejection fraction (EF) was less than 50%;
6. Myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other history of arrhythmia or clinically serious pericardial disease that requires treatment within the first 6 months of enrollment, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
3. Central nervous system leukemia;
4. Previous or current occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years).
5. Subjects are suffering from any other uncontrollable disease (including but not limited to: uncontrolled diabetes and hypertension, and advanced infection);
6. HIV infection.
7. HBsAg or HBcAb positive, with HBV-DNA≥1x10\^3 copies/mL; or HCV-RNA≥1x10\^3 copies/mL;
8. A history of immediate or delayed allergy to similar drug and excipients of the investigate drug.
9. Pregnant, lactating female or subjects who refuse to use effective contraception during the study.
10. With a history of severe neurological or psychiatric illness.
11. Not suitable for this study as decided by the investigator.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jie Jin, M.D.
**Phone:** +86 571-87236896
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jie Jin, M.D.
- **Phone:** +86 571-87236896
- **Role:** CONTACT
**Country:** China
**Facility:** The First Affiliated Hospital, Zhejiang University School of Medicine
**State:** Zhejiang
**Status:** RECRUITING
**Zip:** 310003
#### Overall Officials
**Official 1:**
**Affiliation:** Zhejiang University
**Name:** Jie Jin, M.D.
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10945
- Name: Leukemia
- Relevance: LOW
- As Found: Unknown
- ID: M10955
- Name: Leukemia, Myeloid
- Relevance: LOW
- As Found: Unknown
- ID: M18127
- Name: Leukemia, Myeloid, Acute
- Relevance: LOW
- As Found: Unknown
- ID: T3995
- Name: Myeloid Leukemia
- Relevance: HIGH
- As Found: Myeloid Leukemia
- ID: T182
- Name: Acute Myeloid Leukemia
- Relevance: HIGH
- As Found: Acute Myeloid Leukemia
- ID: T188
- Name: Acute Non Lymphoblastic Leukemia
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Ancestors
- ID: D000000964
- Term: Antimetabolites, Antineoplastic
- ID: D000000963
- Term: Antimetabolites
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000000998
- Term: Antiviral Agents
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000007166
- Term: Immunosuppressive Agents
- ID: D000007155
- Term: Immunologic Factors
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000059005
- Term: Topoisomerase II Inhibitors
- ID: D000059003
- Term: Topoisomerase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
### Intervention Browse Module - Browse Branches
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Analg
- Name: Analgesics
### Intervention Browse Module - Browse Leaves
- ID: M6766
- Name: Cytarabine
- Relevance: HIGH
- As Found: Multi-
- ID: M249656
- Name: Venetoclax
- Relevance: HIGH
- As Found: 15 minutes
- ID: M11908
- Name: Mitoxantrone
- Relevance: HIGH
- As Found: Move
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
- ID: M4314
- Name: Antiviral Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10212
- Name: Immunosuppressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M10201
- Name: Immunologic Factors
- Relevance: LOW
- As Found: Unknown
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000003561
- Term: Cytarabine
- ID: C000579720
- Term: Venetoclax
- ID: D000008942
- Term: Mitoxantrone
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434649
**Brief Title:** Posterior Extra-fascial RARP in Intermediate or High Risk Prostate Cancer
**Official Title:** Application of the Extra-fascial Robot Assisted Radical Prostatectomy Via the Posterior Approach in Intermediate or High Risk Patients: a Prospective, Multicenter, Double-blind, Randomized Controlled Study
#### Organization Study ID Info
**ID:** FirstAHFujian-Ning Xu
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital of Fujian Medical University
### Status Module
#### Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER_GOV
**Name:** Fujian Cancer Hospital
**Class:** OTHER
**Name:** Zhongshan Hospital Xiamen University
**Class:** OTHER
**Name:** Fuzhou General Hospital
**Class:** OTHER
**Name:** Longyan City First Hospital
**Class:** OTHER
**Name:** The First Hospital of Jilin University
**Class:** OTHER
**Name:** The First Affiliated Hospital of Nanchang University
**Class:** OTHER
**Name:** Ningbo No. 1 Hospital
**Class:** OTHER
**Name:** Hainan People's Hospital
**Class:** OTHER
**Name:** Second Affiliated Hospital of Third Military Medical University
**Class:** OTHER
**Name:** Zhejiang University
**Class:** OTHER
**Name:** Huashan Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** Ning Xu
#### Responsible Party
**Investigator Affiliation:** First Affiliated Hospital of Fujian Medical University
**Investigator Full Name:** Ning Xu
**Investigator Title:** Head of Urology
**Type:** SPONSOR_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** This study was designed as a prospective, multicentre, double-blind, randomised controlled clinical trial. It aims to investigate the feasibility and safety of the posterior approach extrafascial technique and the anterior approach extrafascial technique in robot-assisted radical prostatectomy (RARP) for intermediate- and high-risk prostate cancer patients, to compare the oncological prognosis, functional prognosis, and safety of the two techniques in intermediate- and high-risk prostate cancer patients, and to provide evidence-based medical evidence for the choice of surgical treatment modality for intermediate- and high-risk prostate cancer patients.
**Detailed Description:** This study was designed as a prospective, multicentre, double-blind, randomised controlled clinical trial. It aims to investigate the feasibility and safety of the posterior approach extrafascial technique and the anterior approach extrafascial technique in robot-assisted radical prostatectomy (RARP) for intermediate- and high-risk prostate cancer patients, to compare the oncological prognosis, functional prognosis, and safety of the two techniques in intermediate- and high-risk prostate cancer patients, and to provide evidence-based medical evidence for the choice of surgical treatment modality for intermediate- and high-risk prostate cancer patients.
About 118 subjects will be enrolled in this study in a total of 12 research centres across the country, and eligible subjects will be randomly assigned to the posterior approach extrafascial technique group and the anterior approach extrafascial technique group in a 1:1 ratio. All subjects routinely underwent comprehensive and systematic physical examination, laboratory tests and imaging examinations before surgery. After surgery, subjects were followed up at 1 week (visit 2, day 14±2), 1 month (visit 3, day 28±5), 3 months (visit 4, day 90±7), 6 months (visit 5, day 180±7), and 12 months (visit 6, day 360±14) after removal of the urinary catheter after the surgery, and then annually thereafter (visit 7), with urine control rate (defined as 0/ 1 pad) and 24-h pad weight questionnaires, PSA examination, International Prostate Symptom Score (IPSS), International Consultation on Incontinence Questionnaire Short Form (ICI-QSF), International Index of Erectile Function (IIEF), and related scores such as General Health-Related Quality of Life (EORTC QLQ-C30) and Prostate Cancer-Specific Quality of Life (QLQ-PR25). ) and other relevant scores; in case of clinical suspicion of local recurrence, imaging (pelvic MRI), whole-body bone imaging in patients with bone pain, and whole-body PET/CT if necessary. Subjects will be monitored and evaluated for adverse events (AE) throughout the trial. Subjects will participate in the clinical trial for an expected duration of approximately 1 year, after which they will be followed up periodically according to the usual follow-up strategy.
### Conditions Module
**Conditions:**
- Surgical Procedure, Unspecified
- Prostate Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** QUADRUPLE
**Masking Description:** Double-blind technique will be used in this study. The blinding process will be done by a statistician unrelated to this clinical trial. Treatment group assignment will not be known to the subject or to the study followers or to the investigator who clinically evaluates the subject for the entire duration of the trial. Allocation concealment was achieved in this study through an interactive response system. In the absence of serious complications or other emergencies in the subjects during the study period, normal procedures were followed for revealing blinding, this study provides for the use of secondary blinding.
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 118
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** In 2010, Italian urologist Dr Bocciardi carried out the first clinical practice of separation and resection of the prostate via the vesicorectal fossa, and this new surgical procedure was called Retzius-sparing Robotic Assisted Radical Prostatectomy (RS-RARP). In recent years, the posterior approach extrafascial technique of RS-RARP which has been used to widely resect the prostate and its surrounding fascia and neurovascular bundles, compared with RS-RARP, has been proposed to provide more complete resection of the tumour and reduce the rate of positive margins. The patients are included into the posterior approach extrafascial technique group who undergo the posterior approach extrafascial technique of RS-RARP.
**Intervention Names:**
- Procedure: Extrafascial robotic assisted radical prostatectomy via posterior approach
**Label:** the posterior approach extrafascial technique group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Anterior approach extrafascial technique is the most traditional method of radical prostatectomy for prostate cancer, in which the prostate is tied ventrally to expose the prostate by cutting the deep dorsal penile vein complex and the surrounding ligaments and fascia, and intraoperatively extensive resection is required to remove the prostate and its surrounding fascia and neurovascular bundles. The patients are included into the anterior approach extrafascial technique group who undergo the anterior approach extrafascial technique robotic assisted radical prostatectomy.
**Intervention Names:**
- Procedure: Extrafascial robotic assisted radical prostatectomy via anterior approach
**Label:** the anterior approach extrafascial technique group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- the posterior approach extrafascial technique group
**Description:** Extrafascial robotic assisted radical prostatectomy via posterior approach will be applied in the intermediate or high risk patients.
**Name:** Extrafascial robotic assisted radical prostatectomy via posterior approach
**Type:** PROCEDURE
#### Intervention 2
**Arm Group Labels:**
- the anterior approach extrafascial technique group
**Description:** Extrafascial robotic assisted radical prostatectomy via anterior approach will be applied in the intermediate or high risk patients.
**Name:** Extrafascial robotic assisted radical prostatectomy via anterior approach
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** rate of the preservation of urinary control function at 1 week after postoperative removal of the urinary catheter status
**Measure:** rate of continence
**Time Frame:** 1 week after postoperative removal of the urinary catheter
**Description:** according to International Consultation on Incontinence Questionnaire Short Form, change in voiding score from baseline period at each visit viewpoint
**Measure:** voiding score
**Time Frame:** through study completion, an average of 1 year
**Description:** according to International Index of Erectile Function, change in erectile function score from baseline period at each visit viewpoint
**Measure:** erectile function score
**Time Frame:** through study completion, an average of 1 year
#### Secondary Outcomes
**Description:** the rate of positive specimen margins after surgery
**Measure:** the rate of positive specimen margins
**Time Frame:** after surgery, , an average of 1 year
**Description:** according to EORTC QLQ-C30, quality of life scores at each visit
**Measure:** quality of life scores
**Time Frame:** through study completion, an average of 1 year
**Description:** biochemical recurrence or imaging recurrence/progression at each visit
**Measure:** biochemical recurrence or imaging recurrence/progression
**Time Frame:** through study completion, an average of 1 year
**Description:** deaths (overall survival time) at each visit
**Measure:** overall survival time
**Time Frame:** From date of randomization until date of death from any cause, an average of 5 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. intermediate- and high-risk prostate cancer patients assessed by comprehensive clinical evaluation;
2. prostate volume \<80 ml;
3. life expectancy of patients \>10 years;
4. patients sign the "informed consent";
5. Routine preoperative examination has been improved (chest CT, electrocardiogram, and color Doppler echocardiography), and there is no serious basic disease. After clinical evaluation, it can tolerance robot-assisted radical prostatectomy (RARP).
Exclusion Criteria:
1. life expectancy \<10 years;
2. comorbidities with other malignancies;
3. uncorrected coagulation dysfunctions;
4. patients with severe underlying diseases such as severe pulmonary insufficiency who could not tolerate the surgery;
5. patients or family members who did not accept radical prostatectomy.
**Minimum Age:** 18 Years
**Sex:** MALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ning Xu, Dr.
**Phone:** 13235907575
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** the First Affiliated Hospital, Fujian Medical University
**Name:** Xue-Yi Xue
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000005834
- Term: Genital Neoplasms, Male
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000005832
- Term: Genital Diseases, Male
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000011469
- Term: Prostatic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M14335
- Name: Prostatic Neoplasms
- Relevance: HIGH
- As Found: Prostate Cancer
- ID: M8946
- Name: Genital Neoplasms, Male
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8944
- Name: Genital Diseases, Male
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14333
- Name: Prostatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27095
- Name: Male Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000011471
- Term: Prostatic Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434636
**Brief Title:** The Effect of Tranexamic Acid in Endoscopic and Microscopic Ear Surgery Cases on Surgeon Satisfaction
**Official Title:** The Effect of The Use of Low Dose Tranexamic Acid on Surgeon Satisfaction, Side Effects and Complications in Endoscopic and Microscopic Ear Surgery Cases Which Are Used With Controlled Hypotension
#### Organization Study ID Info
**ID:** 2024/88
#### Organization
**Class:** OTHER
**Full Name:** TC Erciyes University
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** TC Erciyes University
#### Responsible Party
**Investigator Affiliation:** TC Erciyes University
**Investigator Full Name:** Talha Ersoy
**Investigator Title:** Principal Investigator
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** By using tranexamic acid, an antifibrinolytic drug, the aim is to prevent the restriction of the field of view of the surgical field due to bleeding in middle ear microscopic and endoscopic surgery operations in which controlled hypotension is applied, and therefore the prolongation of the surgical time, and to increase surgeon satisfaction.
**Detailed Description:** After obtaining approval from our university and the Turkish Ministry of Health's pharmaceutical and medical device agency and written consent from the patients, 100 patients who underwent middle ear surgery using controlled hypotension under general anesthesia will be included in the study.
The study will be conducted in a randomized controlled, double-blind manner. Patients between the ages of 18-65 and with American Society of Anesthesiologists (ASA) Scores I and II will be included in the study. Patients will be divided into two groups: Intervention (M) and Control (C). Just before the operation begins, 10 mg/kg tranexamic acid (TXA) will be administered to the intervention group in 100 mL of 0.9% physiological saline (SF) solution in 15 minutes. 100 mL of 0.9% SF solution will be sent to the control group in 15 minutes. At the end of the operation, the operator's quality of vision of the surgical field will be recorded by questioning the surgeon's satisfaction with the Boezaart Score and the Surgeon Satisfaction Score.
### Conditions Module
**Conditions:**
- Middle Ear Disease
**Keywords:**
- tranexamic acid
- controlled hypotension
- middle ear surgery
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** Patients will be divided into two groups: Intervention (M) and Control (C). Just before the operation begins, 10 mg/kg tranexamic acid (TXA) will be administered to the intervention group in 100 mL of 0.9% physiological saline (SF) solution in 15 minutes. 100 mL of 0.9% SF solution will be sent to the control group in 15 minutes.
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- INVESTIGATOR
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 100
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients' vital values will be recorded before surgery.10 mg/kg tranexamic acid (Transamine 10% IV/IM Solution for Injection) is added into 100 cc serum through the appropriate vascular access and injected for 15 minutes.The amount of bleeding in the surgical field will be evaluated by the surgeon using the Boezaart Scale.Intraoperatively, hemodynamic changes such as bradycardia, tachycardia, arrhythmia and agents used such as vasopressors, antiarrhythmics and vagolytics will be recorded in the patient.Post-Operatively the surgeon's quality of vision will be questioned with the Surgeon Satisfaction Scale.Postoperative 0th, 12th, and 24th developments - the presence of vomiting and postoperative complaints will be questioned.The presence of bleeding or complications in the first 2 weeks after surgery will be questioned.The presence of thromboembolic events and other services will be questioned within 12 weeks after surgery.
**Intervention Names:**
- Drug: Transamine 10% IV/IM Solution for Injection
**Label:** Intervention Group (I)
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Preoperative vital values of the patients will be recorded.100 cc of physiological saline will be sent through the appropriate vascular access in 15 minutes.
The amount of bleeding in the surgical field will be evaluated by the surgeon using the Boezaart Scale. Intraoperatively, hemodynamic changes such as bradycardia, tachycardia, arrhythmia that develop in the patient, and agents such as vasopressors, antiarrhythmics, and vagolytics used will be recorded.
Postoperatively the surgeon's quality of vision will be questioned with the Surgeon Satisfaction Scale. The presence of nausea and vomiting and postoperative complaints will be questioned at the 0th, 12th, and 24th postoperative hours. The presence of surgical bleeding or complications that occur in the first 2 weeks of surgery will be questioned. The presence of thromboembolic events and other complications will be questioned within 12 weeks postoperatively.
**Intervention Names:**
- Drug: %0.9 Saline
**Label:** Control Group (C)
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention Group (I)
**Description:** 10 mg/kg tranexamic acid (Transamine 10% IV/IM Injectable Solution) will be placed into 100 cc physiological saline through the appropriate vascular access and injected within 15 minutes.
**Name:** Transamine 10% IV/IM Solution for Injection
**Other Names:**
- tranexamic acid
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Control Group (C)
**Description:** 100 cc %0.9 Normal Saline will be injected through the appropriate vascular access within 15 minutes
**Name:** %0.9 Saline
**Other Names:**
- Physiological Saline
- %0.9 NaCl
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** At the end of a surgery, the surgical field was graded in terms of bleeding by the surgeon using the scale used by Boezaart et al in 1995;
0 : No bleeding (cadaveric conditions).
1. : Slight bleeding: no suctioning required.
2. : Slight bleeding: occasional suctioning required.
3. : Slight bleeding: frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.
4. : Moderate bleeding: frequent suctioning required and bleeding threatens surgical field directly after suction is removed.
5. : Severe bleeding: constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible.
**Measure:** Boezaart et al grading scale
**Time Frame:** 2-3 hours
**Description:** At the and of surgery , surgeon's satisfaction with surgical field quality was also graded in a 5-item Likert scale, where 1 = poor and 5 = excellent
**Measure:** Surgeon Satisfaction Score
**Time Frame:** 2-3 hours
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Individuals between the ages of 18-65
* Individuals with ASA I (no additional disease) or ASA II (mild systemic disease)
* Those who do not have a disease such as thrombophilia or bleeding diathesis will be included in the study
Exclusion Criteria:
* Patients with ASA III (those with uncontrolled chronic disease) or above
* Patients with cardiovascular disease, congestive heart failure, coronary artery disease, cerebrovascular insufficiency, renal or hepatic failure
* Patients with thrombophilia, bleeding diathesis, coagulation defects
* Pregnant patients
* Those with a history of any allergic reaction to tranexamic acid and its derivatives will be excluded from the study
**Gender Based:** True
**Gender Description:** All genders will be included this study
**Healthy Volunteers:** True
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Talha ERSOY, MD
**Phone:** +905316682730
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Nesibe ERSOY, MD
**Phone:** +905079157672
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** TC Erciyes University
**Name:** Talha ERSOY, MD
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000010038
- Term: Otorhinolaryngologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC09
- Name: Ear, Nose, and Throat Diseases
### Condition Browse Module - Browse Leaves
- ID: M10072
- Name: Hypotension
- Relevance: LOW
- As Found: Unknown
- ID: M7601
- Name: Ear Diseases
- Relevance: HIGH
- As Found: Ear Disease
- ID: M12961
- Name: Otorhinolaryngologic Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004427
- Term: Ear Diseases
### Intervention Browse Module - Ancestors
- ID: D000000933
- Term: Antifibrinolytic Agents
- ID: D000050299
- Term: Fibrin Modulating Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000006490
- Term: Hemostatics
- ID: D000003029
- Term: Coagulants
- ID: D000000928
- Term: Antidepressive Agents
- ID: D000011619
- Term: Psychotropic Drugs
- ID: D000008996
- Term: Monoamine Oxidase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000014151
- Term: Anti-Anxiety Agents
- ID: D000014149
- Term: Tranquilizing Agents
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
### Intervention Browse Module - Browse Branches
- Abbrev: PhSol
- Name: Pharmaceutical Solutions
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Coag
- Name: Coagulants
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: PsychDr
- Name: Psychotropic Drugs
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: VaCoAg
- Name: Vasoconstrictor Agents
### Intervention Browse Module - Browse Leaves
- ID: M21860
- Name: Pharmaceutical Solutions
- Relevance: LOW
- As Found: Unknown
- ID: M16902
- Name: Tranexamic Acid
- Relevance: HIGH
- As Found: Stage IV
- ID: M16945
- Name: Tranylcypromine
- Relevance: HIGH
- As Found: Thromboembolic Events
- ID: M4213
- Name: Anti-Arrhythmia Agents
- Relevance: LOW
- As Found: Unknown
- ID: M17409
- Name: Vasoconstrictor Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4252
- Name: Antifibrinolytic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M9576
- Name: Hemostatics
- Relevance: LOW
- As Found: Unknown
- ID: M6259
- Name: Coagulants
- Relevance: LOW
- As Found: Unknown
- ID: M4247
- Name: Antidepressive Agents
- Relevance: LOW
- As Found: Unknown
- ID: M14474
- Name: Psychotropic Drugs
- Relevance: LOW
- As Found: Unknown
- ID: M11960
- Name: Monoamine Oxidase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M16905
- Name: Anti-Anxiety Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000014191
- Term: Tranylcypromine
- ID: D000014148
- Term: Tranexamic Acid
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434623
**Brief Title:** Federal Learning Algorithm for an Intelligent Insulin Decision System for Dynamic Glucose Control in Type 2 Diabetic Patients
**Official Title:** A Multicenter Federal Learning Algorithm to Build an Intelligent Insulin Decision System for Dynamic Glucose Control in Type 2 Diabetic Patients
#### Organization Study ID Info
**ID:** 20240324025304420
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Zhongshan Hospital
### Status Module
#### Completion Date
**Date:** 2026-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shanghai Zhongshan Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** True
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Constructing an intelligent insulin decision-making system for dynamic glucose control in type 2 diabetes mellitus via a multicentre federated learning algorithm, comparing the performance of the federated learning model, the local model and the initial model, and evaluating their feasibility and safety.
**Detailed Description:** Constructing an intelligent insulin decision-making system for dynamic glucose control in type 2 diabetes mellitus via a multicentre federated learning algorithm, comparing the performance of the federated learning model, the local model and the initial model, and evaluating their feasibility and safety.
### Conditions Module
**Conditions:**
- Diabetes
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 30100
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: patient record
**Label:** patients record
### Interventions
#### Intervention 1
**Arm Group Labels:**
- patients record
**Description:** using patient record to construct AI models
**Name:** patient record
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** the accuracy of AI models
**Time Frame:** up to 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* type 2 diabetes inpatients receiving insulin therapy
Exclusion Criteria:
* use of insulin pumps or glucocorticoids during hospitalisation
* less than two days of insulin therapy
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** type 2 diabetes who
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xiaoying Li, PhD.
**Phone:** 02164041990
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Ying Chen
**Phone:** 13482
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** Fudan University
**Name:** Xiaoying Li, Professor
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: LOW
- As Found: Unknown
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434610
**Brief Title:** A Study of B013 in Combination With Paclitaxel in Patients With Platinum-resistant Recurrent Ovarian Cancer.
**Official Title:** A Multicenter, Randomized, Double-blind, Parallel-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of B013 Combined With Paclitaxel in the Treatment of Platinum-resistant Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer.
#### Organization Study ID Info
**ID:** SPH-B013-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Shanghai Jiaolian Drug Research and Development Co., Ltd
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** INDUSTRY
**Name:** Shanghai Pharmaceuticals Holding Co., Ltd
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Shanghai Jiaolian Drug Research and Development Co., Ltd
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
### Conditions Module
**Conditions:**
- Platinum-resistant Recurrent Ovarian Cancer
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** DOUBLE
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: B013
- Drug: Paclitaxel
**Label:** B013
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Paclitaxel
- Drug: Placebo
**Label:** Placebo
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- B013
**Description:** B013: The subjects will receive IV dose of B013 600 mg on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
**Name:** B013
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- B013
- Placebo
**Description:** Paclitaxel: 80 mg/m\^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.
**Name:** Paclitaxel
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Placebo
**Description:** Placebo: The subjects will receive IV dose of placebo matched to B013 on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
**Name:** Placebo
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** From the date of randomization to the date of progression disease or death , whichever occurred first.
**Measure:** Progression-free survival (PFS)
**Time Frame:** Approximately 2 years
#### Secondary Outcomes
**Description:** Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
**Measure:** Objective response rate (ORR)
**Time Frame:** Approximately 2 years
**Description:** DCR was defined as the percentage of participants who have achieved complete response, partial response and stable disease.
**Measure:** Disease control rate (DCR)
**Time Frame:** Approximately 2 years
**Description:** DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause.
**Measure:** Duration of remission (DOR)
**Time Frame:** Approximately 5 years
**Description:** Determination of the overall survival times of all participants.
**Measure:** Overall Survival (OS)
**Time Frame:** Approximately 2 years
**Description:** The incidence of adverse event (regardless of its relationship to study drug) will be classified using MedDRA and the severity of each adverse event will be graded using NCI CTCAE v5.0.
**Measure:** Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
**Time Frame:** Approximately 5 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Subjects who voluntarily participate in this study and sign informed consent form;
2. Ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by histopathological examination and meeting the criteria for platinum resistance recurrence;
3. ECOG performance status of 0 or 1;
4. Expected survival \> 12 weeks;
5. The subject has at least one measurable lesion;
6. Normal function of major organs;
7. The fertile subjects agree to use reliable contraception from signing the informed consent to at least 6 months after the last dose.
Exclusion Criteria:
1. Subjects who have received prescribed treatment previously;
2. Subjects who are still using anti-tumor traditional Chinese patent medicines at the time of signing informed consent;
3. Subjects with known central nervous system metastasis and multiple bone metastasis;
4. Subjects who had clinical symptoms of pleural effusion, pericardial effusion or ascites before randomization and needed puncture drainage, or had received puncture drainage within the previous 2 weeks;
5. Have a history of other malignant tumors within 5 years before signing the informed consent;
6. Subjects with prescribed cardiovascular diseases;
7. Subjects with infections requiring intravenous antibiotic infusion within 2 weeks prior to randomization;
8. Had severe lung disease before randomization;
9. Before randomization, the peripheral nerve toxicity of previous anti-tumor treatment was \> grade 2, and other reversible toxicity was \> grade 1;
10. Subjects who had undergone surgery within 28 days prior to randomization and did not recover from adverse effects of surgery;
11. Subjects who participated in clinical trials within 30 days prior to randomization and received other unmarketed investigational drugs;
12. Subjects who are known to be allergic to any component of B013 or paclitaxel.
13. Subjects with a known history of substance abuse, alcohol or drug use; Subjects with a known history of neurological or psychiatric disorders;
14. Female subjects who are pregnant or breastfeeding;
15. Other situations determined by the researchers and/or sponsors as unsuitable for participation in this trial.
**Gender Based:** True
**Maximum Age:** 75 Years
**Minimum Age:** 18 Years
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Xiaohua Wu
**Phone:** 0086-021-64175590
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Name:** Xiaohua Wu
- **Role:** CONTACT
**Country:** China
**Facility:** Fudan University Shanghai Cancer center
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020969
- Term: Disease Attributes
- ID: D000010335
- Term: Pathologic Processes
- ID: D000004701
- Term: Endocrine Gland Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000010049
- Term: Ovarian Diseases
- ID: D000000291
- Term: Adnexal Diseases
- ID: D000005831
- Term: Genital Diseases, Female
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000005833
- Term: Genital Neoplasms, Female
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000091662
- Term: Genital Diseases
- ID: D000004700
- Term: Endocrine System Diseases
- ID: D000006058
- Term: Gonadal Disorders
- ID: D000002277
- Term: Carcinoma
- ID: D000009375
- Term: Neoplasms, Glandular and Epithelial
- ID: D000009370
- Term: Neoplasms by Histologic Type
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: HIGH
- As Found: Recurrent
- ID: M12974
- Name: Ovarian Neoplasms
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M1704
- Name: Carcinoma, Ovarian Epithelial
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: M5534
- Name: Carcinoma
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: M7863
- Name: Endocrine Gland Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M12972
- Name: Ovarian Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M3643
- Name: Adnexal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M8943
- Name: Genital Diseases, Female
- Relevance: LOW
- As Found: Unknown
- ID: M2876
- Name: Genital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M2875
- Name: Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M27093
- Name: Female Urogenital Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14127
- Name: Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8399
- Name: Female Urogenital Diseases and Pregnancy Complications
- Relevance: LOW
- As Found: Unknown
- ID: M8945
- Name: Genital Neoplasms, Female
- Relevance: LOW
- As Found: Unknown
- ID: M17315
- Name: Urogenital Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M9163
- Name: Gonadal Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M12320
- Name: Neoplasms, Glandular and Epithelial
- Relevance: LOW
- As Found: Unknown
- ID: M12315
- Name: Neoplasms by Histologic Type
- Relevance: LOW
- As Found: Unknown
- ID: T4352
- Name: Ovarian Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: T4354
- Name: Ovarian Epithelial Cancer
- Relevance: HIGH
- As Found: Ovarian Cancer
- ID: T2189
- Name: Fallopian Tube Cancer
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010051
- Term: Ovarian Neoplasms
- ID: D000077216
- Term: Carcinoma, Ovarian Epithelial
- ID: D000012008
- Term: Recurrence
### Intervention Browse Module - Ancestors
- ID: D000000972
- Term: Antineoplastic Agents, Phytogenic
- ID: D000000970
- Term: Antineoplastic Agents
- ID: D000050257
- Term: Tubulin Modulators
- ID: D000050256
- Term: Antimitotic Agents
- ID: D000050258
- Term: Mitosis Modulators
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M19537
- Name: Paclitaxel
- Relevance: HIGH
- As Found: Surgery
- ID: M231
- Name: Albumin-Bound Paclitaxel
- Relevance: LOW
- As Found: Unknown
- ID: M26197
- Name: Tubulin Modulators
- Relevance: LOW
- As Found: Unknown
- ID: M26196
- Name: Antimitotic Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000017239
- Term: Paclitaxel
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434597
**Brief Title:** A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patients.
**Official Title:** A Multicenter, Open, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH5030 Tablets in Subjects With Her2-positive/Mutated Biliary Tract OR Colorectal Cancer.
#### Organization Study ID Info
**ID:** SPH5030-201
#### Organization
**Class:** INDUSTRY
**Full Name:** Shanghai Pharmaceuticals Holding Co., Ltd
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Shanghai Pharmaceuticals Holding Co., Ltd
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** To evaluate the efficacy and safety of SPH5030 tablets in subjects with Her2-positive/mutated biliary tract OR colorectal cancer.
### Conditions Module
**Conditions:**
- Biliary Tract or Colorectal Cancer With Her2-positive/Mutated
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: SPH5030
**Label:** SPH5030
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- SPH5030
**Description:** SPH5030:Oral, QD, 600mg
**Name:** SPH5030
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
**Measure:** Objective response rate (ORR)
**Time Frame:** Approximately 2 years
#### Secondary Outcomes
**Description:** DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause.
**Measure:** Duration of remission (DOR)
**Time Frame:** Approximately 2 years
**Description:** DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease.
**Measure:** Disease control rate (DCR)
**Time Frame:** Approximately 2 years
**Description:** From the start date of study treatment to the date of progression disease or death , whichever occurred first.
**Measure:** Progression-free survival (PFS)
**Time Frame:** Approximately 2 years
**Description:** Determination of the overall survival times of all patients
**Measure:** Overall Survival (OS)
**Time Frame:** Approximately 2 years
**Description:** Adverse event type, incidence, duration
**Measure:** Incidence of Treatment-Emergent Adverse Events
**Time Frame:** Approximately 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Metastatic and/or unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and/or unresectable advanced biliary tract carcinoma
2. HER2 positive or HER2 gene mutation;
3. Meet the requirements of previous treatment;
4. ECOG performance status of 0 or 1;
5. Expected survival ≥ 3 months;
6. No serious abnormalities in hematopoietic function, liver or kidney function;
7. Females who are not pregnant, non-lactating.. Subjects who complied with the contraceptive requirements of the protocol.;
8. Fully informed subjects who voluntarily sign the ICF.
Exclusion Criteria:
1. Subjects who have previously received anti-HER2 molecular targeted therapy;
2. Subjects who have been treated with any other clinical trial drug within 4 weeks prior to the first dose;
3. Subjects with uncontrolled or severe cardiovascular and cerebrovascular diseases; Subjects with severe lung disease; 4. Subjects who may have conditions that affect the absorption, distribution, metabolism, or excretion of the study drug determined by the investigator;
5 Subjects who are taking potent CYP3A4 or CYP2C8 inhibitors or inducers; 6 Subjects with other malignancies in the past 5 years; 7 Subjects with CNS system metastasis with clinical symptoms; 8 Subjects who do not meet the protocol requirements for hepatitis B and C at screening, have a history of immunodeficiency, or other acquired、congenital immunodeficiency diseases, or have a history of organ transplantation; 9. Other situations that do not meet the requirements of the protolol.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jianming Xu
**Phone:** 0086-010-66937166
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Name:** Jianming Xu
- **Role:** CONTACT
**Country:** China
**Facility:** Chinese PLA General hospital
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434584
**Brief Title:** Explainable Insulin Decision-making System to Assist Physicians in Diabetes Management
**Official Title:** Explainable Insulin Decision-making System to Assist Physicians in Diabetes Management
#### Organization Study ID Info
**ID:** 20240218043800077
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Zhongshan Hospital
### Status Module
#### Completion Date
**Date:** 2023-06-10
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-03-20
**Type:** ACTUAL
#### Start Date
**Date:** 2022-12-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Shanghai Zhongshan Hospital
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The investigators plan to conduct a multi-case, multi-reader observational study with the primary objective of exploring the effects of an interpretable insulin-assisted decision-making system on physicians' (1) decision accuracy and (2) decision confidence.
### Conditions Module
**Conditions:**
- Diabetes
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** OTHER
#### Enrollment Info
**Count:** 48
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Other: without AI assistance
- Other: with AI dosage assistance
- Other: with explainable AI assistance
- Other: with faulty explainable AI assistance
**Label:** senior doctor group
#### Arm Group 2
**Intervention Names:**
- Other: without AI assistance
- Other: with AI dosage assistance
- Other: with explainable AI assistance
- Other: with faulty explainable AI assistance
**Label:** junior doctor group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- junior doctor group
- senior doctor group
**Description:** provide insulin dosage and confidence score without AI assistance
**Name:** without AI assistance
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- junior doctor group
- senior doctor group
**Description:** provide insulin dosage and confidence score with AI dosage assistance
**Name:** with AI dosage assistance
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- junior doctor group
- senior doctor group
**Description:** provide insulin dosage and confidence score with explainable AI assistance
**Name:** with explainable AI assistance
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- junior doctor group
- senior doctor group
**Description:** provide insulin dosage and confidence score with faulty explainable AI assistance
**Name:** with faulty explainable AI assistance
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The investigators used MAE and clinical agreement to quantitatively assess the accuracy of clinician-recommended insulin doses.
1. Mean Absolute Error (MAE) represents the error between the clinician-recommended value and the expert-recommended value (gold standard).
2. Clinical agreement: Clinical agreement is calculated as the proportion of clinically consistent insulin doses (clinician-given adjustments in the same direction as the expert's protocol and within 20% of the dose difference) to the total insulin dose.
**Measure:** Doctors' decision-making accuracy
**Time Frame:** up to 2 months
**Description:** Clinicians' confidence in decision-making was assessed using a 10-point Likert scale from 1 (not at all confident) to 10 (completely confident).
**Measure:** Doctors' decision-making confidence
**Time Frame:** up to 2 months
### Eligibility Module
**Eligibility Criteria:** Case:
Inclusion Criteria:
* Patients with T2DM who were admitted to Zhongshan Hospital of Fudan University from 2022.12 to 2023.3.
* Insulin regimen is one of the following: a. Basal regimen: once a day subcutaneous injection of long-acting or ultra-long-acting insulin; b. Premixed regimen: two/three times a day subcutaneous injection of premixed insulin; c. Basal mealtime regimen: three times a day before meals subcutaneous injection of short-acting or rapid-acting insulin, plus once a day injection of long-acting or ultra-long-acting insulin.
Exclusion Criteria:
- Cases will be excluded if there is insufficient information for a valid assessment (missing data on insulin or blood glucose \>40%).
Doctor
Inclusion Criteria:
licensed medical practitioner.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** include 40 patient cases and 8 doctors (4 senior and 4 junior)
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Shanghai
**Country:** China
**Facility:** Xiaoying Li
**State:** Shanghai
**Zip:** 200032
#### Overall Officials
**Official 1:**
**Affiliation:** Fudan University
**Name:** Xiaoying Li, Professor
**Role:** STUDY_CHAIR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000044882
- Term: Glucose Metabolism Disorders
- ID: D000008659
- Term: Metabolic Diseases
- ID: D000004700
- Term: Endocrine System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
- Abbrev: BC19
- Name: Gland and Hormone Related Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M7115
- Name: Diabetes Mellitus
- Relevance: HIGH
- As Found: Diabetes
- ID: M11639
- Name: Metabolic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M25403
- Name: Glucose Metabolism Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M7862
- Name: Endocrine System Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000003920
- Term: Diabetes Mellitus
### Intervention Browse Module - Browse Branches
- Abbrev: Hypo
- Name: Hypoglycemic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M10365
- Name: Insulin
- Relevance: LOW
- As Found: Unknown
- ID: M173166
- Name: Insulin, Globin Zinc
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434571
**Acronym:** CLEAR
**Brief Title:** Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
**Official Title:** Comparing Telehealth-Delivered Cognitive Behavioral Therapy for Insomnia to Web-Based to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection
#### Organization Study ID Info
**ID:** STUDY00160591
#### Organization
**Class:** OTHER
**Full Name:** University of Kansas Medical Center
### Status Module
#### Completion Date
**Date:** 2028-07-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-07-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Kansas Medical Center
#### Responsible Party
**Investigator Affiliation:** University of Kansas Medical Center
**Investigator Full Name:** Catherine Siengsukon, PT, PhD
**Investigator Title:** Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.
### Conditions Module
**Conditions:**
- Multiple Sclerosis
- Insomnia
**Keywords:**
- Cognitive behavioral therapy for insomnia
- CBT-I
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 90
**Type:** ESTIMATED
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 1x/week, 6-week 45-60 min one-one-one manualized program via video conferencing (HIPAA-compliant Zoom) with a trained research assistant that includes time in bed restriction, stimulus control, relaxation strategies, cognitive restructuring, and sleep health promotion education.
**Intervention Names:**
- Behavioral: Telehealth cognitive behavioral therapy for insomnia (tCBT-I)
**Label:** Telehealth cognitive behavioral therapy for insomnia (tCBT-I)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The Go!ToSleep online program is a 6-week interactive, web-based program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, relaxation techniques and cognitive restructuring with daily lessons (41 lessons in total)
**Intervention Names:**
- Behavioral: Web-based cognitive behavioral therapy for insomnia (wCBT-I)
**Label:** Web-based cognitive behavioral therapy for insomnia (wCBT-I)
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** The treatment as usual comparison group will be encouraged to continue with their usual care recommended by their physician and their usual activities and sleep habits during the period between baseline and 6-month reassessment.
**Intervention Names:**
- Behavioral: Treatment as usual (TAU)
**Label:** Treatment as usual (TAU)
**Type:** OTHER
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Telehealth cognitive behavioral therapy for insomnia (tCBT-I)
**Description:** The general sessions outlines are as follows with each session:
Session 1: determine treatment plan, set up sleep schedule and stimulus control, discuss strategies for how to stay awake to prescribed hour and what to do if wake up in middle of night, sleep hygiene education Session 2: continue upward titration of total sleep time, review sleep hygiene; introduce diaphragmatic breathing Session 3: continue upward titration of total sleep time, introduce mindfulness Session 4: continue upward titration of total sleep time, introduce progressive muscle relaxation Session 5: continue upward titration of total sleep time, discuss negative sleep beliefs Session 6: assess global treatment gains, discuss relapse prevention
**Name:** Telehealth cognitive behavioral therapy for insomnia (tCBT-I)
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Web-based cognitive behavioral therapy for insomnia (wCBT-I)
**Description:** Participants receive a daily e-mail reminder to access the program and to complete a sleep log for the prior night's sleep. After completing the sleep log, the daily lesson is made available. Each participant will be provided with a unique password to access the online program.
**Name:** Web-based cognitive behavioral therapy for insomnia (wCBT-I)
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- Treatment as usual (TAU)
**Description:** They will be encouraged to avoid starting any new treatment for their sleep unless recommended by their physician. They will be offered access to the web-based CBT-I program following the 6-month reassessment to complete if they wish.
**Name:** Treatment as usual (TAU)
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** Disability will be assessed using the PDDS scale which is a single-item 9 point scale ranging from "normal" (score of 0) to "bedridden" (score of 8).
**Measure:** Patient-Determined Disability Steps (PDDS)
**Time Frame:** baseline
**Description:** Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9), with a score of ≥20 suggesting severe depression. It consists of 9 items with a score ranging from 0-27.
**Measure:** Patient Health Questionnaire (PHQ-9)
**Time Frame:** baseline, Week 6, Month 6
**Description:** Anxiety symptoms will be assessed using the 7-item GAD-7, with a score of ≥15 indicating severe anxiety. This questionnaire consists of 7 items, and the score from each item is summed for an overall score ranging from 0-21 with a higher score indicating a higher level of anxiety
**Measure:** Generalized Anxiety Disorder Assessment (GAD-7)
**Time Frame:** baseline, Week 6, Month 6
**Description:** To assess adherence to the CBT-I intervention, the sleep log will be used to assess number of mornings/week got out of bed at agreed upon time and the number of times got out of bed if unable to sleep. A total percentage will be calculated and used as the outcome of interest.
**Measure:** Adherence to CBT-I intervention
**Time Frame:** Each CBT-I session Week 1-6
**Description:** Participants will be asked "In general, how healthy is your overall diet?" and will rate on a 5-point Likert scale (5 = "excellent", 4 = "very good", 3 = "good", 2 = "fair", 1 = "poor")
**Measure:** Diet quality
**Time Frame:** baseline
**Description:** Participants will mark on the sleep log at each assessment period the time period for eating breakfast, lunch, and dinner. Variability in mealtime will be quantified as the standard deviation from the individual's mean meal start time.
**Measure:** Eating regularity
**Time Frame:** baseline, Week 6, Month 6
**Description:** Participants will mark on the sleep log the number of times they wake up to void their bladder during the sleep opportunity window.
**Measure:** Nighttime urination frequency
**Time Frame:** baseline, Week 6, Month 6
**Description:** PainDetect includes 13 items that assesses neuropathic pain. A total score ranges from -1 to 38, with higher scores indicating higher levels of neuropathic pain.
**Measure:** PainDetect
**Time Frame:** baseline, Week 6, Month 6
**Description:** Fibromyalgia Survey Questionnaire includes the assessment of the number of painful body regions. Scores ranges from 0-31. A higher score indicates worse symptoms.
**Measure:** Fibromyalgia Survey Questionnaire
**Time Frame:** baseline, Week 6, Month 6
**Description:** Measures max and average pain intensity during past 7 days. The T-score value, with a mean of 50 and standard deviation of 10 representing the rescaled raw score, will be reported.
**Measure:** PROMIS SF v.1.0 - Pain Intensity
**Time Frame:** baseline, Week 6, Month 6
#### Primary Outcomes
**Description:** The ISI consists of 7 questions, each rated on a 0-4 scale. The range of scores on the ISI is 0-28, with a score of ≥ 10 suggesting clinical insomnia. The lower the score the less severe insomnia.
**Measure:** Insomnia Severity Index (ISI)
**Time Frame:** baseline, Week 6, Week 12
#### Secondary Outcomes
**Description:** The PSQI consists of 9 items within 7 sleep categories. The 7 sleep category scores are summed to form a single global score ranging from 0-21. A global score of \>5 reflects poor sleep quality.
**Measure:** Pittsburgh Sleep Quality Index (PSQI)
**Time Frame:** baseline, Week 6, Month 6
**Description:** Consists of eight scenarios of daily activity, and participants use a four-point Likert scale to rate how likely they are to doze. Score ranges 0-24 with a higher score indicating daytime sleepiness.
**Measure:** Epworth Sleepiness Scale (ESS)
**Time Frame:** baseline, Week 6, Month 6
**Description:** This assessment is a 10 item Likert-scale self-report questionnaire. Higher scores indicate more dysfunctional beliefs.
**Measure:** Dysfunctional Beliefs About Sleep
**Time Frame:** baseline, Week 6, Month 6
**Description:** The PANAS is a 20-item self-report questionnaire used to measure positive and negative emotions. There are two subscales (Positive Affect and Negative Affect) with 10 items each. The respondent scores how applicable a list of emotions are on a 5-point Likert scale with 1 = "Very slightly or not at all" to 5 = "Extremely". A higher score on the Positive Affect subscale indicates greater intensity of positive emotions, and a high score on Negative Affect indicate greater intensity of negative emotions.
**Measure:** Positive Affect and Negative Affect Schedule (PANAS)
**Time Frame:** baseline, Week 6, Month 6
**Description:** The SESS is a 9 item self-report Likert-scale questionnaire use to identify sleep self-efficacy. Scores range from 0-45 and a higher score indicates higher sleep self-efficacy.
**Measure:** Sleep Self-Efficacy Scale (SESS)
**Time Frame:** baseline, Week 6, Month 6
**Description:** Participants will wear an actigraph on their non-dominant wrist for 7 nights to assess sleep/wake cycle. Mains variables of interest are sleep regularity, timing, efficiency, and duration
**Measure:** Actigraphy
**Time Frame:** baseline, Week 6, Month 6
**Description:** The MFIS assesses the impact of fatigue on daily activities for the month prior. The MFIS consists of 21 items with 3 subscales: physical, cognitive, and psychosocial. The score on the 21 items are scored with a range of 0-84 with a higher score indicating a greater impact of fatigue.
**Measure:** Modified Fatigue Impact Scale (MFIS)
**Time Frame:** baseline, Week 6, Month 6
**Description:** The FSS assesses the impact of fatigue on activities for the week prior and consists of 9 questions. The mean of the 9 scores is calculated with a range of 0-7.
**Measure:** Fatigue Severity Scale (FSS)
**Time Frame:** 'baseline, Week 6, Month 6
**Description:** Quality of life will be assessed using the Multiple Sclerosis Impact Scale (MSIS-29). MSIS-29 is total of 29 items scale, with subscales of physical (20 items) and psychological (9 items). Responses computed in a range from 0-100, and higher scores indicating a worse quality of life due to physical and physiological impacts of MS
**Measure:** Multiple Sclerosis Impact Scale (MSIS-29)
**Time Frame:** baseline, Week 6, Month 6
**Description:** The CFQ assesses perception of cognitive abilities over the past 6 months. consists of 25 items that the individual rates on a 5-point Likert scale with 0 = "never" and 4 = "Very Often" with a summary score of 0-100 with a higher score indicating poorer perceived cognitive abilities.
**Measure:** Cognitive Failures Questionnaire (CFQ)
**Time Frame:** baseline, Week 6, Month 6
**Description:** blood marker of axonal damage
**Measure:** plasma neurofilament light (NfL)
**Time Frame:** baseline, Week 6, Month 6
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 18-65 years old
* Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines21 and verified by their neurologist
* Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale)
* Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5
* ≥10 on Insomnia Severity Index
* English speaking
* ≥31 on Telephone Interview of Cognitive Status
* Has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study
* Report having access to internet service or a data plan and access to a computer, tablet, or smart phone
Exclusion Criteria:
* Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)
* \>3 on STOP BANG indicating increased risk of sleep apnea
* Restless legs syndrome as determined by RLS-Diagnosis Index
* Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised
* Parasomnia as determined by the Sleep Disorders-Revised
* If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking \< 3 months or dose has changed in past 3 months
* Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9)
* Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety
* Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by DSM-5 criteria
* History of other nervous system disorder such as stroke or Parkinson's disease
* Currently pregnant or intending to become pregnant in the next 6 months
* Severe mental illness such as schizophrenia or bipolar disorder
* Severe neurological or sensory impairments that would interfere significantly with testing
* Relapse and/or corticosteroid use in the past 8 weeks
* History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am
* Currently receiving a behavioral sleep health intervention
**Maximum Age:** 65 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Eryen Nelson, MPH
**Phone:** 913-945-7349
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Catherine Siengsukon, PhD
**Phone:** 913-588-6913
**Role:** CONTACT
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000020278
- Term: Demyelinating Autoimmune Diseases, CNS
- ID: D000020274
- Term: Autoimmune Diseases of the Nervous System
- ID: D000009422
- Term: Nervous System Diseases
- ID: D000003711
- Term: Demyelinating Diseases
- ID: D000001327
- Term: Autoimmune Diseases
- ID: D000007154
- Term: Immune System Diseases
- ID: D000020919
- Term: Sleep Disorders, Intrinsic
- ID: D000020920
- Term: Dyssomnias
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: BC20
- Name: Immune System Diseases
- 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: M12060
- Name: Multiple Sclerosis
- Relevance: HIGH
- As Found: Multiple Sclerosis
- ID: M15415
- Name: Sclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M8364
- Name: Fatigue
- Relevance: LOW
- As Found: Unknown
- ID: M10356
- Name: Sleep Initiation and Maintenance Disorders
- Relevance: HIGH
- As Found: Insomnia
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22098
- Name: Demyelinating Autoimmune Diseases, CNS
- Relevance: LOW
- As Found: Unknown
- ID: M22094
- Name: Autoimmune Diseases of the Nervous System
- Relevance: LOW
- As Found: Unknown
- ID: M6909
- Name: Demyelinating Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22242
- Name: Parasomnias
- Relevance: LOW
- As Found: Unknown
- ID: M22654
- Name: Sleep Disorders, Intrinsic
- Relevance: LOW
- As Found: Unknown
- ID: M22655
- Name: Dyssomnias
- Relevance: LOW
- As Found: Unknown
- ID: M15696
- Name: Sleep Wake Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009103
- Term: Multiple Sclerosis
- ID: D000007319
- Term: Sleep Initiation and Maintenance Disorders
### Intervention Browse Module - Browse Branches
- Abbrev: CNSSti
- Name: Central Nervous System Stimulants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Ot
- Name: Other Dietary Supplements
### Intervention Browse Module - Browse Leaves
- ID: M5373
- Name: Caffeine
- Relevance: LOW
- As Found: Unknown
- ID: T370
- Name: Caffeine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434558
**Acronym:** ICE-OSA
**Brief Title:** Imaging Predictors of Cryolysis Efficacy for Treatment of Obstructive Sleep Apnea
**Official Title:** Imaging Predictors of Cryolysis Efficacy for Treatment of Obstructive Sleep Apnea
#### Organization Study ID Info
**ID:** 855200
#### Organization
**Class:** OTHER
**Full Name:** University of Pennsylvania
### Status Module
#### Completion Date
**Date:** 2030-08
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-10
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Pennsylvania
#### Responsible Party
**Investigator Affiliation:** University of Pennsylvania
**Investigator Full Name:** Raj Dedhia, MD
**Investigator Title:** Associate Professor of Otorhinolaryngology & Medicine | Director, Division of Sleep Surgery & CPAP Alternatives Clinic
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The goal of this observational study is to further evaluate the efficacy and mechanism of action of the Cryosa Procedure, a novel procedure intended to treat obstructive sleep apnea (OSA). The patient population includes participants with OSA who are enrolled in the ARCTIC-3 study and are undergoing the Cryosa Procedure. The main questions we aim to answer are:
(1) evaluate predictors of successful treatment with the Cryosa Procedure, which is described in more detail in the ARCTIC-3 protocol (IRB #854182), and (2) evaluate a potential mechanism of action of this novel therapy.
We hypothesize that higher baseline quantities of oropharyngeal fat and higher baseline upper airway neurotonic activity will be correlated with a successful reduction in OSA symptom severity as measured by a change in apnea-hypopnea index values. We also hypothesize that responders will have a decrease in oropharyngeal fat, which would indicate the mechanism of action of this novel therapy is a loss in oropharyngeal fat.
Participants will be asked to:
1. have an MRI before undergoing the Cryosa Procedure
2. have an ultrasound before the Cryosa Procedure
3. permit the use of pressure-sensing catheters and ultrasound during their drug-induced sleep endoscopy, which is part of the ARCTIC-3 protocol
4. have an MRI after the Cryosa Procedure
5. have an ultrasound after the Cryosa Procedure.
**Detailed Description:** Previous research has shown there is increased fat at the base of the tongue and other locations of the oropharynx in patients with Obstructive Sleep Apnea (OSA) compared to match control non-OSA patients. Subsequently, Cryosa developed the Cryosa Procedure, which is further detailed in the ARCTIC-3 protocol (IRB #854182). This procedure involves the Cryosa System, a device intended to induce adipose cryolysis, a non-surgical removal of by inducing cell death (apoptosis) with a controlled freezing of the soft tissue, in the upper airway.
Whereas the objective of the ARCTIC-3 study is to determine the efficacy and safety of the Cryosa Procedure, the co-primary aims of the ICE-OSA study are to (1) evaluate predictors of successful treatment with the Cryosa Procedure and (2) evaluate a potential mechanism of action of this novel therapy. We hypothesize that (1) higher baseline quantity of oropharyngeal fat and higher baseline upper airway neurotonic activity are correlated with a successful reduction in OSA severity, and (2) responders will have a decrease in quantity of oropharyngeal fat (as measured by post-operation magnetic resonance imaging, MRI). Investigating the mechanisms and predictors of this novel therapy is necessary to inform future clinical trials and patient selection for the Cryosa Procedure. To assess these metrics, the ICE-OSA study utilizes MRI, point-of-care ultrasound (POCUS), and the addition of pharyngeal manometry and ultrasound (US) during drug-induced sleep endoscopy (DISE) for ARCTIC-3 participants.
Study Statistics:
These prognostic data are going to be collected as part of a small pilot study to inform the upcoming pivotal trial. For this reason, we seek independent variables with large effect sizes to update and enhance patient selection criteria for the future trial.
We propose use of Student's t-test for responders/non-responders (responder defined as reduction of AHI by \>50%) for the surgical intervention. Our expected ratio of responders to non-responders is 1:1 based on data provided by the study sponsor (unpublished).
Our previous data examining tongue fat in MRI demonstrated values of quantity of fat tissue in fatty tongues to be roughly 14,000 mm3 and fat tissue in non-fatty tongues to be roughly 7,000 mm3. Using these parameters, we calculated that 10 subjects total would be required (assuming a standard deviation of 4,000 mm3) to detect significant differences between responders/non-responders with an alpha of 0.05 and a power of 80%.
### Conditions Module
**Conditions:**
- Obstructive Sleep Apnea of Adult
**Keywords:**
- Obstructive Sleep Apnea
- ultrasound
- MRI
- cryotherapy
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** The Cryosa Procedure is part of the ARCTIC-3 protocol (IRB #854182). Therefore, all patients enrolled in this study are expected to undergo the Cryosa Procedure. Undergoing the Cryosa Procedure is not a part of this protocol.
**Name:** Cryosa Procedure
**Other Names:**
- Cryotherapy
- OSA Cryotreatment
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Quantity of oropharyngeal fat will be measured with magnetic resonance imaging (MRI) before the Cryosa Procedure and 6 months after the Cryosa Procedure in all subject participants.
**Measure:** Change from Baseline in Oropharyngeal Fat at 6 Months
**Time Frame:** Baseline and 6 months
**Description:** All participants in this study, who are also enrolled in the ARCTIC-3 study, are undergoing a polysomnogram as part of the ARCTIC-3 study at baseline and at 6 months. AHI is measured during these sleep studies in every patient at both timepoints.
**Measure:** Change in Baseline Apnea Hypopnea Index at 6 Months
**Time Frame:** Baseline and 6 Months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Enrolled in the ARCTIC-3 clinical trial at the University of Pennsylvania\*
* Provision of signed and dated informed consent form for ICE-OSA
Exclusion Criteria:
* MRI contraindications (claustrophobia, ferromagnetic implants/foreign bodies, etc.)
* Patient is pregnant or becomes pregnant during their enrollment
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
**Study Population:** This study enrolls only participants that are previously enrolled in the ARCTIC-3 trial and are subsequently undergoing the Cryosa Procedure as part of the ARCTIC-3 protocol. As required by the eligibility criteria in the ARCTIC-3 study, these patients have a BMI less than or equal to 40 kg/m2, are 22 to 70 years old, and have moderate to severe obstructive sleep apnea (OSA).
Additionally, eligibility requirements from the ARCTIC-3 trial include having never previously undergone uvulopalatopharyngoplasty or tongue base reduction for the treatment of OSA. Patients are also excluded for any other reasons the principal investigator would deem a contraindication to undergoing procedures outlined by the ARCTIC-3 protocol.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Erica R Kent, BS
**Phone:** 215-615-8777
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Everett Seay, BS,, RPSGT
**Phone:** 215-615-8777
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Philadelphia
**Country:** United States
**Facility:** University of Pennsylvania
**State:** Pennsylvania
**Zip:** 19104
#### Overall Officials
**Official 1:**
**Affiliation:** University of Pennsylvania
**Name:** Raj Dedhia, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-05-15
- Filename: ICF_000.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 454764
- Type Abbrev: ICF
- Upload Date: 2024-05-23T16:06
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012120
- Term: Respiration Disorders
- ID: D000012140
- Term: Respiratory Tract Diseases
- ID: D000012818
- Term: Signs and Symptoms, Respiratory
- ID: D000020919
- Term: Sleep Disorders, Intrinsic
- ID: D000020920
- Term: Dyssomnias
- ID: D000012893
- Term: Sleep Wake Disorders
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC08
- Name: Respiratory Tract (Lung and Bronchial) Diseases
- Abbrev: BC10
- Name: Nervous System Diseases
- 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: 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: M4361
- Name: Apnea
- Relevance: HIGH
- As Found: Apnea
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M14957
- Name: Respiration Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14977
- Name: Respiratory Tract Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15623
- Name: Signs and Symptoms, Respiratory
- Relevance: LOW
- As Found: Unknown
- ID: M22242
- Name: Parasomnias
- Relevance: LOW
- As Found: Unknown
- ID: M22654
- Name: Sleep Disorders, Intrinsic
- Relevance: LOW
- As Found: Unknown
- ID: M22655
- Name: Dyssomnias
- Relevance: LOW
- As Found: Unknown
- ID: M15696
- Name: Sleep Wake Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001049
- Term: Apnea
- ID: D000012891
- Term: Sleep Apnea Syndromes
- ID: D000020181
- Term: Sleep Apnea, Obstructive
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434545
**Acronym:** SMEtH
**Brief Title:** Symptom Management Essentials at Home
**Official Title:** SMEtH - Symptom Management Essentials at Home
#### Organization Study ID Info
**ID:** 80-86300-98-060
#### Organization
**Class:** OTHER
**Full Name:** UMC Utrecht
### Status Module
#### Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2026-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2021-11-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** Zorgbelang Inclusief
**Class:** OTHER
**Name:** Comprehensive Cancer Centre The Netherlands
**Class:** UNKNOWN
**Name:** ROC Midden Nederland
**Class:** OTHER
**Name:** University of Applied Sciences Utrecht
#### Lead Sponsor
**Class:** OTHER
**Name:** UMC Utrecht
#### Responsible Party
**Investigator Affiliation:** UMC Utrecht
**Investigator Full Name:** Everlien de Graaf
**Investigator Title:** Doctor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** A cluster Randomized Controlled Trial (cRCT) that aims to determine the effect of the Palliative Reasoning (PR) methodology on the quality of life and symptom burden of patients dealing with a life-limiting illness and their loved ones, receiving palliative care services at home. Palliative Reasoning will be implemented from the first of may 2024 to 30 april 2025 in twenty nursing teams of a large homecare organization in Utrecht, the Netherlands, and will be compared with twenty control nursing teams. The effect of PR will be measured by means of questionnaires filled out by clients with a life expectancy of less than one year according to the surprise question "Would I be surprised if this person would die within one year?" and family caregivers. Parallel to the effect study, a process evaluation will be conducted in order to understand the implications of the results and its' societal and practical impact.
**Detailed Description:** The Palliative Reasoning (PR) methodology has been developed by University Medical Centre Utrecht (UMCU) in collaboration with the Netherlands Comprehensive Cancer organization (IKNL) to support nursing teams and other HCPs with the inter- and intradisciplinary communication and the early recognition, analysis and treatment of symptoms in patients requiring palliative care. This stepwise, iterative approach starts with HCPs identifying patients with palliative care needs by asking the surprise question "Would I be surprised if this patient would die within one year?". If the answer to the previous question is no, indicating not being surprised, a patient can be marked as being in a palliative phase of life. After the identification of the patient the method follows four steps: (1) Map out current symptoms, values, wishes and needs of patient and loved ones; (2) Analyze symptoms; (3) develop a proactive treatment plan; (4) Make agreements for the evaluation of the treatment plan.
After the training twenty of the forty nursing teams working for a large homecare organization, patients and family caregivers of both intervention teams and control teams can be included. The perceived symptom control, quality of life and symptom burden of patients and symptom burden of family caregivers, will be compared between intervention and control teams, to assess the effectiveness of the intervention.
### Conditions Module
**Conditions:**
- Symptom Management
**Keywords:**
- Symptom management
- Palliative Care
- Primary care
- life-limiting illness
- Palliative Reasoning
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- PARTICIPANT
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 800
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The intervention group consists of 20 nursing team, each recruiting 20 clients with palliative care needs. This results in a total of 400 clients for the intervention group. A nursing team consists of nurse assistants, registered nurses and specialized nurses.
**Intervention Names:**
- Behavioral: Palliative Reasoning methodology
**Label:** Intervention group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The control group consists of 20 nursing teams that will continue to provide care as previous to the start of the study. Contact persons also recruit 20 clients per nursing team, resulting in a total of 400 client for the control group.
**Label:** Control group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention group
**Description:** Twenty nursing teams will be trained in the Palliative Reasoning methodology during a four hour training, split into two sessions. Additionally, teams receive a coaching session ones a month and practice with a real life case every week or two weeks during a one hour team meeting. This will be compared with 20 other nursing teams that will continue to provide care as usual.
**Name:** Palliative Reasoning methodology
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** age, gender, marital status, education level, employment status (retired, unemployed, employed), (past) illness, type of employment (in the past), duration of illness, treatment, phase of illness, comorbidity, performance status (KPS), time under nursing care, number of visits per day/week.
**Measure:** Client demographics
**Time Frame:** Questioned at baseline
**Description:** age, gender, education level, role, employment status assessed at enrollment.
**Measure:** Primary caregiver demographics
**Time Frame:** Questioned at baseline
**Description:** education level, local collaborations with GP and paramedics, symptom management practices.
**Measure:** Nursing team demographics
**Time Frame:** Questioned after baseline
#### Primary Outcomes
**Description:** This outcome will be measured by asking the participant "Do you feel your symptoms are under control?".
**Measure:** Perceived symptom control of clients and family caregivers dealing with a life-limiting illness
**Time Frame:** One month after implementation
#### Secondary Outcomes
**Description:** EORTC QLQ C15 will be used to determine the QoL.
**Measure:** Quality of life of clients dealing with a life-limiting illness
**Time Frame:** Assessed after one month, three months and six months after implementation.
**Description:** Utrecht Symptom Diary Four Dimensional (USD4D) will be used to determine symptom burden. The USD4D comprises of questions regarding the physical, psychological, social, and spiritual dimension, which are rated on a scale from 0-10 (0 = symptom is absent to 10 = severity symptom is the worst imaginable).
**Measure:** Symptom burden of clients dealing with a life-limiting illness
**Time Frame:** Assessed at one month, three months and six months after implementation.
**Description:** The primary caregiver burden Is assessed by means of the Self Rated Burden Scale, which is a one item numerical scale answering the question "How do I perceive the care for my loved one at the moment?"(35-38). The question is answered on a scale of 0 to 10, in which 0 refers to "not at all straining" and 1 refers to "much to straining". In addition, the perceived burden of informal care (Dutch: Ervaren Druk Informele Zorg (EDIZ)) will be used, assessing aspects of informal care contributing to the perceived burden(39). The EDIZ is developed for the use in caregivers of patients suffering from dementia at home, however, this measurement instrument is widely used to assess the level of burden of caregivers of patients with a life-limiting illness. This instrument contains 9 statements to which patients must answer "no!", "no", "more or less", "yes" or "yes!".
**Measure:** Primary caregiver burden
**Time Frame:** Assessed at one, three and six months after implementation.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria client:
1. The client is 18 years or older.
2. The client is diagnosed with a life limiting illness or frailty syndrome with a life expectancy of less than a year, estimated by the nursing team, based on the Surprise Question.
3. The client lives at home and receives homecare
4. The client suffers from at least 1 symptom identified by means of the problem list of the Distress Thermometer.
Inclusion Criteria primary caregiver:
1. The primary caregiver is 18 years or older.
2. The primary caregiver has a relative with a life-limiting illness with a life expectancy \<1 year.
3. Is able to speak and read Dutch
A nursing team is eligible when:
1. The nurses that are part of the nursing team are motivated to participate in the study.
2. The Nursing team consists of nurses that are sufficiently experienced in the work that they to effectively learn new competences during training sessions.
Exclusion Criteria:
Clients and primary caregivers that are diagnosed with cognitive impairment and/or unable to read and speak Dutch, will be excluded from the study.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Utrecht
**Country:** Netherlands
**Facility:** University Medical Center Utrecht
**Zip:** 3584 CX
#### Overall Officials
**Official 1:**
**Affiliation:** UMC Utrecht
**Name:** Saskia Teunissen, Prof. dr.
**Role:** STUDY_DIRECTOR
## Document Section
### Large Document Module
#### Large Docs
- Date: 2022-12-20
- Filename: Prot_000.pdf
- Has ICF: False
- Has Protocol: True
- Has SAP: False
- Label: Study Protocol
- Size: 517068
- Type Abbrev: Prot
- Upload Date: 2024-04-26T02:42
- Date: 2023-08-04
- Filename: SAP_001.pdf
- Has ICF: False
- Has Protocol: False
- Has SAP: True
- Label: Statistical Analysis Plan
- Size: 249287
- Type Abbrev: SAP
- Upload Date: 2024-04-26T02:44
- Date: 2023-08-04
- Filename: SAP_002.pdf
- Has ICF: False
- Has Protocol: False
- Has SAP: True
- Label: Statistical Analysis Plan
- Size: 249287
- Type Abbrev: SAP
- Upload Date: 2024-04-26T02:44
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434532
**Brief Title:** Exploring the Effectiveness of an Interprofessional Game-based Learning
**Official Title:** An Exploratory Study on the v-Care Interprofessional Online Game for Healthcare Students
#### Organization Study ID Info
**ID:** HSEARS20230729001
#### Organization
**Class:** OTHER
**Full Name:** The Hong Kong Polytechnic University
### Status Module
#### Completion Date
**Date:** 2024-07-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-19
**Type:** ACTUAL
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-24
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** The Hong Kong Polytechnic University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this waitlist control study is to evaluate the benefits of online game pedagogy to evaluate the readiness of health care students for interprofessional learning in nursing students.
Interprofessional (IP) collaboration is a core competence of health care education to enable effective teamwork and improve health outcomes. Taking into account the characteristics of our students and the pragmatic issues, v-Care (Virtual Care) is a novel strategy to deliver Interprofessional Education using gamification. Colleagues from nursing (SN), rehabilitation sciences (RS) and health technology and informatics (HTI) will collaborate in the design of v-Care, and implement and evaluate it effectiveness in nursing, physiotherapy and radiography related subjects.
To evaluate the effectiveness of interprofessional learning of the health faculty students using a multi-player point-and-click on line motivational game.
Theoretical Framework The v-Care design is based on the Self-Determination Theory (SDT) and Motivational Gamification.
Outcomes:
The primary outcome is to improve the readiness for interprofessional learning. A peer learning community will be established to improve the motivation to learn based on SDT: (1) autonomy, (2) competence and (3) relatedness.
**Detailed Description:** BACKGROUND lnterprofessional education is a core competence of health care education to enable effective collaboration and improve health outcomes \[1\] (lnterprofessional Education Collaborative Expert Panel, 2011). Numerous initiatives were implemented, including the Freshman Seminar for Broad Disciplines in Health Science (FS) in the undergraduate curriculum. IPE was explicitly listed in the FS intended learning outcomes to (1) understand the professional identity of the learners' own discipline and the other professional's roles on the health care team; and (2) Identify innovative strategies in managing selected major health issues implement using an interprofessional (IP) collaborations approach; and (3) reflect on the experience on interprofessional learning and its implications on lifelong learning and career development. Starting from 2002/23 academic year, this subject was replaced by artificial intelligence and data analytics (AIDA). Since IP is an integral part of the curriculum, implementing IPE under other teaching modes (such as gamification, peer-learning or learner-directed) must be reconsidered.
Motivational gamification is a strategy rooted in the Self-Determination Theory (SDT), gamification and micro-learning are the merits much preferred by the millennials in learning. This strategy leverages on the millennial characteristics that technology has been embedded to their daily life, they enjoy fun and games and are motivated by immediate positive rewards, such as points and badges. Furthermore, they have relatively shorter attention span and enjoy simulation in virtual environments with high quality visuals and graphics. Game features such as click-to-reveal, drag-and-drop, pop quizzes tend to engage the millennial learners. As such, the proposed project is feasible to improve the learning experience and possibly learning outcomes.
AIM To evaluate the effectiveness and impact of interprofessional learning of health faculty students using a multi-player point-and-click on line motivational game. A pretest-posttest non-equivalent waitlist control group design was employed.
METHOD Convenience sampling was adopted to recruit subjects. Inclusion criteria - Participants were recruited from the students who had enrolled in the nursing, physiotherapy and radiography subjects. Students retaking the subject will be excluded from the study.
They were assigned into two study groups according to the tutorial teaching schedule: the control and the experimental groups. The Control group attended the usual teaching activities: paper case study, whereas the intervention group participated in the vCare eGame (intervention). Surveys will be implemented before any learning activities, and at the same time for both groups after the intervention group completed the vCare eGame.
OUTCOME MEASURES Primary outcome will be measured by the Readiness for Interprofessional Learning Scale (19-items).
Secondary outcome on students' autonomy will be measured by a 24-items Perceived Peer Autonomy Support Scale and the 18-item Intrinsic Motivation Inventory.
### Conditions Module
**Conditions:**
- Educational Problems
**Keywords:**
- Interprofession
- online game
- nursing
- multidisciplinary education
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** waitlist control
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 350
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** the v-Care online game consist of a clinical scenario. Participants are requested to join the online game in small groups, consisting of nursing and radiography students, to discuss the patient's condition presented in the scenario. They will also be required to watch relevant mini-videos that cover the knowledge check points within the game.
As part of the activity, participants will be expected to submit a mini interprofessional project that explains their respective roles and responsibilities in managing the patient's condition.
To enhance engagement and motivation, an online game reward system has been implemented. This system includes the opportunity to earn badges upon completing the knowledge check points or participating in learning activities such as watching tutorials or engaging in interprofessional discussions. These discussions will be recorded and summarized to highlight the key points of their conversation.
**Intervention Names:**
- Other: v-Care Online Game
**Label:** v-Care online game
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants are requested to engage in case-based discussions within small groups, comprising nursing and radiography students. As part of this activity, students are required to complete a conventional assignment using a worksheet, which will allow them to elaborate on their individual roles and responsibilities in managing the patient's condition.
In addition, students are encouraged to utilize traditional learning and teaching methods by reading and exploring relevant materials pertaining to the patient's condition.
**Intervention Names:**
- Other: Case-based online discussion
**Label:** Case-based online discussion
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- v-Care online game
**Description:** A regular 2 hours traditional learning mode session - case study session and 2-hour online game session with peer-led discussion and interprofessional project submission. This spreads in 3 weeks interval
**Name:** v-Care Online Game
**Type:** OTHER
#### Intervention 2
**Arm Group Labels:**
- Case-based online discussion
**Description:** A 2-hour traditional learning mode session with online peer-led discussion and submission of an interprofessional worksheet as an assignment
**Name:** Case-based online discussion
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** A 5-point Likert scale questionnaire will be used. There are four subscales that included teamwork and collaboration, negative professional identity, positive professional identity, and roles and responsibility. The higher scores mean a better outcome.
**Measure:** Readiness of Health Care Students for Interprofessional Learning (RIPLS)
**Time Frame:** This will be administered immediately before the start of the learning activity and immediately after the activity is completed
#### Secondary Outcomes
**Description:** This is a 9-items instrument with 3 subscales: interest/enjoyment, perceived competence, and pressure/tension; on a 7-point Likert Scale - Not at all true, somewhat true to very true.
The higher scores mean a better outcome
**Measure:** Intrinsic Motivation Inventory
**Time Frame:** This will be administered immediately before the start of the learning activity and immediately after the activity is completed
**Description:** One 6-items scale will be used to assess the perceive autonomy after the students have completed the learning activity. This is rated on a 7-point Likert Scale - from 1 strongly disagree to 7 strongly agree.
The higher scores mean a better outcome
**Measure:** Perceived Autonomy Scale
**Time Frame:** This will be administered immediately before the start of the learning activity and immediately after the activity is completed
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All students learning colorectal cancer and or frailty when taking the specified subject in the Bachelor Nursing Programme and,
* all students taking Bachelor of Science (Honours) Scheme in Medical Laboratory Science and Radiography in Radiography will be recruited
Exclusion Criteria:
* Students retaking these specified subjects will be excluded.
* Students learning other disorders but not colorectal cancer or frailty are not eligible
**Maximum Age:** 25 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kitty Chan, PhD
**Phone:** 91683233
**Phone Ext:** 6883
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hung Hom
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kitty Chan
- **Phone:** 91683233
- **Role:** CONTACT
**Country:** Hong Kong
**Facility:** School of Nursing
**State:** Hong Kong Island
**Status:** RECRUITING
**Location 2:**
**City:** Hung Hom
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kitty Chan
- **Phone:** 91683233
- **Phone Ext:** 6883
- **Role:** CONTACT
**Country:** Hong Kong
**Facility:** The Hong Kong Polytechnic University
**State:** Hong Kong Island
**Status:** RECRUITING
#### Overall Officials
**Official 1:**
**Affiliation:** The Hong Kong Polytechnic University
**Name:** Kitty Chan, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** access by sending email to the corresponding author
**Description:** Once the project is completed, and paper published, we are happy to share the IPD.
**Info Types:**
- STUDY_PROTOCOL
- CSR
**IPD Sharing:** YES
**Time Frame:** When the project is completed and publication available
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434519
**Brief Title:** Metronidazole SC Penetrance With Moisturizers
**Official Title:** Evaluation of the Effect of Moisturizers on the Absorption of Metronidazole Into the Stratum Corneum of Rosacea Patients With Tape Stripping and Liquid Chromatography-mass Spectrometry
#### Organization Study ID Info
**ID:** Pro00114776
#### Organization
**Class:** OTHER
**Full Name:** Duke University
### Status Module
#### Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** National Rosacea Society
#### Lead Sponsor
**Class:** OTHER
**Name:** Duke University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** Topical metronidazole is a widely used first line treatment for erythemotelangiectatic and inflammatory rosacea. Commonly, a moisturizer is also used to restore the skin barrier and reduce inflammation. The purpose of this study is to assess the whether the common practice of applying moisturizer prior to topical metronidazole affects this medication's stratum corneum penetrance in rosacea patients. Participants will have one research office visit that will consist of having a randomly assigned combination of metronidazole and one of four moisturizers applied to their face, followed by non-invasive tape stripping of skin at the 1 hour and 4 hour time points. These tape strip samples will be analyzed with liquid chromatography mass spectrometry (LC-MS) for assessment of metronidazole penetrance in the stratum corneum in the presence of moisturizers. The target population will be rosacea patients in the age range of 18-60 years of age. This study has minimal risks/safety issues as topical metronidazole is an already FDA approved medication with an indication for rosacea and all investigated moisturizers are over-the-counter formulations commonly used within the rosacea patient population. Tape stripping will remove 5 levels of superficial stratum corneum, and will not result in bleeding, scarring, or other prolonged cosmetic disfigurement. Small, transient bruising may result from tape strip collection. The collected samples will have no to minimal biohazard risk, as the collected specimen for analysis will only contain skin scale; samples will be extracted with organic solvents and decontaminated with a 0.2 micron nylon filter prior to analysis on the LC-MS instrumentation.
**Detailed Description:** Rosacea is a debilitating spectrum of disease causing both socially embarrassing erythema and disfiguring rhinophyma. Treatment is challenging and life-long, often requiring clinicians to trial multiple medications, such as azelaic acid, metronidazole, or ivermectin to achieve disease control. The skin of rosacea patients inherently has impaired skin barrier function, resulting in inflammation and hypersensitivity to most therapeutics. Thus, many clinicians encourage patients to augment their topical medications with personal moisturizers to optimize the skin barrier. However, there is limited data to support that moisturizers do not affect drug epidermal penetrance and efficacy. To the investigator's knowledge, only a single trial assessing the effect of moisturizers on skin penetrance of azelaic acid has been published in the English literature. In the era of evidence-based medicine, it is critical to provide either the scientific data to support or to refute this medical dogma. The investigator's proposal addresses this gap in the basic science literature and will provide data to evaluate a long and widely-held dermatologist recommendation for the treatment of rosacea. The investigators anticipate that there may be preferred combinations of medication and moisturizers based upon the matched lipophilicities and other chemical properties of the occlusive agent and therapeutic drug. Identification of such combinations may lead to improved outcomes for those struggling with treatment-resistant rosacea and lead to additional pharmaceutical advances in the treatment of rosacea.
Drug formulation is critical to the successful treatment of dermatologic disease. An active ingredient must diffuse through the stratum corneum (SC) to reach the dermis to achieve its therapeutic effect. In addition to the intrinsic chemical properties of the active compound dictating the kinetics of the diffusion process, chemists tweak a topical formulation's vehicle, emulsifiers, and polymers to enhance drug SC penetrance and overcome the skin's evolutionary role as a barrier to the outside world. The combination of drug with additional topical moisturizers inherently changes the chemical environment that the active drug must diffuse through to reach the dermis. Moisturizers and other topical cosmetics are well established to affect dermal drug and toxin absorption. For example, moisturizers have been demonstrated to enhance dermal penetrance of herbicide 2,4-dichlorophenoxacetic acid in murine models. Similarly, occlusive moisturizers are often applied over steroids to enhance their anti-inflammatory efficacy, presumably through improved epidermal penetration. Increased penetrance is a case-by-case scenario, however, and considerable attention is dedicated to topical formulation to appropriately modulate therapeutic drug penetrance of the SC during the drug design process.
To the investigator's knowledge, the formulation and timing of moisturizer application on drug efficacy in rosacea is understudied. An extensive literature review revealed only a single study addressing this important question for the special case of azelaic acid with an in vitro Franz cell diffusion assay using donated trunk skin biopsies. In this study, a 14C radiolabeled 15% azelaic acid gel was applied to epidermis before or after the application of Dove Lotion, CeraVe Moisturizer Lotion, and Cetaphil Moisturizing Lotion. The penetrance of azelaic acid into the SC was then assessed up to 48 hours post-application using liquid scintillation spectrometry. Azelaic acid SC penetration was not statistically different between the moisturizers or timing of application, although trends towards decreased penetration was noted in 1 of 3 studied moisturizers. There are several limitations to this study. First, azelaic acid occupies a unique chemical space among rosacea therapies. Azelaic acid's lipophilicity (LogP), an important chemical property affecting epidermal drug penetrance, is 1.6 compared with 5.83, 0.0, -0.3 and -0.7 for ivermectin, metronidazole, monocycline, and doxycycline, respectively, suggesting that azelaic acid is between 1.4e2 times more lipophilic to 1.7e4 times less lipophilic than other therapies. Thus, azelaic acid is a poor standard with which to assess moisturizers' impact on SC drug penetrance. Second, truncal skin was used to assess azelaic acid SC penetrance. Consequently, the study's clinical relevance is limited as rosacea exclusively affects the face, where the skin is much thinner and transdermal absorption occurs more readily. Finally, although a tritium diffusion control was implemented to select skin samples with relatively intact barrier function, a Franz cell diffusion assay inherently utilizes dead, enzymatically inactive skin. Thus, the results of a Franz cell assay is not necessarily clinically relevant or reflective of physiologically active skin on patients. Further work is necessary to determine whether moisturizers affects drug SC penetrance in rosacea patients.
In prior work, the investigators made method advances that overcome many of the limitations of the Franz cell assay as it relates to clinical relevance. Specifically, the investigators have established a track record of assessing drug penetrance of topically delivered medications, e.g. tazarotene, allantoin, ketoconazole, and betamethasone dipropionate, in the SC using minimally invasive D-squame tape stripes of human subjects in combination with liquid chromatography mass spectrometry (LC-MS). In these studies, the investigators are able to assess drug penetrance with physiologically relevant skin and on skin affected by the disease of interest. Therefore, the methods the investigators propose for assessing metronidazole SC penetrance in the presence of moisturizers is now established as an efficient and reliable method for quantitating drug in the SC in a minimally invasive and clinically relevant context.
### Conditions Module
**Conditions:**
- Rosacea, Erythematotelangiectatic
**Keywords:**
- rosacea
- metronidazole
- LC-MS
- tape strip
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** 5 patients will enrolled in 4 study arms. Each study arm will represent a different combination of moisturizer applied to the face, followed by metronidazole cream. No moisturizer will be applied to the left side of each patient's face, permitting for each patient to represent their own negative (no metronidzole cream applied) and positive control (metronidazole cream + no moisturizer). Metronidazole penetrance in the stratum corneum will be assess with tape strips and LC-MS
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 20
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Apply Cetaphil (glycerin (humectant) and petrolatum (occlusive)) moisturizer followed by metronidazole cream. Tape striping will occur at 1 hours and 4 hours post metronidazole application.
**Intervention Names:**
- Drug: Metronidazole cream
- Other: Cetaphil moisturizer
**Label:** Metronidazole cream + Cetaphil moisturizer
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Apply CeraVe (glycerin/hyaluronic acid (humectant), ceramides (intercellular lipid component), and dimethicone/petrolatum (occlusive)) moisturizer followed by metronidazole cream. Tape striping will occur at 1 hours and 4 hours post metronidazole application.
**Intervention Names:**
- Drug: Metronidazole cream
- Other: CeraVe moisturizer
**Label:** Metronidzole cream + CeraVe moisturizer
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Apply Eucerin Healing Lotion (mineral oil (occlusive) and sorbitol/propylene glycol (humecants)) followed by metronidazole cream. Tape striping will occur at 1 hours and 4 hours post metronidazole application.
**Intervention Names:**
- Drug: Metronidazole cream
- Other: Eucerin Healing Lotion moisturizer
**Label:** Metronidzole cream + Eucerin Healing Lotion moisturizer
**Type:** EXPERIMENTAL
#### Arm Group 4
**Description:** Apply Aveeno Calm and Restore Oat Gel (glycerin (humectant) and dimethicone (occlusive) and oat kernel flour based gel moisturizer) moisturizer followed by metronidazole cream. Tape striping will occur at 1 hours and 4 hours post metronidazole application.
**Intervention Names:**
- Drug: Metronidazole cream
- Other: Aveeno Calm and Restore Oat Gel moisturizer
**Label:** Metronidazole cream + Aveeno Calm and Restore Oat Gel moisturizer
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Metronidazole cream + Aveeno Calm and Restore Oat Gel moisturizer
- Metronidazole cream + Cetaphil moisturizer
- Metronidzole cream + CeraVe moisturizer
- Metronidzole cream + Eucerin Healing Lotion moisturizer
**Description:** After application of one of the moisturizers under investigation in this study to the right side of the patient's face, x5 tape strips will be collected from the left side of a patient's face. These will provide negative controls for quantitation of metronidazole in the stratum corneum. Then, 0.5 mL of a 1% metronidazole cream will be applied to both the right and left sides of a patient's face with clean gloves to prevent cross contamination. Tapes strips x5 will subsequently be collected from the left and right sides of the face at 1 hour and 4 hour time points to assess penetrance of metronidazole through the stratum corneum.
**Name:** Metronidazole cream
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Metronidazole cream + Cetaphil moisturizer
**Description:** 1 mL of moisturizer will be dispensed using a pre-loaded syringe applied to the right face of each patient the patient's standard practice. No moisturizer will be applied to the left side of the face to provide for negative and positive tape strip controls to assess metronidazole penetrance through the stratum corneum in the presence of the moisturizer.
**Name:** Cetaphil moisturizer
**Type:** OTHER
#### Intervention 3
**Arm Group Labels:**
- Metronidzole cream + CeraVe moisturizer
**Description:** 1 mL of moisturizer will be dispensed using a pre-loaded syringe applied to the right face of each patient the patient's standard practice. No moisturizer will be applied to the left side of the face to provide for negative and positive tape strip controls to assess metronidazole penetrance through the stratum corneum in the presence of the moisturizer.
**Name:** CeraVe moisturizer
**Type:** OTHER
#### Intervention 4
**Arm Group Labels:**
- Metronidzole cream + Eucerin Healing Lotion moisturizer
**Description:** 1 mL of moisturizer will be dispensed using a pre-loaded syringe applied to the right face of each patient the patient's standard practice. No moisturizer will be applied to the left side of the face to provide for negative and positive tape strip controls to assess metronidazole penetrance through the stratum corneum in the presence of the moisturizer.
**Name:** Eucerin Healing Lotion moisturizer
**Type:** OTHER
#### Intervention 5
**Arm Group Labels:**
- Metronidazole cream + Aveeno Calm and Restore Oat Gel moisturizer
**Description:** 1 mL of moisturizer will be dispensed using a pre-loaded syringe applied to the right face of each patient the patient's standard practice. No moisturizer will be applied to the left side of the face to provide for negative and positive tape strip controls to assess metronidazole penetrance through the stratum corneum in the presence of the moisturizer.
**Name:** Aveeno Calm and Restore Oat Gel moisturizer
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** Metronidazole stratum corneum penetrance will be ascertained with LC-MS (liquid chromatography-mass spectrometry). Tape strips (x5) will be collected at the 1 hour and 4 hour time points post application of metronidazole.
**Measure:** Metronidazole penetrance through the stratum corneum (SC)
**Time Frame:** 1 hours and 4 hours post metronidazole application
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Healthy, non-pregnant individual 18+ years of age;
2. Subjects willing to allow a series of tape pieces to be pressed and removed from their faces over an 4 hour period;
3. Subjects can remain calm and quiet at the research facility for 6 hours;
4. Subjects in general good health as determined from a medical history;
5. Subjects must read and sign the informed consent form after the nature of the study has been fully explained.
Exclusion Criteria:
1. Subjects with known allergies or sensitivities to ingredients contained in the test products;
2. Subjects with an allergy to latex or adhesives;
3. Subjects with excessive visible sun damage on the face, such that the dermatologist investigator considers the subject unsuitable for study entry;
4. Subjects with skin growths or other issues on the face that could interfere with the tape sampling;
5. Subjects who are currently participating in any other clinical study (i.e., dermal patch, use tests, investigational drug or devices, etc.);
6. Subjects viewed by the investigator as not being able to complete the study;
7. Subjects unwilling to refrain from using any type of lotion, medication, or other topical product to the face for a set amount of time prior to the study.
**Healthy Volunteers:** True
**Maximum Age:** 60 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Matthew M Draelos, MD PhD
**Phone:** (919) 684-3432
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Jessica Oxendine, CMA III
**Phone:** 919-684-1299
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Durham
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Matthew M Draelos, MD PhD
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Jessica Oxendine, CMA III
- **Phone:** 919-684-1299
- **Role:** CONTACT
***Contact 3:***
- **Name:** Matthew M Draelos, MD PhD
- **Role:** PRINCIPAL_INVESTIGATOR
***Contact 4:***
- **Name:** John Murray, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** Duke University Medical Center
**State:** North Carolina
**Zip:** 27710
#### Overall Officials
**Official 1:**
**Affiliation:** Duke University
**Name:** Matthew M Draelos, MD PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** Duke University
**Name:** John Murray, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Thiboutot D, Anderson R, Cook-Bolden F, Draelos Z, Gallo RL, Granstein RD, Kang S, Macsai M, Gold LS, Tan J. Standard management options for rosacea: The 2019 update by the National Rosacea Society Expert Committee. J Am Acad Dermatol. 2020 Jun;82(6):1501-1510. doi: 10.1016/j.jaad.2020.01.077. Epub 2020 Feb 7.
**PMID:** 32035944
**Citation:** Gallo RL, Granstein RD, Kang S, Mannis M, Steinhoff M, Tan J, Thiboutot D. Rosacea comorbidities and future research: The 2017 update by the National Rosacea Society Expert Committee. J Am Acad Dermatol. 2018 Jan;78(1):167-170. doi: 10.1016/j.jaad.2017.06.150. No abstract available.
**PMID:** 29102687
**Citation:** Del Rosso JQ, Lehman PA, Raney SG. Impact of order of application of moisturizers on percutaneous absorption kinetics: evaluation of sequential application of moisturizer lotions and azelaic acid gel 15% using a human skin model. Cutis. 2009 Mar;83(3):119-24.
**PMID:** 19363903
**Citation:** Draelos ZD, Draelos MM, Steele F, Georgiou M, Praestegaard M. Enhanced Skin Deposition of Betamethasone Dipropionate from a Novel Formulation and Drug Delivery Technology. Dermatol Ther (Heidelb). 2023 Aug;13(8):1763-1771. doi: 10.1007/s13555-023-00959-3. Epub 2023 Jun 23.
**PMID:** 37351830
**Citation:** Draelos ZD, Draelos MM. Development of a Tape-Stripping Liquid Chromatography-Mass Spectrometry Method for Evaluating Skin Deposition of Topical Tazarotene. J Drugs Dermatol. 2021 Oct 1;20(10):1105-1111. doi: 10.36849/JDD.6211.
**PMID:** 34636513
**Citation:** Gether L, Overgaard LK, Egeberg A, Thyssen JP. Incidence and prevalence of rosacea: a systematic review and meta-analysis. Br J Dermatol. 2018 Aug;179(2):282-289. doi: 10.1111/bjd.16481. Epub 2018 May 31.
**PMID:** 29478264
**Citation:** Turpeinen M. Absorption of hydrocortisone from the skin reservoir in atopic dermatitis. Br J Dermatol. 1991 Apr;124(4):358-60. doi: 10.1111/j.1365-2133.1991.tb00597.x.
**PMID:** 2025556
**Citation:** Danby SG, Draelos ZD, Gold LFS, Cha A, Vlahos B, Aikman L, Sanders P, Wu-Linhares D, Cork MJ. Vehicles for atopic dermatitis therapies: more than just a placebo. J Dermatolog Treat. 2022 Mar;33(2):685-698. doi: 10.1080/09546634.2020.1789050. Epub 2020 Jul 16.
**PMID:** 32654550
**Citation:** Ghadially R, Halkier-Sorensen L, Elias PM. Effects of petrolatum on stratum corneum structure and function. J Am Acad Dermatol. 1992 Mar;26(3 Pt 2):387-96. doi: 10.1016/0190-9622(92)70060-s.
**PMID:** 1564142
**Citation:** Brand RM, Charron AR, Sandler VL, Jendrzejewski JL. Moisturizing lotions can increase transdermal absorption of the herbicide 2,4-dichlorophenoxacetic acid across hairless mouse skin. Cutan Ocul Toxicol. 2007;26(1):15-23. doi: 10.1080/15569520601182791.
**PMID:** 17464745
**Citation:** Huh Y, Lee DH, Choi D, Lim KM. Effect of Cosmetics Use on the In Vitro Skin Absorption of a Biocide, 1,2-Benzisothiazolin-3-one. Toxics. 2022 Feb 24;10(3):108. doi: 10.3390/toxics10030108.
**PMID:** 35324733
**Citation:** Feldmann RJ, Maibach HI. Regional variation in percutaneous penetration of 14C cortisol in man. J Invest Dermatol. 1967 Feb;48(2):181-3. doi: 10.1038/jid.1967.29. No abstract available.
**PMID:** 6020682
**Citation:** Tipthara P, Kobylinski KC, Godejohann M, Hanboonkunupakarn B, Roth A, Adams JH, White NJ, Jittamala P, Day NPJ, Tarning J. Identification of the metabolites of ivermectin in humans. Pharmacol Res Perspect. 2021 Feb;9(1):e00712. doi: 10.1002/prp2.712.
**PMID:** 33497030
**Citation:** Vanol PG, Sanyal M, Shah PA, Shrivastav PS. Quantification of metronidazole in human plasma using a highly sensitive and rugged LC-MS/MS method for a bioequivalence study. Biomed Chromatogr. 2018 Aug;32(8):e4242. doi: 10.1002/bmc.4242. Epub 2018 Apr 22.
**PMID:** 29572903
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000012871
- Term: Skin Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC11
- Name: Eye Diseases
### Condition Browse Module - Browse Leaves
- ID: M15214
- Name: Rosacea
- Relevance: HIGH
- As Found: Rosacea
- ID: M6539
- Name: Corneal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012393
- Term: Rosacea
### Intervention Browse Module - Ancestors
- ID: D000000890
- Term: Anti-Infective Agents
- ID: D000000900
- Term: Anti-Bacterial Agents
- ID: D000000981
- Term: Antiprotozoal Agents
- ID: D000000977
- Term: Antiparasitic Agents
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Infe
- Name: Anti-Infective Agents
- Abbrev: Gast
- Name: Gastrointestinal Agents
- Abbrev: Derm
- Name: Dermatologic Agents
### Intervention Browse Module - Browse Leaves
- ID: M9878
- Name: Hyaluronic Acid
- Relevance: LOW
- As Found: Unknown
- ID: M11767
- Name: Metronidazole
- Relevance: HIGH
- As Found: Stage III
- ID: M15814
- Name: Sorbitol
- Relevance: LOW
- As Found: Unknown
- ID: M13485
- Name: Petrolatum
- Relevance: LOW
- As Found: Unknown
- ID: M11869
- Name: Mineral Oil
- Relevance: LOW
- As Found: Unknown
- ID: M4214
- Name: Anti-Infective Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4222
- Name: Anti-Bacterial Agents
- 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
### Intervention Browse Module - Meshes
- ID: D000008795
- Term: Metronidazole
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434506
**Brief Title:** Prevalence of the Wire Syndrome
**Official Title:** Prevalence and Risk Factors Associated With Wire Syndrome
#### Organization Study ID Info
**ID:** 24Odonto01
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Nice
### Status Module
#### Completion Date
**Date:** 2023-07-31
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2023-07-31
**Type:** ACTUAL
#### Start Date
**Date:** 2022-07-02
**Type:** ACTUAL
**Status Verified Date:** 2024-01
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-29
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Centre Hospitalier Universitaire de Nice
#### 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 Wire Syndrome problem referred to dental displacements that can be described as aberrant, inaccurate, unexplained, or excessive on teeth still contained by an intact orthodontic wire, without detachment or fracture, leading to evolving dental and periodontal, aesthetic and/or functional consequences. The objective of this study was to define the prevalence of mandibular wire syndrome and the associated risk factors.
### Conditions Module
**Conditions:**
- Orthodontic Wires
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 59
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** non-wire syndrome group
**Intervention Names:**
- Other: no intervention
**Label:** NWS group
#### Arm Group 2
**Description:** wire syndrome group
**Intervention Names:**
- Other: no intervention
**Label:** WS group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- NWS group
- WS group
**Description:** No intervention
**Name:** no intervention
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** The prevalence of wire syndrome is the number of people affected by the wire syndrome at a given time in a given population. The prevalence rate is calculated by dividing this number of cases by the size of the exposed population. This study was design as a cross-sectional study conducted in the Orthodontics Unit of the Nice University Hospital from July 2022 to July 2023.
**Measure:** Prevalence of the Wire Syndrome
**Time Frame:** End : July 2023
#### Secondary Outcomes
**Description:** Questionnaire: 20 clinical questions without score
**Measure:** Identify risk factors associated with wire syndrome - questionnaire
**Time Frame:** End : July 2023
**Description:** Intraoral clinical examination:
type of periodontium: thin and scalloped or flat and thick
**Measure:** Identify risk factors associated with wire syndrome - clinical examination periodontium
**Time Frame:** End : July 2023
**Description:** Intraoral clinical examinations:
molar and canine relationships according to the Angle's classification class I, class II, Class III
**Measure:** Identify risk factors associated with wire syndrome - clinical examination - Angle
**Time Frame:** End : July 2023
**Description:** Intraoral clinical examinations:
overbite and overjet in milimeters
**Measure:** Identify risk factors associated with wire syndrome - clinical examination: overbite / overjet
**Time Frame:** End : July 2023
**Description:** Intraoral clinical examinations:
presence/absence of an incisal guidance (YES / NO), presence/absence of parafunctions signs, (YES / NO)
**Measure:** Identify risk factors associated with wire syndrome - clinical examination / presence/absence clinical signs
**Time Frame:** End : July 2023
**Description:** Intraoral clinical examinations:
clinical signs: observations : swallowing and tongue (no score / no mesure : only clinical observations)
**Measure:** Identify risk factors associated with wire syndrome - clinical examination / description clinical signs
**Time Frame:** End : July 2023
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:-students in their 4th, 5th, and 6th year of dental studies at the Côte d'Azur University
- have undergone orthodontic treatment and are wearing a fixed mandibular retainer from canine to canine.
Exclusion Criteria:'- orthodontic treatment in progress
* absence/fracture of orthodontic fixed mandibular retainer
* wearing a removable mandibular retainer.
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** students in their 4th, 5th, and 6th year of dental studies at the Côte d'Azur University who have undergone orthodontic treatment and are wearing a fixed mandibular retainer from canine to canine
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Nice
**Country:** France
**Facility:** CHU NICE
**State:** Alpes Maritimes
**Zip:** 0600
#### Overall Officials
**Official 1:**
**Affiliation:** Centre Hospitalier Universitaire de Nice
**Name:** Carole Charavet
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434493
**Acronym:** EMPHATIC
**Brief Title:** Evaluation of Combined Modality Protons and Hepatic Transplantation for Hilar Cholangiocarcinoma
**Official Title:** Evaluation of Combined Modality Protons and Hepatic Transplantation for Hilar Cholangiocarcinoma (an Evaluative Commissioning in Protons Study)
#### Organization Study ID Info
**ID:** CFTSp218 (02)
#### Organization
**Class:** OTHER
**Full Name:** The Christie NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 2029-01-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-25
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** University College London Hospitals
**Class:** OTHER
**Name:** University College, London
**Class:** OTHER
**Name:** Royal Free Hospital NHS Foundation Trust
#### Lead Sponsor
**Class:** OTHER
**Name:** The Christie NHS Foundation 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:** Proton Beam Therapy (PBT) is an advanced radiotherapy technique. There are two National Health Service (NHS) PBT treatment centres in the United Kingdom (UK), in Manchester and London. The NHS is committed to ensuring the best use of this limited resource by investigating which patients will benefit from PBT.
Evaluative Commissioning in Protons (ECIP) is a programme of studies exploring the role of PBT in different types of cancer. The studies are funded by NHS England. ECIP studies are not randomised studies, which means that all eligible patients will be offered PBT. Any eligible patient in the UK can be referred, and accommodation is available for patients who don't live close to a PBT centre.
The main benefit of PBT, compared with standard photon radiotherapy, is the predicted reduction in radiation dose to surrounding healthy tissues. With photon radiotherapy, some radiation passes beyond the target area, affecting healthy tissues and causing side-effects. With PBT, the radiation dose stops within the target area, causing less damage to surrounding tissues, and limiting side effects.
EMPHATIC is a study within the ECIP programme. In EMPHATIC, the investigators are looking to see whether a combination of treatments, including PBT, chemotherapy and a liver transplant, can be used to treat patients with cholangiocarcinoma (bile duct cancer).
EMPHATIC offers patients whose cancer can't be removed with surgery (unresectable) a potentially curative treatment option. There is evidence that liver transplant is a curative treatment option in patients with cholangiocarcinoma. There is a risk that the cancer may grow or spread whilst waiting for a transplant, potentially making patients ineligible. PBT and chemotherapy is thought to be the best way to control the cancer, until a liver transplant can be performed. EMPHATIC will look at how a combination of PBT and chemotherapy, followed by a liver transplant, can be used to curatively treat patients with unresectable cholangiocarcinomas.
**Detailed Description:** Liver and bile duct resection with lymphadenectomy is the standard of care for patients with hilar cholangiocarcinoma. Unfortunately, resection is only possible in a minority of patients for many reasons including, the extent of cancer or the presence of background primary sclerosing cholangitis (PSC). For patients with a background of PSC, liver transplantation is a potential treatment, and it was recently approved as an indication for a commissioned pilot service evaluation of liver transplantation in the UK.
Until recently, the use of liver transplantation for hilar cholangiocarcinoma was confined to a few centres in the United States. The initial publications from the Mayo Clinic and Nebraska, as well as more recent experience from other centres, support strict selection protocols to identify patients likely to benefit from liver transplantation. In 2000, the initial experience at the Mayo Clinic in which 19 patients enrolled in a pre-transplant neoadjuvant therapy protocol was published. 11 patients underwent subsequent liver transplantation. Of the 8 with long term follow up (median 44 months), only one patient developed cancer recurrence. Similarly, the long-term experience of patients in Nebraska, where 11 patients underwent liver transplantation after neoadjuvant chemoradiotherapy was published in 2002. 5 of the 11 patients were alive and disease free at a median follow up of 7.5 years .
Most recent experience is based on adopting the Mayo protocol. In general, the inclusion criteria define patients with early cancers, with a dominant stricture or tumour less than 3cm. Intra and extrahepatic disease including any site of nodal metastases precluded selection. Controversially, histology or cytology was not considered essential for diagnosis of cholangiocarcinoma by most centres. Elevated Ca 19.9 of \>100, Fluorescence In Situ Hybridization (FISH) polysomy 9p21 or tumour mass in the presence of a dominant stricture were considered sufficient for enrolment. Prior (attempts at) trans-peritoneal biopsy was another exclusion criterion based on concerns of increased risk of tumour dissemination. Neoadjuvant therapy involved external beam radiation therapy (EBRT) with concurrent chemotherapy (chemo sensitisation), followed by brachytherapy whenever possible. Patients were then re-staged and remain on systemic chemotherapy until the time of transplant.
A recent review looked at all studies from 2000 until 2019. 20 studies with 428 patients were eligible for analysis. The pooled 1, 3-, and 5-year overall survival rates following liver transplantation without neoadjuvant therapy (n=156) were 71.2%. In patients who had neoadjuvant therapy prior to transplantation (n=272), the survival improved to 82.8% at 1,3 and 5 years respectively.
The cancer recurrence rate was 51.7% in patients who did not receive neoadjuvant therapy compared to 24.1% for patients who had. Only 4 of the 20 studies reported pre-transplant histological confirmation of adenocarcinoma or malignant/suspicious cells on cytology. 98% of liver explants from studies not using neoadjuvant therapy confirmed malignancy, compared to 50.5% in those who had received neoadjuvant therapy. Patients in whom malignancy was not found are presumed to have had complete pathological response to neoadjuvant therapy (approximately 50% following neoadjuvant therapy). Patients with background PSC had better outcomes compared to patients with de novo cancers.
Study Design \& development of an evaluative commissioning study within ECIP:
It is not possible to design EMPHATIC, a study for patients with unresectable cholangiocarcinoma, as a randomised controlled trial (RCT), because there is no ethically acceptable control arm. In an RCT, patients in a theoretical control arm would be offered either no transplant, or no neoadjuvant therapy prior to the transplant. Based on the published literature summarised above, the adverse anticipated outcomes of patients in such a control arm would not be considered justified.
Neoadjuvant therapy is required to control the tumour prior to transplant. In the Mayo protocol described above, patients received external beam (chemo)radiotherapy followed by brachytherapy, and thereafter received chemotherapy until the time of transplant. Unfortunately, in the UK, brachytherapy services were not seen as a viable option, and hence the Mayo protocol is not feasible.
There is good scientific rationale that proton beam radiotherapy (PBT) offers the optimal technique for delivering neoadjuvant therapy as it is non-invasive, and spares as much functional liver as possible, compared with alternatives such as photon-EBRT techniques or invasive techniques (e.g. brachytherapy). Compared with photon-EBRT techniques, PBT delivers highly conformal radiotherapy, with a significantly reduced integral body dose, and no exit beam. It is expected to be associated with an improved toxicity profile.
### Conditions Module
**Conditions:**
- Cholangiocarcinoma
**Keywords:**
- proton beam therapy
- protons
- evaluative commissioning
- liver transplant
### 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:** All patients to be offered neoadjuvant proton beam therapy to a dose of 45 Gray (Gy) in 15 fractions over 3 weeks, with a tumour boost to 67.5 Gray (Gy), and alongside concurrent oral capecitabine 625mg/m2 twice daily on radiation days.
**Intervention Names:**
- Radiation: Proton Beam Therapy
- Drug: Concurrent oral capecitabine chemotherapy
- Drug: Cisplatin & Gemcitabine intravenous chemotherapy
- Procedure: Orthotropic Liver Transplant
**Label:** Proton Beam Therapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Proton Beam Therapy
**Description:** All patients to be offered neoadjuvant proton beam therapy to a dose of 45 Gray (Gy) in 15 fractions over 3 weeks, with a tumour boost to 67.5 Gray (Gy)
**Name:** Proton Beam Therapy
**Type:** RADIATION
#### Intervention 2
**Arm Group Labels:**
- Proton Beam Therapy
**Description:** All patients to be offered concurrent oral capecitabine 625mg/m2 twice daily on radiation days
**Name:** Concurrent oral capecitabine chemotherapy
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Proton Beam Therapy
**Description:** Following chemoradiotherapy (PBT + capecitabine), and whilst on the liver transplant waiting list, patients will be offered up to 6 cycles of standard chemotherapy with cisplatin and gemcitabine.
**Name:** Cisplatin & Gemcitabine intravenous chemotherapy
**Type:** DRUG
#### Intervention 4
**Arm Group Labels:**
- Proton Beam Therapy
**Description:** If still eligible after neoadjuvant treatment (PBT + capecitabine), patients will be added to the liver transplant waiting list.
**Name:** Orthotropic Liver Transplant
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Incidence of Grade ≥ 3 toxicity using CTCAE (grades 0-5) up to 90 days following completion of neoadjuvant (chemo)-PBT and liver transplant. Higher score indicates worse outcome.
**Measure:** Incidence of Common Toxicity Criteria for recording Adverse Events (CTCAE) Grade 3 and above toxicity
**Time Frame:** Up to 90 days post neoadjuvant chemo-radiation.
**Description:** The proportion of patients who, following neoadjuvant (chemo)-PBT, undergo a successful liver transplant (measured at 90 days post-transplant).
**Measure:** Proportion of patients who undergo a successful liver transplant
**Time Frame:** 90 days post transplant.
#### Secondary Outcomes
**Description:** Number of patients completing planned radiotherapy
**Measure:** Number of patients completing planned radiotherapy
**Time Frame:** Up to 1 year
**Description:** Rate of Common Toxicity Criteria for recording Adverse Events (CTCAE) Grade 3 and above toxicity (Grades 0-5). Higher score may mean a worse outcome.
**Measure:** Incidence of severe treatment related side effects
**Time Frame:** Up to 2 years
**Description:** Calculated from date of last PBT treatment and defined as time to death or censoring at 1 year.
**Measure:** 1 year post completion of neoadjuvant therapy cancer-related mortality
**Time Frame:** At 1 year
**Description:** Calculated from date of liver transplant and defined as time to death or censoring at 1 year.
**Measure:** 1 year post transplant overall survival
**Time Frame:** At 1 year
**Description:** Calculated from date of transplant and defined as time to death or censoring at 1 year.
**Measure:** 1 year post transplant graft survival
**Time Frame:** At 1 year
**Description:** Calculated from the date the patient was added to the transplant waiting list and defined as time to death or censoring at 1 year.
**Measure:** 1 year post listing patient survival
**Time Frame:** At 1 year
**Description:** Calculated as time to cancer recurrence or death whichever is earliest, from date of transplant, with censoring at 1 year.
**Measure:** Disease free survival from transplant
**Time Frame:** At 1 year
**Description:** Described as local, regional or metastatic disease
**Measure:** Recurrent cancer within 6 months of transplant
**Time Frame:** Up to 6 months following transplant
**Description:** Reported as time to loss of cancer control with censoring at time of transplant
**Measure:** Cancer control at time of transplant
**Time Frame:** Up to 2 years
**Description:** Reported as time to loss of cancer control with censoring at date of removal from transplant waiting list
**Measure:** Cancer control at time of removal from transplant list
**Time Frame:** Up to 2 years
**Description:** Surgical complication rates according to Clavien Dindo scale, measured from grades 1-5, higher grade may mean worse outcome.
**Measure:** Transplant complication rates
**Time Frame:** Within 3 months of surgery
**Description:** Review of patient pathway deliverability defined as time interval from patient referral to the start of chemo-PBT treatment
**Measure:** Patient pathway
**Time Frame:** Up to 2 years
**Description:** Measured in days from last day of PBT to date of transplant
**Measure:** Time to completion of neoadjuvant chemo-PBT treatment to liver transplant
**Time Frame:** Up to 2 years
**Description:** Measured in weeks from transplant listing date to liver transplant date
**Measure:** Time spent on transplant waiting list
**Time Frame:** Up to 2 years
**Description:** Review annual referral rates to the study
**Measure:** Referral rates
**Time Frame:** At 6 months, 12 months, 18 months and 24 months following the opening of the study
**Description:** Number of patients participating in the study
**Measure:** Recruitment rates
**Time Frame:** At 6 months, 12 months, 18 months and 24 months following the opening of the study
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
General criteria
* Age 17 years and over
* Performance status 0 or 1 (Eastern Cooperative Oncology Group)
* Suitable for liver transplantation as determined by Multi Disciplinary Team (MDT)
* Able to tolerate neoadjuvant therapy.
* A history of primary sclerosing cholangitis (PSC) will be a necessary eligibility criterion at the start of the study. Part-way through recruitment to the study, the eligibility criteria may be broadened, allowing patients with sporadic / non-PSC unresectable cholangiocarcinoma to also be considered. The decision to do this will be taken by the Study Management Group, who will be monitor results closely, following an interim analysis after the first 10 patients. Suitability for Orthotropic Liver Transplant will continue to be confirmed in the regional Hepato Biliary cancer MDT.
Specific criteria
* Presence of a dominant hilar stricture or mass \<3cm on cross-sectional imaging
* Histologically proven cholangiocarcinoma by brush cytology or biopsy via Endoscopic Retrograde Cholangiopancreatography (ERCP) or Percutaneous Transhepatic Cholangiography (PTC)
* No metastatic disease, including to regional lymph nodes.
Exclusion Criteria:
General criteria
* Inability to consent
* Poor performance status
* Failed fitness assessment
* Extrahepatic disease at any stage of presentation, assessment and treatment
* Prior biliary resection or hilar dissection for attempted resection within the past 12 months
* Prior malignancy in the last 5 years (excluding early breast, prostate, cervix and non melanoma skin cancers)
Specific criteria
* Estimated Glomerular Filtration Rate (eGFR) \<30
* Prior radiation to the upper abdomen
* Uncontrolled infection
* Duodenal invasion
**Minimum Age:** 17 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Romelie Rieu
**Phone:** 0044 1619187172
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sally Falk
**Phone:** 0044 1619187172
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University College, London
**Name:** Maria Hawkins
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** The Royal Free NHS Foundation Trust
**Name:** Douglas Thorburn
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** De Vreede I, Steers JL, Burch PA, Rosen CB, Gunderson LL, Haddock MG, Burgart L, Gores GJ. Prolonged disease-free survival after orthotopic liver transplantation plus adjuvant chemoirradiation for cholangiocarcinoma. Liver Transpl. 2000 May;6(3):309-16. doi: 10.1053/lv.2000.6143.
**PMID:** 10827231
**Citation:** Sudan D, DeRoover A, Chinnakotla S, Fox I, Shaw B Jr, McCashland T, Sorrell M, Tempero M, Langnas A. Radiochemotherapy and transplantation allow long-term survival for nonresectable hilar cholangiocarcinoma. Am J Transplant. 2002 Sep;2(8):774-9. doi: 10.1034/j.1600-6143.2002.20812.x.
**PMID:** 12243499
**Citation:** Cambridge WA, Fairfield C, Powell JJ, Harrison EM, Soreide K, Wigmore SJ, Guest RV. Meta-analysis and Meta-regression of Survival After Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma. Ann Surg. 2021 Feb 1;273(2):240-250. doi: 10.1097/SLA.0000000000003801.
**PMID:** 32097164
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000000230
- Term: Adenocarcinoma
- 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
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M20426
- Name: Cholangiocarcinoma
- Relevance: HIGH
- As Found: Cholangiocarcinoma
- ID: M20430
- Name: Klatskin Tumor
- Relevance: HIGH
- As Found: Hilar Cholangiocarcinoma
- ID: M3585
- Name: Adenocarcinoma
- 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: T755
- Name: Bile Duct Cancer
- Relevance: HIGH
- As Found: Cholangiocarcinoma
- ID: T3241
- Name: Klatskin Tumor
- Relevance: HIGH
- As Found: Hilar Cholangiocarcinoma
### Condition Browse Module - Meshes
- ID: D000018281
- Term: Cholangiocarcinoma
- ID: D000018285
- Term: Klatskin Tumor
### 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
- Abbrev: Hemat
- Name: Hematinics
### 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: M11110
- Name: Liver Extracts
- Relevance: LOW
- As Found: Unknown
- ID: M4281
- Name: Antimetabolites
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000093542
- Term: Gemcitabine
- ID: D000069287
- Term: Capecitabine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434480
**Brief Title:** SBRT in HCC With Oligoprogression on Atezo-Bev
**Official Title:** Stereotactic Body Radiotherapy (SBRT) in Advanced Hepatocellular Carcinoma With Oligoprogression on Atezolizumab Plus Bevacizumab
#### Organization Study ID Info
**ID:** HCC07X
#### Organization
**Class:** OTHER
**Full Name:** Chinese University of Hong Kong
### Status Module
#### Completion Date
**Date:** 2028-03-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2027-03-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-09-02
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Chinese University of Hong Kong
#### Responsible Party
**Investigator Affiliation:** Chinese University of Hong Kong
**Investigator Full Name:** Landon Chan
**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:** HCC is a huge healthcare burden in Hong Kong and is one of the top 5 cancers in terms of incidence and mortality in Hong Kong. Patients with advanced HCC are treated with immunotherapy-based combination atezolizumab plus bevacizumab as first-line treatment as a standard of care. At the moment, there is limited evidence to guide subsequent treatments after patients progressed on atezolizumab plus bevacizumab. Oligoprogression is a term used to describe patients who had limited progression (usually less than 3 sites) on systemic therapy, with the rest of the lesions controlled. Previous studies in non-HCCs have shown that addition of locoregional treatment (e.g. radiotherapy) may prolong the use of systemic therapy, resulting in improved survival, but this has been relatively unexplored for HCC. In this prospective, single-arm study, we aim to evaluate the treatment outcome, efficacy and safety of the addition of radiotherapy to oligoprogressive sites for patients who had limited progression on atezolizumab plus bevacizumab.
### Conditions Module
**Conditions:**
- HCC
**Keywords:**
- SBRT in HCC
### 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:** After screening procedures, suitable patients are consented and enrolled with the following treatment being given
* Continue Atezolizumab 1200mg Day 1 plus Bevacizumab 15mg/kg Day 1, given intravenously every 3 weeks, till the next progression, or death.
* Radiotherapy will start 4 to 6 weeks after consent
* For intrahepatic progression: 27.5-50Gy in 5 fractions over 2 weeks will be given.
* For extrahepatic progression: an aim to give ablative dose (i.e. BED10≥100Gy) will be given (allow lower dose based on nearby OAR dose constraints and is at the discretion of the treating radiation oncologist)
* Bevacizumab will need to be withhold 4 weeks prior and after radiotherapy.
* Dose constraints to organ at risk (OAR) will take reference from RTOG-1112 and UK 2022 consensus on normal tissue dose-volume constraints
**Intervention Names:**
- Radiation: Stereotactic Body Radiation Therapy (SBRT)
**Label:** Radiotherapy
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Radiotherapy
**Description:** * For intrahepatic progression: 27.5-50Gy in 5 fractions over 2 weeks will be given.
* For extrahepatic progression: an aim to give ablative dose will be given.
**Name:** Stereotactic Body Radiation Therapy (SBRT)
**Type:** RADIATION
### Outcomes Module
#### Primary Outcomes
**Measure:** Progression-free survival (PFS) with the addition of SBRT to oligo-progressive sites
**Time Frame:** 2 years
#### Secondary Outcomes
**Measure:** Overall survival (OS)
**Time Frame:** 2 years
**Measure:** Objective response rates (ORR) of the irradiated lesion(s)
**Time Frame:** 2 years
**Measure:** Overall objective response rates (ORR)
**Time Frame:** 2 years
**Measure:** Additional treatment related adverse events (TRAE)
**Time Frame:** 2 years
**Description:** Four types of progression pattern:
* EHG (extrahepatic growth)
* IHG (intrahepatic growth)
* NEH (new extrahepatic lesion)
* NIH (new intrahepatic growth)
**Measure:** Pattern of progression
**Time Frame:** 2 years
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Patients aged ≥ 18 years old
2. ECOG performance 0 to 1
3. Confirmed diagnosis of HCC
4. Oligoprogression on Atezolizumab plus Bevacizumab, as defined as ≤3 lesions (intra- and extrahepatic lesions all together; vascular tumor thrombus is counted as one lesion)
5. Progressed lesion(s) amenable to SBRT:
* At most one site of intrahepatic and one site of extrahepatic lesion will be irradiated
* For intrahepatic progression:
* Number of intrahepatic progression ≤ 3
* Total intrahepatic tumours ≤ 5
* Maximum sum of HCC ≤ 20cm
* Any one HCC ≤ 15cm
* Normal liver volume minus intrahepatic GTV \> 700cc
* Mean liver dose ≤ 15Gy
* No measurable common or main branch biliary duct involvement
* No direct tumor invasion into the stomach, duodenum, small bowel or large bowel
* For extrahepatic progression:
* Maximal tumor size ≤ 3cm
* Respective dose constraints of organ at risks as listed on the UK 2022 Consensus on Normal Tissue Dose-Volume Constraints for Oligometastatic, Primary Lung and Hepatocellular Carcinoma Stereotactic Ablative Radiotherapy can be met.
6. Prior radiofrequency ablation (RFA) or trans-arterial chemoembolization (TACE) are eligible
7. Child-Pugh A liver function
8. Life expectancy longer than 12 weeks
9. At least one measurable treatment lesion according to RECIST 1.1
10. Written informed consent must be obtained prior to any study related procedures
11. Adequate haematological function (Hb ≥ 8.5g/dL; Plt ≥ 75x109/L; ANC ≥ 1.5x109/L; INR ≤ 1.5)
12. Adequate hepatic function (albumin ≥ 28g/l; Bilirubin ≤ 1.5xULN; ALT \< 5 times upper limit normal)
13. Adequate renal function (serum creatinine ≤ 1.5 times the upper limit of normal range; Na ≥ 130mmol/L; K ≥ 3.0mmol/L)
14. Able to read, understand and provide written consent
Exclusion Criteria:
1. History of another malignancy except appropriately-treated BCC of skin or CIN of cervix during the last 5 years
2. Previous radiotherapy to the abdomen
3. Previous yttrium-90 chemoembolization
4. Repetitive history of non-healing wounds or ulcers within 2 months of inclusion
5. Pregnant or lactating females at any time during the study
6. Active autoimmune disease requiring systemic therapy in the past 2 years
7. Diagnosis of immunodeficiency (including HIV)
8. Ongoing corticosteroid therapy \>10mg prednisone daily
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Landon L CHAN, MBChB, MSc
**Phone:** 3505 1042
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hong Kong
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Landon L CHAN, MBChB, MSc
- **Phone:** 3505 1042
- **Role:** CONTACT
**Country:** Hong Kong
**Facility:** Department of Clinical Oncology, Prince of Wales Hospital
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### 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: LOW
- As Found: Unknown
- ID: M9613
- Name: Carcinoma, Hepatocellular
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Browse Branches
- Abbrev: ANeo
- Name: Antineoplastic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M246
- Name: Bevacizumab
- Relevance: LOW
- As Found: Unknown
- ID: M349417
- Name: Atezolizumab
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434467
**Brief Title:** The Efficacy and Safety of Nelarabine Injection in Patients With T-lymphoblastic Leukemia and T-lymphoblastic Lymphoma
**Official Title:** The Efficacy and Safety of Nelarabine Injection in the Treatment of Refractory or Recurrent T-lymphoblastic Leukemia (T-ALL) and T-lymphoblastic Lymphoma (T-LBL) in Children and Adults
#### Organization Study ID Info
**ID:** NLB-III-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2026-05
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-12
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05
**Type:** ESTIMATED
**Status Verified Date:** 2023-11
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This is a single-arm, open-label, multicenter, phase III clinical study that aims to evaluate the efficacy and safety of Nelarabine injection in the treatment of refractory or recurrent T-lymphoblastic leukemia (T-ALL) and T-lymphoblastic lymphoma (T-LBL) in both children and adults. The trial includes 83 subjects, consisting of 35 adults and 48 children, and aims to evaluate the composite complete response rate (CCR) within 2 cycles, assessed by the Independent Review Committee (IRC), following treatment with Nelarabine injection for children and adults with refractory or recurrent T-ALL and T-LBL.
The sample size of this study is estimated according to the treatment period of 4 cycles.
### Conditions Module
**Conditions:**
- T-lymphoblastic Leukemia
- T-lymphoblastic Lymphoma
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 83
**Type:** ESTIMATED
**Phases:**
- PHASE3
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Adults (≥18 years old): 1500 mg/m², administer intravenously for at least 2 hours on days 1, 3, and 5, repeating every 21 days.
Children (1-17 years old): 650 mg/m ², administer intravenously for 1 hour daily for 5 consecutive days, repeating every 21 days.
**Intervention Names:**
- Drug: Nelarabine injection
**Label:** Nelarabine injection
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Nelarabine injection
**Description:** Nelarabine is a prodrug of the nucleotide metabolism inhibitor deoxyguanosine analogue 9-β-arabinoguanine (ARA-G). Nelarabine undergoes catalytic transformation by adenosine deaminase (ADA), resulting in the removal of its methoxy group and conversion into ARA-G, Subsequently, ARA-G undergoes sequential monophosphorylation by deoxyguanosine kinase and deoxycytosine nucleoside kinase, yielding the active compound 5'-Guanosine triphosphate (GTP), ARA-GTP. This active compound accumulates within leukemic blast cells and binds to deoxyribonucleic acid (DNA), effectively inhibiting DNA synthesis and ultimately leading to cell death.
**Name:** Nelarabine injection
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Proportion of complete responses (CCR) after 2 cycles of antineoplastic therapy as determined by independent review committee (IRC) assessment
**Measure:** Composite complete response rate (CCR) assessed by the Independent Review Committee (IRC)
**Time Frame:** During the study period (Baseline up to two months)
#### Secondary Outcomes
**Description:** Proportion of complete responses (CCR) after 2 cycles of antineoplastic therapy as determined by the investigator.
**Measure:** Composite complete response rate (CCR) assessed by the investigator
**Time Frame:** During the study period (Baseline up to two months)
**Description:** The best Objective Remission Rate (ORR) for both complete response (CR) and partial response (PR) cases within 2 cycles.
**Measure:** Objective Remission Rate (ORR)
**Time Frame:** During the study period (Baseline up to two months)
**Description:** Proportion of patients whose tumor shrinks or stabilizes for some time, including cases of complete response (CR), partial response (PR), and stable disease (SD).
**Measure:** Duration of complete remission (DOCR)
**Time Frame:** During the study period (Baseline up to two years)
**Description:** It refers to the time from the first day of absence of disease to the recurrence of disease.
**Measure:** Disease-free survival (DFS)
**Time Frame:** During the study period (Baseline up to two years)
**Description:** It indicates the time interval from randomization to death from any cause.
**Measure:** Overall survival (OS)
**Time Frame:** During the study period (Baseline up to two years)
**Description:** Adverse events refer to all adverse medical events that occur after a patient or clinical trial subject receives an experimental drug, which can be expressed as symptoms, signs, diseases, or abnormalities in laboratory tests, but are not necessarily related to the treatment of the experimental drug.
**Measure:** Incidence of adverse events (AEs)
**Time Frame:** During the study period (Baseline up to two years)
**Description:** Serious adverse events include death, life-threatening, permanent or serious disability or loss of function, hospitalization or prolonged hospitalization, and adverse medical conditions such as congenital abnormalities or birth defects.
**Measure:** Incidence of serious adverse events (SAEs)
**Time Frame:** During the study period (Baseline up to two years)
**Description:** Time to maximum plasma concentration.
**Measure:** Peak time (Tmax)
**Time Frame:** During the study period (Baseline up to two years)
**Description:** Pharmacokinetic parameters, including but not limited to: Peak concentration(Cmax)
**Measure:** Peak concentration(Cmax)
**Time Frame:** During the study period (Baseline up to two years)
**Description:** It is the time required for half of the drug to be eliminated from the plasma
**Measure:** Half-life(t1/2)
**Time Frame:** During the study period (Baseline up to two years)
**Description:** The proportion of trace leukemic cells negative in patients with hematologic tumors after treatment.
**Measure:** Negative rate of minimal residual disease in bone marrow (MRD)
**Time Frame:** During the study period (Baseline up to two years)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* The subjects voluntarily joined this study, signed an informed consent form, and had good compliance;
* Age: ≥ 1 year old and ≤ 65 years old (if the child has no reading ability, the child's immediate family/guardian can fully read the informed consent form, sign and witness the informed consent process); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0-2 points; Expected survival period exceeds 3 months;
* Subject population:
1. According to the revised classification criteria for myeloid tumors and acute leukemia in 2016, morphology, immunology, cytogenetic and molecular (MICM) classification and/or pathological and imaging diagnosis confirmed by local laboratories as T-ALL or T-LBL stage II-IV;
2. Philadelphia chromosome negative (Ph -);
3. Difficult to treat or disease recurrence status;
4. Previously received two chemotherapy regimens without response, or experienced recurrence after treatment.
* The main organ functions well and meets the following standards:
1. Biochemical examination must meet the following standards:
Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN) (if T-ALL/T-LBL affects the liver, total bilirubin ≤ 3 times the upper limit of normal value); Alanine transferase (ALT) and aspartate transferase (AST) ≤ 3 × ULN (if T-ALL/T-LBL affects the liver, ALT and/or AST ≤ 5 × ULN);
Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate estimated based on Cockcroft Gault glomerular filtration formula ≥ 50 mL/min.
2. The coagulation function test needs to meet the following standards: prothrombin time (PT), activated partial thromboplastin time (APTT), international standardized ratio (INR) ≤ 1.5 x ULN (without receiving anticoagulant treatment).
* Before starting to use the investigational drug, all non hematological toxicity (except for hair loss and fatigue) of previous anti leukemia treatments must have been restored to level 1 or baseline levels ((NCI Common Terminology Criteria for Adverse Events(CTCAE) version5.0));
* Female participants of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment, the serum pregnancy test was negative and must be a non lactating subject; Male participants should agree to adopt avoidance measures during the study period and within 6 months after the end of the study period.
Exclusion Criteria:
* Previous treatment:
1. Within 3 weeks prior to the first medication, chemotherapy (including intrathecal injection, excluding ALL/LBL maintenance therapy) was received. Within 12 weeks prior to the first medication, radiation therapy (brain spine, pelvis, and other radiation areas exceeding 25% of the total bone marrow volume), immune checkpoint inhibitors, Chimeric Antigen Receptor T-Cell (CAR-T) Therapy were received. Other small molecule anti-tumor treatments received before the first medication (washout period calculated from the end of the last treatment) were within 5 half-lives;
2. Within 7 days prior to the first administration, receive ≥ 5 days of intravenous or oral prednisone ≥ 30mg/m2 or an equal amount of other glucocorticoids. Within 28 days prior to the first administration, receive ≥ 14 days of intravenous or oral prednisone ≥ 30mg/m2 or an equal amount of other glucocorticoids. Single dose prevention or treatment of airway stenosis is allowed to be used; Note: If the patient's white blood cell (WBC) is ≥ 30 × 10\^9/L, or if the liver, spleen, or lymph nodes are significantly enlarged; Patients with tumor lysis characteristics (biochemical tests, etc.) may undergo pre-treatment, and the use of prednisone/dexamethasone ± cyclophosphamide during the pre-treatment period is allowed to prevent tumor lysis syndrome;
3. Vaccination received within 4 weeks prior to the first medication, or planned vaccination during the study period;
4. Participated in clinical trials of other anti-tumor drugs within 4 weeks prior to the first medication use;
5. According to the researcher's judgment, there are individuals with accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or individuals who are deemed unsuitable for enrollment due to other reasons.
* Concomitant diseases and medical history:
1. Has experienced or currently suffers from other malignant tumors within 3 years prior to the first medication use. The following two situations can be included in the study: achieving disease-free survival (DFS) for 5 consecutive years for other malignant tumors treated with a single surgery; Cured cervical cancer in situ, thyroid cancer, non melanoma skin cancer, and superficial bladder tumors \[Ta (non invasive tumor), Ti (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\];
2. Unresolved neurotoxicity of ≥ CTC AE II grade due to any previous treatment;
3. Within 28 days prior to the start of the research treatment, significant surgical treatment, open biopsy, and obvious traumatic injury were received;
4. Within 3 months prior to the first medication, there have been incidents of arterial/venous thrombosis, such as cerebrovascular accidents (including cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
5. Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
6. Within 6 months prior to the first medication, the patient had ≥ grade 2 myocardial ischemia or infarction, arrhythmia (QTcF\>450ms in males and\>470ms in females), ≥ grade 2 congestive heart failure (NYHA classification), and left ventricular ejection fraction (LVEF) assessed by echocardiography\<50%.
7. Existence of active infection (≥ CTC AE level 2 infection);
8. Active hepatitis \*; Hepatitis B reference: hepatitis B virus (HBV) DNA detection value ≥ upper limit of normal value; Hepatitis C reference: hepatitis C virus (HCV) antibody positive, and HCV virus titer detection value exceeds the upper limit of normal value;
9. Individuals with a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
10. Have a history of epilepsy;
11. Have a history of Down syndrome;
12. Merge central nervous system leukemia/lymphoma.
* The patient plans to receive chest radiation therapy.
**Maximum Age:** 65 Years
**Minimum Age:** 1 Year
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Jun Ma, Doctor
**Phone:** 13304518000
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Yizhuo Zhang, Doctor
**Phone:** 18819241079
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hefei
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xiaoyu Zhu, Doctor
- **Phone:** 15255456091
- **Role:** CONTACT
**Country:** China
**Facility:** Anhui Provincial Hospital
**State:** Anhui
**Zip:** 230000
**Location 2:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jingbo Wang, Doctor
- **Phone:** 13693587668
- **Role:** CONTACT
**Country:** China
**Facility:** Aerospace Medical Center
**State:** Beijing
**Zip:** 100049
**Location 3:**
**City:** Beijing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Dongsheng Huang, Doctor
- **Phone:** 13601113102
- **Role:** CONTACT
**Country:** China
**Facility:** Beijing Tongren Hospital,CMU
**State:** Beijing
**Zip:** 100730
**Location 4:**
**City:** Chongqing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jie Yu, Doctor
- **Phone:** 13983762652
- **Role:** CONTACT
**Country:** China
**Facility:** Children's Hospital of Chongqing Medical University
**State:** Chongqing
**Zip:** 400010
**Location 5:**
**City:** Chongqing
**Country:** China
**Facility:** The Second Affiliated Hospital of Army Military Medical University
**State:** Chongqing
**Zip:** 400037
**Location 6:**
**City:** Lanzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zijian Li, Doctor
- **Phone:** 18993115461
- **Role:** CONTACT
**Country:** China
**Facility:** The first hospital of Lanzhou University
**State:** Gansu
**Zip:** 730000
**Location 7:**
**City:** Guangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yizhuo Zhang, Doctor
- **Phone:** 18819241079
- **Role:** CONTACT
**Country:** China
**Facility:** Sun Yat-sen University Cancer Prevention Center
**State:** Guangdong
**Zip:** 510062
**Location 8:**
**City:** Nanning
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Hong Cen, Doctor
- **Phone:** 13507711671
- **Role:** CONTACT
**Country:** China
**Facility:** Cancer Hospital Affiliated to Guangxi Medical University
**State:** Guangxi
**Zip:** 530021
**Location 9:**
**City:** Nanning
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yunyan He, Doctor
- **Phone:** 13607868275
- **Role:** CONTACT
**Country:** China
**Facility:** First Affiliated Hospital of Guangxi Medical University
**State:** Guangxi
**Zip:** 530021
**Location 10:**
**City:** Yulin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zhao Lv, Bachelor
- **Phone:** 15277931749
- **Role:** CONTACT
**Country:** China
**Facility:** Yulin Red Cross Hospital
**State:** Guangxi
**Zip:** 537000
**Location 11:**
**City:** Zunyi
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yan Chen, Doctor
- **Phone:** 13985261758
- **Role:** CONTACT
**Country:** China
**Facility:** Affiliated Hospital of Zunyi Medical University
**State:** Guizhou
**Zip:** 563000
**Location 12:**
**City:** Shijiazhuang
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jingyu Zhang, Doctor
- **Phone:** 18032227288
- **Role:** CONTACT
**Country:** China
**Facility:** The second Hospital of Hebei Medical University
**State:** Hebei
**Zip:** 50004
**Location 13:**
**City:** Xingtai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Zongjiu Jiao, Doctor
- **Phone:** 18631921299
- **Role:** CONTACT
**Country:** China
**Facility:** Xingtai People's Hospital
**State:** Hebei
**Zip:** 54001
**Location 14:**
**City:** Harbin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Aichun Liu, Doctor
- **Phone:** 13633611958
- **Role:** CONTACT
**Country:** China
**Facility:** Affiliated cancer hospital of harbin medical university
**State:** Heilongjiang
**Zip:** 150001
**Location 15:**
**City:** Harbin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jun Ma, Doctor
- **Phone:** 13304518000
- **Role:** CONTACT
**Country:** China
**Facility:** Institute of Hematology & Oncology, Harbin First Hospital
**State:** Heilongjiang
**Zip:** 150010
**Location 16:**
**City:** Zhengzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Wei Liu, Doctor
- **Phone:** 13673710016
- **Role:** CONTACT
**Country:** China
**Facility:** Henan Children's Hospital
**State:** Henan
**Zip:** 450018
**Location 17:**
**City:** Wuhan
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Aiguo Liu, Doctor
- **Phone:** 13807196944
- **Role:** CONTACT
**Country:** China
**Facility:** Tongji Medical College of HUST
**State:** Hubei
**Zip:** 430030
**Location 18:**
**City:** Changsha
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mincui Zheng, Master
- **Phone:** 13908467333
- **Role:** CONTACT
**Country:** China
**Facility:** Hunan Children's Hospital
**State:** Hunan
**Zip:** 410007
**Location 19:**
**City:** Nanjing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yongjun Fang, Doctor
- **Phone:** 18951769586
- **Role:** CONTACT
**Country:** China
**Facility:** Nanjing childrens Hospital
**State:** Jiangsu
**Zip:** 210008
**Location 20:**
**City:** Nanjing
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yu Zhu, Doctor
- **Phone:** 13851435363
- **Role:** CONTACT
**Country:** China
**Facility:** Jiangsu Provincial People's Hospital
**State:** Jiangsu
**Zip:** 210029
**Location 21:**
**City:** Changchun
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yehui Tan, Doctor
- **Phone:** 15804302605
- **Role:** CONTACT
**Country:** China
**Facility:** The First Hospital Of Jilin University
**State:** Jilin
**Zip:** 130000
**Location 22:**
**City:** Weihai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Jie Yu, Doctor
- **Phone:** 13869058479
- **Role:** CONTACT
**Country:** China
**Facility:** Weihai Municipal Hospital
**State:** Shandong
**Zip:** 264200
**Location 23:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xiaoqin Wang, Doctor
- **Phone:** 13621851543
- **Role:** CONTACT
**Country:** China
**Facility:** Huashan Hospital Fudan University
**State:** Shanghai
**Zip:** 200040
**Location 24:**
**City:** Shanghai
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xiaowen Zhai, Doctor
- **Phone:** 18017590808
- **Role:** CONTACT
**Country:** China
**Facility:** Children's Hospital of Fudan University
**State:** Shanghai
**Zip:** 201102
**Location 25:**
**City:** Xi'an
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yi Wang, Doctor
- **Phone:** 13571936193
- **Role:** CONTACT
**Country:** China
**Facility:** Shanxi Provincial People's Hospital
**State:** Shanxi
**Zip:** 710068
**Location 26:**
**City:** Chengdu
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xiaobing Huang, Doctor
- **Phone:** 18981838236
- **Role:** CONTACT
**Country:** China
**Facility:** Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
**State:** Sichuan
**Zip:** 610072
**Location 27:**
**City:** Tianjin
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Yafei Wang, Doctor
- **Phone:** 18622221250
- **Role:** CONTACT
**Country:** China
**Facility:** Tianjin Cancer Hospital
**State:** Tianjin
**Zip:** 300202
**Location 28:**
**City:** Urumqi
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xinhong Guo, Doctor
- **Phone:** 15292898288
- **Role:** CONTACT
**Country:** China
**Facility:** First Affiliated Hospital of Xinjiang Medical University
**State:** Xinjiang
**Zip:** 830000
**Location 29:**
**City:** Kunming
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mingxia Shi, Doctor
- **Phone:** 13888060581
- **Role:** CONTACT
**Country:** China
**Facility:** The First Affiliated Hospital of Kunming Medical University
**State:** Yunnan
**Zip:** 650000
**Location 30:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Xiaojun Xu, Doctor
- **Phone:** 13858067554
- **Role:** CONTACT
**Country:** China
**Facility:** Children's Hospital of Zhejiang University School of Medicine
**State:** Zhejiang
**Zip:** 310000
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000009370
- Term: Neoplasms by Histologic Type
- ID: D000009369
- Term: Neoplasms
- ID: D000008232
- Term: Lymphoproliferative Disorders
- ID: D000008206
- Term: Lymphatic Diseases
- ID: D000007160
- Term: Immunoproliferative Disorders
- ID: D000007154
- Term: Immune System Diseases
- ID: D000006402
- Term: Hematologic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC15
- Name: Blood and Lymph Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M14850
- Name: Recurrence
- Relevance: LOW
- As Found: Unknown
- ID: M10945
- Name: Leukemia
- Relevance: HIGH
- As Found: Leukemia
- ID: M27585
- Name: Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Relevance: HIGH
- As Found: Lymphoblastic lymphoma
- ID: M10951
- Name: Leukemia, Lymphoid
- Relevance: HIGH
- As Found: Lymphoblastic Leukemia
- ID: M11220
- Name: Lymphoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: M18120
- Name: Leukemia-Lymphoma, Adult T-Cell
- Relevance: LOW
- As Found: Unknown
- ID: M11222
- Name: Lymphoma, Non-Hodgkin
- Relevance: HIGH
- As Found: Lymphoblastic 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: M9490
- Name: Hematologic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T175
- Name: Acute Lymphoblastic Leukemia
- Relevance: HIGH
- As Found: Lymphoblastic lymphoma
- ID: T3533
- Name: Lymphoblastic Lymphoma
- Relevance: HIGH
- As Found: Lymphoblastic lymphoma
- ID: T3543
- Name: Lymphosarcoma
- Relevance: HIGH
- As Found: Lymphoma
- ID: T224
- Name: Adult T-cell Leukemia/lymphoma
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000008223
- Term: Lymphoma
- ID: D000007938
- Term: Leukemia
- ID: D000054198
- Term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
- ID: D000007945
- Term: Leukemia, Lymphoid
- ID: D000008228
- Term: Lymphoma, Non-Hodgkin
### Intervention Browse Module - Browse Branches
- Abbrev: AnArAg
- Name: Anti-Arrhythmia Agents
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: Analg
- Name: Analgesics
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: ANeo
- Name: Antineoplastic Agents
### Intervention Browse Module - Browse Leaves
- ID: M3595
- Name: Adenosine
- Relevance: LOW
- As Found: Unknown
- ID: M90325
- Name: 9-arabinofuranosylguanine
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434454
**Acronym:** EFT STUDENT
**Brief Title:** EFT AND SLEEP QUALITY
**Official Title:** EFT and Sleep Quality
#### Organization Study ID Info
**ID:** E-54022451-050.04-137924
#### Organization
**Class:** OTHER
**Full Name:** Bezmialem Vakif University
#### Secondary ID Infos
**Domain:** BezmialemVU
**ID:** MMeseduzu
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-09-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Bezmialem Vakif University
#### Responsible Party
**Investigator Affiliation:** Bezmialem Vakif University
**Investigator Full Name:** Merve Meşedüzü
**Investigator Title:** LECTURER
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** True
### Description Module
**Brief Summary:** The purpose of this clinical study is to determine whether the application of EFT (Emotional Freedom Techniques) is effective in reducing sleep problems among university students. Additionally, the study aims to gather information on the safety of EFT application. The primary questions it seeks to answer are:
Does EFT application reduce sleep problems among university students? Is EFT application feasible for addressing sleep problems in university students? Researchers will compare the effectiveness of EFT to traditional sleep education on non-pharmacological interventions for preventing sleep problems among university students.
Participants:
Pre-EFT application survey scale questions will be asked to university students.
EFT will be applied once by the researcher to university students. EFT will be applied a second time by the researcher to university students 15 days after the initial application.
For control, the same survey scale questions will be asked to the same students one day after the EFT application for post-test purposes.
The same procedures will be applied in the same manner to the control group that will receive education.
**Detailed Description:** DATA COLLECTION TOOLS AND THEIR FEATURES For data collection, a questionnaire including socio-demographic characteristics, the Insomnia Severity Index, the Epworth Sleepiness Scale, and the Pittsburgh Sleep Quality Index will be used.
1. Personal Information Form The personal information form, prepared by the researchers, includes questions about socio-demographic characteristics such as age and gender. The last part of the questionnaire consists of questions evaluating the sleep status of the participants.
2. Insomnia Severity Index (ISI) This scale, developed to determine the severity of insomnia symptoms, can be used in both general population screenings and clinical assessments of insomnia. It is a seven-item, five-point Likert-type scale. Each item is scored between 0 and 4, with the total score ranging from 0 to 28. Scores of 0-7 indicate no clinically significant insomnia, 8-14 indicate subthreshold insomnia, 15-21 indicate clinical insomnia (moderate severity), and 22-28 indicate severe clinical insomnia.
3. Epworth Sleepiness Scale (ESS) The ESS is an easy-to-administer and widely used scale. It is a four-point Likert-type scale. Each item is scored 0, 1, 2, or 3, with higher scores indicating greater daytime sleepiness. It aims to measure the general level of daytime sleepiness and is a simple self-report tool.
4. Pittsburgh Sleep Quality Index (PSQI) The PSQI\& index comprises 18 items grouped into 7 component scores. Each item is evaluated on a scale of 3 points. The sum of the seven component scores provides the total PSQI score, ranging from 0 to 21. Higher total scores indicate poorer sleep quality. A total PSQI score of 0-4 signifies good sleep quality, while scores between 5-21 indicate poor sleep quality.
indicates and shows a serious deterioration in at least two components or moderate deterioration in three components of the PSQI.
5. Fatigue Severity Scale (FSS) The FSS consists of 9 questions measuring the degree of fatigue experienced in the past week. Each question is rated on a scale from 0 (strongly disagree) to 7 (strongly agree), and the total score is the sum of these ratings. The highest possible total score is 63. A score of 36 or above indicates significant fatigue.
6. Sleep Education (control group):
The sleep education content will be prepared by the researcher based on the literature and will be reviewed by at least three experts.
### Conditions Module
**Conditions:**
- Sleep Quality
**Keywords:**
- student
- sleep qualıty
- emotioanal freedom techniques
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** The young individuals in the control group will be informed about the study, including its purpose and methodology, and their consent will be obtained. The control group will receive sleep education, consisting of two educational presentations provided 15 days apart. The questionnaires of the scales used for analysis will be administered to assess their sleep problems. The content of the education will be prepared based on the literature and will be reviewed by at least three experts.
The young individuals in the experimental group will be informed about the study, including its purpose and methodology, and their consent will be obtained. Emotional Freedom Techniques (EFT) will be applied to groups of 20 individuals to improve sleep quality, and all scales will be administered beforehand. EFT will be applied twice, with a 15-day interval between sessions, and the same scale questionnaires will be administered again after the second EFT session. Subsequently, the analysis
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 74
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The young individuals in the intervention group will be informed about the study, including its purpose and methodology, and their consent will be obtained. Emotional Freedom Techniques (EFT) will be applied to groups of 20 individuals to improve sleep quality, and all scales will be administered beforehand. EFT will be applied twice, with a 15-day interval between sessions, and the same scale questionnaires will be administered again after the second EFT session. Subsequently, the analysis will be conducted.
**Intervention Names:**
- Behavioral: EFT Group:Emotional Free Technıcal
**Label:** EXPERİMENTAL: EFT GROUP
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** The young individuals in the control group will be informed about the study, including its purpose and methodology, and their consent will be obtained. The control group will receive sleep education, consisting of two educational presentations provided 15 days apart. The questionnaires of the scales used for analysis will be administered to assess their sleep problems. The content of the education will be prepared based on the literature and will be reviewed by at least three experts.
**Label:** CONTROL GROUP
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- EXPERİMENTAL: EFT GROUP
**Description:** The young individuals in the intervention group will be informed about the study, including its purpose and methodology, and their consent will be obtained. Emotional Freedom Techniques (EFT) will be applied to groups of 20 individuals to improve sleep quality, and all scales will be administered beforehand. EFT will be applied twice, with a 15-day interval between sessions, and the same scale questionnaires will be administered again after the second EFT session. Subsequently, the analysis will be conducted.
**Name:** EFT Group:Emotional Free Technıcal
**Other Names:**
- emotional free technıcal
**Type:** BEHAVIORAL
### Outcomes Module
#### Other Outcomes
**Description:** The FSS consists of 9 questions measuring the degree of fatigue experienced in the past week. Each question is rated on a scale from 0 (strongly disagree) to 7 (strongly agree), and the total score is the sum of these ratings. The highest possible total score is 63. A score of 36 or above indicates significant fatigue.
**Measure:** Fatigue Severity Scale (FSS)
**Time Frame:** one month
**Description:** The index comprises 18 items grouped into 7 component scores. Each item is evaluated on a scale of 3 points. The sum of the seven component scores provides the total PSQI score, ranging from 0 to 21. Higher total scores indicate poorer sleep quality. A total PSQI score of 0-4 signifies good sleep quality, while scores between 5-21 indicate poor sleep quality. indicates and shows a serious deterioration in at least two components or moderate deterioration in three components of the PSQI.
**Measure:** Pittsburgh Sleep Quality Index (PSQI)
**Time Frame:** one month
#### Primary Outcomes
**Description:** This scale is a seven-item, five-point Likert-type scale. Each item is scored between 0 and 4, with the total score ranging from 0 to 28. Scores of 0-7 indicate no clinically significant insomnia, 8-14 indicate subthreshold insomnia, 15-21 indicate clinical insomnia (moderate severity), and 22-28 indicate severe clinical insomnia
**Measure:** Insomnia Severity Index Scale
**Time Frame:** 1 months
#### Secondary Outcomes
**Description:** The ESS is a four-point Likert-type scale. Each item is scored 0, 1, 2, or 3, with higher scores indicating greater daytime sleepiness. It aims to measure the general level of daytime sleepiness and is a simple self-report tool.
**Measure:** Epworth Sleepiness Scale (ESS)
**Time Frame:** 1 months
### Eligibility Module
**Eligibility Criteria:** * Inclusion Criteria:
* Görsel Analog Ölçeğe (VAS) göre 5 ve üzerinde uyku sorunu bildiren öğrenciler
* 18-24 yaş aralığında olan öğrenciler
* Herhangi bir kronik hastalığı bulunmayan öğrenciler
* Araştırmaya gönüllü olarak katılmak isteyen öğrenciler yer almaktadır.
* Exclusion Criteria:
* Individuals who wish to withdraw from the study.
**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:** MERVE MESEDUZU
**Phone:** 800-555-5555
**Role:** CONTACT
**Contact 2:**
**Name:** HANDAN ÖZCAN LECTURER
**Phone:** 800-555-5555
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** İ̇stanbul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Merve MESEDUZU, LECTURER
- **Phone:** 800-555-5555
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Bezmialem Vakif Universty
**State:** Topkapı Mahallesi
**Zip:** 34093
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434441
**Brief Title:** Bone Augmentation Using Calvarial Versus Iliac Crest Bone Blocks.
**Official Title:** Radiographic Assessment of Horizontal Bone Augmentation of Full Atrophic Maxillary Alveolar Ridges Using Calvarial Versus Iliac Crest Bone Blocks:
#### Organization Study ID Info
**ID:** 13
#### Organization
**Class:** OTHER
**Full Name:** Beni-Suef University
### Status Module
#### Completion Date
**Date:** 2024-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-06-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-08-10
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Beni-Suef University
#### Responsible Party
**Investigator Affiliation:** Beni-Suef University
**Investigator Full Name:** Amr Gibaly
**Investigator Title:** Associate Professor of Oral and Maxillofacial Surgery
**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 aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones
**Detailed Description:** Although the calvarial bones represent a nearby donor site for maxillary augmentation of matching bone origin, the excessive volume of bone needed to reconstruct a severely deficient arch, the limited cancellous bone volume, and the arciform pattern of the skull cap that yield the curvatures of the harvested cortical blocks incompatible with the topography of the maxillary arch, all represent limitations for the calvarial graft.
The anterior iliac crest is frequently used for free bone grafting by being subcutaneous and generous to afford ample bone blocks of favorable curvatures. However, the minute cortical overlay and its endochondral origin contribute to excessive graft resorption. Pikos et al. demonstrated that a reasonable amount of graft resorption could occur with atraumatic surgical intervention and intimate graft fixation.
This study aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones.
### Conditions Module
**Conditions:**
- Bone Atrophy
**Keywords:**
- Bone graft
- Iliac crest blocks
- Calverial bone blocks
- Horizontal bone gain
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
**Intervention Model Description:** A) The Study group:
The patients within the study group will receive mono-cortical bone block calvarial grafts
B) The Control group:
The patients within the control group will receive mono-cortical bone block iliac crest grafts,
##### Masking Info
**Masking:** SINGLE
**Masking Description:** Masking in not applicable for the patients or the operators
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** The patients will receive calverial grafts, to reconstruct the deficient maxillary ridge
**Intervention Names:**
- Procedure: Autogenous bone augmentation
**Label:** Study group:
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** The patients will receive iliac crestgrafts, to reconstruct the deficient maxillary ridge
**Intervention Names:**
- Procedure: Autogenous bone augmentation
**Label:** Control group:
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Control group:
- Study group:
**Description:** Maxillary alveolar bone reconstruction
**Name:** Autogenous bone augmentation
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** the study compares the horizontal bone gain of reconstructed maxillary alveolar ridges after being augmented with calverial and iliac crest bone grafts radiographically by millimeters
**Measure:** Horizontal bone gain
**Time Frame:** 6 months consolidation period
#### Secondary Outcomes
**Description:** the study compares the bone area percent of the consolidated calverial and iliac crest bone grafts
**Measure:** Immunohistochemical bone formation
**Time Frame:** 6 months consolidation period
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Patients with the clinical and radiographic interpretation of horizontal maxillary ridge deficiency of less than 5 mm
Exclusion Criteria:
* Any previous maxillary reconstructive or dental implant treatment.
* Any local pathologic lesion or systemic disease that would affect the typical pattern of bone healing.
**Maximum Age:** 55 Years
**Minimum Age:** 20 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Amr Gibaly
**Phone:** 01113336634
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cairo
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Amr Gibaly
- **Phone:** 01113336634
- **Role:** CONTACT
**Country:** Egypt
**Facility:** Amr Gibaly
**Status:** RECRUITING
**Zip:** 62764
### 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: Atrophy
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001284
- Term: Atrophy
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434428
**Brief Title:** Comparison Between Intranasal vs Intravenous Dexmedetomidine for EEG Sedation of Children With Behavior Disorders.
**Official Title:** Comparison Between Intranasal Versus Intravenous Administration of Dexmedetomidine for EEG in Children With Behavior Disorders
#### Organization Study ID Info
**ID:** AO/18/4422
#### Organization
**Class:** OTHER
**Full Name:** Azienda Ospedaliera di Padova
### Status Module
#### Completion Date
**Date:** 2022-09-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-28
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2021-08-30
**Type:** ACTUAL
#### Start Date
**Date:** 2018-03-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Azienda Ospedaliera di Padova
#### Responsible Party
**Investigator Affiliation:** Azienda Ospedaliera di Padova
**Investigator Full Name:** angela amigoni
**Investigator Title:** Head of the Pediatric Intensive Care Unit
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The aim of the project was to compare the efficacy and safety of intranasal (IN) and intravenous (IV) dexmedetomidine (DEX) in procedural sedation for electroencephalogram (EEG) in pediatric patients with behavioural disorders.
Single-centre comparative observational study in the tertiary care centre of Padua, regarding all consecutive pediatric patients affected by behavioural disorders, who needed sedation for EEG recording. A group of children received IV administration of DEX, the following year a second group of children received IN administration of the same drug. Target of sedation was level 2, according to the Paediatric Sedation State Scale (PSSS).
**Detailed Description:** OBJECTIVE: The aim of the project was to compare the efficacy and safety of intranasal (IN) and intravenous (IV) dexmedetomidine (DEX) in procedural sedation for electroencephalogram (EEG) in pediatric patients with behavioural disorders.
METHODS: Single-centre comparative observational study in the tertiary care centre of Padua, regarding all consecutive patients \< 18 years old affected by behavioural disorders, who needed sedation for EEG recording. From 2018 to 2020 a group of children received IV administration of DEX (IV DEX), the following year a second group of children received IN administration of the same drug (IN DEX). In both groups, target of sedation was level 2, according to the Paediatric Sedation State Scale (PSSS). Heart rate (HR), pulse oxygen saturation and blood pressure (BP) were registered. EEG recording quality and caregivers' satisfaction were collected.
### Conditions Module
**Conditions:**
- Sedation Complication
**Keywords:**
- sedation
- dexmedetomidine
- safety
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 48
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients treated intravenously receives a bolus of DEX (2 mcg/kg over ten minutes), followed by continuous infusion (1-2 mcg/kg/hour), stopped at the end of the procedure. The bolus could be repeated up to three times to reach the optimal target level of sedation before starting the continuous infusion.
**Intervention Names:**
- Drug: dexmedetomidine (IV)
**Label:** IV DEX
#### Arm Group 2
**Description:** For the IN administration, after a first bolus of 4 mcg/kg it is possible to repeat boluses of 1-2mcg/kg of DEX (maximum dose for each administration is 200mcg). The drug dose is divided into two equal aliquots, with one aliquot administered into each nostril by a nurse using an atomizer device.
**Intervention Names:**
- Drug: dexmedetomidine (IN)
**Label:** IN DEX
### Interventions
#### Intervention 1
**Arm Group Labels:**
- IV DEX
**Description:** Administration of IV dexmedetomidine
**Name:** dexmedetomidine (IV)
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- IN DEX
**Description:** Administration of IN dexmedetomidine
**Name:** dexmedetomidine (IN)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** the patient reaches the level 2 of the Pediatric Sedation State Scale
**Measure:** efficacy (PSSS level 2)
**Time Frame:** 20 minutes after dexmedetomidine administration
#### Secondary Outcomes
**Description:** presence of adverse events (desaturation, bradycardia, tachycardia, hypertension, hypotension)
**Measure:** safety (Sat > 90%; change < 25% of heart frequency and systemic pressure values)
**Time Frame:** during the procedure
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* children affected by behavioural disorders, who need sedation to perform EEG
* American Society of Anaesthesiologists (ASA) status \< 3
* Written informed consent by a parent or legal guardian.
Exclusion Criteria:
* previous hypersensitivity reaction or contraindications to administration of DEX (cardiac failure, cardiac arrhythmias, long QT syndrome, bradycardia, hypotension, use of beta-blockers or digoxin, uncontrolled arterial hypertension, recent stroke or intracranial bleeding, Moya-Moya syndrome)
* for IN administration, children with runny nose/mild respiratory infection
**Maximum Age:** 18 Years
**Minimum Age:** 1 Month
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
**Study Population:** children affected by behavioural disorders
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Padova
**Country:** Italy
**Facility:** University Hospital of Padova
**Zip:** 35128
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Browse Branches
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M4815
- Name: Mental Disorders
- Relevance: HIGH
- As Found: Behavior Disorder
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000001523
- Term: Mental Disorders
### Intervention Browse Module - Ancestors
- ID: D000006993
- Term: Hypnotics and Sedatives
- ID: D000002492
- Term: Central Nervous System Depressants
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000018712
- Term: Analgesics, Non-Narcotic
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000058647
- Term: Adrenergic alpha-2 Receptor Agonists
- ID: D000000316
- Term: Adrenergic alpha-Agonists
- ID: D000000322
- Term: Adrenergic Agonists
- ID: D000018663
- Term: Adrenergic Agents
- ID: D000018377
- Term: Neurotransmitter Agents
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M22662
- Name: Dexmedetomidine
- Relevance: HIGH
- As Found: Placebo-controlled
- ID: M10043
- Name: Hypnotics and Sedatives
- 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: M20746
- Name: Adrenergic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M3668
- Name: Adrenergic alpha-Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M3673
- Name: Adrenergic Agonists
- Relevance: LOW
- As Found: Unknown
- ID: M20504
- Name: Neurotransmitter Agents
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000020927
- Term: Dexmedetomidine
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434415
**Brief Title:** Prognostic Value of Coronary Angiography-Derived Index of Microcirculatory Resistance in Hypertrophic Cardiomyopathy Patients
**Official Title:** Prognostic Value of Coronary Angiography-Derived Index of Microcirculatory Resistance in Hypertrophic Cardiomyopathy Patients
#### Organization Study ID Info
**ID:** 2024005
#### Organization
**Class:** OTHER
**Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
### Status Module
#### Completion Date
**Date:** 2024-05-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** ACTIVE_NOT_RECRUITING
#### Primary Completion Date
**Date:** 2024-01-31
**Type:** ACTUAL
#### Start Date
**Date:** 2017-01-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** Coronary microvascular dysfunction (CMD) is among pathophysiological states of significance in hypertrophic cardiomyopathy (HCM). The index of microcirculatory resistance (IMR) has been recognized as an indicator of CMD and considered of important prognostic value in various conditions. The angiography-derived index of microcirculatory resistance (angio-IMR) is a novel guidewire-free method to assess IMR and proved to have favourable correlation with it. This study was designed to assess prognostic impact of CMD in HCM patients, using angio-IMR as a novel non-invasive assessment tool.
### Conditions Module
**Conditions:**
- Hypertrophic Cardiomyopathy
### Design Module
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** RETROSPECTIVE
#### Enrollment Info
**Count:** 470
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Label:** HCM patients with low IMR
#### Arm Group 2
**Label:** HCM patients with high IMR
### Outcomes Module
#### Primary Outcomes
**Description:** a composition of cardiac death, readmission for heart failure, and cardiac infraction
**Measure:** MACE composite
**Time Frame:** within 24 months' follow-up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. diagnosed with hypertrophic cardiomyopathy(HCM) based on clinical guidelines
2. have qualified image for analysis of angio-IMR
Exclusion Criteria:
1. referred to hospital due to ST-segment elevation myocardial infarction(STEMI), heart failure and cardiopulmonary arrest;
2. severe valve dysfunction;
3. history of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation;
4. meet the criteria of implantation of implantable cardioverter-defibrillator or pacemaker, septal myectomy or septal myocardial ablation;
5. impaired life-span expectancy due to cancer or other clinical conditions;
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** We retrospectively enrolled patients who were diagnosed with hypertrophic cardiomyopathy(HCM) and underwent invasive coronary angiography between 2017 and 2024 at the Second Affiliated Hospital of Zhejiang University School of Medicine.The diagnosis of HCM was based on current clinical guidelines.
### Contacts Locations Module
#### Overall Officials
**Official 1:**
**Affiliation:** Second affiliated Hospital Zhejiang University School of Medicine
**Name:** Jun Jiang, MD, PhD
**Role:** STUDY_DIRECTOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000020763
- Term: Pathological Conditions, Anatomical
- ID: D000001020
- Term: Aortic Stenosis, Subvalvular
- ID: D000001024
- Term: Aortic Valve Stenosis
- ID: D000082862
- Term: Aortic Valve Disease
- ID: D000006349
- Term: Heart Valve Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M12154
- Name: Cardiomyopathies
- Relevance: HIGH
- As Found: Cardiomyopathy
- ID: M10035
- Name: Hypertrophy
- Relevance: HIGH
- As Found: Hypertrophic
- ID: M5568
- Name: Cardiomyopathy, Hypertrophic
- Relevance: HIGH
- As Found: Hypertrophic Cardiomyopathy
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M22519
- Name: Pathological Conditions, Anatomical
- Relevance: LOW
- As Found: Unknown
- ID: M6475
- Name: Constriction, Pathologic
- Relevance: LOW
- As Found: Unknown
- ID: M4340
- Name: Aortic Valve Stenosis
- Relevance: LOW
- As Found: Unknown
- ID: M2379
- Name: Aortic Valve Disease
- Relevance: LOW
- As Found: Unknown
- ID: M9437
- Name: Heart Valve Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T449
- Name: Aortic Valve Stenosis
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009202
- Term: Cardiomyopathies
- ID: D000002312
- Term: Cardiomyopathy, Hypertrophic
- ID: D000006984
- Term: Hypertrophy
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434402
**Brief Title:** A Virtual, Group-Based, Expressive Writing Intervention for Survivors of Adolescent and Young Adult Cancer
**Official Title:** A Virtual, Group-Based, Expressive Writing Intervention for Survivors of Adolescent and Young Adult Cancer
#### Organization Study ID Info
**ID:** 2024-0440
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**Domain:** NCI-CTRP Clinical Registry
**ID:** NCI-2024-04531
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2026-09-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** NIH
**Name:** National Cancer Institute (NCI)
#### 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:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** To learn more about the experiences of adolescent and young adult cancer survivors and investigate whether a group-based writing intervention can help to improve quality of life of adolescent and young adult cancer survivors.
**Detailed Description:** Primary Objective:
To evaluate the feasibility of a virtual, group-based expressive writing intervention for survivors of adolescent and young adult cancer.
Secondary Objective:
To preliminarily assess the impact of the study for cancer survivors.
### Conditions Module
**Conditions:**
- Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** SUPPORTIVE_CARE
#### Enrollment Info
**Count:** 30
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants will be asked to write about your experiences 1 time each week for 4 weeks. You will receive prompts for these essays from the study staff.
You will also complete 3 questionnaires about things like your mood, your health, and demographic information (age, race, sex, and so on). These should take about 20 minutes to complete each time. You will complete these at the beginning of the study, and then 1 and 3 months later.
**Intervention Names:**
- Behavioral: Emerging adults (ages18-25 years)
**Label:** Emerging adults (ages18-25 years)
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants will be asked to write about your experiences 1 time each week for 4 weeks. You will receive prompts for these essays from the study staff.
You will also complete 3 questionnaires about things like your mood, your health, and demographic information (age, race, sex, and so on). These should take about 20 minutes to complete each time. You will complete these at the beginning of the study, and then 1 and 3 months later.
**Intervention Names:**
- Behavioral: Young adults (ages 26-39 years)
**Label:** Young adults (ages 26-39 years)
**Type:** EXPERIMENTAL
#### Arm Group 3
**Description:** Participants will be asked to write about your experiences 1 time each week for 4 weeks. You will receive prompts for these essays from the study staff.
You will also complete 3 questionnaires about things like your mood, your health, and demographic information (age, race, sex, and so on). These should take about 20 minutes to complete each time. You will complete these at the beginning of the study, and then 1 and 3 months later.
**Intervention Names:**
- Behavioral: General group (ages 18-39 years)
**Label:** General group (ages 18-39 years)
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Emerging adults (ages18-25 years)
**Description:** Participants may be randomly selected to participate in a 30-minute interview discussing your experiences with the study activities. The study team will inform you if you are selected and provide further details.
**Name:** Emerging adults (ages18-25 years)
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Young adults (ages 26-39 years)
**Description:** Participants may be randomly selected to participate in a 30-minute interview discussing your experiences with the study activities. The study team will inform you if you are selected and provide further details.
**Name:** Young adults (ages 26-39 years)
**Type:** BEHAVIORAL
#### Intervention 3
**Arm Group Labels:**
- General group (ages 18-39 years)
**Description:** Participants may be randomly selected to participate in a 30-minute interview discussing your experiences with the study activities. The study team will inform you if you are selected and provide further details.
**Name:** General group (ages 18-39 years)
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Assed utilizing the Functional Assessment of Cancer Therapy-General (FACT-G) will be used to measure multidimensional QOL (physical, social, emotional, and functional well-being)
**Measure:** Quality of Life (QoL)
**Time Frame:** Through study completion; an average of 1 year.
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
* Age 15-39 years at cancer diagnosis
* Age 18-39 years at study entry
* Within 5 years of diagnosis of stage II-IV cancer
* Completed active treatment (participants receiving maintenance therapy remain eligible)
* No evidence of disease
* Can speak, read, and write in English.
Exclusion criteria:
* Nonmelanoma skin cancer
* Major mental health disorder (e.g., schizophrenia or bipolar disorder \[determined from patient records or self-disclosure\])
* No internet access.
**Maximum Age:** 39 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Qian Lu, MD,PHD
**Phone:** (713) 745-8324
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Qian Lu, MD,PHD
- **Phone:** 713-745-8324
- **Role:** CONTACT
***Contact 2:***
- **Name:** Qian Lu, MD,PHD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** MD Anderson Cancer Center
**State:** Texas
**Status:** RECRUITING
**Zip:** 77030
#### Overall Officials
**Official 1:**
**Affiliation:** M.D. Anderson Cancer Center
**Name:** Qian Lu, MD,PHD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### See Also Links
**Label:** MD Anderson Cancer Center
**URL:** http://www.mdanderson.org
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434389
**Brief Title:** A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery
**Official Title:** A Point-of-care Electrochemical-based Device for Rapid Detection of Fibrinogen on Type A Aortic Dissection Surgery
#### Organization Study ID Info
**ID:** 2024-0415
#### Organization
**Class:** OTHER
**Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
### Status Module
#### Completion Date
**Date:** 2024-11-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-08-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
### Description Module
**Brief Summary:** This study compares the results of the existing fibrinogen concentration monitoring technology to the Electrochemical-based device, a point-of-care and rapid method,using a small amount of extra blood obtained in Type A Aortic Dissection Surgery.
**Detailed Description:** Electrochemical-based device for rapid detection of fibrinogen is a novel POC diagnostic method, which is suitable for operating theatres and emergency rooms.
The novel fibrinogen detection based on Gel electrodes combined with immunobiosensing strategies and use magnitude of current to characterize the fibrinogen concentration , which will be a POC assay of fibrinogen detection for critically ill patients.
This single-center, prospective, observational pilot study will evaluate the analytical performance as well as compared to conventional Clauss laboratory reference method.
### Conditions Module
**Conditions:**
- Hypofibrinogenemia
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 150
**Type:** ESTIMATED
**Patient Registry:** True
**Study Type:** OBSERVATIONAL
**Target Duration:** 1 Day
### Arms Interventions Module
#### Arm Group 1
**Description:** Part1 Phase I-Laboratory calibration. Phase II-Assay performance using clinical samples. using human biological samples already collected for routine coagulation analysis.
Part2 Subject underwent surgery for acute type A aortic dissection and requires routine TEG test, residual blood samples collected for fibrinogen detection by the Clauss method and electrochemical method.
**Intervention Names:**
- Diagnostic Test: the Electrochemical-based device
**Label:** The patients undergoing routine coagulation tests
### Interventions
#### Intervention 1
**Arm Group Labels:**
- The patients undergoing routine coagulation tests
**Description:** Electrochemical-based device for rapid detection of fibrinogen is a novel POC diagnostic method, which is suitable for operating theatres and emergency rooms.
**Name:** the Electrochemical-based device
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Measure:** The fibrinogen concentration values obtained using the Clauss method and electrochemical method were compared
**Time Frame:** 1 day
#### Secondary Outcomes
**Measure:** the time of the two detection methods
**Time Frame:** 1 day
### Eligibility Module
**Eligibility Criteria:** Part1 Phase I-Laboratory calibration. The electrochemical method was employed to detect the fibrinogen concentration of standard quality control materials with varying concentration gradients, and the corresponding current values were recorded for constructing a standard curve of fibrinogen concentration.
Phase II-Assay performance using clinical samples. Subject is 18 years and underwent routine hemostasis analysis. using human biological samples already collected for routine hemostasis analysis, The samples were centrifuged at 2500g for 15 min at room temperature, to obtain PPP (residual platelet count of \<10 × 10\^9/L) and stored at-20℃used for determination by electrochemical method within 2 weeks, Each clinical sample was tested three times
Part2
Inclusion Criteria:
Subject underwent surgery for acute type A aortic dissection at our hospital, Subject is 18 years, Subject requires routine TEG measurement, Subject use human fibrinogen concentrate during surgery.
Exclusion Criteria:
Use Extracorporeal Membrane Oxygenation after surgery, inability to obtain written informed consent
**Minimum Age:** 18 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Participants for this study will be recruited at the Second Affiliated Hospital Zhejiang University School of Medicine. For part 1:The study participants will be adult underwent routine hemostasis analysis. For part 2:The study participants will be adult underwent surgery for acute type A aortic dissection and requires routine TEG test, residual blood samples collected for fibrinogen detection by the Clauss method and electrochemical method.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Fengjiang ZHANG
**Phone:** +8613858007629
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Hangzhou
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Fengjiang ZHANG
- **Phone:** +8613858007629
- **Role:** CONTACT
**Country:** China
**Facility:** The Second Affiliated Hospital of Zhejiang University anesthesiology department
**State:** Zhejiang
**Zip:** 310009
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000094665
- Term: Dissection, Blood Vessel
- ID: D000000783
- Term: Aneurysm
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000094683
- Term: Acute Aortic Syndrome
- ID: D000001018
- Term: Aortic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M4114
- Name: Aortic Dissection
- Relevance: HIGH
- As Found: Aortic Dissection
- ID: M3081
- Name: Dissection, Blood Vessel
- Relevance: LOW
- As Found: Unknown
- ID: M4113
- Name: Aneurysm
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M16355
- Name: Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M3085
- Name: Acute Aortic Syndrome
- Relevance: LOW
- As Found: Unknown
- ID: M4334
- Name: Aortic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000000784
- Term: Aortic Dissection
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434376
**Brief Title:** MRD-positive Colorectal Cancer Patients Combined With Personalized Immune Regulation Diagnosis
**Official Title:** Study on Adjuvant Treatment of MRD-positive Colorectal Cancer Patients With Routine Chemotherapy Combined With Personalized Immune Regulation Diagnosis and Treatment Technology
#### Organization Study ID Info
**ID:** SAHoWMU-CR2024-02-110
#### Organization
**Class:** OTHER
**Full Name:** Second Affiliated Hospital of Wenzhou Medical University
### Status Module
#### Completion Date
**Date:** 2026-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-04
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Second Affiliated Hospital of Wenzhou Medical 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:** Establish the clinical technology system of routine adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology for postoperative anti-relapse adjuvant therapy: Patients with MRD positive and high risk of recurrence after colorectal cancer surgery were enrolled. Surgical tumor tissue and blood samples were collected, tumor tissue samples were sequenced, neoantigens were analyzed, personalized immunomodulators were prepared, and routine adjuvant therapy combined with personalized immunomodulatory diagnosis and treatment technology were performed to prevent postoperative recurrence. To establish the clinical technology system of routine adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology for postoperative anti-relapse adjuvant therapy
### Conditions Module
**Conditions:**
- Colorectal Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- EARLY_PHASE1
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Conventional adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology
**Intervention Names:**
- Biological: Conventional chemotherapy combined with personalized immune regulation diagnosis and treatment technology
**Label:** Experimental group
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Experimental group
**Description:** Blood samples were collected for MRD detection within one month (week 3) after colorectal cancer surgery, and MRD-positive patients were selected for routine chemotherapy (course of 6 months). Blood and tumor tissue samples of enrolled patients were collected, and relevant clinical data were recorded. The whole exon and expression profile of surgical tumor tissue samples were sequenced, neoantigens were analyzed, and immunomodulators were prepared. After the preparation of individualized immunomodulators, combined treatment was performed simultaneously with chemotherapy. During the treatment process, patients' response to treatment and survival were observed, and tumor load, ctDNA changes, imaging and other indicators before and after treatment were compared. To evaluate the efficacy of immunotherapy.
**Name:** Conventional chemotherapy combined with personalized immune regulation diagnosis and treatment technology
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** Exploration of the efficacy of Conventional adjuvant therapy combined with personalized immune regulation diagnosis and treatment technology
**Measure:** ORR
**Time Frame:** Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months
#### Secondary Outcomes
**Description:** Observe and evaluate the progression free survival (PFS) of Postoperative MRD positive patients with with routine chemotherapy combined with personalized immune regulation diagnosis and treatment technolog
**Measure:** PFS
**Time Frame:** Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months
**Description:** Observe and evaluate the overall survival(OS) of Postoperative MRD positive patients with with routine chemotherapy combined with personalized immune regulation diagnosis and treatment technology
**Measure:** OS
**Time Frame:** Visits were conducted at the end (or termination) of each course and at 30, 90, and 120 days after the end of the last course for 4 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. They must give informed consent, indicating that they understand the purpose of the study and the procedures required, and are willing to participate in the study.
2. Age 18-80.
3. Pathological examination confirmed colorectal adenocarcinoma.
4. For patients with stage II with high risk factors or stage III with radical surgery, stage II (high risk) colon cancer is defined as (any of):
a )T4 b)≥ Level 3 c) The clinical manifestations are intestinal obstruction or intestinal perforation d) Histological signs of vascular, lymphatic, or perineural invasion e) Check \< 12 nodes
5. Patients with liver or lung metastases that can be resected in one stage with the primary lesion.
6. There must be sufficient formalin to fix the tumor material in the paraffin embedded (FFPE) block or section tissue (only after sponsor approval), preferably obtained from excision.
7. Patients should meet the following biochemical indicators: total bilirubin ≤2× upper limit of normal (ULN); AST and ALT≤2× upper limit of normal (ULN); Creatinine clearance ≥60 ml/min.
8. Patients should meet the following hematological indicators: neutrophil count ≥1.5×109 /L; Hemoglobin ≥10.0 g/dL; Platelet count ≥100×109 /L.
9. Expected survival ≥ 3 months.
10. Postoperative ctDNA MRD test was positive, routine blood indexes were negative, and imaging was negative.
Exclusion Criteria:
1. Stage I patients and stage II patients without risk factors or MSI-H.
2. Stage IV patients who cannot be surgically resected.
3. Patients with liver, kidney, heart, lung and other dysfunction, unable to tolerate surgery or unable to complete follow-up chemotherapy.
4. Patients who refuse adjuvant therapy such as chemotherapy, are allergic to chemotherapy drugs and have poor compliance.
5. Patients who have received other immunotherapy within 1 month (such as immune checkpoint inhibitor therapy, therapeutic antibody therapy, immune cell therapy, and immune system modulator therapy)
6. Patients with a known past or current malignancy, except where a diagnosis is included, except in the following cases:
1. Stage 1B or below cervical cancer.
2. Non-invasive basal cell or squamous cell skin cancer.
3. Non-invasive superficial bladder cancer.
4. Prostate cancer with a current PSA level \< 0.1 ng/mL.
5. Any curable cancer with a complete response (CR) duration of \> 2 years.
7. Patients with hematological and autoimmune diseases.
8. Patients with active hepatitis B or C.
9. Patients affected by drug abuse, clinical or psychological or social factors that make informed consent or the implementation of research.
10. Pregnant and lactating women.
11. Patients with mental illness, senile dementia, etc.
**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:** Yaojun Yu
**Phone:** +86 138 6884 9180
**Role:** CONTACT
### IPD Sharing Statement Module
**Description:** publication
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007414
- Term: Intestinal Neoplasms
- ID: D000005770
- Term: Gastrointestinal Neoplasms
- ID: D000004067
- Term: Digestive System Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000004066
- Term: Digestive System Diseases
- ID: D000005767
- Term: Gastrointestinal Diseases
- ID: D000003108
- Term: Colonic Diseases
- ID: D000007410
- Term: Intestinal Diseases
- ID: D000012002
- Term: Rectal Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BC06
- Name: Digestive System Diseases
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M17890
- Name: Colorectal Neoplasms
- Relevance: HIGH
- As Found: Colorectal Cancer
- ID: M10448
- Name: Intestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8886
- Name: Gastrointestinal Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M7256
- Name: Digestive System Neoplasms
- Relevance: LOW
- As Found: Unknown
- ID: M8883
- Name: Gastrointestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7255
- Name: Digestive System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6336
- Name: Colonic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10444
- Name: Intestinal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M14844
- Name: Rectal Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000015179
- Term: Colorectal Neoplasms
### Intervention Browse Module - Browse Branches
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M2853
- Name: Immunomodulating Agents
- Relevance: LOW
- As Found: Unknown
- ID: M3628
- Name: Adjuvants, Immunologic
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434363
**Brief Title:** Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
**Official Title:** Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
#### Organization Study ID Info
**ID:** 2024-0208
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**Domain:** NCI-CTRP Clinical Trials Registry
**ID:** NCI-2024-04434
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2030-12-31
**Type:** ESTIMATED
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2028-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-11-30
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** 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:** The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN.
The goal of Phase 1 is to find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab and lymphodepleting chemotherapy that can be given to patients with the disease.
The goal of Phase 2 is to learn if the dose of AD-PluReceptor-NK cells found in Phase 1 in combination with tafasitamab and lymphodepleting chemotherapy can help to control the disease.
**Detailed Description:** Primary Objectives:
To determine the safety, tolerability and optimal cell dose of AD-PluReceptor plus Tafasitamab cxix and lymphodepleting chemotherapy in patients with systemic sclerosis and systemic lupus erythematosus (including lupus nephritis).
Secondary Objectives:
To assess the overall response rate.
To evaluate the persistence and kinetics of infused allogeneic donor AD-PluReceptor cells in the recipient.
To conduct comprehensive immune reconstitution studies.
To evaluate the number of patients not requiring any systemic immunosuppressive therapy for their autoimmune disease at 1 year post infusion.
### Conditions Module
**Conditions:**
- Autoimmune Disorders
- Systemic Sclerosis
### Design Module
#### Design Info
**Allocation:** NON_RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 47
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Drug: Tafasitamab
**Label:** Safety Lead-In
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Drug: Tafasitamab
- Drug: Fludarabine phosphate
- Drug: Cyclophosphamide
**Label:** Dose Escalation
**Type:** EXPERIMENTAL
#### Arm Group 3
**Intervention Names:**
- Drug: Tafasitamab
- Drug: Fludarabine phosphate
- Drug: Cyclophosphamide
**Label:** Dose Expansion
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Dose Escalation
- Dose Expansion
- Safety Lead-In
**Description:** Given by vein (IV)
**Name:** Tafasitamab
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Dose Escalation
- Dose Expansion
**Description:** Given by vein (IV)
**Name:** Fludarabine phosphate
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Dose Escalation
- Dose Expansion
**Description:** Given by vein (IV)
**Name:** Cyclophosphamide
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** ncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
**Measure:** Adverse Event
**Time Frame:** Through study completion; an average of 1 year.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* 4.1.1 Systemic Sclerosis Specific Inclusion Criteria
A. Diagnosis of SSc defined as follows:
i) Fulfilling 2013 American College of Rheumatology (ACR)and European League Against Rheumatism classification (EULAR) criteria for SSc.46 ii) Antinuclear Antibody (ANA) by immunofluorescence positive at titer ≥ 1:80 at screening or prior to screening.
B. SSc disease activity i) Diffuse SSc meeting the following criteria:
(1) Disease duration ≤ 5 years (from onset of first non-Raynaud manifestation) AND (2) mRSS ≥ 15 at screening (Appendix 2) ii) Participants diagnosed with diffuse or limited cutaneous SSc AND progressive ILD on HRCT and ≤ 5 years duration (from onset of first non-Raynaud manifestation) defined by either (1) or (2)
1. Progressive ILD as defined by Raghu et al47 (≥ 2 of the following):
1. worsening respiratory symptoms
2. physiological evidence of disease progression (≥ 1 of the following):
(i) Absolute decline in FVC ≥ 5% predicted within 1 year of follow-up (ii) Absolute decline in DLCO (corrected for Hb) ≥ 10% predicted within 1 year of follow-up radiological evidence of disease progression (iii) Increased extent or severity of traction bronchiectasis and bronchiolectasis.
(iv) New ground-glass opacity with traction bronchiectasis (v) New fine reticulation (vi) Increased extent or increased coarseness of reticular abnormality. (vii) New or increased honeycombing (viii) Increased lobar volume loss
2. FVC \< 80% predicted and moderate to severe ILD, as assessed by a radiologist. C. Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, and/or tocilizumab.
4.1.2 SLE Specific Inclusion Criteria
1. A clinical diagnosis of SLE, based on the 2019 EULAR/ ACR classification criteria for adult SLE.
2. Positive ANA titer ≥1:80 or positive anti-dsDNA antibody at screening.
3. For LN subjects only: Active, biopsy-proven lupus nephritis class III or IV, with or without the presence of Class V, using the 2018 Revised International Society of Nephrology/Renal Pathology Society criteria48.
4. Diagnosed with active SLE. Subjects with either LN or without LN will be eligible if they meet the following criteria:
1. For LN subjects: urine protein-to-creatinine ratio (UPCR) ≥1 mg/mg on 2 first morning void urine samples during screening despite prior or current treatment with standard of care therapy for at least 12 weeks, including corticosteroids, MMF/mycophenolic acid (MPA), CY, calcineurin inhibitors, belimumab, and/or rituximab.
2. For non-renal SLE subjects: SLEDAI-2K ≥8 and clinical SLEDAI-2K ≥6 (excluding headache, alopecia, mucosal ulcers, fever, and organic brain syndrome) during screening despite prior or current treatment with standard of care therapy, including corticosteroids, rituximab or other B cell depleting agents, CY, MMF/MPA, azathioprine, methotrexate, 6-mercaptopurine, sirolimus, tacrolimus, thalidomide, leflunomide, mizorbine, anifrolumab, and/or belimumab.
5. If a subject is currently receiving:
1. Standard immunosuppressive therapy (including MMF/MPA, CY, azathioprine, antimalarial therapy, methotrexate, 6-mercaptopurine, sirolimus, tacrolimus, thalidomide, leflunomide, or mizorbine), the therapy must have been initiated at least 12 weeks prior to screening and on a stable dose for at least 8 weeks prior to screening, except for dose reduction due to safety or tolerability.
2. A renin-angiotensin-aldosterone inhibitor, (including direct renin inhibitors, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and mineralocorticoid receptor blockers), the subject must be on a stable dose for at least 8 weeks prior to screening.A sodium-glucose cotransporter-2 (SGLT2) inhibitor, the subject must be on a stable dose for at least 8 weeks prior to screening.
3. Regarding oral corticosteroid, doses \<0.5 mg/kg prednisone equivalent at the time of infusion are required.
6. Adequate renal function, defined as:
1. For LN subjects: Estimated glomerular filtration rate of ≥45 mL/min/1.73m2 using the chronic kidney disease-epidemiology equation.
2. For non-renal SLE subjects: Estimated glomerular filtration rate of ≥60 mL/min/1.73m2 using the chronic kidney disease-epidemiology equation
4.2.3 Inclusion Criteria: For both SLE and SSc
1. Able to provide informed consent.
2. Age ≥18 to ≤65 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix 1).
4. Adequate organ function i) Peripheral blood absolute neutrophil count (ANC) ≥ 1 × 109/L. iii) Hemoglobin ≥ 8 g/dl. iv) Platelet count ≥ 50 × 109/L without platelet transfusion support, no active bleeding.
vi) Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 1.5 × upper limit of normal (ULN) and total bilirubin \< 1.5 × ULN (or direct bilirubin \< 1.5× ULN with documented Gilbert's syndrome).
viii) Oxygen saturation (SaO2) ≥ 92% on room air. ix) Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
5. Recovery to ≤ Grade 1 or baseline of any non-hematological toxicities due to prior therapy.
6. Negative pregnancy test in WOCBP.
7. All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of therapy. Acceptable forms of birth control for female patients include hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor. Participant is willing and able to adhere to the study visit schedule and other protocol requirements and willing to sign informed consent.
Exclusion Criteria:
* 4.2 Exclusion Criteria 4.2.1 SSc specific exclusion criteria
1. SSc related pulmonary arterial hypertension (PAH) requiring active treatment.
2. Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular ectasia.
3. Prior scleroderma renal crisis.
4. Uncontrolled or rapidly progressive ILD (FVC \< 50; DLCO \< 50%); oxygen saturation (SaO2) \< 92% (room air at rest); or who have required mechanical breathing assistance (ventilator) within 1 year of signing informed consent.
4.2.2 SLE specific Exclusion Criteria
Subjects are excluded from the study if any of the following criteria apply:
1. Treatment with rituximab or other B cell-depleting agent within 26 weeks prior to screening, or within 12 weeks if there are laboratory results indicating presence of CD19+ B cells.
2. Treatment with voclosporin or other calcineurin inhibitor within 8 weeks prior to screening.
3. Treatment with anifrolumab, belimumab, or other biologic agent within 12 weeks prior to screening.
4. For LN subjects only: Evidence of severe chronicity on kidney biopsy, defined as a modified National Institute of Health chronicity index score of 3+ for any of the following individual biopsy features: total glomerulosclerosis score, fibrous crescents, tubular atrophy, or interstitial fibrosis.
5. A diagnosis of antiphospholipid antibody syndrome by the 2006 Revised Sapporo International Consensus Criteria at the time of screening49
6. The presence of biopsy-proven kidney disease other than active lupus nephritis
7. Moderate-to-severe chronic pulmonary disease, including asthma requiring or refractory to medium or high-dose inhaled corticosteroids combined with other longer-acting medications, In subjects who have had pulmonary function tests: Spirometry results of forced expiratory volume (FEV1)/forced vital capacity \<0.7 and FEV1 \<80% predicted after bronchodilators, or diffusing capacity of the lungs for carbon monoxide results \<60% predicted.
8. Active, severe cardiac manifestations of SLE, including constrictive pericarditis, hemodynamically significant pericardial effusions, and myocarditis at the time of screening.
4.2.4 Exclusion Criteria for both SLE and SSc
Subjects are excluded from the study if any of the following medical conditions apply:
1. Other systemic autoimmune diseases (e.g., multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded.
2. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or unwillingness or inability to follow the procedures required in the protocol.
3. Active, clinically significant central nervous system pathology
4. Prior history of malignancies or lymphoproliferative disease, following are allowed: Basal or squamous cell carcinoma of the skin, Carcinoma in situ of the cervix or breast. History of malignancy that has been treated with a curative intent and is in remission \> 5 years may be allowed after discussion with PI.
5. Active hepatitis B, active hepatitis C, active syphilis, any human immunodeficiency virus (HIV), human lymphocytic T-cell virus type 1 and/or type 2 (HTLV-1 and/or HTLV-2
6. Uncontrolled or active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at screening or within 72 hours before LD chemotherapy, or 5 days before AD-PluReceptor administration.
7. History of any one of the following cardiovascular conditions within the 6 months prior to screening: Class III or IV heart failure as defined by the New York Heart Association, myocardial infarction, unstable angina, or other clinically significant cardiac disease.
8. Prior CAR T cell therapy, genetically modified T cell therapy, concurrent immunosuppressive drugs, e.g., mycophenolate mofetil, systemic steroids, tocilizumab.
9. History of anaphylactic or severe systemic reaction to FLU, CY, or any of their metabolites.
10. Active infection requiring medical intervention at screening.
11. Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal (on TPN), pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.
12. Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures.
13. Autoimmune disorder other than SLE or SSc requiring immunosuppressive therapies.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Chitra Chitra Hosing, MD
**Phone:** (713) 745-3219
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Chitra Chitra, MD
- **Phone:** 713-745-3219
- **Role:** CONTACT
***Contact 2:***
- **Name:** Chitra Hosing, MD
- **Role:** PRINCIPAL_INVESTIGATOR
**Country:** United States
**Facility:** MD Anderson Cancer Center
**State:** Texas
**Zip:** 77030
### References Module
#### See Also Links
**Label:** MD Anderson Cancer Center Website
**URL:** http://www.mdanderson.org
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000003240
- Term: Connective Tissue Diseases
- ID: D000012871
- Term: Skin Diseases
- ID: D000007154
- Term: Immune System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC20
- Name: Immune System Diseases
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M15415
- Name: Sclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4629
- Name: Autoimmune Diseases
- Relevance: HIGH
- As Found: Autoimmune Disorders
- ID: M15412
- Name: Scleroderma, Systemic
- Relevance: HIGH
- As Found: Systemic Sclerosis
- ID: M25560
- Name: Scleroderma, Diffuse
- Relevance: HIGH
- As Found: Systemic Sclerosis
- ID: M6464
- Name: Connective Tissue Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15674
- Name: Skin Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M10200
- Name: Immune System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T5565
- Name: Systemic Scleroderma
- Relevance: HIGH
- As Found: Systemic Sclerosis
### Condition Browse Module - Meshes
- ID: D000012595
- Term: Scleroderma, Systemic
- ID: D000045743
- Term: Scleroderma, Diffuse
- ID: D000001327
- Term: Autoimmune Diseases
### 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
### 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: HIGH
- As Found: Cycle
- ID: M283230
- Name: Fludarabine
- Relevance: HIGH
- As Found: Combined
- ID: M225513
- Name: Fludarabine phosphate
- Relevance: HIGH
- As Found: Coated
- 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
### Intervention Browse Module - Meshes
- ID: D000003520
- Term: Cyclophosphamide
- ID: C000024352
- Term: Fludarabine
- ID: C000042382
- Term: Fludarabine phosphate
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434350
**Brief Title:** Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)
**Official Title:** Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)
#### Organization Study ID Info
**ID:** 2024-0071
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**Domain:** NCI-CTRP Clinical Registry
**ID:** NCI-2024-04592
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2027-09-24
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-09-24
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-11-29
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** 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 if the combination of enfortumab vedotin plus radiation therapy could help to control the disease.
**Detailed Description:** Primary Objectives:
1. Primary Objective #1: To estimate progression free survival for concurrent enfortumab vedotin with RT in locally advanced MIBC
2. Primary Objective #2: To evaluate the safety/tolerability of enfortumab vedotin with RT in participants with locally advanced MIBC
3. Primary Objective #3: To evaluate global health-related quality of life (HRQOL) using EQ-5D-5L, EORTC MIBC module, and EPIC bowel domain surveys
Secondary Objectives:
1. Secondary Objective #1: To estimate the overall survival at 12 months after study enrollment.
2. Secondary Objective #2: To estimate the metastasis free survival at 12 months after study enrollment.
3. Secondary Objective #3: To determine the treatment related toxicities associated with enfortumab vedotin with RT as part of definitive local therapy for advanced MIBC.
4. Secondary Objective #4: To estimate the freedom from GU events after enfortumab vedotin with RT
5. Exploratory Objective #1: To determine the association of translational biomarkers including peripheral blood tumor markers and urine tumor markers with participant outcomes.
### Conditions Module
**Conditions:**
- Advanced Bladder Cancer
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 41
**Type:** ESTIMATED
**Phases:**
- PHASE1
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Particpants will receive enfortumab vedotin by vein over about 1-2 hours on Days 1 and 8 of every 28-day cycle. Two dose levels of enfortumab vedotin will be tested. The dose of enfortumab vedotin participants receive will depend on when the participant join the study.
Participants will also receive radiation therapy 5 times a week (Monday through Friday) for about 4-5 weeks.
**Intervention Names:**
- Drug: Enfortumab Vedotin
- Radiation: Radiation Therapy
**Label:** Enfortumab Vedotin with Radiation
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Enfortumab Vedotin with Radiation
**Description:** Given by IV
**Name:** Enfortumab Vedotin
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Enfortumab Vedotin with Radiation
**Description:** Given by Radiation Therapy
**Name:** Radiation Therapy
**Type:** RADIATION
### 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) 4.0
**Measure:** Safety and adverse events (AEs)
**Time Frame:** Through study completion; an average of 1 year.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. Pathologically confirmed diagnosis of urothelial carcinoma of the bladder including patients with T4N0 and T1-4N2-3 disease. Participants with mixed urothelial carcinoma of bladder will also be included.
2. Be ≥ 18 years of age on the day of signing informed consent.
3. ECOG performance status 0-2. NOTE: If participants is unable to walk due to paralysis, but is mobile in a wheelchair, participants is ambulatory for the purpose of assessing their performance status.
4. The participant has the following baseline laboratory data:
1. Hemoglobin ≥ 9 g/dL
2. Platelet count ≥ 100 x 109 g/dL
3. Creatinine clearance (CrCl) ≥ 30 mL/min as estimated per institutional standards (glomerular filtration rate \[GFR\] can also be used instead of CrCl)
4. Absolute neutrophil count (ANC) ≥ 1500/mm3
5. Male participants must consistently use highly effective methods of birth control starting at screening and continue throughout study period and for at least 6 months after radiation completion
6. Female participants must consistently use highly effective methods of birth control starting at screening and continue throughout the study period and for at least 6 months after radiation completion As the CORe system in MDACC is set up as a one-step enrollment process, the above inclusion criteria will be assessed prior to CORe enrollment. Following CORe enrollment, the below inclusion criteria will be assessed.
1. Candidate for definitive local therapy to active disease per the discretion of the treating physicians.
Exclusion Criteria:
1. Has a diagnosis of active scleroderma, lupus, ulcerative colitis, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe radiation therapy.
2. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial as determined by the treating physician and/or member of the study team.
3. Distant metastatic disease beyond lymph node metastases, which by the discretion of the treating physician cannot be treated definitively in a radiation field
4. Has history of prior pelvic radiation therapy
5. Has ongoing clinically significant toxicity (Grade 2 or higher with exception of alopecia) associated with prior systemic therapy
6. History of uncontrolled diabetes mellitus within 3 months of enrollment. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥ 8% or HbA1c between 7 and \< 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
7. Has estimated life expectancy of less than 12 weeks
8. Has preexisting sensory or motor neuropathy Grade ≥ 2
9. Participants receiving ongoing systemic intravenous antimicrobial treatment for active infection at time of randomization
10. Participants have a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. No testing for hepatitis B and hepatitis C is required unless mandated by local health authority.
11. Has a known history of human immunodeficiency virus (HIV) infection. Testing is not required unless mandated by the local health authority.
12. Has conditions requiring high doses of steroids (\>10 mg/day of prednisone or equivalent) or other immunosuppressive medications are excluded. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.
13. Has a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
14. Has received a prior allogeneic stem cell or solid organ transplant.
15. Has active tuberculosis As the CORe system in MDACC is set up as a one-step enrollment process, the above inclusion criteria will be assessed prior to CORe enrollment. Following CORe enrollment, the below exclusion criteria will be assessed.
1. Is pregnant or expecting to conceive within the projected duration of the trial at the screening visit.
* Female participants of childbearing potential should have a negative urine or serum pregnancy within 6 weeks prior to study registration up to the first fraction of radiation.
* Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Comron Hassanzadeh, MD
**Phone:** (713) 657-9802
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Comron Hassanzadeh, MD
- **Phone:** 713-657-9802
- **Role:** CONTACT
***Contact 2:***
- **Name:** Comron Hassanzadeh, 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:** Comron Hassanzadeh, MD
**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: D000014571
- Term: Urologic Neoplasms
- ID: D000014565
- Term: Urogenital Neoplasms
- ID: D000009371
- Term: Neoplasms by Site
- ID: D000009369
- Term: Neoplasms
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000001745
- Term: Urinary Bladder Diseases
- ID: D000014570
- Term: Urologic Diseases
- ID: D000052801
- Term: Male Urogenital Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC04
- Name: Neoplasms
- Abbrev: BXS
- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions
- Abbrev: All
- Name: All Conditions
### Condition Browse Module - Browse Leaves
- ID: M5030
- Name: Urinary Bladder Neoplasms
- Relevance: HIGH
- As Found: Bladder Cancer
- 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: M5026
- Name: Urinary Bladder 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
### Condition Browse Module - Meshes
- ID: D000001749
- Term: Urinary Bladder Neoplasms
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434337
**Brief Title:** Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)
**Official Title:** Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)
#### Organization Study ID Info
**ID:** 2024-0020
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**Domain:** NCI-CTRP Clinical Registry
**ID:** NCI-2024-04598
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-03-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-03
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-03-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-11-29
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** M.D. Anderson Cancer Center
#### 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:** To learn if new HPV tests can provide the same results as standard HPV tests. The findings from this study may aid in the development of new HPV tests that require less equipment and are more accessible.
**Detailed Description:** Primary Objectives
1. To evaluate the performance of 3 versions of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test").
Secondary Objectives
1. To evaluate the results of the Rice HPV test with corresponding pathology results to assess the association of HPV test results with the presence of high-grade cervical dysplasia (CIN 2+).
2. To assess how different sample processing methods affect the performance of the Rice HPV test.
3. To assess how different test readout methods affect the performance of the Rice HPV test.
Exploratory Objectives
1. Compare the performance of the Rice HPV test between provider-collected and self-collected samples.
2. Conduct a survey on participant experiences with self-sampling to assess whether participants prefer self-sampling over provider-collected sampling.
3. Compare the performance of the Rice HPV test to other benchmark HPV tests such as GeneXpert.
### Conditions Module
**Conditions:**
- Human Papillomavirus
### Design Module
#### Design Info
**Observational Model:** CASE_ONLY
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 600
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Standard-of-care (SOC) procedures will be performed as part of the routine visit, and the provider will collect up to two additional cervical swabs for research. One research cervicovaginal swab may also be self-collected by the patient (optional procedure) in the clinic during the routine visit. All research swab samples, in addition to residual material from standard of care HPV testing, will be transferred to Rice University for testing as described below.
**Intervention Names:**
- Diagnostic Test: Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")
**Label:** Research Group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Research Group
**Description:** Given by Diagnostic Test
**Name:** Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** To evaluate the performance of the 3 version of a novel point-of-care diagnostic test for detecting HPV ("Rice HPV test").
**Measure:** Novel point-of-care diagnostic test for detecting HPV ("Rice HPV test")
**Time Frame:** Through study completion; an average of 1 year
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. People with a cervix 21 years of age or older.
2. Scheduled to undergo hrHPV testing at MD Anderson and The Harris Health System (LBJ Hospital) according to national and institutional guidelines at time of enrollment.
3. Willing and able to provide informed consent.
4. Able to perform protocol-required activities. Able to speak and read English or Spanish.
Exclusion Criteria
1. Participant or provider decision not to perform HPV testing.
2. Participant or provider decision not to collect a sample for this study.
3. Participants that are pregnant.
**Minimum Age:** 21 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** FEMALE
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** MD Anderson Cancer Center
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Kathleen Schmeler, MD
**Phone:** (713) 745-3518
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Houston
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Kathleen Schmeler, MD
- **Phone:** 713-745-3518
- **Role:** CONTACT
***Contact 2:***
- **Name:** Kathleen Schmeler, 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:** Kathleen Schmeler, MD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### See Also Links
**Label:** MD Anderson Cancer Center
**URL:** http://www.mdanderson.org
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434324
**Brief Title:** Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in Empyema/Complicated Parapneumonic Effusion
**Official Title:** A Study to Evaluate the Efficacy of Pleural Space Saline Irrigation in Addition to Standard Intrapleural Thrombolytic Therapy in the Management of Empyema/Complicated Parapneumonic Effusion
#### Organization Study ID Info
**ID:** 23-013234
#### Organization
**Class:** OTHER
**Full Name:** Mayo Clinic
#### Secondary ID Infos
**Domain:** US Dept of Defense
**ID:** HT9425-24-C-0010
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2026-05-04
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-01-04
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Mayo Clinic
#### Responsible Party
**Investigator Affiliation:** Mayo Clinic
**Investigator Full Name:** Dagny K. Anderson
**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 purpose of this study is to see if there is any benefit in adding saline irrigation through a chest tube to the standard course of treatment for people diagnosed or suspected of having a pleural space infection.
**Detailed Description:** Pleural space infections portend considerable morbidity and require procedural and sometimes surgical intervention in the context of prolonged hospital stays (median length of stay has been reported as 14-19 days) for definitive management. Key aspects of management include pleural space evacuation and appropriate antimicrobial therapy. The antimicrobial regimen is initiated intravenously and is often transitioned to an oral regimen as guided by clinical improvement, radiographic improvement, and microbiologic studies though conventional bacterial cultures remain negative in as many as 40% of cases of pleural space infection. There is variability in antimicrobial duration though this is typically continued for at least 3 weeks. The MIST 2 trial investigated the role of intrapleural tissue plasminogen activator (t-PA) and dornase (DNase) in the management of pleural space infections, noting that disrupting septations and reducing pleural fluid viscosity were necessary steps to achieve successful drainage in in-vitro studies. MIST 2 demonstrated that a combination of intrapleural t-PA and DNase improved pleural space evacuation on serial chest x-ray and reduced the frequency of surgical referral and hospital length of stay.
Saline irrigation of the pleural space has been proposed to reduce stasis and dilute bacteria, cytokines, and coagulation factors, which induce pleural space organization. The Pleural Irrigation Trial was a pilot study evaluating the role of 250 cc 0.9% sodium chloride irrigation three times daily for 3 days in comparison to standard care, which included maintaining thoracostomy tubes on suction and flushing with 30 cc three times daily. Saline irrigation led to a 32.3% reduction in pleural fluid volume as assessed by computed tomography in comparison to 15.3% in the standard care arm. Fewer patients in the irrigation group were referred for surgery (OR 7.1).
To our knowledge, the efficacy of intrapleural saline irrigation in addition to fibrinolytic therapy has not been studied in comparison to fibrinolytic therapy alone. The Mayo Clinic Interventional Pulmonary practice in Rochester, MN intends to study this in the context of the inpatient pleural service, the team that is routinely consulted for patients with proven or suspected pleural space infections. This team routinely places and manages ultrasound-guided locking-loop thoracostomy tubes and additionally manages patients with thoracostomy tubes placed by intensivists, surgeons, and interventional radiologists when consulted. Our team intends to recruit hospitalized patients that meet the inclusion/exclusion criteria of the study. Those that provide informed consent to participate in the study will be randomized to usual care versus intrapleural saline irrigation + usual care.
### Conditions Module
**Conditions:**
- Pleural Infection
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects will receive twice daily fibrinolytic therapy in addition to daily saline irrigation through their chest tube until the treating physician determines that the pleural space has been adequately evacuated
**Intervention Names:**
- Procedure: Saline Irrigation
**Label:** Saline Irrigation Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Subjects will receive twice daily fibrinolytic therapy through their chest tube until the treating physician determines that the pleural space has been adequately evacuated
**Label:** Standard of Care Group
**Type:** NO_INTERVENTION
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Saline Irrigation Group
**Description:** 250 cc waves of warmed saline irrigation (up to 2000 cc) through thoracostomy tube on a daily basis
**Name:** Saline Irrigation
**Type:** PROCEDURE
### Outcomes Module
#### Primary Outcomes
**Description:** Number of intrapleural fibrinolytic doses to achieve adequate pleural space evacuation (defined as \<=2.5 cm separation between parietal and visceral pleural layers on bedside ultrasound or no more than small residual effusion on clinically-directed CT chest imaging).
**Measure:** Adequate pleural space evacuation
**Time Frame:** Approximately 3 days
#### Secondary Outcomes
**Description:** Number of additional interventions to achieve satisfactory pleural space evacuation, such as additional paired lytics beyond 6 doses, ipsilateral thoracentesis, additional ipsilateral thoracostomy tube placement, surgical intervention, or discharge with an empyema tube in situ.
**Measure:** Need for additional interventions
**Time Frame:** Approximately 10 days
**Description:** Number of thoracostomy tube days from the time that treatment is initiated
**Measure:** Thoracostomy tube days
**Time Frame:** Approximately 10 days
**Description:** Number of hospital days from the time that treatment is initiated
**Measure:** Number of hospital days
**Time Frame:** Approximately 14 days
**Description:** Measured using a visual analog scale (VAS) questionnaire that assesses pain experienced during treatment utilizing a scale of 0 to 10, with 10 meaning the worst pain imaginable.
**Measure:** Pain tolerance of pleural space irrigation
**Time Frame:** Approximately 3 days
**Description:** Total number of adverse events including new/worsened respiratory failure, septic shock, hemothorax
**Measure:** Number of adverse events
**Time Frame:** Approximately 10 days
### Eligibility Module
**Eligibility Criteria:** Inclusion criteria:
* Purulent pleural fluid versus pleural fluid analysis demonstrating pH \<7.2, glucose \<60 mg/dL, positive Gram stain, or positive pleural fluid culture versus multiseptated pleural effusion with infection at top of differential diagnosis
* Patients initiating intrapleural lytic therapy under the care of the Interventional Pulmonary consult service at Mayo Clinic in Rochester, MN
Exclusion Criteria:
* Unwillingness to give informed consent
* Patients with known bleeding diathesis
* Platelet count \<50,000 per μL
* INR \>2.2 (of note, INR can be allowed to drift down or be reversed pharmacologically prior to initiation of intrapleural lytics/saline)
* Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable)
* Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment
* Incarcerated patients
* Presence of ipsilateral bronchopleural fistula
* Current or recent (within past 30 days) presence of tunneled pleural catheter on the same side as the current proven/suspected pleural space infection
**Healthy Volunteers:** True
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Rochester
**Country:** United States
**Facility:** Mayo Clinic in Rochester
**State:** Minnesota
**Zip:** 55905
#### Overall Officials
**Official 1:**
**Affiliation:** Mayo Clinic
**Name:** Dagny Anderson, MD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Bedawi EO, Ricciardi S, Hassan M, Gooseman MR, Asciak R, Castro-Anon O, Armbruster K, Bonifazi M, Poole S, Harris EK, Elia S, Krenke R, Mariani A, Maskell NA, Polverino E, Porcel JM, Yarmus L, Belcher EP, Opitz I, Rahman NM. ERS/ESTS statement on the management of pleural infection in adults. Eur Respir J. 2023 Feb 2;61(2):2201062. doi: 10.1183/13993003.01062-2022. Print 2023 Feb.
**PMID:** 36229045
**Citation:** Birkenkamp K, O'Horo JC, Kashyap R, Kloesel B, Lahr BD, Daniels CE, Nichols FC 3rd, Baddour LM. Empyema management: A cohort study evaluating antimicrobial therapy. J Infect. 2016 May;72(5):537-43. doi: 10.1016/j.jinf.2016.02.009. Epub 2016 Mar 15.
**PMID:** 26987740
**Citation:** Rahman NM, Maskell NA, West A, Teoh R, Arnold A, Mackinlay C, Peckham D, Davies CW, Ali N, Kinnear W, Bentley A, Kahan BC, Wrightson JM, Davies HE, Hooper CE, Lee YC, Hedley EL, Crosthwaite N, Choo L, Helm EJ, Gleeson FV, Nunn AJ, Davies RJ. Intrapleural use of tissue plasminogen activator and DNase in pleural infection. N Engl J Med. 2011 Aug 11;365(6):518-26. doi: 10.1056/NEJMoa1012740.
**PMID:** 21830966
**Citation:** Mismetti V, Froudarakis ME. Medical management of pleural infection: Why not saline intrapleural lavage? Clin Respir J. 2022 Nov;16(11):693-695. doi: 10.1111/crj.13548. Epub 2022 Sep 29. No abstract available.
**PMID:** 36173249
**Citation:** Hooper CE, Edey AJ, Wallis A, Clive AO, Morley A, White P, Medford AR, Harvey JE, Darby M, Zahan-Evans N, Maskell NA. Pleural irrigation trial (PIT): a randomised controlled trial of pleural irrigation with normal saline versus standard care in patients with pleural infection. Eur Respir J. 2015 Aug;46(2):456-63. doi: 10.1183/09031936.00147214. Epub 2015 May 28.
**PMID:** 26022948
#### See Also Links
**Label:** Mayo Clinic Clinical Trials
**URL:** https://www.mayo.edu/research/clinical-trials
## Document Section
### Large Document Module
#### Large Docs
- Date: 2024-04-24
- Filename: ICF_000.pdf
- Has ICF: True
- Has Protocol: False
- Has SAP: False
- Label: Informed Consent Form
- Size: 366679
- Type Abbrev: ICF
- Upload Date: 2024-05-22T18:41
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000013492
- Term: Suppuration
- ID: D000007239
- Term: Infections
- ID: D000007249
- Term: Inflammation
- ID: D000010335
- Term: Pathologic Processes
### Condition Browse Module - Browse Branches
- Abbrev: BC01
- Name: Infections
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
### Condition Browse Module - Browse Leaves
- ID: M10283
- Name: Infections
- Relevance: LOW
- As Found: Unknown
- ID: M6368
- Name: Communicable Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M7819
- Name: Empyema
- Relevance: HIGH
- As Found: Empyema
- ID: M16273
- Name: Suppuration
- Relevance: LOW
- As Found: Unknown
- ID: M10293
- Name: Inflammation
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000004653
- Term: Empyema
### Intervention Browse Module - Browse Branches
- Abbrev: FiAg
- Name: Fibrinolytic Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M8473
- Name: Fibrinolytic Agents
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434311
**Brief Title:** Test-Retest Reliability and Concurrent Validity of the 3 Meter Backward Walk Test in Patients With Knee Osteoarthritis
**Official Title:** Test-Retest Reliability and Concurrent Validity of the 3 Meter Backward Walk Test in Patients With Knee Osteoarthritis
#### Organization Study ID Info
**ID:** MarmaraU- AYDOĞDU-SÜZÜK001
#### Organization
**Class:** OTHER
**Full Name:** Marmara University
### Status Module
#### Completion Date
**Date:** 2024-06-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2024-05-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-03-15
**Type:** ACTUAL
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Marmara 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:** Osteoarthritis of the knee is a common joint disease that causes loss of balance and proprioception. Changes in the knee joint such as mechanoreceptor loss, muscle strength imbalance, muscle weakness, capsular hypertrophy, subchondral edema, and increased loss of balance and proprioception lead to an increased risk of falls. In the literature, knee osteoarthritis is repeatedly mentioned as an independent risk factor for falls, and knee osteoarthritis is associated with recurrent falls.
There are many performance-based clinical measurement tests that assess fall risk in knee osteoarthritis. Some of these tests include the timed up and walk test, the five-step sit-to-stand test, and the one-leg stand test. These tests cannot evaluate backward walking. Backward walking requires more neuromuscular control and proprioception than forward walking. The 3-meter backward walk test is a performance-based test that assesses backward walking, balance, proprioception, and neuromuscular control. The participant is asked to walk 3 meters backwards on a flat surface at the highest speed at which they feel comfortable without running. It is administered by recording the time elapsed.
The validity and reliability of the 3-meter walk back test have been previously investigated in many patient populations and healthy individuals. However, to our knowledge, there is no research on the reliability and validity of a 3-meter walk back test in knee osteoarthritis. Clinical measurement tests should be valid and reliable in the patient population to which they are applied.
The aim of this study was to examine the test-retest reliability and concurrent validity of the 3-meter backward walk test in participants with knee osteoarthritis. In addition, we aim to compare the 3-meter backward walk test scores of individuals with and without knee osteoarthritis and to examine the change in 3-meter backward walk test scores with the change in disease severity.
The data collection tools to be used in the study are the 3-meter walk back test, the timed get up and walk test, the Knee Injuries and Osteoarthritis Outcome Score, the Frail Scale, the Modified Falls Efficacy Scale, and fall history. All of these measures will be taken at the initial assessment, and the 3-meter walk back test will be repeated after 3-7 days.
We hope that our study will help physiotherapists working in this field in the clinical decision-making process by providing a valid and reliable performance test for the assessment of fall risk.
### Conditions Module
**Conditions:**
- Knee Osteoarthritis
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients who who have knee osteoarthritis categorized as 1 or 2 according to Kellgren - Lawrence
**Intervention Names:**
- Diagnostic Test: 3 meter Backward Test
**Label:** Early knee Osteoarthritis
#### Arm Group 2
**Description:** Patients who who have knee osteoarthritis categorized as 3 or 4 according to Kellgren - Lawrence
**Intervention Names:**
- Diagnostic Test: 3 meter Backward Test
**Label:** Severe Knee Osteoarthritis
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Early knee Osteoarthritis
- Severe Knee Osteoarthritis
**Description:** evaluation
**Name:** 3 meter Backward Test
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** It is a performance-based test developed by Carter et al. A 3 meter long strip is drawn on the ground. It assesses fall risk, balance, neuromuscular control. Participants are expected to walk backwards for 3 meters as fast as possible. The time until the participant completes the walk is recorded. A lower score indicates higher performance (Carter et al., 2019).
**Measure:** 3 meter Backward Test
**Time Frame:** At the baseline
**Description:** It is a performance-based test developed by Carter et al. A 3 meter long strip is drawn on the ground. It assesses fall risk, balance, neuromuscular control. Participants are expected to walk backwards for 3 meters as fast as possible. The time until the participant completes the walk is recorded. A lower score indicates higher performance (Carter et al., 2019).
**Measure:** 3 meter Backward Test
**Time Frame:** One week later
#### Secondary Outcomes
**Description:** The timed up and go test was developed in 1991 as a modified version of the get up and go test (Barry et al., 2014). The participant is asked to sit on a chair approximately 46 cm tall. Then, the participant gets up from the chair, walks 3 meters, walks the same distance back, and sits on the chair. The elapsed time is recorded (Barry et al., 2014; Ortega-Bastidas et al., 2023). A shorter time means a better score. The participant's failure to complete the test in less than 12 seconds indicates a high risk of falling (Nightingale et al., 2019).
**Measure:** Timed Up Go Test
**Time Frame:** At the baseline
**Description:** It is a scale used to evaluate frailty in the elderly. The scale, consisting of 5 items, questions resistance, fatigue, ambulation, illness, and weight loss. Each question takes one of the values 0 or 1, with a total value of 0, indicating that the person is not frail. Values ranging from 1 to 2 are called pre-frail, and values above 2 are called fragile. In the disease questioning, the participant is asked how many of the 11 diseases he has. Having more than 5 diseases indicates a score of 1. The lowest score that can be obtained is zero, while the highest score is 5 (HYMABACCUS et al., 2023; Morley et al., 2012). Turkish validity and reliability study by Hymabaccus et al. Made by. Its reliability and validity have been reported as excellent, and the intraclass consistency coefficient varies between 0.68 and 0.82. (HYMABACCUS et al., 2023).
**Measure:** Frail Scale
**Time Frame:** At the baseline
**Description:** It has been translated into more than fifty languages. The commonly used knee injury and osteoarthritis outcome score consists of 5 subcategories. It is a 5-point Likert type scale consisting of 42 questions. A score ranging from 0 to 4 is given for each question. The total score for each subcategory is one hundred. While 0 indicates serious knee problems, 100 indicates no knee problems (Roos, 2023). Turkish validity and reliability were determined by Paker et al. It was conducted in 2007 and reported moderate validity and reliability (Paker et al., 2007). Internal consistency was calculated with Cronbach's alpha and was reported as 0.66 - 0.95 (Paker et al., 2007).
**Measure:** Knee injury and Osteoarthritis Outcome Score (KOOS)
**Time Frame:** At the Baseline
**Description:** It evaluates the individual's self-confidence regarding the fall. It is an expanded version of the falls effectiveness scale. It consists of 14 items. It evaluates a person's self-confidence during various daily activities. Each item is given a value ranging from 0-10. While 0 represents unsafe, the number 10 is considered completely safe. The highest score that can be obtained is 140 and the lowest score is 0 (Soh et al., 2021). Turkish validity and reliability study by Korkmaz et al. Made by. The intra-class consistency coefficient was reported as 0.978 (Korkmaz et al., 2019).
**Measure:** Modified Falls Efficacy Scale
**Time Frame:** At the Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* To have been diagnosed with osteoarthritis by a specialist physician according to the clinical and radiological criteria of the American College of Rheumatology. Be between 40 and 75 years of age. Being in grade 1-4 according to Kellgren-Lawrence staging. To participate in the study voluntarily
Exclusion Criteria:
* Having undergone surgery involving the lower extremity Having prosthesis or orthosis in the lower extremity Other neurological and cardiopulmonary diseases that may affect walking and balance Having undergone surgery or invasive treatment in the last 6 months Body mass index above 45 Having severe heart disease that prevents exercise Having pain originating from L3 - S1
**Maximum Age:** 75 Years
**Minimum Age:** 40 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** People who have diagnosed as knee osteoarthritis
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Merve SÜZÜK Research Assistant
**Phone:** 05317351127
**Role:** CONTACT
**Contact 2:**
**Email:** onur.aydogdu@[email protected]
**Name:** Onur AYDOĞDU Assistant Professor
**Phone:** 05055377277
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Istanbul
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Merve SÜZÜK
- **Phone:** 05317351127
- **Role:** CONTACT
***Contact 2:***
- **Email:** [email protected]
- **Name:** Onur AYDOĞDU
- **Phone:** 05055377277
- **Role:** CONTACT
**Country:** Turkey
**Facility:** Marmara University
**State:** Maltepe
**Status:** RECRUITING
**Zip:** 34854
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001168
- Term: Arthritis
- ID: D000007592
- Term: Joint Diseases
- ID: D000009140
- Term: Musculoskeletal Diseases
- ID: D000012216
- Term: Rheumatic Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC17
- Name: Skin and Connective Tissue Diseases
### Condition Browse Module - Browse Leaves
- ID: M22168
- Name: Osteoarthritis, Knee
- Relevance: HIGH
- As Found: Knee Osteoarthritis
- ID: M12926
- Name: Osteoarthritis
- Relevance: HIGH
- As Found: Osteoarthritis
- ID: M4476
- Name: Arthritis
- Relevance: LOW
- As Found: Unknown
- ID: M10621
- Name: Joint Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12097
- Name: Musculoskeletal Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M15045
- Name: Rheumatic Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6323
- Name: Collagen Diseases
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000010003
- Term: Osteoarthritis
- ID: D000020370
- Term: Osteoarthritis, Knee
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434298
**Brief Title:** Provincial Scale-up of Choose to Move (CTM) Phase 4
**Official Title:** Continued Evaluation of Provincial Scale-up of Choose to Move (CTM) Phase 4
#### Organization Study ID Info
**ID:** H23-02336
#### Organization
**Class:** OTHER
**Full Name:** University of British Columbia
### Status Module
#### Completion Date
**Date:** 2027-08-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-06-06
**Type:** ESTIMATED
**Last Update Submit Date:** 2024-06-04
**Overall Status:** ENROLLING_BY_INVITATION
#### Primary Completion Date
**Date:** 2026-08-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2023-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-06
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** British Columbia Ministry of Health
#### 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 expand delivery of the optimized Phase 4 program with large and small partner organizations and will describe and assess scale-up, implementation, and impact of CTM Phase 4.
**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 include even more older adults living in communities 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 either in person or online.
In this study, the central support unit (CSU) will work with community-based seniors' services (CBSS) organizations in large and small communities across BC to deliver CTM to more older adults. The investigators will then evaluate implementation of CTM programs, and the impact of the CTM program on older adults' physical and social health.
Objectives:
To assess whether CTM (Phase 4) was implemented as planned (fidelity) and investigate factors that support or inhibit its implementation at scale across BC (Part I - Implementation Evaluation).
To assess the impact (effectiveness) of CTM (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 scale-up of CTM Phase 4. 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
- Physical Inactivity
- Mobility Limitation
- Loneliness
- Social Isolation
**Keywords:**
- Older adults
- Physical activity
- Mobility
- Social isolation
- Loneliness
- Social connectedness
- Behavior change
- Implementation
- Scale-up
- Health equity
### Design Module
#### Design Info
**Allocation:** NA
**Intervention Model:** SINGLE_GROUP
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 5720
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** CTM (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:** 3 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:** 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 delivery costs will be recorded using a cost capture template developed in house.
**Measure:** Cost
**Time Frame:** 0, 3 months
**Description:** Adaptations or modifications to the Choose to Move program include any additions, deletions, substitutions, repetitions, etc will be assessed by survey (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 activities that increase bone and/or muscle strength.
**Measure:** Change in bone/muscle-strengthening physical activity
**Time Frame:** 0, 3 months
**Description:** A single item will be used to assess frequency (days/week) of activities 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;
* Non-English speaking older adults will also be invited to participate in the evaluation as long as an intermediary who has the necessary language skills to ensure effective communication/translation of the consent and surveys is present.
Exclusion Criteria:
* None
**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:** Centre for Hip Health and Mobility, Robert H.N. Ho Research Centre, University of British Columbia
**State:** British Columbia
**Zip:** V5Z 1M9
#### Overall Officials
**Official 1:**
**Affiliation:** University of British Columbia
**Name:** Heather A McKay, PhD
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of British Columbia
**Name:** Joanie Sims Gould, 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:** Subedi R, Aitken N, Greenberg L. Canadian Social Environment Typology User Guide. Ottawa, ON: Statistics Canada; 2022. Available at: https://www150.statcan.gc.ca/n1/pub/17-20-0002/172000022022002-eng.htm
#### 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:** NCT06434285
**Acronym:** 4PiQ
**Brief Title:** A 4Pi Questionnaire for Service User and Carer Involvement Experience
**Official Title:** Development of a 4Pi Framework-based Questionnaire to Evaluate Service User and Carer Involvement Experience in SLaM
#### Organization Study ID Info
**ID:** 321452
#### Organization
**Class:** OTHER
**Full Name:** King's College London
### Status Module
#### Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-29
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-09-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-24
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** South London and Maudsley NHS Foundation Trust
#### Lead Sponsor
**Class:** OTHER
**Name:** King's 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:** Service user (SU) and carer involvement in planning healthcare services and improving their quality is crucial and required by the NHS. Research has shown that SUs and carers can greatly benefit healthcare; however, effective involvement can be challenging due to barriers such as language, lack of training or support, and undervaluing the input of patients and the public compared to that of professionals.
The 4Pi framework sets out standards for good involvement practices by focusing on principles such as respect and inclusivity, shared purposes, diversity, accurate planning, and ensuring involvement leads to improvements in people's lives.
This study, funded by King's Health Partners, aims to take the 4Pi framework a step further by developing a questionnaire to evaluate how well patients and carers are involved in improving mental health services. The researchers will work closely with SUs and carers to create this questionnaire, with the ultimate goal to ensure that involvement in healthcare leads to real, positive changes for everyone involved.
The research questions for the study is: to what extent, from SUs and carers' perspectives, is the questionnaire understandable and successful in capturing the meaning of 4Pi domains?
To be eligible for the study, participants need to be at least 18 years old and have experience of involvement activities/projects in SLaM. Researchers, SUs, and carers will define the questionnaire to ensure it is understandable, comprehensive, and feasible; this will be done via virtual (or in person at Denmark Hill/King's College London campus depending on participants' preferences) group interviews. The questionnaire will then be piloted on a small sample of individuals, and the final questionnaire refined based on any potential additional feedback from them.
This study is part of the King's Improvement Science programme's research portfolio that is funded by King's Health Partners.
### Conditions Module
**Conditions:**
- Mental Health
### Design Module
#### Design Info
**Observational Model:** OTHER
**Time Perspective:** CROSS_SECTIONAL
#### Enrollment Info
**Count:** 8
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
### Interventions
#### Intervention 1
**Description:** Cognitive interviewing group will be run to inform questionnaire development.
**Name:** Questionnaire development
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Measure:** Questionnaire
**Time Frame:** Day 1
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
1. be at least 18 years old;
2. have experience of being involved in service involvement activities in SLaM NHS Foundation Trust.
Exclusion Criteria:
a) No experience of being involved in service improvement activities.
**Minimum Age:** 18 Years
**Sampling Method:** PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
**Study Population:** Service users and carers with experience in service involvement activities.
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434272
**Acronym:** BEAN
**Brief Title:** Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture
**Official Title:** The Effectiveness of Low-load Blood Flow Restriction Exercise in Patients With an Acute Achilles Tendon Rupture Treated Non-surgically
#### Organization Study ID Info
**ID:** BEAN (1-10-72-192-23)
#### Organization
**Class:** OTHER
**Full Name:** University of Aarhus
### Status Module
#### Completion Date
**Date:** 2026-01-09
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-01-09
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-08-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-03
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Aarhus University Hospital
**Class:** OTHER
**Name:** Gødstrup Hospital
**Class:** UNKNOWN
**Name:** Regional Hospital Horsens
**Class:** OTHER
**Name:** Aalborg University Hospital
#### Lead Sponsor
**Class:** OTHER
**Name:** University of Aarhus
#### 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 gain insights into the effects of Blood Flow Restriction Exercise (BFRE) in patients with an acute Achilles tendon Rupture. The main questions it aims to answer are:
Is BFRE an effective adjunct to usual care when compared with only usual care? When is the optimal timing for initiating BFRE: In the early treatment stage or at the later stage after hospital treatment? Participants will receive an intervention comprising 12 weeks of BFRE as an adjunct to usual care.
* Either in the initial 1-12 weeks after Achilles tendon rupture, or
* In the following 13-24 weeks after Achilles tendon rupture
Researchers will compare the two groups at 13 weeks to compare BFRE to usual care, and at 25 weeks to compare the two time points for initiating BFRE (early vs. late).
**Detailed Description:** This is an assessor-blinded, randomized, controlled multicenter trial with patients allocated 1:1 to one of two parallel groups, with follow-up times at weeks 13 and 25 after allocation.
Patients with an acute Achilles tendon rupture treated non-surgically are eligible for inclusion. All patients will receive a 12-week BFRE program, either in weeks 1-12 or 13-24 post allocation, as an add-on to usual care.
The BFRE program is performed three times weekly on the injured leg at 80% of the limb occlusion pressure required to restrict the arterial blood flow fully.
Outcome measures are assessed at baseline, week 13, and week 25 after allocation. The primary outcome at the week 13 follow-up is the Single-Leg Heel-Raise test which assesses the patient's ability to raise the heel of the injured leg a minimum of 2 cm. The primary outcome at the week 25 follow-up is the Achilles Total Tendon Rupture Score which assesses the patient's self-reported symptoms and physical activity.
During most of the initial trial phase (weeks 1-12), patients are treated at local hospitals, where recruitment, assessment, and randomization occur. Usual care at the hospitals consists of ankle immobilization with a gradual return to weight-bearing in the following weeks. In the latter half of the trial phase (weeks 13-24), patients have transitioned to municipal care, where usual care includes diverse exercises performed at home or training facilities.
### Conditions Module
**Conditions:**
- Achilles Tendon Rupture
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 218
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Receives an intervention in adjunct to usual care in weeks 1-12, and continues with usual care in weeks 13-24.
**Intervention Names:**
- Other: Exercise with partial Blood Flow Restriction
**Label:** Early initiated Blood Flow Restriction Exercise
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Receives usual care in weeks 1-12, and receives an intervention in weeks 13-24.
**Intervention Names:**
- Other: Exercise with partial Blood Flow Restriction
**Label:** Late initiated Blood Flow Restriction Exercise
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Early initiated Blood Flow Restriction Exercise
- Late initiated Blood Flow Restriction Exercise
**Description:** The intervention comprises of 12 weeks of Blood Flow Restriction Exercise (BFRE). Three weekly exercise sessions are performed. Six supervised sessions are provided during the 12 weeks.
Blood flow restriction of 80% of the limb occlusion pressure required to fully restrict the arterial blood flow is epmployed in both interventions arms (Early BFRE and Late BFRE)
The Early BFRE intervention comprises two exercises: Seated leg extension and seated heel-rise, performed at home.
The Late BFRE intervention comprises three exercises: Leg press in machine, heel-rise in machine, knee flexion in machine, performed at training facilities.
Each exercise, regardless of study arm, is performed in four sets of 30, 15, 15, +1 repetitions, with the fourth set (+1) being as many repetitions as possible.
Pause in between sets is 30 seconds. Pause in between exercises are 120 seconds.
**Name:** Exercise with partial Blood Flow Restriction
**Other Names:**
- BFR
- BFRE
- Blood Flow Restriction Exercise
- BFR-T
- Blood Floow Restriciton Training
- LL-BFR
- Low Load Blood Flow Restriction
**Type:** OTHER
### Outcomes Module
#### Other Outcomes
**Description:** ultrasound using the Copenhagen Achilles length measure (CALM) will be used in a subset of the study population to validate the tendon length results.
**Measure:** Copenhagen Achilles Length Measure (CALM)
**Time Frame:** CALM is measured at 13 week test and 25 week test.
**Description:** The Achilles tendon cross-sectional area is measured using ultrasound \[28\] in a subset of the study population.
**Measure:** Tendon cross-sectional area.
**Time Frame:** Tendon cross-sectional area is measured at 13 week test and 25 week test.
#### Primary Outcomes
**Description:** Patient's ability to perform a Single-Leg Heel-rise, defined as the ability to raise the heel of the injured leg at least 2 cm while keeping the knee straight. The test is performed with patients standing on a flat surface with the ankle in a neutral position. Patients will be allowed to keep their balance by lightly touching a wall.
**Measure:** Single-leg heel-rise test
**Time Frame:** 13 week test
**Description:** The ATRS is a validated patient-reported, injury-specific questionnaire regarding physical activity and symptoms. The ATRS consists of 10 items scored from 0 (major limitations) to 10 (no limitations), resulting in a score between 0 (worst) to 100 (best).
**Measure:** Achilles tendon Total Rupture Score (ATRS)
**Time Frame:** 25 week test
#### Secondary Outcomes
**Description:** The unilateral 30 second Sit to Stand test (unilateral 30STS) is a clinical test of lower extremity function. The unilateral 30STS tests how many correct repetitions of a sit to stand from a chair, a patient can complete in 30 seconds
**Measure:** 30 seconds unilateral Sit to Stand test
**Time Frame:** The test will be performed on both legs at 13 week test and 25 test.
**Description:** The calf circumference is measured on both legs using a tape measure 15 cm below the medial pal-pable joint line of the knee. Repeated measurements will be made until a consistent measurement is found.
**Measure:** Calf circumference
**Time Frame:** The measurement will be performed on both legs at baseline, 13 week test, and 25 test.
**Description:** Thigh circumference is measured on both legs using a tape measure 10 cm proximal to the apex pa-tella. During measurement patients lay supine on an examination table with knees bent in a 90-degree angle.
**Measure:** Thigh circumference
**Time Frame:** The measurement will be performed on both legs at baseline, 13 week test, and 25 test.
**Description:** The Achilles tendon length is indirectly measured by the Achilles tendon resting angle (ATRA), measuring the difference in passive dorsiflexion when lying prone with knees in a 90-degree angle.
**Measure:** Achilles tendon elongation (ATRA)
**Time Frame:** The test will be performed on both legs at 13 week test and 25 test.
**Description:** The TSK-13 is a 13-item self-reported measure for fear of movement or reinjury \[29\]. It was origi-nally validated for patients with backpain but has previously been used in patients with Achilles tendon rupture.
**Measure:** Tampa Scale of Kinesiophobia 13-items (TSK-13)
**Time Frame:** TSK-13 is measured at baseline, 13 week test, and 25 test.
**Description:** The EQ-5D-5L is a generic self-reported measure for health-related quality of life consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five severity levels each.
**Measure:** EQ-5D-5L
**Time Frame:** EQ-5D-5L is measured at baseline, 13 week test, and 25 week test.
**Description:** The IPAQ-SF consists of 7 items on physical activity as time spent performing vigorous and moder-ate activities, the time spent walking, and time spent sitting during the past week. The IPAQ pro-vides an estimate of the total weekly physical activity measured in MET-minutes per week and total minutes spent sitting.
**Measure:** International Physical Activity Questionnaire-short form (IPAQ-SF)
**Time Frame:** IPAQ-SF is measured at baseline (re-call prior to rupture), 13 week test, and 25 week test.
**Description:** Patients' adherence with the exercise sessions (completed sessions) and progression during the inter-vention period will be recorded in self-reported exercise diaries by the patients. . Exercise diaries will also be provided to patients in the control group, to monitor usual care exercise.
**Measure:** Exercise adherence and progression
**Time Frame:** Measured continously, and evaluated at 13 week test and 25 week test.
**Description:** The number of adverse events and serious adverse events will be recorded and reported to a Data Safety Monitoring Board. Adverse events are defined as unexpected medical events related to the initial treatment. Serious adverse event are complications requiring further inpatient care, such as re-rupture of the Achilles tendon, non-union of the Achilles tendon, or deep venous thromboembolism and pulmonary embolism. Muscle soreness or mild pain following exercise is expected and not con-sidered an adverse event.
**Measure:** Adverse events
**Time Frame:** Measured continously, and evaluated at 13 week test and 25 week test.
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* aged 18 years or older
* have started initial treatment within 72 hours of Achilles tendon rupture
* understand written and spoken Danish
Exclusion Criteria:
* bilateral Achilles tendon rupture
* previous Achilles tendon rupture in either leg
* decreased lower extremity function, caused by conditions other than Achilles tendon rupture
* treated with fluoroquinolones or corticosteroids within the last six months
* diabetes
* previous diagnosed thrombosis
* no identifiable pulse in the injured leg
* other reasons for exclusion (cognitive deficits, inability to provide informed consent, requiring cast-treatment due to low compliance regarding gradual wedge removal, etc.)
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Andreas Bentzen, MHSc
**Phone:** (+45) 5310 9112
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Inger Mechlenburg, DMSc
**Phone:** (+45) 2167 9062
**Role:** CONTACT
#### Overall Officials
**Official 1:**
**Affiliation:** University of Aarhus
**Name:** Andreas Bentzen, MHSc
**Role:** PRINCIPAL_INVESTIGATOR
**Official 2:**
**Affiliation:** University of Aarhus
**Name:** Inger Mechlenburg, DMSc
**Role:** STUDY_DIRECTOR
**Official 3:**
**Affiliation:** Aarhus University Hospital
**Name:** Per H. Gundtoft, MD, PhD
**Role:** STUDY_DIRECTOR
**Official 4:**
**Affiliation:** Regional Hospital Horsens
**Name:** Stian L. Jørgensen, PT, PhD
**Role:** STUDY_DIRECTOR
### IPD Sharing Statement Module
**Access Criteria:** Data access will be reviewed by the author group. Requesters will be required to sign a data access agreement.
**Description:** Anonymised patient-level data will be made available if required by the scientific journal, in which the results of the trial are published. Additionally, researchers presenting a justified cause for receiving the data can obtain it after a data access agreement has been signed.
**Info Types:**
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
**IPD Sharing:** YES
**Time Frame:** Data will be available after publication of the trial.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000014947
- Term: Wounds and Injuries
### Condition Browse Module - Browse Branches
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: All
- Name: All Conditions
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M15241
- Name: Rupture
- Relevance: HIGH
- As Found: Rupture
- ID: M17685
- Name: Wounds and Injuries
- Relevance: LOW
- As Found: Unknown
- ID: T170
- Name: Acute Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000012421
- Term: Rupture
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434259
**Brief Title:** Evaluation of Long-term Digital Childhood Obesity Treatment
**Official Title:** Long-term Results of an Interactive Mobile Health Support System and Daily Home-weighing as an add-on to Pediatric Obesity Lifestyle Treatment: A 3-year Pragmatic Clinical Trial
#### Organization Study ID Info
**ID:** Evira100
#### Organization
**Class:** OTHER
**Full Name:** Karolinska Institutet
### Status Module
#### Completion Date
**Date:** 2022-09-30
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-30
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-09-30
**Type:** ACTUAL
#### Start Date
**Date:** 2018-09-01
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Karolinska Institutet
#### Responsible Party
**Investigator Affiliation:** Karolinska Institutet
**Investigator Full Name:** Pernilla Danielsson
**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 evaluate if a web-based digital support system aiming to replacing or complement standardized pediatric behavioural obesity treatment. The hypothesis is that a digital system of communication between the family and the clinic can generate improved treatment results (change in BMI SDS) and reduce the number of missed visits.
**Detailed Description:** Childhood obesity treatment is time consuming for both the health care system, and for the involved families. There is an association between the intensity and the outcome of treatment.
In this study all children who start treatment for childhood obesity will use a digital support system as a complement to behavioral treatment. The digital support system includes daily weighing on scales that do not show any digits, linked to a mobile app where weight development is shown as a moving average in the form of BMI standard deviation score (SDS). The app also provides an individual target curve visualizing the expected weight journey. Weight in growing children is complex to interpret why BMI SDS is used. Objective data from scale are automatically transferred to the database and the clinic and the family have direct contact with the clinic via the app.
The present study is a continuation of the investigators previous one-year study, Clinicaltrials.gov ID: NCT04323215. In this follow-up study, the investigators aim to assess the treatment outcomes over a three-year period.
The evaluation will be carried out on 107 children who underwent digi-physical treatment for three years. The results will be compared with a matched control group (n=321) from the Swedish childhood obesity treatment register, BORIS.
### Conditions Module
**Conditions:**
- Childhood Obesity
- Treatment Adherence
**Keywords:**
- Mobile Health
- Support System
- Behavioral Treatment
- Self-Monitoring
### Design Module
#### Design Info
**Observational Model:** CASE_CONTROL
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 428
**Type:** ACTUAL
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Usual care (behavioral treatment) plus the support system for self- monitoring of weight and communication with the clinic during three years of treatment.
**Intervention Names:**
- Device: Digi-physical support system
**Label:** Digi-physical treatment group
#### Arm Group 2
**Description:** Children treated with usual care according to regular treatment routines registered in the Swedish childhood obesity treatment register, BORIS
**Label:** Control group
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Digi-physical treatment group
**Description:** A support system named Evira will be used to provide behavioral treatment.
**Name:** Digi-physical support system
**Type:** DEVICE
### Outcomes Module
#### Primary Outcomes
**Description:** Measured by BMI standard deviation score. Digi-physical group vs. control group
**Measure:** Change in degree of obesity
**Time Frame:** From start of treatment to three years follow-up
#### Secondary Outcomes
**Description:** Number of weighings/week
**Measure:** The use of the support system - weighings
**Time Frame:** From start of treatment to three years follow-up
**Description:** Number text messages/week
**Measure:** The use of the support system - text messages
**Time Frame:** From start of treatment to three years follow-up
**Description:** Visits to the clinic. Digi-physical group vs. control group
**Measure:** Number of physical visits
**Time Frame:** From start of treatment to three years follow-up
**Description:** Visits to the clinic. Digi-physical group vs. control group
**Measure:** Number of cancelation of physical visits
**Time Frame:** From start of treatment to three years follow-up
**Description:** Visits to the clinic. Digi-physical group vs. control group
**Measure:** Number of patients not showing up to physical visit
**Time Frame:** From start of treatment to three years follow-up
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Obesity according to International Obesity Task Force (IOTF)
Exclusion Criteria:
* None
**Maximum Age:** 18 Years
**Minimum Age:** 4 Years
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
- ADULT
**Study Population:** All children who start treatment for childhood obesity at Martina children Hospital will use a digital support system as a complement to behavioral treatment. 107 children in the digit-physical group and 321 children in the control group, aged 4-17.9 years, will be included.
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Stockholm
**Country:** Sweden
**Facility:** Childrens Hospital Martina
**Zip:** 114 28
#### Overall Officials
**Official 1:**
**Affiliation:** Karolinska Institutet, CLINTEC, Division of pediatrics
**Name:** Pernilla Danielsson Liljeqvist, PhD
**Role:** PRINCIPAL_INVESTIGATOR
### References Module
#### References
**Citation:** Hagman E, Johansson L, Kollin C, Marcus E, Drangel A, Marcus L, Marcus C, Danielsson P. Effect of an interactive mobile health support system and daily weight measurements for pediatric obesity treatment, a 1-year pragmatical clinical trial. Int J Obes (Lond). 2022 Aug;46(8):1527-1533. doi: 10.1038/s41366-022-01146-8. Epub 2022 May 31.
**PMID:** 35641569
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000050177
- Term: Overweight
- ID: D000044343
- Term: Overnutrition
- ID: D000009748
- Term: Nutrition Disorders
- ID: D000001835
- Term: Body Weight
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC18
- Name: Nutritional and Metabolic Diseases
### Condition Browse Module - Browse Leaves
- ID: M5114
- Name: Body Weight
- Relevance: LOW
- As Found: Unknown
- ID: M12701
- Name: Obesity
- Relevance: HIGH
- As Found: Obesity
- ID: M30155
- Name: Pediatric Obesity
- Relevance: HIGH
- As Found: Childhood Obesity
- ID: M26186
- Name: Overweight
- Relevance: LOW
- As Found: Unknown
- ID: M25307
- Name: Overnutrition
- Relevance: LOW
- As Found: Unknown
- ID: M12684
- Name: Nutrition Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000009765
- Term: Obesity
- ID: D000063766
- Term: Pediatric Obesity
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434246
**Brief Title:** Effect of Pully System on Hemiplegic Children
**Official Title:** Effect of Pully System Exercise on Upper Limb Function in Hemiplegic Cerebral Palsy Children: A Randomized Clinical Trials
#### Organization Study ID Info
**ID:** KFSIRB200-193
#### Organization
**Class:** OTHER
**Full Name:** Kafrelsheikh University
### Status Module
#### Completion Date
**Date:** 2025-11-20
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-08-20
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-11-20
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Kafrelsheikh University
#### Responsible Party
**Investigator Affiliation:** Kafrelsheikh University
**Investigator Full Name:** Ahmed Ali Mohammed Torad
**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:** Introduction Cerebral palsy (CP) is a group of sensory, motor, and postural disorders caused by non-progressive brain injury in early development. It can manifest in various forms, including hemiplegia, which affects about 21% to 40% of CP cases. Upper extremity (UE) impairments in CP individuals are significant, impacting daily activities and quality of life.
Objective This study aims to investigate the effects of pulley system exercises on improving upper limb function in children with hemiplegic CP.
Methods Design: Randomized controlled double-blinded trial. Participants: 32 children aged 3-7 years with hemiplegic CP, divided into intervention and control groups.
Intervention: The intervention group receives pulley system exercises plus standard care, while the control group receives standard physical therapy.
Duration: Conducted between June 2024 and August 2024. Inclusion Criteria: Diagnosed with hemiplegic CP, aged 3-7 years, able to follow instructions, and with upper limb motor deficits.
Exclusion Criteria: Additional neurological disorders, recent upper limb surgery, previous rehabilitation programs, severe medical conditions, or contraindications to physical activity.
Assessment Tools: Assisting Hand Assessment (AHA), Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), Quality Upper Extremity Skills Test (QUEST), and Lafayette Manual Muscle Tester.
Timing: Baseline and after 3 months of intervention. Treatment Intervention Group: 45-60 minute sessions, three times a week, involving warm-up, pulley system exercises, and cool-down.
Control Group: Standard care physical therapy, twice a week, 45-60 minute sessions.
Statistical Analysis Methods: Descriptive statistics and Analysis of Covariance (ANCOVA) to analyze improvements in upper limb function.
Significance Level: p \< 0.05. Analysis: Intention-to-treat to handle missing data. This study aims to provide evidence on the effectiveness of pulley system exercises in enhancing upper limb function in children with hemiplegic CP, potentially improving their independence and quality of life.
**Detailed Description:** Cerebral palsy (CP) is a collection of sensory and motor disorders, as well as postural disorders, caused by non-progressive injury to the immature brain1,2. It can be classified according to the topographical presentation as monoplegia, hemiplegia, diplegia, and quadriplegia2 . These obvious motor difficulties are frequently accompanied by cognitive disturbances and other neurologic difficulties3 . CP is considered the most prevalent mobility disorder in children, with an average frequency of 3 per 1,000 live births worldwide and a high prevalence of 60 to 150 per 1,000 among preterm infants who are born weighing less than 1,500 g 4 . Hemiplegic CP accounts for 21% to 40% of all cases of CP5,6.
Impairments in the upper extremity (UE) are a major factor for activity limitation and participation restriction in individuals with CP and may affect up to 50% of CP subjects \[7\]. UE limitations are mostly due to a lack of trunk control, decrease in shoulder girdle motor control and imbalance between spastic and paretic muscles \[8\]. That makes it difficult for people with CP to perform UE-specific tasks, such as reaching, grasping and manipulation, and it leads to the significant involvement of the positioning and functioning of the elbows, wrists and hands . Moreover, a lack of autonomy and dependence on other people may affect the individuals' quality of life \[9\].
Pulley therapy is a part of universal exercise unit which formed of spider cage and a system of pulley, straps and weights for resistance. It is a new method used for strengthening of weak muscles by isolating the target specific muscle for training \[10\] . There are several benefits of pulley therapy as: improving passive/active ROM, flexibility of muscle, enhancing strength and endurance of muscle without any associated movement and improving functional skills and dynamic movement \[11\] .
So, this study was conducted to investigate the effect of pully system exercise in improvement of upper limb function in hemiplegic cerebral palsy children
Subjects materials and methods:
Randomized controlled double blinded study design was used. The study will be conducted at El salam university out- patient clinic between June 2024 and August 2024 Subjects G power v2.1.9.7 was used to calculate proper sample size based on pilot testing that revealed effect size of 1.05. the proposed sample size is 32 when using alpha of 0.05 and power of 80%.
The sample size will equal 32 (randomly divided into two group) study group will receive poly system exercise on upper limb, Control group will receive designed physical therapy programme.
Once participants meet the inclusion criteria and consent to participate, they are randomly assigned to either the intervention group (receiving pulley system exercises in addition to standard care) or the control group (receiving standard care). Use a computer-generated random number table or software to assign participants.
The therapists or researchers who conduct the evaluations (e.g., AHA, BOT-2, QUEST) will not be informed of the participant's group assignment. This can be achieved by using different individuals to provide the intervention and assess the outcomes, or by ensuring that assessment data are coded in such a way that the assessor does not know the group codes.
Participants will be randomly assigned to one of two groups:
Group (A): Intervention Group: 16 Children will undergo a pulley system exercise regimen tailored to improve upper limb function in addition to designed physical therapy program for CP.
Group (B): Control Group: Children will receive designed physical therapy program for CP only.
### Conditions Module
**Conditions:**
- Cerebral Palsy, Spastic
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** SINGLE
**Who Masked:**
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 32
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** 16 Children will undergo a pulley system exercise regimen tailored to improve upper limb function in addition to designed physical therapy program for CP.
**Intervention Names:**
- Behavioral: pulley system exercise regimen
- Biological: physical therapy program for CP
**Label:** Intervention Group
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Children will receive designed physical therapy program for CP only
**Intervention Names:**
- Biological: physical therapy program for CP
**Label:** Control Group
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Intervention Group
**Description:** The warm-up consists of gentle stretching and basic mobility exercises to prepare the muscles and joints for the activity. Following this, the main segment of the session involves specific exercises using the pulley system, designed to target and improve motor function, strength, and coordination of the upper limbs. The therapist will adjust the exercises according to each child's individual abilities and progression over time. The session concludes with a cool-down period involving light activities and relaxation techniques to ensure a gradual return to baseline physiological states.
**Name:** pulley system exercise regimen
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Control Group
- Intervention Group
**Description:** Participants in the control group will attend physical therapy sessions twice per week. These sessions aim to maintain or improve physical functioning and manage the symptoms of cerebral palsy. Each session lasts approximately 45 to 60 minutes, These sessions include a variety of therapeutic exercises tailored to each child's needs but do not include the use of the pulley system. Typical activities might involve stretching, strengthening exercises, and manual therapy techniques to enhance joint mobility and muscle function.
**Name:** physical therapy program for CP
**Type:** BIOLOGICAL
### Outcomes Module
#### Primary Outcomes
**Description:** will be used to evaluate how effectively children with upper limb impairments can use their affected hand together with their well-functioning hand to perform bimanual tasks. This assessment involves observing the child while they engage in play activities that require bimanual coordination. The performance is video-recorded and scored based on specific criteria that assess the spontaneous use of the involved hand. The scoring system provides a measure of the child's ability to effectively use their affected hand in bimanual tasks, with higher scores indicating better function.
**Measure:** Assisting Hand Assessment (AHA)
**Time Frame:** 3 months
**Description:** will be conducted to measures fine and gross motor skills, including hand function. Specific subtests related to hand function are administered, such as fine motor precision, fine motor integration, and manual dexterity tasks. Performance on these tasks is quantitatively scored, allowing for the assessment of motor proficiency and hand function improvements
**Measure:** The Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) for Hand Function
**Time Frame:** 3 months
**Description:** will be used to assess movement patterns and hand function in children with cerebral palsy. It evaluates dissociated movements, grasp patterns, protective extension, and weight bearing under four domains: dissociated movements, grasp, weight bearing, and protective extension. Each item is scored based on the child's ability to perform the task, with scores reflecting the quality of upper extremity skills.
**Measure:** Quality Upper Extremity Skills Test (QUEST)
**Time Frame:** 3 months
**Description:** will be used to objectively measure the strength of specific muscles and muscle groups. The muscle tester is applied to the muscle group being evaluated while the child performs a muscle contraction. The device provides a digital readout of the force exerted, which can be measured in pounds or kilograms. In this study, the tester will be used to evaluate the strength of upper limb muscles before and after the intervention to assess any changes due to the pulley system exercises
**Measure:** Lafayette Manual Muscle Tester
**Time Frame:** 3 months
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria
* Children aged between 3 and 7 years.
* Diagnosed with hemiplegic cerebral palsy, confirmed by a pediatric neurologist.
* Ability to follow simple instructions and participate in exercise sessions.
* Presence of upper limb motor function deficits attributable to hemiplegic cerebral palsy.
Exclusion Criteria
1. Children with additional neurological disorders or severe cognitive impairments that might interfere with the ability to participate in exercise regimens.
2. Recent surgery (within the last 6 months) on the upper limbs.
3. Children who have been involved in similar rehabilitation programs in the past 3 months.
4. Severe uncontrolled medical conditions such as cardiac or respiratory diseases. Presence of any contraindication to physical activity as advised by a medical professional.
**Maximum Age:** 7 Years
**Minimum Age:** 3 Years
**Sex:** ALL
**Standard Ages:**
- CHILD
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Ahmed Ali M Torad, PHD
**Phone:** 01008889975
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Sara Elsebahy, PHD
**Phone:** 01094998882
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Cairo
**Country:** Egypt
**Facility:** Faculty of physical therapy, Kafrelsheik university
#### Overall Officials
**Official 1:**
**Affiliation:** Department of pediatric physical therapy and its surgery, Elsalam University
**Name:** Ahmed salim, PHD
**Role:** STUDY_DIRECTOR
**Official 2:**
**Affiliation:** Paediatric physical therapy department, Kafrelsheik University
**Name:** Sara Elsebahy, PHD
**Role:** STUDY_DIRECTOR
**Official 3:**
**Affiliation:** Basic science department, kafrelsheik university
**Name:** Ahmed Ali M Torad, PHD
**Role:** PRINCIPAL_INVESTIGATOR
### IPD Sharing Statement Module
**Access Criteria:** Researchers who wish to access the data must submit a formal request to the principal investigator. The request should include a research proposal outlining the purpose of the data use, the intended analysis, and the potential benefits of the research. Requests will be reviewed based on scientific merit and ethical considerations.
**Description:** Data to be Shared: The de-identified individual participant data that will be shared includes baseline demographic information, outcome measures from the Assisting Hand Assessment (AHA), Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), Quality Upper Extremity Skills Test (QUEST), and muscle strength data from the Lafayette Manual Muscle Tester. This also includes data on the intervention details such as session frequency, duration, and adherence.
Time Frame: Data will be available for sharing beginning 6 months after the publication of the study results. The data will be accessible for a period of 5 years.
**Info Types:**
- STUDY_PROTOCOL
**IPD Sharing:** YES
**Time Frame:** Data will be available for sharing beginning 6 months after the publication of the study results. The data will be accessible for a period of 5 years.
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000001925
- Term: Brain Damage, Chronic
- ID: D000001927
- Term: Brain Diseases
- ID: D000002493
- Term: Central Nervous System Diseases
- ID: D000009422
- Term: Nervous System Diseases
### Condition Browse Module - Browse Branches
- Abbrev: BC10
- Name: Nervous System Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: BC05
- Name: Musculoskeletal Diseases
- Abbrev: BC26
- Name: Wounds and Injuries
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M5796
- Name: Cerebral Palsy
- Relevance: HIGH
- As Found: Cerebral Palsy
- ID: M13157
- Name: Paralysis
- Relevance: LOW
- As Found: Unknown
- ID: M12085
- Name: Muscle Spasticity
- Relevance: LOW
- As Found: Unknown
- ID: M5207
- Name: Brain Injuries
- Relevance: LOW
- As Found: Unknown
- ID: M5202
- Name: Brain Damage, Chronic
- Relevance: LOW
- As Found: Unknown
- ID: M5204
- Name: Brain Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M5742
- Name: Central Nervous System Diseases
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000002547
- Term: Cerebral Palsy
### 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:** NCT06434233
**Brief Title:** Opioid Use After Laparoscopic Salpingectomy
**Official Title:** A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy
#### Organization Study ID Info
**ID:** IRB00308549
#### Organization
**Class:** OTHER
**Full Name:** Johns Hopkins University
### Status Module
#### Completion Date
**Date:** 2025-06
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** RECRUITING
#### Primary Completion Date
**Date:** 2025-05
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-04-25
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Johns Hopkins University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Is US Export:** False
### Description Module
**Brief Summary:** The purpose of this study is to evaluate patient-reported post-operative pain scores following minimally invasive tubal sterilization procedures to determine if a multimodal, non-opioid pain control regimen is non-inferior to a pain control regimen including opioids.
The study team hypothesizes that with extensive counseling on pain management, multimodal medication use, and expectation with non-opioid methods can effectively eliminate the need for opioid prescriptions after laparoscopic salpingectomy.
### Conditions Module
**Conditions:**
- Opioid Use
- Post-operative Pain
- Sterility, Female
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 120
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Patients randomized to Arm 1 will receive the current most commonly prescribed pain control regimen after a minimally invasive tubal sterilization procedure at discharge.
These medications include:
Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and Oxycodone 5 mg orally every 4 hours as needed x 12 tablets
All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter
**Intervention Names:**
- Drug: Acetaminophen
- Drug: Ibuprofen
- Drug: Oxycodone
**Label:** Arm 1 - Opioid Post-Op Pain Regimen
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Patients randomized to Arm 2 will not receive an opioid prescription after minimally invasive tubal sterilization procedures at discharge. They will receive only Tylenol and Ibuprofen as follows:
Tylenol 500 mg orally every 6 hours scheduled x 30 tablets Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets and
All patients will be instructed to use Acetaminophen and Ibuprofen around the clock for the first 72 hours and as needed thereafter.
Participants will be informed that if they need additional pain medications, these will not be withheld. Participants in the second arm who require additional pain medications will receive the same amount of oxycodone as in arm 1.
**Intervention Names:**
- Drug: Acetaminophen
- Drug: Ibuprofen
**Label:** Arm 2 - Non-Opioid Post-Op Pain Regimen
**Type:** EXPERIMENTAL
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Arm 1 - Opioid Post-Op Pain Regimen
- Arm 2 - Non-Opioid Post-Op Pain Regimen
**Description:** All patients will receive Acetaminophen 500 mg orally every 6 hours scheduled x 30 tablets at post-operative discharge.
All patients will be instructed to take Acetaminophen around the clock for the first 72 hours and as needed thereafter.
**Name:** Acetaminophen
**Other Names:**
- Tylenol
**Type:** DRUG
#### Intervention 2
**Arm Group Labels:**
- Arm 1 - Opioid Post-Op Pain Regimen
- Arm 2 - Non-Opioid Post-Op Pain Regimen
**Description:** All patients will receive Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets at post-operative discharge.
All patients will be instructed to take Ibuprofen around the clock for the first 72 hours and as needed thereafter.
**Name:** Ibuprofen
**Type:** DRUG
#### Intervention 3
**Arm Group Labels:**
- Arm 1 - Opioid Post-Op Pain Regimen
**Description:** Patients randomized to Arm 1 will receive Oxycodone 5 mg orally every 4 hours as needed x 12 tablets at post-operative discharge
Patients randomized to Arm 2 will not receive an Oxycodone prescription at post-operative discharge.
However, participants will be informed that if they need additional pain medications, these will not be withheld. Participants in the second arm who require additional pain medications will receive the same amount of Oxycodone as in arm 1
**Name:** Oxycodone
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Patient reported pain on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" using the Likert pain scale from 0 to 10, where 0 is no pain and 10 is severe pain. A higher score indicates a worse outcome.
**Measure:** Numeric post-operative pain score
**Time Frame:** post-operative day 1 and post-operative day 7
#### Secondary Outcomes
**Description:** As indicated on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" by a binary "yes" or "no" response. "Yes" indicates a favorable outcome and "no" indicates a worse outcome.
**Measure:** Satisfaction with post-operative pain relief
**Time Frame:** post-operative day 1 and post-operative day 7
**Description:** As indicated on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" by a binary "yes" or "no" response. "Yes" indicates a favorable outcome and "no" indicates a worse outcome.
**Measure:** Satisfaction with post-operative mobility
**Time Frame:** post-operative day 1 and post-operative day 7
**Description:** Number of Oxycodone pills used by each patient by the end of post-operative day 7
**Measure:** Total narcotic consumption at one week post-operative
**Time Frame:** post-operative day 7
**Description:** As indicated on "Post-Operative Day 1 Survey" and "Post-Operative Day 7 Survey" by a binary "yes" or "no" response. "No" indicates a favorable outcome and "yes" indicates a worse outcome.
**Measure:** Occurrence of defined opioid related side effects (N/V, constipation, dizziness, itchiness)
**Time Frame:** post-operative day 1 and post-operative day 7
**Description:** Number of patients who request additional pain medications at the time of post-operative surveys, call provider phone line for additional pain medications, or return to an Emergency Department, clinic/office, etc due to a pain related issue.
**Measure:** Suboptimal pain control as assessed by the number of patients requesting additional medication or seeking unplanned medical care for a post-surgical pain-related concern
**Time Frame:** Within 30 days of surgery
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Individuals with a fallopian tube (unilateral and/or bilateral)
* Age 18 years old and above
* Undergoing minimally invasive (laparoscopic or robotic) unilateral or bilateral salpingectomy or other tubal sterilization procedure as the primary procedure
* Benign indications for salpingectomy/tubal sterilization
* Agreeing to participate
Exclusion Criteria:
* Chronic pain syndromes patients including fibromyalgia
* Patients currently on long-term (i.e. for more than three months) opioid use
* Conversion to laparotomy
* Allergy or other contraindication to the prescribed medications such as acetaminophen or oxycodone
* Salpingectomy that occurs in conjunction with a major Gyn surgery (i.e. hysterectomy, etc)
* Salpingectomy performed for treatment of ectopic pregnancy
* Patients with a history of gastritis and/or GI bleeding
**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:** Mostafa Borahay, MD
**Phone:** 4439970400
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Shannon Osborne, MD
**Phone:** 4105502786
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Baltimore
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Mostafa Borahay, MD
- **Phone:** 443-997-0400
- **Role:** CONTACT
**Country:** United States
**Facility:** Johns Hopkins Bayview Medical Center
**State:** Maryland
**Status:** RECRUITING
**Zip:** 21224
#### Overall Officials
**Official 1:**
**Affiliation:** Johns Hopkins University
**Name:** Mostafa Borahay, MD
**Role:** PRINCIPAL_INVESTIGATOR
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000011183
- Term: Postoperative Complications
- ID: D000010335
- Term: Pathologic Processes
- ID: D000010146
- Term: Pain
- ID: D000009461
- Term: Neurologic Manifestations
- ID: D000091662
- Term: Genital Diseases
- ID: D000091642
- Term: Urogenital Diseases
- ID: D000005831
- Term: Genital Diseases, Female
- ID: D000052776
- Term: Female Urogenital Diseases
- ID: D000005261
- Term: Female Urogenital Diseases and Pregnancy Complications
### 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: BC10
- Name: Nervous System Diseases
### Condition Browse Module - Browse Leaves
- ID: M10290
- Name: Infertility
- Relevance: HIGH
- As Found: Sterility
- ID: M13069
- Name: Pain, Postoperative
- Relevance: HIGH
- As Found: Post Operative Pain
- ID: M13066
- Name: Pain
- Relevance: LOW
- As Found: Unknown
- ID: M10291
- Name: Infertility, Female
- Relevance: HIGH
- As Found: Sterility, Female
- ID: M14065
- Name: Postoperative Complications
- Relevance: LOW
- As Found: Unknown
- ID: M12404
- Name: Neurologic Manifestations
- 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: M8943
- Name: Genital Diseases, Female
- 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: D000007246
- Term: Infertility
- ID: D000007247
- Term: Infertility, Female
- ID: D000010149
- Term: Pain, Postoperative
### Intervention Browse Module - Ancestors
- ID: D000018712
- Term: Analgesics, Non-Narcotic
- ID: D000000700
- Term: Analgesics
- ID: D000018689
- Term: Sensory System Agents
- ID: D000018373
- Term: Peripheral Nervous System Agents
- ID: D000045505
- Term: Physiological Effects of Drugs
- ID: D000058633
- Term: Antipyretics
- ID: D000000894
- Term: Anti-Inflammatory Agents, Non-Steroidal
- ID: D000000893
- Term: Anti-Inflammatory Agents
- ID: D000018501
- Term: Antirheumatic Agents
- ID: D000016861
- Term: Cyclooxygenase Inhibitors
- ID: D000004791
- Term: Enzyme Inhibitors
- ID: D000045504
- Term: Molecular Mechanisms of Pharmacological Action
- ID: D000000701
- Term: Analgesics, Opioid
- ID: D000009294
- Term: Narcotics
- ID: D000002492
- Term: Central Nervous System Depressants
### Intervention Browse Module - Browse Branches
- Abbrev: Analg
- Name: Analgesics
- Abbrev: CNSDep
- Name: Central Nervous System Depressants
- Abbrev: All
- Name: All Drugs and Chemicals
- Abbrev: Antipy
- Name: Antipyretics
- Abbrev: Infl
- Name: Anti-Inflammatory Agents
- Abbrev: ARhu
- Name: Antirheumatic Agents
### Intervention Browse Module - Browse Leaves
- ID: M13020
- Name: Oxycodone
- Relevance: HIGH
- As Found: Valve
- ID: M2340
- Name: Acetaminophen
- Relevance: HIGH
- As Found: Set
- ID: M10102
- Name: Ibuprofen
- Relevance: HIGH
- As Found: Wound
- ID: M4032
- Name: Analgesics
- Relevance: LOW
- As Found: Unknown
- ID: M4033
- Name: Analgesics, Opioid
- Relevance: LOW
- As Found: Unknown
- ID: M20786
- Name: Analgesics, Non-Narcotic
- Relevance: LOW
- As Found: Unknown
- ID: M29176
- Name: Antipyretics
- Relevance: LOW
- As Found: Unknown
- ID: M4217
- Name: Anti-Inflammatory Agents
- Relevance: LOW
- As Found: Unknown
- ID: M4218
- Name: Anti-Inflammatory Agents, Non-Steroidal
- Relevance: LOW
- As Found: Unknown
- ID: M20604
- Name: Antirheumatic Agents
- Relevance: LOW
- As Found: Unknown
- ID: M19209
- Name: Cyclooxygenase Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M7951
- Name: Enzyme Inhibitors
- Relevance: LOW
- As Found: Unknown
- ID: M12245
- Name: Narcotics
- Relevance: LOW
- As Found: Unknown
### Intervention Browse Module - Meshes
- ID: D000000082
- Term: Acetaminophen
- ID: D000007052
- Term: Ibuprofen
- ID: D000010098
- Term: Oxycodone
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434220
**Brief Title:** Effect of Predictive Model on ED Physician Assessments of Patient Disposition
**Official Title:** Effect of Predictive Model on ED Physician Assessments of Patient Disposition
#### Organization Study ID Info
**ID:** IRB-P00048537
#### Organization
**Class:** OTHER
**Full Name:** Boston Children's Hospital
### Status Module
#### Completion Date
**Date:** 2026-09-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2026-07-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2026-05-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Boston Children's Hospital
#### Responsible Party
**Investigator Affiliation:** Boston Children's Hospital
**Investigator Full Name:** William La Cava
**Investigator Title:** Assistant Professor
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The goal of this study is to measure the impact of fairness-aware algorithms on physician predictions of ED patient admission. Using an experimentally validated machine learning model tuned for equitable outcomes, the investigators quantify the impact of model recommendations on ED physician assessments of admission risk in a silent, prospective study. The investigators survey ED physicians who are not currently caring for patients using live site data. To quantify the impact of the model on ED physician assessments of admission risk, the investigators collect physician assessments before and after consulting the (original or updated) model prediction.
The investigators measure ED physician adherence to model suggestions, along with the predictive accuracy and equity of downstream patient outcomes. The outcome of this study is an empirical measure of the extent to which fair ML models may influence admission decisions to mitigate health care disparities.
**Detailed Description:** Specific Aims/Objectives:
1. Measure the effect of the sharing of a model prediction of admission on an attending physician's assessment of patient disposition within one hour from presentation at a tertiary academic pediatric hospital.
2. Measure the effect of the sharing of a model prediction from a model tuned for equal subgroup performance on an attending physician's assessment of patient disposition within one hour from presentation at a tertiary academic pediatric hospital.
Background and Significance:
Machine learning (ML) models increasingly provide clinical decision support (CDS) to care teams to help prioritize individuals for specific care based on their predicted health needs and outcomes. AI/ML methods can have a particularly high impact on resource allocation in emergency departments (EDs) across the U.S., which have been described by the Institute for Medicine as "nearing the breaking point" of over-capacity. Unfortunately, models often perform poorly on disinvested subpopulations relative to the population as a whole. As a result, ML models may exacerbate downstream health disparities by under-performing on marginalized patient subpopulations, especially when models are expanded to multiple care centers and or used without subgroup monitoring for long periods of time.
Many prediction models have been developed in recent years to predict patient disposition from the ED, including a prediction tool developed by our group and currently in piloting stages at Boston Children's Hospital, South Shore Hospital, and Children's Hospital of Los-Angeles. Our prediction tool, the Predictor of Patient Placement (POPP) provides an accurate, real-time likelihood of admission based on data available in the electronic health record at the time of the visit. Advance notice of likely admissions can have an important impact on ED waiting and boarding times with the potential to improve flow and patient satisfaction.
To this end, the investigation team has submitted a grant proposal to the National Library of Medicine (NLM) \[1R01LM014300 - 01A1\] that researches the development and validation of fairness-aware prediction models of patient admission. Aim 2 of this grant studies the effect of these models on ED physician assessments of patient disposition, and corresponds to this protocol. The NLM has indicated its intention to fund this proposal and the investigators are in the process of submitting documents to finalize the award. This component of the study is slated for year 3 of the study.
Preliminary Studies
The investigators conducted a series of initial retrospective studies that established that patient admission could be predicted with machine learning models ahead of time in the BCH ED, progressively during the visit, as well as across other medical centers with good accuracy (AUROC 0.9-0.93).
Next, the investigators found that the accuracy of POPP in predicting admission likelihood added value to the gestalt assessments of ED attending physicians. The positive predictive value for the prediction of admission was 66% for the clinicians, 73% for POPP, and 86% for a hybrid model combining the two.
Finally, the investigators developed methods for post-processing the ED prediction models to make them well-calibrated across patient demographic groups defined by race, sex, and insurance product.
The model predictions are currently used to help with bed coordination, but given their high value, may also improve decision making at the bed-side. With this study, our goal is to now test, in a simulated, safe, and realistic setting, how model recommendations affect the assessments of admission likelihood by ED attending physicians.
### Conditions Module
**Conditions:**
- Patient Outcome Assessment
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** SEQUENTIAL
##### Masking Info
**Masking:** TRIPLE
**Masking Description:** We conduct a randomized, double-blind, controlled before-after (CBA) study of board-certified ED attending physicians not currently caring for patients in the BCH ED over a period of six to twelve weeks. In this experiment, the "treatment" consists of an ML recommendation provided to the ED physicians, who predict admission decisions for individual patients before and after receiving it. The "control" surveys receive the original POPP model recommendation, and "treatment" surveys receive a "fairness-aware" model, determined in prior work to mitigate biases in performance with respect to patient demographics
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
**Primary Purpose:** OTHER
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** No intervention. Physician is surveyed to provide their assessment of patient disposition.
**Label:** Physician assessment before intervention
**Type:** NO_INTERVENTION
#### Arm Group 2
**Description:** Physician is shown a baseline model recommendation for patient disposition including description of factors driving the model prediction.
**Intervention Names:**
- Diagnostic Test: Baseline model
**Label:** Physician assessment after baseline model intervention
**Type:** ACTIVE_COMPARATOR
#### Arm Group 3
**Description:** Physician is shown a model recommendation form a model tuned for subgroup performance for patient disposition including description of factors driving the model prediction.
**Intervention Names:**
- Diagnostic Test: Fairness-aware model
**Label:** Physician assessment after fairness-aware model intervention
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Physician assessment after baseline model intervention
**Description:** Model prediction of patient disposition including feature importance scores driving prediction.
**Name:** Baseline model
**Type:** DIAGNOSTIC_TEST
#### Intervention 2
**Arm Group Labels:**
- Physician assessment after fairness-aware model intervention
**Description:** Model prediction of patient disposition including feature importance scores driving prediction. This model has been tuned to minimize subgroup calibration errors.
**Name:** Fairness-aware model
**Type:** DIAGNOSTIC_TEST
### Outcomes Module
#### Primary Outcomes
**Description:** The primary outcome is physician-assessed ED disposition (categorized as admission or discharge), before and after viewing a model prediction, compared to final disposition of patient
**Measure:** Physician-assessed ED disposition (likelihood of admission)
**Time Frame:** Within 24 hours of survey
**Description:** The final disposition of the patient, whether admitted to an inpatient service or discharged
**Measure:** Patient final disposition (admitted/discharged)
**Time Frame:** Within 24 hours of survey
#### Secondary Outcomes
**Description:** The model prediction's assessment of ED disposition compared to final disposition of patient
**Measure:** Model-assessed ED disposition
**Time Frame:** Within 24 hours of survey
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Board certified emergency department attending physicians currently employed by Boston Children's Hospital
Exclusion Criteria:
* Physicians are excluded from completely surveys for patients who they are currently caring for
**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:** William La Cava, PhD
**Phone:** 4133200544
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Andrew Fine, MD
**Phone:** 617-355-9696
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
### References Module
#### References
**Citation:** Barak-Corren Y, Israelit SH, Reis BY. Progressive prediction of hospitalisation in the emergency department: uncovering hidden patterns to improve patient flow. Emerg Med J. 2017 May;34(5):308-314. doi: 10.1136/emermed-2014-203819. Epub 2017 Feb 10.
**PMID:** 28188202
**Citation:** Barak-Corren Y, Agarwal I, Michelson KA, Lyons TW, Neuman MI, Lipsett SC, Kimia AA, Eisenberg MA, Capraro AJ, Levy JA, Hudgins JD, Reis BY, Fine AM. Prediction of patient disposition: comparison of computer and human approaches and a proposed synthesis. J Am Med Inform Assoc. 2021 Jul 30;28(8):1736-1745. doi: 10.1093/jamia/ocab076.
**PMID:** 34010406
**Citation:** Barak-Corren Y, Chaudhari P, Perniciaro J, Waltzman M, Fine AM, Reis BY. Prediction across healthcare settings: a case study in predicting emergency department disposition. NPJ Digit Med. 2021 Dec 15;4(1):169. doi: 10.1038/s41746-021-00537-x.
**PMID:** 34912043
**Citation:** Barak-Corren Y, Fine AM, Reis BY. Early Prediction Model of Patient Hospitalization From the Pediatric Emergency Department. Pediatrics. 2017 May;139(5):e20162785. doi: 10.1542/peds.2016-2785.
**PMID:** 28557729
**Citation:** La Cava WG, Lett E, Wan G. Fair admission risk prediction with proportional multicalibration. Proc Mach Learn Res. 2023;209:350-378.
**PMID:** 37576024
## Derived Section
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434207
**Acronym:** EVmiRNA
**Brief Title:** Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
**Official Title:** Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
#### Organization Study ID Info
**ID:** IRB-P00048093
#### Organization
**Class:** OTHER
**Full Name:** Boston Children's Hospital
### Status Module
#### Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2024-12-31
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** OTHER
**Name:** Boston Children's Hospital
#### Responsible Party
**Investigator Affiliation:** Boston Children's Hospital
**Investigator Full Name:** Juan Ibla
**Investigator Title:** Principal Investigator, MD
**Type:** PRINCIPAL_INVESTIGATOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** Newborns with congenital heart disease (CHD) are at increased risk of developing postpartum and postoperative blood clots after cardiac surgery. The molecular mechanisms that are responsible for the clotting profile predisposing children to blood clots in the early stages of life are currently not well described.
The goal of this proposal is to prospectively collect plasma samples from ten (10) neonates with antenatal diagnosis of severe congenital heart disease (CHD) to better understand mechanisms responsible for abnormal clotting in the perioperative period.
### Conditions Module
**Conditions:**
- Congenital Heart Disease
- Single-ventricle
- Thrombosis
### Design Module
#### Bio Spec
**Description:** Whole blood from neonate
**Retention:** SAMPLES_WITH_DNA
#### Design Info
**Observational Model:** COHORT
**Time Perspective:** PROSPECTIVE
#### Enrollment Info
**Count:** 10
**Type:** ESTIMATED
**Study Type:** OBSERVATIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Neonates born with severe Congenital Heart Disease undergoing corrective heart surgery within the first week of life under cardiopulmonary bypass at Boston Children's Hospital will be eligible for participation. As part of standard clinical care, neonates having cardiac surgery at Boston Children's Hospital have clinical labs drawn during and after surgery. All blood collected from neonates as part of this study will be discarded blood from those routine clinical samples. One sample will be taken before surgery and one sample will be taken after surgery.
**Intervention Names:**
- Other: Collecting discarded blood samples
**Label:** Neonates with Congenital Heart Disease
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Neonates with Congenital Heart Disease
**Description:** Discarded blood samples will be collected from routine clinical labs collected before and after surgery.
**Name:** Collecting discarded blood samples
**Type:** OTHER
### Outcomes Module
#### Primary Outcomes
**Description:** isolation, purification and sequencing of patterns of miRNA and clustering analysis will be performed to determine predominant populations of miRNA related to inflammation, complement activation, and coagulation among other pathways
**Measure:** Characterization of microRNA in whole blood samples from neonates
**Time Frame:** 2 days
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life
Exclusion Criteria:
* None
**Maximum Age:** 7 Days
**Minimum Age:** 1 Day
**Sampling Method:** NON_PROBABILITY_SAMPLE
**Sex:** ALL
**Standard Ages:**
- CHILD
**Study Population:** All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life.
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Rachel Bernier, MPH
**Phone:** 857-218-5348
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Hanna Van Pelt, BS
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Boston
**Country:** United States
**Facility:** Boston Children's Hospital
**State:** Massachusetts
**Zip:** 02115
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000016769
- Term: Embolism and Thrombosis
- ID: D000014652
- Term: Vascular Diseases
- ID: D000018376
- Term: Cardiovascular Abnormalities
- ID: D000000013
- Term: Congenital Abnormalities
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BC16
- Name: Diseases and Abnormalities at or Before Birth
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M9419
- Name: Heart Diseases
- Relevance: HIGH
- As Found: Heart Disease
- ID: M9418
- Name: Heart Defects, Congenital
- Relevance: HIGH
- As Found: Congenital Heart Disease
- ID: M16686
- Name: Thrombosis
- Relevance: HIGH
- As Found: Thrombosis
- ID: M2100
- Name: Univentricular Heart
- Relevance: HIGH
- As Found: Single Ventricle
- ID: M7784
- Name: Embolism
- Relevance: LOW
- As Found: Unknown
- ID: M19128
- Name: Embolism and Thrombosis
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M12
- Name: Congenital Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: M20503
- Name: Cardiovascular Abnormalities
- Relevance: LOW
- As Found: Unknown
- ID: T5247
- Name: Single Ventricular Heart
- Relevance: HIGH
- As Found: Single Ventricle
### Condition Browse Module - Meshes
- ID: D000006331
- Term: Heart Diseases
- ID: D000013927
- Term: Thrombosis
- ID: D000006330
- Term: Heart Defects, Congenital
- ID: D000080039
- Term: Univentricular Heart
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434194
**Brief Title:** Serrantor OCT Study
**Official Title:** Serranator OCT: Understanding the Mechanism of Action of Serration Angioplasty by Serranator Versus Conventional Balloon Angioplasty for below-the Knee (BTK) Artery Disease Using Optical Coherence Tomography (OCT)
#### Organization Study ID Info
**ID:** CSP
#### Organization
**Class:** INDUSTRY
**Full Name:** Cagent Vascular LLC
### Status Module
#### Completion Date
**Date:** 2025-06-01
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-01-01
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-06-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Lead Sponsor
**Class:** INDUSTRY
**Name:** Cagent Vascular LLC
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** True
**Is FDA Regulated Drug:** False
**Is US Export:** True
### Description Module
**Brief Summary:** TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
### Conditions Module
**Conditions:**
- Critical Limb Ischemia
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Who Masked:**
- PARTICIPANT
- CARE_PROVIDER
- OUTCOMES_ASSESSOR
**Primary Purpose:** TREATMENT
#### Enrollment Info
**Count:** 60
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Subjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon
**Intervention Names:**
- Device: Serranator PTA Serration Catheter
**Label:** Serrantor
**Type:** ACTIVE_COMPARATOR
#### Arm Group 2
**Description:** Subjects randomized to the PTA Arm of the study will be treated with a standard of care percutaneous transluminal angioplasty (PTA) balloon.
**Intervention Names:**
- Drug: PTA (Standard of Care)
**Label:** PTA
**Type:** ACTIVE_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Serrantor
**Description:** The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
**Name:** Serranator PTA Serration Catheter
**Type:** DEVICE
#### Intervention 2
**Arm Group Labels:**
- PTA
**Description:** A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.
**Name:** PTA (Standard of Care)
**Type:** DRUG
### Outcomes Module
#### Primary Outcomes
**Description:** Residual lumen volume stenosis derived by OCT comparing Serration Angioplasty and conventional plain balloon angioplasty (PTA) measured at 10-15min post procedure. The lesion segment is defined as the entire treated segment where the balloon has been inflated.
**Measure:** Residual Lumen Volume Stenosis
**Time Frame:** Baseline
#### Secondary Outcomes
**Description:** Residual stenosis as measured by OCT
**Measure:** OCT Residual Diameter Stenosis
**Time Frame:** Baseline
**Description:** Residual stenosis as measured by angiography
**Measure:** Angiography Residual Diameter Stenosis
**Time Frame:** Baseline
**Description:** The incidence of dissection pattern between the study arms as reported by the OCT Corelab. The CoreLab will evaluate OCT images of each dissection including analysis of the length of the dissection, arc of the dissection, number of serrations, and the length of the serration.
**Measure:** Dissection Pattern
**Time Frame:** Baseline
**Description:** The correlation of the plaque modification achieved as determine from the OCT evaluation after treatment with the Study Device to the luminal gain achieved by conventional angioplasty as evaluated by the Core Lab.
**Measure:** Correlation of Luminal Gain and Plaque Modification
**Time Frame:** Baseline
**Description:** Rate of procedures that achieve optimal PTA (\<30% diameter stenosis without flow-limiting dissection measured by angiography)
**Measure:** Rate of Optimal PTA
**Time Frame:** Baseline
**Description:** Rate of bail-out stenting
**Measure:** Bail-out Stenting
**Time Frame:** Baseline
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Rutherford clinical category 4-6 of the target limb
* Age of subjects is \>18 years old
* Patients has given informed consent to participate in this study
Exclusion Criteria:
* De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion
* Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries.
* Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm.
* Lesion length less than 220 mm
**Minimum Age:** 19 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Feeny
**Phone:** 4197878496
**Role:** CONTACT
**Contact 2:**
**Email:** [email protected]
**Name:** Wittwer
**Role:** CONTACT
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000007511
- Term: Ischemia
- ID: D000010335
- Term: Pathologic Processes
- ID: D000058729
- Term: Peripheral Arterial Disease
- ID: D000050197
- Term: Atherosclerosis
- ID: D000001161
- Term: Arteriosclerosis
- ID: D000001157
- Term: Arterial Occlusive Diseases
- ID: D000014652
- Term: Vascular Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000016491
- Term: Peripheral Vascular Diseases
- ID: D000002908
- Term: Chronic Disease
- ID: D000020969
- Term: Disease Attributes
### Condition Browse Module - Browse Branches
- Abbrev: BC23
- Name: Symptoms and General Pathology
- Abbrev: All
- Name: All Conditions
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: Rare
- Name: Rare Diseases
### Condition Browse Module - Browse Leaves
- ID: M10543
- Name: Ischemia
- Relevance: LOW
- As Found: Unknown
- ID: M2714
- Name: Chronic Limb-Threatening Ischemia
- Relevance: HIGH
- As Found: Critical Limb Ischemia
- ID: M29213
- Name: Peripheral Arterial Disease
- Relevance: LOW
- As Found: Unknown
- ID: M18894
- Name: Peripheral Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M26188
- Name: Atherosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4469
- Name: Arteriosclerosis
- Relevance: LOW
- As Found: Unknown
- ID: M4465
- Name: Arterial Occlusive Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M17400
- Name: Vascular Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6147
- Name: Chronic Disease
- Relevance: LOW
- As Found: Unknown
- ID: M22700
- Name: Disease Attributes
- Relevance: LOW
- As Found: Unknown
- ID: T1303
- Name: Chronic Graft Versus Host Disease
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000089802
- Term: Chronic Limb-Threatening Ischemia
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434181
**Brief Title:** Beetroot Juice for Boosting Immunity During a Time of Stress.
**Official Title:** Beetroot Juice for Boosting Immunity During a Time of Stress.
#### Organization Study ID Info
**ID:** 1866308
#### Organization
**Class:** OTHER
**Full Name:** Baylor University
### Status Module
#### Completion Date
**Date:** 2022-12-13
**Type:** ACTUAL
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** COMPLETED
#### Primary Completion Date
**Date:** 2022-12-13
**Type:** ACTUAL
#### Start Date
**Date:** 2022-04-11
**Type:** ACTUAL
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** OTHER
**Name:** Southern Methodist University
#### Lead Sponsor
**Class:** OTHER
**Name:** Baylor University
#### Responsible Party
**Type:** SPONSOR
### Oversight Module
**Is FDA Regulated Device:** False
**Is FDA Regulated Drug:** False
**Oversight Has DMC:** False
### Description Module
**Brief Summary:** The purpose of the present study is to explore the effects of a dietary nitrate supplement (i.e., beetroot juice) on nitric oxide levels, immunity, mood, and cardiovascular activity during and following final exam stress in healthy individuals.
**Detailed Description:** Research has demonstrated that during times of high stress (i.e., during final exam period), there is a decrease in fraction of exhaled nitric oxide (FeNO) in healthy undergraduate students. Additionally, a separate line of research has demonstrated periods of high stress impact immunity and the cardiovascular system. Nitric oxide may have a benefit in improving the physiological and psychological consequences of stress.
The present research aims to explore the impact of a dietary supplement (beetroot juice drink) on immunity, nitric oxide levels, cardiovascular activity, and mood during and following final exam stress. In this study, investigators monitor changes in cold symptoms, IL-8, blood pressure, airway nitric oxide, and mood in students during the time of final exams and a comparable time of low stress during the term. There are three laboratory assessment visits, as well as a brief questionnaire on a separate day. During the final exam period, half of the participants are randomly assigned to the experimental group provided with a dietary supplement (beetroot juice drink) of which they are asked to take two doses every day (one in the morning and one in the evening) for seven days. The other half of the participants are randomly assigned to the placebo control group provided with a placebo supplement (placebo drink) of which they are asked to take two doses every day (one in the morning and one in the evening for seven days). For the final exam period, the first of the two sessions takes place early in the examination period (first half), and the second assessment takes place in the later exam period (second half). The online questionnaire assessing symptoms is measured 3 days after the final examination period.
### Conditions Module
**Conditions:**
- Healthy
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** TRIPLE
**Masking Description:** The lead researcher, data collectors, and participants were blinded to the conditions. The distribution of the supplements for each condition was performed by a member of the staff that was not involved with the study.
**Who Masked:**
- PARTICIPANT
- INVESTIGATOR
- OUTCOMES_ASSESSOR
**Primary Purpose:** BASIC_SCIENCE
#### Enrollment Info
**Count:** 114
**Type:** ACTUAL
**Phases:**
- PHASE2
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Description:** Participants in this group are given 7 daily doses of a dietary nitrate supplement (Beet-it Sport beetroot juice shots, ) and asked to drink two doses daily during the week of their final academic examinations of that term in college.
**Intervention Names:**
- Dietary Supplement: Beetroot Juice
**Label:** Beetroot Juice
**Type:** EXPERIMENTAL
#### Arm Group 2
**Description:** Participants in this group are given 7 daily doses of a placebo matched in appearance and taste (Beet-it Sport placebo juice shots) and asked to drink two doses daily during the week of their final academic examinations of that term in college.
**Intervention Names:**
- Dietary Supplement: Placebo Control
**Label:** Placebo Control
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Beetroot Juice
**Description:** Beet-It Sports Shot, 70mL, containing 6.5 mmol nitric oxide (taking two shots per day in active group)
**Name:** Beetroot Juice
**Type:** DIETARY_SUPPLEMENT
#### Intervention 2
**Arm Group Labels:**
- Placebo Control
**Description:** Beet-It Placebo Shot, 70mL (taking two shots per day in placebo group)
**Name:** Placebo Control
**Type:** DIETARY_SUPPLEMENT
### Outcomes Module
#### Primary Outcomes
**Description:** Assesses symptoms of acute upper respiratory tract infections (common cold symptoms) by questionnaire
**Measure:** Wisconsin Upper Respiratory Symptom Survey (WURSS)
**Time Frame:** Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period), 1-3 days after finishing beetroot shots (after final examinations)
**Description:** Change in IL-8 levels
**Measure:** Changes in IL-8 levels
**Time Frame:** Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)
#### Secondary Outcomes
**Description:** Resting blood pressure (systolic and diastolic)
**Measure:** Resting blood pressure
**Time Frame:** Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)
**Description:** Perceived Stress Scale
**Measure:** Acute stress
**Time Frame:** Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)
**Description:** PANAS negative affect scale
**Measure:** Change in negative affect
**Time Frame:** Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)
**Description:** Participants will upload a cell phone video of their intake for that day to a secure cloud folder, time stamp in comparison to assigned intake windows provides measure of adherence
**Measure:** Adherence monitoring (feasibility )
**Time Frame:** Every day, twice a day during active beetroot
**Description:** The Fraction of NO in Exhaled Breath (FENO, in ppb) will be measured with an electrochemical gas analyzer (NIOX vero).
**Measure:** Exhaled Nitric Oxide
**Time Frame:** Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)
**Description:** Hospital Anxiety and Depression Scale
**Measure:** Change in depressive symptomology
**Time Frame:** Baseline (non-stress mid point of semester), 1-3 days into active beetroot shots (during final examination period), 4-6 days into active beetroot shots (during final examination period)
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Currently enrolled at Baylor University or Southern Methodist University
Exclusion Criteria:
* Current smoker
* Clinically significant asthma, COPD, Emphysema, heart disease, cerebrovascular disease, thyroid dysfunction, out of control diabetes
* Pregnancy, diagnosis of schizophrenia, psychosis, mood disorder, psychosis, drug or alcohol dependance
**Healthy Volunteers:** True
**Maximum Age:** 40 Years
**Minimum Age:** 18 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
### Contacts Locations Module
#### Locations
**Location 1:**
**City:** Dallas
**Country:** United States
**Facility:** Southern Methodist University
**State:** Texas
**Zip:** 75205
**Location 2:**
**City:** Waco
**Country:** United States
**Facility:** Annie T. Ginty
**State:** Texas
**Zip:** 76798
### IPD Sharing Statement Module
**IPD Sharing:** UNDECIDED
## Derived Section
### Intervention Browse Module - Browse Branches
- Abbrev: VaDiAg
- Name: Vasodilator Agents
- Abbrev: Resp
- Name: Respiratory System Agents
- Abbrev: All
- Name: All Drugs and Chemicals
### Intervention Browse Module - Browse Leaves
- ID: M12507
- Name: Nitric Oxide
- Relevance: LOW
- As Found: Unknown
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |
## Protocol Section
### Identification Module
**NCT ID:** NCT06434168
**Brief Title:** Impact of Yoga on Cognitive Function
**Official Title:** A Pilot and Feasibility Study of a Yoga Intervention in Heart Failure Patients With Mild Cognitive Impairment
#### Organization Study ID Info
**ID:** AU-24-001
#### Organization
**Class:** OTHER
**Full Name:** Auburn University
### Status Module
#### Completion Date
**Date:** 2025-12-31
**Type:** ESTIMATED
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Last Update Submit Date:** 2024-05-23
**Overall Status:** NOT_YET_RECRUITING
#### Primary Completion Date
**Date:** 2025-06-30
**Type:** ESTIMATED
#### Start Date
**Date:** 2024-07-01
**Type:** ESTIMATED
**Status Verified Date:** 2024-05
#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module
#### Collaborators
**Class:** UNKNOWN
**Name:** VCOM, Auburn campus
#### Lead Sponsor
**Class:** OTHER
**Name:** Auburn University
#### Responsible Party
**Investigator Affiliation:** Auburn University
**Investigator Full Name:** Chin-Yen Lin
**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:** Mild cognitive impairment is highly prevalent in patients with heart failure and results in poor well-being and quality of life. While yoga has proven effective in promoting cognitive health in older adults through its gentle movements, controlled breathing, and meditation, its effects on patients with heart failure remain unknown. Therefore, this feasibility and pilot study plans to deliver a 12-week yoga intervention and test its effects on cognitive function in patients with heart failure and mild cognitive impairment.
**Detailed Description:** A prospective, 2-arm comparative feasibility design will be used. The investigators will enroll 24 patients with a confirmed heart failure diagnosis with mild cognitive impairment. Patients will be randomized equally into yoga intervention or control group. Patients in the yoga intervention group will receive a 60-minute yoga session twice per week for 12-week. Survey, cognitive function data, MRI scans, and blood samples will be collected at baseline and at 3 months (after completion of yoga intervention).
### Conditions Module
**Conditions:**
- Heart Failure
- Mild Cognitive Impairment
**Keywords:**
- Yoga intervention
- cognitive function
### Design Module
#### Design Info
**Allocation:** RANDOMIZED
**Intervention Model:** PARALLEL
##### Masking Info
**Masking:** NONE
**Primary Purpose:** PREVENTION
#### Enrollment Info
**Count:** 24
**Type:** ESTIMATED
**Phases:**
- NA
**Study Type:** INTERVENTIONAL
### Arms Interventions Module
#### Arm Group 1
**Intervention Names:**
- Behavioral: Yoga intervention
**Label:** Yoga intervention
**Type:** EXPERIMENTAL
#### Arm Group 2
**Intervention Names:**
- Behavioral: Control condition
**Label:** Control condition
**Type:** PLACEBO_COMPARATOR
### Interventions
#### Intervention 1
**Arm Group Labels:**
- Yoga intervention
**Description:** Patients in the yoga group will receive a 60-minute session, twice per week over 12 weeks for a total of 24 sessions. Each yoga session consists of a warm-up, yoga postures standing or seated depending on the capability of the patient, and relaxation.
**Name:** Yoga intervention
**Type:** BEHAVIORAL
#### Intervention 2
**Arm Group Labels:**
- Control condition
**Description:** Patients in the control group will receive care-as-usual from their healthcare providers and will be asked to avoid engaging in yoga during their 3 months in the study.
**Name:** Control condition
**Type:** BEHAVIORAL
### Outcomes Module
#### Primary Outcomes
**Description:** Using structural magnetic resonance imaging to examine brain structure between intervention and control groups. Less brain alteration is optimal.
**Measure:** Brain structure
**Time Frame:** Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
**Description:** Functional magnetic resonance imaging is used to examine functional connectivity between intervention and control groups. A balance of activity across different brain regions is optimal.
**Measure:** Brain functional connectivity
**Time Frame:** Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
**Description:** Using cognitive tests to examine cognitive function and performance between intervention and control groups. A higher score on cognitive tests indicates better cognitive function.
**Measure:** Cognitive function
**Time Frame:** Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
**Description:** A blood sample will be obtained using phlebotomy to measure the levels of serum brain-derived neurotrophic factor and reported in pg/mL. Higher concentrations are optimal.
**Measure:** Serum brain-derived neurotrophic factor
**Time Frame:** Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
### Eligibility Module
**Eligibility Criteria:** Inclusion Criteria:
* Aged 55 years and older
* Confirmed heart failure diagnosis with mild cognitive impairment
* New York Heart Association functional class II-IV
Exclusion Criteria:
* Co-existing neurological disorders, traumatic brain injury, psychiatric disorders, or terminal illnesses
* Have implanted defibrillator, left ventricular assist device placement or cardiac transplant
* Have any other implanted metals that interfere with the MRI magnetic field for patient safety
* Substance abuse
* Pregnant
* Unable to perform yoga due to physical limitations or severity of illness
**Maximum Age:** 70 Years
**Minimum Age:** 55 Years
**Sex:** ALL
**Standard Ages:**
- ADULT
- OLDER_ADULT
### Contacts Locations Module
#### Central Contacts
**Contact 1:**
**Email:** [email protected]
**Name:** Chin-Yen Lin, RN, PhD
**Phone:** 334-844-5619
**Role:** CONTACT
#### Locations
**Location 1:**
**City:** Auburn
**Contacts:**
***Contact 1:***
- **Email:** [email protected]
- **Name:** Chin-Yen Lin, RN, PhD
- **Phone:** 334-844-5619
- **Role:** CONTACT
**Country:** United States
**Facility:** Auburn University
**State:** Alabama
**Zip:** 36849
### IPD Sharing Statement Module
**IPD Sharing:** NO
## Derived Section
### Condition Browse Module - Ancestors
- ID: D000006331
- Term: Heart Diseases
- ID: D000002318
- Term: Cardiovascular Diseases
- ID: D000003072
- Term: Cognition Disorders
- ID: D000019965
- Term: Neurocognitive Disorders
- ID: D000001523
- Term: Mental Disorders
### Condition Browse Module - Browse Branches
- Abbrev: BC14
- Name: Heart and Blood Diseases
- Abbrev: All
- Name: All Conditions
- Abbrev: BXM
- Name: Behaviors and Mental Disorders
### Condition Browse Module - Browse Leaves
- ID: M9421
- Name: Heart Failure
- Relevance: HIGH
- As Found: Heart Failure
- ID: M29705
- Name: Cognitive Dysfunction
- Relevance: HIGH
- As Found: Mild Cognitive Impairment
- ID: M9419
- Name: Heart Diseases
- Relevance: LOW
- As Found: Unknown
- ID: M6301
- Name: Cognition Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M21836
- Name: Neurocognitive Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M4815
- Name: Mental Disorders
- Relevance: LOW
- As Found: Unknown
- ID: M14473
- Name: Psychotic Disorders
- Relevance: LOW
- As Found: Unknown
### Condition Browse Module - Meshes
- ID: D000006333
- Term: Heart Failure
- ID: D000060825
- Term: Cognitive Dysfunction
### Misc Info Module
- Version Holder: 2024-06-06
**Has Results:** False |