linjc16/ctgov huggingface dataset:
Validation of a Smartphone-based Intelligent Diagnosis and Measurement for Strabismus

Study Overview
=================
Brief Summary
-----------------
The current measurement methods of strabismus include the corneal light reflection method, prism alternate covering, etc., which especially rely on the subjective experience of doctors, and there is a large error between different measurers， leading to serious underestimation of strabismus prevalence and insufficient care for strabismus patients. Here, the investigators established and validated an artificial intelligence system to achieve an automatic diagnosis of strabismus based on patient-sourced videos of programmatic cover tests. Three-dimensional reconstruction methods are used to digitize the parameters of head and eye positions. This system has been integrated into a smartphone platform to be further validated through hospital-based and population-based clinical trials.

Official Title
-----------------
Validation of a Smartphone-based Intelligent Diagnosis and Measurement for Strabismus

Conditions
-----------------
Strabismus, Exotropia, Esotropia, Vertical Strabismus

Intervention / Treatment
-----------------
* Diagnostic Test: A new technology based on 3D reconstruction and deep learning algorithm to achieve an automatic diagnosis of strabismus based on patient-sourced videos of programmatic cover tests.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The quality of facial videos should be clinically acceptable.

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- |
| Eligible participants for smartphone-based strabismus measurement and diagnosis<br>Facial videos dataset Facial videos were collected using smartphone and following the programmatic cover tests. | Diagnostic Test: A new technology based on 3D reconstruction and deep learning algorithm to achieve an automatic diagnosis of strabismus based on patient-sourced videos of programmatic cover tests.<br>* Digital ruler of strabismus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of smartphone-based diagnosis | The accurate and the area under curve of the smartphone-based diagnosis. | Baseline | 
| The consistency between manual and smartphone measurement | Agreement between the manual and automated tests was represented in Bland-Altman plots and concordance correlation coefficients. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mobile health, Artificaial intelligence medicine, Pediatric ophthalmology
A Phase 1/2 Study of Epofolate (BMS-753493) in Subjects With Advanced Cancer (Schedule 1)

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to study the safety of Epofolate (BMS-753493) in patients with advanced cancers (in Phase 1 portion) and to determine whether Epofolate (BMS-753493) can shrink or slow the growth of the cancer in patients with advanced ovarian, renal or breast cancer (in Phase 2 portion).

Official Title
-----------------
A Phase 1/2, Ascending Multiple-Dose Study to Evaluate the Safety, Efficacy and Pharmacokinetics of BMS-753493 in Subjects With Advanced Cancer (Schedule 1)

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Drug: Epofolate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced cancer, excluding cancer in the blood Availability of 10 tumor tissue slides Exclusion: Known brain metastases Severe nerve damage Significant cardiovascular disease Inadequate blood counts Inadequate liver or kidney function Inadequate thyroid function or uncontrolled thyroid 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Epofolate<br>* Intravenous solution, intravenous, initially 3 patients will be treated and if there is a DLT then additional 3 patients will be treated in that dose level. 3-5 minute IV bolus on Days 1, 4, 8 and 11 of a 21-day cycle, until the disease progresses<br>* Other names: BMS-753493;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the Maximum Tolerated Dose, the Dose Limiting Toxicity and the recommended dose of Epofolate (BMS-753493) |  | at the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and exposure levels of Epofolate (BMS-753493) in the body and the anticancer activity of Epofolate (BMS-753493) |  | every 21 days |
Comparison Between Sutureless Devices for PICC and a New System KT FIX PLUS

Study Overview
=================
Brief Summary
-----------------
PICC (Peripherally Inserted Central Catheter) are commun used. Just one paper report morbidity with suture as fixation system for PICC (dislodgement, infection) In the guidelines it's recommended to use sutureless device. The devices actually used are unsatisfactory because of the high risk of migration, accidental removal. A new device, called KTFIX PLUS, seem to be more secure for PICC fixation and offer the possibility to simplify the after care. This device may stay on patient for 4 weeks. Others devices may be changed 1/week. The investigators aimed to compare morbidity between this new device and the old one. The investigators also want to perform an economic evaluation of this device and compare patient quality of life.

Official Title
-----------------
Comparison Between Actually Sutureless Devices for PICC to a New Device KT FIX PLUS

Conditions
-----------------
Catheter Complications, Thrombosis, Displacement of Infusion Catheter, Quality of Life

Intervention / Treatment
-----------------
* Device: KTFIX PLUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with indication for PICC according guidelines hospitalized in a departement of your hospital with the possibility to use a sutureless device Exclusion Criteria: infection thrombosis pediatric patient emergency context

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Group with the sutureless device actually used | |
| Experimental: Innovative group<br>Group with the new device ( KTFIX PLUS) | Device: KTFIX PLUS<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity assessed as a composite of: | Catheter infection Symptomatic superficial or deep venous thrombosis Catheter occlusion Premature withdrawal Catheter migration Hematoma occurred within 24 hours after installation in incidence density | from baseline up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | internal satisfaction scale | 1 year | 
| cost | direct costs of PICCS fastening systems | 1 year | 
| efficacy of urokinase | recanalization rates of PICC after application of urokinase protocol | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Central Venous Catheter, Catheter Bloodstream Related Infection, Economic evaluation
Pilot Study of Edaravone to Treat Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Early reperfusion therapy has improved the clinical outcomes of patients with acute myocardial infarction (AMI), but these benefits are limited in some patients by reperfusion injuries. There is now increasing evidence that reactive oxygen species cause reperfusion injury. This study was designed to examine the effects of edaravone, a novel free radical scavenger, in patients with AMI.

Detailed Description
-----------------
Initial AMI patients were randomly assigned to receive 30 mg of edaravone or a placebo intravenously just before reperfusion. We compared infarct size, using serial determination of serum biomarkers and Q wave formations, and the incidence of reperfusion arrhythmia between the groups. Cardiovascular event-free curves were estimated by Kaplan-Meier method. In addition, we determined serum thioredoxin levels, an oxidative stress marker, to assess the antioxidant effect of edaravone.

Official Title
-----------------
Effects of Edaravone in Patients With Acute Myocardial Infarction

Conditions
-----------------
Myocardial Infarction, Reperfusion Injury

Intervention / Treatment
-----------------
* Drug: edaravone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Initial AMI patients admitted to the investigators' institution within 6 hours of symptom onset and treated primary percutaneous coronary intervention. Exclusion Criteria: Renal insufficiency defined as serum creatinine > 1.2 mg/dl and altered hepatic function defined as serum asparate aminotransferase > 50 IU/L, alanine aminotransferase > 50 IU/L and total bilirubin > 1.2 mg/dl.
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Edaravone Group | Drug: edaravone<br>* intravenous administration of 30mg Edaravone just before reperfusion therapy<br>|
| No Intervention: 2<br>Placebo Group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Death | number of cardiac death | 415±32 days | 
| Nonfatal Myocardial Reinfarction | number of nonfatal myocardial reinfarction | 415days | 
| Refractory Angina Pectoris | number of refractory angina pectoris | 415days | 
| Nonfatal Ischemic Stroke | number of nonfatal ischemic stroke | 415days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Edaravone, Randomized Control Trial, ST-Elevation Myocardial Infarction, Coronary Angioplasty
EpSSG (European Soft Tissue Sarcoma Study Group) Protocol for Non-Metastatic Rhabdomyosarcoma in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is achieve standardization treatment of low and intermediate risk rhabdomyosarcoma patients, with an attempt to improve treatment results in high and very high risk patients by the addition of doxorubicin as induction treatment and at the maintenance phase.

Conditions
-----------------
Rhabdomyosarcoma

Intervention / Treatment
-----------------
* Drug: doxorubicin, cytoxan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: child non metastatic rhabdomyosarcoma adequate heart, kidney, liver function Exclusion Criteria: age over 21 years, under 6 months metastatic disease heart, kidney, liver disease

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: doxorubicin, cytoxan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| event free survival |  |  | 
| overall survival |  |  |
NDT Effectiveness Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether there is a functional change in children with Cerebral Palsy (CP) and other neuromuscular disorders participating in Neurodevelopmental Treatment (NDT) intervention using the contemporary practice model (CPM).

Official Title
-----------------
Determining the Efficacy of the Neurodevelopmental Treatment Contemporary Practice Model for the Treatment of Children With Cerebral Palsy or Other Neuromuscular Conditions to Improve Functional Outcomes.

Conditions
-----------------
Cerebral Palsy, Neuromuscular Diseases, Neurodevelopment Treatment

Intervention / Treatment
-----------------
* Behavioral: Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The children will be aged 2 to 15 years with a diagnosis of CP, hypotonia, global developmental delay and/ or neuromuscular disorders not otherwise specified. Children must also be willing to receive physical guidance for movement and clearly attempt to respond to simple instructions on request. Children and their families are available and willing to attend the practicum portion of the course for both blocks. Exclusion Criteria: Parent/Guardian unable to complete the 4 required interview sessions. Unable to commit to attending 75% of practicum sessions.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NDT<br>Therapy will be provided 2 days to 4 days per week for one-hour sessions | Behavioral: Therapy<br>* The intervention performed in the practicum will not be able to be influenced by the study investigators and the intervention may be different for each child based on their needs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant increase in functional outcomes in COPM scores | Change functional outcomes in COPM scores after NDT-CPM treatment. | Significant change after an 8 week NDT-CPM treatment occurring from November 2, 2021 to completion on March 12, 2022 |
Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans

Study Overview
=================
Brief Summary
-----------------
We wanted to test the hypotheses that methylprednisolone up regulates u-AQP-2 in fasting healthy humans

Official Title
-----------------
Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Methylprednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Genders; both mal and female (2) Age; 18- 65 years old (3) BMI; below 30 (4) Females had to bee in oral contraceptive treatment Exclusion Criteria: (1) Clinical signs or history of disease in the heart, lungs, kidneys or endocrine organs (2) Abnormal laboratory test (blood haemoglobin, white cell count, platelets, plasma sodium, plasma potassium, plasma creatinine, plasma albumin, plasma bilirubin, plasma alanine aminotransferase, plasma cholesterol and blood glucose) (3) Albuminuria or glucosuria (4) Cancer (5) Arterial hypertension (6) Alcohol abuse (7) Use of tobacco (8) Medical treatment, except oral contraceptives (9) Pregnancy or breast feeding (10) Medicine abuse (11) Donation of blood less than 1 month before the study.

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| u-AQP-2 |  |  | 
| FeNa+ |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AQP-2, Methylprednisolone, Urinary concentrating ability
Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The goal of this research study is to evaluate the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease.

Official Title
-----------------
Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease, Dementia, Alzheimer Type

Intervention / Treatment
-----------------
* Drug: rivastigmine transdermal patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of dementia of the Alzheimer's type Males, and females who are surgically sterile or one year postmenopausal A primary caregiver willing to accept responsibility for supervising the treatment Exclusion Criteria: Any condition (other than Alzheimer's) that could explain patient's dementia An advanced, severe or unstable disease that may put the patient at special risk Current diagnosis of active, uncontrolled seizure disorder or unstable cardiovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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: rivastigmine transdermal patch|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognition from baseline at week 24 |  |  | 
| Global clinical impression of change from baseline at week 24 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at week 24 in activities of daily living |  |  | 
| Change from baseline at week 24 in behavioral symptoms |  |  | 
| Change from baseline at week 24 in global cognitive testing |  |  | 
| Change from baseline at week 24 in executive function |  |  | 
| Change from baseline at week 24 in attention |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's Disease, Dementia
Pilot Study of Familial Nonsyndromal Mondini Dysplasia

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the mode of inheritance of nonsyndromal Mondini inner ear dysplasia, an inner ear malformation causing deafness, vestibular dysfunction, and recurrent meningitis.

Detailed Description
-----------------
PROTOCOL OUTLINE: The parents of 1 family with known Mondini dysplasia are screened for the disorder using temporal bone computerized tomography without contrast. This information is used to determine the mode of inheritance.

Conditions
-----------------
Mondini Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Parents of a study family with nonsyndromal Mondini dysplasia

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mondini dysplasia, genetic diseases and dysmorphic syndromes, rare disease
Peritoneal Microdialysis in Patients Undergoing Low Anterior Resection (LAR) for Recto-sigmoid Cancer

Study Overview
=================
Brief Summary
-----------------
Anastomotic leakage is a serious complication after LAR with high morbidity and mortality rates. Early diagnosis and treatment is mandatory. The primary aim of the present study is to investigate the clinical use of peritoneal microdialysis and whether is able to detect anastomotic leakage prior to clinical symptoms develops.

Detailed Description
-----------------
Patients undergoing LAR for recto-sigmoid cancer is subjected to peritoneal microdialyses during the postoperative period until discharge. Subcutaneous microdialysis serve as control. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient. Patients undergoing abdomino-perineal rectal resection will serve as a control group. A total of 50 patients will be included in this pilot study. The results of the peritoneal microdialyses will be compared with the clinical course in each patient. The results form the uncomplicated courses will be used to define the normal variations in peritoneal microdialysis. This will be compared to results from patients with various complications. The study is approved by the local scientific ethical committee No. ------

Official Title
-----------------
Intraperitoneal Microdialysis Monitoring of Patients During the Early Postoperative Period After LAR With Reference to Early Diagnosis of Anastomotic Leakage

Conditions
-----------------
Cancer of Rectum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological verified cancer The cancer must be located in rectum or the sigmoid colon Diverting stoma is allowed Perioperative radio-chemotherapy is allowed Exclusion Criteria: Disseminated cancer ASA-group 4 ore higher
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 |
| --- | --- | --- |
| anastomotic leakage |  | within 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peritoneal microdialysis, Low anterior resection, Recto-sigmoid cancer, Anastomotic leakage