bioihbjkbjnl/mcl2 huggingface dataset:
Determination of Threonine Requirements in Healthy School-aged Children
Condition: Threonine Requirements in Children
Study type: Interventional

Summary: 
      Threonine is an indispensable amino acid (nutrient containing nitrogen), which cannot be made
      in the body and must be consumed from food. Amino acids are the building blocks of protein in
      your body, and need to be eaten in required amounts to maintain health and growth. Deficiency
      in threonine can affect small intestine growth due to its structural importance in the
      intestinal protein mucin. While threonine is found in many foods, deficiency can occur in
      developing countries where nutrition is primarily plant based, and low in available protein.

      Therefore, the purpose of this study is to determine the requirement of the indispensable
      amino acid Threonine, in school-aged children (6-10y). Secondly, we wish to determine the
      availability of threonine from three test proteins (soy, green pea, casein).
    

Detailed description: 
      The threonine intake requirement for children are based on factorial calculations. In the
      current study we will use a new and modern technique, the indicator amino acid oxidation
      technique (IAAO), to determine threonine requirements in children.

      This technique is a newer technique which involves the consumption of protein shakes composed
      of specific amounts of threonine mixed with a stable isotope tracer. The oxidation of this
      isotope will be measured in urine and breath to determine a breakpoint (requirement) of
      threonine.

      Determining the requirement for threonine, as well as the availability of threonine from
      various food products will help us to develop better food recommendations for children.

      Research Method This study will be carried out in a repeated measures design. Participants
      will be recruited and screened for eligibility. Six participants will be brought in for 6
      testing visits with reference amino acid, where they will be randomized to a level of
      threonine intake. A further 3 visits will be carried out during which participants will be
      randomized to a level of threonine consumption derived from alternative proteins (casein,
      soy, peas) which is at a threshold below the requirement for threonine to determine
      availability.
    

Intervention name(s): Protein intake
Intervention type(s): Dietary Supplement
Intervention description(s): Oral consumption of eight hourly experimental meals
4 tracer free experimental meals containing a mixture of free amino acids and calories from protein free flavoured liquid, protein free cookies and corn oil
4 isotopically labeled experimental meals.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: IAAO; Threonine; Children
Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in Korea
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Study title

        -  A randomized, open label, multicenter, phase 4 study for the comparison of efficacy of
           tiotropium plus salmeterol/ fluticasone propionate compared with tiotropium alone in
           COPD patients

      Study objectives

        -  To investigate clinical outcomes of combining tiotropium with fluticasone
           propionate/salmeterol (FSC) 250/50μg bid compared with tiotropium alone in patients with
           moderate or severe COPD in Korea

      Study Design

        -  Randomized, open-label, multicenter, parallel-group, two group study

      Study assessment

        -  FEV1

        -  Inspiratory capacity (IC)

        -  History of COPD exacerbation

        -  History of hospitalization for COPD exacerbation and all causes

        -  QoL (SGRQ-C)
    


Intervention name(s): tiotropium with fluticasone propionate/salmeterol (FSC); tiotropium
Intervention type(s): Drug; Drug
Intervention description(s): COPD patients treated with tiotropium with fluticasone propionate/salmeterol (FSC); COPD patients treated with tiotropium
Other intervention name(s): tiotropium]:Spiriva; fluticasone propionate/salmeterol (FSC): Seretide; tiotropium: Spiriva
Intervention MeSH terms: Fluticasone; Xhance; Tiotropium Bromide; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light
      Emitting Diode) photobiomodulation device, on orthodontic treatment time. This is a
      double-blinded RCT with half the patients receiving treatment from a sham non-functional
      device, serving as controls, and the other half receiving light therapy treatment from a
      functional OrthoPulse™. Orthodontic treatment time for the sham-control patients are compared
      to that of the OrthoPulse™ patients.
    


Intervention name(s): Fixed Orthodontic Appliance Treatment; OrthoPulse™; Non-Functional OrthoPulse™
Intervention type(s): Other; Device; Device
Intervention description(s): Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.; Patients carry out daily OrthoPulse™ treatments at home.; Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Photobiomodulation; Orthodontic treatment; Malocclusion; OrthoPulse™
Sensory and Psychomotor Profile in Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Despite a possible psychomotor retardation during a depressive episode, standardized
      psychomotor assessment is rare. So, other possible psychomotor disorders or neurological
      "soft signs" are not known in depression.

      The investigator propose in this study to explore the psychomotor characteristics of patients
      with a major depressive disorder from the realization of a psychomotor assessment in
      comparison with adult without depressive disorder (control). It will be specifically assess
      muscle tone, gross motor skills, praxis, body schema and the body image and the perceptions.
    


Intervention name(s): Psychomotor assessment
Intervention type(s): Other
Intervention description(s): the intervention include a depression scale, an anxiety scale, a sensory profile scale, a body image questionnaire, a self-esteem questionnaire, a psychomotor retardation scale and a standardized assessment of : muscle tone (dangling and extensibility); gross motor skills (walks, jump, static balance, dynamic balance); manual performance; manual praxis; adaptation of rhythm; manual gnosis; executive function
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: depression; psychomotor assessment; sensory profile; perception; motricity
The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin
Condition: Cellulitis
MeSH terms: Cellulitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary: To determine the influence of daptomycin on inflammatory cytokine (IL-1, TNF and
      IL-6) for the treatment of complicated cellulitis/erysipela compared with alternative
      treatment (vancomycin or oxacillin). Secondary: To evaluate the clinical outcome of both
      groups according to levels of the cytokines evaluated.
    


Intervention name(s): Daptomycin; Vancomycin
Intervention type(s): Drug; Drug
Intervention description(s): daptomycin 4-6mg/kg qd 10 - 14 days; Vancomycin 1g q12h 10 - 14 days
Intervention MeSH terms: Vancomycin; Daptomycin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Mechanism and Predictor of Side Branch Jailing
Condition: Bifurcating Coronary Artery Lesions; Main Branch Stent Implantation; Side Branch Jailing
Study type: Observational

Summary: 
      Coronary artery bifurcation lesion is still one of the most challenging lesion subsets in the
      field of non-surgical treatment for a stenotic coronary artery. When one stent is placed in
      the main brach, it increases the side branch's stenosis degree. However, its mechanism and
      incidence are not known. This study will be performed to search for the mechanism and
      incidence of that phenomenon.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with bifurcating coronary artery lesion in left anterior descending coronary
        artery
      
Keywords: coronary artery; bifurcation; stent; intravascular ultrasound; fractional flow reserve
Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is assess the long-term safety and tolerability of voclosporin
      compared with placebo for up to an additional 24 months following completion of treatment in
      the AURORA 1 study in subjects with lupus nephritis (LN).
    

Detailed description: 
      The aim of the Phase 3 continuation study (AURORA 2) is to assess the long-term safety and
      tolerability of voclosporin, added to the standard of care treatment in LN, for an additional
      24 months, following a treatment period of 52 weeks in the AURORA 1 study (AUR-VCS-2016-01).
      All subjects will continue to receive background therapy of mycophenolate mofetil (MMF)
      and/or oral corticosteroids starting at the same dose as at the end of the AURORA 1 study.
      Subjects with LN, who have completed 52 weeks of treatment with study drug in the AURORA 1
      study, will be eligible to enter the study. The long-term safety and tolerability of the drug
      combination will be assessed from its safety profile while demonstrating the continued
      ability to achieve and maintain long-term renal response.
    

Intervention name(s): Voclosporin; Placebo Oral Capsule
Intervention type(s): Drug; Drug
Intervention description(s): Calcineurin inhibitor, oral, 23.7 mg twice daily (BID); Voclosporin placebo, oral, 3 capsules twice daily (BID)
Other intervention name(s): ISA247
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lupus nephritis; calcineurin inhibitors; voclosporin
Metformin for Brain Repair in Children With Cranial-Spinal Radiation for Medulloblastoma
Condition: Brain Tumor Treated With Cranial or Cranial-Spinal Radiation
MeSH terms: Medulloblastoma
Study type: Interventional
Phase: Phase 3

Summary: 
      A placebo controlled double blind crossover trial of metformin in 30 children treated with
      radiation for medulloblastoma - the most common malignant brain tumour. The investigators
      used tests of thinking and learning and brain imaging techniques to examine whether metformin
      can enhance cognition or promote brain repair following radiation-induced brain injury.
    

Detailed description: 
      We conducted a pilot randomized, double-blind, placebo-controlled trial with crossover in
      survivors of pediatric brain tumors with primary endpoints of safety and feasibility and
      secondary endpoints of cognitive and magnetic resonance imaging (MRI) measures. Twenty-four
      participants were enrolled and randomly assigned to complete 12-week cycles of metformin (A)
      and placebo (B) in either a group AB (AB) or group BA (BA) sequence. At the point of
      crossover, there was a 10-week washout period in which neither group received any treatment.
      During the first week of each treatment cycle, a daily dose of 500 mg/m2 of metformin or
      placebo was administered orally. The dose was increased to 1000mg/m2 daily beginning in the
      second week and continuing for the remainder of the 12-week cycle.

      Test procedures (Clinical & current medications reviews, Blood draws, and MRI and Cognitive
      testing) were performed at 4 times points during the study: 1. at study entry (Baseline 1),
      2. after 12 weeks of treatment (Outcome 1), 3. after a 10-week washout period at 22 weeks
      (Baseline 2), and 4. At the end of the trial at 34 weeks (Outcome 2).
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Metformin doses will be 500 mg/m2 po daily given in 2 doses for one week and if there are no concerns increased to 1000 mg/m2 po daily given in 2 doses for the rest of the 12 week trial. The investigators will use the closest dose according to body surface area (250-500-750-1000) BID.; Placebo doses will be 500 mg/m2 po daily given in 2 doses for one week and if there are no concerns increased to 1000 mg/m2 po daily given in 2 doses for the rest of the 12 week trial. The investigators will use the closest dose according to body surface area (250-500-750-1000) BID.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Paediatrics; Medulloblastoma; Metformin
Safety and Efficacy Study of MT-2990 in Women With Endometriosis
Condition: Endometrial Related Pain
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and efficacy of MT-2990 for treatment of
      moderate to severe endometriosis-related pain in women with surgically diagnosed
      endometriosis.
    


Intervention name(s): MT-2990; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV; IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endometriosis
Bevacizumab Intravitreal for Myopic Choroidal Neovascularization
Condition: Myopic Choroidal Neovascularization
MeSH terms: Choroidal Neovascularization; Myopia; Neovascularization, Pathologic
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary
      to pathologic myopia (PM-CNV).
    

Detailed description: 
      Nineteen consecutive patients (19 eyes) with subfoveal PM-CNV, 18 of whom had been
      unsuccessfully treated with Visudyne PDT, were treated with IVT of 1.25 mg bevacizumab or
      0.5mg ranibizumab. ETDRS best corrected visual acuity, macular thickness on OCT scans, and
      angiographic features were recorded and evaluated. The aspect of OCT scans passing across the
      PM-CNV was also analyzed. IVTs were repeated only in case of persistent angiographic leakage
      and if OCT scans showed retinal thickening or edema and serous retinal detachment. The
      follow-up period was at least 6 months.
    

Intervention name(s): Injection
Intervention type(s): Drug
Intervention description(s): Intravitreal injection of 1.25 mg bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bevacizumab; Myopia; Complications; Neovascularization; OCT
Pain and Fear of Venous Blood Collection in Children
Condition: Pain; Fear
Study type: Interventional

Summary: 
      Nurses are in the position of primary health care provider in relieving children's pain and
      fears of bloodletting in the wards where they work. As a result of this study, it is aimed to
      encourage nurses to apply non-pharmacological interventions during painful medical
      procedures, to facilitate the provision of necessary and different means of distraction to
      blood collection services, and to contribute to the development of in-house health policies
      and the preparation of appropriate clinical guides and to add an innovative perspective.
    


Intervention name(s): Chocolate Scent
Intervention type(s): Other
Intervention description(s): Chocolate Scent:Children in this group will be given chocolate scent sniffing as a non-pharmacological distraction method.
Stress Ball:Stress ball squeezing will be used as a non-pharmacological distraction method for children in this group.
Other intervention name(s): Stress Ball
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Dexmedetomidine in IVRA
Condition: Regional Anesthesia Morbidity
Study type: Interventional
Phase: Phase 4

Summary: 
      A prospective randomized controlled double-blinded study will be conducted on 90 patients
      assigned randomly into three equal groups,
    

Detailed description: 
      After obtaining approval of the medical and ethical committee of Menoufia University & Nasser
      Institute for Research and Treatment, an informed and written consent from the patients, a
      prospective controlled randomized double blinded study will be performed

      Sample size:

      MedCalc® version 12.3.0.0 program "Ostend, Belgium" was used for calculations of sample size,
      statistical calculator based on 95% confidence interval and power of the study 80% with α
      error 5%, According to a previous study (13), showed that the duration of tourniquet time in
      group A was mean 51.60±5.157 and Group B was mean 53.80±4.773, with p-value >0.05, while
      Quality of block of excellent in group A 83.3% and group B 90%, it turns out that there is
      success in the group B compared to group A, but there is no difference. So it can be relied
      upon in this study, based on this assumption, sample size was calculated according to these
      values produced a minimal samples size of 86 cases were enough to find such a difference.
      Assuming a drop-out ratio of 5%, the sample size will be 90 cases, subdivided into three
      groups 30 cases in each group. Patients will be randomly categorized into three equal groups
      (30 patients each): The patients will be randomly allocated to one of these three groups,
      using a computer-generated sequence of random numbers and a sealed envelope technique.
    

Intervention name(s): Dexmedetomidine Injectable Solution [Dexdomitor]; Lidocaine IV
Intervention type(s): Drug; Drug
Intervention description(s): two different doses of dexemedetomidine (0.25 μg /kg and 0.5 μg/kg) as adjunct to lignocaine in intravenous regional anesthesia for upper limb orthopedic surgeries; Intravenous regional anaesthesia
Intervention MeSH terms: Lidocaine; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: Dexmedetomidine; Lignocaine; Upper Limb Orthopedic Surgery; Intravenous Regional Anaesthesia
A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity
Condition: Hallux Valgus Deformity
MeSH terms: Hallux Valgus; Bunion; Congenital Abnormalities
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose,
      sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with
      sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to
      active, and 2 will be randomized to placebo.
    

Detailed description: 
      This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose,
      sequential-group Phase 1 study.

      The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects.
      Within each dose cohort, 6 subjects will be randomized to active, and 2 will be randomized to
      placebo. Placebo patients from each cohort were pooled for analysis. The initial cohort will
      receive the lowest planned dose of CA-008, and sequential cohorts will receive escalating
      doses of CA-008 in a fixed volume of administration. There will be at least a 6-day period
      between cohorts, in order to ensure a minimum of 3 days to review safety data from the last
      subject in a cohort and to allow the meeting of the Data Monitoring Committee (DMC) to review
      the safety data from the entire cohort prior to a making decision for dose escalation. Dose
      escalation rules will be protocol defined.

      Subjects will be undergoing unilateral transpositional first metatarsal osteotomy for the
      correction of hallux valgus deformity (bunionectomy). In accordance with standard of care,
      subjects will receive regional anesthesia (MAYO block) with 0.5% bupivacaine. Prior to wound
      closure, 10 mL of study drug will be injected into the soft tissues and periosteum of the
      surgical site.

      After the surgery, subjects will be monitored for 48 hours at the trial site. Safety and
      efficacy evaluations will be performed as described herein. Subjects will be required to meet
      certain pre-specified criteria prior to discharge.
    

Intervention name(s): CA-008; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Local administration during surgery; Local administration during surgery
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Unilateral Transpositional First Metatarsal Osteotomy
18612 - Sun Protection Factor Assay
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY 987521
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment