linjc16/ctgov huggingface dataset:
Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome

Study Overview
=================
Brief Summary
-----------------
the presence of cesarean section niche has adverse effects on success of ART outcome

Detailed Description
-----------------
A common finding by ultrasound in secondary infertility patients with previous cesarean sections is the presence of niche, which is formally defined as an indentation of the uterine myometrium of at least 2 mm at the site of the caesarean scar. The most common symptom of niche is abnormal uterine bleeding, other symptoms include dysmenorrhea, chronic pelvic pain, dyspareunia, and sub-fertility/infertility. It has been reported that a niche can reduce the chances of embryo implantation and may lead to spontaneous miscarriages if the implantation is close to or in the niche. The presence of a niche may render the actual embryo transfer procedure technically more difficult, and clinicians need to be aware of its presence and perform the transfer under ultrasound guidance to ensure the catheter bypasses the niche and enters the uterine cavity. Still the impact of c.s niche and its characteristics on outcome of ART is not clear.

Official Title
-----------------
Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome

Conditions
-----------------
Cesarean Section Niche Impact on ART

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women should have the following: Aged from 18 - 37 years old. Undergoing fresh ICSI cycles. A normal uterus with no anomalies or pathologies. At least one good-quality embryo/blastocyst available for transfer (3 BB and more according to Gardner and Schoolcraft grading system). Easy mockup embryo transfer (i.e. the catheter is smoothly inserted without touching the fundus, no cervix tenaculum is used and the catheter is clean of blood). Exclusion Criteria: Younger than 18 or older than 37 years old. Congenital uterine abnormality or pathology. Presence of a hydrosalpinx. Chronic diseases which are not suitable for pregnancy. ICSI cycles with fresh or frozen TESE samples.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 37 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effect of cesarean section scar niche on ongoing pregnancy rate in ART cycles. | cesarean section scar niche will be measured by TVS | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean Section niche
Assisted Fluid Management vs Manual GDFT

Study Overview
=================
Brief Summary
-----------------
Goal-directed fluid therapy (GDFT) strategies based on cardiac output (CO) optimization have been shown to benefit moderate- to high-risk surgery patients and have recently been recommended by professional societies in the UK, in France, and in Europe. However, despite the growing evidence, these strategies are often not implemented in current practice. One of the reasons for this lack of implementation is that GDFT strategies, like any other complex clinical protocol, require significant provider attention and vigilance for consistent implementation and it is well known that even under study conditions protocol compliance rates are often not greater than 50%. To overpass this problem, our CO monitoring devices (EV1000, Edwards Lifesciences) have now an incorporated assisted fluid management software. This software determines fluid responsiveness by estimating the predicted change in stroke volume and suggests to the anesthesiologist when fluid is required .

Detailed Description
-----------------
The aim of this study was to assess an assisted fluid management strategy in a moderate-to-high risk surgical cohort and compare that cohort to matched patients who received manual GDFT. Our hypothesis was that the assisted fluid management system would result in higher mean percentage time spent during surgery with a SVV < 13%

Official Title
-----------------
Assisted Versus Manual Goal Directed Fluid Therapy in Major Abdominal Surgery

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing major abdominal surgery and requiring a CO monitoring for fluid management Exclusion Criteria: Emergency surgery Arrhythmia (e.g. atrial fibrillation) Aortic regurgitation

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 |
| --- | --- | --- |
| percentage time spent with SVV < 13% | defined as preload independent state | intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of fluid administered | amount of cristalloid ( baseline ) AND fluid boluses (250 ml) received | intraoperative period | 
| amount of vasopressors required | amount of ephedrine, phenylephrine and norepinephrine | intraoperative period | 
| fluid balance | FLUID IN - FLUID OUT | intraoperative period | 
| incidence of major and minor complications | see study protocol NCT03039946 for the description of these complications | until 30 days post surgery | 
| PACU/ICU and hospital length of stay | time spent in ICU and PACU | until 30 days post surgery |
Reduction of Immunization Discomfort in Children

Study Overview
=================
Brief Summary
-----------------
A combination of topical anesthetic, plastic arm gripper, visual focusing task and hypnotic suggestions will reduce the discomfort associated with immunization of pre-kindergarten aged children.

Detailed Description
-----------------
Randomization of 42 children evaluated the method described above against an office routine control group.

Official Title
-----------------
Reduction of Immunization Discomfort in 4-6 Year Old Children: A Randomized Clinical Trial.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Behavioral: Topical anesthetic and hypnotic distraction
* Behavioral: Office routine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children ages 4-6 years scheduled to receive routine pre-kindergarten immunizations Exclusion Criteria: Inability to follow verbal directions Significant concurrent illness Prior invasive procedures, excluding neonatal circumcision

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Ethyl chloride spray, plastic arm gripper, vibrating instrument, hypnotic suggestions | Behavioral: Topical anesthetic and hypnotic distraction<br>* Ethyl chloride spray, plastic arm gripper, vibrating instrument, hypnotic suggestions.<br>* Other names: Wahl vibrator;|
| Placebo Comparator: 2<br>Office routine | Behavioral: Office routine<br>* Standard vaccine administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial Pain Scale and Faces-Legs-Activity-Cry-Consolability Scale measurements of degree of discomfort. |  | 10 Minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunizations, Children, Injections, aged 4-6 Years, Hypnosis
The Effect of Green Tea or Cocoa Extracts in Endothelial Dysfunction in Patients With Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether green tea or cocoa extracts are effective in improve endothelial dysfunction in patients with diabetes mellitus and nephropathy and arterial hypertension.

Official Title
-----------------
Randomized Clinical Trial, Placebo Controlled, With Parallel Groups to Investigate Whether Green Tea or Cocoa Extracts Improves Endothelial Dysfunction in Patients With Diabetes Mellitus and Nephropathy and Hypertension

Conditions
-----------------
Diabetes Mellitus, Diabetic Nephropathy, Arterial Hypertension

Intervention / Treatment
-----------------
* Other: green tea extract
* Other: cocoa extract rich in polyphenols
* Other: placebo
* Other: low polyphenol cocoa extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or type 2 diabetes mellitus Diabetic nephropathy Hypertension Exclusion Criteria: GFR < 30 ml/min/1.73m2 Serum K > 5.5 mEq/L Age < 18 y Pregnancy Breast feeding Cocoa or green tea intolerance Alcohol and drugs abuse Incapacity to understand the information related to the study

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 |
| --- | --- |
| Active Comparator: green tea extract<br> | Other: green tea extract<br>* 1.21g of green tea extract (965 mg of flavonols)<br>* Other names: Green tea extract, sunphenon 90DCF-T, Tayo, CO., LTD;|
| Active Comparator: Cocoa extract rich in polyphenols<br> | Other: cocoa extract rich in polyphenols<br>* 2.14 g of cocoa extract rich in polyphenols equivalent to 965 mg of polyphenols<br>* Other names: Acticoa cocoa extract NCE-PO803-W41, Barry Callebaut, Belgium;|
| Placebo Comparator: placebo<br> | Other: placebo<br>* placebo<br>|
| Placebo Comparator: cocoa extract with low polyphenol<br> | Other: low polyphenol cocoa extract<br>* placebo<br>* Other names: placebo cocoa extract, Barry Callebaut, Belgium;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow-mediated dilation (FMD) |  | up to 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial blood pressure and cardiac rate |  | up to 4 hours | 
| plasma levels of flavonols |  | up to 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes mellitus, diabetic nephropathy, hypertension, green tea, cocoa, polyphenol, nitric oxide
PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections

Study Overview
=================
Brief Summary
-----------------
Implantation of joint prostheses is currently the second largest diagnosis-related group in the Danish health service, and in view of the demographic development and spread of lifestyle diseases, this type of intervention is expected to continue to increase. Unfortunately, 5% of patients experience significant discomforts and complications. The second most frequent and serious complication is infection. While the established laboratory analyses (culture of tissue biopsies) are good at diagnosing acute infections, they are not satisfactory to diagnose a large group of patients especially with chronic infections. This can lead to prolonged diagnosing time and even to wrong diagnosis. Several studies have shown that analyses of prosthetic parts and the use of molecular biological methods for detecting infecting microorganisms can significantly improve diagnostics accuracy. The purpose of this project is primarily to demonstrate that analyses of bacterial specific DNA (16S rRNA genes) can confirm or rule out infection as fast (or faster) as cultivation methods. Rapid clarification can promote targeted treatment and in order to demonstrate this, the trial is conducted as a randomized study. .

Official Title
-----------------
PRO-DIAG: Improved Diagnosis of Prosthetic Joint Infections

Conditions
-----------------
Prosthesis-Related Infections

Intervention / Treatment
-----------------
* Procedure: revision surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: revision of hip platelets (THA) or knee replacement (TKA) on indication of likely infection Exclusion Criteria: surgery within the last 4 months. The same applies to patients with short history of illness, pronounced acute symptoms and systemic response (reducing the likelihood of biofilm infection).
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: DNA based diagnosis<br> | Procedure: revision surgery<br>* If DNA based diagnosis detects infection, standard revision surgery will be conducted<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved diagnostic accuracy | DNA based method can detect patients with hidden chronic infections more often than culture | 6 months post surgery |
Use of Rainbow Acoustic Monitoring in Pediatric Patients - A Clinical Engineering Data Collection Protocol

Study Overview
=================
Brief Summary
-----------------
The study will capture high resolution waveform data and numerical data from three respiratory rate methods: end tidal CO2, impedance pneumography, and bioacoustic sensing (Rainbow Acoustic Monitoring, RAM).

Official Title
-----------------
Use of Rainbow Acoustic Monitoring in Pediatric Patients - A Clinical Engineering Data Collection Protocol

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

Intervention / Treatment
-----------------
* Device: RAM sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 0 to 18 years old inclusive, male and female patients Only patients with written informed consent signed by parents or legal guardians will be enrolled In children 10 and older, patient's assent will be obtained Exclusion Criteria: Patients who are unable to give their consent and/or assent Patients with skin abnormalities (rash, eczema, etc) at the planned application sites that would interfere with sensor, cannula or electrode applications

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Subjects<br>All test subjects were pediatric patients following general anesthesia who received the RAM sensor which measures respiration rate. | Device: RAM sensor<br>* Acoustic Respiration Monitor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of RAM sensor to detect respiration rate | Accuracy will be determined by comparing the noninvasive respiratory rate measurement of the sensor to that obtained from a reference and calculating the arithmetic root mean square (Arms) error value. | 1-6 hours |
Intraoperative Blood Pressure and Cognitive Performance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prospectively determine the association between incidence of neurological morbidity and minimum fractional blood pressure reached during laminectomy procedures under general anesthesia in hypertensive and normotensive subjects 40 years old and older.

Official Title
-----------------
Impact of Intraoperative Blood Pressure on Cognitive Performance in Patients With and Without Hypertension: a Prospective Observational Study

Conditions
-----------------
Cognitive Performance, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English as first language, or as a learned language as long as the patient is proficient No history of any neurological disease with the exception of patients without functional impairment who suffered a single episode of transient ischemic attack No history of axis I psychiatric diagnosis or drug abuse 40 years old or older Undergoing laminectomy under general anesthesia Must not take antihypertensive medication for purposes other than treatment of hypertension Exclusion Criteria: Anyone who do not fit the inclusion criteria.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hypertensive<br> | |
| normotensive<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative cognitive performance |  | 1 |
Airway Management During TCI vs RSI Anesthesia Induction

Study Overview
=================
Brief Summary
-----------------
The aims of this observational study is to evaluate and compare feasibility of airway management during standardized TCI and RSI anesthesia induction.

Detailed Description
-----------------
The aims of this study are to evaluate and compare feasibility of airway management and risk for desaturation during standardized target controlled infusion (TCI) and rapid sequence induction (RSI) of anesthesia. A conventional way to induce anesthesia, i.e. manual injection of anesthetics, may be more accurate and predictable compared to dosing regimes based on complex mathematical algorithms used in TCI-systems. In addition, today many different models are presented and there is no consensus which kind of TCI-algorithm should be used universally. Moreover, dosing algorithms are most complex and challenging in underweight and morbid obesity. There are many publications on this field, but no data of feasibility of airway management can be found. Indeed, RSI induction is traditionally blamed to be risky and not recommended as a first choice.

Official Title
-----------------
Airway Management and Safety Aspects During Target Controlled Infusion (TCI) Compared to Rapid Sequence Induction (RSI) of Anesthesia in Non-cardiac Surgery

Conditions
-----------------
Adverse Effect, Anesthesia, Airway Complication of Anesthesia

Intervention / Treatment
-----------------
* Procedure: Induction of anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed informed consent BMI < 35 kg/m2 preoperative assessment accepted by consultant anesthesiologist scheduled for breast cancer surgery, endocrinological surgery (thyroid, parathyroid) or minor general abdominal surgery. Exclusion Criteria: not signed consent instable angina pectoris severe bronchial asthma severe chronic obstructive pulmonary disease dementia severe heart valve disease severe renal failure body mass index > 35 kg/m2

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

| Intervention/Treatment |
| --- |
|Procedure: Induction of anesthesia|Standardized TCI and RSI anesthesia induction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety time for apnea | measurement of length of period for apnea during TCI and RSI induction by a timer | 10min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of spontaneous breathing | measurement of duration of spontaneous breathing during TCI and RSI induction by a timer | 10min |
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.

Study Overview
=================
Brief Summary
-----------------
The aim of the project is to investigate the clinical and patient centred outcomes of people with Peripheral Arterial Disease (PAD) attending a podiatry led integrated care pathway, utilising advice on diet, activity and smoking cessation. The podiatry clinic will be delivered from the Move More centre (NCSEM) and participants will be encouraged to access these facilities as part of their activity programme which will be agreed with the physical activity team. Primary and secondary outcomes will be clinical - claudication pain, distance walked at 3 and 6 months, blood pressure and lipid monitoring, weight management, reduced BMI, and the success of any smoking cessation. Quality of life and patient satisfaction with the programme will also be assessed.

Official Title
-----------------
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Other: PAD tailored care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patient between the ages of 50-90 years, Patient attending for podiatry treatment diagnosis of PAD or is showing signs of symptoms of PAD wishes to take part in the study. Exclusion Criteria: Anyone unable to give informed consent due to lack of mental capacity. Anyone who would be unable to participate in increased activity due to other co-morbidities

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>PAD tailored care | Other: PAD tailored care<br>* PAD tailored care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance walked before onset of intermittent claudication | Distance walked before onset of intermittent claudication | 6 months |