bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      To provide open-label re-treatment with PROCHYMAL to subjects enrolled in companion Protocol
      603 to evaluate the safety in subjects with active Crohn's disease who are resistant to
      standard Crohn's disease therapies.
    

Detailed description: 
      Subjects will receive infusions of PROCHYMAL on Day 42, Day 84, and Day 126 after initial
      infusion of PROCHYMAL in Protocol 603. Each infusion will contain 200 million cells. As
      subjects will be required to be in Protocol 603 during the entire duration of their
      participation in Protocol 611, all concomitant medication and safety information will be
      monitored by Protocol 603 and the combination of data from the two protocols
    

Intervention name(s): adult human mesenchymal stem cells
Intervention type(s): Drug
Intervention description(s): PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603.
Other intervention name(s): Prochymal; remestemcel-L
Intervention MeSH terms: Remestemcel-l
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's Disease; Adult Stem Cell Therapy; inflammation of the gastrointestinal tract
Infectivity, Replication & Immunogenicity of Live nH1N1 Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine the amount of live virus that can be recovered from
      the nose of people who are vaccinated with the licensed live vaccine against H1N1, and to
      describe the immune response to vaccination.
    

Detailed description: 
      By looking at the immune response before and after vaccine, we hope to understand the factors
      that determine the immune response and detailed shedding patterns of live novel H1N1 vaccine.
    

Intervention name(s): A/California/07/09 live monovalent H1N1 vaccine
Intervention type(s): Biological
Intervention description(s): 0.1mL per nares intranasally, second identical dose given 28 days after first vaccine
Other intervention name(s): Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Swine Flu; H1N1
Daily Magnesium-supplement for Severe Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The present study is part of a project titled 'Magnesium in asthma and chronic obstructive
      pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement
      will benefit patients with asthma and chronic obstructive pulmonary disease.

      The aim of this part of the project is to reveal possible beneficial effects of daily
      magnesium supplement for severe asthmatics, refractory to conventional treatment.
    


Intervention name(s): Mablet (Magnesium-supplement); Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 3 tablets daily for 12 weeks of Mablet (360 mg magnesium hydroxide/ -oxide) Produced by: Gunnar Kjems APS; 3 placebo tablets daily for 12 weeks
Other intervention name(s): Mablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Steroid-resistant; Severe asthmatics; Annual symptoms; Daily magnesium supplement; ACT (asthma control test)
Gamified Fitness Training to Promote Children's Physical Activity
Condition: Physical Activity Levels
Study type: Interventional

Summary: 
      The study aimed to introduce gamified physical fitness training in health education with the
      goal of enhancing physical activity levels and assessing its feasibility within a small-scale
      context involving 11-12-year-old children.
    

Detailed description: 
      A cluster experimental design was conducted in a small-scale context of school children.
      Participants were recruited by inviting two elementary schools located in the same district
      area for testing the physical fitness training effects. Two schools were randomly assigned to
      either the training group (TG; n = 47) receiving physical fitness training or the control
      group (CG; n = 44) without the training. Through a three-step process, gamified physical
      fitness training was developed by a multidisciplinary team from the TG school. PA outcome
      indicators were assessed using AI-wireless sensors attached to participants' wrists over 12
      weeks. Participants' satisfaction was used to assess the feasibility of implementing gamified
      physical fitness training in health education classes. Data collection occurred during school
      days for one week at three-time points: the first week (T1), 6th week (T2), and the 12th week
      (T3). Generalized estimating equation statistics were used to assess the program effects.
    

Intervention name(s): physical fitness training
Intervention type(s): Other
Intervention description(s): Through a three-step process, gamified physical fitness training was developed by a multidisciplinary team.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
The Influence of Reducing Diets on Changes in Thyroid Parameters in Obese Women With Hashimoto's Disease
Condition: Hashimoto Disease; Obesity
MeSH terms: Obesity; Hashimoto Disease
Study type: Interventional

Summary: 
      Hashimoto's disease is listed among the most common endocrine causes of obesity. As treatment
      of obesity in women with Hashimoto's disease is frequently unsuccessful, the aim of this
      study was to evaluate the effectiveness of two different reducing diets and their influence
      on changes in thyroid parameters in the female patients. A six-month
      observational/interventional study was performed on 100 women aged 18-65 years, previously
      diagnosed with Hashimoto's disease and obesity and receiving L-thyroxine. The women were
      randomly assigned to the test group (group A, n=50) following elimination/reducing diets, and
      the control group (group B, n=50) following reducing diets with the same caloric content
      (without elimination). Anthropometric and thyroid parameters were evaluated at the beginning,
      after 3 months and after 6 months of treatment.
    


Intervention name(s): Individually balanced elimination/reducing diets; Individually balanced reducing diets (without elimination)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants received diets in the range of 1400-1600 kcal/day (with a deficit of about 1000 kcal/day, depending on the resting metabolism and energy expenditure during the day). At the initial visit and every subsequent month, the women received individually balanced elimination/reducing diets, in accordance with the previously performed food sensitivity tests for 6 months. Laboratory tests for type III food sensitivity in the IgG1-3 class using the ELISA method were performed in an accredited medical laboratory. Diets were designed by a qualified dietitian using the Aliant (Poland) diet calculator. Each diet had the same macronutrient content - 25% protein, 30% fat, and 45% carbohydrate, and met the daily requirements for micro and macro elements for the given age group.; Participants received diets in the range of 1400-1600 kcal/day (with a deficit of about 1000 kcal/day, depending on the resting metabolism and energy expenditure during the day). At the initial visit and every subsequent month, the women received individually balanced reducing diets (without elimination) for 6 months.Diets were designed by a qualified dietitian using the Aliant (Poland) diet calculator. Each diet had the same macronutrient content - 25% protein, 30% fat, and 45% carbohydrate, and met the daily requirements for micro and macro elements for the given age group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hashimoto; Obesity; Elimination diet; Thyroid gland; Adults
A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001
Condition: Androgenetic Alopecia
MeSH terms: Alopecia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001
    

Detailed description: 
      A Randomized, Open-Label, Exploratory, Pharmacokinetic, Sequential Single Ascending dose
      Study of IVL3001 Versus Propecia (Finasteride) Tablets in Healthy Adult Participants
    

Intervention name(s): Finasteride 1mg Tablet; IVL3001
Intervention type(s): Drug; Drug
Intervention description(s): Propecia Tablet 1mg; Finasteride long acting injection
Intervention MeSH terms: Finasteride
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Cohort 1 / Cohort 2 (Group 1, Group 2) / Cohort 3
Masking: None (Open Label)
Primary purpose: Treatment
Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      In a double-blind, placebo-controlled 16-week trial investigators administered daily doses of
      either youths with autism spectrum disorders.ARA and DHA supplementation significantly
      improved communication as well as social withdrawal symptoms. This pilot study provides the
      first evidence that supplementation with larger ARA doses added to DHA improve impaired
      social interaction in youths with Autism Spectrum Disorders (ASD).
    

Detailed description: 
      We recruited 13 individuals who met the DSM-IV criteria for a diagnosis of high functioning
      autistic disorder (n=1) or Asperger's Disorder (n=12),corroborated by the Autism Diagnostic
      Interview-Revised. Participants were free of any medical or comorbid psychiatric disorders.
      Other inclusion criteria included weigh of at least 16 kg, either a verbal or performance
      intelligence quotient (IQ) above 80, and a score greater than 10 on the social withdrawal
      subscale of the Aberrant Behavior Checklist-Community.
    

Intervention name(s): Aravita including arachidonic acid and docosaheaenoic acid
Intervention type(s): Other
Intervention description(s): Nine of 13 Participants were treated with 6 capsules of Aravita per day for 16-week trial, remaining 4 participants aged under 12 years received 3 capsules per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: arachidonic acid; autism spectrum disorders; social interaction; randomized controlled trial; DHA
Dengue Seroprevalence Study in Blood Donors in the French West Indies
Condition: Blood Donors; Dengue
MeSH terms: Dengue
Study type: Observational

Summary: 
      Dengue is an infectious disease most prevalent in the world. This disease is endemic in the
      Caribbean, with an increase in seasonal rains. Several outbreaks have been observed in recent
      years, in 2001, 2005 and 2007, during which further particularly virulent serotypes have
      emerged. The clinical expression of dengue fever is variable, ranging from no symptoms to a
      classical form with fever, and even of severe or lethal bleeding. With the possible existence
      of silent forms of the disease, there are no data identifying the current level of protection
      of the population in Martinique / Guadeloupe.
    

Detailed description: 
      1. Principal objective:

           To estimate the prevalence of the specific antibodies of the dengue (IgG) in blood
           donors in the French West Indies.

        2. Secondary objective:

      To specify the serotypic specificity of the anti-dengue antibodies detected during the study.
    

Intervention name(s): Biological sample collection
Intervention type(s): Other
Intervention description(s): Blood (serum) sample collection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult, résidents in Martinique/ Guadeloupe (french west indies), aged 18 to 65 years coming
        to give their blood in one of the building or mobile collection facilities of the French
        Blood Establishment in French West Indies.
      
Biospecimen description: 
      serum
Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE)
Condition: Neuromyelitis Optica Spectrum Disorder
MeSH terms: Neuromyelitis Optica
Study type: Interventional
Phase: Phase 4

Summary: 
      In this research, a prospective, multicenter(Tangdu Hospital of Fourth Military Medical
      University, Xi'an Gaoxin Hospital of Xi'an Medical College, Xianyang Central Hospital, Baoji
      Central Hospital, Xi'an Central Hospital, The First Hospital of Xi'an, The Fourth Hospital of
      Xi'an) open-label, follow-up clinical trial will carry out to evaluate the efficacy and
      safety of low-dose rituximab in treating NMOSD in Northwest China.
    

Detailed description: 
      Neuromyelitis optica spectrum disorder (NMOSD) is a group of autoimmune inflammatory
      demyelinating disease of the central nervous system primarily characterized with recurrent
      optic neuritis and longitudinally extensive transverse myelitis, leading to blindness and
      paralysis. Incremental disability due to clinical attacks make it essential to prevent
      relapses with immunosuppressive therapy. Since the serological pathogenic marker
      anti-aquaporin 4 immunoglobulin G (anti-AQP4 IgG) has been identified, NMOSD has unveiled its
      autoimmune features with close connections to B cell-mediated humoral immunity. Rituximab, a
      chimeric monoclonal antibody directly against human CD20 molecular on the surface of B cells,
      has been reported to deplete peripheral CD20+ B cells and to be highly effective for treating
      NMOSD, and therefore been recommended as first-line therapy for this disorder. Unfortunately,
      there are still no consensus statements on dosing and follow-up regimens, which needs
      investigations to explore the efficacy and safety of different rituximab strategies. Previous
      studies have provided pilot evidence supporting the use of low-dose rituximab in preventing
      relapses in Chinese patients with NMO/NMOSD, however, prospective multicenter studies are
      still needed to determine the effectiveness of the modified strategy in treating NMOSD.
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): A scheduled therapeutic regimen with low-dose rituximab was performed.
Other intervention name(s): Rituxan
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuromyelitis Optica Spectrum Disorder; Rituximab
Divalproex Sodium ER in Adult Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      12-week open label treatment trial of divalproex sodium extended release (Depakote ER) in 10
      patients with a diagnosis of autism. Our objective is to determine how well these patients
      can tolerate the prescribed doses and what added benefits can be attributed to divalproex
      sodium ER.
    

Detailed description: 
      Based on positive research with divalproex in children/adolescents with autism, we would like
      to extend this research to autistic adults with high levels of aggression, irritability,
      affective instability, or agitation. We aim to have 10 adult autistic patients enrolled in
      our study of the treatment of aggression/irritability with divalproex sodium ER. This will be
      an open treatment for adult patients to determine if the tolerability of divalproex sodium is
      better with the extended release. We propose this open label design because previous
      double-blinded studies of divalproex sodium were only done in children, not adults. These
      results will serve as pilot data for a future blinded study for autistic adults with the
      extended release formulation. This naturalistic design will allow for prior stable (3 months)
      use of concomitant medications. Our objective is to determine how well these patients can
      tolerate the prescribed doses and what added benefits can be attributed to divalproex sodium
      ER.
    

Intervention name(s): Divalproex Sodium ER
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autism; divalproex sodium ER; aggression; irritability
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline
      (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with
      diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio
      virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm infants as a 3-dose
      primary immunization course during the first 6 months of life.

      This protocol posting deals with objectives & outcome measures of the primary study. The
      objectives & outcome measures of the Booster study are presented in a separate protocol
      posting (NCT number = 00609492)
    

Detailed description: 
      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Intervention name(s): Pneumococcal conjugate vaccine GSK1024850A; Infanrix hexa
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Other intervention name(s): DTPa-HBV-IPV/Hib
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pneumococcal vaccine; Preterm; Safety; Pneumococcal disease; Immunogenicity
Safety and Efficacy of a Contact Lens for Daily Disposable Use
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact
      lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by
      current soft contact lens wearers on a daily disposable wear basis.
    


Intervention name(s): Test, daily disposable contact lens; SofLens daily disposable contact lens
Intervention type(s): Device; Device
Intervention description(s): Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.; Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: contact lens
Empa/Lina FDC Food Effect Study (Japan)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial will be performed as an open-label, randomised, single-dose, two-sequence crossover
      design for the assessment of effect of food on bioavailability of empagliflozin / linagliptin
      fixed dose combination (FDC) tablet.
    


Intervention name(s): empagliflozin/linagliptin FDC
Intervention type(s): Drug
Intervention description(s): empagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet
Intervention MeSH terms: Empagliflozin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Compare the DHE pharmacokinetic profiles observed following administration of:

        1. MAP0004 (oral inhalation DHE)

        2. MAP0004 co-administered with oral Ketoconazole

        3. Intravenous (IV) DHE (D.H.E.45®, the approved reference therapy)

      Compare the tolerability of MAP0004, IV DHE, and MAP0004 with co-administration of
      Ketoconazole.
    


Intervention name(s): MAP0004; IV DHE; Ketoconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2; IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3; Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2
Other intervention name(s): D.H.E.45®; Nizoral®
Intervention MeSH terms: Ketoconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Drug Interaction Study in Normal Healthy Volunteers
Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #1
Condition: Healthy Participants
Study type: Interventional

Summary: 
      The purpose of this study is to set an optimal measurement time for assessing driving ability
      in a driving simulator in healthy volunteers.
    


Intervention name(s): Road-tracking test; Car-following test; Harsh-braking test
Intervention type(s): Other; Other; Other
Intervention description(s): Driving with simulator program for SDLP measurement; Driving with simulator program for DCV measurement; Driving with simulator program for BRT measurement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other