linjc16/ctgov huggingface dataset:
Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of atomoxetine hydrochloride in treating adults who have attention deficit hyperactivity disorder with comorbid social anxiety disorder

Official Title
-----------------
Phase IV Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety Disorder

Conditions
-----------------
Attention Deficit Hyperactivity Disorder, Comorbid Social Anxiety Disorder

Intervention / Treatment
-----------------
* Drug: Atomoxetine hydrochloride
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You must be 18 to 65 years old. You must have been diagnosed with attention deficit hyperactivity disorder and social anxiety disorder. You must be able to visit the doctor's office at least 8 times over a 16 week period. You must agree to participate with all tests and examinations that are required for this study. Exclusion Criteria: You are a woman and pregnant or breastfeeding. You presently have an acute or unstable medical illness. You have a history of allergic reaction to atomoxetine hydrochloride. You are taking medications that are not permitted in this study. Your physician will discuss these with you. You have taken part in another clinical research trial within the last 30 days or have received treatment with a drug in the last 30 days that has not received regulatory approval.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Atomoxetine hydrochloride|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in signs and symptoms of ADHD as measured by the mean changes from baseline to endpoint in Conner's adult ADHD rating scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in signs and symptoms of social anxiety as measured by the mean changes from baseline to endpoint in Liebowitz social anxiety scale |  |  |
The Role of Microparticles as a Biomarker

Study Overview
=================
Brief Summary
-----------------
The investigators propose to characterize MPs in aHUS and TTP both at the onset and throughout treatment. The investigators believe that the number, size, and cell origin of MPs will differ between these two diseases. The hypothesis is that endothelial derived MPs will be higher in number and comprise a larger portion of the MP population in aHUS and that platelet MPs will comprise a larger number and greater proportion of MPs in TTP. The investigators believe that MP identity and number can be used to reliably differentiate between aHUS and TTP at disease onset.

Official Title
-----------------
The Role of Microparticles as a Biomarker in Distinguishing Between Thrombotic Thrombocytopenic Purpura (TTP) and Atypical Hemolytic Uremic Syndrome (aHUS)

Conditions
-----------------
Atypical Hemolytic Uremic Syndrome, Thrombotic Thrombocytopenic Purpura, Microparticles, Microangiopathic Hemolytic Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with MAHA, TTP, and/or aHUS Exclusion Criteria: Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- |
| aHUS<br>atypical Hemolytic Uremic Syndrome | |
| TTP<br>Thrombotic thrombocytopenic purpura | |
| MAHA<br>other microangiopathic hemolytic anemias | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microparticle/Nanoparticle number (an absolute number) |  | an average of 3 months | 
| Microparticle/Nanoparticle size (in nanometers or micrometers) |  | an average of 3 months | 
| Microparticle/Nanoparticle identity (identity of cell type from which they are derived) |  | an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidities |  | 3 months | 
| Mortality |  | 3 months |
A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study

Study Overview
=================
Brief Summary
-----------------
Background: Conditions of reduced perfusion are characterized by redistribution of blood flow away from the skin to more vital organs. Study Objectives: To assess the efficacy of a non-invasive, dermal blood flow (DBF) monitor in detecting changes in perfusion in critically ill patients. Preliminary Study Study Population: critically ill patients in a general ICU

Detailed Description
-----------------
DBF, finger plethysmography and invasive mean arterial pressure (MAP) were recorded over an 8-hour period. DBF was measured using the I.S. MedTech DBF monitor, based on the hot-wire principle of thermal balance of a heater cooled by a moving medium, via a skin probe placed on the anterior chest wall. Sensitivity was evaluated by visual inspection during active states, either induced, e.g. fluid administration, or spontaneous, e.g. altered hemodynamics. Specificity was evaluated during stable states (minimal fluctuations of MAP and no active interventions applied or required). Data are expressed in terms of standard deviation (SD) and of the difference (SDD) between the MAP and each of the tested methods.

Official Title
-----------------
A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study

Conditions
-----------------
Positive-Pressure Respiration, Intrinsic, Critically Ill Patients

Intervention / Treatment
-----------------
* Other: Dermal blood flow measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients were ventilated and sedated during an 8-hour period of measurement Exclusion Criteria: Age < 18 years old

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group-Dermal blood flow measurements<br>Dermal blood flow was measured with the Dermal Blood Flow (DBF) monitor | Other: Dermal blood flow measurements<br>* Dermal blood flow was measured with the Dermal Blood Flow (DBF) monitor (I.S. MedTech, Israel), which consists of a skin probe and a measuring and control feedback unit.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermal blood flow measurements | DBF monitor - non-invasive method for detecting changes in perfusion in critically ill patients. | over an 8-hour period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dermal blood flow, critically ill
Retinal Imaging by Adaptive Optics in Healthy Eyes and During Retinal and General Diseases

Study Overview
=================
Brief Summary
-----------------
Using an adaptive optics imaging device, retinal structures are observed in healthy and diseased subjects.

Detailed Description
-----------------
Most cases of severe visual loss in developed countries are due to retinal diseases affecting a specialized class of neurons, the photoreceptors. Currently available systems for retinal imaging in humans do not allow neuronal imaging at the cellular level, which is crucial to understand, diagnose and monitor retinal diseases. In recent years, adaptive optics (AO) fundus imaging has proven its capability to image individual photoreceptor cells in the human retina. This technology is now reaching technical maturation. A prototypic AO system (manufactured by Imagine Eyes) is currently in operation in a clinical setting (Clinical Investigation Center 503) and has proven its reliability to monitor single photoreceptors over time. Yet, the clinical evaluation of AO imaging is still in its infancy, and biomarkers issued from AO imaging have not been validated. The goal of the iPhot project is thus to optimize the process of AO imaging (from the implementation of novel technical solution to image processing and data analysis) in order to obtain morphological, quantitative and longitudinal information concerning retinal microstructures in humans. For instance, we will aim at detecting early photoreceptor damage during retinal dystrophies.

Official Title
-----------------
Observational, Follow-up Study of Adaptive Optics Retinal Imaging in Controls and During Retinal or General Diseases

Conditions
-----------------
Retinal Dystrophies, Age-related Macular Degeneration, Arterial Hypertension, Diabetes, Traumatic Retinopathy, Toxic Retinopathies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 10 years old Exclusion Criteria: ocular media opacities, unstable fixation

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- |
| Controls<br>subjects older than 10 years old, with no know ocular or general disease | |
| Age-related macular degeneration<br> | |
| inherited retinal dystrophies<br> | |
| retinal trauma<br> | |
| toxic retinopathies<br> | |
| arterial hypertensive patients<br> | |
| diabetic patients<br> | |
| inflammatory diseases<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| photoreceptor density | the variations of the density of photoreceptors over time will be evaluated | 01/12/2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
photoreceptors, retinal pigment epithelium, adaptive optics
Generation of Dendritic Cell Precursors From Cord Blood Stem Cells

Study Overview
=================
Brief Summary
-----------------
There is a growing interest in generating dendritic cells (DCs) for using as vaccines. Several cytokines, especially stem cell factor (SCF) and FLT3-ligand (FL), have been identified as essential to produce large numbers of myeloid precursors and even to increase DC yield obtained by the action of granulocyte-macrophage colony-stimulating factor (GM-CSF) and tumor necrosis factor alpha (TNF-α). However, there are few studies on the effect of the early-acting cytokines, commonly used to expand CD34+ progenitor cells, on DC generation. We have established a serious of functional analysis of maturated or immaturated DCs including surface markers screening or cytokine production. Here, we design this two-year project to evaluate the possible methodology in the generation of CD14+CD1a- and CD14- CD1a+ myeloid DC precursors from CD34+ cells. In the first year of the project, we will set up the standard protocol to generate DC precursors from cord blood stem cells. In the first step, we will isolate CD34+ cells from cord blood and amplify these cells. Purity of the CD34+ cell populations obtained will be greater than 90%. In the next step, these primary cultures of CD34+ cells will treat with early-acting cytokines such as GM-CSF and IL-4 to further induction into dendritic cells. Functional analysis of dendritic cells would be performed in this stage. In the second year of the project, we will further evaluate the induction of DCs by CD34+ stem cells could be affected by combination of mesenchymal stromal cells. These results of this research with CD34+-based DCs induction provide the basis for materials to develop the DC-based vaccine against viral and fungal infections, and might be a powerful tool in anti-tumor immunotherapy.

