linjc16/ctgov huggingface dataset:
Factor XIII Activity in Gastrointestinal Bleedings

Study Overview
=================
Brief Summary
-----------------
The aim of this retrospective study is to investigate the relationship between factor XIII activity and the outcome of gastrointestinal bleedings. Since factor XIII is of great importance in haemostasis and plays a key role in stabilizing the fibrin clot, it can be assumed that a deficiency of factor XIII leads to an unfavorable course of gastrointestinal bleedings. Our hypothesis is that early detection of such a deficiency can prevent a more severe course and that substitution of factor XIII contributes to faster cessation of bleeding, improves patient outcome and reduces the number of red cell concentrates required.

Official Title
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Influence of Factor XIII Activity on the Outcome of Gastrointestinal Bleedings

Conditions
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Gastro Intestinal Bleeding

Intervention / Treatment
-----------------
* Drug: Factor XIII Injection


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Age over 18 years Confirmed diagnosis of gastrointestinal bleeding Assessment of factor XIII activity during the gastrointestinal bleeding episode Exclusion Criteria: Age under 18 years Diagnosis of hemophilia A or B or other congenital coagulation disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Normal factor XIII acitivity<br>Patients with GI bleeding and normal factor XIII activity | |
| Reduced factor XIII activity<br>Patients with GI bleeding and reduced factor XIII activity | Drug: Factor XIII Injection<br>* Patients could have had an Factor XIII Injection in clinical routine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red cell concentrates | Number of red cell concentrates transfused during the hospital stay caused by the gastrointestinal bleeding episode | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization | Length of the hospital stay caused by the gastrointestinal bleeding episode | 1 year | 
| Interventions | Number of endoscopic, radiological, and surgical interventions for bleeding treatment within the hospital stay caused by the gastrointestinal bleeding episode | 1 year | 
| Mortality | In hospital-mortality during the hospital stay caused by the gastrointestinal bleeding episode | 1 year |
SWE in Assessment of CKD Patients

Study Overview
=================
Brief Summary
-----------------
Elastography is a developing technique to assess tissue elasticity. It is software that can be integrated to the ultrasonography machines. Shear wave Elastography (SWE) is an Elastography technique that does not require external pressure on the tissue and supplies quantitative data. It uses real-time short-duration acoustic push pulse to generate shear waves that propagate perpendicular to the main ultrasound beam. When the waves hit the targeted tissue, the tissue is pushed in the direction of propagation, causing it to temporarily deform or displace. The ultrasound scanner can monitor the tissue displacement, measuring the time-to-peak displacement and the recovery time. Shear wave velocity increases in diseased tissues, which can be significantly stiffer than normal ones. The parameters are expressed in pressure units of kilopascals (kPa) and velocity (m s-1). SWE have been used to study breast, thyroid, prostate and liver diseases. However, the application of SWE in assessment of renal fibrosis in CKD patients is still unclear.

Official Title
-----------------
Feasibility of Shear Wave Elastography in Assessment of Renal Stiffness in Chronic Kidney Diseased Patients

Conditions
-----------------
Elastography ,CKD Patients

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients are those older than 18 years diagnosed with CKD based on the KDIGO (Kidney Disease Improving Global Outcomes) definition i.e. eGFR less than 60 mL/min and/or the presence of markers of kidney damage (pathological albuminuria of at least 30 mg per 24 hours or proteinuria, hematuria, casts) persisting for more than 3 months. Exclusion Criteria: Patients whose BMI >35kg/m 2 Any condition that precludes visualization of the kidney by ultrasound or transmission of shear waves as pregnancy or marked ascites patients with surgical kidney problems like hydro or pyonephrosis patients unwilling to complete the study. Patients with a history of renal replacement therapy (hemodialysis, peritoneal dialysis) , renal transplant, or acute kidney injury within the last 3 months Patients with cystic kidney disease Patients with renal masses

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Normal subjects<br> | |
| Diseased subjects<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of the study is the difference in renal SWE values between normal subjects and CKD patients . |  | From 2 to 3 years |
Sleep, Pain and Stress in Adolescents With Persistent Pain

Study Overview
=================
Brief Summary
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The main aim is the gain information of sleep structures in adolescents with persistent pain. Also to study simple interventions to support their sleep and pain management. The main aim of this study is to test the efficacy and feasibility of suggestive presleep relaxation technique in improving sleep quality and sleep-related emotional memory processing.

Official Title
-----------------
Sleep, Pain and Stress in Adolescents With Persistent Pain

Conditions
-----------------
Pain, Chronic, Sleep

Intervention / Treatment
-----------------
* Behavioral: suggestive relaxation
* Behavioral: Neutral story


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Patients aged 15-17 years with persistent (> 3months) pain reporting average pain intensity over 3/10 on the Numerical Rating Scale (NRS). Exclusion Criteria: ongoing medication for sleep or pain.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 17 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: Crossover Assignment
Interventional Model Description: Experimental within-subject study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: neutral story<br>Neutral story before the sleep onset | Behavioral: Neutral story<br>* neutral story before sleep<br>|
| Experimental: suggestive story<br>Suggestive story to find out the effect of relaxation to sleep structures. | Behavioral: suggestive relaxation<br>* suggestive story before sleep onset<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality | The overnight PSG (Somnomedics) is used to measure sleep during two nights (Somnomedics, Somnoscreen plus HD), with the following recorded parameters: electroencephalography (left and right for F, C, O); left and right eletrooculogram; left and right electromyogram; electrocardiogram. Sleep recordings are done with portable devices so that the patients will sleep at their home during the recordings. | one night |
A Prospective Exploratory Clinical Study of Metronomic Capecitabine as Adjuvant Therapy in Locoregionally Advanced Hypopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
To explore whether the adjuvant therapy of metronomic capecitabine could improve the disease-free survival of locoregionally advanced hypopharyngeal carcinoma (stage IV：T4N0-1M0，anyTN2-3M0).

Official Title
-----------------
A Prospective Exploratory Clinical Study of Metronomic Capecitabine as Adjuvant Therapy in Locoregionally Advanced Hypopharyngeal Carcinoma

Conditions
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to Explore Whether the Adjuvant Therapy of Metronomic Capecitabine Could Improve the Disease-free Survival of Locoregionally Advanced Hypopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Drug: Capecitabine 500Mg Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Age between 18 and 65 years old. 2. Histologically confirmed hypopharyngeal carcinoma, staged as IV (T4N0-1M0，anyTN2-3M0) (as defined by the 8th AJCC edition), Complete the recommended standard treatment (curative chemoradiotherapy, or radical surgery + postoperative chemo/radiotherapy ). 3. No clinical evidence of persistent locoregional disease or distant metastases after definitive chemoradiotherapy. 4. Within 8 weeks after completion of the last radiation dose. 5. Performance status of ECOG grade 0 or 1. 6. Adequate hematologic (neutrophil count > 1.5×10^9/L, hemoglobin > 90g/L and platelet count > 100×10^9 /L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase < 2.5×ULN) and renal function (creatinine clearance > 50 ml/min). 7. Patients must be appraised of the investigational nature of the study and provide written informed consent. Exclusion Criteria: 1.Patients who were known to be intolerable or allergic to capecitabine. 2. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. 3. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control). 4. With esophagus cancer. 5. Pregnancy or lactation. 6. Other conditions that are not eligible for enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capecitabine 500Mg Oral Tablet|650 mg/m² body surface area twice daily for 1 year|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival | the time from enrolled to disease recurrence (distant metastasis or locoregional recurrence) or death due to any cause | 2023.7-2025.7 |
The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures

Study Overview
=================
Brief Summary
-----------------
Background : Vertebral fracture is the most common complication of osteoporosis. Vertebroplasty is a widespread treatment modality for osteoporotic vertebral fractures, providing consolidation, rapid pain relief and preventing secondary vertebral collapse. Performing a biopsy at the same time as the operation does not lengthen the procedure or increase the risk of complications. The question therefore arises as to whether it is cost-effective diagnostically: are non-osteoporotic vertebral lesions detected when biopsies are taken? Methods: The investigators carried out a single-centre retrospective study at Nice University Hospital. From January 2016 to March 2022, 1729 biopsies were performed during 1439 vertebroplasty procedures on 1120 patients. The pre-operative laboratory work-up included a blood count, a C-reactive protein assay and a coagulation test. The imaging work-up systematically included MRI, unless contraindicated, in which case CT alone was performed. Vertebroplasty was performed in an interventional CT suite under dual CT and fluoroscopic guidance. The systematic biopsy sample was then sent to the anatomopathology department for analysis. Findings : The samples detected cancer in 35 patients, including 5 (0.44%) for whom the pre-operative work-up had not raised any suspicion. All the incidental findings were haemopathies, including 4 myelomas and one lymphoma. Conclusion : These results highlight the good performance of MRI in distinguishing osteoporotic vertebral fractures from solid tumour metastases. However, an exhaustive pre-operative work-up does not seem to be able to formally rule out an underlying malignant lesion. The investigators therefore recommend that biopsies be taken systematically when performing vertebroplasty.

Official Title
-----------------
The Value of Systematic Biopsies During Vertebroplasty for the Treatment of Osteoporotic Vertebral Fractures

Conditions
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Vertebral Compression Fracture, Myeloma, Bone Metastases, Malignant Bone Tumour, Lymphoma, Plasmocytoma

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: all patients who underwent a vertebroplasty with bone biopsy Exclusion Criteria: non-vertebral bone biopsies not performed during vertebroplasty

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 96 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 incidental discovery of malignant lesions during systematic biopsies for the treatment of vertebral compression fractures | incidental findings of neoplasia during vertebroplasty for presumed osteoporotic fractures | 5 years and 2 months |
A Prospective, Randomized Controlled Study of Cyclophosphamide, Bevacizumab With or Without Envafolimab in Recurrent Epithelial Ovarian Cancer (EOC), Fallopian Tube Cancer, and Primary Peritoneal Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the efficacy and safety of cyclophosphamide and bevacizumab in combination with Envafolimab in the treatment of recurrent epithelial ovarian cancer (EOC), fallopian tube cancer, and primary peritoneal cancer.

Official Title
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A Prospective, Randomized Controlled Study of Cyclophosphamide, Bevacizumab With or Without Envafolimab in Recurrent Epithelial Ovarian Cancer (EOC), Fallopian Tube Cancer, and Primary Peritoneal Cancer

Conditions
-----------------
Epithelial Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: Envafolimab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 years Histologically or pathologically confirmed epithelial ovarian cancer (EOC), fallopian tube cancer, primary peritoneal cancer Patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer following platinum-based chemotherapy measurable lesions (according to RECIST 1.1 criteria, non-lymph node lesions CT scan long diameter ≥ 10 mm, lymph node lesions CT scan short diameter ≥ 15 mm) ECOG PS score: 0 - 1; Exclusion Criteria: Subject has prior or concurrent other malignancy Prior treatment with other PD-L1/PD-L1 inhibitors cannot be enrolled; Subject has known previous hypersensitivity to macromolecular protein preparations or applied drug components

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| EBC<br>cyclophosphamide and bevacizumab in combination with Envafolimab | Drug: Envafolimab<br>* With or without Envafolimab<br>|
| BC<br>cyclophosphamide in combination with Envafolimab | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate;ORR | CR+PR | 2years |
Application of PNE in Postoperative Pain Management of Patients With Primary Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This study intends to carry out pain neuroscience education intervention for TKA patients to clarify the effect of this method on the degree of postoperative pain, the incidence of pain catastrophizing, kinesiophobia, and knee joint function rehabilitation in TKA patients, so as to provide a basis for clinical nursing of such patients.

Official Title
-----------------
Application of PNE in Postoperative Pain Management of Patients With Primary Total Knee Arthroplasty

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Behavioral: Pain Neuroscience Education
* Behavioral: Routine Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as KOA according to the criteria and undergoing unilateral total knee arthroplasty for the first time; The subjects included in this study were men or women aged 45-74 years; Clear self-cognition, can browse the text by themselves or can answer questions correctly; Those who voluntarily participated in the study and signed an informed consent form after understanding the relevant information of the study; Without serious physical diseases such as heart, liver or kidney; No history of mental illness or drug dependence. Exclusion Criteria: Combined with severe trauma in other parts; Accompanied by serious damage to other organs, such as heart and cerebrovascular diseases, lung and kidney diseases; Patients with knee tumor and severe knee deformity who could not complete the rehabilitation; With neurological diseases that limit physical activity; Participating in other investigators during the same period.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 74 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain Neuroscience Education Group<br> | Behavioral: Pain Neuroscience Education<br>* Carry out pain neuroscience education intervention for TKA patients<br>|
| Experimental: Routine Education Group<br> | Behavioral: Routine Education<br>* Carry out routine education intervention for TKA patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale pain score, (VAS) | Status of pain | 3 months after discharge |
10-year Results of Open Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
The main goal of the research is to evaluate the long-term results of open anterior alloplasty of inguinal hernia, mainly the occurrence of recurrences. The secondary aim of the study is to clarify the incidence of chronic pain and foreign body sensation 10 years after inguinal hernia surgery. Patients who meet the criteria for inclusion in the study are invited to an appointment, where a questionnaire is filled out, an clinical examination and an ultrasound examination are performed.

Official Title
-----------------
10-year Results of Open Inguinal Hernia Repair. A Prospective Study

Conditions
-----------------
Recurrence, Chronic Pain

Intervention / Treatment
-----------------
* Procedure: Open inguinal hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary inguinal hernia operated between 2008-2013 at the Tartu University Hospital elective surgery age at least 18 years old at the time of the operation ability to understand the guidelines and willing to participate in the study Exclusion Criteria: recurrent hernia strangulated hernia age under 18 years at the time of surgery does not agree to participate in the study does not understand the guidelines. Regarding the last exclusion criterion: since it is an assessment of the remote results of the treatment and probably relatively many of the subjects are very elderly, it may happen that when contacting the patient by phone it turns out that the patient is no longer adequate to make a decision about participating in the study or to answer questions (experienced cerebral infarction, dementia, etc. .) - in this case, the patient is not invited to the appointment.

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 |
| --- |
|Procedure: Open inguinal hernia repair|Lichtenstein hernioplasty or open inguinal hernia repair with self-gripping mesh|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Inguinal hernia recurrence on clinical examination or in ultrasound | at 10-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain | Chronic pain after open inguinal hernia repair. The pain questionnaire includes questions about pain at rest, on coughing, when rising from lying to sitting position and during physical effort and exercise (yes-or-no questions). If the answer to these questions are positive, then the pain is measured on visual analogue scale. | at 10-year follow-up |