bioihbjkbjnl/mcl2 huggingface dataset:
Phase II Study of Grass Pollen Allergy Vaccine BM32
Condition: Grass Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the efficacy and safety of BM32 in grass pollen allergic subjects. It
      will test the hypothesis that either of two doses of BM32 will lead to a sustained relief off
      allergy symptoms over a two year study period.
    

Detailed description: 
      The present study is designed to evaluate the efficacy and safety of a treatment with the
      recombinant vaccine BM32 during two consecutive grass pollen seasons. Efficacy evaluation
      will be performed on the basis of allergy symptoms and use of relief medication as well as
      based on immunological parameters. After patient assessment during a screening season,
      patients will be randomized to one of two doses of BM32 or placebo. Patients will receive
      three injections of BM32 pre-season and one post-season boost injection to maintain optimal
      allergen specific IgG responses. Outcome will be measured after both seasons individually.
    

Intervention name(s): BM32; BM32; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Subcutaneous injection of 20 micrograms of each of the protein components of BM32 adsorbed on 0.6 mg of aluminum hydroxide every 4 weeks for a total of 3 injections before each pollen season and one boost injection after pollen season; Subcutaneous injection of 40 micrograms of each of the protein components of BM32 adsorbed on 1.2 mg of aluminum hydroxide every 4 weeks for a total of 3 injections before each pollen season and one boost injection after pollen season; Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every four weeks before each pollen season and one injection after pollen season for a total of 7 injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Grass pollen allergy; Immunotherapy; Recombinant vaccine; Rhinitis, allergic, seasonal
Effects of Protein Blends on Muscle Protein Synthesis in Healthy Older Adults
Condition: Muscle Synthesis
Study type: Interventional

Summary: 
      During aging there is a tendency for muscle protein synthesis (growth) to become less
      efficient and the resulting consequence leads to reduced muscle mass (sarcopenia) which can
      affect strength and mobility. Protein consumption may be one opportunity to alleviate this
      problem especially when consumed in appropriate amounts following resistance training. This
      study is designed to determine if a soy dairy protein blend, shown to be effective in younger
      adults, will produce beneficial muscle protein synthesis in older healthy adults following
      resistance exercise.
    


Intervention name(s): Soy Dairy Protein Blend; Positive Control (Dairy Whey Protein)
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: soy; whey; muscle; older; mTOR; sarcopenia
A Phase III Study of NK105 in Patients With Breast Cancer
Condition: Breast Cancer Nos Metastatic Recurrent
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To verify the non-inferiority of NK105, a paclitaxel-incorporating micellar nanoparticle, to
      paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent
      breast cancer.
    

Detailed description: 
      This study is a randomized, open-label, multi-national phase III study.
    

Intervention name(s): NK105; Paclitaxel
Intervention type(s): Drug; Drug
Intervention description(s): IV, Weekly; IV, Weekly
Intervention MeSH terms: Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NK105, Paclitaxel, Breast cancer, Micelle
Stress Levels and Mental Well-Being Among Slovak Students During e-Learning
Condition: Anxiety State; Depression
MeSH terms: Depression
Study type: Observational

Summary: 
      Introducing restrictions on human contact has been effective in preventing the uncontrolled
      spread of COVID-19, however, it appears to have negatively impacted mental health.
      Psychological problems in different age groups occur with different intensity and duration of
      the pandemic. This study was aimed to assess the impact of introducing distance learning
      (e-Learning) on the stress levels and mental well-being among Slovak Students.
    

Detailed description: 
      Socially isolated young people, condemned to constant contact with the Internet, find
      themselves in sorrowful situations where their basic need were impossible. Previous studies
      report that university students report high levels of stress, anxiety, and depression, which
      affects student motivation and attitudes toward learning; however, to date, no such studies
      have been conducted on a population of Slovakian Students. This study considered 4 Slovak
      universities. Using standardized questionnaires, students' mental status during e-Learning
      was assessed at the beginning of the summer semester (February, March 2021).
    

Intervention name(s): Stress Levels and Mental Well-Being assessment
Intervention type(s): Diagnostic Test
Intervention description(s): At the beginning of the summer semester of the 2020/2021 academic year, stress levels as well as symptoms of anxiety and depression were assessed in students at four universities.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Students participating in active learning
      
Keywords: depression; e-Learning; COVID-19; anxiety
BG9928 in Subjects With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the effect of hepatic function on the
      pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic
      impairment and in subjects with normal hepatic function.
    


Intervention name(s): BG9928
Intervention type(s): Drug
Intervention description(s): Oral 75 mg single dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics
Cerebral Regional Oxygenation With Manual Versus AutoFlow Ventilation
Condition: Oxygen Deficiency
MeSH terms: Hypoxia
Study type: Observational [Patient Registry]

Summary: 
      Anesthesia induction is associated with hemodynamic imbalances that can affect the blood flow
      to major organs. Moreover it can result in deoxygenation as well. During standard anesthesia
      induction the patient is manually ventilated with a circle-valve-mask system until the effect
      of muscle relaxant shows of. Near-infrared spectroscopy (NIRS) is a modification of a
      well-known peripheral pulse oxymetry that is used in the detection of the regional oxygen
      saturation (rSO2) in organs, including brain, liver, muscle, and intestines. In this study we
      will compare the regional oxygenation status of the patients during anesthesia induction in
      which either standard manual ventilation or mechanical ventilator-assisted ventilation was
      performed. AutoFlow(R) mode of Draeger-Perseus mechanical ventilator will be used for the
      ventilator-assisted ventilation.
    


