bioihbjkbjnl/mcl2 huggingface dataset:
The Suppression of Toll Like Receptors by Insulin
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      This study will help us understand the possible beneficial effects of insulin in
      inflammation. Inflamamtion is considered to be the cause of atherosclerosis and heart
      disease.
    

Detailed description: 
      Obesity and type 2 diabetes are major health problems in the United States and the world.
      Both conditions are characterized by increased inflammation and oxidative stress and are
      associated with increased risk of cardiovascular disease.

      Our previous work shows that insulin exerts a prompt and powerful anti-inflammatory effect,
      on circulating blood cells and in plasma in healthy subjects and in critically ill patients.

      Toll like receptors (TLRs) recognize bacterial and viral products like endotoxin and viruses
      and are major determinants of the inflammatory response against foreign pathogens. In view of
      the recent data showing that TLRs recognize a range of molecules and proteins that are not of
      pathogenic source like saturated lipids and that TLRs are involved in the pathogenesis of
      atherosclerosis which leads to cardiovascular disease and insulin resistance which leads to
      type 2 diabetes (DM) we hypothesized that insulin infusion suppresses TLRs expression.

      Our preliminary data show that insulin infusion for 4 hours reduces the levels of many TLRs
      and thus might protect from inflammation induced conditions We therefore propose to
      investigate, in more detail, the effect of infusing different doses of insulin on TLRs mRNA
      and protein levels and its activity in obese and DM subjects over a longer infusion period
      and a larger number of subjects in circulating white blood cells and in fat tissue. Also we
      will be comparing the baseline levels of TLRs and TLRs related proteins as well as their
      modulation by insulin between normal, obese and DM subjects.
    

Intervention name(s): insulin infusion; Dextrose infusion; Saline Infusion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): insulin to be infused at 3.5 units/hour along with Dextrose 12.5% at a rate to achieve blood glucose levels between 80-120mg/dl; Dextrose 12.5% will be infused at a rate to maintain blood glucose level 80-120mg/dl; Saline will be infused at 100ml/hr
Other intervention name(s): Intravenous regular insulin infusion; Intravenous dextrose solution infusion; normal saline infusion
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Inhaled Nitric Oxide for the Adjunctive Therapy of Severe Malaria: a Randomized Controlled Trial
Condition: Severe Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Despite the use of highly effective anti-malarial medications, 10-30% of African children
      with severe malaria will die, underscoring the need for adjunctive therapies that can be
      applied in endemic areas. A clinical trial of adjunctive inhaled nitric oxide (iNO) in severe
      malaria is warranted on the basis of firm proof of concept from animal studies and a human
      study using the NO donor L-arginine, together with evidence of safety from clinical
      experience and trials of iNO for other conditions. Our objective is to determine whether
      supplemental iNO (80 ppm) in addition to Ugandan Standard of Care treatment reduces levels of
      Angiopoietin-2 (Ang-2), a quantitative biomarker of malaria severity, in children with severe
      malaria compared to Standard of Care treatment alone. We will conduct a randomized
      placebo-controlled trial among children 1-10 years of age admitted to Jinja Hospital (Uganda)
      with severe malaria to test the efficacy of inhaled nitric oxide in severe malaria.
    

Detailed description: 
      Severe malaria remains a major cause of global morbidity and mortality. While the use of
      artemisinin-based antimalarial therapy has improved outcomes in severe malaria, the mortality
      rate remains high. Adjunctive therapies that target the underlying pathophysiology of severe
      malaria may further reduce morbidity and mortality. Endothelial activation plays a central
      role in the pathogenesis of severe malaria, of which the angiogenic factors angiopoietin-1
      (Ang-1) and angiopoietin-2 (Ang-2) have recently been shown to function as key regulators.
      Nitric oxide (NO) is a major inhibitor of Ang-2 release from endothelium and has been shown
      to decrease endothelial inflammation and reduce the adhesion of parasitized erythrocytes.
      Low-flow inhaled nitric oxide gas (iNO) is a US FDA-approved treatment for hypoxic
      respiratory failure in neonates. Based on compelling data on the efficacy of iNO in
      experimental cerebral malaria in animal models, coupled with the documented safety of iNO in
      clinical practice and trials for other diseases, we propose a randomized clinical trial of
      iNO for the adjunctive treatment of severe malaria in Ugandan children.
    

Intervention name(s): Inhaled Nitric Oxide
Intervention type(s): Drug
Intervention description(s): Form: Gas (inhalational) Dose: 80 ppm Dosing schedule: Continuous Treatment period: Maximum 72 hours (may be discontinued earlier if patient recovers and no longer tolerates face mask)
Other intervention name(s): NO, nitrogen monoxide
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: malaria; children
Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery
Condition: Surgery, Laparoscopic; Sexual Dysfunction, Physiological; Colorectal Surgery
MeSH terms: Sexual Dysfunction, Physiological
Study type: Observational

Summary: 
      Research Populations: Male patients scheduled for laparoscopic colorectal surgery

      Study Method: Questionnaire and function tests

      Hypothesis: A laparoscopic nerve-sparing operation is not inferior to reported open surgery
      in preserving urinary and sexual function.
    

Detailed description: 
      There have been some reports that laparoscopically assisted rectal resection is associated
      with a higher rate of male sexual dysfunction compared with the open approach. But these
      reports are studied retrospectively.

      We examine the frequency of bowel, urinary and sexual dysfunction prospectively in patients
      who received laparoscopic colorectal surgery.

      We examine before operation, 7 days after, 3 months after, 6 months after and 12 months after
      operation, by questionnaires (International Index of Erectile Function (IIEF) 、Short Form-8
      (SF8)、International Consultation on Incontinence Questionnaire-Short
      Form(ICIQ-SF)、International Prostate Symptom Score(IPSS)、Gastro-Intestinal Functional
      Outcome(GIFO)) and function tests (uroflowmetry and US).
    

Intervention name(s): laparoscopic colorectal surgery
Intervention type(s): Procedure
Intervention description(s): laparoscopic colorectal surgery
Other intervention name(s): endoscopic surgery
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male patients who will receive laparoscopic colorectal surgery
      
Keywords: Laparoscopic; Colon; Rectal; Surgery; Urinary function; Sexual function; Bowel function; Male
The Comparison of Single Incision Laparoscopic Appendectomy and Three Port Laparoscopic Appendectomy
Condition: Acute Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery
      with minimal trauma. In numerous studies, when conventional laparoscopic appendectomy using 3
      ports is compared with open appendectomy, it has advantages of reduced pain, reduced hospital
      stay, and enhanced cosmetic effects. Single incision laparoscopic surgery (SILS) was
      developed with the aim of reducing the invasiveness of conventional laparoscopy. In this
      study the investigators aimed to compare results of SILS appendectomy and three port
      conventional laparoscopic appendectomy prospectively.
    

Detailed description: 
      Total of 50 patients who undergoing laparoscopic appendectomy for acute appendicitis will
      randomly assign to undergo SILS appendectomy group (n = 25) or Three port laparoscopic
      appendectomy group (n= 25) according to a computer-generated table of random numbers.
      Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology
      (ASA) score, need for conversion to a standard or three port laparoscopic appendectomy, need
      for conversion to an open appendectomy will be recorded. Outcome measures include operative
      morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of
      colonic leak, wound infection, intrabdominal abscess hospital readmission, and hernia.
    

Intervention name(s): SILS appendectomy; Three port laparoscopic appendectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Single incision laparoscopic appendectomy will be performed; Three port laparoscopic appendectomy will be performed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: appendicitis, laparoscopy, single incision
YEARS Score vs CTPA in Pulmonary Embolism
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Interventional

Summary: 
      The investigators' aim in this study is to assess the sensitivity and accuracy of YEARS
      algorithm in the diagnosis of PE.
    

Detailed description: 
      Pulmonary embolism (PE) is a relatively common acute cardiovascular disorder with high early
      mortality rates that, despite advances in diagnosis and treatment over the past 30 years,
      have not changed significantly. Due to pulmonary bed obstruction, PE can result in acute
      right ventricular (RV) failure. Because most patients ultimately die within the first hours
      of presentation, early diagnosis is of paramount importance.

      The incidence of PE is estimated to be approximately 60 to 70 per 100,000, and that of venous
      thrombosis approximately 124 per 100,000 of the general population.

      Because of its diagnostic accuracy and wide availability, multidetector row computed
      tomography pulmonary angiography (CTPA) is the imaging test of choice to confirm acute
      pulmonary embolism in most patients. Increasing use of CTPA with diminishing prevalence of
      pulmonary embolism to even less than 10% has led to overdiagnosis of mostly subsegmental
      pulmonary embolism and unnecessary risks of radiation exposure and contrast medium induced
      nephropathy.

      To avoid these problems, validated diagnostic algorithms for suspected acute pulmonary
      embolism, using sequential testing, have been introduced. In these algorithms, a normal
      D-dimer test result in patients with low probability safely excludes pulmonary embolism.

      YEARS scoring system is an algorithm to predict diagnosis of pulmonary embolism according to
      clinical signs and D-dimer. The aim of this study is to test predictive accuracy, sensitivity
      and specificity of YEARS score compared to CTPA in the diagnosis of PE as CTPA is an invasive
      procedure, expensive and not readily available in many settings, thus, finding an alternative
      easier method that can diagnose PE may help save the time and resources.
    

Intervention name(s): Performance of CTPA
Intervention type(s): Diagnostic Test
Intervention description(s): Exposure to CT scan and injection of IV contrast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection
Condition: Abscess; Methicillin-Resistant Staphylococcus Aureus Infection
MeSH terms: Infections; Communicable Diseases; Staphylococcal Infections; Abscess
Study type: Interventional

Summary: 
      Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke
      Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated
      skin abscess.
    

Detailed description: 
      All patients will receive incision and drainage and wound cultures. Patients will then be
      randomized to 1) septa double strength two pills orally twice a day x 7 days or 2)placebo.
      Patients will then return to the emergency room on days 3 and 7 for wound repacking and
      evaluation. The primary outcome recurrence rates within 30 days of treatment. Patients who
      are not improving at the following visit will then be treated with additional antibiotics if
      needed. Data will be analyzed both by initial randomization and intention to treat.
    

Intervention name(s): Trim/ Sulfa DS; placebo
Intervention type(s): Drug; Drug
Intervention description(s): bactrim DS (800/160) two tablets PO BID x 7 days; matched placebo 2 pills PO BID x 7 days
Other intervention name(s): Bactrim
Intervention MeSH terms: Trimethoprim, Sulfamethoxazole Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Abscess; Cellulitis; Antibiotics; MRSA
Evaluation of a Novel Bionic Foot, AMPfoot 4+
Condition: Prosthesis User; Cognitive Change; Physical Activity
Study type: Interventional

Summary: 
      Background: Evaluating the use of a novel motorized ankle prosthesis during walking and under
      dual task circumstances is an important step in product development.

      Objective: To iteratively evaluate the effectiveness of a novel bionic foot, the Ankle
      Mimicking Prosthetic device 4+ (or AMPfoot 4+), during walking.

      Study design: Case study (crossover) research design.

      Methods: One male subject will conduct a baseline experimental trial with the current
      prosthetic device and several experimental trials with the AMPfoot 4+ to evaluate the
      effectiveness of the novel device and investigate the adaptation period. Prior to baseline
      experiments, a familiarization trial will be performed to determine intra-subject variability
      of the dual task. An experimental trial consists of 2 walking tasks, i.e. the 6-minute walk
      test (6MWT) and the 10-meter walk test. The 6MWT will be combined with a cognitive task, i.e.
      backwards counting, to create dual task circumstances. The outcome measurements for the dual
      task are the distance covered and the walking speed, heart rate (HR) (Polar), rating of
      perceived exertion (RPE), VO2 (Cosmed K5), electro-encephalography (EEG), electro-myography
      (EMG), electro-cardiography (ECG), electrodermal activity (/skin conductance),accuracy and
      total duration of the cognitive task, BodyMedia (physical activity) and the visual analogue
      scale (VAS) for fatigue and comfort. A 10-meter walk test will be evaluated on duration.

      Expected findings: In a first phase the novel device will probably reduce walking and
      cognitive performance, whereas fine-tuning the mechatronics (after several retests) should
      improve walking and cognitive performance during walking.
    


Intervention name(s): Ankle Mimicking Prosthetic Foot prototype 4+
Intervention type(s): Device
Intervention description(s): The amputee will walk with AMPfoot 4+, a novel bionic foot, designed and built by an engineer of department MECH (VUB, B)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AMPfoot; dual-task; cognitive performance; physical performance; lower-limb prosthesis
BLI1100-202: BLI1100 for the Treatment of Moderate to Severe Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the safety and efficacy of BLI1100 formulations to
      placebo for the treatment of moderate to severe acne vulgaris.
    


Intervention name(s): BLI1100; BLI1100 - modified formulation; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BLI1100 topical cream; BLI1100 topical cream; Placebo topical cream
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Transverse Supraumbilical Versus Pfannenstiel Incision for Cesarean Section in Morbidly Obese Women
Condition: Cesarean Section
Study type: Interventional

Summary: 
      This study aims to evaluate the efficacy and safety of transverse supraumbilical incision
      over Pfannenstiel incision in performing cesarean section for morbid obese pregnant women.
    

Detailed description: 
      Research Question In Morbidly obese women undergoing cesarean section, is transverse
      supraumbilical incision superior to Pfannenstiel incision? Research Hypothesis Transverse
      supraumbilical incision is superior to Pfannenstiel incision in morbidly obese women
      undergoing cesarean section.
    

Intervention name(s): transverse supraumbilical; pfannenstiel incision
Intervention type(s): Procedure; Procedure
Intervention description(s): transverse Supraumbilical Incision, in which the skin incision is a straight transverse skin incision slightly higher than the Pfannenstiel (5- 6) cm. from the upper border of the symphysis pubis The high transverse incision facilitated access to the fascia of the rectus abdominalis; Pfannenstiel Incision, in which the skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 ) cm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Bacteriuria
Study type: Interventional

Summary: 
      This study tests the following hypothesis: Does induced asymptomatic bacteriuria (E. coli
      83972) protect against symptomatic urinary tract infections in individuals with bladder
      emptying dysfunctions and prone to recurrent infection episodes? The study is performed using
      a double-blind randomized study protocol with a cross-over, with re-inoculations being
      patient-blinded (phase 1). After patients have fulfilled the cross-over, those who have had
      bacteriuria or placebo-periods < 12 months will be subjected to additional patient blinded
      inoculations (phase 2). During the entire study (phase 1+2) the study-team and the patients
      are unaware of urine culture results.
    


Intervention name(s): E. coli 83972
Intervention type(s): Biological
Intervention description(s): Active arm: Intravesical inoculation (by urethral catheterization) on three subsequent days with 30 ml E. coli 83972 (100 000 cfu/ml).
Placebo arm: Identical procedure but with saline, 30 ml.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Report of Urinary Tract Infection episode
Study to Develop a Group-Based E-Health Intervention for YA Cancer Survivors
Condition: Cancer Survivor; Young Adult
Study type: Interventional

Summary: 
      Investigators will test an evidence-based behavioral intervention that is responsive to Young
      Adults (YA's) expressed needs and priorities
    


Intervention name(s): Cognitive-Behavioral Stress Management and Health Education
Intervention type(s): Behavioral
Intervention description(s): Participants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and will be held once weekly for 10 weeks. Sessions will include Cognitive-Behavioral Stress Management and health education content.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Iron Fortified Wheat Flour on Cognition and Iron Status in Indian School Children
Condition: Iron Deficiency; Iron Deficiency Anemia; Cognition
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      This study is designed to evaluate the efficacy of NaFeEDTA-fortified whole wheat flour in
      improving cognition, hemoglobin, iron status and total body iron among school children in
      urban Bangalore.
    

Detailed description: 
      Background: Iron (Fe) deficiency is a major cause of anemia in children. Fortification of
      wheat flour with NaFeEDTA, a highly bioavailable iron fortificant that protects Fe from the
      phytic acid present in wheat flour, could be a practical approach to addressing this problem.

      Aims: To evaluate the efficacy of NaFeEDTA-fortified whole wheat flour in improving mental
      performance and reducing iron deficiency and improving body iron stores in urban, school
      going Indian children.

      Methods: A randomized, double-blind, 7 month, school-based feeding trial was carried out in
      Bangalore, India. Iron-depleted (serum ferritin, SF <20 µg/L), and/or iron deficient (serum
      transferrin receptor, TfR >7.6 mg/L), 6 -13 year old children (N=194) were randomly assigned
      to either receive a whole wheat flour based lunch meal fortified with 6 mg Fe as NaFeEDTA or
      an identical unfortified control meal. The meals were administered under supervision and left
      overs were weighed. Hemoglobin (Hb) and iron status were measured at baseline, 3.5 months,
      and 7 months. At baseline and at 7 months, the study children were also subjected to a
      battery of cognitive tests to assess attention/concentration, motor development, visuospatial
      and verbal abilities. Sensory evaluation using triangle tests were carried out using meals
      prepared from the fortified and unfortified whole wheat flour.
    

Intervention name(s): Fortification of wheat flour with NaFeEdta
Intervention type(s): Other
Intervention description(s): NaFeEdta Fortified Wheat Flour (100g)provided as a lunch meal. Fortification level of 6mg Fe/100g/day/child for 7 months
Intervention MeSH terms: Fe(III)-EDTA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Food Fortification; Iron deficiency; NaFeEdta; Iron deficiency anemia; Cognition