bioihbjkbjnl/mcl2 huggingface dataset:
The Metabolic Effects of Acute Hyperglycemia in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of the study is to characterize the changes in amino acid, lipid and glucose
      metabolism in patients with type 2 diabetes exposed to acute hyperglycemia. Moreover we wish
      to assess the effect of acute hyperglycemia on cardiac output.
    

Detailed description: 
      Cardiovascular disease is the main cause of death in modern Western societies. Obesity,
      diabetes and the metabolic syndrome are the main risk factors for cardiovascular disease.
      People with type 2 diabetes and no history of heart disease have a risk of myocardial
      infarction similar to the risk in non-diabetic patients with known heart disease.

      However, the causal relationship between obesity, diabetes and cardiovascular disease is
      unclear. Insulin resistance leads to many metabolic abnormalities, including high circulating
      levels of free fatty acids (FFA). FFA induces insulin resistance and may lead to beta cell
      failure. In addition FFA may directly worsen the metabolic and electrochemical performance of
      the working heart. Moreover it is still unclear how acute hyperglycemia affects cardiac
      output.

      In this study our purpose is to characterize the changes in amino acid, lipid and glucose
      metabolism in patients with type 2 diabetes exposed to acute hyperglycemia (blood glucose
      between 18 and 20 mmol/L) compared to the amino acid, lipid and glucose metabolism at a
      normal glucose level (blood glucose between 5 and 7 mmol/L). The results from the patients
      with type 2 diabetes will be compared with results from healthy controls examined in a
      fasting basal state. The patients must not suffer from any kind of serious heart disease and
      should be treated with insulin.

      Moreover we wish to compare cardiac output at high and normal blood glucose levels,
      respectively. Cardiac output will primarily be assessed by doppler echocardiography.
    

Intervention name(s): Actrapid (human insulin)
Intervention type(s): Drug
Intervention description(s): On day one the patients will receive glucose and insulin in order to reach a blood sugar around 18 and 20 mmol/L and on day two the patients will receive glucose and insulin in order to have a blood sugar around 5 and 7 mmol/L. On both days amino acid, lipid and glucose metabolism will be assessed by means of whole body isotope dilution.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Type 2 diabetes; Dysregulation; Metabolism; Cardiac output
Atrial Fibrillation Ablation Pilot Study
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective, non-randomized, multicenter, multi-country pilot study to evaluate the
      safety and effectiveness of the Ablation Frontiers Cardiac Ablation System for the ablative
      treatment of symptomatic permanent atrial fibrillation.
    

Detailed description: 
      The study shall be conducted according to ISO 14155. Results of this research study will be
      used to assess the performance and safety of the System and its components. Data may be
      combined with similar research at additional sites to create a greater understanding of the
      endpoints. Up to sixty (60) patients (including "roll-in" or training patients) will be
      enrolled in a non-randomized study to assess the safety and efficacy of the Ablation
      Frontiers Cardiac Ablation System. Further studies may be performed to gather additional data
      regarding the safety and efficacy of the system.

      Patients with a history of symptomatic permanent AF, willing and able to sign an informed
      consent, and meeting all inclusion/exclusion criteria, as identified by the clinical
      investigator, will be enrolled in the study. Comparative and descriptive statistics will be
      used to summarize patient outcomes for the specified study endpoints.
    

Intervention name(s): Ablation procedure and/or cardioversion
Intervention type(s): Procedure
Intervention description(s): Ablation Frontiers Cardiac Ablation System
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial fibrillation
Association of Probable Bruxism With Periodontal Status
Condition: Bruxism
MeSH terms: Bruxism
Study type: Observational

Summary: 
      This cross-sectional study was conducted to assess i) the prevalence of probable bruxism ii)
      the association between probable bruxism and periodontal status.The age, gender, education
      level, tooth loss, presence of probable bruxism and periodontal status of patients were
      evaluated. Periodontal statuses of the participants were defined according to the American
      Association of Periodontology/European Federation of Periodontology, 2017 consensus and
      assessment of probable bruxism was performed according to the 2018 consensus report on the
      assessment of bruxism.
    

Detailed description: 
      This cross-sectional study was conducted to assess i) the prevalence of probable bruxism ii)
      the association between probable bruxism and periodontal status dental examination, all
      participants completed a standardized questionnaire. Sociodemographic findings comprised age,
      gender and educational level. Periodontal statuses of the participants were defined according
      to the American Association of Periodontology/European Federation of Periodontology, 2017
      consensus. Participants were diagnosed with periodontitis if interdental clinical attachment
      loss (AL) was detected at ≥2 non-adjacent teeth, or buccal or oral AL was ≥3 mm with probing
      depth >3 mm was detected at ≥2 teeth. 12 In addition number of missing teeth is
      recorded.Assessment of probable bruxism was performed according to the 2018 consensus report
      on the assessment of bruxism.Presence of masticatory muscle hypertrophy, temporomandibular
      joint pain, indentations on the tongue or lip and/or a linea alba on the inner cheek, damage
      to the dental hard tissues (eg, cracked teeth), mechanical wear of the teeth (ie, attrition),
      repetive failures of restorative work/prosthodontics constructions were examined in clinical
      evaluation.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The patients who applied to Department of Periodontology, Baskent University were included
        into the study.
Effects of Non-invasive Neuromodulation on Food Desire, Chewing Pattern, Executive Functions and Oxidative Stress.
Condition: Craving; Mastication Disorder; Memory Disorders; Executive Dysfunction; Transcranial Direct Current Stimulation; Inflammation; Oxidative Stress
MeSH terms: Memory Disorders; Inflammation
Study type: Interventional

Summary: 
      From the change in self-regulation, memory is inhibited, allowing individuals to suppress or
      ignore unwanted or outdated associations and thus help to filter information relevant to
      dietary goals from irrelevant information. Provoking changes in neuroplasticity and cortical
      excitability contribute to the regulation of neural activity. Both could be modified by
      applying direct electrical current to the sensorimotor cortex, with
      polarity/current-dependent results, and their effect would last for hours after the end of
      stimulation. Transcranial Direct Current Stimulation (tDCS), translated into Portuguese as
      Estimulação Transcraniana por Corrente Contínua (ETCC) is a neuromodulating tool in which a
      low-intensity electrical current is applied to the scalp to modulate neuronal activity.
    


Intervention name(s): speech therapy for chewing + real tDCS
Intervention type(s): Behavioral
Intervention description(s): participants will be instructed to chew their food correctly during the tDCS session, but the participant does not know if the tdcs is real or sham.
Other intervention name(s): speech therapy for chewing + sham tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will be a randomized, double-blind, parallel clinical trial. Participants will receive real tDCS or tDCS sham for 10 sessions during the treatment period. The interstice period of the total intervention will be 15 days (2 subsequent weeks, 10 working days, to apply the intervention). The probabilistic, simple randomized sample will consist of participants with randomized food cravings into two groups, there will be subdivision to receive or not neuromodulation, according to the flowchart.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Craving; Executive Dysfunction; Oxidative Stress; Transcranial Direct Current Stimulation
Study to Evaluate Electrocardiographic Effects of Therapeutic & Supratherapeutic Doses of Cytisinicline in Healthy Smokers
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to assess the effects of cytisinicline at therapeutic
      and supratherapeutic doses on cardiac repolarization relative to placebo in healthy adult
      subjects who are smokers.
    


Intervention name(s): Cytisinicline; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): compressed film-coated tablet containing 3 mg cytisinicline; Placebo tablets to match compressed film-coated tablet containing 3 mg cytisinicline; 400 mg tablets
Other intervention name(s): Cytisine
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Vitamin D AND Glucose Handling Evaluated by Glucose Clamp
Condition: Insulin Sensitivity; Intraocular Pressure
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study the investigators want to compare glucose handling (insulin secretion and
      insulin sensitivity) in 100 persons with low and 50 persons with normal-high levels of
      vitamin D, using a hyperglycemic clamp technique, were sugar is given intravenously for 3
      hours in order to keep the blood sugar level at 10 mmol/L. Those with low vitamin D levels
      will be randomized to treatment with vitamin D3 (cholecalciferol) 40 000 IU/week or placebo
      for 6 months before a new clamp is performed.

      The study hypothesis is that persons with low vitamin D levels have impaired glucose handling
      which might be improved by vitamin D supplementation.
    


Intervention name(s): cholecalciferol
Intervention type(s): Drug
Intervention description(s): capsules, 20 000IU, twice a week, 6 months duration
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the efficacy of LDX treatment group compared to placebo on the change
      from Baseline ADHD-RS-IV score at endpoint.
    


Intervention name(s): LDX 30 mg; LDX 50 mg; LDX 70 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.; Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.; Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.; Placebo will be identical to test product.
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Alcohol Based Hand Sanitizer: Can Frequent Use Cause an Elevated Blood Alcohol Level?
Condition: Healthy
Study type: Observational

Summary: 
      Ethanol based hand sanitizers do not raise blood alcohol levels to a measurable amount. This
      study will determine to what extent, if any, heavy use of ABHS changes blood alcohol levels.
    

Detailed description: 
      Ethanol continues to be the most frequently abused intoxicant in the United States.4 Drug
      testing in various work environments has become commonplace during the past two decades and
      will at times include blood, breath, or urine alcohol testing.5 While valid reasons for false
      positive drug tests do occur, a plethora of unusual and dubious explanations have been
      likewise tendered. Medical Review Officers (MRO) involved in evaluating such reports rely on
      past case reports, knowledge of laboratory analytical techniques, and other scientific
      evidence to validate or negate claims of drug use in the workplace. ABHS are now found in
      most hospitals and health-care facilities.1,3 Only one human report of serum ethanol levels
      following frequent clinical use of the ABHS has been reported.7 This finding of a negative
      serum ethanol level in this case is likely to be reproducible in all clinical settings as the
      physician attempted to simulate the most extreme use of the product that would be consistent
      with labeling instructions. Since alcohol breathalyzer testing is based upon exhaled portions
      of ethanol found within the blood stream, this method of testing would likely be negative as
      well.

      Participants will be the investigators and associate investigators of the study, who are all
      employees in the emergency department at Darnall Army Community Hospital. There will be no
      financial reward offered. Consent will be obtained on all participants. The study will be
      performed in the Darnall Emergency Department outside of regular duty hours. Enrolled
      subjects will apply 5 ml of the product (62% denatured ethanol alcohol manufactured by
      Kimberley-Clark) to both hands and rub until dry. This will be repeated 50 times over
      approximately 4 hours. Participants will have their blood drawn prior to, as well as, after
      completing the study. No other laboratory tests will be performed other than the alcohol
      level. Pre study blood alcohol levels will be ordered to assure a pre-study level of 0 mg/dl.
    

Time perspective: Prospective
Keywords: Ethanol levels; Dermal absorbtion
PD of VAY736 in Patients With Primary Sjögren's Syndrome
Condition: Primary Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to evaluate the safety, tolerability, pharmacokinetics and
      therapeutic efficacy of a single intravenous infusion of VAY7346 monoclonal antibody in pSS
      patients
    

Detailed description: 
      Patients were enrolled in 2 sequential cohorts:

      Cohort 1: 6 patients received 3 mg/kg or Placebo (2:1 ratio) Cohort 2: 21 patients received
      10 mg/kg, 3 mg/kg or Placebo (6:1:3 ratio)

      At week 24 the blind was broken to assess continuation in the trial:

        -  If a patient received VAY736 and their B cell recovery was demonstrated at Week 24, then
           patients completed the trial.

        -  If a patient received VAY736 and their B cell recovery was NOT demonstrated at Week 24,
           then patients were followed up until B cell recovery was demonstrated

        -  If a patient received placebo, they were offered the option of receiving open-label
           VAY736 (10 mg/kg) in a separate treatment arm.
    

Intervention name(s): VAY736; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: primary Sjögren's syndrome, pharmacodynamics
The Effect of Alpha-tocopherol in Hemolysis and Oxidative Stress Marker on the Red Cell Membrane Beta-thalassemia Major
Condition: Beta Thalassemia Major Anemia; Hemolysis; Oxidative Stress
MeSH terms: Thalassemia; beta-Thalassemia; Hemolysis
Study type: Interventional

Summary: 
      The accumulation of unpaired α-globin chains in β-thalassemia major patients may clinically
      create ineffective erythropoiesis, hemolysis, and chronic anemia. Multiple blood transfusions
      and iron overload cause cellular oxidative damage. However, α-tocopherol, an antioxidant, has
      been known as a potent scavenger of lipid radicals in the red cell membrane of β-thalassemia
      major patient. By this randomized controlled trial, the investigators would like to evaluate
      the effects of α-tocopherol in hemolysis and oxidative stress on the red cell membrane of
      β-thalassemia major.
    

Detailed description: 
      Background: The accumulation of unpaired α-globin chains in β-thalassemia major patients may
      clinically create ineffective erythropoiesis, hemolysis, and chronic anemia. Multiple blood
      transfusions and iron overload cause cellular oxidative damage. However, α-tocopherol, an
      antioxidant, has been known as a potent scavenger of lipid radicals in the red cell membrane
      of β-thalassemia major patients.

      Purpose: To evaluate the effects of α-tocopherol in hemolysis and oxidative stress on the red
      cell membrane of β-thalassemia major.

      Methods: In this randomized controlled trial, the investigators allocated subjects in the
      placebo and α-tocopherol groups. Doses of α-tocopherol were based on the recommendation of
      Institute of Medicine: 4-8 years old 200 mg/day; 9-13 years old 400 mg/day; 14-18 years old
      600 mg/day. Hemolysis, oxidative stress, and antioxidant variables were evaluated before and
      after 4 weeks of consuming either α-tocopherol or placebo, performed prior to blood
      transfusions.
    

Intervention name(s): Alpha-Tocopherol; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): all of the subjects in the alpha-tocopherol group received alpha-tocopherol orally, doses adjusted by age for 4 weeks of treatment.
Other intervention name(s): Santa E; Alpha-tocopherol placebo
Intervention MeSH terms: Tocopherols; Vitamin E; Tocotrienols; alpha-Tocopherol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Beta thalassemia major children
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Haptoglobin; Hemopexin; Hemolysis; Malondialdehyde; Glutathione; Oxidative stress; Alpha-Tocopherol
Pilot Study of OXP005 to Assess Gastroduodenal Irritation
Condition: Gastroduodenal Erosions
Study type: Interventional
Phase: Phase 1

Summary: 
      Oxford Pharmascience Ltd (the Sponsor) is developing a new naproxen tablet formulation (the
      study drug, OXP005), for the potential treatment of rheumatic and painful conditions. The
      study will compare the study drug to an already marketed formulation of prescription strength
      naproxen (Naprosyn® the reference product) by looking at the relative impact of both products
      on gastroduodenal (GD) irritation by performing a specialist procedure called an endoscopy
      (or more specifically, a gastroscopy). The safety and tolerability of the study drug will
      also be assessed.
    


Intervention name(s): OXP005; Naproxen
Intervention type(s): Drug; Drug
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Prilosec Bioequivalence Study in Healthy Volunteers
Condition: Bioequivalence, AUC, Cmax, Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is An Open-label, Randomized, Single-center, 4-way Crossover, Single dose Bioequivalence
      Study Comparing Omeprazole 20 and 40-mg Aqueous solvent Based Capsules Manufactured by
      AstraZeneca with Omeprazole 20 and 40-mg Organic-solvent Based Capsules Manufactured by Merck
    


Intervention name(s): Omeprazole
Intervention type(s): Drug
Intervention description(s): Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)
Other intervention name(s): Prilosec
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Omeprazole, Prilosec, Phase I, Healthy Subjects, Pharmacokinetics, Bioequivalence
Acute Anterior or Posterior Cerebral Artery Occlusion Recanalization Therapy and Relationships With Clinical Outcome (ACAPULCO)
Condition: Ischemic Stroke; Thrombi
MeSH terms: Ischemic Stroke
Study type: Observational

Summary: 
      Nearly 3% of patients with ischaemic stroke (IS) have an isolated occlusion of the anterior
      or posterior cerebral artery in the acute phase of the disease. In those patients,
      intravenous thrombolysis (IT) is indicated for 4.5 hours after symptoms onset. Due to a lack
      of data, mechanical thrombectomy (MT) is not considered as a gold standard to treat IS alone
      or in addition with IT. Therefore, observational studies are needed to understand the
      clinical evolution of patients with IS treated with IT and/or MT. The ACAPULCO retrospective
      observational study aims to highlight potential benefits of MT in those patients to improve
      their management and to propose targeted therapies in the future.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Subjects having clinical signs and imaging criteria consistent with acute ischemic stroke
        who presented within 6 hours of stroke symptoms onset with isolated occlusion of the
        anterior or the posterior artery.