linjc16/ctgov huggingface dataset:
An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001

Study Overview
=================
Brief Summary
-----------------
This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.

Detailed Description
-----------------
Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind study 6002-INT-001 are eligible to enter into this long-term open safety study with a starting istradefylline dose of 20 or 40mg per day.

Official Title
-----------------
An Open-Label Multicenter Study of the Continued Safety of Istradefylline (KW-6002) In Subjects With Parkinson's Disease Who Have Recently Completed One Year of Treatment With Istradefylline.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Istradefylline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of study 6002-INT-001 Not of childbearing potential Exclusion Criteria: Cancer within 5 years of enrollment ALT/AST levels > 2.5 times ULN

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Single Arm<br>Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily. | Drug: Istradefylline<br>* Oral istradefylline (KW-6002) 20 or 40 mg once daily.<br>* Other names: KW-6002;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as Measured by Adverse Events | Investigation of the long-term tolerability and safety of istradefylline | Every 2 months up to 32 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's Disease, levodopa, end of dose wearing off, OFF time
Bangladesh Vitamin E and Selenium Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether selenium and/or vitamin E are effective in preventing non-melanoma skin cancers.

Official Title
-----------------
Bangladesh Vitamin E and Selenium Trial

Conditions
-----------------
Non-melanoma Skin Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Selenium
* Dietary Supplement: vitamin E


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Manifest arsenic skin lesions (melanosis, leucomelanosis, or keratosis) Aged 25 to 65 years Permanent resident of study area Exclusion Criteria: Pregnancy Clinically too ill (enlarged spleen or liver) Presence of gangrene Cancer

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Selenium | Dietary Supplement: Selenium<br>* 200 ug Selenium daily<br>|
| Experimental: 2<br>Vitamin E | Dietary Supplement: vitamin E<br>* 100 mg Vitamin E daily<br>|
| Experimental: 3<br>Vitamin E + Selenium | Dietary Supplement: Selenium<br>* 200 ug Selenium daily<br>Dietary Supplement: vitamin E<br>* 100 mg Vitamin E daily<br>|
| No Intervention: Arm 4<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Cancer |  | Incidence during the 6-year study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Occurrence during the 6-year study period | 
| Diabetes |  | Incidence within 6-year study period |
A Multicenter Data Registry for Outcomes From Surgical Treatment of Atrial Arrhythmias

Study Overview
=================
Brief Summary
-----------------
Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation. The fundamental goal of STAR Outcomes registry is to improve the understanding of the efficacy of surgical ablation intervention in the treatment of atrial fibrillation.

Official Title
-----------------
Surgical Treatment for Atrial Arrhythmia Registry (STAR Outcomes)

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

Intervention / Treatment
-----------------
* Procedure: Minimally Invasive Maze Procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with paroxysmal (intermittent) or persistent atrial fibrillation > 18 years of age Exclusion Criteria: Patients unable to give adequate informed consent Patients who are known to be pregnant, plan to become pregnant or are lactating Inability to return for follow up Patients who are prison inmates or institutionalized Patients in an emergency state Patients under the age of 18

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 |
| --- |
|Procedure: Minimally Invasive Maze Procedure|Minimally Invasive Surgical Correction of Atrial Fibrillation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation |  | One Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Afib, Atrial Fibrillation, Maze, Mini-Maze
Follow-Up to the Usability Evaluation of a Portable Oxygen Concentrator

Study Overview
=================
Brief Summary
-----------------
This study was a follow-up evaluation of modifications made to the instructions in the User Manual following the initial study evaluating how well an individual can put together and use a Portable Oxygen Concentrator (POC).

Detailed Description
-----------------
The Belluscura X-PLO2R Portable Oxygen Concentrator (POC) is intended for the provision of supplemental oxygen to patients with chronic pulmonary diseases, such as Chronic Obstructive Pulmonary Disease (COPD), and for a patient requiring supplemental oxygen, as prescribed by a physician. The purpose of this study is to evaluate if the X-PLO2R POC can be used by the intended users without serious errors or problems for the intended use and under the expected use conditions. Specifically, the study is to evaluate if potential users of the device can correctly, safely and effectively set-up, activate and operate the X-PLO2R POC to receive the required supplemental oxygen; if the intended user can understand and apply the information contained in the Belluscura X-PLO2R Quick Start Guide and User Manual; and to identify any and all use difficulties, problems and errors made during device assembly and operation, and to subsequently mitigate each identified instance of use error through device and/or materials modification, and to subsequently evaluate the effectiveness of each modification.

Official Title
-----------------
Follow-Up to Human Factors Validation Testing for Use of the Belluscura X-PLO2R™ Portable Oxygen Concentrator System

Conditions
-----------------
Supplemental Oxygen

Intervention / Treatment
-----------------
* Device: X-PLO2R


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older. Male or female. Suitable for supplemental oxygen use from a suitably qualified and licensed medical professional. Voluntarily signed subject consent form. Exclusion Criteria: Company employee. Former human factors study participants.

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: X-PLO2R|Portable Oxygen Concentrator (POC)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to correctly assemble and use the X-PLO2R POC | A subject who is able to follow the instructions to correctly assemble and receive oxygen through the X-PLO2R POC will be considered a study pass.A subject who is not able to follow the instructions and does not correctly assemble and receive oxygen through the X-PLO2R POC will be considered a study fail. | 2 hours |
Atrial Fibrillation Feasibility Certoparin Trial - AFFECT

Study Overview
=================
Brief Summary
-----------------
This trial is designed to provide data about feasibility and safety of short-term treatment with the low-molecular-weight heparin certoparin in patients with persistent nonvalvular atrial fibrillation

Official Title
-----------------
An Open Label, Multi-center Trial to Evaluate the Feasibility and Safety of Short-term Treatment With Subcutaneously Injected Certoparin (8000 U Anti-Xa Twice Daily) in Patients With Persistent Nonvalvular Atrial Fibrillation

Conditions
-----------------
Persistent Nonvalvular Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Certoparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persistent AF (electrical cardioversion is planned) written informed consent Exclusion Criteria: acute clinical signs of venous thromboembolism current oral anticoagulation indication for medical cardioversion

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events |  |  |
Safety of Intravenous Lidocaine Infusions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prospectively determine the side effects profile in adults with neuropathic pain receiving intravenous infusions of lidocaine 5 mg per kg of lean body weight, infused over 45 minutes.

Detailed Description
-----------------
Eligibility Criteria: Adults > 18 yrs with chronic central or peripheral neuropathic pain at the St Joseph's Health Care Pain Clinic between June and December 2009. Outcome measures: All side effects spontaneously reported. Sedation, nausea, dizziness by Visual Analog Score Q 15 minutes; hemodynamic data q 5 minutes during and after infusion for 30 minutes. Daily diary of side effects and Visual Analogue score of Pain for 7 days post-infusion.

Official Title
-----------------
Safety of Intravenous Lidocaine Infusions for Chronic Neuropathic Pain

Conditions
-----------------
Neuropathic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult outpatients > 18 years < 80 years diagnosed with chronic neuropathic pain Exclusion Criteria: Unable to provide informed consent Unable to speak and understand English Liver, kidney, or cardiac failure Allergy to Lidocaine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Lidocaine<br>Adults >18 yrs , attending St Joseph's Health Care Pain Clinic with a diagnosis of chronic neuropathic pain who are being treated with an lidocaine infusion of 5 mg/kg over 45 minutes Consecutive patients from two time periods: June 15 to August 21, 2009 October 15-Dec 22,2009 | |

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
-----------------
Lidocaine,Intravenous Infusions,Neuropathic Pain,Side Effects
DAPROCA Pelvic Lymph Node Irradiation to Prostate for High Risk Prostate Cancer: Phase I/II Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective, open label 1 arm study, multicentre, Phase I/II clinical safety study. The trial is designed to gain initial safety and efficacy data on pelvic lymph node radiation with simultaneous integrated boost to prostate in high risk prostate cancer patients.

Official Title
-----------------
Pelvic Lymph Node Irradiation With Simultaneous Integrated Boost to Prostate for High Risk Prostate Cancer Patients: A Phase I/II Study

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Radiation: Radiation: pelvic lymph nodes with boost to prostate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adenocarcinoma T3 tumor and either Gleason 8-10 and PSA ≤ 70,or PSA ≥ 30 and PSA ≤ 70, or T1-T3 and PSA ≤ 70 and N1 no distant metastases Exclusion Criteria: pelvic co-morbidity such as Crohns disease or ulcerative colitis uncontrolled heart or lung morbidity prior radiation treatment of pelvic region age > 75 years

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients are allocated for lymph node irradiation, either up front combined with prostate irradiation or lymph node irradiation after primary lymph adenectomy after combined with prostate irradiation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiation<br> | Radiation: Radiation: pelvic lymph nodes with boost to prostate<br>* 78(74)Gy/39(37) fractions to prostate, 56(55)GY /39(37) fractions to pelvic lymph nodes, 5 fractions per week.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of late gastro-intestinal toxicity ≥ grade 2. | based on CTCAE v.4.0 og in-house questionnaire. | 3 years and beyond | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  | 10 years | 
| recurrence |  | 10 years | 
| Incidence of late genito-urinary toxicity ≥ grade 2. | Based on CTCAE vers. 4.0 and in-house questionnaire | 3 years and beyond | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, locally advanced, lymph node positive, radiation therapy, morbidity, early morbidity, late morbidity
Influence of the Sensory Profile of Deaf Children With Autism Spectrum Disorders on the Outcome of Cochlear Implantation

Study Overview
=================
Brief Summary
-----------------
An unpublished study conducted at Toulouse University Hospital revealed that 30% of implanted children with Autism Spectrum Disorders abandon their implant, while 70% of them keep it. The aim of this study is to evaluate the causes of this disparity, which is much greater than in children with cochlear implants without associated Autism Spectrum Disorders. Our problem is as follows: do the sensory hypersensitivity and hyposensitivity of deaf children with Autism Spectrum Disorders have an effect on the expected results after a cochlear implantation from a language and auditory reaction point of view?

Detailed Description
-----------------
The present study will specifically focus on the sensory profile of these children with Autism Spectrum Disorders, which could be the cause of these developmental difficulties in language and communication development.

Official Title
-----------------
Influence of the Sensory Profile of Deaf Children With Autism Spectrum Disorders on the Outcome of Cochlear Implantation

Conditions
-----------------
Deafness

Intervention / Treatment
-----------------
* Other: Dunn's sensory profile questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Deaf child with cochlear implant 15 months to 10 years old and 6 months old at the time of implantation Child with autism spectrum disorder (only for children group with autisme spectrum disorder) No opposition from the legal representative of the authority to participate in the study Exclusion Criteria: Opposition by the legal representative of the child Child under legal protection

Ages Eligible for Study
-----------------
Minimum Age: 15 Months
Maximum Age: 10 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 |
| --- | --- |
| Child with cochlear implant<br>15 childs with coclear implant but without autism spectrum disorder | Other: Dunn's sensory profile questionnaire<br>* all children will complete the Dunn Sensory Profile questionnaire<br>|
| Child with cochlear implant and autism spectrum disorder<br>15 childs with coclear implant and with autism spectrum disorder | Other: Dunn's sensory profile questionnaire<br>* all children will complete the Dunn Sensory Profile questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the sensory profile | To determine the sensory profile of implanted deaf children with autism spectrum disorders, each parent complete the questionnaire Dunn's sensory profile | inclusion visit |
Postoperative Quality of Recovery in Patients Receiving Anaesthesia

Study Overview
=================
Brief Summary
-----------------
The investigator's study is designed to evaluate the recovery of patients receiving anaesthesia for surgeries; in different domains like the physiological, nociceptive, cognitive and emotional to the participants' preoperative state.

Official Title
-----------------
Postoperative Quality of Recovery in Patients Receiving Anaesthesia: A Prospective Observational Study

Conditions
-----------------
Elective Surgeries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients aged 18 years or over who are undergoing surgery with anesthesia Exclusion Criteria: Inability to complete the baseline questionnaire for any reason as assessed by the examiner Patient with any current psychiatric disturbance Patient undergoing a neuropsychological procedure that may impair their ability to participate in the assessment Patients undergoing emergency surgery

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 |
| --- | --- | --- |
| quality of recovery from anaesthesia | include the quality of recovery in each domain over the postoperative follow-up period as compared to the same in preoperative period (baseline value) using the postoperative quality of recovery scale. The different domains include physiological (with subdomains: systolic blood pressure, heart rate, temperature, respiratory rate, oxygen requirement, airway, agitation, consciousness and ability to lift head, each scoring from 1 to 3), nociceptive ( scoring 1to 5, higher score means more pain), emotional (1 to 5), activity of daily living( 1 to 3), cognitive ( with subdomains orientation(1 to 3), number forward and backward(1 to 6), word task and executive memory) and impact on ability to work(1 to 3) | 24 hours post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| factors delaying recovery | factors associated with delay in recovery from anaesthesia for surgery | 24 hrs post operatively |
Vestibular System in Migrainous Vertigo Patients

Study Overview
=================
Brief Summary
-----------------
Do migrainous vertigo patients have more pathology in their vestibular system than migraine patients without vertigo? The aim of this study is to compare the vestibular system of migraine patients with and without vertigo in the symptom-free period by vestibular function tests, videonystagmography, vestibular evoked myogenic potentials, and subjective visual vertical.

Official Title
-----------------
Do Migrainous Vertigo Patients Have More Hypersensitivity in Their Vestibular System Than Migraine Patients Without Vertigo?

Conditions
-----------------
Migraine Disorders, Migraine Variant, Episodic Recurrent Vertigo

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: migraine according to IHS criteria migrainous vertigo according to the Neuhauser-criteria Exclusion Criteria: no history of other neurological, vestibular, opthalmologic and ENT disorders no medications that could possibly influence test results intact hearing measured by audiometry pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 61 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 |
| --- | --- |
| 1<br>migrainous vertigo | |
| 2<br>migraine without vertigo | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in vestibular function |  | Symptomfree interval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in hypersensitivity |  | Symptomfree interval | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
migraine, migrainous vertigo, vestibular evoked myogenic potentials, vestibular function test, vestibular disorders