bioihbjkbjnl/mcl2 huggingface dataset:
Transcutaneous Bilirubinometers in the Community
Condition: Jaundice, Neonatal
MeSH terms: Jaundice, Neonatal; Jaundice
Study type: Interventional

Summary: 
      Jaundice is the most frequent reason for readmission for healthy newborns after discharge
      from the nursery. In the Capital Health area, around 2.5% (315 babies in 2005) of all healthy
      newborns were admitted to the hospital for jaundice. Although jaundice is very common, it is
      not always a benign condition. If left untreated, it can have devastating consequences
      including cerebral palsy and hearing loss. It is therefore critical to be able to identify
      the newborns at risk for severe jaundice. So far, heel puncture of blood collection has been
      the traditional method to monitor jaundice in newborns. This causes pain to infants,
      generates anxiety in parents, and consumes significant health care resources. The aim of this
      study is to evaluate the efficacy of a new and noninvasive screening tool, the transcutaneous
      bilirubinometer, in detecting babies in our communities who require hospital readmission.
      This study will demonstrate whether incorporating transcutaneous bilirubinometer in the home
      care program delivered by nurses of Healthy Beginning allows the early detection of babies at
      risk of developing severe jaundice at a lower cost and with less discomfort.
    


Intervention name(s): Transcutaneous Bilirubinometer
Intervention type(s): Device
Intervention description(s): For all eligible babies living in the 7 intervention community health centers, a Transcutaneous Bilirubinometer will be routinely used by all community nurses in conjunction with an algorithm that will guide the nursing management of the neonates based on the values obtained
Other intervention name(s): Minolta/Drager Air Shields JM-103 Jaundice Meter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Neonatal Jaundice; Physiological Neonatal Jaundice; Neonatal Hyperbilirubinemia; Transcutaneous Bilirubinometer
Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      The goal of this study is to gather input from patients who have undergone PCI, their family
      and/or caregivers, and clinicians to develop a patient decision aid. The purpose of the
      decision aid is to deliver information, including individualized estimates of patients'
      restenosis risk, in an understandable format that would be informative and assist in
      decision-making for patients undergoing PCI.
    

Detailed description: 
      Study Plan: Qualitative research methods (focus groups) will be used to gather the
      information that would be helpful in decision making as well as review several possible
      output formats. Several sets of focus groups will be convened, with particular attention to
      recruitment of a diverse population, including women and underserved minority groups.

      Study Procedure: We will gather input to create a clinically useful format for presenting the
      risk estimates for desired outcomes and support clinical decision-making.

      Subjects: We anticipate 2 or 3 patient focus groups of 6-8 individuals and 2 clinician focus
      groups of 3-5 individuals will be scheduled. Fliers will be posted to enlist potential
      patients. If necessary, patients will also be contacted by a Cardiovascular Research
      Coordinator and invited to attend a scheduled focus group. After receiving
      patient/family/caregiver input, selected clinicians from the Saint Lukes Hospital Staff,
      including cardiologists, cardiac nurses and other cardiology staff, will be invited to attend
      a scheduled focus group. The invitation will be sent via email and followed up with a phone
      call, if necessary. If a clinician focus group is unable to be scheduled, then individual
      interviews will be conducted.

      Setting: Patient and Clinician focus group sessions will be held at Saint Luke's Hospital.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Adults with and without coronary artery disease
      
Keywords: coronary artery disease; cardiac stent; PCI procedure; Patient preference
Physical Activity and Nutrition Intervention in Afterschool Programs
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The investigators long-term goal is to advance the adoption and successful implementation of
      policies that promote PA and nutrition in after school programs (ASP) nationwide. The
      investigators objective here is two fold. First, the investigators will test the
      effectiveness of two promising strategies designed to 1) increase the amount of PA children
      accumulate while attending an ASP and 2) promote changes in the nutritional quality of the
      snacks served. This represents a fundamental step in establishing practice-based guidelines
      (best practices) for the uptake and achievement of public health policy goals (CA and
      Harvard). Second, the investigators will examine the barriers and facilitators to
      implementing these strategies. The expected outcome of this study is evidence supporting best
      practices for ASPs to employ to meet policy goals.
    

Detailed description: 
      The investigators will use a 3-year delayed treatment, cluster randomized controlled trial
      design with 20 ASPs that serve mostly low-income and minority children (approximately 1300
      children ages 6-12yrs) in Columbia, SC and address the following specific aims: Aim 1.
      Evaluate the impact of a staff-level intervention, a professional development training
      program focused on core competencies to promote physical activity, on children's physical
      activity levels; Aim 2. Evaluate the impact of a site-level intervention, a snack
      modification program that includes a discount buying program, on the quality of snacks served
      and consumed; and Aim 3. Evaluate the implementation of the staff-level and site-level
      interventions and identify organizational, staff, and setting characteristics that influence
      the process of implementing these strategies.
    

Intervention name(s): Healthy Eating and Physical Activity
Intervention type(s): Behavioral
Intervention description(s): Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards.
Other intervention name(s): HEPA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions
Condition: Intrauterine Adhesion
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      The aim of present study is to evaluate the effect of the use of platelet rich plasma in
      decreasing recurrence of intrauterine adhesions after its lysis.
    

Detailed description: 
      Research question:

      In women undergoing hysteroscopic adhesiolysis, does postoperative use of platelet rich
      plasma decrease the recurrence of intrauterine adhesions?

      Research hypothesis:

      In women undergoing hysteroscopic adhesiolysis for Asherman's syndrome, postoperative use of
      platelet rich plasma may decrease the recurrence of intrauterine adhesions.
    

Intervention name(s): Platelet Rich Plasma; Intrauterine Foley's Catheter
Intervention type(s): Biological; Device
Intervention description(s): After hysteroscopic adhesiolysis, 30 patients will undergo once injection of 5ml PRP into the wall then lining the uterine cavity by 5ml platelet rich plasma gel. Finally, Foley balloon catheter will be inserted intrauterine then inflated and cutting its stem and to be left for two weeks.; After hysteroscopic adhesiolysis, 30 patients will undergo intrauterine insertion of one inflated Foley balloon catheter with cutting its stem only to be left for two weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Tadalafil for the Treatment of Raynaud's
Condition: Raynaud
MeSH terms: Raynaud Disease
Study type: Interventional

Summary: 
      The investigators propose that tadalafil will increase digital blood flow and improve the
      symptoms and signs of secondary Raynaud's phenomenon.
    

Detailed description: 
      The primary goal of our study is to decrease the frequency, duration and severity of
      vasospastic attacks in patients with secondary Raynaud's. The secondary goal is to document
      increased blood flow and lessened capillary dysfunction in these patients. Both of these
      goals are to be achieved using a course of treatment with Tadalafil.We anticipate a decrease
      in the frequency, duration and severity of Raynaud's attacks. Improved digital blood flow and
      digital blood pressures, and a decrease in digital capillary dysfunction.
    

Intervention name(s): Tadalafil
Intervention type(s): Drug
Intervention description(s): Subjects will be randomized to receive either tadalafil for the first month followed by placebo or placebo for the first month and followed by tadalafil
Other intervention name(s): Cialis
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Secondary Raynaud's Phenomenon
A Multicenter Study for Pre-Surgical Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the safety and initial efficacy of the EndoBarrier
      device compared to a diet control in patients who require weight loss prior to their
      Bariatric surgery.

      It is a randomized, prospective controlled, open label, pilot study of 40 patients. Thiry
      patients will receive an implant of the EndoBarrier device and the other 10 patients will
      receive the principle investigator's standard of care diet program. All patients will be
      treated for 12 weeks with the exception of the last 10 device patients who will continue to
      24 weeks if the principle investigator determines that it is safe and in their best interest
      to continue.

      The primary efficacy endpoint is:

        -  Assessment of the difference in % excess weight loss between the 2 groups

      Secondary endpoints are:

        -  Resolution or Improvement in type II Diabetic status as defined as:

        -  Resolution = patient is off their diabetes medication and has normal diabetic blood
           parameters (fasting glucose)

        -  Improvement = normalizing diabetic blood parameters (fasting glucose) and/or a reduction
           in dosing or frequency of their diabetic medication

        -  The percent of patients who achieve at least a 10% excess weight loss will be calculated
           as a secondary outcome.
    


Intervention name(s): EndoBarrier Device; Diet & Lifestyle Counseling
Intervention type(s): Device; Behavioral
Intervention description(s): NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp and EndoBarrier Device for 12 weeks; NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp
Other intervention name(s): EndoBarrier Gastrointestinal Liner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2; Delivery Systems
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The objective of the study is to investigate the effect
      and safety of continously basal delivered insulin aspart given by a pump versus once daily
      injection of insulin glargine.
    


Intervention name(s): pump; insulin glargine; insulin aspart
Intervention type(s): Device; Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Marketed Soft Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a bilateral, 2-week dispensing, non-randomized, controlled, single-masked, single-arm
      study to evaluate overall vision and comfort
    


Intervention name(s): Dailies Total 1 (DT1)
Intervention type(s): Device
Intervention description(s): TEST Lens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Risk Adapted Beacopp Regimen for Standard and High Risk Hodgkin Lymphoma
Condition: Classical Hodgkin Lymphoma; Nodular Sclerosis; Mixed Cellularity; Lymphocyte Depletion; Lymphocyte Rich
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional

Summary: 
      .This study is trying to address change of chemotherapy dosage according to individual
      patient response to initial cycles of chemotherapy in order to reduce cumulative dose of
      chemotherapy.The study includes patients with early unfavorable and advanced hodgkin
      lymphoma. Patients with low risk were started with standard beacopp and only high risk
      patients were started with escalated beacopp.Following 2 cycles of therapy the patients were
      reassessed.Based on scintigraphy results decision was made regarding further therapylative
      chemotherapy for early responders and maximize dose intensity for late responders.
    

Detailed description: 
      Patients were eligible if they had early unfavorable disease or patients who presented with
      stage III or IV disease .Pt assigned to receive 6 cycles of Bleomycin Etoposide, Doxorubicin,
      Cyclophosphamide Procarbazine, Prednisone (BEACOPP) or increased dose BEACOPP. (IDB). Patient
      with Stage I or II with ³4 sites of disease, age ³50, ESR³50 "B" symptoms lymphocyte depleted
      histology "E" site, or bulky disease were defined as early unfavorable disease and were given
      standard BEACOPP (SB). Those with I, II B or bulky disease or Stage III, IV were defined
      according the IPS. Increased dose BEACOPP (IDB) cycles of therapy was initiated only to
      patients with IPS of 3 or more risk factors (high risk) Standard BEACOPP (SB) cycles were
      initiated to those with a score of 0-2 (standard risk). All patients had baseline GA67 or
      hybrid PET\CT scan at diagnosis and post first cycle for gallium scan or second cycle for
      hybrid PET\CT. Upon the scan results therapy was planned and given for addition of 4 cycles.
      Those with negative scan received cycles of SB as of the third cycle. Dose was reduced to
      level I to III if patient was hospitalized due to fever and neutropenia of 5 days or longer
      or pt had an episode of sepsis with unstable vital signs.

      Patient with residual uptake interpreted as positive scan had additional cycles of IDB for a
      total of 6 cycles
    

Intervention name(s): interim therapy scintigraphy study gallium scan or PET/CT; "interim gallium or PET/CT"
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Hodgkin Lymphoma; BEACOPP; PET; Gallium; Tailored therapy
A Comprehensive Assessment of Anterior Corneal Power by Different Devices
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      To comprehensively assess the precision and agreement of anterior corneal power measurements
      using 8 different devices.
    

Detailed description: 
      Volunteers with healthy corneas will be measured by different instruments to detect their
      anterior corneal power. Only the right eye of each subject was selected. Measurements were
      repeated in the second session scheduled 1 to 2 weeks later.
    

Intervention name(s): Corneal power measurement
Intervention type(s): Device
Intervention description(s): All subjects will be underwent a full ophthalmic examination including vision, auto- and subjective refraction, slit-lamp examination, non-contact tonometry, corneal power measurements with the 8 devices and fundus examination.
Other intervention name(s): Tomey RC-5000
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The present study's definitions of reproducibility, repeatability and agreement were based
        on those adopted by the British Standards Institute and the International Organization for
        Standardization.

        Corneal curvature measurement provides crucial information for calculating intraocular lens
        power,screening and managing corneal refractive surgeries and corneal disease.

        Volunteers with healthy corneas will be measured by different instruments to detect their
        anterior corneal power.Only the right eye of each subject was selected.Measurements were
        repeated in the second session scheduled 1 to 2 weeks later, at almost the same time as the
        first session, by the same examiner using the same protocol.
      
Keywords: Anterior corneal power; Placido topographer; Scheimpﬂug; Precision; Agreement
Clinical Trial to Evaluate the Safety and Efficacy of Scarclinic™ Thin in Surgical Scars
Condition: Hypertrophic Surgical Scar
MeSH terms: Cicatrix; Hypertrophy
Study type: Interventional

Summary: 
      Compare the efficacy and safety of Scarclinic™Thin and Scarclinic™ Normal for the treatment
      of surgical scars.

      Participant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™
      Normal Randomization: Table of random number
    

Detailed description: 
      For evaluating the efficacy

        -  The investigator check Vancouver Scar Scale at 1 and 3 month after application to
           evaluate vascularity, pigmentation, elasticity, height, pain and itchiness

        -  The participant filled out survey included questions regarding convenience in use at 1
           and 3 month after application.
    

Intervention name(s): Scarclinic™ Thin; Scarclinic™ Normal
Intervention type(s): Device; Device
Intervention description(s): Apply Scarclinic™ Thin on the scar and dispense 4 ea.for each participant for 3 month.; Apply Scarclinic™ Normal on the scar and dispense 4 ea.for each participant for 3 month.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertropic scar, Vancouver scar scale, silicon gel sheet
The Comparison of the Transversalis Fascia Plane Block With Ilioinguinal/Iliohypogastric Nerve Block
Condition: Postoperative Pain; Inguinal Hernia Unilateral; Children, Only
MeSH terms: Pain, Postoperative; Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      This study compares the transversalis fascia plane block with the
      ilioinguinal/iliohypogastric nerve block in children undergoing hernia repair surgery.

      Half of participants will receive the transversalis fascia plane block, while the other will
      receive the ilioinguinal/iliohypogastric nerve block.
    

Detailed description: 
      The ilioinguinal/iliohypogastric nerve block (II/IH B)is a widely used regional anesthesia
      technique in inguinal hernia repair surgery. However, this block provides limited analgesia
      during and after surgery, and the patients feel pain when walking. The transversalis fascia
      plane block (TFPB) is a recently developed technique and several case reports presented its
      efficacy for inguinal repair surgery in adult patients. It may block not only ilioinguinal
      and iliohypogastric nerves but also splanchnic nerves, which is conveyed via the
      thoracolumbar fascia. Therefore, we compare the effect of the TFPB and II/IH B on
      postoperative pain and walking form.
    

Intervention name(s): Transversalis Fascia Plane Block; Ilioinguinal/iliohypogastric Nerve Block
Intervention type(s): Drug; Drug
Intervention description(s): block will be performed under real-time ultrasound guidance; block will be performed under real-time ultrasound guidance
Other intervention name(s): TFPB; II/IH B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transversalis fascia; ilioinguinal/iliohypogastric nerve; inguinal hernia repair; children
Stress Level and the Relationship With IVF Outcomes.
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      The effect of stress on IVF outcomes.
    

Detailed description: 
      The purpose of this study is to describe the pattern of psychological distress (depression,
      anxiety and stress) as assessed by both subjective and objective measures throughout the
      course of IVF treatment and to investigate its impact on IVF outcome.
    

Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): Questionnaires are completed such as self-evaluation questionnaire (STAI), Beck Depression Inventory, FertiQol International and Daily stress questionnaire
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        IVF patients doing IVF for the first time, or doing it for the third or more time doing it
        for the sole purpose to donate their eggs
Effects of Continuous Infusion of Intravenous Nefopam on Postoperative Pain and Opioid Consumption After VATS
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This prospective, randomized, double-blinded study is designed to evaluate the postoperative
      analgesic effect of the continuous infusion of intravenous nefopam in patients undergoing
      video-assisted thoracic surgery (VATS). We hypothesize that the continuous infusion of
      intravenous nefopam can significantly reduce postoperative opioid consumption and pain
      severity in patients with VATS.
    

Detailed description: 
      Adult patients undergoing elective unilateral VATS segmentectomy or lobectomy are randomly
      allocated to receive continuous nefopam infusion (n=45) or not (n=45), in addition to a
      standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled
      analgesia (PCA). At the end of induction, the nefopam group will receive intravenous nefopam
      20mg mixed with 50ml of normal saline, and at the end of surgery this group will receive
      intravenous nefopam 60mg mixed with 50ml of normal saline at a rate of 2ml/hr. The control
      group will receive intravenous normal saline 50ml at the end of induction and receive
      intravenous normal saline 50ml at a rate of 2ml/hr.
    

Intervention name(s): Nefopam 80mg/day; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): continuous nefopam infusion; continuous normal saline infusion
Intervention MeSH terms: Nefopam
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective randomized double-blinded study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative Pain