bioihbjkbjnl/mcl2 huggingface dataset:
Analysis of Correlation of Amplitude-Integrated EEG and Neurodevelopmental Outcome in Preterm Infants
Condition: Brain Activity; Neurodevelopmental Outcome
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The study included analysis of longitudinal recordings of amplitude-integrated EEG (aEEG)
      tracings on a weekly basis in preterm infants and evaluation of their neurodevelopmental
      outcome at the age of three years.

      Aim of the study was to observe if there is a correlation of the aEEG tracings of the first
      weeks of life to later neurodevelopmental outcome and to evaluate if aEEG can be used as
      prognostic tool.
    

Detailed description: 
      From the first week of life on aEEG-recordings were obtained on a weekly basis and the
      results of the first eight weeks of life were analyzed for this study.

      aEEG-tracings were analyzed with regard to background activity (percentages of continuous and
      discontinuous patterns), the presence/absence of sleep-wake-cycles and the occurrence of
      seizure activity. These items where summed up in a score including three grades (normal,
      moderately and severely abnormal).

      The aEEG was recorded as a single channel EEG from biparietal surface disk electrodes using a
      CFM (CFM 5330, Lectromed Devices Ltd., UK) or the CFM 6000 (Olympic Medical, USA). Assessment
      of neurodevelopmental outcome was done at three years of age by assessment of the Bayley
      Scales of Infant Development II (BSID-II) During the study period from January 1st 2000, and
      December 31st 2002 a total of 284 preterm infants less than 30 weeks´ gestational age were
      admitted to the neonatal intensive care unit of the Medical University of Vienna.
      Neurodevelopmental outcome could be obtained in 148/284 infants at the age of three years and
      these infants therefore fulfilled the inclusion criteria for this study
    

Intervention name(s): aEEG recording
Intervention type(s): Device
Intervention description(s): weekly recordings with aEEG
Other intervention name(s): 1 - all infants < 30 weeks gestational age
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        inclusion of all preterm infants born below 30 weeks gestational age within the study
        period at medical university vienna
      
Keywords: aEEG; preterm infants; predictive value; outcome
Effect of Discharge Via an Intermediate Care Unit
Condition: Patients; Aged
Study type: Interventional

Summary: 
      The main goal is to investigate the following topics:

        1. Can discharge via the Intermediate Care Unit in Stjørdal, compared to direct discharge
           to Verdal Municipality, be equally effective in preventing aggravation of disease and
           loss of function for patients over 60 years that have been hospitalized in Levanger
           hospital?

        2. Are the cost by discharge to the Intermediate Care Unit in Stjørdal, when the hospital
           is not located in the same Municipality, comparable to the cost by direct discharge to
           the Municipality of Verdal, for patients over 60 years that have been hospitalized in
           Levanger hospital?

        3. Which issues are considered important by patients and health personnel during discharge,
           arrival and follow up in the Municipality, to ensure an optimal interaction between the
           involved units.
    


Intervention name(s): Intermediate care unit; Local health care 1; Local health care 2
Intervention type(s): Other; Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hospital Readmissions; Community Health Services; Preventive Health Services; Norway
Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy of Children With Obstructive Hypertrophic Cardiomyop...
Condition: Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      Several studies have shown that specialized pacemaking devices (DDD pacing) can improve the
      symptoms associated with hypertrophic cardiomyopathy (HCM) in adults. In addition, studies
      have also shown that specialized pacemaking devices (DDD pacing) can improve conditions of
      HCM in children. However, growth of the body and organs, including the heart, is very rapid
      during childhood. Therefore the long-term effects of DDD pacing in children are unknown.

      The purpose of this study is to examine the growth rate and nutrition of children with HCM.
      Due to this heart condition and the restrictions that are often placed on the child's
      activity level, children with HCM may grow at a slower rat and may have a greater tendency to
      be overweight.

      Children participating in the study will have their growth rate and nutritional status
      measured before the study begins and throughout the course of the study.

      Findings in this research study will not directly benefit the patients participating in it.
      However, information gathered as a result of this study may lead to improvements in the
      management of children with HCM in the future.
    

Detailed description: 
      Several studies have shown that dual chamber (DDD) pacemaker therapy relieves LV outflow
      obstruction and improves symptoms in most adult patients with obstructive hypertrophic
      cardiomyopathy (HCM). It is however, uncertain whether DDD pacing will be efficacious in
      children with obstructive HCM, because of evolving cardiac morphology and increased LV
      hypertrophy and outflow obstruction associated with rapid body growth. We propose to monitor
      clinical progress, and cardiac morphologic and hemodynamic changes over several years
      following implantation of a DDD pacemaker in children who present with obstructive HCM
      between the ages of 5 to 15 years. Functional status, myocardial ischemia, arrhythmias, and
      LV outflow obstruction will be evaluated by exercise tests, echocardiography, thallium
      scintigraphy, Holter monitoring, electrophysiologic and cardiac catheterization studies. The
      results of pacemaker therapy will be compared with the findings in a cohort of young patients
      with obstructive HCM who elect not to be treated with DDD pacemaker.
    

Intervention name(s): Paragon Pacemaker
Intervention type(s): Device
Primary purpose: Treatment
Keywords: Pacemaker; Pediatric; Obstructive HCM
Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is designed to estimate the effect of rifampin (600 mg orally every 24
      hours for 7 days) on pharmacokinetics of single 30 mg dose (CP-690,550) in normal healthy
      volunteers
    


Intervention name(s): Tasocitinib (CP-690,550) plus Rifampin
Intervention type(s): Drug
Intervention description(s): Period 1, Day 1: Tasocitinib (CP-690,550) 30 mg (single oral dose) as six 5 mg tablets Period 2, Day 1-7: Rifampin 600 mg (single oral dose) q24h Period 2, Day 8: Tasocitinib (CP-690,550) 30 mg (single oral dose) as six 5 mg tablets Period 2, Day 9: No treatment (discharge)
Intervention MeSH terms: Rifampin; Tofacitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-Drug Interaction; Tasocitinib (CP-690; 550); Rifampin; Healthy Volunteers
Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional

Summary: 
      The investigators would like to test the treatment of onychomycosis using a 0.65 millisecond
      pulsed 1064 nm laser fitted with a special onychomycosis handpiece. The investigators will
      compare the success rates of those receiving laser treatments with untreated patients. This
      study will provide a clinical basis for determining the relative effectiveness of an
      increasingly utilized treatment method.
    

Detailed description: 
      Current antifungal treatments have low cure rates and numerous side effects. A new treatment
      method, pulsed laser, has been purported to have high rates of treatment in a much shorter
      time frame than other treatments. While the treatment method has become increasingly popular,
      studies of its efficacy are few. The investigators hope to learn the cure rate of a novel
      treatment that is being used by more and more patients. This knowledge will be essential to
      physicians as they consider employing this new technology in their treatment methods.
    

Intervention name(s): Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)
Intervention type(s): Device
Intervention description(s): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Iron Absorption From Capsules Containing Lactobacilli and Iron
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to study the effect of a probiotic product on iron absorption in
      healthy females of child-bearing age.
    


Intervention name(s): L plantarum DSM 9843 or placebo
Intervention type(s): Dietary Supplement
Intervention model: Crossover Assignment
Primary purpose: Basic Science
Keywords: iron absorption; healthy females; child bearing age
Thoracic Fluid Content During Hypervolemic Hemodilution
Condition: Pulmonary Edema
MeSH terms: Pulmonary Edema; Placenta Accreta
Study type: Interventional

Summary: 
      Thoracic fluid content (TFC) is one of the many variables measured by the ICON electrical
      cardiometry (EC) device (Osypka Medical). The ICON device is often called "thoracic
      electrical bio-impedance" that based on measuring the changes in total resistance of the
      thorax to electric current and is considered a numerical measure of total (intravascular and
      extravascular) thoracic fluid. Although TFC is a measure of both extra and intra-vascular
      thoracic fluid, it provides an estimate of the increase in intrathoracic fluids such as to
      facilitate the risk of pulmonary edema.

      Although many studies were done on the ability of TFC to detect pulmonary edema in
      preeclampsia, ARDS, heart failure, weaning from mechanical ventilation and during fluid
      management in prolonged surgery , yet, there is no study before was done on the use of TFC as
      a guide for fluid therapy during hypervolemic hemodilution in major obstetric surgery in
      patients with placenta accreta as one of the most common etiologies of life-threatening
      obstetric hemorrhage and the most common cause of peripartum hysterectomy

      Aim of the work:

      To use TFC as a guide for 6% HES infusion of hypervolemic hemodilution in patients with
      placenta accreta to avoid fluid overload.

      Objectives:

        -  To calculate LUS score at the end of infusion.

        -  To evaluate TFC in k ohm-1.

        -  To assess oxygen saturation, PO2 and P/F ratio in ABG.

        -  To calculate the total infused volume in milliliters.
    


Intervention name(s): Thoracic fluid content estimation
Intervention type(s): Device
Intervention description(s): The patient will be monitored for thoracic fluid content and LUS score. The infusion will stop if TFC reaches 40 k ohm-1 or after completion of the infused volume. LUS evaluation will be done before the start and after the end of the infusion.
Other intervention name(s): extravascular lung water estimation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Thoracic fluid content; lung ultrasound; cesarean section; placenta accreta; colloid
The Effect of Whole Blood Viscosity on Contrast-Induced Nephropathy Development in Patients Undergoing Percutaneous Coronary Intervention
Condition: Percutaneous Coronary Intervention Patients
MeSH terms: Kidney Diseases
Study type: Observational

Summary: 
      In our study, we aimed to investigate how whole blood viscosity (WBV) affects the development
      of contrast-induced nephropathy (CIN) in patients undergoing percutaneous coronary
      intervention (PCI).
    

Detailed description: 
      In our study, 500 patients who applied to the cardiology clinic and underwent PCI for
      elective procedure, ST segment elevation myocardial infarction (STEMI), and non-STEMI were
      prospectively included. Before the procedure, we calculated WBV using the formula [(0.12 ×
      hematocrit) + (0.17 × (total protein - 2.07)]. We defined CIN as the absolute (≥0.5 mg/dl) or
      relative increase (≥25%) in serum creatinine 48-72 h after exposure to a contrast agent
      compared with baseline serum creatinine values.
    

Intervention name(s): Blood Viscosity Testing
Intervention type(s): Other
Intervention description(s): we calculated WBV using the formula [(0.12 × hematocrit) + (0.17 × (total protein - 2.07)]. We defined CIN as the absolute (≥0.5 mg/dl) or relative increase (≥25%) in serum creatinine 48-72 h after exposure to a contrast agent compared with baseline serum creatinine values.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study started with the approval of the local ethics committee. Five hundred patients
        between ages 18 and 90 who underwent PCI in our hospital between July 10, 2017, and October
        31, 2017, were prospectively included. Informed consent forms were obtained from the
        patients. Patients with chronic kidney disease (CKD) who underwent hemodialysis or
        peritoneal dialysis for this reason and patients who underwent to coronary bypass surgery
        within 48 h were excluded from the study.
      
Keywords: Viscosity; Contrast; Nephropathy; Coronary Intervention
A Study of the Safety, Tolerability, and Efficacy of Topical SM04554 Solution in Male Subjects With Androgenetic Alopecia (AGA)
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to characterize the safety, tolerability, and efficacy of
      topical SM04554 solution (0.15% and 0.25%) applied to the scalp of male subjects with
      Androgenetic Alopecia (AGA).
    


Intervention name(s): SM04554; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Topical solution, applied once a day; Topical solution, applied once a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: alopecia; topical; Samumed
Durability of Weight Loss After Bariatric Surgery
Condition: Obesity
MeSH terms: Weight Loss
Study type: Observational

Summary: 
      The present study is a retrospective cohort study. Patients older than 18 years of age and
      underwent Roux-en-Y gastric bypass (RYGB) surgical treatment during the period from 2014 to
      2019 and paired severely overweight controls who had no longer gone through bariatric
      surgery. Patients having BMI (Body Mass Index) much lower than 35 (calculated as the weight
      (kilograms) / length2 (meters)), a base line diagnosis taken into consideration a medical
      exclusion for surgical treatment died in one year of surgical operation and missed statistics
      at scientific information had been excluded from the study. The primary final results of the
      study was the weight-change percentage at follow-up in comparison with baseline one and the
      clinical events after surgery.
    

Detailed description: 
      This is a retrospective cohort study. The sample size of our study includes one hundred case
      older than 18 years of age and underwent RYGB surgical treatment during the period from 2014
      to 2019 and paired severely overweight controls who had no longer gone through bariatric
      surgery. Patients having BMI (Body Mass Index) much lower than 35 (calculated as the weight
      (kilograms) / length2 (meters)), a base line diagnosis taken into consideration a medical
      exclusion for surgical treatment, died in one year of surgical operation and missed
      statistics at scientific information had been excluded from the study. Data was collected
      taking in to account each patient history (age, sex, length, weight, BMI, occupation, marital
      status, and comorbidities) and weight record in every visit from measurements statistics.
      Outcomes: The primary final results of the study was the weight-change percentage at
      follow-up in comparison with baseline one. The secondary effects including the clinical
      events after surgery, micronutrient levels, incidence of diabetes, hypertension, and
      dyslipidemia.
    

Intervention name(s): Bariateric surgery
Intervention type(s): Procedure
Intervention description(s): Adult patients underwent RYGB surgical treatment during the period from 2014 to 2019
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients in Al-Azhar University hospital for overweight or obesity problems
      
Keywords: Bariateric surgery; Durability
Single and Multiple Ascending Doses of AZD1981 in Japan
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to study safety, tolerability and pharmacokinetics of AZD1981 in
      healthy Japanese subjects
    


Intervention name(s): AZD1981; AZD1981; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablet, 250 mg single dose; Suspension, 15, 75, 1000 and 2000 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Evaluation of oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the
      treatment of RA patients with clinical efficacy and safety.Open-labeled, randomized,
      prospective multi-center clinical trial. Observation period of 24 weeks.
    


Intervention name(s): Tripterygium wilfordii Hook F; Methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.; Oral methotrexate 7.5-12.5mg per week for 24 weeks. The starting dose was 7.5mg per week, then increased to 12.5mg（max 0.3mg/Kg） per week in 4 weeks. Folic acid at the dose of 10mg per week were applied to all patients.
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Methotrexate; Tripterygium
Evolution of Swallowing in Patients Undergoing Lateral Pharyngoplasty With Preservation Stylopharyngeal Muscle
Condition: Sleep Apnea
MeSH terms: Sleep Apnea Syndromes
Study type: Observational

Summary: 
      Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation
      stylopharyngeal muscle.
    

Detailed description: 
      refer patients to the side pharyngoplasty with total preservation of stylopharyngeal muscle
      and evaluate the total recovery time of swallowing, making a daily assessment.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with obstructive sleep apnea, indicating the lateral pharyngeal
      
Keywords: Sleep apnea, obstructive; Deglutition Disorders
Tapfinger Psychomotor Target
Condition: Functional Brain Mapping
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims at mapping the magnetoencephalographic (MEG) activities induced in normal
      volunteers by tapping the finger .
    

Detailed description: 
      Normal healthy (20) volunteers and tetraplegic patients(10) will be submitted to the
      temporo-spatial mapping of their brain activity, both sensory and motor, induced by a simple
      behavioral task, consisting on tapping with the finger on a detection pad. This will be done
      in a light and then dark environment, on a rythm spontaneous and then paced by sound bips.
      Accelerometric recording will provide the three dimensionnal displacements of the finger as
      well as the time code.

      Brain activity is simultaneously recorded using MEG (306 channels) and EEG (64 channels. Data
      will be processed by an INPLS algorithm to detect the predictors of activity, their location
      and time-course.

      3D mapping data will be matched with the patient's anatomy provided by 1.5T MRI previously
      performed.

      The aim of the study is to prepare the strategy of implantation of multielectrodes ECoG
      implants to restore motility in tetraplegic patients in a human BCI protocol currently under
      development.
    

Intervention name(s): Psychomotor tasks
Intervention type(s): Behavioral
Intervention description(s): the acquisition of data will be performed in one unique session no drug administration no surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: MEG; EEG; MRI; Brain mapping; functional imaging; brain computer interface
E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma
Condition: Peripheral T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase 1 study is to determine the maximum tolerated dose (MTD) through
      observation of dose limiting toxicity (DLT), which is in advance defined, in patients with
      peripheral or cutaneous T-cell lymphoma.
    


Intervention name(s): denileukin diftitox (E7777)
Intervention type(s): Biological
Intervention description(s): E7777 will be administered by intravenous (IV) infusion for 5 days from Day 1 through 5 of each cycle (21 days/cycle) with 8 cycles in maximum for E7777 alone therapy. E7777 dose will be escalated from 6 micro-g/kg/day to 12, 15 and then to 18 in a stepwise fashion.
Intervention MeSH terms: Denileukin diftitox
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoplasms; Neoplasms by Histologic Type; Lymphoma; Non-Hodgkin; T- Cell; Lymphatic Diseases; Lymphoproliferative Disorders; lmmune System Diseases; lmmunoproliferative Disorders