bioihbjkbjnl/mcl2 huggingface dataset:
Different Vitamin D Preparations & FGF23 in Humans
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Fibroblast growth factor 23 (FGF23) is a new hormone which controls phosphate and vitamin D
      levels in humans. Excess FGF23 is associated with an increased risk of death in patients with
      chronic kidney disease. In this study the investigators are investigating the effects of
      different forms of vitamin D on FGF23 levels in the blood in order to increase our
      understanding of how this important hormone works.
    

Detailed description: 
      Fibroblast growth factor 23 (FGF23) is a novel hormone involved in phosphate and vitamin D
      physiology. X-linked hypophosphatemia (XLH), autosomal dominant hypophosphatemic rickets
      (ADHR), and tumor induced osteomalacia (TIO) are 3 rare diseases characterized by
      rickets/osteomalacia, fractures, and hypophosphatemia secondary to renal phosphate wasting
      and inappropriately low levels of activated vitamin D (calcitriol), which are caused by
      excess amounts of or mutated FGF23. FGF23 excess also occurs in renal failure, where elevated
      FGF23 levels predict increased mortality. Thus, abnormal FGF23 appears to be central to both
      rare and common diseases. While FGF23 appears to be regulated by vitamin D, dietary and serum
      phosphate, much is still unknown. The effects of different forms of vitamin D on FGF23
      stimulation are not well characterized. Similarly, any racial differences in the regulation
      of FGF23 by vitamin D have not been investigated.

      To address these knowledge deficits, we will randomize 52 vitamin D deficient (25OHD < or =
      24 ng/mL by LC/MS) Caucasian and African-American men and women to treatment with either
      dietary vitamin D or activated vitamin D for 12 weeks. Our primary endpoint will be the
      change in FGF23 with dietary versus activated vitamin D.
    

Intervention name(s): Ergocalciferol; Calcitriol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ergocalciferol 50000 international units by mouth weekly for 12 weeks; Calcitriol 0.5 mcg by mouth daily for 12 weeks
Intervention MeSH terms: Calcitriol; Ergocalciferols; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Vitamin D; FGF23; FGF-23; Phosphate
Trospium Chloride XR in Obese Female Patients With Overactive Bladder
Condition: Obesity; Overactive Bladder; Incontinence
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluated the effectiveness of trospium chloride extended release (XR) in obese
      female patients with overactive bladder (OAB). Patients received either placebo and trospium
      chloride XR or placebo only. The study assessed the change from baseline in urinary
      frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill. The
      study was 14 weeks in duration.
    


Intervention name(s): Trospium Chloride, Extended Release (XR); placebo
Intervention type(s): Drug; Other
Intervention description(s): Trospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks.; Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.
Other intervention name(s): Sanctura XR™ 60 mg
Intervention MeSH terms: Trospium chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see how many people respond to a smallpox vaccine when a sore
      forms where the shot was given.

      The world was declared free of smallpox in 1980. General routine vaccinations for smallpox
      were stopped in the U.S. in 1971. In 1976, the recommendation for routine vaccination of
      healthcare workers was also discontinued. The only people who presently receive this vaccine
      are people who work with vaccinia virus or monkeypox virus. Because the world was considered
      free of smallpox infections, this vaccine was no longer produced; there is a limited supply
      available in the United States.

      Because of the limited amount of Dryvax vaccine (vaccinia virus) against smallpox, this study
      will look at the ability to dilute the vaccine making more doses available in the event of a
      smallpox outbreak. The study seeks to characterize a strategy of vaccination against smallpox
      with various doses of Dryvax, followed by revaccination with the same dose, if required, in
      volunteers 18-32 years of age with a negative history of smallpox vaccination.
    


Intervention name(s): Dryvax vaccine
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccine prophylaxis
Disposal of Oral Fructose During Exercise
Condition: Carbohydrate Metabolism at Exercise
Study type: Observational

Summary: 
      There is evidence that total carbohydrate oxidation during exercise is higher after ingestion
      of fructose:glucose mixture than after ingestion of equimolar amounts of glucose alone. This
      may possible contribute to improve performance, provided that the extra carbohydrate
      oxidation induced by fructose:glucose co-ingestion occurs in skeletal muscle. The present
      study aims at assessing the hypothesis that, during exercise, a substantial portion of oral
      fructose is converted into lactate prior to oxidation To identify the major pathways of
      fructose disposal, 7 healthy endurance trained male volunteers will be studied. For each
      participant the following measurement will be performed

        -  a measurement of maximal oxygen consumption (VO2 max) on an ergometric bicycle

        -  a 2 hour exercise protocol with oral administration of a glucose drink. 6,6-2H2 glucose
           (0.44 µmol/kg/min) and 13C3 lactate (2.25 µmol/kg/min) will be infused to calculate
           glucose and lactate kinetics. Indirect calorimetry will be performed to measure total
           carbohydrate oxidation and expired 13CO2 will be monitored to calculate whole body
           lactate oxidation

        -  a 2 hour exercise protocol with oral administration of a glucose:fructose (72 + 48 g
           every hour) mixture. 6,6-2H2 glucose (0.44 µmol/kg/min) and 13C3 lactate (2.25
           µmol/kg/min) will be infused to calculate glucose and lactate kinetics. Indirect
           calorimetry will be performed to measure total carbohydrate oxidation and expired 13CO2
           will be monitored to calculate whole body lactate oxidation

        -  a 2 hour exercise protocol with oral administration of a glucose:fructose (72 + 48 g
           every hour) mixture with fructose labelled with 13C6 fructose to evaluate exogenous
           fructose metabolic fate and oxidation. 6,6-2H2 glucose (0.44 µmol/kg/min) will be
           infused to calculate glucose kinetics. Fructose conversion into lactate and glucose will
           be evaluated by monitoring the systemic appearance of plasma 13C-labelled lactate and
           13C-labelled glucose. Total exogenous fructose oxidation will be measured by monitoring
           13CO2 production.

      Based on these measurements, semi-quantitative estimates of total fructose oxidation,
      fructose conversion into glucose, fructose conversion into lactate, and oxidation of
      fructose-derived lactate will be obtained
    


Intervention name(s): Fructose:glucose drink; glucose drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Sampling method: Non-Probability Sample
Study population: 
        Healthy, endurance trained male volunteers
Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch
Condition: Allergy
Study type: Interventional
Phase: Phase 2

Summary: 
      Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS
      Birch in regard to pharmacodynamic efficacy and tolerability.
    


Intervention name(s): oral immunotherapy
Intervention type(s): Biological
Intervention description(s): orally applied specific immunotherapy
Other intervention name(s): SLITone birch
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of
      MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in
      healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months
    

Detailed description: 
      At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
      name SmithKline Beecham
    

Intervention name(s): Engerix™-B; HBV-MPL vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 1 or 3 doses; Intramuscular injection, 1 or 3 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Hepatitis B; Engerix™-B; Recombinant hepatitis B vaccine
International Multicenter Study of the Immunogenicity of Medicinal Product GamEvac-Combi
Condition: Ebola Virus Disease; Prevention
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate immunogenicity, epidemiological efficacy and safety
      of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine against Ebola Virus
      Disease, 0.5 ml+0.5 ml/dose
    

Detailed description: 
      This clinical trial is designed as a double blind randomized placebo-controlled study to
      evaluate immunogenicity of medicinal product GamEvac-Combi - Combined Vector-Based Vaccine
      against Ebola Virus Disease, 0.5 ml+0.5 ml/dose.

      The study includes three periods: screening, administration of the investigated product and
      follow-up. Vaccine will be administered to groups of volunteers (each group will include not
      more than 40 volunteers at a time; a new group of volunteers cannot be hospitalized before
      the earlier vaccinated volunteers are discharged from the hospital. In total, 8 visits will
      be held, including a screening visit; two of the visits will take place during the inpatient
      stage and six - during the outpatient observation.

      Study design in the both facilities will be the same for all volunteers, except that the
      biomaterial collected for immunogenicity evaluation from volunteers included in the study in
      the Russian Federation will be delivered directly to the testing laboratory; biomaterial from
      volunteers included in the study in the Republic of Guinea will undergo primary specimen
      processing, be frozen and stored under the assigned temperature conditions in the research
      center and, as biomaterial is accumulated, it will be transported in a fridge to the study
      site.

      In addition, laboratory tests for such concomitant infectious diseases, as yellow fever,
      Denge fever, Ebola and Marburg virus diseases will be carried out for epidemiological
      indications (i.e. in the endemic regions if disease cases are reported).
    

Intervention name(s): GamEvac-Combi (vaccine); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): vaccination; vaccination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This clinical trial is designed as a double blind randomized placebo-controlled study
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Ebola Virus Disease; Hemorrhagic Fever, Ebola; Vaccines; GP protein, Ebola virus; Ebola Virus Vaccines
Family Risk Analysis of Substance Use in Attention Deficit Hyperactivity Disorder (ADHD) Youth Treated With Concerta
Condition: ADHD; Smoking
MeSH terms: Substance-Related Disorders
Study type: Observational

Summary: 
      The researchers will study 100 families over three years, each with a child (proband) between
      the ages of 12-17, with the Diagnostic and Statistical Manual of Mental Disorders, Fourth
      Edition (DSM-IV) diagnosis of ADHD. The researchers hypothesize smoking will be familial and
      ADHD probands with a family history of tobacco use will be at increased risk for early
      initiation and persistence of smoking, compared to ADHD probands with no family history of
      tobacco use.
    

Detailed description: 
      As Attention Deficit Hyperactivity Disorder (ADHD) is a documented risk factor for smoking in
      adolescents, and as theoretical considerations suggest that ADHD and tobacco use may share
      common underlying mechanisms, the proposed study looks to examine the association between
      smoking and ADHD. Since both ADHD and smoking are known to be familial disorders, one
      approach to examine the nature of the association between the two disorders is to conduct a
      familial risk analysis comparing ADHD youth who smoke and ADHD youth who don't smoke. Another
      approach is to conduct a genetic study, to identify candidate genes associated with nicotine
      abuse and dependence in ADHD youth and relatives.

      This study includes:

        1. assessment of psychopathology and substance use/dependence,

        2. assessment of the family environment, and

        3. assessment of molecular genetics in 100 families with at least one child (proband)
           between the ages of 12-17 with a DSM-IV diagnosis of ADHD.
    

Observational model: Family-Based
Sampling method: Non-Probability Sample
Study population: 
        First-degree relative between the ages of 6-55 years of a family member (proband) between
        the ages of 12-17 with the DSM-IV diagnosis of ADHD
      
Keywords: ADHD; smoking; familial risk
Characterization of T Cell Responses Following Yellow Fever Virus Vaccination in Healthy Adults
Condition: Yellow Fever
MeSH terms: Yellow Fever; Fever
Study type: Observational

Summary: 
      The investigators at Rockefeller University are doing this research to study how the immune
      system responds to viruses and other infectious agents by using the yellow fever 17D vaccine
      as a model. The YFV-17D vaccine is one of the safest and most effective vaccines known and
      has been used to vaccinate humans against yellow fever virus (YFV) infection since the 1930s.
      By studying how the human immune system responds to the YFV vaccine we hope to learn more
      about the normal functioning of the immune system so that it might be possible to design new,
      more effective types of vaccines to prevent important infectious diseases.

      The reason for doing this research is:

      Currently there is very little information about which factors determine the effectiveness of
      the initial (primary) immune response to a foreign substance (antigen), such as a virus, that
      person may be exposed to. There is also very little known about what determines how
      effectively and for how long a person's immune system can react to the same antigen to
      prevent another infection. Studies in animals have given us important information about how
      the immune systems of other animals behave upon initial or repeated exposure to antigens,but
      these topics have not been studied in detail in humans.

      The following hypotheses will be tested:

        -  The magnitude of the initial expansion of T lymphocytes (the "clonal burst") specific
           for the infecting virus determines the level at which memory T cell responses are
           generated against the specific viral antigen and the duration of the memory T cell
           response generated in the body.

        -  The majority of CD8 T cells generated after immunization are yellow fever specific and
           not "bystander activation" of non-specific cells.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Rockefeller University Personnel
      
Keywords: Yellow Fever
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen (IONIS-PKK-LRx) Administered Subcutaneously to Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of
      Donidalorsen administered subcutaneously to Healthy Volunteers
    


Intervention name(s): Placebo; Donidalorsen
Intervention type(s): Drug; Drug
Intervention description(s): Saline .9%; Donidalorsen administered subcutaneously
Other intervention name(s): ISIS 721744; IONIS-PKK-LRx
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: IONIS PKK-LRx
The Effect of Microneedle Pretreatment on Topical Anesthesia
Condition: Pain
Study type: Interventional

Summary: 
      This study evaluates the role of microneedle pretreatment in the speed at which anesthesia
      develops after application of topical 4% lidocaine.
    

Detailed description: 
      This study evaluates whether the time to anesthesia with topical 4% lidocaine can be
      accelerated with the use of microneedle pretreatment. The study will evaluate the anesthesia
      as a randomized split-body study where each subject serves as their own control. The study
      will be performed on the volar forearm. Prior to application of the topical 4% lidocaine, one
      arm will be exposed to a microneedle pretreatment on a microneedle roller and the other arm
      will be exposed to sham microneedle treatment that will consist of a flat roller with no
      microneedles. Then pain will be assessed with the use of a spring loaded needle lancet that
      will be applied at 2 min, 5 min, 10 min, and 30 minutes after treatment.
    

Intervention name(s): Microneedle Roller; Sham microneedle Roller
Intervention type(s): Device; Device
Intervention description(s): 200 micrometer length microneedles (MR2 roller, Clinical Resolution Laboratories, Inc.) mounted on a disposable roller; Flat roller without microneedles
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each subject will serve as his or her own control. The right forearm and the left forearm will be randomized through a binary randomization to determine whether the right arm will receive microneedle treatment or sham microneedle treatment (roller with no microneedles). This randomization is developed through code in Excel that will result in binary result of either the value 0 or 1 for each subject. For those subjects assigned a binary code of 0, the right forearm will receive microneedle treatment and the left forearm will receive sham microneedle treatment. For those subjects assigned a binary code of 1, the left forearm will receive microneedle treatment and the right forearm will receive sham microneedle treatment.
Masking: Single (Participant)
Primary purpose: Prevention
BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      The primary objective of this trial is to establish an equivalence in efficacy between BI
      695501 and US-licensed Humira® in patients with active Rheumatoid arthritis based on a
      statistical comparison of the proportion of patients meeting American College of Rheumatology
      20% (ACR20) response rate at Week 12 and ACR20 response rate at Week 24 between BI 695501 and
      US-licensed Humira®.

      Secondary Objectives:

      The secondary objectives of this trial are to compare the efficacy, safety and immunogenicity
      of BI 695501 and US-licensed Humira® in patients with active RA including those undergoing
      the transition from US-licensed Humira® to BI 695501 after 24 weeks.
    


Intervention name(s): BI 695501; US-licensed Humira®
Intervention type(s): Drug; Drug
Intervention description(s): BI 695501, every two weeks for 48 weeks (25 injections in total); one injection every 2 weeks for 48 weeks (25 injections in total)
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether prucalopride is safe and effective in
      patients with chronic idiopathic constipation.

      Hypothesis:

      At all doses administered prucalopride given once daily for 4 weeks is safe and well
      tolerated in patients with chronic idiopathic constipation.
    

Detailed description: 
      This was a double-blind, placebo-controlled, randomized, parallel group, multicentre, Phase
      II, dose comparison trial, in which 313 subjects, with a history of chronic idiopathic
      constipation were enrolled. The trial was conducted in three phases:

        1. a 4-week drug-free run-in phase,

        2. a 4-week double-blind (DB) phase during which subjects were treated with R093877 (0.5
           mg, 1 mg, 2 mg, or 4 mg capsule) or matching placebo once daily, prior to breakfast,

        3. a 4-week drug-free run-out phase (RO).

      To qualify for the run-in phase (Visit 1, Week 1) subjects had to have experienced, for at
      least 3 months, 2 or less spontaneous, bowel movements (SBM)/week with the occurrence of
      lumpy (scyballae) and/or hard stools, a sensation of incomplete evacuation for at least a
      quarter of their stools, or straining during defecation at least a quarter of the time.
    

Intervention name(s): prucalopride; prucalopride; 2 mg prucalopride; 4 mg prucalopride; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): 0,5 mg once daily; 1 mg once daily; 2 mg once daily; 4 mg once daily; placebo once daily
Other intervention name(s): Resolor; Resolor; Resolor; Resolor
Intervention MeSH terms: Prucalopride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Constipation; prucalopride