linjc16/ctgov huggingface dataset:
Effects of Chloral Hydrate on Induction, Maintenance, and Recovery From Sevoflurane Anesthesia in Day-case Pediatric Surgery

Study Overview
=================
Brief Summary
-----------------
Effects of Choral Hydrate on Induction, Maintenance, and Recovery from Sevoflurane Anesthesia in Day-case Pediatric Surgery

Conditions
-----------------
Pediatric

Intervention / Treatment
-----------------
* Drug: chloral hydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I or II 1-5 years children elective day-case orchiopexy Exclusion Criteria: congenital hear disease renal disease liver disease growth retardation coagulopathy

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 Years

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

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

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 |
| --- | --- |
| Placebo Comparator: placebo control<br> | Drug: chloral hydrate<br>* 30 min before the induction of anesthesia, chloral hydrate (40 mg/kg) or placebo was administered to the children orally.<br>|
| Experimental: oral medication chloral hydrate<br> | Drug: chloral hydrate<br>* 30 min before the induction of anesthesia, chloral hydrate (40 mg/kg) or placebo was administered to the children orally.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative Anxiety | Preoperative Anxiety Score Modified Yale Preoperative Anxiety Scale (YPAS, 0-100) was assessed by observer Anesth Analg 1997;85:783-8 |  | 
| Induction Compliance | Induction Compliance Checklist Induction Compliance Checklists (ICC, 0-10) was assessed by anesthetist Anesthesiology 1998;89:1147-56 |  | 
| Postoperative Pain | -Postoperative Pain Score Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale (0-10) was assessed by observer Am J Crit Care. 2010 Jan;19(1):55-61 |  | 
| Posthospitalization Behavior | Posthospitalization Behavior Questionnaire Posthospitalization Behavioural Questionnaire (27-135)was sent to all parents of children Paediatr Anaesth. 2001 Nov;11(6):719-23. |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric patients, ASA physical status I or II, aged between 1-5 yrs
Adherence to Computer-assisted Maxillofacial Reconstructions

Study Overview
=================
Brief Summary
-----------------
The study was approved by the Local Ethics Committee and was conducted in compliance with the World Medical Association Declaration of Helsinki on medical research. A total of 335 patients who underwent oral and maxillofacial reconstruction were recorded from Jan 2014 to Jun 2020. Reconstruction with computer-assisted surgery ( CAS), which included, virtual surgical planning, computer-aided design-computer-aided manufacturing (CAD-CAM) surgical guides/templates and pre-bent plates on 3D printed models. Reasons for tissue defect were oncologic, osteoradionecrosis, trauma and osteoporosis. Patients undergoing dental implant placement and orthognathic surgery were excluded. Finally, 136 patients were selected and the reasons for partial or abandon surgical plan performance were described and analyzed.

Detailed Description
-----------------
computer-aided design

Official Title
-----------------
Adherence to Computer-assisted Surgical Planning in 136 Maxillofacial Reconstructions

Conditions
-----------------
Maxillofacial Abnormalities, Computer-assisted Surgery, Virtual Surgical Planning

Intervention / Treatment
-----------------
* Device: Computer-assisted surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Maxillofacial reconstruction with CAS, including virtual surgical planning, CAD-CAM surgical guides/templates and pre-bent plates on 3D printed models. Reasons for reconstruction were oncologic, osteoradionecrosis, trauma and osteoporosis. Exclusion Criteria: Patients undergoing computer-assisted implant surgery were excluded. Patients undergoing computer-assisted orthognathic surgery were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Computer-assisted surgery|The reconstruction was performed with the help of virtual surgical plan and 3D printed models.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adherence of computer-assisted surgery | The original plans were classified as completely executed, partially executed or abandoned. | The outcome were recorded preoperatively or intraoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Computer-Assisted Surgery, Treatment Adherence and Compliance, Patient-Specific Modelling
Real-life Data of Constitutional Von Willebrand Disease in Western France

Study Overview
=================
Brief Summary
-----------------
The objective of this observational study HOPSCOTcH-WILL II is to provide an accurate and detailed account of current Von Willebrand Disease (VWD) therapeutic management by collecting real-life data on hemorrhagic treated events in the 5 Western French Hemophilia Treatment Center. The HOPSCOTCH-WILL II study aims to describe therapeutic management of patients with VWD, following the provision of a recombinant drug in France; It will also permit to carry out a budget impact analysis to quantify the economic significance of this new era.

Official Title
-----------------
Real-life Data of Constitutional Von Willebrand Disease in Western France: Treatment Outcomes With the Recombinant Von Willebrand Factor

Conditions
-----------------
Von Willebrand Diseases

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Constitutional Von Willebrand Disease patient, of any severity, with or without Von Willebrand Factors inhibitors Patient included in the research database BERHLINGO Patient treated or not by desmopressin or Von Willebrand Factor/FVIII/by-passing agents available on the French market (at baseline) Patient who agrees to participate in the HOPSCOTcH-Will II and followed in one of the 5 investigator centers Exclusion Criteria: - Patients under guardianship
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observational study, description of the global therapeutic modalities required for severe treated hemorrhagic events in constitutional Von Willebrand Disease patients of any severity | Data collection for evaluation of Clotting factors quantities used by collection of treatments for severe hemorrhagic events | 4 years |
The Human Sperm Survival Assay (HSSA) as an Internal Quality Control for the IVF Consumables (REPROTOX 2)

Study Overview
=================
Brief Summary
-----------------
The main embryotoxicity quality controls are the mouse embryo test (MEA = Mouse Embryo Assay) and the human sperm survival test (HSSA = Human Sperm Survival Assay). The HSSA test measures the survival (or mobility) of human sperm after exposure to the tested consumable for a predetermined period of time and compares it to that of unexposed sperm. It would appear that the HSSA is comparable in terms of sensitivity to the MEA test for the detection of toxicity.

Detailed Description
-----------------
The main objective is to assess the embryotoxicity of the main IVF consumables using the HSSA test before their introduction to the IVF laboratory.

Official Title
-----------------
The Human Sperm Survival Assay (HSSA) as an Internal Quality Control for the IVF Consumables

Conditions
-----------------
Human Sperm Survival Assay, Embryotoxicity, in Vitro Fertilization

Intervention / Treatment
-----------------
* Biological: HSSA test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male over 18 years-old Normal spermogram (concentration ≥15 million / ml or total count> 39 million, progressive mobility ≥32% or total mobility ≥40%) Progressive mobility ≥70% after selection Total number of progressive motile spermatozoa recovered after TMS> 10 million Patient affiliated or beneficiary of a social security scheme Patient having been informed and not opposing to this research. Exclusion Criteria: Male over 65 years-old Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sperm with normal spermogramm and more than 10 millions spermatozoids<br>Normal spermogramm : concentration ≥15 million / ml or total count> 39 million, progressive mobility ≥32% or total mobility ≥40% | Biological: HSSA test<br>* Human Sperm Survival Assay testing performed on different batches of different types of IVF consumables. In practice, 3 consumables from the same batch will be tested with 3 different sperms to ensure the repeatability of the result / test.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of embryotoxicity | Presence of embryotoxicity, defined by a mobility index relative to the control (SMI) <0.85 observed on at least 2 of the three tests carried out on consumables from the same batch (isolated embryotoxicity). | 1 day |
The Gut Microbiome in Women With Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
Testing two different strategies for weight loss intervention and revealing possible changes in composition of gut microbiota, in order to provide more insight in the effect of dietary changes and weight loss treatments on gut microbiome in overweight and obese women with polycystic ovary syndrome (PCOS). The two strategies are: dietary advice plus myo-inositol and folic acid dietary advice plus liraglutide, glucagon-like peptide-1 (GLP-1) receptor agonist Primary outcome will be weight loss. Secondary outcomes are longitudinal changes in clinical features associated with PCOS and metabolic syndrome, longitudinal changes in gut microbiome with interventions. Subjects will be treated during 16 weeks and follow-up will take 16 weeks after stop of treatment.

Official Title
-----------------
Novel Strategies in Weight Loss in Women With Polycystic Ovary Syndrome: do Changes in the Gut Microbiome Play a Role?

Conditions
-----------------
PCOS, Metabolic Syndrome, Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: dietary advice plus myo-inositol and folic acid
* Drug: dietary advice plus Liraglutide Pen Injector


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCOS according to ROtterdam criteria BMI ≥ 27 kg/m2 and at risk of metabolic syndrome or BMI ≥ 30 kg/m2 Exclusion Criteria: pregnancy pancreatitis (in the past) oral contraceptive pill use inflammatory bowel disease auto-immune disease immuno-modulatory drugs antidiabetic drugs anti-inflammatory drugs

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dietary advice plus myo-inositol and folic acid<br>2gram myo-inositol and folic acid twice daily orally lack of consistent evidence for myo-inositol as treatment of women with PCOS | Dietary Supplement: dietary advice plus myo-inositol and folic acid<br>* dietary advice and lifestyle interventions and myo-inositol<br>|
| Active Comparator: dietary advice plus liraglutide pen injector<br>liraglutide starting at 0.6 mg, gradually increasing up to a dose of 3 mg daily after four weeks no evidence for weight loss in women with PCOS | Drug: dietary advice plus Liraglutide Pen Injector<br>* dietary advice and lifestyle interventions and liraglutide pen injector<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 32 weeks |
HFpEF and 2-year Mortality of COPD Patients

Study Overview
=================
Brief Summary
-----------------
This study was designed to assess potential relationship between heart failure with preserved ejection fraction and 2- year mortality of patients with chronic obstructive pulmonary disease

Official Title
-----------------
The Influence of hearT Failure With Preserved Ejection Fraction on 2year Mortality of Patients With cHronic obstructivE pulmonaRy disEaSE- THERESE Study

Conditions
-----------------
Heart Failure, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Cardiac function assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exacerbation of chronic obstructive pulmonary disease requiring hospitalization Age 40 - 80 years Performance status 0-1 according to Eastern Cooperative Oncology Group (ECOG) Long acting beta agonist (LABA)/ long acting antimuscarinic (LAMA) bronchodilator treatment Exclusion Criteria: Presence of major heart valve dysfunction Documented noncompliance with treatment Presence of active malignancy Body mass index > 40 Interstitial lung disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| Normal cardiac function<br>Normal cardiac function | Diagnostic Test: Cardiac function assessment<br>* Echocardiography, cardiac enzymes analysis<br>|
| Heart failure with reduced ejection fraction<br>Heart failure with reduced ejection fraction | Diagnostic Test: Cardiac function assessment<br>* Echocardiography, cardiac enzymes analysis<br>|
| Heart failure with preserved ejection fraction<br>Heart failure with preserved ejection fraction | Diagnostic Test: Cardiac function assessment<br>* Echocardiography, cardiac enzymes analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality of patients | 2 year |
Vytorin As Strategy To Reduce Dislipidemia In Adults (0653A-148)

Study Overview
=================
Brief Summary
-----------------
This study is intended to allow physicians to check the superior clinical efficacy of Vytorin compared to atorvastatin, as the most adequate therapy using the ATP-III goals achievement and cardiovascular risk reduction in adult patients with dislipidemia.

Official Title
-----------------
Vytorin As Strategy To Reduce Dislipidemia In Adults

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: ezetimibe (+) simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Who Voluntary Accept To Participate In The Study After Been Informed By The Doctor And Signed The Informed Consent Form. Exclusion Criteria: Any Another Kind Of Contraindication For Use Of Statins Hypersensitivity To Any Of The Active Ingredients Increased Serum Hepatic Enzymes (Over 3 Times Only) Patients With Severe Hepatic Insufficiency Women who are Pregnant or Potentially Pregnant

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ezetimibe (+) simvastatin|ezetimibe 10mg (+) simvastatin 20 mg once daily for 4 weeks of treatment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the hypolipidemic effect of Vytorin after 4 weeks treatment in adult patients with mix dislipidemia to reduce the cardiovascular risk and achieve the ATP-III goals. |  | After 4 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the capability of Vytorin to allow adults patients with dislipidemia and previously treated with atorvastatin to get further reduction of the cardiovascular risk and to achieve the ATP-III goals. |  | After 4 weeks treatment |
Optimization of PK/PD Target Attainment for Ceftriaxone in Critically Ill Patients With Community-acquired Pneumonia.

Study Overview
=================
Brief Summary
-----------------
WP2.1. PK/PD target attainment Plasma exposure ELF exposure WP2.2. Predictive dosing algorithm WP2.3. ECMO subset

Detailed Description
-----------------
First, the investigators will document exposure to ceftriaxone in plasma and epithelial lining fluid. Second, the investigators will try to identify risk factors for not attaining PK/PD target. Based on significant predictors for target non attainment a predictive dosing algorithm will be constructed. Finally in a small subset of ECMO patients PK exposure will be explored.

Official Title
-----------------
Impact op Capillary Leak and Hypoalbuminemia on PK/PD of Ceftriaxone in Critically Ill Patients With Overwhelming Pneumonia

Conditions
-----------------
Pharmacokinetics, Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pneumonia Admitted to an ICU ward Treated with ceftriaxone Exclusion Criteria: Pregnancy DNR code 2-3 Renal replacement therapy

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 |
| --- | --- | --- |
| Risk factors for target non attainment | risk factors will be assessed by comparing patients who attain target vs. those who don't | on day of sampling | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Ceftriaxone, critical illness, capillary leak, hypoalbuminemia
Haemodynamic Monitoring in Head and Neck Cancer Patients

Study Overview
=================
Brief Summary
-----------------
In order to estimate the effect of fluid management in regard to postoperative complications this observatory study will document every kind of fluid intervention peri- and intraoperatively.

Detailed Description
-----------------
The extend of mass transfusions is known to correlate with postoperative complications. However, also crystalloid and colloidal infusions are under suspicion to cause postoperative complications. This study will capture any kind of fluid intervention perioperatively as well as intraoperatively. Intraoperative fluid management will be documented and matched with the operation steps respectively. The extend of fluid therapy will be correlated with general postoperative complications and especially with the survival of microvascular transplants. For this purpose, there will be four questionaires. After informed consent, the first questionaire will cover the patient's history, risk factors and previous operations. The second questionaire will cover intraoperative fluid management, documented with the actual operation step. Furthermore, it will also intraoperative complications, cardiovascular-active medication. For closer monitoring, data from Picco will also be included. The third questionaire will be complete in the ICU covering similar content as the second questionaire. The last questionaire will cover the patient's progress on the general ward. Fluid management and tube feeding, as well as general postoperative complication and flap specific complications will be noted. This study aims for 50-80 patients.

Conditions
-----------------
Postoperative Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or older admitted for head and neck surgery with microvascular transplantation due to head and neck tumors Exclusion Criteria: Pregnancy underage missing informed consent revisions and relapse operations non tumor-associated operations surgery without microvascular transplants

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 |
| --- | --- | --- |
| Postoperative Complications | General Complications e.g. affecting lung, cardiovascular system, kidneys | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant Survival via Clinical Examination | Transplant Survival via Clinical Examination/ Need for further microvascular Transplant | One week |