linjc16/ctgov huggingface dataset:
A Multi-Center Study to Assess the Performance of Saturation Patterns.

Study Overview
=================
Brief Summary
-----------------
A multi-center, prospective, single-visit study designed to acquire physiologic pulse oximeter waveform data during standard polysomnography (PSG) studies performed at multiple different Sleep Lab Centers.

Detailed Description
-----------------
The polysomnograms are clinically indicated studies in patients suspected of having sleep-disordered breathing, including, but not limited to: obstructive sleep apnea, complex sleep apnea and/or central sleep apnea. Subjects who have been prescribed with needing a polysomnography (PSG) will be enrolled into the study.

Official Title
-----------------
A Multi-Center Study to Assess the Performance of the Saturation Pattern Detection (SPD) Software Algorithm.

Conditions
-----------------
Sleep-Disordered Breathing, Obstructive Sleep Apnea, Sleep Apnea, Central Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be referred to the Sleep Lab Center for evaluation of possible sleep-disordered breathing. Polysomnography (PSG) is obtained as part of normal, standard clinical practice. Subject is able to and willingly signs the informed consent form. Exclusion Criteria: Subject and/or parent/legal guardian is, in the opinion of the investigator, mentally and/or physically unable to provide informed consent/child assent and/or to complete all requirements of the protocol. Subject is currently participating in or has participated in an investigational drug study within seven (7) days of enrollment.

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 |
| --- | --- |
| Polysomnography (PSG) Subjects<br>Subjects who have been prescribed with needing a polysomnography (PSG) will be enrolled into the study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA). | Sensitivity and specificity were computed from the count of instances in which the Saturation Pattern Detection (SPD) index value (vs. Polysomnography) within a discrete ten minute interval correctly identified a Repetitive Reduction in Airflow (RRiA) as being present within that interval (True Positive), absent (True Negative), or incorrectly identified presence or absence (False Positive and False Negative, respectively). Sensitivity is True Positive divided by True Positive plus False Negative TP/(TP+FN). Specificity is True Positive divided by True Negative plus False Positive TP/(TN+FP). | 9 Hours |
Insertion Depth Comparison of Tracheal Tubes

Study Overview
=================
Brief Summary
-----------------
There will be a difference of the insertion depth between the types of the endotracheal tube.

Conditions
-----------------
Intubation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing surgery under general anesthesia - Exclusion Criteria: upper airway or pulmonary problems neck and/or chest distortion patients at risk for pulmonary aspiration of gastric content -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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 |
| --- | --- |
| plain tube<br> | |
| reinforced tube<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the distance between endotracheal tube tip and carina |  | within 1 minute after intubation |
BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to learn if a new 7 day patch ECG recording monitor can serve the same purpose as standard monitoring systems. The new 7day patch is significantly smaller and lighter than previous ECG recorders.

Detailed Description
-----------------
The primary purpose of this research is to evaluate ECG signal quality of the BDx 7 day ECG Patch heart monitor after 7 full days of wear, establishing that the device is safe and effective to wear for up to 7 days.

Official Title
-----------------
BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study

Conditions
-----------------
Cardiac Patients, ECG Monitoring

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiac patient volunteers (5 male and 5 female) Exclusion Criteria: skin rash or infection over the sternum Sternal incision within 3 months from the date of enrollment

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adhesive performance/durability | The study will evaluate adhesive performance/durability by evaluating the Signal Quality of ECG data on the subjects (5 men and 5 women) in accordance with the requirements of FDA's ECG Electrode Guidance (section 5.A.3)1 and the ANSI/AAMI EC-12 Disposable ECG electrode technical standard (sections 4.4 and 5.4)2. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| human factors | Skin comfort or discomfort Device comfort Device stability and contact | 7 days |
Dexmedetomidine or Hyalase : Which of Them Can Augment Lumbar Epidural Steroid Injection in Failed Back Surgery Patients. A Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
hyalase and dexmedtemodine are well known adjuvants given epidurally to alleviate chronic back pain. Use in failed back surgery is an up to date field to hasten analgesia and py off recurrence .

Official Title
-----------------
Dexmedetomidine or Hyalase : Which of Them Can Augment Lumbar Epidural Steroid Injection in Failed Back Surgery Patients. A Randomized Clinical Trial

Conditions
-----------------
Pain, Chronic

Intervention / Treatment
-----------------
* Drug: Hylase versus dexmedtemodine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age group. 25-75ys old Both sex. persistent (at least 6 month) pain and or disability following laminectomy with or without sensory-motor neurological deficits or any form of urinary or bowel incontinence Patients suffering from persistent (> 6 months) back pain following laminectomy for spinal canal stenosis and/or discectomy for herniated nucleus pulposus documented by magnetic resonance imaging (MRI) were included for screening and enrollment. Exclusion Criteria: Diabetic patients. Refusal to participate MRI with disc sequestration, concurrent sacro-ilitis, facet arthropathy . Coagulopathic patients Surgical induced discitis.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: hyalase group<br>Bupivacaine 5 mg (1 mL) + Triamcinolone 40 mg (1 mL) + Saline solution (2 mL) + Hyaluronidase 1,500 IU reconstituted in 1 mL distilled water (HYL) | Drug: Hylase versus dexmedtemodine<br>* fluroscopic guided lumber epidural injection<br>|
| Active Comparator: dexmedtemodine group<br>Bupivacaine 5 mg (1 mL) + Triamcinolone 40 mg (1 mL) + Saline solution (2 mL) + Dexmedetomidine 0.5 mic/kg | Drug: Hylase versus dexmedtemodine<br>* fluroscopic guided lumber epidural injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain assesment | Visual analogue scale... 0= no pain .... 10= worst pain | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional disability | Modified oswestry diability questionnaire. 0% to 20%: minimal disability:....21%-40%: moderate disability: 41%-60%: severe disability...61%-80%: crippled | 6 months | 
| acute complications | number of patients with epidural hematoma | 6 hours |
Community Surveillance of Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
To conduct a surveillance study of congestive heart failure (CHF).

Detailed Description
-----------------
DESIGN NARRATIVE: Systematic surveillance was conducted of CHF among residents, 35-84 years old, of the Minneapolis-St.Paul metropolitan area (population 2.45 million, 1995 estimate) in two complementary domains: 1) hospitalization for CHF in two calendar years, five years apart (1995 and the year 2000); and 2) newly diagnosed CHF over a 9-year period (1993-2001) among members of a large Health Maintenance Organization (HMO). The magnitude and characteristics of hospitalized CHF were assessed in all 21 acute care hospitals of the metropolitan area. One-third of all discharges with ICD-9 CHF codes were sampled randomly (n about 5,000 per surveillance year), abstracted by trained nurses, and classified according to clinical criteria and the results of diagnostic tests. Newly diagnosed CHF was distinguished from recurrent episodes of decompensated CHF by thorough review of the hospital record. A complementary perspective on CHF, including the outpatient setting, was provided by a systematic study of members of HealthPartners, one of the largest HMOs in Minneapolis-St. Paul. Using the HealthPartners database, all newly diagnosed CHF cases between January 1, 1993 and December 31, 2001 (n about 1,900) were identified and the diagnosis validated. Beginning in January 1, 1999, newly diagnosed CHF cases were identified on an ongoing basis (n about 600), surveyed by mail, and followed for one-year from the original diagnosis. Surveillance of the HealthPartners population supplemented hospital surveillance and contributed data on incidence, prevalence, treatment, use of resources, and patient outcomes. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Failure, Congestive, Heart Diseases, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 84 Years

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 |
| --- | --- | --- |
Eating Away From Home and Mortality

Study Overview
=================
Brief Summary
-----------------
The proposed study will test the hypothesis that frequency of eating away from home meals is independently related to the prospective risk of mortality in the US population. The study will use public-domain mortality linked data from US national Surveys to address this question.

Detailed Description
-----------------
This study uses public domain data collected in the National Health and Nutrition Examination Surveys (NHANES) conducted in 1999-2000, 2001-2002, and 2003-2004 by the National Center for Health Statistics. Data on frequency of eating restaurant meals were collected at that time. The surveys have been linked to the National Death Index and mortality status information is available in public-release files. The investigators aim to examine if exposure to restaurant meals at baseline is prospectively linked to the risk of mortality. All data are anonymized and available in the public domain.

Official Title
-----------------
Eating Away From Home and Subsequent Risk of All-cause Mortality in the US Population

Conditions
-----------------
Mortality

Intervention / Treatment
-----------------
* Other: This is an observational study--there is no intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: National Health and Nutrition Examination Surveys, 1999-2004, respondent Aged 40 or older at baseline Exclusion Criteria: Pregnant or lactating No mobile examination center exam No exposure information No National Death Index linkage No followup time

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Thirds of number of restaurant meals<br>Respondent self-reports of # of times/week restaurant prepared meals were consumed. The respondents will be categorized into approximate thirds. | Other: This is an observational study--there is no intervention.<br>* This is an observational study, there is no intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Mortality from all causes | Through end date of National Death Index followup, 12/31/2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cause-specific mortality | mortality from specific causes | Through end date of National Death Index followup, 12/31/2011 |
Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The key focus of this survey will be to collect data on physicians awareness of the content of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to patients. The data collected with atrial fibrillation patients will show if and how well this information is received and understood.

Detailed Description
-----------------
Purpose:

Official Title
-----------------
Post-authorisation Study to Evaluate the Effectiveness of the Risk Minimisation Activities in the Treatment of SPAF

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Pradaxa® prescribers (cardiologists and primary care physicians) Patients with atrial fibrillation treated with Pradaxa® Exclusion criteria: As defined in Summary of Product Characteristics for patients treated with Pradaxa®

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 |
| --- | --- |
| Patients<br> | |
| Physicians<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire) | The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing. This Outcome measure is applicable only for the Physicians group. | Day 1 | 
| Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire) | The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding. This Outcome measure is applicable only for the Patients group. | Day 1 |
Non Invasive Imaging of Abdominal Aorta Aneurysm Hemodynamics and Wall Structure

Study Overview
=================
Brief Summary
-----------------
The development of the abdominal aorta aneurysm is multifactorial. Through use of magnetic resonance imaging without contrast, this study will look closely at flow, the stresses hereby induced, as well as signs of inflammation in the vessel wall.

Detailed Description
-----------------
The etiology of the abdominal aorta aneurysm is complex and multi-factorial. Biomechanic and hemodynamic stress contributes to aneurysmal growth, and the relevance of inflammation is gaining in terms of pathological influence. The technical advances of imaging now enable one to utilize magnetic resonance in reconstructing aortal blood flow. Newer post-imaging software then enables one to perform complex data analysis, wherein shear and wall-stress can be calculated. The goal of this study is to analyze the aneurysms of twenty patients. Values will be obtained for shear and wall stress. Additionally, the utilization of short tau wave inversion recovery (STIR) sequences will be performed to evaluate the presence or absence of acute edema and inflammation of the region. It should also be noted that particular attention will be placed on the so-called neck of the aneurysm, where the aneurysm typically tapers into what is often regarded as normal aortic tissue. This region is important for both the placement of a surgical bypass prosthesis or a deployed stent graft.

Official Title
-----------------
Non Invasive in Vivo Evaluation of Abdominal Aorta Aneurysm Hemodynamics, Wall Stress, and Inflammation Using Magnetic Resonance Imaging

Conditions
-----------------
Aortic Aneurysm, Abdominal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infrarenal abdominal aorta aneurysm (AAA) Exclusion Criteria: Lack of signed, informed consent Pacemaker or other implanted metal prostheses Claustrophobia Dementia Diabetes Mellitus Thoracoabdominal aorta aneurysm, per Crawford/Safi criteria Ehlers-Danlos, Marfans, or other diagnosed connective tissue disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Left ventricular longitudinal strain for perioperative cardiac monitoring in aortic aneurysm surgery using transthoracic 2-dimensional echocardiography: a a feasibility and repeatability study.feasibility and repeatability study. |  | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal Aortic Aneurysm, Wall Stress, Shear Stress, Inflammation, Magnetic Resonance Imaging
Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated estrogens tablets produced using a new manufacturing process

Official Title
-----------------
An Open-Label, Single-Dose, Randomized-to-Sequence, 2-Period, Crossover, Pivotal Bioequivalence Study Between Bazedoxifene Acetate/Conjugated Estrogens (Premarin Current Process) and Bazedoxifene Acetate/Conjugated Estrogens (Premarin New Process) Tablets Administered to Healthy Postmenopausal Women

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Drug: bazedoxifene/conjugated estrogens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Healthy, postmenopausal women aged 35 to 70 years and weighing at least 50 kg (approx. 110 lbs). At least 6 months of spontaneous amenorrhea (with follicle-stimulating hormone levels of 39 mIU/mL or greater). Nonsmoker or smoker of fewer than 10 cigarettes per day, with ability to abstain for 5 days. Exclusion Criteria Women with amenorrhea starting after 54 years of age. A history or active presence of clinically important medical diseases. Use of oral estrogen-, progestin, androgen-, or SERM-containing drug products within 30 days before receiving study drug.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: bazedoxifene/conjugated estrogens|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic measures of blood levels of endogenous estrogen hormones, conjugated estrogens and bazedoxifene. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated from reported signs and symptoms, scheduled physical examinations, gynecologic examinations, vital sign measurements, 12-lead ECG and clinical laboratory test results. |  |  |