bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Between Bioactive Silica Graft Plus Platelet Rich Fibrin and Only Platelet Rich Fibrin Graft in Intrabony Defects With Diabetes
Condition: Intrabony Periodontal Defect
Study type: Interventional

Summary: 
      Various regenerative procedures used for the treatment of intabony defects.The Aim of this
      study is to compare the treatment outcome of bioactive silica graft with platelet rich fibrin
      Vs bioactive silica graft in the treatment of intrabony defects in patients with diabetes
      mellitus.
    

Detailed description: 
      Platelet rich fibrin has emerged as one of the promising regenerative material.It is a second
      generation platelet concentrate and is defined as an autologous leucocyte-and platelet-rich
      fibrin biomaterial.Platelet-rich fibrin membrane consists of a fibrin 3-D polymerized matrix
      in a specific structure ,with the incorporation of almost all the platelets and more than
      half of leucocytes along with growth factors.It enhance the stabilization and
      revascularization of the flaps and grafts.

      Bioactive silica graft (Novabone dental putty )is being used for regenerative procedures is a
      premixed composite of bioactive calcium -phospho-silicate particulate which is composed
      solely of elements that exist naturally in normal bone (ca,p,na,si,o) and an absorbable
      binder which is a combination of polyethylene glycol and glycerine.Treatment of intrabony
      defects with bioactive silica graft has led to clinically and statistically significant
      probing depth reduction ,relative attachment level gain and radiographic osseous defect fill.
    

Intervention name(s): Conventional Flap Surgery
Intervention type(s): Procedure
Intervention description(s): After administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back.
After administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this study the patients are divided into two test groups-group A, group B. Each patient will be given careful instructions on proper oral hygiene measures. Under local anesthesia full-mouth supragingival and subgingival scaling and root planning procedure will be performed. After therapy, a periodontal evaluation will be done and the selected sites will be divided into group A and group B.
The Group A subjects will be treated with conventional flap surgery using Bioactive silica graft with PRF as a graft.
Group B will be treated with conventional flap surgery +bioactive silica graft alone in intrabony defects.
Masking: Single (Participant)
Primary purpose: Treatment
Effectiveness of Sealants and Fluoride Varnish in Caries Prevention in Children With Autism Spectrum Disorders
Condition: Autistic Disorder; Dental Caries; Pit and Fissure Caries
MeSH terms: Dental Caries; Autism Spectrum Disorder; Autistic Disorder
Study type: Observational

Summary: 
      The aim of the study is to compare application of sealants together with fluoride varnishes
      versus only fluoride varnishes in preventing caries lesions development in the occlusal
      surface of first permanent molars of children with ASDs.
    

Detailed description: 
      The aim of the study is to evaluate if the application of pit and fissure sealants together
      with fluoride varnishes is more effective than the application of the only fluoride varnishes
      in preventing caries lesions development in the occlusal surface of first permanent molars of
      children with ASDs.

      Patients with at least 10-year follow-up and ASDs are recruited and allocated to two cohort
      according to the strategy adopted for prevention of caries in first permanent molars: FA
      group (only fluoride varnishes) and FA+S group (sealants together with fluoride varnishes).

      Caries incidence and sealants retention after the follow-up period are recorded. Demographic
      and clinical characteristics of patients at first dental visit are also recorded (age, level
      of cooperation, presence of systemic diseases other than ASDs, caries severity) to evaluate
      if they play a potential protective and/or risk factors for caries development.

      Logistic and multivariate analysis are run to evaluate caries incidence and retention rate of
      sealants in first permanent molars over a period of at least 10 years.
    

Intervention name(s): Fluoride varnish and pit and fissure sealants onto first permanent molars
Intervention type(s): Procedure
Intervention description(s): Quarterly application of fluoride varnish. Application of pit and fissure sealant, and replacements if necessary.
Intervention MeSH terms: Fluorides; Fluorides, Topical
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic: participants were enrolled among those who have being received dental
        care at the Dental Service for ASD children of San Paolo Hospital, Milan, Italy.
      
Keywords: Dental sealant; Pit and Fissure sealant; Preventive dentistry; Fluoride varnish
Body Composition Reference Data for Preterm Infants
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The American Academy of Pediatrics has recommended that growth in size (weight, length, and
      head circumference) and in body composition (fat and lean mass) in preterm infants should
      adhere as close as possible to the growth and body composition of a healthy infant in utero
      at the same gestational age. However, there are no body composition reference curves
      available at this time for the preterm infant population. The purpose of this study is to
      collect cross-sectional body composition data using air displacement plethysmography (PEA POD
      Infant Body Composition System, Life Measurement, Inc) on approximately 240 preterm infants
      within 3 days of birth, for the purpose of generating means, standard deviations, and
      percentile values for total body fat mass, total fat free mass, and percent body fat for
      infants born at 30-36 weeks gestation. Relatively healthy infants without evidence of growth
      retardation will be selected for form the reference sample. The goal is to generate a set of
      common reference curves to be used in clinical centers against which to compare body
      composition status for individual infants.
    


Intervention name(s): Body Composition
Intervention type(s): Other
Intervention description(s): No intervention. This is an observational, normative study of body composition variation in preterm infants
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        AGA, singleton, healthy infants born between 30+0 and 36+6 weeks gestation were eligible.
        The study was conducted between 2010 and 2015 at three tertiary NICU's in the United
        States: the University of Minnesota Masonic Children's Hospital in Minneapolis, MN
        (referred to hereafter as the MN site), Santa Clara Valley Medical Center in San Jose, CA
        (referred to as the SC site), and Baystate Medical Center in Springfield, MA (referred to
        as BS).
High Volume Plasma Exchange in Children With Acute Liver Failure and Acute on Chronic Liver Failure
Condition: Acute Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure; Liver Failure, Acute
Study type: Interventional

Summary: 
      All the children with acute liver failure who are candidates for transplant but have
      constraints for transplant will be randomized either to receive standard medical therapy or
      high volume plasma exchange along with standard medical therapy with the aim to assess the
      effect of high volume plasma exchange on transplant free survival.
    


Intervention name(s): High Volume Plasma Exchange; Hypertonic 3% saline; Mannitol; Elective positive pressure ventilation
Intervention type(s): Biological; Drug; Drug; Device
Intervention MeSH terms: Mannitol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Blinatumomab in Adults With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma
Condition: High-risk Diffuse Large B-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2, multicenter, open-label, single arm clinical trial in adults with newly diagnosed
      aggressive high-risk DLBCL.
    

Detailed description: 
      The safety profile of blinatumomab after frontline rituximab (R)-chemotherapy, consisting of
      either R-CHOP (14 or 21) (rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone) or
      R-DA-EPOCH (rituximab and dose adjusted-etoposide, prednisone, vincristine, cyclophosphamide,
      and doxorubicin), or R-CHOEP (rituximab and cyclophosphamide, doxorubicin, vincristine,
      prednisone, and etoposide), will be determined. The study will consist of a screening period
      of up to 14 days, a standard of care (SOC) R-chemotherapy run-in period of approximately 21
      weeks, a 12 to 16 week blinatumomab treatment period, a 30-day safety follow-up visit, and a
      long-term follow-up period that begins after the safety follow-up visit is completed until 1
      year from the first dose blinatumomab.
    

Intervention name(s): Blinatumomab; Investigator's Choice Chemotherapy; Dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Blinatumomab monotherapy was supplied in single-use sterile glass injection vials and administered as an IV infusion.; During the run-in period participants received 6 cycles of standard of care rituximab-chemotherapy dosed per investigator's institution standard as follows:
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine,prednisone)
R-DA-EPOCH (rituximab and dose adjusted-etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) or
R-CHOEP (rituximab and cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide).; Dexamethasone 20 mg IV: within 1 hour prior to start of treatment in each treatment cycle, and within 1 hour prior to dose-step (increase).
Other intervention name(s): AMG103; BlinCyto; corticosteroid
Intervention MeSH terms: Dexamethasone; Blinatumomab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Two groups of hearing aid candidates will be fit with extended wear technology. One group
      will be fit with the commercially available models, and the other group will be fit with
      either the commercially available model or a new model with different fitting characteristic.

      After an appropriate trial period, the success rate of each group will be determined by the
      desire to purchase devices.
    

Detailed description: 
      Hearing aid candidates will be assigned to either Group A or Group B. Group A will be fit
      only with extended wear devices that are commercially available. Group B will be fit with
      either the commercially available devices, or a set of devices that have a new fitting
      characteristic, depending on what is most appropriate and the best fit. Because extended wear
      devices are inserted by a hearing care professional and sit deep within the ear canal,
      participants will be blinded as to which devices they are wearing. After a typical hearing
      aid trial period (i.e. 30 days), participants will be asked to make a determination on
      whether they would purchase if given the option. The percentage of people that indicate a
      desire to purchase devices from Group A will be compared to the percentage of people that
      indicate a desire to purchase devices from Group B to determine if the offering of additional
      fitting options results in an increase in intent to purchase, or a trial to success rate.
    

Intervention name(s): Lyric Hearing Aid- Experimental Design; Lyric Hearing Aid- Commercially Available
Intervention type(s): Device; Device
Intervention description(s): Extended wear hearing aid with a fitting modification that is currently not available; Extended wear hearing aid that is currently available
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this study, new hearing aid candidates will be randomly assigned to one of two groups, but such that each group will have an equal number of participants.
Masking: Single (Participant)
Primary purpose: Treatment
Micronutrient-supplemented Milk Study in Women of Childbearing Age
Condition: Increase the Concentration of Folic Acid in Women of Childbearing Age
Study type: Interventional

Summary: 
      The purpose of this study is to determine if consuming ANMUM Materna (a fortified milk
      product) over a 12-week period increases red blood cell folate concentrations in women of
      childbearing age in Singapore, compared to an equivalent amount of standard (unfortified)
      milk.
    

Detailed description: 
      Folic acid (~400 µg/day) taken around the time of conception significantly reduces the risk
      of a neural tube defect (NTD)-affected pregnancy. Strategies to reduce NTD with folic acid,
      include supplement use and food fortification. An attractive strategy for NTD prevention is
      the use of fortified foods targeted for use by women planning a pregnancy. Fonterra currently
      markets a fortified-milk (ANMUM Materna) in Asia, designed for use prior to and during
      pregnancy. This milk product, if consumed as directed, provides ~400 µg folic acid per day.
      It is not known whether ANMUM Materna will reduce NTD rate. However, in a case-control study
      the risk of NTD was inversely associated with maternal red blood cell (RBC) folate
      concentrations. Accordingly, if ANMUM Materna increases RBC folate, it could be expected to
      decrease NTD risk.

      In this study, the ANMUM Materna fortified milk will be tested against a standard control
      (unfortified) milk over a 12 week period. The subjects will consume 75g of milk powder daily
      throughout the supplementation period.
    

Intervention name(s): ANMUM Materna; Control (milk powder)
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Folic acid supplement; Neural tube defect-affected pregnancy; Homocysteine concentration; Plasma Folate concentration; Plasma vitamin B12 concentration
Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether PED-1 (15mg) and PED-2 (30mg) are tolerable
      and effective in the treatment of premature ejaculation.
    

Detailed description: 
      This study is to evaluate whether PED-1 and PED2 are tolerable and effective in the treatment
      of premature ejaculation. The patients will be randomized and allocated to three treatment
      groups into placebo, PED-1, and PED-2. The creteria for IELT for enrollment will be > or =2
      min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the
      PEDT will be used. The patients ungone drug free baseline line period will take test drugs
      for 4 weeks.
    

Intervention name(s): Clomipramine
Intervention type(s): Drug
Intervention description(s): 15mg and 30mg on demand
Other intervention name(s): PED-1; PED-2
Intervention MeSH terms: Clomipramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PE; IELT; DCIT
Boston Children's Hospital Post Anesthesia Care Unit Outcomes Study
Condition: Surgical Procedures, Operative
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the quality of outcomes in the Post Anesthesia Care
      Unit (PACU) at BCH and to identify preoperative demographic and behavioral data as well as
      intraoperative and anesthetic predictors of adverse PACU outcomes. The investigators
      hypothesize quality of PACU outcomes will correlate with preoperative demographic and
      behavioral characteristics as well as intraoperative and anesthetic procedures/techniques.
      This study will help the investigators improve post anesthetic care quality and create a
      higher level of satisfaction for patients, family, and health care providers.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators will enroll all patients ages 6 months to 30 years undergoing the
        following qualifying surgeries:

        • Genito-Urinary/Urology Department

        Circumcision, Orchidopexy, Hypospadias Repair, Hernia Repair, Cystoscopy, Pyeloplasty, and
        Ureteral Reimplants or Ureteral Stents

        • Otolaryngology Department

        Tonsil and/or Adenoid Removal, Tympanostomy, Tympanoplasty, and Mastoidectomy

        • Orthopaedics Department

        Hip and Knee Arthroscopies, Hardware Removal, and Tendon Lengthening

        • Plastic Surgery Department

        Alveolar Cleft Repair
Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
Condition: Abdominal Aortic Aneurysms
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary goal of the study is to assess the safety and performance of the Treovance device
      in subjects with infrarenal aortic aneurysms, specifically to evaluate if the diseased
      pathology can be treated with an acceptable adverse event rate and that the device performs
      as expected. The results of this study will permit the establishment of endpoints and
      clinical design for a subsequent U.S. trial.
    


Intervention name(s): Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System
Intervention type(s): Device
Intervention description(s): Stent-graft implant
Intervention model: Single Group Assignment
Intervention model description: AAA device
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treovance; aneurysm; AAA
Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 2

Summary: 
      Determine the effect of treatment with INCB013739 administered as an 'add-on' to metformin
      therapy in type 2 diabetic subjects on safety and tolerability and glycemic control.
    


Intervention name(s): INCB013739; INCB013739; INCB013739; INCB013739; INCB013739; Placebo comparator matching INCB013739; Metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): INCB013739 5 mg QD tablet; INCB013739 15 mg QD tablet; INCB013739 50 mg QD tablet; INCB013739 100 mg QD tablet; INCB013739 200 mg QD; Orally once daily tablet
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of a fixed dose combination
      tablet of canagliflozin and metformin immediate release (IR) in comparison with the
      individual components of canagliflozin and metformin IR.
    

Detailed description: 
      This is an open-label (identity of study drug will be known to volunteer and study staff),
      single-center study to evaluate the bioequivalence of canagliflozin and metformin when
      administered orally (by mouth) as individual components (ie, separate tablets of
      canagliflozin and metformin) (Treatment A) and when administered as a fixed dose combination
      tablet (ie, canagliflozin and metformin in the same tablet) (Treatment B). Healthy volunteers
      participating in the study will be randomly (by chance) assigned to receive Treatment A
      followed by Treatment B or Treatment B followed by Treatment A with a period of approximately
      15 days between treatments.
    

Intervention name(s): Treatment A: Canagliflozin tablet; Treatment A: Metformin IR tablets; Treatment B: Canagliflozin/metformin fixed dose combination tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Type=exact number, unit=mg, number=100, form=tablet, route=oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period A.; Type=exact number, unit=mg, number=850, form=tablet, route=oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period A.; Type=exact number, unit=mg, number=50/850, form=tablet, route=oral use. Two canagliflozin/metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period B.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Bioequivalence; Canagliflozin (JNJ-28431754); Metformin