bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin D Status and the Adequacy of Vitamin D Intake in Early Preterm Infants
Condition: Hypovitaminosis D
MeSH terms: Rickets; Avitaminosis; Vitamin D Deficiency
Study type: Observational

Summary: 
      Vitamin D is an essential nutrient. Deficiency of vitamin D is widespread. The prevalence of
      vitamin D deficiency in early preterm infants is unknown. The American Academy of Pediatrics
      recommends a daily intake of 400 IU in order to achieve a serum concentration of 20 ng/ml of
      vitamin D. This recommendation presumes exposure to sunlight, the best source of vitamin D.
      This study assesses vitamin D status at birth and during hospital stay in infants delivered
      delivered at earlier than or at 32 weeks gestation. We also assess the adequacy of intake
      relative to the target set by the American Academy of Pediatrics for children.
    

Detailed description: 
      Vitamin D is important for bone health. Deficiency of vitamin D is widespread and is
      associated with a variety of diseases. Preterm infants are susceptible osteopenia of
      prematurity (OP). Vitamin D deficiency may contribute to OP. The American Academy of
      Pediatrics (AAP) recommends a daily intake of 400 IU in order to achieve a serum
      concentration of 20 ng/ml of vitamin D. This recommendation presumes exposure to sunlight,
      the best source of vitamin D. Whether this level of intake or target serum concentration are
      achieved in early preterm infants is unknown. We hypothesize that because early preterm
      infants are sequestered in the Newborn Intensive Care Units for an extended period of time,
      they will be deficient in vitamin D and that the current nutritional intake may not be
      adequate in meeting the AAP recommendation. We assessed the concentration of serum
      25-hydroxyvitamin-D in parturient mothers and in their newborns if they were less than 32
      week gestation. We monitored vitamin D intake during hospitalization in the Newborn Intensive
      Care Unit and serum 25-hydroxyvitamin-D at discharge.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All infants born at or less than 32 weeks postmenstrual age admitted to the Newborn
        Intensive Care Unit at University of Cincinnati Medical Center were eligible. Intake of
        vitamin D and serum 25-hydroxyvitamin-D concentrations were assessed during stay in the
        Newborn Intensive Care Unit.
Bioequivalence Of Zoloft ODT To Jzoloft In Healthy Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of Zoloft ODT 50 mg with and
      without water to Japanese commercial oral tablet of JZoloft 50 mg under fasting condition
      with water in Healthy Japanese Subjects
    


Intervention name(s): JZoloft; sertraline ODT; sertraline ODT
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg tablet on Day 1 of each period; 50 mg tablet on Day 1 of each period; 50 mg tablet on Day 1 of each period
Other intervention name(s): sertraline hydrochloride
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: JZoloft; Sertraline hydrochloride; ODT; bioequivalence
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Slovakia
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is a Slovakian, Multicentre, Observational Study to study Adherence and Long Term
      Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth
      hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter longitudinal observational study. Parents/
      subjects will provide their Informed Consent/assent to upload their data for population-based
      analyses and, ultimately, clinical outcomes. Adherence data will be primarily derived from
      the easypod™ device combined with physician data entry of outcome measures. Data will be
      collected retrospectively and prospectively. This will allow the establishment of adherence
      profiles and subsequent clinical outcomes. Collected data will be also analyzed in a
      multinational pooled analysis of comparable national studies.

      Primary Objective:

      • To assess the level of adherence of subjects receiving SAIZEN® via easypod™.

      Secondary Objective:

        -  To identify adherence subject profiling

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via easypod™

        -  To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above,
           below or within normal ranges)
    

Intervention name(s): easypod™
Intervention type(s): Device
Intervention description(s): Saizen (Somatotropin) as per Summary of Product Characteristics (SmPC) administered by easypod™
Other intervention name(s): Somatotropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject
Newly Diagnosed Mature B-ALL, Burkitt's Lymphoma and Other High-grade Lymphoma in Adults
Condition: Burkitt's Lymphoma; Burkitt's Leukemia; Mediastinal Neoplasms; Lymphoblastic Lymphoma; Large Cell Anaplastic Lymphoma
MeSH terms: Burkitt Lymphoma; Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Mediastinal Neoplasms; Lymphoma, Large-Cell, Anaplastic
Study type: Interventional
Phase: Phase 4

Summary: 
      The study evaluates the efficacy and tolerability of alternating short cycles of high-dose
      and conventional chemotherapy in combination with rituximab in CD20 positive patients,
      followed by local radiation therapy in the case of initial mediastinal or central nervous
      system (CNS) involvement or a residual tumor after chemotherapy. A dose-reduced regimen is
      offered for patients estimated to be over 55 years, biologically.
    


Intervention name(s): Adriamycin; Cyclophosphamide; Cytarabine; Dexamethasone/Prednisolone; VP16; Ifosfamide; Methotrexate; G-CSF; Rituximab; Vincristine/Vindesine; Irradiation (in specific conditions)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Cytarabine; Dexamethasone; Prednisolone; Cyclophosphamide; Ifosfamide; Rituximab; Methotrexate; Vincristine; Doxorubicin; Vindesine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High-grade NHL; De novo; Mature B-ALL; Burkitt'S NHL; Chemotherapy; Rituximab; Primary mediastinal diffuse large cell lymphoma; B-precursor lymphoblastic lymphoma
In-use Cross-over Study of Two Different Menstrual Cups
Condition: Menstruation
Study type: Interventional

Summary: 
      This study evaluated the safety and tolerability of two different menstrual cups on vaginal
      health
    


Intervention name(s): Tampax menstrual cup; Other menstrual cup
Intervention type(s): Device; Device
Intervention description(s): regular flow size; size 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Study of Outpatient Management for Promontofixation by Laparoscopy
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      Laparoscopic promontofixation is becoming increasingly common and is currently the standard
      surgical procedure for pelvic prolapse, with few complications including exposure and mesh
      infection.

      The research hypothesis is that laparoscopic promontofixation is a relatively painless
      procedure and can be performed on an outpatient basis without increasing the number of
      postoperative complications and impairing patients' quality of life.

      The objective of this study is to evaluate the number of rehospitalizations after management
      of promontofixation by laparoscopy on an outpatient basis.

      To evaluate the feasibility of a postoperative H8 exit after laparoscopic promontofixation.

      Each patient will complete a questionnaire on the experience of management, both in terms of
      pain management, anxiety and overall satisfaction.
    


Intervention name(s): outpatient management for promontofixation by laparoscopy; questionnaire
Intervention type(s): Other; Other
Intervention description(s): postoperative H8 exit after laparoscopic promontofixation; Each patient will complete a questionnaire on the experience of management, both in terms of pain management, anxiety and overall satisfaction.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Laparoscopic Promontofixation; Outpatient management
A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG3067 in Healthy Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled, single
      center study, evaluating single and multiple ascending oral doses of GLPG3067 and the
      combination of GLPG3067 and GLPG2222 and the combination of GLPG3067,GLPG2222 and GLPG2737
      given for 14 days in healthy women of non-childbearing potential.

      The purpose of the study is to evaluate the safety and tolerability of single ascending oral
      doses and multiple ascending oral doses of GLPG3067 given to healthy women of
      non-childbearing potential compared to placebo, as well as of multiple oral doses of the
      combination of GLPG3067/GLPG2222 compared to matching placebo for each compound and multiple
      oral doses of the combination of GLPG3067/GLPG2222/GLPG2737 compared to matching placebo for
      each compound.
    


Intervention name(s): GLPG3067 single dose; Placebo single dose; GLPG3067 multiple dose; Placebo multiple dose; GLPG3067 oral suspension; GLPG3067 oral tablet; GLPG3067/GLPG2222 multiple dose; GLPG3067/GLPG2222 Placebo multiple dose; GLPG3067/GLPG2222/GLPG2737 multiple dose; GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): GLPG3067 oral suspension, single ascending doses, daily; Placebo, oral suspension, daily; GLPG3067 oral suspension, multiple ascending doses, daily for 14 days; Placebo, oral suspension, daily for 14 days; GLPG3067 oral suspension, single dose, daily; GLPG3067 oral tablet, single dose, daily; GLPG3067 oral suspension and GLPG2222 oral tablet, multiple doses, daily for 14 days; GLPG3067 matching placebo oral suspension and GLPG2222 matching placebo oral tablet, multiple doses, daily for 14 days; GLPG3067 oral tablet, GLPG2222 oral tablet and GLPG2737 oral capsule, multiple doses, daily for 14 days; GLPG3067 matching placebo oral tablet, GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule, multiple doses, daily for 14 days
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients
Condition: End-stage Renal Disease; Cardiovascular Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      End-stage renal disease (ESRD) patients often develop cardiovascular complications, and
      cardiovascular disease is the leading cause of death in this population. Ranolazine's ability
      to treat angina without reducing heart rate or blood pressure makes it an important option
      for ESRD patients. The hemodialysis clearance of ranolazine is unknown. A single-dose
      pharmacokinetic study is needed to characterize ranolazine and its metabolites in ESRD
      patients on and off hemodialysis. Results of the proposed study will provide initial dosing
      estimates for a follow-up, multiple-dose pharmacokinetic study in this population.
    


Intervention name(s): Ranolazine; Pharmacokinetic Blood and Dialysate Sampling; QT Interval
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): A single dose of two oral ranolazine extended release 500 mg tablets; Blood samples collected to assess ranolazine plasma and dialysate concentrations.; Calculation of a QT interval will be performed throughout subject participation.
Other intervention name(s): Ranexa; Ranexa; PK sampling; Ranexa; QT interval calculation
Intervention MeSH terms: Ranolazine; Dialysis Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ranolazine; end-stage renal disease; pharmacokinetics; cardiovascular disease
Parent Management Training, Oregon
Condition: Child Behavior Problems
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      The purpose of the study is to examine the effects of Parent Management Training Oregon
      (PMTO) compared to treatment as usual (TAU) for parents with children aged 3 and 12 showing
      behavioral problems.
    

Detailed description: 
      This project estimates the causal effect of Parent Management Training, Oregon (PMTO) in a
      Danish context. The study design is an RCT where PMTO is compared to Treatment As Usual
      (TAU). The target population is parents with children aged 3 and 12 showing behavioral
      problems. The primary outcome estimates changes in child behavior, and is measured three
      times: baseline, seven months follow-up, and 19 month follow-up.
    

Intervention name(s): PMTO; TAU
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parent Management Training, Oregon; Other kinds of family training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parent training; Child behavior; Randomized Controlled Trials
IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia
Condition: Cesarean Section Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess the efficacy of IM neostigmine (0.5 mg) for acceleration
      of bladder evacuation and prevention of postoperative urine retention following cesarean
      delivery carried out under spinal anesthesia
    

Detailed description: 
      Following cesarean delivery, women will receive either 0.5 mg IM neostigmine (study group) or
      IM NaCl 0.9% (control group). Bladder ultrasonography will be done every hour until
      spontaneous voiding occurs. If postoperative urine retention occurred (void inability with
      bladder volume > 600 ml by ultrasound), urinary catheterization will be done.
    

Intervention name(s): Neostigmine; NaCl 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 0.5 mg IM neostigmine; Participants will receive IM NaCl 0.9% as a placebo
Other intervention name(s): Epistigmin; Normal Saline
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cesarean Section; Spinal anesthesia; Postoperative urine retention (POUR)
Bioavailability Study of Ciprofloxacin 1000 mg ER Tablets of Dr. Reddy's Under Non-Fasting Conditions
Condition: Fed
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the relative bioavailability of ciprofloxacin 1000 mg
      ER tablets of Dr.Reddy's with that of CIPRO® XR 1000 mg of Bayer Pharmaceuticals Corporation
      in healthy, adult, non-smoking subjects under non-fasting conditions.
    

Detailed description: 
      This single dose, randomized, two-period, two-treatment, two sequence crossover study was
      conducted to compare the relative bioavailability of ciprofloxacin 1000 mg ER tablets of Dr.
      Reddy's and CIPRO® XR 1000 mg of Bayer Pharmaceuticals Corporation under non-fasting
      conditions.
    

Intervention name(s): CIPRO®XR
Intervention type(s): Drug
Intervention description(s): Ciprofloxacin 1000 mg Tablets Dr. Reddy's Laboratories Limited
Other intervention name(s): CIPRO®XR tablets of Bayer Health Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy
Condition: Ureter Stone
MeSH terms: Ureteral Calculi; Ureterolithiasis
Study type: Interventional

Summary: 
      This study aims to compare three groups of patients who underwent uncomplicated ureteroscopic
      lithotripsy (URSL) to evaluate whether stents could be eliminated after the procedure
    


Intervention name(s): no stent
Intervention type(s): Other
Intervention description(s): following uretroscopy, no stent will be placed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quadratus Lumborum Block in Pediatric Patients
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Quadratus lumborum block (QLB) is a newly-defined trunk block performed with local anesthetic
      injection by imaging the abdominal muscles with ultrasonography (US) guidance; thus,
      analgesia is expected to be ensured from the T7-L1 dermatomal segment level.

      In the study, the aim was to compare the postoperative analgesic effect of quadratus lumborum
      block in pediatric patients undergoing lower abdominal surgery
    

Detailed description: 
      Patients included in the study were randomly divided into 2 groups. Cases were assessed as
      intravenous opioid with 1 mg/kg tramadol HCl (Group O, n=20) or ultrasonography-guided
      quadratus lumborum block (Group B, n=20).

      Total analgesic amounts in 24 hours and first analgesic requirement times recorded.
    

Intervention name(s): Tramadol Hydrochloride; Morphine Sulfate
Intervention type(s): Drug; Drug
Intervention description(s): The Wong-Baker facial pain scale was used to assess pain (1: no pain, 10: worst possible pain). During monitoring patients with pain score ≥3 had intravenous 1 mg/kg tramadol hydrochloride administered, After 15 minutes following tramadol injection, cases with pain score continuing ≥3 were to be assessed as insufficient analgesia and had 0.1 mg/kg morphine hydrochloride planned for intravenous administration.; The Wong-Baker facial pain scale was used to assess pain (1: no pain, 10: worst possible pain). During monitoring patients with pain score ≥3 had intravenous 1 mg/kg tramadol hydrochloride administered, After 15 minutes following tramadol injection, cases with pain score continuing ≥3 were to be assessed as insufficient analgesia and had 0.1 mg/kg morphine hydrochloride planned for intravenous administration.
Intervention MeSH terms: Morphine; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients included in the study were randomly divided into 2 groups. Cases were assessed as intravenous opioid with 1 mg/kg tramadol HCl (Group O, n=20) or ultrasonography-guided quadratus lumborum block (Group B, n=20).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Quadratus lumborum block, abdominal trunk block
Intraoperative EEG Monitoring and Postoperative Delirium in Elderly Patients With Sevoflurane Anesthesia
Condition: Postoperative Delirium; Sevoflurane; Electroencephalogram
MeSH terms: Delirium; Emergence Delirium
Study type: Interventional

Summary: 
      Delirium is an acute onset of attentional and cognitive impairment. BIS guided anesthesia can
      reduce the incidence of postoperative delirium. Long term electroencephalogram (EEG)
      suppression during operation is related to postoperative delirium. The latest research shows
      that the anesthesia depth guided by EEG does not reduce the incidence of postoperative
      delirium. The purpose of this study was to explore the relationship between anesthesia
      exposure with different minimum alveolar concentration(MAC) and postoperative delirium(POD),
      and to observe the characteristics of EEG.
    

Detailed description: 
      More and more studies have focused on the relationship between EEG inhibition and
      postoperative delirium in general anesthesia. At present, there are two kinds of commonly
      processed quantitative EEG monitoring to evaluate the depth of anesthesia, one is bispectral
      index (BIS) and the other is patient state index (PSI). The relationship between
      intraoperative anesthetic exposure and postoperative delirium is unclear, or whether
      potential patient characteristics increase the risk of EEG suppression and postoperative
      delirium.

      Gastrointestinal surgery can lead to long-term changes in colonic flora, which can remotely
      regulate brain function through the gut brain axis. We speculated that the abnormal
      composition of intestinal flora before abdominal operation might be the influencing factor of
      POD.
    

Intervention name(s): Low MAC; High MAC
Intervention type(s): Drug; Drug
Intervention description(s): To maintain a target of sevoflurane inhalation concentration 0.8 MAC.; To maintain a target of sevoflurane inhalation concentration 1.0 MAC.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment