bioihbjkbjnl/mcl2 huggingface dataset:
XOLAIR (Omalizumab) Outcomes in Pediatric Allergic Asthma Patients in the United States
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      A retrospective database pre-post cohort study, identifying asthmatic patients, aged 6- 11,
      with omalizumab use over 24 months
    

Detailed description: 
      This was a retrospective database pre-post cohort study, identifying asthmatic patients with
      omalizumab use over 24 months. Omalizumab use was analyzed in two categories. First,
      initiators were defined as individuals with ≥ 1 omalizumab claims. "Responders" were defined
      as individuals with at least 4 omalizumab claims. Descriptive statistics are provided for
      both groups, but outcomes are reported only for responders.

      For this study, any persons from the Marketscan database with an asthma diagnosis and >= 1
      omalizumab prescription/administration during the index period were identified. From this
      patient population the inclusion and exclusion criteria were applied, resulting in the final
      study cohort. Each person was assigned an index date based on their initial use of
      omalizumab.

      Study Period: 07/07/2015 - 12/31/2019 Index Period: 07/07/2016 - 12/31/2018 Index Date: The
      date of the first medical or pharmacy claim of omalizumab Baseline Period (pre-index): 12
      months before index date Follow up Period (post-index): 12 months after index date

      The MarketScan® Claims Database (including commercial and Medicaid claims) was used. The
      claims database included data from 07/08/2015 - 12/31/2019. The MarketScan® Databases capture
      personspecific clinical utilization, expenditures, and enrollment across inpatient,
      outpatient, prescription drug, and carve-out services from a selection of large employers,
      health plans, and government and public organizations. The current study used the Commercial,
      Medicare Supplemental and Multi-State Medicaid Databases.
    

Intervention name(s): Omalizumab
Intervention type(s): Drug
Intervention description(s): Omalizumab use was analyzed in two categories. First, initiators were defined as individuals with ≥ 1 omalizumab prescription. "Responders" were defined as individuals with at least 4 administrations of omalizumab.
Intervention MeSH terms: Omalizumab
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        asthmatic patients, aged 6-11, with omalizumab use
      
Keywords: Asthma,; Omalizumab (Xolair),; Asthma Control,; Corticosteroids,; Pediatric,; Children,; Adolescents,; Healthcare Expenditures
BEhavioral EConomics for Oral Health iNnovation Trial
Condition: Toothbrushing; Dental Plaque; Parent-Child Relations; Oral Hygiene; Dental Caries
MeSH terms: Dental Caries; Dental Plaque
Study type: Interventional

Summary: 
      This Phase II stratified randomized prevention trial will assess the efficacy of a behavioral
      economic theory-based financial incentive drawing program versus a control regimen to promote
      early childhood caries (ECC) preventive health behaviors (toothbrushing performance) for
      young children of predominantly Latino parents/caregivers in Early Head Start (EHS) and day
      care center programs.
    


Intervention name(s): Drawing Incentive
Intervention type(s): Behavioral
Intervention description(s): The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible consenting parent-child participant dyads, within strata and permuted blocks, will be randomized in equal allocation to one of two arms. Strata will be based on site and smartphone operating system (iOS or Android).
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Preventive Dentistry; Health Disparities; Health Behavior; Behavioral Economics
tES Effects on Associative Memory Performance
Condition: Healthy; Mild Cognitive Impairment; Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Previous studies showed that transcranial electric stimulation (tES) applied over the
      prefrontal cortex improves cognitive performance in healthy elderly adults as well as in
      patients suffering from mild cognitive impairment or early Alzheimer's disease. Therefore,
      tES methods might be a useful intervention tool for patients suffering from memory impairment
      in early terms of the disease.

      The present study aims at establishing a connection between the stimulation-induced changes
      on associative memory performance and its underlying neurophysiological parameters. tES
      effects and their underlying mechanisms will be compared between healthy elderly controls and
      clinical study populations receiving either real or sham tES over the left ventrolateral
      prefrontal cortex during an associative memory task.
    


Intervention name(s): real anodal transcranial direct current stimulation; real transcranial alternating current stimulation; sham transcranial electric current stimulation
Intervention type(s): Device; Device; Device
Intervention description(s): The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used.; The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used.; The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
UARK 2003-33, Total Therapy III
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma
Study type: Interventional
Phase: Phase 2

Summary: 
      There have been two previous Total Therapy studies for multiple myeloma (MM) at the Myeloma
      Institute for Research and Therapy (MIRT): Total Therapy I (from 1989 through 1994) and Total
      Therapy II (from 1996 to 2004). Results have shown that patients treated on these studies had
      better outcomes (meaning patients have lived longer and had better responses to treatment)
      when compared to patients treated with standard chemotherapy.

