linjc16/ctgov huggingface dataset:
Methadone in Pediatric and Adult Sickle Cell Patients

Study Overview
=================
Brief Summary
-----------------
To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.

Official Title
-----------------
Methadone in Pediatric and Adult Sickle Cell Patients

Conditions
-----------------
Sickle Cell Disease

Intervention / Treatment
-----------------
* Drug: Morphine
* Drug: Methadone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than or equal to 7 years and less than or equal to 40 years Confirmed diagnosis of any form of sickle cell disease, including sickle cell anemia, sickle-hemoglobin C disease, and sickle-B thalassemia Currently experiencing a vaso-occlusive episode (VOE), defined as acute pain in the extremities Admitted to the inpatient unit for further treatment Started on morphine patient controlled analgesia and infusion for pain management Exclusion Criteria: Diagnosis of acute chest syndrome New focal neurologic findings or clinical concern of stroke Aplastic crisis with hemoglobin 2 g/dl below steady-state value Allergy to morphine or methadone Any other medical condition that the attending physician deems to be a contraindication to therapy Liver or renal insufficiency or failure, and congestive heart failure

Ages Eligible for Study
-----------------
Minimum Age: 7 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methadone-Children<br>Methadone comparison to standard of care for pain management | Drug: Methadone<br>* Compare to standard of care for pain management of acute episode of pain<br>|
| Active Comparator: Morphine-Children<br>Morphine standard of Care pain management | Drug: Morphine<br>* Standard of care for pain management of acute episode of pain<br>|
| Active Comparator: Methadone-Adults<br>Methadone comparison to standard of care for pain management | Drug: Methadone<br>* Compare to standard of care for pain management of acute episode of pain<br>|
| Active Comparator: Morphine-Adults<br>Morphine standard of Care pain management | Drug: Morphine<br>* Standard of care for pain management of acute episode of pain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE. | R-Methadone AUC | 96 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief | Pain relief score using the 10CM VAS, which has a pain scale of 0-10, with 0=no pain and 10=worst pain experienced | 72 hr |
Neurological Fate, Prematurity and Genetic Susceptibility Factors

Study Overview
=================
Brief Summary
-----------------
This study could help identify aggravating or protective genetic polymorphisms associated with cerebral palsy. Populations of premature babies at different risk of cerebral palsy could thus be individualized with an impact on their monitoring and on the pathophysiological understanding of the processes leading to neurological lesions.

Official Title
-----------------
GENIMOC : Neurological Fate, Prematurity and Genetic Susceptibility Factors

Conditions
-----------------
Polymorphism, Restriction Fragment Length, Premature, Infertility of Cervical Origin

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children born prematurely at term <34 weeks between 2008 and 2015 assessed at the age of 2 within the Growing Together Network in Pays de Loire parental consent for the collection of data from their child and for intraoral sampling for the search for genetic factors. Exclusion Criteria: children who died after the age of 2 children who refused and / or whose parents refused to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br> | Other: no intervention<br>* no intervention<br>|
| Control<br> | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify a polymorphism associated with the risk of developing cerebral palsy at 2 years in a regional population of premature infants of gestational age <34 weeks gestation. | frequency of variants within the case and control groups using the statistical criterion level of significance (also called p-value and known by the English word p-value) of 5.10-8 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify a specific polymorphism of certain forms of cerebral palsy | neurological examination | 2 years | 
| Develop a prognosis algorithm for the occurrence of cerebral palsy for personalized monitoring in a population at risk. | neurological examination | 2 years |
Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the necessity of considering posterior corneal toricity on refractive outcome of patients with cataracts and corneal astigmatism after implantation of intraocular lenses. This is determined by comparing total corneal and refractive astigmatism,and by comparing the expected refractive result with actual refractive astigmatism postoperatively,using total corneal and anterior corneal astigmatism to calculate respectively.

