bioihbjkbjnl/mcl2 huggingface dataset:
Spine Biomechanics During Gait Following Lower Extremity Treatment in Different Patient Groups
Condition: Leg Length Inequality; Cerebral Palsy
MeSH terms: Leg Length Inequality; Cerebral Palsy
Study type: Interventional

Summary: 
      Measuring spine dynamics is a necessity in order to better understand gait deviations
      throughout the whole body and to evaluate treatment effects on spinal movement during gait.
      However, the full body marker sets that are typically used in opto-electronic 3D gait
      analyses either disregard the spine entirely or regard it as a rigid structure. Therefore,
      the purpose of this study is to use an enhanced trunk marker set in order to evaluate the
      biomechanical effects of lower extremity treatments on spine dynamics in patients with
      different pathologies.

      It has been hypothesized that

        1. the enhanced trunk marker set is a reliable method for the measurement of spine dynamics
           during gait in patients with deviations occurring secondary to leg length inequality.

        2. the enhanced trunk marker set is a reliable method for the measurement of spine dynamics
           during gait in patients that present both primary and secondary deviations such as seen
           in hemiplegic and diplegic cerebral palsy.

        3. treatment by means of either a shoe insole or a modified shoe with sole lift on the
           shorter side has an effect on spine dynamics during gait in patients with leg length
           inequality.

        4. treatment by means of an ankle foot orthosis to control the foot position has an effect
           on spine dynamics during gait in patients with hemiplegic and diplegic cerebral palsy.

      To verify the hypotheses, instrumented gait analyses with a standard full body marker set and
      the enhanced trunk marker set will be carried out before and immediately after an orthotic
      lower extremity treatment in the respective patient group.
    


Intervention name(s): Ankle foot orthosis; Shoe insole; Modified shoe with sole lift
Intervention type(s): Other; Other; Other
Intervention description(s): Ankle foot orthoses are a common treatment method to control the foot position during walking and to prevent ankle plantar flexion contractures in cerebral palsy patients.; The heel of the shorter leg of the patient is lifted by a shoe insole. This procedure is commonly applied with leg length differences of up to 20mm.; The heel of the shorter leg of the patient is lifted by building up the sole of the shoe (shoe sole lift). This procedure is commonly applied with leg length differences of 20mm and more.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Slow and Fast Transition From Stimulants to Atomoxetine in Children and Adolescents With Attention Deficit/Hyperactivity Disorder(ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not
      tolerating or not responding well to stimulant therapy will be included in this study. Two
      different strategies for transition from Stimulant to Atomoxetine will be used: Slow (10
      weeks) and fast (2 weeks). Changes in ADHD symptoms and tolerability of medication will be
      compared between the two different switching approaches.
    

Detailed description: 
      Study B4Z-EW-LYFJ is a phase IV multicentre, open label, controlled study in approximately
      120 patients with ADHD from 6 years to 16 years of age. After the screening period, patients
      will be randomized (centrally in a 1:1 ratio) either to a transition period of 10 weeks (slow
      switching arm) or to a transition period of 2 weeks (fast switching arm). After completion of
      the 10 week open phase patients will be treated for a further 4 weeks with atomoxetine.
    

Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention description(s): 1.2 mg/kg/day up to 1.8 mg/kg/day, orally (PO)
Other intervention name(s): LY139603; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Children; Stimulant; Atomoxetine; Adolescents
Risperidone for Treatment of Cocaine Dependence in Outpatients - 12
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate pharmacological efficacy and clinical safety of
      risperidone in the treatment of cocaine and amphetamine dependence.
    


Intervention name(s): Risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cocaine dependence
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A
      in treating overactive bladder in spinal cord injury or multiple sclerosis patients.
    


Intervention name(s): botulinum toxin Type A (200U); botulinum toxin Type A (300U); Normal Saline (Placebo); botulinum toxin Type A (200U); Normal Saline (Placebo); botulinum toxin Type A (300U)
Intervention type(s): Biological; Biological; Other; Other
Intervention description(s): botulinum toxin Type A 200 U (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval; botulinum toxin Type A 300 U (tx 1) followed by botulinum toxin Type A 300 U (tx 2); injections into detrusor, at > 12 weeks interval; Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval; Placebo (tx 1) followed by botulinum toxin Type A 300 U (tx 2), injections into detrusor, at > 12 weeks interval
Other intervention name(s): BOTOX®; BOTOX®; BOTOX®; BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate Safety, Tolerability and Pharmacokinetics of VM-1500A-LAI Single and Multiple Ascending Doses in Healthy Subjects
Condition: HIV-1-infection
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate safety and tolerability of VM-1500A-LAI after its single and multiple
      intramuscular ascending dose to healthy volunteers
    

Detailed description: 
      Primary Objective:

      To evaluate safety and tolerability of VM-1500A-LAI after its single and multiple
      intramuscular ascending dose to healthy volunteers.

      Secondary Objectives:

      To evaluate pharmacokinetic parameters of VM-1500A after its single and multiple
      intramuscular ascending dose administration to healthy volunteers.

      To evaluate safety and tolerability of ELPIDA®, administered in the run-in period
    

Intervention name(s): VM-1500A-LAI
Intervention type(s): Drug
Intervention description(s): VM-1500A (parent drug of elsulfavirine) IM injection dosage form
Other intervention name(s): VM-1500; VM-1500A
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1
Rural-urban Disparities in the Nutritional Status of Younger Adolescents in Tanzania.
Condition: Undernutrition; Stunting; Adolescent Development
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      Africa faces rapid urbanization, has the second highest population growth rate, makes up
      one-fifth of the world's youth population, and experiences stagnant rates of undernutrition.
      These challenges point to the need for country-specific data on rural-urban health
      disparities to inform development policies. This cross-sectional study examined disparities
      in body mass index-for-age-and-sex (BAZ) and height-for-age-and-sex z-scores (HAZ) among 1125
      adolescents in Tanzania. Rural-urban disparities in nutritional status were significant and
      gendered. Findings confirm place of residence as a key determinant of BAZ, HAZ, and stunting
      among adolescents in Tanzania. Targeted gender-sensitive interventions among adolescents,
      particularly in rural areas, are needed to limit growth faltering and improve health
      outcomes.
    

Detailed description: 
      Africa faces rapid urbanization, has the second highest population growth rate, makes up
      one-fifth of the world's youth population, and experiences stagnant rates of undernutrition.
      These challenges point to the need for country-specific data on rural-urban health
      disparities to inform development policies. This cross-sectional study examined disparities
      in body mass index-for-age-and-sex (BAZ) and height-for-age-and-sex z-scores (HAZ) among 1125
      adolescents in Tanzania. Pearson's chi-square tested associations between rural/urban
      residence and undernutrition (BAZ <-2SD), stunting (HAZ <-2SD), anthropometric,
      socioeconomic, and health indicators. Multivariate linear regression identified predictors of
      BAZ and HAZ.

      Funding: UNICEF/ Tanzania; United States National Institute of Mental Health (R01 MH66801).
    

Intervention name(s): Cross-sectional study/no intervention
Intervention type(s): Other
Intervention description(s): Cross-sectional study/no intervention.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This cross-sectional study merged and analyzed two independent samples of adolescents
        living in Tanzania. One study was conducted in Tanzania by Cordeiro et al. (2012) and the
        other was conducted in an urban setting by Carlson, Brennan, and Earls (2012); both
        conducted in 2004. The Kilosa/rural dataset was derived from a two-stage sampling plan for
        selection of villages and adolescents. The Moshi/urban dataset was derived from a two-stage
        sampling plan for a cluster randomized control trial (CRCT). From a total combined sample
        of 1476 adolescents aged 10-19 years across both datasets, 1237 met the age criterion for
        younger adolescents (10-14 years). The analytical sample for this study was 1125.
SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose
      ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD)
      effects of SP-304 in patients with chronic idiopathic constipation.
    

Detailed description: 
      This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose
      ranging study to determine the safety, PK and PD effects of SP-304 in patients with chronic
      idiopathic constipation. Patients diagnosed with chronic idiopathic constipation (CIC) will
      be screened for the anticipated 4 cohorts, to yield 80 randomized patients for enrollment.
      Four dose cohorts are planned (0.3 mg, 1.0 mg, 3.0mg, and 9.0 mg) with 20 patients per dose
      cohort [randomization ratio 3:1 (15 receive SP-304:5 receive placebo)]. Patients who continue
      to meet all the entry criteria and complete the pre-treatment bowel movement (BM) diary will
      receive, in a double-blind, randomized fashion, SP-304 or matching placebo. It is expected
      that each patient will complete all 14 days of dosing (including making accurate BM diary
      entries for all 14 days in the treatment period). All patients receiving at least one dose of
      SP-304 or matching placebo will be considered evaluable for the safety endpoints. If a
      patient receives at least 5 doses per treatment week (1 dose per day for 7 days) and has
      completed BM diary entries for those 5 dosing days in each corresponding treatment week,
      he/she will be considered evaluable.
    

Intervention name(s): SP-304 0.3 mg; SP-304 1.0 mg; SP-304 3.0 mg; SP-304 9.0 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): SP-304 0.3 mg; SP-304 1.0 mg; SP-304 3.0 mg; SP-304 9.0 mg; Placebo
Intervention MeSH terms: Plecanatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Idiopathic Constipation; Constipation; Irritable Bowel Syndrome
Triamcinolone Acetonide in Patients With Serous Pigment Epithelial Detachment
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness and safety of triamcinolone
      acetonide in patients with serous pigment detachment associated with age-related macular
      degeneration
    

Detailed description: 
      The purpose of this study is to determine the effectiveness and safety of triamcinolone
      acetonide in patients with serous pigment epithelial detachment associated with age-related
      macular degeneration.

      This study is planned as a follow-up. Patients with with serous pigment epithelial detachment
      associated with age-related macular degeneration included in it will receive triamcinolone
      acetonide in accordance with the approved indications for use indicated in the instructions
      for the use of drugs in Ukraine.

      The treatment proposed in this study is based on the world experience and scientific
      developments of the Filatov Institute of Eye Diseases and Tissue Therapy of the NAMS of
      Ukraine ". Therefore, it is expected that the benefit / risk ratio in relation to the
      participation in this study should not be different from that described in the scientific
      literature and the benefits outweigh the risk. It is known that the absence of treatment in
      these diseases leads to an irreparable loss of central vision.
    

Intervention name(s): Subtenon injection of 40 mg triamcinolone acetonide; Intravitreal injection of 4 mg triamcinolone acetonide; Visometry; Fluorescent angiography; Refractometry; Slit lamp examination; Ophthalmoscopy; OKT; IOP
Intervention type(s): Procedure; Procedure; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Subtenon injection of 40 mg triamcinolone acetonide: 1 initial injection of 40 mg triamcinolone acetonide, further injections will be base at month 3 examination.; Intravitreal injection of 4 mg triamcinolone acetonide: 1 initial injection of 4 mg triamcinolone acetonide, further injections will be base at month 3 examination.; Ophthalmic examination; Ophthalmic examination; Ophthalmic examination; Ophthalmic examination; Ophthalmic examination; Ophthalmic examination; Ophthalmic examination
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Age-related macular degeneration; serous pigment epithelium detachment; triamcinolone acetonide
Video Laryngoscope, New Intubation Device
Condition: Elective Intubation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      new glidoscope was tested on 401 patients
    

Detailed description: 
      Four hundred and one patients who were scheduled for elective operation, were randomly
      assigned to be intubated by direct laryngoscopy using a Macintosh blade size 3rd (DL, n=196)
      or intubation using the video laryngoscope (VL, n=205). Prior to intubation all patients were
      given a similar regimen of induction of anesthesia. The patients were then intubated, using
      direct laryngoscopy or the VL, by a different anesthetist during which the larynx was
      inspected and given a laryngoscopy score. Time to intubate, failure rate, injuries, personnel
      pleasure and, aspiration rate were measured
    

Intervention name(s): video laryngoscope; traditional laryngoscope
Intervention type(s): Device; Device
Intervention description(s): newly developed innovatory device; traditional way for intubation
Other intervention name(s): glidescope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laryngoscopy; Equipment; Video Laryngoscope
Efficacy of Split-dose of Oral MMS for Bowel Preparation in Elderly Patients
Condition: Colonic Adenoma; Bowel Preparation
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      Adequate bowel preparation is critical for successful colonoscopy and a large volume of PEG
      was required for bowel preparation in patients undergoing colonoscopy. The investigators
      conducted a a prospective, randomized, controlled study to compare low dose of oral magnesium
      sulfate solution with high dose PEG. The investigators found that patients who took low dose
      of oral magnesium sulfate solution had similar bowel preparation quality to patients who took
      PEG,but accompanied with fewer adverse events and better tolerance.
    


Intervention name(s): split-dose of Magnesium Sulfate solution; split-dose of PEG
Intervention type(s): Other; Other
Intervention description(s): purgative for bowel preparation; purgative for bowel preparation
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: bowel preparation; Oral magnesium sulfate solution; polyethylene glycol solution
Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      BFI-751 is being developed by BioFactura Australia Pty Ltd as a biosimilar drug to Stelara®
      (EU licenced and US licenced) (ustekinumab) is a prescription biologic medicine used to treat
      people with Crohn's disease, Ulcerative Colitis, plaque psoriasis and psoriatic arthritis.
      Stelara® is an immune suppressant that reduces the effects of inflammatory proteins within
      the body.

      This is the first time BFI-751 will be given to humans. The primary purpose of this study is
      to compare the pharmacokinetics (the study of what the body does to the drug, referring to
      the movement of any drug going into, through, and out of the body) by checking to see if the
      blood levels of 751-BFI are comparable with US-Stelara® and EU-Stelara® following a single
      injection under the skin.

      The secondary purposes of this study are:

        -  to assess the safety of BFI-751,

        -  study how well the healthy volunteers tolerate it and

        -  to also assess the immune response to it in healthy volunteers.
    

Detailed description: 
      This is a two centre, bioequivalence, randomized, double-blind, 3 parallel group Phase 1
      study of BFI-751 compared with EU-Stelara ® and US-Stelara ® in healthy adult volunteers.

      Within 28 days of screening, eligible participants will commence a confinement period on Day
      -1. The participants will receive a 45mg dose of either BFI-751, Stelara-US ® or Stelara-EU®
      in a blinded manner on Day 1 and will remain in the clinic until Day 2.

      Participants will then return to the clinic as outpatients on Days 3, 5, 8, 11, 15, 22, 29,
      36, 43,57, 71 and 85 for safety assessments.

      A total of up to 228 eligible participants will be enrolled and randomised in a 1:1:1 ratio
      (BFI-751: EU-Stelara ® : US-Stelara ® ).
    

Intervention name(s): BFI-751; EU-STELARA®; US-STELARA®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single use vial, solution; Pre-filled syringe, solution; Pre-filled syringe, solution
Other intervention name(s): Ustekinumab Biosimilar; STELARA® (ustekinumab); STELARA® (ustekinumab)
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded, randomized, parallel group
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
AED/Statin Interaction Study
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the amount of the cholesterol-lowering drug atorvastatin available
      in the bloodstream, when taken together with the anti-seizure drugs lamotrigine or phenytoin.
    


Intervention name(s): lamotrigine; atorvastatin; phenytoin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lamotrigine tablets will be available in 25, 50, 100 and 200 mg dose strength.; Atorvastatin will available as 40 mg tablets.; Phenytoin will available as 100 mg capsules.
Intervention MeSH terms: Lamotrigine; Phenytoin; Atorvastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drug interaction; pharmacokinetics; healthy volunteers
Post-Op Lidocaine Patch
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized control trial evaluating use of lidocaine vs placebo patch for post-operative
      cesarean incision pain.
    

Detailed description: 
      The purpose of this study is to determine if lidocaine patches decrease post-operative pain
      associated with cesarean births. While the Lidoderm lidocaine patch has been FDA approved for
      the treatment of skin pain, it has not been studied in women undergoing cesarean birth who
      experience postoperative pain. Even though this medication has been used in post-operative
      pain in published studies, the use of this medicine under these circumstances is still
      considered experimental. A lidocaine patch may provide added benefit for pain control in
      addition to standard medicines participants would receive after surgery, such as spinal,
      intravenous, and oral pain medications following cesarean delivery.
    

Intervention name(s): Lidoderm 5 % Topical Patch; Sham Topical Patch
Intervention type(s): Drug; Other
Intervention description(s): Lidocaine patch after cesarean section delivery.; Sham patch after cesarean section delivery.
Other intervention name(s): lidocaine patch; sham patch
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cesarean section; Postoperative pain