louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00845117: Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency
Official title: Cultivated Stem Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Limbal Stem Cell Deficiency
Keywords: Aniridia,
Steven Johnsons Syndrome,
Ocular burns,
Pterygium
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
name: European Society of Cataract and Refractive Surgeons
name: Agentschap voor Innovatie door Wetenschap en Technologie
First posted: 2009-02-18
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether cultivated stem cell transplantation is effective for the treatment of patients wtih corneal stem cell deficiency.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from LSCD IIa and IIb. Those suffering from IIc may be included once inflammation has subsided and cornea can be staged as IIb.
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
* Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation

Exclusion Criteria:

* Subjects who are pregnant or lactating
* Subjects who have sensitivity to drugs that provide local anesthesia
* Subjects suffering from active infection of the external eye
* Medical conditions that prohibit the use of systemic immunosuppression (in cases of allogenic transplantation)

Primary outcomes:
measure: Visual Acuity
timeFrame: Just before surgery and upto 1 years after surgery
measure: Conjunctivalization
timeFrame: Just before surgery and upto 1 years after surgery
measure: Vascularization
timeFrame: Just before surgery and upto 1 years after surgery
measure: Epithelialization
timeFrame: Just before surgery and upto 1 years after surgery
Secondary outcomes:
measure: Prolonged subsequent corneal graft survival time
timeFrame: 1 year post corneal transplant
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
state: Edegem
Study officials:
affiliation: University Hospital, Antwerp
name: Nadia Zakaria, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Antwerp
name: Carina Koppen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Antwerp
name: Marie J Tassignon, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital, Antwerp
name: Zwi Berneman, MD,PhD
role: STUDY_CHAIR
References:
citation: Zakaria N, Koppen C, Van Tendeloo V, Berneman Z, Hopkinson A, Tassignon MJ. Standardized limbal epithelial stem cell graft generation and transplantation. Tissue Eng Part C Methods. 2010 Oct;16(5):921-7. doi: 10.1089/ten.TEC.2009.0634.
Clinical trial NCT03809117: Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea
Official title: A Randomized Controlled Trial of Biofire Film Array Gastrointestinal Panel Compared to Usual Care for Evaluation of Acute Infectious Diarrhea in the Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infectious Diarrhea
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: BioFire Diagnostics, LLC
First posted: 2019-01-18
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study will test a laboratory test called Film-Array Gastrointestinal (GI) Panel. This GI Panel is a test that can identify the bacteria or viruses that may cause diarrhea. This test will enable the ED doctor to better understand the cause of diarrhea to try to determine the best treatment.

The primary objective of this study is to determine if testing ED patients who complain of diarrhea will lead to more optimal use of antibiotics. Optimal use of antibiotics is defined as the most appropriate antibiotic to treat a specified pathogen.


Eligibility criteria: Inclusion Criteria:

* Presumed infectious diarrhea (3 or more loose stools in past 24 hours)
* Must have one of the 3 following features or symptoms lasting more than 7 days.

  1. Symptoms greater than 24 hours;
  2. Dehydration (defined as the need for intravenous fluid or per clinician's judgement ((based on the general appearance and alertness of the patient, the pulse, the blood pressure, the presence or absence of postural hypotension, the mucous membranes and tears, sunken eyes, skin turgor, capillary refill, and jugular venous pressure.))
  3. Inflammation (defined as fever (greater than 100.1), blood in stool per patient, DRE, or tenesmus.)

Exclusion Criteria:

* Chronic Symptoms (\>14 days)
* Inability to Follow- Up (i.e. no telephone)
* Prisoner
* Likely non-infectious cause of diarrhea (Crohn's disease, radiation colitis, irritable bowel syndrome, or celiac disease)
* Confirmed C. Diff Diarrhea
* Unable to provide written consent
* Non- English speaker

Primary outcomes:
measure: Number of Participants With Optimal Antibiotic Chosen
timeFrame: 30 Days post ED Discharge
Secondary outcomes:
measure: ED Length of Stay
timeFrame: 30 Days post ED Discharge
measure: Hospital Admission Rate
timeFrame: 30 Days post ED Discharge
measure: Rate of Abdominal/Pelvic CT Scans
timeFrame: 30 Days post ED Discharge
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George Washington University, Department of Emergency Medicine
state: District of Columbia
Study officials:
affiliation: The George Washington University
name: Andrew Meltzer, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02558517: Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus
Official title: Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic Lupus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
Corticosteroids
Chronic disease
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Systemic Lupus (SLE) is a chronic disease for which long term treatments are warranted. The aim of this study was to study the possibility of corticosteroids interruption in patients with quiescent SLE treated since at least one year with 5 milligrams of predonisone per day.


Eligibility criteria: Inclusion Criteria:

* Patients with SLE according to the ACR revised criteria.
* Quiescent disease without flare since at least one year (SELENA SLEDAI \< or equal to 4, BILAG C, D or E, PGA 0) _ Treatment with 5 milligrams/day of prednisone since at least 1 year

Exclusion Criteria:

* failure to sign the informed consent or unable to consent
* Patient participating to another clinical trial
* Pregnancy or plan to become pregnant

Primary outcomes:
measure: Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpêtrière, Service de médecine Interne 2, Institut e3m
Study officials:
affiliation: Groupe Hospitalier Pitié-Salpêtrière
name: Zahir AMOURA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mathian A, Pha M, Haroche J, Cohen-Aubart F, Hie M, Pineton de Chambrun M, Boutin THD, Miyara M, Gorochov G, Yssel H, Cherin P, Devilliers H, Amoura Z. Withdrawal of low-dose prednisone in SLE patients with a clinically quiescent disease for more than 1 year: a randomised clinical trial. Ann Rheum Dis. 2020 Mar;79(3):339-346. doi: 10.1136/annrheumdis-2019-216303. Epub 2019 Dec 18.
Clinical trial NCT02825017: Sun Protection Factor Assay (SPF Assay 18677)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-07-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing.
* Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01024517: GLPG0259 Solid Formulation Bioavailability and Food Effect
Official title: An Open Label Study to Compare the Oral Bioavailability of a Solid Dose Formulation of GLPG0259 Relative to an Oral Solution After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Solid Dose Formulation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to compare the pharmacokinetics of GLPG0259 as a solid dosage formulation (with and without food)and an oral solution, and to assess its safety and tolerability.


Eligibility criteria: Inclusion Criteria:

* healthy male, age 18-50 years
* BMI between 18-30 kg/m², inclusive.

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse

Primary outcomes:
measure: Bioavailability of a solid dosage formulation of GLPG0259 (with/without food) compared to an oral solution of GLPG0259.
timeFrame: up to 96 hours postdose
Secondary outcomes:
measure: Safety and tolerability of GLPG0259
timeFrame: up to 96 hours postdose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Stuivenberg
Study officials:
affiliation: Galapagos NV
name: Johan Beetens, PharmD, PhD
role: STUDY_DIRECTOR
affiliation: SGS Stuivenberg
name: Wouter Haazen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01666717: Characterization of Disease Related Changes in Inflammatory Bowel Disease Using Fecal Metabolite Profiling
Official title: Characterization of Disease Related Changes in Inflammatory Bowel Disease Using Fecal Metabolite Profiling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The purpose of the study is to evaluate fecal metabolites profiles of Inflammatory Bowel Disease(IBD) patients versus healthy controls (HC).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of IBD
* Age \>18 years

Exclusion Criteria:

* Use of antibiotics in the preceding month
* Intake of pre- or probiotics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KULeuven-UZLeuven
state: Vlaams-Brabant
Study officials:
References:
citation: De Preter V, Machiels K, Joossens M, Arijs I, Matthys C, Vermeire S, Rutgeerts P, Verbeke K. Faecal metabolite profiling identifies medium-chain fatty acids as discriminating compounds in IBD. Gut. 2015 Mar;64(3):447-58. doi: 10.1136/gutjnl-2013-306423. Epub 2014 May 8.
Clinical trial NCT03166917: Clinical Application of Personal Designed 3D Printing Implants in Bone Defect Restoration
Official title: Shenzhen Hospital of Southern Medical University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Defect; Internal Prosthetic Device, Implants and Grafts, Orthopedic, Bone Graft
Lead sponsor: Shenzhen Hospital of Southern Medical University
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: Clinical application of 3D printing implant in bone defect treatment.

Study design: multicenter randomized controlled study . Methods:patients randomly grouped according to register number into internal fixation and bone graft group and 3D printing group. Reconstruct 3D models ,evaluate models preoperatively , simulate surgery in computer,design 3D implant, and 3D print implants,perform surgery with 3D implants to achieve the greatest degree of physiological reconstruction.Evaluate surgical efficacy .


Eligibility criteria: Inclusion Criteria:

* Open fracture with bone defect
* Burst fracture of spine with bone defect
* Bone tumor with bone defect
* Bone tuberculosis with bone defect
* Nonunion with bone defect

Exclusion Criteria:

* Patients who can not tolerate anesthesia and surgery due to severe impairment of heart and lung function
* Systemic or local infection

Primary outcomes:
measure: operative time
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
city: Guanzhou
country: China
facility: Zhujing hospital of southern medical university
city: Shenzhen
country: China
facility: Shenzhen Hospital of Southern Medical University
Study officials:
References:
citation: Li X, Wang Y, Zhao Y, Liu J, Xiao S, Mao K. Multilevel 3D Printing Implant for Reconstructing Cervical Spine With Metastatic Papillary Thyroid Carcinoma. Spine (Phila Pa 1976). 2017 Nov 15;42(22):E1326-E1330. doi: 10.1097/BRS.0000000000002229.
citation: Yang F, Chen C, Zhou Q, Gong Y, Li R, Li C, Klampfl F, Freund S, Wu X, Sun Y, Li X, Schmidt M, Ma D, Yu Y. Laser beam melting 3D printing of Ti6Al4V based porous structured dental implants: fabrication, biocompatibility analysis and photoelastic study. Sci Rep. 2017 Mar 28;7:45360. doi: 10.1038/srep45360.
citation: Mustafa SF, Evans PL, Sugar AW, Key SJ. Streamlining the manufacture of custom titanium orbital plates with a stereolithographic three-dimensional printed model. Br J Oral Maxillofac Surg. 2017 Jun;55(5):546-547. doi: 10.1016/j.bjoms.2016.03.003. Epub 2017 Apr 6. No abstract available.
citation: Tan XP, Tan YJ, Chow CSL, Tor SB, Yeong WY. Metallic powder-bed based 3D printing of cellular scaffolds for orthopaedic implants: A state-of-the-art review on manufacturing, topological design, mechanical properties and biocompatibility. Mater Sci Eng C Mater Biol Appl. 2017 Jul 1;76:1328-1343. doi: 10.1016/j.msec.2017.02.094. Epub 2017 Feb 24.
Clinical trial NCT06236217: Prediction of Spinal Anesthesia-Induced Hypotension in Cesarian Section: Carotid Artery-Corrected Flow Time Versus Cardiometry
Official title: Prediction of Spinal Anesthesia-Induced Hypotension in Cesarian Section: Carotid Artery-Corrected Flow Time Versus Cardiometry: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthesia
Hypotension
Cesarian Section
Carotid Artery
Corrected Flow Time
Cardiometry
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research aimed to evaluate and compare the role of carotid corrected flow time (FTc) and electrical cardiometry (EC) in the prediction and prevention of post-spinal hypotension in elective cesarian section.

Detailed description: Spinal anesthesia is the procedure of choice for elective cesarean section (CS) because it avoids the most common side effects related to general anesthesia, such as the risk of aspiration, airway problems and the negative effects of intravenous anesthetic drugs on the fetus.

Accurate prediction of post-spinal hypotension could enhance clinical decision-making, optimize management, and facilitate early intervention. More than thirty predictors were used in the prediction of post-spinal hypotension including demographic data, hemodynamic variables, postural stress testing, peripheral perfusion indices, volume and fluid responsiveness indices, and genetic polymorphism.

The baseline parameters obtained via the bioreactance-based system may serve as a predictor of post-spinal anesthesia hypotension in parturient.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years.
* American Society of Anesthesiologists (ASA) physical status II.
* Gestational age (GA) ≥ 36 weeks.
* Women planned elective cesarean section under spinal anesthesia.

Exclusion Criteria:

* Patient refusal to participate in the study.
* Gestational age of \< 36 or ≥40 weeks of pregnancy.
* Pregnancy-induced hypertension.
* Diabetes.
* Cardiovascular diseases, arrhythmia.
* Antepartum hemorrhage.
* Body Mass Index (BMI) above 36 kg/m2.
* Clinical fetal complications.

Primary outcomes:
measure: The incidence of post-spinal hypotension
timeFrame: Intraoperatively
Secondary outcomes:
measure: The amount of intravenous fluids
timeFrame: Intraoperatively
measure: The amount of vasopressor
timeFrame: Intraoperatively
measure: Umbilical cord PH
timeFrame: Immediately after fetal delivery
measure: Neonatal APGAR score
timeFrame: 5 minutes after fetal delivery
measure: Complications
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT06329817: Incidence of Regurgitation in Patients Undergoing Intubation in Semi-fowler v/s Supine Position
Official title: Incidence of Regurgitation in Patients Undergoing Intubation in Semi-fowler v/s Supine Position in a Tertiary Care Hospital
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inguinal Hernia Bilateral
Lead sponsor: Pak Emirates Military Hospital
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: One of the most dreaded complication of general anaesthesia is aspiration of gastric contents after induction of general anaesthesia.Many endeavours and measures have been practiced to reduce the incidence of aspiration pneumonia.One such method is to intubate the patient in semi-fowler or supine posture.My study is aimed to find out safe and best position between these two after induction of general anaesthesia to prevent aspiration pneumonia.


Eligibility criteria: Inclusion Criteria:

* Adults 18-60 years of age
* Must be able to talk

Exclusion Criteria:

* patients less than 18 years of age or above 60,
* Pregnant women
* Handicapped individuals
* patients with intestinal obstruction

Primary outcomes:
measure: Prevention of aspiration pneumonia
timeFrame: 06 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: PEMH
state: Punjab
Study officials:
affiliation: CPSP
name: IRB PEMH Rwp
role: STUDY_DIRECTOR
References:
Clinical trial NCT03582917: The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis
Official title: The Role of VitD in Rehabilitation of Idiopathic Adolescent Scoliosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Scoliosis; Adolescence
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this current prospective study is to determine the role of vitamin D in the development and restoration of spinal deformities in adolescence.

Detailed description: The investigator will record the medical history of each patient and information such as age, body size (weight, height) and body mass index (BMI = kg / m \^ 2). Girls will also be given the time of appearance of menstruation, a factor that needs to be evaluated because the growth of the skeleton continues three years after its appearance. Patients will be subjected to Adam's Test, x-ray's and as well as lateral bending radiographs.In the first contact with each patient, will be evaluated bone density measured by DEXA as well as haematological testing including PTH, alkaline phosphatase (ALP), calcium (Ca), phosphorus( P ), Calcitonin and, of course, vitamin D (total and metabolite 25 (OH) D).

Each patient's follow-up will be completed in two years by a clinical examination every six months and a clinical, laboratory and radiological examination per year. Patients will be divided into two groups. In a group with patients with normal 25 (OH) D and in a second group with patients with low levels of 25 (OH) D. Members of the second group will receive substitution treatment with an appropriate formulation. The results will be collected and evaluated using statistical programme.

Eligibility criteria: Inclusion Criteria:

* Idiopathic Adolescent Scoliosis
* Risser sign \<3-4

Exclusion Criteria:

* Neuromuscular diseases
* metabolic disease
* Liver, lung, thyroid and parathyroid gland disorders.

Primary outcomes:
measure: 25(OH)D
timeFrame: 48 weeks
measure: X - rays
timeFrame: 48 weeks
measure: Dexa
timeFrame: 48 weeks
measure: BMD (weight in kilograms, height in meters)
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Asvestochori
country: Greece
facility: Papanikolaou General Hospital
city: Ioannina
country: Greece
facility: Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina
Study officials:
References: