linjc16/ctgov huggingface dataset:
Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether patients can use the AliveCor case to record their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus rhythm

Detailed Description
-----------------
AliveCor is a new monitoring technology used with a smart phone which allows patients to record their rhythm. The study will compare AliveCor recordings and automated interpretation of the rhythm with the interpretation by an Electrophysiologist.

Official Title
-----------------
Assessing the Accuracy of an Atrial Fibrillation Detection Algorithm Using Novel Smart Phone Technology in Detecting the Presence of Atrial Fibrillation. iRead Study

Conditions
-----------------
Atrial Fibrillation, Atrial Flutter

Intervention / Treatment
-----------------
* Device: Record and transmit heart rhythm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female between > 18 and < 80 years of age Paroxysmal or persistent atrial fibrillation Admitted for antiarrhythmic drug loading (Dofetilide or Sotalol) Already has iPhone 4, 4S or 5 with data plan that accommodates the AliveCor case Willing to use the Alive Cor case Written informed consent Exclusion Criteria: Unable or unwilling to use the Alive Cor case for their smart phone Presence of a permanent pacemaker

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Atrial Fibrillation<br>Patients with Atrial Fibrillation admitted to the hospital for drug loading with Dofetilide or Sotalol willing to record and transmit heart rhythm using AliveCor. | Device: Record and transmit heart rhythm<br>* The patient uses the AliveCor device to record and transmit heart rhythm two times a day. The patient, device software, and Electrophysiologist interpret the rhythm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine the accuracy of the AliveCor software in detecting AF or sinus rhythm compared to the physician interpretation | Both the software nd overreading electrophysiologist come to the same conclusion regarding the rhythm of the ECG and Alivecor reading. Both determining that the tracing is either normal sinus rhythm or atrial fibrillation. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the correlation between QT interval derived from the AliveCor device compared to standard 12 lead ECG, as assessed by the overreading electrophysiologists. |  | 6 months |
Whole Body Vibration Therapy in a Participant With Multiple Sclerosis Related Balance Deficits - A Case Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigation is to determine the effect of Whole Body Vibration Therapy (WBV) on balance in a participant with multiple sclerosis (MS) related balance deficits as measured by the NeuroCom Balance Master, the Sapphire IIME EMG Device and the Kurtzke Expanded Disability Status Scale (EDSS) and the Berg Balance Score.

Official Title
-----------------
Whole Body Vibration Therapy in a Participant With Multiple Sclerosis Related Balance Deficits - A Case Study

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Device: Whole Body Vibration machine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Logan student, staff, or faculty or general public with a minimal of 2 year history of diagnosed Multiple Sclerosis (MS) Exclusion Criteria: 1)visual or vestibular condition that would affect balance; 2) Non-Ms related systemic illness that would have an adverse effect on balance; 3) Local infection, acute inflammation, injury, tumors or other malignancy, recent wounds, diabetes; 4) Any unstable joints of the lower extremity, recent hip and knee joints or fitted hip or knee pins, bolts and/or plates; 5) Acute thrombosis; 6) Severe migraine, epilepsy; 7) Serious cardiovascular disease, wearing a pacemaker; Any Spinal manipulation within 48 hours; 8) Acute disc herniation, discopathy or spondylolysis; 9) Prescription or herbal muscle stimulants, relaxants, etc. that could affect balance; 10) Any implanted device or prosthesis or intrauterine IUD type of device; 11) Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

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

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 |
| --- |
|Device: Whole Body Vibration machine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NeuroCom Balance Master |  |  | 
| SF-EMG Nerve conduction velocity test |  |  | 
| Berg balance score |  |  |
A Clinical Study of Systane® Lid Wipes in Brazil

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to verify the skin and ocular tolerance of the product Systane® Lid Wipes.

Official Title
-----------------
Assessment Of The Skin And Ocular Tolerance Of The Product Systane® Lid Wipes (050343-01) And Assessment Of The Study Subject Acceptance, Under Normal Use Conditions

Conditions
-----------------
Ocular Tolerance, Skin Tolerance

Intervention / Treatment
-----------------
* Other: Systane® Lid Wipes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must sign informed consent. Agree to adhere to the procedures and requirements of the study. Wears makeup daily. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Pregnant or breastfeeding. Ocular conditions as specified in protocol. Medical conditions as specified in protocol. Skin conditions as specified in protocol. Other protocol-specified exclusion criteria may apply.

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

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane<br>Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days | Other: Systane® Lid Wipes<br>* Commercially-marketed, individually-packaged, pre-moistened eyelid wipe for daily cleaning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Contact-dermatitis Adverse Reaction | Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis. | Day 21 | 
| Number of Participants With Ocular Clinical Signs and Discomfort Sensations | Participants were assessed by an ophthalmologist. Ocular clinical signs included palpebral edema, conjunctival edema, orbicular secretion, keratoconus, blepharitis, meibomitis, pterygium, hyperemia, chemosis, keratitis, secretion and lacrimation. Both eyes contributed to the analysis. | Day 21 |
Screening for Convergence Insufficiency in School-age Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to assess the ability of common tests of eye alignment, convergence, and accommodation to identify children with convergence insufficiency in a school screening setting.

Detailed Description
-----------------
The purpose of the Screening for Convergence Insufficiency in School-age Children study was to assess the ability of common tests of eye alignment, convergence, and accommodation to identify children with convergence insufficiency in a school screening setting (where it may not be feasible to do more than one test).

Official Title
-----------------
Screening Eye Coordination Study Screening for Convergence Insufficiency in School-age Children

Conditions
-----------------
Convergence Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 9 to 17 years Enrolled in participating school Parental permission, assent Ability to complete testing Exclusion criteria: referral on vision screening for reduced distance visual acuity or significant uncorrected refractive error

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 17 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Normal
Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
Thyroidectomy is a common surgical procedure in France. Recurrent paralysis is one of the main complications. Oral corticosteroid therapy are frequently used at a dosage of 1mg/kg for seven days, in case of recurrent paralysis to obtain remobilization as early as possible. The main objective is to evaluate the efficacy of oral corticosteroid therapy in remobilization of vocal cords at seven days in patients with unilateral recurrent paralysis after thyroidectomy.

Official Title
-----------------
Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy

Conditions
-----------------
Recurrent Paralysis of Vocal Cords

Intervention / Treatment
-----------------
* Drug: Corticoids
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for simple total thyroidectomy or lobo-isthmectomy Patients over eighteen years old Free subject, whitout tutorship or curatorship or subordination Informed consent and signed by the patient after clear and fair information about the study. Exclusion Criteria: Patients operated on a total thyroidectomy with médiastino-recurrent dissection for cancer etiology Patients with preoperative recurrent paralysis Patients with hypersensitivity to prednisolone or any of the excipients. Patients with contraindication to use Solupred Patients with anti-inflammatory of acetylsalicylic acid Patient with evolving virosis (hepatitis, herpes, chicken pox, zoster)

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corticoids<br> | Drug: Corticoids<br>* Patients will receive corticosteroids therapy: 1mg/kg of prednisolone daily for seven days.<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Patients will receive placebo for seven days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of oral corticosteroid in remobilization of vocal cords at seven days for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy | evaluated by naso fibroscope inspection | Seven days |
Double-blind, Placebo-controlled Study of Levetiracetam in Adults With POS

Study Overview
=================
Brief Summary
-----------------
clinical efficacy and safety of Levetiracetam as add-on therapy in adult Chinese subjects with partial seizures.

Official Title
-----------------
A Double-blind, Placebo-controlled, Randomized Study: 16-week Evaluation of the Efficacy and Safety of Levetiracetam (LEV) as add-on Therapy in Adults and Adolescents Older Than 16 Years Suffering From Partial Seizures.

Conditions
-----------------
Epilepsy, Partial

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subject suffering from partial onset seizures, whether or not secondarily generalized, presence of the following during the eight weeks of the historical baseline period: at least eight partial seizures (type IA, IB or IC) with or without secondary generalization. subject on a stable dose of at least one and no more than two other concomitant antiepileptic drugs (AEDs). subject who has been exposed to at least one classical AEDs, CT scan or MRI performed within the last 2 years and free of neoplasia, progressive cerebral disease or any other progressively neurodegenerative disease. Exclusion Criteria: history of status epilepticus within three months prior to the Selection visit, subjects whose seizures cannot reliably be counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries), use of any medication (other than the concomitant AED) that influences the central nervous system (CNS) unless on a stable regimen for at least 1 month prior to the Selection visit. Antidepressants (except amitriptyline, mianserin and fluoxetine), anxiolytics and hypnotics are allowed. Intermittent benzodiazepines are allowed as long as the frequency is not greater than one single administration per week for at least 3 months prior to the Selection visit. Neuroleptics and Traditional Chinese AEDs are not allowed., history or presence of pseudoseizures,

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The partial onset (type I) seizure frequency reduction per week over the 16-week treatment period (titration and maintenance) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure freedom ; |  |  | 
| The partial onset (type I) seizure reduction response rate ; |  |  | 
| Safety and tolerability |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy, Partial Onset Seizures; Keppra; Levetiracetam
Reduction of Secondhand Smoke Exposure in Healthy Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of a health center based counselling method for the prevention of infant exposure to secondhand smoke.

Detailed Description
-----------------
This study, a two group randomised controled trial, investigates whether an intervention for parents would persuade them to enforce smoking bans inside the home and in other locations. A total of 130 parents with children aged 12 months or younger will be recruited. Each group (n=65) will complete a baseline and follow up questionnaire. Urine samples from the infants will be collected to measure the amount of cotinine, a metabolite of nicotine. The parent-report and infant's urinary cotinine measures will be obtained at baseline and at a 3-month follow up. In the intervention group, parents will be given three counselling sessions. For mothers, one being face to face and two telephone counselling and for fathers we will conduct three telephone counselling. The control group receives no intervention. Both groups will also complete a Fagerstrom test for nicotine dependence.

Official Title
-----------------
Reduction of Secondhand Smoke Exposure in Healthy Infants

Conditions
-----------------
Secondhand Smoke Exposure

Intervention / Treatment
-----------------
* Behavioral: Counseling, educational pamphlet and a sticker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Families with healthy infants under 12 months of age The infant resides with at least one smoking parent Parents being able to speak Persian and having a telephone Exclusion Criteria: Parent(s) reporting consumption of other addictive substances Parent(s) in smoking cessation treatment

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Counseling, educational pamphlet and a sticker|Infants exposed to secondhand smoke will be recruited and randomized based on parents to receive or not receive counseling, an educational pamphlet and a sticker on SHS.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant's urinary cotinine levels |  | At baseline and at a 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home smoking bans status, Car smoking bans status, Parental cigarette consumption |  | At baseline and at a 3-month follow-up |
Patient-Centered Advance Care Planning

Study Overview
=================
Brief Summary
-----------------
Based on theories regarding decision-making and patient education the investigators have developed Patient-Centered Advance Care Planning (PC-ACP). This intervention is designed to improve patient and surrogate knowledge of ACP, increase the congruence between patient and surrogate in treatment decisions, decrease the patient's and surrogate's conflict in making such decisions, and increase the consistency between patient preferences and the actual care they receive. The ACP intervention is conducted with the patient in the presence of the surrogate.

Official Title
-----------------
A Patient-Centered Approach to Advance Care Planning of Patients With End Stage Heart Failure and Renal Disease

Conditions
-----------------
Heart Failure, Renal Failure

Intervention / Treatment
-----------------
* Behavioral: Patient-Centered Advance Care Planning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At high risk for impending death in the next 12 months Exclusion Criteria: Patient not having decision-making capacity

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Patient-Centered Advance Care Planning|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of PC-ACP |  |  |
Bariatric Surgery and Pharmacokinetics of Fluoxetine

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on fluoxetine are investigated.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics Fluoxetine: BAR-MEDS Fluoxetine

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Fluoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fluoxetine|Patients are tested for their normal prescription fluoxetine medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoxetine concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Fluoxetine, Bariatric surgery, Gastrointestinal tract, Biological availability
Airway Anatomy of the SimBaby

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to compare radiographic upper airway measurements of the SimBabyTM pediatric patient high-fidelity simulator with actual human airway anatomy to assess the grade of realism of the simulator.

Official Title
-----------------
A Comparison of Pediatric Airway Anatomy With the SimBaby High-Fidelity Simulator

Conditions
-----------------
Airway Reality

Intervention / Treatment
-----------------
* Other: CT, MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MRI or CT head or neck including upper airway age: 1-12 months Exclusion Criteria: no pathology of airway, face, neck no airway device in place head not in neutral position neck collar

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 12 Months

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 |
| --- | --- |
| SimBaby<br> | Other: CT, MRI<br> <br> |
| Infants (1-12 mo)<br> | Other: CT, MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharyngeal measurements |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anatomic structures of the upper airway | distances, volumes and cross sectional areas of the tongue, soft palat, pharyngeal structures as well as oral airspace |  |