linjc16/ctgov huggingface dataset:
Virtual Assistant for Plastic Surgery Patients

Study Overview
=================
Brief Summary
-----------------
Researchers are trying determine the long term impact when patients have access to the artificial intelligence virtual assistant (AIVA) as a complimentary resource.

Detailed Description
-----------------
Eligible subjects will be randomized into to two groups. One group of subjects will be given access to the AIVA will be instructed to ask, at home, questions regarding the planned surgery to the AIVA application on their mobile phone. The other group will be instructed to call to the Standard of Care call center with questions related to their treatments. Researchers will follow up with all subjects from both groups for a 1 year amount of time.

Official Title
-----------------
Virtual Assistant for Plastic Surgery Patients - Impact on the Clerical Burden, Resource Utilization, Patient and Provider Satisfaction, and Patient Surgical Outcomes.

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Other: Artificial Intelligence Virtual Assistant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects above 18 years old Able to use applications on mobile phones and consent to participate Adult subjects in the Plastic Surgery outpatient clinic of Mayo Clinic Florida Exclusion Criteria: -

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with virtual assistance<br>Subjects receiving current standard of care for a surgical procedure within the department of plastic surgery will have access to artificial intelligence virtual assistance (AIVA) | Other: Artificial Intelligence Virtual Assistant<br>* Virtual assistance application for subjects to ask questions and get information regarding planned surgery<br>* Other names: AIVA;|
| No Intervention: Subjects without virtual assistance<br>Subjects receiving current standard of care for a surgical procedure within the department of plastic surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of phone calls | The total number of phone calls from subjects | 12 months | 
| Duration of phone call | Length of phone calls from subjects. Measured in minutes | 12 months | 
| Nature of phone call | The total number of phone calls related to the intervention | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Plastic, Virtual Assistant
The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

Study Overview
=================
Brief Summary
-----------------
Isoflavonoids, through their estrogen-like activity, are in part responsible for the cholesterol lowering properties of soy foods. If this is found to be so, then it would be advantageous not only to promote soy consumption, but also to identify and use soy cultivars with high isoflavonoid content in production of soy food products. These foods may have a use in the reduction of serum cholesterol and if they effectively increase the phytoestrogen activity of soy, may have a role in the prevention of other hormone dependent diseases (e.g. osteoporosis, certain cancers) in the same way as natural estrogens.

Official Title
-----------------
The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy

Conditions
-----------------
Hyperlipidemia, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Procedure: dairy food control diet and high- and low- isoflavone soyfood diets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and post-menopausal women LDL-C > 4.1mmol/L at recruitment living within a 40 km radius of St. Michael's Hospital Exclusion Criteria: lipid lowering medications clinical or biochemical evidence of diabetes, renal or hepatic disease body mass index (BMI) >38 kg/m2 antibiotic use within the last three months hormone replacement therapy smoking or significant alcohol use (>1 drink/d) triglyceride level > 4.0mmol/L

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: dairy food control diet and high- and low- isoflavone soyfood diets|nan|

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
-----------------
Diet Therapy
Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the time course of duloxetine efficacy on the symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort Syndrome(STDS) via use of 24-hour Actigraph™ measures. We hypothesize that there will be a reduction in both MDD and STDS symptoms in MDD patients with co-morbid STDS symptoms. We further hypothesize that there will be a rapid improvement in functional outcome ratings and 24-hour activity in MDD patients with co-morbid STDS symptoms which may occur even before the antidepressant effect is observed.

Official Title
-----------------
Functional Change and Efficacy of Duloxetine in Patients With Major Depression and Co-Morbid Soft Tissue Discomfort Symptoms

Conditions
-----------------
Major Depressive Disorder, Soft Tissue Discomfort Syndrome, Pain

Intervention / Treatment
-----------------
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 17 years old All races and ethnicity DSM IV-TR Axis I diagnosis of MDD Co-morbid STDS Baseline 17-item Hamilton Depression Rating > 13 Exclusion Criteria: Primary Axis I disorder other than MDD History of mania or psychosis Actively suicidal Required hospitalization A alcohol or substance abuse or dependence within the preceding 3 months Pregnant or nursing Unstable medical condition (other than STDS) Narrow-angle glaucoma Sensitivity to duloxetine, concurrent antidepressant, tranquilizer, or mood stabilizer use Hepatic or renal insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duloxetine<br> | Drug: Duloxetine<br>* 30-60 mg daily for 8 weeks<br>* Other names: Cymbalta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour Activity Level |  | Baseline and Week One of Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Symptom Questionnaire |  | Baseline; Week 6 and Week 8 of Treatment |
Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Study Overview
=================
Brief Summary
-----------------
The objective of our study was to compare the safety and efficacy of oral midazolam during pediatric endoscopy.

Detailed Description
-----------------
Although gastrointestinal endoscopy is widely accepted as fundamental to the diagnosis and treatment of digestive disorders in children, considerable controversy and practice differences persist with respect to the methods and agents used to achieve optimal endoscopic sedation. Comparison:oral midazolam vs midazolam IV in sedation and comfort scale of pediatric endoscopy.

Official Title
-----------------
Clinical Trial of Oral Midazolam in Pediatric Endoscopy

Conditions
-----------------
Endoscopy

Intervention / Treatment
-----------------
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All of patients scheduled for endoscopy participated in the study. Exclusion Criteria: Exclusion criteria were as follows: Children younger than 3 years; Children with significant neurological disability; Children with a history of allergies to benzodiazepines, or to their components; Children with metabolic, cardiac or renal disease; children with previous - Complications to IV sedation; Children with respiratory distress Age under 1 mo and bigger than 17y History of erythromycin used in 4 week ago

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Oral midazolam | Drug: Midazolam<br>* oral midazolam, was prepared into a final solution (2.5 mg/mL) from injectable midazolam hydrochloride and a orange flavored syrup. For preparation, midazolam injection (5 mg/mL) was diluted 1:1 with the flavored syrup.<br>|
| Active Comparator: 2<br>IV Midazolam | Drug: Midazolam<br>* oral midazolam, was prepared into a final solution (2.5 mg/mL) from injectable midazolam hydrochloride and a orange flavored syrup. For preparation, midazolam injection (5 mg/mL) was diluted 1:1 with the flavored syrup.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy and safety of endoscopy in children with used midazolam |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of sedation |  |  | 
| patient complications, ease of performing the procedure, time of preparation, time for recovery |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopy, Midazolam, pediatric, sedation, comfort
Safety and Efficacy of Botulinum Toxin Type A (BOTOX®) to Treat Chronic Migraine in Korea

Study Overview
=================
Brief Summary
-----------------
This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of botulinum toxin Type A to treat Chronic Migraine in clinical practice.

Conditions
-----------------
Migraine Disorders, Headache

Intervention / Treatment
-----------------
* Biological: botulinum toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with botulinum toxin Type A for chronic migraine in clinical practice. 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BOTOX®<br>Patients who receive botulinum toxin Type A (BOTOX®) treatment for chronic migraine as per local standard of care in clinical practice. | Biological: botulinum toxin Type A<br>* Botulinum toxin Type A treatment for chronic migraine as per local standard of care in clinical practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events and Adverse Drug Reactions |  | 4 Years | 
| Headache Impact Test-6 (HIT-6) Score Using a 5-Point Scale |  | 4 Years |
On Site Sensors Monitoring Impacts of Cognitive Decline on ADLs

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to compare the effectiveness of a continuous monitoring system to assess Activities of Daily Living (ADLs) over time compared to the traditional assessments used by medical professionals as Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) progresses.

Official Title
-----------------
Improved AD/ADRD Assessment Sensitivities Using a Novel In-Situ Sensor System

Conditions
-----------------
Dementia, Dementia Alzheimers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fluent in English to understand and sign the consent or assent documents. Adult over 65 years of age with no children under 18 years old living in residence. Adult anticipates they will be living primarily at designated residence over next 18 months. Must receive caregiver interaction at least 6 hours/week. Must undergo a Mini-Mental State Exam (MMSE) assessment at baseline during recruitment as well as at the end of the study with a resulting score of 11-25 as part of the recruitment phase of the study. Must be willing to have home or facility equipped with sensors to obtain activity and location data. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Demonstrate equivalency of the proposed IoT system against ADCS-ADL/23 Assessment | The ADCS-ADL/23 assessment will be utilized to measure changes in activities of daily living in the sample population while BC's system is also in place independently measuring the changes in activities of daily living. | 18 months | 
| Identify improved sensitivities for detection of early and moderate-stage AD/ADRD activities of daily living changes | AI techniques will search sensor data for subfactor and novel groupings for statistically significant improvements from what is measured by the ADCS/ADL-23 assessment of decline. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish initial data sets and protocols for use of the developed ADL/IADL system data for integration with AD/ADRD research | Database structures and meta-data will be established for anonymous data sets. | 18 months |
Simvastatin Therapy in Women With Polycystic Ovary Syndrome.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether statins (simvastatin) improve clinical (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).

Official Title
-----------------
Effects of Simvastatin on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Prospective, Randomized Trial.

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCO - ESHRE/ASRM criteria: oligomenorrhea (<8 spontaneous menses per year) and hyperandrogenism (hirsutism or acne) or hyperandrogenemia (testosterone >70ng/dl) Normal prolactin, TSH, 17-OH progesterone No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly Age 18-40 Reliable use of birth control pill for at least 3 months and no plans of pregnancy Exclusion Criteria: Elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminases) above 2 times of upper limit of normal Use of any of the following medications: cyclosporine, fibrates, niacin, antifungal agents, macrolide antibiotics. Use of oral contraceptives and other steroid hormones 3 months prior to the study Contraindications to oral contraceptives

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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: simvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum testosterone |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum lutropin |  |  | 
| serum follitropin |  |  | 
| serum lipids |  |  | 
| serum DHEA-S |  |  | 
| serum SHBG |  |  | 
| serum insulin |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, statin, testosterone, lipids
BÜHLMANN fPELA in the Diagnosis of Exocrine Pancreatic Insufficiency

Study Overview
=================
Brief Summary
-----------------
The study shall determine the clinical performance of the BÜHLMANN fecal pancreatic elastase (fPELA) assays in the diagnosis of exocrine pancreatic insufficiency (PEI). This is a observational and cross-sectional performance study. Specimens and clinical data are collected by a single study site. Included are subjects for which pancreatic elastase testing was indicated due to a suspected exocrine pancreatic insufficiency and which were at least 18 years of age. Subjects which suffered from diarrhea (stool water content ≥ 75%) at the time of sample collection are excluded from the study.

Official Title
-----------------
Clinical Evaluation of BÜHLMANN Fecal Pancreatic Elastase (fPELA) Tests in the Diagnosis of Exocrine Pancreatic Insufficiency (PEI)

Conditions
-----------------
Exocrine Pancreatic Insufficiency

Intervention / Treatment
-----------------
* Diagnostic Test: BÜHLMANN fPELA assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected exocrine pancreatic insufficiency at least 18 years of age. Exclusion Criteria: diarrhea (stool water content ≥ 75%) at the time of sample collection

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 |
| --- | --- |
| exocrine pancreatic insufficiency (PEI)<br>Established diagnosis of PEI based on a routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT). | Diagnostic Test: BÜHLMANN fPELA assay<br>* BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.<br>|
| no exocrine pancreatic insufficiency (no PEI)<br>No evidence of PEI according to routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT). | Diagnostic Test: BÜHLMANN fPELA assay<br>* BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI | Diagnostic sensitivity and specificity of BÜHLMANN fPELA assays | December 2021 |
Mutations of Glucocorticoid Receptor in Bilateral Adrenal Hyperplasia

Study Overview
=================
Brief Summary
-----------------
As the investigators observed a case of glucocorticoid mutation revealed by incidentally discovered bilateral adrenal nodular hyperplasia, it was postulated that this molecular anormality could be more frequent than previously described. To validate this hypothesis, it was decided to study 150 multicenter consecutive patients, presenting with incidentally discovered bilateral adrenal masses without clinical signs of Cushing's disease. In all these patients GR gene will be studied, mutations will be detected and described, functional disturbance will be tested. Usual polymorphisms will be described. Correlation between clinical signs, hormonal and morphological abnormalities and presence or absence of GR mutations will be searched.

Official Title
-----------------
Prevalence of Mutations of Glucocorticoid Receptors in Bilateral Adrenal Hyperplasia

Conditions
-----------------
General Glucocorticoid Resistance

Intervention / Treatment
-----------------
* Genetic: blood collection for mutation characterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients more than 18 years of age patients with bilateral adrenal masses Exclusion Criteria: Refusing to participate in the study Protected by law Have obvious signs of Cushing's syndrome No progressive neoplastic disease

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient<br> | Genetic: blood collection for mutation characterization<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of mutations |  | DAY 0 |