bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will be conducted to evaluate the effect of once daily treatment with fluticasone
      furoate (FF) on lower leg growth in pediatric subjects with persistent asthma by using
      knemometry. Approximately 65 paediatric asthmatic subjects, aged 5 to 11 years (inclusive),
      will be screened to achieve 60 randomised and 50 evaluable subjects. Subjects meeting the
      eligibility criteria will enter the 2 week run-in period. After completing run-in period,
      each subject will be randomly allocated to one of two treatment sequences: inhaled
      fluticasone furoate followed by placebo or placebo followed by inhaled fluticasone furoate.
      Each treatment will be administered via the ELLIPTA™ dry powder inhaler. The two treatment
      periods will be separated by a two-week wash-out period. Subjects completing two treatment
      period will enter into 7 days follow-up period. ARNUITY™ ELLIPTA (FF) is approved in the US
      for adults and adolescents aged 12 and above.

      ARNUITY and ELLIPTA are a registered trademarks of the GlaxoSmithKline group of companies.
    


Intervention name(s): Fluticasone furoate; Placebo; Salbutamol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): FF will be provided as a dry powder inhaler containing 50 μg of FF as a dry white powder per blister, to be inhaled orally via ELLIPTA.; Placebo will be provided as dry powder inhaler containing placebo as a dry white powder per blister, to be inhaled orally via ELLIPTA.; Salbutamol will be provided as a inhaler.
Intervention MeSH terms: Fluticasone; Xhance; Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: inhaled corticosteroids; pediatric subjects; asthma; fluticasone furoate
EC PK in Women With Normal and Obese BMI
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      A well-designed pharmacokinetics (PK) study may identify the physiologic basis for observed
      differences in levonorgestrel emergency contraception (LNG-EC) and ulipristal acetate
      emergency contraception (UPA-EC) failure rates in women with normal and obese BMI. The
      investigators propose a study to compare serum LNG and UPA levels after administration of a
      single-dose of LNG-EC or UPA-EC. The investigators hypothesize that there will be no
      difference in PK parameters between women with normal BMI and obese women.
    

Detailed description: 
      Eligible women will present to the division research office, at which time a history and
      physical exam will be completed. Each participant's BMI will be confirmed and she will be
      assigned to one of two BMI groups (18.5-24.9 versus 30-39.9). At the conclusion of the
      enrollment visit, the research coordinator will randomize each woman to receive a single-dose
      pill of either levonorgestrel 1.5mg (like Plan B One-Step® or its generic formulations) or
      ulipristal acetate 30mg (ellaOne®) on two separate occasions.
    

Intervention name(s): LNG-EC; UPA-EC
Intervention type(s): Drug; Drug
Intervention description(s): FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg; FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg
Other intervention name(s): Levonorgestrel (LNG) emergency contraceptive (EC); Next Choice One Dose; Ulipristal acetate (UPA) emergency contraceptive (EC); ella
Intervention MeSH terms: Contraceptive Agents; Levonorgestrel; Ulipristal acetate; Contraceptives, Postcoital
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Emergency contraception
Effect of Yakult Ingestion on Diet-induced Insulin Resistance in Humans
Condition: Insulin Sensitivity; Insulin Resistance; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      Participants will be randomly allocated to either Yakult ingestion or a control group. For
      the first 20 days, subjects will consume their normal diet (keeping a detailed food diary
      throughout). On days 21-28 they will switch to a high-fat/high-calorie diet.

      The investigators hypothesise that consuming a high-fat, high-energy diet for 7 days will
      alter the composition of the gut microbiota and induce metabolic endotoxaemia / systemic
      inflammation as well as decreasing whole body insulin sensitivity (as we have shown
      previously). In contrast, the investigators hypothesise that consuming Yakult for 21 days
      before and 7 days throughout the high-fat diet will maintain a favourable gut microbiota and
      prevent metabolic endotoxaemia / systemic inflammation and thus maintain insulin action /
      insulin sensitivity.
    


Intervention name(s): Yakult light
Intervention type(s): Dietary Supplement
Intervention description(s): A fermented milk drink containing the probiotic Lactobacillus casei Shirota
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label, control trial
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gut Microbiota; High Fat Diets; Probiotics; Glycaemic Control
Salivary Bacterial Profiles in Relation to Periodontal Treatment
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      The purpose of the present investigation is to record and compare bacterial compositions in
      subgingival plaque samples and saliva samples in subjects receiving periodontal treatment.
      The hypothesis is that the composition of the salivary microbiota might reflect local
      bacterial alterations in relation to periodontal treatment.
    

Detailed description: 
      In this study we plan to enroll 35 subjects with manifest periodontitis, which will be
      treated according to national and international guidelines. Clinical registration and
      collection of subgingival plaque samples and saliva samples will be performed at baseline and
      2, 6 and 12 weeks after treatment.
    

Intervention name(s): Conventional periodontal treatment
Intervention type(s): Procedure
Intervention description(s): Non-surgical periodontal treatment including thorough instruction in self-performed oral hygiene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: periodontitis; saliva; bacteria
Effects of Supervised Physical Therapy With Early Activation of the Rotator Cuff Versus Home Exercises in Patients After Arthroscopic Subacromial Decompression
Condition: Subacromial Decompression
Study type: Interventional

Summary: 
      The objective of this study was to evaluate and compare two different post-surgical
      rehabilitation strategies, Rehabilitation supervised by a physical therapist including
      exercises with progressive early activation of the rotator cuff versus basic home exercises
      regarding shoulder function, pain, health related quality of life and return to work after
      arthroscopic subacromial decompression.
    

Detailed description: 
      Patients scheduled for surgery (arthroscopic subacromial decompression)and in the age 25-65
      were offered to participate in the study. After surgery they were randomized to either
      Supervised Physical therapy with early activation of the rotator cuff (PT-group) or to home
      exercises (H-group). Patients in the PT group met the physical therapist twice a week for
      exercises and in between these visits they did their exercises at home daily. The H-group did
      home exercises daily. Shoulder function and pain(primary outcomes)and health related quality
      of life, returning to work(secondary outcomes)were assessed before surgery, one week
      after(baseline), 1,2,3 and 6 months after surgery by an independent physical therapist.
    

Intervention name(s): Exercises
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: arthroscopic subacromial decompression; exercise; physical therapy; rotator cuff; shoulder impingement syndrome; Subacromial impingement after arthroscopic subacromial decompression
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Dabigatran Etexilate in Patients With and Without Renal Impairment
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effect of different degrees of renal impairment on the pharmacokinetics and
      pharmacodynamics of dabigatran etexilate administered orally.
    


Intervention name(s): Dabigatran etexilate high dose; Dabigatran etexilate low dose
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dabigatran
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of a Pre-Workout Supplement
Condition: Exercise Ergogenics
Study type: Interventional

Summary: 
      This study is assessing the effects of a pre-workout dietary supplement.
    

Detailed description: 
      The purpose of this study is to examine the acute effects of a pre-workout dietary supplement
      at a standard dose and one that is delivered at 150% of the standard dose on energy
      metabolism, cardiovascular hemodynamics, blood metabolites and mental focus.
    

Intervention name(s): C4/Generation 4; C450X; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 12 grams of C4/Generation 4; 12 grams of C450X; 12 grams of flavored dextrose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Improving Compliance With Medical Testing Guidelines
Condition: Breast Cancer; Cervical Cancer; Prostate Cancer; Colon Cancer; Lung Cancer
MeSH terms: Uterine Cervical Neoplasms; Colonic Neoplasms
Study type: Interventional

Summary: 
      The study hypothesis is that clearer visual presentation of guideline recommendations and
      educational outreach, or academic detailing, can improve guideline compliance. However, it
      will investigate other aspects of screening-related decision-making, such as provider and
      patient beliefs about screening, provider-patient communication and patient's willingness to
      forgo expected testing. The research question is whether educational interventions can
      decrease non-compliance with screening guidelines for 5 common cancers.
    

Detailed description: 
      This study is a cluster randomized trial that compares the immediate post-encounter
      impressions of 12 physicians and 18 of their patients about the discussion of screening for
      breast, cervical, colorectal, lung and prostate cancer as well as their beliefs about
      screening efficacy and patient reports of the screening experience. The interventions are
      educational materials and academic detailing (educational outreach) for providers. The
      investigators are particularly interested in contrasting the patient and provider
      recollections, the differential impact on underuse and overuse compliance and whether patient
      behaviors are consistent with their stated screening plans.
    

Intervention name(s): Color-coded materials; Academic detailing; Standard support; No academic detailing
Intervention type(s): Other; Other; Other; Other
Intervention description(s): A summary of treatment recommendations for each cancer screening is color-coded to indicate the strength and direction of the recommendation; Educational outreach to address the rationale and data supporting recommendations for and against screening; Screening recommendations presented in standard format; Physician receives study orientation for not the academic detailing curriculum
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Screening; Shared Decision Making
A Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be a Phase 1, randomized, double-blind, placebo-controlled, single dose
      escalation study designed to evaluate the safety and PK of intravenously administered
      superoxide dismutase mimetic GC4711 in healthy volunteers.
    


Intervention name(s): GC4711 30mg; GC4711 60mg; GC4711 90mg; GC4711 120mg; Placebo; GC4711 75mg; GC4711 105mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single dose given via a 15 minute intravenous infusion; single dose given via a 15 minute intravenous infusion; single dose given via a 15 minute intravenous infusion; single dose given via a 15 minute intravenous infusion; single dose of normal saline given via a 15 minute intravenous infusion; single dose given via a 15 minute intravenous infusion; single dose given via a 15 minute intravenous infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Fenofibrate on Gene Expression in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess how fenofibrate modify gene expression in circulating
      monocytes of healthy volunteers after 6 weeks.
    


Intervention name(s): Fenofibrate
Intervention type(s): Drug
Intervention description(s): 145 mg
Intervention MeSH terms: Fenofibrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Fenofibrate; Gene Expression; DNA methylation
Cerebral Oximetry With Near-infrared Spectroscopy and Negative Postoperative Behavioral Changes in Pediatric Surgery
Condition: Cognitive Dysfunction
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      The main objective of the present study was to evaluate whether cerebral oxygen saturation is
      associated with an increase of NPOBC in pediatric patients undergoing major surgery.
    

Detailed description: 
      This prospective and observational study involved consecutive patients aged between 2 and 12
      years undergoing a major surgery using general anesthesia. Cerebral oxygen saturation,
      non-invasive arterial pressure, pulse oximetry, and heart rate were recorded at the following
      stages of the surgical intervention: baseline, induction, intubation, surgical incision, end
      of surgery, and extubation. Preoperative anxiety was evaluated by using the modified Yale
      Preoperative Anxiety Scale, and NPOBC was determined by using the Post-Hospital Behaviour
      Questionnaire on 7th and 28th postoperative days. A logistic regression was created to
      identify factors associated with the development of NPOBC
    

Intervention name(s): monitoring cerebral oxygen saturation
Intervention type(s): Other
Intervention description(s): Children undergoing urological surgery also required of locoregional blockade. Anesthetic induction was achieved with high concentration sevoflurane 6-8% (Sevorane®, Abbvie) and oxygen 50%. Anesthetic maintenance was done with sevoflurane 2-3%, 50% O2/air mixture, fentanyl 1 µg.kg.-1 iv, and rocuronium 0.3 µg.kg.-1 iv if required. Electrocardiogram (ECG), non-invasive arterial pressure, pulse oximetry, end-tidal carbon dioxide and cerebral NIRS oximetry was monitoring by using an INVOSTM5100 (Somanetics Corporation, Troy, MI, USA).
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This prospective and observational study involved consecutive patients aged between 2 and
        12 years undergoing a major surgery using general anesthesia.Children undergoing urological
        and general surgery also required of locoregional blockade. Anesthetic induction was
        achieved with high concentration sevoflurane 6-8% (Sevorane®, Abbvie) and oxygen 50%.
        Anesthetic maintenance was done with sevoflurane 2-3%, 50% O2/air mixture, fentanyl 1
        µg.kg.-1 iv, and rocuronium 0.3 µg.kg.-1 iv if required. Electrocardiogram (ECG),
        non-invasive arterial pressure, pulse oximetry, end-tidal carbon dioxide and cerebral NIRS
        oximetry was monitoring by using an INVOSTM5100 (Somanetics Corporation, Troy, MI, USA)
      
Keywords: postoperative; behavioral changes
Strength Training Induced Alterations in Markers of Immune Function
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Exercise has been used to help prevent or slow the progression of inflammation-related
      disease; however, the mechanism by which this activity may lower concentrations of
      inflammatory markers remains unclear. The melanocortin receptors 1,3 and 5 (MC1R, MC3R and
      MC5R) have been shown to function in an anti-inflammatory manner and have the potential to
      mediate the positive immune adaptations associated with regular physical activity.

      Preliminary data suggest that MC3R gene expression increases in whole blood after chronic
      exercise training. The primary aim of the current study is to explore whether this change in
      gene expression translates into alterations in MC1R, MC3R, or MC5R monocyte surface
      expression. The secondary aim is to examine the relationship between surface expression of
      these receptors and circulating inflammatory profiles.

      The investigators will recruit 42 untrained, healthy males and females aged 18-35 yrs. Half
      of the group will be placed on an exercise program for 15 weeks. The other half will serve as
      untrained control subjects. In addition to basic anthropometric measures, the investigators
      will measure concentrations of inflammatory and anti-inflammatory cytokines (ELISA) and cell
      surface expression of MC1R, MC3R, and MC5R on monocytes (flow cytometry).
    

Detailed description: 
      Abstract:

      Chronic exercise reduces inflammation, but the mechanisms involved are unclear. Recent
      studies have shown that stimulation of melanocortin 1 and 3 receptors (MC1R and MC3R) on
      immune cells increases anti-inflammatory cytokine production. PURPOSE: To examine the
      influence of 12 weeks of resistance training (RT) on body composition, monocyte cell-surface
      expression of MC1R and MC3R and circulating markers of inflammation. METHODS: Healthy, active
      males and females (age 20-27 yr) were recruited into a RT group (RE; n = 23) and an active
      control group (AC; n = 19). RE completed 12 weeks of progressive, periodized RT 3d/wk while
      AC maintained normal activity habits. Measures of body composition (DXA) were taken and blood
      was collected prior to (PRE) and following the intervention period (POST). Blood samples were
      analyzed for monocyte cell-surface expression MC1R, MC3R, MC5R and C-reactive protein (CRP)
      and the plasma cytokines interleukin 6 (IL-6) and interleukin 10 (IL-10) using flow cytometry
      and ELISAs respectively.
    

Intervention name(s): Strength Training
Intervention type(s): Behavioral
Intervention description(s): Each Member of this group completed 12 weeks of progressive, periodized resistance training for 3d/wk.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Melanocortin Receptor; Monocyte; Resistance Training; Inflammation; Markers of Inflammation
Study of SON-1010 (IL12-FHAB) in Healthy Adults
Condition: Healthy Adult
Study type: Interventional
Phase: Early Phase 1

Summary: 
      SB102 is a randomized, double-blind, single center, placebo-controlled study in healthy
      adults starting with sentinel participants at each dose level to carefully assess the safety,
      tolerability, PK, and PD of SON-1010.
    

Detailed description: 
      This is a study of SON-1010, a single-chain human Interleukin-12 (IL12) cytokine linked to a
      single-chain variable region (scFv) antibody fragment, known as the fully human albumin
      binding domain (FHAB). The albumin binding domain moiety of SON-1010 attaches to albumin in
      the bloodstream, resulting in significantly enhanced drug PK properties, potentially lower
      risk than IL12 alone, and a broader therapeutic index. Healthy volunteers will be assessed
      with single ascending doses of SON-1010. The design comprises up to 5 separate dosing
      cohorts, with a total of 8 participants (minimum of 7) in each cohort randomized to receive
      either SON-1010 (6 participants) or placebo (2 participants), for up to 40 participants.
    

Intervention name(s): SON-1010 (IL12-FHAB)
Intervention type(s): Biological
Intervention description(s): SON-1010 is a single-chain human IL-12 cytokine linked to a single-chain variable region known as the FHAB.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Thermage CPT for Treatment of Facial and Neck Laxity
Condition: Skin Aging
Study type: Interventional

Summary: 
      The purpose of this study to evaluate treatment with the Thermage CPT system for facial and
      neck laxity.
    


Intervention name(s): Thermage CPT
Intervention type(s): Device
Intervention description(s): Treatment with Thermage patterned, total, or framed tip
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of rhGAA in Patients With Late-Onset Pompe Disease
Condition: Pompe Disease (Late-onset); Glycogen Storage Disease Type II (GSD-II); Acid Maltase Deficiency Disease; Glycogenosis 2
MeSH terms: Glycogen Storage Disease Type II; Glycogen Storage Disease; Deficiency Diseases; Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a
      critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the
      body's cells to break down glycogen (a stored form of sugar) within specialized structures
      called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates
      and is stored in various tissues, especially heart and skeletal muscle, which prevents their
      normal function. The overall objective is to evaluate the safety, pharmacokinetics (PK) and
      efficacy of Myozyme treatment.
    


Intervention name(s): Myozyme
Intervention type(s): Biological
Intervention description(s): 20 mg/kg qow
Other intervention name(s): alglucosidase alfa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glycogen Storage Disease Type II; GSD-II; Pompe Disease