linjc16/ctgov huggingface dataset:
Relation Between Oculocardiac Reflex and Laryngospasm

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate whether there is a significant relation between various arrhythmias during the surgeon's stretching the eye muscles and laryngospasm and emergence agitation in strabismus surgeries

Detailed Description
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Background: Laryngospasm is one of the serious complications that can be seen in perioperative period, especially during anesthesia induction and extubation. The aim of this study is to evaluate whether there is a significant relation between various arrhythmias during the surgeon's stretching the eye muscles and laryngospasm and emergence agitation in strabismus surgeries

Official Title
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Evaluation of Correlation Between Laryngospasm, Emergence Agitation and Oculocardiac Reflex in Strabismus Surgery

Conditions
-----------------
Eye Abnormalities, Arrythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for the strabismus surgery ASA 1-2 patients 2-65 yo patients Exclusion Criteria: Patients with kidney, cardiac diseases Being treated with sedative or anticonvulsant drugs ASA 3-4 patients Patients with upper respiratory tract disease in the last 2 weeks Patients who do not want to participate in the study Patients with behavioral disorders

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Laryngospasm ratio | Laryngospasm during emergence in patients with oculocardiac reflex in surgery will be recorded | an average of 20 minutes during emergence | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence agitation in children | The Paediatric Anaesthesia Emergence Delirium(PAED) score/scale will be evaluated. There are five scale items in PAED scale. Each item is scored from 1 to 4 and the scores are summed to obtain a total scale score. Higher scores indicate emergence agitation in the patient. | an average of 30 minutes | 
| Emergence agitation in adults | Aono's Four Point Agitation Scale will be evaluated. There are four scores from 1 to 4 on the scale. A high score is associated with emergence agitation in the patient. | an average of 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
strabismus surgery, laryngospasm, oculocardiac reflex, emergence agitation
Effect of Follicle Flushing on Oocyte Fertilization Rate

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the impact of follicular flushing on fertilization rate in women undergoing IVF treatment

Detailed Description
-----------------
This will be a prospective observational study on the effect of follicular flushing on fertilization rate in women undergoing IVF treatment. Oocytes from each woman will be allocated to one of three groups, depending on the aspirate or flush they are recovered from: Group I= egg retrieved in the follicular fluid of the first aspirate (no flushing) Group II= egg retrieved in the 1st-2nd flush Group III= egg retrieved in the 3rd-5th flush development and utilization. Pregnancy rates will be reported as a surrogate outcome.

Official Title
-----------------
Effect of Follicle Flushing on Oocyte Fertilization Rate

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: intracytoplasmic sperm injection (ICSI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Up to 40 years old Both ovaries present Triggering final oocyte maturation using hCG or GnRH agonist Exclusion Criteria: Egg donation PGD cases

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>Group I= egg retrieved in the follicular fluid of the first aspirate (no flushing) | Procedure: intracytoplasmic sperm injection (ICSI)<br>* All eggs will be fertilized by ICSI<br>|
| Group II<br>Group II= egg retrieved in the 1st-2nd flush | Procedure: intracytoplasmic sperm injection (ICSI)<br>* All eggs will be fertilized by ICSI<br>|
| Group III<br>Group III= egg retrieved in the 3rd-5th flush | Procedure: intracytoplasmic sperm injection (ICSI)<br>* All eggs will be fertilized by ICSI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate | Number of fertilized eggs per oocyte retrieved | Day 1 post oocyte retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maturation rate | Number of mature (MII) eggs per oocyte retrieved | Day of oocyte retrieval | 
| Good quality embryos | Number of good quality embryos on Day 2 | Day 2 post oocyte retrieval | 
| Blastocyst formation rate | Number of blastocysts on Day 5 per fertilized egg | Day 5 post oocyte retrieval |
Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare two pulpotomy medicaments in primary molars clinically.A total of 200 primary molars with deep caries were treated with two different pulpotomy medicaments (Mineral Trioxide Aggregate and BiodentineTM) in this study. The inclusion criteria for tooth selection were no clinical and radiographic evidence of pulp pathology. During 36 months of follow-up at 3-month intervals, clinical and radiographic success and failures were recorded.

Official Title
-----------------
Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up

Conditions
-----------------
Pulpotomy, Dental Caries

Intervention / Treatment
-----------------
* Drug: Biodentine
* Drug: ProRoot (Aggregate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no clinical and radiographic evidence of pulp pathology, no clinical and radiographic symptoms, no history of spontaneous pain and tenderness, no percussion, swelling or sinus tracts and pathologic mobility. Exclusion Criteria: any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (PDL) furcal or periapical radiolucency teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure. without permanent successor

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biodentine<br>Dental materials | Drug: Biodentine<br>* Biodentine pulpotomy agent<br>* Other names: 77509635;Drug: ProRoot (Aggregate)<br>* ProRoot MTA pulpotomy agent<br>* Other names: 75896452;|
| Experimental: ProRoot MTA<br>Dental Materials | Drug: Biodentine<br>* Biodentine pulpotomy agent<br>* Other names: 77509635;Drug: ProRoot (Aggregate)<br>* ProRoot MTA pulpotomy agent<br>* Other names: 75896452;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total success rate |  | 12 months after pulpotomy treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total success rate |  | 24 months after pulpotomy treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary molars, pulpotomy, pediatric dentistry
Multiple Dose Japanese Bridging Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects

Official Title
-----------------
Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 125 mg in Healthy Japanese and Non-Japanese Subjects

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: BMS-708163
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Japanese and non-Japanese subjects Japanese subjects must be first generation Japanese and must demonstrate both maternal and paternal Japanese ancestry Non-Japanese subjects must not be of Japanese or Asian descent, ie, neither parent nor grandparent was born in Japan or in any Asian country BMI of 19 to 25 kg/m², for Japanese and non-Japanese subjects Men ages 20 to 45 years Exclusion Criteria: Serum creatinine values above the normal range Urine protein or blood levels above the normal range Liver function tests above the normal range TSH, free T3, or free T4 outside the normal range Amylase or lipase levels above the normal range Positive Fecal Immunochemical Test (FIT™)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1 (BMS-708163)<br>Healthy Japanese Subjects | Drug: BMS-708163<br>* Capsules, Oral, 125 mg, once daily, 14 days<br>* Other names: (GAMMA SECRETASE inhibitor);|
| Placebo Comparator: A2 (Placebo)<br>Healthy Japanese Subjects | Drug: Placebo<br>* Capsules, Oral, 0 mg, once daily, 14 days<br>|
| Active Comparator: B1 (BMS-708163)<br>Healthy Non-Japanese Subjects | Drug: BMS-708163<br>* Capsules, Oral, 125 mg, once daily, 14 days<br>* Other names: (GAMMA SECRETASE inhibitor);|
| Placebo Comparator: B2 (Placebo)<br>Healthy Non-Japanese Subjects | Drug: Placebo<br>* Capsules, Oral, 0 mg, once daily, 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs) |  | Every day for 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMS-708163 pharmacokinetic parameters (Cmax, Cmin, Ctrough, Tmax, AUC(TAU), AI, and CLT/F and T-HALF (only following Day 14 dose)) |  | Days 1, 7, and 14 |
Safety Study of Rufinamide Given as an add-on Therapy to Treat Patients With Seizures

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of Rufinamide in reducing seizure frequency in subjects with partial seizures not fully controlled despite treatment with 1 to 3 concomitant antiepileptic drugs.

Official Title
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A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

Conditions
-----------------
Refractory Partial Seizures

Intervention / Treatment
-----------------
* Drug: Rufinamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female patients between 12 and 80 years of age Dx of epilepsy with partial onset seizures woth or woth out secondarily generalized seizures Non controlled partial seizures despite treatment with 2 different AEDs for at least 2 years must have 6 seizures during baseline current treatment with maximum of 3 AEDs stable dose of AED(s)for at least 1 month if patient has VNS, must have been implanted 6 months prior to randomization Exclusion Criteria: Participation in any investigational product for at least 1 month prior to visit 1 Presence of non-motor simple partial seizures only presence of generalized epilepsies Evidence of clinically significant disease Clinically significant ECG Psychogenic seizure in previous year History of drug/alcohol abuse History of suicide attempt Multiple drug allergies Concomitant felbamate use Need for frequent rescue benzodiazepines Concomitant use of vigabatrin All patients diagnosed with congenital short QT syndrome

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 80 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 |
| --- | --- |
| No Intervention: Standard of Care<br> | |
| Experimental: Rufinamide<br> | Drug: Rufinamide<br>* Rufinamide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in total partial seizure frequency from baseline. |  | 22 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seizure, Seizures, Epilepsy
Understanding Immunity Persistence After Adolescent MenC Vaccination

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate the duration of immunity after a booster dose of a MenC-CRM vaccine given to adolescents between 13 and 15 years of age. Does seroprotection persist beyond teenage years and into the early twenties? This is the age group which is most likely to carry the organism and to transmit it to other members of the population. If a booster dose of MenC vaccine given to adolescents does produce protective levels of antibody which persist into early adulthood, this would strengthen the case for such a booster to be added to the UK routine immunisation schedule, to reduce the risk of a resurgence of the disease in the future.

Official Title
-----------------
A Study to Evaluate the Persistence of Antibody Seven Years After a Booster Dose of Either a Glycoconjugate or a Polysaccharide Vaccine Against Serogroup C Neisseria Meningitidis Given to Adolescents

Conditions
-----------------
Antibody Persistance After Booster Dose of Men C Vaccine

Intervention / Treatment
-----------------
* Other: Venepuncture and blood sample collection.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who completed clinical study M14P2E1 Participant who are willing to participate and who would be expected to comply with the requirements of the protocol Participants who have given informed consent for participation in the study Exclusion Criteria: History of invasive meningococcal C disease (or any case of invasive meningococcal disease where the serotype was unknown) Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection Severe blood clotting disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 23 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 |
| --- | --- |
| Follow-on blood sample from previous study<br> | Other: Venepuncture and blood sample collection.<br>* Venepuncture and blood sample collection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with rSBA titre ≥1:8 (correlate of protection). |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean titre (GMT) rSBA. |  | 4 months |
Early-onset Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The present study aimed to review the characteristics and outcome of early-onset rectal cancer in a subset of Egyptian patients aged 40 years or less. Since the previous studies assessed this point of research in CRC overall, the investigators opted to focus upon rectal cancer alone since it may represent a separate category, distinct from colon cancer, in this age group with regards to presentation, tumor behavior, and outcome.

Official Title
-----------------
Patients With Early-Onset Rectal Cancer Aged 40 Year or Less Have Similar Oncologic Outcomes to Older Patients Despite Presenting in More Advanced Stage; A Retrospective Cohort Study

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: Total mesorectal excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of either gender aged 40 years or less who presented with rectal cancer of any stage were included to the study Exclusion Criteria: patients with colon cancer or other gastrointestinal cancer and patients who were lost to follow-up.

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- |
| < 40 years<br>Patients with rectal cancer ageing 40 years or less | Procedure: Total mesorectal excision<br>* Radical resection of rectal cancer and draining lymph nodes<br>|
| > 40 years<br>Patients with rectal cancer ageing more than 40 years | Procedure: Total mesorectal excision<br>* Radical resection of rectal cancer and draining lymph nodes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence | recurrence of rectal cancer within the anatomic vicinity of the pelvis | 36 months after surgery |
Impact of Regional Anesthesia on Blood Pressure in Lower Limb Traumatism

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the hemodynamic impact of two anaesthetic strategies 'Regional anesthesia' versus 'General anesthesia' in leg and ankle fractures surgery.

Detailed Description
-----------------
Leg and/or ankle surgery is frequently performed under General Anesthesia (GA). GA is frequently associated with a high risk of hypotension with significant consequences. Regional anesthesia could be an interesting alternative to GA in order to limit hemodynamic consequences, especially in elderly patients. Furthermore, in the current state of Covid 19 crisis, regional anesthesia could provide solutions in preserving drugs for GA and exposing less medical staff on patient's airway. Currently, unlike neuraxial anesthesia, few data deal with impact of peripheral RA and hemodynamic consequences. The investigators hypothesize that the use of Regional anesthesia reduces the use of intraoperative vasopressor. After ethical committee approval, a retrospective cohort of patients with lower limb traumatism, in Montpellier's University Hospital, was analyzed from 2016 to 2020. An informational note was given to all patients participating to the study.

Official Title
-----------------
Impact of Regional Anesthesia on Blood Pressure in Lower Limb Traumatism : IRB (Impact of Regional Anesthesia on Blood Pressure)

Conditions
-----------------
Fracture, Ankle, Fracture Leg

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria ASA I - IV Ankle and/or leg fracture Operated between january 2016 and december 2020 at Montpellier Exclusion criteria - age < 18 years

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 |
| --- | --- | --- |
| use of vasopressors | use of vasopressors during surgery | during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of vasoconstrictor | Total dose of vasoconstrictor administered | during surgery | 
| Duration of peroperative hypotension | Duration of peroperative hypotension | during surgery | 
| Post-operative complications | Nausea/vomiting ; Cardiovascular complications ( dysrhythmias, ischaemia, Complications related to regional anesthesia (sciatic nerve paralysis, femoral) haematoma thromboembolism, sepsis, postoperative cognitive disorders); | up to 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery for Ankle and/or leg fracture