bioihbjkbjnl/mcl2 huggingface dataset:
Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence
Condition: Varicose Veins
MeSH terms: Varicose Veins
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in
      the relief of symptoms, improvement of appearance, and overall effectiveness and safety in
      the treatment of varicose veins compared to placebo.
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy of polidocanol injectable foam vs
      placebo treatments in relief of symptoms using two disease specific questionnaires,
      establishment of a minimally important difference (MID) for the questionnaires, improvement
      in the appearance of visible varicosities by a patient and medical assessments aided by pre
      and post treatment photographs, and a central independent assessor evaluating pre and post
      treatment photographs. In addition, the study will evaluate the efficacy of polidocanol
      injectable foam vs the placebo treatment in the elimination of SFJ reflux or occlusion of the
      treated vein, and to determine whether the placebo procedure blinds the patient to treatment
      assignment.
    

Intervention name(s): Varisolve (Polidocanol Endovenous Microfoam); Agitated Saline
Intervention type(s): Drug; Drug
Intervention description(s): 1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2); 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session
Intervention MeSH terms: Polidocanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Varicose Veins
PET/CT to Image Hypoxia in Head and Neck Tumours
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Hypoxia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Patients with head and neck cancer will be imaged with PET scan and CT scan in order to
      determine areas of the tumour that are hypoxic.

      It is hypothesized that PET /CT will provide information on hypoxia of the tumors and tumor
      regions in head and neck cancer patients.
    

Detailed description: 
      Patients with head and neck cancer greater than 3 cm will imaged with PET scan and CT scan in
      order to determine areas of the tumour that are hypoxic. Following surgical removal, samples
      of the tumour will be evaluated for the expression of hypoxia genes. The preoperative imaging
      will be compared to the "gold standard" measures of hypoxic response at the level of gene
      transcription and a new hypoxia marker with the hypoxyprobe detection system (pimonidazole).

      Hypothesis: FDG/PET visualization of glycolysis combined with CT visualization of blood flow
      will correlate with cellular response to hypoxic stress in head and neck tumors and
      intra-tumor regions. Measurement of relative levels of mRNAs encoding hypoxia response genes
      will be performed in cells microdissected from the surgical samples. Good correlation between
      imaging signals and direct molecular measures of hypoxic response in primary human tumors
      will provide information necessary to develop treatment strategies that employ targeted,
      increased radiation to hypoxic tumors.

      Pimonidazole is an exogenous nitro-imidazole marker, which can be detected through
      immunohistochemical analysis of frozen sections. It detects cellular hypoxia upon becoming
      reduced in cells with low oxygen tension, a property that can be detected through antibody
      mediated detection of the reduced form. It has also shown to reliably and specifically stain
      hypoxic regions within the tumor, and to correlate well with patient prognosis and treatment
      outcome.
    

Intervention name(s): PET/CT
Intervention type(s): Device
Intervention description(s): All study participates will be scanned with PET/CT scan before surgery.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: cancer; hypoxia; PET scan; CT scan
Effect of Premedication Type on Preoperative Anxiety in Children
Condition: Preoperative Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Compare the effects of pharmacological and nonpharmacological premedications on preoperative
      anxiety and mask acceptance after adenotonsillectomy
    

Detailed description: 
      Compare the effects of 0.5 mg/kg oral midazolam, watching film 'Suko is being operated'
      animation film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU ,
      playing smartphone game ( subway surfers, snail Bob or angry birds) on preoperative anxiety
      by m-YPAS in the holding area, in the operating room and while induction of anesthesia.

      Investigators also evaluated mask acceptance by Mask Acceptance Scale Investigators also
      evaluated post operative delirium by PAED (postanesthetic emergency delirium) scale at PACU
      at arrive and every 10 minutes.
    

Intervention name(s): oral midazolam; Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.; Playing smartphone game
Intervention type(s): Other; Other; Other
Intervention description(s): 0.5 mg/kg oral midazolam administered 20 minutes before anesthesia induction; Patients will be watched a short movie (at URL:
http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU) 20 minutes before induction.; Patients will be played with smartphone (angry birds, subway surfers or snail Bob) 20 minutes before induction
Other intervention name(s): demizolam
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover assignment Effect of pharmacological and nonpharmacological premedication on anxiety
Masking: Single (Participant)
Primary purpose: Other
A Molecule Basic Study of Early Warning for New Pathogenic Risk of Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional

Summary: 
      The investigators will recruit active ankylosing spondylitis patients for injection treatment
      of Human Mesenchymal Stem Cells (a prospective, open-label, masculine medicine
      controlled(NSAIDs), clinical trial), and collect their Peripheral Blood Lymphocyte (PBMCs)
      and sera before and after the treatment of 24 weeks to test the gene expression profiles and
      study related pathogenesis of AS
    


Intervention name(s): MSC; "celecoxib", "Celebrex®"
Intervention type(s): Biological; Drug
Intervention description(s): human mesenchymal stem cells,1*10^4-6 cells /Kg , IV (in the vein) on day 1 of each 14-60 day cycle,1-6 times treatment.
a total of 24 weeks for follow up.; non-steroid anti-inflammatory drugs (NSAID):"celecoxib", "Celebrex®" 0.2g Bid(twice a day),PO (Per Os);a total of 24 weeks for follow up
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT
Condition: Gastrectomy; Malnutrition
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of efficacy and safety of two lipid emulsion products will be performed on
      gastrectomy patients postsurgically.
    

Detailed description: 
      The comparison of two lipid emulsion product will be performed. Patients who plan to accept
      gastrectomy will be consider for trial and signed content will be obtained. If the patient
      needs total parenteral nutrition (TPN) treatment after surgery for at least 5 days and meets
      all criteria, then he/she will be enrolled and randomized to ether of the groups, SMOFlipid
      or Lipovenoes MCT. During the treatment period, efficacy variables and safety variables will
      be measured. Life quality evaluation will also be performed through questionnaires
      collection.
    

Intervention name(s): lipid emulsion for TPN
Intervention type(s): Drug
Intervention description(s): 1-2 g lipid emulsion /kgBW-day, for consecutive 5 days
Other intervention name(s): SMOFlipid 20%
Intervention MeSH terms: SMOFlipid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Evaluation of Blood Pressure Reduction, Safety, and Tolerability of Canagliflozin in Patients With Hypertension and Type 2 Diabetes Mellitus on Stable Doses of Anti-hyperglycemic and Anti-hypertensive Agents
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood
      pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes
      mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents.
      Overall safety and tolerability of canagliflozin will be assessed.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), double blind (neither the patient nor
      the study doctor will know the name of the assigned treatment), parallel-group, 3-arm
      (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the
      effect of canagliflozin (100 mg and 300 mg) on blood pressure (BP) reduction compared to
      placebo (a pill that looks like all the other treatments but has no real medicine) in
      patients with hypertension and type 2 diabetes mellitus (T2DM). The study will consist of 3
      phases: a screening phase, a double-blind treatment phase and a follow-up period.
      Approximately 153 participants will be randomly assigned to 1 of 3 treatment groups (in a
      1:1:1 ratio) in the double-blind treatment phase to receive canagliflozin 100 mg,
      canagliflozin 300 mg or placebo for 6 weeks. The total duration of participation in this
      study will be approximately 13 weeks.
    

Intervention name(s): Canagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.; One matching placebo capsule orally in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Hypertension; Canagliflozin; JNJ 28431754; Sodium-Glucose Transporter 2; Blood Glucose; Type 2 Diabetes Mellitus
Testing the Effectiveness of a Computer-based Program for Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether completing a computer-based program alters
      changes how the brain processes emotional information and improves symptoms of depression.
    


Intervention name(s): Active computer-based training; Inert computer training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 sessions across 4 weeks.; 8 sessions across 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression
A Study to Assess the Safety and Efficacy of an Investigational Drug (MK-686) in Patients With Osteoarthritis (0686-006)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to assess the safety and tolerability of MK-0686 and to
      evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.
    


Intervention name(s): MK0686
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B
      vaccines with and without MPL will be evaluated in older healthy subjects
    

Detailed description: 
      At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
      name SmithKline Beecham
    

Intervention name(s): Engerix™-B; Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Hepatitis B; Engerix™-B; Recombinant Hepatitis B vaccine
Parental Involvement and Children's Extra-Familial Contexts
Condition: Prevention of Drug Abuse Risk
MeSH terms: Substance-Related Disorders
Study type: Observational

Summary: 
      Parental involvement has been shown to be a robust predictor of child conduct problems (CP)
      and drug use risk in childhood and adolescence, but relatively little attention has been paid
      to the role of parental involvement in relation to child problem behavior during the
      transition to school-age, when children are spending more time in school, after-care
      settings, and in the neighborhood. Concomitantly, as children transition from preschool to
      school-age, there is evidence to suggest that the quality and organization of schools,
      after-school care, and neighborhoods play an increasingly important role in the emergence of
      children's CP and drug use risk. Specifically, we will address: 1) the extent to which the
      quality of school environments, after-school care, and neighborhoods are associated with the
      emergence of CP during the early school-age period; 2) how parental involvement in the
      toddler and preschool period may be associated with parental involvement and monitoring in
      extra-familial contexts in the early school-age years; 3) how parental involvement in
      schools, after-care, and the neighborhood, may moderate relationships between extra-familial
      factors and children's CP; and 4) whether a parenting intervention can increase parental
      involvement in school, after-care, and neighborhood contexts and decrease risk of children's
      subsequent CP. These issues will be tested with an existing sample of 731 ethnically-diverse
      children from urban, suburban, and rural sites. As all families in the study were recruited
      based on the presence of sociodemographic, family, and child risk factors, the cohort of
      children are at high risk for displaying a persistent trajectory of clinically-meaningful CP
      and drug use risk. Thus, the study has the potential to fill a much-needed void on
      associations between extra-familial contexts and risk for early-starting CP and later problem
      behavior during the early school-age years. Equally critical, the study can provide data on
      the potential moderating influence of involved parenting, its malleability for families
      facing multiple adversities, and whether family-based interventions can make a difference for
      children facing multiple adversities.
    


Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        731 toddlers and their families followed from age 2 to 9 recruited on the basis of low
        socioeconomic status, and the presence of family (e.g., parental depression, drug use) and
        child (disruptive behavior) risk.
      
Keywords: drug use, antisocial behavior, early intervention, prevention
A Study to Investigate ABP 654 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy, safety, and immunogenicity of ABP 654
      compared with ustekinumab in participants with moderate to severe plaque psoriasis.
    

Detailed description: 
      This is a multicenter study and will enroll approximately 542 participants.

      The total duration of study participation for each participant will be 56 weeks, with up to 4
      weeks for screening, and for 52 weeks after the first administration of either ABP 654 or
      ustekinumab.

      After confirmation of eligibility, all participants will be randomized in a 1:1 ratio into 2
      treatment groups (Group A will receive ABP 654, and Group B will receive ustekinumab)
      stratified by prior biologic use for psoriasis (yes versus [vs] no), geographic region, and
      baseline body weight (BW).

      Based on the psoriasis area and severity index (PASI) score (to determine better improvement
      or partial improvement) at week 28, the participants in the study will proceed as follows:

        1. Participants who do not achieve PASI 50 response or better improvement at Week 28 will
           be considered to have completed the study and will complete end of study procedures (ie,
           week 52 procedures), and those unable to complete week 28 visit, or did not have a PASI
           assessment completed, will be discontinued from the study.

