bioihbjkbjnl/mcl2 huggingface dataset:
Unknown Glucose Metabolism Disorders In Patients With Coronary Artery Disease
Condition: Diabetes Mellitus
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Observational

Summary: 
      This study aimed to examine the prevalence of glucose metabolism disorders (GMD)in the
      patients with coronary artery disease and the relationship between different GMDs and
      coronary artery disease (CAD).
    

Detailed description: 
      Context: There are more than 220 million people diagnosed with diabetes mellitus (DM) in the
      world. DM is a serious risk factor for coronary artery disease (CAD). This study aimed to
      examine the prevalence of glucose metabolism disorders (GMD) in te patients with coronary
      artery disease and the relationship between different GMDs and CAD.

      Settings: 230 patients with coronary artery disease and without any known GMDs were included
      the study. Coronary angiography was used to diagnose CAD. Patients were administered the 75 g
      Oral Glucose Tolerance Test (OGTT).
    

Intervention name(s): ogtt for patients with coronary artery disease
Intervention type(s): Other
Intervention description(s): 75 g OGTT
Other intervention name(s): no name
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with coronary artery disease and who had no glucose metabolism disorders.
      
Keywords: OGTT; coronary artery disease
Influence of Telmisartan and Lacidipine, Combined or Alone, on QT Interval in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Assessment of the influence of telmisartan, lacidipine and their combination on the QTC
      interval of the ECG
    


Intervention name(s): Telmisartan high; Telmisartan low; Lacidipine high; Lacidipine low; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Telmisartan; Lacidipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy and safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 2 weeks in
      Japanese paediatric subjects ages 6 to < 15 years with perennial allergic rhinitis will be
      evaluated compared with placebo.
    


Intervention name(s): Fluticasone furoate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 55 mcg/day, intranasal, 2 weeks; Placebo, intranasal, 2 weeks
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Multidomain Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention
Condition: Risk Behavior; Cognitive Decline
MeSH terms: Dementia; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The overarching aim is to develop and deploy a multidomain intervention delivered on a mobile
      application to help middle-aged to older adults reduce their risk for dementia by improving a
      set of modifiable lifestyle risk factors associated with cognitive decline/dementia. This
      registration concerns the Pilot Feasibility study which examines different aspects of
      feasibility in a small-scale randomized pilot study, before implementing an efficacy study on
      a larger sample. A secondary objective is to determine whether the program can result in a
      larger improvement on risk factors (measured with Behavioural Risk outcomes) compared to a
      control intervention. It is expected that persons enrolled in the Luci program show larger
      change in Behavioural Risk outcomes than those enrolled in the comparator condition.
    

Detailed description: 
      Multidomain lifestyle interventions show promising results in reducing the risk of cognitive
      decline and dementia.

      In this study, we pilot the feasibility of a coach-based digital multidomain risk-reduction
      program to improve cognitive engagement, physical activity, and healthy eating in older
      adults at risk of dementia. This trial is the second step in the clinical validation process
      of the Luci program (see NCT04616794). In this 24-week study, participants are randomly
      assigned to the Luci Intervention group or to the Waiting-list Control group (i.e.,
      participants receive the program after the end of the trial). Assessments will be done at
      study entry (T1), week 12 (T2), and week 24 (T3).
    

Intervention name(s): Luci Coach Assisted Intervention
Intervention type(s): Behavioral
Intervention description(s): The Luci intervention is a personalized behaviour change program delivered via an interactive mobile platform with the online support of a coach. It targets 3 lifestyle domains: physical activity, healthy diet and cognitive engagement.
Participants in this group will be encouraged to adopt a healthy lifestyle, as a means for cognitive decline/dementia risk reduction. This will be achieved by providing educational materials, practical tips and strategies, and by assisting participants outlining goals to progressively adopt and maintain a healthier lifestyle.
Coaching sessions will be held on a weekly basis from week 1 to 12, and every 2 weeks from week 13 to 24.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Primary Prevention; Aging; Cognition
Seeing the World Through Assorted Glasses
Condition: Sleep
Study type: Interventional

Summary: 
      The purpose of the study is to test the use of amber glasses at night as a method to block
      blue light from the eye, allowing the brain to produce a dim-light melatonin onset. The
      investigators hypothesize that blue-blocking will produce measurable benefits in subjectively
      and objectively rated sleep quality and mood as well as salivary melatonin levels during the
      night.
    

Detailed description: 
      Participants will complete a self-report battery containing measures of sleep quality,
      morningness-eveningness chronotype, and mood. Participants will then wear a wrist-worn
      accelerometer for 14 days to objectively record activity level and sleep quality.
      Participants will also fill out a daily sleep log and short self-report measures assessing
      sleep and mood. On days 4-7 and 11-14 of the study the participants will wear either amber or
      placebo control lenses prior to sleep onset in a randomized crossover design (i.e.,
      participants will be randomized to wear either amber lenses or placebo lenses for the first
      part of the protocol and then switch to wear the opposite lenses for the second part of the
      protocol). Participants will spend nights 7 and 14 of the study in a sleep laboratory in
      order to obtain hourly melatonin samples and wear a wrist sleep monitor to non-invasively and
      objectively measure sleep state and quality using peripheral arterial tone and oxygen
      perfusion.
    

Intervention name(s): Amber Lenses; Placebo Lenses
Intervention type(s): Other; Other
Intervention description(s): Glasses fitted with amber lenses that block the blue spectrum of light (~470 nm) to be worn prior to desired sleep onset time.; Glasses fitted with placebo lenses that allow all visible spectrum of light to be worn prior to desired sleep onset time.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Sleep; Photoreceptor Cells, Vertebrate; Melatonin
Juvista (Avotermin) in Scars Following Varicose Vein Removal
Condition: Varicose Veins; Cicatrix
MeSH terms: Varicose Veins; Cicatrix
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is being undertaken to investigate the efficacy and safety of Juvista in the
      improvement of scar appearance when administered to approximated wound margins following
      varicose vein surgery. The results from this trial will be used to select doses for
      investigation in future clinical trials with the compound.
    

Detailed description: 
      Patients undergoing bilateral removal of the saphenous vein (by ligation and stripping) will
      be invited to participate in the study. Consenting patients will undergo a detailed screening
      examination, after which suitability to progress to randomisation to the study will be
      confirmed.

      Suitable screened patients will attend for scheduled surgery of vein removal as normal - this
      is termed "Day 0" At the time of wound closure, IMP will be administered via intra-dermal
      injection to each of the incisional groin wounds, and exit wounds.

      Each patient will serve as their own control with one leg being administered active IMP (at
      either a 5, 50, 200 or 500ng/100 ul)of dose solution, whilst the other leg is administered
      placebo solution. The study is double-blinded, so neither the Investigator nor patient will
      know which leg wounds receive which treatment.

      Further to Day 0, the patients are requested to attend for a further 5 follow up visits (Week
      6, Month 3, Month 5, Month 7 & Month 12), where photographs of the scars will be taken,
      together with spectrophotometry readings to measure colour of the scar. At each visit, the
      Investigator and patient will rate their opinion of the scar, by global assessment scale &
      VAS, together with patient completed questionnaires.
    

Intervention name(s): Avotermin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study of Fluoxetine in Patients With Depersonalization Disorder
Condition: Depersonalization Disorder
MeSH terms: Depersonalization
Study type: Interventional

Summary: 
      The purpose of this study is to:

      1) Determine the effects of fluoxetine in the treatment of depersonalization disorder, 2)
      Assess the durability of treatment response in these patients, 3) Assess the improvement in
      psychiatric disability in these patients, and 4) Assess the effects of comorbid Axis I
      disorders (depression, social phobia, panic/anxiety, obsessive-compulsive disorder) and Axis
      II personality disorders on treatment outcome in these patients.
    

Detailed description: 
      In this trial, participants will be randomly assigned to receive either fluoxetine or
      placebo. Treatment will consists of two phases (acute treatment and maintenance). In the
      acute treatment phase, participants will receive fluoxetine or placebo daily for 12 weeks.
      Participants will be followed every 2 weeks. In the Maintenance phase, participants showing
      significant improvement after 12 weeks may continue treatment for an additional 6 months. In
      this phase, participants are followed every 4 weeks.

      Participants who do not improve during the acute treatment phase may receive open fluoxetine,
      or another appropriate medication, for 3 months.
    

Intervention name(s): fluoxetine
Intervention type(s): Drug
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: depersonalization disorder; neurologic and psychiatric disorders; rare disease
Safety, Clinical Tolerability and Immunogenicity of Increasing Doses of gpASIT+TM
Condition: Hay Fever
MeSH terms: Rhinitis, Allergic, Seasonal; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      gpASIT+TM product is based on highly purified allergen fragments obtained from grass pollen.
      The purpose of this clinical trial is to confirm the safety, clinical tolerability and
      immunogenicity of increasing doses of gpASIT+TM administered subcutaneously to patients with
      grass pollen-induced allergic rhinoconjunctivitis, and to determine the maximal tolerated
      dose of gpASIT+TM .
    


Intervention name(s): gpASIT+TM
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Seasonal allergic rhinoconjunctivitis; Grass pollen; Allergen specific immunotherapy
S-Equol in Alzheimer's Disease 2 Trial
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      By doing this study researchers hope to learn if S-equol, a compound that acts like estrogen
      in the body, causes an increase in mitochondrial activity. Researchers also hope to determine
      the safety and tolerability of a therapeutic dose of S-equol and whether or not it influences
      cognition.
    


Intervention name(s): S-equol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): S-equol is an estrogen receptor β (ERβ) agonist. Provided in capsules; Placebo capsules matched in size and color to S-equol capsules
Other intervention name(s): AUS-131
Intervention MeSH terms: Equol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Transcutaneous Vagal Nerve Stimulation on Reducing Visually Induced Motion Sickness in Healthy Volunteers
Condition: Visually Induced Motion Sickness in Healthy Volunteers
MeSH terms: Motion Sickness
Study type: Interventional

Summary: 
      Nausea is a common and distressing experience that often precedes vomiting. Amongst symptoms
      emanating from the gastrointestinal (GI) tract nausea can be considered somewhat unique, as
      on one hand it represents a normal, highly conserved, physiological response to an ingested
      toxin yet on the other it may indicate pathology. Nausea may also arise as a consequence of
      pharmaco- and chemotherapeutic interventions. Nausea negatively impacts on quality of life,
      adherence to treatment and is a cause for discontinuation of the development of novel
      compounds. Experimentally, nausea can be induced in humans using a visually induced motion
      stimulus. Previously we have developed a 10-minute motion video of the landscape rotating as
      seen from the perspective of a subject standing on Westminster Bridge, London. The tilted and
      rotating view visual display makes the subject perceive that they are spinning round and
      round on a spot tilted away from centre of gravity due to circular vection. This motion video
      induced nausea in approximately 50% of healthy participants and caused a reduction in cardiac
      vagal tone, a validated measure of the parasympathetic nervous system branch on the autonomic
      nervous system. We therefore are evaluating the role of external transcutaneous vagal nerve
      stimulation in visually induced motion sickness.
    


Intervention name(s): Transcutaneous vagal nerve stimulation; Sham vagal nerve stimulation
Intervention type(s): Device; Device
Other intervention name(s): NEMOS
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Observational Longitudinal Study in Children Affected by Idiopathic Growth Hormone Deficiency (GHD)
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Observational

Summary: 
      The aim of this study is to assess the developmental patterns of lung function in children
      affected by growth hormone deficiency after one year of GH therapy.The assessment by specific
      questionnaires of quality of life and of parental stress index.Parameters will be evaluated
      at the time of the diagnosis and after 12 months of GH therapy.
    

Detailed description: 
      Observational longitudinal study in children affected by idiopathic growth hormone deficiency
      (GHD): lung function parameters assessment; quality of life assessment; stress parenting
      assessment (Pneumo GHD). The aim of this study is to assess the developmental patterns of
      lung function in children affected by growth hormone deficiency after one year of GH
      therapy.The assessment by specific questionnaires of quality of life and of parental stress
      index.Parameters will be evaluated at the time of the diagnosis and after 12 months of GH
      therapy.
    