Official Title
-----------------
Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia

Conditions
-----------------
Astigmatism, Cataract

Intervention / Treatment
-----------------
* Procedure: phacoemulsification
* Device: Pentacam (Oculus,Germany)examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cataract candidates preoperative corneal regular astigmatism >0.75D Willing and able to complete all required postoperative visits Able to comprehend and sign a statement of informed consent Exclusion Criteria: significant intraocular lenses tilt or decentration corneal scarring Irregular corneal astigmatism other ocular diseases surgical complication

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: phacoemulsification|After topical anesthesia with Alcaine, 3.0-mm clear corneal incisions were made. Torsional phacoemulsification was performed using the Infiniti Vision System with the OZil handpiece, a 45-degree Kelman miniflared tip, and DuoVisc viscoelastic (all from Alcon).|
|Device: Pentacam (Oculus,Germany)examination|Total corneal astigmatism is obtained by Pentacam at every visit.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pentacam-derived corneal astigmatism |  | 3month postoperatively | 
| refraction |  | 3month postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
astigmatism, pseudophakia
Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection.

Detailed Description
-----------------
A randomized, double-blind, single-dosing, crossover study to compare the safety and pharmacokinetic characteristics of HD203 Liquid 25 mg with those of Enbrel Prefilled® injection 25 mg after subcutaneous injection.

Official Title
-----------------
Randomized,Double-blind,Single-dosing,Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 With Active Comparator

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: Etanercept (Enbrel)
* Biological: HD203


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 to 40 years of healthy volunteers Weight over 55kg Subject who signed on ICF Exclusion Criteria: Subject who had been treated with Etanercept before

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enbrel, prefilled syringe<br> | Biological: Etanercept (Enbrel)<br>* prefilled syringe, SC<br>|
| Experimental: HD203, prefilled syringe<br> | Biological: HD203<br>* HD203, prefilled syringe, SC injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity |  | up to 49days |
Can Intravenous Vitamin C Improve Skin Hyperpigmentation in Long-Term Hemodialysis Patients?

Study Overview
=================
Brief Summary
-----------------
Intravenous vitamin C may improve skin hyperpigmentation in chronic hemodialysis patients

Detailed Description
-----------------
Melanogenesis is caused by enzymatic conversion of tyrosine to melanin pigments.Ascorbic acid has the ability to inhibit peroxidase and may thus inhibit melanin synthesis.

Official Title
-----------------
Can Intravenous Vitamin C Improve Skin Hyperpigmentation in Long-Term Hemodialysis Patients?

Conditions
-----------------
Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Drug: vitamin C, intravenous injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic hemodialysis patients Exclusion Criteria: allergic to vitamin C, using steroid, etc

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: vitamin C, intravenous injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin pigmentation extent |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood anti-oxidant level |  |  |
Prospective Study on Patients With Obstructive Sleep Apnea in Hong Kong (PrOSA)

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnea syndrome (OSAS) is a common disorder with prevalence rates of at least 4% among the middle-aged male Caucasians and Hong Kong (HK) Chinese populations. It is characterized by repetitive episodes of upper airway obstruction, causing intermittent hypoxia, sleep fragmentation, disabling daytime sleepiness, impaired cognitive function and poor health status. OSAS patients are at increased risks of non-fatal and fatal cardiovascular morbidity and mortality including sudden death, in addition to being more prone to road traffic accidents. However, there is no long term follow up of patients with OSAS on the incidence of cardiovascular disease, compliance on the therapy and the impact of the quality of life. The study is aimed to carry out a prospective observational study assessing the role of OSAS as a possible cause of increased cardiovascular risk and cognitive decline.

Official Title
-----------------
Prospective Study on Patients With Obstructive Sleep Apnea in Hong Kong (PrOSA)

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected obstructive sleep apnea syndrome aged 18 or above must be able to speak, read and understand Chinese or English possess the ability to respond to questions and follow instructions. Exclusion Criteria: already treated sleep apnea, a limited life expectancy due to illness unrelated to sleep apnea human immunodeficiency virus (HIV), advanced renal disease, uncontrolled malignancies documented alcohol or drug abuse up to 1 year prior to inclusion in the study.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of Cardiovascular disease |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Montreal Cognitive Assessment score (MoCA) | MoCA scores range between 0 and 30. Higher scores mean a better cognitive function. | 5 years | 
| Change of Epworth Sleepiness Score | The Epworth Sleepiness Scale can be used to assess daytime sleepiness. The scores range between 0 and 24. Higher scores mean more sleepiness. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive function
Single Lumen Needle Without Flushing or Double Lumen Needle With Follicle Flushing in Oocyte Retrieval

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare whether oocyte flushing during retrieval is effective or not.

Detailed Description
-----------------
In total 300 patients will be randomized for the effectiveness of single or double lumen needle during oocyte retrieval. Double lumen needles give an opportunity of washing to the follicle with flush. Single lumen needles seem to be faster and no need for flushing. We aim to compare to the differences of the use of both needles.

Official Title
-----------------
Single Lumen Needle Without Flushing or Double Lumen Needle With Follicle Flushing in Oocyte Retrieval

Conditions
-----------------
Oocyte Retrieval

Intervention / Treatment
-----------------
* Device: single lumen needle oocyte retrieval
* Device: double lumen needle oocyte retrieval


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing IVF/ICSI cycles. Exclusion Criteria: Poor responder patients who have lower than 6 follicles at hCG administration day. Patients having over 30 follicles.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 41 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Single lumen needle use in oocyte retrieval | Device: single lumen needle oocyte retrieval<br>* single lumen needle use during oocyte retrieval<br>|
| Active Comparator: 2<br>Double lumen needle with follicle flushing during oocyte retrieval | Device: double lumen needle oocyte retrieval<br>* double lumen needle with 1 time follicle flushing with at least 2 ml during oocyte retrieval<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metaphase 2 oocyte number |  | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
follicle flushing, oocyte retrieval, needle
Pediatric Pharmacokinetics And Safety Study Of Moxidectin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the amount of moxidectin in subjects' blood and to measure safety. This study will enroll 36 children aged 4 to 11 years (>=12 kg) with or without Onchocerca volvulus (O volvulus) infection. O volvulus is the nematode, or roundworm, that causes Onchocerciasis, also known as river blindness. Each subject will receive a single dose of 4 mg moxidectin (orally administered) and will be followed inpatient from screening through day 13 and as outpatients through month 6. The study will take place at a single research center.

Official Title
-----------------
A Single-Center, Open-Label, Single-Dose Study To Assess The Pharmacokinetics, Safety, And Tolerability Of Moxidectin In Subjects Aged 4 To 11 Years ( >=12 kg) With Or Without Onchocerca Volvulus Infection

Conditions
-----------------
Onchocerciasis

Intervention / Treatment
-----------------
* Drug: moxidectin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects aged 4 to 11 years, inclusive (weighing >= 12 kg) With or without O volvulus infection Exclusion Criteria: Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study Contraindication or hypersensitivity to moxidectin

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 11 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxidectin<br> | Drug: moxidectin<br>* Single Dose Moxidectin 4 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of moxidectin in subjects blood, as measured by collecting a number of blood samples from each subject, in which the amount of moxidectin will be measured |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and tolerability of a single dose of 4 mg moxidectin in subjects as measured by physical examinations, laboratory tests, vital signs and ECG findings |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
onchocerciasis; river blindness; moxidectin; pediatric
Comparison of Two D-Dimers Dosing Techniques

Study Overview
=================
Brief Summary
-----------------
Study of the possibility of substitution of the automated STAGO D-Dimers method with the semi-automated VIDAS method, which is more expensive, longer to implement and requires the use of a dedicated automaton.

Detailed Description
-----------------
To compare D-Dimer assay techniques in the exclusion of VTE (Thromboembolic Venous Disease):• BIOMERIEUX: D-Dimers VIDAS (considered as reference technique)• STAGO: D-Di PlusOn a population of patients recruited in Brest for a period of 1 year: patients for whom a dosage of VIDAS D-dimers is prescribed (approximately 3700 patients)

Official Title
-----------------
Comparison of Two D-Dimers Dosing Techniques : LIATEST DDI PLUS (STAGO) Versus VIDAS D-DIMERS (BIOMERIEUX)

Conditions
-----------------
Blood Coagulation Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients for whom a dosage of D-Dimers VIDAS is prescribed in the context of a suspicion of VTE at Brest CHRU. No opposition formulated. Exclusion Criteria: Curative dose anticoagulant treatment whatever the indication, Pregnancy in progress, Follow-up at 3 months not possible, Patient refusing to participate

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 |
| --- | --- |
| D-Dimers patients<br>population recruited in Brest for a period of 1 year: patients for whom a dose of VIDAS D-dimers is prescribed (approximately 3700 patients) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomerieux D-Dimer level | quantification of Biomerieux D-Dimer level (VIDAS) | at the inclusion | 
| Stago D-Dimer level | quantification of Biomerieux D-Dimer level (STAGO) | at the inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Coagulation, DDimers