linjc16/ctgov huggingface dataset:
Osmotic Therapy for Patients With Severe Subarachnoid Hemorrhage

Study Overview
=================
Brief Summary
-----------------
The goal of this prospective multi-center observational study is to learn about the osmotic therapy in severe subarachnoid hemorrhage (SAH). The main question[s] it aims to answer are: • whether the two osmotic therapy, 20% mannitol and 10% hypertonic saline(HTS), under the same osmotic equivalent, has similar influence on the outcome of SAH patients? Participants will be given proper treatment according to local expert consensus, including the choice of osmotic medicine. Investigators just record and analyse the data, compare mannitol group and HTS group to see if the outcome of latter is not worse than the former.

Official Title
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Practice of Osmotherapy in Severe SubArachnoid Hemorrhage Patients: Multicenter Observational Study (OSMO-SAH Study)

Conditions
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Subarachnoid Hemorrhage, Traumatic

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: ①age ≥18； ②CT confirmed subarachnoid hemorrhage; ③Hunt-Hess 3-5级 Exclusion Criteria: previous decompressive craniectomy, a leakage or a drainage of cerebrospinal fluid, bilateral fixed and dilated pupils, unstable hemodynamic conditions, oliguric renal failure, hemoglobin < 8g/L, serum osmolality> 320 mOsm/L, combined with serious dysfunction of organs such as heart, lung, liver, and kidney; combined with severe electrolyte disturbances (especially serum sodium concentration <125 mmol/L or >170 mmol/L) and blood gas dysfunction, which are difficult to correct in a short time；use of hypertonic treatment within 6h; pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| modified Rankin score | The Modified Rankin Score (mRS) is the most widely used outcome measure for brain injured patients, which ranges from 0-6. Score of 6 means that patient is dead. | 1 day of discharge | 
| modified Rankin score | The Modified Rankin Score (mRS) is the most widely used outcome measure for brain injured patients, which ranges from 0-6. Score of 6 means that patient is dead. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Subarachnoid Hemorrhage, mannitol, hypertonic saline, outcome
Biobanking and New Biomolecular Metrics

Study Overview
=================
Brief Summary
-----------------
The goal of this Interventional study aims to apply, in our Institutes, a 4p oncological model i.e. predictive, personalized, of precision and participated (Regina Elena and San Gallicano).

Detailed Description
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Patients will be recruited with an innovative and systematic scheme: collection and biobanking of biological materials (tissue biopsy, re-biopsy and liquid biopsy) followed by a molecular monitoring thanks to genomic and epigenomic methods. It's an open-ended study. In particular we will try to identify new actionable signatures and we will try to insert the patients to innovative clinical trials, thanks to the evaluation of all cases with a Molecular Tumor Board. The main objectives are: Introduce a new methodology to improve and integrate the already existent institutional PDTA Evaluate and measure the applicative value Establish a biostatistical platform

Official Title
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Melanoma 4p: Biobanking and New Biomolecular Metrics

Conditions
-----------------
Melanoma (Skin), Liquid Biopsy

Intervention / Treatment
-----------------
* Diagnostic Test: Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Melanoma affected patients Exclusion Criteria: No patiens affected by other pathology
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: The recruiting of two simultaneous cohorts is scheduled. a) patients of illness onset (Cohort 1); b) patients with locoregional disease and/or metastatic designed for systemic therapies (cohort 2).
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Biopsy|Liquid biopsy, re-biopsy, tissue biopsy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncology target therapy | Integration between molecular diagnostic and melanoma histopathology: correlation between mutational miRNA/ncRNA profiles and pathological staging parameters. | 12 months | 
| Oncology target therapy | Correlation between molecular diagnostic and imaging non-invasive instrumental diagnostic | 12 months | 
| Oncology target therapy | Correlation between molecular diagnostic and dermatologic clinical diagnostic; integration of liquid biopsy during oncologic ambulatorial follow-up; lead time of relapse. | 12 months | 
| Oncology target therapy | Complement to surgery | 12 months |
Nasr Fascial Closure: A Novel Device for Fascial Closure in Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
The study will investigate the efficacy and safety of a new fascial closure device Nasr Fascial Closure Device compared to the Karl Storz Berci Fascial Closure Device 26173AM.

Official Title
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Nasr Fascial Closure: A Novel Device for Fascial Closure in Laparoscopic Surgery

Conditions
-----------------
Cholecystolithiasis

Intervention / Treatment
-----------------
* Device: Nasr fascial closure device
* Device: Berci Fascial Closure Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 eligible for Laparoscopic cholecystectomy Exclusion Criteria: refused to participate

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 |
| --- | --- |
| Experimental: Nasr Fascial Closure Device<br> | Device: Nasr fascial closure device<br>* Nasr fascial closure device is a novel device for fascial closure<br>|
| Active Comparator: Berci Fascial Closure Device<br> | Device: Berci Fascial Closure Device<br>* Berci Fascial Closure Device is a known device for fascial closure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of port site closure | Duration in seconds | 1 day | 
| Rate of failure of port site | Rate of failure to close the port site | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of port site infection | Incidence of infection of the port site | 1 month | 
| Incidence of port site hernia | Incidence of hernia at the port site | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic removal
Arthroscopic Biological Augmentation With Subacromial Bursa for Bursal Side Partial-thickness Rotator Cuff Tears

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to compare the results of acromioplasty + arthroscopic debridement and acromioplasty + augmentation with subacromial bursa.

Official Title
-----------------
Arthroscopic Biological Augmentation With Subacromial Bursa for Bursal Side Partial-thickness Rotator Cuff Tears

Conditions
-----------------
Partial Thickness Rotator Cuff Tears

Intervention / Treatment
-----------------
* Procedure: Augmentation with subacromial bursa + acromioplasty
* Procedure: Rotator cuff debridement + acromioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bursal side rotator cuff tears in MRI sections Patients whose pain does not go away despite NSAIDs and standardized physical therapy by the same physiotherapist applied for 3 months 25-50% or 3-6 mm rotator cuff tear (Ellman grade 2) on the bursal side Exclusion Criteria: Previous surgery tears greater than 50% or 6 mm

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rotator cuff debridement + acromioplasty<br>Group A was formed by performing rotator cuff debridement + acromioplasty in 18 patients. | Procedure: Rotator cuff debridement + acromioplasty<br>* Two intervention was planned. Rotator cuff debridement + acromioplasty group is mentioned as Group A (18 patients) and augmentation with subacromial bursa + acromioplasty is Group B<br>|
| Active Comparator: Augmentation with subacromial bursa + acromioplasty<br>Group B was formed by performing augmentation with subacromial bursa + acromioplasty in 22 patients. | Procedure: Augmentation with subacromial bursa + acromioplasty<br>* Two intervention was planned. Rotator cuff debridement + acromioplasty group is mentioned as Group A (18 patients) and augmentation with subacromial bursa + acromioplasty is Group B<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of biological augmentation with bursa using postoperative clinical scores and MRI. | Our Primary Outcome Measure is to investigate the effects of biological augmentation with subacromial bursa in arthroscopic bursal-sided partial thickness rotator cuff repair with postoperative MRI and functional scores with Constant-Murley and Ases scores. | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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partial thickness, bursal side, rotator cuff, full thickness, subacromial bursa
Evaluation of Peripheral Neutrophils in Antisynthetase Syndrome

Study Overview
=================
Brief Summary
-----------------
Antisynthetase syndrome (AS) is a rare overlapping myositis characterized by cellular and humoral autoimmune responses directed against aminoacyl-tRNA synthetases. A pathogenic role of neutrophils was described during inflammatory myopathies, with increased netosis correlated with disease activity and muscle damage. Higher number of alveolar neutrophils was observed in patients with rapidly progressive forms of interstitial lung disease. Peripheral neutrophils could represent a simple biomarker of severity and activity in patients with antisynthetase syndrome. The main objective is to compare circulating neutrophils between severe and non severe patients with antisynthetase syndrome. Secondary objectives are: 1) to evaluate correlation between circulating neutrophils and organ-specific severity, 2) to compare circulating neutrophils at time of diagnosis and circulating neutrophils after 6 months of treatment in patients with antisynthetase syndrome.

Official Title
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Evaluation of Peripheral Neutrophils in Patients With Antisynthetase Syndrome

Conditions
-----------------
Antisynthetase Syndrome

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Patients with antisyntheatse syndrome according to Solomon criteria

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with antisynthetase syndrome<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of circulating neutrophils | circulating neutrophils values (number of cells/mm3) | at diagnosis (Day 0) | 
| Global severity | composite criteria of global severity: severe interstitial lung disease (ILD) and/or severe muscular disease | at diagnosis (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating neutrophils change over time | circulating neutrophils values (number of cells/mm3) | at 6 months of follow-up | 
| ILD severity | %predicted FVC values in patients with ILD | at diagnosis (Day 0) | 
| ILD severity | %predicted DLCO values in patients with ILD | at diagnosis (Day 0) | 
| Muscular severity | manual muscle testing (MMT) grading in patients muscle involvement | at diagnosis (Day 0) | 
| Muscular severity | CPK values (U/L) in patients muscle involvement | at diagnosis (Day 0) |
Breastfeeding Failure: Influence of Smartphone Use and Distraction Factors

Study Overview
=================
Brief Summary
-----------------
The benefits of breastfeeding no longer need to be proven. Many studies have shown its positives effects on both infants and mothers. Exclusive breastfeeding is thus recommended within the first six months of life. Excessive screen use has been shown to be harmful in many aspects of daily life. The impact upon the relation between mother and newborn infant is poorly studied. The study aims to evaluate the impact of the use of smartphones on the success and duration of breastfeeding.

Official Title
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Breastfeeding Failure: Influence of Smartphone Use and Distraction Factors

Conditions
-----------------
Breastfeeding, Smartphone

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breastfeeding mothers of Newborn breastfed infant born in the maternity ward of the Amiens-Picardie University Hospital Exclusion Criteria: Mother refusing to participate in the study; hospitalization during the neonatal period

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| breastfeeding success (Yes)<br>Mothers are to be contacted at 1 month to assess the main outcome: breastfeeding status (Yes vs No) classified as breastfeeding success (Yes) or breastfeeding failure (No). | |
| breastfeeding failure (No)<br>Mothers are to be contacted at 1 month to assess the main outcome: breastfeeding status (Yes vs No) classified as breastfeeding success (Yes) or breastfeeding failure (No). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of Breastfeeding status in both groups | At 2 months after birth, mothers will be contacted to record their breastfeeding status. | at 2 months | 
| Variation of Breastfeeding status in both groups | At 3 months after birth, mothers will be contacted to record their breastfeeding status. | at 3 months | 
| Variation of Breastfeeding status in both groups | At 4 months after birth, mothers will be contacted to record their breastfeeding status. | at 4 months | 
| Variation of Breastfeeding status in both groups | At 6 months after birth, mothers will be contacted to record their breastfeeding status. | at 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breastfeeding, smartphone, screen, distraction, developmental care
Cardiac Changes Associated With Acute Cerebro-vascular Stroke

Study Overview
=================
Brief Summary
-----------------
Cardiovascular disease is regarded as main predisposing risk factor for cerebrovascular stroke. Cardiac dysfunction can both worsen the pre existing cerebral damage and cause new brain injury Diseases of the heart and the brain are closely entangled. Vascular diseases of both organs share the same risk factors.

Official Title
-----------------
Cardiac Changes Associated With Acute Cerebrovascular Stroke

Conditions
-----------------
Cerebrovascular Accident

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 18 years patients presented with cerebrovascular stroke 3-patients diagnosed as cardiac patients and have cerebrovascular stroke Exclusion Criteria: 1-Less than 18 years

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 |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG changes in cerebrovascular accident | ECG QT interval, T wave changes in. cerebrovascular accident | 6 months | 
| Echo changes in cerebrovascular accident | Echo chamber dilatation, valavular, ejection fraction changes in cerebrovascular accident | 6 months |
Long-term Surveillance of Patients With Venous Thromboembolism: a Nationwide Prospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
This observational study aims to establish a prospective nationwide cohort of venous thromboembolism. The main questions it mains to answer are: Which patients with venous thromboembolism should accept long-term anticoagulation therapy? Mechanism and prognosis of venous thromboembolism. Participants will receive yearly follow-ups through telephone, hospitalization, or outpatient care.

Detailed Description
-----------------
Venous thromboembolism (VTE), including deep venous thrombosis and pulmonary embolism, is a class of diseases with strong occultation, high mortality, and a high recurrence rate.Long-term anticoagulant therapy can reduce the risk of recurrence. Although long-term anticoagulation can reduce the risk of VTE recurrence, it will also increase the risk of major bleeding and the economic burden of long-term anticoagulation. Therefore, stratifying the risk of VTE recurrence and preventing recurrence with accurate anticoagulant therapy is an urgent problem in VTE management. Investigators will establish a prospective nationwide cohort of VTE, develop a unified follow-up plan, and conduct whole-life follow-up management for patients. Demographic, clinical, imaging, laboratory indicators, gene, and other information of patients will be collected. A VTE patient database with complete clinical phenotype data, genetic data, and biological samples will be established. Investigators will construct a VTE recurrence risk prediction model based on Chinese data to provide clinical decision suggestions for clinicians to select appropriate individualized anticoagulant duration according to risk stratification. VTE patients with low recurrence risk could avoid long-term anticoagulant therapy.

Official Title
-----------------
Long-term Surveillance of Patients With Venous Thromboembolism: a Nationwide Prospective Cohort Study

Conditions
-----------------
Venous Thromboembolism

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Age greater or equal to 18. Patients diagnosed with venous thromboembolism. Exclusion Criteria: Pregnant or lactating women Patients with active tumor

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 |
| --- | --- | --- |
| Recurrence | recurrence of venous thromboembolism | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding episode | The definition of bleeding episode is consistent with the guideline of international society thrombosis & hemostasis | through study completion, an average of 1 year | 
| All-cause death | All-cause death | through study completion, an average of 1 year |
Study of Brain Anatomo-functional Substrates Related to the Use of Human Tool by Means of Simultaneous Acquisition of Magnetic Resonance Imaging and Electroencephalogram

Study Overview
=================
Brief Summary
-----------------
This is an observational study, conducted on subjects with neurological disorders primarily involving the frontal and parietal lobes of the brain. Throughout the indicated period, the study will aim to enroll 100 subjects divided into 30 units per year. Specifically, the study will be carried out on patients with fronto-parietal dysfunction for whom a prescribed a clinical investigation of electroencephalogram and MRI

Official Title
-----------------
Study of Brain Anatomo-functional Substrates Related to the Use of Human Tool by Means of Simultaneous Acquisition of Magnetic Resonance Imaging and Electroencephalogram

Conditions
-----------------
Patients With Frontal and Parietal Lobe Dysfunction

Intervention / Treatment
-----------------
* Combination Product: electroencephalogram (EEG) and magnetic resonance (MR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects of either sex with fronto-parietal dysfunction, who are able to able to provide voluntary consent, who have been asked for clinical purposes for an EEG and an MRI Exclusion Criteria: pregnant or presumed pregnant subjects and subjects with claustrophobia or with contraindications to the examination.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Combination Product: electroencephalogram (EEG) and magnetic resonance (MR)|High-resolution 3D T1 and T2 sequences, acquired in the sagittal plane and MR reconstructed in the remaining orthogonal planes, for morphological assessment of different cortical and subcortical. EEG tracing involving recording channels such as eye tracking (eye-tracking: electrooculogram, pupillometry, saccades, fixation times on areas predefined areas), performance measures (response times), electrocardiogram and electromyogram proper to clinical acquisition|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combination of EEG and functional MR (fMRI) | Interception of differences during simultaneous acquisition related to the variation of action readiness (action readiness) suggested by the visual-perceptual context | 1-36 months |