bioihbjkbjnl/mcl2 huggingface dataset:
Accelerated Mandibular Molar Protraction: Piezocision at the Time of Molar Protraction or Later?
Condition: Orthodontic Appliance
Study type: Interventional

Summary: 
      This study was conducted to compare the rate of second molar protraction, level of
      Interleukin1-β in gingival crevicular fluid, periodontal health (gingival index, plaque
      index, and periodontal pocket depth) and root resorption in patients treated by molar
      protraction with piezocision performed early at the time of protraction (Group 1),
      piezocision performed 3 months after molar protraction (Group 2), and no piezocision molar
      protraction (Group 3).
    

Detailed description: 
      Detailed Description: Thirty-five subjects who presented with bilaterally extracted
      mandibular first molar were selected to participate in the study. The subjects were
      subdivided into one of 3 groups as follows: group 1 consisted of 20 subjects /20 molars where
      piezocision was performed immediately before molar protraction; group 2 consisted of 20
      subjects/ 20 molars where molar protraction was carried on after 3 months of molar
      protraction with no piezocision; group 3 consisted of 20 subjects (40 molars) where
      protraction was carried out with no piezocision.

      After reaching 0.019X0.025" SS arch wire, NiTi coil spring was used for space closure
      (protraction force was 150g) attached from the lower second molar hook to the head of the
      mini-screw. Piezocision was performed by making 2 vertical incisions mesial and distal to the
      extraction space. Piezotome was inserted in the incisions previously made and bone cuts were
      done with a length up to mucogingival line and depth of 3 mm. Gingival crevicular fluid (GCF)
      sample was obtained from the mesiogingival side of the lower second permanent molar with use
      of Periopaper. GCF sample was repeated 1 day, 1 week and 4 weeks after molar protraction with
      piezocision or with no piezocision. Periodontal parameters were measured and lower molar root
      resorption was assessed using Perapical radiographs.
    

Intervention name(s): Piezocision
Intervention type(s): Other
Intervention description(s): Piezocesion was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split mouth design where piezocision will be performed at the time of molar protraction on the right or left side of the bilateral first molar extraction subjects and 3 months of molar protraction on the other side. A third group of subjects will act as a control where molar protraction will be done with no piezocision.
- Comparison between the 3 groups of subjects; Early piezocision, late piezocision and no piezocision molar protraction groups.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Piezocision; molar protraction; Accelerated
Impact of Dairy Products on Postprandial Inflammation
Condition: Inflammation; Obesity; Nutritional Intervention
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The study will quantitatively evaluate the systemic, postprandial inflammatory and metabolic
      response to the ingestion of three different meals in obese subjects. The administered meals
      will differ in the proportion of dairy products. Postprandial response will be monitored
      during 6 hours after meal consumption.
    


Intervention name(s): consumption of test meal based on dairy products; consumption of high fat test meal without dairy products; consumption of high fat test meal with dairy products
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Dexmedetomidine on Propofol Requirement for Insertion of Laryngeal Mask Airway
Condition: Precedex Effect to Propofol Requirement
Study type: Interventional
Phase: Phase 4

Summary: 
      Propofol frequently used as an inducting medication for insertion Laryngeal mask airway(LMA).
      But propofol alone can be not sufficient for inhibiting upper airway reflex and also result
      in cardiovascular suppression under enough amount. Dexmedetomidine is a selective alplh2
      receptor agonist with analgesic and sedative effects but sparing respiratory function.
      Therefore propofol combined with dexmedetomidine induction could be more effective in
      preserve respiration under same condition for LMA insertion than propofol alone. In this
      study, the investigators investigate the clinical dose of propofol for LMA insertion with
      premedication of dexmedetomidine, and evaluate the effect of dexmedetomidine.
    


Intervention name(s): Dexmedetomidine; Normal saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Prebiotic Intervention for Autism Spectrum Disorders
Condition: Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of a prebiotic (BGOS) on gut microbiota
      and metabolites in children with autism spectrum disorders.
    

Detailed description: 
      Children with ASD have a higher incidence of dietary and/or bowel problems than typically
      developing children. it has been postulated that imbalances in the gut bacteria and/or
      metabolites present in the gut may be a contributing factor to these symptoms, with
      potentially bad (toxin-producing) bacteria colonising the gut. Certain carbohydrates
      (so-called 'prebiotics') are not digested by the human gut and they provide food for
      beneficial bacteria and thus they improve the composition by preventing the growth of bad
      bacteria. Individuals could therefore benefit from these safe and effective dietary
      interventions to maintain the healthy gut bacteria and overall health. This study is being
      carried out to establish the effect of one such prebiotic, called galactooligosaccharide
      (B-GOS) on the relative balance of gut bacteria and metabolites in children with ASD. The aim
      is to enrol 42 children, ages 5-10 with formal ASD diagnosis and with signed informed consent
      from their parents, into double-blind, placebo controlled, parallel study. The trial will
      last 10 weeks in total (2 weeks run in period, 6 weeks treatment and 2 weeks follow up).
      Children will be required to take food supplement daily during the treatment period and their
      parents will collect stool, saliva and urine samples. Various questionnaires will also be
      used for assessments. Children will not be required to make other extra changes to their
      diet, medication or lifestyle.
    

Intervention name(s): B-GOS; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1.8 g/day for 6 weeks; 1.8 g/day for 6 weeks
Other intervention name(s): Bimuno; Corn Starch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Tumor Tissue From Patients With Melanoma Treated on Clinical Trial EST-1690
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may
      help doctors learn more about changes that occur in DNA and identify biomarkers related to
      cancer. It may also help doctors predict how patients will respond to treatment.

      PURPOSE: This research study is looking at tumor tissue samples from patients with melanoma
      treated on clinical trial EST-1690.
    

Detailed description: 
      OBJECTIVES:

        -  To validate the prognostic role of several biomarkers suggested by gene expression
           profiling and tissue microarray (TMA) studies (e.g., NCOA3, SPP1, and RGS1) on the
           outcome associated with melanoma in the EST-1690 cohort using IHC analysis.

        -  To examine the potential predictive role of such biomarkers in patients undergoing
           adjuvant interferon alfa therapy.

        -  To analyze the correlation between the intensity of biomarker expression and survival of
           this cohort both in the observation and in the interferon-treated groups.

        -  To examine the prognostic role of these biomarkers on the outcome associated with
           melanoma in the EST-1690 cohort using quantitative-PCR.

        -  To isolate RNA from the primary specimens from patients enrolled in the EST-1690 cohort
           to assess the expression of genes suggested by cDNA microarray and IHC analyses (e.g.,
           NCOA3, SPP1, and RGS1) as prognostic or predictive markers.

      OUTLINE: Samples from the EST-1690 cohort are obtained and analyzed for several biomarkers
      (i.e., NCOA3, SPP1, and RGS1) via immunohistochemistry and quantitative PCR. RNA is isolated
      from the specimens to assess gene expression via quantitative PCR.
    

Intervention name(s): RNA analysis; gene expression analysis; microarray analysis; polymerase chain reaction; immunohistochemistry staining method; laboratory biomarker analysis
Intervention type(s): Genetic; Genetic; Genetic; Genetic; Other; Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients enrolled on E1690
      
Keywords: stage III melanoma; recurrent melanoma
A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department
Condition: Uncomplicated Bacterial Cystitis
MeSH terms: Cystitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of
      nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC.
    


Intervention name(s): Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days; ciprofloxacin 250 mg BID x 3 days
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ciprofloxacin; Nitrofurantoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of Carvedilol 12.5mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study was to compare the single-dose oral bioavailability of Carvedilol
      12.5 mg tablets of Ohm Laboratories with Coreg 12.5 mg tablets in healthy, adult, human
      subjects under fasting conditions.
    

Detailed description: 
      The study was conducted as an open label, balanced, randomized, two-treatment, two-sequence,
      two-period, single-dose, crossover, bioavailability study on carvedilol formulation comparing
      carvedilol 12.5mg of Ohm Laboratories, Inc. (a subsidiary of Ranbaxy pharmaceuticals Inc,
      USA) with Coreg® 12.5mg tablet (containing carvedilol 12.5 mg) of GlaxoSmithKline, USA in
      healthy, adult, male, human subjects under fasting condition.

      Forty healthy, adult, human subjects who met the inclusion and exclusion criteria as
      described in the protocol were enrolled in the study. Thirty-six subjects completed both the
      periods of the study
    

Intervention name(s): Carvedilol 12.5 mg tablets
Intervention type(s): Drug
Intervention description(s): bioequivalence Carvedilol fasting
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence Carvedilol fasting
Trehalose in Subjects With Neuronal Ceroid Lipofuscinoses
Condition: Neuronal Ceroid-Lipofuscinoses
MeSH terms: Neuronal Ceroid-Lipofuscinoses
Study type: Observational

Summary: 
      Neuronal Ceroid Lipofuscinoses (NCL) or Batten's disease are the most common juvenile
      neurodegenerative disease, characterized by early blindness, movement disorders, cognitive
      and behavioral impairment, epilepsy, and retinopathy.

      This study aims to collect clinical and laboratory data of patients with NCL taking
      Trehalose.
    

Detailed description: 
      This study aims to collect clinical and laboratory data of patients with NCL taking
      Trehalose.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects in regular clinical practice affected by CLN3 o CLN6 diagnose by genetic tests
      
Biospecimen description: 
      Blood samples
    
Keywords: Juvenile Neuronal Ceroid-Lipofuscinoses; Unified Batten Disease Rating Scale
Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune
      system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study
      A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months
      posttransplant. Patients who completed study A3921009 were offered the opportunity to
      participate in study A3921021 which will extend the evaluation of safety and efficacy of
      CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control
      arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects
      will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be
      discontinued.
    


Intervention name(s): Tacrolimus; CP-690,550; CP-690,550
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Standard of care; CP-690,550 5 mg BID; CP-690,550 10 mg BID
Intervention MeSH terms: Tacrolimus; Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: immunosuppression; JAK3 inhibitor; kidney transplant; tofacitinib; Xeljanz; CP-690; 550; tacromilus; mycophenolate mofetil
Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this Phase IIIb study is to evaluate the immunogenicity, reactogenicity &
      safety of GSK Biologicals' Hib-MenC vaccine (Menitorix™) when co-administered with GSK
      Biologicals' DTPa-HBV-IPV vaccine (Infanrix™ penta) & Wyeth's 7-valent pneumococcal conjugate
      vaccine (Prevenar™) in preterm infants as a 3-dose primary vaccination course during the
      first 6 months of life (at 2, 4, 6 months of age) and of a booster dose of Menitorix™ when
      co-administered with GSK Biologicals' DTPa-IPV vaccine (Infanrix IPV) and Wyeth's Prevenar in
      the second year of life (16-18 months of age). The control is a group of full-term infants
      receiving the same vaccines. The Protocol Posting has been updated in order to comply with
      the FDA Amendment Act, Sep 2007.
    

Detailed description: 
      This multicenter study is open & consists of a primary & a booster phase. The study has 2
      treatment groups (Preterm & Full-term) that will receive the same vaccinations; the Full-term
      group will be the active control. Four blood samples will be collected from all subjects for
      immunogenicity analyses; 2 in the primary phase at prior to the first vaccination and one
      month after the third vaccination and 2 in the booster phase at prior to booster dose and one
      month after booster dose.
    

Intervention name(s): Menitorix™; Infanrix™ penta; Prevenar™; Infanrix™ IPV
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.; Intramuscular injection, 3 doses in the primary study; Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.; Intramuscular injection, 1 dose in the Booster study.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Conjugate vaccine; Persistence; Hib vaccine; Combination vaccine; Meningococcal vaccine; Safety; Preterm/full-term infants; Immunogenicity
EMG Biofeedback Based Pelvic Floor Training in Post Partum Women
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      This study intends to determine the effects of Electromyographic biofeedback on performance
      of pelvic floor muscles in urinary incontinence.
    

Detailed description: 
      This is a single blinded randomized controlled trial ,will be conducted at Ripha Rehab
      Clinic,Rawalpindi. (EMG) biofeddback is a adjunct therapy to standard exercise regime for
      increasing muscle strength,this study is planned to determine the effects of
      electromyographic biofeedback on performance of pelvic floor muscles, strength,endurance
      ,rate of biofeedback and its impact on the qulatiy of life (QOL).The sample size was
      calculated to be n=28 through open-epitool version 3 ,with 95%confidence interval (CI),and
      power 80%.

      After completion of therapeutic protocols, the participant will be assessed with the help
      EMG-biofeedback, Pelvic Floor distress inventory, King's Health Questionnaire.
    

Intervention name(s): Electromographic Biofeedback; PFM exercises
Intervention type(s): Device; Other
Intervention description(s): Surface EMG biofeedback is an adjunct therapy to standard exercise regime for increasing muscle strength. Electromyographic biofeedback is a specific form of biofeedback. The device records muscle activity through application of vaginal probe will be inserted in vagina and the reference surface electrode would be placed over the right anterior superior iliac spine.; Patients would be advised to maximally contract the pelvic floor muscles as forcefully a possible for about 5 seconds. Three attempts would be made with 40 seconds rest in between each contraction. The exercises would be performed with the patient initially in supine position, with hip and knee flexed at 30 and 90 degrees.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be two groups of participants, Experimental group will receive pelvic floor strengthening with EMGBF (Electromyographic Biofeedback ) and control group receive excercises without EMGBF.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pelvic floor muscles; Electromyographic Biofeedback; pelvic floor strengthening
Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      A trial in which patients having open abdominal surgery are randomized to receive either
      crystalloids or colloids intraoperatively, guided by esophageal Doppler. The investigators
      test the primary hypothesis that goal-directed colloid administration during elective
      abdominal surgery decreases a composite of postoperative complications within 30 days of
      surgery.
    

Detailed description: 
      Patients will be given 5-7 ml/kg of crystalloid (lactated Ringer's) in the immediate
      preoperative period, which will be followed by 4 ml/kg/h crystalloid for maintenance
      normalized to ideal body weight [Men: Ideal Body Weight (in kilograms) = 52 kg + 1.9 kg for
      every 2.5 cm over 150 cm; Women: Ideal Body Weight (in kilograms) = 49 kg + 1.7 kg for every
      2.5 cm over 150 cm].

      They will then be randomly assigned to additional volume replacement, guided by esophageal
      Doppler, to either lactated Ringer's solution of Voluven starch.
    

Intervention name(s): Crystalloid; Colloid
Intervention type(s): Drug; Drug
Intervention description(s): For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of LR will be given over a period of 5 minutes.; For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of Hydroxyethylstarch 6% 130/0.4 (Voluven®Fresenius-Kabi, Bad Homburg, Germany) will be given over a period of 5 minutes.
Other intervention name(s): Ringer's lactate; Lactated Ringer's solution; Voluven
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IV fluid; recovery; goal directed fluid replacement; improved patient recovery
Single Dose Study in Healthy Participants to Investigate the Safety and Absorption of LY2584702
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, placebo-controlled, two-part study in healthy participants.

      Part A will be a single dose, single period, placebo-controlled pilot study to explore the
      safety, tolerability, absorption and pharmacodynamic [effect of drug on a biological
      marker-phospho-S6 (pS6) levels in skin biopsies] of a single dose of 25 milligrams (mg)
      LY2584702 Reference formulation (RF). Part B is a single dose, placebo-controlled, 4-period
      crossover study to primarily evaluate the absorption of the Test Formulation (TF) in
      comparison with the (RF) of LY2584702.
    


Intervention name(s): LY2584702 Reference Formulation; LY2584702 Test Formulation; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety of NI-071 with Remicade® (infliximab) in
      patients with Rheumatoid Arthritis inadequately treated with Methotrexate.
    


Intervention name(s): Infliximab; Infliximab
Intervention type(s): Biological; Biological
Intervention description(s): 100mg/vial; 100mg/vial
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment