bioihbjkbjnl/mcl2 huggingface dataset:
Stressors, Coping Methods and Social Support in Diabetic Patients
Condition: Type 2 Diabetes
Study type: Observational

Summary: 
      The increasing prevalence of diabetes brought great burden to health status of the
      investigators population. It is meaningful to investigate the stressor, stress perceived,
      social support and coping methods in diabetic population in order to provide appropriate
      assistance to these patients. This study will recruit diabetes patients from
      out-patient-department and they are invited to complete a questionnaire. The contents of the
      questionnaire including stress experienced, stress perceived, social support and coping
      methods. The investigators purpose is to find out the impact of these factors on glycemic
      controlled and their life quality. The results will be useful to diabetes care team when
      health education is delivered to patient.
    

Detailed description: 
      Type 2 diabetes patient aged 30-80 y/o under oral hypoglycemic agents with clear conscious
      enable to answer questions properly who regularly follow up at our metabolism clinic is
      eligible. Patients are asked to complete a questions containing basic personal information,
      diabetes coping method Chinese version (DCM-C)questionnaire, social support and perceived
      stress scale.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1. Type 2 diabetes

          2. Aged 30-80 year old

          3. under oral hypoglycemic agents

          4. clear consciousness
      
Keywords: stress; coping methods; social support; diabetes mellitus
Fiber-enriched Buckwheat Pasta and Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease
Condition: Type 2 Diabetes Mellitus; Celiac Disease
MeSH terms: Celiac Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The intervention was preceded by a 1-week run-in period during which participants underwent
      continuous glucose monitoring (CGM) and filled in a 7-day dietary record to optimize basal
      infusion rate and insulin-to-glycemic load ratio. The study had a randomized crossover design
      with each subject studied on 2 occasions at least 1 week apart. Participants were assigned to
      consume, in random order, two test meals with the same amount of carbohydrates (50g): a meal
      containing fiber-enriched buckwheat pasta (FBP) or corn pasta (CP), used as control. Over the
      experimental period, participants underwent CGM, wearing their sensors 7 days/week.
    


Intervention name(s): Acute test meal with fiber-enriched buckwheat pasta; Acute test meal with corn pasta
Intervention type(s): Other; Other
Intervention description(s): Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil); Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of Intracoronary Adult Human Mesenchymal Stem Cells After Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Early reperfusion strategies in tandem with remarkable advances in drugs and devices for
      treating myocardial infarction (MI) have contributed to a reduction in early mortality, but
      cardiovascular disease remains the leading cause of death worldwide. Current management
      strategies cannot solve the problem of cardiomyocyte loss and consequent progression of heart
      failure. In this respect, stem-cell therapy has shown potential benefits for repairing the
      damaged myocardium. Mesenchymal stem cells (MSCs) have been considered to be attractive
      therapeutic candidates because of their high capacity for replication: paracrine effect:
      ability to preserve potency: and because they do not cause adverse reactions to allogeneic
      versus autologous transplants. Intracoronary injection of stem cells seems to be safe, but
      only one clinical trial using MSCs via the intracoronary route in the setting of acute
      myocardial infarction (AMI) has been carried out. The investigators therefore assessed the
      safety and efficacy of intracoronary autologous bone marrow (BM)-derived human MSCs in
      patients with AMI.
    


Intervention name(s): Mesenchymal stem cell; Control group
Intervention type(s): Drug; Drug
Intervention description(s): Route : intracoronary injection Frequency : single dose of autologous bone-marrow derived mesenchymal stem cells Dosage : 1x1000000 cells/kg Duration : mean injection duration approximately 4 weeks after primary percutaneous coronary intervention; No additional treatment of mesenchymal stem cells
Other intervention name(s): Hearticellgram-AMI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesenchymal stem cells; Myocardial infarction; Left ventricular dysfunction
Central Proprioceptive Processing and Postural Control in LBP
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      This project aims to elucidate neural correlates of proprioceptive deficits in patients with
      recurrent non-specific low back pain, by studying whether brain activation patterns during
      the processing of proprioceptive signals from the ankle muscles and lower back muscles are
      altered compared to healthy control subjects.
    

Detailed description: 
      Low back pain is a highly prevalent health condition, with a reported lifetime prevalence of
      up to 84% worldwide. Currently, it induces more disability than any other health condition,
      such as depression, diabetes, chronic obstructive pulmonary disease or other musculoskeletal
      disorders. Approximately 85% of all low back pain complaints are non-specific, meaning that
      the pain cannot be attributed to a recognizable specific pathology such as an infection or
      vertebral fracture. While many patients with low back pain recover within a month, a large
      number of patients report a recurrence within one year. Current treatment interventions often
      remain unsuccessful, which highlights the current lack of knowledge on the underlying
      mechanisms of non-specific low back pain.

      Postural control deficits have been identified as a key factor in the development and
      recurrence of non-specific low back pain. To achieve optimal postural control, the central
      nervous system needs to process, integrate and weigh proprioceptive signals from different
      body regions (e.g. ankle muscles and lower back muscles) with vestibular and visual inputs.
      Several studies have shown that patients with non-specific low back pain have a decreased
      ability to optimally weigh proprioceptive signals during standing, which leads to reduced
      postural robustness compared to pain-free individuals. More specifically, patients with low
      back pain dominantly rely more on proprioceptive signals from the ankle muscles and are not
      able to up-weigh proprioceptive signals from the lower back muscles when needed. This might
      be due to an impaired central processing of proprioceptive signals. However, up to now no
      studies have investigated central proprioceptive processing in patients with recurrent
      non-specific low back pain.

      Therefore, this project aims to elucidate whether patients with recurrent non-specific low
      back pain showed altered brain activation patterns during the processing of proprioceptive
      signals from the ankle muscles and lower back muscles compared to healthy controls, by
      applying local muscle vibration during functional magnetic resonance imaging (fMRI).
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Leuven and surrounding area
A Human Trial to Evaluate the Efficacy and Safety of Fermented Turmeric in Subjects Showing Mild Hepatic Injury
Condition: Mild Hepatic Injury
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators performed a double-blind parallel study in a group of showing mild hepatic
      injury subjects who were given Fermented turmeric over a period of 12 weeks. The
      investigators measured liver function parameters , including ALT(Alanine Transaminase),
      AST(Aspartate Transaminase), ALP(Alkaline Phosphatase), γ-GT(Gamma-Glutamyl Transferase), and
      serum bilirubin, and monitored their blood pressure.
    


Intervention name(s): Placebo; Fermented turmeric
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Placebo(3.0g/day); Fermented turmeric(3.0g/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Pharmacokinetics Study of Qing'E Pill
Condition: Menopause
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the pharmacokinetics of single and multiple doses of Qing'E pills
      in Chinese menopause volunteers. The main components of Qing'E pill into the blood such as
      psoralen and Isopsoralen will be detected.
    


Intervention name(s): Qing'E pill
Intervention type(s): Drug
Intervention description(s): Qing'E pill is composed of eucommia, psoralen, walnuts and garlic.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Menopause, pharmacokinetic
ENTact™ Septal Stapler Shelf Life Extension
Condition: Deviated Nasal Septum
Study type: Interventional

Summary: 
      This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue
      approximation utilizing staples with extended shelf life. The ENTact™ Septal Stapler will be
      used to approximate the mucoperichondrial flaps in all patients. Each treatment group will be
      implanted with product that has been aged for a specified amount of time.
    


Intervention name(s): ENTact™ Septal Stapler; ENTact™ Septal Stapler
Intervention type(s): Device; Device
Intervention description(s): 1 year aged septal staples; 18 Month Aged Staples
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bevacizumab for Neovascular Age-related Macular Degeneration
Condition: Exudative Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Interventional

Summary: 
      Age-related macular degeneration (AMD) is one of primary blinding eye disease among people
      over 65 years in China. The anti-VEGF antibody treatment is proved useful for Neovascular
      Age-related Macular Degeneration (nAMD) by many studies. Bevacizumab is the only available
      low-cost type of anti-VEGF drug currently in China. This study is a multi-center, randomized
      trial of Bevacizumab effective dose and safety for nAMD. This study is to explore the
      effective therapeutic approach that the majority of patients in China can bear establishing a
      suitable treatment for China.
    


Intervention name(s): Bevacizumab 1; Bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): Bevacizumab, 1.25mg/0.05ml, every 6 weeks, 42weeks; Bevacizumab, 1.25mg/0.05ml, 0week(baseline), 6week, 12week, 24week, 36week
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: neovascular age-related macular degeneration; Bevacizumab; Multicenter Randomized Study
Study Of The Long Term Outcome Of Tuberculous Meningitis In Vietnamese Adults Treated With Adjunctive Dexamethasone
Condition: Tuberculosis Meningitis
MeSH terms: Tuberculosis; Tuberculosis, Meningeal; Meningitis
Study type: Observational

Summary: 
      All patients who were alive at the end of the dexamethasone treatment trial conducted by
      Oxford University CLinical Research Unit from 2001-2005 (n=340) will be eligible to
      participate in this long-term follow-up study.

      All eligible and consenting patients will undergo an assesment consisting of a simple
      questionnaire, a clinical examination and a blood test. Data collected will focus on
      survival, neurological disability and tuberculosis relapse. Data will be collected in
      individual case record forms and entered into a computer database.
    


Intervention name(s): Observation
Intervention type(s): Other
Intervention description(s): Collection of mortality data at 5 years post trial
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Survivors of TBM trial 2001-2005
      
Keywords: Tuberculosis meningitis
Flaxseed Consumption, Alone and in Combination With the Mediterranean-like Diet, on Some Indicators Related to Atherosclerosis
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis
Study type: Interventional

Summary: 
      Flaxseed consumption has beneficial effects on cardiovascular risk factors. In addition, the
      benefit of the Mediterranean-like diet in primary and secondary prevention of cardiovascular
      diseases has been shown.The purpose of this study is to investigate the effects of flaxseed
      consumption, alone and in combination with the Mediterranean-like diet, in adjunct to
      conventional medical treatment, in improving vascular endothelial function, plasma lipid
      profile and high sensitivity c-reactive protein of coronary artery disease (CAD) patients.
    

Detailed description: 
      A randomized placebo controlled clinical trial will be conducted in Rajaie Cardiovascular
      Center in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation
      of the design of the study, written consent form will be completed. The participants are 81
      eligible coronary artery disease patients, aged 20-75 years. Intervention groups will be
      received 30 g/d flaxseed, alone, or with weekly Mediterranean-like diet menu and control
      group will be received capsules of wheat fiber as placebo for 3 months. Vascular endothelial
      function will be evaluated through measurement of flow mediated dilatation (FMD) in brachial
      artery and carotid intima-media thickness (c-IMT) via ultrasound sonography and plasma level
      of asymmetric di-methyl arginine (ADMA). Fasting blood sample will be taken to measure
      malondialdehyde (MDA), lipid profile, high sensitive C-reactive protein and inflammatory
      cytokines (Interleukine-6 [IL-6] and Tumor Necrosis Factor-a [TNF-a]).
    

Intervention name(s): Flaxseed; the Mediterranean-like diet; Placebo
Intervention type(s): Other; Other; Dietary Supplement
Intervention description(s): Daily consumption of 30 grams flaxseed in adjunct to medical treatment for 3 months; Weekly Mediterranean-like diet menu in adjunct to medical treatment for 3 months; Daily consumption of one capsule of wheat fiber as placebo in adjunct to medical treatment for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Evaluate the Effect of Abdominal Electrical Muscle Stimulation on Abdominal Wall Restoration in Post - Partum Women
Condition: Abdominal Wall Restoration; Diastasis Recti
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the safety and efficacy of Abdominal EMS
      (Electrical Muscle Stimulation) on AWR (Abdominal Wall Restoration) in Post - Partum Women
    


Intervention name(s): EMS device
Intervention type(s): Device
Intervention description(s): EMS treatment will be performed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sleep, Circadian Rhythms and Cluster Headache
Condition: Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Observational

Summary: 
      The purpose of this study is to assess both the sleep and circadian (24-hourly biological
      rhythms) physiology of people with cluster headache. For sufferers with the episodic form of
      the disorder this will involve observation at two separate time points, once when
      experiencing attacks (in-bout) and once when attack free (out-of-bout).

      The study will include measurement of basic rest-activity patterns, sleep timing and timing
      of individual attacks, as well as a more detailed study recording sleep and circadian rhythms
      under clinical conditions over consecutive nights.

      Studying the differences in these processes in single individuals when they are both
      experiencing and free from attacks might provide insight into the brain mechanisms involved
      in triggering the bouts of attacks and individual attacks themselves. An improved
      understanding of this area may help design improved treatment options in future.
    


Intervention name(s): Polysomnography; Actigraphy
Intervention type(s): Other; Other
Intervention description(s): Overnight physiological recording of sleep; Wristwatch activity to measure basic rest activity cycle and sleep efficiency
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cluster headache sufferers (both of the episodic and chronic cluster headache) Related
        headache disorders
      
Biospecimen description: 
      Blood hormonal and circulating lymphocyte mRNA assays
    
Keywords: Cluster Headache; Trigeminal Autonomic Cephalalgias; Sleep; Circadian Rhythms
Controlled Exposures to Air Pollution in Patients With Coronary Heart Disease
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Air pollution is a major cause of cardiovascular morbidity and mortality. The components of
      air pollution responsible and the mechanisms through which they might mediate these harmful
      effects remain only partially understood. We hypothesise that these adverse effects are
      mediated by combustion derived air pollutants and that even a brief exposure will effect
      heart and blood vessel function. We assess the effect of dilute diesel exhaust inhalation at
      levels encountered in urban road traffic on heart and blood vessel function in patients with
      stable coronary heart disease.
    

Detailed description: 
      Observational studies suggest that exposure to air pollution may worsen symptoms of angina
      and trigger acute myocardial infarction. These findings are limited by imprecision in the
      measurement of pollution exposure, the effect of potential confounding environmental and
      social factors, and the lack of mechanistic data. Controlled exposures of air pollutants can
      help to address these shortcomings by providing a precisely defined exposure in a regulated
      environment that facilitates investigation with validated biomarkers and surrogate measures
      of cardiovascular health. Using a carefully characterised exposure system, we have previously
      shown in healthy volunteers that exposure to dilute diesel exhaust causes lung inflammation,
      depletion of airway antioxidant defences, and impairment of vascular and fibrinolytic
      function. To date, there have been no controlled exposures in patients with coronary heart
      disease: an important population who may be particularly susceptible to the adverse
      cardiovascular effects of air pollution.

      In a double blind randomized cross-over study, 20 patients with prior myocardial infarction
      will be exposed to dilute diesel exhaust (300µg/m3) or filtered air during periods of rest
      and moderate exercise in a controlled exposure facility. During the exposure, myocardial
      ischemia will be quantified by ST-segment analysis using continuous 12-lead
      electrocardiography. Six hours following exposure, vascular vasomotor and fibrinolytic
      function will be assessed by means of intra-arterial agonist infusions.
    

Intervention name(s): Exposure to dilute diesel exhaust (300µg/m3) or filtered air
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Air pollution; Myocardial ischemia; Endothelium; Fibrinolysis; Pathophysiology; Diesel exhaust
Understanding Sports Nutrition Knowledge of High School Athletes and Influencers
Condition: Sports Nutrition
Study type: Interventional

Summary: 
      The objective of this testing is to gain a better understanding of sports nutrition knowledge
      in high school athletes and their influencers (coaches, strength and conditioning coaches,
      athletic therapists, dieticians). Since the sports nutrition knowledge of the high school
      athletes will be limited, nutrition behaviors will be assessed to infer knowledge of sports
      nutrition.

      The secondary objective is to determine the primary sources of nutrition knowledge in these
      populations.
    


Intervention name(s): Survey of sports nutrition knowledge
Intervention type(s): Other
Intervention description(s): Questionnaire
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single survey, one version for student athletes survey and another version for Influencers of student athletes
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: sports nutrition; survey; nutrition knowledge
Lipid Biomarker Study in Men With Dyslipidemia After Simvastatin Treatment (Study MK-0000-140)(COMPLETED)
Condition: Hypercholesterolemia, Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to provide human lipidomics standards with simvastatin
      treatment that were to be used for comparison with similar preclinical studies.
    


Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg once daily for 2 weeks; Placebo, matching the simvastatin (40 mg) tablet as a single oral daily dose for 2 weeks
Other intervention name(s): Zocor
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypercholesterolemia, Dyslipidemia, simvastatin, Zocor
Posterior Capsule Opacification (PCO) With AcrySof Single-Piece IOL
Condition: Posterior Capsule Opacification
MeSH terms: Capsule Opacification
Study type: Interventional

Summary: 
      The purpose of this study what to evaluate if axial myopia might influence the development of
      PCO.
    

Detailed description: 
      We sought to prospectively compare PCO in eyes with myopia in relation to axial length with
      PCO in eyes with normal axial length, to decipher the role of axial myopia in PCO 4 years
      after surgery for senile cataract.
    

Intervention name(s): Phaco
Intervention type(s): Procedure
Intervention description(s): AcrySof Single-Piece IOL
Other intervention name(s): emmetropic eyes; normal axial length
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PCO; POCO