Intervention name(s): Growth Hormone-Releasing Hormone
Intervention type(s): Drug
Intervention description(s): From Baseline Visit (T0) to 6th Month Visit 0,025 mg/kg Growth Hormone/die. From 6th Month Visit to 12th Month Visit 0,030 mg/Kg Growth Hormone/die.
Other intervention name(s): GH
Intervention MeSH terms: Hormones; Growth Hormone-Releasing Hormone
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        48 children affected by GH deficiency , recruited in the outpatient clinic of Pediatric
        Allergology & Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the
        Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council
        (CNR) of Palermo (RDRC-IBIM CNR), Italy.
      
Keywords: GHD
Study of Different Doses of a Novel Treatment for Onychomycosis
Condition: Distal, Subungual Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the safety and efficacy of 2.5%, 5.0%, and 7.5%
      AN2690 Solutions compared to the vehicle alone in the treatment of distal, subungual
      onychomycosis of the great target toenail.
    

Detailed description: 
      The intent is for all subjects to complete a 180 day treatment period consisting of 90
      consecutive days of once daily treatment with their assigned study treatment followed by an
      additional 90 days of three times weekly dosing, even if the treated toenail(s) is evaluated
      as a "complete responder" prior to the end of treatment 180 day treatment period.

      At the end of the 180-Day treatment period, subjects who remain in the study will be
      classified as complete responders, partial responders, or non-responders. All complete or
      partial responders will continue to be followed for an additional 180 days until the last
      evaluation for inclusion in the final analysis.

      Periodic efficacy and local tolerance evaluations of the test medication will be performed of
      the target great toenail and all other treated toenails. KOH wet mounts and fungal cultures
      from the treatment-targeted great toenail will be performed on the same schedule.

      Subjects will also be queried for adverse events and evaluated for application site
      reactions. Clinical laboratory assessment for safety will be made at Screening, periodically
      throughout the study, and upon premature discontinuation from the study.
    

Intervention name(s): AN2690, 2.5%; AN2690, 5%; AN2690, 7.5%; Vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Once daily application for 90 days and 3 x weekly for 90 days; Once daily application for 90 days and 3 x weekly for 90 days; Once daily application for 90 days and 3 x weekly for 90 days; Once daily application for 90 days and 3x weekly for 90 days
Intervention MeSH terms: Tavaborole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Onychomycosis; Fungal Nail
A Trial of SHR-1701 in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1701 in
      combination with gemcitabine and albumin paclitaxel in first-line treatment of subjects with
      advanced/metastatic pancreatic cancer, and determine the RP2D for SHR-1701 in the combined
      regimen.
    


Intervention name(s): SHR-1701
Intervention type(s): Drug
Intervention description(s): PDL1/TGFβ
Other intervention name(s): Gemcitabine and Albumin Paclitaxel
Intervention MeSH terms: Paclitaxel; Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Ascending Dose Study of AMG 570 in Healthy Subjects
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to obtain initial information on the safety and tolerability
      (effects good or bad), pharmacokinetics (what the body does to the drug), and
      pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.
    


Intervention name(s): AMG 570; AMG 570 Matching Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.; Placebo administered as single dose subcutaneous in healthy volunteers.
Other intervention name(s): Active Comparator, Investigational Product, and Study drug; Placebo, Investigational Product, and Study drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lupus; Healthy Volunteer; Safety Study; Placebo Control; Phase 1
Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the efficacy and safety of initial treatment with sitagliptin and
      metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that
      after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided
      greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin
      alone and with metformin alone.
    


Intervention name(s): Sitagliptin 50 mg; Metformin 500 mg; Sitagliptin 100 mg; Placebo; Metformin 850 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.; Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.; Sitagliptin 100 mg once daily for 24 weeks.; Matching placebo tablets to sitagliptin or metformin for 24 weeks.; Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
Other intervention name(s): Januvia®, Tesavel®, Xelevia®, Ristaben®; Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®; Januvia®, Tesavel®, Xelevia®, Ristaben®; Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment