bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Selective Site Right Ventricular Pacing
Condition: Bradycardia
MeSH terms: Bradycardia
Study type: Observational

Summary: 
      This is a pilot study into the effects on heart function when pacing the right ventricle
      (RV). This study aims to enrol a population with structurally normal hearts. The
      investigators aim to measure heart function directly when pacing.

      When normal conduction within the heart fails, the treatment may be to implant a permanent
      pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical
      impulse to stimulate a beat. The usual site for pacing is the tip of the RV. This has been
      shown to be less efficient than the normal conduction system of the heart and in some cases
      leads to markedly reduced function. What the investigators do not know is why this is the
      case.

      Much effort has been directed at looking at features within the left ventricle (LV) for
      markers of disease progression but little has been investigated regarding the RV.

      There may be some benefit to pacing the heart preferentially from different parts of the RV
      and the investigators aim to measure if any differences are detectable from stimulating the
      heart at various sites within the RV.
    

Detailed description: 
      Inclusion Criteria;

        -  Patients undergoing elective Electrophysiological Studies +/Ablation

        -  Age 18-80

        -  Normal Heart on Pre-procedural Echocardiogram

      Exclusion criteria;

        -  Atrial Fibrillation

        -  Evidence of anterograde conducting accessory pathway

        -  Permanent Pacemaker insitu

        -  Pregnant

        -  Breast Feeding

      Outcome Measures; Change in load-independent indices of LV and RV contractility before and
      after pacing intervention. LV and RV function measured by transthoracic echocardiography and
      tissue Doppler imaging.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing SVT studies
      
Keywords: Pacing; Haemodynamics; Pilot
A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This proof of principle PK study will allow GSKCH to select the most favorable sustained
      release formulation among 3 prototypes to move to the next stage of drug development.
    


Intervention name(s): Paracetamol fast dissolution suspension; Paracetamol medium dissolution suspension; Paracetamol slow dissolution suspension; Paracetamol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: paracetamol
Assessment of Exposures of the Mother-infant Pair to the Air Pollution of São Paulo
Condition: Lung Diseases
MeSH terms: Lung Diseases
Study type: Interventional

Summary: 
      A single group of pregnant women who was analyzed in the first and in the third trimesters of
      pregnancy
    

Detailed description: 
      A single group of 120 pregnant women separated in smokers (n = 17) and nonsmokers (n = 103)
      and first pregnancy (n = 54) or multiparous (n = 66) who underwent pulmonary function test
      and used the individual passive sampler in the first and third trimesters of pregnancy
    

Intervention name(s): Lung function test
Intervention type(s): Procedure
Intervention description(s): Pregnant woman use the individual passive sampler 15 days before the spirometry test at each trimester
Other intervention name(s): Spirometry
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Respiratory Function Tests; Air pollution; Pregnancy; Spirometry
Implication of Stiffness of the Hamstrings, Achilles Tendon and Calf Muscles for Jumping Performance
Condition: Tissue Compliance
Study type: Interventional

Summary: 
      For optimal jumping performance an adequate interaction of muscles and tendons is required. A
      parameter in the functional evaluation of both structures is their stiffness (resistance of
      the tissue against deformation by external forces). It is unclear so far if higher stiffness
      values of tendon or muscle or a specific stiffness relation of both tissues is the cause of
      better jumping performance. The present study examines this based on the Achilles tendon and
      the calf muscles or the patellar tendon and the hamstrings by three different forms of jumps
      (squat jump, counter-Movement Jump, Drop-Jump).

      The plan is to include young healthy volunteers aged 18 to 40 years. In a cross-sectional
      study, the jump height of the participants will be measured for each jump form: squat jump
      (jump from a squatting position), Counter-Movement Jump (jump with backswing by going into
      the knees) or drop jump (jump from small box with direct re-jump). The order of the jump form
      is determined randomly. The measurements are carried out within one day. Furthermore the
      international physical activity questionnaire will be used in order to assess the level of
      physical activity.

      As primary outcome the stiffness of the calf muscles, achilles tendon, hamstring and patellar
      tendon will be detected. The measurement is carried out before the jumps (there are three
      jumps after one sample jump performed). The measurement is executed non-invasively and
      completely painless using Indentometers and MyotonPro. With both devices, minimal pressure on
      the examined tissue will be exerted and measured how much of this can be compressed.
    


Intervention name(s): Tissue stiffness
Intervention type(s): Other
Primary purpose: Diagnostic
Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate-or
      severe Chronic Obstructive Pulmonary Disease (COPD) as measured by

        -  Annualized rate of acute moderate and severe COPD exacerbation (AECOPD)

      Secondary Objectives:

      To evaluate the effect of dupilumab administered every 2 weeks on

        -  Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to
           placebo

        -  Health related quality of life, assessed by the change from baseline to Week 52 in the
           St. George's Respiratory Questionnaire (SGRQ)

        -  Pre-bronchodilator FEV1 over 52 weeks compared to placebo

        -  Lung function assessments

        -  Moderate and severe COPD exacerbations

        -  To evaluate safety and tolerability

        -  To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies (ADA)
    

Detailed description: 
      Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and
      12 weeks of follow-up.
    

Intervention name(s): Dupilumab SAR231893; Inhaled Corticosteroid; Inhaled Long-Acting Beta Agonist; Inhaled Long-Acting Muscarinic Antagonist; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous; Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation; Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation; Pharmaceutical form: Inhaled Powder
Route of administration: Oral inhalation; Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
Other intervention name(s): Dupixent
Intervention MeSH terms: Cholinergic Agents; Muscarinic Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
PK Study in Subjects With Severe Hepatic Impairment
Condition: Severe Hepatic Impairment; Healthy
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose study in male and female subjects with severe hepatic
      impairment and in male and female subjects with normal hepatic function.
    


Intervention name(s): MCI-186
Intervention type(s): Drug
Intervention description(s): 30 mg MCI-186 will be administered intravenously over 60 minutes.
Other intervention name(s): Edaravone; Radicava; Radicut
Intervention MeSH terms: Edaravone
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Severe Hepatic Impairment; Healthy
PK, Safety & Tolerability of CyCol® Versus Sandimmune® in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this Phase I, single centre, multi stage study is to evaluate the safety,
      tolerability, pharmacokinetics and relative colonic mucosal concentrations of cyclosporine
      capsules (CyCol®) compared to intravenous cyclosporine in healthy male volunteers.
    

Detailed description: 
      This is an open label, multiple-dose, multi-stage pharmacokinetic (PK) study. A maximum of 40
      healthy adult male volunteers aged between 18 and 55 years will be enrolled at a single
      clinical research unit.

      For each CyCol® group dosing will last 7 days, whilst the Sandimmun® IV group will have a
      single dose over 24 hours.

      Single dose pharmacokinetics of different doses of CyCol® will be compared to IV Sandimmun®.
      In addition colonic tissue concentrations will be compared after multiple doses of CyCol® to
      a single IV dose of Sandimmun®. Concentrations of unchanged cyclosporine and it's metabolites
      in the faeces will also be explored.

      Stage 1 of the study will investigate the 75mg dose (OD and BID) of CyCol® and IV Sandimmun®.
      Then dependent on results Stages 2 and 3 will investigate either lower (37.5mg) or higher
      (150mg) dose levels. The dosing regimens chosen for Stages 2 and 3 will be based upon safety
      and tolerability, systemic exposure and colonic mucosa tissue concentrations observed at
      other doses.
    

Intervention name(s): Sandimmun® IV; CyCol® capsules
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg/kg IV; 37.5 mg CyCol® capsules
Other intervention name(s): Cyclosporine A; Sandimmun® concentrate for solution for Infusion; Cyclosporine A; oral cyclosporine
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cyclosporine; Healthy Volunteers; Immunosuppressive Agents; CyCol; Pharmacokinetics
Hepatic Pseudoaneurysms After Trauma
Condition: Pseudoaneurysm; Abdominal Trauma
MeSH terms: Aneurysm, False; Abdominal Injuries
Study type: Observational

Summary: 
      Hepatic pseudoaneurysm (HPA) is a rare complication after liver trauma, yet it is potentially
      fatal, as it can lead to sudden severe haemorrhage. The risk of developing posttraumatic
      hepatic pseudoaneurysm is one of the reasons why some trauma centres do follow-up CT of
      patients with liver injuries to take the therapeutic consequence. The aim of this study was
      to investigate the occurrence of HPA post liver trauma.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All patients conservatively managed and radiologically followed-up after liver injury,
        admitted Trauma Centre at the University hospital of Copenhagen, Rigshospitalet from
        January 2000 to December 2010.
Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate
      the effect of concomitant administration of fluconazole or quinidine on the pharmacokinetics
      and safety of EDP-305 in healthy human volunteers.
    


Intervention name(s): Fluconazole; Quinidine; EDP-305; EDP-305
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive fluconazole once daily from Day 5 to Day 18; Subjects will receive quinidine twice daily from Day 5 to Day 12; Subjects will receive a single dose of EDP-305 on Day 1 and Day 14; Subjects will receive a single dose of EDP-305 on Day 1 and Day 8
Intervention MeSH terms: Fluconazole; Quinidine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: 2-Part Single Group study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: drug-drug interaction
Breastfeeding Intervention Study
Condition: Breast Feeding
Study type: Interventional

Summary: 
      To evaluate the benefits of a lactation support intervention, in conjunction with maternal
      nutritional supplementation.
    

Detailed description: 
      This study aims to evaluate the benefits of a lactation support intervention model combining
      a maternal nutritional supplementation starting at 8 weeks before delivery to 12 weeks
      postpartum and a lactation support intervention consisting of 1 prenatal and 3 postnatal
      sessions on exclusive breastfeeding rate.
    

Intervention name(s): Maternal Nutritional Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): S348S0
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Optimized Treatment and Regression of HBV-induced Early Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to
      metavir F4, Ishak 5/6) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2
      years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year,
      entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every
      six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, liver
      ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate
      regression rate of liver fibrosis 1.5 years after initial therapy.
    


Intervention name(s): entecavir; Thymosin-α
Intervention type(s): Drug; Drug
Intervention description(s): anti-viral therapy; antiviral and antifibrosis therapy
Other intervention name(s): entecavir dispersible tablets; Zadaxin
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis B; Liver Cirrhosis; Regression; Efficacy
Acute Metabolic Effects of Estradiol
Condition: Postmenopause
Study type: Interventional

Summary: 
      Estradiol promotes and maintains the typical female phenotype characterized by subcutaneous
      fat accumulation. There is evidence to suggest that this effect relies on the ability of
      estradiol to increase the amount of anti-lipolytic α2A-adrenergic receptors, but whether this
      requires long-term exposure to estradiol or is the result of an immediate effect is not
      clear. Objective: To study acute effects of a single dose (4 mg) of 17β-estradiol on regional
      and systemic lipolysis.
    

Detailed description: 
      Estradiol affects muscle and fat distribution, and thereby lipid metabolism. A reduction in
      muscle power is seen after menopause, readily counteracted by female hormone therapy (HT).
      Treatment with HT through months to previously untreated postmenopausal women, or hormone
      replacement therapy (HRT) to women with Turner syndrome, increases muscle mass and reduces
      fat mass. HT in postmenopausal women furthermore prevents fat accumulation and increases
      lipoprotein lipase activity and lipolysis to an extent comparable to premenopausal women. In
      contrast, it has also been shown that estradiol may actually attenuate lipolysis during basal
      as well as catecholamine stimulated conditions. In addition, one study found whole body fat
      metabolism to be lower during treatment with estradiol than without, and reduced lipolysis is
      present in postmenopausal women during treatment with estradiol, along with an increased
      number of α-adrenergic receptors and a decreased number of β-adrenergic receptors.

      It is not clear whether the lipolytic effect of estradiol happens acutely or is dependent on
      chronic exposure. Moreover, regional differences in the pharmacodynamics of estradiol have
      not been assessed. Finally, effects on skeletal muscle have never been examined.

      The purpose of the present study was 1) by microdialysis to quantify the regional production
      of glycerol in two tissues (muscle and fat), and in two regions (abdominal and femoral). 2)
      To quantify the whole-body lipolytic effect of estradiol, and 3) in biopsies to study
      intracellular mechanisms behind the action of estradiol.
    

Intervention name(s): estradiol
Intervention type(s): Drug
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Estradiol; Lipolysis; Estrogen receptor; Adrenergic receptors; UCP2; Postmenopausal women
Determination of Fiberoptic Bronchoscopy Sedation Protocols in Turkey
Condition: Fiberoptic Bronchoscopy
Study type: Observational

Summary: 
      Fiberoptic bronchoscopy (FOB), which is difficult to tolerate while awake, is recommended to
      be performed by the patient under sedation. The aim of this study is to determine the
      attitudes and behaviors of chest diseases specialists who do FOB in Turkey about sedation
      with a 30-question online questionnaire.
    

Detailed description: 
      Fiberoptic bronchoscopy is the imaging of the tracheobronchial tree for diagnosis and
      treatment in lung diseases. The operation performed through the airway is difficult for the
      patient to tolerate. Therefore, it is recommended to perform the procedure under sedation.
      With this survey study, it was aimed to determine the sedation protocols preferred by
      pulmonologists who perform active fiberoptic bronchoscopy throughout Turkey during the
      procedure.

      Thirty questions were determined for the questionnaire to be used as a data collection method
      by the researchers. The questions generally consist of three parts; In the first part, there
      are 8 questions containing the personal information of the doctors (age, gender, title,
      institution, etc.). In the second part, 13 questions were included in order to make a general
      assessment such as the sedative agents used by the doctors before and during the bronchoscopy
      procedure, and the satisfaction with the sedative method used. In the third part, 9 questions
      were given to determine the preferred follow-up methods during the procedure. The questions
      are designed to be presented to participants over the network using google forms.
    

Intervention name(s): Survey Questions
Intervention type(s): Other
Intervention description(s): Thirty questions generally consist of three parts; In the first part, there are 8 questions containing the personal information of the doctors (age, gender, title, institution, etc.). In the second part, 13 questions were included in order to make a general assessment such as the sedative agents used by the doctors before and during the bronchoscopy procedure and the satisfaction with the sedative method used. In the third part, 9 questions were given to determine the preferred follow-up methods during the procedure.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pulmonologists who are still working in Turkey and have been actively doing FOB for the
        last 5 years
      
Keywords: sedation; non-operating room anesthesia
A Cross-over Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics (PK) of GSK525762 in Healthy Female Subjects of Non Child Bearing Potential
Condition: Drug Interactions; Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single center, two-part, randomized, open label, cross-over study. Part 1
      of this study will evaluate the PK, safety, and tolerability of GSK525762 when administered
      alone and when co-administered following repeat dosing of itraconazole, a known strong
      inhibitor of Cytochrome P450 3A4 (CYP3A4) and a Para-glycoprotein (Pgp) inhibitor. Part 1
      will consist of 2 Cohorts with preliminary PK and safety data obtained from Cohort 1
      informing Cohort 2. Part 2 (one Cohort) of the study will evaluate the PK, safety, and
      tolerability of GSK525762 when administered alone and when co-administered following repeat
      dosing of rifampicin, a known potent inducer of CYP3A4. In vitro inhibition data indicate
      CYP3A4 may be the major route of clearance for GSK525762 and co-administration of drug
      therapies which modulate CYP3A4 (i.e.CYP3A4 inhibitors and inducers) is likely to alter the
      exposure of GSK525762 (i.e. increase or decrease exposure, respectively). The data generated
      from this current study to justify exclusion criteria on concomitant medications which affect
      CYP3A4 or Pgp and also inform potential dose modification in case of co-administration with
      medication affecting CYP3A4 activity. All subjects will undergo a screening visit within 28
      days of the first dose of study drug followed by one treatment period and a follow-up visit
      7-10 days after the last dose of GSK525762. Subjects in Part 1 will participate in the study
      for up to 45 days and subjects in Part 2 will participate for up to 56 days.
    


Intervention name(s): GSK525762 Besylate Tablets; Itraconazole 200 mg; Rifampicin 300 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK525762 is available as a film-coated, white to slightly colored round, biconvex tablets with no markings. It is available in unit dose strength of 5 mg.; Itraconazole is available as a clear yellow solution with unit dose strength of 10 mg/mL; Rifampicin is available as a red capsule with printed markings and as a 300 mg unit dose strength.
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Itraconazole; Rifampicin; Pharmacokinetics; Cross-over