bioihbjkbjnl/mcl2 huggingface dataset:
Validation of Senofilcon A With New UV / HEV Filter
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a bilateral, dispensing, randomized, controlled, subject-masked, 2-arm parallel study
      to evaluate safety and efficacy
    


Intervention name(s): senofilcon A C3; senofilcon A
Intervention type(s): Device; Device
Intervention description(s): TEST Lens; CONTROL Lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in
      subjects with acne vulgaris following 28 days of dosing.
    


Intervention name(s): Dapsone Formulation A; Dapsone Formulation B; Dapsone Formulation C; Dapsone 5% Gel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.; Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.; Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.; Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
Other intervention name(s): ACZONE®
Intervention MeSH terms: Dapsone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma
Condition: Acute Pain Due to Trauma
MeSH terms: Acute Pain; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      Pain is the leading cause of access to the paediatric emergency department (ED) and present
      in up to 78% of cases.

      Acute osteoarticular traumatic pain is often treated inadequately, and there is little data
      about the best treatment for children. The ibuprofen and ketorolac are respectively the most
      used and one of the most powerful NSAIDs. In literature, there is no direct comparison
      between those two medications.

      The objective of the study depends on the level of pain:

        -  in severe traumatic acute pain (>=7 points): to evaluate if ketorolac is superior to
           ibuprofen in the treatment of pain (n=130 children, 65 allocated to ketorolac and 65 to
           ibuprofen)

        -  in moderate traumatic acute pain (<7 points): to evaluate if ibuprofen is not inferior
           to ketorolac in the treatment of pain (n=120 children, 60 allocated to ketorolac and 60
           to ibuprofen)
    


Intervention name(s): Ketorolac; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): Administration of ketorolac 0.5 mg/kg up to 10 mg, one single dose at the enrollment. This group will receive also a placebo indistinguishable from the ibuprofen.; Administration of ibuprofen 10 mg/kg up to 600 mg, one single dose at the enrollment. This group will receive also a placebo indistinguishable from the ketorolac.
Intervention MeSH terms: Ibuprofen; Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: osteoarticular acute pain; ketorolac; ibuprofen
Severe Pneumonia Diagnostic in Pediatric Population by Lung Ultrasonography and Procalcitonin
Condition: Pneumonia Childhood
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      Lung ultrasound (LUS) in combination with a biomarker has not yet been studied. The
      investigators propose a clinical trial where the primary aims are: 1. To assess whether an
      algorithm with LUS and procalcitonin (PCT) may be useful for diagnosing bacterial pneumonia;
      2. To analyse the sensitivity and specificity of LUS vs chest radiograph (CXR).
    

Detailed description: 
      Objectives: The general objective is to analyze whether a new algorithm approach of severe
      pneumonia in pediatric intensive unit (PICU) improves the quality of care. Objectives: 1- To
      analyze the sensitivity and specificity of lung ultrasound (LUS) compared respect to the
      chest radiography (CXR) in severe pneumonia and if LUS discriminates between bacterial and
      viral one. 2- If there is a lower CXR indication. 3- If is possible to reduce the dose of
      irradiation and costs associated with CXR. 4- To analyze the interobserver agreement of the
      LUS. 5- determine whether a diagnosis of pneumonia algorithm using LUS and procalcitonin may
      be useful in directing the indication of antibiotic therapy and / or the duration thereof.

      Methodology: clinical, prospective, controlled, randomized, blinded intervention and 3-year
      trial. Inclusion of children under 18 years, with severe pneumonia, who enter (PICU).
      Experimental Group 1: pediatrician researcher (PR) will conduct a LUS at admission time, as a
      first test of lung image; in Group 2, CXR is conduced as first image. Patients will be
      classified into 3 subgroups, in both branches: a) if PCT is <1 ng /L and LUS is not
      suggestive of bacterial pneumonia, no antibiotic will be prescribed; b) if LUS is suggestive
      of bacterial pneumonia, regardless of the PCT, it will be recommended to start antibiotic
      therapy; c) If the ultrasound is suggestive of bacterial pneumonia but PCT is> 1 ng / L,
      antibiotic therapy will be recommended to cover other causes of infection. The same attitude
      will be performed, but depending on the CXR instead of the LUS, in group 2. Clinical
      variables, complementary tests and evolution data will be collected. Statistics by SPPS®
      20.0. Informed consent will be requested and the study will be conducted according to the
      Helsinki Declaration guidelines and Good Clinical Practice.
    

Intervention name(s): Lung ultrasonography (LUS) or Chest X ray (CXR)
Intervention type(s): Diagnostic Test
Intervention description(s): pediatrician researcher (PR) will conduct a LUS or CXR at admission time as a first test of lung image depending on randomized group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: pneumonia; lung ultrasound; biomarkers; procalcitonin; childhood
Development of an Intranasal Proteosome Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A study to compare multiple dosage regimes of a protesomal intranasal vaccine.
    

Detailed description: 
      A Proteosome-adjuvanted trivalent inactivated influenza vaccine (P-TIV) administered
      intra-nasally was shown to be effective, safe, well tolerated, immunogenic - in both systemic
      and mucosal compartments - and effective at preventing influenza illness.

      In two separate studies using the Human Viral Challenge Model, subjects were selected for
      susceptibility to A/Panama/2007/1999 (H3N2) virus and then dosed with one of three regimens:
      (A/New Caledonia/20/1999 (H1N1), A/Panama/2007/1999 (H3N2), B/Victoria/504/2000 or
      B/Shangdong/7/1997) or placebo via a nasal spray. One or two doses were given, 14 days apart,
      before subjects were challenged with ~8.5 x 105 EID¬50 of A/Panama/2007/1999 (H3N2) virus.
      Immune responses to the vaccine antigens were measured, namely serum IgG (via the
      aemagglutination inhibition assay (HAI)) and nasal wash secretory IgA (sIgA) antibodies (via
      ELISA). Viral titres in nasal washes and symptoms of influenza illness were assessed after
      viral challenge and compared.
    

Intervention name(s): Placebo Protesomal Vaccine; Experimental: Protesomal Vaccine 1 x 30 µg; Experimental: Protesomal Vaccine 2 x 30 µg; Experimental: Protesomal Vaccine 2 x 15 µg
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Intranasal vaccine Protesomal Vaccine; Experimental: Protesomal Vaccine 1 x 30 µg; Experimental: Protesomal Vaccine 2 x 30 µg; Experimental: Protesomal Vaccine 2 x 15 µg
Other intervention name(s): Placebo
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Pharmacokinetic Comparability of Benralizumab Using Accessorized Pre-Filled Syringe or Autoinjector in Healthy Volunteers
Condition: Asthma; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, single dose Pharmacokinetic (PK) comparability study to demonstrate comparable
      drug exposure following Subcutaneous benralizumab administration by using accessorized
      pre-filled syringe (APFS) or autoinjector (AI) devices.
    

Detailed description: 
      A study of descriptive comparison of benralizumab PK by weight and injection site.

      This study will be a multicenter, randomized, open-label, parallel group Phase 1 study
      designed to compare benralizumab PK exposure in healthy subjects following single
      subcutaneous (SC) administration of fixed 30 mg dose of benralizumab by using APFS and
      single-use AI. Eligible subjects will be healthy subjects aged 18 to 55 years, with a body
      weight of 55 to 100 kg and a body mass index of 18 to 29.9 kg/m2 . A total of 180 subjects
      will be randomized. Randomization will be stratified by weight group (55 to 69.9 kg, 70 to
      84.9 kg and 85 to 100 kg), and within each of the 3 weight groups, subjects will be
      randomized 1:1:1:1:1:1 to 1 of the 6 combinations of treatment (APFS or AI) with injection
      site (upper arm, abdomen or thigh), presented in Table 1. This study will be performed at 2
      study centers.
    

Intervention name(s): Benralizumab; Benralizumab
Intervention type(s): Biological; Biological
Intervention description(s): A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.; A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Chronic Obstructive pulmonary Disease; Pharmacokinetics; Healthy volunteers
Acupuncture vs. Core Stability Training in Women With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      This study analyse the effectiveness of a core stability training Physiotherapy programme
      versus Acupuncture treatment for the management of balance and functional capacity
      impairments of women with Fibromyalgia.
    

Detailed description: 
      Objective:

      This study investigated the effectiveness of a core stability training Physiotherapy
      programme versus Acupuncture for the management of balance and functional capacity
      impairments of women with Fibromyalgia.

      Design:

      A single-blind randomized clinical controlled trial.

      Setting:

      University of Extremadura and Olivenza Fibromyalgia Association, Spain

      Subjects:

      Women with Fibromyalgia and balance impairment.

      Interventions:

      135 Participants were randomized to a core stability training physiotherapy programme group
      (n=45), an acupuncture treatment group (n=45) and control group (n=45) for 13 weeks.

      Main Measures:

      Measures were taken at baseline (week 0), post intervention (week 6) and at follow up (week
      13). The primary outcome measures were static balance (posturography) and dynamic balance and
      functional mobility (Berg Balance Test, Time Up and Go test and 10-metre walk) and functional
      capacity (Fibromyalgia Health Assessment Questionnaire (FHAQ) and the physical function item
      from the Spanish Fibromyalgia Impact Questionnaire (SFIQ)).The secondary outcome measure were
      quality of life (Spanish- Fibromyalgia Impact Questionnaire), pain, joint stiffness,
      difficulty to work and depression (measured with the visual analogue scale).
    

Intervention name(s): Acupuncture; Physiotherapy
Intervention type(s): Other; Other
Intervention description(s): Acupuncture 5 weeks treatment. 2 sessions a week (30 minutes each session); Core stability exercises programme. 2 sessions a week (30 minutes each session) during 5 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to a core stability training physiotherapy programme group, an acupuncture treatment group and control group for a 13 week study.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: rehabilitation; balance; functional capacity; quality of life; pain; acupuncture
The Effect of Vitamin D Fortification of Bread and Milk in Danish Families
Condition: Healthy
Study type: Interventional

Summary: 
      Approximately 200 families corresponding to 800 persons are included in the study. The study
      investigate the efficacy of vitamin D fortification of bread and milk on vitamin D status in
      serum. Participants receive milk and bread twice a week. Half of the participants receive
      vitamin D fortified products and the other half similar non-fortified products. The study
      starts in September and runs for 6 months during winter, the period where it is not possible
      to produce vitamin D in the skin through sunlight exposure. The hypothesis is that the usual
      fall in vitamin D status can be prevented by vitamin D fortified food.
    


Intervention name(s): Vitamin D fortification
Intervention type(s): Other
Intervention description(s): Bread and milk fortified with vitamin D3
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vitamin D status (serum 25-hydroxyvitamin D)
Drug-drug Interaction Study Beteewn ASK120067 and Rifampicin or Itraconazole
Condition: Locally Advanced or Metastatic NSCLC
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effects of oral administration rifampicin or itraconazole capsules on the
      pharmacokinetics of ASK120067 and its metabolite CCB4580030 in healthy subjects.

      To evaluate the safety of ASK120067 tablets or combination with rifampicin capsules or
      itraconazole capsules in healthy subjects.
    


Intervention name(s): Rifampicin; ASK120067; ASK120067;itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Take ASK120067 tablets orally once on the first day at 160mg in fast condition;Take rifampicin capsules orally once on the days 8 to 17 at 600mg in fast condition, and a combination of 160mg ASk120067 and 600mg rifampicin were administrated on the 15th day in fast condition.; Take ASK120067 tablets orally once on the first day at 80mg in fast condition;Take itraconazole capsules orally twice on the days 8 to 13 at 200mg in fed condition, and a combination of 80mg ASK120067 and 200mg itraconazole were administrated on the 11th day in fast condition.
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Six Months DHEA Treatment in Female Adrenal Failure
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Interventional

Summary: 
      DHEA is an adrenal deriven androgen precourser. The impact of DHEA substitution therapy in
      adrenal failure is unknown as well as the physiologically effects of DHEA is unknown. Effects
      of physiologically DHEA substitution is investigated in the model of female adrenal failure.
    


Intervention name(s): dehydroepiandrosterone (DHEA)
Intervention type(s): Drug
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Bolus Calculator and Wireless Communication With Blood Glucose Meter in Management of Type 1 Diabetes Mellitus (T1DM).
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Bolus calculator (BC) is one of the advanced functions in modern insulin pumps (CSII)models.
      Together with wireless communication with blood glucose meter potentially facilitates
      achieving the target post prandial glucose levels. In this RCT authors assessed whether use
      of wireless communication between compatible devices: MiniMed insulin pump and blood glucose
      meter Contour Link (CL), Bayer results in more frequently bolus calculator using and what is
      the impact of exerting this tool on metabolic control in type 1 diabetic patients.
    

Detailed description: 
      In this RCT 156 patients were randomly assigned to one of the 3 arms: group A- subjects using
      insulin pump bolus calculator wirelessly connected with blood glucose meter, group B-
      subjects using insulin pump bolus calculator without wireless communication with blood
      glucose meter or group C- insulin pump, without bolus calculator function. We compared the
      glycated hemoglobin levels and post- prandial hypoglycaemia after 3 months of observation
      between the groups. We also assessed secondary endpoints (mentioned above).

      Patients were estimated at three time points: at the beginning, after 6 weeks and after 3
      months of intervention. Investigators performed computer reports at each visit, with
      Medtronic CareLink Pro software.
    

Intervention name(s): CSII+BC+CL; CSII+BC
Intervention type(s): Device; Device
Intervention description(s): Insulin pump bolus calculator wirelessly communicated with blood glucose meter (Contour Link); Insulin pump bolus calculator without wireless communication with blood glucose meter (Contour Link)
Other intervention name(s): Insulin pump, bolus calculator, bolus Wizard, Contour Link; Insulin pump, bolus calculator, bolus Wizard
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: diabetes; insulin pump; bolus calculator; Contour Link
Comparison of Outreach Approaches to Increase Enrollment in a Healthy Cholesterol Study
Condition: Diabetes
Study type: Interventional

Summary: 
      This study aims to determine the effectiveness of 4 different recruitment techniques for
      enrollment into a cholesterol study. 2,000 people that meet initial eligibility criteria for
      the study will be randomized into one of 4 groups and will all receive the same recruitment
      letter inviting them to participate in the study by enrolling on an online platform. Group 1
      will receive the recruitment letter in a normal sized envelope, Group 2 will receive the
      recruitment letter in an 8.5 x 11 inch envelope, Group 3 will receive a recruitment letter
      shipped via USPS priority mail and a Group 4 will receive a recruitment letter with the image
      of an Amazon gift card and told they will receive a $25 gift card if they enroll in the
      study. All other groups are told that they will receive a $25 check upon enrollment in the
      study.
    


Intervention name(s): Large Envelope; Priority Mail; Amazon
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Description of an Immune Activation Profile Linked to Insulin Resistance in Subjects Aged 55-69
Condition: Insulin Resistance; Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Insulin Resistance
Study type: Observational

Summary: 
      The aim of the study is to describe an immune activation profile of people at risk of insulin
      resistance based on a wide range of markers which will allow easy identification of patients
      at risk.
    


Intervention name(s): Blood test
Intervention type(s): Other
Intervention description(s): 6ml blood sample taken
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Volunteers aged between 55-69
Trial of Immediate vs. Delayed Cord Clamping in the Preterm Neonate
Condition: PreTerm Birth; PreTerm Neonate
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      To determine the short and long term effects of placental transfusion at birth by milking and
      delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34
      weeks 0 days weeks' gestation.
    

Detailed description: 
      This study is intended to be a randomized controlled trial comparing immediate cord clamping
      which represents the current standard of care at Oklahoma University Medical Center with
      delayed cord clamping among preterm neonates born between 24 weeks and 34 weeks 0 days weeks'
      gestation. Allocation sequence will be generated by simple randomization using random number
      table in the stratum 24-28 weeks 6 days and 29 weeks to 34 weeks 0 days weeks' gestation
      stratum.
    

Intervention name(s): Delayed Cord Clamping; Immediate Cord Clamping
Intervention type(s): Procedure; Procedure
Intervention description(s): Delayed Cord Clamping: 30-35 seconds after birth; Immediate Cord Clamping: within 5 seconds of birth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PreTerm Birth; PreTerm Neonate; High risk pregnancy; Preterm Baby; Premature Baby; Cord Clamping; Milking the cord