linjc16/ctgov huggingface dataset:
Immunological Response After Ablative Therapy in the Liver

Study Overview
=================
Brief Summary
-----------------
Local ablative treatment of Hepatocellular Carcinoma is performed primary on patients not eligible for liver transplant or liver resection. At our Hospital two different methods are used: Microwave ablation, where the tumor cells are heated up and killed, and Irreversible electroporation, where the tumor cells are exposed to an electrical field and nano-pores are formed in the cell membranes and the cells go into apoptosis (programed cell death). Previous studies have shown effects on the immune system after ablative therapies. The purpose of this study is to compare the immunological response after the wo different methods of killing the tumor cells.

Official Title
-----------------
Comparison of Immunological Response After Microwave Ablation and Irreversible Electroporation of Hepatocellular Carcinoma

Conditions
-----------------
Immune Response, Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Device: Microwave ablation
* Device: Irreversible electroporation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatocellular carcinoma, maximum 3 lesions, maximum 30 mm in any cross section diameter Physically fit to undergo general anaesthesia Fully understand swedish instructions regarding the study Exclusion Criteria: Atrial fibrillation (for irreversible electroporation) Pacemaker (for irreversible electroporation) >3 lesions > 30 mm in any cross section diameter

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Microwave ablation<br>20 patients will be treated with microwave ablation | Device: Microwave ablation<br> <br> |
| Other: Irreversible electroporation<br>20 patients will be treated with irreversible electroporation | Device: Irreversible electroporation<br> <br> * Other names: Nano Knife, Angiodynamics;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological response | Change in immunological response | Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with complete radiological response at follow up 3, 6, 9 and 12 months. | Compare the effect of the two different ablative methods | Follow-up every three months for one year with CT scan. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irreversible electroporation, Microwave ablation
A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Study Overview
=================
Brief Summary
-----------------
The objective of this trial is to demonstrate that rotigotine (SPM 936) is effective in subjects with idiopathic RLS based on the PLMI (Periodic Limb Movements Index)(PLMs/total time in bed) as measured by polysomnography (PSG). The primary variable is the reduction of PLMI at the end of the Maintenance Period compared to Baseline. PLMI data will be obtained from PSGs.

Official Title
-----------------
A Multi-center, Double-blind, Randomized, Placebo-controlled, Two-arm, Parallel-group, Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Conditions
-----------------
Restless Legs Syndrome

Intervention / Treatment
-----------------
* Drug: Rotigotine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic RLS Exclusion Criteria: secondary RLS history of sleep disturbances symptomatic orthostatic hypotension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rotigotine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy is assessed by reduction of Periodic Limb Movement Index, which will be obtained from polysomnographic measurements. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Periodic Limb Movement Arousal Index, Sleep efficiency, International RLS sum score, Clinical Global Impression Item 1. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopthic Restless Legs Syndrome
Efficacy of Aurosling in Frontalis Sling Suspension Surgery

Study Overview
=================
Brief Summary
-----------------
To Study the Efficacy of Aurosling as a suspension material in Frontalis suspension surgery in ptosis

Detailed Description
-----------------
Silicon rod is an effective and safe material used in frontalis suspension in treating ptosis with poor levator function.The elasticity and ease of adjustment of silicon rod are ideal characteristics for suspension material used to treat severe ptosis in patients with poor bells phenomenon. In the present study , we attend to study the efficacy of aurosling silicon material as a suspension material for frontalis sling surgery

Official Title
-----------------
Randomized, Double Blind, Active Controlled Study of the Efficacy, Surgical Outcome and Complications of Silicone Rod Sling in Frontalis Sling Suspension Surgery

Conditions
-----------------
Ptosis, Eyelid

Intervention / Treatment
-----------------
* Procedure: Aurosling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Congenital Ptosis Severe Ptosis (MRD<0) Poor levator function (<4mm by Berke's method) Myogenic Ptosis (Myasthenia gravis) Chronic progressive external ophthalmoplegia Neurogenic Ptosis (Third cranial palsy) Blepharospasm Ptosis caused by trauma Exclusion Criteria: Acquired Ptosis Horners syndrome Blepharochalasis/Dermatochalasis Mechanical Ptosis Mild or Moderate Ptosis (MRD 1>1) Good or fair levator function (>4 mm by Berke's method) Previous Ptosis surgery Ptosis associated syndromes/Other anomalies including Marcus Gunn jaw winking syndrome Blepharophimosis syndrome Dry eye syndromes Corneal anesthesia Medical/Pediatric/Anesthesia condition contraindicating to surgery or anesthesia Nystagmus where adequate measurements could not be done Uncorrected vertical squint of any sort
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: 1<br>Aurosling | Procedure: Aurosling<br>* Silicon rod to be used in frontalis suspension surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ptosis Correction |  | 15th day, 90th day postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 15th day, 90th day postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blepharoptosis, Ophthalmoplegia, Blepharospasm
Comparison Between Home Macular Perimeter and Optical Coherence Tomography (OCT) Visual Field Defects in Patients With Choroidal Neovascularization (CNV)

Study Overview
=================
Brief Summary
-----------------
The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with Age Related Macular Degeneration (AMD). However, the device has the ability to detect the development of the lesion post treatment and therefore to assess in determination of the next treatment. The Optical Coherence Tomography (OCT) may be used as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices. The FORESEE HOME can be used as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluating the size and the location of the treated lesions may serve as an additional tool.

Official Title
-----------------
Comparison Between Home Macular Perimeter and OCT Visual Field Defects in Patients With CNV

Conditions
-----------------
Age Related Macular Degeneration, Choroidal Neovascularization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For naïve CNV lesion - diagnosed in less than 60 days. OR For re-activated CNV lesion - treated more than 4 month from the diagnosis. Intent to treat the study eye (SE) Corrected VA better than 6/45 (20/150) in SE Subject is capable and willing to sign a consent form and participate in the study Age > 55 years Subject declared that he or she knows how to operate a computer mouse Exclusion Criteria: Evidence of macular disease other than AMD or glaucoma in SE Presence of any significant media opacity that precludes a clear view of the macular area as identified in the SE by biomicroscopy Any ocular surgery performed within 3 months prior to study entry in the SE * Participation in another study

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- |
| naive CNV subjects<br>Newly diagnosed CNV, before any treatment (naïve) | |
| previously diagnosed CNV subjects<br>Previously diagnosed CNV if last treatment is older than 4 months (reactivated) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the correlation between features of CNV lesions as measured with SD OCT and in the ForeseeHome. | the measures are Height of Pigment Epithelial Detachment , Sub Retinal Fluid Thickness , Maximum Diameter of Largest Retinal Cyst , Maximum Retinal Thickness , Central Retinal Thickness | 3-4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CNV, AMD, Wet-treated CNV
Compassionate Use for Subcutaneous (SC) Belimumab

Study Overview
=================
Brief Summary
-----------------
GlaxoSmithKline (GSK) have submitted a Biologic License Application (BLA) for the subcutaneous formulation of belimumab which is currently under review by the Food and Drug Administration (FDA). The goal of this individual patient compassionate use supply is to provide a patient with subcutaneous belimumab for the period of 1 year or until the subcutaneous formulation of belimumab becomes approved for use by the FDA and is commercially available to this patient, whichever is sooner. You can access GSK's Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf.

Official Title
-----------------
Compassionate Use for Subcutaneous (SC) Belimumab

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: SC belimumab 200 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
This is a protocol to support an emergency IND for compassionate use in one patient requiring use of belimumab subcutaneous for SLE treatment (lacks venous access and cannot receive IV belimumab). Eligibility criteria is based on the following, as provided within GSK's policy on compassionate use: The illness being treated is life threatening or seriously debilitating. There are no satisfactory alternative treatments (confirmed by the HCP). There is sufficient evidence to believe the benefit to the patient justifies the risk You can access GSK's Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SC belimumab 200 mg|Belimumab subcutaneous 200 mg will be supplied for compassionate use for the identified individual subject.|

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
-----------------
subcutaneous Belimumab, Individual Patient Compassionate Use, SLE, GSK1550188
2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides

Study Overview
=================
Brief Summary
-----------------
To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine for mydriasis in diabetic patient with darkly pigmented irides.

Detailed Description
-----------------
One hundred patients with diabetes from Srinagarind Hospital Eye Clinic were enrolled and randomized into two groups by block randomization. In group I (50 patients), 1% tropicamide combined with 2.5% phenylephrine were administered to dilate pupil whereas 1% tropicamide combined with 10% phenylephrine were used in Group II (50 patients). Pupil diameter, blood pressure and heart rate were measured before and after eye drop instillations.

Official Title
-----------------
2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: 2.5% or 10% phenylephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic patients Exclusion Criteria: history of intraocular surgery or laser treatment, any ocular diseases that might affect pupil size such as glaucoma,uveitis,Horner's syndrome, Adies' pupil, history of allergy to any drug used, and hypertension

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 2.5% or 10% phenylephrine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupil diameters were measured. |  | before and after phenylephrine eye drop instillations | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure and heart rate were measured |  | before and after phenylephrine eye drop instillations | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phenylephrine, mydriasis, diabetes mellitus
Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.

Study Overview
=================
Brief Summary
-----------------
Hearing loss can be the result of chronic ear infections. The role of bacteria of the genus Achromobacter is not known in these conditions. An epidemiological study including a large number of patients is needed to compare the prevalence of these bacteria in sick and healthy subjects, and to highlight the characteristics of the strains and the factors favouring their emergence.

Official Title
-----------------
Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.

Conditions
-----------------
Achromobacter, Epidemiology, Chronic Ear Infection

Intervention / Treatment
-----------------
* Biological: Ear canal swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person or parent who has given his or her non-opposition Person over 10 years of age Sick Subjects Group : diagnosis of chronic infection by an ENT specialist doctor if patient already included: new episode > 3 months after the complete clinical recovery from the previous episode observed by the ENT doctor - Healthy group: no ear infection in the last 6 months and no antibiotics in the previous month. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- |
| Healthy Subjects<br> | Biological: Ear canal swab<br>* Ear canal swab<br>|
| Patients with ear infections<br> | Biological: Ear canal swab<br>* Ear canal swab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achromobacter positive sample number |  | Through study completion, an average of 3 years |
Phase I Randomized Study of CPX for the Treatment of Adult Patients With Mild Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the safety of ascending doses of CPX administered to adult patients with mild cystic fibrosis. II. Evaluate the pharmacokinetics of ascending doses of CPX in this patient population.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, dose escalation study. There are 7 experimental cohorts, each treated with a different oral dose of CPX or placebo. Within each cohort, 4 patients receive a single dose of CPX and 1 patient receives placebo. Each patient is monitored 24 hours postdose. Escalation to the next dose level for each subsequent cohort begins only after the safety data obtained from the previous cohort is reviewed and found not to limit dose escalation. All patients return for a follow up evaluation 1 week after dosing.

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: CPX


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Mild cystic fibrosis Not pregnant or nursing Negative pregnancy test

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CPX|nan|

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
-----------------
cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease
Cardiovascular Outcome of Cancer Patients: The GMEDICO Cohort

Study Overview
=================
Brief Summary
-----------------
The Mediterranean Group of Cardio-Oncology (GMEDICO) brings together French cardiologists and oncologists who have developed a protocol for the monitoring and cardio-oncological management of patients treated for cancer. This unique organization makes it possible to envisage the creation of a large cohort from which the incidence and predictive factors of cardiovascular toxicity can be determined. Primary objective: to determine the cardiovascular prognosis of patients treated for cancer and followed up in cardio-oncology. Secondary objectives To determine the clinical, biological and imaging factors associated with cardiovascular events under cancer treatment, in order to define a risk score including clinical, biological (biomarker) and imaging data. To create a biological source for testing other biomarkers and conducting genome-wide association studies and genetic factors associated with cardiovascular events under cancer treatment.

Detailed Description
-----------------
Each patient will be monitored for 5 years. Cardio-oncological follow-up and management within these centers will follow a common protocol established and validated in March 2016 on the basis of international recommendations and summaries of the characteristics produced for each drug. Additional blood samples will be taken for the biobanking. Depending on the case, a small skin biopsy will be carried out to analyze the cardiovascular response of in vitro immunotherapy using a reprogramming model of fibroblasts in hiPSC hiPSC (human induced Pluripotent Stem cells)-cardiomyocytes.

Official Title
-----------------
Cardiovascular Outcome of Cancer Patients: The GMEDICO Cohort

Conditions
-----------------
Cardiovascular Prognosis

Intervention / Treatment
-----------------
* Biological: blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults referred for specialist cardio-oncology consultations before the initiation of a cancer treatment according to pre-established indications will be eligible. Exclusion Criteria: Failure to provide information that makes it impossible to complete a consultation form or refuse to sign the consent. Minor or major patient under guardianship Pregnant or breastfeeding woman

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiovascular patients treated for a cancer<br> | Biological: blood samples<br>* blood samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of cardiac biomarkers | dosage of troponine | 5 YEARS |