linjc16/ctgov huggingface dataset:
Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation

Study Overview
=================
Brief Summary
-----------------
The aim of this randomized double-blinded study is to determine whether transition to propofol for 3 min at the end of sevoﬂurane anaesthesia reduces the incidence of EA in children undergoing genito-urinary paediatric surgeries.

Official Title
-----------------
Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation in Genito-urinary Paediatric Surgeries

Conditions
-----------------
Emergence Agitation

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children Aged 3 - 8 years ASA (I - II) Genito-urinary Surgeries: hernia, varicocele, etc. Exclusion Criteria: Patients or parental refusal Allergy to Propofol or egg products; or a family history of malignant hyperthermia Operating time more than 60 minutes Performance of any other procedure under the same anaesthetic Presence of co-morbidities or congenital anomalies mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 8 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol<br>propofol 1 mg/kg IV bolus will be given to the patient with a further 2 mg/kg administered manually over the next 3 min prior to the patient leaving the OR | Drug: Propofol<br>* propofol 1 mg/kg IV bolus will be given to the patient with a further 2 mg/kg administered manually over the next 3 min prior to the patient leaving the OR<br>|
| Placebo Comparator: Control<br>Normal saline will be administered IV over the next 3 min prior to the patient leaving the OR | Drug: Normal saline<br>* Normal saline will be administered manually over the next 3 min prior to the patient leaving the OR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence Agitation | The incidence of EA according to the Watcha scale (deﬁned as a score ≥3 at any time in the 30 min after emergence) | 30 min after emergence | 
| Emergence Agitation | The incidence of EA according to the Paediatric Emergence Anaesthesia Delirium (PAED) scale (deﬁned as a score >12 at any time in the 30 min after emergence ) | 30 min after emergence |
Walking Ability and Limit of Stability in Children With Spastic Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
Trunk control in children with spastic Cerebral Palsy (CP) is impaired. They have weaker trunk muscle strenght, and insufficient sitting/standing balance according to their developing peers. Since their weak trunk muscles and insufficient balance responses, they are not able to walk as functional similar to their peers. Additionaly limit of stability is worsen in children with CP. Investigation of the relationship between walking ability and limit of stability when seated position is important to understand which child is acceptable for training of walk. However we did not found any study to explain it. Therefore the aim of this study is to investigate walking ability and limit of stability in children with spastic CP, and to compare their developing peers.

Official Title
-----------------
an Investigation of the Relationship Between Walking Ability and Limit of Stability in Children With Spastic Cerebral Palsy

Conditions
-----------------
Gait, Spastic

Intervention / Treatment
-----------------
* Other: GAITRite gaitway system, Bertec Balance System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: spastic serebral palsy, between the ages 6-15 years, between the I-IV. levels of GMFCS, be able to understand command given by physical therapist Exclusion Criteria: undergone botulinum toxin A to upper and/or lower extremities, undergone any surgery to their extremities, be at the V. levels of GMFCS

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 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 |
| --- | --- |
| Spastic Cerebral Palsy<br>Children with spastic cerebral palsy | Other: GAITRite gaitway system, Bertec Balance System<br>* GAITRite gaitway system will use to assess gait parameters, Bertec Balance System will use to assess limit of stability<br>|
| Healthy Developing Peers<br>Children with healthy developing peers | Other: GAITRite gaitway system, Bertec Balance System<br>* GAITRite gaitway system will use to assess gait parameters, Bertec Balance System will use to assess limit of stability<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait parameters (stride length in cm, step width in cm, time in swing phase in second, time in stance phase in second) | Gait parameters will be assessed by GAITRite walking way system. | 20 minutes | 
| Limit of stability when sitting and standing position in cm | Limit of stability will be evaluated by BERTEC balance system. | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gait, walking ability, limit of stability, cerebral palsy
Effectivity of Laparoscopic Inguinal Hernia Repair (TAPP) in Daily Clinical Practice - Early and Long-term Results

Study Overview
=================
Brief Summary
-----------------
The effectiveness of laparoscopic inguinal hernia repair still remains unclear. During a one year period a total of 1208 inguinal hernias in 952 patients were consecutively operated using the laparoscopic technique by a total of 11 general surgeons in daily clinical routine. Laparoscopic hernia repair in the TAPP technique seems to have the potential to become the standard procedure in inguinal hernia repair in future.

Detailed Description
-----------------
Objective: Hernia repair is the most frequent operation in general surgery worldwide, but about 25 years after the advent of minimal invasive surgical techniques the effectiveness of laparoscopic inguinal hernia repair still remains unclear. Methods: All patients admitted to the hospital for surgery of an inguinal hernia during a one year period were prospectively documented and included in a follow-up study. The follow-up was performed at least 5 years after surgery and consisted of a clinical examination, ultrasound investigation and a questionnaire.

Official Title
-----------------
Effectivity of Laparoscopic Inguinal Hernia Repair (TAPP) in Daily Clinical Practice - Early and Long-term Results

Conditions
-----------------
Unilateral Inguinal Hernia With Gangrene and Obstruction

Intervention / Treatment
-----------------
* Device: Laparoscopic hernia repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients fit for general anesthesia and presenting an inguinal hernia. Exclusion Criteria: Not fit for general anesthesia, young age (>21 years), not wanting a mesh.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Laparoscopic hernia repair|Preperitoneal mesh implantation because of inguinal hernia disease using the laparoscopic technique|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of the trial was recurrence of a hernia within five years after the repair. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome was chronic pain. | Chronic pain was measured by VAS scale | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inguinal hernia repair, laparoscopic inguinal hernia repair, TAPP
PMS of Trazenta on the Long-term Use as Add-on Therapy

Study Overview
=================
Brief Summary
-----------------
Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as add-on therapy in patients with type 2 diabetes mellitus.

Official Title
-----------------
Post Marketing Surveillance on Long Term Drug Use of Trazenta® Tablets as add-on Therapy in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Trazenta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with type 2 diabetes mellitus who are treated with anti-diabetic drugs and have never been treated with Trazenta® Tablets (linagliptin) before enrollment will be included. Exclusion criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trazenta<br> | Drug: Trazenta<br>* 1 tablet of 5 mg Trazenta tablets once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Drug Related Adverse Events | Percentage of participants with drug related adverse events. | From first drug administration until last drug administration, up to approximately 156 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c) | The mean change from baseline to last observation of the treatment period in Haemoglobin A1c (HbA1c). | Baseline (before administration of treatment) and last observation of the treatment period; up to 156 weeks. |
Ceribell Delirium Data Collection Study

Study Overview
=================
Brief Summary
-----------------
This study is designed as a prospective, non-randomized, observational clinical study. The study will collect clinical and rrEEG (Ceribell EEG) data when monitoring subjects for delirium subtypes. EEG and clinical data will be collected for the development of future software algorithms to assess the presence and severity of delirium.

Official Title
-----------------
Ceribell Delirium Data Collection Study

Conditions
-----------------
Delirium

Intervention / Treatment
-----------------
* Device: Electroencephalogram (EEG) Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All must be present Age is 18 years or older Admitted to the Intensive Care Unit (ICU) Subject must be fluent in the language in which the delirium assessment is performed Exclusion Criteria: All must be absent - Any condition that prevents use of the Ceribell EEG system on the subject for the entire anticipated EEG monitoring period. Examples may include: Craniectomy with missing bone flap in an area where Ceribell EEG electrodes are placed. Expected use of continuous clinical EEG for the entire anticipated monitoring period.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Electroencephalogram (EEG) Test|EEG test and delirium assessments will be performed on subjects experiencing delirium in the ICU.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perform Confusion Assessment Method for the ICU (CAM-ICU) assessment | Research coordinator will perform and collect CAM-ICU assessment data on study subjects | 3 times per day, for a maximum of six (6) days | 
| Perform Electroencephalogram (EEG) Test | Record and collect EEG brain waves on study subjects using Ceribell Rapid Response EEG to assess multiple time-frequency EEG features to differentiate between delirium positive and delirium negative patients. | 6-8 hours per day, for a maximum of six (6) days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EEG, delirium, Electroencephalogram
A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.

Official Title
-----------------
A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: ITCA 650 60 mcg/day
* Drug: sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HbA1c between 7.5% - 10.5% on metformin monotherapy BMI between 25 & 45 kg/m2 Exclusion Criteria: taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months history of pancreatitis

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITCA 650 60 mcg/day<br>ITCA 650 is exenatide in DUROS | Drug: ITCA 650 60 mcg/day<br>* exenatide in DUROS<br>|
| Active Comparator: sitagliptin<br>sitagliptin 100 mg/day | Drug: sitagliptin<br>* oral sitagliptin 100 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c between Week 52 and Day 0 |  | 52 weeks |
Testing Methods of Screening for Woman Abuse in Health Care Settings.

Study Overview
=================
Brief Summary
-----------------
Recent reviews have identified the need for additional high quality exploratory and evaluative research to understand 1) the actual impact on all women of instituting mass screening procedures versus using indicator-based approaches to identifying woman abuse and 2) the extent to which early identification through screening -- either universal or indicator-based is effective in preventing or ameliorating important outcomes. This is a critical first step in developing a larger randomized controlled trial (RCT) which examines the effectiveness of screening in preventing woman abuse, improving quality of life and other associated outcomes. This study prepares for the RCT by testing the optimal method of administration for the two screening instruments that will be used in the RCT. The administration formats are: computer-based screen, paper and pencil screen and face-to-face screen. They study will also determine recruitment rates.

Official Title
-----------------
Testing Screening Formats for Indicator-Based and Universal Screening Measurements in the Identification of Woman Abuse.

Conditions
-----------------
Domestic Violence

Intervention / Treatment
-----------------
* Procedure: Woman Abuse Screening Tool
* Procedure: Partner Violence Screen
* Procedure: Computerized screening
* Procedure: Face to face screening
* Procedure: Written screening on forms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18-64 years Patients at the health care site Able to participate in English Able to separate from accompanying person(s) Exclusion Criteria: Too ill to participate Unable to separate from accompanying person(s) Unable to speak, read, or write English

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Woman Abuse Screening Tool|nan|
|Procedure: Partner Violence Screen|nan|
|Procedure: Computerized screening|nan|
|Procedure: Face to face screening|nan|
|Procedure: Written screening on forms|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disclosure rates for past year exposure to intimate partner violence |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| participant satisfaction with completing the instruments |  |  | 
| missing data |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
screening, screening methods, intimate partner violence
Observation of Change in Clinical Global Impression Scores in Schizophrenia Patients Receiving Seroquel XR Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess severity of illness in schizophrenia patients in routine clinical practice at the time of entry in the study and after the treatment with Seroquel XR for 8 weeks. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
Observation of Change in Clinical Global Impression Scores in Schizophrenia Patients Receiving Seroquel XR Treatment

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with Schizophrenia prescribed on Seroquel XR according to the approved product information before inclusion in this non-interventional study Signed and dated Patient Informed Consent (ICF) Exclusion Criteria: Hypersensitivity to the active substance or to any of the excipients of Seroquel XR

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 |
| --- | --- |
| 1<br>Adult schizophrenia patients already on Seroquel XR therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in CGI scores and BPRS comparing visits 1 and 3. |  | twice with 4 week interval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate compliance to therapy |  | twice with 4 week interval | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CGI, Schizophrenia, Seroquel XR
Comparison of Telemedicine Versus Traditional Practice in a University Health Center

Study Overview
=================
Brief Summary
-----------------
This study is to determine if telemedicine visits provide similar quality and patient/physician satisfaction as traditional office visits in a college health population.

Detailed Description
-----------------
This study which is open to students at Arizona State University who require follow-up care after their visit to ASU Health Services. Patients who are seen by a Mayo Clinic physician working at the ASU Health Services are randomized to either be seen for followup at the health center with the same physician or seen at the health center by the same physician at Mayo clinic utilizing telemedicine. After the visit, patients and the physician will fill out an patient satisfaction survey and the record will be reviewed by an independent investigator for determining quality of care by reviewing the record.

Official Title
-----------------
Comparison of Telemedicine Versus Traditional Practice in a University Health Center

Conditions
-----------------
Health Service Research on Telemedicine

Intervention / Treatment
-----------------
* Other: Traditional versus Telemedicine office visit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Arizona State University students who require a follow-up care visit. ages 18 and above Exclusion Criteria: patients who are medically unstable to be randomized to a telemedicine visit.

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine Visit<br>Patients who are seen by use of an off-site telemedicine physician. | Other: Traditional versus Telemedicine office visit<br> <br> |
| Active Comparator: Traditional Visit<br>Patients who are seen in followup with a traditional in-office visit. | Other: Traditional versus Telemedicine office visit<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of care score between the two groups | Using a independent quality assessor, each visit whether telemedicine will give a quality score based on adequacy of care, ability to examine/determine the diagnosis based on the documented care in the record. | At the 24 hour visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemedicine