linjc16/ctgov huggingface dataset:
Predictive Value of Dynamic Contrast Enhancement MRI on a Cerebral Tumor Response to Gamma Knife Treatment

Study Overview
=================
Brief Summary
-----------------
Hypothesis: the pattern of MRI contrast enhancement after gadolinium injection is different in tumors that respond well to gamma knife. We are going to acquire sequential T1-weighted images of brain lesions before, during and after injection of Gd-DTPA. This will be repeated before and after a treatment with gamma knife. We will then analyse our results to see if there are common enhancement characteristics between lesions that will respond well to the radiosurgery treatment. Response will be clinically assessed by tumor volume as determined by MRI approximately 4 to 6 months after treatment.

Official Title
-----------------
Prospective Study of Predictive Value of Dynamic Contrast Enhancement Magnetic Resonance Imaging With Gadolinium on the Response of a Cerebral Tumor to a Treatment With Gamma Knife

Conditions
-----------------
Cerebral Metastases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with intracerebral lesion benign or malignant wich are not concerned by the exclusion criteria Exclusion Criteria: Pancranial radiotherapy Residual postop lesion Gliomas Patients < 18 years old Anterior allergic reaction to gadolinium Claustrophobia.

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 |
| --- | --- | --- |
| MRI parameters | Tumor volume, Ktrans, ve, time at maximum signal enhancement, maximum signal difference, ADC, basal T1 value | Before treatment with the Gamma Knife | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral metastases, dynamic contrast enhanced magnetic resonance imaging, DCE-MRI, gamma knife
OPTIMA Bi-ventricular Capture Verification Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the morphology (shape) of the intracardiac electrograms(EGM) from patients with a resynchronization therapy device.

Detailed Description
-----------------
morphology of EGM during loss of capture in either right ventricle (RV) or left ventricle (LV) at different AV delays and LV offsets and during exercise. These EGM signals will be used to design and develop improved automatic threshold and automatic capture algorithms for CRT defibrillators (CRT-D). As well, the data collected from the study will be used to to develop other automatic algorithms for CRT-D, such as pacing parameter optimization.

Official Title
-----------------
Bi-ventricular Capture Verification Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: CRT device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent indicating a willingness to participate, have indications for and have been implanted with a Guidant Renewal 4 CRT-D device Exclusion Criteria: Patients in atrial fibrillation that cannot be cardioverted for the study, sustained uncontrolled ventricular tachycardia (VT), sinus rhythm < 40 bpm or > 100 bpm, complete AV node block, AV node ablation, Severe aortic valve stenosis (valve area < 1.0 cm squared), frequent ectopic beats that would preclude adequate testing, lead in the great cardiac vein, women who are pregnant or who plan to become pregnant.

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 |
| --- |
|Device: CRT device|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ketogenic Diet for Child Epilepsy and Seizure Control

Study Overview
=================
Brief Summary
-----------------
Twenty to thirty percent of children with epilepsy continue to suffer from seizures, even when treated with currently available anticonvulsant medications. Children with Lennox-Gastaut Syndrome (LGS) are particularly handicapped by atonic-myoclonic seizures. Preliminary data suggest that even when other medications have failed, these seizures may respond rapidly and dramatically to a high-fat-low-carbohydrate ketogenic diet. The purpose of the study is to assess if the classic ketogenic diet is efficacious in reducing seizure frequency, medication toxicity, and improves quality of life.

Detailed Description
-----------------
The ketogenic diet (KD) is a form of therapy for seizures that involves a brief period of fasting followed by a very carefully controlled high fat-low protein and carbohydrate diet. Studies suggest it is useful in children whose seizures could not be controlled by any of the medicines available. This study is designed to test, in a carefully controlled fashion, how well the diet works in children with drop seizures. Children who experience 15 or more drop seizures each day, despite having used at least two medications, may be eligible to participate. This study requires children to undergo periods of fasting and to maintain a carefully controlled diet. Parents of participating children monitor their children's diets and keep daily meal and seizure diaries.

Official Title
-----------------
Efficacy of the Ketogenic Diet -- a Blinded Study

Conditions
-----------------
Epilepsy, Seizures, Lennox-Gastaut Syndrome

Intervention / Treatment
-----------------
* Behavioral: Ketogenic diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >15 myoclonic or atonic seizures a day EEG with Lennox-Gastaut pattern Exclusion Criteria: <15 atonic or myoclonic seizures a day on >3 medications previously on diet and/or evidence of metabolic disorder

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 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 |
| --- |
|Behavioral: Ketogenic diet|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
-----------------
LGS, child, children, epilepsy, seizure, ketogenic, diet, Lennox-Gastaut Syndrome
Late Cardial Assessment in Children Who Were Diagnosed With Post Streptococcal Reactive Arthritis - a Long Term Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether there is late cardial involvement in children diagnosed with post streptococcal reactive arthritis after discontinuation of prophylactic antibiotic therapy.

Official Title
-----------------
Late Cardial Assessment in Children Who Were Diagnosed With Post Streptococcal Reactive Arthritis - a Long Term Study

Conditions
-----------------
Post Streptococcal Reactive Arthritis

Intervention / Treatment
-----------------
* Device: echocardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PSRA patients under 18 who were diagnosed at least one year prior to the study Exclusion Criteria: PSRA patients under 18 who were diagnosed less one year prior to the study patients who do not fulfill PSRA criteria patients who fulfill Jones criteria patients with a known heart defect

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Post streptococcal reactive arthritis (PSRA)<br>children who were diagnosed with psra at least one year before the study | Device: echocardiogram<br>* echocardiogram<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac valve function |  | at least 1 year after termination of antibiotic treatment |
A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
A study to examine the safety (and potential efficacy) of the adult stem cell investigational product, MultiStem, in adults who have Acute Respiratory Distress Syndrome (ARDS). The primary hypothesis is that MultiStem will be safe in ARDS patients.

Official Title
-----------------
A Phase 1/2 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome

Conditions
-----------------
Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Biological: MultiStem
* Biological: MultiStem
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of moderate to severe ARDS, as defined by the Berlin definition, requiring an endotracheal or tracheal tube Able to receive investigational medicinal product within 96 hours of meeting the last of the ARDS diagnosis criterion Exclusion Criteria: Concurrent illness that shortens life expectancy to less than 6 months Other serious medical or psychiatric illness

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Low dose MultiStem | Biological: MultiStem<br> <br> |
| Experimental: Cohort 2<br>High dose MultiStem | Biological: MultiStem<br> <br> |
| Experimental: Cohort 3<br>Highest safe MultiStem dose (from Cohorts 1 and 2) or Placebo | Biological: MultiStem<br> <br> Biological: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of sustained hypoxemia or hypotension |  | 4 hours | 
| Suspected Unexpected Serious Adverse Reactions (SUSARs) |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events |  | Up to 365 days | 
| Changes in vital signs |  | Up to 7 days | 
| Changes in blood safety laboratories |  | Up to 7 days | 
| Ventilator-free days |  | 28 days | 
| ICU-free days |  | 28 days | 
| Total length of hospital stay |  | 28 days | 
| All-cause mortality |  | 28 days | 
| Changes in levels of oxygenation |  | Up to 28 days | 
| Changes in positive end-expiratory airway pressure |  | Up to 28 days | 
| Changes in respiratory physiologic measures including lung compliance and airway resistance (peak and plateau pressures) |  | Up to Day 365 | 
| All-cause mortality |  | Up to Day 365 |
Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide

Study Overview
=================
Brief Summary
-----------------
Octreotide is a somatostatin analog with a long half-life in vivo. Octreotide has interesting anti-inflammatory and anti-fibrotic properties in vitro and in vivo. Somatostatin receptors are increased and Octreotide uptake is increased in the lung in patients with idiopathic pulmonary fibrosis. Our hypothesis is that octreotide may slow the degradation of lung function in patients with IPF. In this proof of concept study, patients with IPF will receive an intramuscular injection of slow release octreotide (Sandostatin LP, 30 mg)every 4 weeks for 48 weeks. Lung function (FVC, DLCO), HRCT scores for fibrosis and ground glass, 6 minute walking test,quality of life and survival will be monitored.

Official Title
-----------------
Phase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary Fibrosis

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Drug: octreotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confident diagnosis of IPF according to ATS/ERS criteria Exclusion Criteria: known intolerance to somatostatin or octreotide another disease with predicted survival < 12 months pregnancy or lactation previous treatment with somatostatin or somatostatin analogs patient on a waiting list for transplantation antifibrotic treatment or prednisone > 10 mg/day within the last 6 weeks symptomatic biliary lithiasis blood coagulation disorders that prevent intra-muscular injections HIV infection hepatitis B or C active infection

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: octreotide<br>octreotide SR 30 mg intra muscularly every 4 weeks | Drug: octreotide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FVC changes |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLCO changes |  | 12 months |
Prilocaine for Spinal Anesthesia in Ambulatory Setting

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to retrospectively analyze data from more than 3000 procedures, to better define the safety profile of spinal prilocaine and the incidence of complications and side effects.

Detailed Description
-----------------
We designed a retrospective cohort study to analyze the safety profile and the incidence of side effects associated with prilocaine for spinal anesthesia in ambulatory settings. Data will be obtained from an internal database where are prospectively recorded clinical data from spinal anesthesia consecutively performed with prilocaine at our institution for ambulatory surgery from 2011 to 2019. Variables recorded in the database and analyzed will include demographic data, type of surgery, presence of surgical, anesthesiological or general complications, need for unplanned admission and percentage of completed database records.

Official Title
-----------------
Prilocaine for Spinal Anesthesia in Ambulatory Setting: an Observational Retrospective Study

Conditions
-----------------
Anesthesia, Spinal, Prilocaine, Ambulatory Surgical Procedures

Intervention / Treatment
-----------------
* Drug: Prilocaine Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory surgical procedures performed under spinal anesthesia with Prilocaine Exclusion Criteria: General Anesthesia Procedures lasting longer than 2 hours

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Prilocaine Hydrochloride|Spinal Prilocaine for Ambulatory Surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anesthesia-related complication | urinary retention, lipotimia, postoperative nausea, arrhythmia, hypotension, transient neurological symptoms, headache | 2011-2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Anesthesia, Prilocaine, Ambulatory Surgery, Safety
Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).

Official Title
-----------------
Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric Intraocular Lens (IOL): Postmarket Evaluation

Conditions
-----------------
Cataracts

Intervention / Treatment
-----------------
* Device: AcrySof ReSTOR Aspheric IOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation. 50 75 years of age <1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings. Exclusion Criteria: Patients with pre-existing conditions that could skew the results. Any of conditions before and during surgery specified in the product information.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReSTOR Aspheric IOL<br>Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) | Device: AcrySof ReSTOR Aspheric IOL<br>* Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected and Best Corrected Visual Acuities (Near and Distance) | Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity. | 6 Months Following Cataract Surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract, visual acuity, AcrySof ReSTOR Aspheric Intraoculare Lens, Bilateral cataract
Comparison of Outcome and Complications Encountered in Flapless Surgery and Immediate Loading Versus the Classical Surgical Approach and Loading After 6-8 Weeks in the Posterior Maxilla

Study Overview
=================
Brief Summary
-----------------
This study is a comparison of outcome and complications encountered in flapless surgery and immediate loading versus the classical surgical approach and loading after 6-8 weeks in the posterior maxilla.

Official Title
-----------------
Comparison of Outcome and Complications Encountered in Flapless Surgery and Immediate Loading Versus the Classical Surgical Approach and Loading After 6-8 Weeks in the Posterior Maxilla

Conditions
-----------------
Dental Implants

Intervention / Treatment
-----------------
* Procedure: Placement of implants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Exclusion Criteria: Smoking Medical risk patients

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Placement of implants|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival at 6-12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosthetic complications |  |  | 
| Patient opinion |  |  |
Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or Stage 1 hypertension.

Detailed Description
-----------------
Patients are double-blind placebo-controlled randomized to either aliskiren or sugar pill/placebo. Effects on blood parameters and arteries are evaluated in both groups.

Official Title
-----------------
Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects

Conditions
-----------------
Hypertension, Diabetes, Pre-hypertension

Intervention / Treatment
-----------------
* Drug: aliskiren 300 mg once daily
* Drug: Placebo/sugar pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes prehypertension or Stage 1 hypertension Exclusion Criteria: Type 1 diabetes Stage 2 hypertension CKD recent MI, revascularization, CVA or TIA

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: aliskiren 300 mg once daily for 12 weeks<br>aliskiren 300 mg daily | Drug: aliskiren 300 mg once daily<br>* aliskiren 300 mg daily<br>* Other names: Tekturna;|
| Placebo Comparator: Sugar pill/ placebo<br>Patients were double-blind placebo-controlled randomized to either aliskiren 300 mg once daily or sugar pill/ placebo | Drug: Placebo/sugar pill<br>* Sugar pill/placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Flow-mediated Dilation | Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion | Baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Central Aortic Pressure at 3 Months | Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor) | 3 months after start of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aliskiren, endothelial function, hypertension