bioihbjkbjnl/mcl2 huggingface dataset:
Postoperative Pain of Root Canal Therapy With Three Techniques
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this prospective, randomized, double-blind study was to compare the
      prospective pain in asymptomatic mandibular molar teeth with necrotic pulp and periapical
      lesion using three different instrumentation files: Hand, Protaper Universal, and Wave-One
      files.
    

Detailed description: 
      ProTaper Universal system is one of the conventional multi-file rotary systems that prepared
      root canals with six files: three shaping files and three finishing files. A unique design
      element is varying tapers along the instruments' long axes. The three shaping files have
      tapers that increase coronally, and the reverse pattern is seen in the five finishing files.
      Wave-One is reciprocation-based systems that instrumented root canals with only single file.
      Some studies demonstrated that it has outperformed conventional continuous rotary
      nickel-titanium (NiTi) preparation in some aspects. The reciprocating motion of Wave-One
      relieves the stress on the file by special counterclockwise (cutting action) and clockwise
      (release of the instrument) movements and, therefore, extends the durability of a NiTi
      instrument and increases its fatigue resistance in comparison with continuous rotation
      motion.
    

Intervention name(s): Instrumentation technique with hand file; Instrumentation technique with ProTaper; Instrumentation technique with WaveOne
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): type of instrumentation technique for root canal treatment; type of instrumentation technique for root canal treatment; type of instrumentation technique for root canal treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: pain; root canal therapy; endodontics; file
Ultrasound Findings of Finger, Wrist and Knee Joints in Mucopolysaccharidosis
Condition: MPS I; MPS IV
MeSH terms: Mucopolysaccharidoses
Study type: Observational

Summary: 
      Hardly any imaging studies specifically addressing the articular and periarticular structures
      in MPS patients are available at this point. The investigators propose to do for the first
      time a pilot study using musculoskeletal ultrasound in patients with various types of MPS.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with MPS I and IV
Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to determinate the effect of combined oral therapy of long acting
      metformin/glimepiride in a single dose in patients with type 2 diabetes mellitus and
      monotherapy failure.
    

Detailed description: 
      A randomized double-blind clinical trial, to determine the effect of combined therapy of oral
      prolonged-release metformin/glimepiride in a single dosage form on fasting glucose and HbA1c.
      Patients will be included in this study are patients with diabetes mellitus and secondary
      failure to monotherapy. Will also assess the effect of combined therapy on the oral lipid
      profile (total cholesterol, LDL, HDL, VLDL, Triglycerides) and on the sensitivity and insulin
      secretion. We evaluate the clinical measurements, laboratory and safety during 3 months,
      through the allocation of subjects to three study groups (metformin, glimepiride and
      metformin extended release / glimepiride)
    

Intervention name(s): metformin/glimepiride combination; metformin; glimepiride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): long acting metformin/glimepiride 1g/2mg; long acting metformin 1g once a day with fasting glucose 130-199mg/dL or long actin metformin 1g twice a day (before dinner and before breakfast) with fasting glucose 200-270mg/dL; glimepiride 2mg once a day with fasting glucose 130-199mg/dL, or glimepiride 2mg twice a day (before dinner and before breakfast) with fasting glucose 200-270mg/dL
Intervention MeSH terms: Metformin; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Effect of B-GOS on the Wellbeing and Ageing in Healthy 52-65 Years Old Individuals
Condition: Healthy
Study type: Interventional

Summary: 
      To investigate the potential of B-GOS to beneficially influence the wellbeing and ageing in
      healthy adults (52-65 years old). The study will consist of a 4 month randomised double blind
      parallel treatment period with either B-GOS of Placebo, and 1 month follow up period without
      treatments.
    

Detailed description: 
      With age, several important alterations occur within the gastrointestinal (GI) tract, that
      are responsible for altered microbial environment (e.g. reduced diversity and number of
      beneficial bifidobacteria and higher populations of enterobacteria and clostridia).

      Research over the past two decades has provided evidence that administration of probiotics
      (live microorganisms which, when administered in adequate amounts, confer a health benefit on
      the host) could be used to optimise gut microbiota and prevent and treat a range of diseases,
      as well as enhance immune function. Somewhat less documented and more recent concept is the
      use of prebiotics (nondigestible food ingredients that beneficially affect the host by
      selectively stimulating the growth and/or activity of one, or a limited number of bacteria in
      the colon). Prebiotics are naturally available in breast milk and in certain vegetables but
      can also be synthetic oligosaccharides of which the best known and the most researched
      examples include fructooligosaccharides (FOS) and galactooligosaccharides (GOS). B-GOS is a
      low molecular weight GOS mixture, shown to increase the number of probiotic bacteria,
      especially bifidobacteria, in younger and older adults, irritable-bowel sufferers and
      overweight adults. B-GOS also significantly decreases the colonisation and pathology of
      salmonellosis and incidence and duration of traveller's diarrhoea.

      Our aim is to investigate the potential of B-GOS to beneficially influence the wellbeing and
      ageing in healthy adults (52-65 years old). The assessment would consist of various
      questionnaires covering quality of life, bowel function, mood and sleep and blood markers of
      inflammation and ageing.
    

Intervention name(s): B-GOS; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): comparison versus placebo; placebo
Other intervention name(s): Bimuno; corn starch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effectiveness of Group GDS and Individual GDS for Treatment of Low Back Pain in Primary Care
Condition: Subacute Nonspecific Low Back Pain; Chronic Nonspecific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      A cluster, randomized, controlled clinical trial, where the hypothesis is that Group GDS and
      Individual GDS are effective in the treatment of nonspecific low back pain. The clusters will
      be the participating physiotherapy departments in primary care who treat patients with low
      back pain. In each physiotherapy department there will be 3 groups: education group, Group
      GDS and Individual GDS. Patients will be followed for 12 months. Variables will be:
      demographic,intensity of pain, disability, quality of life, patient satisfaction, medication
      intake for current episode, non-pharmacologic treatment for current episode, co-morbidity,
      diagnostic tests, sick leave, and habitual physical activity. The questionnaires to be used
      are: Roland Morris Disability Questionnaire, PI-NRS, VAS, SF-12 and EQ-5d.
    


Intervention name(s): Education on active management; Group GDS physiotherapy; Individual GDS physiotherapy
Intervention type(s): Behavioral; Other; Other
Intervention description(s): Routine clinical practice plus education on active management.; Routine clinical practice (which will be substituted by Group GDS) plus education on active management.; Routine clinical practice (except for usual physiotherapy, which is substituted by Group and Individual GDS) plus education on active management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; physiotherapy; exercise; active management
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery
Condition: Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD
      75mg/1ml s.c. with the marketed reference product, Voltarol® 75mg/3ml i.m. in the treatment
      of acute moderate-to-severe pain after dental impaction surgery.
    


Intervention name(s): Diclofenac HPBCD s.c. 75mg/ml; Voltarol 75mg/3ml i.m.
Intervention type(s): Drug; Drug
Intervention description(s): 1 single injection at day of dental surgical extraction; 1 single injection at day of dental surgical extraction
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Influence of Pain Sensitivity on Lumbar Surgery Outcomes
Condition: Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Study type: Observational

Summary: 
      Pain sensitivity would be associated with surgical outcomes after lumbar spine surgery.
    


Intervention name(s): Surgery for lumbar spinal stenosis
Intervention type(s): Procedure
Intervention description(s): decompression with or without fusion for lumbar spinal stenosis
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The inclusion criteria were the following: 1) patients aged 40-80 years; 2) an lumbar
        spinal stenosis diagnosis and scheduled spine surgery at a tertiary-care teaching
        institution between June 2012 and April 2013
Allopurinol in Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Condition: Endoscopic Retrograde Cholangiopancreatography
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      -  The investigators evaluated the role of allopurinol in prevention of post-ERCP
           pancreatitis.

        -  100 Egyptian patients who were candidates for ERCP were included and divided into two
           groups. Group 1 (study group) included 50 patients who received two doses of allopurinol
           300 mg each, 15 hours and 3 hours before ERCP and Group 2 (control group) included 50
           patients who did not receive allopurinol prophylaxis.
    

Detailed description: 
      A diagnosis of procedure-related pancreatitis was based on an increased serum amylase level
      greater than three times the upper normal limits, associated with abdominal pain requiring
      analgesics and persisting for at least 24 hours after the procedure.
    

Intervention name(s): Allopurinol
Intervention type(s): Drug
Intervention description(s): 600 mg of allopurinol divided in two oral doses before the procedure (300 mg at 15 hours and 300 mg at 3 hours before ERCP)
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Investigate the Safety and Pharmacodynamics of Repeat Intranasal Administration of the TLR7 Agonist GSK2245035 in Subjects With Respiratory Allergies
Condition: Asthma and Rhinitis
MeSH terms: Rhinitis; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK2245035 is a highly selective Toll-like receptor 7 (TLR7) agonist that stimulates
      preferentially the induction of type I interferons. Intranasal (i.n.) administration of
      GSK2245035 in humans causes immune changes in the upper airways milieu that may alter
      bystander immune responsiveness to aeroallergens and contribute to reduction of allergic
      reactivity in subjects with respiratory allergies. The purpose of this study is to examine
      the safety and pharmacodynamics (PD) of repeat dosing with i.n. GSK2245035 in subjects with
      respiratory allergies. The safety and pharmacodynamic response of four weekly administrations
      of escalating doses of i.n. GSK2245035 will be investigated and the maximum tolerated dose
      will be established. The study will be conducted in patients with symptomatic allergic
      rhinitis and mild asthma. The overall duration of the study will be up to a maximum of
      approximately 122 days considering 90 days screening period, 22 days treatment period and 10
      days follow-up period.
    


Intervention name(s): GSK2245035; Type 1 amber glass bottle; Placebo
Intervention type(s): Drug; Device; Other
Intervention description(s): GSK2245035 nasal spray solution. A solution formulation in saline, preserved with Benzalkonium Chloride and Disodium Edetate; fitted with a metered Valios VP7 pump; As for GSK2245035 nasal spray solution except for omission of the active ingredient
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: TLR7 agonist, Respiratory Allergies, Allergic Rhinitis, Mild Allergic Asthma, Repeat Dose Safety, Reduction of Allergic Reactivity
Recovery Housing For Drug Dependent Pregnant Women
Condition: Drug Addiction
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      For the past several years our research program has developed and tested an intensive
      outpatient intervention that is based in social learning theory and employs abstinence
      contingent access to recovery housing as a routine aspect of an intensive day treatment
      counseling program. The present project proposes to extend this treatment intervention to the
      special population of pregnant drug using women enrolled at the Center for Addiction and
      Pregnancy (CAP). We will compare an enhanced treatment that includes abstinence contingent
      recovery house living plus intensive individual therapy, to standard care at the CAP program.
      Specific aims of the project are derived from testing a two-group design are described below:

        1. To determine whether financially supported abstinence-contingent recovery house
           placement plus individual counseling in pregnant drug-dependent women improves prenatal
           outpatient treatment retention.

        2. To determine whether financially supported abstinence-contingent recovery house
           placement plus individual counseling in pregnant drug-dependent women reduces prenatal
           drug use.

        3. To determine whether financially supported abstinence-contingent recovery house
           placement plus individual counseling results in better maternal and infant clinical
           birth outcomes (e.g., birth weight, estimated gestational age (EGA) at delivery, medical
           complications).
    


Intervention name(s): RBT; usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Contingency management and behavioral counseling including motivational interviewing; receives usual comprehensive care at Center for Addiction and Pregnancy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cocaine; opiate; pregnancy; post-partum; neonatal abstinence syndrome; contingency management; Reinforcement Based Treatment; women
Maraviroc and NeuroAIDS Pathogenesis
Condition: AIDS Dementia Complex
MeSH terms: AIDS Dementia Complex; Dementia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Maraviroc is an antiretroviral medication that may help in improving mental function in HIV
      infected patients with mental problems by decreasing inflammatory tendencies. We will test
      this in a clinical trial of 42 HIV infected individuals with some mild to moderate mental
      problems who are already on HIV medications and doing well. We will add Maraviroc or a sugar
      pill to their HIV medications and see if mental function improves over 48 weeks. This study
      will be conducted at 2 sites in Hawaii and Puerto Rico.
    

Detailed description: 
      We hypothesize that maraviroc (MVC) will lead to improved cognition as assessed by
      improvement in neuropsychological (NP) performance. We hypothesize that MVC therapy leads to
      (1) decrease in HIV infection of monocytes (MO), particularly of CD16-expressing MO and (2)
      phenotypic and functional secretory changes suggestive of decrease in MO immune activation,
      and that these changes will lead to less HIV infected activated MO trafficking to the CNS,
      less CNS inflammation and neuronal damage, and ultimately improved cognition. We will test
      this in a 48 week trial in 42 HIV infected individuals on suppressive antiretroviral therapy
      (ART) with mild to moderate cognitive dysfunction. These individuals will be randomized to
      intensify their ART in double-blind fashion to MVC vs placebo. The primary endpoint will be
      change in NPZglobal. Magnetic resonance spectroscopy (MRS)/magnetic resonance spectroscopic
      imaging (MRSI) will be conducted to assess potential alterations in inflammatory and neuronal
      brain chemicals.
    

Intervention name(s): Maraviroc; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Maraviroc administered twice daily, dosage based on concomitant medication being taken.; Maraviroc placebo administered twice daily, dosage based on concomitant medication being taken.
Other intervention name(s): Selzentry
Intervention MeSH terms: Maraviroc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Human Immunodeficiency Virus; AIDS Dementia Complex
Combined Gut-brain Therapy for Children With Autism
Condition: Autism Spectrum Disorder; Functional Gastrointestinal Disorders; Neurodevelopmental Disorders; Anxiety
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Autistic Disorder; Autism Spectrum Disorder; Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      CLINICAL ISSUE: Children with Autism Spectrum Disorder (ASD) are four times more likely to
      suffer with functional gastrointestinal disorders (FGIDs) than their neurotypical peers. The
      presence of FGIDs are linked to increased undesirable behaviour and ASD severity. Current
      behavioural approaches for ASD therapy do not alleviate the high comorbidity of FGIDs within
      this population.

      BACKGROUND: Dysfunction of the microbiome-gut-brain (MGB) axis has been implicated in
      pathogenesis of both ASD and FGIDs. Probiotics and prebiotics can modulate the gut microbiome
      and research has shown efficacy at improving gastrointestinal (GI) symptoms in children with
      ASD and neurotypical (NT) children with FGIDs. Gut-directed hypnotherapy (GDH) has shown
      utility in treating FGIDs in NT children and adults but has not yet been trialed in children
      with ASD. Targeting therapies to address the dysfunction of the bidirectional MGB axis will
      likely be more effective than either brain/behavioural or gut-based therapy alone.

      HYPOTHESIS: A synbiotic (prebiotic + probiotic mixture) with combined GDH will be more
      effective than a synbiotic alone at reducing GI symptoms in children with ASD aged 5.00 to
      10.99 years over a 12-week period.
    


Intervention name(s): Synbiotic; Gut-directed Hypnotherapy
Intervention type(s): Combination Product; Behavioral
Intervention description(s): Prebiotic + Probiotic; Psychotherapy sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be recruited and randomised (1:1) to one of two 12-week treatment intervention groups: 1) synbiotic or 2) synbiotic + gut-directed hypnotherapy. Follow-up will occur at week 24.
Masking: None (Open Label)
Primary purpose: Treatment
Allogeneic Stem Cell Transplantation Followed By Targeted Immune Therapy In Average Risk Leukemia
Condition: Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Juvenile Myelomonocytic Leukemia
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myelomonocytic, Acute; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Allogeneic stem cell transplantation (AlloSCT) followed by targeted immune therapy Gemtuzumab
      Ozogamicin patients with acute myeloid leukemia (AML)/juvenile myelomonocytic leukemia
      (JMML)/myelodysplastic syndromes (MDS) will be safe and well tolerated.
    

Detailed description: 
      Gemtuzumab Ozogamicin (CMA-676) is a chemotherapeutic agent consisting of a recombinant
      humanized anti-CD33 antibody conjugated with calicheamicin, a highly potent cytotoxic
      antitumor antibiotic. The antibody portion of Gemtuzumab binds specifically to the CD33
      antigen, a sialic acid-dependent adhesion protein expressed on the surface of leukemic
      blasts, normal and leukemic myeloid colony-forming cells, including leukemic clonogenic
      precursors, but excluding pluripotent hematopoietic stem cells and nonhematopoietic cells.
      This results in formation of a complex that is internalized, upon which the calicheamicin
      derivative is released within the lysosomes of the myeloid cell. The free calicheamicin
      derivative then binds to deoxyribonucleic acid (DNA), resulting in DNA double strand breaks
      and consequential cell death. Over 80% of AML patients possess myeloid blast cells with CD33
      surface antigen expression.
    

Intervention name(s): Fludarabine; Busulfan; GVHD Prophylaxis; Gemtuzumab Ozogamicin; Anti-Thymocyte Globulin; Isotretinoin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Conditioning Regimen; Conditioning Regimen; Can be FK506 (Tacrolimus/Prograf®), mycophenolate mofetil ((MMF)/Cellcept®), or methotrexate (MTX, amethopterin); Dose Escalation; Unrelated Donors only; JMML patients only
Other intervention name(s): Fludara®; Busulfex®; Mylotarg®; Thymoglobulin®; Accutane®; 13-cis-Retinoic Acid (cis-RA)
Intervention MeSH terms: Fludarabine; Busulfan; Gemtuzumab; Isotretinoin; Thymoglobulin; Antilymphocyte Serum
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allogeneic Stem Cell Transplantation; Targeted Immune Therapy; Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Juvenile Myelomonocytic Leukemia; AML; MDS; JMML