linjc16/ctgov huggingface dataset:
RSA Study on the Behaviour of the Growth Plate During and After Temporary Hemi-epiphysiodesis and Epiphysiodesis

Study Overview
=================
Brief Summary
-----------------
By using radiostereometric analysis (RSA) we will be able to study growth during and after temporary epiphysiodesis and with great accuracy be able to detect asymmetric growth following this procedure. By using the same method we also want to analyse patients with axial deviations operated with guided growth (tension band plating) to study the growth during and after the procedure and be able to set the correct timing for removal of the implant.

Detailed Description
-----------------
The RSA method consists of implantation of small tantalum beads on either side of the physis during surgery on the the physis. Later analysis of the RSA Pictures with the RSA-method will give us an microscopically accurate measure of the growth in three planes.

Official Title
-----------------
Behaviour of the Growth Plate in Patients Operated With Either Permanent or Temporary Hemi-epiphysiodesis or Epiphysiodesis Through by the Use of Radiostereometric Analysis (RSA)

Conditions
-----------------
Anisomelia, Deformity of Limb

Intervention / Treatment
-----------------
* Other: Temporary hemi-epiphysiodesis or epiphysiodesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with idiopathic axial deviations in the lower extremities Children with limb length discrepancys where timing of epiphysiodesis is difficult because of a big discrepancy in skeletal age and chronological age Exclusion Criteria: Children with axial deviations and pathological physis

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 16 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Axial deviations in children<br>Children with axial deviations in the lower extremity treated with guided growth | Other: Temporary hemi-epiphysiodesis or epiphysiodesis<br>* Tension band plate (eight-plate, pedi plate), staple or locking plate<br>|
| Limb length discrepancy in children<br>Children with limb length discrepancy treated with temporary epiphysiodesis | Other: Temporary hemi-epiphysiodesis or epiphysiodesis<br>* Tension band plate (eight-plate, pedi plate), staple or locking plate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behaviour of the growth plate during and after temporary hemi-epiphysiodesis and epiphysiodesis | Radiostereometric analysis of growth | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LLD, guided growth
Non Syndromic Congenital Heart Defect and Array-CGH in Prenatal Diagnosis

Study Overview
=================
Brief Summary
-----------------
Comparative genomic hybridization (CGH)-based microarrays are now often used during pregnancy in case of fetal polymalformation in order to assess significant genomic alterations. However, it is not clear whether array-CGH provide a diagnostic utility in case of isolated congenital heart defect. This is the first prospective study aiming at defining the right chromosomal screening when a fetal isolated congenital heart defect is identified by ultrasound.

Detailed Description
-----------------
Comparative genomic hybridization (CGH)-based microarrays are now often used during pregnancy in case of fetal polymalformation in order to assess significant genomic alterations. Up to now, in case of isolated heart defect, only fetal karyotype with FISH 22q11 was usually offered. However, micro deletions or duplications could not be identified elsewhere throughout the genome. Then, in case of fetal chromosomal micro-rearrangements, parents could not be fully informed for global and neurodevelopmental prognosis. To our knowledge, clear-cut study, to assess whether array-CGH provide a diagnostic utility in case of isolated congenital heart defect, don't exist. After informed consent, 80 women will be enrolled during two years in 2 official prenatal diagnosis centers in France. This survey is assumed to identify at least 8% of unbalanced chromosomal abnormalities. This will be also compared with 22q11 rearrangements rate. This is the first prospective study aiming at defining the right chromosomal screening when a fetal isolated congenital heart defect is identified by ultrasound.

Official Title
-----------------
Prospective Study for Diagnosis Utility of Array-CGH Screening in Case of Non Syndromic Congenital Heart Defect in Prenatal Diagnosis (CAPA)

Conditions
-----------------
Non Syndromic Congenital Heart

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant woman over 18-year-old ; Ongoing health insurance ; Informed consent ; Prenatal samples from amniotic fluid ; Isolated congenital heart defect. Exclusion Criteria: Transposition of great arteries ; Amniotic fluid sample refusal.

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

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

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 |
| --- | --- | --- |
| Identification a significant rate of chromosomal imbalances on ACPA > 8% |  | J0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare rates of abnormalities identified by karyotype FISH 22q11 versus ACPA |  | J0 | 
| To compare cardiac ultrasound prenatal data with postnatal data including pathological data (if TOP) |  | J0 | 
| To compare the nature of chromosomal imbalances with the type of MCC |  | J0 |
Effectiveness of T2* MRI in Cervical Spondylotic Myelopathy

Study Overview
=================
Brief Summary
-----------------
Utilization of T2* MRI in predicting prognosis in patients with cervical spondylotic myelopathy (CSM)

Detailed Description
-----------------
Cervical spondylotic myelopathy (CSM), an age-related degenerative disease that is common worldwide, is mainly caused by compression of the spinal cord and may possibly lead to disability. Surgery to reduce direct compression of the spinal cord might alleviate disease progression; due to individual differences, some patients do not benefit from surgery. Prognostic prediction is important because it affects subsequent treatment decision making. Currently, prognosis is generally based on magnetic resonance imaging (MRI) with a detailed macrostructural evaluation of the spinal cord. Unfortunately, the use of conventional MRI indicators (e.g., increased intensity signal [ISI]) to predict CSM outcomes has been controversial because of their subjectivity or the insufficient information contained therein. A new biomarker, T2* MRI gray matter to white matter signal intensity ratio (GM/WM), is associated with demyelination and gliosis. Previous studies have shown that patients with CSM can have T2* MRI WM / GM changes at the early stage of disease, and the WM / GM value is increased, which is significantly higher than that of normal people, and is related to the spinal cord function score. However, the correlation between this index and long-term prognosis remains to be studied.

Official Title
-----------------
Effectiveness of T2* MRI in Predicting Prognosis in Patients With Cervical Spondylotic Myelopathy (CSM)

Conditions
-----------------
Cervical Spondylotic Myelopathy

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with CSM and operated on by one senior orthopedist available preoperative MRI results high-quality image data with no motion artifacts available preoperative and long-term follow-up (≥1 years) mJOA score Exclusion Criteria: prior head or neck surgery a history of notable additional diseases (spinal cord tumor, multiple sclerosis, syringomyelia, spinal cord injury, or motor neuron disease).
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mild CSM<br>preoperative modified Japanese Orthopedic Association (mJOA) score ≥15 | Other: MRI<br>* T2* MRI<br>|
| moderate CSM<br>preoperative mJOA score 13 14 | Other: MRI<br>* T2* MRI<br>|
| severe CSM<br>preoperative mJOA score ≤12 | Other: MRI<br>* T2* MRI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of neurologic function | Postoperative modified Japanese Orthopaedic Association (mJOA) at follow-up time | at follow-up time (≥1 years) |
A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow

Study Overview
=================
Brief Summary
-----------------
It is known that several common eye diseases are associated with ocular perfusion abnormalities. Moxaverine is used in the therapy of perfusion abnormalities in the brain, the heart and the extremities because of its direct vasodilatory effects. The present study seeked to investigate whether moxaverine alters ocular blood flow in healthy volunteers after intravenous administration.

Official Title
-----------------
A Randomized, Double-Masked, Placebo-Controlled Two Cross Over Study Comparing the Effects of Moxaverine and Placebo on Ocular Blood Flow

Conditions
-----------------
Ischemia

Intervention / Treatment
-----------------
* Drug: Moxaverine
* Drug: physiological saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 healthy volunteers of either sex Age 18-35 yrs. Body mass index between 15th and 85th percentile, nonsmokers Exclusion Criteria: Regular use of medication Abuse of alcoholic beverages or drugs Participation in a clinical trial in the 3 weeks preceding the study Treatment in the previous 3 weeks with any drug Symptoms of a clinically relevant illness in the 3 weeks before the first study day History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs Blood donation during the previous 3 weeks Ametropy less 3 dpt Acute gastric bleeding, massive cerebral hemorrhage related to stroke Women: pregnancy or lactation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Moxaverine<br>* intravenous administration<br>|
| Placebo Comparator: 2<br> | Drug: physiological saline<br>* intravenous administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal and Choroidal Blood flow |  | 2 hours |
A Study of Donanemab (LY3002813) in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to assess how fast donanemab (LY3002813) gets into the blood stream and how long it takes the body to remove it when administered as single dose in healthy participants. The study will also evaluate the safety and tolerability of donanemab. The study will last up to approximately 22 weeks.

Official Title
-----------------
A Phase 1, Open-Label Study to Characterize the Pharmacokinetics of Donanemab Following Intravenous Doses in Healthy Participants

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

Intervention / Treatment
-----------------
* Drug: Donanemab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who are overtly healthy as determined by medical evaluation Have a body mass index (BMI) of 19.0 and 32.0, kilograms per meter squared (kg/m²), inclusive. Females of childbearing potential will be excluded from the study. Exclusion Criteria: Have allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone Have a history within the past 5 years of a primary or recurrent malignant disease Have used over-the-counter or prescription medications, including herbal medication, within 7 days prior to dosing Are pregnant or intend to become pregnant or to breastfeed during the study Smoke more than 10 cigarettes per day or are unable to abide by investigative site smoking restrictions Have a history of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, carotid, carotid artery occlusion, stroke or epilepsy or family history of dementia or Down's syndrome

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Donanemab<br>Donanemab administered intravenously (IV). | Drug: Donanemab<br>* Administered IV.<br>* Other names: LY3002813;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Four weeks (AUC[0-4 weeks]) of Donanemab | PK: AUC[0-4 weeks] of Donanemab | Predose up to 28 days postdose | 
| PK: Maximum Observed Concentration During a Dosing Interval at Steady State (Cmax, ss) of Donanemab | PK: Cmax, ss of Donanemab | Predose up to 28 days postdose | 
| PK: Area Under the Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCτ,ss) of Donanemab | PK: AUCτ,ss of Donanemab | Predose up to 28 days postdose |
Ozurdex for Combined Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine where a sustained steroid delivery system (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients after Cataract Surgery

Official Title
-----------------
Phase 2 Study of Ozurdex for Combined Pseudophakic Cystoid Macula Edema and Diabetic Macula Edema After Cataract Surgery

Conditions
-----------------
Pseudophakic Cystoid Macular Edema,, Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Dexamethasone Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DIABETIC PATIENTS WHO DEVELOP CYSTOID MACULA EDEMA AFTER CATARACT SURGERY (WITHIN 4-10 WEEKS AFTER SURGERY VISUAL ACUITY WORSE THAN 20/32 Exclusion Criteria: VISUAL ACUITY WORSE THAN 20/200 MODERATE OR SEVERE GLAUCOMA (AS DEFINED AS USING >2 TOPICAL GLAUCOMA MEDIATIONS. USE OF SYSTEMIC, PERIOCULAR OR INTRAOCULAR CORTICOSTEROIDS WITHIN 30 DAYS OF ENROLLMENT

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dexamethasone Implant<br>Patients will be treated with the Ozurdex (Dexamethasone Implant) | Drug: Dexamethasone Implant<br>* Ozurdex (Dexamethasone Implant), 0.7 mg will injected intravitreally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BEST CORRECTED VISUAL ACUITY (ETDRS) |  | AT DAY 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY | CENTRAL FOVEAL THICKNESS AND MACULAR VOULUME | 90 and 180 DAYS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pseudophakic cystoid macular edema, diabetic macular edema, Irvine Gass Syndrome, cataract surgery, ozurdex, dexamethasone
Bortezomib, Rituximab and Dexamethasone (BORID) for Relapsed/Refractory Mantle Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
Mantle cell lymphoma (MCL) remains difficult to treat by standard treatment approaches. Novel drugs have shown promising results in early clinical evaluations. In the current trial, we investigate a combination of bortezomib (a proteasome inhibitor), rituximab (a monoclonal antibody), and dexamethasone in patients with MCL, who have already been pretreated by standard chemotherapy and show again signs of disease progression. The study objectives include remission rates, safety of this drug combination, and survival time.

Detailed Description
-----------------
Description of the treatment regimen: Bortezomib: 1.3 mg/m2 as i.v. bolus injection, given on days 1, 4, 8, and 11 of each treatment cycle; Rituximab: 375 mg/m2 infusion, day 1 of each cycle; Dexamethasone: 40 mg per day orally (days 1 - 4) of each treatment cycle. Treatment will be given for a total of 6 cycles (every 21 days), followed by maintenance treatment with rituximab (375 mg/m2 every two months for 4 times)

Conditions
-----------------
Lymphoma, Mantle-Cell

Intervention / Treatment
-----------------
* Drug: bortezomib
* Drug: rituximab
* Drug: dexamethasone
* Procedure: treatment protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mantle cell lymphoma at stage II - IV, previously treated with at least one line of prior therapy (CHOP or CHOP-like), measurable disease, age 19 - 75 years, adequate cardiac, liver and renal function tests, patient's written informed consent Exclusion Criteria: second malignancy, evidence for CNS involvement, clinically significant peripheral neuropathy (grade II or higher), HIV positivity, pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bortezomib|nan|
|Drug: rituximab|nan|
|Drug: dexamethasone|nan|
|Procedure: treatment protocol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  |  | 
| progression free survival |  |  | 
| overall survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
relapsed or chemotherapy-refractory disease
Tooth Mousse and Fluoride in Dentin Hypersensitivity Treatment

Study Overview
=================
Brief Summary
-----------------
GC Tooth Mousse, a complex containing amorphous calcium phosphate (ACP) and casein phosphopeptide (CPP), is recommended in dentin hypersensitivity reduction due to its ability to block opened dentinal tubules. It acts synergistically with fluorine in slowing caries progression. Whether CPP-ACP can act synergistically with fluorine in the dentin hypersensitivity treatment is unknown. The aim of this study was to assess the effect of CPP-ACP combined with fluoride varnish in cervical dentin hypersensitivity treatment.

Official Title
-----------------
Combined Tooth Mousse and Fluoride Varnish in Dentin Hypersensitivity Treatment

Conditions
-----------------
Dentin Hypersensitivity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects with a minimum of three cervical hypersensitive teeth at both sides of the dental arch Exclusion Criteria: dentin hypersensitivity caused by caries lesions fracture of restoration chipped teeth marginal gaps post-operative sensitivity cracked-tooth syndrome, and which were confirmed by periapical radiographs and teeth with cervical fillings

Ages Eligible for Study
-----------------
Minimum Age: 26 Years
Maximum Age: 66 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 |
| --- | --- |
| Tooth Mousse<br> | |
| fluoride varnish<br> | |
| Tooth Mousse + fluoride varnish<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ANOVA |  | June 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-test |  | June 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dentin hypersensitivity, Tooth Mousse, fluoride varnish