bioihbjkbjnl/mcl2 huggingface dataset:
ESP Block in VATS: Programmed Intermittent Bolus Versus Continuous Infusion on Quality of Recovery
Condition: Pain, Acute; Surgery
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      Fascial plane blocks, such as ESP, rely on the spread of local anaesthetic on an interfacial
      plane, automated boluses may be particularly useful for this group of blocks. However, until
      recently, ambulatory pumps capable of providing automated boluses in addition to
      patient-controlled boluses were not widely available. To best of our knowledge, there are no
      randomised controlled trials comparing continuous infusion versus intermittent bolus
      strategies for Erector Spinae Plane Block for MITS in terms of patient centred outcomes such
      as quality of recovery.
    

Detailed description: 
      Minimally invasive thoracic surgery (MITS) has been shown to reduce postoperative pain,
      reduce tissue trauma and contribute to better recovery as compared to open thoracotomy.
      However, it still causes significant acute post-operative pain. Our Mater research group has
      shown that fascial plane blocks such as the Erector Spinae Plane block (ESP) contribute to
      post-operative analgesia after MITS. Case reports have described the improved quality of
      analgesia following ESP using programmed intermittent boluses (PIB) instead of continuous
      infusion. It is hypothesised that larger, repeated bolus doses provide superior analgesia,
      possibly as a result of improved spread of the local anaesthetic. Evidence for improved
      spread of local anaesthetic may be found in one study which demonstrated that PIB increased
      the number of affected dermatomal levels compared to continuous infusions for continuous
      paravertebral blocks. Similarly, with regard to labour epidural analgesia, PIB provides
      better analgesia compared with continuous infusion.

      Because fascial plane blocks, such as ESP, rely on the spread of local anaesthetic on an
      interfacial plane, automated boluses may be particularly useful for this group of blocks.
      However, until recently, ambulatory pumps capable of providing automated boluses in addition
      to patient-controlled boluses were not widely available. To the best of our knowledge, there
      are no randomised controlled trials comparing continuous infusion versus intermittent bolus
      strategies for Erector Spinae Plane Block for MITS in terms of patient-centered outcomes such
      as quality of recovery.
    

Intervention name(s): Ultrasound Guided ESP Block with Programmed Intermittent Bolus (PIB) for VATS; Ultrasound Guided ESP Block with Continuous Infusion (CI) for VATS
Intervention type(s): Procedure; Procedure
Intervention description(s): Programmed Intermittent Bolus (PIB) of Levobupivacaine; Continuous Infusion (CI) of Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Regional Anesthesia; Erector Spinae Block; VATS; Quality of Recovery; Acute pain
The Effect of Liraglutide on the Treatment of Coronary Artery Disease and Type 2 Diabetes
Condition: Coronary Artery Disease; Diabetes Mellitus, Type 2
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effect of combined glucagon-like-peptide-1
      (GLP-1) analogue and metformin therapy on glucose metabolic and cardiovascular endpoints
      compared to metformin monotherapy in patients with coronary artery disease (CAD) and newly
      diagnosed type 2 diabetes (T2D).

      It is hypothesized that GLP-1 analogue added to backbone therapy of metformin in CAD patients
      with T2D will improve beta-cell function, left ventricular ejection fraction (LVEF), heart
      rate variability and lower 24h blood pressure among other selected endpoints.

      The present study on CAD patients with newly diagnosed T2D will address these selected
      endpoints during an investigator initiated, randomized, double blind, crossover,
      placebo-controlled 12 + 12 weeks intervention study with a 2 week wash-out period.
    

Detailed description: 
      The total study period for each patient will be 26 weeks (12 plus 12 weeks of intervention
      with a 2 week wash-out period).

      The endpoints will be evaluated at baseline (week 0), at week 12, at week 14 (following 2
      weeks of wash-out) and finally at week 26.
    

Intervention name(s): Liraglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Liraglutide injection pen is administered by the participant once daily by subcutaneous injection. It is given independent of meals. The starting dose is 0.6 mg. After 2 weeks the dose will be increased to 1.2 mg. The dose will be further increased after 4 weeks to 1.8 mg. After a total of 12 weeks of treatment, a wash-out period of 2 weeks follows. Subsequently, the participant will be crossed over to a second period of 12 weeks of treatment with placebo.; Volume-matched placebo injection pen is administered by the participant once daily by subcutaneous injection. It is given independent of meals. The starting dose is 0.6 mg volume-matched placebo. After 2 weeks the dose will be increased to 1.2 mg. The dose will be further increased after 4 weeks to 1.8 mg. After a total of 12 weeks of treatment, a wash-out period of 2 weeks follows. Subsequently, the participant will be crossed over to a second period of 12 weeks of treatment with liraglutide.
Other intervention name(s): Brand name: Victoza; Active substance: liraglutide; EMA Product number: EMEA/H/C/001026; ATC Code: A10BX07
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronary Artery Disease; Diabetes Mellitus; Left ventricular ejection fraction; Beta-cell function
Lithium Versus Anticonvulsants and the Risk of Physical Disorders
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      Nationwide population-based register linkage study covering the entire 5.9 million
      inhabitants in Denmark systematically investigating the associations between sustained
      long-term use of lithium versus lamotrigine and valproate, and the risk of a range of
      physical disorders emulating a randomized trial.
    

Detailed description: 
      The study includes two cohorts. Cohort 1: all 12.607 patients with a diagnosis of bipolar
      disorder (ICD-10 code: DF30-31.9) who subsequently were exposed to either lithium,
      lamotrigine or valproate between 1997 and 2021. Cohort 2: as Cohort 1, but regardless of
      prior diagnosis of bipolar disorder (N= 156.678).

      Main analyses considered a patient exposed to a drug 92 days after a prescription and a
      10-year follow-up and 4 sensitivity analyses considered a patient exposed to a drug for 60
      and 180 days after a prescription, respectively, and with 5- and 15-years follow-up,
      respectively.
    

Intervention name(s): Lithium
Intervention type(s): Drug
Intervention description(s): Sustained long-term exposure
Other intervention name(s): Lamotrigene; Valproate
Intervention MeSH terms: Valproic Acid
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Nationwide population-based register linkage study covering the entire 5.9 million
        inhabitants in Denmark and two cohorts. Cohort 1: all 12.607 patients with a diagnosis of
        bipolar disorder (ICD-10 code: DF30-31.9) who subsequently were exposed to either lithium,
        lamotrigine or valproate between 1997 and 2021. Cohort 2: as Cohort 1, but regardless of
        prior diagnosis of bipolar disorder (N= 156.678).
      
Keywords: Lithium; Lamotrigerne; Valproate; Physical disorders
Effect of Ziprasidone on Glucose & Plasma Lipids in Diabetes (II) and Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the protocol is to study the effects of 320 mg/day of ziprasidone (Geodon) on
      glucose and lipid metabolism of patients with both Diabetes Type II (DM) and schizophrenia or
      schizoaffective disorder, after switching their antipsychotic medication/s from typical
      and/or atypical to ziprasidone monotherapy.
    

Detailed description: 
      Inpatients with DSM IV diagnosis of schizophrenia or schizoaffective disorder and DM II will
      be enrolled after giving informed consent. Participants may stay on their original ward at
      MPC, if their clinical care would be better served on their home ward because of patient
      programs and/or continuity of care reasons. Patients recruited from other participating sites
      will be transferred to MPC research ward.

      There will be a screening phase (two weeks) on the prior antipsychotic regimen, a
      cross-titration phase (three week) and a ziprasidone phase (eight weeks; four time points).

      All medications, except for the antipsychotic agents, will be kept stable throughout the
      protocol. These medications may include anticholinergics, mood stabilizers and
      antidepressants. After the screening phase lasting two weeks, patients will enter the
      cross-titration phase lasting three week. The cross titration schedule will be changed in
      accordance with Deutschman & Deutschman's 2005 recommendations. The current antipsychotic
      will be gradually decreased to zero and ziprasidone will be started at 40 mg bid po and
      raised up to 160 mg po bid during the cross-titration phase, according to clinical response
      and tolerance. After the cross-titration phase has concluded, the ziprasidone dose will range
      from 80 mg bid p.o. to 160 mg bid p.o. daily according to clinical response during the eight
      week treatment phase.
    

Intervention name(s): Ziprasidone
Intervention type(s): Drug
Intervention description(s): Ziprasidone dose of between 40 mg po bid to 160 mg po bid for 8 weeks
Other intervention name(s): Geodon
Intervention MeSH terms: Ziprasidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; Schizoaffective Disorder; metabolic markers; ziprasidone; diabetes
Effect of Ketoconazole on the Pharmacokinetics of Refametinib
Condition: Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if there is a difference between the way your body
      absorbs and distributes BAY86-9766 when given alone or in combination with ketoconazole, a
      drug which may affect how much BAY86-9766 is absorbed, distributed or eliminated from the
      body
    


Intervention name(s): BAY86-9766; Ketoconazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ketoconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy Volunteers; Refametinib; Ketoconazole; Pharmacokinetics
Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome
Condition: Obesity; Pregnancy; Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Metabolic Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the effect of exercise during pregnancy upon maternal
      metabolism, including weight gain, fat distribution, and levels of glucose and cholesterol.
      We will also conduct a pilot study to examine the feasibility of studying the health of
      infants born to women in this study.
    

Detailed description: 
      Obesity and overweight have become important public health problems in the United States, and
      measures are urgently needed to address these issues. For many women, pregnancy is a time of
      excessive weight gain and decreases in physical fitness, both of which may be followed by
      postpartum weight retention. Women who develop hypertension or diabetes mellitus during
      pregnancy are at higher risk for development of these disorders in the future. Because of the
      implications of pregnancy-related weight gain and the metabolic changes during pregnancy for
      future maternal health, interventions to maintain or improve fitness during pregnancy may
      have important downstream health effects. In addition, maternal metabolic parameters and the
      intra-uterine environment have important implications for neonatal outcomes and subsequent
      child health. This study will provide data about the effects of an intervention to increase
      vigorous physical activity during pregnancy on short-term maternal and fetal outcomes.
    

Intervention name(s): Experimental group
Intervention type(s): Behavioral
Intervention description(s): Intervention group will exercise 3 times per week at moderate-vigorous intensity for 45 minutes per session. Control group women will continue their usual physical activity throughout pregnancy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Obesity; Physical activity; Pregnancy; Diabetes mellitus
Resting Metabolic Rate, Fat Distribution, Endocrine and Metabolic Features in Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      In a longitudinal, prospective and observational study, patients with PCOS and controls wore
      the SenseWear Armband for 2 days. Resting metabolic rati (kcal/die), total energy expenditure
      (MET, kcal) were evaluated. Ultrasonographic pelvic examinations, hirsutism score,
      anthropometric and menstrual pattern evaluation, hormonal profile assays, oral glucose
      tolerance test (OGTT) and lipid profile were performed.
    


Intervention name(s): SenseWear Armband (SWA) monitoring; total body dual-energy X-ray absorptiometry
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Participants wore the SWA on their right arm; DEXA was used to estimate abdominal visceral adipose tissue and subcutaneous adipose tissue
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        group 1: women with PCOS diagnosed according with the Rotterdam Consensus Conference
        criteria group 2: healty women
The Effect of Vinegar on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Tolerance or Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Intolerance
Study type: Interventional

Summary: 
      This open, randomized, cross-over, placebo-controlled study aims to investigate the effects
      of vinegar on glucose metabolism, endothelial function and circulating lipid levels in
      subjects with impaired glucose tolerance or type 2 diabetes, using the arteriovenous
      difference technique.
    

Detailed description: 
      Subjects with IGT or type 2 diabetes will be randomised to consume 20ml vinegar (6% acetic
      acid) or placebo before a mixed meal. Plasma samples will be taken for 300min from the radial
      artery and from a forearm vein for measurements of glucose, insulin, triglycerides,
      non-esterified fatty acids (NEFA) and glycerol. Muscle blood flow will be measured with
      strain-gauge plethysmography. Glucose flux will be calculated as the arteriovenous difference
      of glucose multiplied by the blood flow rates.
    

Intervention name(s): Vinegar; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 0,50mmol vinegar (6% acetic acid); 50 ml water
Intervention MeSH terms: Acetic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Glucose Kinetics After Wheat and Rye Breads
Condition: Diabetes Mellitus, Type 2. Physiology of Glucose Kinetics
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Certain functional properties of cereal products, e.g. their postprandial glucose and insulin
      responses, have been characterized as steps towards obtaining a greater understanding of
      their beneficial health effects. A low-glycemic index diet results in decreased postprandial
      insulin and glucose responses, which is thought to be beneficial for insulin and glucose
      metabolism.

      In healthy subjects, it has been shown that rye breads (RBs) produce a lower postprandial
      insulin response compared with refined wheat breads (RWB) despite similar glucose responses.
      Juntunen et al. (2003) suggested that the difference in the structural characteristics
      between rye and wheat breads is a possible explanatory mechanism. However, the underlying
      mechanism of this discrepancy between insulin and glucose responses to rye bread, the
      so-called "rye factor" (RF), is still largely unknown. Faster starch digestibility and higher
      postprandial insulin responses for RWB compared with RBs may indicate faster intestinal
      glucose absorption and faster glucose disappearance respectively.

      Therefore our hypothesis is that despite having similar glucose responses, RWB has faster
      turn over (kinetics) compared with RBs. The present study is aiming to apply an experimental
      set up which can comprehend the hypothetical differences in RWB and RBs kinetics.
    

Detailed description: 
      The human subjects after an overnight fasting 10-12 hours are coming to the clinic. On
      arrival, catheters are inserted into a forearm vein of each arm for blood sampling and
      isotope infusion, respectively. A primed followed by a constant-rate infusion of [6,6-2H2]
      glucose are administered. The enrichment of [6,6-2H2] glucose in the blood is then measured
      at different time points after the breakfast. The glucose kinetics can be calculated from
      this.
    

Intervention name(s): Rye/Wheat
Intervention type(s): Other
Intervention description(s): Mechanistic study of glucose kinetics after ingestion two kinds of bread
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study was carried out using a crossover design with a three-week washout period. The participants stayed overnight at the facility and had one out of two types of breakfast in the morning.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Rye; Wheat; Rye factor; Glucose kinetics
Ultrasound of the Knee in Obese Patients With Knee Osteoarthritis; Weight Loss
Condition: Osteoarthritis; Obesity
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Weight Loss
Study type: Observational

Summary: 
      This is a substudy to a randomised trial investigating the effect of liraglutide on body
      weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In
      the parent trial, patients will be subjected to an 8-week diet intervention phase including a
      low-calorie diet and dietetic counseling, after which patients will be randomised to receive
      either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on
      re-introducing regular foods and a focus on continued motivation to engage in a healthy
      lifestyle.

      This substudy aims to investigate any changes in Ultrasound (US) measures associated with the
      initial 8-week weight loss intervention.
    


Intervention name(s): Dietary Supplement: Intensive dietary intervention
Intervention type(s): Dietary Supplement
Intervention description(s): Participants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants eligible for parent trial (NCT02905864), i.e. overweight/obese individuals
        with knee osteoarthritis
      
Keywords: Osteoarthritis; Obesity; Ultrasound; Liraglutide; Liraglutide 3mg
Angioplasty in Peripheral Arterial Disease and Endothelial Function
Condition: Peripheral Arterial Obstructive Disease; Intermittent Claudication
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication; Arterial Occlusive Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate whether endovascular revascualrization of infrainguinal arterial obstructive
      disease has an effect on brachial artery reactivity
    

Detailed description: 
      Peripheral arterial disease (PAD) is a common manifestation of atherosclerosis affecting a
      large proportion of the aged population. It is associated with a more or less severe
      impairment in functional activity and with an increased risk of future cardiovascular events.
      In PAD patients, an increased inflammatory status and a depressed endothelial function,
      assessed as flow-mediated dilation of the brachial artery have been demonstrated. Moreover, a
      prognostic value has been found in PAD patients for both inflammatory parameter and
      flow-mediated dilation (FMD). One of the reasons of the increased inflammatory activation and
      endothelial dysfunction in PAD patients could be the ischemia-reperfusion injury associated
      with intermittent claudication. The hypothesis is that repeated episodes of acute
      inflammation and endothelial dysfunction following ischemia-reperfusion injury linked to
      intermittent claudication could be in part responsible for the increased inflammatory status
      and chronically depressed endothelial dysfunction of these patients. Taking into account
      these considerations, it is reasonable to assume that the correction of leg ischemia by
      interventional procedure, such as peripheral transluminal angioplasty (PTA) should determine
      a reduction in inflammatory mediators and an improvement in endothelial function.

      The study is a prospective, open, randomised, controlled, single-centre, follow-up
      evaluation, assessing the efficacy of peripheral catheter interventions in patients with
      symptomatic PAD on endothelial dysfunction and plasmatic procoagulant activity. Patients will
      be randomly assigned to immediate revascularization or to no treatment for one month. The
      assessment of parameters (brachial artery flow-mediated and nitrate-mediated dilation, plasma
      levels of C reactive protein, fibrinogen, microparticles and coagulation factors) will be
      performed at baseline and after 4 weeks in both, patients undergoing interventional
      procedures and in those, who will not be treated.
    

Intervention name(s): Endovascular Revascularization
Intervention type(s): Procedure
Intervention description(s): Angioplasty/Stenting of femoro-popliteal lesions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peripheral arterial obstructive disease; Intermittent Claudication; Endovascular treatment; Flow-mediated dilation