bioihbjkbjnl/mcl2 huggingface dataset:
PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections (Study P01893)
Condition: Mycoses
MeSH terms: Infections; Mycoses; Invasive Fungal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II study will be conducted to:

        1. evaluate the pharmacokinetics, safety, tolerance, and efficacy of different dosing
           schedules of Posaconazole in immunocompromised hosts with a variety of refractory
           invasive fungal infections or in subjects who require empiric antifungal therapy and

        2. identify the dosing schedule that provides the most consistent therapeutic drug exposure
           in this patient population.
    

Detailed description: 
      This is an open-label, randomized, parallel group, study of pharmacokinetics, safety,
      tolerance, and efficacy of Posaconazole in the treatment of immunocompromised hosts with
      refractory invasive fungal infections or in subjects who require empiric antifungal therapy.

      The projected number of subjects planned for enrollment is 100 evaluable subjects. The number
      of planned study sites is approximately ten in the United States and approximately eight in
      the rest of the world.
    

Intervention name(s): Posaconazole oral suspension
Intervention type(s): Drug
Intervention MeSH terms: Posaconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aspergillosis, Candidiasis, Mucormycosis, Cryptococcosis; Invasive Fungal Infections
Facilitated Tucking Position, Gentle Human Touch Practices and Pain
Condition: Pain; Premature
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This prospective study is planned as a randomized controlled study to evaluate the effect of
      facilitated tucking position and gentle human touch practices on the pain experienced by
      newborns during heel blood collection. This study is planned to be carried out between 15
      July and 15 December 2023 in the neonatal intensive care unit of a training and research
      hospital in the Southeastern Anatolia Region. The sample size was calculated based on the
      study of premature infants to determine the effect of facilitated tucking position on
      procedural pain. According to the results of the study, PIPP pain scores were determined as
      11.88±3.05 in the intervention group (n=17) and 9.06±2.95 in the control group (n=17). The
      effect size of the study was determined as d= 0.939 at α=0.05 level and 95% confidence
      interval. It was decided to conduct the study with a total of 90 premature babies, 30 of whom
      were in the groups, in case of data loss during the study.
    

Detailed description: 
      Neonatal pain negatively affects prognosis, behavior, environmental adaptation, development
      of the brain and senses, and interaction. Effective management of neonatal pain supports
      health and recovery, shortens hospital stays, and reduces care costs and the prevalence of
      neurobehavioral problems. Therefore, proper management of pain in newborns is important for
      the healthy development of newborns. Many invasive procedures are applied to newborns
      hospitalized in neonatal intensive care units. Non-nutritive sucking, oral sucrose, kangaroo
      care, facilitated tucking position, and gentle human touch have proven to have positive
      effects on the pain experienced by newborns during interventional procedures. In this study,
      the effect of facilitated tucking position and gentle human touch practices applied during
      heel blood collection on the perception of pain in premature newborns will be examined.
    

Intervention name(s): Facilitated Tucking Position; Gentle Human Touch
Intervention type(s): Behavioral; Behavioral
Intervention description(s): a sub-form of method of nesting the baby and the procedure of bringing the body to middle or even close position by holding the upper and lower extremities of the baby in flexion with hands; It is a form of healing touch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Impact of Supplemental Parenteral Nutrition in ICU Patients on Metabolic, Inflammatory and Immune Responses
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional

Summary: 
      Having previously demonstrated that supplemental parenteral nutrition to complete an
      insufficient enteral nutrition (EN) between D4 and D8 improves outcome after critical
      illness, by reducing infectious complications, the present trial aims at investigating the
      underlying carbohydrate and protein metabolism changes, as well as the immune and
      inflammatory modulations associated with this improvement.
    

Detailed description: 
      Enrollment on day 3 of critically ill patients, without contraindication to EN, not achieving
      60% of the ICU per protocol energy target.

      Intervention: Randomization to either continued pure EN, or from day 4 to supplemental PN to
      complete EN at target validated by indirect calorimetry.

