linjc16/ctgov huggingface dataset:
Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®)

Study Overview
=================
Brief Summary
-----------------
The aim is to demonstrate a new application for a blood collection device. This device is already widely used in pharmacology. It is not currently used for metabolic diseases. Its ease of use enables repeated sampling at home. What's more, the device can be sent by post, making it ideally suited to the needs of this cohort of children, whose phenylalanine levels need to be monitored very regularly.

Official Title
-----------------
Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®) in the Context of Metabolic Diseases and, in Particular, Pediatric Monitoring of Phenylketonuria

Conditions
-----------------
Phenylketonuria, Metabolic Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: DM-DIV MITRA®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 3 months to 18 years suffering from phenylketonuria or hyperphenylalaninemia who have had a capillary and blood test including a phenylalanine assay at CHUGA Whose parents or legal guardians are affiliated to the social security system. For whom parents or legal guardians have not objected to the MitrAlanine study. Exclusion Criteria: Parents or legal guardians opposed to the MitrAlanine study

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: DM-DIV MITRA®|Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of phenylalanine concentrations | Comparison of phenylalanine concentrations in the new device with those in the current device (blotter). | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use of research device | ease of use of DM-DIV MITRA® and DM-DIV HemaPEN® via a 3 questions-and-answer guide for samplers | Day 1 | 
| sample conformity | Conformity of blood sample on DM-DIV MITRA® and DM-DIV HemaPEN® versus DM-DIV Perkin Elmer | Day 1 | 
| comparison of concentrations of tyrosin | comparison of concentrations of other amino acids (tyrosin) dosed at the same time as phenylalanine | Day 1 | 
| comparison of concentrations of total leucin | comparison of concentrations of other amino acids (total leucin) dosed at the same time as phenylalanine | Day 1 | 
| comparison of concentrations of methionin | comparison of concentrations of other amino acids (methionin) dosed at the same time as phenylalanine | Day 1 |
Burn Pivotal Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate the algorithm for burn healing assessment by the Spectral MD DeepView device which would provide burn healing potential assessment.

Official Title
-----------------
PERFORMANCE EVALUATION OF THE DEEPVIEW AI-BURNS FOR ASSESSMENT OF THERMAL BURN HEALING POTENTIAL

Conditions
-----------------
Wounds and Injuries, Burns, Wound Heal

Intervention / Treatment
-----------------
* Device: DeepView SnapShot Portable (DV-SSP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to give informed consent or have a Legally Authorized Representative (LAR) able to do so; Life expectancy > 6 months; Thermal burn mechanism (flame, scald, or contact); The Study Burn(s) occurred less than 72 hours prior to the time of first imaging; and Minimum burn wound size for adult or pediatric patients is 0.5% TBSA per region For adult Subjects: Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn. For pediatric Subjects: Have 1 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn Exclusion Criteria: Burn pattern distribution isolated to head, face, neck, hands, feet, genitalia, and/or joints; Subject has burns involving > 50% total body surface area (TBSA); Sepsis at the time of enrollment; Immunosuppression/radiation/chemotherapy < 3 months prior to enrollment; Concurrent use of investigational products with a known effect on the burn sites; and/or Any condition that in the opinion of the Investigator may prevent compliance with the study requirements or compromise subject safety.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Emergency Department Burn Subjects<br>Subjects with Thermal Burn Injury enrolled through the emergency department | Device: DeepView SnapShot Portable (DV-SSP)<br>* DV-SSP assistive imaging to collect observational data<br>|
| Burn Center Burn Subjects<br>Subjects with Thermal Burn Injury enrolled through the burn center | Device: DeepView SnapShot Portable (DV-SSP)<br>* DV-SSP assistive imaging to collect observational data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary BC Endpoint | Demonstrate the DeepView AI-Burns' sensitivity is superior to BC HCPs' bedside examination while maintaining non-inferior specificity to burn HCPs. | 3 weeks |
Lung and Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation in COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to learn about the function of lung and diaphragm ultrasound during weaning from mechanical ventilation in COVID-19 patients. The aim of this study was that the lung ultrasound score and diaphragm muscle mobility could be a potential predictive factor of weaning success.

Official Title
-----------------
Lung and Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation in COVID-19 Patients：A Prospective, Observational Study

Conditions
-----------------
Weaning, COVID-19, Lung Ultrasound, Diaphragm Ultrasound

Intervention / Treatment
-----------------
* Other: Point-of-Care Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years, critically ill patients with COVID-19 (defined as those requiring mechanical ventilation due to respiratory failure), and eligible for their first SBT according to the attending physician's judgement that the underlying disease which led to intubation had sufficiently resolved. Exclusion Criteria: patients with previous cardiothoracic surgery or pleurodesis and patients who presented with stridor (due to upper airway involvement) as a cause of extubation failure neuromuscular 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ultrasound<br>Pulmonary and diaphragm ultrasound was evaluated within one hour before withdrawal | Other: Point-of-Care Ultrasound<br>* Ultrasonographic scans of the lung and right hemidiaphragm were acquired after 30 min from the beginning of the SBT, or immediately before reconnecting the patient to the ventilator in the case of SBT failure occurring before<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end-point was to verify the lung and diaphragm ultrasound evaluation if the predicts weaning success/failure from mechanical ventilation | Weaning failure was defined as failure to pass the spontaneous-breathing trial or the need for re-intubation within 48 h following extubation | spontaneous-breathing trial started until 48 hours following extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome was to verify the predictive value of the traditional weaning parameters | Weaning failure was defined as failure to pass the spontaneous-breathing trial or the need for re-intubation within 48 h following extubation | spontaneous-breathing trial started until 48 hours following extubation |
Pain After Laparoscopic Hysterectomy

Study Overview
=================
Brief Summary
-----------------
The investigators evaluated postoperative pain after total laparoscopic hysterectomy. Two arm are evaluated. During laparoscopic hysterectomy, in one arm; abdominal cavity was washed by saline at normal room temperature. In another arm; abdominal cavity was washed heated saline . Postoperative pain was evaluated by using visual analogy scale.

Detailed Description
-----------------
The aim of this study was evaluated the effect of washing abdominal cavity by heated or normal temperature saline on postoperative pain. This study is double blind randomized controlled study. inclusion criteria: all of cases that had laparoscopic hysterectomy for bening condition exclusion criteria: maling cases and conversion to laparotomy after randomization and completion of surgery, investigator was evaluated postoperative pain at 0-4-8 th hours by using visual analog scale participants and investigator were blinded .

Official Title
-----------------
The Effect of Intraabdominal Saline Washing After Laparoscopic Hysterectomy on Postoperative Pain: Double Blind Randomized Controlled Study

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Other: Study group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all of cases that had laparoscopic hysterectomy for bening conditions Exclusion Criteria: maling cases conversion to laparotomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Washing by heated saline group<br> | Other: Study group<br>* Washing by heated saline group<br>|
| Active Comparator: Washing by normal room temperature saline group<br> | Other: Study group<br>* Washing by heated saline group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessed by visual analog scale | To assess postoperative pain incidence by using visual analog scale | 5 months |
Coronary Microvascular Disease (CMD) Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to provide appropriate administrative and technical supports for the warehousing and use of a database of patients with coronary microvascular disease (CMD). This protocol will outline the process for identification and capture of data, storage, as well as data use and sharing internally and externally for research purposes.

Official Title
-----------------
Coronary Microvascular Disease (CMD) Registry

Conditions
-----------------
Coronary Microvascular Dysfunction

Intervention / Treatment
-----------------
* Other: Outcomes for Patients with CMD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those with Coronary Microvascular Disease

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: Outcomes for Patients with CMD|Our objective is to perform a retrospective/prospective descriptive study on the short term to longterm (up to 5 years of follow-up) outcomes of patients with coronary microvascular disease diagnosis invasively|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish a Registry of CMD patients |  | 10 years |
Short- and Long-term Behavioral, Cognitive and Motor Outcomes of Frameless Deep Brain Stimulation in Patients With Parkinson's Disease: a Prospective Observational Study

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to evaluate the improvement in quality of life after deep brain stimulation surgery with frameless technique by comparing the PDQ-39 scale score at baseline (before surgery) and one year after surgery.

Official Title
-----------------
Short- and Long-term Behavioral, Cognitive and Motor Outcomes of Frameless Deep Brain Stimulation in Patients With Parkinson's Disease: a Prospective Observational Study

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: Clinical examinations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria; patients who are candidates for deep brain stimulation intervention, according to the international criteria of the Core assessment program for surgical interventional therapies in Parkinson's disease (CAPSIT-PD). Exclusion Criteria: - patients unable to give informed consent.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Clinical examinations|Clinical examinations and administration of clinical scales|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of quality of life | Evaluation of the PDQ-39 scale score at baseline (before surgery) and one year after surgery. | One year |
Effects of Spinal Cord Stimulation

Study Overview
=================
Brief Summary
-----------------
The goal of this interventional study is to test effects of spinal cord stimulation in patients receiving treatment for their chronic pain. The main question of the study is: • What is the effect of spinal cord stimulation when compared to placebo? Participants will rate their pain with their usual spinal cord stimulation on and off.

Official Title
-----------------
Effects of Spinal Cord Stimulation

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Device: Spinal cord stimulation turned on (suggestions: off)
* Device: Spinal cord stimulation turned off (suggestions: on)
* Device: Spinal cord stimulation turned on with suggestions (suggestions on)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients (>18 years of age) with SCS implanted to treat chronic pain. Patients who consent to participation and can cooperate in the study. Use of continuous paresthesia-free SCS for minimum 6 months prior to participation in the study. Pain score of 7 or less on a 0-10 scale in the most painful area treated with SCS, rated upon inclusion. Patients not receiving other neuromodulation treatment. Patients who have not undergone changes in their (pain relevant) medication during the last 30 days (pro necessitate medication allowed).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spinal cord stimulation turned on<br> | Device: Spinal cord stimulation turned on (suggestions: off)<br>* Spinal cord stimulation turned on with verbal suggestions of treatment off<br>|
| Placebo Comparator: Spinal cord stimulation turned off<br> | Device: Spinal cord stimulation turned off (suggestions: on)<br>* Spinal cord stimulation turned off with verbal suggestions of treatment on<br>|
| Active Comparator: Spinal cord stimulation turned on and suggestions<br> | Device: Spinal cord stimulation turned on with suggestions (suggestions on)<br>* Spinal cord stimulation turned on with verbal suggestions of treatment on<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity, Visual Analogue Scale | 0-10 (0=no pain, 10=worst imaginable pain). Continual assessments to register changes. | Every 30 minutes during study session (max 5 hours) |
Gallbladder Volvulus Diagnosed Intraoperatively: Case Report

Study Overview
=================
Brief Summary
-----------------
85-year-old female patient presented with right upper quadrant pain of one day duration, diagnosed with acalculous cholecystitis, and intraoperatively diagnosed with gallbladder volvulus.

Detailed Description
-----------------
85-year-old female patient presented with right upper quadrant pain of one day duration that is associated with nausea and vomiting, but no fever or jaundice. She was tachycardiac and had severe abdominal right upper quadrant tenderness with positive Murphy's sign. Laboratory results showed only increase in inflammatory markers. Both ultrasound and computed tomography scan of the abdomen were done and acalculous cholecystitis was diagnosed. Open cholecystectomy was done but gallbladder volvulus was noted intraoperatively. Cholecystectomy was done and the patient had smooth postoperative recovery.

Official Title
-----------------
Gallbladder Volvulus Diagnosed Intraoperatively: Case Report

Conditions
-----------------
Gallbladder Volvulus

Intervention / Treatment
-----------------
* Procedure: Laparoscopic cholecystectomy for gallbladder volvulus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient presenting with right upper quadrant pain Exclusion Criteria: patients having non gallbladder related pathologies explaining right upper quadrant pain
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Laparoscopic cholecystectomy for gallbladder volvulus|Laparoscopic cholecystectomy for volvulus of gallbladder|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gallbladder volvulus | Intraoperative presence of gallbladder volvulus | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gallbladder volvulus, Acalculous cholecystitis
Accuracy of the Characterization of Adnexal Masses, Indeterminate at Ultrasonography, Using a MRI Protocol Without Contrast: Validation of the Cambridge Score

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective observational study is to evaluate the accuracy and to validate the Cambridge Score,a Test Index to predict the malignancy of the ovarian lesions on the basis of an MRI examination without contrast

Official Title
-----------------
Accuracy of the Characterization of Adnexal Masses, Indeterminate at Ultrasonography, Using a Magnetic Resonance Imaging Protocol Without Contrast: Validation of the Cambridge Score

Conditions
-----------------
Adnexal Mass

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years; Indeterminate adnexal masses at the ultrasonography; Signed Informed Consent. Exclusion Criteria: Diagnosis of an extraovary mass; Synchronous tumors; Previous history of neoplasy.

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

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

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 |
| --- | --- | --- |
| Evaluation of generalizability of the Cambridge Score through external validations |  | Through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Cambridge Score when diagnosed by different readers |  | Through study completion, an average of 3 years | 
| Evaluation of diagnostic agreement between the Non-contrast and contrast-enhanced MRI |  | Through study completion, an average of 3 years |