bioihbjkbjnl/mcl2 huggingface dataset:
Mucosal Impedance in Pediatric Population
Condition: Gastroesophageal Reflux Disease (GERD); Eosinophilic Esophagitis (EoE); Functional Dyspepsia
MeSH terms: Gastroesophageal Reflux; Esophagitis; Eosinophilic Esophagitis; Dyspepsia
Study type: Observational

Summary: 
      Our hypothesis is that patients with GERD and/or Eosinophilic Esophagitis (EE) have lower
      esophageal impedance measurements when compared to patients who do not have GERD or EE.
    

Detailed description: 
      The overall goal of this project is to develop and assess a novel, inexpensive, minimally
      invasive technology to detect mucosal damage based on mucosal conductivity changes in the
      pediatric population. The study is based on preliminary work between Sandhill Scientific,
      Inc. and our adult gastroenterology department. They have collaborated to create a novel,
      minimally invasive Mucosal Impedance (MI) test (proprietary technology) based on animal
      studies which have shown esophageal tissue exposed to acidic and weakly acidic injurious
      agents causes dilation of intercellular spaces and loss of tight junctions along the squamous
      epithelial lining of the esophagus and results in measurable decreased baseline impedance.9
      Adult studies have confirmed the correlation between decreased impedance and diseased tissue,
      however this has not been studied in children. We hypothesize that pediatric patients with
      histologic damage seen in GERD and EoE will have mucosal changes resulting in decreased
      electrical impedance compared to those with normal histology. We propose that this technology
      will accurately and reliably measure the mucosal consequence of chronic esophageal exposure
      to injurious gastroduodenal agents or food allergens. Thus, this test would serve as a
      minimally invasive screening tool for GERD and EoE prior to endoscopy, and allow longitudinal
      monitoring of mucosal response to therapy.
    

Intervention name(s): Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance
Intervention type(s): Diagnostic Test
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients of our Vanderbilt Pediatric Gastroenterology Clinic undergoing routine
        evaluation of dyspepsia with endoscopy that meet the inclusion/exclusion criteria as
        defined above.
      
Keywords: GERD; EGD; pH testing; eosinophilic esophagitis; impedance testing
Effect of Vitamin D3 Supplementation in Pregnancy on Risk of Pre-eclampsia
Condition: Vitamin D Deficiency; Pre-Eclampsia
MeSH terms: Eclampsia; Pre-Eclampsia; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Vitamin D deficient pregnant ladies were selected and randomized into 2 groups for routine
      daily dose of multivitamin (400IU vitamin D3) versus maximum safest treatment daily dose
      (4000IU vitamin D3). Participants were assessed and compared for number of pre-eclampsia
      cases.
    

Detailed description: 
      Vitamin D3 has key role in decidualization and implantation of placenta.Vitamin D deficiency
      is thought to have positive association with pre-eclampsia.Vitamin D deficiency is highly
      prevalent in some parts of the world and it is not universally screened antenatally.
      Pre-eclampsia is a known multifactorial pregnancy disorder with significant maternal and
      perinatal morbidity and mortality. Vitamin D3 has a down-regulating effect on inflammatory
      pathways and reducing endothelial cell damage.

      Investigators want to assess in vitamin D deficient group whether treatment reduces the risk
      of pre-eclampsia.
    

Intervention name(s): 400 IU Vitamin D3; 4000 IU Vitamin D3
Intervention type(s): Drug; Drug
Intervention description(s): Antenatal multivitamin; 4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily
Other intervention name(s): Materna; Vidrop
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Maternal vitamin D; Deficiency; Insufficiency; Pregnancy; Pre-eclampsia; IUGR
Safety and Efficacy of Fludarabine and Cyclophosphamide + Rituximab
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose of this study was to assess the safety profile and the anti-lymphoma activity of the
      FC+R combination.
    

Detailed description: 
      The natural history of follicular lymphomas is characterized by a high initial response rate
      to chemotherapy followed invariably by relapse, with subsequent remissions of progressively
      shorter duration. The majority of patients eventually die of their disease. As yet, there is
      no gold standard for the treatment of newly diagnosed or relapsed advanced FL.Rituximab(R)
      has been shown to be a highly effective agent in the treatment of FL, either alone or in
      combination with chemotherapy. The ability of R to sensitize indolent lymphoma derived cell
      lines to cytotoxic chemotherapy agents has been demonstrated. Furthermore, fludarabine (F)
      may also sensitize cells to the effects of R. Cyclophosphamide (C) and F have shown in vivo
      synergistic activity. In view of the single agent activity and demonstrated synergy between C
      and F, and between F and R, we evaluated FC+R in previously treated patients with advanced
      FL. The primary aim of this study was to assess the safety profile and clinical activity of
      the FC+R combination. The secondary goal was to evaluate the ability of the treatment to
      convert bone marrow Bcl2 positivity such that patients achieved molecular remissions.
    

Intervention name(s): rituximab; rituximab,fludarabine, cyclophosphamide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: follicular lymphoma; non-Hodgkin lymphoma; Fludarabine; Cyclophosphamide; Rituximab; combination; immuno-chemotherapy; relapsed
Thin Catheter for Hysterosalpigography
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Hysterosalpingography is usually painful and the use of thin catheters of IUI could be an
      attractive alternative . we conducted a randomised controlled trial to compare the standard
      metal cannula to the thin catheter originally manufactured for intrauterine insemination.
      Pain assessment was done using visual analogue scale
    

Detailed description: 
      HSG is widely practiced in our country, however, for cost effective reasons, the standard
      metal cannula is the only method used at our hospital. It is painful procedure because it
      requires grasping the cervix with a tenaculum and inducing some cervical dilatation during
      introduction of the cannula. The aim of this pilot study was to modify the technique of HSG
      using a thinner than normal catheter, and without grasping the cervix with a tenaculum.
      Leakage of the dye through the cervix was prevented by pressing on the portiovaginalis of the
      cervix using the vaginal speculum.
    

Intervention name(s): HSG cannula
Intervention type(s): Device
Intervention description(s): a thin catheter originally designed for IUI was introduced through the cervical canal into the lower part of the uterine cavity. After introducing the catheter, the screw of the vaginal speculum was loosened to allow the two valves of the speculum to press on the portiovaginalis of the cervix to prevent leakage of the dye. Then the dye was injected slowly and the procedure was watched on the screen and x-ray films were taken.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: hysterosalpingography, catheter, pain, visual analogue scale
ONSET and OFFSET of Ticagrelor in ESRD
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with severe chronic kidney disease or end stage renal disease (ESRD) on hemodialysis
      (HD) exhibited higher platelet reactivity to clopidogrel than did those with normal renal
      function. Not enough study has been conducted about the antiplatelet effects of ticagrelor in
      these cardiovascular high risk patients. We hypothesized ticagrelor would achieve more and
      faster antiplatelet effects compared with clopidogrel in ESRD patients on HD.
    

Detailed description: 
      Chronic kidney disease (CKD) is a strong risk factor for cardiovascular morbidity and
      mortality, and confers an increasing risk of stent thrombosis even when dual antiplatelet
      therapy (clopidogrel and aspirin) is administered. Recently, we demonstrated that patients
      with severe CKD or end stage renal disease (ESRD) on hemodialysis (HD) exhibited higher
      platelet reactivity to clopidogrel than did those with normal renal function. One of good
      option to overcome high platelet reactivity in ESRD patients would be ticagrelor which has
      been already shown improved clinical outcomes. But little is known the antiplatelet effects
      of ticagrelor in ESRD patients on HD. The present study was designed to determine the
      antiplatelet effect as well as the onset and offset action of ticagrelor compared with
      clopidogrel in patients with ESRD undergoing maintenance HD.
    

Intervention name(s): Ticagrelor; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): After randomization, an initial loading dose of ticagrelor (180 mg) was given and maintenance doses (ticagrelor 90 mg twice daily) was treated for 14 days.; After randomization, an initial loading dose of clopidogrel (300 mg) was given and maintenance doses (clopidogrel 75 mg once daily) was treated for 14 days.
Other intervention name(s): Ticagrelor (Brilinta); Clopidogrel (Plavix)
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: platelet; ticagrelor; clopidogrel; end stage renal disease; hemodialysis
Clove In The Treatment Of Relapsed Or Resistant Acute Leukemia In Children
Condition: Acute Leukemia
MeSH terms: Leukemia; Acute Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able
      to induce remission in resistant/refractory acute leukemias in pediatric.

      Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute
      Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40
      mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440 mg/m2/day)
      in 1 or 2 induction cycles End point were complete remission (CR)or CR without platelet
      recovery (CRp) and toxicity
    


Intervention name(s): Clofarabine VP 16 ciclophospahamide
Intervention type(s): Drug
Intervention description(s): Clofarabine intravenously 2-hour infusion,dose 40 mg/m2, followed by Etoposide (VP 16)100 mg/m2 i.v. over 2 hours and Cyclophosphamide 440 mg/m2 i.v. over 1 hour
Other intervention name(s): Evoltra; Etoposide; Endoxan
Intervention MeSH terms: Etoposide; Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Healed Patients
Condition: Chronic Low Back Pain; Postural Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Pretending with the use of accelerometers and pressure platform, determine indicators that
      are useful to therapists to assess postural control and balance, to subsequently allow to
      evaluate the effect of therapeutic interventions through therapeutic exercise of motor
      control in patients with chronic low back pain .
    

Detailed description: 
      The records are made simultaneously with the different evaluation equipment, accelerometer
      and pressure platform. The tests are performed in a control group of healthy subjects, and in
      an experimental group with DLC receiving a program of therapeutic exercise based and pain
      education based on neuroscience.

      After the collection of the records, the behavior patterns in both groups are evaluated, the
      possible differences among them are established for the clinimetric indicators analyzed
      related to the postural control, as well as a characteristic of the sample.

      Subsequently, through the evaluation after the intervention of the experimental group we will
      analyze the effect of a physiotherapy treatment based on the therapeutic exercise of motor
      control on parameters related to postural control and clinical variables (perceived pain,
      mechanosensitivity, disability and proprioceptive repositioning of the lumbar spine )
    

Intervention name(s): Control. no therapeutic program; Experimental. Therapeutic program
Intervention type(s): Other; Other
Intervention description(s): The control group continued to perform their daily activities without changing any habit. Group of healthy subjects Assessment of postural control through accelerometry and pressure platform; People with chronic back pain of at least 3 months duration, to whom the therapeutic exercise of motor control and pain education based on neuroscience will be applied 2 days a week for 2 months.
Prior to the intervention, a postural control assessment will be made by accelerometry and pressure platform
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: postural control; Chronic Low Back Pain; therapeutic excercise; healed patients
Dexmedetomidine Versus Clonidine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Aim to study the efficacy of co-administered Dexmedetomidine Or Clonidine with Bupivacaine
      and that of bupivacaine 0.25% alone for Transversus Abdominis Plane (TAP) Block for
      Postoperative Analgesia in Patients Undergoing Elective Caesarean Section.

        -  Group 1: bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml
           each side) was used for the TAP block.)

        -  Group 2: 20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml
           each side) was used for the TAP

        -  Group3: bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used
           for the TAP A prospective Randomized Interventional double-blind study.
    

Detailed description: 
      Women, following Caesarean delivery, have even more compelling reasons to receive optimal
      post-operative pain relief, for improved maternal and neonatal well-being. Also, adequate
      pain relief helps the patient to ambulate early and prevent any thrombotic incidents .
      Dexmedetomidine, an imidazole compound, is the pharmacologically active dextroisomer of
      medetomidine that displays specific and selective α 2-adrenoceptor agonist activity and
      causes sedation, analgesia without any delirium, or respiratory depression. The mechanism of
      action is unique and differs from those of currently used agents, including clonidine.
    

Intervention name(s): bupivacaine; Dexmedetomidine; clonidine; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): bupivacaine 0.25% a total volume of 40 ml (20 ml each side; Dexmedetomidine 0.5 mcg/kg; 1ug/kg clonidine; add placebo 9normal saline)
Other intervention name(s): Active Comparator; Active Comparator; Active Comparator; placebo comparator
Intervention MeSH terms: Clonidine; Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective Randomized Interventional double-blind study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bupivacaine; Dexmedetomidine; Clonidine; Transversus Abdominis Plane Block
Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma
Condition: Oncology; Endometrial Cancer; Advanced Cancer; Recurrent Cancer; Metastatic Cancer
MeSH terms: Endometrial Neoplasms; Recurrence
Study type: Observational

Summary: 
      This is a national observational retrospective multi-site chart review study of patients with
      advanced, recurrent or metastatic endometrial carcinoma.
    


Intervention name(s): Chemotherapy
Intervention type(s): Drug
Intervention description(s): Patients with confirmed advanced, recurrent or metastatic endometrial cancer, treated by chemotherapy in real life-setting, between 1st January 2019 to 31rd December March 2019, in first or second line of chemotherapy.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population musy respect all the inclusion and exclusion criteria.
Early Versus Delayed Artificial Rupture of Membranes (AROM Trial)
Condition: Induction of Labor Affected Fetus / Newborn
MeSH terms: Rupture
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This randomized controlled trial of consenting women undergoing induction of labor with
      combined combination Foley catheter and pharmacologic cervical ripening seeks to efficacy of
      early amniotomy.

      This project will include 157 women presenting at Christiana Care Health System. Women will
      be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact
      membranes and are undergoing an induction of labor using a Foley catheter combined with
      either misoprostol or pitocin. Following admission, women will be randomized into either
      early or delayed amniotomy

      Women will be randomized with equal probability to the intervention group using block
      randomization stratified by party.

      Prior to discharge from the hospital, baseline demographic and clinical data will be obtained
      via chart review
    


Intervention name(s): amniotomy; Foley Catheter; Misoprostol
Intervention type(s): Procedure; Device; Drug
Intervention description(s): Artificially rupturing membranes; Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline.; Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg.
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Biomarkers of Exposure to Air Pollutants (AEROTOX-2)
Condition: Biomarkers of Air Pollution Exposure
Study type: Interventional

Summary: 
      Nowadays, an increase of inflammatory chronic diseases and/or tumors incidence has been
      reported in part due to the rising in life expectancy. For instance, exposure to air
      pollution, and in particularly to fine particles has been classified by the International
      Agency for Research on Cancer (IARC) as a risk factor for cancer, being the elderly
      population particularly sensitive. However, no validated biomarkers have been identified to
      assess the exposure to fine particles maybe correlated to cancerogenesis.

      AEROTOX-2 is a prospective pilot study on the ex vivo effects of the atmospheric pollution
      exposure. The study aims to identity new biomarkers after an exposure of leukocytes to doses
      of fine particles.

      Secondly, the study aims to analyze, according to age, the leukocytes response to the urban
      pollution exposure.
    

Detailed description: 
      To estimate the influence of the atmospheric pollution on the whole adult population,
      subjects will be recruited in a wide range of age (20 - 80 years).

      Samples of atmospheric particles will be collected in Dunkerque (North of France), one of the
      most important industrial areas in France. This city is influenced by car traffic, urban and
      industrial activities, and the wide sea traffic of the North Sea. Therefore, Dunkerque is a
      reference site to study the atmospheric pollution and its impact on health.

      These markers will be searched in association with the different mechanisms involved in the
      toxicity of the fine particles such as: inflammatory response, genotoxicity, metabolic
      activity and epigenetic changes after exposure of leukocytes isolated from patients to doses
      of fine particles.

      The study of the correlation between biological observations and conditions of exposure to
      air particles will bring answers about the impact of the environmental pollution on the
      health of vulnerable populations.
    

Intervention name(s): Blood sampling
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Environmental Pollution; Fine particles; Biomarkers; Elderly
Multi-Center Pilot Study of truSculpt Device
Condition: Bulging; Body Fat
Study type: Interventional

Summary: 
      An exploratory pilot study to evaluate the safety, efficacy and ergonomics of Cutera
      truSculpt device
    

Detailed description: 
      This is a multi-center, pilot study in approximately 40 subjects, ages 18 to 65. Subjects
      will receive treatments and will be followed at 12 weeks post final treatment.
    

Intervention name(s): truSculpt
Intervention type(s): Device
Intervention description(s): Subjects will receive utreatments and will be followed at 12 weeks post final treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment