linjc16/ctgov huggingface dataset:
Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain

Study Overview
=================
Brief Summary
-----------------
Obtained 19 lead EEG data from 50 chronic pain patients along with their clinical history and self-reported pain scored. Machine learning was used to analyze the EEG data and derive a chronic pain biomarker.

Official Title
-----------------
Development of a Medical Device Utilizing an EEG-Based Algorithm for the Objective Quantification of Pain

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

Intervention / Treatment
-----------------
* Device: IRIS System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female chronic pain patients Patients between the ages of 18-85 years Patients exhibiting the presence of symptoms in excess of 3 months duration Patients suffering from neuropathic (e.g., lower back pain), osteoarthritis, or muscular skeletal pain Patients with evidence of pathology related to the painful condition on which diagnosis was made (e.g., results of imaging or diagnostic pain code) Patients with NRS pain scores across the full range (1-10) at the time of testing Exclusion Criteria: Patients with medically diagnosed psychotic illness Patients with medically diagnosed drug or alcohol dependence in the past 12 months Patients with a medical history of head injury with loss of consciousness and amnesia (within the last 2 years) Patients with skull abnormalities that preclude the proper placement of the electrodes for the EEG data acquisition Patients who have a spinal cord stimulator, or other implantable devices Patients for whom the source of pain at the time of the evaluation is associated with: neurological disorders (multiple sclerosis, Parkinson, dementia), diabetes, migraines, or those with reflex / sympathetic dystrophy disorder/complex regional pain syndrome, fibromyalgia, or visceral pain Patients with cancer Patients on workers compensation or disability Patient on anticonvulsant medication Patients who have a history of seizures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: IRIS System|A QEEG based pain biomarker that scales with the patient reported NRS|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pearsons Correlation between IRIS derived pain biomarker and patient reported Numeric Rating Scale (0-10) | A Pearson Correlation of 1.0 is perfection correlation and 0 no correlation between the two measured variables | 6 Months |
The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease

Study Overview
=================
Brief Summary
-----------------
There is preliminary evidence that Omega 3, a compound naturally found in fish oil, reduces the amount of fat stored in the liver and improves liver function. The purpose of this study is to see whether this observation is correct.

Official Title
-----------------
The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease

Conditions
-----------------
Non Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Drug: Omacor
* Drug: lactose tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a diagnosis of non-alcoholic fatty liver disease fatty infiltration on ultrasound abnormal serum liver function tests. Exclusion Criteria: any other identified cause of chronic liver disease the prescription of medication which would cause non-alcoholic fatty liver - disease (e.g. tamoxifen) already taking supplementary fish oil alcohol intake of >20g/day for women, >40g/ day for men known allergy to fish oil on anticoagulants (antiplatelets are permitted) severe heart failure (NYHA class IV) pregnancy/ lactation age under 18 years.

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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omacor<br> | Drug: Omacor<br>* Active comparator: omacor 4g/day<br>* Other names: N-3 Fatty acids;|
| Placebo Comparator: Lactose tablet<br> | Drug: lactose tablet<br>* placebo: lactose tablet 4g/day<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver appearance on ultrasound | The primary endpoint is improvement in grading on ultrasound assessment at six months. Liver brightness and posterior attenuation on ultrasound has previously been shown to correlate significantly with fat scores on liver biopsy. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function tests | the effect of omega-3 fatty acids on serum liver function tests will be assessed following 6 months of treatment. | 6 months | 
| hepatocyte mitochondrial function | heptocyte mitochondrial function will be measured by breath testing following 6 months of omega-3 supplementation | 6 months | 
| Health-related Quality of Life | Health related quality of life scores will be compared with baseline following 6 months of omega-3 supplementation | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non alcoholic fatty liver disease
Vitamin D Supplementation and Effects on Mood in Emergency Medicine Residents

Study Overview
=================
Brief Summary
-----------------
Seasonal mood changes, and even feelings of depression, appear to have an association with decreased amounts of vitamin D in people living in geographic areas where exposure to sunlight during the winter months is relatively low. In this study, PGY-2 and PGY-3 Emergency Medicine residents at Lakeland Health will fill out PHQ-9 surveys for a total of 6 months (October-March), filled out at the end of each month. This is the time of year in southwest Michigan where exposure to direct sunlight is the lowest. The results of the individual surveys will be trended for the entire six months to see if individuals responds more positively after Vitamin D supplementation is initiated between months 3 and 4. Vitamin D supplementation will be 5000 units daily for the months of January-March.

Official Title
-----------------
Correlation of Vitamin D Supplementation in Emergency Medicine Residents and Seasonal Mood Symptoms

Conditions
-----------------
Seasonal Mood Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D
* Dietary Supplement: No Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PGY-2 and PGY-3 Emergency Medicine Residents at Lakeland Health Exclusion Criteria: Nonresidents and PGY-1 and PGY-4 Emergency Medicine residents at Lakeland Health

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Non-vitamin D supplementation<br>Group not receiving vitamin D supplementation | Dietary Supplement: No Vitamin D<br>* No vitamin D supplementation<br>|
| Experimental: Vitamin D supplementation<br>Group receiving vitamin D supplementation | Dietary Supplement: Vitamin D<br>* Group will receive 5000 units of vitamin D daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of vitamin D on resident mood | Using the Patient Health Questionnaire 9 (PHQ-9) survey results, data will be analyzed to determine if vitamin D helped increase positive responses as it correlates to mood. Using the Patient Health Questionnaire - 9 to determine the severity of the depressive moods. (Scaled from 0-27 with higher numbers being more severe. 0-4 is minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe) | 6 months |
Intravenous Voriconazole in Patients With Renal Compromise

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether patients with compromised renal function (CrCl < 50mL/min) receiving intravenous voriconazole experienced any adverse effects related to serum chemistries or other imaging studies of the kidney due to the potential accumulation of the vehicle cyclodextran.

Detailed Description
-----------------
The purpose of this study is to determine whether patients with compromised renal function (CrCl < 50mL/min) receiving intravenous voriconazole experienced any adverse effects related to serum chemistries or other imaging studies of the kidney due to the potential accumulation of the vehicle cyclodextran. t has been previously shown by a large multi-centered, prospective, randomized study that voriconazole is superior to the then gold standard amphotericin B in the treatment of patients with invasive aspergillosis - a disease with significant morbidity and mortality. In patients with these infections who have severe renal insufficiency may be denied the best therapy due to the accumulation of a diluent with unknown clinical consequences. Qualifying and or quantifying these consequences are important to these patients so that potentially life-threatening therapy should not be unduly denied.

Official Title
-----------------
Intravenous Voriconazole in Patients With Renal Compromise

Conditions
-----------------
Renal Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients > 18 years old receiving voriconazole with a serum creatinine of > 2mg/dl (a proxy marker for Creatinine clearance < 50ml/min). Control group in this study will have serum creatinine < 1.5mg/dl. Solid organ transplant patient. Patient that received at least 2 doses of voriconazole. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Voriconazole, renal transplant, kidney function, kidneys
The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of experimental knee pain on the muscle strength gain after 8 weeks of strengthening exercises for the quadriceps. It is hypothesized that experimental knee pain will reduce the muscle strength gain following strengthening exercises in healthy volunteers.

Official Title
-----------------
The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain

Conditions
-----------------
Muscle Strength

Intervention / Treatment
-----------------
* Other: Experimental knee pain
* Other: Non-painful control injections


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 20 to 35 years healthy untrained (non-regular exercise participation [i.e. < 1 day/week]) Exclusion Criteria: symptomatic musculoskeletal diseases history of traumatic injuries to muscles, tendons or joints of the lower extremity knee joint pain within a month prior to enrollment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Knee Pain<br>Experimental knee pain induced by injections of 1 ml hypertonic saline in to the infrapatellar fat pad | Other: Experimental knee pain<br>* Injection of 1 ml hypertonic saline (5.8%) into the infrapatellar fat pad<br>|
| Active Comparator: Control<br>non-painful injections of isotonic saline into the infrapatellar fatpad. | Other: Non-painful control injections<br>* Injection of isotonic saline into the infrapatellar fat pad<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isokinetic knee muscle strength |  | At baseline and after 8 weeks of exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One-leg chair rise |  | At baseline and after 8 weeks of exercise |
Toward an Automated Method of Abdominal Fat Segmentation of MR Images

Study Overview
=================
Brief Summary
-----------------
Subjects will undergo a brief magnetic resonance (MRI) scan. The resulting images will be used to compare two abdominal fat segmentation techniques. The first technique is already validated and in use. The second technique was recently developed and has not been validated. The hypothesis is that the second technique will be the faster and more reliable of the two.

