bioihbjkbjnl/mcl2 huggingface dataset:
Managerial Database II
Condition: Acquired Immunodeficiency Syndrome
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Observational

Summary: 
      This study will collect information on health status and risk behaviors, as well as basic
      demographic and biomedical information for a group of HIV positive adolescents receiving care
      at sites newly participating in ATN III.
    

Detailed description: 
      The proposed study is a cross sectional study intended to be conducted at each of the
      Adolescent Medicine Trials Units (AMTUs) newly participating in ATN III and to enroll all
      participating patients followed at each site. This approach will allow for the examination of
      the broad spectrum of youth participating in the ATN, including those newly entered into
      care.

      Psychosocial and risk-taking behavioral data will be collected using Audio Computer-Assisted
      Self-Interview (ACASI) for English-speaking participants, or a paper-and-pencil
      Spanish-language survey with identical measures to the ACASI for Spanish-speaking
      participants; biomedical information will be collected through medical chart abstraction.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All HIV-infected adolescents and young adults engaged in care at sites newly participating
        in ATN III and their affiliates who are between 12 and 24 years of age, inclusive, are
        aware of their HIV status and understand written and/or verbal English will be eligible for
        inclusion in the study. In addition, new patients who have their initial clinic visit
        within the enrollment period will also be eligible for participation
      
Keywords: Medication adherence; Substance use; Sexual risk behaviors
Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      This study will investigate the longitudinal efficacy of two experimental oral rinses
      containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX), formulated at pH
      4.5 and pH 7 respectively, for the relief of dentinal hypersensitivity (DH), compared to a
      placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride
      toothpaste.
    


Intervention name(s): Experimental Oral Rinse 1; Experimental Oral Rinse 2; Placebo Oral Rinse; Standard fluoride toothpaste
Intervention type(s): Device; Device; Other; Drug
Intervention description(s): (1.5% w/w KOX, pH 4.5); (1.5% w/w KOX, pH 7); (0% w/w KOX, pH 4.5); 1000ppm fluoride as sodium monofluorophosphate
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
DOCICAR: Cardiac Dysfunction in Cirrhosis
Condition: Cirrhosis; Cirrhotic Cardiomyopathy
MeSH terms: Liver Cirrhosis; Cardiomyopathies; Fibrosis
Study type: Observational

Summary: 
      Patients with cirrhosis have a altered cardiac response to stress. This study evaluate the
      cardiac response by MRI during dobutamine stress. Hypothesis: impared increase in cardiac
      output, cardiac index, ejection fraction.
    


Intervention name(s): Dobutamine
Intervention type(s): Drug
Intervention MeSH terms: Dobutamine
Time perspective: Prospective
An Integrated Intervention to Reduce Secondhandsmoke in Children
Condition: Secondhand Exposure; Smoking Status
Study type: Interventional

Summary: 
      This is a community essay to assess the effectiveness of a multi-level (individual, family,
      and school) school-based intervention to prevent the exposure to secondhand smoke (SHS) in a
      population of 1,734 schoolchildren (12-14 years old) in Terrassa (Catalonia, Spain). Schools
      were assigned to the intervention or the controlgroup at random. The investigators assessed
      SHS exposure in different settings (at school, at home, on transportation and leisure time)
      and tobacco consumption by means of a questionnaire before and one year after the
      intervention. Based on a previously evaluated intervention to prevent smoking initiation
      (PASE/ESFA program) the investigators designed a new intervention (the RESPIR•NET Program)
      including two new activities to prevent passive smoking to be applied at three levels: in the
      classroom (pupils), at the school (pupils, teachers, and parents), and in the family (pupils
      and parents).
    


Intervention name(s): RESPIRNET Program
Intervention type(s): Behavioral
Intervention description(s): The intervention at the classroom consisted of six sessions with the pupils of one hour each that were conducted by the teacher/tutor. We provided the teachers with a training session and a teachers' guide, and we gave each pupil a workbook with the activities. At the school level, the intervention consisted of four types of posters with specific messages directed to students, teachers, and parents, and the fourth poster type advertised the new smoking laws. we gave teachers and school managers the guide "Towards a Smoke-Free School" to facilitate the prevention and control of smoking (active and passive) in the school environment. Family level activities: Parents were required to complete the "My risk thermometer" activity at home with their children. Parents received a brochure with information on the risks of SHS exposure and recommendations to prevent SHS exposure, and a refrigerator magnet with the logo of the program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: tobacco smoke pollution; Tobacco use
Clinical and Biochemical Effects of Multipass Hemodialysis
Condition: Uremia
MeSH terms: Uremia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate whether recycled dialysis fluid can supply enough
      clearance for hemodiaysis patients.
    

Detailed description: 
      Conventional hemodialysis uses large amounts of water, which hinders travel possibilies for
      home hemodialysis (HD) patients. We have developed a recycling system using 25-30 l dialysate
      per dialysis. In vitro investigations show that this results in adequate dialysis.

      12 HD patients will be studied during two dialysis sessions. The first HD will be a
      conventional 4 hour dialysis, using single pass dialysate. The second will be an 8-hour HD
      using multipass (recycled) dialysate 25-30 l. Clearance of urea, creatinine, phosphate and
      cobalamin will be measured both in the patient and the dialysate. Patient symptoms will be
      recorded.
    

Intervention name(s): Multipass hemodialysis
Intervention type(s): Device
Intervention description(s): 8-hour dialysis using a recycled dialysis bath of 25-30 l
Other intervention name(s): dialysis; hemodialysis; dialysate
Intervention MeSH terms: Dialysis Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dialysis; hemodialysis; Effect of recycled low-volume dialysate on dialysis efficacy
Bioequivalence of Ethylenediamine Dihydrochloride Study
Condition: Allergic Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when
      prepared using methylcellulose versus preparation using polyvinylpyrrolidone.
    

Detailed description: 
      We propose an open, prospective, single-site study to evaluate the bioequivalence of
      ethylenediamine dihydrochloride in methylcellulose (MC)and polyvinylpyrrolidone (PVP)
      formulations. Bioequivalence will be determined in minimum of 15 adult subjects, with a
      clinical history of contact dermatitis and a positive patch test (current or previous) to
      ethylenediamine ("sensitives").
    

Intervention name(s): Ethylenediamine dihydrochloride allergen patch
Intervention type(s): Drug
Intervention description(s): 1 allergen panel containing 2 allergen and 2 control patches
Other intervention name(s): T.R.U.E. Test allergen ethylenediamine dihydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: ethylenediamine dihydrochloride
A Study of Two Different Test Formulations Compared to the Reference Formulation of Macitentan in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the rate and extent of absorption of a single oral
      dose of macitentan given as 2 test formulations compared to the reference formulation under
      fed conditions in healthy adult participants.
    


Intervention name(s): Macitentan
Intervention type(s): Drug
Intervention description(s): Macitentan film coated tablets will be administered orally as per assigned treatment sequence.
Other intervention name(s): Opsumit
Intervention MeSH terms: Macitentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
AQUApay (AQUA Predictive Ability in Youths): Study on the Predictive Ability of the Questionnaire AQUA© in Children and Adolescents
Condition: Young Athletes
Study type: Observational

Summary: 
      Allergic diseases like asthma, rhinitis, conjunctivitis and dermatitis are very frequent in
      athletes, even if those complaining allergic symptoms do not always receive a medical
      diagnosis. Many athletes already start competitive sport activities in pediatric age, but
      allergy screening tests are usually not performed when assessing eligibility to sport
      practice. Therefore, the objective of the present study is assessing the predictive ability
      of the Allergy Questionnaire for Athletes (AQUA©), pediatric version, to predict the atopic
      status in young athletes.
    


Intervention name(s): Questionnaire AQUA©, pediatric version
Intervention type(s): Diagnostic Test
Intervention description(s): A version of AQUA© recently adapted and pretested in young athletes. It is a self-administered questionnaire composed of 25 items includes items about type, duration and intensity of training sessions, allergic status, habits of children (supplements and drugs intake) and their parents (smoking), presence and burden of infections.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Athletes aged 7 to 14 years old, recruited from several sport associations located in the
        city of Palermo (Italy).
A Study to Evaluate the Immune Response and Safety of a Seasonal Virus-Like Particle Influenza Vaccine in Healthy Young Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the immune response of three dose levels of the
      Novavax Quadrivalent vaccine in healthy young adults (18-64). The study is broken down into 5
      treatment groups. Each group will enroll 100 subjects, for a total of 500 subjects. Group 1-3
      will receive one of three dose levels of the Novavax Quadrivalent vaccine, Group 4 will
      receive a dose of the Novavax Trivalent vaccine, and Group 5 will receive a commercially
      available trivalent influenza vaccine (TIV). The study will also evaluate the safety and
      tolerability of the Novavax Quadrivalent vaccine.
    


Intervention name(s): Novavax Quadrivalent vaccine; Novavax Quadrivalent vaccine; Novavax Quadrivalent vaccine; Novavax Trivalent vaccine; cTIV
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Quadrivalent VLP vaccine: low dose; intramuscular injection, deltoid; Quadrivalent VLP vaccine: medium dose; intramuscular injection, deltoid; Quadrivalent VLP vaccine: high dose; intramuscular injection, deltoid; Trivalent Dose; intramuscular injection, deltoid; Preconfigured dose; intramuscular injection, deltoid
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bioequivalency Study of 300 mg Lithium Carbonate Under Fasting Conditions
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg
      extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release
      tablet under fasting conditions using a single-dose, randomized, 2 treatment, 2-period,
      2-sequence crossover design.
    


Intervention name(s): Lithium
Intervention type(s): Drug
Intervention MeSH terms: Lithium Carbonate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom
Condition: Chronic Obstructive Pulmonary Disease; Asthma
MeSH terms: Asthma; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to assess the effectiveness for small airway inflammation of 4
      weeks lysozyme administration in Chronic Obstructive Pulmonary Disease (COPD) and/or asthma.
    


Intervention name(s): lysozyme 90 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication); Lysozyme Matching Placebo three times daily for 4 weeks followed by Lysozyme 90 mg three times daily for 4 weeks (plus usual COPD medication)
Other intervention name(s): PRT10T; PRT10T
Intervention MeSH terms: Muramidase
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD; Asthma; Lysozyme Hydrochloride
Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients
Condition: Critical Limb Ischemia (CLI); Diabetes
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A prospective, multicenter, open, randomized, parallel-group controlled study for two levels
      of dose.

      The study population will consist of 30 non-diabetic patients with critical chronic ischemia
      in at least one of the lower limbs (CLI) and without possibility of revascularization, from
      whom results can clinically be evaluable, of whom, 20 patients will be included in the
      experimental group (10 for each dose level) and 10 in the control group.

      In each of the two dose levels to be used in the study, 15 patients will be included, who
      will be randomized to the experimental group or the control group according to a distribution
      2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level,
      we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose
      tissue) and 5 patients in the control group (conventional treatment)
    


Intervention name(s): Autologous adipose derived mesenchymal stem cells
Intervention type(s): Drug
Intervention description(s): Intra-arterial administration through a selective cannulation of target common femoral artery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Critical Limb Ischemia (CLI); Diabetes; Mesenchymal Stem Cells; Regenerative Therapy
Hip Denervation in Juvenile Idiopathic Arthritis With Hip Arthritis
Condition: Juvenile Idiopathic Arthritis; Hip Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients having juvenile idiopathic arthritis (according to ILAR criteria) with hip arthritis
      were divided into 3 groups. Group 1 received hip denervation and group 2 controlled and
      received a subcutaneous injection of saline, and group 3 received intra-articular
      triamcinolone. Outcome measures included pain, tenderness, range of motion, SOLAR, HARISS
      score. These outcomes were measured at baseline, 2 weeks, and 16 weeks
    

Detailed description: 
      The aim of the study is to test the effect of denervation of the active hip in JIA and
      compare it with a placebo without changing systemic treatment during the study. Outcome
      measures included pain, range of motion, SOLAR score, and Harris functional score.
    

Intervention name(s): Lidocaine; Placebo; Steroid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): denervation of the obturator and femoral genicular branches by Lidocaine 2 %; an equivalent amount of saline will be injected subcutaneously in 2 points similar to the active group; Intra-articular injection of 80mg of triamcinolone
Other intervention name(s): The active denervation group; The control group; The active steroid group
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparative Study of 3 Dose Regimens of BioChaperone to Becaplermin Gel for the Treatment of Diabetic Foot Ulcer
Condition: Diabetic Foot Ulcers
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open-label, active-control, multicentre, parallel group, randomised and
      dose-finding efficacy and safety study.

      Compare the efficacy and safety of BioChaperone PDGF-BB applied at 12.5 µg/cm² every two days
      for up to 20 weeks to becaplermin gel (Regranex® Gel 0.01%) applied daily for up to 20 weeks
      for the treatment of neuropathic diabetic foot ulcer.

      Assess the effect of a double dose of BioChaperone PDGF-BB (25 µg/cm²) applied every two days
      for up to 20 weeks.
    

Detailed description: 
      After the screening visit, the eligible patient population randomly receive one of the three
      following topical drugs:

        -  BioChaperone™ PDGF-BB 12.5 µg/cm²/application for 20 weeks,

        -  BioChaperone™ PDGF-BB 25 µg/cm²/application for 20 weeks, or

        -  BioChaperone™ PDGF-BB 4 µg/cm²/application for 20 weeks, or

        -  Beclapermin gel 6.25 µg/cm²/application for 20 weeks.

      The assessment schedule for all the four groups is weekly once (7 day duration) till the 8th
      week (visit 10) and once in two weeks (14 day duration) thereafter till the end of study. The
      maximum number of visits expected is 16. The study data is presented at the end of 20 weeks.
    

Intervention name(s): Biochaperone PDGF-BB Low dose; Biochaperone PDGF-BB High dose; Regranex; Biochaperone PDGF-BB Very Low Dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): BioChaperone PDGF-BB low dose is applied as a spray every two days at the dose of 12.5 µg/cm2 for up to 20 weeks; BioChaperone PDGF-BB high dose is applied as a spray every two days at the dose of 25 µg/cm2 for up to 20 weeks; Regranex gel is applied once daily at the dose of 6.25 µg/cm2 for up to 20 weeks; BioChaperone PDGF-BB Very Low Dose sprayed on the wound every two days (e.g., Mondays, Wednesdays and Fridays) for 20 weeks or until complete wound healing, at the dose of 4 µg/cm²/application
Other intervention name(s): BC low dose; BC high dose; Becaplermin; BC Very low dose
Intervention MeSH terms: Becaplermin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rhPDGF, diabetic foot ulcer,
A Study to Evaluate Once Daily Low Dose and High Dose Solabegron or Placebo Given for 12 Weeks to Treat Women With Symptoms of Overactive Bladder: Sudden Urge to Urinate, Frequent Urination Associated With Wetting Episodes (VEL-2001)
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group
      study designed to evaluate the efficacy, safety, and tolerability of solabegron modified
      release low dose or high dose tablets, compared to matched placebo, administered once daily
      for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency,
      and predominantly urgency incontinence) for at least 6 months.
    


Intervention name(s): Solabegron modified release tablets, low dose; Solabegron modified release tablets, high dose; Matching Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.; Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.; Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.
Intervention MeSH terms: Solabegron
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Eligible female subjects (N=1200) with symptoms of overactive bladder for at least 6 months will enter a 14-day single-blind Run-in Period. Subjects (N=375) who meet prespecified criteria based on data entered into an electronic diary over 3 days will be randomized 1:1:1 (125 subjects per arm) to receive solabegron modified release tablets, low dose or high dose, or matching placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: overactive bladder; urinary conditions; urgency urinary incontinence; urgency; micturitions
Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions
Condition: Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a comparative study to assess bioavailability of a proposed alternate dosage form
      against the current FDA-approved branded product.
    


Intervention name(s): Dronabinol Capsules, 5 mg; Dronabinol Oral Solution
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of different routes of administration of a drug using the approved Abbott 5 mg capsule product under fasting conditions; two treatment periods with a washout period separating the study periods; Comparison of different routes of administration of a drug using a proposed oral solution formulation under fasting conditions; two treatment periods with a washout period separating the study periods
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Dronabinol; fasting