Intervention name(s): Mechanical ventilator-assisted ventilation
Intervention type(s): Behavioral
Intervention description(s): After the intravenous anesthesia induction, mechanical ventilator-assisted ventilation with AutoFlow mode of the anesthesia machine (Draeger-Perseus) will be applied before intubation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric surgical patients aged 5-10 years scheduled for elective surgery.
DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Type 2 Diabetes
Condition: Chronic Foot Ulcers
MeSH terms: Foot Ulcer; Diabetes Mellitus, Type 2; Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized versus placebo trial designed to evaluate the clinical and humoral effects of 4
      months of vildagliptin on healing of chronic ulcers in type 2 diabetes.
    

Detailed description: 
      The chronic foot ulcer is a leading cause of hospital admissions for people with diabetes in
      the developed world and is a major morbidity associated with diabetes, often leading to pain,
      suffering, and a poor quality of life for patients. Chronic diabetic foot ulcers are
      estimated to occur in 15% of all patients with diabetes and precede 84% of all
      diabetes-related lower-leg amputations.The pathophysiology of chronic diabetic ulcers is
      complex and still incompletely understood, the most important predisposing factors being
      diabetic neuropathy and vasculopathy. Both micro and macroangiopathy strongly contribute to
      development and delayed healing of diabetic wounds, through an impaired tissue feeding and
      response to ischemia. HIF-1α and VEGF, as well as the NO production from iNOS, may contribute
      to limitation of hypoxic injury by promoting angiogenesis and wound healing. Experimental and
      pathological studies suggest that suggest that he incretin hormone glucagon-like peptide-1
      (GLP-1) may improves VEGF generation, and promote pancreatic islet viability through the
      up-regulation of HIF1α.

      Therefore, aim of this study is to evaluate the effect of the augmentation of GLP-1, by
      inhibitors of the dipeptidyl peptidase IV (DPP-4), such as vildagliptin, on HIF-1α, VEGF and
      iNOS in diabetic chronic ulcers.
    

Intervention name(s): Placebo; vildagliptin
Intervention type(s): Drug; Drug
Intervention description(s): Placebo is added to the standard good medical practice. Plus Metformin and/or Sulfonylurea; 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.Plus Metformin and/or Sulfonylurea
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: type 2 diabetes; healing; foot ulcers; vildagliptin
Effects of OMT on Interoception
Condition: Chronic Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      Recent evidence suggested that the anterior insula cortex seems to be the main site of
      interoception. Several studies showed an association between change in insula function and
      interoception, bodily perception and consciousness in subjects with chronic pain. Although
      osteopathic research has been demonstrated to be effective in reducing pain, studies
      exploring the effect of osteopathy on interoception are lacking. Therefore, the aim of the
      present study is to explore the extent to which osteopathic treatment could modify
      interoception parameters both measuring brain functional connectivity and clinical
      questionnaires.
    


Intervention name(s): osteopathic manipulative treatment; sham osteopathic treatment
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteopathic manipulative treatment; interoception
Circulating Myokine Levels and Bone Metabolism
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Observational

Summary: 
      Circulating levels of several myokines will be measured in serum samples obtained from women
      in various categories of bone density and according to the presence of fracture or not as
      well as before and after treatment with teriparatide and denosumab
    

Detailed description: 
      Serum samples for the measurement of several myokines will be obtained from: 1) equal groups
      of premenopausal women with normal BMD, postmenopausal women with normal BMD, postmenopausal
      women with osteopenia, and postmenopausal women with osteoporosis; 2) women with hip fracture
      compared with controls (women subjected to surgery due to knee osteoathritis); 3) women with
      osteoporosis treated with teriparatide or denosumab for 12 months
    

Intervention name(s): Teriparatide; Denosumab
Intervention type(s): Drug; Drug
Intervention description(s): 1 subcutaneous injection daily for 12 months; 1 subcutaneous injection every 6 months for 12 months
Other intervention name(s): rhPTH 1-34; RANKL inhibitor
Intervention MeSH terms: Denosumab; Teriparatide
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Substudy 1: equal groups (n=25) of premenopausal women with normal BMD, postmenopausal
        women with normal BMD, postmenopausal women with osteopenia, and postmenopausal women with
        osteoporosis Substudy 2: postmenopausal women with an incident hip fracture (n=40) compared
        with controls (postmenopausal women with knee osteoarhtritis) Substudy 3: postmenopausal
        women with osteoporosis will receive treatment with either teriparatide or denosumab for 12
        months
      
Biospecimen description: 
      serum samples
Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
Condition: Insomnia; Schizophrenia; Schizoaffective Disorder; Sleep Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The major goal of this project is to investigate established insomnia treatments in a
      schizophrenia population to see if the improved sleep leads to overall better quality of
      life. In addition, we hypothesize that the insomnia treatment may also lead to observed
      improvements in other symptoms associated with schizophrenia such as cognitive impairments,
      obesity, and negative symptoms.
    

Detailed description: 
      The primary aim of this study is to investigate the clinical efficacy of eszopiclone for the
      treatment of schizophrenia-related insomnia over 8 weeks. A two-week, single-blind placebo
      phase followed the double-blind phase to evaluate rebound and withdrawal effects after abrupt
      discontinuation.
    

Intervention name(s): Eszopiclone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eszopiclone 2mg each night for the first week then Eszopiclone 3mg each night for the remaining weeks.; Placebo or inactive substance ("sugar pill")taken each night for all weeks of the study
Other intervention name(s): Lunesta
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the BunnyLens TR Intraocular Lens
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      With age, a human crystalline lens opacifies (cataract) disabling the eye in generating a
      clear, well contrasted image. The only therapeutic solution to this problem is surgical
      replacement of the crystalline lens with an intraocular lens (cataract surgery).

      In addition to the cataract, the person might suffer from pre-existing cormeal astigmatism.
      In cases of severe corneal astigmatism, the standard IOL might not provide the optimal
      result, and additional surgical procedures as Incisional Keratotomy or Limbal Relaxing
      Incisions might be required.

      BunnyLens TR IOL is an Aspheric Toric intraocular lens providing a precise, superior
      alternative to surgical treatment of pre-existing corneal astigmatism.

      The BunnyLens TR IOL is designed for micro-incision cataract surgery (MICS), through 1.8mm
      incisions.

      The aims of this study are to:

        -  Demonstrate a reduction in refractive cylinder compared to pre-operative corneal
           astigmatism

        -  Exceed monocular best corrected distance visual acuity results provided in ISO
           guidelines.
    

Detailed description: 
      The reduction in refractive cylinder compared to pre-operative corneal astigmatism will be
      assessed using pre- and postoperative subjective refraction evaluation. Units of the
      measurement: diopters.

      Monocular best corrected distance visual acuity will be assessed using ETDRS charts. Units of
      the measurement: logMAR.

      There are no complications related to the BunnyLens TR implantation beyond those that might
      be expected in standard cataract surgery. The complications will be reported using Ocular
      condition forms included in the CRFs.
    

Intervention name(s): BunnyLens TR
Intervention type(s): Device
Intervention description(s): BunnyLens TR IOL is an Aspheric Toric intraocular lens providing a precise, superior alternative to surgical treatment of pre-existing corneal astigmatism.
Other intervention name(s): toric inta-ocular lens
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cataract; cataract surgery; intaocular lens; toric lens
Korean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the current study is to compare the antiplatelet efficacy and safety of
      clopidogrel napadisilate and clopidogrel bisulfate in Coronary Artery Disease (CAD) patients
      after coronary stent implantation.
    


Intervention name(s): clopidogrel napadisilate + aspirin; clopidogrel bisulfate + aspirin
Intervention type(s): Drug; Drug
Intervention description(s): clopidogrel napadisilate 75mg + aspirin 100mg; clopidogrel bisulfate 75mg + aspirin 100mg
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CAD; PCI; Percutaneous Coronary Intervention
First Impressions and Attractiveness Levels of Smiling Individuals With and Without a Mask
Condition: First Impressions; Attractiveness
Study type: Observational

Summary: 
      Evaluation on the effects of smiling on first impressions and attractiveness with and without
      wearing a facial surgical mask.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Inclusion Criteria:

          1. Models who are males and females of ages 21-39.

          2. Live and random raters who are males and females of ages 18-39.

          3. Models and raters that understand the purpose and aspects of the study, freely sign
             the consent and complete the required visit.

          4. Models and raters must all be able to understand English fluently.

        Exclusion Criteria:

          1. Model participants younger than 21 or older than 40 will not be included.

          2. Live and random rater participants younger than 18 and older than 40 will not be
             included.

          3. Models with unusual hair styles or colors

          4. Facial piercing other than ears

          5. Facial and/or neck scaring or tattooing

          6. Models and raters that do not understand the purpose and aspects of the study, do not
             sign the consent and do not complete the required visit will also be excluded.
      
Keywords: attractiveness; first impressions; smiling; mask; masking; rating
A Study of Galcanezumab (LY2951742) in Participants With Migraine Headache
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to evaluate whether the study drug known as galcanezumab is
      safe and effective in the prevention of migraine headaches.
    


Intervention name(s): Galcanezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SQ; Administered SQ
Other intervention name(s): LY2951742
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate Safety and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the pharmacokinetics (PK) of BIIB104 in
      healthy Japanese and non-Japanese participants. The secondary objective of the study is to
      evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered twice
      daily (BID) for 9 days, with an additional dose occurring in the morning on Day 10 in healthy
      Japanese and non-Japanese participants.
    


Intervention name(s): BIIB104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm; Administered as specified in the treatment arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment