linjc16/ctgov huggingface dataset:
Natural History of Netherton Syndrome

Study Overview
=================
Brief Summary
-----------------
The goal of this non-interventional study (NIS) is to collect real-world data to describe the natural history of Netherton Syndrome (NS).

Official Title
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Non-interventional Study of Patients With Netherton Syndrome to Characterise the Natural History of Disease

Conditions
-----------------
Netherton Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria [for Part 1 and Part 2] Confirmed diagnosis of NS by at least one of the following: Genetic testing of mutations in Serine Protease Inhibitor of Kazal Type 5 (SPINK5); Absence or major deficiency of the protein Lympho-Epithelial Kazal-Type-Related Inhibitor (LEKTI) in skin biopsy; Clinical assessment (signs and symptoms). Provision of consent or assent (i.e., by parent or legal guardian) as required by local regulations: [Part 1] to authorise access to existing medical records for study data collection; [Part 2] to participate in the longitudinal 52-week evaluation of disease severity and clinical outcome assessments. [for Part 2 only] 3. Not participating in a clinical trial at the time of study enrolment for Part 2. Exclusion criteria [for Part 1 and Part 2] 1. Deceased patients and patients whose survival status are not known, who were diagnosed prior to 2002.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients diagnosed with Netherton Syndrome<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Netherton Syndrome (NS) assessed by the Ichthyosis Area Severity Index (IASI) | For patients participating in Part 2. IASI is a composite score that evaluates severity of erythema (subscale IASI-E) and scaling (subscale IASI-S) in different body regions as a function of their respective body surface areas. Severity of erythema and scaling is rated on a 5-point Likert scale of 0-4 in each of 4 body regions: head and neck (including scalp), arms (including palms), legs (including soles) and trunk, prorated based on body surface area in these body regions and the percentage of involvement in each of these body regions. The total IASI score ranges between 0-48 (i.e., sum of a maximum score of 24 for erythema and maximum score of 24 for scaling). Higher score denotes worse clinical severity. | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity Netherton Syndrome (NS) assessed by the Investigator Global Assessment (IGA) | For patients participating in Part 2. IGA for NS will assess the global severity of erythema and scaling in NS using 5-point Likert scale ranging from 0=clear, to 4=severe. | up to 1 year |
Unexpected Diagnosis in Right Lower Quadrant Pain: Right Colon Diverticulitis

Study Overview
=================
Brief Summary
-----------------
BACKGROUND: Acute right lower quadrant pain is a common symptom in emergency departments. The most common etiology is thought to be acute appendicitis. Other etiologies may be overlooked. Acute right colon diverticulitis is one of them. It is usually seen in male and young patients. It is more common in Asian population and rare in Western countries. Ultrasonography (USG) and computed tomography (CT) are used for radiologic diagnosis. OBJECTIVES: The aim of this study was to investigate the diagnosis, treatment and surgical management of right colon diverticulitis.

Detailed Description
-----------------
DESIGN: Retrospective cross-sectional analysis SETTING: Research and training hospital (Tertiary care center) In our study, patients hospitalized in our hospital clinic between 2018 and 2022 with the diagnosis of right colon diverticulitis were retrospectively analyzed. Age, gender, WSES grade, whether surgery was performed or not, laboratory values, iv antibiotherapies given, length of hospitalization and mortality were evaluated. MAIN OUTCOME MEASURES: The CRP, the need for surgical intervention vs conservative treatment .

Official Title
-----------------
Unexpected Diagnosis in Right Lower Quadrant Pain: Right Colon Diverticulitis

Conditions
-----------------
Diverticulitis, Colonic

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with right colonic diverticulitis Exclusion Criteria: <18 years of age

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 |
| --- | --- |
| Patient with right colonic diverticulitis<br> | Other: no intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The need for surgical intervention | The patients were followed up conservatively if they had their diagnosis in the acute settings. | time frame is the length of stay usually between 1-14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, acute diverticulitis, right colon, emergency
A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.

Detailed Description
-----------------
The OCEAN-AIS-EVT-Registry is a multicenter, observational, registry study, and aims to assess the safety and outcome of endovascular treatment for acute ischemic stroke in real clinical practice. The primary endpoint is functional outcome, defined as a shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±14 days).

Official Title
-----------------
Oriental Collaboration Group on Emerging Advanced Therapy for Neurovascular Diseases Consortium-Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study (OCEAN-AIS-EVT REGISTRY)

Conditions
-----------------
Acute Ischemic Stroke, Large Vessel Occlusion, Thrombectomy, Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of AIS with anterior or posterior circulation LVO confirmed by CTA, MRA or DSA; To receive endovascular treatment; Agree to participate in the study and signed informed consent form. Exclusion Criteria: This study does not set exclusion criteria
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 |
| --- | --- | --- |
| Functional outcome | Shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±7 days). The value range 0-6: higher scores mean a worse outcome. | 90days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dichotomized modified Rankin scale (mRS) | Dichotomized modified Rankin scale (mRS) at 90 days after the procedure (0-1 versus 2-6, 0-2 versus 3-6, 0-3 versus 4-6). The value range 0-6: higher scores mean a worse outcome. | 90days | 
| NIHSS at 24 hours | Change in stroke severity (NIHSS score) at 24 hours post treatment. The value range 0-42: higher scores mean a worse outcome. | 24 hours post treatment | 
| NIHSS at 7 days | Change in stroke severity (NIHSS score) at 7 days post procedure. The value range 0-42: higher scores mean a worse outcome. | 7 days post procedure | 
| Reperfusion outcome | Reperfusion outcome (eTICI 2b or greater) in final angiogram. The expanded treatment in cerebral infarction (eTICI) score is a modified from the modified treatment in cerebral infarction (mTICI) and thrombolysis in cerebral infarction (TICI) scales. The value range 0-3: higher scores mean a better outcome. | Immediately post-procedure | 
| Reperfusion outcome | Reperfusion outcome (eTICI 2b or greater) at 7 days post procedure. The expanded treatment in cerebral infarction (eTICI) score is a modified from the modified treatment in cerebral infarction (mTICI) and thrombolysis in cerebral infarction (TICI) scales. The value range 0-3: higher scores mean a better outcome. | 7 days post procedure |
Movement Analysis in Musculoskeletal Oncology: a Pilot Study

Study Overview
=================
Brief Summary
-----------------
Noninterventional, prospective, multicenter pilot study of patients with primary and secondary musculoskeletal tumors designed to investigate functional outcomes after therapy using both subjective and quantitative motion detection techniques

Official Title
-----------------
Movement Analysis in Musculoskeletal Oncology: a Pilot Study

Conditions
-----------------
Motion Analysis in Musculoskeletal Oncology

Intervention / Treatment
-----------------
* Device: Motion Analysis in Musculoskeletal Oncology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 6 years Diagnosis of primary and secondary tumors of the musculoskeletal system Patients who will need to undergo surgery for bone resection or wide excision of soft tissue lesion, and/or radiation or drug treatments Availability of follow-up data (for at least 6 months) Written informed consent Exclusion Criteria: - Inability to perform pre-post treatment assessment

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Popolation<br> | Device: Motion Analysis in Musculoskeletal Oncology<br>* Noninterventional, prospective, multicenter pilot study of patients with primary and secondary musculoskeletal tumors designed to investigate functional outcomes after therapy using both subjective and quantitative motion detection techniques<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | To investigate any differences found using the two methods (quantitative/movement analysis technique versus subjective/qualitative technique) in changes in walking/motor characteristics in post-treatment versus pre-treatment. | Baseline |
Predictive Value of Soluble CD146 in Glioblastoma Patients

Study Overview
=================
Brief Summary
-----------------
Glioblastoma is the most common malignant primary brain tumor with poor prognosis because of its diffusive and infiltrative nature. The FDA approved the use of the anti-VEGF antibody bevacizumab in recurrent GBM. However, resistance to this anti-angiogenic reagent is frequent and fails to enhance patients' overall survival. The investigators previously identified one novel mechanism responsible for bevacizumab-resistance in CD146-positive glioblastoma (Joshkon et al. Acta Neuropathol Commun, 2022). Now, the investigators objective is to prospectively monitor the soluble CD146 value in plasma from patients treated by bevacizumab for recurrent glioblastoma. The investigators will collect plasma at baseline, before the first bevacizumab administration, before the second administration, at the time of first MRI evaluation and at progression. Plasma CD146 value will be analyzed by ELISA. The investigators expect to confirm the correlation between soluble CD146 value in plasma and patient response to bevacizumab.

Official Title
-----------------
Predictive Value of Soluble CD146 in Patients With Recurrent Glioblastoma Treated by Bevacizumab

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Other: plasma collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adult patients with recurrent IDHwt glioblastoma Relapse after standard first line treatment (radio-chemotherapy) Candidate for bevacizumab treatment Able to be monitored by MRI KPS ≥ 60% Written signed consent form Exclusion Criteria: Pregnancy or breast feeding Life expectancy less than 3 months Bevacizumab in first line treatment Other concomitant life-threatening disease Under legal protection

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: plasma collection<br>Plasma samples will be prospectively collected at relevant time points during patient treatment. | Other: plasma collection<br>* Plasma samples will be prospectively collected at relevant time points during patient treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between soluble CD146 plasma value and patient response (RANO) | Soluble CD146 plasma value will be assessed using ELISA. Patient response will be evaluated by MRI and clinical response using the international RANO criteria. | first evaluation (2 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glioblastoma, CD146, bevacizumab
Robotic Hand on Hand Functions in Strokes

Study Overview
=================
Brief Summary
-----------------
robotic glove training could be a useful aid for these patients. The aim of this study was to investigate the effect of Robotic gloves versus mirror therapy on Hand function in patients with cerebral vascular accident .

Detailed Description
-----------------
Post stroke patients aged over 40 years were randomly assigned into three groups (A , B and C ). Group . Maximum hand grip strength and Hand function were assessed before and after the intervention using hand dynamometer and box and block test respectively.

Official Title
-----------------
Effect of Robotic Hand Versus Mirror Therapy on Hand Functions in Stroke Patients

Conditions
-----------------
CVA (Cerebrovascular Accident)

Intervention / Treatment
-----------------
* Other: Robotic
* Other: Mirror
* Other: Traditional Physical Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spasticity level 1 or 1+ according to modified Ashworth scale Exclusion Criteria: Uncontrolled seizures hand fractures or surgery

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 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
Interventional Model Description: Randomized Control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>received robotic gloves training | Other: Robotic<br>* Patients receive robotic training (grasp and grip)<br>|
| Experimental: Group B<br>received mirror therapy | Other: Mirror<br>* Patients receive mirror therapy<br>|
| Active Comparator: Group C<br>received traditional physical therapy | Other: Traditional Physical Therapy<br>* Traditional exercise and Neurophysiological approaches<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hand grip strength | Hand Dynamometer will be used to evaluate the hand's grip strength | 8 weeks | 
| Hand manual function | Box and block test for measuring the manual dexterity of patients | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Hand Grip Strength
Prevalence and Predictors of Esophageal Thermal Lesions in High-power-Short-duration Ablation of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Patients with documented atrial fibrillation who were referred to our clinic for catheter ablation will undergo standard HPSD ablation and subsequent esophagoscopy. After esophagoscopy patients will be followed up for one month in the form of a telephone follow-up. The primary endpoint of the study assessed by esophagoscopy performed on the day after the index catheter ablaton is the incidence of esophageal thermal lesions. Secondary endpoints include: The size of the esophageal thermal lesions. The severity of esophageal thermal lesions.

Official Title
-----------------
Prevalence and Predictors of Esophageal Thermal Lesions in High-Power-Short-Duration Ablation of Atrial Fibrillation

Conditions
-----------------
Esophagus Injury, Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atrial fibrillation documented in the 12-lead ECG Indication for catheter ablation in accordance with currentn ESC guidelines Exclusion Criteria: Pregnancy Women of childbearing potential without a negative pregnancy test within 48 hours prior to ablation procedure Known intracardiac or other thrombi Contraindication to anticoagulation Contraindication to esophagoscopy: diseases and deformities of the cervical spine, esophageal varices

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of ablation-related esophageal thermal lesions | It will be assessed by means of Esophagoscopy | One day after Catheter ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of ablation-related esophageal thermal lesions | It will be assessed by means of Esophagoscopy | One day after Catheter ablation | 
| Severity of ablation-related esophageal thermal lesions | It will be assessed by means of Esophagoscopy | One day after Catheter ablation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Esophagus Injury, Pulmonary vein isolation, Esophagoscopy
Patient Blood Management in the Approach to Prosthetic Surgery [PBM(L4178)]

Study Overview
=================
Brief Summary
-----------------
We have been well guided in the Good use of blood during major surgery for many years, reaching a percentage of 4% of patients transfused after elective prosthetic operations. Valid patient blood management must provide for the possibility of limiting/zeroing the transfusion risk dependent on preoperative anemia, and the national guideline on PBM (Patient blood management) also underlines this Hypothesis and relevance

Detailed Description
-----------------
We want to analyse patients from a diagnostic point of view (occult blood, diverticulitis, gastrorrhagia) and from the point of view of laboratory parameters (blood count, serum iron, transferrinemia, ferritinemia, transferrin saturation) in ordr to be able to suggest the best approach in preparation to the intervention. We want to evaluate the effectiveness of this approach, considering the proposed treatments (ferric carboxymaltose, chelated iron, folic acid, sideremil vita) and the transfusion result (or not) obtained

Official Title
-----------------
Patient Blood Management in the Approach to Prosthetic Surgery in Orthopedic

Conditions
-----------------
Anemia, Iron Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: sideremil vita cp


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidates for prosthetic surgery Patients of both sexes over 40 years of age Hemoglobin values <12 g% for females and 13 g% for males % transferrin saturation < 10% Willingness and ability to provide informed consent. Exclusion Criteria: Patients with Mediterranean anemia Patients with coagulation disorders Patients who do not sign the consent form Pregnant or breastfeeding women (self-declaration) Minor aged

Ages Eligible for Study
-----------------
Minimum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long assumption<br>Assumpion of SideremilVita for 30 days | Dietary Supplement: sideremil vita cp<br>* assunzione per 30 giorni dell'integratore<br>|
| Active Comparator: Standard assumption<br>Assumpion of SideremilVita for 15 days | Dietary Supplement: sideremil vita cp<br>* assunzione per 30 giorni dell'integratore<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in transfusion patients | Evaluate the reduction of transfusions in anemic patients treated with SideremilVita for 30 days before the intervention (group B experimental), compared to patients assuming SideremilVita at 15 days before surgery (control group A) | 7 days post-surgery |