linjc16/ctgov huggingface dataset:
Platelet Rich Fibrin(PRF) Injection for Treatment of Dental Pulp Exposure:Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
platelet rich fibrin(PRF) obtained from patient from patient blood sample (before start of treatment)is injected in the site of exposure of exposure(intervention group) control group will receive normal pulp capping procedure by MTA follow up will be one year

Detailed Description
-----------------
intervention group:patient with deep caries lesion ,free from sign and symptoms of irreversible pulpitis the blood sample will be taken before the beginning of dental treatment..PRF will be obtained by blood centrifugal and injected in the site of exposure covered by glass ionomer restoration control group: patient with same condition will receive pulp capping procedure by MTA followed by glass ionomer restoration

Official Title
-----------------
Platelet Rich Fibrin(PRF) Versus Pulp Capping in Treatment of Dental Pulp Exposure:Randomized Clinical Trial

Conditions
-----------------
Dental Pulp Exposure, Dental Caries

Intervention / Treatment
-----------------
* Procedure: PRF pulp capping
* Procedure: MTA pulp capping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: deep carious lesion- no sign of irreversible pulpitis Exclusion Criteria: old age- periapical lesion-

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRF<br> | Procedure: PRF pulp capping<br>* PRF is injected in the site of exposure<br>|
| Active Comparator: MTA<br> | Procedure: MTA pulp capping<br>* conventional pulp capping procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulp vitality | no sign of irreversible pulpitis or pulpal necrosis | After 1 year |
Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia

Study Overview
=================
Brief Summary
-----------------
This is prospective and randomized study to compare the pharmacodynamics (t>MIC) of 0.5 g every 6 h of imipenem in twelve patients with febrile neutropenia following administration by a 4 h infusion or bolus injection. Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to %PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response.

Official Title
-----------------
Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia Following Administration by 4-hour Infusion and Bolus Injection.

Conditions
-----------------
Patients With Febrile Neutropenia

Intervention / Treatment
-----------------
* Drug: Imipenem
* Drug: Imipenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged > or = 20 years Patients who have febrile neutropenia with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion Patients who are likely to survive 3 days Exclusion Criteria: Patients who have documented hypersensitivity to imipenem or other carbapenems Patients who have an estimated creatinine clearance of < 50 ml/min Patients who are in circulatory shock or hypotension (systolic < 90 mmHg) Patients who are pregnant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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: Conventional arm<br>Infusion of 0.5 g of imipenem for 0.5 hr every 6 hr for 2-5 days | Drug: Imipenem<br>* Each patient will receive 0.5 g of imipenem, 0.5 hr infusion every 6 hr at room temperature<br>* Other names: Tienam;|
| Experimental: Extended infusion arm<br>Infusion of 0.5 g of imipenem for 4 hr every 6 hr for 2-5 days | Drug: Imipenem<br>* Each patient will receive 0.5 g of imipenem, 4 hr infusion every 6 hr of at room temperature<br>* Other names: Tienam;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of imipenem in plasma | Concentration of imipenem in plasma will be determined by HPLC method and simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response). | 6 hours profile after 8th dose of imipenem | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Imipenem, Febrile neutropenia, Gram-negative infection, Pharmacodynamic, Monte Carlo Simulation
Visual Function Changes After Intraocular Pressure Reduction

Study Overview
=================
Brief Summary
-----------------
During the glaucomatous disease process, subpopulations of cells may be dead, damaged or healthy. Visual function changes could be observed due to a recovering of the suffering ganglion cells after the intraocular pressure reduction. This study aims at evaluating the correlation between intraocular pressure reduction and visual function changes in glaucoma patients after using antiglaucoma medications.

Detailed Description
-----------------
Primary open angle glaucoma patients without use of antiglaucoma medications will be enrolled in this study. After inclusion, the patients will randomly receive one of three antiglaucoma medications (timolol maleate 0,5%, brimonidine tartrate 0,2% or travoprost 0,004%) in one randomly selected eye. The patients will be evaluated with Goldmann applanation tonometry, visual acuity test, contrast sensitivity test, visual quality perception test (visual analogue scale) and standard automated perimetry before and after 4 weeks of glaucoma treatment onset.

Official Title
-----------------
Visual Function Changes After Intraocular Pressure Reduction Using Antiglaucoma Medications: A Randomized Clinical Trial

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: timolol maleate 0,5%
* Drug: brimonidine tartrate 0,2%
* Drug: travoprost 0,004%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary open angle glaucoma Intraocular pressure greater than 21 mmHg Exclusion Criteria: Best corrected visual acuity (BCVA) worse than 20/80 Significant media opacity History of steroid use

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: timolol maleate 0,5%|nan|
|Drug: brimonidine tartrate 0,2%|nan|
|Drug: travoprost 0,004%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure |  |  | 
| contrast sensitivity |  |  | 
| visual quality perception |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean deviation of the visual field (MD) |  |  | 
| Pattern Standard Deviation of the visual field (PSD) |  |  | 
| visual acuity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraocular pressure, contrast sensitivity, visual function
A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.

Study Overview
=================
Brief Summary
-----------------
This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus

Detailed Description
-----------------
Trial includes a two week washout period before entering the treatment period for subjects on oral anti-diabetic medication.

Official Title
-----------------
A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Multiple Dose Study to Assess the Safety and Tolerability of ASP1941 in Adult Subjects With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: ASP1941
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established diagnosis of type 2 diabetes mellitus HbA1c value between 7.0 and 10.0% Body mass index between 20 and 45 kg/m2 Exclusion Criteria: Established diagnosis of type 1 diabetes mellitus Serum creatinine > upper limit of normal range Proteinuria (microalbumin/creatinine ratio > 300 mg/g) Urinary tract infection Severe uncontrolled Hypertension Significant renal, hepatic or cardiovascular disease HIV Positive History of drug or alcohol abuse/dependency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP1941 Lowest Dose<br>Oral | Drug: ASP1941<br>* Oral<br>|
| Experimental: ASP1941 Low Dose<br>Oral | Drug: ASP1941<br>* Oral<br>|
| Experimental: ASP1941 Medium Dose<br>Oral | Drug: ASP1941<br>* Oral<br>|
| Experimental: ASP1941 High Dose<br>Oral | Drug: ASP1941<br>* Oral<br>|
| Placebo Comparator: Placebo<br>Oral | Drug: Placebo<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of safety through clinical safety labs and adverse events |  | 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of routine PK and PD parameters |  | 6 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP1941, Type 2 Diabetes Mellitus
Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula

Study Overview
=================
Brief Summary
-----------------
To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator. Hypothesize there will be no difference between formula groups.

Official Title
-----------------
Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula

Conditions
-----------------
Healthy Term Infants Solely Formula Fed

Intervention / Treatment
-----------------
* Other: Enfamil LIPIL with iron
* Other: Good Start Supreme with DHA and ARA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton birth Term infant at birth Birth weight of 2500 g (5 lbs 8 oz) or more 4 - 18 days of age at Study Visit 1 Exclusion Criteria: History of underlying metabolic or chronic disease or congenital malformation Infant switched formulas more than one time between birth and Study Visit 1 Known feeding problems at Study Visit 1

Ages Eligible for Study
-----------------
Minimum Age: 4 Days
Maximum Age: 18 Days

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

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: 1<br>Cow's milk based infant formula | Other: Enfamil LIPIL with iron<br>* cow's milk based infant formula<br>|
| Active Comparator: 2<br>Partially hydrolyzed cow's milk based infant formula | Other: Good Start Supreme with DHA and ARA<br>* partially hydrolzed cow's milk protein<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant temperament |  | 60 days |
Encouraging Calcium Absorption and Bone Formation During Early Puberty

Study Overview
=================
Brief Summary
-----------------
Increasing bone mass during puberty can ultimately decrease the risk of developing osteoporosis, which causes bones to weaken and break more easily later in life. The purpose of this study is to compare calcium absorption and bone growth in boys and girls on diets including either a nondigestible oligosaccharide (NDO) or simple sugar.

Detailed Description
-----------------
Rapid increases in bone mass occur during calcium absorption and bone calcium deposition during puberty, and these increases can enhance peak bone mass and ultimately decrease the lifetime risk of osteoporosis. However, dietary, hormonal, and genetic factors likely affect increased bone mass. This study will examine if adding NDO to a pubertal diet allows more absorption of calcium by the body, producing stronger bones. The study will also assess how the hormones produced by the body during puberty affect bone growth and whether genetic factors affect calcium absorption or bone growth. This study will last 2 years. At study entry, baseline pubertal hormone levels and bone mass will be assessed. Both a dual-energy X-ray absorptiometry (DEXA) scan and a calcium stable kinetic study measuring calcium absorption will be performed. Participants will then be randomly assigned to receive calcium fortified food with or without added NDO for 1 year. Calcium absorption will be measured again at 2 months. After the first year, calcium kinetic, hormonal, and DEXA studies will be performed and compared to baseline results. A final DEXA scan will be performed at the end of 2 years.

Official Title
-----------------
Optimization of Calcium Absorption and Bone Formation During Early Puberty

Conditions
-----------------
Osteoporosis, Osteopenia

Intervention / Treatment
-----------------
* Drug: Nondigestible oligosaccharide (NDO)


Participation Criteria
=================
Eligibility Criteria
-----------------
Tanner Stage 2 or 3 Girls must not have started menstruating In the 10th to 90th percentile in body mass index (BMI) for their age

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nondigestible oligosaccharide (NDO)|nan|

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
-----------------
Bone growth, Calcium, Children, Diet, Puberty
A Study of RO4917523 in Pediatric Patients With Fragile X Syndrome

Study Overview
=================
Brief Summary
-----------------
This randomized, double-blind, placebo-controlled, parallel-arm study will evaluate the safety and exploratory efficacy and pharmacokinetics of RO4917523 in pediatric patients with fragile X syndrome. Patients will be randomized to receive one of 2 dose levels of RO4917523 or placebo orally daily for 12 weeks.

Official Title
-----------------
A Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Safety and Exploratory Efficacy and Pharmacokinetic, Study of RO4917523 in Pediatric Patients With Fragile X Syndrome

Conditions
-----------------
Fragile X Syndrome

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: RO4917523
* Drug: RO4917523


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and adolescents, 5 to 13 years of age Diagnosis of fragile X syndrome based on prior DNA testing confirming Fragile X Mental Retardation 1 (FMR1) full mutation and qualifying scores on the ABC and CGI-S Exclusion Criteria: Previous treatment with another mGlu5 receptor antagonist within the prior 3 months Participation in a clinical trial involving an investigational drug (unapproved) or non-drug treatment within the prior 6 weeks or 5 times the half-life (whichever is longer) before the start of this study Any uncontrolled, unstable clinically significant psychiatric condition other than fragile X syndrome History of suicidal behavior Other protocol defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 13 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* orally daily, 12 weeks<br>|
| Experimental: RO4917523 Dose A<br> | Drug: RO4917523<br>* Dose A orally daily, 12 weeks<br>|
| Experimental: RO4917523 Dose B<br> | Drug: RO4917523<br>* Dose B orally daily, 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Neuropsychological/behavioral assessment scales (ADAMS/Clinical Global Impressions CGI-S, CGI-I/ GBAS/Aberrant Behavior Checklist ABC/Repeatable Battery for the Assessment of Neuropsychological Status RBANS/VAS behavior) |  | 15 weeks | 
| Pharmacokinetics: Clearance (CL/F) |  | up to Week 12 | 
| Pharmacokinetics: Volume of distribution at steady-state (Vss/F) |  | up to Week 12 |
Study of the Modification of the Retinal Nerve Fiber Layer in Patients Treated With Intravitreous Injection of Anti-VEGF

Study Overview
=================
Brief Summary
-----------------
The intra-vitreous injection (IVT) of anti-VEGF (vascular endothelial growth factor) is currently the standard treatment for retinal neovascularization. The VEGF stimulates endothelial cells' proliferation and migration. It also increases microvascular permeability. If the VEGFs have proven their efficiency in the decrease of choroidal neovascular proliferation, their impact of the head of the optic nerve's microvasculature is yet unknown. Knowing that this microvasculature provides the retinal nerve fibers with oxygen, located in the area of the head of the optic nerve, a vasoconstriction induced by the anti-VEGF may have an incidence on the loss of retinal nerve fibers.

Conditions
-----------------
Retinal Neovascularization

Intervention / Treatment
-----------------
* Device: Gonioscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years old Patients treated with anti-VEGF according to the French summary of product characteristics (SPC) Patients who have been informed of the trial and who are not opposed to participate in the study Exclusion Criteria: Patients presenting a retinal condition, including the optic nerve Patients treated with anti-VEGF in both eyes Pregnant women Lack of affiliation to social security or universal health coverage

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients treated with anti-VEGF<br> | Device: Gonioscopy<br>* Study of the trabecular structure by gonioscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in RNFL's thickness in the nasal quadrant of the optic nerve after intra-vitreous Injection of Anti-VEGF | RNFL's thickness (in microns) measured with the Heildelberg glaucoma module of the spectral domain Optical Cohérence Tomographie (OCT Spectralis, Heidelberg engeening). | Change from baseline RNFL's thickness at Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinal neovascularization, Anti-VEGF, Retinal Nerve Fiber Layer (RNFL)