bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Nerve Block Under Ultrasound on Postoperative Prognosis in Children
Condition: Quality of Recovery
Study type: Interventional

Summary: 
      The goal of this study was to compare the incidence of pain and recovery agitation after
      single-port laparoscopic inguinal hernia repair in children. The main questions it aims to
      answer are:

        -  Reduction of postoperative pain by rectus sheath block compared with local anesthesia
           infiltration and control group

        -  A comparison between rectus sheath block and local anesthesia infiltration and control
           group on the reduction of agitation during postoperative recovery If there is a
           comparison group: The researchers will compare the ultrasound-guided rectus sheath group
           with the local anesthesia infiltration group and the control group to look at
           postoperative pain indicators and the incidence of waking agitation.
    

Detailed description: 
      Postoperative emergence delirium is a common phenomenon in clinical practice, with an
      incidence rate of up to 20% to 80%. It has long been a concern and research topic in the
      medical community. In recent years, with the continuous improvement and updating of
      anesthesia technology, research on pediatric emergence delirium has become more and more
      in-depth.

      The goal of this study was to compare the incidence of pain and recovery agitation after
      single-port laparoscopic inguinal hernia repair in children. The main questions it aims to
      answer are:

        -  Reduction of postoperative pain by rectus sheath block compared with local anesthesia
           infiltration and control group

        -  A comparison between rectus sheath block and local anesthesia infiltration and control
           group on the reduction of agitation during postoperative recovery If there is a
           comparison group: The researchers will compare the ultrasound-guided rectus sheath group
           with the local anesthesia infiltration group and the control group to look at
           postoperative pain indicators and the incidence of waking agitation.
    

Intervention name(s): Ultrasound-guided lower abdominis rectus sheath block; Local anesthesia infiltration
Intervention type(s): Procedure; Procedure
Intervention description(s): Under ultrasound guidance, the probe was transversely placed at the lateral level of the umbilicus . Using the in-plane technique, the needle was advanced until the posterior aspect of the rectus muscle was penetrated. No blood and no gas were drawn back; furthermore, a small volume of saline was initially injected to ensure that the needle tip was correctly positioned. When the needle was located between the posterior rectus muscle and posterior sheath, 5ml of 0.25% ropivacaine was injected bilaterally; Local anesthesia drugs were injected into the peri-umbilicus cord
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nerve block; Hernia in the groin; PAED score; FLACC score
Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of multiple doses of Gemfibrozil on the
      plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to
      assess the safety and tolerability of co-administration of SAM-531 and Gemfibrozil.
    


Intervention name(s): SAM-531 and gemfibrozil
Intervention type(s): Drug
Intervention description(s): 2 single doses of 5 mg SAM-531 (capsules) a daily dose of 1200 mg Gemfibrozil (one tablet of 600mg at approximately 8 a.m. and one tablet of 600 mg at approximately 6 p.m.) for 14 days
Intervention MeSH terms: Gemfibrozil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer Disease
Multiparametric High-resolution Ultrasound of the Breast
Condition: Breast Cancer
Study type: Interventional

Summary: 
      Despite advances in mammographic technique, mammography is limited in the detection and
      diagnosis of breast lesions with respect to sensitivity and specificity. In recent decades,
      ultrasound has become an essential adjunct to mammography for the further characterization of
      mammographically detected or palpable lesions or in the diagnosis of patients with dense
      breasts.

      However, in spite of defined morphological criteria for the differentiation of benign from
      malignant lesions, ultrasound of the breast also shows limitations regarding sensitivity and
      specificity. On the one hand, benign lesions may have one or more malignant characteristics
      and thus require a biopsy. On the other hand, malignant lesions can also show benign
      characteristics and thus make an accurate assessment difficult.

      To overcome these limitations, newer sonographic methods have been developed. These include
      elastography, color and power Doppler imaging, contrast enhanced imaging and 3D sonography.

      The application of elastography is based on the fact that cancer has a higher stiffness than
      healthy breast parenchyma.

      In addition, cancers are characterized by neoangiogenesis and thus generally show an
      increased vascularization in color and power Doppler. The detection of neoangiogenesis can be
      improved by the application of contrast agents. The latter provides both morphological and
      functional information about tumors, through the study of the contrast agent kinetics.

      Finally, 3D sonography allows for tumors to be examined in a third, coronal plane. This way,
      the interaction between the tumor and the surrounding healthy tissue can be better
      appreciated.

      The objective of this study is the evaluation of suspicious (classified as BI-RADS 4 and 5)
      breast lesions by using high-resolution sonography, including elastography, color/power
      Doppler, contrast agent application and 3D sonography. Both morphological and functional
      information can thus be obtained. The primary hypothesis of this study is that this
      multiparametric approach will improve the detection and characterization of breast lesions.
    


Intervention name(s): Ultrasound of the breast
Intervention type(s): Diagnostic Test
Intervention description(s): Multiparametric ultrasound of the breast including elastography, color/power Doppler, contrast agent application and 3D sonography.
Intervention model: Single Group Assignment
Primary purpose: Diagnostic
Keywords: Ultrasound; Elastography; Doppler Ultrasound; Contrast enhanced Ultrasound; Three-dimensional Ultrasound
Respiratory Quotient in Post Roux-en-Y Gastric Bypass Patients
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Observational

Summary: 
      Through the values of respiratory quotient (RQ) it is possible to estimate the utilization of
      energy substrates by the body, or if there is a higher or lower fat oxidation. Experimental
      and clinical studies have shown that after Roux-en-Y Gastric Bypass (RYGBP) there is a
      decrease in the values of RQ, which may be associated with increased lipid oxidation in the
      postoperative period.

      Diet Induced Thermogenesis (DIT) is an important part of Total Energy Expenditure. We would
      like to know how it functions among RYGBP patients.

      The purpose of this study is to evaluate the RQ and DIT of patients in the post operative
      phase and compare the result with a control group consisting of morbid obese population.
    


Intervention name(s): breakfast (a chicken sandwich with juice)
Intervention type(s): Other
Intervention description(s): patients received a breakfast after de initial measurement
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Bariatric post operative population
      
Keywords: respiratory quotient; fat oxidation; morbid obesity; bariatric; Bariatric Surgery
Cangrelor Prasugrel Transition Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate that patients treated with cangrelor can be directly switched to oral
      prasugrel and that patients treated with prasugrel can be switched to cangrelor without a
      significant decrease in the extent of inhibition of platelet aggregation.
    


Intervention name(s): Cangrelor; Prasugrel
Intervention type(s): Drug; Drug
Intervention description(s): Cangrelor IV administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8; Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.
Intervention MeSH terms: Prasugrel Hydrochloride; Cangrelor
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: CAD
Clinical and Histological Assessment of Free Gingival Graft or Collagen Matrix for Socket Sealing After Bone Grafting
Condition: Socket Sealing; Free Gingival Graft; Collagen Membrane
Study type: Interventional

Summary: 
      The goal of this study was to compare, clinical and histologically, the use of the suine
      collagen matrix (Mucograft Seal [MS], Geisthlich®) and the free gingival graft (FGG) for the
      alveolar sealing after inserted bone graft biomaterial. It was included 18 patients with
      tooth referred to extraction (maxilar incisives, canines, or pre-molars) which were randomly
      divided in 2 groups, according to the material for alveolus sealing: control (FGG) and test
      (MS). After the minimally traumatic extraction, all the alveoli were filled with bovine
      mineral matrix (Bio-Oss®), and the material for alveolar sealing were positioned and
      stabilized with sutures. The follow-up (clinical and photographic) happened on the immediate
      post-operatory period, and with 3, 7, 15, 30, 60, 90, and 120 days. After 120 days, before
      implant placement, tissues samples were obtained with a 3.5mm punch scalpel for histological
      analysis. Qualitative information related to the patient's perception considering the
      treatment were collected.
    


Intervention name(s): Socket preservation
Intervention type(s): Procedure
Intervention description(s): Tooth extraction and preservation with a biomaterial
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alveolar sealing; Free gingival graft; Autogenous graft; Collagen matrix
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.
Condition: Bioequivalence; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to evaluate and compare the bioavailability and therefore to
      assess the bioequivalence of two different formulations of sitagliptin/metformin extended
      release tablets after a single oral dose administration under fasting conditions.
    


Intervention name(s): Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet
Intervention type(s): Drug
Intervention description(s): The subjects randomly received single oral dose of Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet (Test or reference)
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Angiotensin Converting Enzyme Inhibitors and Periprocedural Myocardial Infarction
Condition: Metabolic Syndrome; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Infarction; Metabolic Syndrome; Syndrome; Infarction
Study type: Observational

Summary: 
      Metabolic syndrome (MS) has been reported as a risk for cardiovascular events. The aim of the
      present cohort study is to investigate whether ACEi therapy reduces the rate of
      periprocedural myocardial injury (PPMI) after elective percutaneous coronary intervention
      (PCI) among patients with metabolic syndrome.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Metabolic syndorme (MS) was defined as the presence of 3 or more of these components:

          1. high fasting glucose (fasting serum glucose ≥100 mg/dl or drug treatment for elevated
             blood glucose)

          2. abdominal obesity (given as waist circumference >102 cm in men and >88 cm in women)

          3. high blood pressure (>130/>85 mmHg or drug treatment for hypertension)

          4. hypertriglyceridemia (serum triglycerides ≥150 mg/dl)

          5. low high-density lipoprotein (HDL) cholesterol (<40 mg/dl in men and <50 mg/dl in
             women).
      
Keywords: Angiotensin converting enzyme inhibitor; inflammation; metabolic syndrome; myonecrosis; percutaneous coronary intervention; periprocedural myocardial injury
Study of Topical Calcitriol in Children With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Determine the therapeutic efficacy and safety of topical calcitriol in children with
      psoriasis.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients apply topical calcitriol in petrolatum on a psoriatic lesion
      daily. Patients also apply petrolatum without calcitriol to another psoriatic lesion daily.

      Patients have both lesions photographed prior to therapy, monthly during therapy, and at the
      completion of therapy. Lesions are assessed weekly for 1 month and then every 2 weeks while
      on study. Blood samples are collected every 1 to 2 months and urine samples are collected
      every 2 weeks while on study.
    

Intervention name(s): calcitriol
Intervention type(s): Drug
Intervention MeSH terms: Calcitriol
Primary purpose: Treatment
Keywords: dermatologic disorders; psoriasis; rare disease
Influence of Corticoids on Renal Function in Cardiac Surgery
Condition: Elective Cardiac Surgery
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypothesis: Corticoid treatment in cardiac surgery works renal protective.

      Study design: Randomized, double blind trial in which one group of patients will receive
      methylprednisolone and the other group (control) will receive placebo NaCl 0.9%.
    


Intervention name(s): Methylprednisolone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Methylprednisolone; Placebo (NaCl 0.9%)
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Long-term Value of Preoperative Duplex Before Surgery for Varicose Veins
Condition: Varicose Veins
MeSH terms: Varicose Veins
Study type: Interventional

Summary: 
      Duplex imaging is costly and time-consuming, but is used increasingly for preoperative
      evaluation of varicose veins. Its value in terms of the long-term results of surgery is not
      clear. 293 patients (343 limbs) with primary varicose veins were randomized to operation with
      or without preoperative duplex imaging. Reoperation rates, clinical and duplex findings were
      compared at 2 months and 2 years after surgery. Routine preoperative duplex examination led
      to an improvement in results. However two years is a short time, and with a longer follow-up
      other mechanisms for recurrence may become more important, e.g. neovascularization (new
      vessel formation) or progression of disease, hence the value of a detailed preoperative
      diagnosis may be diminished. The aim of this phase of the investigation is to study the
      results after 8 years, in particular what mechanisms for recurrences were most important.
    


Intervention name(s): preoperative duplex examination; Preoperative duplex
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: varicose veins; venous insufficiency; surgery; duplex; recurrence
A Study to Estimate the Time Course of PF-00241939 Concentration in the Blood Following Dosing by Oral Inhalation From Dry Powder Inhalers
Condition: Pharmacokinetics
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the time course of PF-00241939 concentrations in
      the blood following dosing by oral inhalation using dry powder inhalers.
    


Intervention name(s): Treatment A; Treatment B
Intervention type(s): Drug; Drug
Intervention description(s): PF-00241939 750ug using inhaler A; PF-00241939 750ug using inhaler B
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
HR-QoL and Sexuality in Mirena Inserted Contraception Users
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the changes in the quality of life, as well as in
      the sexual activity, in women inserted with MIRENA, a hormonal contraceptive intra-uterine
      system, over the first 12 months of use. Patients switching from oral contraception to an
      intrauterine contraceptive device (here: MIRENA) will be observed in the first year post
      MIRENA insertion.
    


Intervention name(s): Mirena
Intervention type(s): Drug
Intervention description(s): Mirena 52mg during 1 year
Intervention MeSH terms: Levonorgestrel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intra-uterine contraception; Intrauterine Devices
Muscle Energy Technique Versus Myofacial Release in Adolescents With Spinal Deformity
Condition: Idiopathic Spinal Deformities
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      Spinal deformity may not only alter the physical appearance, but may also have a
      psychological impact on the child, particularly in the adolescent to whom self- image is so
      important.

      This study will investigate the effect of muscle energy technique compared to myofacial
      release in the adolescent with spinal deformities( scoliosis and/ or kyphosis).
    


Intervention name(s): muscle energy technique and myofacial release (physiotherapy techniques)
Intervention type(s): Other
Intervention description(s): Each technique will be applied for three month (3 session/week)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy
Condition: Hip Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Hip arthroscopy is performed frequently and the postoperative course often involves moderate
      to severe pain. There remains no definitive perioperative pain regimen that has been proven
      to be effective and safe for this ambulatory procedure. Some institutions perform peripheral
      nerve blocks either preoperatively or postoperatively as a rescue block. All of these PNBs
      lead to quadriceps weakness which may impede earlier mobilization and physical therapy. While
      some case reports exist, there have not been any studies evaluating the QLB for hip
      arthroscopy patients. As previously mentioned, the technique is easy to perform,
      well-tolerated by patients, and avoids side effects such as hypotension, urinary retention,
      or the quadriceps weakness associated with lumbar plexus blockade.
    


Intervention name(s): Bupivacaine + dexamethasone; Ultrasound
Intervention type(s): Drug; Device
Intervention description(s): Anesthetic that will help treat pain and sensation after hip arthroscopy; Ultrasound will help guide the anesthesiologist in performing the nerve block
Intervention MeSH terms: Dexamethasone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Turkish Adaptation of Segmental Assessment of Trunk Control Scale
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Observational

Summary: 
      In infants with Down syndrome at risk in terms of neurosensory motor development retardation,
      the level of trunk control can determine the level of trunk control towards motor development
      in infants with down syndrome.

      For this reason, the purpose of this study is to adapt the segmental assessment of trunk
      control scale to Turkish by evaluating the motor development in children with Down syndrome.
      It is the investigation of validity and reliability.
    

Detailed description: 
      Independent sitting of babies with Down syndrome is very important because sitting is the
      primary position on improving play activities. It is a known fact that late acquisition of
      sitting posture has negative effects on gross motor skills such as crawling and walking as
      well as fine motor skills. The extent to which trunk development affects the developmental
      stages of the child and his performance in motor behaviors and skills should be evaluated. At
      the same time, trunk control should be evaluated at various periods in order to determine
      early intervention and treatment strategies in babies with Down syndrome who are at risk for
      motor development.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Down Syndrome
Study to Evaluate Immunological Equivalence Between Two Investigational Influenza Vaccines in Adults (H1N1)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of the study is to assess the equivalence of the immune response elicited
      by two GSK Biologicals' adjuvanted influenza investigational vaccines (GSK2340272A and
      GSK2340274A) in adults aged 18 to 60 years. The second purpose of the study is to evaluate
      the safety and reactogenicity of these two vaccines.
    

Detailed description: 
      This Protocol Posting has been updated following Protocol Amendment 4, July 2010, leading to
      removal of one of the secondary outcome measures.
    

Intervention name(s): Influenza vaccine GSK2340272A; Influenza vaccine GSK2340274A
Intervention type(s): Biological; Biological
Intervention description(s): Two intramuscular injections at Day 0 and Day 21; Two intramuscular injections at Day 0 and Day 21
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: influenza infection; GSK Biologicals' influenza vaccine GSK2340272A and GSK2340274A