linjc16/ctgov huggingface dataset:
Study of Human Central Nervous System (CNS) Stem Cells Transplantation in Pelizaeus-Merzbacher Disease (PMD) Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and preliminary effectiveness of human central nervous system stem cells (HuCNS-SC®) transplantation in patients with Connatal Pelizaeus-Merzbacher Disease (PMD).

Detailed Description
-----------------
Enrolled subjects will be transplanted with HuCNS-SC cells into the brain and will receive immunosuppression for nine months. The study observation period is for one year after transplant surgery. Thereafter, subjects will be enrolled in a long-term observational follow-up study for four years.

Official Title
-----------------
Phase I Study of the Safety and Preliminary Efficacy of Intracerebral Transplantation of HuCNS-SC® Cells for Connatal Pelizaeus-Merzbacher Disease (PMD)

Conditions
-----------------
Pelizaeus-Merzbacher Disease

Intervention / Treatment
-----------------
* Biological: HuCNS-SC cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed clinical diagnosis of connatal PMD Molecular genetic confirmation of mutation in the proteolipid protein 1 (PLP1) gene MRI consistent with PMD as interpreted by a qualified neuroradiologist Exclusion Criteria: Other significant congenital brain abnormality not related to PMD Previous participation in gene transfer or cell transplant trial Presence of neurological signs and symptoms not consistent with PMD Current or prior malignancy Prior organ, tissue or bone marrow transplant

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HuCNS-SC cells<br>Intracerebral implantation of HuCNS-SC via direct injection during surgery | Biological: HuCNS-SC cells<br>* intracerebral transplantation<br>* Other names: Human central nervous system stem cells;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment through clinical neurological and MRI evaluation. |  | one year post transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI examination for post-transplant myelination |  | one year post transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PMD, stem cells, Pelizaeus-Merzbacher Disease, human stem cells, central nervous system stem cells
Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of three concentrations of ZK 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic dermatitis and to obtain dose-response information for the three concentrations.

Official Title
-----------------
Double-blind, Randomized, Dose Escalation Study of the Efficacy and Safety of ZK 245186 Ointment in Concentrations of 0.01%, 0.03%, and 0.1% Over 4 Weeks in Patients With Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: ZK 245186
* Drug: Placebo (vehicle ointment)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of atopic dermatitis (Hanifin and Rajka criteria) mild to moderate atopic dermatitis at beginning of study wash-out periods for systemic and topical treatments for atopic dermatitis females must use effective contraception Exclusion Criteria: pregnant or lactating women conditions that in the opinion of the investigator may pose a risk or interfere with the evaluation of the study wide-spread atopic dermatitis requiring systemic treatment diagnosed with immunocompromised status skin diseases - other than atopic dermatitis - in the treatment area mental handicap or legally incompetent

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zk 245186 0.01% ointment<br>Active treatment, lowest dose | Drug: ZK 245186<br>* Once daily topical non-occlusive application for up to 4 weeks<br>|
| Active Comparator: ZK 245186 0.03% ointment<br>Active comparator middle dose | Drug: ZK 245186<br>* Once daily topical non-occlusive application for up to 4 weeks<br>|
| Active Comparator: ZK 245186 0.1% ointment<br>Active comparator highest dose | Drug: ZK 245186<br>* Once daily topical non-occlusive application for up to 4 weeks<br>|
| Placebo Comparator: Vehicle ointment<br>Placebo comparator | Drug: Placebo (vehicle ointment)<br>* Once daily topical non-occlusive application for up to 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the severity of atopic dermatitis at target lesion, based on clinical signs of inflammation |  | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment of target area |  | up to 4 weeks |
Bayesian Networks in Pediatric Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Pediatric cardiac surgery with cardiopulmonary bypass is associated with significant morbidity and mortality. Also score systems for risk factors, such as Risk Adjustment for Congenital Heart surgery (RACHS 1) score or the ARISTOTLE score, have been developed, outcome prediction remains difficult. New mathematical methods using deep neural networks associated with Bayesian statistical methods have been developed to give a better understanding of the complex interaction between different risk factors, to identify risk factors and group them in related families. This method has been successfully used to predict mortality in dialysis patient as well as to better describe complex psychiatric syndromes. The primary hypothesis of this study is that the use of these tools will give a better understanding on the factors affecting outcome after pediatric cardiac surgery. A network analysis using Gaussian Graphical Models, Mixed Graphical models and Bayesian networks will be used to identify single or groups of risk factors for morbidity and mortality after pediatric cardiac surgery under cardiopulmonary bypass.

Official Title
-----------------
Use of Deep Neural Networks and Bayesian Analysis to Identify Risk Factors for Poor Outcome After Pediatric Cardiac Surgery

Conditions
-----------------
Cardiac Surgical Procedures, Pediatrics, Cardiopulmonary Bypass

Intervention / Treatment
-----------------
* Procedure: Pediatric cardiac surgery under cardiopulmonary bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 0 to 16 years cardiac surgery under cardiopulmonary bypass Exclusion Criteria: ASA (American Society of Anesthesiologists) status 5 Jehovah's Witness

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- |
| Pediatric cardiac surgery<br>All patients with pediatric cardiac surgery under cardiopulmonary bypass between 2008 and 2018 will be included | Procedure: Pediatric cardiac surgery under cardiopulmonary bypass<br>* All patients with pediatric cardiac surgery under cardiopulmonary bypass between 2008 and 2018 operated at our institution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome predictors | All preoperative, peroperative and postoperative variables will be entered into a deep neural network with Bayesian statistics to identify groups or individual risk factors for postoperative morbidity and mortality | 28 days |
Eealy Improvement Predicts Antidepressants Response in Adults With Major Depression Disorder

Study Overview
=================
Brief Summary
-----------------
Early improvemrnt, decreased 20% in the 17 items of Hamilton Depression Rating Scale (HAMD-17) at the second week of the treatment of major depression disorder (MDD), can arguably predict the remission at the 12th week. Our observation study including 80 MDD patients will access resting-state function MRI to finding factors which infuencing early improvemrnt, respone and remission of antidepressants.

Official Title
-----------------
Eealy Improvement Predicts Antidepressants Response in Adults With Major Depression Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: antidepressant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: right-handed; HAMD-17 more than 17; diagnosed with MDD by the Structured Clinical Interview for DSM-IV Exclusion Criteria: patients diagnosed with other condition in DSM-IV Axis I; pregnency; Thyroid disease; Heart Disease

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 55 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 |
| --- | --- |
| major depressive disorder<br> | Drug: antidepressant<br>* regular one-drups treatment of selective serotonin reuptake inhibitor(SSRIs)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early improvement | obtain 20% decrease of HAMD-17 | the second week of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response | obtain 50% decrease of HAMD-17 | the 12th week of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early improvement, antidepressants, major depression diorder, resting-state fMRI
ANDRO 2002: Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo in Men With Sexual Dysfunction

Study Overview
=================
Brief Summary
-----------------
Androgen deficiency in the aging male is poorly understood. The objective of this study will be to determine the role of testosterone and DHEA in enhancing sexual interest and sexual performance.

Detailed Description
-----------------
120 men with a diagnosis of Erectile dysfunction (ED) will be randomized to one of three arms in the study, DHEA (50 mg), testosterone [T] (80 mg) or placebo. Patients will be evaluated after starting blinded medication at 30 day intervals for a total of 90 days. Response will be evaluated with blood parameters, physical examination including rectal examination, validated questionnaires and global assessment scales.

Official Title
-----------------
A Randomized Double-Blind Placebo-Controlled Study Comparing the Safety and Efficacy of Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo in Men With Sexual Dysfunction

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: DHEA
* Drug: Testosterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Erectile dysfunction (ED) Exclusion Criteria: Prior use of DHEA or T

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DHEA|nan|
|Drug: Testosterone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rates based upon questionnaires |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ED, DHEA, testosterone
Evaluation of Pupil Dilation Speed With the MAP Dispenser

Study Overview
=================
Brief Summary
-----------------
After screening, eligible subjects will be scheduled for 2 treatment visits where either 1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan. Safety evaluations and efficacy measurements will be performed at specified time intervals thereafter. Pupil dilation for each treatment will be compared at each time interval.

Official Title
-----------------
A Study Evaluating Pupil Dilation Speed With the Micro-Array Print (MAP) Dispenser Comparing 2 Dosing Regimens of Tropicamide-Phenylephrine Fixed Combination Ophthalmic Solution

Conditions
-----------------
Mydriasis

Intervention / Treatment
-----------------
* Drug: tropicamide-phenylephrine fixed combination ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Photopic screening pupil diameter ≤ 3.5 mm in each eye Exclusion Criteria: Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride. Use of benzodiazepines, monoamine oxidase inhibitors, tricyclic antidepressants, anticonvulsants, cholinergic drug at screening or anticipated during the study period. History of closed-angle glaucoma. Anatomically narrow anterior chamber angles (Van Herrick grade ≤ 2 in either eye). Ocular surgery or laser treatment of any kind prior to the Screening Visit. History of iris trauma, surgery, or atrophy. Irregularly-shaped pupil secondary to ocular trauma or congenital defect, or history of neurogenic pupil disorder.

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1 Mist<br>One mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser | Drug: tropicamide-phenylephrine fixed combination ophthalmic solution<br>* Tropicamide-phenylephrine fixed combination ophthalmic solution is a tropical drug solution for mydriasis<br>|
| Other: 2 Mists<br>Two mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser | Drug: tropicamide-phenylephrine fixed combination ophthalmic solution<br>* Tropicamide-phenylephrine fixed combination ophthalmic solution is a tropical drug solution for mydriasis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in pupil diameter from baseline |  | 35 minutes post drug administration |
Ivabradine to Improve Endothelial Function in Patients With Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of ivabradine on endothelial function in patients with coronary artery disease (CAD) after complete revascularization with percutaneous coronary angioplasty (PCI). At least 30 days after PCI, patients will be randomized to receive ivabradine 5 mg twice daily or to continue with standard medical therapy.

Official Title
-----------------
Heart Rate Reduction by IVabradine for Improvement of ENDothELial Function in Patients With Coronary Artery Disease: the RIVENDEL Study

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Ivabradine
* Drug: Standard medical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of stable coronary disease complete coronary revascularization with PCI at least 1 month prior to recruitment sinus rhythm absence of anginal symptoms Exclusion Criteria: resting heart rate <60 beats per minute severe reduction of left ventricle ejection fraction (<40%) coronary artery by-pass surgery myocardial infarction, stroke or cerebral transient ischemic attack within the previous 6 months implanted pacemaker, cardioverter, or defibrillator sick sinus syndrome sinoatrial block congenital long QT complete atrioventricular block
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 |
| --- | --- |
| Active Comparator: Ivabradine group<br>Ivabradine 5 mg twice daily + standard medical therapy | Drug: Ivabradine<br>* Ivabradine 5 mg twice daily<br>Drug: Standard medical therapy<br>* Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions<br>|
| Other: Control group<br>Standard medical therapy | Drug: Standard medical therapy<br>* Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated dilation of the brachial artery |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with flow-mediated dilation of the brachial artery <7% |  | 8 weeks | 
| Endothelium-independent dilation of the brachial artery | Dilation of the brachial artery after administration of 0.5 mg sublingual nitroglycerin | 8 weeks | 
| Correlation between heart rate and flow-mediated dilation of the brachial artery |  | 8 weeks |
Observational Study of Patients With Mucopolysaccharidosis (MPS) VI Who Previously Participated in ASB-00-02

Study Overview
=================
Brief Summary
-----------------
There is limited information on the long-term effects of treating patients with MPS VI with Naglazyme® and limited data on the natural history of treated and untreated MPS VI patients. The Re-survey Study ASB-00-03 will assist in understanding the effects of long-term Naglazyme treatment and the natural history of the MPS VI patient population.

Official Title
-----------------
A Re-Survey Study of Patients With MPS VI (Maroteaux-Lamy Syndrome) Who Previously Participated in ASB-00-02

Conditions
-----------------
MPS VI

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to provide written, signed informed consent, or in the case of patients under the age of 16 years, provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures. Previously participated in Survey Study ASB-00-02, and met the criteria of a MPS VI diagnosis. Willing to perform all study assessments and procedures as physically possible. Exclusion Criteria: Concurrent disease or condition that would interfere with study participation or safety. Any condition that, in the view of the Investigator would place the patient at high risk of not completing the study. Concurrent enrollment and randomization into a clinical study of MPS VI treatment. Patients enrolled in the BioMarin MPS VI Clinical Surveillance Program may be enrolled in the Re-survey Study ASB-00-03.
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 |
| --- | --- | --- |
| Linear Comparison of assessments completed for Survey Study ASB-00-02 and and Re-Survey StudyASB-00-03 | This study is designed to be performed in a similar manner to the Survey Study ASB-00-02. Similar assessments will be performed in order to make linear comparisons in outcomes over a long-term period. | Variable dependent on date of assessment performed fo rthe Survey STudy ASB-00-02 |