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Treatment with reverse intermingled-skin graft vs MEEK graft in extensively full-thickness burned patients: a within person randomized controlled clinical trial

2.      Background:

•      • Burn injuries are associated with substantial morbidity and mortality. In 2018, WHO estimates that 11 million burn injuries of all types occur annually worldwide, 180,000 of which are fatal.

•      Skin graft is one of the most indispensable techniques in burn patients. There is no standard graft suit for all burn wounds. Since J.P. Reverdin, a  medical student invented skin graft in 1869, several types of skin graft techniques developed, such as meshed skin graft, Meek micro-derma-graft, sandwich skin graft technique, composite skin graft.

•       Now, modified MEEK technique and Chinese intermingled technique(one is auto-skin graft in alloskin hole/Shanghai Ruijin Hospital technique, another is microskin graft/Beijing Beijing Jishuitan Hospital) ware widely used for extensive full-thickness burn wound. MEEK technique graft preparation is quick but susceptible to infection. Shanghai technique has the strength of less contracture formation, less infection by allograft protective layer but tedious procedure.  Beijing technique has the strength of quicker preparation, but more scar formation. Graft technique trends to cover much more wound by utilizing a minimal amount of donor skin(table 1). The novel reverse intermingled-skin graft (RMG) mix above three  graft methods mix three methods’ characteristics. The objective is to testify the effectiveness of the new method.

•      Study objective(s):

• Population: extensive full-thickness burn patients.

• Intervention: novel reverse intermingled-skin graft (RMG)

• Comparator : MEEK technique

• Outcome:     Split square skin survival rate，wound healing rate

3.    Eligibility criteria:

All burn inpatients in SAHZU burn center

inclusion criteria:

l  age 12-70

l  at least one limb, or front or back trunk injured with full-thickness burn

exclusion criteria:

l  age<12 or >70

l  pregnancy

l  patients refuse to rescue.

l  patients with no informed consent

l  fourth degree involved in graft wound

l  patients supposed to be dead within 14 days

l  patients with severe comorbidities

4.    Research question for a randomised clinical trial:

treatment with reverse intermingled-skin graft vs MEEK graft in extensive full-thickness burned wounds

5.    Trial design:  

A within person randomized controlled clinical trial

6.    Unit of randomization (Cluster/Individual):

Cluster（）

7.    Number of arms:

Two arms

8.    Expected total sample size:

Power=0.9, 2-sided ɑ=0.05, count data type(split square skin survival rate): Meek control=85%, SD=7, expected treat group>=80%, lost to FU=2%, Means – Sample Size/Clustered=86

9.    Allocation ratio (test vs control):

1:1,

10. Number of recruitment sites (Single/multi-centre):

single centre.

11. Which method of random sequence generation: Simple/block/stratified block

Each injured limb or trunk divide into several paired wound, Computer sequence one block at graft time and block2- 8 depend on graft wound site and size

12. Any key prognostic factors for stratifying random sequence along with the categories (e.g., site, sex):

Site(up arm, leg, trunk)

13. Blinding: (Blinded or open-label)

Open-label

14. Method of allocation concealment: (IVRS/IWRS/SNOSE):   In real graft time, researcher be responsible and recruitment

15. Outcome measurement: table1

16.  Ethical and research integrity principles: : vulnerable participants, informed consent by proxy

17.  Trial visits schedule and data collection: table 2

P: Ovarian cancer with supradiaphragmatic lymph node metastases;

I: Radiotherapy;

C: Lymphadenectomy;

O: Progression free survival;

T: 3 years

➢ Paticipants: STBI patients during inpatient rehabilitation with or without hyperbaric  oxygen adjunctive therapy

➢ Intervention: hyperbaric oxygen combined with rehabilitation therapy

➢ The control intervention(s): rehabilitation therapy

➢ The primary outcome: the Function Independent Measure (FIM) and the extended Glasgow Outcome Scale (GOSE)

➢ Time points: one years after STBI-related injury

➢ Intervention allocation: 50 patients in intervention subgroup and 50 in control subgroup

➢ Study design: Uncontrolled trial

➢ Objective: to demonstrate superiority of the test intervention over control intervention

Zhihua Zhang

My research question is

Immune therapy maintaining or just follow up? The choice for stage Ⅲ non-small cell lung cancer cases, who achieve pathological complete regression after new-adjuvant immunochemotherapy and subsequent R0 resection.

non-small cell lung cancer---NSCLC

pathological complete regression----PCR

population

Stage Ⅲ NSCLC cases, who achieve PCR after new-adjuvant immunochemotherapy and proceeding R0 resection.

Intervention

For these patients, the standard proceeding therapy does not exist yet, lack of convincing proof, either Immune therapy maintaining or follow up is recommended by some researchers and clinical doctors.

Control

Follow up group

The primary outcome

Recurrence free survival (RFS), rate

Overall survival (OS) rate

Adverse reaction (safety)

The time points of the primary outcomes

2-year recurrence free survival (RFS) rate,

5-year overall survival (OS) rate

Allocation of the intervention

1:1

Study design

Randomized controlled trial

Objective

Demonstrate the superiority of Immune therapy maintaining over control (follow up) for stage Ⅲ NSCLC cases, who achieve PCR after new-adjuvant immunochemotherapy and subsequent R0 resection.

High-risk population for prediabetes

D.2) Describe the new/test intervention:

digital therapy

D.3) Describe the control intervention(s):

Routine outpatient face-to-face management

D.4) Describe the primary outcome: (define the outcome of interest and describe how you plan to measure)

occurrence of prediabetes

D.5) Describe the time point(s) of the primary outcome measurement:

sixth month, twelfth month

D.6) How do you plan to allocate the intervention?

randomization

D.7) Study design. Randomized/Quasi-experimental/Uncontrolled trial:

Randomized trial

D.8) Objective – demonstrate superiority of the test intervention over control intervention, non-inferiority of intervention over standard, or equivalence of intervention over control:

superiority of the test intervention: Patients can be managed continuously outside the hospital

Does " Separation Surgery (surgery for spinal metastases with neurological symptoms)" improve patient outcomes?

Identify the study design to answer the question.

Are you interested in measuring the effects of an intervention? (Go to section D)

D.1) Describe the population:

Spinal metastases patients with spinal cord compression.

D.2) Describe the new/test intervention:

  Separation Surgery

D.3) Describe the control intervention(s):

radiotherapy

D.4) Describe the primary outcome: (define the outcome of interest and describe how you plan to measure)

Improvement in neurological function(eg: walking)

D.5) Describe the time point(s) of the primary outcome measurement:

  Maybe 3 months after the treatment?

D.6) How do you plan to allocate the intervention?

  It's up to the doctor and the patient to make a joint decision.

D.7) Study design. Randomized/Quasi-experimental/Uncontrolled trial:

  Uncontrolled trial

D.8) Objective – demonstrate superiority of the test intervention over control intervention, non-inferiority of intervention over standard, or equivalence of intervention over control:

Patients get better function, less pain.

Intervention (I): Patients exhibiting behavior of using the internet to search for medical information and treatment options.

Control (C): Patients not engaging in internet searches for medical information and treatment options.

Outcome (O): Incidence of complications in Crohn's Disease within a one-year period.

Study Type: A prospective cohort study.

Whether rTMS can be a safe and effective method in the treatment of Major syndrome (MS).

Objective

To explore the safety and efficacy of rTMS in MS by a single arm clinical trial, and to provide preliminary clinical evidence.

PICOT

Population/patients (P): Patients with Meige syndrome

Intervention (I): rTMS for 2 weeks

Comparison (C): pre-post

Outcomes (O):

1)Primary outcomes: Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS）

2)Secondary outcomes: Hamilton Depression Rating Scale, 24-item version (HAMD24)，Hamilton Anxiety Rating Scale, 14-item version (HAMA14), Short Form-36 Health Survey (SF-36)

3)Safety outcomes: headache, dizziness, mood swings, hearing impairment, epilepsy

Time (T): six months follow-up

Eligibility criteria

1)Inclusion criteria

1. Patients who were diagnosed with Meige’s syndrome.

2. Synchronous contraction of the bilateral orbicularis oculi muscle and explosive discharge of the bilateral orbicularis oris muscle were observed on facial electromyography before the operation.

3. Age >18 years old

2)Exclusion criteria

1. A history of Parkinson’s disease or tremor,

2. A history of Craniocerebral trauma, cerebral space-occupying lesions or cerebrovascular accident.

3. Metal implants inside or within the skull, such as aneurysm clips, metallic coils and deep brain stimulation electrodes.

4. Patients with severe psychotic symptoms (such as acute mania, acute phase of schizophrenia) or history of epilepsy.

D. Interventional studies:

Research question:

Complex high-risk Percutaneous Coronary Intervention (PCI) is not well defined, especially in surgically Ineligible patients.

IABP has limited support for these patients and does not have guidelines to recommend it.

The Safety and Efficacy of the Percutaneous LAVD (left ventricular assist device) for Intraoperative Circulatory Support during High-risk PCI, and superior to IABP.

D.1) Describe the population:

Patients with severe coronary artery disease who are undergoing High-risk PCI with stable hemodynamics.

D.2) Describe the new/test intervention:

Percutaneous LAVD (left ventricular assist device)

D.3) Describe the control intervention(s):

IABP (Intra-aortic Balloon Pump)

D.4) Describe the primary outcome: (define the outcome of interest and describe how you plan to measure)

The primary end point was the composite rate of intra- and postprocedural major adverse events (MAEs) at discharge or 30-day follow-up, whichever was longer. A follow-up of the composite primary end point was performed at 90 days.

The composite primary end point components included all-cause death, Q-wave or non–Q wave MI, stroke, or transient ischemic attack, any repeat revascularization procedure (PCI or coronary artery bypass grafting), need for a cardiac or a vascular operation (including a vascular operation for limb ischemia), acute renal insufficiency, severe intraprocedural hypotension requiring therapy, cardiopulmonary resuscitation or ventricular tachycardia requiring cardioversion, aortic insufficiency, and angiographic failure of PCI.

D.5) Describe the time point(s) of the primary outcome measurement:

30,60,90-day

D.6) How do you plan to allocate the intervention?

Randomized

D.7) Study design:

Prospective, Multi-center, Randomized controlled superiority Trial

D.8) Objective – demonstrate superiority of the test intervention over control intervention, non-inferiority of intervention over standard, or equivalence of intervention over control:

Superiority Trial

• Explain why these gaps need to be filled and how this trial can do that.

The purpose of this study was to solve the problem that patients could not be dissuade from chewing betel nut clinically, and to alleviate the abnormal keratosis of oral mucosa and the changes of oral submucosal fiber through oral vitamin A, so as to reduce the probability of oral mucosal cancer. Through 5-year clinical intervention, the change of incidence of oral cancer in people chewing betel nut was studied.

2. Study objective(s):

• Population

The betel nut chewing population in the social group was observed for 5 years, regardless of ag.

• Intervention

The patients who chewed betel nut were randomized, one group was given vitamin A, the other group was set up as a control, and the follow-up time was five year.

• Comparator

The prevalence of oral cancer after 5 years was compared.

• Outcome

The prevalence of oral cancer in patients with oral vitamin A prevention was significantly lower than that in the control group, indicating that vitamin A has an obvious effect on the prevention of oral cancer caused by betel nut.

P:Patients with ascending aortic aneurysm and aortic valve disease, with surgical indications and without contraindications

I:parasternal right anterior mini-thoracotomy

C: sternotomy

O: Primary outcome: Major adverse cardiovascular events (MACE: a composite endpoint of mortality, myocardial infarction, urgent revascularization, stroke and major bleeding) postoperative 30-day

Secondary outcomes:

All-cause mortality postoperative 30-day and 1 year

Total hospitalization costs

Total length of stay

Duration of the Operation，CPB and aortic clamping

  Quality of life - physical function

T: postoperative 30-day and 1 year

Study design: RCT

Objective:  Parasternal is non-inferiority vs Sternotomy in the operation of Wheat.

A new biological agent, UST, is used to treat Crohn's Disease (CD). The standard treatment involves intravenous (IV) induction twice, followed by subcutaneous (SC) maintenance (every 4-12 weeks, adjusted based on condition). However, in China, the price of SC UST is significantly higher than IV UST. Therefore, IV UST (every 4-12 weeks, adjusted based on condition, 3-12 times a year) for maintenance treatment is common in our center. The safety and efficacy of IV maintenance therapy are unclear. Retrospective analysis is conducted.

P (Population):

Patients with CD in the Zhejiang University Second Hospital cohort who have received more than two IV UST inductions for maintenance within one year.

I (Intervention):

High frequency of IV UST inductions (e.g., more than 4 times a year).

C (Comparison):

Low frequency of IV UST inductions (e.g., 3-4 times a year within a year).

O (Outcome):

Primary outcome: Clinical remission rate at six months and one year.

Secondary outcome: Endoscopic remission rate at one year (approximately 50% will undergo endoscopy). Safety.

Question:

Can this complicated situation (unstable dosage and interval) be considered a retrospective observational study of a cohort?

If so, what should the I and C be? Is what I wrote above acceptable? If using the number of inductions, which one between 3-12 is appropriate? Based on experience?

If grouping by the number of inductions, the baseline of the two groups will definitely differ (e.g., those with more inductions have a higher baseline severity). Can these differences be interpreted as possible correlations (e.g., those with more severe baseline conditions may require more inductions)? How should the data be presented?

Is it possible to analyze the differences in baseline characteristics between patients with and without endoscopic remission within one year? Can multiple factor analysis be used?

Can I have another study？

Since some patients in the cohort are also receiving SC UST maintenance therapy, can a separate retrospective study be conducted?

for example：

P (Population):

Patients with CD in the Zhejiang University Second Hospital cohort who have been treated with UST for over one year.

I (Intervention):

Intermittent or continuous IV UST maintenance (defined as more than 2 times a year).

C (Comparison):

SC UST maintenance, with low frequency of IV inductions (e.g., 1-2 times a year).

O (Outcome):

Primary outcome: Clinical remission rate at six months and one year. Secondary outcome: Endoscopic remission rate at one year. Safety.

Can I have another study？

Since some patients in the cohort are also receiving other biological agents (such as Infliximab, IFX) for maintenance therapy, can a separate retrospective study be conducted?

P (Population):

Patients with CD in the Zhejiang University Second Hospital cohort who have been treated with biological agents for over one year.

I (Intervention):

UST treatment.

C (Comparison):

IFX treatment.

O (Outcome):

Primary outcome: Clinical remission rate at six months and one year. Secondary outcome: Endoscopic remission rate at one year. Safety.

Can I have another study？

In the cohort, there are also patients who switched from IFX to UST after ineffectiveness, or vice versa. How should these data be analyzed and compared?

Please note that the translation provided is a direct translation of the provided text, and some medical terms and specific details may require further clarification or adaptation based on the actual context and standard medical terminology in English.

Thanks a lot!

• Population:  Highly active rheumatic polymyalgia

• Intervention:  ivarmacitinib 2mg/d  12 weeks

• Comparator: Prednisone or equivalent dose of methylprednisolone for 12 weeks

• Outcome: At weeks 12 , all patients in both groups (100%) had PMR-AS<10

P: Unplanned ICU readmission within 3 days

I/E: Preventable ICU readmission

C: Unpreventable ICU readmission

O: Likelihood that an ICU readmission could have been prevented.

Participants: Patients with endotracheal intubation in the intensive care unit

Inclusion criteria:

①　Age over 18 years old

②　Require mechanical ventilation

③　Admitted to intensive care unit

Exclusion criteria:

①　GCS score less than 5

②　Upper limb amputation

③　Paraplegia

④　Pregnant women

⑤　Brain dead

⑥　People with no civil capacityMain

Intervention: AI-assisted early warning of agitation behavior

Control: Conventional agitation behavior early warning identification

Outcome:

Primary outcome: Incidence of agitation behavior and accidental extubation

Secondary outcomes: Shorten the effective treatment time of agitation behavior and shorten the hospital stay in the intensive care unit

Time: 1 year

1. Proposed study title:

Effectiveness of Unfractionated Heparin During Endovascular Thrombectomy for Large Vessel Occlusion

Short title: HEAT (Heparin Effectiveness in Endovascular Thrombectomy)

2. Background:

Acute ischemic strokes represent approximately 87% of all stroke cases, with large vessel occlusions (LVOs) accounting for about 24-46% of these cases. The mortality rates for LVO strokes are exceptionally high. Even with treatment, many survivors suffer significant long-term disabilities. Endovascular thrombectomy for LVO patients has been shown to significantly improve outcomes if performed promptly. Despite the effectiveness of endovascular thrombectomy, there remains uncertainty about the perioperative management, including the optimal use of anticoagulants such as unfractionated heparin during the procedure.

3. Rationale:

Unfractionated heparin is routinely employed in non-acute neurointerventional procedures, such as balloon angioplasty or stent placement for intracranial and extracranial arterial stenosis, due to its efficacy in reducing perioperative thrombosis complication. However, during thrombectomy for acute large vessel occlusion, there are concerns that its use may increase the hemorrhagic risk because the reperfusion injury following recanalization inherently carries a high risk of hemorrhage. Nevertheless, unfractionated heparin has potential benefits, including the reduction of secondary thrombosis caused by endothelial damage during the thrombectomy procedure. Therefore, the effectiveness and safety of unfractionated heparin in this acute setting remain uncertain.

The MR CLEAN-MED trial results, published in The Lancet in 2022, indicated that unfractionated heparin increased the risk of hemorrhage. However, most patients in this study had received intravenous thrombolysis, which may not be the ideal population, as the combination of intravenous thrombolysis and heparin could synergistically elevate the bleeding risk. Consequently, there is a need for new randomized controlled trials (RCTs) to specifically evaluate the effectiveness and safety of unfractionated heparin in patients undergoing thrombectomy without intravenous thrombolysis, to provide more definitive evidence.

4. Study objective(s):

• Population

acute large vessel occlusion patients who are treated with endovascular thrombectomy

• Intervention

Use of unfractionated heparin during endovascular thrombectomy

• Comparator

Endovascular thrombectomy without the use of unfractionated heparin

• Outcome

Primary outcome

1. Proportion of patients who will be independent at 3 months (using mRS ≤2 taken as a good outcome)

Secondary outcome

1. Proportion of patients who achieve recanalization mTICI grade 2c/3 at the end of the EVT procedure.

2. Rate of symptomatic ICH as defined using ECASS II criteria

5. Eligibility criteria (to be completed on Day 9)

Inclusion criteria

1. Age ≥18 years.

2. Patients with AIS Within 24 hours of onset of stroke.

3. Presence of a proximal large vessel occlusion (Distal Internal Carotid artery (ICA), M1 Middle Cerebral artery (MCA), proximal M2 MCA, Basilar artery) on CTA/MRA.

4. Do not receive intravenous thrombolysis

5. Eligible for endovascular treatment (EVT) as per the current guidelines.

6. Informed and signed consent.

Exclusion criteria

1. History of ICH, subarachnoid haemorrhage, arteriovenous malformation, aneurysm or cerebral neoplasm.

2. Onging Gastrointestinal, respiratory or urinary bleeding.

3. Clinically significant hypoglycaemia.

4. Persistently elevated blood pressure greater than 180 mmHg systolic and 110 mmHg diastolic.

5. Hereditary or acquired haemorrhagic diathesis.

6. Active pregnancy.

7. Any condition that, in the judgement of the investigator, could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

Kidney stones are a common urological condition with a high recurrence rate. Approximately 60% of patients experience recurrence after initial treatment, with recurrence rates reaching 70-80% within 2-3 years of treatment. Low-Intensity Pulsed Ultrasound (LIPUS) can interfere with the formation and attachment of crystals in the urine through physical oscillation, thereby preventing the recurrence of kidney stones. This modality also reduces inflammation and pain associated with kidney stones, potentially lowering the recurrence rate.

PICO Summary

· Population (P): Patients who have undergone initial treatment for kidney stones.

· Intervention (I): Low-Intensity Pulsed Ultrasound (LIPUS) therapy.

o Group 1: 28 KHz, 1.0 W, 3 times per week, 10 minutes per session.

o Group 2: 28 KHz, 0.5 W, 3 times per week, 10 minutes per session.

· Comparison (C): Standard care without LIPUS therapy.

· Outcome (O): Time to stone recurrence and 2-year recurrence rate.

the Effectiveness of U-AKIpredTM in Predicting Acute Kidney Injury within 12 Hours in Critically Ill Patients：a prospective multicenter cohort study

2. Background:

The incidence of AKI in critically ill patients ranges from 30% to 50%. The mortality rate for critically ill patients with AKI is significantly higher than for those without AKI, reaching 50% to 70%.

It is clear that the availability of large high-resolution datasets combined with novel statistical and machine learning tools opens opportunities to develop and validate robust predictive models for acute kidney injury of potential benefit in patient care and risk stratification.

Furthermore, we aim to validate the effectiveness of U-AKIpred™ in early warning of acute kidney injury in critically ill patients through a multicenter prospective cohort study.

3. Rationale:

The current AKI diagnosis standards are based on serum creatinine and urine output indicators. The sensitivity and specificity of serum creatinine for AKI diagnosis are suboptimal, and serum creatinine often increases with a delay when kidney injury occurs. Urine output can be easily influenced by fluid infusion, diuretics, hemodynamics, and measurement biases, making it an inaccurate reflection of kidney damage.

Early prediction indicator of AKI for critical ill Patients is crucial for the early diagnosis and early intervention of AKI, which is of great significance in improving the prognosis of critically ill patients with AKI."

4. Study objective(s):

• Population：critically ill patients admitted to the ICU

• Intervention： Positive group: U-AKIpredTM ≥ cutoff

• Comparator：Negative group: U-AKIpredTM ＜ cutoff ,

• Outcome：AKI Occurrence within 48 Hours.

5. Eligibility criteria (to be completed on Day 9)

Inclusion Criteria:

1）Critically ill patients admitted to the ICU

2）Age ≥ 18 years old;

3）ICU stay ≥ 24 hours;

4）At the time of enrollment, the APACHE score of critically ill patients is ≥ 15.

Exclusion Criteria:

1）Patients who have developed acute kidney injury (AKI) upon admission to the ICU

2）Patients who have developed acute renal disease other than AKI upon admission to the ICU: eGFR < 60 ml/min/1.73 m², or a decrease in GFR by ≥ 35%, or an increase in serum creatinine > 50%, within less than 3 months;

3）Patients who have developed chronic kidney disease (CKD) upon admission to the ICU

4）Patients who have previously undergone renal dialysis;

5）Patients with a renal transplant;

6）Pregnant women.

4. Study objective(s):

• Population

Adults with active, moderate-to-severe Crohn’s disease (Crohn’s Disease Activity Index [CDAI] 220–450 and Simple Endoscopic Score in Crohn’s Disease [SES-CD] ≥3) for whom  incomplete response to Ustekinumab

• Intervention 

Administering UST intravenous maintenance (two injections of 360mg, intravenously every 8 weeks).

• Comparator 

Standard subcutaneous intensification （90mg，Subcutaneous injection (every 4 to 8 weeks, adjust the injection interval according to the condition).

• Outcome

Primary outcome：

Endoscopic response at week 48 (SES-CD score ≥50% decrease from baseline)

Secondary outcome：at week 48

Clinical response：(HBI ≥3 or CDAI ≥70)

Clinical remission：(HBI ≤4 or CDAI ≤150)

Biochemical response：CRPo r FCP ≥50%decrease from baseline 

Biochemical remission：FCP<250 μg/g, CRP<5mg/L

Endoscopic remission：SES-CD ≤2，absence of mucosal ulcer     

5. Eligibility criteria (to be completed on Day 9)

Add participant inclusion and exclusion criteria (take ethics, safety, statistical power, generalizability and feasibility into consideration)

Inclusion criteria

1、 18-80  age old;

2、  Active Crohn's Disease (CD) patients  meet at least one of the following objective criteria:

- C-reactive protein (CRP) > 5 mg/L

- Fecal calprotectin (Fc) > 250 µg/g

- Radiological evidence of disease activity

- Endoscopic evidence of disease activity

- And/or Harvey-Bradshaw Index (HBI) > 4 or Crohn's Disease Activity Index (CDAI) ≥ 150 (clinical scores not used as the primary reference)

3、 Have a baseline colonoscopy result (within 6 months) and  colon involved lesion

4、 Experience  incomplete response to Ustekinumab 90 mg administered every 8 weeks or 12 weeks (having received at least one subcutaneous injection after intravenous induction).

incomplete response as defined lack of improvement of clinical symptoms after initial improvement of symptoms, according to the physician’s judgement

Exclusion criteria

1 、With significant stenosis ;

2、With elevated inflammatory markers due to infections in other areas;

3、Patients who have undergone surgery within the past 2 weeks or are planning surgery in 2 months;

4、Pregnant or lactating women

5、with stoma

1. Proposed study title:

• Ensure the title concisely conveys the main aspects of the study, as much as possible, (population, intervention, comparator, and outcome) and identifies the study as a clinical trial

Implementing of a Nudge-Inspired AI-Driven electronic monitoring system improved hand hygiene compliance in the intensive care unit

2. Background: 

• Describe the significance of the health issue being addressed

• Include statistics on disease burden, such as prevalence, morbidity, mortality, impact on quality of life, and economic burden.

• If relevant, discuss current prevention and/or management strategies.

Hospital-acquired infections present a significant global health challenge,

Results show an initial 100% bacterial carriage rate among healthcare workers, significantly reduced to 20.8% after handwashing, demonstrating the effectiveness of standardized hand hygiene protocols in decreasing the risk of hospital-acquired infections by 30% to 50%.

 3. Rationale:

• Identify specific gaps in the current knowledge or clinical practice that the study aims to address.

• Explain why these gaps need to be filled and how this trial can do that.

Inadequate adherence to hand hygiene protocols leads to the unchecked spread of hospital-acquired infections, resulting in prolonged patient hospitalizations, increased financial burdens, and heightened workloads for medical personnel and institutions

4. Study objective(s):

• Population

healthcare workers：  nurses,

 patient care assistants,

 doctors,

• Intervention

The EHHMS, incorporating facial recognition, motion tracking, sensor positioning, and voice reminders, enabled real-time monitoring and feedback on hand hygiene practices among healthcare personnel.

• Comparator

Hand hygiene compliance and quality were compared before and after the EHHMS intervention.

• Outcome

hand hygiene compliance rates, proficiency rates of hand hygiene performance,

5. Eligibility criteria (to be completed on Day 9)

Add participant inclusion and exclusion criteria (take ethics, safety, statistical power, generalizability and feasibility into consideration)

Inclusion criteria：

   Doctors, nurses, and care workers working in the ICU

Exclusion criteria：

    Refusing to join the study (poor compliance)

Failure to enter hand hygiene examination data

Population: patients with single isthmic thyroid cancer (cT1bN0M0)

Intervention: less than total thyroidectomy

Comparator: total thyroidectomy

Outcomes: primary outcome: recurrence(for intervention group: ultrasound; for comparator group: ultrasound and Tg level); Secondary outcome: quality of life (Thypro-Qol), surgical complications(hematoma, transient/permanent hypoparathyroidism, transient/permanent RLN injury )Outcomes measured at post-operation 1,3,6,12,24month

inclusion criteria:

1. patients with solitary PTC located in the thyroid isthmus

2. cT1bN0M0

3. age >18

exclusion criteria:

1. Patients with clinically suspected cervical lymph node metastasis

2. patients with clinically suspected gross extrathyroidal extension

3. patients with suspicious nodules at the thyroid gland other than the thyroid isthmus on pre- operative imaging

4. patients with other types of malignancy

Treatment guided by bronchial provocation test or peak flow meter in addition to standard care in adult CTVA: a prospective RCT

2. Background:

The prevalence of asthma among adults in China is 4.2%, with a total number of adult patients reaching 45.7million, far exceeding estimates. Including children, China has nearly 60 million asthma patients. The large number of patients leads to a heavy burden of disease. The diagnosis and treatment rates of asthma patients in China are relatively low. Chest tightness variant asthma (CTVA) is an atypical form of asthma, characterized by chest tightness as the primary symptom, without the typical asthma symptoms such as recurrent wheezing and shortness of breath. It is a condition that can be easily overlooked or misdiagnosed due to its lack of typical asthma symptoms and signs, and it is prone to being missed or misdiagnosed. A cross-sectional study from China found that among 9,318 patients with AHR (Airway Hyperresponsiveness), 1,024cased of typical asthma(10.99%)，3,247 cases of cough-variant asthma (34.85%), and 1,159 cases of CTVA (12.44%), with an asthma incidence rate of 58.27%. Currently, the awareness of CTVA needs to be further enhanced, and how to standardize the treatment of this disease also requires further support from evidence-based research.

3.Rationale:

Currently, the understanding and evidence of Chest Tightness Variant Asthma (CTVA) in the world is not sufficient, and CTVA has not yet been included in the international guidelines GINA. Based on the expert consensus on CTVA in China，the treatment principles for CTVA are the same as typical asthma. If the symptoms of CTVA are controlled and lung function is stable for more than 3 months, it is considered to downgrade the treatment. However, the optimal treatment plans and treatment courses of the CTVA are still not well defined. Therefore, there is an urgent need for more effective approaches to guide clinical treatment.

4.Study objective(s):

• Population

adult CTVA patients

• Intervention

Group A: Asthma treatment guided by symptoms plus bronchial provocation test

Group B: Asthma treatment guided by symptoms plus a weekly variability in diurnal peak expiratory flow (PEF)

• Comparator

Asthma treatment guided by symptoms alone (standard care)

• Outcome

The primary outcome measure: asthma exacerbations treated with oral corticosteroids in the year post randomisation.

 Secondary outcomes included time to first exacerbation, number of exacerbations, lung function, fractional exhaled nitric oxide, daily dose of inhaled corticosteroid, asthma control and quality of life.

5.Eligibility criteria:

Add participant inclusion and exclusion criteria (take ethics, safety, statistical power, generalizability and feasibility into consideration)

Treatment-naive CTVA patients (14-80 years of age) who had a history of chest tightness for at least 6 months. The definition of CTVA was made based on the chest tightness being the sole symptom and at least one of the following conditions was met: (a) an increase of >12% and >200 mL in forced expiratory volume in 1s(FEV1) after inhaling salbutamol; (b) airway hyperresponsiveness as evidenced by a positive finding of bronchial provocation test; (c) a weekly variability in diurnal peak expiratory flow (PEF) of greater than 10%; and (d) a marked clinical improvement in response to β2 receptor agonists, with or without inhaled corticosteroids (ICS). All patients were treated with ICS plus long-acting β2 receptor agonist based on the Global Initiative for Asthma (GINA) guidelines.

For patients with primary, localized extremity and truncal soft tissue sarcoma(STS) following an unplanned excision, compared with preoperative radiotherapy and oncologic resection,  does postoperative RT have a lower local recurrence?

• Population

patients with primary, localized extremity and truncal soft tissue sarcoma(STS) following an unplanned excision

• Intervention

oncologic resection and postperative radiotherapy

• Comparator

preoperative radiotherapy and oncologic resection

• Outcome

First outcome：  Local recurrence

Second outcome：Overall survival, wound complications, post-treatment function

Including criteria：

Primary, localized extremity and truncal soft tissue sarcoma

With an unplanned excision

Diagnosis of by an approved reference pathologist

Age >15 years

Written informed consent

Chest CT

Local CT and  MRI

Exclusion criteria：

Previous chemotherapy

Previous radiotherapy to the local site Chemotherapy needed for this soft-tissue sarcoma

 Age <15 years

Presence of regional or distant metastasis, Previous or concurrent malignant disease Histologies generally treated with chemotherapy

Embryonal and alveolar rhabdomyosarcoma

Soft-tissue osteosarcoma and Ewings’ sarcoma

Primitive neuroectodermal tumour

Benign histologies

Dermatofibrosarcoma protruberans

Aggressive fibromatosis

ICL size selection

2. Background:

ICL (Implantable Collamer Lens) operation is an innovatiove surgery for the treatment of high myopia,or the patients not fit corneal refractive surgeries, has been for only 10 years aroud. So far, the intraocular lens provided by Staars only have 4 sizes,and Staars provides an online calculator to guide the lens choice. Now the choice made by operators commonly based on combiding experience and calculate formula, determines the postoperative vault of the lens and the complication possibility.  Operaror’s experience has a significant impact.

3. Rationale:

For operaror’s experience, there haven’t been regular formula or convergence to monitor the lens selection, which seems to be subject.

4. Study objective(s):

• Population

Myopia patients tend to receive ICL operation

May divided into different groups depending on refractive statu/ axial length 

• Intervention

New selection principle including newly introduced factors

• Comparator

Normal online calculator nomogram

• Outcome

Primary: vault postoperative

Second: complication as intraocular pressure, anterior chamber depth

5．            Eligibility criteria (to be completed on Day 9)

Include & Exclude criteria: same as the usual surgical criteria

As the common lens selection now is sometimes subject up to operators’experince to some extent, the design of this study just wants to decrease the centainty. And I also plan to a repeated assessment reseach at first to analyse the bias between the two assessments by the same operator.

• Population

Central Serous Chorioretinopathy patients

• Intervention

patients with IVA

• Comparator

patients with Subthreshold Micropulse Laser Therapy

• Outcome

The clinical effectiveness and anatomical changes of SML and IVA in the treatment of CSCR.

D.1) Describe the population:

Central Serous Chorioretinopathy patients

D.2) Describe the new/test intervention:

IVA

D.3) Describe the control intervention(s):

SML

D.4) Describe the primary outcome: (define the outcome of interest and describe how you plan to measure)

The clinical effectiveness and anatomical changes of SML and IVA in the treatment of CSCR.

The changes in best-correct visal acuity (BCVA), central retinal thickness (CRT), subretinal fluid (SRF) and subfoveal choroidal thickness (SFCT) values from OCT at 1^st month, 3^rd month, 6^th month,12^th month of follow-up visit were evaluated among the groups.

D.5) Describe the time point(s) of the primary outcome measurement:

First month,third month, sixth month, twelfth month

D.6) How do you plan to allocate the intervention?

randomization

D.7) Study design. Randomized/Quasi-experimental/Uncontrolled trial:

Randomized trial

D.8) Objective – demonstrate superiority of the test intervention over control intervention, non-inferiority of intervention over standard, or equivalence of intervention over control: equivalence or noninferiority

superiority of the test intervention: Anti-VEGF(IVA) Therapy can be used for Refractory Central Serous Chorioretinopathy patients.

Research Gap

There is currently a lack of systematic clinical research on the application of energy CT in assessing intestinal ischemia in elderly patients with partial intestinal obstruction and the effect of pentoxifylline on the recovery of intestinal function. Although previous studies have reported the therapeutic effects of pentoxifylline on other conditions, its use in patients with intestinal ischemia has not been fully validated.

Significance of Addressing the Gap

Addressing this research gap is crucial for several reasons:
1. Accurate Diagnosis: The study will validate the accuracy of energy CT in assessing intestinal ischemia in elderly patients with partial intestinal obstruction, providing new evidence for clinical diagnosis.
2. New Treatment Strategies: The study will explore the role of pentoxifylline in improving intestinal ischemia and promoting intestinal function recovery, offering new treatment strategies for elderly patients with partial intestinal obstruction.
3. Improved Prognosis: Early and accurate diagnosis and effective treatment can improve patient prognosis and quality of life.

PICO Summary

Population (P): Patients aged 60 and above diagnosed with partial intestinal obstruction without indications for emergency surgery
Intervention (I): Use of energy CT to detect intestinal ischemia and addition of pentoxifylline to standard treatment
Comparison (C): Standard treatment (including fasting and gastrointestinal decompression)
Outcome (O): Time to recovery of gastrointestinal function, proportion of patients requiring emergency surgery, improvement in intestinal ischemia

Background

Partial intestinal obstruction is a common clinical condition, particularly in elderly patients over the age of 60. As people age, intestinal function gradually declines, leading to an increased incidence of intestinal obstruction. Patients with partial intestinal obstruction usually do not have indications for emergency surgery and require conservative treatment. However, intestinal ischemia caused by obstruction can lead to further deterioration of intestinal function, affecting the prognosis and quality of life of patients. Energy CT, an advanced imaging technology, can accurately assess intestinal ischemia without adding to the patient's burden. Pentoxifylline is a drug known for its anti-inflammatory, antioxidant, and microcirculation-promoting effects. It may play a significant role in improving intestinal ischemia and promoting the recovery of intestinal function.

Research Gap

There is currently a lack of systematic clinical research on the application of energy CT in assessing intestinal ischemia in elderly patients with partial intestinal obstruction and the effect of pentoxifylline on the recovery of intestinal function. Although previous studies have reported the therapeutic effects of pentoxifylline on other conditions, its use in patients with intestinal ischemia has not been fully validated.

Significance of Addressing the Gap

Addressing this research gap is crucial for several reasons:

1. Accurate Diagnosis: The study will validate the accuracy of energy CT in assessing intestinal ischemia in elderly patients with partial intestinal obstruction, providing new evidence for clinical diagnosis.

2. New Treatment Strategies: The study will explore the role of pentoxifylline in improving intestinal ischemia and promoting intestinal function recovery, offering new treatment strategies for elderly patients with partial intestinal obstruction.

3. Improved Prognosis: Early and accurate diagnosis and effective treatment can improve patient prognosis and quality of life.

Study Design

This study will use a randomized controlled trial (RCT) design. Participants will be elderly patients (aged 60 and above) diagnosed with partial intestinal obstruction who do not have indications for emergency surgery and require conservative treatment.

Inclusion Criteria

- Aged 60 years and above

- Clinically diagnosed with partial intestinal obstruction

- No indications for emergency surgery

- Requires conservative treatment

- Has signed an informed consent form

Exclusion Criteria

- Allergic to CT contrast agents

- Recently underwent abdominal surgery

- Severe heart, liver, or kidney dysfunction

- Severe mental illness or inability to cooperate with the study

Study Procedure

1. Admission Assessment: All admitted patients will undergo energy CT to assess the presence of intestinal ischemia.

2. Randomization:

- Patients with intestinal ischemia who do not have indications for surgery will be randomly divided into two groups:

- Control Group: Receives standard treatment, including fasting and gastrointestinal decompression.

- Experimental Group: Receives standard treatment plus pentoxifylline.

3. Outcome Measures:

- Time to recovery of gastrointestinal function

- Proportion of patients requiring emergency surgery

- Improvement in intestinal ischemia

PICO Summary

Population (P): Patients aged 60 and above diagnosed with partial intestinal obstruction without indications for emergency surgery

Intervention (I): Use of energy CT to detect intestinal ischemia and addition of pentoxifylline to standard treatment

Comparison (C): Standard treatment (including fasting and gastrointestinal decompression)

Outcome (O): Time to recovery of gastrointestinal function, proportion of patients requiring emergency surgery, improvement in intestinal ischemia

Ethical Considerations

Ethical Review

The study protocol must be approved by the hospital's Ethics Committee.

Informed Consent

All participants must sign an informed consent form, clearly understanding the study's purpose, process, and potential risks.

Study Timeline

Preparation Phase: 3 months (including ethical approval, research team training, etc.)

Recruitment and Intervention Phase: 12 months

Follow-up and Data Collection Phase: 6 months

Data Analysis and Reporting Phase: 3 months

Expected Results

Improved Diagnosis: Validate the accuracy of energy CT in assessing intestinal ischemia in elderly patients with partial intestinal obstruction, providing new evidence for clinical diagnosis.

Enhanced Treatment Efficacy: Explore the role of pentoxifylline in improving intestinal ischemia and promoting intestinal function recovery, offering new treatment strategies for elderly patients with partial intestinal obstruction.

Better Quality of Life: Early and accurate diagnosis and effective treatment can improve patient prognosis and quality of life.

• Ensure the title concisely conveys the main aspects of the study, as much as possible, (population, intervention, comparator, and outcome) and identifies the study as a clinical trial

Randomized Controlled Study on the Reduction of Medical Costs and Improvement of Medical Efficiency through Remote Imaging Platforms

2. Background: 

• Describe the significance of the health issue being addressed

• Include statistics on disease burden, such as prevalence, morbidity, mortality, impact on quality of life, and economic burden.

• If relevant, discuss current prevention and/or management strategies.

With the advancement of medical technology and information technology, telemedicine has become an important means to improve the accessibility and efficiency of medical services. Remote imaging platforms can transmit imaging examination results to expert centers for diagnosis and consultation, thereby shortening diagnosis time, improving diagnostic accuracy, and potentially reducing medical costs. However, existing studies lack systematic evaluations of the specific effects of remote imaging platforms on reducing medical costs and improving medical efficiency. This study aims to assess the economic benefits and efficiency improvements of remote imaging platforms in clinical practice through a prospective randomized controlled trial (RCT).

3. Rationale:

• Identify specific gaps in the current knowledge or clinical practice that the study aims to address.

• Explain why these gaps need to be filled and how this trial can do that.

Current studies on remote imaging platforms mainly focus on technical implementation and preliminary application effects, with insufficient systematic evaluation of their effects on reducing medical costs and improving medical efficiency. Specifically, there is a lack of multicenter, large-sample prospective randomized controlled trials to verify their effects in real clinical settings. This research gap limits the broader application and promotion of remote imaging platforms.

Filling this research gap is essential because it will:

This study will provide high-quality evidence to demonstrate the actual effects of remote imaging platforms on reducing medical costs and improving medical efficiency. This will help promote the wider application of remote imaging platforms, improve the quality of medical services and patient satisfaction, and ultimately achieve optimal allocation of medical resources and equitable access to healthcare services.

4. Study objective(s):

• Population

Patients aged 18 years and older requiring imaging diagnosis

• Intervention

Remote imaging platform for imaging diagnosis and consultation

• Comparator

Traditional imaging diagnosis and consultation methods

• Outcome

Medical costs (direct and indirect costs), medical efficiency (diagnosis waiting time, report generation time, total time from diagnosis to treatment), diagnostic accuracy (sensitivity, specificity, predictive values), patient satisfaction.

5. Eligibility criteria (to be completed on Day 9)

Add participant inclusion and exclusion criteria (take ethics, safety, statistical power, generalizability and feasibility into consideration)

Inclusion Criteria

· Age: Patients aged 18 years and older.

· Imaging Requirement: Patients requiring imaging diagnosis such as X-ray, CT, MRI, etc.

· Informed Consent: Patients who have signed the informed consent form.

Exclusion Criteria

· Allergy: Patients known to be allergic to imaging contrast agents.

· Pregnancy and Lactation: Pregnant or breastfeeding women.

· Mental Health: Patients with severe mental disorders or those unable to cooperate with the study.

Study objective(s):

• Population：Non-elderly patients with severe TBI

• Intervention：Hyperbaric oxygen therapy+ standard rehabilitation, participants were divided into two subgroups based on the quantity of hyperbaric exposures: low exposure (20 sessions) and high exposure (40 sessions).

• Comparator：Standard rehabilitation

Outcome

Primary outcome measure: The Glasgow Outcome Scale-Extended (GOSE)

Secondary outcome measure: The Function Independent Measure (FIM)

Exploratory outcome measure: Diffusion Tensor Imaging MR sequences

Eligibility criteria

Inclusion criteria:

1)age range of 18 to 60 years at the time of injury;

2)Glasgow Coma Scale (GCS) score <8 on emergency admission or GCS score ≥ 13 in emergency department but fell to less than 13 within 48 hours after injury;

3)HBO treatment within 90 days after injury.

Exclusion criteria:

pre-morbid cognitive and/or psychiatric disorders, pregnancy, history of severe coagulopathy, severe multiple organ failure, penetrating brain damage, history of intracranial diseases, and spinal cord injury.

1.      Proposed study title:

Surgical options for medial collateral ligament repair in terrible triad injury of the elbow – a randomized controlled trial

2.      Background:

Terrible triad injury is a rare fracture-dislocation combination which consists of the posterior elbow dislocation, fractures in the radial head and coronoid process. Recently, a systematic protocol for surgical treatment was advocated based on the anatomical and biomechanical knowledge. Although this algorithmic approach could lead to improve the outcomes in terms of elbow pain and its function, there remain some problems postoperatively including heterotopic ossification and arthrosis.

3.      Rationale:

Even with use of the established guideline, postoperative arthrosis still remains with the prevalence of approximately 8-67% over 1-year follow-up. To date, it is still controversial whether surgical approach to the MCL should be performed or not. A small-scale study indicated that pathological findings could occur in association with unrepaired MCL.  Further high-quality study should be required to determine if such arthritis findings could occur in association with unrepaired MCL.

4.      Study objective(s):

• Population

Patients with terrible triad injury

• Intervention

Standard surgery+ MCL repair

• Comparator

Standard surgery

• Outcome

Primary: incidence of arthritis at last follow-up (24 months)

Secondary:  elbow motion, elbow function, fracture healing rate, ulnar nerve damage