linjc16/ctgov huggingface dataset:
Cancer Biology of Retinoblastoma

Study Overview
=================
Brief Summary
-----------------
Many children with the childhood cancer, Retinoblastoma, have surgery to remove the tumor and sometimes the entire eye. The purpose of this study is to collect the extra tissue from patients who undergo tumor removal for laboratory experiments that will help us understand not only what occurs in retinoblastoma cells but also how cells normally function. Some of these studies will include an evaluation of how cells control the way that genes are expressed, how cells know to become retinal cells, how cells remain retinal cells, how cells lose their identity as retinal cells, what changes make retinoblastoma cells different from normal retinal cells, and what changes make some retinoblastomas worse than others.

Official Title
-----------------
Cancer Biology of Retinoblastoma

Conditions
-----------------
Retinoblastoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must have retinoblastoma Patient must be receiving biopsy, partial surgical excision of the tumor, complete excision of the tumor, or enucleation of the eye as part of their standard care. Parental consent Exclusion Criteria: Diagnosis other than Retinoblastoma No surgical sampling of tumor is planned as part of standard care Parental preference to not participate.

Ages Eligible for Study
-----------------
Maximum Age: 5 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 |
| --- | --- |
| retinablastoma tumor tissue<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in efficiency of reprogramming in cells with naturally occurring retinoblastoma mutations | Comparison of number of reprogramming events (defined by colony formation assay and normalized for number of cell plated) as well as the time to reprogramming. | After appropriate time, e.g., 7, 10, 14 days after reprogramming | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retinoblastoma
Pancreaticogastrostomy for High-Risk Pancreas

Study Overview
=================
Brief Summary
-----------------
In 2013, a double purse-string telescoped pancreaticogastrostomy (PG) technique appeared to significantly reduce the risk of postoperative pancreatic fistula (POPF). This study compared the incidence of clinically relevant POPF in patients with high-risk anastomosis after undergoing PG or pancreaticojejunostomy (PJ) techniques.

Detailed Description
-----------------
From 2013 to 2019, consecutive patients with high-risk anastomosis (i.e., updated alternative-Fistula Risk Score (ua-FRS) >20%) underwent pancreatoduodenectomy with either the PJ or PG technique. Optimal mitigation strategy (external stenting and octreotide omission) was applied for all patients. The primary endpoint of the study was the incidence of clinically relevant POPF. Data were entered prospectively into an institutional clinical database (NCT02871336).

Official Title
-----------------
Double Purse-String Telescoped Pancreaticogastrostomy for High Risk Anastomosis: A 6-Year Single Center Case-Controlled Study

Conditions
-----------------
Anastomosis; Complications, Pancreatic Fistula

Intervention / Treatment
-----------------
* Procedure: pancreaticogastrostomy
* Procedure: pancreaticojejunostomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pancreatoduodenectomy High updated alternative -Fistula Risk Score which was defined > 20%, as the higher-risk category of the alternative-Fistula Risk Score Exclusion Criteria: Explorative laparotomy Hard pancreatic parenchyma

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 |
| --- | --- |
| Pancreaticogastrostomy (PG) group<br>Patients underwent pancreatoduodenectomy with the PG technique | Procedure: pancreaticogastrostomy<br>* Pancreaticogastrostomy technique was performed according to the precise description of Addeo et al.<br>|
| Pancreaticojejunostomy (PJ) group<br>Patients underwent pancreatoduodenectomy with the PJ technique | Procedure: pancreaticojejunostomy<br>* Pancreaticojejunostomy technique was performed using the 5/0 polypropylene interrupted monofilament suture in a one-layered duct-to-mucosa end-to-side anastomosis (Cattell-Warren anastomosis).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of clinically relevant post operative pancreatic fistula | clinically relevant post operative pancreatic fistula according to the 2016 International Study Group of Pancreatic Surgery (ISGPS) definition | at hospital discharge assessed up to 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High Risk Pancreatic Anastomosis, Clinically Relevant Pancreatic Fistula, Pancreaticogastrostomy
Validation of the Utility of Rare Disease Intelligence Platform

Study Overview
=================
Brief Summary
-----------------
The prevention and treatment of diseases via artificial intelligence represents an ultimate goal in computational medicine. The artificial intelligence for systematic clinical application has not yet been successfully validated. Currently, the main prevention strategy for rare diseases is to build specialized care centers. However, these centers are scattered, and their coverage is insufficient, resulting in inadequate health care among a large proportion of rare disease patients. Here, the investigators use deep learning to create CC-Cruiser, an intelligence agent involving three functional networks: pick-up networks for diagnostics, evaluation networks for risk stratification and strategist networks to provide assisted treatment decisions. The investigator also establish a cloud intelligence platform for multi-hospital collaboration and conduct clinical trial and website-based study to validate its versatility.

Official Title
-----------------
Validation of the Utility of Rare Disease Intelligence Platform: A Multicenter Cluster Clinical Trial

Conditions
-----------------
Cataract, Artificial Intelligence

Intervention / Treatment
-----------------
* Device: CC-Cruiser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent ophthalmic examination of the eye and recorded their ocular information in the collaborating hospital. Exclusion Criteria: -

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eligible patients for CC-Cruiser test<br> | Device: CC-Cruiser<br>* An artificial intelligence to make comprehensive evaluation and treatment decision of congenital cataracts<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of accurate, mistaken and miss detection of CC-Cruiser. |  | Up to 4 years |
Spironolactone in Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to evaluate the renoprotective effect (i.e. albuminuria- and bloodpressure lowering effect) of spironolactone 25 mg o.d. in type 1 and type 2 diabetic patients with albuminuria despite recommended antihypertensive treatment.

Official Title
-----------------
Spironolactone in Diabetic Nephropathy

Conditions
-----------------
Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: Spironolactone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes Mellitus Diabetic Nephropathy Glomerular filtration rate > 30 ml/min/1.73 m2 Blood pressure > 130/80 mm Hg Exclusion Criteria: Child bearing potential Plasma-potassium >4.5 mmol/l Breastfeeding Abuse of alcohol or drugs Non-diabetic kidney disease

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Spironolactone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in albuminuria |  |  | 
| Changes in blood pressure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in glomerular filtration rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic nephropathy, Spironolactone, Aldosterone antagonism, Renoprotection
Metabolomics in Occupational Asthma

Study Overview
=================
Brief Summary
-----------------
The project aims to increase the diagnostic accuracy in occupational asthma (OA), with emphasis on Irritant Induced Asthma (IIA). Currently, most patients are evaluated in occupational medicine by comparing the exposure and symptom characteristics with epidemiological data. Biological markers may be present in AA, but presently not in IIA. The majority of cases evaluated are considered as possible IIA, i.e. low-dose multiple exposures. VOC features will be analyzed with the Breath Biopsy® and TD-GS-MS (Owlstone Medical Ltd, UK).

Official Title
-----------------
Pilot Study of Metabolomics in Occupational Asthma

Conditions
-----------------
Asthma, Occupational

Intervention / Treatment
-----------------
* Device: Breath Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: capable of informed consent. asthma diagnosis established by lung specialist or healthy control. Exclusion Criteria: skin allergy towards plastics or rubber. immunocompromised by oral medication. contagious respiratory disease. biopsy of lung parenchyma within the last 36 hours.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Occupational Asthma<br>Patients refered for assesment of occupational asthma | Device: Breath Biopsy<br>* ReCIVA breath sampler (Owlstone Medical, Cambridge, UK)<br>|
| Respiratory Healthy Control<br>Employees at Oslo University Hospital | Device: Breath Biopsy<br>* ReCIVA breath sampler (Owlstone Medical, Cambridge, UK)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discovery of VOC Biomarkers in Asthma | To evaluate the sensitivity, specificity, positive and negative predictive value of VOC biomarkers in exhaled breath samples to identify asthma. | Baseline | 
| Discovery of VOC Biomarkers in Occupational Irritant Asthma | To evaluate the sensitivity, specificity, positive and negative predictive value of VOC biomarkers in exhaled breath samples to identify irritant asthma after occupational exposures. | Baseline |
MRI Guided High Intensity Focused Ultrasound (HIFU) and ThermoDox for Palliation of Painful Bone Metastases

Study Overview
=================
Brief Summary
-----------------
This study will evaluate treatment with High Intensity Focused Ultrasound (HIFU)in combination with ThermoDox (liposomal doxorubicin) is safe and effective in reducing pain for patients with painful bone metastases.

Official Title
-----------------
Phase II Trial of Phillips MRI-Guided High Intensity Focused Ultrasound (Sonalleve) and Lyso-thermosensitive Liposomal Doxorubicin (ThermoDox) for Palliation of Painful Bone Metastases

Conditions
-----------------
Painful Bone Metastases, Breast Carcinoma, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological confirmation of breast carcinoma, non-small cell lung cancer, small cell lung cancer, or adenocarcinoma of the prostate Bone metastases index lesion in the ribs, clavicle, scapula, upper extremities, pelvis, or posterior aspects of the lumbar vertebra L3-L5 or sacral S1-S5. Patients will have failed at least one prior attempt or will not be eligible for external beam radiation therapy (EBRT) Exclusion Criteria: Greater than 450 mg/m2 of prior free doxorubicin and/or non-heat activated liposomal doxorubicin LVEF < 50% Significant Cardiac History Brain Metastases Contraindication for MR imaging (as incompatible implanted metallic device, weight >250 lbs etc) or known intolerance or allergy to MRI contrast agents.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm RT: HIFU plus ThermoDox<br>Index lesion has been treated with EBRT and is currently painful, but these subjects have already received their maximum cumulative EBRT dose. | Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox<br> <br> |
| Experimental: Arm NRT: HIFU plus ThermoDox<br>Subjects have no yet received any radiation to the index lesion. | Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete pain response |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Painful bone metastases, Bone Cancer, Bone Cancer Pain, Patients with
Troponin Release Induced by Procedure - Czech

Study Overview
=================
Brief Summary
-----------------
A prospective study aiming to analyse the relation between different variables and high sensitivity troponin I (hsTnI) elevation within a group of patients undergoing a coronary angiography with or without subsequent percutaneous coronary intervention.

Detailed Description
-----------------
The study tries to seek potential causes and context of subclinical myocardial injury within patients with baseline concentration of hsTnI below the 99th percentile value upper reference limit or with demonstrated fall of hsTnI levels.

Official Title
-----------------
Myocardial Injury Related to Coronary Angiography in the Era of High-sensitivity Cardiac Troponin I

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable or unknown coronary artery disease acute coronary syndrome without ST-segment elevation meeting the criteria of low risk with demonstrated fall of cTn levels Exclusion Criteria: acute coronary syndrome with persistent ST-segment elevation acute coronary syndrome without ST-segment elevation meeting the criteria of high or intermediate risk

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 |
| --- | --- |
| CAG without PCI<br>Diagnostic coronary angiography only | |
| CAG with PCI<br>Diagnostic coronary angiography and subsequent percutaneous coronary intervention (PCI) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subclinical myocardial injury |  | up to 24 hours after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprocedural myocardial infarction |  | up to 24 hours after procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myocardial injury, high-sensitivity troponin I, periprocedural myocardial infarction
Lethargic Depression Study

Study Overview
=================
Brief Summary
-----------------
This is a study of Major Depressive Disorder (MDD) in patients with decreased energy, pleasure and interests.

Detailed Description
-----------------
A Multicenter, Double-Blind, Placebo-controlled comparison of the efficacy and safety of flexible dose extended-release bupropion (HCl) 300-450 mg/day and placebo administered for eight weeks for the treatment of adult outpatients with major depressive disorder including symptoms of decreased energy, pleasure, and interest

Official Title
-----------------
An 8 Week, Multicenter, Randomized, Double-blind, Placebo Controlled Comparison of the Efficacy of Extended Release Bupropion Hydrochloride and Placebo in the Treatment of Adult Outpatients With Major Depressive Disorder With Lethargic Symptoms

Conditions
-----------------
Epilepsy, Major Depressive Disorder (MDD)

Intervention / Treatment
-----------------
* Drug: Extended-release bupropion (HCl)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Primary diagnosis of MDD with current duration lasting 12 weeks but no greater than 2 years. Generally in good health. Subject must read and write at a level sufficient to provide written informed consent. Exclusion criteria: Current or past history of seizure disorder. Subject has a primary diagnosis or received treatment for panic disorder, obsessive compulsive disorder (OCD), post traumatic stress disorder (PTSD), acute stress disorder, Bipolar I or II disorder, schizophrenia, or other psychotic disorder. Currently using illicit drugs or other psychotropic drugs. Patient poses a current suicidal risk or has attempted suicide in the past 6 months.

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

| Intervention/Treatment |
| --- |
|Drug: Extended-release bupropion (HCl)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from randomization on the Inventory of Depressive Symptomatology, self report and clinician rated. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of responders. Percent of remitters. Quality of Life Enjoyment and Satisfaction Questionnaire. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lethargic, decreased interest, decreased motivation, depression
Deep Anterior Lamellar Keratoplasty (DALK)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.

Detailed Description
-----------------
Purpose: To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique. Methods: Thirty four unselected consecutive patients were submitted to DALK big-bubble technique. Intraoperative and postoperative complications, postoperative uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), spherical equivalent (SE), corneal topography, and endothelial cell density were evaluated. All patients were followed for at least 6 months.

Official Title
-----------------
Deep Anterior Lamellar Keratoplasty by Big-Bubble Technique: Results and Complications

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Procedure: Deep anterior lamellar keratoplasty (DALK)
* Procedure: Penetrated keratoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: keratoconus Exclusion Criteria: central endothelial cell count less than 2000 cells/mm2 glaucoma or intraocular pressure greater than 21 mmHg amblyopia retinal abnormalities diabetes mellitus steroid or immunosuppressive treatment connective tissue diseases

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Submitted to deep anterior lamellar keratoplasty (DALK) using the big-bubble technique. | Procedure: Deep anterior lamellar keratoplasty (DALK)<br>* Deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.<br>* Other names: GROUP 1: DALK;|
| Active Comparator: 2<br>Submitted to regular penetrating keratoplasty | Procedure: Penetrated keratoplasty<br>* Regular corneal transplant using the penetrated keratoplasty technique<br>* Other names: GROUP 2: PK;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lamellar keratoplasty, keratoconus, penetrated keratoplasty, Visual acuity