linjc16/ctgov huggingface dataset:
Detection Rate of Serrated Adenomas in Screening Colonoscopy

Study Overview
=================
Brief Summary
-----------------
An observational prospective will be conducted to determine the detection rate of serrated adenoma during screening colonoscopy at our institution. Additionally, the variability of serrated adenoma detection among endoscopists will be evaluated and the characteristics of serrated adenomas will be described.

Detailed Description
-----------------
Colonoscopy screening is a preventative measure for colorectal carcinoma (CRC), a highly malignant and dangerous cancer. Extensive research on the adenoma detection rate has provided national standards and quality metrics to help assess competence of endoscopists. Currently, there are no standards established for serrated adenomas. The proposed study would be conducted at Good Samaritan Hospital (GSH) and TriHealth Surgery Center West. This is an observational study and does not involve any patient interventions. However, because patient healthcare data will be collected for research, informed consent will be obtained shortly before the procedure. The main study objective is to determine the detection rate of serrated adenoma during screening colonoscopy at our institution. Additionally, the variability of serrated adenoma detection among endoscopists will be evaluated and the characteristics of serrated adenomas will be described.

Official Title
-----------------
Detection Rate of Serrated Adenomas in the Screening Colonoscopy Population

Conditions
-----------------
Healthy Patients Undergoing Screening Colonoscopy

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females Exclusion Criteria: First degree relative (patient's parent, sibling or child) diagnosed with colorectal carcinoma at age of 59 or under New onset of iron deficiency anemia (within past 3 months) Abnormal imaging of colon within past 3 months Inadequate visualization reported by endoscopist Pregnant women

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No Intervention|This is an observational study, so standard of care will be followed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serrated Adenoma | Prevalence of Serrated Adenoma | March 2018 to October 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Serrated Adenoma, Colonoscopy
Management of Nailbed Injuries

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether nail plate removal in suspected nailbed injury improves patient outcomes.

Official Title
-----------------
Management of Nailbed Injuries

Conditions
-----------------
Nail Bed Injury

Intervention / Treatment
-----------------
* Procedure: Nail plate removal, nail bed repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any individual greater than or equal to 2 years of age presenting with a suspected nailbed injury (laceration adjacent to or through nail plate and/or subungual hematoma) with the nail plate present Exclusion Criteria: nail plate absent over the nailbed injury

Ages Eligible for Study
-----------------
Minimum Age: 2 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nail plate removal, nail bed repair<br>Participants will undergo nail plate removal and nail bed repair, and follow up at clinic visits at 1 week, 3 months, and 6 months | Procedure: Nail plate removal, nail bed repair<br>* Injection of local anesthetic, removal of nail plate, inspection of nail bed, repair of nail bed with suture and/or adhesive<br>|
| No Intervention: Observation<br>Participants will follow up at clinic visits at 1 week, 3 months, and 6 months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who experience complications over time | Any complication, including but not limited to infection or wound healing complications | 6 months | 
| Change in pain score over time as measured on a pain scale | Scored from 0-10 (higher scores indicate worse pain) | 6 months | 
| Change in cosmetic appearance over time as measured by the Oxford Finger Nail Appearance Score | Oxford Finger Nail Appearance Score | 6 months | 
| Change in upper extremity function over time as measured by the QuickDash score | QuickDASH score | 6 months |
Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Minimal Encephalopathy

Study Overview
=================
Brief Summary
-----------------
The study aimed to assess the effectiveness and safety of L-ornithine-L-aspartate in the management of hepatic encephalopathy.

Detailed Description
-----------------
Hepatic encephalopathy continues to be a major clinical problem in cirrhosis. Patients with minimal hepatic encephalopathy are at risk for accidents, had a decline in work performance, or complain of cognitive symptoms, with poor health-related quality of life. This study will compare L-ornithine-L-aspartate with placebo for 60 days to assess the effectiveness, safety and health-related quality of life of this drug.

Official Title
-----------------
Therapeutic Efficacy of Oral L-Ornithine-L-Aspartate on Liver Cirrhosis and Minimal Encephalopathy: a Single Center Placebo Control Double Blind Study

Conditions
-----------------
Hepatic Encephalopathy

Intervention / Treatment
-----------------
* Drug: L-ornithine-L-aspartate
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis and diagnosis of minimal hepatic encephalopathy using psychometric tests and critical flicker frequency Exclusion Criteria: Hepatic encephalopathy grade 1 to 4 Use of drugs to treatment of hepatic encephalopathy (lactulose, neomycin) Psychoactive substance use within 72 hours

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L-ornithine-L-aspartate<br>5 g L-ornithine-L-aspartate (1 sachet) three times per day for 60 days | Drug: L-ornithine-L-aspartate<br>* L-ornithine-L-aspartate: 5 g (1 sachet) three times per day for 60 days<br>|
| Placebo Comparator: placebo<br>5 g (1 sachet) of placebo comparator three times per day for 60 days | Drug: placebo<br>* Placebo: 5 g (1 sachet) three times per day for 60 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychometric tests and critical flicker frequency |  | day 0, 15, 30, 45 and 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ammonia concentration |  | time 0 and 60 days after | 
| Health-related quality of life |  | time 0 and 60 days after | 
| Safety analysis |  | time 0 and 60 days after | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
minimal hepatic encephalopathy, L-ornithine-L-aspartate, psychometric test, critical flicker frequency, quality of life, Treatment, Health-related quality of life
Outcomes Following Delta Xtend Reverse Shoulder System

Study Overview
=================
Brief Summary
-----------------
To collect medium to long-term survivorship implant outcomes on the DePuy Delta Xtend Reverse Shoulder Stystem.

Conditions
-----------------
Reverse Total Shoulder Arthroplasty

Intervention / Treatment
-----------------
* Device: DePuy Delta Xtend Reverse TSA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients whom were implanted with the DePuy Delta Xtend Reverse Total Shoulder System in the time frame indicated. Patients must be willing to sign the consent form and complete all follow-up visits.

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 |
| --- | --- |
| DePuy Delta Xtend RTSA<br> | Device: DePuy Delta Xtend Reverse TSA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survivorship |  | 10 years post-operative |
Kneipp Water Applications for Insomnia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to ascertain whether warm footbathes are effective on sleep disturbances in women before climacteric.

Official Title
-----------------
Effects of Ascending Warm Footbaths on Sleep Disturbances in Women Before Climacteric

Conditions
-----------------
Sleep Disturbance

Intervention / Treatment
-----------------
* Procedure: footbath
* Behavioral: care of sleep


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age: 18 years Regularly recurring sleeping disease (not less then 2 times a week for minimum 3 month) Exclusion Criteria: secundary sleeping disease Mental diseases which require therapy Medication: benzodiazepine,Z-drugs, barbiturat, antihistaminika, melatonin Severe comorbidity Gravidity Shift work Voyages (>3 times during the study) regulary application of Kneipp Participation on other studies to therapy sleeping diseases or stress

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Footbath, care of sleep<br>Warm water (37°C) filled up to the level of the ankle. Water has to be heated up to 42°C and increased to the calf 's half height within 15 minutes. Information about wrong and correct behaviour. | Procedure: footbath<br> <br> Behavioral: care of sleep<br> <br> |
| Active Comparator: Care of sleep<br>Information about wrong and correct behaviour. | Behavioral: care of sleep<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of sleep quality | Use Pittsburgh sleep quality index | T1: At the beginning of intervention, T2: After 4 weeks of intervention, T3: 12 weeks after randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep disturbance, footbath, Kneipp, care of sleep, sleep
Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream

Study Overview
=================
Brief Summary
-----------------
Earliest Stage Treatment of Actinic Keratosis with Imiquimod 3.75% Cream: The study is to demonstrate that Aktinic Keratosis are present before they are clinically visible, i.e. in a subclinical stage. Since on the basis of the research situation, also subclinical AK can proliferate into the dermis, it is possible that with the application of Imiquimod on chronically light-exposed skin, undetected squamous cell carcinoma can be recognized and treated at the same time.

Official Title
-----------------
Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream

Conditions
-----------------
Actinic Keratoses

Intervention / Treatment
-----------------
* Drug: Imiquimod 3.75% Cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Male and female supposed-healthy volunteer outpatients, age: > 50 years. Diagnosis: patients with chronically UV-exposed photodamaged facial skin. Consent by signing the ICF (Informed Consent Form) Exclusion Current participation in another clinical trial Patients who are using topical glucocorticoids on the face. Known intolerance/hypersensitivity to imiquimod Pregnant/breastfeeding women Systemic disease, immunodeficiency

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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: Earliest Stage Treatment of Aktinic Keratosis<br> | Drug: Imiquimod 3.75% Cream<br>* Imiquimod 3.75% Cream<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunomodulatory-induced inflammatory reaction | Percentage of subjects in whom an immunomodulatory-induced inflammatory reaction occurs on chronically light-exposed uv-damaged facial skin after two weeks. | two weeks |
Total Hip Arthroplasty Outcomes With Regional and Multimodal Analgesia

Study Overview
=================
Brief Summary
-----------------
The goal of this retrospective chart review is to evaluate if the implementation of lumbar plexus block placement for postoperative pain and administration of multimodal oral analgesia have improved conditions in the postoperative period for patients undergoing total hip arthroplasty when compared to the placement of epidurals for postoperative pain management.

Detailed Description
-----------------
Primary outcome: 48 hour opiate consumption in patients following THA. ' Secondary outcome: Time to first ambulation, assitstance needed with ambulation, opiate and regional related side effects, time to discharge orders.

Official Title
-----------------
Improvement in Total Hip Arthroplasty Patient Outcomes With Regional Anesthesia and Multimodal Analgesia: A Retrospective Analysis

Conditions
-----------------
Arthroplasty, Replacement, Hip, Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary total hip arthroplasty, (identified by current procedural terminology (CPT) code 27130) and Either a) Epidural or b) Lumbar plexus peripheral nerve block with the administration of multimodal medication after July 2012. - Exclusion Criteria:Exclusion criteria include THA Revision, ICU admission postoperatively, and dementia, not allowing pain score communication. -

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 |
| --- | --- |
| Lumbar plexus<br>Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively. | |
| Lumbar Epidural<br>Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate Consumption | Cumulative 48 Hours Opiate Consumption in Intravenous (IV) Morphine mg Equivalents (MME) | 48 hours postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthroplasty, Replacement, Hip
Do Hostility and Stress Predict Cardiovascular Mortality in MRFIT?

Study Overview
=================
Brief Summary
-----------------
To test the hypothesis that high levels of hostility, depressive symptoms, and stressful life events would be associated with all cause and cardiovascular disease (CVD) mortality after 16 years of follow-up in the Multiple Risk Factor Intervention Trial (MRFIT).

Detailed Description
-----------------
BACKGROUND: MRFIT was a randomized, multicenter primary prevention trial designed to determine whether a special intervention consisting of smoking cessation, cholesterol reduction and control of high blood pressure, would result in a significant reduction in coronary heart disease (CHD) mortality, compared to usual care. The study presented a unique opportunity to test in a cost-efficient manner the association of psychosocial factors and mortality in a large, well characterized sample of middle-aged men. DESIGN NARRATIVE: The sample was composed of 12,866 men who at the time of study entry were in the top 15 percent of a risk score distribution based on the Framingham Heart Study data, but had no clinical evidence of CHD. During the trial, annual measurements were taken, which included some health behaviors, stressful life events, feelings of anger and hostility. A subset of 3,110 men also were administered once the Type A Structured Interview from which Potential for Hostility could be rated and all men who survived until the sixth year of the trial were administered the CES-Depression scale. After approximately seven years of the active phase of the trial, the men were followed for an additional 9 years for mortality and cause of death. To test the major study hypotheses, the investigators coded all Type A Structured Interview tapes for Potential for Hostility, and components of hostility (Style, Intensity, Content) and constructed and validated a self-report measure of hostility from items administered to all participants. Cox proportional hazard regression techniques were used to test the association of hostility, depression, and stressful life events with all cause and CVD mortality. If the major study hypotheses were confirmed, then educational attainment, baseline risk factors, change in risk factors, and adherence indicators would be included in subsequent analyses. 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, Coronary Disease, Heart Diseases, Depression

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

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Bioavailability of Anthocyanins of Blue Potatoes as Compared With Bilberries

Study Overview
=================
Brief Summary
-----------------
In this study, the postprandial glycemia and insulinemia caused by boiled potato with blue-fleshed or yellow-fleshed tubers, or a gel prepared with bilberries and potato starch, is studied in healthy males. Additionally, the appearance and metabolism of the flavonoids and their metabolites is studied in plasma and urine.

Official Title
-----------------
Bioavailability of Anthocyanins of Blue Potatoes as Compared With Bilberries

Conditions
-----------------
Postprandial Glycemia

Intervention / Treatment
-----------------
* Other: Dietary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-45 Male No regular medication No participation in a drug trial or blood donation within 2 months Non-smoker Signs informed consent Body mass index 18.5-27 kg/m2 Fasting plasma cholesterol < 5.5 mmol/l Fasting plasma triacylglycerols < 2.6 mmol/l Fasting plasma glucose 4-6 mmol/l blood pressure <140/80 mmHg hemoglobin>130 g/l Fasting plasma alanine amino transferase (ALAT) <60 U/l (normal liver function) Fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function) Fasting plasma creatinine <118 µmol/l (normal kidney function) Exclusion Criteria: Regular smoking Alcohol abuse Regular medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blue-fleshed potato tubers<br>Intervention: Steam cooked mashed potato tubers | Other: Dietary intervention<br> <br> |
| Experimental: Yellow-fleshed potato tubers<br>Intervention: Steam cooked mashed potato tubers | Other: Dietary intervention<br> <br> |
| Experimental: Bilberries and potato starch<br>Intervention: A gel boiled with bilberries and potato starch | Other: Dietary intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose concentration |  | 20min, 40min, 60min, 90min, 120min, 180min, 240min | 
| Plasma insulin concentration |  | 20min, 40min, 60min, 90min, 120min, 180min, 240min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations and quality of flavonoid color compounds or their metabolites in plasma and urine (HPLC-measurement) |  | 20min, 40min, 60min, 90min, 120min, 180min, 240min | 
| Concentrations and quality of flavonoid color compounds or their metabolites in plasma and urine (NMR-measurement) |  | 20min, 40min, 60min, 90min, 120min, 180min, 240min |