linjc16/ctgov huggingface dataset:
Conotruncal Cardiac Defects and Nutrigenetic Etiopathogeny

Study Overview
=================
Brief Summary
-----------------
The investigators planned to study the etiopathogenic factors of conotruncal cardiac defects regarding the relations between the metabolic, the genetic and the environmental factors which lead to these cardiopathy.

Official Title
-----------------
Conotruncal Cardiac Defects and Metabolism, Nutrigenetic Factors of Etiopathogeny of Conotruncal Cardiac Defects

Conditions
-----------------
Conotruncal Cardiac Defects

Intervention / Treatment
-----------------
* Biological: Bood sampling for biochemicals and genetic analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Conotruncal cardiac defects patients and theirs mothers Weight: > 3750 g Exclusion Criteria: Syndromic conotruncal cardiac defects 22q11 deletion Holder's Patients whose mother's took anti-folates before and during first pregnancy semester

Ages Eligible for Study
-----------------
Minimum Age: 1 Month

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 |
| --- | --- |
| Conotruncal cardiac defects patients<br> | Biological: Bood sampling for biochemicals and genetic analysis<br>* There will be one blood sampling for the nutritionnal, metabolic and genetic parameters studied in the protocol<br>|
| Mothers of patients<br> | Biological: Bood sampling for biochemicals and genetic analysis<br>* There will be one blood sampling for the nutritionnal, metabolic and genetic parameters studied in the protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Conotruncal cardiac defects, methylation, genotype, cobalamin, folates, nutrition
Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects

Study Overview
=================
Brief Summary
-----------------
Non-interventional study to evaluate safety and efficacy of NOVOCART 3D in adult and adolescent patients with full thickness cartilage defects after the treatment with NOVOCART 3D.

Detailed Description
-----------------
A 36-month post treatment follow up of adverse and serious adverse effects as well as the measurement of efficacy with the International Knee Documentation Committee (IKDC) Score.

Official Title
-----------------
Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects

Conditions
-----------------
Cartilage Diseases

Intervention / Treatment
-----------------
* Biological: NOVOCART 3D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female adult patients Children and adolescents with closed epiphysial plate Defect size ≥2.5 and ≤10 cm2 post-debridement Localized full thickness articular cartilage defect of the knee (Grade 3 & 4 International Cartilage Repair Society (ICRS) classification) Exclusion Criteria: Radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade >2 More than 2 defects or 2 corresponding lesions Ankylosis Arthrofibrosis Diffuse chondromalacia Total/subtotal resected meniscus Insufficient Ligament guidance Patella malignement Inflammatory joint disease General cartilage degeneration or increased joint deterioration Cancer, present or within the last 5 years Primary treatment in children and adolescents with open epiphysial plate Chronical infection diseases Untreated coagulation disorder Pregnancy and lactating Known history of allergies against ingredients of NOVOCART® 3D

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: NOVOCART 3D|Autologous Chondrocyte Implantation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety | Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety | 36 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - International Knee Documentation Committee (IKDC) 2000 | International Knee Documentation Committee (IKDC) 2000 | 36 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cartilage Defect in the Knee, MACT
Articaine Versus Lidocaine Buccal Infiltration

Study Overview
=================
Brief Summary
-----------------
assess the effect of articaine versus lidocaine in only buccal infiltration of local anethesia in lower anterior teeth

Official Title
-----------------
Articaine Versus Lidocaine in Only Buccal Infiltration Anesthesia for the Extraction of Mandibular Anterior Teeth.Asplit Mouth Clinical Trail

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

Intervention / Treatment
-----------------
* Drug: articaine local anethesia with vasoconstrictor
* Drug: lidocaine local anethesia with vasoconstrictor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: medically stable 18years or older patient with bilateral lower anterior teeth requiring non surgical removal Exclusion Criteria: grade 3 mobility neurological disease allergy to anethesia

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 |
| --- | --- |
| Experimental: articaine group<br> | Drug: articaine local anethesia with vasoconstrictor<br>* buccal infiltration only of articaine local anethesia during extraction of lower anterior teeth<br>|
| Experimental: lidocaine group<br> | Drug: lidocaine local anethesia with vasoconstrictor<br>* buccal infiltration only of lidocaine local anethesia during extraction of lower anterior teeth<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain during extraction | by (VAS) visual analouge scale | during extraction | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
buccal infiltration, lidocaine, articaine
Genistein and Endometrial Hyperplasia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to verify the anti-estrogenic activity of Genistein, on the non atypical endometrial hyperplasia, in premenopausal women.

Detailed Description
-----------------
Although isoflavones alone (example: Genistein) have weak estrogenic effects on endometrial stromal and glandular cells, it was demonstrated, in several research efforts, that in the presence of E2 they act as antiestrogens. Considered that endometrial hyperplasia is due to strong and extended estrogenic stimulation, not offset by a proportionate amount of progesterone, we suppose that genistein could be therapeutic in these cases inducing a decrease of the hyperplasia and a change from the proliferative to a secretory phase of the endometrium.

Official Title
-----------------
Effect of Genistein on Endometrial Hyperplasia

Conditions
-----------------
Endometrial Hyperplasia

Intervention / Treatment
-----------------
* Dietary Supplement: Genivis
* Drug: Norethisterone Acetate
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premenopausal women Age > = 44 years Dysfunctional uterine bleeding No treatment with other hormonal drugs (estrogen, progesterone) No local or general pathology negatively influenced by administration of genistein or progesterone No intrauterine pathologies (polyps, myomas) A non atypical endometrial hyperplasia, confirmed by hysteroscopy with biopsy and histological examination Exclusion Criteria: All the other conditions

Ages Eligible for Study
-----------------
Minimum Age: 44 Years
Maximum Age: 55 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genistein<br>Genistein 54 mg/day | Dietary Supplement: Genivis<br>* 54 mg/day daily for 6 months<br>* Other names: Fosteum;|
| Active Comparator: Norethisterone Acetate<br>Norethisterone Acetate 10mg/day | Drug: Norethisterone Acetate<br>* tablets 10mg/day from day 16 to 25 of menstruation<br>|
| Placebo Comparator: Placebo<br>Placebo tablets, daily | Other: placebo<br>* tablets daily for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery from endometrial hyperplasia |  | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differential expression of ER-a and ER-b in endometrial specimens |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrial hyperplasia, Genistein, Isoflavones, dysfunctional uterine bleeding
Effect of Dexamethasone on Migraine Headache

Study Overview
=================
Brief Summary
-----------------
Dexamethasone is a safe and cheap abortive therapy for migraine headache. The effect of it is never evaluate and not correlate with the effect of popular anti migraine medication such as dihydroergotamine. The investigators proposal is to compare its effect with dihydroergotamine.

Official Title
-----------------
The Effect of Dexamethasone in the Attack of Migraine Headache and to Prevent of Its Relapse After Discharge From Emergency Department: a Randomized, Double-Blind, Controlled Trial.

Conditions
-----------------
Migraine Headache

Intervention / Treatment
-----------------
* Drug: dexamethazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Migraine attack according to international headache society criteria Migraine without aura; at least 5 attack with mean duration of 4 to 72 hours and 2 of following: Unilateral Pulsatile Severe enough to impair daily activity Aggravate with walking and climbing, also 1 of following: Nausea and or vomiting Photophobia and phonophobia, and not contributed to other headache. Migraine with aura; at least 2 attacks with 3 of following: One reversible aura Aura became apparent at least in 4 minutes Aura not lasting more than 60 minutes Headache develops in less than 60 minutes after aura Exclusion Criteria: Hypertension Ischemic heart disease Basilar migraine with sign and symptoms such as: Diplopia Ataxia Dysarthria Dysphagia Weakness Sensory disorder Drowsiness Peripheral vascular disease Sepsis Age more than 40 and less than 15 year old Pregnancy Use of triptans and ergots derivatives in past 24 hours

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: dexamethazone<br>* injection form, 8 miligram, injected once<br>|
| Active Comparator: 2<br> | Drug: dexamethazone<br>* injection form, 8 miligram, injected once<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the efficacy of dexamethazone in abortive therapy of migraine attack and prevent of recurrence |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
migraine, dexamethasone, dihydroergotamine
The Effect of Therapy With Bevacizumab in Chronic Central Serous Chorioretinopathy

Study Overview
=================
Brief Summary
-----------------
The pathophysiology of central serous chorioretinopathy remains controversial. traditional treatment is laser photocoagulation or photodynamic therapy.Recently Bevacizumab (Avastin, Genetech),an antibody to vascular endothelial growth factor (VEGF),has known antipermeability properties and therefore may theoretically reverse the changes seen in central serous chorioretinopathy. The aim of this study is To investigate concentrations of growth factors and inflammatory cytokines and to report the effect of therapy with bevacizumab in eyes with central serous chorioretinopathy

Official Title
-----------------
Intraocular Concentrations of Growth Factors and Cytokines in Chronic Central Serous Chorioretinopathy And the Effect of Therapy With Bevacizumab

Conditions
-----------------
Central Serous Chorioretinopathy

Intervention / Treatment
-----------------
* Procedure: intravitreal injection with anterior paracentesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of central serous chorioretinopathy Idiopathic neurosensory retinal elevation demonstrated by optical coherent tomography Presence of focal leaks at the level of the RPE on fluorescein angiography Exclusion Criteria: Known side effects of systemic bevacizumab administration Have a significant cardiovascular or thromboembolic history or were pregnant

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: intravitreal injection with anterior paracentesis|0.1cc Aqueous humor samples were taken each time an intravitreal injection of bevacizumab (2.5 mg in 0.1 ml)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of growth factors and inflammatory cytokines in Aqueous humor |  | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central macular thickness at optical coherence tomography |  | baseline, 1 month, 3 months, 6 months |
Remimazolam and Remifentanil Without Neuromuscular Blocking Agent

Study Overview
=================
Brief Summary
-----------------
Remimazolam is a novel drug approved for induction and maintenance of general anesthesia. This study aims to check the appropriate dose and patient response by administering remimazolam and remifentanil in surgery that does not require a neuromuscular blocking agents.

Official Title
-----------------
General Anesthesia Using Remimazolam and Remifentanil Without Neuromuscular Blocking Agent: Prospective Observational Study

Conditions
-----------------
Myoma;Uterus, Polyp Endometrium, Unspecified Condition Associated With Female Genital Organs and Menstrual Cycle

Intervention / Treatment
-----------------
* Drug: Remimazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult woman scheduled for gynecological surgery under general anesthesia American Society of Anesthesiology grade 1 or 2 When using a laryngeal mask airway to maintain general anesthesia Exclusion Criteria: Underlying diseases: liver, kidney, brain nervous system, glaucoma Patients with BMI greater than 30 and less than 18.5 Patients diagnosed with sleep apnea Alcohol or drug dependent patients Patients with severe or acute respiratory failure Lactose intolerance Dextran 40 hypersensitivity Patients in shock or coma

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General anesthesia using remimazolam and remifentanil<br>Adult female patients scheduled for gynecological surgery under general anesthesia using remimazolam and remifentanil | Drug: Remimazolam<br>* Loading for anesthesia induction: Remimazolam 6 mg/kg/h until loss of consciousness Continuous infusion for anesthesia maintenance: Remimazolam 1-2 mg/kg/h under the Bispectral index monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remimazolam induction dose |  | During the anesthesia induction (from initiation of anesthesia until the insertion of laryngeal mask airway) | 
| Remimazolam maintenance dose |  | During the anesthesia maintenance (from the insertion of laryngeal mask airway until stopping remimazolam infusion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of rescue midazolam |  | During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion) | 
| Use of rescue rocuronium |  | During the anesthesia (from initiation of anesthesia until stopping remimazolam infusion) | 
| Use of flumazenil |  | During the anesthesia recovery (from stopping remimazolam infusion until the recovery of consciousness) |
Rapid Postoperative Recovery Pathway in Adolescent Idiopathic Scoliosis.

Study Overview
=================
Brief Summary
-----------------
the study will evaluate the clinical outcomes of an intra- and postoperative fast-track protocol in patients undergoing instrumented posterior arthrodesis surgery for adolescent idiopathic scoliosis.

Official Title
-----------------
Rapid Postoperative Recovery (Fast-track) Pathway in Adolescent Idiopathic Scoliosis: a Pilot Study

Conditions
-----------------
Scoliosis Idiopathic

Intervention / Treatment
-----------------
* Other: Fast Track recovery pathway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 14-18 years iagnosis of adolescent idiopathic scoliosis requiring an instrumented posterior arthrodesis surgical procedure Males and females. Exclusion Criteria: spinal infection neoplastic diseases heart disease hypersensitivity to tranexamic acid history of coagulopathy and/or previous thromboembolic events severe renal failure

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Fast Track recovery pathway|Multidisciplinary approach alongside the orthopedic surgeon|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the Fast track protocol | Evaluation of an intra- and post-operative fast-track protocol in terms of postoperative pain management. | at baseline (Day0) | 
| Evaluation of the Fast track protocol | Evaluation of an intra- and post-operative fast-track protocol in terms of duration/times of hospitalization | at baseline (Day0) | 
| Evaluation of the Fast track protocol | Evaluation of an intra- and post-operative fast-track protocol in terms of blood loss | at baseline (Day0) | 
| Evaluation of the Fast track protocol | Evaluation of an intra- and post-operative fast-track protocol in terms of patient education in early recovery of function. | at baseline (Day0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical and clinical outcome | evaluation of the hemocytometric examination (performed as per normal clinical practice). | at baseline (Day0) | 
| Surgical and clinical outcome | evaluation of the main circulating inflammatory mediators. | at baseline (Day0) | 
| Surgical and clinical outcome | evaluation of culture examinations on the surgical wound drainage fluid and microstructural analysis of the surgical drainage tube by scanning electron microscope. | at baseline (Day0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scoliosis