Official Title
-----------------
Toward an Automated Method of Abdominal Fat Segmentation of MR Images

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ambulatory cognitively sound Exclusion Criteria: body mass index less than 18 or greater than 45 kilograms per square meter

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Volunteers<br>Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visceral Fat Volume With Automated Analysis | This is the measurement of Abdominal Visceral Fat in cubic centimeters as determined with a new automated segmentation program. | five minutes | 
| Visceral Fat Volume With Manual Segmentation | This is the measure of visceral fat found with our older manual segmentation method | five minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subcutaneous Fat Volume With Automated Analysis | This is the volume of Abdominal Subcutaneous Fat in cubic centimeters as determined with new automated anatomical segmentation software. | five minutes | 
| Subcutaneous Fat Volume With Manual Segmentation | This is the volume of Abdominal Subcutaneous Fat in cubic centimeters as determined with the older manual segmentation technique. | five minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity
Followup of Infants Fed Non-routine Infant Formula

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare physical development of infants fed one of three study formulas.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed Study 3369-5 Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 4 Months
Maximum Age: 4 Months

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Other: Infant formula<br>* Arm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL) Arm 2. partially hydrolyzed infant formula with probiotics Arm 3. extensively hydrolyzed infant formula with probiotics<br>* Other names: No other names are applicable to the 3 intervention arms;|
| Experimental: 2<br> | Other: Infant formula<br>* Arm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL) Arm 2. partially hydrolyzed infant formula with probiotics Arm 3. extensively hydrolyzed infant formula with probiotics<br>* Other names: No other names are applicable to the 3 intervention arms;|
| Experimental: 3<br> | Other: Infant formula<br>* Arm 1. extensively hydrolyzed infant formula without probiotics (Nutramigen LIPIL) Arm 2. partially hydrolyzed infant formula with probiotics Arm 3. extensively hydrolyzed infant formula with probiotics<br>* Other names: No other names are applicable to the 3 intervention arms;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieved weight |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical development
Diagnosis and Characterization of Coronary Artery Stenosis by Doppler Ultrasound

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the feasibility of acquisition of coronary blood flow velocity signals over the whole length of the LAD with transthoracic pulsed Doppler, and to evaluate the diagnostic power of the transthoracic Doppler analysis package for detecting and estimating the degree of coronary artery stenosis. Finally we hope to optimize the currently available analysis package on the basis of the comparison of the Doppler with the angiographic stenosis results and evaluation.

Official Title
-----------------
Diagnosis and Characterization of Coronary Artery Stenosis by Transthoracic Doppler Ultrasound

Conditions
-----------------
Coronary Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are clinically suspected of having significant coronary artery stenosis. Patients with CAD. Patients who are scheduled to undergo coronary angiography. Signed informed consent. Exclusion Criteria: Patients with arrhythmia / irregular pulse Patients with unstable conditions: unstable angina, uncontrolled CHF Patients with COPD Any physical or medical disability that prevent lying in supine position Patients with chest wall deformity

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Patients with an acute coronary syndrome that are candidates for coronary angiography. Doppler results will be compared to angiographic findings. | |

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
-----------------
doppler, coronary stenosis, non-invasive testing, A prospective study of a new diagnostic method., Study consists of a transthoracic doppler of LAD., Doppler to be performed prior to coronary angiography., F/U doppler examination for those who undergo PCI., Doppler results will be compared with coronary angiography.
Temporalis Myofascial Flap Effectiveness

Study Overview
=================
Brief Summary
-----------------
This research is conducted as trial to improve lifestyle of patients with cranio-maxillofacial defects following major insults like trauma or tumor resection in form of speech problems or dysphagia by usage temporalis myofascial flap and assessment of it's effectiveness

Official Title
-----------------
The Efficacy of Temporalis Myofascial Flap in Reconstruction of Various Cranio-maxillofacial Defects

Conditions
-----------------
Maxillary Sinus Neoplasms

Intervention / Treatment
-----------------
* Procedure: Temporalis Myofascial flap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with: TMJ ankylosis Osteomyelitis following mucormycosis Following tumor resection like maxillectomy or temporal bone resection Following orbital exentration due to tumors or infections Following massive trauma Facial reanimation Exclusion Criteria: • History of head & neck embolization as it may compromise blood supply of the flap Extensive tumors involving maxillary artery History of head & neck radiation or chemotherapy Temporalis muscle wasting due to any reason Bad general condition
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Assessment of temporalis myofascial flap effectiveness in reconstruction of cranio-maxillofacial defects
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flap survival<br>Harvesting temporalis myofascial flap for cranio-maxillofacial defects | Procedure: Temporalis Myofascial flap<br>* Improvement of speech and feeding quality in patients with palatal defects by temporalis myofascial flap<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of versatility of temporalis myofascial flap in reconstruction of craniomaxillofacial defects in means of flap viability, healing and epithelization | Assessment by regular follow up by pin bricks | 6 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of phonation and swallowing efficacy postoperatively | Assessment will be done in regular follow up visits by video fluoroscopy , trials of swallowing and phonation will be assessed by phoniatricians | 6 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Temporalis flap, Maxillofacial defects, Reconstruction