linjc16/ctgov huggingface dataset:
The Use of Self Inflating Tissue Expanders In The Treatment Of Alveolar Cleft

Study Overview
=================
Brief Summary
-----------------
patient receiving treatment using the osmed expander will have enough soft tissue coverage securing the bone graft which will be placed in a later stage to close the alveolar cleft.

Detailed Description
-----------------
to prove that the group treated with osmed expanders will suffer no soft tissue dehiscence and will have a higher volume of soft tissue at the stage of bone grafting.

Official Title
-----------------
The Use of Self Inflating Tissue Expanders In The Treatment Of Alveolar Cleft

Conditions
-----------------
Cleft of Alveolar Ridge

Intervention / Treatment
-----------------
* Device: Osmed self inflating tissue expanders
* Other: Iliac bone graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically free patients. Patients suffering from alveolar cleft with anterior fistulas. Age Between 7 and 13 Years Both sexes. Patients physically able to tolerate surgical and restorative procedures. Good oral hygiene. Highly motivated patients. Exclusion Criteria: non motivated patients

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osmed self inflating tissue expanders<br>All patients will undergo a two-stage procedure ,second stage under General endotracheal anesthesia. The first stage will be placement of the expanders. The second stage will be 21 days later, with removal of the expanders, palatal revision, and closure of the oronasal fistula | Device: Osmed self inflating tissue expanders<br>* Osmed self inflating tissue expanders will be placed 21 days before bone grafting the cleft to gain soft tissue coverage<br>|
| Experimental: Iliac bone graft<br>Placement of bone graft without the use of self inflating expanders | Other: Iliac bone graft<br>* Bone grafting the cleft without the use of osmed self inflating tissue expander<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome : Absence of nasal regurgitation. Binary (Yes/No) |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome : absence of soft tissue Dehiscence and preservation of bone graft volume , volume per cubic meter(Measured by cbct) |  | 6 months |
Anterior Only Surgery for Management of Traumatic Subaxial Cervical Spine Instability

Study Overview
=================
Brief Summary
-----------------
Classic management of cervical spine sublaxation and dislocation is combined anterior and posterior approach. Unfortunately there are disadvantages for this approach like: increasing morbidity related to each approach, increasing surgical costs, increasing operative time as well as the risk of blood loss. Anterior approach has the advantages of supine position, less surgical trauma and direct anterior decompression of neural elements. Disadvantages include less mechanical stability and postoperative dysphagia.

Official Title
-----------------
Anterior Only Surgery for Management of Traumatic Subaxial Cervical Spine Instability

Conditions
-----------------
Traumatic Cervical Spine Instability

Intervention / Treatment
-----------------
* Procedure: anterior approach only in cervical spine trauma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute traumatic cases of adult patients with sub axial cervical spine injury presenting to trauma unit of Assiut university hospital Exclusion Criteria: Patients who need cervical corpectomy. Pediatric injuries

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: improved anterior approach only in traumatic cervical spine<br> | Procedure: anterior approach only in cervical spine trauma<br>* evaluation of efficacy of single approach<br>|
| Active Comparator: failed anterior approach only in traumatic cervical spine<br> | Procedure: anterior approach only in cervical spine trauma<br>* evaluation of efficacy of single approach<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological analysis | Fusion state by: Presence of crossing bone, mobility on motion films and CT scan | 6 months |
Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx Paraganglioma

Study Overview
=================
Brief Summary
-----------------
The main objective of the pilot phase of PGLEXPO will be to assess the faisability and to precise methodology of a case-control study designed for testing the impact of environmental and professional exposures on the tumoral risk in SDHx-mutation carriers

Detailed Description
-----------------
The main objective of the pilot phase of PGLEXPO will be to assess the faisability and to precise methodology of a case-control study designed for testing the impact of environmental and professional exposures on the tumoral risk in SDHx-mutation carriers. Patients will be selected from subjects with a mutation in one of the SDHx genes. The cases will have developed a tumor, while the controls will be tumor-free. Controls will be matched to the cases according to sex, age and type of gene affected. Past exposures will be sought through a telephone questionnaire.

Official Title
-----------------
Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx-related Paragangliomas, Pilot Phase

Conditions
-----------------
Genetic Predisposition, SDH Gene Mutation, Environmental Exposure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor Controls: SDHx mutation carriers with no SDHx-related tumor Exclusion Criteria: Incapacity to exercise free and informed consent for the study

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 |
| --- | --- | --- |
| Feasability of the protocol of a national case/control study (PGL.EXPO2) | Successful pairing of 50 cases with 50 controls | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of matching cases and controls | Proportion of cases for which a control could be identified | 2 years | 
| Ease of matching cases and controls | Mean number of controls matching for a case | 2 years |
Carotid Atherosclerotic Plaque Load and Neck Circumference

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to establish a deep learning model to automatically detect the presence and scoring of carotid plaques in neck CTA images, and to determine whether this model is compatible with manual interpretations.

Detailed Description
-----------------
Modeling CTA images for carotid artery segments with deep learning method and automatic carotid plaque presence and scoring will be useful and beneficial in clinical practice. The aim of this study is to establish a deep learning model to automatically detect the presence and scoring of carotid plaques in neck CTA images, and to determine whether this model is compatible with manual interpretations.

Official Title
-----------------
Determination of Carotid Atherosclerotic Plaque Load and Neck Circumference in Cranial CT Angiography With Machine Learning Method and Their Relationship With Each Other

Conditions
-----------------
Metabolic Syndrome, Machine Learning, Atherosclerosis of Artery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Having cranial CTA withdrawn Having blood lipids, HbA1c, blood glucose, AST, ALT measured in 3 months before and 3 months after cranial CTA Exclusion Criteria: Thyroid disease Having had neck surgery Use of corticosteroids for more than 6 months Presence of lymph nodes in the anterior neck Hypertrophy of neck muscles

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the machine learning model and manual interpretation | Evaluation of the correlation of the presence of plaque in the carotid segments with manual interpretation in the model obtained by machine learning method | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atherosclerosis of Artery, Metabolic Syndrome, Machine Learning
Comparison Between LDCT With DL Recontruction and Standard Dose CT

Study Overview
=================
Brief Summary
-----------------
This prospective study aims to perform intra-individual comparison of the image quality between low dose liver CT with deep learning reconstruction and standard dose liver CT with iterative reconstruction in patients with liver metastasis.

Official Title
-----------------
Comparison of Low Dose Contrast Enhanced Abdominal CT With Deep Learning Reconstruction With Standard Dose CT With Iterative Reconstruction in Patients With Suspected Liver Metastases: A Prospective Multicenter Study

Conditions
-----------------
Liver Metastases

Intervention / Treatment
-----------------
* Diagnostic Test: contrast-enhanced abdomen CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with underlying malignancy and suspicion of liver metastasis patients with known liver metastasis and on follow-up AND scheduled for contrast enhanced abdomen CT signed informed consent Exclusion Criteria: absolute or relative contra-indication for contrast-enhanced CT diffuse infiltrative liver lesion or multiple (> 10) metastases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- |
| Liver metastasis<br>Patients with suspicion of liver metastasis and scheduled for CT | Diagnostic Test: contrast-enhanced abdomen CT<br>* contrast-enhanced abdomen CT using dual-source CT scanner using A-tube (67% radiation) and B-tube (33% radiation). full dose CT data (A +B tubes, 100%) are reconstructed with iterative reconstruction (conventional) low dose CT data (A-tube only, B-tube only) are reconstructed with deep learning commercially available software. images are reconstructed using full dose (A- & B- tubes) and smaller dose (A-tube only, B-tube only)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver lesion conspicuity | graded on a five-point scale (1-5) with higher score indicates a better conscpicuity. | 6 months after the CT scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver lesion detectability | liver lesion detection rate on standard dose CT and low dose CT by blinded reviewers | 6 months after the CT scan | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CT, metastasis, liver
Effects of Intraoperative Oxygen Therapy on Oxygenation of Newborns Born Via Elective Cesarian Section

Study Overview
=================
Brief Summary
-----------------
In this study the investigators examine the effects of intraoperative oxygen administration to the mother on certain enzyme functions of the newborn. With this object blood samples are taken from the newborn's umbilical chord - which is otherwise a routine practice at the investigators clinic - and the mother's radial artery in parallel with umbilical clamping and cutting for blood gas and reactive oxygen species analyses. Samples are analyzed locally in a properly equipped laboratory.

Detailed Description
-----------------
Whole-blood superoxide and hydrogen peroxide production was measured from the newborn's umbilical chord.

Official Title
-----------------
Effects of Intraoperative Oxygen Therapy on Oxygenation and Reactive Oxygen Species Levels of Newborns Born Via Elective Cesarian Section

Conditions
-----------------
Obstetrical Complication of Anesthesia

Intervention / Treatment
-----------------
* Other: Oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective cesarean section. Signed informed consent form. Exclusion Criteria: Subject meets the definition of a vulnerable subject as defined in International Organization for Standardization 14155:2011.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxygen support<br>5 liter / minute oxygen has given to the mothers on face mask. | Other: Oxygen<br>* Oxygen administration<br>|
| No Intervention: Room air<br>Oxygen support has not given to the mothers. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperoxia Newborns | We measured umbilical vein blood gas parameters. | through study completion up to two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal hyperoxia | We measured arterial blood gas parameters of the mother from radial artery. | through study completion up to two years | 
| Alterations in newborns' enzyme functions due to maternal hyperoxia | We measured umbilical vein reactive oxygen species (ROS) of the newborn. | through study completion up to two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
reactive oxygen species, elective cesarean section, oxygen therapy, newborn
Study of the Safety, Tolerability, PK, and PD of ILV-094 Administered IV or SC to Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of ascending single IV doses of ILV-094 (an investigational drug) and one SC dose of ILV-094 in healthy subjects.

Detailed Description
-----------------
This is a randomized, double-blind, placebo-controlled, inpatient/outpatient, sequential-group study of ascending single IV doses of ILV-094 administered to healthy Japanese male subjects.

Official Title
-----------------
Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-094 Administered IV and One Dose of SC Administered to Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: ILV-094


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged 20 to 45 years inclusive at screening. Body mass index in the range of 17.6 to 26.4 kg/m2 and body weight>45. Nonsmoker or smoker of fewer than 10 cigarettes per day. Must be abstain from smoking during inpatient stay. Healthy as determined by the investigator on the basis of screening evaluation.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ILV-094|Single, ascending doses of 5, 15, 50, 100, 300, and 600 mg IV or SC dose of ILV-094 or placebo|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide safety, tolerability, PK and immunogenicity profiles |  | 1 year |
Natural History of Liver Cirrhosis Diagnosed by Transient Elastography in HIV/HCV-coinfected Patients

Study Overview
=================
Brief Summary
-----------------
Prospective multicenter cohort recruiting consecutive patients from 7 hospitals in Andalusia, southern Spain, according to following criteria: 1) HIV infection, 2) Chronic active HCV infection, 3) Older than 18 years, 4) New diagnosis of liver cirrhosis on the basis of a liver stiffness above 14 kiloPascals, 5) No previous or concomitant decompensation of liver disease. Patients are prospectively followed-up according to a uniform protocol of care. Epidemiological, clinical and laboratory variables are periodically recorded. The primary outcomes are the emergence of a liver decompensation (including hepatocellular carcinoma), liver transplant or death. The predictors of these outcomes are analyzed.

Official Title
-----------------
Natural History of Liver Cirrhosis Diagnosed by Transient Elastography in HIV/HCV-coinfected Patients

Conditions
-----------------
HIV, Liver Cirrhosis, Hepatocellular Carcinoma, HCV Coinfection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV Infection HCV chronic active infection (positive serum RNA HCV at inclusion) New diagnosis of cirrhosis on the basis of a liver stiffness equal or greater than 14 kiloPascals. No previous or concomitant decompensation of liver disease Exclusion Criteria: -

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 |
| --- | --- | --- |
| Proportion of patients who developed a first liver decompensation of cirrhosis during follow-up | Episodes of liver decompensation will include those episodes of ascites, spontaneous bacterial peritonitis, portal hypertensive gastrointestinal bleeding, hepatorrenal syndrome, hepatic encephalopathy, hepatocellular carcinoma, non obstructive jaundice and acute on chronic liver failure. These episodes will be diagnosed according to standard definitions of clinical practice guidelines in the field (i.e. HCC diagnosis will be diagnosed according to AASLD criteria, spontaneous bacterial peritonitis and hepatorenal syndrome will be diagnosed following the EASL criteria, portal hypertensive gastrointestinal bleeding according Baveno VI consensus definition,…) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver-related mortality | Probability of liver-related death after enrollment | 3 Years | 
| All cause mortality | Probability of death of any cause | 3 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCV, HIV, Liver cirrhosis, Hepatocellular carcinoma, Liver transplant, Liver stiffness, Transient elastography
Physiological Upper Eyelid Laxity

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single-center study in normal subjects aged 20 to 89 years. The objective was to describe upper eyelid laxity by age group (20/29 years old, 30/39 years old, 40/49 years old, 50/59 years old, 60/69 years old, 70/79 years old and 80/89 years old) measured with the method of McNab and studying it according to her customary side of sleep. In addition, we evaluated a method for measuring tarsal laxity.

Official Title
-----------------
Physiological Upper Eyelid Laxity

Conditions
-----------------
Eyelid Laxity

Intervention / Treatment
-----------------
* Other: Measurement of the upper eyelid laxity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 to 89 years be free be able to give informed consent Exclusion Criteria: History of facial paralysis, upper palpebral trauma or palpebral surgery History of sleep apnea syndrome Impossibility to give consent Pregnant or lactating women Persons enjoying enhanced protection and persons deprived of their liberty by a judicial or administrative decision

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 89 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Measurement of the upper eyelid laxity|Measurement using a soft slider of the distance between our 2 marks The difference obtained between the measurement and the initial 10 millimeters corresponds to the tarsal laxity.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of upper eyelid laxity | Comparison of upper right and left palpebral laxity values in millimeters between different age groups | 10 minutes |