bioihbjkbjnl/mcl2 huggingface dataset:
Impact of General Anaesthetics on Excitability of the Peripheral Sensory Nerve
Condition: Scheduled for Surgery
Study type: Observational

Summary: 
      The aim of this study is to investigate the effect of general anaesthetics on nerve
      excitability. We use the method of threshold tracking to measure selected parameters of nerve
      excitability.
    


Intervention name(s): Nerve excitability measurement
Intervention type(s): Behavioral
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inclusion criteria: German speaking patients scheduled for surgery under general
        anaesthesia
Cardioprotective Effects of Omega-3 Fatty Acids Supplementation in Healthy Older Subjects Exposed to Air Pollution Particles
Condition: Healthy
Study type: Interventional

Summary: 
      Exposure to ambient levels of air pollution increases cardiovascular morbidity and mortality.
      Advanced age is among the factors associated with susceptibility to the adverse effects of
      air pollution. Dietary fatty acid supplementation has been shown to decrease cardiovascular
      risk through multiple mechanisms. This study evaluated the efficacy of supplementation with
      marine fish oil or olive oil in protecting against cardiovascular effects induced by
      controlled exposure of middle-aged healthy volunteers to concentrated ambient air pollution
      particles. Subjects (ages 50 to72 years), were randomly assigned to receive 3 g/d of fish oil
      (1.2 g eicosapentaenoic acid and 0.82 g docosahexaenoic acid), or olive oil (3g/d) for 28 d.
      Subjects were then exposed to concentrated ambient air pollution particles or filtered air
      for 2 hr on sequential days. Heart rate variability (HRV), plasma lipids, coagulation
      markers, and endothelial function measured by flow-mediated dilation of the brachial artery
      (FMD) were assessed pre-, immediately post-, and 20 hr post-exposure.
    


Intervention name(s): Fish oil; Olive oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects (ages 50 to 75 years), were randomly assigned to receive 3 g/d of fish oil (1.2 g eicosapentaenoic acid and 0.82 g docosahexaenoic acid) for 28 d.; Subjects (ages 50 to 75 years) were randomly assigned to receive 3 g/d of olive oil for 28 d.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: air pollution; fatty acid supplementation
Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Essential Blepharospasm
Condition: Essential Blepharospasm
MeSH terms: Blepharospasm
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in
      adults with essential blepharospasm.
    

Detailed description: 
      Subjects are randomly assigned into the two groups at the ratio of 1:1. The purpose of study
      is to confirm the non-inferiority of Neuronox to Botox in terms of the efficacy and safety in
      subjects with essential blepharospasm.
    

Intervention name(s): Neuronox; Botox
Intervention type(s): Drug; Drug
Intervention description(s): Clostridium Botulinum Toxin A 100 U; Clostridium Botulinum Toxin A 100 U
Other intervention name(s): Botulinum Toxin Type A for injection; Botulinum Toxin Type A for injection
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Autism, Emotional Processing, and the Amygdala
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      Empathy imbalance hypothesis suggests that individuals with autism Spectrum Disorder (ASD)
      should have a deficit of cognitive empathy and a surfeit of emotional empathy. Considering
      that inconsistent amygdala reactivity to emotional faces might be ascribed to aberrant
      attention in ASD, the investigators hypothesized to investigate if there would be an
      imbalance between conscious and nonconscious emotional processing. This fMRI study recruited
      26 youths and young adults with autism spectrum disorder and 25 matched controls, and
      measured their amygdala reactivity and functional connectivity in response to conscious and
      nonconscious (backward masked) perception of threatening faces.

      Keywords: Autism Spectrum Disorder; amygdala reactivity; emotional processing; fMRI
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Autism group: 26 individuals with ASD meeting DSM-V criteria Control group: 25 gender, and
        age matched healthy controls
Influence of Different Forms of Exercise Training in Patients With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The aim of the study is to compare the effect of water-based and land-based exercise
      training, and usual care (no exercise training) in patient with coronary artery disease, on
      exercise capacity, vascular function, arrhythmogenic potential and cardiac autonomic
      function, and markers of neurohormonal activity, activated hemostasis and inflammation.
    

Detailed description: 
      Swimming and other water-based physical activities represent an effective form of
      aerobic-dynamic exercise. However, existing guidelines mainly advise caution when
      recommending water-based activities to patients with coronary artery disease. To date, safety
      and efficacy of short-term water-based exercise in patients with coronary artery diseases
      have only scarcely been addressed.

      Cardiovascular rehabilitation is an integral part of management after a myocardial infarction
      or coronary procedure. Most rehabilitation programs are exercise-based, since the beneficial
      effects of physical activity undisputed, and corroborated by a large body of evidence.

      Most rehabilitation programs are exercise-based, since the beneficial effects of physical
      activity undisputed, and corroborated by a large body of evidence.

      Research has mainly been focused on the impact assessment of the standard forms of physical
      training, they studied various forms of physical exercise, mainly land-based. No previous
      study has reported on the effect of exercise in water as an integral element of standard
      cardiac rehabilitation in coronary patients on exercise capacity, vascular function,
      arrhythmogenic potential and cardiac autonomic function, and markers of neurohormonal
      activity, activated hemostasis and inflammation.
    

Intervention name(s): water-based exercise training; land-based exercise training
Intervention type(s): Other; Other
Intervention description(s): Water-based training will be performed in upright position, in waist to xyphoid process deep thermo-neutral water at temperature of 32,8 C. The immersed exercise will include two session of aerobic and calisthenic exercise per day, six days of a week, both lasting 30 minutes; Land-based training will include two aerobic and calisthenic exercise session per day, six days of a week, both lasting 30 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiac rehabilitation; coronary artery disease
Paclitaxel in Treating Patients With Refractory or Recurrent Acute Leukemia or Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel in treating patients with
      refractory or recurrent acute leukemia or chronic myelogenous leukemia.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose of paclitaxel given as a 96-hour infusion
      in patients with acute leukemia refractory to or recurrent after standard chemotherapy, in
      patients with blast crisis of chronic myelogenous leukemia, or in elderly patients (65-75)
      with newly diagnosed acute leukemia. II. Determine the rate of complete and partial
      remissions to paclitaxel treatment in these patients. III. Assess the toxic effects of
      paclitaxel given as a 96-hour infusion in these patients. IV. Determine the duration of
      remission after paclitaxel treatment in these patient populations.

      OUTLINE: This is a dose escalation, multicenter study. Patients receive paclitaxel as a
      96-hour continuous infusion. Patients may receive a second course of treatment after 4 weeks
      in the absence of unacceptable toxicity irrespective of the treatment results after 1 course.
      Cohorts of 3 patients are treated at escalating doses of paclitaxel in the absence of dose
      limiting toxicity (DLT). If 1 out of 3 patients develops DLT, then 3 additional patients are
      treated at the same dose level. If DLT occurs in more than 1 out of 3-6 patients, dose
      escalation stops and this is considered the maximum tolerated dose (MTD). Once the MTD has
      been defined, the next patients are entered at the dose level preceding the MTD for the phase
      II portion of the study. Patient are followed at 2 weeks after completion of study and then
      every 3-6 months thereafter.

      PROJECTED ACCRUAL: There will be a total of 33 patients accrued (22 patients in the first
      stage and 11 in the second stage) in this study.
    

Intervention name(s): paclitaxel
Intervention type(s): Drug
Intervention MeSH terms: Paclitaxel
Primary purpose: Treatment
Keywords: recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; blastic phase chronic myelogenous leukemia; untreated adult acute lymphoblastic leukemia; untreated adult acute myeloid leukemia
Dysport® Pediatric Lower Limb Spasticity Study
Condition: Cerebral Palsy; Muscle Spasticity; Children
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to determine whether Dysport® is effective in the
      treatment of increased stiffness of the calf muscles and to evaluate the safety of this
      treatment in children with Cerebral Palsy. In addition this study will also check whether
      Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.
    


Intervention name(s): Botulinum toxin type A; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): I.M. (in the muscle) injection on day 1 of a single treatment cycle.; I.M. injection on day 1 of a single treatment cycle.
Other intervention name(s): AbobotulinumtoxinA (Dysport®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study Investigating the Safety and Efficacy of Bio-Active Silver Hydrosol™ in Providing Immune Support
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study is to investigate the ability of Bio-Active Silver Hydrosol™ in
      providing immune support in healthy adult males and females participating in intense aerobic
      exercise. Sixty eligible participants are planned to be randomized into either the
      investigational product or treatments arms and will consume the study product for 60 days
      (check-in visit on day 28). Questionnaires will be completed and blood and saliva samples
      will be collected to measure the endpoints.
    


Intervention name(s): Silver Hydrosol; Placebo
Intervention type(s): Other; Other
Intervention description(s): Silver quantity will be 7 doses per day, with 50 mcg per dose.; Placebo water with no active ingredients
Other intervention name(s): Sovereign Silver, Bio-Active Silver Hydrosol™
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, parallel study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Immune Support; Active lifestyle; Silver; Healthy Adults; Cold; WURSS
Proteus Discover in Subjects With Uncontrolled Hypertension and Type 2 Diabetes
Condition: Hypertension; Diabetes Mellitus, Type 2; Hypercholesterolemia
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypercholesterolemia
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the efficacy of a new digital health offering,
      Proteus Discover to lower blood pressure and glycated hemoglobin in patients with
      uncontrolled hypertension and type 2 diabetes.
    

Detailed description: 
      "Cardiometabolic diseases" as defined in this protocol refer to diseases that increase risk
      for cardiovascular disease. Proteus® Digital Health is operationally defining cardiometabolic
      (CMB) conditions for this study as including hypertension, type 2 diabetes, and
      hypercholesterolemia. The prevalence of metabolic diseases is growing. Factors contributing
      to this rise include the obesity epidemic and the aging population. In particular, because of
      the costs and risk of complications associated with diabetes and hypertension, many health
      systems and payers are increasing focus on interventions to reduce the burden of these
      diseases.

      The purpose of the study was to evaluate the ability of a new digital health offering,
      Proteus Discover to lower blood pressure and glycated hemoglobin in patients with
      uncontrolled hypertension and type 2 diabetes.

      The study enrolled subjects with uncontrolled hypertension and type 2 diabetes failing at
      least 2 antihypertensives and metformin and/or a sulfonylurea. Subjects were randomized to
      one of 3 arms: use of Proteus Discover for 4 weeks, use of Proteus Discover for 12 weeks, or
      usual care.

      Subjects randomized to the intervention arms, used a digital health offering to (1) provide
      automatic and passive electronic documentation of medication adherence and patterns of
      medication taking, (2) assist providers in distinguishing inadequate medication adherence or
      pharmacologic unresponsiveness as the root cause for uncontrolled hypertension and type 2
      diabetes, and (3) inform management decisions (dose adjustment, medication addition or
      substitution, adherence counseling, referral to a hypertension specialist).

      Subjects randomized to usual care, received usual medical care such as medication changes,
      adherence counseling, and lifestyle coaching. Providers could also schedule additional visits
      without restrictions.
    

Intervention name(s): Proteus Discover; Usual Care
Intervention type(s): Other; Other
Intervention description(s): FDA cleared Wearable Sensor with Ingestible Sensor and Mobile Device Application; Routine medical care including medication titration, adherence counseling, and lifestyle coaching.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diabetes Mellitus and Vulvovaginal Candidiasis
Condition: Diabetes Mellitus; Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical and mycological response to oral fluconazole and boric acid suppositories was
      assessed in patients with diabetes mellitus and vulvovaginal candidiasis.
    

Detailed description: 
      A high proportion of vulvovaginal candidiasis is due to C.glabrata that responds poorly to
      fluconazole therapy. We assessed the clinical relief and mycological cure in response to oral
      fluconazole and boric acid suppositories in patients with diabetes mellitus and vulvovaginal
      candidiasis given in a Randomized trial. Fluconazole was given in standard oral single dose
      (150 mg) fluconazole and boric acid vaginal suppositories was given in dose of 600 mg/daily
      for 14 uninterrupted days.
    

Intervention name(s): Boric; Fluconazole
Intervention type(s): Drug; Drug
Intervention description(s): Gelatin capsules filled with 600 mg of boric acid; 150 mg oral fluconazole gives once in 14 days
Intervention MeSH terms: Fluconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Increasing Knowledge of Alcohol as a Risk Factor for Breast Cancer Among Women Attending Breast Screening Services
Condition: Health Knowledge, Attitudes, Practice; Alcohol Consumption
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      Alcohol is a major modifiable risk factor for breast cancer in women, yet this is not widely
      understood by health practitioners or policy makers, let alone the general population. The
      investigators aim to test the effects of a targeted alcohol and lifestyle brief intervention
      for women attending breast screening services, to improve knowledge of alcohol as a risk
      factor for breast cancer and reduce harmful alcohol use.
    


Intervention name(s): alcohol brief intervention; lifestyle health promotion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Nested within the lifestyle health promotion provided in both conditions, participants randomised to the experimental condition will receive an alcohol brief intervention. The strong evidence-base for alcohol brief intervention, amplified by Co-Investigators' Smith and Bragge's (BehaviourWorks) approaches to applied behaviour change, has provided the framework for the development of the alcohol brief intervention used in this study. This intervention comprises personalised feedback on alcohol consumption levels, comparison to gender/age drinking norms, and information and behaviour-change content regarding alcohol consumption (i.e. negative-framed messaging around alcohol risks and harms, positive-framed messaging on the health benefits of reducing alcohol intake, alcohol harm reduction strategies).; Lifestyle health promotion specific to physical activity and maintaining a healthy weight, developed to be relevant to women attending breast screening services, will be provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Women's health; Public Health; Health promotion/education
Study to Assess the Bioequivalence of Acalabrutinib Tablet and Acalabrutinib Capsule
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a multicenter, Phase I, open-label, randomized, 2-sequence, 2-treatment,
      2-period, crossover, bioequivalence study with single doses of acalabrutinib administered
      orally in healthy participants. The study is designed to demonstrate the bioequivalence of
      acalabrutinib tablet (Treatment A) compared with marketed acalabrutinib capsule (Treatment B)
      in the fasted state.
    

Detailed description: 
      Eligible healthy participants will be randomized to receive either treatment sequence 1 (AB)
      or treatment sequence 2 (BA), as follows:

        -  Treatment A: Acalabrutinib tablet, 100 mg, fasted state

        -  Treatment B: Acalabrutinib capsule, 100 mg, fasted state

      Participants will receive fixed single doses of acalabrutinib on 2 occasions, under fasted
      conditions.

      The study will comprise:

        -  Visit 1: A screening period of up to 28 days before first dosing.

        -  Visit 2: Two treatment periods:

             -  Participants will be admitted to the study center on Day -2 of Treatment Period 1
                to confirm eligibility before first dosing. Eligibility criteria will be
                reconfirmed on Day -1 of each treatment period.

             -  On Day 1 of Treatment Periods 1 and 2, participants will be administered the
                assigned treatment (A or B) as randomized, followed by a protocol defined washout
                period between Treatment Periods 1 and 2.

        -  Visit 3: A Follow-up Visit/Early Termination Visit at 7 to 10 days after last
           administration of study drug.

      Each participant will be involved in the study for approximately 6 weeks.
    

Intervention name(s): Treatment A: Acalabrutinib tablet; Treatment B: Acalabrutinib capsule
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive fixed single doses of acalabrutinib tablet in 2 treatment periods, under fasted conditions.; Participants will receive fixed single doses of acalabrutinib capsule in 2 treatment periods, under fasted conditions.
Other intervention name(s): CALQUENCE; CALQUENCE
Intervention MeSH terms: Acalabrutinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics; Healthy participants; Bruton tyrosine kinase; Acalabrutinib
New Biomarkers in the Intracystic Liquid of Inflammatory and Non-inflammatory Pancreatic Cysts
Condition: Pancreatic Cyst
MeSH terms: Pancreatic Cyst
Study type: Observational

Summary: 
      Due to the advances made in the field of the imaging techniques and their common use,
      pancreatic cysts are more and more incidentally found.

      Pancreatic pseudocysts can be misdiagnosed as cystic neoplasms, in particular when there is
      no clinical history of acute or chronic pancreatitis. Pancreatic cystic neoplasms on the
      other hand are rare, but are difficult to diagnose accurately.

      Neutrophil gelatinase-associated lipocalin (NGAL) , interleukin 1 Beta (IL1beta) and High
      Mobility Group AT-Hook 2 (HmgA2) are molecules implicated in the process of inflammation and
      tumour development. The diagnostic value of their concentration in pancreatic cysts is not
      established yet.

      Study aim to asses the significance of NGAL,IL1Beta and HMGA2 concentration in cystic fluid
      obtained by endoscopic ultrasound (EUS) with EUS-guided fine-needle aspiration (EUS-FNA) and
      serum level for discriminating between inflammatory and non-inflammatory pancreatic cyst.
    


Intervention name(s): Endoscopic ultrasound fine needle aspiration (EUS-FNA)
Intervention type(s): Diagnostic Test
Intervention description(s): Patients with pancreatic cysts who underwent endoscopic ultrasound and endoscopic fine needle aspiration for diagnostic and therapeutic purpose. A sample of the cyst fluid and frozen serum was collected from the patients and stored at minus 80 degrees.
Other intervention name(s): ELISA measurements of cystic fluid
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients aged 18-90 years diagnosed with an unclear specific diagnosis of
        pancreatic cysts >15mm on Computer tomography scan (CT) or Magnetic resonance imaging (MRI)
        and patients with pseudocysts with indication for drainage , admitted to our hospital (the
        Regional Institute of Gastroenterology and Hepatology in Cluj-Napoca, Romania)
      
Biospecimen description: 
      serum, cystic fluid
    
Keywords: pancreatic cyst; EUS-FNA; intracystic fluid