linjc16/ctgov huggingface dataset:
Hypofractionated Radiation by CyberKnife as a Mean of the Tumor Site's Radiation After Conventional Breast Radiation.

Study Overview
=================
Brief Summary
-----------------
The CyberKnife (CK) has been developed recently. This is a linear accelerator carried by an industrial robot. It has, due to its tumor tracking capabilities and high accuracy, an interest in irradiation (boost) of tumor site after conventional irradiation. The radiation boost is currently issued by electrons, protons or brachytherapy. These techniques require several fractions and are associated with cutaneous toxicities and aesthetic problems. CK has an interest in reducing the number of fractions and a reduction of dose delivered to the skin. CK has been used in a phase I protocol (CYBERNEO) with concomitant chemotherapy for inoperable breast tumors and has proven its effectiveness and safety of treatments. The investigator is considering conducting a Phase II protocol to a single dose of 8 Grays issued by CK for boost to the tumor site after conventional breast irradiation. The results, in terms of local control, will be evaluated on clinical monitoring.

Official Title
-----------------
PHASE II STUDY : Hypofractionated Radiation by CyberKnife as a Mean of Radiation of the Tumor Site After Conventional Breast Radiation.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: CK Boost radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unifocal breast cancer histologically proven Age> 18 years old, in good general condition (ECOG 0-2) No cons-indication for radiotherapy Patient who underwent lumpectomy and axillary dissection or sentinel node technique. carcinoma histology ductal or lobular carcinoma surgical margins microscopically without residual disease (> 1 mm) tumors classes T1 or T2, N0 Exclusion criteria residual calcifications on X-ray examination Inflammatory breast cancer, ductal (and / or in situ) and invasive lobular multifocal breast Cancer prior Breast radiotherapy Patient who received chemotherapy

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

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

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 |
| --- | --- |
| Other: A - CK boost radiation<br>CK boost radiation | Device: CK Boost radiation<br>* single dose of 8 Grays is issued by the CK to the 6th week after conventional radiation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC score for erythema, telangiectasia, edema, pain | early skin toxicity evaluation by clinical examination (radiation oncology and dermatologist) using EORTC score for erythema, telangiectasia, edema, pain. | 2 months |
Collaborative Study of 1,3 Butadiene Biomarkers

Study Overview
=================
Brief Summary
-----------------
Butadiene is a suspect human carcinogen to which most people are exposed daily. Exposures are difficult to measure by air sampling. This study examines the relationship between air levels and several biomarkers of exposure. Biomarkers are substances analyzed in human tissues or waste products. Adducts are materials formed when a chemical reacts with a biological material. In this study we are looking at biomarkers in the blood: hemoglobin and DNA adducts, and urinary metabolites. If a strong relationship is found then the amounts of biomarkers in a person's blood or urine can tell us how much they have been exposed. The tests are being conducted on petrochemical workers who have a wide range of exposures to butadiene. An international group of investigators is conducting the study.

Official Title
-----------------
Collaborative Study of 1,3 Butadiene Biomarkers

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy adults without metabolic disorders

Ages Eligible for Study
-----------------
Minimum Age: 19 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
-----------------
biomarkers, exposure, adducts, metabolites, butadiene
The Neural Substrates for Working Memory Training

Study Overview
=================
Brief Summary
-----------------
This study aims to conduct a contrast study on the characteristics of functional and structural connectivity of neural networks of working memory in patients with acquired brain injury versus normal controls, using resting-state functional connectivity magnetic resonance imaging, task-specific functional magnetic resonance imaging and diffusion tensor imaging, combined with cognitive behavioral examinations. Another purpose is to reveal the characteristics of dynamic change of neural networks of working memory pre- and post-intervention in patients with working memory dysfunction.

Official Title
-----------------
The Study on the Brain Mechanisms for the Rehabilitation of Working Memory Deficits in Patients With Acquired Brain Injury Using Multimodal Magnetic Resonance Imaging

Conditions
-----------------
Rehabilitation, Working Memory

Intervention / Treatment
-----------------
* Behavioral: Working memory training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Right handedness Diagnosis of traumatic brain injury or stroke Course of disease within one year The score of MoCA test > 24 Able to understand instructions Exclusion Criteria: Aphasia, unilateral spatial neglect, agnosia, apraxia Hearing impairment or visual impairment History of taking psychiatric drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Working Memory Training<br>The subjects of experimental group received a series of working memory training, 30 min for 5 days per week during 6 weeks. | Behavioral: Working memory training<br> <br> |
| No Intervention: Non-Working Memory Training<br>The subjects of control group performed traditional cognitive rehabilitation without working memory training, 30 min for 5 days per week during 6 weeks. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Training-induced brain activations during working memory tasks in fMRI | Training-induced increased and decreased brain activations (Number of voxels) during n-back verbal WM task compared to the pre-training baseline | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The fluid intelligence measured by Raven's Standard Progressive Matrices (RSPM) test |  | six weeks | 
| Attention ability assessed by Stroop color-word test |  | six weeks |
Cecal Intubation Time in Colonoscopy: Prospective Clinical Trial

Study Overview
=================
Brief Summary
-----------------
During colonoscopy, body mass index, waist circumference and waist / hip ratio is the relationship between the cecal intubation difficulty aims to define.

Conditions
-----------------
Endoscopy, Colonoscopy

Intervention / Treatment
-----------------
* Other: colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Above 18 Exclusion Criteria: Bad bowel preparation Failure of cecum intubation Inflammatory bowel disease Colectomy story

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 |
| --- | --- |
| BMI <18.5 underweight (Group 1)<br>BMI was calculated as weight in kilograms divided by the square of height in meters. BMI <18.5 underweight (Group 1) | Other: colonoscopy<br> <br> |
| BMİ: 18.5 - 24.9 normal weight (Group 2)<br>BMI was calculated as weight in kilograms divided by the square of height in meters. BMİ: 18.5 - 24.9 normal weight (Group 2) | Other: colonoscopy<br> <br> |
| BMİ: 25- 29.9 overweight (Group 3)<br>BMI was calculated as weight in kilograms divided by the square of height in meters. BMİ: 25- 29.9 overweight (Group 3) | Other: colonoscopy<br> <br> |
| BMİ>30 obese (Group 4)<br>BMI was calculated as weight in kilograms divided by the square of height in meters. BMİ>30 obese (Group 4) | Other: colonoscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (kg/m2) |  | 12/01/2016- 05/01/2017 | 
| waist circumference (centimeter) |  | 12/01/2016- 05/01/2017 | 
| waist / hip ratio |  | 12/01/2016- 05/01/2017 |
COVID-19 Biological Samples Collection

Study Overview
=================
Brief Summary
-----------------
The coronavirus disease 2019 (COVID-19) outbreak is now considered as a public health emergency of international concern by the World Health Organization. In the context of the health emergency, research on the pathogen (the SARS-CoV-2 coronavirus), the disease and the therapeutic care is being organized. Research projects require the use of biological samples. This study aims at setting up a collection of biological samples intended for application projects in any discipline. The main objective of the study is to collect, process and store biological samples from patients and caregivers infected with SARS-CoV-2 (COVID-19) at the biological ressources center of the Bordeaux University Hospital.

Official Title
-----------------
Biological Samples Collection From Patients and Caregivers Treated at Bordeaux University Hospital for Asymptomatic and Symptomatic Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) Infection (COVID-19).

Conditions
-----------------
Infection Viral

Intervention / Treatment
-----------------
* Other: biological samples collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients / caregivers treated at Bordeaux University Hospital for asymptomatic or symptomatic infection by SARS -CoV-2 men and women, adults and minors as well as pregnant or breastfeeding women patients who died following infection with SARS-CoV-2 (specific criterion for post-mortem biopsies) Be affiliated with or beneficiary of a social security scheme Free and informed consent obtained and signed by the patient Exclusion Criteria: Under guardianship or curatorship

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- |
| COVID-19 infected patients<br> | Other: biological samples collection<br>* collection of whole blood samples, urine and stool samples, upper respiratory samples, post-mortem biopsies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 desease description | From blood samples: protein levels, whole genome sequence, transcriptomic analysis data. From upper respiratory samples: protein levels, virus transcriptomic analysis data. From stool: microbiota analysis data. From urine: protein level. | Inclusion visit (Day 1) | 
| COVID-19 desease description | From blood samples: protein levels. | Day 30 to 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, SARS-CoV-2, coronavirus, biological samples
Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy

Study Overview
=================
Brief Summary
-----------------
This is a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial. Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.

Detailed Description
-----------------
This trial will be conducted as a long-term, open-label, extension of the OMC-SXB-7 trial. Participants from the OMC-SXB-7 open-label trial may be entered without any requirement as to length of participation in that trial. Approximately 70 patients are expected to participate at up to 6 investigative centers located in Canada. The trial will continue for up to 24 months or until marketing approval, whichever occurs sooner.

Official Title
-----------------
Long-Term, Open-Label, Multi-Center Extension Trial of Xyrem® (Sodium Oxybate) Oral Solution for the Treatment of Narcolepsy

Conditions
-----------------
Narcolepsy

Intervention / Treatment
-----------------
* Drug: Xyrem (sodium oxybate) oral solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Remained on satisfactory treatment with Xyrem® therapy in the OMC-SXB-7 trial Signed and dated an informed consent

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Xyrem (sodium oxybate) oral solution|Xyrem (sodium oxybate) oral solution|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Experiences | Number of Subjects with treatment-emergent adverse events. | continuous | 
| Vital Signs | Average Respiratory Rate at 1 year. | At 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Narcolepsy, Cataplexy
Qualitative Analysis of Barriers to Consistent Use of Neuromuscular Monitoring in General Anaesthesia

Study Overview
=================
Brief Summary
-----------------
Monitoring the degree of neuromuscular blockade in general anaesthesia reduces complications and patient discomfort. However, monitoring is not applied consistently by Danish anaesthesia personnel. Surveys show that part of the explanation is that the anaesthetists often experience problems with the equipment used for monitoring, though the problems have not been described in detail. We hypothesise that the lack of consistent monitoring in general anaesthesia is caused by insecurity in the anaesthesia personnel's set-up and use of the equipment, as well as in interpreting the measurement results.

Official Title
-----------------
Qualitative Analysis of Barriers to Consistent Use of Neuromuscular Monitoring in General Anaesthesia

Conditions
-----------------
Neuromuscular Blockade

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: has been working in the field of anaesthesiology for at least 1 year. Exclusion Criteria: none

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 |
| --- | --- |
| Anaesthesia personnel<br>Anaesthesiologists and nurse anaesthetists | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the barriers to consistent neuromuscular monitoring, based on a qualitative analysis of focus group interviews with anaesthesiologists and nurse anaesthetists | Focus group interviews will collect participants' perspectives and will be analyzed for thoughts, opinions, and feelings in regard to neuromuscular monitoring. Specific problems experienced with the equipment and other possible barriers to the consistent use of monitoring will be described qualitatively. | Focus group interviews conducted Sep. - Oct. 2014 (2 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the problems experienced with neuromuscular monitoring in daily clinical practice | The problems experienced with neuromuscular monitoring will be described through a qualitative analysis of clinical observations of the personnel's daily use of the monitoring equipment, | Clinical observations conducted in Sep. - Oct. 2014 (2 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuromuscular blockade, Neuromuscular monitoring, Focus group interview, Clinical observation
The Lateral Tibial Tunnel in ACL Surgery

Study Overview
=================
Brief Summary
-----------------
The Lateral Tibial Tunnel technique is a new concept in Anterior Cruciate Ligament (ACL) surgery. In this technique a tibial tunnel is drilled from the antero-lateral side of the tibia towards the ACL footprint. This technique allows the surgeon to deal with bone stock problems in the antero-medial part of the tibia as often encountered in ACL revision surgery. In ACL revision surgery it is often impossible to perform a one-stage revision surgery procedure due to bone stock deficiency in the antero-medial side of the tibia. It is hypothesized that the Lateral tibial tunnel technique allows the surgeon to perform a one-stage procedure instead of a two stage procedure. Furthermore the lateral tibial tunnel technique allows better graft fixation in two-stage ACL revision surgery. Several biomechanical studies proved biomechanical superiority of the new technique compared to the classical technique.

Official Title
-----------------
The Lateral Tibial Tunnel in Anterior Cruciate Ligament Surgery. A Clinical and Ct-graphic Study.to Evaluate the Concept

Conditions
-----------------
Anterior Cruciate Ligament Revision Surgery

Intervention / Treatment
-----------------
* Procedure: Lateral tibial tunnel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients requiring ACL revision surgery patients requiring ACL surgery who have bone stock problems at the medial side of the proximal tibia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Lateral Tibial Tunnel technique<br> | Procedure: Lateral tibial tunnel<br>* To reduce the rehabilitation time after ACL revision surgery due to a better surgical technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of clinical scores pre-operative |  | pre-operative | 
| evaluation of clinical scores at 3 months |  | 3 months post operative | 
| Evaluation of clinical scores at 6 months |  | 6 months post operative | 
| Evaluations of clinical scores at 1 year |  | 1 year post operative | 
| Evaluation of CT scan and X-ray pre-operative |  | pre-operative | 
| Evaluation of CT scan and X-ray post-operative |  | post-operative | 
| Evaluation of CT scan and X-ray 1 year post-operative |  | 1 year post-operative |
Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate how well the Stereo Navigator Biopsy Accessory for the PEM Flex solo II PET Scanner works for performing breast biopsy on suspicious lesions. This study will also allow the doctors to describe the features of PEM detected lesions and the results obtained using the PEM guided biopsy and will compare the time it took to complete a pre-operative work up using PEM versus MRI in patients with a suspicious breast lesion resulting in cancer.

Detailed Description
-----------------
See brief summary.

Official Title
-----------------
Clinical Utility and Initial Experience With PEM Flex Solo II PET Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: PEM Breast Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female subject is 25-100 years of age subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy subject is able to provide informed consent Exclusion Criteria: subject is pregnant subject is actively lactating or discontinued breastfeeding less than 2 months ago subject has breast implants subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study subject has contraindications for core biopsy and other invasive procedures subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEM Breast Biopsy<br>All patients underwent PEM biopsy. | Procedure: PEM Breast Biopsy<br>* Breast biopsy using PEM guidance and Stereo Navigator software<br>* Other names: Stereo Navigator Accessory;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day. |  | At time of biopsy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET, PEM, Positron Emission Mammography, Breast Biopsy