louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01375283: Sensory Mapping Following Video-assisted Thoracic Surgery
Official title: Sensory Mapping Following Video-assisted Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Paresthesia
Dysesthesia
Pain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-06-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing video-assisted thoracic surgery

Brief summary: This is a prospective observational cohort study on changes in sensory mapping.


Eligibility criteria: Inclusion Criteria:

* Age \< 18 years old
* Elective lung cancer surgery (VATS)

Exclusion Criteria:

* does not understand Danish
* cognitive reduction
* bilateral procedure planned
* previous thoracic surgery
* pregnant or nursing
* known nerve affection from other cause
* alcohol/substance abuse
* inability to cooperate to pain scoring/sensory examination
* \> 5 mg methylprednisolone/day

Primary outcomes:
measure: Area (cm2)
timeFrame: 3 months
Secondary outcomes:
measure: Pain
timeFrame: 3 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Section for Surgical Pathophysiology 4074
Study officials:
affiliation: Multidisciplinary Pain Center
name: Mads Werner, MD,
role: STUDY_CHAIR
affiliation: Section for Surgical Pathophysiology
name: Kim Wildgaard
role: PRINCIPAL_INVESTIGATOR
affiliation: Section for Surgical Pathophysiology
name: Henrik Kehlet, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06332183: GWAS and EWAS in Patients With Erdheim-Chester Disease
Official title: Genome-wide Association Study (GWAS) and Epigenome-wide Association Study (EWAS) in Patients With Erdheim-Chester Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Erdheim-Chester Disease
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Incident and prevalent patients with ECD

Brief summary: Erdheim-Chester Disease (ECD) is a rare form of histiocytosis characterized by the proliferation of blood cells, known as histiocytes, which infiltrate various organs and tissues, often causing irreversible damage. The causes of the condition are still unknown, and although some mutations in genes involved in cell proliferation have been identified, other factors may be involved. Susceptibility to developing rare diseases like ECD is typically associated with genetic factors, including DNA polymorphisms and epigenetic modifications.

This study aims to analyze the entire genome of a large cohort of patients with ECD and healthy controls to determine whether there are polymorphisms and epigenetic variants associated with susceptibility to developing the disease. The study could thus clarify the genetic predisposition to ECD development, provide insights into disease pathogenic mechanisms, and identify proteins or cellular mechanisms potentially targeted by specific treatments.


Eligibility criteria: Inclusion Criteria:

- ECD with histological confirmation of disease

Exclusion criteria:

- previously treated patients (for methylation and gene expression)

Primary outcomes:
measure: Polymorphisms and genetic variants correlated with disease development
timeFrame: 5 years
measure: Methylation in Erdheim-Chester disease
timeFrame: 5 years
measure: Gene expression in Erdheim-Chester disease
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Pitié Salpetrière
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Parma
country: Italy
facility: AOU Parma
city: Granada
country: Spain
facility: Genetics Lab, CSIC
Study officials:
References:
Clinical trial NCT02582983: A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection
Official title: An Open-Label Safety Trial of Enfuvirtide (T-20/RO 29-9800, HIV-1 Fusion Inhibitor) in Combination With Free Choice Antiviral Regimen in Thai Patients With Advanced HIV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 23
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study assessed the safety and tolerability of enfuvirtide in participants with advanced HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens containing at least one product from each anti-retroviral class, or had experienced intolerance to previous anti-retroviral regimens received enfuvirtide, 90 milligrams (mg) subcutaneously (SC) twice daily (BID) as long as there were no enfuvirtide related treatment limiting toxicities and participants benefited from study treatment as per investigator's discretion. The anticipated time on study treatment was based on the commercial availability of enfuvirtide in Thailand, and the target sample size was 30 individuals.


Eligibility criteria: Inclusion Criteria:

* Individuals at least 16 years of age infected with HIV-1
* CD4 lymphocyte count less than equal to (\<=) 100 cells per cubic millimeter (cells/mm\^3) and HIV-1 ribonucleic acid (RNA) viral load greater than equal to (\>=) 10,000 copies/mL while on highly active antiretroviral therapy (HAART)
* Genotypic or phenotypic resistance and/or treatment-limiting toxicity on previous antiretroviral regimens

Exclusion Criteria:

* Evidence of ongoing alcohol and/or drug or substance abuse
* Prior non-adherence to antiretroviral treatment regimens
* Evidence of active, untreated opportunistic infection, intercurrent illness, drug toxicity or any other condition.

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
measure: Number of Participants With Premature Withdrawal Due to Adverse Events
timeFrame: Up to 96 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Nonthaburi
country: Thailand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT00736983: Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's
Official title: Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease With Perianal Fistulas
Keywords: Perianal fistulas
Crohn's disease
Lead sponsor: Foundation for Liver Research
Sponsor class: OTHER
First posted: 2008-08-18
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone for the treatment of perianal fistulas in Crohn's disease

Detailed description: Dutch multicenter, randomized, double-blind study with two arms. 146 patients will be included.

Eligibility criteria: Inclusion Criteria:

* proven Crohn's disease
* Single or multiple draining perianal fistulas

Exclusion Criteria:

* Abscesses
* Infliximab, cyclosporine, tacrolimus and antibiotics for Crohn's disease within past 3 months
* active viral infection
* significate cardiovascular dysfunction
* Pregnancy, Lactation
* Surgical bowel resection to be expected within 6 months
* Positive stool culture for enteric pathogens
* Total parental nutrition

Primary outcomes:
measure: Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas.
timeFrame: 12 week
Secondary outcomes:
measure: Proportion of patients in remission
timeFrame: 12 week
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: AMC
city: Amsterdam
country: Netherlands
facility: VU
city: Den Haag
country: Netherlands
facility: Haga ziekenhuis
city: Deventer
country: Netherlands
facility: Deventer ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: UMC Gronigen
city: Leiden
country: Netherlands
facility: LUMC
city: Maastricht
country: Netherlands
facility: AZ Maastricht
city: Nieuwegein
country: Netherlands
facility: St Antonius ziekenhuis
city: Nijmegen
country: Netherlands
facility: UMC Radboud
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: Erasmus Medical Center
name: C.J. van der Woude, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dewint P, Hansen BE, Verhey E, Oldenburg B, Hommes DW, Pierik M, Ponsioen CI, van Dullemen HM, Russel M, van Bodegraven AA, van der Woude CJ. Adalimumab combined with ciprofloxacin is superior to adalimumab monotherapy in perianal fistula closure in Crohn's disease: a randomised, double-blind, placebo controlled trial (ADAFI). Gut. 2014 Feb;63(2):292-9. doi: 10.1136/gutjnl-2013-304488. Epub 2013 Mar 23.
Clinical trial NCT04389983: Ketone Levels Achieved After Medium Chain Triglyceride (MCT) Oil
Official title: Ketone Levels Achieved After Medium Chain Triglyceride (MCT) Oil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacokinetics
Keywords: MCT oil
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Assessing Ketone levels achieved after varying doses of Medium Chain Triglyceride (MCT) oil

Detailed description: Assessing Ketone levels achieved after varying doses of Medium Chain Triglyceride (MCT) oil in three study populations: \<65 year healthy, 65 and older healthy, and Alzheimer's disease.

Each subject attends for 4 study days, receiving incrementally larger MCT doses at each visit for 0g, to 14g, to 28g to 42g.

Eligibility criteria: Inclusion Criteria:

* adult, healthy or with AD

Exclusion Criteria:

* unable to attend all study days
* coconut allergy
* Diabetes

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 3 months
measure: Time to maximum plasma concentration (tmax)
timeFrame: 3 months
measure: Area under the curve (AUC)
timeFrame: 3 months
Secondary outcomes:
measure: weight
timeFrame: 3months
measure: height
timeFrame: 3 months
measure: BMI
timeFrame: 3months
measure: Body fat
timeFrame: 3 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Angela Juby
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01198483: Microincision Versus Smallincision Combined Surgery
Official title: Microincision Cataract Surgery Combined With 23-gauge Vitrectomy Versus Smallincision Cataract Surgery Combined With 23-gauge Vitrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract Extraction
Keywords: refraction
refractive error
combined surgery
microincision
smallincision
cataract surgery
vitrectomy
Lead sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare refractive outcomes after two different types of combined cataract surgery, namely microinscision cataract surgery and smallincision cataract surgery, and sutureless 23-gauge vitrectomy in patients presenting with vitreoretinal disorders and coexisting cataracts.

Detailed description: Purpose:

To compare refractive outcomes after combined cataract and vitreoretinal surgery.

Methods:

Patients with a diagnosis of vitreoretinal disorder and a coexisting significant cataract were randomly assigned to be treated with a microincision cataract surgery and a 23-gauge vitrectomy (treatment group 1) or with a smallincision cataract surgery and a 23-gauge vitrectomy (treatment group 2).

Main outcome measures:

Refractive outcomes, stability of the intraocular lens (IOL), intraocular pressure (IOP) and functional outcomes.

Eligibility criteria: Inclusion Criteria:

* diagnosis vitreoretinal disorder with coexisting cataract
* combined surgery
* age over 60 years
* IOL master for preoperative intraocularlens (IOL) calculation

Exclusion Criteria:

* ultrasound for IOL calculation due to hazy media (dense cataract,vitreous hemorrhage)
* macular edema, proliferative diabetic retinopathy
* myopia or hyperopia more than 5 diopters, astigmatism more than 2 diopters
* previous refractive surgery, retinal detachment surgery, glaucoma surgery and vitrectomy

Primary outcomes:
measure: Refractive outcome
timeFrame: 12 weeks after surgery
Secondary outcomes:
measure: measurements of anterior chamber depth (ACD)
timeFrame: 12 weeks after surgery
measure: intraocular pressure (IOP)
timeFrame: 12 weeks after surgery
measure: functional outcome
timeFrame: 12 weeks after surgery
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Rudolf Foundation Clinic
Study officials:
affiliation: Ludwig Boltzmann Institute of Retinology and biomicroscopic Lasersurgery
name: Susanne Binder, Univ.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ludwig Boltzmann Institut of Retinology and biomicroscopic Lasersurgery
name: Christiane I Falkner-Radler, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00235183: Plasma Transfusion in Liver Transplantation
Official title: Plasma Transfusion in Liver Transplantation : a Randomized, Double Blind, Multicenter Trial of Methylene Blue, Solvent/Detergent and Quarantined Plasma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bleeding in Liver Transplantation
Keywords: plasma
bleeding
liver transplantation
Lead sponsor: Etablissement Français du Sang
Sponsor class: OTHER
First posted: 2005-10-10
Enrollment: 300
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: The aim of the study is to compare the clinical efficacy of three types of plasma secured on the viral level either by quarantine or by chemical treatment in patients undergoing liver transplantation.

Detailed description: Three types of plasma are transfused in bleeding patients undergoing liver transplantation:

* quarantined plasma,
* methylene blue treated plasma,
* solvent/detergent plasma. The main purpose is to show that the volume of methylene blue treated plasma consumed intraoperatively is equivalent to that of the 2 other types of plasma.

In addition, the correction of coagulation abnormalities are studied.

Eligibility criteria: Inclusion Criteria:

* age 18 yo and above
* consent is signed,
* liver transplantation is indicated,
* plasma is transfused

Exclusion Criteria:

* multiorgan transplantation (except combined kidney and liver transplantation)
* allergy to methylene blue.

Primary outcomes:
measure: Volume of transfused plasma during surgery
timeFrame: 5 years
Secondary outcomes:
measure: correction of coagulation abnormalities
timeFrame: 5 years
measure: immediate and delayed adverse events
timeFrame: 15 days
Other outcomes:
Locations:
city: Paris
country: France
facility: EFS
Study officials:
affiliation: Hôpital Cochin, Paris, France
name: Yves Ozier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: hôpital Jean Minjoz, Besançon, France
name: Emmanuel Samain, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Paul Brousse, Villejuif, France
name: Marie - Christine Gillon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Pontchaillou
name: Loïc Villalon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bartelmaos T, Chabanel A, Leger J, Villalon L, Gillon MC, Rouget C, Gomola A, Denninger MH, Tardivel R, Naegelen C, Courtois F, Bardiaux L, Giraudeau B, Ozier Y. Plasma transfusion in liver transplantation: a randomized, double-blind, multicenter clinical comparison of three virally secured plasmas. Transfusion. 2013 Jun;53(6):1335-45. doi: 10.1111/j.1537-2995.2012.03895.x. Epub 2012 Sep 24.
Clinical trial NCT03493828: Efficacy of TAP Block in Cesarean Section Patients
Official title: A Randomized Double Blinded Controlled Trial on the Efficacy of TAP Block in Cesarean Section Patients When Compared to Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain Control
Lead sponsor: New York Presbyterian Brooklyn Methodist Hospital
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Bupivacaine 05%, arm 2: Bupivacaine 0.25%, and arm 3: placebo (Normal saline)
Primary purpose: TREATMENT

Brief summary: TAP Block done with 2 different concentrations of bupivacaine and placebo

Detailed description: TAP Block was done using 2 different concentrations of bupivacaine (0.5% and 0.25%) and placebo and the post operative sedation was measured in each arm and compared together.

Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women

Exclusion Criteria:

* Allergy to local anesthetics

Primary outcomes:
measure: Effect of Transversus Abdominis Plane (TAP) Block Using Either 0.5% or 0.25% Bupivacaine on Analgesia for Cesarean Section Patients When Compared to Placebo.
timeFrame: 0-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
Study officials:
affiliation: New York Presbyterian Brooklyn Methodist Hospital
name: Adel Guirguis, MD, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT05992428: Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults
Official title: An Open-label, 2-Part, Phase 1 Clinical Trial to Evaluate Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-15
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 2-part
Primary purpose: TREATMENT

Brief summary: This is an open-label, 2-Part, phase 1 study to evaluate drug interactions when DA-8010 is co-administered with Paroxetine or Mirabegron in healthy adult subjects


Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteer 19 years to 50 years
* Body weight in the range of 40.0 to 90.0 kg and body mass index in the range of 18 to 28kg/m2
* The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate
* In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in a surgical infertility condition (both tubular obstruction, hysterectomy, bilateral tubular resection, etc.)
* The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire

Exclusion Criteria:

* Subject with serious active hepatobiliary (severe hepatic failure, etc.), renal(severe renal impairment, etc.), neurologic, immunologic, respiratory, digestive, endocrine, hematologic, cardiovascular(heart failure, Torsades de pointes, etc), urologic, psychological disease or history of such disease
* Subject with gastrointestinal disease (peptic ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or history of such disease/surgery (excluding simple appendic surgery, hernia surgery, hemorrhoid surgery)
* Subject Hypersensitive to any of the IP components or other drug components(Aspirin, Antibiotics, etc.)
* Subject who is positive for serum test results (hepatitis B test, hepatitis C test, HIV test, syphilis test)
* Subject who have history of drug/alcohol abuse or Positive in Urine drug screen test
* Subject who determined that Investigator is unfit to participate in a clinical trial due to other reasons other than the above items

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 0~48hours
measure: Area under the plasma concentration versus time curve of DA-8010 (AUClast)
timeFrame: 0~48hours
Secondary outcomes:
Other outcomes:
Locations:
city: Soeul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03999528: 14-3-3η Protein, Disease Activity and Bone Mineral Density, in Female Patients With Rheumatoid Arthritis
Official title: 14-3-3η Protein, Disease Activity and Bone Mineral Density, in Female Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Osteoporosis
Keywords: 14-3-3η Protein
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 45
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with rheumatoid arthritis attending the Rheumatology department, at Al-Azhar faculty of medicine from May 2019 to August 2019

Brief summary: Is to investigate the relation between 14-3-3η protein, disease activity, and bone mineral density in female patients with rheumatoid arthritis.

Detailed description: Methods: all patients in the study will subject to:

* Clinical assessment, WT, Height ,BMI, parity, medications,
* DAS 28.
* Serum 14-3-3η protein.
* DEXA scan.

Grouping:

* Group I: RA Patients with low BMD.
* Group II: RA Patients with normal BMD.
* Group III: normal control.

Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis according to ACR 2010 criteria with at least one year duration.
* Premenopausal females.
* On conventional DMARD with maximum 5 mg steroids.

Exclusion Criteria:

* Biological treatment.
* Previous antiresorptive treatment, or bone anabolics.
* High dose corticosteroid.
* Chronic renal or kidney disease.
* Medications affecting bone metabolism.
* Thyroid or adrenal dysfunction,

Primary outcomes:
measure: 14-3-3η Protein and RA disease activity
timeFrame: three months
Secondary outcomes:
measure: 14-3-3η Protein and osteoporosis in RA patients
timeFrame: three months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar Faculty of medicine, Rheumatology Department
Study officials:
affiliation: Al-Azhar Faculty of medicine- Cairo
name: AHMED ABOGAMAL
role: STUDY_CHAIR
References: