bioihbjkbjnl/mcl2 huggingface dataset:
Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators hypothesize that treatment with the iron chelator, Deferoxamine Mesylate,
      improves the outcome of patients with brain hemorrhage.

      The purpose of this study is to determine whether treatment with Deferoxamine Mesylate is of
      sufficient promise to improve outcome before pursuing a larger clinical trial to examine its
      effectiveness as a treatment for intracerebral hemorrhage.
    

Detailed description: 
      This is a prospective, multi-center, double-blind, randomized, placebo-controlled, phase-II
      clinical trial.

      Subjects will be randomized to either deferoxamine mesylate (DFO) at 32 mg/kg/day (up to a
      maximum daily dose of 6000 mg/day), or saline placebo, given by IV infusion for 3 consecutive
      days.

      Treatment will be initiated within 24 hours after ICH symptom onset. Randomization will
      control baseline imbalances associated with baseline ICH score, ICH onset-to-treatment time
      (OTT), ICH volume, baseline NIHSS score, and warfarin use.

      All subjects will be followed for 6 months and will receive standard of care therapy while
      participating in the study.

      Throughout the study, we will continue to assess the safety of DFO. At the conclusion of the
      study, the proportion of DFO-treated subjects with a good clinical outcome at 3 months
      (defined as modified Rankin Scale (mRS) score of 0-2) will be compared to the placebo
      proportion in a futility analysis to determine if it is futile to move DFO forward to Phase
      III efficacy evaluation.
    

Intervention name(s): Deferoxamine Mesylate; Placebo (for Deferoxamine Mesylate)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Deferoxamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brain hemorrhage; Cerebral hemorrhage; Bleeding in the brain; Deferoxamine; iDEF trial
A Phase 1, Multiple Oral Administrations of TNP-2092 Capsules in Asymptomatic Healthy People With Helicobacter Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was a single-center, randomized, double-blind, placebo-controlled, dose-ascending
      multiple-dose-administration study. The aim of this study was to evaluate the safety,
      tolerability, and pharmacokinetic profile of TNP-2092 Capsules in asymptomatic healthy
      subjects with Helicobacter pylori infection, and to explore the preliminary efficacy of
      TNP-2092 Capsules in eradicating Helicobacter pylori.
    


Intervention name(s): TNP-2092 capsules; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg, 300 mg, and 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.; Subjects received Placebo orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
Other intervention name(s): Rifaquizinone capsules
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to evaluate the immunogenicity and safety of a pneumococcal
      conjugate vaccine when co-administered with DTPa-IPV-Hib or DTPa-HBV-IPV/Hib in infants as a
      three-dose primary immunisation course during the first 6 months of life and as a booster
      dose at 11-12 months of age. The impact of the pneumococcal conjugate vaccine on
      nasopharyngeal carriage of S. pneumoniae and H. influenzae in children in their first two
      years of life will also be assessed. The Protocol Posting has been updated in order to comply
      with the FDA Amendment Act, Sep 2007.
    


Intervention name(s): GSK Biologicals´ Pneumococcal Conjugate Vaccine GSK1024850A (Synflorix™); Infanrix™ hexa.; Pediacel™; Prevenar™
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses in the primary vaccination and 1 dose in the booster vaccination; Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination; Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination; Intramuscular injection, , 3 doses in the primary vaccination and 1 dose in the booster vaccination
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
Condition: Hyperlipidemia; NAFLD
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Hypercholesterolemia; Hyperlipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering
      LDL-C and liver fat content in patients with primary hypercholesterolemia and fatty liver
      disease. The primary efficacy endpoint is percent change from baseline LDL-C at the end of
      the treatment period (Week 12). Secondary endpoints include effects on liver fat content and
      other liver and lipid markers, as well as effects on safety and tolerability, and
      pharmacokinetic (PK) measurements.
    


Intervention name(s): VK2809; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy and safety of upadacitinib compared
      to placebo as induction therapy in adults with moderately and severely active Crohn's disease
      (CD).
    

Detailed description: 
      This study includes two parts:

        -  Part 1: a randomized double-blind placebo-controlled induction period and

        -  Part 2: an extended treatment period for non-responders from Part 1.

      In Part 1, participants will be randomized in a 2:1 ratio to upadacitinib 45 mg once daily
      (QD) or matching placebo for 12 weeks. The randomization will be stratified by baseline
      corticosteroid use (yes or no), endoscopic disease severity (Simplified Endoscopic Score for
      Crohn's disease [SES-CD] < 15 and ≥ 15), and number of prior biologics with prior inadequate
      response or intolerance (0, 1, > 1).

      Participants who do not achieve clinical response at Week 12 will be able to enroll in Part 2
      to receive a double-blind extended treatment with upadacitinib until Week 24. Clinical
      response is defined as a ≥ 30% decrease in average daily very soft or liquid stool frequency
      (SF) and/or ≥ 30% decrease in average daily abdominal pain (AP) score (both not worse than
      Baseline).

      Participants who achieve clinical response at Week 12 may be eligible to enter the 52-week,
      double-blind, maintenance portion of Study M14-430 (NCT03345823).
    

Intervention name(s): Upadacitinib; Placebo for Upadacitinib
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Tablet; Oral; Tablet
Other intervention name(s): ABT-494; RINVOQ
Intervention MeSH terms: Upadacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Upadacitinib; ABT-494; Efficacy; Safety; Crohn's Disease
Effects of Stress-reducing Aromatherapy
Condition: Stress-related Problems
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about how
      aromatherapy works.
    

Detailed description: 
      The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about how
      aromatherapy works by comparing participants' physiologic responses to laboratory challenge
      tasks with and without experiencing aromatherapy.
    

Intervention name(s): aroma
Intervention type(s): Other
Intervention description(s): Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects
Other intervention name(s): lavandula angustifolia; cocos nucifera; aqua destillata
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: aromatherapy; stress; older adults; stress-related change
The COPACC Study: Utilization, Health and Economic Evaluation of a Community-Based Primary Care Geriatric Hub at Whampoa
Condition: Delivery of Health Care; Health Services; Costs and Cost Analysis; Quality of Life
Study type: Observational

Summary: 
      This study evaluates the Community for Successful Ageing (ComSA) Patient-Centered Medical
      Home (PCMH), a model of community-based primary care geriatric hub at Whampoa, Singapore.
    

Detailed description: 
      This study evaluates the Community for Successful Ageing (ComSA) Patient-Centered Medical
      Home (PCMH), a model of community-based primary care geriatric hub at Whampoa, Singapore.
      This study aims to evaluate the impact of ComSA PCMH on health service utilisation,
      healthcare cost, clinical quality and effectiveness, as well as patient activation, quality
      of life, satisfaction and experience of care. The first component of the study is a single
      arm prospective pre-post cohort design, which aims to evaluate the impact on enrolled
      patients' self-reported health outcomes, experience of care, and cost effectiveness. The
      second component of the study evaluates the quality of the implementation processes via
      clinical quality indicators. The third component is a match-controlled retrospective pre-post
      study design, which aims to evaluate the impact on healthcare utilisation. Data sources
      include both survey data and administrative data.
    

Intervention name(s): Patient-centred care home (PCMH)
Intervention type(s): Other
Intervention description(s): New model of care defined by care provision by a team of people centered in the community that is both proactive and coordinated to improve the health and wellness of the people in that community.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Older adults aged 40 years and above who reside in Whampoa, Singapore, and have complex
        healthcare needs.
      
Keywords: patient-centred care; patient-centred medical home; older adults; complex needs; healthcare utilisation; economic evaluation; cost analysis; health services research
Clinical Evaluation of Silver Nanoparticles in Comparison to Silver Diamine Fluoride in Management of Deep Carious Lesions
Condition: Caries,Dental
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      this clinical study will be carried out to evaluate the effect of fluoride varnish with
      silver nanoparticles in comparison to silver diamine fluoride in management of deep carious
      lesions.
    


Intervention name(s): silvernanoparticles; SDF
Intervention type(s): Drug; Drug
Intervention description(s): silvernanoparticles in fluoride varnish; silver diamine fluoride
Other intervention name(s): silver diamine fluoride
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Inulin on Iron Absorption in Humans
Condition: Iron Absorption; Gut Bacteria
Study type: Interventional

Summary: 
      Prebiotics are non-digestible food ingredients that beneficially affect the host by
      selectively stimulating the growth or activity of species in the colon that can improve host
      health.

      Inulin-type fructans (inulin and oligofructose) are natural food ingredients with prebiotic
      activity. Fermentation of inulin and oligofructose by lactic acid producing bacteria results
      in an increase in bacterial biomass and the production of SCFA (acetate, propionate and
      butyrate), lactic acid and the gases CO2 and H2. They are naturally present in significant
      amounts in several vegetables such as garlic, artichoke, onion, asparagus, leek and wheat
      (1-4%). Based on consumption data, the daily intake of inulin in Europe varies between 3.2
      and 11.3g mainly from wheat (2-7.8g/d). However, this might have changed recently since
      inulin and oligofructose are used by the food industry either as sucrose and fat replacements
      or due to their health benefits for the human host.

      Several human absorption studies evaluated the effect of inulin/oligofructose on mineral
      absorption. It was shown that calcium and magnesium absorption was positively influenced.
      Until now, the positive effect on iron absorption was only shown in animals. The influence on
      human iron absorption was investigated twice. Both studies reported no effect of
      inulin/oligofructose on iron absorption, but this was most likely due to poorly conceived
      study designs.

      The aim of the present study is to demonstrate that inulin consumption over several weeks can
      lead to enhanced iron absorption in humans under optimized conditions.
    


Intervention name(s): inulin; maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 20g/day for 4 weeks; 20g/day for 4 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetics of Salmeterol Via HandiHaler® in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to investigate if the systemic drug exposure of at least 25 μg
      and perhaps 50 μg salmeterol presented as inhalation powder in PE capsules and administered
      via HandiHaler® 2 does not exceed that of 50 μg Serevent® Diskus® and to investigate safety
      and tolerability of salmeterol presented as inhalation powder in PE capsules and administered
      via HandiHaler® 2
    


Intervention name(s): Salmeterol capsule - low; Salmeterol capsule - high; Salmeterol via Serevent® Diskus®
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Food on the Bioavailability of 15 mg Estetrol/3 mg Drospirenone Tablets in Healthy Female Volunteers
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, open-label, randomized, balanced, single-dose, two-treatment, two-period,
      two-sequence crossover study was conducted under medical supervision in 28 healthy female
      volunteers.
    

Detailed description: 
      Food effect bioavailability studies are usually conducted for new drugs and drug products to
      assess the effect of food on the rate and extent of absorption of a drug when the drug
      product is administered shortly after a meal (fed conditions), as compared to administration
      under fasting conditions. Therefore, this study was designed to characterize the effect of a
      high fat meal on the bioavailability of E4 and DRSP after administration of a single tablet
      containing 15 mg E4 and 3 mg DRSP.

      All subjects entered the study site at least 12 hours before each dosing and fasted for at
      least 10 hours prior to each dose.

      All subjects were to receive both Treatment A (Reference; a single 15 mg E4/3 mg DRSP tablet
      without food (fasted)) and Treatment B (Test; a single 15 mg E4/3 mg DRSP tablet with food
      (fed)) either at the first treatment period (Period 1) or the second treatment period (Period
      2). Approximately half of the subjects were randomized to receive either Treatment A followed
      by Treatment B (Sequence AB), or Treatment B followed by Treatment A (Sequence BA).
    

Intervention name(s): 15 mg E4/3 mg DRSP
Intervention type(s): Drug
Intervention description(s): All subjects received both Treatment A and Treatment B either at the first treatment period (Period 1) or the second treatment period (Period 2). Approximately half of the subjects was randomized to receive either Treatment A followed by Treatment B (Sequence AB), or Treatment B followed by Treatment A (Sequence BA)
Other intervention name(s): 15 mg Estetrol/3 mg Drospirenone
Intervention MeSH terms: Drospirenone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Erectile Dysfunction in Patients With Non Ocular Behçet's Disease
Condition: Behçet Disease; Behcet Syndrome; Erectile Dysfunction
MeSH terms: Behcet Syndrome; Erectile Dysfunction
Study type: Observational

Summary: 
      It was aimed to demonstrate whether erectile dysfunction is affected by BH pathogenesis and
      whether there is a relationship between erectile dysfunction and BD pathogenesis by assessing
      both sexual function and retinal micro-vascular blood flow in BH which may involve vessels
      from all calibrations and nature.
    

Detailed description: 
      Patients with factors and results that could cause sexual dysfunction will be excluded from
      the study.An International Index of ErectileFunction (IIEF) questionnaire will be applied to
      a total of 35 patients under 45 years old who met the inclusion criteria. IIEF's erectile
      function,sexual desire,sexual satisfaction,orgasmic function and general satisfaction sub
      parameters and Optical Coherence Eye Tomography (OCTA) data will compared.
    

Intervention name(s): Erectil dysfunction
Intervention type(s): Other
Intervention description(s): A complete ophthalmological examination including best-corrected visual acuity using the decimal system (BCVA), measurement of intraocular pressure (IOP) and axial length (AL), slit-lamp examination and dilated fundus examination
Other intervention name(s): Ophthalmological Examination
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Behçet's disease (BD) is a chronic, multi-systemic vasculitis characterized by remissions
        and exacerbations, where etiology hasn't been fully elucidated [1]. It was first described
        as oral aphthae, genital ulcerations, and iridocyclitis with hypopyon by Hulusi Behçet in
        1937 [2]. Although its etiology hasn't been fully understood, it is widely accepted that
        the disease is caused by excessive inflammatory response triggered by environmental factors
        in individuals with genetic susceptibility
      
Keywords: Behçet's disease; erectile dysfunction
A Trial on the Efficacy and Safety of Virgin Coconut Oil Compared to Mineral Oil in the Treatment of Uremic Xerosis
Condition: Uremic Xerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Among adult patients with chronic kidney disease undergoing hemodialysis, what is the
      efficacy and safety of virgin coconut oil compared to mineral oil as a therapeutic
      moisturizer for uremic xerosis?
    

Detailed description: 
      Objectives of the Study: The general objective of this study is to assess the efficacy and
      safety of virgin coconut oil (VCO) compared to mineral oil as a therapeutic moisturizer for
      uremic xerosis. The specific objectives are as follows: 1) to determine and compare changes
      in the over-all dry skin score within and between treatment groups at baseline, 2 weeks-post
      and 4-weeks post application; 2) to quantitatively measure the following skin parameters at
      baseline, 2-weeks and 4-weeks post application (skin hydration using a corneometer, skin
      lipids using a sebumeter); 3) to determine and compare changes in quality of life scores
      within and between treatment groups at baseline, and 4-weeks post application; and 4) to
      identify the adverse effects of virgin coconut oil and mineral oil when used as moisturizer
      for uremic xerosis
    

Intervention name(s): Virgin Coconut Oil; Mineral Oil
Intervention type(s): Other; Other
Intervention description(s): Virgin coconut oil applied to the test site twice daily for four weeks; Mineral oil applied to the test site twice daily for four weeks
Intervention MeSH terms: Mineral Oil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Effects of Daytime Eszopiclone Administration in Shift Workers
Condition: Shift-Work Sleep Disorder
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of eszopiclone on daytime sleep and
      overnight wakefulness in shift workers.
    

Detailed description: 
      The current study seeks to extend the currently available treatments for SWSD by addressing
      the putative root cause of the problem-the inability of night-shift workers with or without
      SWSD- to obtain adequate daytime sleep in the face of the circadian drive for alertness that
      increases across the biological day. Even healthy, young subjects who are sleep-deprived
      overnight exhibit daytime sleep marked by frequent awakenings and low sleep efficiency, less
      slow-wave sleep, and altered sleep architecture, e.g. earlier predominance of REM sleep. Many
      night-workers routinely report 3-6 hours of habitual sleep duration for daytime sleep.
      Pharmacological interventions to decrease awakenings and improve total sleep time during
      daytime sleep could improve subsequent alertness during a night shift. Improving the
      wakefulness of night-shift workers over the nighttime could result in substantial benefits
      for the individual workers, improve workplace productivity and safety, and improve public
      health.
    

Intervention name(s): eszopiclone; matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab); matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)
Other intervention name(s): Lunesta; placebo
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Shift-work; SWSD; eszopiclone; MWT; shiftworkers