bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study of B-Type Natrieutic Peptide (BNP) Levels in Patients With Congenital Heart Disease(BNP)
Condition: Congenital Heart Disease; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      The object of this study is to measure the levels of B-type Natriuretic Peptide (BNP) in
      patients with congenital heart disease, normal individuals, and patients with acquired heart
      failure, and compare the results from each group.
    

Detailed description: 
      Enrollment: Patients with congenital heart disease seen at Emory Clinics, Adult Congenital
      Heart Disease program, Crawford Long Hospital will be asked to participate in this pilot
      study. Sample size: 20 patients (5 in each group) Screening Phase: Demographic data, medical
      history, physical examination including vital signs and room air oxygen saturation, and
      medications will be recorded. New York Heart association functional class will be recorded.

      BNP Levels: Approximately 7 cc of blood will be collected. The blood will be analyzed for
      B-type natriuretic peptide on a rapid assay in the clinic.

      Exercise Tolerance: will be measured by a 6 minute walk test on day of visit Echocardiogram:
      A complete echocardiogram including assessment of anatomy, ventricular function and valvular
      function will be performed following the phlebotomy.

      Quality of life: The minnesota living with heart failure questionnaire will be administered
      on the day of collection of neurohormonal levels. A research nurse will be available to
      assist the patient if needed.
    

Intervention name(s): Six minute walk test; Minnesota Living with Heart Failure Questionnaire
Intervention type(s): Procedure; Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Congenital, BNP
Microbiome and Immunologic Analysis - Women With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      The primary goal of this study is to assess differences in the microbiome between women with
      and without endometriosis.

      A second goal of this study is to assess immunologic differences between the eutopic (within
      the uterus) and ectopic (outside of the uterus) endometrial tissue in women with
      endometriosis.

      In order to investigate these areas of interest, 25 women with endometriosis and 25 women
      without endometriosis will be enrolled. All women will be undergoing a previously scheduled
      surgical procedure at which time presence or absence of endometriosis will be confirmed and
      specimens will be obtained.
    

Detailed description: 
      Endometriosis is a chronic gynecologic condition where implants of endometrial glands and
      stroma are present outside of the uterus. It occurs in 6-10% of women of reproductive age and
      is characterized by dysmenorrhea, chronic pelvic pain, dyspareunia, or infertility. In
      addition to symptom burden, there are significant direct costs related to diagnosis and
      treatment of disease, as well as indirect costs related to absenteeism from school and work,
      loss of productivity, and unemployment. The estimated national economic burden in the United
      States related to these costs is approximately 78 billion dollars per year. While clinical
      signs and symptoms may be suggestive of endometriosis, the gold standard for diagnosis
      requires surgical confirmation of disease.

      The pathogenesis of endometriosis is complex and likely multifactorial with genetic,
      epigenetic, environmental, and immunologic factors. An increasing number of studies have also
      suggested the role of the microbiome in human health and development of disease. This study
      aims to investigate possible differences in the microbiome and immunologic factors that could
      contribute to pathogenesis of this disease. Findings from this study could potentially
      contribute to the development of of a less invasive, non-surgical diagnostic test for
      endometriosis.
    

Intervention name(s): Tissue and blood collection
Intervention type(s): Other
Intervention description(s): Tissue and swab (cells) collection for microbiome analysis. Blood collection for immune markers.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Premenopausal women with or without endometriosis, planning to undergo laparoscopic surgery
        for non-cancer indications.
Project LEaH: Learning to Eat at Home
Condition: Autism Spectrum Disorder; Feeding Behavior
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The investigators are trying to determine if delivery a feeding intervention program using
      videoconferencing technology is feasible.
    

Detailed description: 
      The investigators hope to recruit 10 participants who have a diagnosis of autism spectrum
      disorder and food selectivity. A Multidisciplinary feeding assessment will be conducted and
      factors which contribute to the participant's feeding challenges will be identified.
      Treatment goals will be identified using the Canadian Occupational Performance Measure
      (COPM). Intervention geared to address the goals identified by parents will be delivered by
      the clinician(s) via videoconferencing. Participants will participate in up to 12 weekly 1hr
      visits over the study period.
    

Intervention name(s): Parent coaching
Intervention type(s): Behavioral
Intervention description(s): Parents will be coached to implement behavioural strategies to address factors which are contributing to difficult mealtime behaviours and feeding challenges.
Intervention model: Single Group Assignment
Intervention model description: Participants will be recruited to participate in a multidisciplinary feeding assessment, after which an intervention plan will be developed to address the participants feeding challenges.
Masking: None (Open Label)
Primary purpose: Treatment
Study on the Effects of Mutations Under Inherited Retinal Disease in Korean
Condition: Inherited Retinal Dystrophy Primarily Involving Sensory Retina; Inherited Retinal Dystrophy Primarily Involving Retinal Pigment Epithelium
MeSH terms: Retinal Diseases; Retinal Dystrophies
Study type: Observational

Summary: 
      To develop comprehensive genetic maps of inherited retinal diseases in Korean

        -  Establishment of comprehensive genetic database in Koreans with inherited retinal
           diseases including frequently mutated genes, genotype-phenotype correlations, and visual
           prognosis."
    

Detailed description: 
      Group/ Cohort Label : Subject with age between 6 months and 65 years who have not receive
      molecular genetic testing Group / Cohort Description : Consecutive subjects with inherited
      retinal disease who are willing to do genetic testing using whole exome sequencing (n=265)
      and whole genome sequencing (n=15) and agree to informed consent of the study
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        "Subject with inherited retinal disease, age between 6 months and 75 years who have not
        receive molecular genetic testing"
      
Biospecimen description: 
      Blood DNA samples
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to test the immunogenicity and safety of an investigational influenza
      vaccine, in children compared to two other influenza vaccines.
    


Intervention name(s): Quadrivalent seasonal influenza vaccine GSK2282512A; Fluarix™ VB; Fluarix™ YB; Quadrivalent seasonal influenza vaccine GSK2282512A
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 17 years of age, single intramuscular dose.; For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose.; For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose; Single intramuscular dose for primed subjects, two doses for unprimed subjects.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza
Effects of tDCS on Craving, Relapse and Cognitive Functions Among Patients With Cocaine Use Disorder
Condition: Cocaine Addiction
MeSH terms: Cocaine-Related Disorders; Behavior, Addictive
Study type: Interventional

Summary: 
      Repetitive bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation
      (tDCS) over the dorsolateral prefrontal cortex (DLPFC) reduces craving and seems to decrease
      relapse risk in addiction. However, little is known about the relapse rates in cocaine
      addiction after tDCS, despite the need for neurobiological treatments to reduce the high
      relapse rates in this population. The current study explores the effects of repetitive tDCS
      in a larger sample (N=60) of cocaine addicted patients on number of relapse days after three
      months. We expect that a decrease in relapse risk after tDCS is associated with cognitive
      control functioning. Therefore, risky decision making and inhibitory control will be measured
      before and after the interventions, and at three months follow-up. Ecological momentary
      assessment (EMA) will be used as a reliable measure for relapse, craving and mood.
    

Detailed description: 
      For this study, 60 cocaine addicted patients will receive real or sham bilateral tDCS (left
      cathodal/right anodal) over the DLPFC after one week in detox. The participants will receive
      this two times daily for 5 consecutive days. It is expected that this particular tDCS method
      will reduce relapse probability, as was previously seen in alcohol addicted patients.
      Furthermore, it is hypothesized that this therapeutic effect is associated with diminished
      craving and enhanced cognitive control. Craving, temptations and relapse, will be explored by
      means of Ecological Momentary Assessment (EMA). The mixed results in previous studies of tDCS
      on craving may be explained by the fact that craving in addiction is a momentary phenomenon
      which is difficult to reliably measure with more traditional methods like retrospective
      self-reports, for which EMA provides a solution. Cognitive control will be measured by means
      of inhibitory control during a Go/NoGo task and reward processing during a gambling task. The
      tasks will be performed at baseline, one day after the tDCS sessions and at three months
      follow up.
    

Intervention name(s): transcranial Direct Current Stimulation (tDCS)
Intervention type(s): Device
Intervention description(s): tDCS is an electrical brain stimulation method Participants will receive real-tDCS or sham twice daily for 13 min with an interval of 20 min for five consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cocaine; tDCS; EMA; Inhibitory control; Reward processing; Addiction; dlPFC; craving; cognitive control
Evaluation of a 28-day Fermented Milk Product Consumption Twice Daily as Compared to a Non-fermented Milk Product on Intestinal Gas Production in Healthy Subjects High Dihydrogen Producers
Condition: Excessive Intestinal Gas Production
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of a 28-day fermented milk product
      consumption twice daily on intestinal gas production of dihydrogen (H2) and methane (CH4) in
      healthy subjects high H2 producers.
    


Intervention name(s): Milk product fermented by lactic bacteria or not fermented
Intervention type(s): Other
Intervention description(s): 2 pots of 125g consumed daily during 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy subjects; Probiotics; Breath test; Dihydrogen; Methane; Intestinal gas production; Gut microbiota
Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy
Condition: Breast Implant Infection; Mammoplasty
Study type: Interventional
Phase: Phase 1

Summary: 
      Breast implants, either cosmetic or reconstructive, are among the most common procedures
      performed by plastic surgeons. Bacterial infections or biofilms are implicated in the
      majority of breast implant complications including infection requiring explantation, capsular
      contracture (CC), and/or breast-implant associated anaplastic large cell lymphoma (BIA-ALCL).
      The research team, which has already extensively characterized bacterial pathogenesis in the
      urinary tract and designed non-antibiotic therapeutics to reduce the incidence of
      catheter-associated urinary tract infections (CAUTIs), and proposal will study
      bacteria-breast implant interactions and explore further the impact of the breast microbiome.
      The proposed research provides a greater understanding of which bacteria can colonize breast
      implants, their source, and how effective antibiotic pocket irrigation is at eliminating
      them, and begins to examine the mechanisms by which bacteria bind and colonize the implant
      surface. These insights will set the groundwork for developing new therapeutic agents that
      can disrupt the binding of certain bacteria to breast implants. Strategies that minimize
      problems bacteria can cause, while avoiding antibiotics, will reduce bacteria-related implant
      complications, limit antibiotic-related side effects, and reduce bacterial resistance.
    


Intervention name(s): Normal saline; Cefazolin; Skin biopsy; Bilateral skin- or nipple-sparing mastectomies; Tissue expander; Breast implant; Autologous flap; Acellular dermal matrix sling; Gentamicin; Bacitracin
Intervention type(s): Other; Drug; Procedure; Procedure; Device; Device; Procedure; Other; Drug; Drug
Intervention description(s): Intraoperative pocket irrigation with normal saline; Cefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed; Biopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange.; Standard of care; Standard of care; Standard of care
Either breast implant or autologous flap; Standard of care
Either breast implant or autologous flap; Standard of care; Cefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed; Cefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed
Other intervention name(s): NS; Ancef; Garamycin
Intervention MeSH terms: Gentamicins; Cefazolin; Bacitracin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia
Condition: Anesthesia, Spinal; Cesarean Section; Echocardiography; Cardiac Output
Study type: Observational

Summary: 
      Cardiac output will be measured in healthy parturients undergoing cesarean delivery under
      spinal anesthesia
    

Detailed description: 
      ASA-II women undergoing cesarean delivery under spinal anesthesia will be included. Cardiac
      output will be measured using transthoracic echocardiography at 4 time points: Baseline,
      after 10 minutes of intrathecal injection, after delivery, and after 1 hour of intrathecal
      injection. Spinal anesthesia will be administered with 2.5 ml bupivacaine 0.5% and fentanyl
      15 μg.
    

Intervention name(s): Transthoracic Echocardiography; Spinal Anesthesia; Intrathecal Bupivacaine; Intrathecal Fentanyl; Crystalloid Coload 1000 mL; Cesarean Delivery; Intravenous Ephedrine; Oxytocin
Intervention type(s): Radiation; Procedure; Drug; Drug; Drug; Procedure; Drug; Drug
Intervention description(s): Measurement of cardiac output in supine position with left lateral tilt at baseline, at 10 minutes after intrathecal injection, immediately after delivery, and at 1 hour after intrathecal injection; Performed at the L3-L4 or L4-L5 interspace using 25-gauge spinal needle; Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space; Fentanyl 15 μg will be administered in the subarachnoid space; Ringer acetate 1000 mL will be administered over 10 minutes starting immediately after intrathecal injection; Lower segment cesarean section using the Pfannenstiel incision and uterine exteriorization; Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively.; Intravenous oxytocin 10 U in 500 mL Ringer acetate will be administered over 30 minutes starting immediately after delivery of the fetus
Intervention MeSH terms: Ephedrine; Fentanyl; Bupivacaine; Oxytocin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy women with full term, singleton pregnancy presenting for elective cesarean delivery
        under spinal anesthesia in a tertiary obstetric hospital
Evaluation of How Different Dosages of Spinal Manipulation Modulate Spinal Stiffness in Participants With Back Pain
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      This study evaluate the relationships between spinal manipulative therapy dosage (speed and
      peak force), the resulting modulation of thoracic spinal stiffness and changes in the
      clinical status in participants with chronic thoracic pain. Participants will attend four
      sessions of one hour over 2 weeks. During session 1 to 3, participants will receive one of
      three different spinal manipulative therapy dosages based on their group assignment and
      preceded and followed by the measurement of their thoracic spinal stiffness. Session 4 will
      include spinal stiffness measurement and clinical status evaluation through questionnaires.
    

Detailed description: 
      Spinal manipulative therapy (SMT) is based on the premise that clinicians can identify spine
      mechanical changes and accordingly determine the dosage of its biomechanical parameters:
      preload force, rate of force application and peak force. In recent years, our research team
      showed, using an apparatus to deliver specific dosage SMTs, that SMT-related
      neurophysiological responses depend on the dosage of these parameters. Beside determining the
      SMT dosage, clinicians have to select the spinal level to be treated which is partly done by
      applying a light pressure to each spinous process (spinal stiffness assessment). This study
      consist of a randomized controlled trial including 75 participants with chronic thoracic pain
      who will be randomized in one of three groups. Based on their group assignment, participants
      will receive a specific dosage SMT delivered at T7 three times over 2 weeks. These SMT
      dosages are distinct regarding their speed and/or their peak force in order to generate
      either a high vertebral displacement or a high muscle reflex response. T6, T7 and T8 spinal
      stiffness will be measured just before and after treatment and clinical status will be
      assessed at each session beginning through questionnaires. Session four will include the
      questionnaires and the spinal stiffness measurement procedure. Both SMT and spinal stiffness
      measurement will be performed using an apparatus aiming at simulating force-time profiles.
      Surface electromyography electrodes and accelerometers will be positioned over the upper back
      skin in order to measure the muscle response and vertebral displacement during SMT and spinal
      stiffness measurement procedures.
    

Intervention name(s): Spinal manipulative therapy
Intervention type(s): Procedure
Intervention description(s): A SMT will be delivered by contacting the transverse processes of T7 through our apparatus. Each participant will receive one SMT per session for 3 sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: chronic thoracic pain; spine stiffness; spinal manipulation; spinal manipulative therapy