      Measurements: Indirect calorimetry on Days 3, 4, 9 (twice). Primary endpoints = glucose and
      leucine metabolism On days 4 and 9-10: isotopic investigation of glucose metabolism, and
      immune and inflammatory responses// Day 9-10: isotopic investigation of protein (leucine)
      metabolism Secondary endpoints: Insulin requirements, area under the curve (AUC) of blood
      Glucose, infections after day 9, overall complications, length of mechanical ventilation, of
      ICU and hospital stay.
    

Intervention name(s): Supplemental parenteral nutrition (SPN)
Intervention type(s): Dietary Supplement
Intervention description(s): The amount of energy delivered by SPN will depend on the indirect calorimetry measurement and actual enteral feed delivery. SPN will be reduced with progressing EN
Other intervention name(s): Standard industrial PN solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Energy requirements, Glucose turnover, Protein turnover
Informed Implementation of Breast Density Reporting
Condition: Breast Density, Breast Cancer Prevention
Study type: Interventional

Summary: 
      1. To develop brief informational videos, Vidscrips, that can be sent to women following
           their mammogram to provide personalized information that integrates breast density with
           overall breast cancer risk, and provides information about additional care
           recommendations and talking tips for conversations with the health care providers.

        2. To test the effectiveness of this tool in a trial of 300 women undergoing mammography.
           The investigators hypothesize that individuals in the intervention arm (vs. those in the
           standard care arm who receive a letter with the language required by the legislation)
           will have more accurate knowledge of their overall risk of breast cancer, their
           Mammographic Breast Density (MBD) result, more appropriate observed and intended use of
           additional screening [i.e., use of screening Magnetic Resonance Imaging (MRI) will be
           reserved only for women at high risk of breast cancer], better satisfaction with their
           episode of breast cancer screening, less decisional conflict about their personal
           decision for any additional evaluation, and less worry about breast cancer.
    


Intervention name(s): Vidscrip educational video
Intervention type(s): Behavioral
Intervention description(s): Vidscrip educational video provide to women
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
One Year Glargine Treatment in CFRD Children and Adolescents
Condition: Cystic Fibrosis; Glucose Metabolism Disorders
MeSH terms: Cystic Fibrosis; Metabolic Diseases; Glucose Metabolism Disorders; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Glargine treatment can improve the clinical features in Cystic Fibrosis patients affected by
      glucose derangements
    

Detailed description: 
      To evaluate the effect of glargine treatment on BMI, lung function, acute pulmonary
      infections and HbA1c in cystic fibrosis (CF) patients with different glucose derangements,
      eighty-seven patients were screened for glucose derangements with fasting hyperglycaemia or
      abnormalities at the oral glucose tolerance test. They were classified on the basis of a
      "gluco-score" ranging 0-5. Patients with gluco-score > 1 were treated with glargine. We
      report on the results of the first 20 patients who completed 12 months of treatment. BMI
      z-score, forced expiratory volume in the first second (FEV1), number of acute lung infections
      in the previous year and HbA1c were the study outcomes.
    

Intervention name(s): Glargine
Intervention type(s): Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystis Fibrosis; Glucose intolerance; Glargine; FEV1%
Myopia Control Using Optimized Optical Defocus RCTs
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The aims of the study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia
      progression and axial length growth in myopic children as compared with single vision soft
      contact lenses.
    

Detailed description: 
      The purpose of the current study is to evaluate whether the DISC3.5 Plus contact lens will
      slow myopia progression and axial length growth in myopic children as compared with single
      vision soft contact lenses.

      The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens
      that comprises of simultaneous distance optical prescription and myopic defocus areas.

      The efficacy of the DISC3.5 Plus lens in slowing myopia progression (change in refractive
      error) will be compared to a spherical (front and back surface) single vision soft contact
      lenses in this one-year prospective, randomised and double-masked clinical trial. The
      hypothesis of this study is that the DISC3.5 Plus will slow myopia progression more than
      spherical single vision soft contact lenses.
    

Intervention name(s): DISC3.5 plus
Intervention type(s): Device
Intervention description(s): The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: myopia; Myopic Defocus; contact lens; myopia control
Feasibility Study: Evaluation of the Treatment of Striae Using Ultherapy® in Combination With Laser Treatment
Condition: Scars; Striae
MeSH terms: Striae Distensae
Study type: Interventional

Summary: 
      Up to 20 subjects will be enrolled. Enrolled subjects will receive one of three study
      treatments in the abdominal region: Ultherapy® only, Ultherapy® and CO2 laser treatment, or
      CO2 laser treatment only. Follow-up visit will occur at 14, 90 and 180 days post-treatment.
      Study images will be obtained pre-treatment, approximately 30 minutes post-treatment, and at
      each follow-up visit.
    

Detailed description: 
      This is a prospective, randomized, single-blinded, pilot clinical trial to evaluate the use
      of the Ulthera® System in combination with the 70W Alma Pixel CO2 laser for efficacious
      results in the treatment of abdominal striae rubra and striae alba. Subjects will be
      randomized to one of three treatment groups. Study personnel conducting efficacy measures
      will be blinded to the assigned treatment groups.

      Changes from baseline in overall skin texture and appearance of abdominal striae will be
      assessed at study follow-up visits. 2D images, 3D images and patient satisfaction
      questionnaires will be obtained.
    

Intervention name(s): Ultherapy® treatment only; Ultherapy® treatment and CO2 laser treatment; CO2 Laser treatment only
Intervention type(s): Device; Device; Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin; Ultherapy® treatment: Focused ultrasound energy delivered below the surface of the skin;
CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.; CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.
Other intervention name(s): Ulthera® System treatment; Ulthera® System treatment; CO2 Fractional Ablative Laser teatment; CO2 Fractional Ablative Laser teatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy® Treatment; Ulthera, Inc.; Ultrasound treatment for skin
Safety Study of the Effects of Inhaled Fluticasone Furoate/GW642444 on the Hypothalamic-Pituitary-Adrenal (HPA) Axis
Condition: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effect of six weeks' treatment with two once-daily
      strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system
    


Intervention name(s): Placebo Inhalation Powder; Fluticasone Furoate/GW642444 Inhalation Powder; Fluticasone Furoate/GW642444 Inhalation Powder; Placebo Oral Capsule; Prednisolone Oral Capsule
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo Inhalation powder inhaled once daily for 6 weeks' treatment; Dose B inhaled once daily for 6 weeks' treatment; Dose A inhaled once daily for 6 weeks' treatment; One placebo capsule taken each day on the last 7 days of the study; Prednisolone 10mg oral capsule taken each day on the last 7 days of the study
Intervention MeSH terms: Fluticasone; Xhance; Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HPA axis
Evaluation of Difficult Laryngoscopy With Ultrasonography in Pediatric Patients
Condition: Intubation; Difficult or Failed; Difficult Laryngoscopy
Study type: Observational

Summary: 
      Pediatric patients pose challenges in airway management due to anatomical and physiological
      changes. Using recommended predictive tests for predicting difficult airway can be improved
      by combining them with ultrasound measurement of the anterior soft tissues of the neck. In
      this study, the investigators aim to evaluate the ultrasound measurement of anterior neck
      soft tissues in paediatric patients before anesthesia induction, to anticipate difficult
      laryngoscopy.
    

Detailed description: 
      Eligible participants for this study will be patients aged 2-8 years scheduled for elective
      surgery under general anesthesia who have provided informed consent. During the preoperative
      evaluation, demographic data and airway physical examination results (Mallampati score) of
      the patients will be recorded. Patients who have received preoperative sedation will be
      positioned supine on the operating table, and ultrasound-guided measurements of soft tissue
      distances will be taken using a linear probe with a frequency range of 6-13 Hz. The distance
      between the hyoid bone and skin (DSHB), distance between the vocal cord anterior commissure
      and skin (DSAC), and distance between the epiglottis and skin (DSE) will be measured. The A/E
      (Anterior Commissura/Epiglottis) ratio will be calculated after measurements.

      After standard monitoring and anesthesia induction, difficult laryngoscopy will be evaluated
      using the Modified Cormack Lehane Score, which grades the visibility of vocal cords and
      glottic structures. A grade of 3 or 4 on this scale will be considered as difficult
      laryngoscopy and recorded as such. Tracheal intubation will be performed by an
      anesthesiologist with at least two years of experience who is unaware of the ultrasound
      measurements.
    

Intervention name(s): Distance between Skin-Hyoid Bone(DSHB); Distance between Skin-Vocal Cord Anterior Commissura(DSAC); Distance between Skin-Epiglottic(DSE)
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Hyoid bone-skin distance Other Name: DSHB; Vocal cord anterior commissura-skin distance Other Name: DSAC; Skin-epiglottic distance Other Name: DSE
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A hundred twenty patients, aged 2-8 years-old, with an American Anesthesiology Association
        physical classification (ASA) I-III planned to undergo general anesthesia for elective
        surgery, will be included in the study.
      
Keywords: Difficult laryngoscopy; Ultrasonography; Pediatric Airway
A Study Investigating the Safety, Absorption, and Elimination of Radioactively Labeled Etrumadenant, a New Compound in the Treatment of Cancer
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess absorption, metabolism, and excretion of Radioactively Labeled
      Etrumadenant in healthy volunteers.
    


Intervention name(s): [14C]-etrumadenant
Intervention type(s): Drug
Intervention description(s): Administered as specified in the treatment arm.
Other intervention name(s): [14C]-AB928
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Etrumadenant; Pharmacokinetics; AB928; Healthy participants
Treating PTSD in Patients With Borderline Personality Disorder
Condition: Stress Disorders, Post-Traumatic; Borderline Personality Disorder; Suicide; Self-Injurious Behavior
MeSH terms: Suicide; Personality Disorders; Borderline Personality Disorder; Stress Disorders, Post-Traumatic; Self-Injurious Behavior
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Individuals with borderline personality disorder (BPD) are the quintessential multi-problem
      patients, often presenting to treatment with numerous dysfunctional behaviors and comorbid
      diagnoses. Dialectical Behavior Therapy (DBT) is a comprehensive, cognitive-behavioral
      treatment for BPD that has been shown effective in reducing the primary problems it is
      designed to treat; namely, the frequency and severity of self-injurious and suicidal
      behavior, maintenance in treatment, and severe problems in living. However, the DBT treatment
      manual does not currently include a protocol specifying when or how to treat posttraumatic
      stress disorder (PTSD), a comorbid diagnosis that is prevalent in BPD patients and may
      maintain or exacerbate BPD criterion behaviors. Similarly, many of the existing treatment
      outcome studies for PTSD have excluded suicidal, substance abusing, and multiply diagnosed
      patients, thereby making it difficult to determine the generalizability of these approaches
      to individuals with BPD. The research proposed here is focused on the development of a
      protocol based on Prolonged Exposure therapy to treat PTSD in BPD patients that can be
      integrated into standard DBT, as well as the initial evaluation of this protocol's
      feasibility, acceptability, and efficacy. The treatment development and pilot testing process
      will occur in two phases, including measure development and standardization of the treatment
      protocol via clinical pre-testing (Phase 1); and pilot and feasibility testing of the
      intervention via a randomized controlled trial (RCT) comparing standard DBT + PTSD Protocol
      to standard DBT Only (Phase 2). Information gathered during the pilot RCT will be used to
      inform the design and conduct of a subsequent full-scale RCT. This research has the potential
      to significantly expand and improve upon the most empirically supported treatment currently
      available for BPD, while also demonstrating that exposure treatments for PTSD can be
      implemented safely and effectively in a BPD population.
    


Intervention name(s): Dialectical Behavior Therapy; PTSD Protocol
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Standard Dialectical Behavior Therapy as described in the 2 DBT treatment manuals (Linehan, 1993a,b).; A modified version of Prolonged Exposure therapy for PTSD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Ilaprazole and Aceclofenac
Condition: Drug Interaction Potentiation
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluate the pharmacokinetic drug interactions and safety after co-administration
      of ilaprazole and Aceclofenac in healthy adults.
    


Intervention name(s): Ilaprazole; Aceclofenac
Intervention type(s): Drug; Drug
Intervention description(s): Ilaprazole 10mg; Aceclofenac 100mg
Other intervention name(s): Noltec(the brand name); Airtal(the brand name)
Intervention MeSH terms: Aceclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomization, Open-label, Repeated administration, Crossover
Masking: None (Open Label)
Primary purpose: Treatment