linjc16/ctgov huggingface dataset:
Neuropathy Evaluation Using the Vibration of a Mobile Phone

Study Overview
=================
Brief Summary
-----------------
A single centre validation/method comparison study of the experimental NERVE device for the measurement of vibration perception threshold against the established 'Neurothesiometer' device, evaluating agreement and reliability. It will also include collecting feedback from patients, carers and clinicians on the usability of the device

Official Title
-----------------
Neuropathy Evaluation Using the Vibration Function of a Mobile Phone - the NERVE Study

Conditions
-----------------
Diabetic Foot

Intervention / Treatment
-----------------
* Diagnostic Test: Neurothesiometer
* Diagnostic Test: NERVE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Formally Diagnosed With Diabetes Exclusion Criteria: 1. Un- willing or un-able to provide free informed consent (no time limit) 2. Un-willing or un-able to comply with all protocol requirements including study assessments; 3. Bilateral foot ulcers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Person With Diabetes<br>A health care professional will conduct the vibration perception threshold testing using both the Neurothesiometer and NERVE diagnostic testing on the person with diabetes. The person with diabetes will conduct the vibration perception threshold testing using the NERVE device. There is an option for a carer/buddy to conduct the vibration perception threshold testing with the NERVE device on the person with diabetes. | Diagnostic Test: Neurothesiometer<br>* The 'gold standard' device for Vibration Perception Threshold testing<br>Diagnostic Test: NERVE<br>* The experimental device for Vibration Perception Threshold testing developed by the project team<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vibration Perception Threshold (volts) as measured by Health Care Professionals | Measured using Neurothesiometer and NERVE device | Baseline | 
| Vibration Perception Threshold (volts) as measured by Health Care Professionals | Measured using Neurothesiometer and NERVE device | Follow up within baseline visit | 
| Vibration Perception Threshold (volts) as measured by person with diabetes | Measured using NERVE device | Baseline | 
| Vibration Perception Threshold (volts) as measured by person with diabetes | Measured using NERVE device | Follow up within baseline visit |
An In Depth Study Evaluating The Experiences of Patients In Schizophrenia Research

Study Overview
=================
Brief Summary
-----------------
Historically, research participation has been biased toward certain demographics. However, there is a shortage of studies that delve into the underlying factors that influence patient participation, both positively and negatively. Several people will be invited to enroll in this study so that it may collect a variety of data about schizophrenia clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal. The data collected from this study will be analyzed and used to improve the experiences of future schizophrenia patients who are recruited for medical trials.

Official Title
-----------------
Pinpointing the Factors Affecting Clinical Study Experiences of Schizophrenia Patients

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has self-identified as planning to enroll in a clinical trial Patient has been diagnosed with schizophrenia Patient is a minimum of 18 years or older Exclusion Criteria: Patient does not understand, sign, and return consent form Inability to perform regular electronic reporting Patient is pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who decide to participate in a schizophrenia research |  | 3 months | 
| Rate of patients who remain in schizophrenia clinical trial to trial completion |  | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia
The Spinopelvic Parameters, Body Mass Index and Waist Circumference in Patientd Chronic Non-specific Low Back Pain

Study Overview
=================
Brief Summary
-----------------
This pilot study aims at styding the correlations between body mass index, waist circumference and the potential for positional adaptation of the pelvis to support overweight or obesity

Detailed Description
-----------------
Record cards of patients presenting with non specific low back pain between January 1st 2020 and December 23rd 2022 were analysed. All included patients had undergone a full spine X-ray allowing to calculate the pelvic index (PI). Weight status was described in 4 categories, in-line with the WHO definitions; Underweight (boddy mass index (BMI)) < 18.5 kg/m²; normal weight BMI 18.5 - 24.9 kg/m² , overweight BMI 25 - 29.9 kg/m², and obesity BMI ≥ 30 kg/m². To identify people with increased BMI-values and central (abdominal) fat distribution, we used the waist circumference (WC). The cut-off points of waist measurement that are used are 102 cm and 88 cm for men and women respectively. A high sacral slope (SS) means a greater the lumbar curvature, which results in a dynamic back. Due to the correlation between SS and PI, people with high PI values generally have higher values of SS. Therefore types 1 and 2 have a low-grade PI and types 3 and 4 have a high-grade PI Analysis of 272 patient records, shows that the mean PI is significantly different in the group with a low WC compared with the group with a high WC. BMI and WC show a significant correlation with PI

Official Title
-----------------
The Spinopelvic Parameters, Body Mass Index and Waist Circumference in Patients With Chronic Non-specific Low Back Pain: an Observational Cross-sectional Correlation Study

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Measurement of baseline characteristics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presenting with non-specific low back pain having undergone full spine X-ray during the diagnostic proces Exclusion Criteria: patients with missing data double entry of patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Measurement of baseline characteristics|Calculation of the correlation between BMI, WC and PI|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinopelvic parameters and correlation with BMI and WC | Cross sectional study | January 1st 2020 - December 23, 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight,, Body mass index, Pelvic index, Waist circumference
Quantra QStat Sample Type Comparison

Study Overview
=================
Brief Summary
-----------------
This is a single center prospective observational study to compare QStat parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing liver transplantation.

Detailed Description
-----------------
In this single center prospective observational study, 25 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 75 matched samples for analysis on the Quantra System with the QStat Cartridge.

Official Title
-----------------
Impact of Sample Type on the Performance of the Quantra QStat System

Conditions
-----------------
Coagulation Defect; Bleeding

Intervention / Treatment
-----------------
* Device: Diagnostic Test: Quantra QStat Cartridge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is >=18 years Subject is scheduled for liver transplant surgery Subject or subject's legally authorized representative (LAR) is willing to provide informed consent Exclusion Criteria: Subject is younger than 18 years of age Subject is pregnant Subject is incarcerated at the time of the study Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks Subject, or subject's LAR, is unable or unwilling to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Diagnostic Test: Quantra QStat Cartridge|Whole blood coagulation testing system|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of QStat Clot time (CT) in arterial and venous samples | Coagulation function assessed in two sample types | During liver transplantation surgery | 
| Comparison of QStat Clot stiffness (CS) in arterial and venous samples | Coagulation function assessed in two sample types | During liver transplantation surgery | 
| Comparison of QStat Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples | Coagulation function assessed in two sample types | During liver transplantation surgery | 
| Comparison of QStat Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples | Coagulation function assessed in two sample types | During liver transplantation surgery | 
| Comparison of QStat Clot Stabilty to Lysis (CSL) in arterial and venous samples | Coagulation function assessed in two sample types | During liver transplantation surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quantra, Liver transplantation, Coagulation
Construction and Validation of a Risk Prediction Model for Secondary Vertebral Fracture in Patients With Osteoporotic Vertebral Compression Fractures After Percutaneous Vertebroplasty

Study Overview
=================
Brief Summary
-----------------
Retrospectively collecting clinical data from post-PVA (Percutaneous Vertebroplasty) patients, recording incidences of secondary vertebral fractures, and conducting statistical analysis to create a risk prediction model for recurrent fractures.

Official Title
-----------------
Construction and Validation of a Risk Prediction Model for Secondary Vertebral Fracture in Patients With Osteoporotic Vertebral Compression Fractures After Percutaneous Vertebroplasty

Conditions
-----------------
Osteoporotic Vertebral Fracture, Prediction Model

Intervention / Treatment
-----------------
* Other: No interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets the diagnostic criteria for primary osteoporosis as per the Osteoporosis Diagnosis and Treatment Guidelines (2022); No history of high-energy trauma; Patient complains of pain in the lumbar region, confirmed by MRI showing a newly developed vertebral fracture from T5 to L5 (i.e., MRI shows low signal on T1 and high or slightly high signal on T2); Has undergone Percutaneous Vertebroplasty (PVA) treatment. Exclusion Criteria: Incomplete imaging or medical record data; History of spinal surgeries other than PVA; Pre-existing symptoms of spinal cord compression or nerve root injury; Patients undergoing PVA treatment due to conditions such as tumors, vascular malformations, infections, or symptomatic Schmorl's nodes; Chronic conditions like Kummell's disease or non-union of old fractures; Concurrent vertebral burst fractures; Diagnosis of central nervous system diseases such as dementia or stroke before or during the follow-up period post-PVA procedure; History of violent trauma after PVA procedure.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sun Yat-sen memorial hospital<br> | Other: No interventions<br>* All procedures are observation. No intervention in this study.<br>|
| Second People's Hospital of Foshan City<br> | Other: No interventions<br>* All procedures are observation. No intervention in this study.<br>|
| The Fifth People's Hospital of Nanhai District, Foshan City<br> | Other: No interventions<br>* All procedures are observation. No intervention in this study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary vertebral fractures | Recording the secondary vertebral fractures | 2 years post-operative |
Re-irradiation Therapy of Locally Recurrent Rectal Cancer With Carbon Ion

Study Overview
=================
Brief Summary
-----------------
Prospective phase II clinical study aim to explore the clinical outcome of patients with unresectable locally recurrent rectal cancer (LRRC) treated with re-irradiation by carbon ion radiotherapy (CIRT)

Official Title
-----------------
A Prospective Phase II Clinical Study of Carbon Ion Re-irradiation in Unresectable Locally Recurrent Rectal Cancer

Conditions
-----------------
Rectal Cancer, Recurrent

Intervention / Treatment
-----------------
* Radiation: Carbon ion radiation therapy DT: 74Gy/20 fractions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and LRRC confirmed by biopsy or clinical diagnosis, 2) received a radical operation for their primary tumor and regional lymph nodes, 3) received chemo-radiation or radiation in pelvic before CIRT, 4) received re-irradiation by CIRT after their pelvic radiotherapy. Exclusion Criteria: 1) received more than once prior radiotherapy in the same treatment field, 2) time to the last radiotherapy was <1 year, 3) space between the lesion to organ at risk (OARs) (bladder or digestive tract) was too close (<5 mm).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: carbon ion therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carbon ion therapy for unresectable local recurrent rectal cancer<br> | Radiation: Carbon ion radiation therapy DT: 74Gy/20 fractions<br>* patients with unresectable local recurrent rectal cancer will be treated with carbon ion radiation therapy as re-irradiation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local control | local control rate of the lesion treated by CIRT | Local control at 3 years after CIRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | survival rate after CIRT | 3 years after CIRT or patient died, measured erery 3 months after CIRT | 
| progression free survival | progression free survival rate after CIRT | 3 years after CIRT or patient died, measured erery 3 months after CIRT |
Evaluation of Lung Metastases Based on Ultrashort Echo Time MRI

Study Overview
=================
Brief Summary
-----------------
Analyze the diagnostic efficiency (including performance, diameter, and location of nodules) of UTE-MRI in lung metastases of hepatoblastoma with chest CT as gold standard

Official Title
-----------------
The Diagnostic Value of Lung Ultrashort Echo Time MRI for Potential Lung Metastases in Children With Hepatoblastoma

Conditions
-----------------
Hepatoblastoma, Radiology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children diagnosed as hepatoblastoma (including treated with neoadjuvant chemotherapy but not surgery) Recent chest CT scan (within 14 days) No MRI contraindications The guardian of the children are willing to undergo the examination after full communication and informed consent Exclusion Criteria: MRI contraindications (including but not limited to: contrast medium allergy; Claustrophobia;Metal implants;chronic kidney disease≥stage 3 (glomerular filtration rate < 60 mL min-1 (1.73 m2)-1)) Patients with hepatoblastoma aged 14 years and above Children after surgery for hepatoblastoma Application of any contrast medium within 24 h before the MRI and/or CT examinations There is a concomitant medical condition (e.g. poorly controlled hypertension, severe diabetes, neurological or psychiatric illness, etc.) or any other condition that would seriously endangers the subject's safety, may confuse the study results, or may interfere with the subject's completion of the study according to the investigator's judgment.

Ages Eligible for Study
-----------------
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UTE-MRI assessment of lung metastases with chest CT as gold standard | Analyze the diagnostic efficiency (including performance, diameter, and location of nodules) of UTE-MRI in lung metastases of hepatoblastoma. | Baseline to 14 days |
Transcriptome Analysis of Human Bone Regeneration After Using an Anorganic Bovine Bone Graft With or Without a Combination of Polynucleotides and Hyaluronic Acid

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to compare the expression of multiple genes related to bone regeneration in maxillary bone after being grafted with a commonly used biomaterial supplemented or not with a combination of hyaluronic acid and polynucleotides.

Official Title
-----------------
Transcriptome Analysis of Human Bone Regeneration After Using an Anorganic Bovine Bone Graft With or Without a Combination of Polynucleotides and Hyaluronic Acid

Conditions
-----------------
Sinus Floor Augmentation

Intervention / Treatment
-----------------
* Procedure: Maxillary sinus floor augmentation
* Procedure: Maxillary sinus floor augmentation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Partially edentulous patients. Kennedy class I in the upper jaw. Less than 5 mm of residual crestal bone to the maxillary sinus. Need for the replacement of teeth with dental implants. Exclusion Criteria: Sinus pathology (sinusitis, mucocele, cysts). Smokers. Previous long-term (&gt;3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anorganic bovine bone<br>Maxillary sinus floor augmentation grafted with anorganic bovine bone | Procedure: Maxillary sinus floor augmentation<br>* Maxillary sinus floor augmentation through a lateral window grafted with anorganic bovine bone<br>|
| Experimental: Anorganic bovine bone + polynucleotides and hyaluronic acid<br>Maxillary sinus floor augmentation grafted with anorganic bovine bone + polynucleotides and hyaluronic acid | Procedure: Maxillary sinus floor augmentation<br>* Maxillary sinus floor augmentation through a lateral window grafted with anorganic bovine bone + polynucleotides and hyaluronic acid<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcriptome analysis | Transcriptome analysis of a sample of the regenerated bone will be performed 6 months after grafting immediately before implant placement | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinus floor height change | CBCT scans will be performed after the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change | 6 months |
The Effect of rTEM in the Prognosis and Severity of Sepsis Induced ARDS

Study Overview
=================
Brief Summary
-----------------
To observe the changes of plasma rTEM levels in patients with sepsis, sepsis induced ARDS, and to explore its clinical significance.

Detailed Description
-----------------
90 patients will be included in this study. Blood samples from these patients in the first day, the third day, were maintained and tested to detect the change of rTEM level. Severity of illness and survival status of every patient were recorded within 28 days. The objective is to observe the changes of plasma rTEM levels in patients with sepsis, sepsis induced ARDS, and to explore its clinical significance.

Official Title
-----------------
The Effect of rTEM in the Prognosis and Severity of Sepsis Induced ARDS

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Other: Taking peripheral blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as Sepsis 3.0 Patients signing informed consent Exclusion Criteria: Pregnant women Patients with tumor、hepatitis、liver cirrhosis、acute myocardial infarction、chronic renal tubular nephritis、interstitial pneumonia、acute pancreatitis、systemic lupus erythenatosus、ulcerative colitis、crohn's disease、HELLP syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Survivors<br>Sepsis induced ARDS patients who survived | Other: Taking peripheral blood<br>* Taking peripheral blood of no more than 3ml<br>|
| Nonsurvivors<br>Sepsis induced ARDS patients who not survived | Other: Taking peripheral blood<br>* Taking peripheral blood of no more than 3ml<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | 28day mortality | 28 day |