bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Gender on Depression and Periodontal Status
Condition: Periodontal Diseases; Depression; Gender; Gingival Diseases
MeSH terms: Periodontal Diseases; Gingival Diseases; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      There is a relationship between depression and periodontal disease. This relationship may be
      double-sided. A psychological state such as anxiety, depression, body image, and self-esteem
      may be affected from the symptoms of periodontal disease.
    

Detailed description: 
      Background: Depression is a multifactorial disease characterized by a variety of symptoms.
      Individuals with psychiatric disorders seem to be more prone to periodontitis. However
      periodontal disease and depression can be considered bidirectional risk factors. Periodontal
      diseases can also be an effect on depression. The purpose of the present study was to
      evaluate the gender-related differences in the relationship between periodontal diseases and
      depression in male and female adults.

      Material and methods: The study population consisted of 339 subjects. Two groups were formed
      from these patients: 171 females with periodontal disease (71 subjects with gingivitis, 100
      subjects with periodontitis); 168 males with periodontal disease (72 subjects with
      gingivitis, 96 subjects with periodontitis). Clinical periodontal and psychological measures
      were performed on females and males group.
    

Intervention name(s): Psychological measurements
Intervention type(s): Other
Intervention description(s): A questionnaire test (Beck depression Inventory) for depression was performed.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: periodontal diseases; depression; gender; gingival diseases
A Pilot Trial of Manlikang in Reducing Salt Intake and Blood Pressure Among Patients With Hypertension
Condition: Hypertension; Hypertension With Abnormal Renal Function
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study is a single arm trial with before-after comparison design. Three groups of
      patients with hypertension will be recruited: not taking antihypertension drugs and having
      normal renal function, taking antihypertension drugs and having normal renal function, and
      having abnormal renal function without regards of antihypertension drugs use. Each group
      includes 30 patients. Based on renal function test, the investigators provide the Manlikang
      containing potassium chloride to patients with normal renal function, and provide the
      Manlikang not containing potassium chloride to patients with abnormal renal function. All
      hypertension patients will use the formula salt with very low sodium (Manlikang) for six
      weeks, and will be followed up at 1, 2, 4 and 6 weeks. The primary outcome will be the
      decrease of patients' systolic blood pressure at the end of the trial.
    


Intervention name(s): formula salt with very low sodium (Brand name: Manlikang)
Intervention type(s): Dietary Supplement
Intervention description(s): hypertension patients will use the formula salt with very low (<20%) sodium （Manlikang) for six weeks, and will be followed up at 1, 2, 4 and 6 weeks to assess the 24-hour urine sodium.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Relationship of SmartPhone Use Addiction With Musculoskeletal System and Cognitive Flexibility
Condition: Smartphone; Musculoskeletal; Cognitive Flexiblity
MeSH terms: Behavior, Addictive
Study type: Observational

Summary: 
      Smartphones have become a part of everyday life, but with some problems. Researches have
      pointed out that smartphone addiction can cause both physical and mental problems.
    

Detailed description: 
      Smartphones have become a part of everyday life, but with some problems. Developments in
      communication technologies have also improved the capacities and limits of smartphones. This
      has led to the increased availability of smartphones in daily life. Smartphones have become a
      part of everyday life, but with some problems. Smartphone addiction has been an important
      topic of research and discussion as a type of addiction that develops depending on the
      frequency of smartphone use. Researches have pointed out that smartphone addiction can cause
      both physical and mental problems. As a result of a study conducted in the literature,
      continuous use of smartphones has been found to cause sleep disturbances, stress, anxiety,
      decrease in physical activities and many diseases. In this study, the relationship between
      the concept of smartphone addiction and musculoskeletal problems and cognitive flexibility in
      young people will be investigated.
    

Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        university students between the ages of 18-25
The Use of Inflammatory Markers to Guide Therapy in Children With Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether using non-invasive measurements of airway
      inflammation can improve clinical decision making in children with severe asthma compared to
      conventional management (British Thoracic Society Guidelines)
    

Detailed description: 
      Children with severe asthma pose a management dilemma; it is difficult to reduce their
      treatment while they are symptomatic, but the plateau of the dose response curve for inhaled
      corticosteroids (ICS) may have been reached. Studies in symptomatic adults and asymptomatic
      children with asthma suggest measuring induced sputum eosinophils allows better asthma
      management. We will recruit 80 children with severe asthma (treated with at least 500 mcg/day
      inhaled fluticasone or equivalent). We will see them every three months for a year, and
      perform sputum induction and measurements of exhaled nitric oxide (eNO). Half will be
      randomised to conventional management; half will have a reduction of ICS if there are no
      sputum eosinophils, or (if a sample cannot be produced) eNO is normal. The trial endpoint is
      whether there is a significant reduction in the median dose of ICS in the inflammatory
      markers group, with no increase in total number of asthma exacerbations. This study is also
      hypothesis generating. We will use our panel of markers (a) to try to improve clinical
      monitoring; and (b) to determine the molecular mechanisms of relapse of severe asthma.
    

Intervention name(s): Non invasive measurement of airway inflammation
Intervention type(s): Other
Intervention description(s): Airway inflammation will be assessed non-invasively using induced sputum and exhaled nitric oxide. In the active group the results of these tests will be used to determine if asthma treatment should be changed. In the comparator group treatment changes will be based according to conventional symptom based management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Asthma; Pediatrics; Airway; Inflammation
Slow-wave Sleep Deprivation in Depression
Condition: Major Depressive Disorder
MeSH terms: Sleep Deprivation; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Sleep deprivation can acutely reverse depressive symptoms in patients with major depression.
      Although underlying mechanisms of the antidepressant action in sleep deprivation are unclear,
      many of these observations can be explained by abnormal slow wave homeostasis. This study
      will test the prediction that selectively reducing slow waves during sleep (slow wave
      deprivation; SWD), without disrupting total sleep time, will yield an antidepressant effect.
    

Detailed description: 
      see above
    

Intervention name(s): Slow-wave deprivation
Intervention type(s): Device
Intervention description(s): Using acoustic tones to suppress slow-wave sleep
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Basic Science
Rheumatoid Arthritis Through Education and US Study (RAEUS)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Patients can potentially monitor disease activity of rheumatoid arthritis (RA) through
      self-assessed swollen joints (clinical synovitis)joint counts but reliability of joint
      swelling is poor. The objective is to evaluate the use of education by ultrasound feedback on
      the ability of patients to assess for clinical synovitis swollen joints in RA.
    

Detailed description: 
      Design: 6-month single centre randomized controlled trial. Patients: established RA.
      Intervention: education on self-assessment of joints that included initial brief patient
      training on tender (TJC) and swollen (SJC) joint counts, followed by US feedback every 3
      months versus standard care without education. Patient and physician independently performed
      28-joint counts at each visit. Outcome variables: (Primary) Percentage of patients with good
      agreement with physician derived swollen joints (prevalence-adjusted bias adjusted kappa,
      PABAK>0.6). Other variables: Agreement in SJC (Bland and Altman 95% limits of agreement),
      feasibility/patient satisfaction survey and disease activity score (DAS28) at 6 months.
    

Intervention name(s): Education using ultrasonography as feedback tool
Intervention type(s): Behavioral
Intervention description(s): Education using ultrasonography as feedback tool
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Comparison of Concussion Education Programs
Condition: Concussion, Brain
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      Importance: Concussion underreporting leads to delays in diagnosis and treatment, resulting
      in prolonged recovery. Athletes' report of concussion symptoms is therefore an important
      component of risk reduction. Numerous educational interventions to improve concussion
      knowledge and reporting exist.

      Objective: Evaluate the comparative efficacy of three concussion education programs in
      improving concussion-reporting intention.

      Design: Randomized clinical trial conducted from August 2018 to October 2018, with assessment
      before, immediately after, and one-month after educational intervention.
    


Intervention name(s): Education
Intervention type(s): Other
Intervention description(s): Education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate the Amount of Drug That Becomes Available to the Blood Circulation When Inhaled by a Nebulizer and Dry Powder Inhaler in Healthy Subjects.
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the relative bioavailability of the AZD7594 nebulized
      formulations (test) and the dry powder formulation (reference).

      The study results will provide information on the pharmacokinetic (PK) profile following use
      of the 2 devices to be used in further clinical development.
    

Detailed description: 
      This study will be an open-label, randomised, 3 period, 3-treatment, crossover study in
      healthy subjects (males and females), performed at a single clinical unit.

      The study will comprise:

        -  A screening period of maximum 28 days;

        -  Three treatment periods during which subjects will be resident from the morning (fasting
           conditions) of the day before dosing with AZD7594 (Day -1) until at least 48 hours after
           dosing; discharged on the morning of Day 3;

        -  Two ambulatory visits (Day 4 and Day 5) within each treatment period; and

        -  A final visit 10 to 14 days after the last administration of AZD7594.

        -  There will be a minimum washout period of 10 days between each dose administration.

      A total of 24 subjects will be randomised to receive single doses of AZD7594 on 3 occasions,
      under fasted conditions (overnight fast of at least 10 hours):

        -  Treatment A: 0.7 mg (delivered dose) AZD7594 via nebulizer, test

        -  Treatment B: 1.6 mg (delivered dose) AZD7594 via nebulizer, test

        -  Treatment C: 720 μg (delivered dose) AZD7594 via dry powder inhaler (DPI), reference

      Each subject will be involved in the study for approximately 10 to 12 weeks.
    

Intervention name(s): AZD7594
Intervention type(s): Drug
Intervention description(s): Treatment A: The study drug is a nebulizer suspension with strength 2.8 mg/mL using 2 mL in the device. The study drug is administered via oral inhalation.
Treatment B: The study drug is a nebulizer suspension with strength 6.3 mg/mL using 2 mL in the device. The study drug was administered via oral inhalation.
Treatment C: The study drug is an inhalation powder. The study drug was administered via oral inhalation.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Pharmacokinetics; Safety; Selective glucocorticoid receptor modulator
Use of Degarelix in Controlled Ovarian Hyperstimulation (COH) Protocol for Women With PoliCystic Ovarian Syndrome (PCOS)
Condition: PCOS; OHSS; INFERTILITY
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in a
      unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian
      hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS.
    

Detailed description: 
      Women with PCOS are at risk to develop OHSS when stimulated with gonadotrophins for IVF. For
      this reason in this study the degarelix was tested in order to minimize the risk of OHSS as
      well as to improve the pregnancy rate in these patients. The use of long acting GnRH
      antagonist promotes a deep suppression of LH and consequently the activity of theca cells,
      which secrete androgens (the precursors of estradiol), and consequently the levels of
      estradiol remains low. Comparing the long acting GnRH antagonist at the first day of cycle
      with a flexible GnRH antagonist protocol in a group of patients with PCOS will be useful in
      order to establish the best way to perform controlled hyperstimulation in IVF cycles and
      minimize the risk of OHSS.
    

Intervention name(s): degarelix (long acting GnRH antagonist); cetrorelix 0.25mg
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg of degarelix the first day of menstrual cycle before starting with gonadotrophins administration; 0.25mg of cetrorelix during treatment with gonadotrophins when estradiol levels were >300pg/ml
Other intervention name(s): Firmagon; cetrotide
Intervention MeSH terms: Cetrorelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: GnRH antagonist; PCOS; OHSS; COH; IVF
A Study of E6011 in Japanese Subjects With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study consist of treatment phase (12 weeks) and extension phase (40 weeks). This study
      is a multicenter, open-label, uncontrolled, multiple ascending dose (MAD) study to evaluate
      mainly the safety and tolerability of 12-week repeated subcutaneous administration of E6011
      in Japanese subjects with Rheumatoid Arthritis. First 12 subjects will enroll as 100 mg
      group, next 12 subjects will enroll as 200 mg group, and last 9 subjects will enroll as 400
      mg group. A total of 33 subjects will receive repeated subcutaneous administration of E6011.
      Subjects who roll over onto the Extension phase will have continued monitoring until 52 weeks
      after the initial administration.
    


Intervention name(s): E6011
Intervention type(s): Drug
Intervention MeSH terms: Quetmolimab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Japanese subjects
Effects of Oral Probiotic Product on Vaginal Microbial Community and Parameters of Vaginal Health
Condition: Vaginal Health
Study type: Interventional

Summary: 
      The purpose of the study is to assess the efficacy and safety of an oral probiotic product on
      the vaginal microbiome and on parameters of vaginal health. Eligible subjects will utilize
      the investigational product as directed for a period of 28 days. The vaginal microbial
      community and parameters of vaginal health will be measured at baseline and after 14 and 28
      days of supplementation. A follow-up post-supplementation visit will be conducted on Day 42.
    


Intervention name(s): Oral probiotic product
Intervention type(s): Dietary Supplement
Intervention description(s): Once per day (QD), 28 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sleep, Autonomic Nervous System and Cardiorespiratory Capacity in Autism Spectrum Disorders Children (APAUTRES)
Condition: Autonomic Nervous System Diseases; Sleep
MeSH terms: Nervous System Diseases; Autonomic Nervous System Diseases; Primary Dysautonomias; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Autism Spectrum Disorders (ASD) is a neurodevelopmental disorder which involves social and
      behavioural impairments. Autonomic dysfunctions and disturbed sleep were often associated to
      ASD. The investigators proposed to explore the impact of physical activity on these
      disorders. In this context, it is necessary to characterize the cardiorespiratory capacities
      of ASD children in order to promote physical activity for this population. To examine
      potential differences between ASD and control children, some explorations were proposed: a
      maximal treadmill test, motor evaluation, and orthostatic test (for the evaluation of
      autonomic nervous system).

      An actimetry during one week (evaluation of physical activity and sleep) completed this study
      in order to specify sleep characteristic and established the possible link between physical
      activity sleep characteristics and physical fitness in ASD children.
    


Intervention name(s): physiological explorations
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: autism spectrum disorder
Eggs as Part of a Healthy Breakfast
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Contrary to popular belief, previous studies have demonstrated beneficial effects of whole
      egg consumption in modifying biomarkers indicative of a greater risk of coronary heart
      disease (CHD), chronic inflammation, and insulin resistance. The following study is designed
      to conduct a comprehensive evaluation of consuming an egg-based breakfast compared to an
      oatmeal-based breakfast on lipid biomarkers, oxidative stress, inflammation, insulin
      sensitivity, and satiety in young, healthy men and women. The investigators hypothesize that
      the consumption of 2 eggs per day will not negatively impact plasma lipids in a young,
      healthy population.
    


Intervention name(s): Eggs - 2 per day for breakfast; 1 packet of oatmeal per day
Intervention type(s): Other; Other
Intervention description(s): 11-week crossover study in which participants consumed 2 eggs or 1 packet of oatmeal per day daily for 4 weeks, separated by a 3-week washout period.; 11-week crossover study in which participants consumed 2 eggs or 1 packet of oatmeal per day daily for 4 weeks, separated by a 3-week washout period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Risk
Embryonic Dopamine Cell Implants for Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to determine if patients who received embryonic dopamine cell
      implant surgery showed significantly greater improvement in their Parkinson's disease than a
      control group undergoing the placebo treatment, and to determine if the cell implant surgery
      was more effective in younger or older patients.
    

Detailed description: 
      Parkinson's disease is caused by the death of a small number of nerve cells that produce a
      critical chemical called dopamine. The drug L-dopa can partially make up for the lack of
      dopamine. As time goes on, however, most patients notice that the drugs do not work as well.
      Oftentimes, patients develop great fluctuations in motor control. Off drugs they cannot move,
      and on drugs they have excess, exaggerated movements. Research in animals over the last 20
      years has shown that dopamine cells can be replaced by transplants of new cells obtained from
      fetal brain tissue. For the past 14 years, several laboratories around the world have been
      performing similar transplants of human fetal brain tissue on patients with Parkinson's
      disease. So far, it has been impossible to compare results from the different groups because
      no two centers are performing transplants in the same way.

      This study seeks to get around that problem using a controlled clinical trial that compares
      the embryonic dopamine cell implant surgery with a placebo treatment. A total of 40 patients
      were recruited--half received the cell implant surgery, while the other half received the
      placebo. After the double-blind phase of the study, patients in the placebo group had the
      option of receiving tissue implants. Fourteen of these patients eventually had transplants.
      At present, this study is providing long-term follow-up evaluation and treatment for the
      subjects.
    

Intervention name(s): embryonic dopamine cell implant surgery; placebo
Intervention type(s): Procedure; Procedure
Intervention description(s): Half of the participants received the cell implant surgery, while the other half received the placebo. After the double-blind phase of the study, patients in the placebo group had the option of receiving tissue implants. Fourteen of these patients eventually had transplants.; sham surgery
Intervention MeSH terms: Dopamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease; PD; dopamine; embryonic dopamine cell implant surgery; tissue implants