Official Title
-----------------
Generation of Dendritic Cell Precursors From Cord Blood Stem Cells

Conditions
-----------------
Normal Full-Term Deliveries

Intervention / Treatment
-----------------
* Procedure: Normal full-term deliveries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal full-term deliveries Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Normal full-term deliveries|Normal full-term deliveries by standard procedures according to institutional guidelines|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| None, we isolate stem cells from cord blood. |  | from CS operation to close |
Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children

Study Overview
=================
Brief Summary
-----------------
To assess the analgetic effect of nitrousoxide-oxygen inhalation on pain perception in 12-15 years old children from 1) the dental pulp; 2) the masseter muscle; 3) the skin on the upper lip

Detailed Description
-----------------
The present study is a randomized, cross-over blinded study on the analgetic effect of nitrousoxide-oxygen on sensitivity of the dental pulp, the skin and muscles. It is conducted in healthy 12-15 year old Danish children attending public schools in the municipality of Aarhus, Denmark

Official Title
-----------------
Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children

Conditions
-----------------
Dental Pain, Muscle Sensitivity to Pressure, Skin Sensitivity to Electric Stimulation

Intervention / Treatment
-----------------
* Drug: Nitrousoxide-oxygen and atmospheric air
* Drug: Atmospheric air; nitrousoxide-oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA-groups I or II 12-15 year of age sound upper central incisors Exclusion Criteria: difficulties breathing through the nose pregnancy trauma to test teeth

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Inhalation of nitrousoxide-oxygen during the first experimental session; inhalation of atmospheric air during the second session | Drug: Nitrousoxide-oxygen and atmospheric air<br>* Nitrousoxide-oxygen and atmospheric air<br>* Other names: Nitrousoxide-oxygen first;|
| Experimental: Arm 2<br>Inhalation of atmospheric air during the first experimental session; inhalation of nitrousoxide-oxygen during the second session | Drug: Atmospheric air; nitrousoxide-oxygen<br>* Atmospheric air; nitrousoxide-oxygen<br>* Other names: Atmospheric air first;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental pain (pulp) threshold |  | During and after inhalation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle sensitivity to pressure |  | During and after inhalation | 
| Skin sensitivity ot electric stimulation |  | During and after inhalation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children, analgesia, dental treatment, inhalation
A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: SK-PC-B70M


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of probable Alzheimer's disease(DSM-IV and NINCDS-ADRDA criteria) MRI within the last 12 months consistent with a diagnosis of AD MMSE score of 10 to 26 and CDR of 1 or 2 AChEI or memantine was not taken at least 3 months prior to screening Exclusion Criteria: Other central nervous disease Hypothyroidism, Vitamin B12/ Folic acid deficiency, Hypercalcemia, Neurosyphilis, AIDS T.I.A or Major infarction within the last 12 months Any serious disorder that could limit the ability of the patient to participate in the study COPD or asthma Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: SK-PC-B70M<br>* for dosage<br>|
| Experimental: SK-PC-B70M 200mg bid<br> | Drug: SK-PC-B70M<br>* for dosage<br>|
| Experimental: SK-PC-B70M 300mg bid<br> | Drug: SK-PC-B70M<br>* for dosage<br>|
| Other: Donepezil<br> | Drug: SK-PC-B70M<br>* for dosage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CIBIC-Plus (Clinician's Interview-Based Impression of Change-Plus caregiver input) |  | 45 minutes | 
| MMSE (Mini Mental State Examination) |  | 10 minutes | 
| CDR-SB (Clinical Dementia Rating Sum of Box) |  | 20 minutes |
Initial Experience With the AngioVac Venous Drainage Cannula

Study Overview
=================
Brief Summary
-----------------
This is a retrospective, record-based study of approximately 100 patients across up to 12 centers within the United States. All patients who have been treated with the AngioVac Venous Drainage Cannula and the Extracorporeal Circuit will be considered for study participation. Eligible subject must meet all of the inclusion criteria and none of the exclusion criteria to be considered enrolled in the study. The purpose of the study is to describe initial experience with the AngioVac Venous Drainage Cannula and the Extracorporeal Circuit.

Official Title
-----------------
Initial Experience With the AngioVac Venous Drainage Cannula and Cardiopulmonary Bypass Circuit: A Retrospective, Multi-Center Chart Review

Conditions
-----------------
Heart Disease

Intervention / Treatment
-----------------
* Device: AngioVac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients treated at each study site between February 1, 2013 and February 28, 2015 will be included. Exclusion Criteria: Patients treated with the AngioVac venous drainage system outside of those dates.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AngioVac|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detailing early clinical experience with the AngioVac Venous Drainage Cannula |  | Experience and success is determined immediately after the procedure is completed. No subject follow up data is collected and retrospective data will be reviewed. |