linjc16/ctgov huggingface dataset:
Study of Memantine in Assessment of Selected Measures of Volumetric Magnetic Resonance Imaging (MRI) and Cognition in Moderate AD (Alzheimer's Disease)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the progression of disease using volumetric MRI techniques and cognitive outcome measures in patients with moderate dementia of the Alzheimer's type treated with open-label memantine.

Official Title
-----------------
An Open-Label Exploratory Study With Memantine: Assessment of Selected Measures of Volumetric MRI and Cognition in Patients With Moderate Dementia of the Alzheimer's Type

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory male or female patients at least 50 years of age (females at least 2 years postmenopausal) A diagnosis of probable AD [according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA) criteria] of moderate severity [Mini-Mental State Examination score between 15 and 20, inclusive] On a stable dose of Food and Drug Administration (FDA)-approved acetylcholinesterase inhibitor Exclusion Criteria: Current Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) Axis I disorder other than AD Previous imaging results not consistent with the diagnosis of AD Modified Hachinski Ischemia Score greater than 4 Evidence of other neurologic disorders Inability to participate in MRI testing No clinically significant systemic disease A known or suspected history of alcohol or drug abuse in the past 10 years Taking excluded medication Previous treatment with commercial memantine

Ages Eligible for Study
-----------------
Minimum Age: 50 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

| Intervention/Treatment |
| --- |
|Drug: memantine HCl|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 
| Total brain atrophy on MRI |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other measures of brain atrophy on MRI, change from baseline in selected cognitive measures assessing multiple cognitive domains including memory, attention, motor-speed, auditory comprehension, and verbal fluency |  |  | 
| Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, memantine, Alzheimer's disease, moderate Alzheimer's disease
Focus Thoracic Ultrasound for Dyspnea Diagnosis in Elderly Patient in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
Brief Summary: The aim of this study is to analyze in elderly patients with undifferentiated dyspnea, the concordance of diagnosis before and after a focus thoracic ultrasound in comparison with the reference one established by an adjudication committee

Detailed Description
-----------------
Dyspnea is associated with a variety of etiology whose diagnosis is challenging especially in elderly patients with unconventional symptoms. Focus thoracic ultrasound is composed by an advanced cardiac ultrasound with Doppler measures and a lung ultrasound. It has already demonstrated its ability to reduce diagnosis uncertainty in emergency patients with dyspnea. However, adequacy of diagnosis before and after thoracic ultrasound has not been investigated in such patients. In this population, after clinical examination and use of any resource deemed necessary, the physician states its hypothesis in closed list. An emergency physician then realizes a thoracic ultrasound exam. An adjudication committee with all the patient's file will state the reference hypothesis.

Official Title
-----------------
Focus Thoracic Ultrasound for Dyspnea Diagnosis in Elderly Patient in the ED: Prospective Observational Study

Conditions
-----------------
Dyspnea

Intervention / Treatment
-----------------
* Other: Focus thoracic ultrasound for dyspnea diagnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute onset dyspnea in patient over 74 years old consulting at the emergency department Exclusion Criteria: Need for ICU Need for a mechanical ventilation Less than 24 hours hospital stay Inability to consent

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Focus thoracic ultrasound for dyspnea diagnosis|Focus thoracic ultrasound is composed by an advanced cardiac ultrasound with Doppler measures and a lung ultrasound.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| main objective | Concordance between initial diagnosis after standard care, after thoracic ultrasound in comparison with the reference stated by the adjudication committee | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency | Frequency of each diagnosis in elderly patients consulting in the emergency department | 3 years | 
| mortality | Assessing hospital mortality in elderly patients consulting at the emergency department | 3 years |
Bedside Respiratory Patient Monitoring System - Sensor Off Study

Study Overview
=================
Brief Summary
-----------------
Use of an investigational oximetry system to evaluate the triggering of the sensor off status with the marketed off-the-shelf sensors.

Detailed Description
-----------------
The Multi-functional Patient Monitoring PCBA is an electronic circuit board in the monitoring system that performs calculations. The study will evaluate the performance of the Sensor Off New Patient Monitoring system by exposing the sensor to an ambient light source, sensor slipping off the finger with the light emitter and detector facing each other or a sensor slipping off under a blanket.

Official Title
-----------------
Sensor Off Studies Using a Nellcor Bedside Respiratory Patient Monitoring System, Configured With the Multi-functional Respiratory PCBA

Conditions
-----------------
Healthy Volunteers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects 18 years or older (inclusive) Subject is able to participate for the duration of the study Subject is willing to sign an informed consent Exclusion Criteria: Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors. Physiologic abnormalities that prevent proper application of pulse oximetry sensor. Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To validate that the device posts a Sensor Off message within one minute after the sensor is removed at least ninety percent of the time. |  | The planned duration of the study is 1 month. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient safety monitors
A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Intelence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety data of etravirine in a natural clinical practice.

Detailed Description
-----------------
This is a non-interventional (a scientific study to make a clear and easy understanding of the cause and effect relationship), prospective (in which the participants are first identified and then followed forward as time passes), consecutive survey for collecting safety and efficacy data of etravirine in treatment of Acquired Immune Deficiency Syndrome (AIDS) in a natural clinical practice.

Official Title
-----------------
Regulatory Post Marketing Surveillance of Intelence Tablet

Conditions
-----------------
Acquired Immune Deficiency Syndrome

Intervention / Treatment
-----------------
* Drug: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are prescribed with etravirine for treatment of Acquired Immune Deficiency Syndrome (AIDS) Exclusion Criteria: Known hypersensitivity to Intelence Intelence coadministered with medicinal products that are highly dependent on CYP3A and CYP2C9 for clearance Patients with galactose intoralance, Lapp lactase deficiency, and glucose-galactose malabsorption

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 |
| --- | --- |
| Etravirine<br>Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking etravirine as per recommended doses. | Drug: No intervention<br>* This is an observational study. Etravirine 200 mg will be adminstered twice daily in patients with Acquired Immune Deficiency Syndrome (AIDS).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | Up to 30 days from end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with viral load |  | Screening, Week 12, Week 24 | 
| Number of patients with CD4 T-cell count |  | Screening, Week 12, Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acquired Immune Deficiency Syndrome, TMC125, Etravirine, Intelence, AIDS
Study of Culturelle in the Prophylaxis of Infection and Diarrhea

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine if probiotic prophylaxis has immunologic and gastrointestinal advantages in pediatric burn patients.

Official Title
-----------------
A Blinded Placebo Controlled Clinical Outcomes Study of Culturelle® in the Prophylaxis of Infection and Diarrhea

Conditions
-----------------
Pediatric Burns

Intervention / Treatment
-----------------
* Dietary Supplement: Culturelle
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute burn injury consented within 10 days of injury feeding tube present- Exclusion Criteria: GI disorder prior to burn milk allergy or insensitivity non-burned

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culturelle<br> | Dietary Supplement: Culturelle<br>* one capsule 2x per day per feeding tube<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* one placebo 2x per day per feeding tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious outcome | Record incidence of infection between the experimental and placebo groups. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome | Plan to measure clinical outcome between the experimental and placebo groups. | 3 years |
A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of VX-548 in treating acute pain.

Official Title
-----------------
A Phase 3, Single-arm Study Evaluating the Safety and Effectiveness of VX-548 for Acute Pain

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: VX-548


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than (<) 40.0 kilogram per meter square (kg/m^2) Non-surgical participants with pain of new origin (not related to a prior known condition) that is moderate or severe on the verbal categorical rating scale (VRS) and ≥4 on the numeric pain rating scale (NPRS) Surgical participants reporting pain at the surgical site that is moderate or severe on the VRS and ≥4 on the NPRS Key Exclusion Criteria: Surgical participants: History of previous surgery due to the same condition, except for procedures for which a previous surgery on the contra-lateral limb or organ is allowed History of a prior surgical procedure in the same region of the body that resulted in any perioperative complications or that, in the opinion of the investigator or medical monitor, would preclude participation in the study History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant Other protocol defined Inclusion/Exclusion criteria may apply.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VX-548<br>Participants will receive VX-548 every 12 hours (q12h) up to 14 days. | Drug: VX-548<br>* Tablets for oral administration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Day 1 up to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Reporting Good, Very Good, or Excellent on a Patient Global Assessment (PGA) |  | Day 2 up to Day 14 |
A Controlled-Study of Fenofibrate 145 mg and Ezetimibe 10 mg in Type IIb Dyslipidemic Patients With Features of the Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
Type IIb dyslipidemia is characterized by elevated triglycerides (TG ³ 150 mg/dL), and elevated LDL-C levels (³160 mg/dL). When in addition, HDL-C is low, the presence of the lipid triad, elevated TG and LDL-C and low levels of HDL-C, seems to confer additional CHD risk in this type of patient, compared to elevated LDL-C alone.Coadministration of fenofibrate and ezetimibe could provide a complementary efficacy therapy and improve the atherogenic profile of this patient population.

Official Title
-----------------
A Randomised, Double-Blind Study Comparing the Efficacy and Safety of 145 mg Fenofibrate, 10 mg Ezetimibe and Their Combination in Patients With Type IIb Dyslipidemia and Features of the Metabolic Syndrome

Conditions
-----------------
Hyperlipidemia Combined

Intervention / Treatment
-----------------
* Drug: Combination of 145 mg fenofibrate and 10 mg ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type IIb dyslipidemia. Exclusion Criteria: Known hypersensitivity to fibrates or ezetimibe. Pregnant or lactating women. Contra-indication to fenofibrate or ezetimibe.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Combination of 145 mg fenofibrate and 10 mg ezetimibe|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TG and HDL-C levels. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperlipidemia Combined and features of the metabolic syndrome, efficacy combination fenofibrate ezetimibe
Neovascular Age Related Macular Degeneration (AMD), Periocular Corticosteroids, and Photodynamic Therapy (PDT)

Study Overview
=================
Brief Summary
-----------------
Randomized controlled clinical trial of periocular corticosteroids as adjunctive therapy to photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration (AMD). Patients undergoing PDT are randomized to either a periocular corticosteroid injection with 40 mg of triamcinolone acetonide or observation just prior to PDT. Patients are followed for 6 months. Primary outcome is leakage from choroidal neovascularization (CNV) at 3 months on fluorescein angiography.

Official Title
-----------------
Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy

Conditions
-----------------
Choroidal Neovascularization, Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Periocular injection of triamcinolone acetonide 40mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active choroidal neovascularization Age related macular degeneration Visual acuity 20/20 to 20/400 Exclusion Criteria: Neovascular lesion >6500 microns is greatest linear diameter More than one prior photodynamic therapy treatment Receiving systemic corticosteroids Intraocular pressure > 21 mm Hg or glaucoma medication use History of glaucoma or history of ocular hypertension

Ages Eligible for Study
-----------------
Minimum Age: 50 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Periocular injection of triamcinolone acetonide 40mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corticosteroids, Triamcinolone, Photodynamic therapy, Choroidal neovascularization, Age-related macular degeneration
A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine the effectiveness of 2 target doses of R228060 in comparison with placebo during 6 weeks of treatment in moderately to severely depressed adult subjects with major depressive disorder. Approximately 488 subjects will be involved in the study.

Official Title
-----------------
A 6- Week, Randomized, Double-Blind, Parallel-Group, Active-and Placebo-Controlled Trial to Assess the Efficacy of R228060 in Adult Subjects With Major Depressive Disorder (MDD)

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

Intervention / Treatment
-----------------
* Drug: R228060
* Drug: Placebo and Paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Generally healthy adults on the basis of a physical examination, medical history, ECG and laboratory work-up. Subject needs to meet criteria for diagnosis of moderate or severe major depression as defined by the protocol. The subject also needs to be an outpatient to participate in this study.

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: R228060|nan|
|Drug: Placebo and Paroxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |