bioihbjkbjnl/mcl2 huggingface dataset:
Collaborative Research Group for Necrotizing Enterocolitis
Condition: Prematurity; Necrotizing Enterocolitis
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing
Study type: Interventional

Summary: 
      This proposal will test the hypothesis that synthesis and catabolism of epidermal growth
      factor (EGF), the genotype of the EGF gene, and the microbiome interact to influence EGF
      expression in infants at risk for necrotizing enterocolitis (NEC).
    

Detailed description: 
      -  Preterm infants will receive a six hour intravenous infusion of [5,5,5-2H3]leucine (2H3)
           through an existing intravenous line (IV) to measure EGF synthesis rate.

        -  Two blood samples will be obtained, one prior to the start of infusion, and one during
           the infusion. The enrichment of the stable isotope labeled leucine will be measured in
           the plasma from these samples; DNA will be extracted from the residual cell pellets. The
           EGF and EGF receptor genes will be sequenced.

        -  Saliva and urine will be obtained for 5 days following infusion to measure EGF and the
           rate of incorporation of leucine into EGF using liquid chromatography (LC)/mass
           spectroscopy (MS)/MS technology, as well as enzyme-linked immunosorbent assay (ELISA) .
           Saliva will be obtained by a Q tip swab and urine and stool obtained from the diaper.

        -  Stool will be obtained every 3 to 7 days through 5 weeks to evaluate inflammatory
           markers and the microbiome.

        -  If breastfeeding, a single sample of mother's milk will be obtained for measurement of
           EGF after adequate volumes for infant feeds are achieved.
    

Intervention name(s): [5,5,5-2H3]leucine (stable isotope labeled leucine)
Intervention type(s): Biological
Intervention description(s): intravenous infusion of labeled leucine dissolved in 5% glucose water: priming dose of 18 micromoles (1.8 ml)/kg over 5 minutes, then 18 micromoles (1.8 ml)/hr for 6 hours; one infusion total
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: newborn; necrotizing enterocolitis; genetics; growth factors; metabolism
Study of Aprepitant (MK-0869) for Chemotherapy-Induced Nausea and Vomiting (CINV) in Adolescent Participants (MK-0869-097)
Condition: Vomiting
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to demonstrate that aprepitant (MK-0869) prevents nausea and
      vomiting caused by emetogenic cancer chemotherapy in adolescent participants. Participants
      treated with emetogenic cancer chemotherapies that include either cisplatin,
      cyclophosphamide, or carboplatin, or participants who experienced nausea and/or vomiting when
      treated with a previously administered chemotherapy regimen that is planned to be repeated
      will be enrolled in this study. In the double-blind Part 1 of this study, enrolled
      participants will be randomized to receive either aprepitant or standard therapy. In Part 2
      of this study, enrolled participants will receive open-label aprepitant.
    

Detailed description: 
      The duration of treatment is the first 4 days of one 28-day cycle (Cycle 1). Participants who
      successfully complete Cycle 1 may be eligible to participate for 9 subsequent optional,
      open-label, 28-day cycles.
    

Intervention name(s): aprepitant; ondansetron; dexamethasone; placebo to aprepitant; placebo to dexamethasone; rescue medication
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): aprepitant capsules; ondansetron IV preparation; dexamethasone tablets; Matching placebo to aprepitant capsules; Matching placebo to dexamethasone tablets; Participants are allowed to take rescue medication throughout for nausea or vomiting. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are: 5-HT3 antagonists, phenothiazines, butyrophenones, benzamides, corticosteroids, benzodiazepines, domperidone, H1-receptor antagonist, and piperazine derivatives.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; Aprepitant; Fosaprepitant; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Renal Denervation to Improve Outcomes in Patients With End-stage Renal Disease
Condition: End-stage Renal Disease; Hypertension
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Sympathetic activation is a hallmark of end-stage renal disease and adversely affects
      cardiovascular prognosis. Hypertension is present in the vast majority of these patients and
      plays a key role in the progressive deterioration of renal function and in the exceedingly
      high rate of cardiovascular events. Selective catheter-based renal denervation has been shown
      to be safe and effective in attaining improved and sustained blood pressure control in
      patients with resistant hypertension and normal renal function. The investigators hypothesize
      that catheter-based renal denervation is a safe and effective intervention to achieve
      sustained reduction in sympathetic nerve activity, BP and target organ damage in hypertensive
      End-Stage Renal Disease (ESRD) patients, which will result in improved cardiovascular
      outcomes.
    


Intervention name(s): Renal Denervation
Intervention type(s): Procedure
Intervention description(s): Renal Denervation
Other intervention name(s): Symplicity Renal Denervation Catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device
Condition: Heart Disease
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The Study plan is a post-market prospective, multi-center, open-label registry. The vein
      graft failure rates for the currently commercialized C-Port devices will be compared to an a
      priori rate taken from the peer-reviewed literature.
    

Detailed description: 
      To satisfy the requirements set forth in post-market surveillance orders issued by the US FDA
      to Cardica, Inc., the following outcomes will be evaluated:

        1. Acute, midterm, and one-year graft failure rates for coronary revascularization using
           the C-Port® xA™ Distal Anastomosis System, C-Port® FlexA™ Distal Anastomosis System, and
           C-Port® XCHANGE™ Distal Anastomosis System when in general use in the United States
           compared to hand-sewn anastomoses.

        2. Technical failure rates when attempting to complete an anastomosis using the C-Port xA,
           FlexA, and XCHANGE Distal Anastomosis Systems.

        3. The technical success rate of hand-sewn anastomoses following technical failures of the
           C-Port devices and the hand-sewn graft patency rates and clinical sequelae at one year.
    

Intervention name(s): Anastomosis (C-Port® )
Intervention type(s): Device
Intervention description(s): creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures
Other intervention name(s): C-Port® Distal Anastomosis System; C-Port® xA™ Distal Anastomosis System; C-Port® FlexA™ Distal Anastomosis System; C-Port® XCHANGE™ Distal Anastomosis System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence
Condition: Primary Spontaneous Pneumothorax
MeSH terms: Pneumothorax; Recurrence
Study type: Interventional

Summary: 
      Primary spontaneous pneumothorax (PSP) defines as presence of air in chest cavity occurs most
      commonly in young, tall, and smoker men without underlying lung disease.

      Trends for PSP treatment tend toward more invasive procedures. Thoracotomy with pleurectomy
      and bullectomy is definitive treatment of PSP which significantly reduces recurrence
      probability. This procedure has been reported to cause high rate of morbidity and mortality.
      Thus video-assisted thoracoscopic surgery (VATS) has become the preferred method for
      treatment of PSP with recurrence rate of 5-10%. For persistent or recurrent cases, mechanical
      or chemical pleurodesis have been suggested.

      Based on guidelines patients with large size of lesions in CT or with unstable condition
      should undergo surgical procedure for recurrence prevention but Patients with small lesion
      size and stable condition can be only observed. Conservative management of PSP is safe and
      effective, but as mentioned this method has high recurrence rate. On the other hand fear of
      recurrence can negatively affect patients' quality of life, so that some patients prefer
      surgical intervention to observation management. Also some studies recommend invasive
      treatments because of cost effectiveness of this methods.

      As mentioned above, chemical pleurodesis is a usual method for treatment in patients with
      persistent or recurrent spontaneous pneumothorax. This method has been done using variety of
      chemical agents including tetracycline, minocycline, blood, and talc to irritate pleura.
      According to different studies tetracycline has the highest efficacy between irritant agents.

      In current study, the investigators have aimed to assess tetracycline chemical pleurodesis
      through tube thoracostomy in prevention of spontaneous pneumothorax in symptom free patients
      with normal CT-scan following first episode of PSP.
    


Intervention name(s): Chemical pleurodesis; Tetracycline Topical Ointment; Normal saline; Lidocaine 2% Injectable Solution
Intervention type(s): Procedure; Drug; Drug; Drug
Intervention MeSH terms: Tetracycline; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Tetracycline; Pleurodesis
Artefill for the Treatment of HIV-associated Facial Lipoatrophy
Condition: HIV-facial Lipoatrophy
MeSH terms: Lipodystrophy; Facies
Study type: Interventional
Phase: Phase 1

Summary: 
      Artefill is an injectable facial filler device that is currently approved by the FDA for the
      correction of nasolabial folds. This study seeks to examine the use of Artefill in the
      treatment of HIV associated facial lipoatrophy. Facial lipoatrophy (facial fat loss) related
      to HIV is a stigmatizing condition characterized by loss of facial fat, most notably in the
      cheeks and temples.
    

Detailed description: 
      The objectives of this study are:

      To evaluate the long-term safety of Artefill injection volumes that are three to four times
      greater (i.e. up to 30 ml) than the volume indicated in the FDA approved product label (i.e.
      8.9 ml)subjects with HIV.

      To evaluate any adverse events associated with the use of Artefill. To evaluate the Quality
      of Life and body image benefit from Artefill treatment in patients with lipoatrophy.
    

Intervention name(s): Artefill dermal filler
Intervention type(s): Drug
Intervention description(s): Four treatment visits will be scheduled at baseline and at weeks 4, 12, and 24. Each treatment session will utilize no more than 8 mL of Artefill and no more than 30 syringes of Artefill.
Other intervention name(s): polymethylmethacrylate (PMMA)
Intervention MeSH terms: Polymethyl Methacrylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Facial lipoatrophy
Transdermal Patch CVD 2000: The Effect of Heat on Fentanyl Release From Fentanyl TDSs in Healthy Adults
Condition: Peer Review, Research
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an Open-label, Non-Randomized, 3-way Crossover Bioequivalence Study to compare
      fentanyl release after heating of a brand name (Duragesic) and generic (Apotex and Mylan)
      fentanyl (transdermal delivery system)TDSs in healthy adults.
    

Detailed description: 
      This research study is intended to determine the effect of heat on FDA-approved fentanyl TDSs
      and whether the heat applied will result in more fentanyl being absorbed through the skin
      than without applying heat. This is important given that little is known about how the
      release of fentanyl is affected by heat, particularly for generic products. This study will
      use fentanyl TDSs (brand name and generic TDSs) that have been approved by the Food and Drug
      Administration (FDA) and are already prescribed to customers in the United States, and will
      not include any placebos.
    

Intervention name(s): Duragesic reference fentanyl TDS; Apotex generic fentanyl TDS; Mylan generic fentanyl TDS
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25 µg/hour; 25 µg/hour; 25 µg/hour
Other intervention name(s): Brand name fentanyl TDS; Generic fentanyl TDS; Generic fentanyl TDS
Intervention MeSH terms: Fentanyl
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Bioequivalence; Therapeutic Equivalency
Safety Study of Dexmedetomidine in Septic Patients
Condition: Sepsis; Agitation
MeSH terms: Psychomotor Agitation
Study type: Interventional

Summary: 
      Septic patients in Intensive Care Unit always need mechanical ventilation and
      conscious-sedation. But the recommended dose 0.2-0.7μg/kg/h could not run well because of
      wide range. The purpose of this study is to find the effective dose of dexmedetomidine adult
      septic patients of mechanical ventilation .
    

Detailed description: 
      Inclusion Criteria:

      Age: between 18 years mechanical ventilation RASS≥2 A diagnosis of sepsis within 48 hours

      Exclusion Criteria:

      Cardiac disease Cardiac rhythm abnormalities liver dysfunction coma severe hypotension muscle
      relaxant users

      Primary Outcome Measures:

      Dose of dexmedetomidine

      Secondary Outcome Measures:

      RASS score Requirement for rescue intervention, RASS will be recorded per hour.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Septic patients are randomly received 1 of 6 doses( 0.2,0.3,0.4,0.5,0.6,0.7μg/kg/h) dexmedetomidine.
Other intervention name(s): precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Oxytocin and Affect Processing in Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators will use multiple methods (including Oxytocin intranasal inhalation,
      neuroimaging, behavioral measures, peripheral hormone measurements) to examine how
      individuals' behavior, cognition, and brain function is impacted by the neuro-hormone
      Oxytocin. Specifically, the investigators plan to evaluate the influence of Oxytocin
      administration on affective processing in non-trauma exposed and trauma-exposed adults (both
      with and without posttraumatic stress disorder, PTSD).
    

Detailed description: 
      The investigators will use multiple methods (including Oxytocin intranasal inhalation,
      neuroimaging, behavioral measures, peripheral hormone measurements) to examine how
      individuals' behavior, cognition, and brain function is impacted by the neuro-hormone
      Oxytocin. Specifically, the investigators plan to evaluate the influence of Oxytocin
      administration on affective processing in non-trauma exposed and trauma-exposed adults (both
      with and without posttraumatic stress disorder, PTSD). The investigators expect oxytocin
      (compared to placebo) to positively influence affect processing in healthy subjects, as well
      as among those diagnosed with PTSD. Given current literature, the investigators expect
      oxytocin to elevate the processing\perception of positive-related stimuli, and reduce the
      salience of aversive or un-pleasant cues. The investigators expect oxytocin to impact
      participants' brain function as measured with functional magnetic resonance imaging (fMRI)
      while visually processing social and affect-related stimuli, rendering brain function and
      affective processing to be "more typical" or "adaptive" compared to placebo. Oxytocin's
      effect on human repertoire is not necessarily direct, but can interact with the individual's
      socioemotional characteristics, early life environment, and psychiatric symptoms. Therefore,
      the investigators will incorporate measures that capture the various dimensions that likely
      shape the effect of oxytocin.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): See arm/group descriptions for dosage amount and procedure.; See arm/group descriptions for dosage amount and procedure.
Other intervention name(s): Pitocin; saline
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Mobile Phone Self-Monitoring Tool to Increase Emotional Self-Awareness and Reduce Depression in Young People
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The mobiletype program is a mental health assessment and monitoring tool that runs on mobile
      phones.

      The program assesses the general mental health of young people in real-time and transmits
      this data to a website to be reviewed by their general practitioner (GP) in consultation with
      their patient. The website consists of individualised feedback reports for each participant,
      and graphical displays of the monitoring data. The primary aims of the current project are to
      examine: (1) whether the process of self-monitoring via the mobiletype program increases
      young people's awareness of their mood and reduces depressive symptoms and (2) whether
      emotional self-awareness mediates the relationship between self-monitoring and depressive
      symptoms.
    


Intervention name(s): Mobile Tracking Young People's Experiences (mobiletype)
Intervention type(s): Device
Intervention description(s): A mobile phone self-monitoring program, based on momentary sampling techniques, that prompts young people to complete it four times a day. The program asks several questions about daily activities, mood, stress, eating and exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Cellular phones; mental health; Early intervention; prevention; momentary sampling; Adolescent
Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 Diabetes Mellitus (DM)
Condition: Diabetes Mellitus, Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The effect of change in diabetes treatment from multiple daily insulin injection therapy to
      continuous subcutaneous insulin infusion on psychosocial outcome measures (quality of life,
      diabetes burden, parents stress level, fear, family conflicts) in families with children and
      adolescents with diabetes mellitus type 1 have been analysed. Additionally the effect on
      metabolic parameters (HbA1c, severe Hypoglycemia, Ketoacidosis) have been analysed.
    

Detailed description: 
      Children and adolescents currently treated with MDI and with an indication for CSII were
      randomized 1:1 to either starting with CSII as soon as possible or to continuing MDI while
      waiting six months for transmission to CSII, stratified by center. The primary outcomes were
      patient-reported diabetes-specific health-related quality of life , and diabetes burden of
      the main caregiver. We also investigated the impact of CSII on main caregiver stress,
      psychological well-being, fear of hypoglycemia, main caregiver's and adolescent's treatment
      satisfaction, family conflict, and HbA1c.
    

Intervention name(s): Continuous subcutaneous insulin infusion therapy; Multiple daily injection therapy
Intervention type(s): Device; Device
Intervention description(s): Insulin is given continuously using an insulin pump. Devices are allowed having marketing approval. Insulins are permitted with marketing approval.; Multiple daily injection therapy with different devices and insulin types. Devices and insulin types have to have marketing approval.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: open multicentre parallel randomised controlled intervention trial with waiting-list-control-group
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Green Tea on Body Weight Reduction and Gut Microbiota
Condition: Obesity
Study type: Interventional

Summary: 
      The investigators randomly assigned green tea extract, fermented green tea extract, or
      placebo in adult subjects whose BMI was 25-35 kg/m2. Participants were 40 in each group, and
      treatment duration was 12 weeks. Primary outcomes were body weight change and fat mass change
      from baseline to 12 weeks, and secondary outcomes were metabolic parameteres and gut
      microbiota.
    

Detailed description: 
      After screening obese subjects who met the inclusion and exclusion criteria, the
      investigators randomly assigned the two treatment arms and one placebo arm at 1:1:1 ratio. At
      baseline, anthropometric and biochemical evaluations were conducted including body weight,
      body composition (DXA and Fat CT), lipid profiles, and liver function test. The tablets were
      supplied to each participants under double-blind conditions. The investigators obtained blood
      and stool samples both baseline and final visit at 12 weeks. For improving compliance for
      treatments, the investigators checked diary for lifestyle and drug compliance every 6 week.
    

Intervention name(s): Green tea
Intervention type(s): Dietary Supplement
Intervention description(s): We made a dietary supplement from Cammellia sinesis O. Kunze, and made tablets containing extract.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment