linjc16/ctgov huggingface dataset:
Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms

Study Overview
=================
Brief Summary
-----------------
Prospective registry study to evaluate safety and efficacy of stent assisted embolization of intracranial aneurysm.

Detailed Description
-----------------
To evaluate stent assisted embolization of intracranial aneurysm, record information about treatment and any event (death, stroke, hemorrhagic event) prospectively.

Official Title
-----------------
Efficacy and Safety of StENt-assisted Treatment for CErebral Aneurysms

Conditions
-----------------
Stent Embolisation

Intervention / Treatment
-----------------
* Procedure: stent assisted embolization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stent assisted embolization of intracranial aneurysm 20 or more year old Exclusion Criteria: not determined

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| stent assisted embolization<br>stent assisted embolization of intracranial aneurysm | Procedure: stent assisted embolization<br>* stent assisted embolization and anti-thrombotic management<br>* Other names: Enterprise VRD;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any death, stroke and major hemorrhagic event | any death, stroke and major hemorrhagic event within 2 years after treatment | 2 years after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any adverse event | death, stroke, hemorrhagic event within 30days or between 31days to 2years after treatment any change of anti-thrombotic therapy within 2years after treatment recanalization or re-treatment within 2years after treatment stent stenosis or occlusion within 2years after treatment any adverse event within 2years after treatment | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stent, intracranial aneurysm, embolization, adverse event
Percutaneous Rupture of Zygapophyseal Joint Cysts

Study Overview
=================
Brief Summary
-----------------
Lumbar zygapophyseal joint cysts can cause lower extremity radiculopathy. These cysts can be cured by a minimally invasive technique: percutaneous cyst distention and rupture

Detailed Description
-----------------
Lumbar zygapophyseal joint cysts can cause lower extremity radiculopathy. These cysts can be cured by a minimally invasive technique: percutaneous cyst distention and rupture. 30 patient with lower extremity radiculopathy caused by lumbar zygapophyseal joint cysts will be included in the study.

Official Title
-----------------
Percutaneous Rupture of Zygapophyseal Joint Cysts

Conditions
-----------------
Zygapophyseal Synovial Joint Cyst

Intervention / Treatment
-----------------
* Procedure: Percutaneous zygapophyseal cyst rupture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with lumbar zygapophyseal joint cyst and compression of a spinal nerve root with lower extremity radiculopathy proven by MRI. Exclusion Criteria: Infection, uncontrollable bleeding disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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>Percutaneous zygapophyseal cyst rupture | Procedure: Percutaneous zygapophyseal cyst rupture<br>* Patients will be treated by introducing a 20G spinal needle in the inferior joint recess of the zygapophyseal joint.1 ml of celestone-chronodose,1 ml of Marcain 5 mg/ml and 1-3 ml of contrast media:Omnipaque 240 will be injected until the cyst ruptures.<br>* Other names: Axiom Artis Siemens;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS(Visual analogue scale)for extremity pain |  | 1-3 and 12 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland-Morris disability index |  | 1-3 and 12 months after intervention | 
| Reduction of cyst size based om T2 MRI |  | 3 and 12 months after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Zygapophyseal, joint, cyst, Fluoroscopy, guided, percutaneous, Lumbar
Defining Sexual Activity

Study Overview
=================
Brief Summary
-----------------
This will be a descriptive study using patients from the Urogynecology and Urology University of South Florida Clinics and Urology clinic at Tampa General Hospital Healthpark on 30th Street to analyze the impact of demographics on the definition of being sexually active. It is believed one's demographics influence their definition of being sexually active.

Official Title
-----------------
Defining Sexual Activity: How Demographics May Impact Our Definition

Conditions
-----------------
Demographics Effecting One's Definition of Being Sexually Active

Intervention / Treatment
-----------------
* Other: Defining Sexual Activity Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and Women >18 who seek urogynecological/urological treatment English speaking Willing and able to provide written and informed consent Exclusion Criteria: Men and Women <18 Not a patient at the appropriate Urogynecological and Urology clinics Non-English speaking Unable or unwilling to provide written and informed consent

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

| Intervention/Treatment |
| --- |
|Other: Defining Sexual Activity Questionnaire|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definition of Sexual Activity | Based on questionnaire answers, the goal is to define sexual activity. | 6 months |
The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants

Study Overview
=================
Brief Summary
-----------------
Sustained inflation (SI) has been reported to be effective for reducing the need for intubation and/or invasive ventilation in preterm infants. However, it has also an important role to support the initial breaths and liquid removal from the airways. Therefore, the investigators hypothesized that SI performed just after birth may help to facilitate the transitional period and decrease the incidence of early respiratory morbidities such as transient tachypnea in term infants.

Official Title
-----------------
The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants

Conditions
-----------------
Respiratory Distress Syndrome, Newborn, Transient Tachypnea of the Newborn, Respiratory Morbidity

Intervention / Treatment
-----------------
* Other: Sustained Inflation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: term newborns parental informed consent inborn infants Exclusion Criteria: major congenital/chromosomal abnormalities lack of informed consent outborn infants Premature infants

Ages Eligible for Study
-----------------
Maximum Age: 2 Minutes

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sustained Inflation Group<br>Includes the infants who administered sustained inflation for 5 seconds with a pressure of 30cm H20 immediately after the delivery. | Other: Sustained Inflation<br>* Administering a pressure of 30 cm H20 by a T-piece resuscitator for 5 seconds immediately after birth.<br>|
| No Intervention: No Intervention group<br>Includes routine neonatal care in the delivery room | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Morbidity | RDS, TTN, requirement for supplemental oxygen, intubation or mechanical ventilation support | 2 hours |
Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, open-label trial to assess safety and tolerability of rotigotine in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year in subjects who previously participated in SP790 (6-month pivotal trial) or SP794 (sleep lab trial). Subjects who successfully completed the Maintenance Period and the Taper Period of SP790 or SP794 are allowed to enroll in this trial.

Official Title
-----------------
An Open-label Extension Trial to Investigate the Safety and Tolerability of Long-term Treatment With Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject completed the Maintenance Period and Taper Period of SP790 or SP794 Exclusion Criteria: Subject has an ongoing serious adverse event (SAE) from SP790 or SP794 that is assessed to be related to the trial medication by the investigator and/or the sponsor. Subject has any medical or psychiatric condition that, in the opinion of the investigator, can jeopardize or would compromise the subject's ability to participate in this trial

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, changes in laboratory tests, vital signs, physical and neurological examination, menstrual and sexual function, 12-lead ECGs. Subject's rating of daytime sleepiness, global subject rating of tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the International Restless Legs Scale (IRLS) sum score, in CGI Items 1 and 2-3, in RLS-6 Rating Scales. IRLS Responder |  | from Baseline at the end of the Maintenance Period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rotigotine, Restless Legs Syndrome
Simultaneous Measurement of Both Fetal's Lateral Ventricles of the Brain

Study Overview
=================
Brief Summary
-----------------
Study designed to measure simultaneously the width of both lateral ventricles of the fetal brain. Thus, will enable to evaluate the normal asymmetry that may exist between the right and the left ventricles during the pregnancy.

Detailed Description
-----------------
Study will enable to evaluate the normal asymmetry that may exist between the right and the left ventricles during the pregnancy.

Official Title
-----------------
Simultaneous Measurement of Both Fetal's Lateral Ventricles of the Brain

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: low risk pregnant women Exclusion Criteria: high risk pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| width of lateral ventricles along the pregnancy | constructing a graph of the width of the lateral ventricles according to the gestational weeks | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ventricles, fetal, brain, asymmetry
A Comparative Trial of TMS Approaches to Treating Depression

Study Overview
=================
Brief Summary
-----------------
Trancranial Magnetic Stimulation (TMS) is a non-drug and non-invasive treatment for depression and has been investigated for the treatment of psychiatric illness for over 15 years. There is now established evidence indicating TMS is an effective treatment for depression. However, the effectiveness of TMS varies between people, thus requiring further research to investigate its optimal application. Investigators want to compare the effectiveness of different forms of TMS, given with differing stimulation settings to the right or left side of the brain that has been associated with depression. This could potentially help clinicians in the future to improve the prescription of TMS as a treatment for depression.

Official Title
-----------------
A Comparative Trial of TMS Approaches to Treating Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Device: Transcranial Magnetic Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years. DSM-IV diagnosis of current Major Depressive Episode. MADRS score of 20 or more. Able to give informed consent. Exclusion Criteria: DSM-IV psychotic disorder. Drug or alcohol abuse or dependence (preceding 3 months). Inadequate response to ECT (current episode of depression). Rapid clinical response required, e.g. high suicide risk. Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy. Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device. Pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transcranial Magnetic Stimulation<br>Active TMS (1) | Device: Transcranial Magnetic Stimulation<br> <br> |
| Active Comparator: Transcranial Magnetic Stimulation 2<br>Active TMS (2) | Device: Transcranial Magnetic Stimulation<br> <br> |
| Active Comparator: Transcranial Magnetic Stimulation 3<br>Active TMS (3) | Device: Transcranial Magnetic Stimulation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Åsberg Depression Rating Scale(MADRS) |  | Participants will be assessed for changes for duration of trial, an expected average of 6 weeks. |
Changes in Motor Latency During Spinal Decompression: Relationship to Outcomes

Study Overview
=================
Brief Summary
-----------------
Is there a relationship between changes in motor evoked potential latency intraoperatively and post-operative changes in walking function in patients undergoing spinal decompression.

Detailed Description
-----------------
Is there a relationship between changes in motor evoked potential latency intraoperatively and post-operative changes in walking function in patients undergoing spinal decompression. Tests will include the pre and post decompression MEP (motor evoked potential) latency and pre and post surgery walking speed and quality of life assessments.

Official Title
-----------------
Changes in Motor Latency During Spinal Decompression: Relationship to Outcomes

Conditions
-----------------
Spinal Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Central spinal stenosis Ability to ambulate prior to onset of symptoms Exclusion Criteria: Arthritis affecting walking ability (hip, knee or ankle). Diabetes Implanted pacemaker or other electrostimulator.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgery Group<br>Consecutive patients from a two surgeon practice | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Evoked Potential Latency | MEP latency at induction and completion of decompression | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 m Timed Walking speed | 10m timed walk | pre-surgery and 3 months post surgery | 
| Quality of Life measured in SF-36 | SF-36 | pre-surgery and 3 months post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Stenosis, Motor Evoked Potential
The Effect of Obesity on Recovery Profile in Children

Study Overview
=================
Brief Summary
-----------------
It is planned to investigate whether obesity affects the recovery profile after anesthesia in pediatric patients. To evaluate recovery profile, time to spontaneous ventilation (the time between anesthetic discontinuation and beginning of spontaneous ventilation), LMA removal time (the time between anesthetic discontinuation and LMA removal), open eyes (the time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching), and PACU discharge will be also noted.

Official Title
-----------------
Does Obesity Effect the Recovery Profile in Children?

Conditions
-----------------
Obesity, Childhood

Intervention / Treatment
-----------------
* Procedure: Recovery profile from general anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I and II Routine surgery under general anesthesia Exclusion Criteria: Any known cerebrovascular disease Long- or short-term (within the previous 24 hours) intake of any drug acting in the central nervous system The patients bypassing the recovery room

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Recovery profile from general anesthesia|It includes the phases during recovery from general anesthesia: Time to spontaneous ventilation, Laryngeal Mask Airway (LMA) removal time, open eyes, and Post-Anesthesia Care Unit (PACU) discharge.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to spontaneous ventilation | The time between anesthetic discontinuation and beginning of spontaneous ventilation. | up to 20 minutes | 
| LMA removal time | The time between anesthetic discontinuation and LMA removal. | up to 25 minutes | 
| Time to open eyes | The time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching | up to 30 minutes | 
| PACU discharge time | The time between entering and leaving the PACU. | up to 45 minutes |
Negative Pressure Therapy, Minimally Invasive and Accessible Technique in the Treatment of Massive Subcutaneous Emphysema in COVID-19 or Non Infected Critical Patients

Study Overview
=================
Brief Summary
-----------------
Background Numerous surgicals treatments have been described for the massive subcutaneous emphysema; however, some of these techniques cannot be carried out in a critical care unit and they are related with high morbidity and exposure in positive SARS COV-2 patients. More effective, less invasive and isolated procedures should be implemented. Technique Negative pressure therapy (NPT) that can allow effective solving of massive subcutaneous emphysema in a short period (5 days) with a minimally invasive approach at the bedside in Covid-19 or non infected critical patients. Conclusion NPT is an effective and low invasive strategy for the management of EES in critical patients with high risk of mortality.

Official Title
-----------------
Negative Pressure Therapy, Minimally Invasive and Accessible Technique in the Treatment of Massive Subcutaneous Emphysema in COVID-19 or Non Infected Critical Patients

Conditions
-----------------
Subcutaneous Emphysema, Covid19

Intervention / Treatment
-----------------
* Device: Vçac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subcutaneous emphysema that compromises ventilation Exclusion Criteria: Declined Therapy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Vçac|VAC THERAPY vs SURGICAL DREINAGE|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution time of emphysema with negative pressure therapy | Days | Days |