bioihbjkbjnl/mcl2 huggingface dataset:
HT-0712 vs. Placebo in Subjects With Age-Associated Memory Impairment (AAMI)
Condition: Age-Associated Memory Impairment (AAMI)
MeSH terms: Memory Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 randomized, multicenter, double-blind, placebo-controlled, parallel-group
      study to evaluate the efficacy of HT-0712 in improving memory and cognitive performance in
      subjects with Age-Associated Memory Impairment (AAMI)
    


Intervention name(s): HT-0712; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bionic Pancreas in Children With Hyperinsulinism and Post-Pancreatectomy Diabetes
Condition: Hyperinsulinism; Diabetes; Pancreatic Diseases; Pancreatectomy; Hyperglycemia
MeSH terms: Pancreatic Diseases; Diabetes Mellitus; Hyperglycemia; Hyperinsulinism
Study type: Interventional

Summary: 
      This is a pilot study designed to determine if the bihormonal bionic pancreas provides
      improved blood glucose control, compared to the current standard of care, in individuals with
      hyperinsulinism who developed diabetes after having a pancreatectomy.
    

Detailed description: 
      The management of diabetes following pancreatectomy for hyperinsulinism (HI) generally
      consists of the same approaches that are used for individuals with type 1 diabetes (T1D).
      However, there are significant differences in individuals with HI and post-pancreatectomy
      diabetes that increases the risk of hypoglycemia in these individuals and prevent achieving
      tight glycemic control. Individuals with HI have glucagon deficiency and unlike T1D, those
      with HI and post-pancreatectomy diabetes have residual dysregulated insulin secretion that
      results in marked hypo- and hyper-glycemia. Furthermore, pancreatic insufficiency can result
      in disturbances in nutrient absorption and fluctuations in glucose concentrations.

      Current treatment approaches with intermittent subcutaneous insulin administration or insulin
      pump therapy offer inadequate glycemic control in these individuals. We propose a novel
      approach to the management of these individuals with the bihormonal bionic pancreas to
      replace both hormones, insulin and glucagon, through an automated glycemic management system.
    

Intervention name(s): Bihormonal Bionic Pancreas
Intervention type(s): Device
Intervention description(s): A 4-day inpatient admission in which subjects will wear the bihormonal pancreas. The bihormonal pancreas will be placed upon admission and there will be 1 day of run-in. This will be followed by 3 days of data collection for comparison with the data obtained from the standard of care during the control admission.
Intervention MeSH terms: Pancrelipase
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be an open-label, pilot clinical trial to assess efficacy and safety of the bihormonal bionic pancreas in children and young adults with HI who have developed post-pancreatectomy diabetes. Subjects will be studied during two research inpatient admissions at the CHOP HI Center. The order of the interventions will be randomized.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Post-Pancreatectomy Diabetes; Insulin Therapy
Bioequivalence Study of Azelastine Hydrochloride/ Fluticasone Propionate 137 Microgram/50 Microgram Nasal Spray and Dymista Nasal Spray
Condition: Seasonal Allergic Rhinitis; Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 1

Summary: 
      Single dose (four sprays) bioequivalence study of Azelastine Hydrochloride/ Fluticasone
      Propionate 137 microgram/50 microgram Nasal Spray and 'DYMISTA' (Azelastine
      Hydrochloride/Fluticasone Propionate) Nasal Spray 137 microgram/50 microgram in healthy adult
      human subjects.
    


Intervention name(s): Azelastine Hydrochloride/ Fluticasone propionate nasal spray; 'DYMISTA' NASAL SPRAY
Intervention type(s): Drug; Drug
Intervention description(s): A single dose [four sprays (two sprays in each nostril)] of Azelastine HCL/ Fluticasone Propionate 137 mcg/50 mcg Nasal Spray; A single dose [four sprays (two sprays in each nostril)] of 'DYMISTA' (AZELASTINE HYDROCHLORIDE/ FLUTICASONE PROPIONATE) NASAL SPRAY 137 Microgram/50 Microgram
Intervention MeSH terms: Fluticasone; Xhance; Azelastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
To Evaluate the Safety and Tolerability of Multiple Doses of GS3-007a Oral Solution in Healthy Subjects.
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of GS3-007a oral solution after multiple oral
      administration in Chinese healthy adult subjects.
    

Detailed description: 
      To evaluate the pharmacodynamic (PD) and pharmacokinetics（PK） characteristics of GS3-007a
      oral solution after multiple oral administration in Chinese healthy adult subjects
    

Intervention name(s): GS3-007 oral liquid
Intervention type(s): Drug
Intervention description(s): The dosage was calculated according to body weight, once a day or twice a day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban
Condition: Nasal Polyps; Asthma, Aspirin-Induced; Aspirin-exacerbated Respiratory Disease; Aspirin-Sensitive Asthma With Nasal Polyps
MeSH terms: Asthma; Respiratory Tract Diseases; Respiration Disorders; Nasal Polyps; Asthma, Aspirin-Induced; Polyps
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall aim of the study is to determine the efficacy of oral ifetroban, a novel
      antagonist of T prostanoid (TP) receptors, as a treatment for patients with
      aspirin-exacerbated respiratory disease (AERD).
    

Detailed description: 
      The protocol involves a 4-week, double-blind, placebo-controlled parallel-design trial of
      oral ifetroban in patients with AERD. At the end of the 4-week treatment phase (ifetroban or
      placebo) each subject will undergo a graded oral aspirin desensitization procedure in order
      to initiate high-dose aspirin therapy, which is standard-of-care at our institution and is
      the only available therapy known to modify the course of AERD.
    

Intervention name(s): Ifetroban; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD; 4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD
Other intervention name(s): ifetroban sodium
Intervention MeSH terms: Ifetroban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Childhood Body Composition and Brain Structure and Function
Condition: Healthy
Study type: Observational

Summary: 
      The specific aim of this research project is to use MRI methods to evaluate and compare brain
      structure and function in normal weight and obese children age 8-10 years.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy normal weight or obese children (age 8-10 years)
A Safety and Efficacy Study of ChAd63/MVA METRAP + RTS,S
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a clinical trial in which healthy volunteers will be administered experimental
      malaria vaccines. One group of volunteers will receive vaccination with the leading malaria
      vaccine candidate, RTS,S/AS01. This vaccine schedule will consist of 3 doses of RTS,S/AS01
      with an interval of 4 weeks between doses (Doses given at 0,4 and 8 week timepoints). Another
      group will receive a vaccination schedule composed of the same dosage and timing regimen of
      RTS,S, but they will also receive vaccination with ChAd63 ME-TRAP, 2 weeks after the first
      RTS,S followed 8 weeks later by vaccination with MVA ME-TRAP (2 and 10 week timepoints).

      The study will assess the safety of the vaccinations, and the immune responses to
      vaccination. Immune responses are measured by tests on blood samples. Volunteers will be
      infected with malaria by mosquito bites, 12 weeks after the first vaccination. In addition, a
      group of volunteers not receiving vaccines will also be infected with malaria by the same
      method. These infection experiments will be used to assess vaccine efficacy: how well the
      vaccines act to prevent malaria disease. A further single volunteer may also be infected with
      malaria; this volunteer participated in a previous trial where they received vaccines and was
      completely protected against malaria disease after infection by mosquito bite.

      The RTS,S/AS01 vaccine is a protein (RTS,S) mixed with an adjuvant (AS01). The ChAd63 ME-TRAP
      and MVA ME-TRAP vaccines are called viral vectored vaccines. They are made from viruses which
      are modified so that they can not multiply. The viruses have extra DNA in them so that after
      injection, the body makes malaria proteins (but malaria does not develop), so that the immune
      system builds a response to malaria without having been infected by it.

      Healthy volunteers will be recruited in England at three research sites: in Oxford, London
      and Southampton.
    


Intervention name(s): RTS,S/AS01B; ChAd63 ME-TRAP; MVA ME-TRAP
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Each RTS,S/AS01B dose will be given intramuscularly, and will contain 50mcg of RTS,S and standard adult dose of AS01; ChAd63 ME-TRAP will be given intramuscularly at a dose of 5 x 1010 vp; MVA ME-TRAP will be given intramuscularly at a dose of 2 x 108 pfu
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Plasmodium Falciparum; Malaria; Vaccine; Plasmodium; Falciparum
Effect of Vestibular Rehabilitation - a Randomized Controlled Trial
Condition: Dizziness; Nausea; Nystagmus; Vestibular Diseases
MeSH terms: Vertigo; Vestibular Diseases; Nystagmus, Pathologic; Nausea; Dizziness
Study type: Interventional

Summary: 
      The aim of this study is to assess if early supported vestibular rehabilitation can reduce
      dizziness and improve daily life activities in patients with acute vestibular injury.

      The study question is: Does early supported vestibular rehabilitation have an additional
      effect on dizziness symptoms and daily life functions compared to standard treatment?
    


Intervention name(s): Vestibular rehabilitation; standard treatment
Intervention type(s): Behavioral; Other
Intervention description(s): Daily home training (4-6 specific exercises) 2-3 times per day. Group training led by a physiotherapist twice per week during the first 10 weeks and once per week from 10 weeks to 12 months or to symptoms are cured.; treatment as usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vestibular rehabilitation; acute vestibular injury; Dizziness; Nausea; Nystagmus; Daily life activities; Balance; physiotherapy
Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
Condition: Hand Dermatoses
MeSH terms: Dermatitis; Skin Diseases; Hand Dermatoses
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid,
      on severe, therapy refractory chronic hand dermatitis.
    

Detailed description: 
      Chronic hand dermatitis (CHaD) is a frequent and distressing disease. Conventional treatments
      yield mostly unsatisfactory results. In addition, chronic hand dermatitis leads to 2-5% of
      all applications for permanent disability pensions in some western countries. In a
      therapeutic dose finding study alitretinoin was clinically effective for patients with
      moderate to severe chronic hand dermatitis refractory to topical treatment.

      Patients with severe refractory CHaD will be allocated either of two active treatments or
      placebo. The primary objective is to demonstrate the response rate based on physicians global
      assessment of the disease.
    

Intervention name(s): alitretinoin
Intervention type(s): Drug
Intervention MeSH terms: Alitretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chronic Hand Dermatitis
Social Cognitive Development in Young Children With Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Through the development of a novel treatment targeting core Autism Spectrum Disorder (ASD)
      social deficits and studying the efficacy of this intervention, the investigators hope to
      provide a means for children with ASD to more effectively and efficiently process social
      information and enable them to more successfully engage in social interactions. Children
      between the ages of 24 and 36 months and their families may join.
    


Intervention name(s): Social Enhancement Intervention; Parent Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention will be conducted at our center and focuses on providing an invigorating learning environment in which emerging social skills/knowledge are the focus of intervention with the aim of bringing them to a higher level of maturity, integrated with existing abilities, and used functionally. Learning with and through peers, provides the opportunity to address abnormal peer relationships for developmental level. Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement we offer the children robust learning experiences. Parent training sessions will focus on strategies aimed at improving child social engagement and communication.; Parent education sessions will focus on topics related to autism, learning styles, interventions, and resources. The curriculum provides parents with information about child development and autism as well as instructional strategies (e.g., responsive teaching strategies, principles of applied behavior analysis) for use at home to enhance their children's communication, engagement, and play development. Concrete examples for home-based implementation are presented. Each week, homework will be given and parents will be encouraged to practice the strategies daily at home. No direct coaching to parents during interaction with their children or direct intervention with the child will be provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; language; social; toddlers
Bioequivalence Study of Two Formulations of Pramipexole Tablets 0.25 mg
Condition: Healthy
Study type: Interventional

Summary: 
      The present study was conducted to find out whether the bioavailability of 0.25 mg
      pramipexole tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals was
      equivalent to the reference drug (Sifrol® tablet 0.25 mg, Boehringer Ingelheim Pharma GmbH &
      Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany).
    

Detailed description: 
      This was a randomized, open label, two-period, two-sequence, crossover study under fasting
      condition. The participating subjects were required to have an overnight fast and in the next
      morning were given orally one tablet of the test drug (Pramipexole 0.25 mg produced by PT
      Dexa Medica for PT Ferron Par Pharmaceuticals) or one tablet of the reference drug (Sifrol®
      0.25 mg, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany for Boehringer Ingelheim
      International GmbH, Germany).

      Blood samples were drawn immediately before taking the drug (control), at 20, 40 minutes, and
      1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours after drug administration. Seven
      days after the first drug administration (washout period), the procedure was repeated using
      the alternate drug. The plasma concentrations of pramipexole were determined by validated
      ultra performance liquid chromatography with mass spectrometry detector (UPLC-MS/MS).
    

Intervention name(s): Pramipexole Dexa Medica; Pramipexole Boehringer Ingelheim Pharma
Intervention type(s): Drug; Drug
Intervention description(s): Pramipexole 0.25 tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals as the test drug.; Pramipexole 0.25 tablets produced by Boehringer Ingelheim Pharma GmbH & Co.KG for Boehringer Ingelheim International GmbH as the reference drug.
Other intervention name(s): Sifrol®
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pramipexole; Bioequivalence; Pharmacokinetics
Phenotypic and Genetic Correlates of Diabetes (Non-Type 1) in Young Non-Obese Asian Indians in North India and A Study to Evaluate the Efficacy of Sitagliptin (DPP-4 Inhibitor) in a Sub-group of the Study Population
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase IV study of 3.5 years duration to evaluate the phenotypic and genetic
      correlates of diabetes (non-Type 1 in young non-obese Asian Indians in North India and pilot
      case control study to evaluate the efficacy of sitagliptin (DPP-4 inhibitor) in a sub-group
      of the study population.
    

Detailed description: 
      A phase IV on T2DM with BMI < 25 kg/m2 and age 14-40 years.

      Primary Objectives:

        -  To investigate phenotype (body composition, anthropometry, pancreatic imaging and
           endocrine function, insulin resistance, autoantibodies, and other biochemical variables)
           and genetic (known mutations and polymorphisms) correlates in young (age 14-40 years)
           diabetic patients (non-type 1).

      Secondary Objectives:

        -  To study anthropometric and body fat distribution including truncal fat, subcutaneous
           and intra-abdominal fat in non-obese young patients with diabetes (non-type 1).

        -  To study whether insulin secretion, insulin resistance or a combination of both is/are
           the predominant defect(s) in non-obese young diabetics (non-type 1).

        -  To study the prevalence of autoimmunity and/or specific genetic abnormalities in this
           subgroup of diabetics.

        -  To estimate approximate prevalence of diagnostic subcategories based on the sample of
           population, and profile of complications in each category.

        -  To propose rational use of specialized investigations (e.g. GAD65, HNF-1α mutations etc)
           while investigating a newly diagnosed young diabetic.

        -  To determine the rational therapeutic option and prognosis in this sub-population of
           diabetics based on anthropometric, biochemical, and etiological profiles.

        -  Sample size: 205 patients to be enrolled and 120 patients to be enrolled for sub group
           study
    

Intervention name(s): Metformin; Lifestyle modification
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Maturity onset diabetes of the young 3 protein, human
Role of Recombinants in Peach Allergy
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Observational

Summary: 
      This study is aimed at verifying the role and the efficacy of the recombinants allergens Pru
      p 1, Pru p 3 and Pru p 4, Bet v 1, Bet v 2 and Bet v 4 in the diagnosis of peach allergy
    

Detailed description: 
      This study intend to verify whether the different levels of severity of the clinical allergic
      reactions to peach are associated to sensitization towards different allergenic molecules of
      peach. In particular, we will analyze the reactivity towards the peach allergens Pru p 1, Pru
      p 3 and Pru p 4 and towards the birch pollen allergens Bet v 1, Bet v 2 and Bet v 4. The
      patients (with allergic symptoms of any severity provoked by the consumption of peach) will
      be divided into two groups: the first group showing oral allergy syndrome (OAS), the second
      group showing systemic symptoms of different severity, up to anaphylaxis.

      All the patients will be submitted to: complete clinical investigation; skin prick test with
      a panel of common food/inhalant commercial extracts; skin tests by the "prick + prick" method
      with fresh fruits and vegetables; skin prick test with purified peach LTP (Pru p 3) The sera
      of the patients will be used for: immunoblotting with peach extract and immunoblotting
      inhibition with purified natural Pru p 3 and, if possible, recombinant Pru p 3, Pru p 1 and
      Pru p 4, using a pool of selected sera; CAP system with a predetermined panel of fruit and
      vegetable allergens; CAP system with recombinant allergens of peach and birch pollen: Pru p
      3, Pru p 1 and Pru p 4 for peach, Bet v 1, Bet v 2 and Bet v 4 for birch pollen. Finally, a
      statistical analysis will be carried out in order to verify if the two groups of patients
      will show significant differences in the allergens recognized. The results of this study will
      be a property of the Unit of Allergology and Immunology as stated by DM 17/2004 and will be
      presented as written publication or oral presentation at National and/or International
      Congresses of Allergy and Immunology, quoting the PHADIA company
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Peach allergic subjects at major risk of anaphylaxis
      
Biospecimen description: 
      Blood sample
    
Keywords: allergy, peach, birch; recombinants allergens diagnosis; OAS; LTP; systemic reactions; subjects with severe reaction to other fruits