linjc16/ctgov huggingface dataset:
Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This was a randomized, double-blind, placebo-controlled, ascending single dose safety, tolerability, and pharmacokinetic study of orally administered EDP-322. This study was conducted at a single site. EDP-322 has a benefit to risk profile that supports testing in target patient populations.

Official Title
-----------------
A Randomized, Double-blind, Placebo-Controlled, Ascending Single-Dose Safety, Tolerability, and Pharmacokinetics Study of EDP-322 in Healthy Adult Volunteers

Conditions
-----------------
Skin and Soft Tissue Infections, Methicillin-resistant Staphylococcus Aureus

Intervention / Treatment
-----------------
* Drug: EDP-322


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males or females [if documentation existed that they were surgically sterilized]. Were in good general health as determined by medical history, physical exam and clinical laboratory tests, and without evidence of clinically significant abnormality, in the opinion of the Investigator and Medical Monitor. The resting 12-lead ECG obtained at Screening shows no clinically significant abnormality and a QTc (Bazett's correction) <450 msec. Weight less than 132 pounds (60kg) with BMI between 18-32 kg/m3, inclusive. Subject has read, understood, and signed the written informed consent form. Exclusion Criteria: History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances. History of gastric surgery, vagotomy, bowel resection, or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption. Any abnormal or screening clinical lab test results... Medication Related exclusions... Lifestyle related...

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: EDP-322|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The study objectives included determining the safety, tolerability and pharmacokinetics of single oral doses of EDP-322 in healthy adult volunteers |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macrolides, Antibiotics, Safety, Tolerability, Pharmacokinetics, Phase I, MRSA/SSTI
Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment in Schizophrenia Patients

Study Overview
=================
Brief Summary
-----------------
Standard antipsychotic drug regimens do not fully address the impact of cognitive symptoms associated with schizophrenia. The NMDA receptor has been connected to the pathophysiology of schizophrenia. Memantine is an uncompetitive NMDA receptor antagonist. It is hypothesized that adjunctive therapy with memantine will reduce NMDA receptor hyperactivity, improving signal to noise ratio and thereby improving cognitive symptoms.

Official Title
-----------------
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment to Atypical Antipsychotics in Schizophrenia Patients With Persistent Residual Symptoms

Conditions
-----------------
Schizophrenia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV diagnosed Schizophrenia or schizoaffective disorder who are on a stable antipsychotic regimen with Brief Psychiatric Rating Scale (BPRS) total score greater than or equal to 26 and greater than or equal to 4 on at least one item Exclusion Criteria: Secondary diagnosis of Bipolar I disorder Suicidal history Organic brain disease Dementia History of substance abuse

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: memantine HCl|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Symptom Scale (PANSS) - Total Score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression - Severity (CGI-S) |  |  | 
| PANNS - Positive Score |  |  | 
| PANSS - Negative Score |  |  | 
| Calgary Depression Scale for Schizophrenia |  |  | 
| Brief Assessment of Cognition |  |  | 
| Clinical Global Impression - Improvement |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
memantine, adjunctive therapy, schizophrenia
Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease

Study Overview
=================
Brief Summary
-----------------
This is a phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with intermittent claudication (IC) will be randomized to receive a single treatment of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline) administered as 21 intramuscular (IM) injections of 2 mL each, bilaterally into the lower extremities during one procedure to evaluate the safety, tolerability, and potential activity of VLTS-934 as compared with a saline placebo.

Detailed Description
-----------------
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with IC will be randomized to receive a single treatment of VLTS-934 (84 mL, or a total of 420 mg poloxamer 188) or placebo (84 mL saline) administered as 21 intramuscular (IM) injections of 2 mL each, bilaterally into the lower extremities during one procedure to evaluate the safety, tolerability, and potential activity of VLTS-934 as compared with a saline placebo.

Official Title
-----------------
A Phase II, Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of VLTS-934 in Subjects With Intermittent Claudication Secondary to Peripheral Arterial Disease

Conditions
-----------------
Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Drug: VLTS-934


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of peripheral arterial disease in both legs History of exercise limiting symptoms Exclusion Criteria: Lower limb revascularization surgery with 2 months of study entry Diagnosis of critical limb ischemia

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 78 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VLTS-934|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the change in peak walking time (PWT) with VLTS-934 from baseline to Day 90 compared to subjects receiving saline placebo |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate changes in total work capacity, ankle-brachial index (ABI), claudication onset time and quality of life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral arterial disease
Study of Integrity of Down Inhibitor Bundle at Patients Suffering of Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
Several studies showed that activity of down inhibitor bundle is weakened in different painful pathologies as the fibromyalgy or the trigeminal nevralgy. The purpose of the protocol is to study the working of down inhibitor bundle at patients suffering of neuropathic pain.

Detailed Description
-----------------
Prospective study with comparison groups

Official Title
-----------------
Study of Integrity of Down Inhibitor Bundle at Patients Suffering of Neuropathic Pain

Conditions
-----------------
Healthy Volunteers, Patients Suffering of Peripheral Neuropathic Pain

Intervention / Treatment
-----------------
* Other: Neuropathic pain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neuropathic patients group Patient suffering of peripheral neuropathic pain 18 years old women or men at least Exclusion Criteria: • Healthy volunteers 18 years old women or men at least

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Neuropathic pain|to study the working of down inhibitor bundle at patients suffering of neuropathic pain|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the amplitude of N2P2 waves between healthy volunteers and patients suffering of peripheral neuropathic pain. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuropathic pain
Effects of Cycling Dual-task in Parkinson's Disease.

Study Overview
=================
Brief Summary
-----------------
Taking into account the process of functional and cognitive evolution that patients with Parkinson's disease experience throughout the evolution of the pathology, the objective of this study is to evaluate the effect of a dual-task program combining cognitive tasks and forced cycling on the functional and cognitive capacity of these patients.

Official Title
-----------------
Effects of a Forced Cycling Program With Cognitive Stimulation on Symptomatology, Physical Condition, and Cognition in People Diagnosed With Parkinson's Disease.

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: Cycling exercise
* Other: Cognitive tasks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson disease Hoehn and Yahr 1 and 2 Exclusion Criteria: Hoehn and Yahr >2
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cycling combined with cognitive tasks<br> | Other: Cycling exercise<br>* 30 minutes of cycling (90 rpm).<br>Other: Cognitive tasks<br>* 30 minutes of cognitive tasks based on the different domains of the Mini Mental Scale.<br>|
| Active Comparator: Cycling<br> | Other: Cycling exercise<br>* 30 minutes of cycling (90 rpm).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go | Dynamic balance | Change from Baseline Timed Up and Go at 12 weeks | 
| Sit to Stand test | Lower limbs strength | Change from Baseline Sit to Stand Test at 12 weeks | 
| Movement Disorder Society - Unified Parkinson's Disease Rating Scale | Parkinson's Disease rating | Change from Baseline Unified Parkinson's Disease Rating Scale at 12 weeks (0-159, better lower values) | 
| Parkinson's Disease Questionnaire - 39 | Quality of life | Change from Baseline Parkinson's Disease Questionnaire - 39 at 12 weeks (0-100, better lower values) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trail Making Test A & B | Attention, visual screening ability and processing speed | Change from Baseline Trail Making Test A & B at 12 weeks | 
| Stroop test | Ability to inhibit cognitive interference | Change from Baseline Stroop Test at 12 weeks |
Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if vaccination rate of eligible patients at a major urban public hospital will increase by having ophthalmologists screen patients for eligibility and a nurse administer the vaccine in the General Eye Clinic.

Detailed Description
-----------------
Patient vaccination behaviors will be assessed after 100 doses of the Zostavax vaccine are provided to underserved patients screened by ophthalmologists at the General Eye Clinic at a public hospital that does not normally provide the vaccine. A nurse will be at the clinic to administer the vaccine. Patients will be contacted by phone 1 month later and seen within 3 months in the Eye Clinic to determine whether there were any side effects.

Official Title
-----------------
Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital

Conditions
-----------------
Herpes Zoster

Intervention / Treatment
-----------------
* Other: Choosing to receive the vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 60 years of age or older Absence of evidence of immune compromise in the medical record Ability to speak and read English, Spanish or Chinese and give informed consent Exclusion Criteria: Vulnerable patients, including the cognitively impaired, prisoners and employee FDA contraindications for Zostavax vaccine

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Subjects who received the vaccine<br>Patients in this arm were eligible for the herpes zoster vaccine and chose to receive it. | Other: Choosing to receive the vaccine<br> <br> |
| No Intervention: Subjects who declined the vaccine<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Answers to Survey Questions | All enrolled patients completed a survey of baseline characteristics, eligibility for the herpes zoster vaccine, and attitudes regarding herpes zoster vaccination. The survey results from patients who agreed to receive the herpes zoster vaccine were compared to the results of patients who declined to be vaccinated. | January 9, 2012 to February 12, 2012 |
Influence of Respiratory Muscle Training in Elderly Hypertensive Women With Respiratory Muscle Weakness

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate pulmonary function and respiratory muscle strength in a group of elderly women with hypertension before and after a respiratory muscle training.

Detailed Description
-----------------
It is a respiratory muscle training using the Threshold for 5 weeks, with a load of 30% of maximal inspiratory pressure obtained in manometer for 30 minutes daily. Furthermore, the assessment includes: test 6-minute walk, the quality of life questionnaire, MINICHAL, the IPAQ short version, manometer and spirometry.

Official Title
-----------------
Influence of Respiratory Muscle Training in Elderly Hypertensive Women With Respiratory Muscle Weakness

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: Threshold


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of hypertension controlled by antihypertensive; aged between 60 and 80 years; absence of dementia or cognitive impairments that limit tests; absence of recent myocardial infarction; absence of musculoskeletal limitations that limit tests; availability of time on training days. Exclusion Criteria: clinical instability; inability to perform any test.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

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

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: threshold<br>Held inspiratory muscle strengthening for 5 weeks with Threshold, charging 30% of maximal inspiratory pressure, 7 days a week, one supervised and unsupervised 6. | Device: Threshold<br>* The load adjustment was done weekly by a single examiner.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| manovacuometry | Evaluates indirectly respiratory muscle strength. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spirometry | Assesses lung function |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension
Language Stimuli Screening in Children

Study Overview
=================
Brief Summary
-----------------
This study will determine baseline language skills in children 4 to 8 years old. The data will be used to design studies using functional magnetic resonance imaging (fMRI) to identify what areas of the brain in children are involved in understanding language. This information is important for children who require brain surgery to control seizures. Healthy normal volunteers between the ages of 4 and 8 years who have an IQ of 70 or more; who have no history of neurologic, psychiatric or language disorder; who are performing at or above grade level, and who are native English speakers may be eligible for this study. Participants will be asked to do the following: name pictures or read words that appear on a computer screen listen to stories and answer questions about them match pictures to a spoken word The children's responses will be recorded.

Detailed Description
-----------------
We propose to study normal children to establish baseline data to use to develop novel sets of stimuli for functional imaging paradigms. Tasks using these stimuli will include object naming, sentence comprehension, and single word reading.

Official Title
-----------------
Language Stimuli Screening in Children

Conditions
-----------------
Language Disorder, Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Children will be between the ages 4 and 8 are eligible. EXCLUSION CRITERIA: Children who meet one of the following criteria are not eligible: IQ below 70; History of neurologic or psychiatric disorders; History of an language disorder; Performing below grade-level; Non-native English speaker.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reading, Naming
Therapy of Essential Hypertension With Kinzal®/ Kinzalplus®

Study Overview
=================
Brief Summary
-----------------
The efficacy and tolerability of an antihypertensive treatment with Telmisartan is followed over 3-4 months

Official Title
-----------------
Data Collection on Hypertension and Its Treatment With Kinzal®/ Kinzalplus®

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)
* Drug: Telmisartan (Kinzal/Pritor, BAY68-9291) + Hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertensive patients seen by the physician requiring antihypertensive treatment Exclusion Criteria: According to the local drug information

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 |
| --- | --- |
| Group 1<br> | Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)<br>* Patients under daily life treatment receiving Kinzal according to local drug information.<br>|
| Group 2<br> | Drug: Telmisartan (Kinzal/Pritor, BAY68-9291) + Hydrochlorothiazide<br>* Patients under daily life treatment receiving Kinzalplus according to local drug information.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | After 1-2 weeks, 1month, 3-4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean heart rate (bpm) |  | Baseline and 3-4 month | 
| Change in Mean Weight (kg) |  | Baseline and 3-4 month | 
| Change in Mean laboratory parameters (total cholesterol, LDL, HDL, triglyceride, fasting blood glucose) |  | Baseline and 3-4 month | 
| Patient Medical History: Duration of hypertension, Pre-treatment of hypertension, Comorbidities and Concomitant treatment |  | Baseline | 
| Final evaluation of efficacy (very good, good, sufficient, insufficient) and tolerability (very good, good, sufficient, insufficient) of treatment by the physician. |  | After 3-4 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension