bioihbjkbjnl/mcl2 huggingface dataset:
Hearing Screening Outcomes of Two Screening Tests in Newborns of Gestational Diabetic Mothers
Condition: Gestational Diabetes; Hearing Loss
MeSH terms: Hearing Loss; Deafness; Diabetes, Gestational
Study type: Observational

Summary: 
      In this study, the investigators have aimed to investigate whether GDM is a risk factor for
      hearing impairment in newborns. To the investigators knowledge, this study is the first
      prospective, controlled study on this subject.
    

Detailed description: 
      Gestational diabetes mellitus (GDM) is an increasingly frequent condition in the world
      causing significant morbidity and mortality. GDM is a metabolic disease that develops in
      pregnancy, and may result in complications in the pregnant women, similar to other patients
      with diabetes. The prevalence of GDM varies in relation with the population and the
      diagnostic criteria. Diabetes affects 6-9% of pregnant women; 99% of the cases have GDM, and
      diabetes is diagnosed before pregnancy in the remaining 1% [(pre-gestational diabetes
      mellitus (pre-GDM)]. Hearing loss is one of the most common birth defect in newborns. The
      incidence of congenital hearing impairment is 2-3 per 1000 births. Early diagnosis and
      treatment is very important for the development of auditory pathways and protection of
      cognitive functions. Therefore, newborn hearing screening programs have been in use in a
      number of countries. Transient evoked otoacoustic emissions (TEOAE) and auditory brainstem
      response (ABR) have been identified as basic convenient and applicable tools for neonatal
      screening of hearing.

      Suboptimal glycemic control during pregnancy has adverse fetal effects. Congenital
      malformations, preterm birth and neonatal respiratory distress in the newborn are more
      common, at varying rates, pre-GDM and GDM. Compared to the normal population, the risk of
      congenital malformations is 1.9-10 fold higher in presence of pre-GDM, and 1.1-1.3 fold
      higher in presence of GDM. Despite our awareness on these important complications, the effect
      of intrauterine hyperglycemia on hearing of the newborn has not yet been studied in detail.
      Diabetes mellitus (DM) often causes hearing impairment, however little is known whether GDM
      is an antenatal risk factor for cochlear damage and hearing loss.
    

Intervention name(s): Hearing screening tests
Intervention type(s): Diagnostic Test
Intervention description(s): Our study was conducted in accordance with the National Hearing Screening Test Protocol. The newborns had transient evoked otoacoustic emissions (TEOAE) with "click" stimulus as a hearing screening test in the first three days after birth, using Otometrics Madsen Accuscreen S/N: 36484 (USA) device.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women with gestational diabetes and women without diabetic pregnancy
      
Keywords: Gestational diabetes; Hearing loss; Newborns
Cartoon Distraction and Parental Presence on Anxiety in Pediatric Anesthesia
Condition: Anxiety, Separation; Psychomotor Agitation
MeSH terms: Psychomotor Agitation; Anxiety Disorders; Anxiety, Separation
Study type: Interventional

Summary: 
      Nearly 50% of young children undergoing surgery exhibit high level of anxiety during
      induction of anesthesia because of exposure to unfamiliar environment and people and
      separation from parents. Increased preoperative anxiety may impact postoperative behavior
      changes such as emergence agitation, separation anxiety and sleep disturbance. Although some
      pediatric anesthesiologists routinely permit parental presence to reduce the anxiety during
      induction of anesthesia, previous studies have reported conflicting results. Recently the
      distraction using video game or animated cartoon has been reported to reduce anxiety of young
      children during induction of anesthesia. However, it was still undetermined whether
      distraction has its own ability to reduce children's anxiety separated from parental presence
      because they evaluated the effect of video method in the parental presence. The investigators
      design to investigated the efficacy of distraction with watching cartoon, parental presence
      and combined with watching cartoon and parental presence on reduction of anxiety during
      inhalational induction of anesthesia using sevoflurane. In addition this study includes
      long-term effect of each intervention such as postoperative emergence agitation and
      postoperative behavior change in children.
    

Detailed description: 
      This study is different from previous reports as follow. First, investigators separate the
      effect of cartoon distraction and parental presence on minimizing preoperative anxiety and
      determine whether an interaction between two different interventions is existent. Second,
      investigators evaluate the effect of preoperative anxiety on the long-term behavioral change
      of children. It was not clarified yet in clinical practice. Third, investigators evaluate the
      effect of each intervention on parental anxiety before and after induction of anesthesia.
    

Intervention name(s): Cartoon; parental presence
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cartoon watching by children during inhalational induction of sevoflurane; parental presence during inhalational induction of sevoflurane
Other intervention name(s): Cartoon watching by children
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics and Pharmacodynamics of FOR-6219
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, double-blind, placebo-controlled, Phase I/Ib study which will assess
      the safety, tolerability, food effect, pharmacokinetics and pharmacodynamics of FOR-6219, a
      hydroxysteroid (17B) dehydrogenase (HSD17B1) inhibitor. The study will be performed in three
      parts: (I) Single ascending doses (SAD) in healthy post-menopausal women; (II) multiple
      ascending doses (MAD) in post-menopausal women; (III) multiple ascending doses in healthy
      pre-menopausal women.
    


Intervention name(s): Placebo; FOR-6219
Intervention type(s): Drug; Drug
Intervention description(s): Placebo capsule to match active drug; FOR-6219 capsule
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hydroxysteroid (17B) dehydrogenase; HSD17B1
A Study on Patients With Chronic Kidney Disease (CKD) to Assess Treatment Experience and Patterns, Effect of the Treatment, Patient Outcomes and Patient Quality of Life
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      DISCOVER CKD is an international observational cohort study in patients with CKD, comprising
      both prospective and retrospective patient cohorts. The study does not attempt to test any
      specific a priori hypotheses, is largely descriptive, and utilises data collected only under
      conditions of routine clinical care.
    

Detailed description: 
      DISCOVER CKD is an international observational cohort study in CKD patients, comprising both
      prospective and retrospective patient cohorts. The study does not attempt to test any
      specific a priori hypotheses, is largely descriptive, and utilises data collected only under
      conditions of routine clinical care. No additional invasive clinical tests or procedures are
      mandated per study protocol, and all data collected/extracted is based solely on observations
      of disease management and treatment decisions made between the treating physicians and their
      patients, and is not intended to be interventional in anyway. Patients will not receive any
      experimental intervention or experimental treatment as a result of participating in this
      study. Analyses will be conducted separately for prospective and retrospective CKD cohorts
      (via interim reports), and then in aggregate by combining prospective and retrospective data,
      to the extent possible, at the end of the study.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        For prospective (primary and secondary) data collection/extraction, all individuals with
        CKD fulfilling the inclusion criteria but none of the exclusion criteria will be
        considered; attempts will be made to enrich the data collection/extraction of patient
        samples by ensuring sufficient numbers of each CKD stage with comorbidities including
        diabetes mellitus, heart failure, coronary artery disease, etc.

        For retrospective (secondary) data extraction, all individuals with CKD fulfilling the
        inclusion criteria and who have at least 1-year of medical history (within the selected
        registry, EHR, or database) prior to baseline (index) date will be considered.
      
Keywords: Observational study; Real-world data; Prospective and retrospective data capture; DISCOVER CKD
Comparison of Delivery Routes of Flu Vaccine in Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This protocol is to compare the immune response of different influenza vaccines given by two
      different routes of administration in healthy adults ages 18 to 64 years.
    

Detailed description: 
      This is a multi-center, randomized, partially blinded trial to compare the safety and
      immunogenicity of intramuscularly versus intradermally administered influenza vaccine in
      healthy 18-64 year old adults. Subjects will have blood drawn immediately prior to and
      approximately three to four weeks after vaccination. After the completion of the trial, all
      subjects will be offered influenza vaccine of the 2005-2006 formulation.
    

Intervention name(s): Trivalent inactivated influenza vaccine; Trivalent inactivated influenza vaccine; Trivalent inactivated influenza vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain.. Group 4: 382 subjects receive Fluzone 15 mcg IM on day 0; A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Group 1: 382 subjects receive 6 mcg ID with BD system. Group 2: 382 subjects receive 9 mcg ID with BD system, all doses on day 0.; A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain..Group 3: 382 subjects receive 3 mcg Fluzone ID using Mantoux technique on day 0.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: inactivated, trivalent, influenza, vaccine, Fluzone
TIP (Paclitaxel + Ifosfamide + Cisplatin) Combined With Nimotuzumab & Triprilimab as Neoadjuvant Treatment in Locally Advanced Penile Cancer
Condition: Penile Cancer
MeSH terms: Penile Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:To evaluate the efficacy and safety of TIP (paclitaxel + ifosfamide +
      cisplatin) combined with nimotuzumab & triprilimab as neoadjuvant treatment in locally
      advanced penile cancer.
    

Detailed description: 
      Penile cancer is a rare malignant tumor, which often occurs in the inner plate of prepuce and
      glans. Squamous cell carcinoma is the most common pathological type. Lymph node metastasis is
      a crucial factor that leads to poor prognosis of penile cancer. The 5-year OS of penile
      cancer patients without lymph node metastasis is 90%. Still, it goes down sharply in patients
      with inguinal lymph node metastasis and pelvic lymph node metastasis, which is 50% and 0%,
      respectively.

      Using neoadjuvant chemotherapy to treat patients with locally advanced penile cancer (T4, any
      N stage, or any T stage, N3) may improve their prognosis. TIP (Paclitaxel + Ifosfamide +
      Cisplatin) regimen is the first line neoadjuvant treatment recommended by NCCN guidelines.
      Epidermal growth factor receptor (EGFR) plays a vital role in the development of penile
      cancer. It's also an important therapeutic target for penile cancer. PD-1 is an immune
      checkpoint molecule on the surface of T cells. In recent years, immune-checkpoint inhibitors
      targeting PD-1 have shown good efficacy in a variety of tumors. Some phase II / III clinical
      trials have shown that PD-1 inhibitors can improve the prognosis of patients with lung
      squamous cell carcinoma, head and neck squamous cell carcinoma and cervical cancer. Previous
      studies have found that PD-L1 is highly expressed in 40% - 60% of penile cancer, suggesting
      that penile cancer patients may benefit from immunotherapy.

      The management of penile cancer with lymph node metastasis is difficult, especially for N2-3
      stage. This phase II study aim to explore an effective combination therapy for locally
      advanced penile cancer. 29 patients need to be enrolled.TIP & nimotuzumab & triprilimab will
      be administered per 21-day until surgery, evidence of disease progression or onset of
      unacceptable toxicity.
    

Intervention name(s): Albumin-Bound Paclitaxel; Ifosfamide; Cisplatin; Nimotuzumab; Triprilimab
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 260 mg/m² IV over 30 minutes on Day 1; 1200 mg/m² IV over 2 hours on Days 1-3; 25 mg/m² IV over 2 hours on Days 1-3; 400 mg IV on Day 1; 240 mg IV on Day 1
Intervention MeSH terms: Paclitaxel; Ifosfamide; Albumin-Bound Paclitaxel; Nimotuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Ectoin Dermatitis Cream 7% on Skin Hydration and Skin Barrier Function
Condition: Atopic Dermatitis Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      The aim of this prospective, uncontrolled clinical study is to evaluate the clinical effect
      of Ectoin® Dermatitis Cream-EHK02 on skin hydration and transepidermal water loss (TEWL) in
      subjects with atopic dermatitis after single and multiple applications. Furthermore, data
      concerning the subjective impression of the study preparation should be collected.
    

Detailed description: 
      The principle mode of Ectoin is based on the physical interaction of this compatible solute
      with water. Ectoin® Dermatitis Cream 7% (EHK02) is able to build an Ectoin® Hydro Complex on
      the skin providing an effective protection against external stress factors, stabilizing the
      skin barrier and moisturizing the dry skin. In former studies, it has been shown that it can
      be used for the symptomatic treatment of atopic dermatitis. This study should confirm the
      efficacy and safety of EHK02.
    

Intervention name(s): Ectoin Dermatitis Cream 7% (EHK02)
Intervention type(s): Other
Intervention description(s): Application of Ectoin Dermatitis Cream in accordance with the instructions for use
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals diagnosed with atopic dermatitis without flare up (in eczema free interval).
      
Keywords: Ectoin; Ectoin Dermatitis Cream; Atopic dermatitis
Investigate the Effect of Neramexane Mesylate IR Tablet on Driving Fitness and Capability to Operate Machines in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Determination of the ability to drive and operate machines after single and multiple oral
      dose of Neramexane as compared to placebo
    


Intervention name(s): Neramexane mesylate
Intervention type(s): Drug
Intervention description(s): tablets Group A: duration: 12,5 mg for 7 days and 25 mg for 8 days Group B: duration: 25 mg for 7 days and 50 mg for 8 days Group C: duration: 50 mg for 7 days and 75 mg for 8 days Group D: duration: placebo for 15 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: fitness to drive; operate machines; To determine the fitness to drive and operate machines.
Study Conducted Among Patients With CML
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Observational

Summary: 
      Retrospective, non-interventional observational cohort study conducted among patients with
      CML.
    

Detailed description: 
      A retrospective, non-interventional cohort study was used to address the study objectives. A
      cohort of adult patients with CML who were treated with TKIs were identified using the IBM®
      MarketScan® Commercial and Medicare Supplemental databases (commercial claims; the MarketScan
      database) to have a better understanding of real-world treatment patterns, HRU and healthcare
      costs among patients with CML treated with later lines of therapy (i.e., third line or
      later).

      For Phase I, the IBM® MarketScan® Commercial Claims and Encounters and Medicare Supplemental
      Databases were used (commercial claims). The commercial claims covered the period from
      01/01/2001 to 06/30/2019.

      The study consisted of the following periods:

        -  The baseline period was defined as the 6-month period before the first line therapy
           initiation for CML.

        -  The observation period was defined as the period of at least 12 months from the first
           CML diagnosis to the end of data availability or end of health plan coverage, whichever
           occurs first; the observation period varied by patient.
    

Intervention name(s): Tyrosine Kinase Inhibitors (TKIs)
Intervention type(s): Other
Intervention description(s): The study included patients with CML who were previously treated with TKIs, who are relapsed/refractory to/intolerant of TKIs on third or later lines of therapy in the US.
Intervention MeSH terms: Tyrosine Protein Kinase Inhibitors
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study was conducted among patients with CML.
      
Keywords: Chronic myeloid leukemia,; tyrosine kinase inhibitors,; treatment patterns,; HRU,; costs
Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to investigate the efficacy of neuroscience-guided computerized
      cognitive training exercises on the remediation of cognitive deficits and symptoms associated
      with recent-onset schizophrenia and to examine the influence of subject characteristics,
      brain structure and function, and pharmacotherapy on the response to remediation.
    

Detailed description: 
      Participation in this study will last approximately 12 months and will involve individuals
      with recent-onset schizophrenia. All participants will undergo baseline assessments that will
      include an interview, written tests, blood draws, and electroencephalogram (EEG) and magnetic
      resonance imaging (MRI) scans. Participants will then be assigned randomly to receive
      treatment with either computerized neuroadaptive cognitive training or commercially available
      computer games. Participants will be asked to complete 60-minute sessions of their assigned
      treatments 5 days per week for 8 weeks. For participants receiving cognitive training,
      exercises will focus on improving speed and accuracy in the perception of and response to
      verbal and visuospatial targets. The 8 weeks of treatment will focus on targeted cognitive
      training (TCT). Participants assigned to practice computer games will play standard
      commercially available games, with no targeted response.

      Participants will repeat baseline assessments after the computer training and Month 6 of
      follow-up. The EEG and MRI will be repeated only at post training assessment visit. There
      will be a blood draw at Week 2 of treatment as well. After the Month 6 assessment,
      participants in the control condition will be offered an opportunity to complete an
      additional 8 weeks of computer training with different modules.
    

Intervention name(s): Neuroadaptive cognitive training; Computer games
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Neuroadaptive cognitive training includes cognitive remediation exercises that participants will practice 1 hour per day, 5 days per week, for 8 weeks. The exercises are specifically designed to improve speed and accuracy in the perception of and response to verbal targets. The treatment will focus on TCT.; The control treatment involves commercially available computer games that participants will practice 1 hour per day, 5 days per week, for 16 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Psychosis; First Episode; Schizophrenia; Cognitive Remediation