bioihbjkbjnl/mcl2 huggingface dataset:
Physiological Complexity of Pediatric Surgery Between Types of Hospitals
Condition: Health Services
Study type: Observational

Summary: 
      When considered from a provincial perspective, quantification of surgical procedures
      undertaken by different hospitals and healthcare networks is necessary for informing resource
      allocation and modelling of healthcare services. The investigators hypothesized that i)
      non-physiologically complex surgical procedures would account for most (>1/2) of pediatric
      surgical procedures performed at both pediatric specialist hospitals and the other hospitals
      performing pediatric surgery, ii) surgical discharges for non-physiologically complex
      surgical procedures would account for most (>1/2) in-hospital bed nights among pediatric
      surgical admissions at both pediatric specialist hospitals and the other hospitals performing
      pediatric surgery, and iii) the relative distributions of non-physiologically complex
      surgical procedures, but not physiologically complex procedures, would be at least moderately
      similar between pediatric specialist hospitals and the other hospitals performing pediatric
      surgery. To test these 3 hypotheses, the specific objectives of this study were to estimate
      i) the proportion (primary outcome) of non-physiologically complex pediatric surgical
      procedures, and ii) the similarity and diversity (secondary outcomes) of non-physiologically
      and physiologically complex surgical procedures between the pediatric specialist hospitals
      and the other hospitals performing pediatric surgery in Ontario, Canada.
    


Intervention name(s): Pediatric surgical procedures
Intervention type(s): Procedure
Intervention description(s): Eligible surgical procedures were identified using Canadian Classification of Health Interventions (CCI) therapeutic intervention codes.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric surgical procedures
      
Keywords: Similarity; Diversity
The Influence of Local Bone Status on Complications After Surgical Treatment of Distal Radius Fractures
Condition: Distal Radius Fractures; Poor Bone Quality; Treatment Complications
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Observational

Summary: 
      The purpose of this study is to evaluate if poor bone quality increases the risk of specific
      types of treatment complications in patients with distal radius fractures treated with open
      reduction and Locking Compression Plates(LCP).
    

Detailed description: 
      Despite fractures of the wrist being widely regarded as "fragility fractures", there is good
      evidence that they are caused by diminished Bone Mineral Density (BMD) and that a low BMD
      value predicts a higher fracture risk at the distal radius. Both measurements of areal BMD
      with DXA and volumetric BMD with peripheral Quantitative Computer Tomography (pQCT)showed a
      lower BMD in women with Colles' fractures. Thus, Colles' fractures can be recognized as a
      good indication of underlying osteoporosis. High resolution peripheral Quantitative Computer
      Tomography at the distal radius will be evaluated in a subset of patients.

      Clinical experts are concerned that osteoporosis increases the risk for poor outcomes and
      complication rates in surgical patients with osteoporosis. However, this has not yet been
      confirmed in clinical studies. It is important to investigate this question in order to
      correctly advise clinicians and patients and possibly develop tailored approaches for
      treatment of osteoporotic patients with distal radius fractures.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        participating clinics will identify all eligible patients who meet the inclusion and
        exclusion
      
Keywords: Radius fracture; Adverse effects; Wrist; Postoperative complications; Colles' fracture; Intraoperative complications; Osteoporosis; Dual-energy x-ray absorptiometry (DXA); Bone Density
The Effect of Vitamin D on Fertility
Condition: Infertility; Infertility, Female; Vitamin D Deficiency; Vitamin D3 Deficiency
MeSH terms: Infertility; Infertility, Female; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: To examine the effect of vitamin D supplements on the pregnancy and clinical
      pregnancy rate in embryo transfer cycles.

      Design: Experimental study with a pre- and post-test. Setting: In Vitro Fertilization Center
      Patients: Its sample consisted of 118 women, 58 in the experimental group and 60 in the
      control group.

      Intervention(s): At the beginning of the infertility treatment, the experimental group took
      vitamin D supplements, and the control group did not. Vitamin D supplementation for infertile
      women includes regulation of a diet rich in vitamin D, educational and motivational
      interviews about insolation, and taking vitamin D orally.

      Main Outcome Measure(s): 25(OH)D and beta HCG levels
    


Intervention name(s): DEVIT-3
Intervention type(s): Drug
Intervention description(s): The physicians gave the women in the experimental group vitamin D oral drops in an ampoule of 300,000 IU and a vial of 50,000 IU to take during the IVF treatment. Written and verbal information about how to take vitamin D was provided to the participants by the nurses. The women took 300,000 IU vitamin D orally for the first week. In the second week of the treatment, 50,000 IU vitamin D (15 drops/day) was used as maintenance dose until the pregnancy test day.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: vitamin D; vitamin D supplementation; infertility; D vitamin deficiency; infertile women; embryo transfer; pregnancy rate
Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects and Subjects With Renal Impairment
Condition: Healthy; Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This multiple ascending dose (MAD) study in healthy subjects and subjects with mild to
      moderate renal impairment will evaluate the safety, tolerability and pharmacokinetics of
      KBP-5074. Safety/tolerability data and Pharmacokinetics (PK)/Pharmacodynamics (PD) (plasma
      aldosterone, serum potassium, UACR and Blood Pressure) relationships will be explored to
      support the selection of dosing regimens of KBP-5074 that are suitable for the Phase II/III
      study.
    

Detailed description: 
      This study consists of two parts: Part 1 is an open-label, multiple ascending dose (MAD)
      study to evaluate the safety, tolerability and pharmacokinetics of KBP-5074 in healthy
      subjects. The safety and tolerability will be assessed at each dose level before progressing
      to the next higher dose. Part 2 is an open label, randomized, parallel study to assess the
      safety and tolerability, the effect of renal dysfunction on the pharmacokinetics of KBP-5074,
      as well as the PK/PD relationship in subjects with mild to moderate renal impairment.
    

Intervention name(s): KBP-5074
Intervention type(s): Drug
Other intervention name(s): mineralocorticoid receptor antagonist
Intervention MeSH terms: Mineralocorticoids; Mineralocorticoid Receptor Antagonists
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) When Dosed With Efavirenz (EFZ)
Condition: Obstetric Labour, Premature
MeSH terms: Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized single sequence open label study. This study is designed to
      determine if chronic dosing with efavirenz (EFZ) will have an effect on the pharmacokinetics
      (PK) of intravenously-administered retosiban in healthy volunteers. The study consists of
      screening (28 days), treatment (1 dosing session) and follow-up (7 to 14 days) period, and
      the total duration of study participation for each subject will be approximately 8 weeks.
      During the treatment period, subjects will be admitted to the clinical research unit the day
      before dosing (Day 1) and will remain until completion of the last assessment on Day 20. All
      subjects will receive on Day 1, a 6 milligrams (mg) bolus of retosiban for 5 minutes (min),
      followed by a 6 mg/hour (hr) infusion for 12 hrs. On Day 2, a washout day will occur. On Days
      3-17, subjects will receive EFZ 600 mg once daily in the evening. On Day 18, subjects will
      receive a 6 mg bolus of retosiban for 5 mins, followed by a 6 mg/hr infusion for 12 hrs plus
      a 600 mg dose of EFZ.
    


Intervention name(s): Retosiban; EFZ 600 mg
Intervention type(s): Drug; Drug
Intervention description(s): Retosiban will be supplied as clear colorless solution for infusion (300 mg in 20 mL via). Subject will receive loading dose of 6 mg over 5 min infusion followed by 6 mg/hour infusion for 12 hrs on Day 1 and Day 18.; EZF 600 mg will be supplied as a yellow, capsular-shaped, film-coated tablet. Subjects will receive EFZ 600mg OD in the evening from Day 3 till Day 18.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Retosiban, Efavirenz, Induction
The Effect of Maternal Scent on Sleep Wake States
Condition: Development, Infant
Study type: Interventional

Summary: 
      This study will be a prospective, randomized controlled study, which aims to determine if a
      maternal scent intervention improves the sleep wake states, brain maturation, and heart rate
      variability in premature infants admitted to the neonatal intensive care unit (NICU). Infants
      will be randomized to either 24 hours of exposure to maternal scent or standard of care.
      Sleep wake states will be obtained using behavioral coding. Brain maturation will be measured
      using several electroencephalogram (EEG) parameters. Heart rate variability will be collected
      as part of vital sign collection.
    

Detailed description: 
      Sleep is important for the growth and development of infants. There are different states that
      make up sleep wake cycles including quiet sleep, active sleep, and transitional sleep. The
      amount of time that infants spend in quiet sleep increases as they mature. There are
      different tools that can be used to measure sleep state including EEG, behavior, and vital
      signs. Recent research has looked at ways to improve sleep in infants admitted to the NICU
      including music and maternal voice. The investigators are interested in studying maternal
      scent. Maternal scent has been shown to improve infant feeding and to reduce infant crying
      during painful procedures. Therefore, the investigators are interested in studying how
      maternal scent might affect sleep wake state in infants admitted to the NICU. The
      investigators will observe infant behavior and use EEG and vital signs to assess sleep state
      in infant after they are exposed to maternal scent.
    

Intervention name(s): Maternal Scent
Intervention type(s): Other
Intervention description(s): Mothers will wear a breast pad during their visit. The breast pad will be placed in the hats of infants for 24 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Sleep wake cycles; Quiet sleep; Active sleep; Maternal scent
A Study to Determine the Patient Preference Between Zosano Pharma Parathyroid Hormone (ZP-PTH) Patch and Forteo Pen
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine which of two delivery methods of Parathyroid
      Hormone (PTH) is preferred by patients after 14 days of use for each.
    

Detailed description: 
      The purpose of this study is to determine which of two delivery methods of PTH is preferred
      by patients after 14 days of use for each. Patient preference will be determined by means of
      patient questionnaires at the end of each treatment period and a final questionnaire after
      both treatment periods are complete. Adverse events will also be collected.
    

Intervention name(s): ZP-PTH; FORTEO
Intervention type(s): Drug; Drug
Intervention description(s): Patch applied daily for 30 minutes, 14 days; Subcutaneous injection administration daily for 14 days
Other intervention name(s): PTH; parathyroid hormone; teriparatide; PTH; FORSTEO; teriparatide
Intervention MeSH terms: Teriparatide; Parathyroid Hormone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Nursing Staff on Empiric Antibiotic in Septic Shock
Condition: Septic Shock; Compliance; Antibiotic; Nursing Caries
MeSH terms: Shock, Septic; Shock
Study type: Observational

Summary: 
      A retrospective, observational study was performed about the patients with septic shock who
      admitted into intensive care unit (ICU) from January 1, 2015 to February 29, 2016. The number
      of patients who received empiric antibiotic treatment within first hour after septic shock
      diagnosis were collected. Detailed information about clinical ladder for nursing stuff and
      nursing shift were collected . Clinical ladder for nursing stuff is a new definition based on
      education background and work experience and nurses stuff are classified into four levels. N0
      was defined who got college degree or above, nurse qualification certificate and working time
      less than one year. N1 an N2 were defined as who got nurse qualification certificate and
      working time between 1~3 years and more than three years, respectively. N3 was defined who
      was nurse-in-charge qualification or got nurse practitioner qualification for more than five
      years. Compliance of empiric antibiotic treatment within first hour and evaluate the effect
      of nursing stuff on the compliance were calculated.
    


Intervention name(s): work Time
Intervention type(s): Behavioral
Intervention description(s): nurse got qualification certificate and the working time
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All adult patients whose age of 18 years or older admitted to the ICU with septic shock
        from between January 01, 2015 to February 29, 2016
The Effects of Adrenaline and Milrinone in Patients With Myocardial Dysfunction After CABG
Condition: Cardiac Output, Low
MeSH terms: Cardiac Output, Low
Study type: Interventional
Phase: Phase 3

Summary: 
      Myocardial dysfunction necessitating inotropic support is a typical complication after
      on-pump cardiac surgery. This prospective, randomized pilot-study analyses the metabolic and
      renal effects of the inotropes adrenaline and milrinone in patients needing inotropic support
      after coronary-artery-bypass-grafting. With respect to data derived from patients with sepsis
      shock and results from studies using phosphodiesterase-inhibitors prophylactically, the
      hypothesis is tested that adrenaline may be associated with unwarranted metabolic effects
      (hyperlactatemia and hyperglycemia) and renal dysfunction.
    

Detailed description: 
      Following preoperative written informed consent, patients presenting with a cardiac-index
      (CI) < 2.2 l/min/m2 upon ICU-admission - despite adequate mean arterial (titrated with
      noradrenaline or sodium-nitroprusside) and filling pressures - will be randomized to 14 hour
      treatment with adrenaline or milrinone to achieve a CI > 3.0 l/min/m2.

      A group of patients not needing inotropes will be used as controls. Hemodynamics, metabolism
      (plasma lactate, pyruvate, glucose, acid-base status, insulin requirements) and renal
      function (urinary excretion of alpha-1-microglobulin, creatinine clearance, plasma cystatin-C
      levels) will be determined during the treatment period and up to 48 hours after surgery
      (follow up period).

      The study is designed as a pilot study including 20 patients per group.
    

Intervention name(s): adrenaline; milrinone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Milrinone; Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: coronary artery bypass grafting; inotropes; metabolism; renal failure
Interaction Between Genetic Factors and Maternal Stressors During Pregnancy in the Risk of Postpartum Depression
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Observational

Summary: 
      "The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with a
      higher maternal morbidity and mortality, and also with pervasive effects on the emotional,
      cognitive and behavioral development of the infant.

      Stressful life events, socio-demographic and obstetrical risk factors have been associated
      with the risk of PPD. Genetics risk factors of PPD have also been identified. We are
      presently studying for the first time how maternal stressors may interact with genetic
      factors to increase the risk of PPD (Gene x Environment interaction)".
    

Detailed description: 
      "The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with a
      higher maternal morbidity and mortality, and also with pervasive effects on the emotional,
      cognitive and behavioral development of the infant.

      Stressful life events, socio-demographic and obstetrical risk factors have been associated
      with the risk of PPD. Genetics risk factors of PPD have also been identified. We are
      presently studying for the first time how maternal stressors may interact with genetic
      factors to increase the risk of PPD (Gene x Environment interaction).

      We want first to analyze the allelic association between SNPs of 5-HT, HPA and
      neurodevelopment genes and PPD with a case control association study We then analyse the
      interaction between maternal stressors during pregnancy and SNPS of our candidate genes
      (CRHR1, 5-HTT, TPH, BDNF, HMCN1).

      3000 Caucasian mothers are included after pregnancy in 8 maternities and are evaluated at the
      inclusion, at 8 weeks and at 1 year with DIGS, FISC, EPDS and HAD, Stressful life events
      (Paykel). Blood are collected for all subjects for DNA extraction.

      At week 8 and 1 year after pregnancy we search PPD with EDPS and DSM-IV criteria of
      depression".
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        causasian mothers after pregnancy
      
Biospecimen description: 
      Blood sample
Effect of Massage Treatment in Temporomandibular Joint
Condition: Massage Therapy; Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      Temporomandibular disorders (TMD) have multiple and broad clinical effects on orofacial
      structures and are often diagnosed in patients with a prevalence of between 5% and 12%. Among
      treatment options, massage therapy is one of the common therapeutic procedures and allows
      interesting clinical outcomes by reducing TMD symptoms successfully. However, there has been
      no attempt to validate this knowledge. Thus, the aim of this study is to evaluate the effect
      of massage and its properties in patients with TMD.
    


Intervention name(s): Massage therapy; non-effective treatment
Intervention type(s): Other; Other
Intervention description(s): Massage therapy performed by a physiotherapist; non-effective treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Massage
Microcirculation of the Thenar Eminence
Condition: Elective Cardiac Surgery
Study type: Observational

Summary: 
      Microcirculatory disturbances following cardiac surgery with cardiopulmonary bypass (CPB)
      have been thought to be at the origin of organ dysfunction. Though, few studies correlated
      microvascular alterations with outcome. Investigators aimed at firstly describing
      microcirculation with near infra red spectroscopy (NIRS) and secondly correlating NIRS
      parameters with intensive care length of stay and organ dysfunction.
    

Detailed description: 
      40 patients at high risk of post operative systemic inflammatory response syndrome after an
      elective cardiac surgery with CPB were included in this prospective observational study.
      Patients were studied during the first 48 postoperative hours. Microcirculation of the thenar
      eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after
      an ischemic challenge. Organ dysfunction was assessed with the SOFA score.
    

Intervention name(s): microcirculatory reactivity
Intervention type(s): Other
Intervention description(s): Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients at high risk of post operative systemic inflammatory response syndrome after an
        elective cardiac surgery with CPB
      
Keywords: StO2; microcirculation; NIRS
Ultrasound vs Palpation for Radial Artery Cannulation
Condition: Obese
Study type: Interventional

Summary: 
      The primary purpose of this study is to compare the palpation technique with ultrasound
      guidance for radial artery cannulation for bariatic surgery.
    


Intervention name(s): Ultrasound -guided cannulation; Palpation -guided cannulation
Intervention type(s): Procedure; Procedure
Intervention description(s): radial artery cannulation using the ultrasound; radial artery cannulation using the palpation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment