linjc16/ctgov huggingface dataset:
Analysis of in Vitro Biological Reaction of Diaphragmatic Prothesis When Congenital Diaphragmatic Hernia (CDH) Repair

Study Overview
=================
Brief Summary
-----------------
In case of CDH, the incomplete development of a part of the diaphragm allows abdominal viscera to herniate into thorax cavity during fetal development and impaired lung and heart development. After birth, CDH patients who survived thanks to an active reanimation management undergo diaphragmatic repair. In case of large defect, a patch is needed to complete diaphragmatic closure. Thanks to primary cell culture from foreskin, peritoneal epithelium or cremaster dedicated to incineration investigators want to analyse biological integration of actually used prothesis and others innovations.

Official Title
-----------------
Mecanical Properties of Biomaterials and Biological Integration of Diaphragmatic Prothesis in Infancy

Conditions
-----------------
Congenital Diaphragmatic Repair

Intervention / Treatment
-----------------
* Procedure: Foreskin resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minor aged 0 (day of birth) to 14 years Patient for whom an indication of posthectomy and / or cure of inguinal hernia and / or testicular ectopy is retained Patient whose legal representatives have agreed to the use of operational waste from mesenchymal tissues (foreskin, cremaster and peritoneum) destined for incineration. Patient affiliated to a social security scheme Exclusion Criteria: - parents don't agree to the use of its operating waste for research purposes

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 14 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Foreskin resection|During the pediatric surgery consultation, the doctor will decide between Foreskin resection, orchidopexie or inguinal hernia repair.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cell colonization | Study cell colonization | samples are processed immediately after sampling | 
| quality of the extracellular matrix | Quality of the extracellular matrix produced in vitro in contact with the currently used implant materials compared to biomaterials under development | samples are processed immediately after sampling |
Study of Blood Flow Changes and Microemboli During Carotid Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the clinical and radiologic implications of the intraoperative microemboli during carotid revascularization.

Official Title
-----------------
Hemodynamic Alterations in Middle Cerebral Artery and Intraoperative Microemboli During Carotid Endarterectomy and Angioplasty

Conditions
-----------------
Carotid Endarterectomy, Percutaneous Transluminal Angioplasty, Cognitive Aspects, Diffusion Weighted MRI

Intervention / Treatment
-----------------
* Procedure: carotid stenting
* Procedure: carotid endarterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acoustic window for transcranial Doppler surgical criteria proposed by the NASCET and ACAS studies postoperative follow-up for at least six months patient consent Exclusion Criteria: carotid restenosis combined surgery emergency surgery
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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: carotid stenting<br> | Procedure: carotid stenting<br>* A group of patients will be operated by endovascular technique. Then will be analyzed and compared with the other group in relation to clinical and radiological criteria, emphasizing the cognitive aspects.<br>|
| Active Comparator: carotid endarterectomy<br> | Procedure: carotid endarterectomy<br>* A group of patients will be operated by open technique. Then will be analyzed and compared with the other group in relation to clinical and radiological criteria, emphasizing the cognitive aspects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic alterations in middle cerebral artery and intraoperative microemboli during carotid endarterectomy and angioplasty | The blood flow velocity of the middle cerebral artery will be measured in cm / s and the number of microemboli will be represented by the number of microemboli signals measured by transcranial Doppler ultrasound. | 6 months | 
| Number of ischemic areas detected by magnetic resonance |  | 6 months | 
| Neuropsychological changes | Neuropsychological alterations will be assessed through cognitive tests, which generate scores. It will be used: Mini Mental State Examination, Rey's Auditory-Verbal Learning Test, Copy and evocation of Rey's Complex Figure, Weschsler's Immediate Memory Test (direct and indirect digit span ), Lexical and Categorical Verbal Fluency, Stroop Test, Visuospatial Perception Test of Luria's Neuropsychological Investigation, Trail Making Test A e B, Boston Naming Test. | 6 months |
Unilateral vs Bilateral Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study was to determine whether unilaterally operated total hip arthroplasty (THA) patients were superior to bilaterally operated THA patients with respect to aerobic endurance capacity, muscle strength and gait patterns 3-5 years after surgery, and to what extent medial femoral head offset (FO) influenced hip abductor strength.

Official Title
-----------------
Unilateral vs Bilateral Total Hip Arthroplasty - the Influence of Medial Femoral Head Offset and Effects on Strength and Aerobic Endurance Capacity

Conditions
-----------------
Osteoarthritis, Hip

Intervention / Treatment
-----------------
* Procedure: total hip arthroplasty one side
* Procedure: total hip arthroplasty both sides


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergone hip surgery 3-5 years ago Age < 70 years Exclusion Criteria: Heart or lung diseases Malign diseases No muscle/skeletal diseases that compromises testing

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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 |
| --- | --- |
| unilateral normal<br>total hip arthroplasty one side, normal offset of medial femoral head | Procedure: total hip arthroplasty one side<br>* unilateral total hip arthroplasty<br>|
| bilateral normal<br>total hip arthroplasty both sides, normal offset of medial femoral head | Procedure: total hip arthroplasty both sides<br>* bilateral total hip arthroplasty<br>|
| bilateral abnormal offset<br>total hip arthroplasty both sides, abnormal offset of medial femoral head | Procedure: total hip arthroplasty both sides<br>* bilateral total hip arthroplasty<br>|
| controls<br>Healthy, age-matched control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
BAY59-7939 Japanese in Atrial Fibrillation (2nd)

Study Overview
=================
Brief Summary
-----------------
This study was a randomized, parallel group, open label trial using warfarin as comparator. Pharmacokinetics (PK) and pharmacodynamics (PD) were investigated only in BAY59-7939 groups (originally described in Japanese).

Official Title
-----------------
BAY 59-7939 (Factor Xa Inhibitor) Phase II Low Dose Study in Patients With Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Xarelto (Rivaroxaban, BAY59-7939)
* Drug: Xarelto (Rivaroxaban, BAY59-7939)
* Drug: Xarelto (Rivaroxaban, BAY59-7939)
* Drug: Warfarin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese subjects with non-valvular AF who met all of the following criteria: Persistent or paroxysmal non-valvular AF with >/=2 episodes before enrollment, at least 1 of which had been verified by ECG recording within 4 weeks before randomization Male subjects aged 20 years or older and postmenopausal female subjects Subjects with at least one risk factor for thromboembolism or aged 60 years or older (Risk factor for thromboembolism: hypertension, diabetes mellitus, coronary artery disease, congestive heart failure). Exclusion Criteria: History or presence of stroke or transient ischemic attack. History of intracerebral hemorrhage. History or presence of bleeding at randomization; intraocular or gastrointestinal bleeding within the last 6 months prior to randomization.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Xarelto (Rivaroxaban, BAY59-7939)<br>* 2.5mg bid<br>|
| Experimental: Arm 2<br> | Drug: Xarelto (Rivaroxaban, BAY59-7939)<br>* 5mg bid<br>|
| Experimental: Arm 3<br> | Drug: Xarelto (Rivaroxaban, BAY59-7939)<br>* 10mg bid<br>|
| Active Comparator: Arm 4<br> | Drug: Warfarin<br>* Dose-adjusted warfarin based on target INR values<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Safety) Incidence of bleeding |  | Throughout treatment and followup period | 
| (PK/PD) BAY 59-7939 concentrations / Factor Xa activity, PT, PT-INR, PTT and HEPTEST |  | Day 14 and Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BAY59-7939, Rivaroxaban, Non-valvular atrial fibrillation, Japanese Patients, Phase II
Stereotaxis and Chronic Total Occlusion

Study Overview
=================
Brief Summary
-----------------
Wire-crossing of a chronic total coronary occlusion (CTO) is time-consuming and limited by the amount of contrast agent and time of radiation exposure. Magnetic wire navigation might accelerate wire-crossing by maintaining a coaxial vessel orientation. This study compares magnetic with conventional wire navigation for recanalization of CTOs.

Conditions
-----------------
Chronic Total Coronary Occlusion

Intervention / Treatment
-----------------
* Procedure: Magnetic wire navigation
* Procedure: Conventional wire navigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic preserved wall motion or viable myocardium chronic total occlusion Exclusion Criteria: chronic renal failure prior allergic reactions against contrast agent hyperthyreosis claustrophobia pregnancy contraindications to aspirin or clopidogrel

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotaxis<br>Magnetic wire navigation | Procedure: Magnetic wire navigation<br> <br> |
| Active Comparator: Conventional<br>Conventional wire navigation | Procedure: Conventional wire navigation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of contrast medium |  | 8 hours |
Registration Study Sarcoma

Study Overview
=================
Brief Summary
-----------------
The prospective and retrospective data collection on bone and soft tissue sarcoma is an observational cohort study aimed to collect clinical data and patient reported outcomes of all patients who have been diagnosed with bone or soft tissue sarcoma in the Netherlands. All patients diagnosed with bone or soft tissue sarcoma who are treated, planned for treatment or currently being treated, will be asked to participate in this project.

Detailed Description
-----------------
The main objectives of this project are: To improve the knowledge and therefore the treatment care, in patients with bone or soft tissue sarcoma in the Netherlands To start an observational cohort study of bone and soft tissue sarcoma patients from their primary diagnosis until death To prospectively and retrospectively collect data on medical history, co-morbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, functional outcome, cosmetic outcome, hospital stays and interventions. To collect data on health related quality of life and work ability, to collect data on patient reported outcomes measures. To create a continuous basis for a large variety of research purposes including: Prognostic and predictive research Health care policies and cost-effectiveness studies

Official Title
-----------------
Registration Study on Bone and Soft Tissue Sarcoma - An Observational Cohort Study -

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Other: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven bone or soft tissue sarcoma, excluding Gastrointestinal Stromal Tumours Exclusion Criteria: Altered mental status that would prohibit the understanding of and giving of 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: Surgery|all interventions are allowed|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | PFS | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life | measured by EORTC QOL questionnaires | up to 5 years | 
| grade 3/4 serious adverse events | AE | up to 5 years | 
| Disease free survival | DFS | up to 10 years | 
| Overall survival | OS | up to 10 years |
Development of a Model to Evaluate Regenerative Endodontic Techniques Using Extract Human Teeth

Study Overview
=================
Brief Summary
-----------------
Millions of teeth are saved each year by root canal therapy. Although current treatment modalities offer high levels of success for many conditions, an ideal form of therapy might consist of regenerative approaches in which diseased or necrotic pulp tissues are removed and replaced with healthy pulp tissue in order to revitalize teeth.

Detailed Description
-----------------
The long term goal of this research project is to develop a method to regenerate dental pulp-like tissue as an alternative method to conventional root canal treatment. The objective of this study is to identify the methods necessary to regenerate dental pulp-like tissue in human teeth. We will collect small ( 4X4mm) pieces of oral mucosa that are normally removed during surgical tooth extractions, isolate human postnatal progenitor/stem cells and, using an in vitro cell culture system, combined isolated cells with various scaffolds and test compounds to determine optimal conditions to differentiate pulp-like tissue (eg, odontoblasts, fibroblasts, endothelium, etc) grown in segments of human roots.

Official Title
-----------------
Development of a Model to Evaluate Regenerative Endodontic Techniques

Conditions
-----------------
Dental Pulp Regeneration, Dental Pulp Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-existing indication for surgical extraction of impacted teeth Age 16-65 Exclusion Criteria: Ages less than 16 or over 65 No pre-existing indication for surgical extraction of impacted teeth

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental Pulp, Regenerative Medicine, Odontoblasts, Stem Cells, Growth factor differentiation of stem/progenitor cells, Odontoblast-specific cell phenotypes
System-level Monitoring of Immune Activation Concerning Susceptibility to Sepsis in Trauma Patients

Study Overview
=================
Brief Summary
-----------------
Sepsis remains a common entity in critical care patients with remarkable mortality. Despite extended research activities, no reliable bio-markers or scoring systems attributing the individual risk of developing sepsis have been found so far. Patients with multiple trauma are at high risk of developing sepsis. Due to local and systemic immune reactions, high plasma levels of known pro-inflammatory cytokines can be found. Simultaneously, certain anti-inflammatory reactions such as changes in immune cell activity and serum cytokine levels, known as compensatory anti-inflammatory response syndrome (CARS) take place. In addition to changes of cytokine levels and immune cell activity, underlying genetic reactions are present. For instance, expression of miRNA (as an potential important step of immune cell activation) is likely changed during systemic and local immune reactions. In the present study levels of pro- and antiinflammatory cytokines, a detailed assay of immune cell activation and the various expression of miRNA will be evaluated in patients of multiple trauma on day 1 and day 4. Additionally, clinical parameters of organ function, current infection markers as CRP and Procalcitonin, cardiovascular function such as Indocyanin clearance and hemodynamic measures delivered with PiCCO-system and heart rate variability will be assessed. Parameters of local tissue perfusion will be measured with transcutaneous laser doppler.

Conditions
-----------------
Trauma, Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: multiple trauma, ISS > 16 Exclusion Criteria: resuscitation pregnancy malignancy chronic renal insufficiency steroid intake

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sepsis |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, immune cells, immune reaction, trauma, Immune activation
Short Term Feeding for Asian Patients With Liver Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The benefits of short-term naso-gastric feeding in patients with advanced cirrhosis remain uncertain. This was a randomised study comparing naso-gastric feeding and oral feeding in Asian patients with cirrhosis who were admitted to hospital for decompensation.

Detailed Description
-----------------
Consecutive patients with decompensated cirrhosis who fitted the inclusion criteria, will be randomised to either naso-gastric or oral feeding. Total feeding will be for 2 weeks only. Following intervention specific nutritional and liver-related parameters will be measured during the 2 weeks and up to 6 weeks later. Comparison between both groups will then be made.

Official Title
-----------------
Short Term Feeding for Hospitalised Asian Patients With Liver Cirrhosis - a Randomised Trial of Naso-gastric vs Oral Feeding

Conditions
-----------------
CIRRHOSIS

Intervention / Treatment
-----------------
* Dietary Supplement: Osmolite and B.C.A.A.
* Dietary Supplement: Normal oral intake & supplementation if necessary


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with decompensated cirrhosis of any etiology. Exclusion Criteria: Advanced hepatic encephalopathy, Variceal bleeding, Hepatocellular carcinoma.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naso-gastric tube feeding<br> | Dietary Supplement: Osmolite and B.C.A.A.<br>* Feeding inserted into enteral tubes<br>* Other names: Enteral supplementation;|
| Active Comparator: Oral feeding<br> | Dietary Supplement: Normal oral intake & supplementation if necessary<br>* Enteral nutrition<br>* Other names: Enteral supplementation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Child-Pugh score | Change in the Child-Pugh score, assessing liver damage in cirrhosis | Up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in nutritional parameters | Improvement in nutritional anthropometry and assessment tool markers after intervention | up to 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cirrhosis, Malnutrition, Enteral nutrition