linjc16/ctgov huggingface dataset:
Visual and Optics Impact of Refractive Surgery

Study Overview
=================
Brief Summary
-----------------
Refractive surgery includes interventions to correct refractive errors, using a medical device such as a laser or an implant (intraocular lenses) or surgical instruments. The study distinguishes corneal interventions, carried on the surface of the eye, and intraocular interventions, performed on the lens or in the anterior or posterior chamber of the eye. The number of procedures in refractive surgery is growing significantly. They seem to offer satisfactory visual results but a number of issues remains unresolved. In order to get emmetropia, refractive surgery corrects optical defects by decreasing aberrations of lower orders (ie spherical refractive error and astigmatism). This increases high-order aberrations (the most common is a bright halo on the edge of the image). The cutting of the flap to the surface of the cornea in the case of LASIK increases high-order aberrations, which have the effect of reducing post-surgical visual performance (ie visual acuity and contrast sensitivity) and can't be corrected by glasses, while the adaptation of contact lenses on a post-operative cornea is more complex. It is therefore necessary to limit these post-surgical aberrations and to identify their possible sources. Indeed, some authors have provided insight into the effects of some high-order aberrations, but the influence of several factors characterizing the preoperative eye on refractive surgery are still unknown, such as pupillary diameter, depth of the anterior chamber, Intra Ocular Pressure or astigmatism.

Conditions
-----------------
Refractive Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient candidate for Laser in Situ Keratomileusis (LASIK) refractive surgery 18 to 40 years old corrective glasses or lenses ranging from -9.00 to + 6.00 diopter astigmatism less than or equal to 5 diopter Exclusion Criteria: patient opposition to participate in the study patient under legal protection Pregnant or breast feeding patient no health insurance coverage

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- | --- |
| number of high order aberrations after refractive surgery |  | 3 months after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Refractive Surgery, higher order aberrations
METHORIVAC - Vaccinal Pharmacoepidemiologic

Study Overview
=================
Brief Summary
-----------------
This project is the pilot step necessary to develop a system of vaccination pharmacoepidemiology that associates a sophisticated analytical approach, appropriate for this challenge and case series analysis, with the use of linked medicoadministrative data for hospitalisations the reimbursement of healthcare costs. This linkage of medicoadministrative data is new in France. The example of the risk of hospitalisation for febrile convulsions in infants less than two years old following vaccination against diphtheria, tetanus and pertussis is given as the reference association. This choice is justified by the numerous publications over many years on the existence of this association (Miller et al BMJ 1981, Farrington et al Lancet 1995). In addition, as case series analyses have been carried out to assess this risk, the results can be compared directly (Lancet 1995). The study to determine whether the analysis tools are suitable for the data will be tackled at the following levels: Validity of the selection of cases from administrative records alone using coding based on the international classification of diseases ICD10 Validity of the risk assessment. This methodology feasibility project must make it possible to identify the different potential problems. This is a prerequisite necessary for the systematic implementation.

Official Title
-----------------
Pharmacoepidemiological Methodology to Evaluate the Vaccination Risk in Young Infants

Conditions
-----------------
Infants Likely to Present Febrile Convulsions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - For reimbursement data: All of the data concerning delivery (purchase of the vaccine at a pharmacy, prescription) and vaccination (consultation following the date of purchase) for infants younger than 2 years old, in the years 2007 and 2008. - For PMSI data: All of the hospitalisations in 2007 and 2008 for febrile convulsions in infants less than 3 years old in hospitals of the following departments: Côte d'Or, Doubs and Bas-Rhin Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants likely to present febrile convulsions<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DATA EXTRACTION | Dates of delivery (purchase of the vaccine at the pharmacy), prescription, and date of vaccination (consultation) and when necessary, the age, doses, dates of adverse events, identification of the hospital | At the selection of patients |
A Clinical Study to Assess the Effect of Vildagliptin on Postprandial Lipid Parameters in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study was not conducted in the United States. Many people with type 2 diabetes also have high cholesterol levels. The purpose of this study was to evaluate the effects of vildagliptin, an unapproved drug, on blood lipid measures such as triglycerides and cholesterol in people with type 2 diabetes.

Official Title
-----------------
A Clinical Study to Assess the Effect of Vildagliptin on Postprandial Lipid Parameters in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood glucose criteria must be met Genetic markers associated with increased risk of cardiovascular disease Not currently on drug therapy for type 2 diabetes Body mass index (BMI) in the range 25-40 Exclusion Criteria: Pregnancy or lactation Type 1 diabetes High cholesterol as defined by the protocol Evidence of serious diabetic complications Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial serum total triglycerides at 4 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial total cholesterol at 4 weeks |  |  | 
| Postprandial total apo B at 4 weeks |  |  | 
| Postprandial triglycerides in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks |  |  | 
| Postprandial cholesterol in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks |  |  | 
| Postprandial apo B-48 and apo B-100 in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, vildagliptin
Using PRP and Cord Blood in Treatment of Covid -19

Study Overview
=================
Brief Summary
-----------------
covid - 19 is a critical viral infection that affects humans

Detailed Description
-----------------
Covid -19 pandemic started was declared in 2020

Official Title
-----------------
the Effect of PRP and Cord Blood in Improving the Symptoms of Covid-19

Conditions
-----------------
Virus

Intervention / Treatment
-----------------
* Combination Product: stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with positive covid -19 and has symptoms and isolated in the hospital Exclusion Criteria: patients with negative test for covid -19

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patients receiving LGF<br> | Combination Product: stem cells<br>* giving stem cells to patients with covid - 19<br>|
| No Intervention: patients not receiving LGF nor PRP<br> | |
| Active Comparator: patients receiving Platelet rich plasma<br> | Combination Product: stem cells<br>* giving stem cells to patients with covid - 19<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of patients with positive covid 19 who will improve after receiving stem cells | patients with positive covid 19 who will improve after receiving stem cells | 2 weeks |
The Effect of Stellate Ganglion Block on Intracranial Pressure Predicted by Ultrasonographic Assessment of Optic Nerve Sheath Diameter

Study Overview
=================
Brief Summary
-----------------
The stellate ganglion block increase cerebral blood flow, as the consequence of that, it has the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. Therefore, this study is aim to confirm the increased ICP by ultrasonographic measurement of ONSD after the stellate ganglion block.

Conditions
-----------------
Pain, Intracranial Pressure

Intervention / Treatment
-----------------
* Procedure: ultrasonographic measurement of optic nerve sheath diameter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (20-70 years of age) who were scheduled to receive stellate ganglion block at our pain management clinic Exclusion Criteria: Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery Patients with coagulation disorder Patients with severe obesity Patients with severe cardiovascular or pulmonary disease Patients with cognitive deficits or psychiatric illness

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| stellate ganglion block<br>Patients receiving stellate ganglion block at our pain management clinic | Procedure: ultrasonographic measurement of optic nerve sheath diameter<br>* A thick layer of gel is applied on the upper closed eyelid. The linear 13- to 6-MHz ultrasound probe is then placed in the gel, without exerting pressure on the eye. Two measurements are taken for each optic nerve: one in the transverse plane, with the probe being horizontal, and one in the sagittal plane, with the probe being vertical. The final ONSD is the mean of these measurements.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ultrasonographic measurement of optic nerve sheath diameter |  | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stellate ganglion block
Perinatal Depression Treatment and Child Development

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether the successful perinatal depression intervention among mothers (Thinking Healthy Programme, THP) has led to improved developmental outcomes in the children 6 years later. Economic and human resources aspects of the intervention will also be evaluated to determine overall societal benefits from investment in such a program, feasibility of scaling up the intervention and its sustainability in the long-term. The primary hypothesis is that children of mothers who participated in the THP will have better cognitive outcomes and socio-emotional functioning when compared to children of mothers randomized to the control group.

Official Title
-----------------
Perinatal Depression Treatment and Child Development: A Follow-Up of the Thinking Healthy Programme

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children of women who were eligible to participate in the Thinking Healthy Programme Exclusion Criteria: developmental disability, visual or hearing impairment

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 7 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 |
| --- | --- |
| depressed mother/child dyad - intervention<br> | |
| depressed mother/child dyad - no intervention<br> | |
| non-depressed mother/child dyad<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate of general intelligence |  | Re-enrollment visit, approximately 7 years post-intervention | 
| Measures of executive functions | Working memory, cognitive flexibility, inhibitory control, and sustained attention will be measured by standard tests of cognitive functioning. | Re-enrollment visit, approximately 7 years post-intervention | 
| Level of literacy and numeracy |  | Re-enrollment visit, approximately 7 years post-intervention | 
| Presence of behavioral and emotional problems (socio-emotional development) |  | Re-enrollment visit, approximately 7 years post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height-for-age |  | Re-enrollment visit, approximately 7 years post-intervention | 
| Weight-for-age |  | Re-enrollment visit, approximately 7 years post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Cognitive Behavior Therapy, Child Development
A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome

Study Overview
=================
Brief Summary
-----------------
Investigation of efficacy and safety of treatment with milnacipran in the treatment of fibromyalgia syndrome.

Official Title
-----------------
A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome

Conditions
-----------------
Fibromyalgia Syndrome

Intervention / Treatment
-----------------
* Drug: milnacipran
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with a diagnosis of fibromyalgia according to the 1990 American College of Rheumatology (ACR) criteria Exclusion Criteria: psychiatric illness depression of generalised anxiety disorder suicidal risk substance abuse active cardiac disease pulmonary dysfunction liver disease renal impairment autoimmune disease chronic inflammatory rheumatoid disease current systemic infection epileptic active cancer sleep apnea active peptic ulcer inflammatory bowel disease unstable endocrine disease for men : prostatic enlargement of genito-urinary disorders for women : pregnancy or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Experimental: Minalcipran<br> | Drug: milnacipran<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria |  | 12 weeks | 
| establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS). |  | 19 weeks |
Economisation of Whipple Resection Using Electrosurgical Sealing Device

Study Overview
=================
Brief Summary
-----------------
Including 89 randomised patient, the studies aim is to determine whether an economisation and/or improvement in terms of operating time, drainage fluid, blood loss, time of hospitalisation can be found using an electrosurgical sealing device versus traditional surgical methods such as stitches an ligations.The study is performed for patients undergoing partial pancreatoduodenectomy.

Official Title
-----------------
Prospective, Controlled, Randomized Study of Economisation of the Preparation in Partial Duodenopancreatectomy Using an Electrosurgical Sealing Device Versus Traditional Methods

Conditions
-----------------
Duodenopancreatectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: resectable tumor Exclusion Criteria: palliative resection
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Electrosurgical vessel sealing device | |
| 2<br>traditional surgical methods:stitches and ligations | |

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
-----------------
Partial duodenopancreatectomy using electrosurgical vessel sealing device
Pharmacokinetics of Ciprofloxacin in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
Measuring serum and urine concentrations of ciprofloxacin after IV and oral administration in children aged 3 months - 17 years who are treated for urinary tract infections.

Official Title
-----------------
Pharmacokinetics of Ciprofloxacin in Pediatric Patients With Emphasis on Renal Excretion

Conditions
-----------------
Urinary Tract Infection, Pyelonephritis

Intervention / Treatment
-----------------
* Drug: ciprofloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 3 months and 17 years of age confirmed diagnosis of febrile urinary tract infection (a rectal body temperature of 38.5 °C.in combination with either significant leukocyturia or a positive urine nitrite test in a reliable urine sample. indication for treatment or uroprophylaxis with ciprofloxacin at discretion of the treating physician. Exclusion Criteria: pregnancy impaired renal function as defined by 2x serum creatinine level for age and sex epilepsy myasthenia gravis long QT-syndrome glucose 6 phosphatase deficiency (G6PD) allergy to one of the substances of cipro concomitant use of corticosteroids for the oral group: co medication of antacidic drugs, ferrofumarate, calcium, magnesium or Zinc supplements.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 17 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: intravenous<br>Participants who are treated with ciprofloxacin intravenously, at discretion of the treating physician. | Drug: ciprofloxacin<br>* Serum and urine concentrations after ciprofloxacin administration. pharmacokinetic testing after ciprofloxacin administration<br>|
| Other: oral<br>Participants who are treated with ciprofloxacin via the oral route, at discretion of the treating physician. | Drug: ciprofloxacin<br>* Serum and urine concentrations after ciprofloxacin administration. pharmacokinetic testing after ciprofloxacin administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentrations |  | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine concentrations |  | 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ciprofloxacin, pharmacokinetics, excretion, clearance, infant, children, adolescent