      With this new study, Total Therapy III, researchers will take what they have learned from the
      first two studies and add new treatment strategies to try to improve the outcomes even more,
      especially for patients with chromosome abnormalities.
    

Detailed description: 
      1.1 To determine, in a historical comparison with TT II (Thalidomide arm), whether two cycles
      of VDTPACE induction (instead of four induction cycles in TT II) followed by more timely MEL
      200-based transplant with DEX + THAL between transplants can:

      1.1.1 Increase the CR frequency from 50% to 60% at 18 months from initiation of therapy;

      1.1.2 Increase > n-CR rate pre-transplant #1 from 20% to 40%;

      1.1.3 Raise 2-year EFS rates from 55% to 75% in patients with CA and from 80% to 95%, in
      patients without CA.
    

Intervention name(s): Velcade; Thalidomide
Intervention type(s): Drug; Drug
Intervention description(s): Two cycles of induction on days 1,4,8,11 at 1.0mg/m^2. Two cycles of consolidation on days 1,4,8,11 at 1.0mg/m^2. Maintenance year one 1.0mg/m^2 1,4,8,11 q 28 days.; Two cycles of VDTPACE 200mg thal days 4-7(cycle 1)and days 1-4 cycle 2 interim Thal 50mg qd between VTDPACE cycles and between cycle 2 and transplant. Thal 100mg between transplants d/c 7 days prior to each transplant. Consolidation therapy cycles 3 and 4 VDTPACE 200mg days 1-4 both cycles. Interim maintenance to maintenance 100mg qd. Maintenance year 1 thal 100mg qd. Maintenance years 2 and 3 Thal 100mg qd.
Intervention MeSH terms: Thalidomide; Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Integrative Psychosocial Group Treatment
Condition: Chronic Pain; Opioid Misuse
MeSH terms: Chronic Pain; Opioid-Related Disorders
Study type: Interventional

Summary: 
      A fundamental challenge for healthcare is to achieve a balance between decreasing the misuse
      of opioids and associated harms while optimizing patient care, including the provision of
      multidisciplinary treatments for chronic pain. However, despite recommendations that
      non-pharmacological interventions are rudimentary in the management of chronic pain, the
      literature describing which psychosocial interventions are best practice is nearly
      non-existent. Most of the psychosocial treatments that target either CNCP or opioid misuse
      are very general and broad-based therapies. However, there is a lack of evidence-informed
      direction guiding which psychosocial treatments should be adapted to this specialized
      population and thus, further research is needed.
    

Detailed description: 
      This project is a pilot randomized controlled trial (RCT) of an Integrated Psychosocial Group
      Treatment (IPGT) in patients with chronic pain who are at risk for opioid misuse. IPGT is a
      comprehensive approach that blends evidenced-based psychosocial treatments for chronic pain
      and opioid misuse and addresses each issue individually, but also the interconnections
      between the overlapping problems. IPGT consists of 6 weekly group sessions of motivational
      interviewing and behavioral change, self-management, and pain education focused on
      appropriate adherence to treatment and resisting urges to misuse prescription medications.
      The intervention also entails an education session on knowledge pertaining to overdose and
      naloxone distribution. This study will involve the randomization of 40 patients to receive
      either: (1) treatment as usual (TAU; n=20); or (2) integrated psychosocial group intervention
      (IPGT; n=20). This study will: (1) establish feasibility; (2) demonstrate acceptability; and
      (3) demonstrate preliminary efficacy for an integrated psychosocial group treatment model for
      patients with chronic pain who are at risk of opioid misuse. The data generated from this
      study will also serve as a foundation for future implementation to support a subsequent
      fully-powered RCT.
    

Intervention name(s): IPGT; Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral Intervention for Patients with Chronic Pain; Standard Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Behavioral Intervention; Medication Adherence; Psychosocial Treatment
Gestational Metabolic Abnormalities and Maternal and Infant Nutrition and Health
Condition: Gestational Diabetes; Hyperglycemia; Insulin Resistance; Obesity
MeSH terms: Diabetes, Gestational; Insulin Resistance; Hyperglycemia
Study type: Observational

Summary: 
      Childhood obesity is on the rise and is a major risk factor for type 2 diabetes later in
      life. Recent evidence indicates that abnormalities that increase risk for diabetes may be
      initiated early in infancy. Since the offspring of women with diabetes have an increased
      long-term risk for obesity and type 2 diabetes, the impact of maternal metabolic
      abnormalities on early nutrition and infant metabolic trajectories is of considerable
      interest. The purpose of the study is to investigate the impact of maternal nutrition and
      metabolic abnormalities in pregnancy on human milk and subsequently on infant health over the
      first year of life.
    

Detailed description: 
      The current investigation is a prospective study conducted within ongoing cohort studies of
      women and their offspring. Pregnant women attending outpatient obstetrics clinics in Toronto,
      Canada are recruited. The overall study protocol includes four study visits between the
      second half of pregnancy and the first year of infant's life and interim phone call
      interviews:

        -  Pregnant women undergo an oral glucose tolerance test at an expected average of 30 weeks
           of gestation and complete medical and lifestyle questionnaires including food frequency
           questionnaires.

        -  Infant birth anthropometry measurements and human milk samples are collected at an
           expected average of 3 days postpartum. The timing of onset of lactogenesis II is asked
           at 3d, 5d, 7d postpartum or until the event occurrence up to day 7.

        -  At 3 months postpartum, follow-up assessments including infant anthropometry, medical
           and lifestyle questionnaires and human milk sample collection are completed.

        -  Interim telephone interviews are conducted at 6 weeks and 5, 7, 9 months postpartum to
           characterize infant feeding and supplementation behaviors.

        -  At 12 months postpartum, infant anthropometric assessments are conducted.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women are recruited in outpatient clinic waiting areas at Mount Sinai Hospital in
        Toronto, Canada, a large tertiary care centre.
      
Keywords: Gestational Diabetes; Gestational Hyperglycemia; Gestational Insulinemia; Maternal Obesity; Human Milk; Lactogenesis; Obstetrics; Nutrition; Infant Growth
Molecular Imaging of Epidermal Growth Factor Receptor in Colorectal Neoplasia Using Confocal Laser Endomicroscopy
Condition: Colorectal Cancer; Colorectal Adenoma
MeSH terms: Adenoma; Neoplasms
Study type: Observational

Summary: 
      The study aims to:

        1. Achieve molecular imaging of EGFR in patients with colorectal neoplasia in vivo using
           confocal laser endomicroscopy.

        2. Compare the results of in vivo EGFR-specific molecular imaging with CLE and ex vivo
           immunohistochemistry .
    

Detailed description: 
      Various kinds of tumor markers have been shown to be over-expressed in colorectal cancer,
      including epidermal growth factor receptor(EGFR). The conventional detection method of EGFR
      expression in colorectal neoplasia is immunohistochemistry which is time-consuming, and the
      immunoreactivity can be affected by storage and fixation of tissues. Confocal laser
      endomicrosopy is a newly developed device which could identify the cellular and subcellular
      structures clearly with the magnification at×1000, making it possible to explore the
      physiological and pathological molecular mechanism of the gastrointestinal tract. So the
      study aims to achieve molecular imaging of EGFR in colorectal neoplasia in vivo using
      confocal laser endomicroscopy.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients known to have large polypoid lesions in colon or rectum from previous examinations
        from outpatients and inpatients at Qilu Hospital were enrolled into the study
      
Biospecimen description: 
      Take biospecimen during colonoscopy.
    
Keywords: molecular imaging; epidermal growth factor receptor; colorectal neoplasia; confocal laser endomicroscopy
Comparison of Different Umbilical Port Entry Techniques in Terms of Cosmetic Results
Condition: Cicatrix
MeSH terms: Cicatrix
Study type: Interventional

Summary: 
      Investigators selected participants who operated by laparoscopic technique due to any
      gynecologic indication according to random number table. The ten mm trocar was inserted
      supraumbilical, infraumbilical and intraumbilical. The verres needle was not used in all of
      patients. One month after we evaluated umbilical scar by used vancouver scar scale and
      compared results of vancouver scar scale.
    


Intervention name(s): Ten mm trocar
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Long Term Follow-Up Study of Immuncell-LC Group and Non-Treatment Group in Hepatocellular Carcinoma Patients.
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational [Patient Registry]

Summary: 
      To observation that long term follow-up study of 'Immuncell-LC groups' and 'Non-treatment
      groups' in patient undergo curative resection (PEIT, RFA or Operation) for hepatocellular
      carcinoma in Korea
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This long term follow-UP study is observation about the Immuncell-LC Groups' and
        'Non-treatment Groups' in patient undergo curative resection (PEIT, RFA or Operation) for
        Hepatocelluar Carcinoma in Korea.
      
Keywords: Immuncell-LC, Hepatocellular carcinoma
Highlighting the Benefits of a Screening Protocol Delivered by Orthoptists to Identify Visual Impairment in Children Aged 3 to 4
Condition: Visual Impairment in Children
MeSH terms: Vision Disorders; Vision, Low
Study type: Observational

Summary: 
      Visual developmental abnormalities affect 10 to 15% of the population under 6 years of age
      and leads to amblyopia in 30% of cases if left untreated. Untreated amblyopia in adulthood
      has consequences on the quality of life of individuals but will also represent a cost to
      society due to the increased risk of visual impairment.

      The screening protocol for this study recommends that a screening examination for amblyopia
      and amblyogenic factors be routinely performed by an orthoptist in children between 3 and 4
      year old. This examination should include, as a minimum, a standardised measurement of visual
      acuity, a cover test and a measurement of refraction by photoscreener. In the event of a
      positive screening, the child must then be referred to an ophthalmologist so as to complete
      an ophthalmological examination.

      The aim of this protocol is to propose screening tests usually performed with a high
      specificity, in order to avoid congestion of ophthalmological services (i.e. by avoiding
      excessive or unnecessary referral of children to the ophthalmologist) without losing
      sensitivity by combining several tests.

      The orthoptists' role in this screening protocol is to facilitate an extensive screening
      coverage of the population in this age group, as they are more easily accessed by the
      patients and more equitably spread in the community than ophthalmologists.

      Therefore, by initially screening and then referring less children to the ophthalmologist,
      the aim is to reduce waiting times in the access of ophthalmological services which could be
      detrimental in terms of treatment success rates for patients acutely needing care.

      Based on the referral of children between 3 and 4 years of age by the orthoptist to an
      ophthalmologist, the analysis of the data from the standard screening protocol used in our
      centre will enable us to validate it scientifically. The referral thresholds can thus be
      secondarily adjusted for each test if the initial objectives are not achieved (specificity >
      90% and sensitivity > 87%). The aim of this study is also to observe a change in the patient
      flow by reducing the volume of consultations with the ophthalmologist currently required
      based on the present referral rate. The efficiency of the screening protocol by calculating
      the probable economic gain linked to the modification of the screening circuit will be
      secondarily studying in this protocol
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children from 3 to 4 years old, girls or boys, with a medical reason for consultation
        (paediatric orientation) or parent's request (child's complaint)
Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects
Condition: Pharmacokinetics; Cytochrome P-450 CYP2D6; CYP3A4 Protein, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine
      Sustained Release (SR) on the pharmacokinetics of Aripiprazole when coadministered to healthy
      adult subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine
      SR and Aripiprazole when coadministered to healthy adult subjects.
    


Intervention name(s): Aripiprazole; Aripiprazole + desvenlafaxine succinate sustained release
Intervention type(s): Drug; Drug
Intervention description(s): Period 1-Aripiprazole 5mg on study day 1.; Period 2-Desvenlafaxine SR 100mg on days 1-19 with coadministration of Aripiprazole 5mg on day 7.
Other intervention name(s): DVS-233; Pristiq
Intervention MeSH terms: Aripiprazole; Desvenlafaxine Succinate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetic; safety and tolerability; genetic testing; CYP 2D6 and CYP 3A4
Evaluation of the Stinging Potential of Sunscreen Products in Human Eyes
Condition: Sunscreen Agents
Study type: Interventional

Summary: 
      The objective of this study was to compare the human eye stinging potential of experimental
      formulas and an industry standard shampoo mixture. The study was conducted under the
      supervision of a Board Certified Ophthalmologist.
    


Intervention name(s): BAY98751 (Y65-110); BAY 98751 (Y65-102); BAY 98751 (Y65-106); Standard shampoo mixture (Control)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 µL in one eye; 10 µL in one eye; 10 µL in one eye; 10 µL in other eye
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Ultrasound-guided Inguinal Field Block (Genitofemoral, Iliohypogastric and Ilioinguinal Nerve Block) for Inguinal Hernia Surgery
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the analgesic efficacy of an ultrasound-guided
      inguinal field block (block of the genitofemoral, iliohypogastric and ilioinguinal nerve).
    

Detailed description: 
      Inguinal hernia repair accounts for 10-15% of all operations in general surgery. Moderate to
      severe pain can occur at the first day after inguinal hernia repair in 25% of patients at
      rest and in 60% during activity. On day 6 after the operation the incidence can be as high as
      11% at rest and 33% during activity.

      Ultrasound imaging for regional anesthesia techniques have improved the success and safety
      rate of nerve blocks. We hypothesized that a procedure consisting of an ultrasound-guided
      inguinal field block (genitofemoral, iliohypogastric and ilioinguinal nerve block and
      incision line infiltration) could effectively control postoperative pain compared to
      selective unilateral subarachnoid anesthesia.
    

Intervention name(s): Triple inguinal nerve block.; Unilateral subarachnoid anesthesia
Intervention type(s): Other; Other
Intervention description(s): Ultrasound-guided genitofemoral, iliohypogastric and ilioinguinal nerve block with ropivacaine 5 mg/ml, 150 mg.; Subarachnoid anesthesia with hyperbaric bupivacaine 10 mg/ml, 12 mg, homolateral to inguinal hernia.
Other intervention name(s): Regional anesthesia for the groin.; Regional anesthesia for the groin.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment