bioihbjkbjnl/mcl2 huggingface dataset:
I-Smads in Periodontitis
Condition: Periodontitis; Treatment Adherence
MeSH terms: Periodontitis
Study type: Observational [Patient Registry]

Summary: 
      Recently, it has been stated that Smads play an active role in all conditions where
      transforming growth factor-beta (TGF-β) is involved, including periodontal inflammation. This
      study aimed to examine the levels of TGF-β and inhibitor Smads in saliva and gingival
      crevicular fluid (GCF) in patients with Stage 3 Grade B periodontitis before and after
      non-surgical periodontal treatment. Twenty (20) stage 3 grade B periodontitis and 20
      periodontally healthy individuals were included in the study. Clinical periodontal
      measurements were recorded; periodontitis patients received non-surgical periodontal
      treatment, and GCF and saliva samples were obtained at baseline and one month after
      treatment. TGF-β, Smad6, and Smad7 were determined by ELISA.
    


Intervention name(s): Periodontally healthy group; Periodontitis
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) < 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium; : interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        1. group (Control): Periodontally and systemically healthy

          2. group: Systemically healthy and periodontitis
      
Keywords: Smad; Periodontitis; Gingival crevicular fluid; Saliva
Sunlight Exposures Effect on Serum Vitamin D Levels
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      When people eat a meal, some, but not all of the calcium in that meal is absorbed, that is,
      moved into the bloodstream. When the skin is exposed to sunlight during summer months,
      Vitamin D is made there and then modified into more active forms by the liver and kidneys.
      These more active forms of Vitamin D improve calcium absorption. Many adults living in the
      U.S. have little or no sun exposure and are low in Vitamin D. We know that specific
      wavelengths of sunlight called Ultraviolet-B cause Vitamin D to be made in the skin.
    

Detailed description: 
      At the beginning of the study we will measure your height, weight, skin color, and draw blood
      to measure your blood levels of Vitamin D and 25-hydroxyvitamin D. Each subject will wear a
      swimming suit and be exposed to sunlight for 30 minutes total (15 minutes lying on back, 15
      minutes lying on stomach).We will draw blood for Vitamin D and 25-hydroxyvitamin D on days
      1,2,3,5, and 7 after sunlight exposure. There will be six blood draws for a total of 102 cc
      of blood drawn (about 3 ½ teaspoons drawn each time).
    

Intervention name(s): Sun Exposure
Intervention type(s): Behavioral
Intervention description(s): Each subject will wear a swimming suit and be exposed to sunlight for 30 minutes total (15 minutes lying on back, 15 minutes lying on stomach).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sunlight; UVB; Vitamin D
Effect of Heart Valve Replacement on Cheyne-Stokes Respiration
Condition: Cheyne-Stokes Respiration; Heart Valve Disease; Central Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Central; Cheyne-Stokes Respiration; Heart Valve Diseases
Study type: Interventional

Summary: 
      Sleep disordered breathing, especially central sleep apnea, is common in patients with
      chronic heart failure. Heart valve replacement could have some effect on central sleep apnea.
      The aim of the study is to investigate effect of heart valve replacement on Cheyne-Stokes
      respiration in patients with rheumatic heart disease.
    

Detailed description: 
      Sleep apnea, especially central sleep apnea, has a high prevalence in patients with chronic
      heart failure. Although sleep disordered breathing (SDB) have been described in patients with
      heart disease, the prevalence is not known because: ①There are various forms of SDBs,
      including obstructive sleep apnea(OSA), central sleep apnea (CSA), and mixed forms of sleep
      apnea syndromes that have variable prevalence; ②Patients suffering from rheumatic valve
      disease usually have varying degrees of heart failure, and this variability affects estimates
      of prevalence; ③There are no international patient registries and SDB is underdiagnosed in
      many parts of the world.

      The previous studies are most focusing on nonvalvular disease. We ①investigate the prevalence
      and the risk factors of Cheyne-Stokes respiration in patients with heart valve diseases,
      ②compare the changes of parameters of Cheyne-Stokes Respiration and heart function (like
      apnea hypopnea index, pulse oxygen saturation, blood pressure, echocardiogram,
      electrocardiogram, 6-minute walk test) before heart valve replacement and 3, 6, and 12 months
      after the surgery.

      With nocturnal polysomnography (PSG) examination 30 patients typical CSR are going to be
      screened out from 300 patients with heart valve disease and waiting for cardiac surgery. The
      Comparison of 30 patients undergoing heart valve replacement will be performed before and 3,
      6, and 12 months following heart valve replacement. We shall analyze the changes of CSR
      before and after valve replacement as well as the correlation among cardiac function and PSG
      parameters.
    

Intervention name(s): heart valve replacement
Intervention type(s): Procedure
Intervention description(s): The patients with heart valve disease and CSR will be received heart valve replacement
Other intervention name(s): cardiac surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Cheyne-Stokes respiration; Heart valve disease; Central Sleep Apnea
Extracorporeal Membrane Oxygenation Effect in Prolonged Cardiopulmonary Resuscitation
Condition: Cardiopulmonary Resuscitation; Cardiac Arrest; Ventricular Tachycardia; Ventricular Fibrillation
MeSH terms: Tachycardia; Tachycardia, Ventricular; Ventricular Fibrillation
Study type: Observational

Summary: 
      Analysis of the patients' data who were rescued with extracorporeal membrane oxygenation and
      without ECMO. The survival rate and the weaning rate were analyzed to see the effect of ECMO
      on the prolonged CPR.
    


Intervention name(s): Extracorporeal membrane oxygenation
Intervention type(s): Procedure
Keywords: ECMO; CPR
Evaluation of the Effect of Metformin on Metastatic Breast Cancer as Adjuvant Treatment
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to determine the effect of metformin along with standard cancer treatment,
      and its effect on the prognosis of the metastatic breast in non-diabetic patients.
    

Detailed description: 
      the role of metformin when combined with traditional metastatic breast cancer treatment in
      non-diabetic patients compared to diabetic patients who are not using metformin. In this
      randomized control study, there will be a demonstration either it is effective to suppress
      tumor burden or not through normal screening for tumor.
    

Intervention name(s): Metformin plus chemotherapy; Chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): determine the effect of metformin along with standard chemotherapy; standard chemotherapy
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metformin; non metastatic breast cancer; non-diabetic
PK Study of Ticagrelor in Children Aged Less Than 24 Months, With Sickle Cell Disease (HESTIA4)
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase I study is to investigate the pharmacokinetic properties of
      ticagrelor in pediatric patients from 0 to less than 24 months with sickle cell disease.

      Ticagrelor dose level adjustment will require a Protocol amendment and regulatory approval.
    

Detailed description: 
      Study design This Phase I paediatric study (in patients aged 0 to <24 months) with ticagrelor
      is planned to be a multi-centre, open-label, single dose study.

      Primary Objective:

      To determine the PK properties of ticagrelor after a single oral dose

      Secondary Objectives:

      To determine the PK properties of the active metabolite (AR-C124910XX) after a single oral
      dose To assess the acceptability and the palatability of a single oral dose of ticagrelor

      Safety Objective:

      To assess safety and tolerability of a single oral dose of ticagrelor

      Duration of treatment At least 20 eligible patients will receive a single open label oral
      dose of ticagrelor on Day 1.

      Statistical methods A population PK analysis approach will be used to determine the PK
      parameters of ticagrelor and its metabolite AR-C124910XX in paediatric patients aged 0 to <24
      months eg, CL/F (oral clearance) (only for ticagrelor) and AUC.

      The PK will also be described by presenting the observed plasma concentrations of Ticagrelor
      and its active metabolite for all individuals, as well as corresponding descriptive
      statistics.

      No statistical comparisons are planned for the primary or secondary objectives, which will be
      summarised descriptively
    

Intervention name(s): Ticagrelor
Intervention type(s): Drug
Intervention description(s): Patients will receive a single dose of ticagrelor
Other intervention name(s): AR-C124910XX is an active metabolite of ticagrelor given orally in a single dose. It will be measured, but it won't be given directly to subjects.
Intervention MeSH terms: Ticagrelor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hb SS disease, Hb S Beta 0 Thalassemia
Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol
Condition: Sickle Cell Anemia
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      The BABY HUG Treatment Study was designed to see if treatment with the drug hydroxyurea (also
      called HU) in children with sickle cell disease could prevent organ damage, especially in the
      spleen and kidneys. There was also a chance that treatment could prevent painful crises, lung
      disease, stroke, and blood infection.
    

Detailed description: 
      The current observational trial, Follow-Up Study ((FUS) II includes enhanced
      neuropsychological, brain, cardiac, and pulmonary evaluations for this very well
      characterized cohort of subjects. Measures of spleen and renal function and markers of DNA
      damage will continue to be collected. Assessment of other target organs in sickle cell
      disease including pulmonary and cardiac function will be performed in addition to evaluation
      of developmental aspects of sickle cell disease (SCD) and potential HU toxicity.
    

Intervention name(s): Hydroxyurea
Intervention type(s): Drug
Intervention description(s): Parents and child's doctor may plan to use or not to use hydroxyurea.
Intervention MeSH terms: Hydroxyurea
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All subjects enrolled in the BABY HUG Follow-Up I Study who participated for at least 24
        months are eligible for the Follow-Up Study II.
      
Biospecimen description: 
      Stored blood and urine
Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, controlled, parallel-group, multicenter, Phase-3 study to
      evaluate the efficacy and safety of ezetimibe with simvastatin taken alone in subjects ages
      10-17 years with Heterozygous Familial Hypercholesterolemia.
    

Detailed description: 
      This study consisted of 3 distinct periods. In Period 1, subjects received daily treatment
      for 6 weeks as part of either the ezetimibe with simvastatin group or part of the simvastatin
      monotherapy group. Subjects in the ezetimibe with simvastatin group received one of three
      treatments: coadministration of ezetimibe 10 mg/day plus simvastatin 10 mg/day, 20 mg/day, or
      40 mg/day. Subjects in the simvastatin monotherapy group received one of three treatments:
      ezetimibe placebo plus simvastatin 10 mg/day, 20 mg/day, or 40 mg/day. The primary and key
      secondary efficacy analysis were based on the evaluations performed during Period 1 and were
      presented as data for subjects pooled from either the ezetimibe with simvastatin treatment
      groups compared with data for subjects pooled from the simvastatin monotherapy treatment
      groups.

      In Period 2, subjects received ezetimibe 10 mg/day plus simvastatin 40 mg/day or ezetimibe
      placebo plus simvastatin 40 mg/day for 27 additional weeks maintaining the same treatment
      assignment (coadministration vs monotherapy) as in Period 1.

      In Period 3, all subjects received ezetimibe 10 mg/day plus open-label simvastatin daily for
      20 weeks.
    

Intervention name(s): ezetimibe with simvastatin; simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Ezetimibe 10 mg plus simvastatin 10 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 20 mg once a day for six weeks, or Ezetimibe 10 mg plus simvastatin 40 mg once a day for six weeks; Ezetimibe matching placebo plus simvastatin 10 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 20 mg once a day for six weeks, or Ezetimibe matching placebo plus simvastatin 40 mg once a day for six weeks
Intervention MeSH terms: Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cholesterol; drugs; hypercholesterolemia; adolescent; randomized controlled trials
Influence of an Capsular Tension Ring on the Rotation of an Intraocular Lens (Aspira®-aA Also Known as MC 6125 AS)
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The purpose of this study is to observe the axial IOL rotation after surgery with a capsular
      tension ring (CTR) and a MC6125 AS IOL.

      At the end of surgery the orientation of the IOL is documented with a short video clip via
      the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6
      months after surgery. Rotational stability of the IOL is assessed using retroillumination
      images with a method to avoid bias from cyclorotation or head tilt.
    


Intervention name(s): cataract surgery; intraocular lens (MC 6125 AS); capsular tension ring (CTR 13/11)
Intervention type(s): Procedure; Device; Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: IOL rotation; capsular tension ring; IOL rotational stability
Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children
Condition: Infections, Streptococcal
MeSH terms: Infections; Streptococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis
      media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine
      GSK2189242A in Native American infants aged less than 24 months, living in the southwestern
      US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the
      impact on acute lower respiratory tract infections (ALRI) up to the second year of life.
    

Detailed description: 
      The study will also evaluate the impact of the pneumococcal vaccine GSK2189242A on
      nasopharyngeal carriage in a subgroup of children called Carriage subgroup. Immunogenicity
      and reactogenicity of the pneumococcal vaccine GSK2189242A will be evaluated in another
      subgroup of children called Immuno/reacto subgroup.

      Protocol Posting has been updated following Protocol Amendment 3, April 2012, leading to the
      addition of a secondary outcome measure.

      Protocol Posting has been updated following Protocol Amendment 7, March 2017, to add
      serological testing for antibodies against the Hib polysaccharide PRP on samples collected 12
      months following booster dose (Month 22) in the Immuno/reacto sub-cohort, in order to
      evaluate the long term persistence of immune responses to co-administered PedvaxHIB vaccine.
    

Intervention name(s): Pneumococcal vaccine GSK2189242A; Placebo; Prevnar 13®; PedvaxHIB®
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 4 doses administered intramuscularly; 4 doses administered intramuscularly; 4 doses administered intramuscularly; 4 doses administered intramuscularly
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: nasopharyngeal carriage; safety; immunogenicity; US; Pneumococcal vaccine; efficacy; Streptococcus pneumoniae; infants
Pharmacokinetic, Immunological and Biochemical Sample Collection and Analysis of a Tysabri Patient Cohort
Condition: Multiple Sclerosis; Relapse
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This is an open-label study of patients with relapsing forms of Multiple Sclerosis designed
      to assess the biochemical, immunological and pharmacokinetic profiles of a large, actively
      infusing natalizumab patient population. A duration effect for progressive multifocal
      leukoencephalopathy (PML) risk associated with natalizumab therapy appears to exist. There is
      minimal data available to understand this effect at the biochemical and cellular level. The
      purpose of this study is to gather preliminary data on several parameters to guide in more
      focused research on the duration effect.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with relapsing forms of MS currently being treated with natalizumab.
      
Biospecimen description: 
      Serum will be collected, and spun for specific tests. The back-up specimens (plasma)will be
      held in case of a laboratory error.
    
Keywords: Multiple Sclerosis, relapsing forms
Chemoradiation Plus Weekly c225 Against Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation
      against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and
      efficacy of this new regimen.
    


Intervention name(s): Intensity-modulated radiotherapy; Concurrent chemotherapy with paclitaxel and nedaplatin; Cetuximab
Intervention type(s): Radiation; Drug; Biological
Intervention description(s): Patients will be given intensity-modulated radiotherapy(IMRT); Patients will be given 2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin; Patients will be given cetuximab weekly during radiation therapy
Intervention MeSH terms: Paclitaxel; Cetuximab; Nedaplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Locoregionally advanced nasopharyngeal carcinoma; cetuximab; chemoradiation
A Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia
Condition: Essential Hypertension, Dyslipidemia
MeSH terms: Hypertension; Essential Hypertension; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this clinical study is to evaluate the efficacy and safety by comparing the
      fimasartan/atorvastatin treatment group to the fimasartan/placebo treatment group and the
      placebo/atorvastatin treatment group respectively at Week 8 in patients with essential
      hypertension and dyslipidemia.
    


Intervention name(s): Fimasartan 120mg; Atorvastatin 40mg; Placebo for Fimasartan 120mg; Placebo for Atorvastatin 40mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Fimasartan 120mg will be administrated once daily for 8 weeks treatment period; Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period; Placebo for Fimasartan 120mg will be administrated once daily for 8 weeks treatment period; Placebo for Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment