linjc16/ctgov huggingface dataset:
Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses

Study Overview
=================
Brief Summary
-----------------
This is a control matched prospective study evaluating the use of seromuscular flap for high risk anastomoses.

Detailed Description
-----------------
30 eligible patients have been enrolled in the study then each case was matched to a control of patients who undwerwent resection anastomosis with primary anastomosis only in the same study period in terms of age, gender, comorbidity, diagnosis.

Official Title
-----------------
Pedicled Seromuscular Flap For Enforcement Of High Risk Intestinal Anastomoses

Conditions
-----------------
Peritonitis

Intervention / Treatment
-----------------
* Other: seromuscular flap enforcement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with high risk anastomoses
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1sup group<br>enforcement of the anastomoses with seromuscular flap | Other: seromuscular flap enforcement<br>* seromuscular flap enforcement<br>* Other names: primary anastomosis only;|
| Placebo Comparator: 2nd group<br>primary anastomosis without enforcement | Other: seromuscular flap enforcement<br>* seromuscular flap enforcement<br>* Other names: primary anastomosis only;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anastomotic leak |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time |  | 2 hours | 
| wound complications |  | 5 weeks |
Comparison of Distally Based Sural Artery and Supramalleolar Flap for Coverage of Dorsum of Foot and Ankle Defects

Study Overview
=================
Brief Summary
-----------------
Our main aim for this study was to evaluate the long-term outcome comparisons between sural artery and Supramalleolar flap in the reconstruction of extensive defects of non-weight bearing regions of foot and ankle. The patients' information were collected through medical records and analyzed through SPSS

Detailed Description
-----------------
In this article we intend to present our experience comparing a series of the two types of flaps in terms of viability, coverage of defect, cosmetic appearance, and functions of foot and ankle based on self-designed Tool . This Tool contains 4 parameters i.e., Activity of daily living, coverage of defect, cosmetic appearance of Skin post flap, and Weight bearing status. A score was given to each parameter and on the basis of these scores, Long term outcome were analyzed of each patient

Official Title
-----------------
Comparison of Distally Based Sural Artery and Supramalleolar Flap for Coverage of Dorsum of Foot and Ankle Defects; A CROSS-SECTIONAL STUDY OF 53 PATIENTS

Conditions
-----------------
Open Wound of Lower Limb

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only defects of foot and ankle around dorsum and perimalleolar areas were included. Exclusion Criteria: The defects reconstructed with other local flaps and free flaps were excluded from this review

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 74 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 |
| --- | --- | --- |
| self-designed assessment tool | The functional outcome of each patient was measured by activity of daily living | 1996-2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Soft Tissue Injuries, fasciocutaneous flaps, Survival Rate
The Use of Aging Biomarkers in Saliva, Based on DNA Methylation Status in Elovl2 to Predict Biological Age

Study Overview
=================
Brief Summary
-----------------
There is a big change in our understanding of aging in recent years. Recent researches has revealed clock-like patterns of epigenetic change across in humans. The aging involves a timed epigenetic reprogramming. However, this biological clock which ticks in our DNA is affected by our experience, diet, stress, etc. and it could be changed by experience and life style potentially. The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in ELOVL2-AS1 gene in saliva samples using a next generation sequencing.

Official Title
-----------------
Clinical Trials on Prediction of Biological Age Using Saliva Samples of Healthy Population, Based on DNA Methylation Status in ELOVL2 Gene

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy population Exclusion Criteria: Chronic diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| The Use of Aging Biomarkers in Saliva, Based on DNA Methylation Status in Elovl2 to Predict Biological Age. | We will develop the linear model and a threshold value correlated with chronological age of the individuals participated in the current study. The model will be provided to the researchers: Methylation score=(CG1*b1+CG2*b2+ CG3*b3+CGn*n) + e CG1 is the methylation value of the first CG b1 is the regression coefficient for the first CG and e equals the intercept. n-is a number of CGs in the model We will develop the regression coefficient and intercept as well as the DNA methylation values for each individual for each CG. | 6 months to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epiaging, biological age, chronological age, DNA methylation, ELOVL2-AS1, ELOVL2
Prediction of Hemodynamic Reactivity During General Anesthesia Using Analgesia/Nociception Index (ANI)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing ear-nose-throat or lower limb orthopedic surgery on desflurane/remifentanil general anesthesia.

Detailed Description
-----------------
Measurement of analgesia/nociception index at different time points during procedure and assessment of analgesia/nociception index to predict hemodynamic reactivity by building receiver observer's characteristic curve.

Official Title
-----------------
Prediction of Hemodynamic Reactivity During Desflurane/Remifentanil General Anesthesia Using Analgesia/Nociception Index (ANI)

Conditions
-----------------
Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 years Ear-nose-throat or lower limb surgery General anesthesia using desflurane and remifentanil Exclusion Criteria: Age <18 yrs or >75 yrs Arrythmia Preoperative use of B-blockers Administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes Psychiatric diseases Autonomic nervous system disorders (epilepsy)

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate and/or systolic blood pressure by more than 20% within 5 minutes |  | Before induction of anesthesia, 1 min after incision, at steady-state anesthesia during procedure (an expected average of 30 min) and at arousal from general anesthesia in the end of procedure (an expected average of 60 min) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthopedic surgery, Analgesia/nociception index, Desflurane, Remifentanil, Ear-nose-throat surgery, Hemodynamic reactivity
Evaluation of Modified Adhesives With Dexcom G6 Sensor

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to collect and compare information on the performance of CGM adhesives in adults.

Official Title
-----------------
Evaluation of Modified Adhesives With Dexcom G6 Sensor

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: Dexcom Continuous Glucose Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older; No previously self-reported adhesive reactions to the any continuous glucose monitor (CGM); Exclusion Criteria: Extensive skin changes/diseases that preclude wearing the required number of devices (e.g., history of severe reactions from adhesive wear, extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites; Current or anticipated use of systemic corticosteroids (oral, injectable, or intravenous)

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Dexcom Continuous Glucose Monitoring System|Dexcom Sensor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesiveness and survivability of the adhesives | Number of adhesives that survive on the body during wear period | 10-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin irritation with the adhesives | Proportion of participants who self-report skin irritation during wear period. | 10-days | 
| Occurrence of adverse events with the adhesives | Highest Draize scale score for adhesive erythema, and edema during wear period. Recorded medical adhesive-related skin injuries (MARSI) and severity during wear period. | 10-days | 
| Assess user preference or acceptance of the adhesives worn during the study | Final day post-study satisfaction questionnaire (for each adhesive) will be given a score by taking the mean response on the scale 1-5. Satisfaction scores will be tabulated by adhesive. | 10-days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Continuous Glucose Monitoring Systems
Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate superior efficacy of DE-108 ophthalmic solution to that of Levofloxacin 0.5% ophthalmic solution as well as safety of the former used for perioperative bacteria eradication in patients who are scheduled for cataract surgery.

Official Title
-----------------
A Randomized, Double-masked, Parallel Group Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery (Levofloxacin 0.5% Ophthalmic Solution as a Comparator) - Phase III, Confirmatory Study of Perioperative Bacteria Eradication -

Conditions
-----------------
Cataract Surgery

Intervention / Treatment
-----------------
* Drug: DE-108
* Drug: Levofloxacin 0.5%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who are scheduled for cataract surgery Exclusion Criteria: Those who with suspected ocular infections based on clinical findings in the study eye. Those who have any eye disease other than cataract which requires treatment in the target eye. Those who have a history of allergy to the drugs to be used during the clinical study (such as fluoroquinolones, topical anesthetics and povidon iodine) Those who need to wear contact lenses during the study period

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DE-108<br>High concentration / Antibacterial Ophthalmic Solution | Drug: DE-108<br>* Subjects will be assigned to receive DE-108 ophthalmic solution to be administrated one drop a time 3 times daily for 3 days prior and for 14 days following cataract surgery.<br>* Other names: Levofloxacin;|
| Active Comparator: Levofloxacin 0.5%<br>Low concentration / Antibacterial Ophthalmic Solution | Drug: Levofloxacin 0.5%<br>* Subjects will be assigned to receive Levofloxacin 0.5% ophthalmic solution to be administrated one drop a time 3 times daily for 3 days prior and for 14 days following cataract surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the percentage of positive bacteriological test results (from Day -3 to Day 0) |  | 3 days (Day -3 to Day0) |
Retrospective Evaluation of the Effect of Ultrasound-guided Obturator Nerve Block on Complications in Transurethral (TUR-M) Resection Surgery for Bladder Side Wall Tumors.

Study Overview
=================
Brief Summary
-----------------
In this study, the effectiveness of obturator nerve block added to spinal anesthesia in the operation of transurethral resection (TUR-M) of bladder lateral-infrolateral wall tumors on the obturator reflex and related complications was investigated.

Official Title
-----------------
Retrospective Evaluation of the Effect of Ultrasound-guided Obturator Nerve Block on Complications in Transurethral (TUR-M) Resection Surgery for Bladder Side Wall Tumors.

Conditions
-----------------
Efficacy of Peripheral Nerve Blocks on Complications, Morbidity and Mortality

Participation Criteria
=================
Eligibility Criteria
-----------------
retrospective study Inclusion criteria: Patients over the age of 18 who have undergone bladder tumor surgery and whose anesthesia method is spinal anesthesia Exclusion Criteria: under 18 years old , received general anesthesia pregnant and pediatric patient data not used

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 |
| --- | --- | --- |
| Effect of ultrasound-guided obturator nerve block on complications in transurethral resection of bladder cancer | patient who underwent spinal anesthesia and obturator block | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of ultrasound-guided obturator nerve block on complications in transurethral resection of bladder cancer | The patient group who underwent spinal anesthesia and obturator block and the group without obturator block | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obturator nerve block, complications of transurethral resection, TUR-M
Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This research is being conducted to assess measurement correlations on different X-ray views on patients who have undergone or will undergo hip reconstruction surgery.

Official Title
-----------------
Study-Dependent Variability in Spinopelvic Parameters Among Patients Undergoing Total Hip Arthroplasty

Conditions
-----------------
Osteoarthritis, Hip

Intervention / Treatment
-----------------
* Diagnostic Test: EOS X-Ray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide informed consent. 40 patients: 20 preoperative THA, 20 postoperative THA; Sex: 20 men, 20 women; Age: 20 patients ≥ 70 years, 10 patients 50-70 years, 10 patients 18-50 years. Exclusion Criteria: - Patients with lumbosacral hardware, contralateral THA.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pre-THA<br>Subjects will be receiving EOS imaging prior to Total Hip Arthoplasty | Diagnostic Test: EOS X-Ray<br>* Repeated AP Pelvis x-ray and Lateral Lumbar EOS x-ray<br>|
| Other: Post-THA<br>Subjects will be receiving EOS imaging after Total Hip Arthroplasty | Diagnostic Test: EOS X-Ray<br>* Repeated AP Pelvis x-ray and Lateral Lumbar EOS x-ray<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pelvic incidence (PI) | Measured from EOS imaging and AP x-ray, reported in degrees | Baseline, 8 hours, 4 weeks | 
| Change in symphysis to sacrococcygeal junction distance (PSCD) | Measured from EOS imaging and AP x-ray, reported in millimeters (mm) | Baseline, 8 hours, 4 weeks | 
| Change in pelvic tilt (PT) | Measured from EOS imaging and AP x-ray, reported in degrees | Baseline, 8 hours, 4 weeks | 
| Change in sacral slope (SS) | Measured from EOS imaging and AP x-ray, reported in degrees | Baseline, 8 hours, 4 weeks | 
| Change in lumbar lordosis (LL) | Measured from EOS imaging and AP x-ray, reported in degrees | Baseline, 8 hours, 4 weeks |
Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Patients currently receiving hemodialysis will be randomized to receive 1 of 3 dialysate sodium prescriptions. The effects on blood pressure, interdialytic weight gain, thirst, and intradialytic symptoms will be assessed.

Official Title
-----------------
Effect of Lowering the Dialysate Sodium on Blood Pressure in Hemodialysis Patients: a Randomized Controlled Trial.

Conditions
-----------------
Hemodialysis

Intervention / Treatment
-----------------
* Other: Lowering the dialysate sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients on 3 times weekly hemodialysis of at least 3 months elevated average ambulatory blood pressures current dialysate sodium prescription 140mEq/L average pre-dialysis serum sodium <140mEq/L Exclusion Criteria: frequent intradialytic hypotension estimated life expectancy <1 year non-adherence to dialysis prescription pregnancy inability or unwillingness to complete study measures

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>standard dialysate Na 140 mEq/L | Other: Lowering the dialysate sodium<br>* Please see above<br>|
| Active Comparator: 2<br>dialysate sodium equal to patient's predialysis serum Na | Other: Lowering the dialysate sodium<br>* Please see above<br>|
| Active Comparator: 3<br>dialysate sodium lower than patient's predialysis plasma sodium | Other: Lowering the dialysate sodium<br>* Please see above<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory blood pressure | Ambulatory blood pressure to be taken over 24 hours at 4 week intervals throughout the study | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thirst |  | 3 months | 
| QOL Scores (KDQOL, mins to recovery) |  | 3 months | 
| intradialytic hypotension rate, intradialytic symptoms |  | 3 months | 
| mechanistic outcomes: interdialytic weight gain, extracellular fluid water, sodium ionic mass balance |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dialysate, sodium, hemodialysis, blood pressure, thirst, intradialytic symptoms, interdialytic weight gain, extracellular fluid balance, mechanisms