bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Fluid Challenge on Glycocalyx
Condition: Anesthesia; Endothelial Dysfunction; Sepsis; Septic Shock; Surgery
MeSH terms: Shock, Septic
Study type: Interventional

Summary: 
      Interventional study comparing effect of two regimes of fluid challenge in patients with
      sepsis and in patients undergoing elective major surgery on glycocalyx by using perfused
      Boundary Region in sublingual microcirculation.
    

Detailed description: 
      Effect of two regimes of fluid challenge on GCX in patients with sepsis and during elective
      surgery under general anesthesia.

      Hypothesis to be tested: Administration of 500 ml of balanced solution as a bolus impairs GCX
      more than prolonged administration.

      The aim of the study: Comparison of two regimes of fluid challenge in patients with sepsis
      and in patients undergoing elective major surgery.

      Type of the study: Open, randomized, interventional.

      Subjects:

      Part A: Patients with sepsis within 48 hours before admission to ICU requiring fluid
      challenge based on clinical or echocardiographic assessment.

      Part B: Patients during major elective surgery requiring fluid challenge based on clinical or
      echocardiographic assessment.

      Sample size calculation (based on expected difference in PRB, alpha error I =0,05 and study
      power = 0,99) = 52 patients. Investigators plan enrolment of 60 patients for each part,
      totally 120 patients.

      Intervention:

        -  500 ml of balanced crystalloid solution within 5 minutes (group "fast")

        -  500 ml of balanced crystalloid solution within 30 minutes (group "slow") Data to be
           recorded and analysed: Demographics, severity score, fluid response assessment,
           sublingual microcirculation by SDF imaging will be recorded at time points: baseline,
           after intervention, after 60 minutes, after 120 minutes, plasma syndecan-1 will be
           analysed before intervention and 120 minutes thereafter, microcirculatory data and
           Perfused Boundary Region.
    

Intervention name(s): Fluid bolus administration
Intervention type(s): Drug
Intervention description(s): Fluid bolus administration either "fast" in 5 minutes or "slow" in 30minutes.
Other intervention name(s): Fluid challenge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Safety and Efficacy Evaluation of Topically Applied AN2690 Solutions for Subjects With Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the safety and efficacy of 1% and 5% AN2690
      solutions in the treatment of distal, subungual onychomycosis of the great toenail.
    

Detailed description: 
      The first group of 30 protocol-qualified subjects will be assigned to Treatment Group 1 and
      given 1% AN2690 Solution. The second group of 30 protocol-qualified subjects will be assigned
      to Treatment Group 2 and given 5% AN2690 Solution.
    

Intervention name(s): AN2690; AN2690
Intervention type(s): Drug; Drug
Intervention description(s): AN2690 1% Solution, once daily for 180 days; AN2690 5% Solution, once daily for 30 days; 3x weekly for 150 days
Intervention MeSH terms: Tavaborole
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Onychomycosis; Fungal Nail
Study Evaluating the Nasopharyngeal Carriage in Healthy Children
Condition: Healthy Subjects
Study type: Observational

Summary: 
      The purpose of this study is to assess the prevalence of pneumococcal stereotypes in the
      nasopharynx of healthy children and to describe the changes of nasopharyngeal carriage at
      different ages over time.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Keywords: S.pneumoniae healthy subjects; Healthy subjects
Study of Remimazolam Tosilate in Patients Undergoing Colonoscopy
Condition: Sedation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the sedation for
      Remimazolam or Propofol in patients undergoing colonoscopy.
    

Detailed description: 
      This is a multi-center, parallel-group, single blind study using Remimazolam or propofol for
      sedation in patients undergoing colonoscopy.Subjects are randomized to different treatment
      groups (including 1 for Remimazolam Tosilate and 1 for propofol). Fentanyl are permitted
      before colonoscopy. Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.
    

Intervention name(s): Remimazolam Tosilate; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Initial dose plus supplemental doses as necessary; Initial dose plus supplemental doses as necessary
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn
Condition: Burns
MeSH terms: Burns
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or
      NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will lower
      the amount of blood lost during burn surgery.
    

Detailed description: 
      To identify the clinical use for Factor VIIa in the operating room to reduce blood loss and
      blood transfusion , determine the Recombinant Factor VIIa (rFVIIa) pharmacokinetics in burned
      patients, determine if fFVIIa should be used to reduce peri-operative blood loss in patients
      undergoing excision greater than or equal to 20 percent of the total body surface area,
      determine the efficacy of the drug in burned patients undergoing excision of burn wounds.
    

Intervention name(s): Recombinant Factor VIIa; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): intravenous infusion of Factor VIIa; intravenous infusion of placebo (sterile water)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Burns
Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To Estimate Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting
      Conditions with 40% Ethanol Compared with Water in Healthy Volunteers
    


Intervention name(s): Oxycodone; Naltrexone; Oxycodone; Naltrexone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with water, under fasting conditions; Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before,and 12 hours after study drug administration).; One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with 40% ethanol, under fasting conditions; Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
Intervention MeSH terms: Naltrexone; Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability; oxycodone; ethanol interaction; healthy volunteers
Hematopoetic Stem Cell Transplant and Physical Function
Condition: Cancer; Walking
Study type: Interventional

Summary: 
      This study will determine if a structured walking intervention will help maintain or improve
      physical activity levels, physical function and quality of life in hematopoietic stem cell
      transplant patients.
    

Detailed description: 
      The researchers will quantify the decline in physical function of HSCT patients using valid
      and reliable tests aimed to mimic activities of daily living, quantify cardiovascular health,
      and quantify muscle power declines. Also, patients will undergo a walking program during
      their hospitalization, which is designed to increase physical activity levels and maintain
      and improve physical function and quality of life. Additionally, using valid and reliable
      questionnaires, the researchers will gauge perception of exercise, quantify current exercise
      levels, determine preference of exercise programs and counseling, and measure differences in
      quality of life before and after HSCT treatment.
    

Intervention name(s): Walk Training and Transplant; Activity Monitoring and Transplant
Intervention type(s): Other; Other
Intervention description(s): Subjects will receive free activity monitors and have three training sessions per week for the duration of their bone marrow transplant treatment; Subjects will receive free activity monitors for the duration of their bone marrow transplant treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cancer; Exercise; Physical Function
Acute Effects of a Heat-not-burn Tobacco Product on Pulmonary Function in Healthy Non Smokers.
Condition: Heated Tobacco; Respiratory Function; Tobacco Toxicity
Study type: Interventional

Summary: 
      IQOS ("I-Quit-Ordinary-Smoking,") is a type of "heat-not-burn" (HNB) tobacco product. There
      is evidence of a growing number of young people who try IQOS as a 'safe' alternative of
      cigarette. The effect of the acute exposure to IQOS smoke on pulmonary function of healthy
      non smokers has not been studied extensively.

      Objectives: Evaluation of the acute effects of IQOS on pulmonary function,exhaled CO, O2
      Saturation, arterial pressure and heart rate.

      Methods: Healthy non smokers, underwent exhaled CO measurement, spirometry including flows,
      volumes and diffusion capacity, and measurement of their respiratory resistances at 5, 10 and
      20 Hz (R5Hz, R10Hz and R20Hz) with the use of an impulse oscillometry system (IOS) before and
      after the use of an IQOS. Additionally heart rate and arterial blood pressure were also
      measured.
    

Detailed description: 
      All participants underwent pulmonary function tests (PFT) (MasterScreen PFT, Jaeger,
      Wurzburg, Germany) and total respiratory resistances measurement with an impulse oscillometry
      system (IOS)( (Viasys Jaeger MasterScreen IOS system).From the basic pulmonary measurements
      (flows and dynamic lung volumes), Forced Expiratory Volume in 1 second (FEV1), Forced Vital
      Capacity (FVC), Tiffenau index (FEV1/FVC, FEV1%), Peak Expiratory Flow (PEF), Maximal
      Expiratory Flow (MEF) at 25%, 50%, and 75% of vital capacity, Functional Residual Capacity
      (FRC), Total Lung Capacity (TLC), Residual Volume (RV), Diffusion Capacity (DLCO) were
      measured. Each manoeuvre was repeated for at least three technically acceptable forced
      expiratory flow curves in order to attain the best results. Respiratory impedance at 5 Hz
      (Z5Hz) and respiratory resistance at 5, 10, and 20 Hz (R5Hz, R10Hz, and R20Hz, respectively),
      reactance at 5, 10, and 20 Hz and resonant frequency were assessed with IOS. Heart rate,
      saturation of O2 (oxymetry) and arterial blood pressure were also measured. Exhaled CO
      measurement (piCO Smokerlyzer,Bedfont Scientific Ltd, Kent, U.K.) was performed After smoking
      heated tobacco (IQOS): 5 minutes after smoking IQOS , they repeated again PFTs, IOS, exhaled
      CO heart rate, saturation of O2 (oximetry) and arterial blood pressure measurements.
    

Intervention name(s): IQOS
Intervention type(s): Other
Intervention description(s): Acute effects of IQOS on pulmonary function, oxygen saturation, exhaled CO, heart rate and arterial blood pressure.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pulmonary function; heated tobacco; IQOS
An Effectiveness Study of the Cool Kids Programme
Condition: Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      The aim of the present study is to investigate the effectiveness of the Cool Kids programme
      after implementation in two outpatient psychiatric clinics for children in Southern Jutland,
      Denmark. The Cool Kids programme is a manualised cognitive behavioural treatment programme
      for children aged 6 to 12 years with anxiety disorders. Previous efficacy studies have found
      that 60-80% of all children who complete the program show marked improvement. However, only
      one previous effectiveness study has ever been conducted. It is therefore relevant to examine
      whether the previously mentioned effect is maintained when the programme is implemented in a
      healthcare setting rather than a research setting.
    

Detailed description: 
      The study was conducted at two outpatient psychiatric clinics for children in Southern
      Jutland, Denmark.

      Data was gathered from 55 patients who completed the Cool Kids programme as a treatment for
      anxiety disorder(s) from autumn 2013 to spring 2016. During the course of treatment both
      children and parents completed the Child Anxiety Life Interference Scale (CALIS) at baseline,
      post-treatment and at a 3-months follow-up booster-session. This data was originally gathered
      for internal quality assessment at the clinics. As the data was utilized for the present
      study in 2017, it has not been possible to control for confounding factors or influence the
      data-collection process.

      All questionnaires were anonymised previous to being manually scored and keyed for secured
      electronic storage. Participants were excluded from the data analysis if they had one or more
      incomplete or missing CALIS. All statistical analysis was carried out in IBM SPSS 24
      Statistical Software and consists of linear mixed effect models and one-way repeated measures
      ANOVAs.
    

Intervention name(s): Cool Kids programme
Intervention type(s): Other
Intervention description(s): A manualised cognitive behavioural treatment programme that consists of 10 session within 12-16 weeks each lasting 2 hours.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants had all been diagnosed with at least one anxiety or obsessive-compulsive
        disorder at the specialised child affective team at one of the two outpatient psychiatric
        clinics.
      
Keywords: Anxiety; Child; Cognitive behaviour therapy; CBT; effectiveness; treatment; Cool Kids
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining more than one drug with either standard radiation therapy or radiation therapy
      given at different times may kill more tumor cells.

      PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
      consisting of paclitaxel and carboplatin, plus either standard radiation therapy or radiation
      therapy given at different times, in treating patients with stage III non-small cell lung
      cancer that cannot be surgically removed.
    

Detailed description: 
      OBJECTIVES: I. Determine response rates, duration of response, and survival of patients with
      unresectable or regionally advanced (M0) stage IIIA or IIIB non-small cell lung carcinoma
      treated with induction paclitaxel and carboplatin followed by conventional vs accelerated
      radiation. II. Evaluate the patterns of local and distant failure for patients treated with
      these regimens.

      OUTLINE: Patients are stratified by histology (squamous vs nonsquamous), performance status
      (0 vs 1), disease stage (IIIA vs IIIB), and response to induction chemotherapy (initial
      response vs no response). All patients receive induction therapy consisting of paclitaxel IV
      over 3 hours followed by carboplatin IV over 30 minutes on days 1 and 22. Treatment repeats
      every 42 days for 2 courses. Patients whose disease has not progressed outside the thorax are
      then randomized to 1 of 2 treatment arms. Arm I: Patients receive standard radiotherapy once
      a day, 5 days a week for 6-7 weeks. Arm II: Patients receive hyperfractionated accelerated
      radiotherapy 3 times daily, 5 days a week over 2.5 weeks. Each fraction is separated by a
      minimum of 4 hours. Radiotherapy begins between days 43 and 50. Patients are followed at 1
      month after radiotherapy, then every 3 months for 2 years, every 6 months for the next 3
      years, and annually thereafter.

      PROJECTED ACCRUAL: Approximately 294 patients will be accrued for this study within 3.5
      years.
    

Intervention name(s): carboplatin; paclitaxel; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention MeSH terms: Paclitaxel; Carboplatin
Allocation: Randomized
Primary purpose: Treatment
Keywords: squamous cell lung cancer; large cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; adenocarcinoma of the lung
The Impact of Intravenous Vitamin C Combined With Nerve Blocks on Postoperative Pain and Recovery After Total Knee Arthroplasty
Condition: Ascorbic Acid; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this prospective randomized-control study was to evaluate the impact of a single
      high-dose intravenous vitamin C added to ultrasound-guided blocks at induction on
      postoperative pain, sngception and early functional rehabilitation of the knee joint in
      patients under-going total knee arthroplasty.
    


Intervention name(s): Ascorbic acid 5000mg; Control Rx
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous loading of 5000mg ascorbic acid with normal saline, totally 100ml Completed before surgical incision; Intravenous loading 100ml normal saline
Intervention MeSH terms: Ascorbic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ascorbic Acid; Total knee arthroplasty; Regional analgesia
Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults
Condition: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to characterize the impact of acetaminophen ingestion on the
      performance of the Guardian™ Sensor (3) (i.e., C algorithm and Zeus algorithm) in subjects
      age 18 - 80 years.
    

Detailed description: 
      The study is a multi-center, prospective, study without controls. The purpose of this study
      is to characterize the impact of acetaminophen ingestion on the performance of the Guardian™
      Sensor (3) (i.e., C algorithm and Zeus algorithm) in subjects age 18 - 80 years.
    

Intervention name(s): Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. C sensor algorithm applied retrospectively to raw sensor data.; Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. Zeus sensor algorithm applied retrospectively to raw sensor data.; Acetominophen
Intervention type(s): Device; Device; Drug
Intervention description(s): Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when C sensor algorithm is used.; Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when Zeus sensor algorithm is used.; One time administration of acetaminophen.
Intervention MeSH terms: Acetaminophen
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
The Rolandic Epilepsy/ESES/Landau-Kleffner Syndrome and Correlation With Language Impairment Study
Condition: Rolandic Epilepsy; Nocturnal Frontal Lobe Epilepsy; Landau-Kleffner Syndrome; Electrical Status Epilepticus During Slow Wave Sleep
MeSH terms: Epilepsy; Status Epilepticus; Epilepsy, Rolandic; Epilepsy, Frontal Lobe; Landau-Kleffner Syndrome; Syndrome
Study type: Observational

Summary: 
      In clinical practice language impairment is frequently reported in association with nocturnal
      epileptiform activity. There is a spectrum of epileptic conditions that are characterized by
      nocturnal epileptiform activity. From mild to severe this spectrum involves: Rolandic
      epilepsy (RE), nocturnal frontal lobe epilepsy (NFLE), Landau-Kleffner syndrome (LKS) and
      electrical status epilepticus during slow wave sleep (ESES). The exact characteristic of the
      relationship between nocturnal epileptiform activity and language impairment is yet to be
      explored. The investigators suggest that nocturnal epileptiform EEG discharges and nocturnal
      epileptic seizures during development will cause diseased neuronal networks that involve
      language. The diseased neuronal networks are less efficient compared with normal neuronal
      networks.

      Objective: Identification of a diseased neuronal network characteristic in children with
      nocturnal epileptiform activity, which can explain language impairment in these children. For
      this the investigators will use functional magnetic resonance imaging (MRI) to analyse brain
      activity and diffusion weighted MRI to investigate white matter connectivity.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children aged 6 to 18 years seen in tertiary referral center for epilepsy Kempenhaeghe with
        a proven diagnosis of Rolandic epilepsy and without intracerebral lesions (e.g. tumour) on
        structural MRI or other pathology, which may influence cognition.

        In addition, children with electrical status epilepticus of sleep (ESES), ESES-like, or
        Landau-Klefner syndrome might be included.
      
Keywords: Language problems; childhood epilepsy; bening (rolandic) epilepsy (of childhood) with centro temporal spikes; brain maturation; structral connectivity; functional connectivity