linjc16/ctgov huggingface dataset:
Maestro Handheld Cardiac Monitor Validation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that the Maestro hand held heart monitor can accurately diagnose Atrial Fibrillation, atrial flutter or normal sinus rhythm in patients.

Detailed Description
-----------------
The purpose of this study is to determine if Maestro can be used to detect heart arrhythmias, specifically atrial fibrillation in humans. Maestro will be used to measure heart rate and rhythm at the same time that patients are being monitored with a standard 3, 5, or 12 lead electrocardiogram (ECG) in a clinical setting. The recorded Maestro results will be compared to the ECG results to assess Maestro's accuracy. Data will be analyzed by a pass/fail criterial. The data will be downloaded and printed for the investigators' interpretation who will first review and code the data from Meastro, blinded to the ECG findings. Then the investigators will interpret the ECG findings and the 2 sets of data will be compared. The ECG result is the true value with which to compare the Maestro result.

Official Title
-----------------
Maestro Handheld Cardiac Monitor Validation

Conditions
-----------------
Cardiac Arrhythmia

Intervention / Treatment
-----------------
* Other: Maestro ECG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ability to provide informed consent Exclusion Criteria: implanted pacemakers open wounds or abrasions on their hands prior damage to hands or thumbs precluding obtaining an ECG tracing

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
Interventional Model Description: 40 subjects with Atrial Fibrillation 10 subjects with Atrial Flutter 20 subjects with Sinus Rhythm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients in afib or flutter<br>Maestro ECG | Other: Maestro ECG<br>* Telemetry is obtained through the Maestro handheld ECG device.<br>|
| Other: Patients in sinus rhythm<br>Maestro ECG | Other: Maestro ECG<br>* Telemetry is obtained through the Maestro handheld ECG device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of atrial fibrillation detection | Each sample acquired by the Maestro system will be automatically analyzed and rhythm categorized by the automated algorithm. This will then be assessed for accuracy and sensitivity and specificity for detection of atrial fibrillation will be calculated. | 6 seconds |
Safety Study of OPC-12759 Ophthalmic Solution

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.

Official Title
-----------------
Safety Study of OPC-12759 Ophthalmic Solution in Healthy Subjects

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: OPC-12759 Ophthalmic solution
* Drug: OPC-12759 Ophthalmic suspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI : {body weight (kg) / [height (m)] 2 } must be 17.6 or greater, and less than 26.4 kg/m2 Exclusion Criteria: Presence of ocular disorder Intraocular pressure of 21mmHg or higher Corrected visual acuity of less than 1.0 Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow History of refractive surgery History of other ocular surgeries within 12 months Those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solution<br>A single dose of OPC-12759 Ophthalmic solution for two-day treatment | Drug: OPC-12759 Ophthalmic solution<br>* 2％ OPC-12759 Ophthalmic solution<br>|
| Active Comparator: Suspension<br>A single dose of OPC-12759 Ophthalmic suspension for two-day treatment | Drug: OPC-12759 Ophthalmic suspension<br>* 2％ OPC-12759 Ophthalmic suspension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Blurred Vision After Instillation | The number of subjects with white blurred vision after first and/or second instillation was calculated for subjects. | The first and second instillation | 
| Number of Subjects With Bitter Taste | The number of subjects with bitter taste on first and/or second instillation was calculated for subjects. | The first and second instillation |
Tolerability of Grazax-R in Children

Study Overview
=================
Brief Summary
-----------------
This trial is performed to assess whether the Grazax-R treatment is safe to use in children aged 5-12 years.

Official Title
-----------------
A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase I Trial Investigating the Safety of GRAZAX-R in Children Aged 5-12 Years With Grass Pollen Induced Rhinoconjunctivitis (With/Without Asthma)

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Biological: ALK Grass tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Grass pollen induced rhinoconjunctivitis Boys and girls, 5-12 years of age Positive skin prick test to grass pollen Exclusion Criteria: Previous treatment with immunotherapy

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: ALK Grass tablet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety by recording of adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergy
Remicade Infusion Management Program

Study Overview
=================
Brief Summary
-----------------
Janssen Inc. plans to collect data on about 3000 to 5000 infliximab infusions per year, starting in the third quarter of 2005. It is expected that about 12 sites from the Remicade Infusion Network (R.I.N.) will participate. This registry will be a multicentre, prospective, observational program that will gather and analyze data on subjects being treated with infliximab.

Official Title
-----------------
Remicade Infusion Management Program

Conditions
-----------------
Crohn Disease, Arthritis, Rheumatoid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a good candidate to receive infliximab as per the Product Monograph Subject is prescribed infliximab by an appropriate physician Subject receives infusion in a community infusion centre. Subject has signed the approved consent form. Exclusion Criteria: Not specified in the protocol
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 |
| --- | --- | --- |
| Type and frequency of infusion reactions |  | Up to 7 years | 
| Pre-infusion treatments and efficacy |  | Up to 7 years | 
| Infusion reaction management approaches |  | Up to 7 years | 
| The number of subjects with adverse events |  | Up to 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's Disease, Rheumatoid Arthritis
Yoga Breath Program and Client-Centered Exposure for Relief of PTSD in Tsunami Victims

Study Overview
=================
Brief Summary
-----------------
Study hypothesis: that a standardized course of Eastern practices (Breath Water Sound Course -BWS) will significantly relieve PTSD and depression in tsunami victims. Further, that a client-centered exposure treatment (Traumatic Incident Reduction- TIR) would provide additional, significant relief of PTSD and depression in tsunami victims. 180 tsunami victims in Southern India will be divided into three groups: those that only receive BWS course, those that receive the BWS course and TIR and a wait-list control. They will be pretested with the PCL-17 (PTSD scale), the Beck Depression Inventory and the General Health Questionaire. These scales will also be administered post-service as well as five weeks post pre-testing and at three and six month intervals.

Official Title
-----------------
Controlled Trial of Yoga Breath Based Group Intervention and Client-Centered Exposure Treatment for Relief of Traumatic Stress and Depression in Tsunami Victims

Conditions
-----------------
Posttraumatic Stress Disorder, Depression

Intervention / Treatment
-----------------
* Behavioral: Breath Water Sound Course and Traumatic Incident Reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tsunami witness, tsunami victim, and/or lost loved one or property. Ages 18-70 Willing to participate for the entire length of this research study. Exclusion Criteria: Drug addiction, notwithstanding alcohol or tobacco. Schizophrenia or other severe pre-existing mental illness Severe physical disability or illness that would prevent study completion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Breath Water Sound Course and Traumatic Incident Reduction|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| That the BWS course and TIR will provide significant reduction in scores on the PCL-C, a standardized measure of PTSD symptoms. |  | improvement in PCL-C scores will occur in one week and persist for the duration of the study: 6 months | 
| That the BWS course and TIR will provide significant relief from clinical depression as measured on BDI. |  | Improvement in scores on BDI will occur in one week and persist for 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Posttraumatic stress disorder, depression, disaster mental health, yoga, Breathwork, exposure treatments
Ischemia and Reperfusion Injury in the Human: An Observational Study

Study Overview
=================
Brief Summary
-----------------
We, the researchers at Lawson Health Research Institute, propose to investigate the impact of surgical ischemia and reperfusion on skeletal muscle microcirculation using a hand-held microscope.

Detailed Description
-----------------
We propose to investigate the impact of surgical ischemia and reperfusion on skeletal muscle microcirculation using a hand-held microscope.

Official Title
-----------------
Ischemia and Reperfusion Injury in the Human: An Observational Study

Conditions
-----------------
Ischemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing femoral distal bypass procedures for chronic limb ischemia Exclusion Criteria: Any severe comorbid conditions (i.e., chronic obstructive pulmonary disease [COPD])

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 |
| --- | --- |
| Vein Stripping<br>Patients undergoing elective varicose vein stripping in our vascular OR. Observe circulation in the exposed soleus/gastrocnemius muscle. | |

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
-----------------
Ischemic Preconditioning, Microvascular Perfusion, Inflammation, Ischemia and Reperfusion, Chronic Limb Ischemia
Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
Open-label, multicenter, multiple-dose, study of population pharmacokinetics of I.V. Synercid (7.5 mg/kg every 8 hours) in 75 pediatric patients. The purpose is to assess the population pharmacokinetics of Synercid in pediatric patients and to collect additional safety and efficacy data in pediatric patients.

Conditions
-----------------
Gram-Positive Bacterial Infections

Intervention / Treatment
-----------------
* Drug: Synercid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serious, suspected or documented gram-positive infection Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 27 Weeks
Maximum Age: 16 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: Synercid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Population pharmacokinetics |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Efficacy |  |  |
Bone Density of Large Newborn Infants and Infants of Diabetic Mothers

Study Overview
=================
Brief Summary
-----------------
Bone density was found to be impaired among lage babies and infants of diabetic mothers as found in small group studies. The assumption is that large weight decreases fetal movements and causes decreased bone mineralization.The aim of the study is to compare 2 study groups - of large infants and infants of diabetic mothers to each other and to controls.

Official Title
-----------------
Bone Density of Large Newborn Infants and Infants of Diabetic Mothers

Conditions
-----------------
Bone Density

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term infants of birth weight 4 kg and above, and Infants of diabetic mothers. Exclusion Criteria: Preterms, Major congenital malformations, Sick babies.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 7 Days

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 |
| --- | --- | --- |
| Bone density |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone density, infant of diabetic mother, large birth weight
Transcutaneous Electric Nerve Stimulation in Sleep of Patients With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Sleep disorders are among the non-motor signs more common in Parkinson's disease (PD). This case series evaluated the effects of Transcutaneous Electrical Nerve Stimulation (TENS) on acupoints in the self-assessment of sleep in 14 PD patients classified between stages 1 and 3 of Hoehn and Yahr original (HY). Patients were assessed using the Sleep Scale for Parkinson's Disease (PDSS) and subjected to treatment with eight TENS sessions on acupoints, with the current Burst. We used the paired sample t-test, considering p ≤ 0.05.

Official Title
-----------------
Transcutaneous Electric Nerve Stimulation in Sleep of Patients With Parkinson's Disease

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

Intervention / Treatment
-----------------
* Procedure: Transcutaneous Electric Nerve Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of idiopathic PD between stages 1 and 3 according to the original version of the Hoehn & Yahr (HY) scale Exclusion Criteria: Patients with Mini Mental State Examination (MMSE) lower than 18 points, with other associated neurological diseases and on medication for depression, anxiety, psychosis and sleep inducers.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Transcutaneous Electric Stimulation<br>Eight sessions were held, once a week, lasting twenty minutes. For this purpose, the electrodes of the acoustic surface Taichong (LR-3), Hé gǔ (Ll-4), Yanglingquan (GB-34) and Neiguan (PC-6) connected to the TENS equipment (EL 608, brand NKL). The current of choice for a BURST type, with intermittent pulses, isolated at a frequency of 2 Hz, ranging from 1 to 10 mA. | Procedure: Transcutaneous Electric Nerve Stimulation<br>* Eight sessions were held, once a week, lasting twenty minutes. For this purpose, the electrodes of the acoustic surface Taichong (LR-3), Hé gǔ (Ll-4), Yanglingquan (GB-34) and Neiguan (PC-6) connected to the TENS equipment (EL 608, brand NKL). The current of choice for a BURST type, with intermittent pulses, isolated at a frequency of 2 Hz, ranging from 1 to 10 mA.<br>* Other names: Tens;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale for Parkinson's disease (PDSS) | A self-administered scale designed to assess nighttime sleep problems, sleep disorders and excessive daytime sleep. Consists of 15 items represented by a ruler (10 cm) where the patient indicates the frequency of the symptom from 0 (always)- 10 (never). | 8 weeks |
Grass Observational Study

Study Overview
=================
Brief Summary
-----------------
Grass pollen allergens are universally recognised as a major cause of allergic diseases in humans, including asthma, allergic rhinitis, conjunctivitis and dermatitis. The purpose of the current study is to evaluate allergy symptoms and allergy medication in subjects with grass-related rhinoconjunctivitis.

Official Title
-----------------
An Observational Multi-Centre Field Study to Assess Symptom Scores and Allergy Medication Usage in Subjects With a History of Grass-Induced Rhinoconjunctivitis

Conditions
-----------------
Grass Allergy, Rhinoconjunctivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of moderate to severe rhinoconjunctivitis consistent with allergy to grass for at least 2 years. Forced Expiratory Volume in 1 Second (FEV1) of at least 70% of predicted value or personal best if available at the Screening Visit. Perennial Rye grass or Timothy grass-specific IgE ≥ 0.35 kU/L as measured by ImmunoCAP®. Positive skin prick test to Perennial Rye grass or Timothy grass allergen Exclusion Criteria: Positive skin prick test ≥ 5 mm to any confounding, co-existing seasonal allergens likely to be present during the pre-season baseline and grass pollen period. Medical records of symptomatic perennial allergic rhinitis and/or asthma or a positive skin test ≥ 5 mm due to a perennial allergen to which the subject is regularly exposed (moulds, dust mites, cockroaches, and animal dander) and which cannot be avoided during the course of the study. Previous immunotherapy treatment with any grass allergen for more than 1 month within 5 years prior to screening. Subjects who had been treated with any non-grass licensed allergen immunotherapy extracts or non-grass investigational immunotherapy for more than 1 month within 1 year.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 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 |
| --- | --- |
| Grass-Induced Rhinoconjunctivitis Subjects<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate Total Rhinoconjunctivitis Symptom Score and allergy medication use as a combine score |  | 6 weeks |