bioihbjkbjnl/mcl2 huggingface dataset:
To Assess the Excretion Balance and Pharmacokinetics of a Single Oral Dose of [14C]GW856553 in Healthy Adult Males
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open label study conducted at one site. Six healthy male subjects will be
      enrolled to ensure at least four fully evaluable subjects. Each subject will receive a single
      10 milligram (mg) oral dose of GW856553 containing 50 microCi (µCi) of [14C] GW856553. Urine
      and fecal samples will be collected until 216 hour after dosing but subjects may be
      discharged after 168 hour if 90% of the dose is recovered and/or <1% of the dose is excreted
      in a 24 hour period. Blood and plasma will be collected at various sample times after dosing
      to measure parent drug and total drug-related material. Samples of urine, faeces and plasma
      will be transferred into a separate study to characterize and quantify metabolites in these
      matrices. Safety will be assessed by adverse event monitoring, vital signs, electrocardiogram
      (ECG) and clinical laboratory tests.
    


Intervention name(s): GW856553
Intervention type(s): Drug
Intervention description(s): A dose of 10mg GW856553 containing 50µCi of [14C]GW856553 will be delivered as 100mL of a 0.1mg/mL GW856553/0.5 µCi/mL oral solution.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GW856553,; radiolabel; ADME,
Comparison of the Effects of Neostigmine With Sugammadex on Postoperative Nausea and Vomiting.
Condition: Incidence of Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative nausea and vomiting is one of most common complications after general
      anesthesia. Female sex, history of postoperative nausea and vomiting, motion sickness, non
      smoker status, opioid administration are known as risk factors for developing postoperative
      nausea and vomiting.

      It has been suggest that antagonism of residual neuromuscular block with a mixture of
      neostigmine and atropine at the end of the surgery increases the risk of postoperative nausea
      and vomiting.

      Sugammadex is a very safe drug with almost no serious adverse effects. The known adverse
      effects include slight coughing, movement, an altered taste sensation in the mouth, transient
      prolongation of the QT interval, hypersensitivity, and a short term prolongation of the
      activated partial thromboplastin time.

      The aim of this study was to compare the sugammadex versus neostigmine plus atropine for
      reversal of rocuronium induced neuromuscular blockade in terms of incidence of postoperative
      nausea and vomiting.
    


Intervention name(s): Neostigmine; sugammadex
Intervention type(s): Drug; Drug
Intervention description(s): for reversal of neuromuscular block: 0,05 mg kg-1 neostigmine + 0,025 mg kg-1 atropine; for reversal of neuromuscular block: sugammadex 2 mg kg-1
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Safety and Efficacy of Oral Bovine Lactoferrin
Condition: Neonatal SEPSIS
MeSH terms: Sepsis; Neonatal Sepsis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Oral lactoferrin versus Placebo will be given to preterm neonates
    

Detailed description: 
      200 patient were included in the study , one hundred received oral placebo in the form of 2
      ml saline , the other 100 preterm neonates received oral lactoferrin with monitoring of
      C-reactive protein , different cultures, complete blood count on day 7 and after one month.
    

Intervention name(s): Lactoferrin; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): lactoferrin is given orally in comparsion to placebp; placebp is given in 2 ml saline
Other intervention name(s): Pravotin sachets; saline
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: placebo group 100 patient will receive 2 ml saline for one month in comparison with oral lactoferrin for the same period to another 100 patient
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: lactoferrin
DeFRA Questionnaire as an Anamnestic Form
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      The DeFRA questionnaire is a new validated algorithm derived from FRAX. Here we use the DeFRA
      as a "primary anamnestic from" to identify subjects at risk of osteoporosis in a population
      never screened before and never treated for this disease.
    

Detailed description: 
      There is an increasing recognition that the management of osteoporosis requires the
      characterization of fracture risk to be based on absolute risk rather than single measures
      such as bone mineral density (BMD). However, the threshold for pharmacological intervention
      for osteoporosis remains controversial.

      The aim of the present project is to perform a large scale study to identify subjects at risk
      of osteoporosis by administering the DeFRA questionnaire in a population never screened or
      treated before for osteoporosis.

      DeFRA questionnaire will be administered before and after DEXA scanning, to further validate
      the questionnaire and to highlight the predictive value of this protocol as a tool to screen
      the general population.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        general population, never screened before for osteoporosis and never subject to treatment
Phase 2 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential Hypetension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Double-blind, Multicenter, Factorial Design, Phase II Study to Evaluate the
      Efficacy and Safety of Irbesartan and Amlodipine Combined or Alone in Patients With Essential
      Hypertension
    


Intervention name(s): Irbesartan/Amlodipine
Intervention type(s): Drug
Intervention description(s): QID
Intervention MeSH terms: Amlodipine; Irbesartan
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Gender Differences of Neuroanatomical and Neurophysiological Correlates of Risk-proneness in Early Adolescents
Condition: Gender; Early Adolescent Behavior
Study type: Observational

Summary: 
      Risk-taking in early adolescence have has been found to be normative and even formative as it
      might fulfill the youth's needs to experiment different sensations, make independent
      decisions and learn from their consequences. Several theoretical models have suggested that
      male and female adolescents differ in risk-taking as a product of individual/contextual
      factors and neocortical functioning; however, the neurophysiological and neuropsychological
      correlates of those differences continue to be underexplored. Informed by Evolutionary
      Neuroandrogenic Theory, the investigators examine the links between gender, risk-proneness,
      gratification delay, self-control, self-efficacy, executive functions and
      neurophysiological-neuroanatomical correlates in early adolescents (age 10-12 years).
      Participants (N=24; 50% females) will complete behavioral measurements on study constructs
      and perform neuropsychological tests using fMRI scanning (e.g., Go/NoGo continuous
      performance, stop-signal reaction time, NIH Cognition Battery, delay discounting). Female and
      male groups will be compared on all outcome measures.
    


Intervention name(s): The study is an observational cross sectional study
Intervention type(s): Other
Intervention description(s): An intervention will not be performed
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of healthy early adolescent (age 10-12 years) male and
        female subjects
Efficacy of Pioglitazone and Metformin on Cardiovascular Risk in Subjects With Insulin-Treated Type 2 Diabetes Mellitus.
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the Anti-Inflammation Effects of Pioglitazone,
      twice daily (BID), and Pioglitazone/Metformin Combination Therapy BID in Type 2 Diabetes
      Subjects Treated with Insulin.
    

Detailed description: 
      It is established that matrix metalloproteinases play an essential role in the degradation of
      collagen and other extra cellular matrix macromolecules. In addition, matrix
      metalloproteinases are implicated in plaque rupture through their capacity to thin the
      protective cap of the plaque, thus rendering it more vulnerable. In fact, matrix
      metalloproteinase-9 levels are elevated in patients with unstable plaques and in patients
      with acute coronary syndrome. In patients with type 2 diabetes mellitus, matrix
      metalloproteinase-1 and matrix metalloproteinase-9 levels are usually elevated and the
      atherosclerotic plaques are more vulnerable compared to non-diabetic patients, confirming the
      role of this proteinase in the development of acute coronary syndrome. Therefore, therapeutic
      strategies that reduce blood glucose levels and attenuate inflammation and matrix
      metalloproteinases activity may be a tool for reducing cardiovascular risk in patients with
      diabetes.

      The purpose of this trial is to investigate whether the anti-inflammatory effects of
      pioglitazone are maintained and sustained over a longer observation period when given in
      combination with insulin in comparison to the metformin plus insulin combination. The
      duration of treatment for patients completing the study is approximately 6 months.
    

Intervention name(s): Pioglitazone and insulin; Pioglitazone and metformin and insulin; Metformin and insulin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pioglitazone 15 mg, tablets, orally, twice daily and metformin placebo-matching tablets, orally, twice daily and insulin glargine stable dose for up to 24 weeks.; Pioglitazone 15 mg, tablets, orally, twice daily and metformin 850 mg, tablets, orally, twice daily and insulin glargine stable dose for up to 24 weeks.; Pioglitazone placebo-matching tablets, orally, twice daily and metformin 850 mg, tablets, orally, twice daily and insulin glargine stable dose for up to 24 weeks.
Other intervention name(s): ACTOS®; ACTOS®
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Drug Therapy
Safety of Direct Oral Anticoagulant During Pregnancy
Condition: Thromboembolic Disease
MeSH terms: Thromboembolism
Study type: Observational

Summary: 
      Pregnancy is a major risk factor of thromboembolic disease (2 to 10 increased risk of
      thromboembolic event for pregnant women). This risk is related to the physiological changes
      inducing venous stasis and hypercoagulability.

      Thromboembolic disease is the first preventable cause of death during pregnancy (in France
      1.1 maternal death per 100 000 living births.

      The recommended treatment for pregnant women is low molecular weight heparin requiring
      subcutaneous injections daily. Vitamin K antagonists are contraindicated due to a teratogenic
      risk. Direct oral anticoagulants (DOAC) are easier to use.

      Currently available preclinical and incidental exposure data on DOAC in pregnant women are
      very limited and insufficient to conclude on their safety. Therefore, its use during
      pregnancy is currently contraindicated for the grounds of precaution. The use of
      reimbursement data from the Système National des données de santé (National Health Data
      System) would provide more information on accidental exposure to DOACs during pregnancy,
      thanks to its completeness.

      The primary objective of SACOD is to compare the prevalence of adverse perinatal outcomes in
      pregnant women treated with a direct oral anticoagulant versus pregnant women treated with
      heparin and Vitamin K antagonist.

      The secondary objectives of the SACOD study are to i) determine the frequency of patients
      exposed to a direct oral anticoagulant during pregnancy according to pregnancy, ii) measure
      the prevalence of adverse perinatal outcomes in pregnant women initiating treatment with a
      direct oral anticoagulant therapy, iii) compare the prevalence of adverse perinatal outcomes
      in pregnant women initiating treatment with direct oral anticoagulants compared with pregnant
      women treated with heparin and a vitamin K antagonist, iv) compare the prevalence of adverse
      perinatal outcomes in pregnant women with Antiphospholipid syndrome treated with a direct
      oral anticoagulant versus pregnant women treated with heparin and anti-vitamin K, v) measure
      the incidence of thrombo-embolic episodes during pregnancy under anticoagulant treatment.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All women with an pregnancy outcome identified in the French nationwide claim database
        (SNDS) exposed to anticoagulation treatment
Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection.
Condition: Side-effect of Antibiotic
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to provide data on the pharmacokinetics (PK) of moxifloxacin (MXF) in
      serum and liver tissue of patients undergoing liver resection due to primary or secondary
      tumor of the liver.
    

Detailed description: 
      After given informed consent, patients scheduled for planned liver resection are enrolled
      into the study. The patients receive MXF 400 mg as one hour intravenous infusion at
      randomized timed intervals prior to liver resection. Blood and healthy liver tissue are
      sampled in 34 patients after administration of MXF. Plasma is sampled concomitantly. In a
      subgroup of 19 patients, additional serum specimens are obtained after 2, 4, 8, 12, 24, 36
      and 48 h to establish the PK. The pharmacokinetic parameters of MXF are calculated applying a
      two-compartment model.
    

Intervention name(s): Moxifloxacin 400 mg
Intervention type(s): Drug
Intervention description(s): The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection.
Other intervention name(s): Avalox 400mg/250ml
Intervention MeSH terms: Moxifloxacin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; liver resection
Auriculotherapy Effectiveness on Stress and Anxiety in Nursing Student
Condition: Stress; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Single-blind randomized controlled trial aimed to assess stress and anxiety levels in Nursing
      School students of Beneficence Portuguese Hospital and review the effectiveness of true and
      placebo auriculotherapy.
    

Detailed description: 
      Although researches on stress have a strong focus on stress at work,it is very important the
      evaluation of the stress and its consequences in Nursing students. This allows to understand
      which stress factors experienced in a negative way could interfere on the adaptive success in
      school activities. Students can experience symptoms of the alarm phase of stress such as
      tachycardia, muscle tension, skin and cold extremities, and also the second phase of stress
      such as headache, sleepiness, irritability and difficulty concentrating. High levels of
      stress have a substantial effect on attention and can lead to errors, lack of concentration
      and fluctuations in the level of attention. The auriculotherapy may have an important role as
      a coping strategy for stress and anxiety. It is a fast, relatively simple, easily performed,
      safe and without major side effects.
    

Intervention name(s): Auriculotherapy; Placebo Group
Intervention type(s): Other; Other
Intervention description(s): Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological.; They were evaluated at the baseline,twelve sessions and 15-day follow-up and received 12 sessions through the Fist and Outer ear points.
Other intervention name(s): Auricular acupuncture; Sham Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: stress disorders; anxiety disorders
COVID-19 Versus Neurological Impairment, Physical Activity, Social Contacts and Education
Condition: Covid19; Neurological Disorder; Balance; Distorted; Gait Disorders, Neurologic; Activity, Motor; Social Isolation; Educational Problems; Quality of Life
MeSH terms: COVID-19; Nervous System Diseases; Gait Disorders, Neurologic
Study type: Observational

Summary: 
      The research will make it possible to assess patients who recovered from COVID-19 for the
      incidence of neurological problems (impaired balance, gait, coordination, concentration and
      attention), and changes in the quality of life, physical activity, social contacts and
      education.
    

Detailed description: 
      The intended size of group - 100 subjects (50 subjects - study group, 50 subjects - control
      group). The above population was determined based on sample size calculator, with the
      following parameters: fraction size of 0.9, Confidence Interval of 95%, maximum error of 9%.
      The proper study will be preceded with a pilot study involving a smaller group of subjects
      (in order to standardise the surveys, and minimise the relationship between the results of
      the survey and side-effect factors). After inclusion and exclusion criteria are considered,
      the subjects will be allocated into two groups:

        -  study group (subjects who had tested positive and recovered from COVID-19)

        -  control group (healthy subjects who did not have COVID-19). The controls will be matched
           to the study group for gender and age.

      The examination will be performed once, at the premises of the University of Rzeszów. The
      participants' condition will be assessed using the following measures:

        -  static and dynamic balance and risk of falls (force plate and computerised
           posturography, clinical tests)

        -  activity in the cerebral cortex of the frontal lobe during focused performance of a task
           (Hemoencephalography HEG-System)

        -  concentration and attention, memory and cognitive functions (Bourdon-Wiersma test and
           Auditory-Verbal Learning Test)

        -  gait velocity and efficiency (10-meter walk test and 6-minute walk test)

        -  physical activity (International Physical Activity Questionnaire IPAQ), as well as
           education, mood, and social contacts (specially designed questionnaire)

        -  quality of life (SF-36 questionnaire)
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will be conducted in the population of people living in south-eastern Poland.
UARK 2014-21 A Phase II Trial of Oncolytic Virotherapy by Systemic Administration of Edmonston Strain of Measles Virus
Condition: Multiple Myeloma
MeSH terms: Measles; Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the clinical efficacy of MV-NIS (measles
      virus-sodium iodide symporter) therapy for people with relapsed/refractory myeloma when given
      with cyclophosphamide
    

Detailed description: 
      The drug used in this trial is a modified version of the measles virus used to vaccinate
      children. The virus has been altered by having an extra gene (piece of DNA) added to it to
      allow a protein called NIS to be inserted into it. NIS is normally found in the thyroid gland
      ( a small gland in the neck) and helps the body concentrate iodine. Having this additional
      gene will make it possible to track where the virus goes in the body.
    

Intervention name(s): MV-NIS
Intervention type(s): Drug
Intervention description(s): one dose in conjunction with a 4 day course intravenously
Other intervention name(s): Recombinant Edmonston measles virus with human NIS gene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Measles virus; Sodium Iodide Symporter; Cyclophosphamide; Refractory multiple myeloma
Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma
Condition: Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the antitumor effects and safety of bendamustine
      hydrochloride (SyB L-0501) in patients with indolent B-cell non-Hodgkin's lymphoma or mantle
      cell lymphoma.
    

Detailed description: 
      Indolent B-cell Non-hodgkin's lymphoma is treated mainly with radiation and chemotherapy
      using a combination of chemotherapies, such as purine-analogues and CHOP (cyclophosphamide,
      doxorubicin, vincristine and prednisolone). After the approval of an antibody therapy agent
      Rituximab®, it alone or combination with CHOP has been introduced. Bendamustine hydrochloride
      has a unique structure compared with the marketed agents, and has an innovative mechanism of
      action. Thus, it is expected that Bendamustine hydrochloride will provide new alternatives
      for patients with refractory/recurrent indolent B-cell Non-hodgkin's lymphoma.
    

Intervention name(s): bendamustine hydrochloride
Intervention type(s): Drug
Intervention description(s): bendamustine hydrochloride is administered by 60-min drip infusion at 120 mg/m2/day for 2 consecutive days, and the course is then observed for 19 days. This is one cycle and administration is repeated for 3 - 6 cycles. From the second cycle, the dose is reduced or administration is discontinued as required based on adverse events observed in the previous cycle or observation of the course.
Intervention MeSH terms: Bendamustine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-Hodgkin's lymphoma; mantle cell lymphoma