bioihbjkbjnl/mcl2 huggingface dataset:
The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Outcomes in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Double Blind Randomized Controlled Trial
Condition: Colon Cancer
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has been
      reported to be an effective treatment approach for peritoneal cancer, however, the stress
      response to HIPEC is major neuroendocrine and cytokine response, which has been considered as
      the homeostatic defense mechanism. Recently, dexmedetomidine has been suggested to exhibit
      anti-inflammatory properties. This study was designed to evaluate the effect of perioperative
      administration of dexmedetomidine on inflammation response and postoperative outcomes in
      patients undergoing hyperthermic intraperitoneal chemotherapy (HIPEC) cytoreductive surgery.
    


Intervention name(s): dexmedetomidine; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Group A: dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum. Group B: Saline infusion during same time period.; Group B: Saline infusion during same time period.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors
Condition: Tumors; Brain Tumors; Rhabdomyosarcoma; Sarcoma, Soft Tissue
MeSH terms: Neoplasms; Sarcoma; Brain Neoplasms; Rhabdomyosarcoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with recurrent or refractory solid tumors or brain tumors that are unresponsive to
      conventional therapy, or with no known effective therapy, will be treated. Experiments in the
      laboratory have shown the experimental drug RAD001C (RAD001, Everolimus) can prevent cells
      from multiplying. RAD001 is now being tested in diseases such as cancer, in which excessive
      cell multiplication needs to be stopped. The drug has been tested in adult cancer patients
      and has been well tolerated by subjects in these studies. It is experimental and, therefore,
      available in clinical trials.
    

Detailed description: 
      Although a Phase II portion of this study was planned, it was never initiated.
    

Intervention name(s): Everolimus
Intervention type(s): Drug
Intervention description(s): The drug is given orally in 28 day courses.
Intervention MeSH terms: Everolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain tumors; Soft Tissue Sarcomas; Refractory solid tumors; Recurrent or Refractory Rhabdomyosarcomatous Soft Tissue and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
Education and Social Media Versus Non-Indicated Caesarean Section Rate in Egypt
Condition: Complications; Cesarean Section
Study type: Observational

Summary: 
      This study focus on measuring effect of Egyptian Primigravidas' education level and
      accessibility to social media on rate of maternal request option offered for non-indicated
      primary caesarean section.
    

Detailed description: 
      A caesarean section (CS) is a life-saving surgical procedure when certain complications arise
      during pregnancy and labour. However, it is a major surgery and is associated with immediate
      maternal and perinatal risks and may have implications for future pregnancies as well as
      long-term effects that are still being investigated. The use of CS has increased dramatically
      worldwide in the last decades particularly in middle- and high-income countries, and some
      studies showing a link between increasing CS rates and poorer outcomes, and reasons for this
      increase are multifactorial and not well-understood.

      In Egypt the CS rate according to WHO (World Health Organization),Health report (2010) is
      27.6 %. Egypt also is considered to be the highest African country in CS rate (51.8 %), in
      which CS rate rose from 4.6 % to 51.8 % over the 24 year period (1990-2014), and more than
      half of all women give birth by CS in Egypt without much difference between urban and rural
      areas.

      Slightly more than half of the live births in the five-year period before 2014 Egypt
      Demographic and Health survey were by CS, and 60 % of primigravidas delivered by CS.

      Updated indications of primary CS including option of maternal request as one of these
      indications were reported in both RCOG (Royal College of Obstetricians and Gynaecologists)
      Press report (2001) and RCOG CS various guidelines.

      Recently, the Egyptian public opinion deviated to obstetricians' desire for self financial
      benefits to be the major cause of increasing Egypt CS rates; depending on newspaper articles
      and social media talks.
    

Intervention name(s): Observation
Intervention type(s): Behavioral
Intervention description(s): Observation of Participants' behaviour
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primigravidas whom been carefully counselled, and the overall risks and benefits of
        caesarean section and vaginal birth, and IOL for prolonged pregnancy discussed with.
      
Keywords: Caesarean Section Rate; Primigravida
Delayed Visual Maturation: Outcome and Predictive Factors
Condition: Delayed Visual Maturation
Study type: Observational

Summary: 
      The objectives of the study are to describe the developmental outcome in a population of
      children with delayed visual maturation.
    

Detailed description: 
      description of the developmental outcome of children with delayed visual maturation.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients seen in UZ Leuven between 1998 and 2016 with diagnosis of delayed visual
        maturation who meet the inclusion criteria.
      
Keywords: delayed visual maturation
Photodynamic Therapy Using HPPH in Treating Patients With Stage 0 Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells.
      The drug becomes active when it is exposed to a certain kind of light. When the drug is
      active, tumor cells are killed.

      PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic
      therapy using HPPH in treating patients with stage 0 non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the maximally tolerated light dose (MTID) in patients with bronchogenic
           carcinoma in situ (CIS) or bronchogenic microinvasive carcinoma.

        -  To identify the systemic and normal tissue toxicity resulting from photodynamic therapy
           using HPPH in these patients.

      Secondary

        -  To study tumor response in these patients.

      OUTLINE: Patients receive HPPH IV over 1 hour on day 1. Approximately 2 days later, patients
      undergo photodynamic therapy (PDT) using laser light passed through the biopsy channel of an
      endoscope. Patients undergo endoscopic debridement on day 5. If viable tumor is found outside
      of the initial treatment area, patients may receive another dose of laser light without
      additional HPPH at that time.

      After completion of study treatment, patients are followed at 4-6 weeks, 6 months, and
      periodically thereafter.
    

Intervention name(s): HPPH
Intervention type(s): Drug
Intervention description(s): IV
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage 0 non-small cell lung cancer; adenocarcinoma of the lung; squamous cell lung cancer; large cell lung cancer
Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia
Condition: Trigeminal Neuralgia
MeSH terms: Trigeminal Neuralgia; Neuralgia; Facial Pain
Study type: Interventional

Summary: 
      This is a 16-week non-blinded, parallel, controlled trial to determine the feasibility and
      potential efficacy of an olive oil dietary intervention to alleviate facial pain caused by
      trigeminal neuralgia type 1 (TGN).
    

Detailed description: 
      Trigeminal neuralgia (TGN) pain is debilitating and unpredictable. Alleviation of intensity
      or frequency to any degree will improve the quality of life of the individuals affected.
      Current medical treatments for TGN are often not effective. In some cases, the pain is a
      result of myelin degeneration. If diet can provide the basic building blocks for myelin
      regrowth, then the investigators may be able to reduce facial pain by supporting the myelin
      nerve sheath.

      Animal studies have shown that a dietary intervention with olive oil favorably impacts myelin
      but no human study has been conducted to date. The investigators propose undertaking a
      feasibility study to determine if a comparable intervention may work in a similar way in
      humans. If olive oil impacts myelin repair, then pain will be decreased by this dietary
      intervention and quality of life will be improved. However, it is not known if individuals
      with TNG will be able to consume a diet relatively high in olive oil. Feasibility will
      include testing the logistics of distributing the olive oil intervention to the study
      subjects, incorporation of olive oil into the participants' daily diets, and online/distance
      monitoring of compliance and reporting of pain intensity, pain frequency, and quality of
      life. This feasibility study will lay the groundwork for potential future studies examining
      the efficacy of olive oil on alleviating facial pain caused by TNG and may provide data for a
      power analysis for a future interventional trial.
    

Intervention name(s): Olive oil and Dietary Guideline recommendations; Dietary Guideline recommendations
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 60 mL of olive oil and healthy diet recommendations; healthy diet recommendations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
7-Keto DHEA for the Treatment of PTSD
Condition: PTSD
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to test the effectiveness of 7-Keto DHEA in reducing
      symptoms of Post-Traumatic Stress Disorder (PTSD).
    

Detailed description: 
      The main purpose of the study is to investigate the possible effect of 7-Keto
      Dehydroepiandrosterone (7-Keto DHEA) on decreasing Post Traumatic Stress Disorder Symptoms
      (PTSD) in a Veteran population. The study proposes, based on a 2006 report, that the use of
      the drug will show significant reduction in overall PTSD symptoms, a decrease in
      physiological stress response and higher patient-reported quality of life compared to
      placebo. This is a Phase 2, randomized, double-blind, crossover design with a placebo
      control. The sponsor for this study is Humanetics Corporation
    

Intervention name(s): 7-Keto Dehydroepiandrosterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 7-Keto Dehydroepiandrosterone, 100 mg capsules given orally twice daily for 4 weeks in one of the two intervention phases, dependent on randomization assignment.; Placebo, 100 mg capsules given orally twice daily for 4 weeks in one of the two intervention phases, dependent on randomization assignment.
Other intervention name(s): 7-Keto DHEA
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Spleen in Sickle Cell Anemia and Sickle Cell Thalassemia
Condition: Sickle Cell Anemia; Thalassemia
MeSH terms: Anemia; Thalassemia; Anemia, Sickle Cell
Study type: Observational

Summary: 
      The spleen in Sickle Cell Anemia and Sickle Cell Thalassemia is usually enlarged in the first
      years of life but the immune protection provided is considered insufficient. In homozygous
      Sickle cell patients the spleen usually developed recurrent infarcts and after the first
      decade of age become fibrotic. Acute splenic sequestration is also frequent in those patients
      and this is considered as an indication for splenectomy.

      In comparison in Sickle cell thalassemia patients, hypersplenism is more frequent.

      The purpose of this study is to compare the clinical and laboratory issues related to the
      spleen in two groups of Sickle cell patients.
    

Detailed description: 
      Clinical and laboratory characteristics related to the spleen in SCA patients will be
      studied.

      Two groups of patient will be compared, a group of Sickle cell patients (Homozygous) and a
      second group of patients with Sickle cell beta thalassemia.

      In those patients that splenectomy was performed the incidence of infections will be recorded
      besides the indications for splenectomy and the incidence of thrombotic events or
      thrombocytosis.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Two groups of patients: 25 patients with homozygous Sickle Cell Anemia and 25 patients with
        Sickle Cell Thalassemia
      
Keywords: Splenectomy; Thrombocytosis; Infections; Spleen; Sickle Cell Thalassemia
Ondansetron Reduce Vomiting Associated With Ketamine PSA
Condition: Conscious Sedation
MeSH terms: Vomiting
Study type: Interventional

Summary: 
      Ondansetron, a commonly used anti-vomiting medication, may reduce the occurrence of vomiting
      associated with ketamine during procedural sedation in the pediatric emergency department.
    


Intervention name(s): Ondansetron
Intervention type(s): Drug
Intervention description(s): ondansetron (0.15 mg/kg/dose; maximum dose 4 mg)
Other intervention name(s): Zofran
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ketamine; children; emesis
Proteins From Duckweed Trial
Condition: Degree of Digestilbility
Study type: Interventional

Summary: 
      This study aims to study the digestibility of isolated duckweed protein. The digestibility of
      the isolated duckweed protein will be compared to an isolated benchmark protein whey.

      Objective: The primary objective is to investigate the digestibility of isolated duckweed
      protein and the isolated benchmark protein whey.

      Study design: The study is a cross-over, double blind, controlled trial in which study
      participants will visit the research facility on two occasions under fasting conditions.
      Subjects will receive two protein sources in randomized order with a washout period of one
      week. Blood will be collected via a catheter before and up-to 3 hours after protein
      consumption.

      Study population: We aim to include 12 healthy volunteers aged 18-50 years. Intervention:
      Study participants will receive 20 grams of isolated duckweed protein and the isolated
      benchmark protein whey.

      Main study parameters/endpoints: The main study parameter is blood amino acids measured
      before and after consumption of 20 g protein.
    


Intervention name(s): Duckweed protein; Whey protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 20 grams isolated protein; 20 grams isolated protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Duckweed protein; protein; degree of digestibility; whey protein
Effects of Blood Transfusion in Healthy Volunteers
Condition: Blood Transfusion, Autologous
Study type: Interventional

Summary: 
      The objective of this study is to assess effects of the storage of PRBC on endothelial
      function, inflammation and platelet activation in healthy volunteers
    

Detailed description: 
      The objective of this study is to assess effects of the storage of PRBC on endothelial
      function, inflammation and platelet activation in healthy volunteers.

      The present study consists of two parts. During one phase of the study, 10 healthy human
      volunteers will donate a unit of blood, which will be leukoreduced and stored in Additive
      Solutions-1 (AS-1), and then transfused back to the subjects after 2 days of storage at 4º C
      in the MGH Blood Bank. The other part of the study consists in the collection of a unit of
      blood from the same volunteers, but which will be transfused back to the same subject after
      40 days of storage. There will be a break of 2 week period in between these 2 study phases.
      The order of these 2 study parts will be randomized.

      We hypothesize that old red blood cells stored under conventional conditions may trigger a
      complex, pro-inflammatory, pro-thrombotic and vasoconstriction response. We will compare the
      response to PRBC stored for 2 days with the response to PRBC stored for 40 days in the same
      healthy volunteers. We will monitor/measure the following markers/parameters:

        1. Endothelium-mediated changes in vascular (arterial) tone

        2. Tissue oxygen saturation will be continuously assessed during and after blood
           transfusion

        3. Hemolysis as quantified by changes in plasma haptoglobin level, plasma free hemoglobin,
           LDH level, bilirubin level, iron level, ferritin, and transferrin

        4. Changes of plasma and red blood cell levels of circulating nitrate, nitrite, RXNO, RNNO,
           NO-heme

        5. Concentration of cytokines, such as IL-6, IL-8, IL-10, IL-12, TNF, IFN-γ

        6. Activation of platelets through circulating P-selectin expression on platelets

        7. Activation of inflammatory lipid mediators

        8. Changes in gene expression profiling analyzing RNA microarray of circulating leukocytes
    

Intervention name(s): Red blood Cells auto-transfusion
Intervention type(s): Procedure
Intervention description(s): Withdrawal from 10 Healthy volunteers of one unit of red blood cells and auto-transfusion after 3 days for one arm of the study, after 40 days for the other. Participants are enrolled in both arms of the study.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Blood Transfusion, Autologous; Blood Preservation/adverse effects; Blood Transfusion/adverse effects; Endothelium, Vascular/physiopathology; Inflammation Mediators
Coronary Heart Disease as Measured by Coronary Calcium Score Among Individuals With Chronic Traumatic Spinal Cord Injury
Condition: Spinal Cord Injuries; Heart Diseases
MeSH terms: Spinal Cord Injuries; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Wounds and Injuries
Study type: Observational

Summary: 
      This study includes male subjects age 45 to 70, who have sustained a traumatic Spinal Cord
      Injury (SCI) at least 10 years prior. Subjects will be interviewed for demographic data,
      including heart disease risk factors. A blood test for cholesterol levels will be drawn. A CT
      scan of arteries of the heart will be performed to determine the presence of coronary
      calcium, a marker of subclinical Coronary Heart Disease. Scoring of Coronary Calcium or
      Coronary Calcium Score (CCS) is automated by the CT scanner. Each subject's Framingham Risk
      Score will be calculated; This is an individuals 10 year risk of having a Coronary Heart
      Disease event (significant symptoms). In addition, it will be determined if subjects are
      being treated for diagnosed dyslipidemia (high cholesterol) according to the National
      Cholesterol Educational Program (NCEP) guidelines.

      The proposed pilot study aims to better understand the problem of Coronary Heart Disease in
      individuals with Spinal Cord Injury, specifically CCS in SCI, when compared to the general
      population.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Male,Spinal Cord Injuries
      
Keywords: spinal cord injury; Coronary artery calcium; Dyslipidemia
Cognitive Process of Diagnostic Error in Emergency Physicians
Condition: Thinking
MeSH terms: Emergencies
Study type: Observational

Summary: 
      Diagnostic error, Dual process model of reasoning) During the last decade, much emphasis has
      been placed on system solutions to patient safety problems. However, diagnostic error,
      despite being responsible for twice as many adverse events as medication error, has received
      little attention. The rate of diagnostic errors have been estimated to be between 0.6% to
      12%.Some estimates are as high as 15%.The rate of negative outcome or adverse effects of
      diagnostic errors range from 6.9% to 17%. Most authors accept that the dual process model of
      reasoning explains how clinicians make diagnoses. The purpose of this study is to investigate
      why diagnostic errors occurred in the emergency departments (EDs).
    

Detailed description: 
      Diagnostic error, Dual process model of reasoning) During the last decade, much emphasis has
      been placed on system solutions to patient safety problems. However, diagnostic error,
      despite being responsible for twice as many adverse events as medication error, has received
      little attention. The rate of diagnostic errors have been estimated to be between 0.6% to
      12%.Some estimates are as high as 15%.The rate of negative outcome or adverse effects of
      diagnostic errors range from 6.9% to 17%. Most authors accept that the dual process model of
      reasoning explains how clinicians make diagnoses. The purpose of this study is to investigate
      why diagnostic errors occurred in the emergency departments (EDs). A qualitative study
      approach was used with in-depth semi-structured interviews conducted with emergency
      physicians to investigate the cognitive diagnosis process. The study takes place in the EDs
      of three hospitals in Taiwan. We chose the participants using a purposive sampling technique
      to yield a sample that would be most likely contribute significant information on the
      diagnostic process. Sampling continued until novel information was no longer being gathered.
      All audiotapes were transcribed verbatim. The transcripts are analyzed by two of the
      investigators based on the ground theory. Once all relevant codes were identified, they were
      grouped together into meaningful categories. These categories were then grouped under
      appropriate themes, which were used to generate a theory of diagnostic errors.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        emergency physicians
      
Keywords: diagnostic error