bioihbjkbjnl/mcl2 huggingface dataset:
Effects of a Double-Blind, Single Dose of PER977 Administered Alone, and Following a Single Dose of Edoxaban
Condition: Anticoagulant Reversal; Reversal of Edoxaban Induced Anticoagulation
Study type: Interventional
Phase: Phase 1

Summary: 
      PER977 monotherapy and co-administration following 60 mg edoxaban will have an acceptable
      safety and tolerability profile with no impact on pro-coagulant biomarkers. A dose of PER977
      that reverses the effects of edoxaban on the pharmacodynamic (PD) biomarkers (point of care
      prothrombin time [PoC-PT]), and/or secondary biomarkers (thromboelastography reaction time
      [TEG-R]) will be identified.
    

Detailed description: 
      Normal subjects will be dosed with PER977 or placebo alone and 1 week later, they will be
      given a single dose of edoxaban followed in 3 hours by a single IV dose of PER977. The
      purpose is to show safety and tolerability of PER977 alone and when combined with a NOAC
      (edoxaban). The study will also provide some insight into the doses that may be required to
      reverse a steady state edoxaban.
    

Intervention name(s): PER977, Placebo
Intervention type(s): Drug
Other intervention name(s): ciraparantag
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: PER977; Activated partial thromboplastin time; Assessment; D-dimer; Enrollment; Investigational drug; Investigational treatment; Period; Premature subject withdrawal; Prothrombin time; Randomization number; Study discontinuation; Study drug; Subject number; Study treatment; Thromboelastography-reaction time
Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 24-week, randomized, double-blind, placebo-controlled trial of exenatide weekly
      injection (2mg per dose) as an adjunctive therapy in 70 schizophrenia subjects to examine
      exenatide's effects on negative symptoms and cognition.
    

Detailed description: 
      The specific aims include:

      Primary aim:

      1. Examine the efficacy of exenatide weekly injection in improving negative symptoms as
      measured by the Scale for the Assessment of Negative Symptoms (SANS) total score.

      Secondary aims:

      1. Examine the efficacy of exenatide in improving cognition as measured by the Measurement
      and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive
      Battery (MCCB) composite score.

      Tertiary/Exploratory aims:

        1. Examine exenatide's effect on schizophrenia symptoms as measured by the Positive and
           Negative Syndrome Scale (PANSS) total score.

        2. Examine the efficacy of exenatide in improving social function as measured by the
           Instrumental Activities of Daily Living Scale (IADL) and the Heinrich Carpenter Quality
           of Life Scale (QLS).

        3. Examine exenatide's effect on neuro-protection as measured by the change in hippocampal
           volume.

        4. Examine exenatide's effects on inflammatory markers including serum levels of high
           sensitivity C-reactive Protein (CRP), Interleukin 6 (IL-6), and tumor necrosis factor
           (TNF-α).

        5. Examine the potential moderator role of baseline serum levels of C-reactive Protein
           (CRP), Interleukin 6 (IL-6), tumor necrosis factor (TNF-α), and baseline hippocampal
           volume for exenatide's effects on negative and cognitive symptoms.

        6. Examine the potential mediator role of changes from baseline in serum levels of
           C-reactive Protein (CRP), Interleukin 6 (IL-6), tumor necrosis factor (TNF-α), and
           hippocampal volume for exenatide's effects on negative and cognitive symptoms.

        7. Examine the efficacy of exenatide in reducing body weight and improving glucose
           metabolism as measured by fasting plasma glucose and HbA1c.

        8. Examine the safety and tolerability of exenatide as measured by changes in the side
           effects questionnaire (SEQ, SEQabbrev), EKG and vital signs
    

Intervention name(s): Exenatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Exenatide SQ 2mg/week for 24 weeks.; Placebo SQ 1x/week for 24 weeks.
Other intervention name(s): Bydureon; Control
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Dietary Nitrate and Cardiovascular Health
Condition: no Medications
Study type: Interventional

Summary: 
      An expanding number of studies suggest a therapeutic role for nitrate and nitrite, most
      notably in treatment and prevention of cardiovascular disease including ischemia-reperfusion
      (IR) injury and hypertension. The nutritional aspects of these cardioprotective effects are
      particularly intriguing since nitrate and nitrite are abundant in our everyday diet.

      Whether increasing the circulating pool of nitric oxide and nitrite by dietary nitrate offers
      a novel mechanistic approach to regulate mobilization of circulating angiogenic cells and
      thus regenerative processes in cardiovascular medicine is not known. Thus, in the present
      study, we tested whether oral application of nitrate leads to an enhanced number of
      circulating angiogenic cells and whether this is associated with an improvement in
      endothelial function.
    

Detailed description: 
      Administration of a single dose of nitrate intervention or water alone to healthy volunteers.
      Before and up to 4 hours (short-term)/6 days (long-term) after ingestion, marker of vascular
      function are measured in plasma and by using high-resolution ultrasound.

      Measurements are taken before and up to 4 h after double blind cross-over per os
      administration of a single dose of nitrate intervention (150 ml tab water with 150 umol/kg
      sodium-nitrate) or water control (100 ml Chapelle mineral water) to healthy volunteers.
      Circulating angiogenic cells are measured as CD34+/KDR+ and CD133+/KDR+ mononuclear cells in
      blood by flow cytometry and plasma is analyzed for nitrate and nitrite, as well as
      mobilization markers and cytokines including stromal cell derived factor, vascular
      endothelial growth factor and stem cell factor. All measurements are performed after >12h
      overnight fasting.
    

Intervention name(s): Dietary nitrate; Water
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 150 ml tab water with 150 umol/kg sodium-nitrate; 150 ml Chapelle mineral water
Other intervention name(s): sodium nitrate; H2O
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Dietary nitrate
Effects of a Probiotics on the Health of Normal Young Males
Condition: Inflammation; Dyslipidemia
MeSH terms: Dyslipidemias; Inflammation
Study type: Interventional

Summary: 
      The important role played by the GI tract microflora on the metabolic health of an individual
      are increasingly recognized. In this respect, the initial studies of Metchinkoff that
      suggested a role of fermented food (specifically yoghourts ) to modulate the gut microflora
      have evolved into the concept of "probiotics". Probiotics are living microorganisms that
      bring a benefit to the host when administered in sufficient quantity (WHO/FAO, 2001).

      Here the investigators will study, in normal young male volunteers, the potential to modulate
      post-prandial metabolic and inflammatory responses by the administration of a yoghourt
      containing the probiotic Lactobacillus rhamnosus (LGG).
    

Detailed description: 
      This is a prospective, randomized, double-blind and cross-over study designed to evaluate the
      potential of a probiotic (Lactobacillus rhamnosus) to modulate the post prandial metabolic
      and inflammatory response of normale healthy individuals.

      After a wash out period during which volunteers will have to follow a diet devoid of all milk
      or milk-derived products, they will receive, in random order, either a daily dose of the
      probiotic, or a daily dose of acidified milk (control) for a total of three consecutive
      weeks. At the end of each of these period, they will be submitted to a day of investigation,
      during which their metabolic and inflammatory profile will be studied following the ingestion
      of a standard test meal. The potential for the probiotic to modulate the metabolic and
      inflammatory parameters will be evaluated.

      The test meal will provide 1004Kcal under the form of 45.4g proteins (17%), 69g total fatty
      acids (62%), and 52.6g glucids (21%) as previously published (Schwander et al, J Nut 2014).
    

Intervention name(s): Probiotic yogurt; Acidified milk
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic yogurt (fermented milk with Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus- YoFlex FD-DVS YC-X11 Fr, with the addition of Lactobacillus rhamnosus GG (LGG)- Culture Collection, University of Göteborg, Sweden CCUG 34291).; Milk will consist in an isocaloric supplement (compared to probiotic yogurt) of unfermented milk
Other intervention name(s): LGG; Milk
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Probiotic; Yoghourt; Inflammation; Metabolomics
To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of
      BI 1026706
    


Intervention name(s): BI 1026706 Placebo; BI 1026706
Intervention type(s): Drug; Drug
Intervention description(s): Placebo to BI 1026706; different dose formulations
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
A Non-interventional Trial of Erlotinib (Tarceva) Metastatic Non-small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      This is a non-interventional, open label, single arm, multicenter study to assess the safety
      and efficacy of erlotinib in participants with non-small cell lung cancer.
    


Intervention name(s): Erlotinib
Intervention type(s): Drug
Intervention description(s): Participants with locally advanced or metastatic non-small cell lung cancer will be treated with erlotinib according to the product label. This non-interventional study will not affect by any means the treatment, medical care or monitoring of the participant, since it reports retrospective data, which already exist in the participants' medical files.
Other intervention name(s): Tarceva
Intervention MeSH terms: Erlotinib Hydrochloride
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants with locally advanced or metastatic NSCLC that are planned to receive
        erlotinib containing regimen according to label will be included in this trial.
      
Keywords: Non-small cell lung cancer
Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.
Condition: Is an Only Child
MeSH terms: Psychomotor Agitation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine efficacy of intraoperative clonidine to prevent
      postoperative agitation in pediatric anesthesia with sevoflurane.
    


Intervention name(s): Clonidine
Intervention type(s): Drug
Intervention description(s): 1μg/Kg, IV (in the vein) intraoperative. Number of Cycles: single dose.
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Clonidine; Psychomotor agitation; Anesthesia recovery period; Tonsillectomy; Child, preschool
Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation
Condition: Postoperative Ileus
MeSH terms: Ileus
Study type: Interventional

Summary: 
      Postoperative ileus is a common after abdominal surgery. Multifactorial etiology such as
      surgical trauma, bowel manipulation and perioperative opioids contributes to delayed return
      of normal gut function Chewing gum has recently been used as a form of sham feeding to
      stimulate acceleration of gut function after abdominal surgery.

      The investigators hypothesize that sham feeding with chewing gum will accelerate return of
      gut function after liver transplantation.
    


Intervention name(s): gum chewing; Control
Intervention type(s): Other; Other
Intervention description(s): gum chewing; Routine care during NPO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sham feeding; postoperative ileus; liver transplantation
Conventional Neck Exercise With and Without Scapular Corrective Exercises in Patients With Forward Head Posture
Condition: Forward Head Posture
Study type: Interventional

Summary: 
      To determine the effects of conventional neck exercises with and without scapular corrective
      exercises on pain, cervical range of motion and disability in patients with forward head
      posture
    


Intervention name(s): scapular corrective exercises; conventional neck exercises
Intervention type(s): Other; Other
Intervention description(s): 40 minutes each, three times a week for six weeks; 40 minutes each, three times a week for six weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Forward head posture; Neck pain; conventional neck exercises; scapular corrective exercises
Procedure For The Reference Range Study For Absolute MA
Condition: Transmission, Blood, Recipient/Donor
Study type: Observational

Summary: 
      CLSI guidelines shall be followed to gather data from a minimum of one hundred and twenty
      normal donors to create reference intervals for various Haemonetics reagents. Venous blood
      from a minimum of 146 reference subjects shall be tested. Blood from 160 donors will be drawn
      at the study site to account for aberrant or outlying data excluded for technical or other
      reasons.
    

Detailed description: 
      As part of an examination of how LY30 is calculated, the investigators would like to explore
      the differences between Maximum Amplitude (MA) and LY30 calculated in the traditional small
      deviation method and by an absolute MA method.

      The maximum amplitude (MA) for a sample is determined in real-time using one of two
      MA-identifying algorithms: Small Deviation MA (the default algorithm) or Absolute MA. Both
      algorithms are available in commercially available software. Both algorithms find an MA for a
      sample; however, the difference between the two algorithms is the "acceptance criteria" which
      each use for identifying the MA. As compared to Small Deviation MA, the Absolute MA has a
      larger and more stringent rules set.

      A study will be run to establish reference intervals following the guidelines set out in CLSI
      document C28-A3c. This guideline calls for a reference interval to be constructed from at
      least 120 donors. To meet the guidance outlined in the CLSI guideline, we will collect a
      minimum of 146 donors.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        community sample
Effect of Vitamin E Supplementation in Methylation and microRNAs Profile
Condition: Obesity
Study type: Interventional

Summary: 
      It is a study of clinical and interventional character, in which individuals who participate
      in the intervention will be selected for convenience of the project database entitled "Second
      Cycle Diagnosis and Intervention Food Situation, Nutrition and Noncommunicable Disease More
      Prevalent Population of the city of João Pessoa / PB ". They will be invited to participate
      in the intervention female subjects, overweight or obese, aged 20 and 59 years. The selected
      individuals will be distributed randomly into four groups: receive daily supplementation of
      01 capsules containing 400 mg of vitamin E synthetic source (Group 1); receive daily
      supplementation of 01 capsules containing 400 mg of natural source vitamin E (Group 2);
      receive daily supplementation of 01 placebo capsule (control group); and non-intervention
      group. Individuals of intervention groups will receive dietary plan respecting individual
      needs, in order to control weight during the 08 weeks period. The subjects of the group
      without intervention, did not follow a diet plan, nor did they take vitamin E or placebo
      capsules, and were asked to continue their current eating habits over the 8-week period This
      project aims to evaluate whether vitamin E supplementation may modify the methylation and
      microRNAs profile.
    


Intervention name(s): vitamin E; starch
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): daily intake of vitamin E; daily intake of starch (control)
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Screening
Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients
Condition: Androgen Profile; Inflammatory Markers; IVF Outcome
Study type: Interventional

Summary: 
      Polycystic ovary syndrome (PCOS) is characterized by enlarged ovaries, menstrual irregularity
      and hyperandrogenism and is the most common cause of oligoovulatory infertility. Insulin
      resistance with resulting hyperinsulinemia is also common among women with PCOS, along with
      increased risk for dyslipidemia, hypertension, diabetes and related cardiovascular
      consequences. Resveratrol is a natural polyphenol with anti-carcinogenic, anti-proliferative
      and pro-apoptotic properties, that has been shown to decrease proliferation and
      steroidogenesis in theca cells, emerging as a potential therapeutic agent in PCOS patients.
      However, little is known about its potential beneficial effect on oocyte quality as well as
      other reproductive outcomes, such as implantation an pregnancy rates. The present study
      evaluates effects of resveratrol on selected biochemical parameters and reproductive outcome
      among patients with PCOS who undergo in vitro fertilization (IVF).
    


Intervention name(s): Resveratrol; Placebo pills
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The patients will take 2 g of resveratrol per day for 40 days.; The patients will take placebo for 40 days.
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Androgen; IVF; Resveratrol; PCOS.
Fluid Management Study to Evaluate Changes in Intravascular Volume After Applying Various Pressure Levels on the Caval Vein
Condition: Intravascular Volume; Respiratory Changes
Study type: Interventional

Summary: 
      Fluid therapy optimization in the perioperative period has been considered as major
      contributor to improve oxygen delivery. A recent, noninvasive approach to estimate fluid
      requirements in the anesthetized patient with arterial line is the assessment of difference
      in pulse pressure (dPP). Intraoperative fluid management by dPP is a goal-directed fluid
      management approach to avoid both hypervolemia and hypovolemia. However, several clinical
      factors may impede dPP measurements. Surgical manipulations in abdominal procedures may
      interfere with hemodynamic stability due to obstruction of the caval vein. Physiological
      considerations make us hypothesize that only intense pressure impedes caval blood flow and
      thus hemodynamics and dPP. Therefore, the investigators want to assess those changes after
      standardized application of three different pressure levels (2 N, 5 N, 10 N) on the caval
      vein.
    


Intervention name(s): Changes of difference in pulse pressure and plethysmography after applying various pressure levels on the caval vein
Intervention type(s): Other
Intervention description(s): Following hepatic resection, a fitting area for pressure application on the caval vein will be identified by the attending surgeon. Baseline assessments of hemodynamic and heart-lung interaction parameters will be taken. Thereafter the surgeon will apply three different pressure levels (2 N, 5 N, 10 N) at random with a force gauge (Fa. ATP Messtechnik, Ettenheim, Germany). Assessment of the parameters will be performed after 2 minutes of pressure application by an investigator, unaware of the pressure applied. After each pressure application 5 minutes will be waited to assure hemodynamic recovery.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: fluid management; fluid therapy; dPP; difference in pulse pressure; PVI; pleth variability index; external pressure applied on the caval vein
Induction of Immunogenicity With Different Doses of Grass MATA in Subjects Allergic to Grass and Rye Pollen
Condition: Type I Hypersensitivity
MeSH terms: Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 2

Summary: 
      Grass MATA (modified pollen allergen tyrosine adsorbate) has been developed to provide
      pre-seasonal specific immunotherapy for patients with hypersensitivity to grass and rye
      pollen. Different doses of Grass MATA will be administered and immunological changes
      following this treatment will be assessed.
    

Detailed description: 
      Grass MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients
      with proven type I hypersensitivity to cross reacting grass pollens.

      The grass pollen extract is modified with glutaraldehyde to produce the active ingredient, an
      allergoid. This modification reduces the reactivity of the extract with IgE antibody, thus
      reducing the risk of side effects. However, a simultaneous reduction in other important
      immunological properties, such as IgG and T cell reactivities, is not seen.

      MPL (Monophosphoryl Lipid A), a purified, detoxified glycolipid derived from the cell wall of
      Salmonella minnesota, is included in the product formulation as an adjuvant to increase the
      immunogenic effect of the product and to enhance the switch from an allergen-specific TH2 to
      a TH1-like T cell profile.

      The purpose of this study is to assess specific immunological changes (IgG, IgG1, IgG4 and
      IgE) in allergic subjects following 2 subcutaneous injections of different doses of study
      medication (Grass MATA or placebo) administered 3 weeks apart. The immunological changes will
      be used to assess the performance of the R7 IgG reactivity assay over a range of clinically
      efficacious doses.
    

Intervention name(s): Grass MATA MPL
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Allergy; Allergoid; Specific Immunotherapy