        2. Participants who achieve PASI 75 response or better improvement will continue on the
           study and will be re-randomized in a blinded fashion such that participants initially
           randomized to Group A (ABP 654) will continue to receive ABP 654 and those in Group B
           (ustekinumab) will re-randomized, to either continue on ustekinumab (Treatment Group B1)
           or switch to ABP 654 (Treatment Group B2).

        3. Participants with PASI 50 response or better but less than PASI 75 response and on the
           Investigator's decision, participants will continue on the originally assigned treatment
           with dose intensification and will not be re-randomized. However, participants that do
           not dose intensify will be re-randomized.
    

Intervention name(s): ABP 654; Ustekinumab
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive SC injection of ABP 654.; Participants will receive SC injection of ustekinumab.
Other intervention name(s): Stelara®
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis; Biosimilar; Psoriasis area and severity index
Evaluation of Chitosan Scaffold and Mineral Trioxide Aggregate Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis
Condition: Pulpitis - Irreversible
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the clinical and radiographic outcomes of Chitosan
      scaffold and Mineral trioxide aggregate (MTA) when used as pulpotomy agents in mature
      permanent teeth with irreversible pulpitis.
    

Detailed description: 
      Thirty permanent mandibular molars of patients with signs and symptoms of irreversible
      pulpitis will be selected. They will be randomly allocated into two groups, Group 1(Chitosan
      scaffold/ MTA pulp dressing materials), Group 2 (MTA pulp dressing material). A single visit
      full pulpotomy procedure will be carried out. Chitosan scaffold and / or MTA will be used as
      the pulp dressing materials. The teeth will be then restored with base of Glass ionomer
      cement followed by composite restoration.
    

Intervention name(s): Chitosan scaffold/ MTA pulp dressing material; MTA pulp dressing material
Intervention type(s): Drug; Drug
Intervention description(s): Chitosan 3-D porous scaffold will be prepared. The chitosan scaffolds will be examined with the Scanning electron microscopy (SEM) to analyze the surface of the chitosan scaffolds. The scaffolds will be sterilized by Ethylene oxide and stored until further use. A piece of 2-mm thick chitosan scaffold will be gently placed onto the pulp chamber floor and covering the canal orifices, and then a 2-3 mm thick layer of fast setting EndoCem Zr MTA will be applied onto the chitosan scaffold and will be gently condensed with moistened cotton pellet to attain adequate thickness which will be confirmed radiographically. MTA will be allowed to set for 4-5 mins.; MTA will be gently placed over the fresh pulp wound using an MTA carrier to a thickness of 2-3 mm. It will be condensed lightly with moistened cotton pellet to attain adequate thickness and confirmed radiographically. MTA will be allowed to set for 4-5 mins.
Intervention MeSH terms: Chitosan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Thirty permanent mandibular molars of patients with signs and symptoms of irreversible pulpitis will be selected. They will be randomly allocated into two groups, Group 1(Chitosan scaffold/ MTA pulp dressing materials), Group 2 (MTA pulp dressing material).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Metabolic Profile of OC000459
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label study in 9 male and 9 female healthy subjects to determine the pharmacokinetics
      of parent compound and metabolite after eight days of dosing.
    

Detailed description: 
      The study will include 9 male and 9 female healthy subjects. Following informed consent and
      satisfactory screening, each will be dosed for seven consecutive days on an outpatient basis
      with OC000459 50 mg daily taken before breakfast. On the seventh day, subjects will report to
      the clinical unit. Following an overnight fast, blood samples will be drawn for baseline
      safety and pharmacokinetic measurements and a urine specimen will be obtained for urinalysis
      and baseline metabolite measurements and subjects will be dosed with 50 mg OC000459. Blood
      samples will then be drawn at selected intervals for 120 hours post dosing and will be
      analysed for OC000459 parent compound and its metabolite. Urine collections will be obtained
      over the same period to determine the excretion of the metabolite and parent compound in
      urine.
    

Intervention name(s): OC000459
Intervention type(s): Drug
Intervention description(s): Taken orally for 8 days
Intervention model: Single Group Assignment
Masking: None (Open Label)