linjc16/ctgov huggingface dataset:
Comparison of Set-up Reproducibility Between Prone and Supine Intensity Modulated Radiotherapy (IMRT) for the Adjuvant Treatment of Breast Carcinoma After Lumpectomy

Study Overview
=================
Brief Summary
-----------------
10 patients will be treated alternating daily between prone and supine position for breast radiotherapy to compare set-up accuracy. Prone treatment will be given on the odds days and supine treatment on the even days.

Official Title
-----------------
Comparison of Set-up Reproducibility Between Prone and Supine Intensity Modulated Radiotherapy (IMRT) for the Adjuvant Treatment of Breast Carcinoma After Lumpectomy

Conditions
-----------------
Breast Carcinoma

Intervention / Treatment
-----------------
* Behavioral: prone and supine position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients multidisciplinary decision of adjuvant radiotherapy after lumpectomy for breast cancer minimum 18 years informed consent obtained, signed and dated before specific protocol procedures. Exclusion Criteria: mastectomy need for axillary irradiation bilateral breast irradiation previous irradiation at the same time pregnant or breastfeeding mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study. patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.

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

| Intervention/Treatment |
| --- |
|Behavioral: prone and supine position|patients will be treated alternating daily between prone and supine position for breast radiotherapy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Random set-up error |  | daily during radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic set-up error |  | daily during radiotherapy | 
| Respiration-related motion amplitude |  |  | 
| time of treatment delivery |  | daily during radiotherapy | 
| Dose-volume parameters |  | of planning |
Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia

Study Overview
=================
Brief Summary
-----------------
Idiopathic Macular Telangiectasia is characterized by incompetent and dilated retinal capillaries in the foveolar region of unknown cause for retinal telangiectasia. In Idiopathic Macular Telangiectasia, proliferative changes occur in the deep retinal capillary network, leading to intraretinal neovascularization that, unlike in age-related macular degeneration, seems to be retinal rather than choroidal in origin. Before the hemorrhagic and fibrotic state, these vessels may lead to exudation and decrease in the visual acuity. Long-term visual prognosis in patients with this complication may be poor and treatment with laser photocoagulation is unproven. Although newly reported treatment, by photodynamic therapy for neovascular membrane associated with Idiopathic Macular Telangiectasia, may show vision and angiographic stability in a few cases, the improvement may be transient. VEGF has been implicated as the major angiogenic stimulus responsible for neovascularization in AMD, ensuing specific anti-VEGF treatment in these cases. The purpose of the study is to evaluate intravitreal injection of bevacizumab (1.25mg/0.05ml) in the treatment of Idiopathic Macular Telangiectasia.

Official Title
-----------------
Intravitreal Bevacizumab for Idiopathic Macular Telangiectasia

Conditions
-----------------
Retina, Telangiectasis

Intervention / Treatment
-----------------
* Drug: Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with idiopathic macular telangiectasia patient consent Exclusion Criteria: heart attack or cerebrovascular attack previous treatment for others retinopathy media opacities that preclude visualization of the fundus inability to understands the implications of the protocol

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intravitreal Injection of Bevacizumab (1.25 mg/0.05ml)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  |  | 
| Optical coherence tomography |  |  | 
| Fluorescein angiography |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fovea centralis/pathology, Fundus oculi, Retinal neovascularization, Telangiectasis/diagnosis, Tomography, optical coherence, Vitreous Body/drug effects
Value of CT-based Autopsy Compared With Conventional Autopsy in ICU Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare findings generated by CT-based autopsy (Virtopsy) with conventional autopsy and clinical diagnoses. Therefore all patients dying while receiving treatment in the Department of Intensive Care Medicine will be undergo virtopsy and, if relatives give informed consent conventional autopsy.

Detailed Description
-----------------
The aim of the study is to compare findings generated by computertomography-based autopsy (Virtopsy) with conventional autopsy and clinical diagnoses. Therefore all patients dying while receiving treatment in the Department of Intensive Care Medicine will be undergo virtopsy and, if relatives give informed consent conventional autopsy.

Official Title
-----------------
Computertomography-based Autopsy (Virtopsy) Versus Conventional Autopsy in Patients Dying in Intensive Care Units

Conditions
-----------------
Autopsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients dying in the Department of Intensive Care Medicine while receiving treatment during the study period 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?
-----------------
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
-----------------
CT-based autopsy, virtual autopsy, medical autopsy, quality control
Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study was to describe neurologists' population of patients treated with pramipexole and suffering from Parkinson's disease (so called 'primary care' population). The secondary objectives were: Evaluate the mean dose of pramipexole prescribed under actual conditions of use depending on the severity of the disease. Evaluate the reasons for choosing pramipexole as treatment. Identify the patient profiles determining the choice of dose of pramipexole prescribed

Official Title
-----------------
Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole by Neurologists in France (ETAP)

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

Intervention / Treatment
-----------------
* Drug: Pramipexole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from idiopathic Parkinson's Disease and treated with pramipexole for at least two months, examined in consultation Exclusion Criteria: Patient refusing to take part Patient taking part in a clinical trial
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson's disease patients<br> | Drug: Pramipexole<br> <br> * Other names: (Sifrol®);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Patient's demographic characteristics |  | 9 months | 
| Assessment of Parkinson's disease characteristics |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Severity of the Parkinson Disease (PD) | (levels of severity of the disease were defined with the scientific committee in 5 stages: treatment initiation phase, honeymoon phase, therapeutic insufficiency phase, start of motor complications phase and advanced motor complications phase) | 9 months | 
| Assessment of Disease Stage Stage according to Hoehn and Yahr and Unified Parkinson Disease Rating Scale III (UPDRS III) scores |  | 9 months | 
| Description of the actual treatments of PD |  | 9 months | 
| Evaluation for reasons for choosing pramipexole as treatment |  | 9 months | 
| Assessment of Treatment history | 3 subgroups: Initiation: no antiparkinson treatment before the implementation of pramipexole Switch: at least one dopamine agonist replaced by pramipexole Add on: pramipexole is implemented in addition to the previous treatment | 9 months | 
| Evaluation of the state of health perceived by the patient using the questionnaire EQ-5D |  | 9 months | 
| Number of patients with adverse events |  | 9 months |
D-Dimer Vs Serial Compression Ultrasound Study

Study Overview
=================
Brief Summary
-----------------
To determine whether d-dimer testing can be used to simplify and reduce the costs of the diagnostic approach to patients with clinically suspected deep vein thrombosis

Official Title
-----------------
Evaluation of the Safety, Efficacy and Cost-Effectiveness of Two Strategies for the Diagnosis of Deep Vein Thrombosis

Conditions
-----------------
Deep Vein Thrombosis

Intervention / Treatment
-----------------
* Procedure: D-dimer
* Procedure: Serial Compression Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first suspected deep vein thrombosis no previous venous thromboembolism referred to thromboembolism outpatient clinic Exclusion Criteria: comorbid condition limiting survival to less than six months contraindication to venography (contrast allergy, etc.) receiving long term warfarin therapy receiving full dose heparin therapy for more than 48 hours absence of symptoms during the five days immediately prior to presentation symptoms of pulmonary embolism pregnancy geographic inaccessibility which precludes follow-up

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: D-dimer|nan|
|Procedure: Serial Compression Ultrasound|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of withholding anticoagulants |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| deep vein thrombosis |  |  | 
| pulmonary embolism |  |  | 
| death |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deep vein thrombosis, d-dimer, serial compression ultrasound
Genomic Study for the Prediction of Efficacy and Adverse Effects of CD11a Monoclonal Antibodies(Raptiva)

Study Overview
=================
Brief Summary
-----------------
The pathogenesis of psoriasis has evolved from epidermal hyperproliferation to immune dysregulation in recent years. A Th1 cytokine profile is universally found is psoriasis. Biologics targeting the immune system have become the focus of study. Raptiva (Efalizumab) is one of biologics indicated for the treatment of psoriasis, and is the first biologic approved for use in psoriasis in the EU (EMEA). In USA, it is the second biologic drug (after Amevive) for psoriasis. Raptiva is a humanized chimeric antibody of CD11a (LFA-1), which blocks the interaction of CD11and ICAM-1, thus preventing lymphocyte trafficking. It is used for moderate to severe chronic plaque type psoraisis. The first clinical trial of Raptiva in Asians iscurrently done in the department of Dermatology, National Taiwan University Hospital and the incidence of psoriatic arthritis (either de novo or aggravation of preexisting psoriatic arthritis) is significantly higher than previously reported in Western countries（30％ versus 7%，and personal communication with doctors in Hong-Kong and Singapore also reveals a similar safety profile. It seems likely that a racial difference is present. Monocytes play a central role in the pathogenesis of psoriatic arthritis. It is thus intriguing to study the pathogenesis of Raptiva-induced aggravation of psoriatic arthritis by comparing the difference of monocyes response in the presence of Raptiva between patients with and without Raptiva-induced psoriatic arthritis. In further study, the CD11a genomic polymorphism will also be investigated. The suudy can provide us with important information on how a novel monoclonal antibody like Raptiva can have both therapeutic and detrimental actions on psoriasis. The short term benefit of the study will be in pharmacogenomics and pharmacoeconomics, finding the best candidates for the expensive drug. The long term goal will be the clarification of the pathogenesis of psoriasis and psoriatic arthritis.

Official Title
-----------------
Ex Vivo Monocyte and Lymphocyte Stimulation Tests and Genomic Study for the Prediction of Efficacy and Adverse Effects of CD11a Monoclonal Antibodies(Raptiva)

Conditions
-----------------
Psoriasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of psoriasis
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 |
| --- | --- | --- |
Measurement of Retinal Venous Pressure in Chronic Low-oxygen Environment

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that the pressure in the retinal veins increases from chronic lack of oxygen and leads to decreased blood flow. On the basis of high altitude mountaineering this hypothesis should be verified. At the same time the adaptation capacity of the blood circulation should be analyzed, and a relationship to mountain sickness should be found.

Detailed Description
-----------------
Conduct a field study to describe and quantify the retinal venous pressure (RVP) in healthy volunteers under conditions of controlled chronically reduced ambient pressure and oxygen partial pressure in the mountains. Obtaining indications regarding the adaptation of the retinal vascular system behavior to controlled, long-term hypoxic changes. Comparisons with blood pressure, pulse, oxygen saturation level and the appearance of symptoms of acute mountain sickness are made in order to obtain a better understanding of the development of high altitude illness.

Official Title
-----------------
Measurement of the Retinal Venous Pressure (RVP) Under Conditions of Chronically Reduced Ambient Pressure and Oxygen Partial Pressure (Field Study)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy Exclusion Criteria: eye diseases systemic diseases term medication (except contraceptives) pregnancy allergies to the ingredients Alcain, Tropicamide and Phenylephrine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Quantify the changes in the retinal venous pressure (RVP). | Quantify the changes in the retinal venous pressure (RVP) | 1-2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retinal venous pressure (RVP), chronically reduced ambient pressure, oxygen partial pressure, mountain sickness
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical study is to evaluate the safety and effectiveness of NB1 Bone Graft in subjects with degenerative disc disease undergoing transforaminal lumbar interbody fusion. It is estimated that up to 30 participants will be enrolled in approximately 3 clinical sites. During baseline and follow-up assessments, patients will be asked to undergo x-rays and CT scans; adverse events and immunology will be collected, and; participants will be requested to complete participant questionnaires regarding quality of life, pain and function.

Official Title
-----------------
A Multi-Center, Prospective, Parallel Group, Randomized, Pilot Study Evaluating Safety And Preliminary Effectiveness Of NB1 Bone Graft In Subjects With Degenerative Disc Disease Undergoing Transforaminal Lumbar Interbody Fusion

Conditions
-----------------
Degenerative Disc Disease, Spondylolisthesis

Intervention / Treatment
-----------------
* Device: NB1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of degenerative disc disease Up to Grade I spondylolisthesis Eligible to undergo a single vertebral level spine fusion (L2 to S1) Exclusion Criteria: Previous spinal instrumentation or previous interbody fusion procedure at the involved level Grade II or greater spondylolisthesis Systemic or local infection at the site of surgery

Ages Eligible for Study
-----------------
Minimum Age: 17 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NB1-1.5<br>NB1 low dose | Device: NB1<br>* rhNELL-1/DBX<br>|
| Experimental: NB1-2.0<br>NB1 high dose | Device: NB1<br>* rhNELL-1/DBX<br>|
| No Intervention: Autograft<br>Autograft | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion | Defined by an independent (blinded to treatment) radiological assessment as less than five degrees angular vertebral motion, less than three millimeters of translational movement and evidence of bridging bone between the involved vertebral endplates based on x-rays at 12 months after surgery | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal, revision, or supplemental fixation | Whether there was removal, revision or supplemental fixation of the graft material that required reoperation at the index level during the follow-up period of the study | 12 months |
Improving Outcomes In Diabetic Patients During CABG Surgery By Optimizing Glycemic Control

Study Overview
=================
Brief Summary
-----------------
This study seeks to determine whether varying the dose of insulin and glucose in diabetic patients during coronary bypass surgery will improve outcomes in these patients.

Detailed Description
-----------------
Our previous study has shown that maintaining serum glucose between 120-180mg/dl in the perioperative period during CABG surgery in diabetic patients improves outcomes. The purpose of this trial is: (1) to determine whether outcomes can be improved by altering the content of glucose or insulin in these solutions (2)to determine the effect of these solutions and glycemic control on the inflammatory response of arterial and venous conduits used during surgery, (3) to determine whether the beneficial effects of improved glycemic control can be correlated with changes in the inflammatory response.

Conditions
-----------------
Glycemic Control

Intervention / Treatment
-----------------
* Drug: A IV Insulin drip
* Drug: B Low Dose GIK
* Drug: C High Dose GIK


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic CABG patients Exclusion Criteria: Renal and hepatic failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B Low dose GIK<br>This group will have low doses of glucose and insulin | Drug: B Low Dose GIK<br>* These patients will receive D5W+80unitsInsulin+40mEqKCL IV to keep blood glucose between 120-180mg/dl<br>|
| Active Comparator: C High Dose GIK<br>This group will have high doses of insulin and glucose | Drug: C High Dose GIK<br>* This group will receive D20W+160units IV insulin to keep blood sugar between 120-180mg/dl<br>|
| Active Comparator: A Insulin<br>This group will receive only an intravenous insulin infusion | Drug: A IV Insulin drip<br>* These patients will receive 100units of insulin in 100ml of saline intravenously to keep blood glucose between 120-180mg/dl.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic control, postoperative morbidity, inflammatory markers |  | 24 hours following surgery | 
| glycemic control |  | 24 hours following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| free fatty acid levels |  | 24 hours following surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes