linjc16/ctgov huggingface dataset:
Visual Function After Bilateral Implantation of AcrySof® Toric

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.

Official Title
-----------------
Visual Function After Bilateral Implantation of AcrySof® Toric

Conditions
-----------------
Visual Function

Intervention / Treatment
-----------------
* Device: AcrySof® Toric IOL
* Device: AcrySof Natural


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral cataracts 40 80 years of age 4 Days - 1 Week interval between a single patient's surgery dilated pupil size (in dim light) ≥ 4.0 mm Anticipated correction with an IOL of +10 Diopters   +25 Diopters 0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings Exclusion Criteria: Preoperative ocular pathology Previous intraocular or corneal surgery An increased risk for complications which could require vitreoretinal surgery Corneal irregularities Corneal opacities Current contact lens usage(within 6 months prior to first surgery)

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AcrySof Toric IOL<br>AcrySof Toric Intraocular Lens (IOL) | Device: AcrySof® Toric IOL<br>* AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery<br>|
| Active Comparator: AcrySof Natural IOL<br>AcrySof Natural Intraocular Lens (IOL) | Device: AcrySof Natural<br>* AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Visual Acuity (UCVA) | Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity. | 6 Months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire Results | Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best). | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Visual function;, Refractive cylinder;, AcrySof® Toric;, AcrySof® Natural
Bile Acid-induced GLP-secretion. A Study in Cholecystectomized Subjects

Study Overview
=================
Brief Summary
-----------------
PURPOSE The goal of the present project is to unravel the importance of bile acid-induced GLP-1 secretion (via the G protein-coupled receptor TGR5) in human physiology. In the present study the investigators examine the GLP-1 secretion in healthy subjects and cholecystectomised patients. Thereby the investigators aim to show, that cholecystectomised patients have reduced bileflow after a meal, and as a consequence exhibit a diminished GLP-1 response as compared to healthy subjects.

Official Title
-----------------
Bile Acid-induced GLP-secretion. A Study in Cholecystectomized Subjects

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (Healthy) Normal fasting plasma glucose Normal glucose tolerance Normal haemoglobin levels Informed content Inclusion Criteria: (cholecystectomy group) Laparoscopic cholecystectomy <6 months. Indication: Gallstones. Normal fasting plasma glucose Normal glucose tolerance Normal haemoglobin levels Informed content Exclusion Criteria: (both groups) Diabetes Pre diabetes (impaired glucose tolerance or impaired fasting glucose) 1st degree relatives with diabetes Obesity (BMI > 30) Inflammatory bowels disease Nephropathy Liver disease Medication which cannot be on hold for 24h

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 adults<br> | |
| Type 2 diabetes<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GLP-1 secretion |  | Postprandial |
The Effect of Colonoscopy on Resting Energy Expenditure

Study Overview
=================
Brief Summary
-----------------
The Effect of Gut Cleaning as a Preparation to Colonoscopy on resting energy expenditure (REE).

Official Title
-----------------
The Effect of Colonoscopy on Resting Energy Expenditure

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

Intervention / Treatment
-----------------
* Procedure: Gut cleaning as a preparation to colonoscopy [resting energy expenditure (REE)]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals before colonoscopy Exclusion Criteria: None

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 group<br>patients before colonoscopy | Procedure: Gut cleaning as a preparation to colonoscopy [resting energy expenditure (REE)]<br>* resting energy expenditure (REE).<br>* Other names: resting energy expenditure (REE).;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the Effect of Gut Cleaning as a Preparation to Colonoscopy on resting energy expenditure (REE). |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, Healthy individuals before colonoscopy
Study of Recombinant Human N-acetylgalactosamine 4-sulfatase (rhASB) in Patients With MPS VI

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the ability of rhASB versus placebo to enhance endurance in patients with Mucopolysaccharidosis VI (MPS VI), as evidenced by an increase in the number of meters walked in the 12 minute walk test at Week 24 compared with baseline.

Conditions
-----------------
Mucopolysaccharidosis VI

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: N-acetylgalactosamine 4-sulfatase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patient consent Patient must be seven years of age or older Patient must have documented biochemical or genetic proof of MPS VI The patient must be able to walk independently at least 5 meters and no more than 270 meters in the first 6 minutes, or no more then 400 meters total in 12 minutes, in the screening 12-minute walk test If female of childbearing potential, patient must have a negative pregnancy test Exclusion Criteria Patient is under consideration for or has undergone a successful bone marrow transplant (BMT) Patient refuses or is unable to complete all screening evaluations Pregnant or lactating patient Patient has received an investigational drug within 30 days prior to study enrollment Patient has been previously treated with rhASB Patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that may significantly confound study results or decrease study compliance The patient has clinically significant spinal cord compression The patient has known hypersensitivity to rhASB or to components of the active or placebo test solutions

Ages Eligible for Study
-----------------
Minimum Age: 7 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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Active Comparator: rhASB<br> | Drug: N-acetylgalactosamine 4-sulfatase<br> <br> * Other names: rhASB;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 12-minute Walk Test at 24 Weeks | Number of meters walked in 12 minutes at week 24 minus number of meters walked in 12 minutes at baseline | baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in 3-minute Stair Climb at 24 Weeks | Number of stairs climbed per minute in 3 minutes at 24 weeks minus number of stairs climbed per minute in 3 minutes at baseline | baseline and 24 weeks | 
| Change From Baseline in Urinary GAG (uGAG) at 24 Weeks | Glycosaminoglycan (GAG) level measured in urine | baseline and 24 weeks |
Medical Gas Humidification During Noninvasive Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators aimed to study the role of medical gas humidification during noninvasive mechanical ventilation.

Detailed Description
-----------------
The medical gases are usually dry and cold thus when they are used during invasive mechanical ventilation they must be conditioned. No data are present on the necessity to condition the medical gases during non invasive mechanical ventilation. In this study the investigators studied the humidity and the temperature of the medical gases with and without any conditioning during non invasive mechanical ventilation in a group of healthy subjects and critically ill patients.

Official Title
-----------------
The Humidification During Noninvasive Mechanical Ventilation Delivered by Helmet

Conditions
-----------------
Respiration, Artificial, Critical Illness

Intervention / Treatment
-----------------
* Device: MR730


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critically ill patients requiring non invasive mechanical ventilation Exclusion Criteria: Comatose patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: MR730<br>* humidity measurement inside the helmet by a capacitative hygrometer and evaluation of patients' comfort<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of temperature and humidity |  | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
temperature, humidity, non invasive mechanical ventilation
The Significance of Arrhythmias in Athletes

Study Overview
=================
Brief Summary
-----------------
Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The aim of the study is to investigate the relevance of ventricular tachyarrhythmias induced by an exercise test in a retrospectively evaluated athletic population.

Detailed Description
-----------------
Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The risk is increased when the athletes are engaged in competitive activities. Ventricular premature beats (VPB's) are a common finding in the athletic heart. In the majority of cases these arrhythmias are part of the athlete's heart syndrome and do not increase the risk of sudden death in the athletes with an apparently normal heart. The data available in the literature deal with ventricular arrhythmias assessed only by 24-h ambulatory electrocardiograms. To date, there are no guidelines concerning athletes who develop ventricular arrhythmias during a stress test. It is unclear whether they should be allowed to continue with their competitive activity or they should be denied to do so. A study looking at the long term follow-up of these athletes will help us determine whether the development of ventricular arrhythmia during a stress test imposes any risk on the athletes.

Official Title
-----------------
The Long Term Significance of Exercise Induced Ventricular Arrhythmias in Trained Athletes

Conditions
-----------------
Sudden Death

Intervention / Treatment
-----------------
* Procedure: stress test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Competitive athletes less than 35 YO Competitive athletes with ventricular arrhythmias on baseline or recovery in a stress test Competitive athletes with ventricular arrhythmia during exercise Exclusion Criteria: Athletes who don't meet the exclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: stress test|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
-----------------
arrhythmias, Athletes, exercise
Survey of Sensory and Motor Tricks in Focal Dystonia

Study Overview
=================
Brief Summary
-----------------
This study will collect information on (tricks) patients with focal dystonia use to relieve their symptoms. Dystonia is a movement disorder caused by sustained muscle contractions often causing twisting and abnormal posturing. Dystonia may be generalized, affecting at least one leg and the trunk of the body, segmental, affecting adjacent body parts, or focal, affecting a single body part, such as the hand or eyelid. It may be task-specific, such as writer's, musician's or sportsman's cramps. Some patients with focal dystonia use (tricks), such as touching the face or hand, to stop or alleviate the abnormal movement. This study will survey the types of tricks people with focal dystonia use in order to learn more about the disorder. Patients 18 years of age and older with focal dystonia may be eligible for this study. Candidates will be screened for eligibility with a medical history, clinical evaluation, and review of their medical records. In one 30- to 45-minute clinic visit, participants will be interviewed about their dystonia symptoms and the tricks they use to relieve the symptoms. They may be asked to show the investigators how the tricks work

Detailed Description
-----------------
The purpose of this study is to collect and organize information concerning a phenomenon known as 'sensory tricks' or Geste antagoniste in focal dystonia. Sensory tricks, which we will refer to as 'tricks' since some involve motor as well as sensory input, are various stimuli used by dystonic patients to transiently diminish their spasms (Jankovic and Fahn 1993). The phenomenon of tricks is evidence for the abnormality of sensorimotor integration in focal dystonia, yet it is little studied or understood. A survey of the history and characteristics of tricks will lead to a better understanding of this puzzling phenomenon, and a step toward the understanding of the mechanism of focal dystonia.

Official Title
-----------------
Survey of Sensory and Motor Tricks in Focal Dystonia

Conditions
-----------------
Focal Dystonia

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA Patients with focal dystonia diagnosed by review of medical record, history, and clinical evaluation. EXCLUSION CRITERIA Any individual without focal dystonia. Any individual who is unable to provide accurate history, or is critically ill.
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
-----------------
TMS, Geste Antagoniste, Sensorimotor Integration, Writer's Cramp, Sensory Input, Focal Dystonia
Transdermal Lisuride: a Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)

Study Overview
=================
Brief Summary
-----------------
The objective of this trial is to compare an individually optimized dose of the lisuride TTS patch against placebo and against an individually optimized dose of oral ropinirole (active- and placebo-controlled design) in idiopathic and uremic RLS patients with regard to efficacy, safety, and quality of life.

Detailed Description
-----------------
Approximately 300 patients will be randomized to receive either lisuride, ropinirole or placebo in a 2:1:1 fashion. After completion of 12 weeks of double-blind treatment, eligible patients will have the option to continue treatment with the lisuride patch for further 36 weeks in an open-label extension of the study. Primary outcome: Changes in the total score of the International Restless Legs Severity Scale (IRLS) from baseline to end of double-blind treatment (12 weeks) will be used as primary efficacy outcome measure. Secondary objectives are to evaluate quality of life, safety and tolerability. After the double-blind period, long-term efficacy of lisuride will be assessed for further 36 weeks in an open-label extension of the study.

Official Title
-----------------
Transdermal Lisuride: a Double-blind, Randomized, Active- and Placebo-controlled Multi-centre Phase III Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)

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

Intervention / Treatment
-----------------
* Drug: Lisuride
* Drug: Ropinirole
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic or uremic RLS RLS Diagnostic Index (RLS-DI) > 10 Total score in the IRLS Rating Scale ≥ 15 at baseline No previous treatment for RLS or insufficient current therapy Exclusion Criteria: Secondary RLS, e.g. due to iron deficiency (exception: uremia) History or presence of sleep disorders other than RLS

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lisuride|nan|
|Drug: Ropinirole|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Restless Legs Severity Scale (IRLS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RLS-6 scales |  |  | 
| CGI |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Restless Legs Syndrome, dopamine agonist, lisuride, ropinirole
Ultrasound-guided Peripheral Vascular Access in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigation is to conduct a randomized, patient-blinded prospective controlled trial comparing peripheral intravenous cannulation in children done by: Conventional landmark cannulation where the intravenous cannulation is done by direct visual guidance or palpation or a combination thereof. Ultrasound guided cannulation by means of DNTP. The investigators hypothesize that with ultrasound-guided peripheral intravenous cannulation the first-attempt success rate will be significantly higher than by the conventional landmark cannulation technique.

Official Title
-----------------
Ultrasound-guided Peripheral Vascular Access in Children - a Single- Blind, Randomized, Cross-over Trial

Conditions
-----------------
Ultrasonography, Vascular Access Devices, Pediatrics

Intervention / Treatment
-----------------
* Procedure: IV puncture guided by ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Requirement for anaesthesia before MRI or operation. Routine need of peripheral intravenous cannulation. Age 0- 3 years at the date of MR scan Exclusion Criteria: Lack of consent Emergency patients needing immediate operation or scan.

Ages Eligible for Study
-----------------
Maximum Age: 3 Years

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Crossover Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: IV puncture guided by ultrasound|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First attempt success | Succes rate of first attempt cannulation for ultrasound and traditional method will be compared. | Intraoperative |