linjc16/ctgov huggingface dataset:
Natural Cycle or Stimulated Cycle Versus Hormone Replaced Cycle for Pre-eclampsia Rate

Study Overview
=================
Brief Summary
-----------------
Recent sutdies indicate that the existence of corpus lutein in the ovary is a key point to prevent preeclampsia, and patients undergoing FET with hormone replaced cycle have no corpus lutein and the absence of corpus lutein significantly increases the risk of preeclampsia in these patients. We aim to conduct a single center randomized trial study to compare the preeclampsia rate between the natural cycle and the hormone replaced cycle in patients undergoing FET.

Official Title
-----------------
The Live Birth Rate in Natural Cycle or Stimulated Cycle Versus Hormone Replaced Cycle in Patients Undergoing Frozen-thawed Embryo Transfer

Conditions
-----------------
Pre-Eclampsia

Intervention / Treatment
-----------------
* Other: natural cycle for endometrium preparation
* Other: hormone replaced cycle for endometrium preparation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 42 years old women; normal ovulation; Scheduled to undergo frozen-thawed embryo transfer. Agreeing with the informed consent. Exclusion Criteria: Those who experienced embryo transfer cycle failure for at least three times; One or both of the ovaries removed; Hypertention disease before embryo transfer; No available embryo for transfer Oocyte or sperm donated cycles

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: natural cycle for endometrium preparation<br>patients will have ovulation before embryo transfer | Other: natural cycle for endometrium preparation<br>* patients will not use oral contraceptive drugs<br>* Other names: non;|
| Experimental: hormone replaced cycle for endometrium preparation<br>patients will do not have ovulation before embryo transfer | Other: hormone replaced cycle for endometrium preparation<br>* patients will receive oral contraceptive drugs for menstruation before embryo transfer<br>* Other names: non;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate | A delivery is considered successful live birth | delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-eclampsia | Preeclampsia is defined using the current American College of Obstetricians and Gynecologists definitions (Gynecologists; and Pregnancy 2013) | From gestational week 20 to delivery |
Frailty Assesment in the Congestive Heart Failure Clinic

Study Overview
=================
Brief Summary
-----------------
Frailty is known as an independent risk factor for morbidity and mortality in older cardiac patients, including patients with congestive heart failure. It is an important factor taken into the cardiologists decision making in the clinic, and influences the intensity of follow up treatment, invasive intervention and the need to ensure a stronger social support system for the patient. Frailty assessment is usually made subjectively by the cardiologist, known in the literature as eyeball testing. In this study the investigators will compare the cardiologists subjective eyeball testing to objective frailty assessment tests based on Fried score and Edmonton frail scale

Detailed Description
-----------------
Elderly patients visiting the congestive heart failure clinic at Meir Medical Center will be assessed for frailty twice. Once in an eyeball test by their cardiologist at the clinic, and a second time in an objective test based on fried and Edmonton frailty scores. The second subjective assessment will be made by geriatric and internal medicine physicians, and the cardiologist won't be aware of the results of the objective assessment. The results of both tests will be compared.

Official Title
-----------------
Frailty Assesment in the Congestive Heart Failure Clinic

Conditions
-----------------
Fragility Syndrome, Congestive Heart Failure

Intervention / Treatment
-----------------
* Diagnostic Test: frailty test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients an the Meir congestive heart failure clinic. age 70 and above can sign an informed consent Exclusion Criteria: patients admitted in the last two month

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: frailty test|questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An objective frailty assessment using fries score an Edmonton frailty scale will be compared to a subjective eyeball frailty assessment. |  | 1 week |
LIdocaine veRsus Sufentanil Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
Since the 90's the concept of morphine sparing and morphine free anaesthesia (OFA) has progressively developed in non-cardiac surgery. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic modifications does not translate into a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, the sympathetic reaction and the inflammatory reaction can be controlled by other therapeutic classes than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In this hypothesis, OFA is more and more practiced in various situations without the real impact in terms of clinical benefit being clearly demonstrated. In cardiac surgery, some centers practice OFA with various protocols.The purpose of this work is to retrospectively evaluate over a defined period the incidence of postoperative complications, length of stay in the ICU/hospital, and death rate between patients managed with/without OFA based on lidocaine.

Official Title
-----------------
Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas

Conditions
-----------------
Opioid Free Anaesthesia, Opioid Anaesthesia

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 years Cardiac surgery with cardiopulmonary bypass performed between January 2019 and June 2021 Exclusion Criteria: LVAD Heart transplantation Incomplete data in relation to outcomes

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 |
| --- | --- |
| Opioid free anaesthesia<br>patient anesthtesized with lidocaine | Other: Data collection<br>* complications: cardiac, neurological, renal, respiratory, red blood transfusion Hospital stays: ICU stays and hospital stay<br>|
| Opioid anaesthesia<br>patients anesthetized with sufentanil | Other: Data collection<br>* complications: cardiac, neurological, renal, respiratory, red blood transfusion Hospital stays: ICU stays and hospital stay<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU stays (days) | Total stay in ICU in day | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | cardiac, neurological, renal, respiratory, red blood transfusion | Day 30 | 
| Hospital stays (days) | hospital stay | Day 30 |
Long-term Use of Spiolto Respimat in Japanese Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting

Official Title
-----------------
Post-marketing Surveillance (PMS) on Long-term Use of Tiotropium+Olodaterol Fixed Dose Combination (Tio+Olo FDC) 5µg/5µg in Patients With Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) in Japan

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Spiolto


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients who have been diagnosed with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) by physician and need relief of various symptoms associated with Long Acting Beta2 Agonist (LABA) or Long Acting Muscarinic Antagonist (LAMA). Patients who are prescribed Tio+Olo FDC 5µg/5µg for the first time Exclusion criteria: Patients who have been registered once in this study (i.e., re-entry of patients is not allowed). Patients who are participating in a registry or clinical trial. Patients who have a contraindication to Tio+Olo FDC 5µg/5µg defined in the package insert for Tio+Olo FDC 5µg/5µg.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Spiolto<br>Patient with COPD to received Spiolto | Drug: Spiolto<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Drug Reactions | Percentage of participants with adverse drug reactions (ADR). An adverse drug reaction (ADR) is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Spiolto® Respimat® as Yes. | From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of COPD Assessment Test (CAT) Score From Baseline to Week 12 | The COPD Assessment Test™ (CAT) is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health). The CAT questionnaire has the advantage of a reduced number of items and could be used to assess the effects of inhaled therapies. The CAT score was the sum of the values corresponding to the answers to the eight questions. | Baseline and Week 12 |
Transfer of Skills From VR-Trainer to Operation Room

Study Overview
=================
Brief Summary
-----------------
The purpose is to determine if skills obtained by training in the laparoscopic virtual reality simulator LapSimGyn can be transferred to a real laparoscopic operation measured as improved score in a technical skills assessment.

Detailed Description
-----------------
The purpose is to determine if skills obtained by training in the laparoscopic virtual reality simulator LapSimGyn can be transferred to a real laparoscopic operation measured as improved score in a technical skills assessment. Design: prospective randomized double blinded intervention study. Subjects:Younger gynaecologists (Postgraduate year 2-8) Half are having conventional training the other half is undergoing virtual reality simulator training before performing their first laparoscopic salpingectomy. Outcome is measured by blinded video evaluation with criteria. The criteria is defined in the previous validated scoring system Objective Structured Assessment of Technical Skills (OSATS)

Official Title
-----------------
Transfer of Skills From LapSimGyn VR-Simulator to a Laparoscopic Salpingectomy

Conditions
-----------------
Clinical Competence

Intervention / Treatment
-----------------
* Behavioral: LapSimGyn training until expert proficiency level is reached
* Behavioral: Traditional clinical education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gyn/obs trainee 1.-2. year, with no experience from advanced laparoscopy Exclusion Criteria: Advanced laparoscopic experience Previous training in simulator

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Simulator training | Behavioral: LapSimGyn training until expert proficiency level is reached<br>* Two consecutive simulations reaching predefined expert level<br>|
| Active Comparator: 2<br>Traditional Clinical education at operating room | Behavioral: Traditional clinical education<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rating Scale Score |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time used to perform operation |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
training, teaching, curriculum
A Comparison of Transcervical Foley Catheter and Prostaglandins for Induction of Labor at Term

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effectiveness and safety of transcervical foley catheter as compared to prostaglandins for preinduction cervical ripening and labor induction in term nulliparous women with unfavorable cervix.

Conditions
-----------------
Failed Induction of Labor

Intervention / Treatment
-----------------
* Device: Transcervical foley catheter, Prostaglandins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy nulliparous women gestational age >= 37.0 weeks Bishop score <= 5 intact amniotic membrane abscence of labor live fetus with vertex presentation no previous uterine surgical procedure Exclusion Criteria: major congenital anomaly
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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transcervical foley catheter<br> | Device: Transcervical foley catheter, Prostaglandins<br>* 16 French foley catheter 10mg dinoprostone vaginal insert<br>|
| Active Comparator: Prostaglandins<br> | Device: Transcervical foley catheter, Prostaglandins<br>* 16 French foley catheter 10mg dinoprostone vaginal insert<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful labor induction | Successful labor induction is defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm. | Twelve hours of initiating oxytocin on the fist day of induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical change in the bishop scores and cervical lengths induced by transcervical foley catheter and prostaglandins | Cervical change based on the bishop score and cervical length induced by cervical ripening method(foley catheter balloon vs prostaglandin) Incidence of cesarean delivery Vaginal delivery with 24 hours of starting of induction The interval from start of oxytocin to delivery Incidence of admission to neonatal intensive care unit and uterine tachysystole Pain score by the type of ripening method | When transcervical foley catheter or prostagladins was removed befor adminitoring oxytocin | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor induction, transcervical foley catheter, prostaglandin
Evaluation of the Long-term Results of Extended Supra-basillary Genioplasty of the Chin Wing Type Without Bone Graft

Study Overview
=================
Brief Summary
-----------------
The correction of maxillomandibular dysmorphoses, responsible for both functional discomfort (lip incompetence, ventilation disorders, periodontal disease) but also aesthetic, calls in particular for genioplasty, of which there are several techniques. One of these chin repositioning techniques, called Chin Wing, cuts the bone to optimize the functional and aesthetic result. While all genioplasty techniques expose the risk of nerve damage and lack of bone consolidation, these parameters are only rarely addressed in the literature in the specific context of this extensive bone cutting. The objective of this work is to assess the satisfaction of patients who have benefited from chin advancement surgery using the Chin Wing technique.

Official Title
-----------------
Evaluation of the Long-term Results of Extended Supra-basillary Genioplasty of the Chin Wing Type Without Bone Graft: Aesthetic and Functional Satisfaction, Sensory Recovery and Bone Healing

Conditions
-----------------
Maxillofacial Abnormalities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major subject (≥ 18 years old) having undergone Chin Wing type genioplasty surgery in the maxillofacial surgery department of Strasbourg between October 1, 2012 and June 30, 2022. Subject who has not expressed his opposition to the reuse of his data for scientific research purposes. Exclusion Criteria: Subject having expressed their opposition to the reuse of their data for scientific research purposes

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 |
| --- | --- | --- |
| Aesthetic and functional satisfaction of the patients' results of surgery | Aesthetic and functional satisfaction of the patients who have benefited from chin advancement surgery using the Chin Wing technique. This satisfaction is assessed by a satisfaction questionnaire of 10 questions. Single answer out of 4 items proposed per question. | 6 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dysmorphoses, Maxillofacial Abnormalities, Maxillomandibular, Lip incompetence, Ventilation disorders, Genioplasty
Prevention in Belgian Hockey : What Does the Staff Really Put in Place?

Study Overview
=================
Brief Summary
-----------------
Purpose: To provide an update on the implementation of prevention among hockey players by their entourage. Materiel and method: This study will be conducted by the means of a questionnaire. The target population consisted of trainers. The questionnaire will be validated by experts and published on an online survey website

Official Title
-----------------
Prevention in Belgian Hockey : What Does the Staff Really Put in Place?

Conditions
-----------------
Primary Prevention, Questionnaire and Survey, Hockey Player

Intervention / Treatment
-----------------
* Other: Primary prevention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Professions: hockey trainer Exclusion Criteria: /

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trainers<br> | Other: Primary prevention<br>* The primary prevention that the trainers put in place for the hockey players<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary prevention by a questionnaire | The trainers will respond to a questionnaire that will inform us about the primary prevention that they put in place in hockey. | Time Frame: The questionnaire will last 15 minutes at most |
TPE in Rennes Hospital

Study Overview
=================
Brief Summary
-----------------
To assess the indications, tolerance and side effects of therapeutic plasma exchange (TPE) performed at a University Hospital over 8 years

Detailed Description
-----------------
Indications were recorded from the patients electronic chart. Side effects were identified from the review of TPE monitoring forms completed prospectively by the nurse who performed the TPE during the course of the procedure

Official Title
-----------------
Tolerance of Therapeutic Plasma Exchange Performed in the Rennes University Hospital 2011-2018

Conditions
-----------------
Therapeutic Plasma Exchange

Intervention / Treatment
-----------------
* Device: Therapeutic plasma exchange (TPE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients who underwent TPE in Rennes University Hospital 2011-2018 Exclusion Criteria: Absence of the monitoring sheet during the EP session Refusal of patient participation after receipt of the information letter Persons over the age of majority who are subject to legal protection (protection of justice, guardianship, guardianship)

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 |
| --- |
|Device: Therapeutic plasma exchange (TPE)|All TPEs were performed by the centrifugation technique using the Fresenius Kabi COMTEC machine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of side effects during Therapeutic plasma exchange | Occurrence of side effects, regardless of their severity during therapeutic plasma exchange sessions (From start of care by the nurse including the preparation for the insertion of peripheral or central venous access to disconnection from the device and removal of peripheral lines or closing the CVC),. Main side effects recorded are hypotension, tachycardia, shock, anaphylaxis, seizure, cardiac arrest, respiratory failure, skin rash, urticaria, catheter dysfunction, catheter related infection hypocalcemia, alkalosis. | The inclusion day (retrospective study) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TPE, therapeutic plasma exchange, Side Effects