linjc16/ctgov huggingface dataset:
Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

Study Overview
=================
Brief Summary
-----------------
The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.

Official Title
-----------------
Impella Real-World Surveillance of Patients Using Sodium Bicarbonate

Conditions
-----------------
Cardiogenic Shock, High Risk PCI

Intervention / Treatment
-----------------
* Device: Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution
* Device: Impella RP with Sodium Bicarbonate used as purge solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Left Sided Impella Inclusion Criteria: Left-sided Impella with bicarbonate in the purge Exclusion Criteria: Known LV thrombus Right Sided Impella Inclusion Criteria: Right-sided Impella with bicarbonate in the purge Exclusion Criteria: Known pulmonary thromboemboli Known DVT
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Left sided device<br>All patients implanted with a left sided support Impella device - this includes but is not limited to Impella 2.5, Impella CP, Impella 5.0, Impella 5.5. | Device: Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution<br>* US commercially approved Abiomed left sided hemodynamic support devices (Impella) will be included.<br>|
| Right sided device<br>All patients implanted with a right sided support Impella device -this includes the Impella RP | Device: Impella RP with Sodium Bicarbonate used as purge solution<br>* US commercially approved Abiomed right sided hemodynamic support devices (Impella) will be included.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint Left Sided Impella | Rate of heiarchical composite of stroke, transient ischemic attack (TIA), left ventricular (LV) thrombus | From hospital admission until hospital discharge, average 5 days | 
| Primary Endpoint Right Sided Impella | Rate of heiarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT) | From hospital admission until hospital discharge, average 5 days |
Marfan Syndrome (MFS) and Facial Dysmorphism: Non-invasive 3D Assessment

Study Overview
=================
Brief Summary
-----------------
The goal of this study observational prospective study is to define the facial morphological features associated with Marfan syndrome (MFS). The main qustion it aims to answer are: To describe the facial morphological features associated with MFS and their evolution over time; To study the association between facial morphology and the features of reference for the diagnosis of MFS.

Detailed Description
-----------------
Marfan syndrome (MFS, OMIM # 154700) is a rare connective tissue disorder caused by mutations in the gene encoding fibrillin-1 glycoprotein (FBN1), involved in the development of microfibrils. Since FBN1 is a constituent of the connective tissue present at a systemic level, mutations in its gene lead to alterations of the connective tissue, even with pleiotropic effects. The clinical manifestations of MFS are heterogeneous and can occur at any time, from neonatal onset to infancy or adolescence. In this sense, the presence of facial dysmorphism could help in early diagnosis of the disease. Considering the craniofacial features, the phenotypic manifestation related to the syndrome MFS are: dolichocephaly, eyelid down-slanting, malar hypoplasia and retrognathia. However, Few studies have so far studied the facial features associated with MFS. Morevoer, there is a gap in the literature for the evaluation of the progression of facial morphology in the pediatric MFS population as well as potential correlations between facial dysmorphism and other manifestations of the disease.

Official Title
-----------------
Marfan Syndrome (MFS) and Facial Dysmorphism: Non-invasive 3D Assessment

Conditions
-----------------
Rare Diseases, Marfan Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: White european ethnicity; Signed informed consent; Exclusion Criteria: Previous relevant traumas affecting the craniofacial district or maxillofacial surgery; Presence of beard and mustache; Pregnancy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MFS Adult patients<br>Patients with clinical and/or gentic diagnosis of MFS older than 18 years | |
| MFS Paediatric patients<br>Patients with clinical and/or gentic diagnosis of MFS younger than 18 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Progression | Prospective evaluation focused in the craniofacial area in MFS patients | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rare Diseases, Marfan syndrome, Facial features
Value of Screening MRI Brain in Stage IV Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Patients with newly diagnosed stage IV non-oncogene addicted NSCLC, who are fit for systemic treatment and don't have any symptoms of brain disease will undergo an MRI of the brain to screen for brain disease.

Official Title
-----------------
ValUe of Screening MRI Brain in Patients With Newly Diagnosed Stage IV Non-oncogene Addicted Non-small Cell Lung CANcer - The VULCAN Trial

Conditions
-----------------
Non Small Cell Lung Cancer Metastatic

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed stage IV metastatic NSCLC, not amenable to curative treatment. Fit for systemic treatment (PS 0-2) according to standard of care. No symptoms of brain disease disease assessed according to standard clinical care by the thoracic oncologist. Exclusion Criteria: Prior/concomitant therapy for stage IV disease. Oncogenic diver mutation (e.g. EGFR, ALK, ROS1, RET, MET, and BRAF) with approved targeted treatment. Contraindications for MRI scan with contrast as per standard of care protocol of the institution.

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: Screening population<br>Patients with newly diagnosed stage IV non-oncogene addicted NSCLC, who are fit for systemic treatment and don't have any symptoms of brain disease. | Diagnostic Test: MRI<br>* MRI scan of the brain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical value of the MRI | Clinical value of the MRI evaluated by the treating thoracic oncologist and assessed by questionnaires completed on three timepoints. | up to 6 months after the MRI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brain metastasis, screening
Predictors of Node Positivity in Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
To investigate the role of histological and moleculr profile of endometrial cancer patietns in predicting the risk of nodal metastases in endoemtrila cancer patients.

Official Title
-----------------
Histological and Molecular Characteristics Predict the Risk of Nodal Involvement in Endometrial Cancer: a Prospective Study

Conditions
-----------------
Endometrial Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Histologically confirmed endometrila cancer Data on molecular genomic profiling (POLE mutated, p53 abnormalities, MMRd/MSI-H, and NSMP) Data on histological characteristics of the ttumor Execution of sentinel node mapping Data on sentinel node status (negative vs. positive) Exclusion Criteria: Stage IVB endoemtrial cancer consent withdraw

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive nodes | positive nodes detected by sentinel node mappinig | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sentinel node, endometrial cancer
Post Trial Access Program of TAK-577 for Von Willebrand Disease (VWD)

Study Overview
=================
Brief Summary
-----------------
The post-trial access program allows eligible participants to gain access to unlicensed treatment on compassionate grounds. Recombinant von Willebrand factor (rVWF) also known as TAK-577, is a medicine to help treat Von Willebrand Disease (VWD). This post-trial access program enables continued access to children and adults who are benefitting from treatment on study SHP677-304 (NCT03879135) study.

Detailed Description
-----------------
This is a post-trial access program in which the drug being given is called TAK-577. This study will provide access to TAK-577 before marketing authorization for eligible participants with severe VWD who are benefitting from treatment on study SHP677-304 and cannot adequately be treated via the current standard of care and cannot enter a clinical trial. All participants will receive TAK-577 as a sequential intravenous infusion based on their weight. This is a multi-center, international program. Participants will continue treatment until a benefit is no longer derived from the treatment (or treatment is no longer tolerable), the sponsor decision to end the program, the participant chooses to discontinue the treatment, or TAK-577 becomes commercially available for children.

Official Title
-----------------
Post Trial Access for Study SHP677-304: Recombinant Von Willebrand Factor (rVWF) for Adult and Pediatric Subjects With Severe Von Willebrand Disease (VWD)

Conditions
-----------------
Von Willebrand Disease (VWD)

Intervention / Treatment
-----------------
* Biological: TAK-577


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant has completed the treatment period of the SHP677-304 study (at least 12 months on study treatment). Participant had good clinical response to rVWF treatment. Participant does not have access to any comparable or satisfactory alternative replacement therapy available at country level. Participant will be/has been negatively impacted by discontinuation of rVWF. Participant and/or a parent(s)/legal guardian is informed of the nature of the post trial access program and can provide written informed consent for themselves or the child to participate (with assent from a child when appropriate) before treatment). Exclusion Criteria: 1. Participants with known hypersensitivity/intolerance to the study drug will not be eligible for this study
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: TAK-577|TAK-577 as IV injection at dose calculated based on the participant's body weight.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Therapy
Developing a Decision Tool for Diverticulitis in the Emergency Department Using Ultrasound

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a decision tool using ultrasound, patient history, and laboratory values to predict a diagnosis of complicated diverticulitis and whether the patient requires further imaging. The accuracy of the decision tool will be evaluated. This study will also assess the ability of ultrasound to diagnose complicated and simple diverticulitis, and the inter-provider reliability of ultrasound interpretation of diverticulitis

Official Title
-----------------
Developing a Decision Tool for Diverticulitis in the Emergency Department Using Ultrasound

Conditions
-----------------
Diverticulitis

Intervention / Treatment
-----------------
* Other: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency department patient Provider suspicion of diverticulitis CT scan ordered Exclusion Criteria: Pregnant patient Prisoner Non-English speaking Inability to provide informed consent Hemodynamically unstable as determined by provider Previous abdominal surgery within last 7 days Unable to lay flat for ultrasound exam

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 |
| --- | --- |
| Simple Diverticulitis<br>Computed tomograpy scan showing isolated inflammation | Other: Ultrasound<br>* Point-of-care ultrasound in the emergency department<br>|
| Complicated Diverticulitis<br>Computed tomograpy scan evidence of diverticulitis with either an associated abscess, fistula, obstruction, bleeding, phlegmon or perforation. | Other: Ultrasound<br>* Point-of-care ultrasound in the emergency department<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simple Diverticulitis | Computed tomography scan showing isolated inflammation | 48 hours |
New Mammographic Techniques Versus MRI in Assessment of Breast Lesions

Study Overview
=================
Brief Summary
-----------------
Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast lesions

Detailed Description
-----------------
Combined use of contrast-enhanced digital mammography (CEDM), and digital breast tomosynthesis (DBT), may be a reasonable alternative to MRI.

Official Title
-----------------
Value of New Mammography Techniques in Comparison to Dynamic Contrast-Enhanced MRI of the Breast in the Detection and Diagnosis of Breast Lesions

Conditions
-----------------
Breast Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: contrast enhanced digital mammography, tomosyntheis and MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Breast Imaging Reporting and Data System (BI-RADS) 3, 4, and 5 breast lesions. Clinical indication for MRI breast imaging. No histologically proven cancer before enrollment. Exclusion criteria 1. Pregnancy or possible pregnancy. 2. History of allergy to an iodinated contrast agent. 3. Renal impairment. 4. Contraindication for MRI examination
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| contrast enhanced mammography, tomosynthesis and MRI<br>CEDM and tomosynthesis versus MRI | Diagnostic Test: contrast enhanced digital mammography, tomosyntheis and MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity, specificity of'tomosynthesis and contrast enhanced mammography and MRI breast are measured in assessment of breast lesions and their pre-operative assessment of breast cancer | diagnostic | 1year |
Capillary-Venous Paired Data Collection

Study Overview
=================
Brief Summary
-----------------
Capillary-venous paired data collection.

Detailed Description
-----------------
An iterative data collection study to continuously assess the performance of our Entia Liberty device with cancer patients. Our device enables a full blood count from a finger prick sample. The participants enrolled in the study will attend the study site for their routine venepuncture blood test. Once enrolled, they will have a finger prick test obtained by a Healthcare Professional (trained member of the clinical research team) to be tested on an Entia Liberty device. Within 4 hours of that same participant's routine venepuncture, a small amount of blood from the venepuncture will be also tested on a second Entia Liberty device in the laboratory. All the results from the capillary finger prick Liberty test, routine venepuncture blood test (gold standard reference method) and the venous blood Liberty test will be compared against each other to regularly assess that the improvements made on the measurement system of the device is sufficient.

Official Title
-----------------
Capillary-Venous Paired Data Collection

Conditions
-----------------
Oncology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years old at the time of study entry Currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle of treatment Scheduled to be undergoing routine venous laboratory blood tests as part of standard of care Can provide written informed consent Exclusion Criteria: History of haematological malignancy Inadequate use and understanding of the English language, requiring a translator

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 |
| --- | --- | --- |
| Coefficient of Variance of the difference between the lab results and the Liberty results | the coefficient of variance (CV) between the lab results and the liberty results would be compared. a lower CV value signifies a better performance of our device. | 3 years |
Performance of New Diagnostic Methods in Older Adults With Pneumonia

Study Overview
=================
Brief Summary
-----------------
Create a clinical diagnostic pathway for older ED adults with pneumonia and its subgroups (bacterial, viral, and co-infection) and determine whether novel biomarkers improve diagnostic accuracy. The investigators will conduct a prospective observational trial of 250 ED patients ≥65 years old with suspected pneumonia. The investigators will perform analyses overall and by subgroups, seeking common models to ease adoption.

Official Title
-----------------
Establishing and Implementing Pneumonia Diagnosis in ED Older Adults: A Mixed Methods Approach

Conditions
-----------------
Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adults aged 65 and older presenting to the ED with suspected pneumonia defined as (1) either a physician order for CXR OR CT OR a chief complaint consistent with dyspnea; AND (2) physician suspicion of pneumonia prior to ED testing (score of 2-5 on Likert scale) Exclusion Criteria: inability to obtain consent from the patient or an LAR active cancer organ transplant immunosuppression trauma activation suicidal ideation incarceration antibiotics in the last 14 days a separate episode of lower respiratory illness in the last 30 days

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Pneumonia | Presence or absence of pneumonia based on adjudicator review of chart. The goal of the study is to create a diagnostic pathway for pneumonia in older adult emergency department patients. | 3 years |
Interstitial Cystitis: Monitoring of the Psychic State and Counseling Intervention in the COVID-19 Era

Study Overview
=================
Brief Summary
-----------------
The target population of this observational study is made up of all patients belonging to the Interstitial Cystitis pathway of the Gemelli University Hospital Foundation - IRCCS, who have accepted to be subjected to remote monitoring and diagnostic investigation. The aim of the study is the evaluation of some outcome parameters at the time of enrollment (T0), and at the end (T1) of subjects affected by Intersitial Cystitis who have carried out a monitoring of the dimensions of the psychic sphere concerning: depression, trait anxiety, state anxiety , well-being, self-efficacy, resilience.The objective is also to evaluate the presence of evolutionary and maturational trends in the mental set-up of the people who participated in the individual counseling intervention.

Official Title
-----------------
Interstitial Cystitis: Monitoring of the Psychic State and Counseling Intervention in the COVID-19 Era

Conditions
-----------------
Cystitis, Interstitial

Intervention / Treatment
-----------------
* Other: Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recruited subjects have a diagnosis of Interstitial Cystitis and are 18 years of age or older. Exclusion Criteria: Previous or current intellectual disability in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-5. Patients who are unable to express consent and who do not have a caregiver who can give it for them.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Counseling|Professional Counseling is an activity that aims to improve the client's quality of life. Supporting his strengths and his ability to self-determination, Counseling offers a space for listening and reflection in which to explore difficulties, related to evolutionary processes, transition phase, states of crisis and reinforcement of the ability to choose or change.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Symptom Rating Scale (GSCG) | Administration of psychometric scales | 12 months | 
| Hospital Anxiety and Depression Scale (HADS) | Administration of psychometric scales | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological General Well-Being Index (PGWBI) | Administration of psychometric scales | 12 months |