linjc16/ctgov huggingface dataset:
Memantine - Communication Study

Study Overview
=================
Brief Summary
-----------------
The study objective is to evaluate the effects of memantine treatment on communication abilities and other cognitive abilities in moderate to severe DAT patients.

Official Title
-----------------
Prospective, Single-arm, Multicenter, Open-label Study to Investigate the Efficacy and Tolerability of the Once Daily (OD) Memantine Treatment

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

Intervention / Treatment
-----------------
* Drug: Memantine-HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatient at least 50 years of age and at least 8 years of education. The patient should have German as a mother-tongue or at least speak the language fluently in order to achieve similar scores in verbal tasks. Current diagnosis of probable Alzheimer's disease consistent with NINCDS- ADRDA criteria or with DSM IV TR criteria for Dementia of the Alzheimer's type. Mini Mental State Examination (MMSE) total score is less than 20 Patients treated with any acetylcholinesterase inhibitor (AChEI) may be included, when treatment has started at least 6 months prior screening and was stable during the last 3 months. Exclusion Criteria: Any type of evident aphasia, which may interfere with patient's communication difficulties caused by Alzheimer's disease History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to amantadine, lactose. Evidence (including CT/MRI results) of any clinically significant central nervous system disease other than Alzheimer's disease. Modified Hachinski Ischemia score greater than 4 at screening. Current evidence of clinically significant systemic disease Known or suspected history of alcoholism or drug abuse within the past 10 years. Previous treatment with memantine or participation in an investigational study with memantine.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Memantine-HCl<br>* 20 mg per day (once daily)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of the memantine OD IR treatment using the Consortium to establish a registry for Alzheimer's Disease (CERAD-NP) total score |  | 4 months |
Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the long-term safety of treating recurrent episodes of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or tinea cruris for 7 days for each recurrence with Product 33525.

Official Title
-----------------
An Open-Label Study to Evaluate the Safety of Long-Term Administration of Product 33525 in Subjects With Tinea Pedis, Tinea Corporis, or Tinea Cruris

Conditions
-----------------
Tinea Pedis, Tinea Cruris, Tinea Corporis

Intervention / Treatment
-----------------
* Drug: Product 33525


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of tinea cruris, tinea pedis, or tinea corporis. Additional criteria listed in protocol Exclusion Criteria: Pregnancy and allergies. Additional criteria listed in protocol

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safety Population<br> | Drug: Product 33525<br>* Daily dosing for 2 weeks each recurrence for patients with tinea pedis and Daily dosing for 1 week each recurrence for patients with tinea cruris and tinea corporis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects with Adverse Events | To examine the long-term safety of treating tinea pedis, tinea corporis or tinea cruris, treatment-emergent adverse events occurring during the study will be recorded. Adverse events will be summarized by the number of subjects reporting events, system organ class, preferred term, severity, relationship to study drug, and seriousness. Baseline and end of study laboratory assessments will be conducted. | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure and Mycological Cure | Proportion of patients achieving effective treatment | 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment |
Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the specific humoral response after an intramuscular and intradermal influenza vaccination in lung transplant recipients

Detailed Description
-----------------
Influenza virus is an important cause of morbidity in the lung transplant population and can lead to viral and bacterial pneumonia and contribute to the bronchiolitis obliterans syndrome. Although the annual influenza vaccine is recommended for lung transplant patients, studies have shown that a single intramuscular (i.m.) dose has poor immunogenicity. There are no studies that define the effect of intradermal doses in this population. We plan to study the immunogenicity of a two-dose regimen of influenza vaccine in 50 lung transplant patients during the 2006-2007 season. After the initial i.m. injection, a second dose will be given intradermally 4 weeks later. Antibody titers will be evaluated by a standard hemagglutination inhibition assay. We hypothesize that the second dose intradermally will significantly increase the proportion of vaccine responders.

Official Title
-----------------
Improving the Humoral Response to Influenza Vaccine in Lung Transplant Recipients by an Intradermal Strategy

Conditions
-----------------
Lung Transplantation, Influenza Vaccines

Intervention / Treatment
-----------------
* Biological: Trivalent Inactivated Influenza Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung transplant recipients greater than 3 months post-transplant Exclusion Criteria: · Egg allergy Previous life-threatening reaction to influenza vaccine (ie Guillain Barre Syndrome) On anticoagulants such as warfarin that precludes intramuscular injection Ongoing therapy for rejection Febrile illness in the past two weeks Unable to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Trivalent Inactivated Influenza Vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIA titers 4 weeks after influenza vaccination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local and systemic adverse events to vaccination and rates |  |  | 
| of allograft rejection in the 6 months following vaccination |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza vaccine, Intradermal, Lung transplantation
Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms

Study Overview
=================
Brief Summary
-----------------
The objective of this study will be to evaluate the ability of IEGMs (Signal recorded from implanted pacing leads) and pseudo ECGs (derived from various IEGMs) to characterize various electrical conduction patterns. Electroanatomic mapping data and 12 Lead ECG will also be collected to characterize electrical conduction patterns during standard electrophysiology exam.

Official Title
-----------------
Enhanced Diagnosis of Ventricular Activation Pattern Using Intracardiac Electrograms

Conditions
-----------------
Arrythmia

Intervention / Treatment
-----------------
* Procedure: LV pacing site


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with SJM CRM device implanted for more than 90 days Exclusion Criteria: Suspicion of lead dislodgment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LV Paced sites<br>LV pacing sites : Patients will be paced from various left ventricular origin, defined by their 3D localization. | Procedure: LV pacing site<br>* Patient will be paced in VVI mode from Left ventricle specific position for a short period of time per position in order to cover spontaneous ventricular activity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of ventricular activation patterns determined by 12-lead ECG and device IEGMs-based method | Correlation coefficient between ventricular activation patterns determined by a traditional technique, 12-lead ECG based vs. device based IEGMs method. | Acute, intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular activation origin location determined by IEGMs based method vs. by detailed mapping | Use of available IEGMs recorded on implanted device to discriminate specific VT origin and pattern and compare the results to the detailed mapping data | Acute, intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ablation
Mortality in Free-fall Trauma Patients

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators aimed to analyze the demographic characteristics, patterns of injury, and mortality after free fall in the emergency department of the National Taiwan University Hospital, and the affiliations, Hsin-Chu branch, and Yun-lin branch.

Detailed Description
-----------------
Falls from a height are the leading cause of accidental deaths. The mechanism of free-fall injury is abrupt vertical deceleration and the severity is dependent on the height, body weight, posture and contact area…etc. Most victims presented to the emergency department with major trauma, so initial evaluation and management are crucial for survival. The knowledge of the unique pattern of injuries helps clinicians to facilitate the diagnosis.

Official Title
-----------------
Patterns of Injury and Mortality in Free-fall Trauma Patients: a Multi-center Study

Conditions
-----------------
Free Fall Trauma

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged more than 20 years after free falls in the emergency department of the National Taiwan University Hospital, and the affiliations, Hsin-Chu branch, and Yun-lin branch. Exclusion Criteria: patients aged less than 20 years after free fall in the emergency department of the National Taiwan University Hospital, and the affiliations, Hsin-Chu branch, and Yun-lin branch.

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

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality after free falls | death rate | 60 days |
Value of Ultrasonographic Enthesitis Assessment in Spondyloarthritis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine how valuable ultrasonographic enthesitis to asssess disease activity, functionality and quality of life.

Conditions
-----------------
Spondyloarthritis, Enthesitis

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spondyloarthritis patients that fulfill 2009 ASAS criteria Exclusion Criteria: history of elbow, ankle or knee surgery, local injection at the examination sites within the six weeks, peripheral neuropathy, infection and wound at examination site

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spondyloarthritis<br> | Diagnostic Test: Ultrasonography<br>* Enthesitis assessment via ultrasonography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease activity, | BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), minimum value 0, maximum value 10, higher scores mean a worse outcome | between November 2016 and January 2017 | 
| Disease activity, | Ankylosing Spondylitis Disease Activity Score (ASDAS). It is calculated by adding CRP (ASDAS-CRP) or ESR (ASDAS-ESR). there is no spesific minimal and maximum value because it depends on CRP or ESR value. Higher scores mean a worse outcome | between November 2016 and January 2017 | 
| functionality | Bath Ankylosing Spondylitis Functionality Index (BASFI). Minimal values 0, maximum value 100. Higher scores mean a worse outcome | between November 2016 and January 2017 | 
| to measure quality of life | Short Form - 12 (SF-12). minimum value 0 maximum value 100. higher scores mean a worse outcome | between November 2016 and January 2017 | 
| to measure quality of life | Ankylosing Spondylitis Quality of Life (ASQoL). minimum value 0 maximum value 18. Higher scores mean a worse outcome | between November 2016 and January 2017 |
Comparison of Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
To compare the effect of two different protocol of fluid therapy in sever preeclamptic patients under spinal anesthesia : Hemodynamic and kidney function .

Official Title
-----------------
Comparison of Two Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia : Hemodynamic and Kidney Function Outcome

Conditions
-----------------
Hypotension Drug-Induced

Intervention / Treatment
-----------------
* Drug: Lactated Ringer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 36 weeks gestation singleton pregnant women planned for elective caesarian section Exclusion Criteria: patient refusal. psychiatric disorders. parturient <36 weeks gestation, twins, abnormal cardiotocography (CTG) tracing. absolute contraindications for spinal anesthesia (patients refusal, raised intracranial pressure, hypovolemic states, abnormal coagulopathy).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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: Group R<br>30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative. | Drug: Lactated Ringer<br>* Patients will be divided into 2 groups according to the amount of fluids received during caesarian section under spinal anesthesia. Group (R) 30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative. Group (L) 30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative. blood loss will be replaced if more than 500 ml in ratio 3 ml crystalloid : 1ml blood in both groups<br>|
| Active Comparator: Group L<br>30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative. | Drug: Lactated Ringer<br>* Patients will be divided into 2 groups according to the amount of fluids received during caesarian section under spinal anesthesia. Group (R) 30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative. Group (L) 30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative. blood loss will be replaced if more than 500 ml in ratio 3 ml crystalloid : 1ml blood in both groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hypotension | decrease in systolic blood pressure more than 20% of base line | 1 hour |
Is There a Relationship Between Serum Sodium Level and Mean Platelet Volume (MPV) Value

Study Overview
=================
Brief Summary
-----------------
Is there a relationship between serum sodium level and mean platelet volume (MPV) value in patients undergoing transurethral prostate resection (TUR)?

Detailed Description
-----------------
Thirty one patients undergoing transurethral prostate resection (TUR)? will be evaluated.The relationship between serum sodium value and MPV value of patients will be evaluated.

Official Title
-----------------
Is There a Relationship Between Serum Sodium Level and Mean Platelet Volume (MPV) Value in Patients Undergoing Transurethral Prostate Resection (TUR)?

Conditions
-----------------
Mean Platelet Volume According to Serum Sodium Value, on Patients Who Will Have Transurethral Resection of the Prostate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist (ASA) physical status 1 and 3 Patients between the ages of 18 and 80 Exclusion Criteria: Patients with bleeding disorder Patients with blood transfusion Patients are that sodium values are lower than normal range.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
| Mean platelet volume | Changes in mean platelet volüme according to sodium value(Measurements of changes will be made twice in the study framework) | one month |
A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether an intensive, eight session behavioral intervention is superior to standard care in achieving abstinence from cigarettes in smokers living with HIV/AIDS.

Official Title
-----------------
A Trial to Test the Efficacy of a Tailored Intensive Smoking Cessation Intervention in Persons With HIV (PWHs)

Conditions
-----------------
Smoking, HIV Infections, AIDS

Intervention / Treatment
-----------------
* Behavioral: Positively Smoke Free
* Behavioral: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infection current cigarette smoker high motivation to quit Exclusion Criteria: Pregnancy breastfeeding

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive behavioral intervention<br>Eight session, behavioral intervention targeting HIV-infected smokers | Behavioral: Positively Smoke Free<br>* An eight session, group therapy intervention targeting smokers living with HIV/AIDS<br>|
| Active Comparator: Standard care<br>Advice to quit, smoking cessation brochure, offer of nicotine patch | Behavioral: Standard care<br>* Advice to quit, smoking cessation brochure, and offer of nicotine patches<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three month point-prevalence abstinence from cigarettes |  | 3 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three month continuous abstinence from cigarettes |  | Three months post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, AIDS, Smoking, Tobacco, Cessation, Tobacco use in persons living with HIV/AIDS