bioihbjkbjnl/mcl2 huggingface dataset:
Diagnostics and Quality of Life With EIA and EILO
Condition: Exercise Induced Asthma; Exercise Induced Pharyngeal Collapse
MeSH terms: Asthma; Asthma, Exercise-Induced
Study type: Observational

Summary: 
      The purpose of this study is to investigate the quality of life of subjects suffering from
      dyspnoea while exercising and quantify the number of diagnoses of Exercise induced Asthma
      (EIA) and Exercise induced laryngeal obstruction (EILO) in our outpatient clinic using an
      exercise-challenge in a cold-chamber and an exercise-challenge with continuous laryngoscopy.
    

Detailed description: 
      In this study investigators want to characterize and investigate the quality of life of all
      patients consulting the outpatient clinic for pediatric pulmonology suffering from dyspnoea
      while exercising.

      Besides standard diagnostics (bodyplethysmograph, spirometry, exhaled NO, skin prick test)
      subjects will take part in an exercise-challenge in a cold chamber at 2-4°C. Subjects showing
      symptoms of exercise-induced asthma will get a treatment with ICS/LABA for six weeks. All
      Patients should fill out a symptom diary. On suspicion of an EILO, subjects not showing
      symptoms in the first exercise-challenge in the cold chamber and all subjects without
      improvement after EIA treatment will take part in a second exercise-challenge in the cold
      chamber with continuous laryngoscopy.

      If EILO is proved by laryngoscopy, speech therapy is recommended. To investigate the symptoms
      and the quality of life of these patients, all patients and there parents should answer
      symptom and quality of life questionnaires (Child Behavior Checklist (CBCL/4-18), Youth
      Self-Report (YSR 11-18), Asthma Control Test, (ACT) Dyspnea Index (DI)) at every visit.

      There are yearly follow ups of these patients for five years in order to collect long-range
      prognosis.
    

Intervention name(s): ECC; ECC with CLE; Speech therapy
Intervention type(s): Other; Other; Other
Intervention description(s): Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.; Continuous Laryngoscopy is endoscopy of the larynx used to obtain a view of laryngeal obstruction during exercise.; Patients with diagnosis of EILO will be sent to a speech therapist for at least 6 training sessions.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients from our outpatient clinic aged 8-18 years with exercise induced dyspnea and at
        least two training session per week.
      
Keywords: Exercise Induced Asthma (EIA); Exercise Induced Laryngeal Obstruction (EILO); Quality of life; Exercise challenge in cold chamber (ECC); Continous laryngoscopy while exercising (CLE)
Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19
Condition: Corona Virus Infection; Virus Diseases; Coronaviridae Infections
MeSH terms: Infections; Communicable Diseases; COVID-19; Virus Diseases; Coronavirus Infections; Coronaviridae Infections
Study type: Observational [Patient Registry]

Summary: 
      This observational study will describe lung ultrasound (LUS) findings over time in
      hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to
      investigate if lung ultrasound can identify and/or predict patients requiring mechanical
      ventilation. Another aim is to describe LUS findings associated with clinical findings and
      patient condition.
    

Detailed description: 
      Study patients with moderate to severe Covid-19 infection will be screened with lung
      ultrasound daily. Lung ultrasound will be assessed by LUS-score for acute respiratory
      distress syndrome (ARDS) (0-36 points, Bouhemad 2015). Findings of B-line artifacts and
      consolidations will be noted. In addition to LUS, clinical parameters from physical
      examination and laboratory tests will be collected. Participants wil be followed until either
      admission to intensive care unit (ICU) for mechanical ventilation or until clinical
      improvement. A group of patients with mild Covid-19 infection will be recruited and screened
      once as reference.

      Apart from assessment with LUS, patients are managed according to routine care.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Hospitalized adult patients with confirmed Covid-19 and oxygen therapy corresponding to
        stage 4-5 on the "Ordinal Scale for Clinical Improvement" of the World Health Organization.
      
Keywords: ultrasonography; lung ultrasound; covid-19; ARDS
Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty
Condition: Wound Heal
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      In this prospective pilot study examining the superficial closure during total knee
      arthroplasty, active subjects will receive the STRATAFIX Spiral Knotless Tissue Control
      Device for subcuticular closure in addition to DERMABOND PRINEO (Ethicon, Johnson and
      Johnson, Somerville, New Jersey) system for dermal closure. The control subjects will receive
      staples (standard-of-care).
    

Detailed description: 
      The DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system is a
      unique two-part skin closure system that consists of: a 2-octyl cyanoacrylate topical skin
      adhesive for proven strength and microbial protection in vitro, and a flexible, self-adhesive
      polyester mesh for excellent approximation and healing. It is aimed to add strength and
      protection when closing medium to long incisions. In addition, it is designed to replace the
      use of subcuticular sutures or staples, with greater holding strength, with the potential to
      reduce skin closure time.

      Various studies have evaluated the outcomes of different closure devices, however, there are
      no reports assessing the length of closure times using DERMABOND PRINEO (Ethicon, Johnson and
      Johnson, Somerville, New Jersey) Knotless Tissue Control Devices during superficial closure
      in orthopaedic surgery. Huemer et al. (1) performed an observational study of 180 patients
      who had 224 excisional body-contouring surgeries utilizing Dermabond Prineo for superficial
      closure. Authors concluded that this closure type enables the surgeon to perform a quick and
      smooth skin closure. However, 4 patients (1.8%) developed local allergic reactions, which
      necessitated early removal and topical corticosteroid treatment. Parvizi et al.(2) performed
      an open, prospective, randomized clinical study of superficial wound closure on 60 patients
      undergoing abdominoplasty with either Dermabond Prineo or conventional superficial closure.
      They found significantly lower price ($134.79 cheaper) and significantly better Hollander
      Cosmesis Scale scores in Dermabond Prineo cohort. In addition, there was a significantly
      better cosmetic outcome at 6 and 12 months after surgery. The use of Dermabond Prineo may be
      able to decrease operative time and costs in other surgical fields, such as orthopedics.
      Careful patient allergy history is necessary to avoid adhesive allergic reactions.
    

Intervention name(s): DERMABOND; Staples
Intervention type(s): Device; Device
Intervention description(s): DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey); staples for skin closure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: adhesive; total knee arthroplasty; wound; closure; time; barbed suture; knoteless suture
Optimum Misoprostol Dose Prior to Office Hysteroscopy
Condition: Infertility; Abnormal Uterine and Vaginal Bleeding, Unspecified; Recurrent Abortion
MeSH terms: Infertility; Uterine Hemorrhage; Abortion, Habitual
Study type: Interventional
Phase: Phase 3

Summary: 
      Misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal
      route is the best, optimum dose not yet known.
    

Detailed description: 
      The investigators will compare between 2 different doses of vaginal misoprostol, group (1)
      200 ug, group (2) 400 ug, 3hours prior to office hysteroscopy , Infertile patient, patients
      with abnormal bleeding and patient with recurrent abortion Outcome measure: pain score,
      easiness of the procedure, procedure time, complications
    

Intervention name(s): Misoprostol; Misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): 200 ug; Misoprostol vaginally, 400 ug
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Office hysteroscopy; Cervical priming; Misoprostol
A Study Investigating The Effects Of An Ankle Rehabilitation Program On High School Athletes With Ankle Instability
Condition: Chronic Ankle Instability; Ankle Sprains; Ankle Rehabilitation
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      A randomized controlled trial investigating the effects of a 4-week ankle rehabilitation
      program on high school athletes with chronic ankle instability.
    

Detailed description: 
      A randomized controlled trial investigating the effects of a three different 4-week ankle
      rehabilitation programs on high school athletes with chronic ankle instability. We will use
      questionnaires to assess subjective level of function and clinical measures to assess
      clinical functionality via static and functional balance.
    

Intervention name(s): Resistance Band Ankle Rehabilitation; Biomechanical Ankle Platform System Rehabilitation; Combination Rehabilitation
Intervention type(s): Other; Other; Other
Intervention description(s): Resistance Band - uses a tension band to provide resistance during ankle motion; Biomechanical Ankle Platform System Board Group - uses different levels of half spheres to increase the amount of motion allowed at the ankle.; Combination Group - includes both the resistance band and Biomechanical Ankle Platform System programs.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 4 independent groups
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Serum Presepsin as Early Predictor for Neonatal Early-onset Sepsis
Condition: Neonatal Sepsis
MeSH terms: Sepsis; Toxemia; Neonatal Sepsis
Study type: Interventional

Summary: 
      124 neonates aged ≤7 days with suspected EOS were clinically evaluated using SNAP-II and gave
      blood samples for BC, total leucocytic count (TLC), lymphocytic and neutrophil count, and
      ELISA estimation of serum levels of PSP, procalcitonin (PCT), and tumor necrosis factor-α
      (TNF-α). Enrolled neonates were categorized as Confirmed EOS: neonates with evident clinical
      sepsis manifestations and positive BC, Suspected EOS: neonates with evident clinical sepsis
      manifestations but had negative BC and No EOS included neonates free of evident clinical
      sepsis manifestations, had negative BC and showed no deterioration till 72-hr after
      admission.
    


Intervention name(s): Serum Presepsin
Intervention type(s): Diagnostic Test
Intervention description(s): Estimation of Serum Presepsin at time of admission
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Early-onset neonatal sepsis; Presepsin; Clinical scoring; Early predictors; Blood culture
The Effects of Methadone and Buprenorphine on Fetal Neurobehavior and Infant Neonatal Abstinence Syndrome - 1
Condition: Opiate Dependence; Pregnancy
MeSH terms: Opioid-Related Disorders
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effects of drugs used by treatment providers on
      the fetuses and infants of opiate dependent women. The subjects in this study are women
      enrolled in a large, multi-site, double blind study that looks at the effects of methadone
      and buprenorphine treatment during pregnancy. This study will evaluate fetal and maternal
      biophysiologic data longitudinally during pregnancy to determine how these substances may
      affect fetal neurobehavior. Additionally, infant neurobehavioral assessments and measurements
      of infant vagal tone will be collected to see how methadone and buprenorphine differentially
      affect the neonatal abstinence syndrome, or "withdrawal" in exposed neonates.
    

Detailed description: 
      Previous research by this group has found that methadone treatment during pregnancy directly
      impacts fetal neurophysiology independently of maternal physiology. Buprenorphine is a new
      therapy for opiate dependent individuals, and its use during pregnancy is currently being
      evaluated. Some research has shown that buprenorphine lessens the neonatal abstinence
      syndrome when compared to methadone. Thirty methadone and 30 buprenorphine maintained women
      will be evaluated at 24, 28, 32 and 36 weeks gestation using a state-of-the-art computerized
      fetal actocardiograph and data analysis program to simultaneously evaluate fetal movement and
      heart rate and maternal physiologic parameters. Investigators will be blinded to treatment
      group. Longitudinal neurodevelopment of the fetuses in each group will be explored. The
      differential effects of methadone and buprenorphine on the neonatal abstinence syndrome will
      also be explored.
    

Intervention name(s): Buprenorphine / methadone
Intervention type(s): Procedure
Intervention description(s): Parallel study to double blind, double dummy study evaluating safety and efficacy of buprenorphine vs methadone treatment for pregnant opioid dependent women
Intervention MeSH terms: Buprenorphine; Methadone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Opioid dependent pregnant women enrolled in parent study (Maternal Opioid treatment: Human
        Experimental Research)
      
Keywords: Buprenorphine; Methadone
Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology in Polycystic Ovary Syndrome Patients During IVF/ICSI
Condition: In Vitro Fertilization; Infertility; Intracytoplasmic Sperm Injection; Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Selection of developmentally competent oocytes enhances IVF efficiency. Usually, oocyte
      quality is determined based on its nuclear maturation and the presence of specific
      cytoplasmic and extracytoplasmic morphologic features. Gonadotropin-releasing hormone
      agonists (GnRH Agonists) and gonadotropin-releasing hormone antagonists (GnRH Antagonists)
      are used during controlled ovarian stimulation (COS) protocols in order to prevent premature
      luteinizing hormone (LH) surge and premature ovulation. However, GnRH receptors are also
      expressed in extra-pituitary tissues such as ovary, but it is still unknown whether the type
      of GnRH analogues used during COS could affect the oocyte morphology in polycystic ovary
      syndrome (PCOS) patients. The aim of this prospective, non-randomised, open-label, clinical
      trial is to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long
      Protocol and GnRH Antagonist-Flexible Protocol on oocyte morphology in PCOS patients during
      IVF/ICSI.
    


Intervention name(s): Triptorelin acetate; Cetrorelix; recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin; Human Chorionic Gonadotropin (hCG)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.05-0.1 mg subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the cycle until the day of ovulation triggering.; 0.25 mg subcutaneously (SC) once daily starting from the day detecting a leading follicle diameter ≥ 14 mm until the day of ovulation triggering.; Dosage adjustment according to the ovarian response.; Ovulation will be triggered by the administration of 10,000 IU of human chorionic gonadotropin when at least three follicles become more than 16-17 mm.
Intervention MeSH terms: Triptorelin Pamoate; Chorionic Gonadotropin; Cetrorelix; Menotropins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GnRH Agonist; GnRH Antagonist; Oocyte morphology; Assisted reproduction technique; In Vitro Fertilization; Intracytoplasmic sperm injection; Polycystic Ovary Syndrome
Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety of alogliptin, once daily (QD),
      following participation in 1 of 7 controlled studies in patients with type 2 diabetes
      mellitus.
    

Detailed description: 
      SYR-322 (alogliptin) is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl
      peptidase IV is thought to be primarily responsible for the degradation of 2 peptide hormones
      released in response to nutrient ingestion, namely glucagon-like peptide-1 and
      glucose-dependent insulinotropic peptide. It is expected that inhibition of dipeptidyl
      peptidase IV will improve glycemic (glucose) control in patients with type 2 diabetes
      mellitus by prolonging the beneficial effects of glucagon-like peptide-1.

      The rising incidence of type 2 diabetes mellitus and the limitations of the currently
      available treatments suggest the need for new therapies for glycemic control. Studies have
      been undertaken in humans that evaluated the effects of directly augmenting glucagon-like
      peptide-1 and glucose-dependent insulinotropic peptide levels and of inhibiting the activity
      of dipeptidyl peptidase IV.

      This study is an extension of 7 controlled phase 3 studies of alogliptin. These phase 3
      studies included 1 monotherapy study of alogliptin (SYR-322-PLC-010; NCT00286455); 4
      placebo-controlled add-on studies of alogliptin, namely in combination with a sulfonylurea
      (SYR-322-SULF-007; NCT00286468), metformin (SYR-322-MET-008; NCT00286442), a
      thiazolidinedione (pioglitazone; SYR-322-TZD-009; NCT00286494), and insulin (SYR-322-INS-011;
      NCT00286429); 1 coadministration study with pioglitazone in combination with metformin
      (01-05-TL-322OPI-001; NCT00328627), and 1 coadministration study with pioglitazone
      (01-06-TL-322OPI-002; NCT00395512).

      The end of treatment or early withdrawal visit from the preceding study will be the screening
      visit for this study, after which enrolled patients will be required to commit to
      approximately 22 additional visits at the study center.
    

Intervention name(s): Alogliptin
Intervention type(s): Drug
Intervention description(s): Alogliptin tablets.
Other intervention name(s): SYR110322; SYR-322
Intervention MeSH terms: Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus,; Lipoatrophic; Dyslipidemia; Drug Therapy
Reconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      Topical steroid use may lead to skin deterioration and spider veins. This study will examine
      long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and
      its effect on skin reconstitution of steroid-damaged skin and disease control.
    


Intervention name(s): Pimecrolimus cream 1%
Intervention type(s): Drug
Intervention description(s): Pimecrolimus cream 1% bid, as needed
Other intervention name(s): ASM981
Intervention MeSH terms: Pimecrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pimecrolimus, skin atrophy, dermoscopy, atopic dermatitis, eczema
Adherence/Outcomes After Use of Constipation Action Plan
Condition: Constipation - Functional
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Adherence to recommendations for treatment of chronic constipation in pediatric population is
      often poor. This study is attempting to improve adherence, and outcomes, by implementing a
      trial of a constipation action plan plus standard of care, compared to standard of care
      alone, in an outpatient pediatric population.
    

Detailed description: 
      Functional Constipation is a common childhood problem. The goal of this study is to evaluate
      if a constipation action plan had any impact on improved adherence in management. Children
      are eligible to participate in the study if they are otherwise healthy children whose primary
      language is English with no conditions that would predispose them to develop constipation,
      between the ages of 3 and 8 years of age and if they meet the ROME IV criteria for functional
      constipation. The primary objective is to assess compliance in pediatric patients with
      functional constipation that have been provided a constipation action plan plus educational
      information. The secondary objectives are to assess improvement of constipation symptoms in
      pediatric patients with functional constipation that have been provided a constipation action
      plan and educational information and to assess the perceived effectiveness of the
      constipation action plan from the viewpoint of the family. The proposed study hypothesizes
      that patients diagnosed with functional constipation will have improved adherence to
      medication treatment plan, to fiber intake, and to toilet sit time and have improved
      constipation symptoms overall when provided with both a constipation action plan and
      educational information regarding dietary changes, toilet sit time, and medications as
      compared to education information alone.
    

Intervention name(s): Constipation Action Plan
Intervention type(s): Other
Intervention description(s): Action plan, adapted from Autism Speaks Network, demonstrating Red, Yellow, and Green levels of symptoms with corresponding steps for treatment or action by parent/guardian, tailored by care provider to the child's condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Control group (standard of care) compared to Intervention group (standard of care plus constipation action plan)
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Action Plan; Adherence; Pediatrics