linjc16/ctgov huggingface dataset:
Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of stem cells for cerebral palsy related to neonatal icterus

Detailed Description
-----------------
The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in 25 patients with cerebral palsy related to neonatal icterus at Vinmec International Hospital, Hanoi, Vietnam

Official Title
-----------------
Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus: An Open-label, Uncontrolled Clinical Trial

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Combination Product: Stem cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cerebral palsy of any types caused by neonatal icterus Exclusion Criteria: Epilepsy Hydrocephalus with ventricular drain Coagulation disorders Allergy to anesthetic agents Severe health conditions such as cancer, failure of heart, lung, liver or kidney Active infections

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 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: Stem cell transplantation<br>Stem cell transplantation 2 intrathecal administrations of autologous bone marrow mononuclear cells at baseline and 6 months afterward | Combination Product: Stem cell transplantation<br>* Transplantation of Autologous Bone Marrow Mononuclear Cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMFM-88 and GMFM-66 Percentile | Change in Total Score of Gross Motor Function Measure GMFM-88 and GMFM-66 Percentile | Time Frame: Baseline and 6 months after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Muscle tone | Muscle tone are assessed by Modified Ashworth Scale | Time Frame: Baseline and 6 months after transplantation | 
| Number of adverse events | Examples of adverse events to look for: fever, infections, vomit, epilepsy | Through study completion, an average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral palsy, Stem cells, Neonatal icterus
Multi-Center Pre-Bariatric Weight Loss Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and efficacy of the GI Sleeve in patients who require weight loss prior to their Bariatric surgery.

Detailed Description
-----------------
This is a randomized, patient blinded, prospective study.Patients will receive either a device or a sham procedure. Patients will be evaluated for the study and randomized to a treatment group if they qualify for the study. Throughout the study their weights will be obtained and various laboratory tests collected. A comparison of weight loss between the two groups will be assessed as the primary outcome measure.

Official Title
-----------------
A Multi-Center, Pilot Efficacy Study of the GI Sleeve for Pre-Surgical Weight Loss

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: GI Sleeve Implantable weight loss device (EndoBarrier)
* Procedure: Sham Procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 35 with a significant comorbid condition or BMI 40-60 Candidate for Bariatric Surgery Exclusion Criteria: No pathologies of the GI Tract No anti-coagulant or non-steroidal anti-inflammatory medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GI Sleeve<br>medical device that mimics gastric bypass mechanism for weight-loss | Device: GI Sleeve Implantable weight loss device (EndoBarrier)<br>* device for weight loss<br>* Other names: endobarrier;|
| Sham Comparator: Sham Control<br> | Procedure: Sham Procedure<br>* Weight loss<br>* Other names: Sham;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Excess Weight Loss (%EWL) at Week 12 | Excess Weight Loss was calculated using the Metropolitan Life Table (MET method) | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight Reduction
Impact of a Relation Training on Empathy of Medical Student

Study Overview
=================
Brief Summary
-----------------
Empathy is an important skill to learn for medical student. However, learning empathy remain difficult. The investigators aim was to assess the efficacy of a specific training, Balint like, on the empathy abilities of medical students in the 4th year. The investigators planned a randomized controlled trial in 3 universities.

Official Title
-----------------
Impact of a Relation Training, Balint-like, on Empathy of Medical Student in the 4th Year.

Conditions
-----------------
Empathy

Intervention / Treatment
-----------------
* Other: Relation learning
* Other: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical student in the 4th year Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relation learning<br>Participants of this group will benefit form a specific learning on relation, Balint like. They will have 7 sessions during 3 months. | Other: Relation learning<br>* Seven session are planned. Each will be supervised by a senior, trained to supervised Balint group.<br>|
| Placebo Comparator: Control group<br>Participants of this group will have no learning related to relation with patient. | Other: Control group<br>* No session will be planned for the participants.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Care | Scale to measure empathy by a simulated patient, during a simulated visit | Two weeks after the last session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
simulated patient, Balint, empathy, medical student
Comprehensive Evaluation of Visual Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the level of visual functioning in patients with various eye conditions while wearing different types of eyeglasses.

Detailed Description
-----------------
The purpose of the research is to study the level of visual functioning in individuals with various eye conditions when using different types of eyeglass lenses. Therefore, the goal of this study is to determine factors that may account for variability in the visual functioning of individuals with a range of refractive errors and their ability to perform everyday activities when equipped with different types of lenses. We hypothesize that the subjects will perform visual tasks of function better when using iZon™ Wavefront-Guided Glasses than with conventional glasses. This hypothesis is based upon the glasses yielding better visual acuity and because the design of the glasses reduces the effects of glare. This research is important so that alternate treatments and vision correction may be implemented which will have a more beneficial impact on those with refractive errors and visual impairment.

Official Title
-----------------
Comprehensive Evaluation of Visual Function

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

Intervention / Treatment
-----------------
* Device: Izon Wavefront-guided lenses
* Device: Conventional lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have normal vision Are far-sighted or near-sighted Have no eye diseases Subjects aged 18 and over, who have refractive errors ranging from +5.0 to -5.0 and/or who have eye disease will be included in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wavefront guided lenses<br> | Device: Izon Wavefront-guided lenses<br>* Subjects will use prescribed eyeglasses for one week. Their visual functioning will be tested at the end of the week.<br>|
| Placebo Comparator: Conventional lenses<br> | Device: Conventional lenses<br>* We will test the subjects with these lenses after they have worn them for one week. Same procedures will be followed as with the other lenses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity, and Contrast Sensitivity |  | Once a week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
This study tests functional ability of patients with refractive error or normal vision while using different types of eyeglasses.
A Prospective Investigation of the VWF-ADAMTS 13 Axis in Acute Ischaemic Brain Injury (TIAs and Stroke).

Study Overview
=================
Brief Summary
-----------------
In patients presenting with acute stroke or transient ischaemic attacks (TIA), von Willebrand factor related parameters, including VWF antigen, activity, FVIII:c and propeptides, ADAMTS13 levels and VWF multimers in cases where ADAMTS 13 was reduced will be measured. Global haemostasis will be assessed using thrombin generation and the relation between increase thrombin generation and VWF explored. Thrombin generation will be performed pre and post filtration for the presence of procoagulant microparticles. These parameters will be investigated acutely, at presentation and in convalescence; in addition, the effect on these parameters of treatment such as thrombolysis may be informative. Correlation between measured parameters and adverse clinical outcome would be used to identify markers of severity and progression of ischaemic stroke and identification of potential novel approaches to therapy that might improve outcome.

Official Title
-----------------
A Prospective Investigation of the VWF-ADAMTS 13 Axis in Acute Ischaemic Brain Injury (TIAs and Stroke).

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged >18 years of age presenting within 9 hours of onset of symptoms will be recruited from the hyperacute stroke unit at UCLH. Patients in whom stroke has been excluded or in whom intracerebral haemorrhage has been diagnosed are to be included as 'controls'. The definitive diagnosis will not be immediately obvious at presentation. Written consent will be obtained from patients or their nearest relative, particularly in patients with aphasia/dysphasia. Exclusion Criteria: Patients <18 years old Patients with systemic vasculitis or active malignancy will be excluded. Patients not wishing to participate

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 |
| --- | --- |
| stroke-ischaemic<br>no interventions | |
| stroke -haemorrhagic<br>no intervention | |
| stroke: not confirmed<br>no intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute ischemic stroke/TIAs are associated with increased levels and activity of VWF and low levels of ADAMTS13 activity. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
presentation with
A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.

Conditions
-----------------
Cervical Dystonia, Blepharospasm

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at least 2 years treatment with Xeomin® and BOTOX® for at least 1 year each Exclusion Criteria: having a neuromuscular junction transmission disorder or taking any medications that could affect neuromuscular junction transmission previous surgical procedure involving bone or muscle for the management of cervical dystonia or blepharospasm

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 |
| --- | --- |
| BOTOX®<br>Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. | Other: No Intervention<br>* No treatment (intervention) was administered.<br>|
| Xeomin®<br>Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered. | Other: No Intervention<br>* No treatment (intervention) was administered.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of Botulinum Toxin Used to Treat Cervical Dystonia | The average dose of botulinum toxin received per patient per year was calculated. | 2 Years | 
| Dose of Botulinum Toxin Used to Treat Blepharospasm | The average dose of botulinum toxin received per patient per year was calculated. | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | An Adverse Event was any unfavorable and unintended sign, symptom, or disease documented in the medical chart that occurred after treatment with botulinum toxin, or pre-existing conditions that worsened during the retrospective period. | 2 Years | 
| Botulinum Toxin Inter-injection Interval | Injection-interval was the time in weeks between injections of botulinum toxin. | 2 Years |
The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The aims of the investigators' study are to characterize the nature of constipation in idiopathic Parkinson's disease (IPD) and to evaluate the usefulness of biofeedback therapy in constipated IPD patients.

Detailed Description
-----------------
The medical treatment of idiopathic Parkinson's disease (IPD) alleviates constipation symptoms due to the restoration of autonomic dysfunction. However, additional laxatives are usually needed in these patients. Other suppository treatments included stool softeners, dopamine-receptor agonists, botulinum toxins, and prokinetic medications such as tegaserod. Biofeedback therapy (BFT) has been the gold standard for functional constipation with dyssynergic defecation or rectal hyposensitivity. However, researchers have not tried to evaluate its usefulness in constipated IPD patients up to now. The aims of our study are to characterize the nature of constipation in IPD and to evaluate the usefulness of BFT in constipated IPD patients.

Official Title
-----------------
The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease

Conditions
-----------------
Idiopathic Parkinson's Disease, Constipation

Intervention / Treatment
-----------------
* Other: biofeedback therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic Parkinson's disease Exclusion Criteria: Secondary Parkinson's disease
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: biofeedback<br> | Other: biofeedback therapy<br>* biofeedback therapy was applied using the surface electromyography (EMG) method with a perianal sensor (Perry, Elan, SRS Medical Systems, Redmond, WA, USA) and biofeedback PC equipment (Orion, Platinum, SRS Medical Systems, Inc., Redmond, WA, USA).<br>* Other names: biofeedback PC equipment (Orion, Platinum, SRS Medical Systems, Inc., Redmond, WA, USA).;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effectiveness of biofeedback therapy in Parkinson's disease |  | usually six sessions per one biofeedback for 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the constipation type in Parkinson's disease |  | 3-6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biofeedback, constipation, Parkinson's disease
A Open-label, Randomized, Crossover Study to Assess PK of Pregabalin

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial to compare the pharmacokinetic characteristics of YHD1119(Pregabalin 300mg) and Lyrica capsule(Pregabalin 150mg). YHD1119 is controlled release formulation which is made by Yuhan Corporation. Primary endpoints are Cmax,ss and AUCtau and secondary endpoints are AUClast,ss, AUCinf,ss, Tmax,ss and t1/2.

Official Title
-----------------
A Open-label, Radomized, Crossover Clinical Trial to Assess the Pharmacokinetics of Pregabalin CR After Multiple Dosing as Compared to Pregabalin IR in Healthy Male Volunteers

Conditions
-----------------
Peripheral Nueropathy Pain

Intervention / Treatment
-----------------
* Drug: YHD1119
* Drug: Lyrica


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 50 years old, healthy male volunteers >55Kg(Body weight) and 18.5<BMI<28 Exclusion Criteria: AST or ALT > 3 * Upper normal range (Lab) Total bilirubin > 2.0 mg/dl Systolic BP >140 OR <90, Diastolic BP >100 OR <60

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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

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 |
| --- | --- |
| Experimental: YHD1119<br>Pregabalin 300mg | Drug: YHD1119<br>* 2 by 2<br>* Other names: Pregabalin 300mg;Drug: Lyrica<br>* 2 by 2<br>* Other names: Pregabalin 150mg;|
| Active Comparator: Lyrica<br>Pregabalin 150mg | Drug: YHD1119<br>* 2 by 2<br>* Other names: Pregabalin 300mg;Drug: Lyrica<br>* 2 by 2<br>* Other names: Pregabalin 150mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss |  | 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours | 
| AUCtau |  | 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast,ss |  | 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours | 
| AUCinf,ss |  | 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours | 
| Tmax,ss |  | 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours |