bioihbjkbjnl/mcl2 huggingface dataset:
Phase 0 Study in Healthy, Hepatic and Renal Impaired Subjects to Obtain Plasma for Lenvatinib Protein Binding
Condition: Hepatic Impairment; Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Early Phase 1

Summary: 
      E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or
      severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy
      participants. The primary objective of the study is to obtain plasma from participants for
      use in in vitro protein binding studies.
    

Detailed description: 
      E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or
      severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy
      participants. Approximately 6 participants with each degree (mild, moderate, or severe) of
      hepatic or renal impairment will be enrolled. Two cohorts of 8 healthy participants will be
      enrolled. One cohort of healthy participants will be matched to the hepatic-impaired
      participants, whereas the other will be matched to the renal-impaired participants.

      The study has 2 phases. The Pre-study Phase consists of a Screening Period and a Baseline
      Period. The Study Phase consists of a 2-day Study Period. No lenvatinib will be administered
      in this study.

      The end of the study will be the date of the last study visit for the last participant in the
      study.

      The following estimates are provided:

        -  From first participant in to last participant out, the study is expected to take
           approximately one year to complete.

        -  The maximum estimated duration of the study for each participant is anticipated to be
           approximately 5 weeks.
    

Intervention name(s): Plasma Sampling
Intervention type(s): Drug
Intervention description(s): No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: in vitro protein binding; hepatic impairment; renal impairment
Return to Work After Potential Severe Injury
Condition: Multiple Trauma
MeSH terms: Multiple Trauma
Study type: Observational

Summary: 
      In Norway an estimated 10 % of the population is injured annually. Of these 36.000 sustain
      permanent functional impairment, 1.200 receive disability pension, and approximately 2.500
      die because of their injuries. Mortality is the most common variable measuring trauma
      outcome. However, measuring only trauma mortality may be looking merely at the tip of the
      iceberg. For every trauma death, there are ten-folds suffering long term functional
      impairment. Mortality is therefore a too crude variable to describe the impact of injuries -
      both for the individual trauma patient and for society as a whole. There is a need for
      variables describing long-term outcomes on a functional level. The aim of this study is to
      use the rate of return to work and education as an alternative outcome measure. The ability
      of returning to work after injury is a central indicator of individual functional outcome,
      combining both physical and mental skills in performing complex and compound tasks. Previous
      studies on return to work after injury are limited by a combination of short follow-up times,
      the use of patient reported outcomes and having mainly been focusing on only severely injured
      patients (ISS > 15). This a population-based study including all patients in working age (16
      - 65 years) received by a trauma team in any of the eight hospitals within the region of
      Central Norway in the time period from June 1st,2007 to May 30th, 2010. Already collected
      trauma registry data will be linked with national register data on sickness and disability
      benefits, employment and education.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients in working age received by a trauma team in any of the eight hospitals within
        the region of Central Norway in the period from June 1st, 2007 to May 30th, 2010
      
Keywords: Outcome Assessment (Health Care); Return to work; Registries; Norway
Teta Burst Versus 10 Hz Repetitive Transcranial Magnetic Stimulation İn Neuropathic Pain: A Sham Controlled Comparison
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      Neuropathic pain is a common complication after spinal cord injury (SCI), which significantly
      affects the patient's quality of life and may be resistant to pharmacological treatment. In
      our study, we aimed to evaluate the efficacies of intermittent theta burst (iTBS) and high
      frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) by comparing them with
      each other and with sham stimulation, in the treatment of neuropathic pain resistant to
      pharmacological treatment in patients with SCI.

      Question 1: İs rTMS anda iTBS treatment, useful for pain severity and the effect of pain on
      daily functions, in the treatment of neuropathic pain in SCI Question 2: Are rTMS and iTBS
      treatments effective in depression in patients with neuropathic pain after spinal cord
      injury?
    

Detailed description: 
      Pharmacological treatments may be insufficient to limit neuropathic pain. Therefore, research
      continues for safe and effective new treatments. Transcranial magnetic stimulation (TMS) is a
      non-invasive brain stimulation method that modulates the cortical excitability of the motor
      area to which it is applied. Theta Burst stimulation (TBS) is a new rTMS method consisting of
      stimulation sequences in a special pattern. It stands out with its ability to deliver high
      pulses in a short time and its high capacity to induce cortical plasticity. Intermittent TBS
      (iTBS) and high frequency rTMS facilitate excitability in the motor area where it is applied,
      and this effect is used in pain treatment. Pain modulation with these methods has been tried
      in some studies. Therefore, repetitive magnetic stimulation of the motor cortex by these two
      methods may be good options for the treatment of neuropathic pain resistant to
      pharmacological treatment in patients with SCI.
    

Intervention name(s): Magstim Rapid2 Magnetic Stimulator
Intervention type(s): Device
Intervention description(s): For TMS, the Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device, available in our center, was used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Repetitive Transcranial Magnetic Stimulation; Intermittent Teta Burst Stimulation; Spinal cord injury; Depression; Pain
Pharmacokinetics and Hepatic Safety of EGCG
Condition: Uterine Fibroids
MeSH terms: Leiomyoma
Study type: Interventional
Phase: Phase 1

Summary: 
      A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without
      uterine fibroids.
    

Detailed description: 
      This will be a randomized, multi-center, pharmacokinetics and hepatic safety trial of EGCG
      with 36 total patients in 3 treatment arms. 36 women will be randomized to one of the
      following groups: EGCG daily alone, EGCG daily with clomiphene citrate and EGCG daily with
      letrozole. The randomization scheme will be stratified for age groups 18-29 and 30-40 and
      presence of uterine fibroids. The pharmacokinetics and hepatic safety of EGCG with clomiphene
      citrate and letrozole are unknown. The trial conducted in women with and without fibroids
      will allow comparisons between these groups. The results of this study will be used to
      confirm hepatic safety for the larger multi-center FRIEND study.
    

Intervention name(s): Epigallocatechin gallate (EGCG); Clomiphene Citrate; Letrozole
Intervention type(s): Dietary Supplement; Drug; Drug
Intervention description(s): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months; 100 mg for 5 days; 5 mg for 5 days
Other intervention name(s): Clomid; Serophene; Femara
Intervention MeSH terms: Letrozole; Epigallocatechin gallate; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The 36 women will be randomized to one of the following groups:
EGCG daily alone.
EGCG daily with clomiphene citrate 100mg for 5 days.
EGCG daily with letrozole 5mg for 5 days.
Masking: None (Open Label)
Primary purpose: Other
Can Shorter Time Intervals Help the Baby Survive the Triad Effect of Maternal Hypertension, Caesarean Section and Spinal Anesthesia?
Condition: Neonatal Hypoxia and Asphyxia
MeSH terms: Hypertension; Hypoxia; Asphyxia
Study type: Interventional

Summary: 
      Patients were classified into two equal groups using the presence or absence of hypertension
      during pregnancy into: hypertensive group (BP>140/90) and normotensive group (BP≤140/90. The
      surgical time intervals are assessed and classified the patients accordingly into short and
      log time interval subgroups (induction of regional anesthesia to delivery (I-D), initial skin
      incision to delivery (S-D), and uterine incision to delivery (U-D)
    

Detailed description: 
      Surgical times components; induction of regional anesthesia till delivery (I-D interval);
      incision of the skin till delivery (S-D interval); and incision of the uterus till delivery
      (U-D interval)) were recorded using a stopwatch.

      Immediately after delivery, umbilical cords were clamped on both ends and an arterial blood
      sample was collected anaerobically in a pre-heparinized insulin syringe. PH, base excess
      (BE), carbon dioxide pressure (PCO2), Oxygen pressure (PO2) and Bicarbonate (HCO3) levels
      were measured at 37oC by pH and gas analyzer (Gem, Premier3000, USA). The gas analysis was
      done in less than 30 minutes after sampling.

      Apgar score was assessed by a neonatologist at the 1st and 5th minutes after birth . Advanced
      resuscitation included positive pressure ventilation, chest compression and/or drugs
      administration. All resuscitated babies were transferred to neonatal intensive care unit for
      post resuscitation care. Fetal distress was defined by an umbilical cord pH <7.12
    

Intervention name(s): Cesarean section
Intervention type(s): Procedure
Intervention description(s): Lower segment elective Cesarean section
Other intervention name(s): Elective Cesarean section
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Extraarticular Distal Radius Fractures, X-fix or Volar Fixation
Condition: Dorsally Displaced Intraarticular Distal Radius Fractures; Age 50 - 74 for Females or 60-74 for Males; Low Energy Trauma
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      Distal radius fractures are treated surgically if severely displaced. This study aims to
      investigate the outcome after surgery. The investigators will randomize patients to either
      external fixation with optional addition of k-wires or open reduction and fixation with a
      volar plate.
    

Detailed description: 
      This study has been merged with study NCT01035359 and a new ethical permission has been
      granted by the Swedish National Ethic board
    

Intervention name(s): External fixation; Volar plate
Intervention type(s): Procedure; Procedure
Intervention description(s): Operation with external fixation and optional addition of k-wire; Operation with a Synthes volar two column plate (TCP)
Other intervention name(s): External Fixation with Hoffman external fixator (Stryker); Synthes volar two column plate (TCP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: radius; fracture; wrist; external; fixation; volar; plate; DASH; PRWE
Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers
Condition: Healthy Volunteer; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn
MeSH terms: Muscular Dystrophies; Musculoskeletal Diseases; Muscular Diseases; Muscular Disorders, Atrophic; Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 2-part, single-center, open-label study in healthy male volunteers. Part A
      will assess the absorption, metabolism, excretion, and pharmacokinetics of one oral dose of
      radiolabeled EDG-5506. Part B will assess bioavailability of EDG-5506 with a single oral dose
      of EDG-5506 and a single intravenous dose of radiolabeled EDG-5506.
    

Detailed description: 
      This is a Phase 1 2-part, single-center, open-label study.

      Up to 15 (8 in Part A and 7 in Part B) healthy male subjects will be enrolled in the study.

      Part A:

      Potential subjects will be screened to assess eligibility within 28 days prior to dose
      administration. Subjects will be admitted on Day -1 and confined to the study site until at
      least Day 30. On Day 1, subjects will receive a single oral suspension. Blood, urine and
      feces samples will be collected for determination of EDG-5506 concentration, total
      radioactivity, and metabolite profiling and identification. Between Day 30 and Day 36,
      subjects will be discharged.

      Part B:

      Potential subjects will be screened to assess their eligibility within 42 days prior to dose
      administration. Subjects will be admitted on Day -1 and confined to the study site until Day
      8. On Day 1, subjects will receive a single oral dose of EDG-5506 in the fasted state
      followed 2 hours later by a single dose of radiolabeled EDG-5506. Subjects will be discharged
      from the study site on Day 8. Blood samples will be collected.
    

Intervention name(s): EDG-5506 Tablet; Radiolabeled EDG-5506 Suspension; Radiolabeled EDG-5506 Intravenous
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single Oral Dose - Tablet; Single Oral Dose; Single Intravenous Dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteer
Sugammadex Provide Better Surgical Condition Compared With Neostigmine in Laryngeal Microsurgery.
Condition: Neuromuscular Blockade
Study type: Interventional

Summary: 
      This study aims to make a comparison of surgical condition and recovery time between
      rocuronium 0.45 mg/kg and neostigmine group and rocuronium 0.9 mg/kg and sugammadex group.
    

Detailed description: 
      This study aims to make a comparison of surgical condition and recovery time between moderate
      neuromuscular bloackade with reversal using neostigmine group and deep neuromuscular
      bloackade with reversal using sugammadex group.
    

Intervention name(s): Injection of neostigmine or sugammadex
Intervention type(s): Other
Intervention description(s): At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected.
Other intervention name(s): neostigmin or sugammadex
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Cardiovascular and Metabolic Responses to a Mixed Meal
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Observational

Summary: 
      The purpose is to determine whether regular endurance exercise and/or body weight influence
      the way our nervous and vascular systems respond during the metabolism of meals.
    

Detailed description: 
      To begin to examine this question we recruited healthy endurance-trained (high fit, HF) and
      normally active (average fit, AF) subjects. It is well characterized that chronic endurance
      training results in enhanced peripheral insulin sensitivity. Therefore, our rationale was
      that inclusion of two healthy subject groups, with distinct differences in insulin
      sensitivity, would allow us to investigate how enhanced insulin sensitivity influences
      insulin-mediated changes in central sympathetic outflow. Direct measurements of central
      sympathetic outflow to skeletal muscle (i.e., MSNA) were recorded, and a mixed meal was used
      as a physiological method to evoke robust and sustained increases in MSNA, which have been
      primarily attributed to insulin. We hypothesized that HF subjects would have a greater MSNA
      response, for a given plasma insulin concentration, following consumption of a mixed meal
      (i.e., greater central insulin sensitivity).
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        young, lean, healthy men
      
Keywords: insulin resistance
Cyclophosphamide Versus Mycophenolate Mofetil for the Treatment of Steroid-dependent Nephrotic Syndrome in Children
Condition: Idiopathic Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Nephrosis, Lipoid; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Idiopathic nephrotic syndrome is steroid-sensitive in more than 90% of cases in children.
      However 60% of cases are steroid dependent and required treatment with immunosuppressive
      agent. Cyclophosphamide and ciclosporin are used for long time to reduce steroid dependency,
      but duration of these treatments should be restricted because of gonadotoxicity for
      cyclophosphamide and nephrotoxicity for ciclosporin.

      Mycophenolate mofetil appears as an alternative treatment without gonadotoxicity and
      nephrotoxicity. However, contrary to cyclophosphamide, mycophenolate mofetil does not seem to
      have a residual action so that treatment must be maintained during months or years.

      The aim of the study is to compare efficacy of cyclophosphamide and mycophenolate mofetil in
      steroid dependent nephrotic syndrome in children.
    

Detailed description: 
      Aim of the study: Comparison of efficacy of cyclophosphamide 148mg/kg in 12 weeks and
      mycophenolate mofetil 1200mg/m² during 18 months, in children with steroid dependent
      nephrotic syndrome.

      The 70 patients will be recruited in the 26 centres of paediatric nephrology in France,
      included and randomized at the time of a relapse. They will receive the same steroid
      treatment in the 2 arms.

      The primary point will be occurrence of a relapse during the 24 months of follow-up.
      Detection of relapse will be done by using dipsticks and confirm by biological dosages
      (albuminemia and proteinuria/CREATININURIA ratio). Clinical and biological check up will be
      done every 3 months during all the study.
    

Intervention name(s): Cyclophosphamide; Mycophenolate mofetil
Intervention type(s): Drug; Drug
Intervention description(s): 2mg/kg/day during 12 weeks (cumulative dose 148mg/kg); 1200mg/m²/jour in two divided doses during 18 months
Other intervention name(s): Endoxan (BAXTER); Cellcept (Roche)
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children; Mycophenolate mofetil; Cyclophosphamide; Idiopathic nephrotic steroid sensitive syndrome
A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effectiveness and safety of 2 concentrations
      of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).
    

Detailed description: 
      AD is a disease mainly characterized by pruritic eczema, and those with the disease
      experience repeated exacerbations and remissions. Therapeutic guidelines for the disease,
      currently being developed in many countries, all recognize AD as chronic eczema that is
      accompanied by the physiological dysfunction of the skin and in which inflammation is caused
      by various nonspecific stimuli or specific allergens. OPA 15406 is a type-4 phosphodiesterase
      (PDE4) inhibitor. PDE4 inhibitors are thought to be useful for allergic inflammatory
      diseases. This is a Phase 2 dose ranging study to evaluate the efficacy of two concentrations
      of OPA 15406 ointment compared to vehicle, when administered topically twice daily in
      participants with mild to moderate AD.
    

Intervention name(s): OPA-15406; Vehicle ointment
Intervention type(s): Drug; Drug
Intervention description(s): OPA-15406 topical ointment; OPA-15406 1%-matching placebo topical ointment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atopic Dermatitis, Eczema
Earliest Lung Ultrasound Time for Predicting the Need of Surfactant
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Observational [Patient Registry]

Summary: 
      Lung ultrasonography (LUS) is fast and easy technique. it also has high reliability, so it
      has started to be used more in evaluating respiratory distress in the neonatal period. The
      most important feature of LUS is being radiation-free. Three LUS findings that show
      respiratory distress syndrome were described. They were white lung appearance, lack of
      preserved areas and loss of pleural integrity. The sensitivity of these findings was found to
      be 98-100% and the specificity 92-100%. A few studies have shown that surfactant need can be
      determined by LUS.

      It was observed that lung findings were more severe in LUS performed in the early period
      because of non-completed fetal lung fluid clearence, but the findings could be improved
      during follow-up. Therefore, it is not known when the earliest time of LUS shows the actual
      clinical condition and course of the patient.

      This study was planned to find the most reliable and earliest US time. Evaluation with LUS
      was done at 30 minutes and repeated at 1, 2, 4 and 6 hours of life. The LUS findings would be
      compared with x-ray findings and the correlation of surfactant need with LUS findings would
      also be investigated.
    


Intervention name(s): lung ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): LUS was performed within first 20 to 30 minutes and repeated at 1, 2, 4 and 6 hours.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        extreme preterm babies with a gestational age 32 weeks or less were admitted to NICU. Only
        babies who were treated with CPAP because of clinical signs of respiratory distress were
        enrolled the study.