bioihbjkbjnl/mcl2 huggingface dataset:
Investigating the Effects of Daily Consumption of Blueberry (Poly)Phenols on Vascular Function and Cognitive Performance
Condition: Healthy Aging; Healthy
Study type: Interventional

Summary: 
      Foods rich in certain (poly)phenols, particularly flavonoids, such as berries and cocoa, have
      been shown to improve measures of vascular function as well as cognitive performance in human
      intervention studies. This is a randomized, double-blind, placebo controlled, parallel trial
      investigating the effects of daily blueberry (poly)phenol consumption on vascular function
      and cognitive performance in healthy elderly individuals. The study will be conducted at
      King's College London, Franklin-Wilkins Building.

      Eligible subjects will be healthy males and females aged 65-80.
    

Detailed description: 
      To date no study has investigated whether daily blueberry consumption can induce an increase
      in cerebral blood flow, with subsequent improvements in vascular and cognitive function. In
      this study, the investigators aim to directly link daily blueberry consumption with improved
      vascular function, increased cerebral blood flow and positive cognitive outcomes in healthy
      elderly individuals. The investigators will use a large group of elderly individuals'
      representative of a healthy population, both males and females, aged 65-80 years to evaluate
      the health effects of daily blueberry consumption.

      The main aim is to investigate whether improvements in vascular and cognitive function
      previously seen after blueberry consumption can be seen following 3-months daily consumption
      in elderly individuals, and whether enhanced cognitive performance is correlated with
      increased cerebral blood flow. The investigators hypothesise that daily consumption of an
      anthocyanin rich blueberry drink will improve cognitive performance and vascular function,
      increasing cerebral blood flow, in healthy older individuals.
    

Intervention name(s): Wild Blueberry powder; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Powdered extract obtained from wild blueberries. A daily administration of 27g wild blueberry powder will be administered.; Identical formulation as the treatment matched for fibre and vitamin C
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: polyphenols; Blueberries; cognition; vascular function; vascular health; cognitive function; anthocyanins; flavonoids
Zanamivir Versus Trivalent Split Virus Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This unblinded pilot study is intended to assess the feasibility of a larger double-blind,
      randomized control trial. For the larger trial the investigators are interested in
      understanding the relative benefits of vaccine and antiviral prophylaxis, the risk factors
      for influenza infection in healthy adults, and in assessing the safety and tolerability of
      seasonal antiviral prophylaxis in healthcare workers.

      The pilot study will be assessing the rate of infection with influenza and the rate of
      adherence to long-term zanamivir in 60 healthy volunteers.
    

Detailed description: 
      Several studies have demonstrated that zanamivir and oseltamivir are effective in preventing
      influenza infection and illness when used either as prophylaxis after exposure to a household
      contact with influenza or when taken for several weeks at the height of influenza activity in
      the general community. However, the longest duration of prophylaxis with neuraminidase
      inhibitors in two clinical trials, to date, has been six weeks.

      Antiviral medication will likely have an important role in the response to the next influenza
      pandemic. Additionally, there may be indications for use during seasons when the major
      infecting strain of influenza in not one whose antigen is well covered by the vaccine.
    

Intervention name(s): Fluviral; Zanamivir
Intervention type(s): Biological; Drug
Intervention description(s): One dose; 10 mg, OD, for duration of influenza season (10-23 weeks)
Other intervention name(s): Relenza
Intervention MeSH terms: Zanamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: antiviral drugs; influenza vaccines
Darunavir Levels, Virological Efficacy, Proviral ADN and Resistances in Patients on Darunavir/Ritonavir Monotherapy
Condition: HIV-infection
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      To evaluate the relationship between plasma and intracellular darunavir (DRV) concentrations
      and virological efficacy in HIV-infected patients on DRV/rtv monotherapy.
    

Detailed description: 
      To be enrolled, subjects had a plasma HIV-RNA <50 copies/mL for at least 6 months based,
      virologic failure while on a PI-containing regimen was allowed if the genotypic resistance
      tests showed no major resistance mutation associated to reduced susceptibility to DRV/rtv
      according to the International AIDS Society. Patients with transitory episodes of detectable
      plasma HIV-RNA viral load ("blip") preceded and followed by a plasma viral load <50 copies/mL
      without changes in antiretroviral treatment could also been included. The only exclusion
      criteria were pregnancy, hepatitis B coinfection and the concomitant use of drugs with
      potential major interactions with DRV/rtv pharmacokinetics.
    

Intervention name(s): Darunavir/ritonavir
Intervention type(s): Drug
Intervention description(s): Darunavir/ritonavir (800/100 mg once daily) monotherapy
Other intervention name(s): Prezista/norvir
Intervention MeSH terms: Ritonavir; Darunavir
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-infected patients who started an antiretroviral regimen based on darunavir-ritonavir
        (800/100 mg) once daily monotherapy between June 2010 and September 2010
      
Biospecimen description: 
      Blood samples (plasma and PBMC)
    
Keywords: Antiretroviral therapy; Boosted-Darunavir monotherapy; Resistance; Proviral DNA-HIV
Combined PECS II and Transeversus Thoracic Plane Blocks Vs Serratus Anterior Plane Block in Modified Radical Mastectomy
Condition: Ultrasound-Guided; Transeversus Thoracic Plane Blocks; Pectoral Nerve (PECS) Block; Serratus Anterior Plane Block; Modified Radical Mastectomy
MeSH terms: Aortic Dissection
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the analgesic efficacy of combined ultrasound
      (US)-guided pectoral nerve (PECS) block II and transversus thoracic plane (TTP) block versus
      US-guided serratus anterior plane (SAP) block in female patients undergoing modified radical
      mastectomy.
    


Intervention name(s): Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block; Serratus anterior plane (SAP) block
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia.; Patients will receive US-guided SAP block after induction of general anesthesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Post-exercise Protein Intake for Active Children
Condition: Child
Study type: Interventional

Summary: 
      Today, there is an important lack of knowledge on the effects of dietary protein on protein
      metabolism after physical activity in children. Here, the investigators will measure changes
      in whole body protein metabolism using minimally invasive techniques and stable isotope
      methodology at rest and after physical activity with the intake of milk protein.
    


Intervention name(s): nutrition
Intervention type(s): Other
Intervention description(s): protein-based food
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
The Role of Off-shift Robotic Telerounding Between Physicians and Nurses in the Surgical Intensive Care Unit
Condition: Off-shift Robotic Telerounding
Study type: Observational

Summary: 
      Hypothesis: The use of a mobile robotic telepresence system for off-hours rounding in the
      surgical intensive care unit has an impact on nurse-physician collaboration.

      Study question: Does the addition of mobile video communication provided by RTP affect
      nurse-physician collaboration during off shift rounding in the surgical intensive care unit
      when compared to the more common clinical practice of off-shift rounding using the telephone?
    

Detailed description: 
      This is a mixed-method study, involving both surveys and ethnographic fieldwork. The research
      team will utilize the Collaboration and Satisfaction About Care Decisions (CSACD) survey
      instrument at regular intervals to assess nurse-physician collaboration. The instrument is
      validated and reliable and has been extensively tested. Permission was obtained to use the
      instrument. The ethnographic investigation will run concurrently and be performed by a
      doctoral student from Massachusetts Institute of Technology (MIT). No part of the study will
      involve patient intervention. The study will be conducted in the surgical intensive care unit
      (SICU).

      The survey-based portion of the study is a prospective, randomized, crossover-controlled
      trial; it will generate ordinal data regarding nurse-physician collaboration and
      satisfaction. The ethnographic portion of the study will involve observation and interviews.
      The MIT student will engage in unobtrusive observational shadowing of APs and nurses
      throughout the study, and will formally interview each observed AP and nurse twice during the
      entire length of the study: once at the onset of the study, and once as the study draws to
      conclusion. This observational shadowing will include visits to the SICU. All participants
      will be consented for the study. Consent for and implementation of these methods will be
      undertaken in a manner consistent with current best research practice; extensive measures
      will be taken to protect staff confidentiality.
    

Intervention name(s): Remote physician rounding
Intervention type(s): Behavioral
Intervention description(s): Use of Remote physician rounding using Remote Telepresence Robotics
Other intervention name(s): RTP; Remote Telepresence Rounding; Telemedicne; Robotic rounds
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Full time Nursing and Physician Staff providing rounding services in the Surgical Intensive
        Care Unit
      
Keywords: Comparing telephone VS RTP in SICU rounding practices
Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of the study is to evaluate the safety, tolerability and
      Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general SLE
      as add on to standard of care treatment during the trial.
    


Intervention name(s): Placebo; Epratuzumab 400 mg; Epratuzumab 1200 mg; Epratuzumab 100 mg; Epratuzumab 600 mg
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Placebo infusions at study weeks 0, 1, 2, and 3.; Epratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.; Epratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.; Epratuzumab 100 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.; Epratuzumab 600 mg infusions at study weeks 0, 1, 2, and 3.
Intervention MeSH terms: Epratuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lupus; Monoclonal antibody; B-cell immunotherapy; Epratuzumab
Efficacy of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes
Condition: Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      In this the investigators will be comparing the effects of Laparoscopic sleeve gastrectomy
      with intensive medical management on weight and metabolic parameters.
    

Detailed description: 
      Intensive medical management will include

        1. VLCD

        2. Physical activity

        3. Exenatide

        4. Metformin

        5. Insulin detemir
    

Intervention name(s): Sleeve gastrectomy; Intensive medical management
Intervention type(s): Procedure; Drug
Intervention description(s): Sleeve gastrectomy; Exenatide 10 mcg BD, Metformin 2-3 gm/day, 800 Kcal diet
Other intervention name(s): Bariatric surgery; Laparoscopic sleeve gastrectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sleeve gastrectomy; Intensive medical management
High Quality Fluorescent Cholangiography
Condition: Extrahepatic Biliary Tree Injury
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goal of this randomized controlled trial is to compare the quality of extrahepatic
      biliary fluorescent visualization under two injection protocols to optimize extrahepatic
      biliary cholangiography.
    

Detailed description: 
      Biliary fluorescence imaging is widely used to identify the extrahepatic biliary tract during
      laparoscopic cholecystectomy. However, fluorescent developer Indocyanine Green（ICG） still
      lacks standardization, and not every visualization of the extrahepatic biliary tract is
      satisfactory. Some research groups have shown that injection of ICG 1 day before surgery can
      achieve the best fluorescence imaging of the biliary tract, but some research groups have
      suggested that injection of a very low dose of ICG 45 minutes before surgery can improve the
      satisfaction of fluorescence imaging. However, no study compares the quality of biliary
      fluorescence imaging between the two injection protocols. This study will compare the
      fluorescence imaging effects of the two schemes to obtain the best injection scheme at
      present and standardize the use of icg.
    

Intervention name(s): Indocyanine green
Intervention type(s): Drug
Intervention description(s): Indocyanine Green 25mg kit for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: icg; fluorescent cholangiograph
Thoraco-abdominal Volume Variations During Anesthesia Studied by OEP.
Condition: Mechanical Ventilation
Study type: Interventional

Summary: 
      The aim of this study is to examine chest wall volume changes monitored by opto-electronic
      plethysmography during recovery from anesthesia and early postoperative period.
    

Detailed description: 
      This is prospective, randomized clinical trial in subjects undergoing elective surgery
      requiring general anesthesia.

      Opto-electronic plethysmography (OEP) has been developed as a non-invasive method for the
      analysis of chest wall motion, allowing highly accurate measurements of chest wall volume
      changes of different respiratory compartments in various conditions.

      The investigators set out to use this technology to study chest wall volume changes during
      recovery from total intravenous anesthesia (from discontinuing the anesthetic agent till
      extubation) and early postoperative period.

      The study protocol compares two different approaches:

        1. The group receiving recruitment maneuver (RM) immediately after intubation and positive
           end expiratory pressure (PEEP) 7 cm H20 until extubation. Inspiratory oxygen
           concentration 40% during recovery from anesthesia.

        2. The group not receiving RM, PEEP 0 cm H2O and inspiratory oxygen concentration 100%
           during recovery from anesthesia.

      The volume changes of the chest wall is monitored continuously by OEP, functional residual
      capacity (FRC) and arterial oxygenation are measured at the defined points in the protocol.
    

Intervention name(s): lung recruitment maneuver
Intervention type(s): Procedure
Intervention description(s): RM: peak inspiratory pressure 30 cmH2O, PEEP 15 cm H20 FiO2 0,4 (from end of surgery till extubation)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: mechanical ventilation; pressure control ventilation; lung recruitment; positive end expiratory pressure; opto-electronic plethysmography; chest wall volume variation; intravenous anesthesia
Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep
Condition: Sleep; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, placebo-controlled, cross-over pilot study to investigate the
      efficacy of Rest-ZZZ in healthy participants with difficulty falling asleep or staying a
      sleep. The study will have 3 study periods. During each study period, eligible participants
      will consume either Rest-ZZZ, comparator product, or placebo for 7 days during each study
      period (1 product per study period), with a 1-week washout period in between each period. The
      primary objective is the comparison in sleep quality using a sleep quality questionnaire from
      pre-supplement to Day 7 between the Rest-ZZZ, comparator, and placebo. Other study outcomes
      include the change in quality of life, profile of mood states (POMS), and safety outcomes
      such as vital signs, clinical chemistry and hematological markers
    


Intervention name(s): Rest-ZZZ; Active Comparator - Diphenhydramine HCl; Placebo
Intervention type(s): Dietary Supplement; Drug; Other
Intervention description(s): A dietary supplement containing melatonin, valerian root, chamomile, passion flower, GABA, hawthorn berry, and lemon balm; DIN 02229960 encapsulated for blinding purposes; No active ingredients
Intervention MeSH terms: Diphenhydramine; Promethazine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Sleep; Healthy; Rest-ZZZ; randomized controlled trial; RCT; dietary supplement; natural health product
The Effects of Supplementing Tyrosine on Blood Pressure in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this experiment is:

        -  Primary: To determine the effects of tyrosine supplementation on orthostatic hypotension
           in people with PD.

        -  Secondary: To determine the effects of tyrosine supplementation in people with PD with
           autonomic insufficiency on HR, BP, and norepinephrine responses during acute exercise
           stress.

      Orthostatic hypotension and autonomic abnormalities are a common problem for individuals who
      suffer from PD, especially as it leads to lightheadedness and falling. For those affected, it
      can drastically reduce quality of life. It has been hypothesized that tyrosine may impact
      upon individuals suffering from PD. There is ample evidence in animal models that supports
      our theory; however there is no clinical evidence of the impact tyrosine supplementation may
      have in PD patients who suffer from orthostatic hypotension and blunted BP and HR responses.
      Positive findings that supplemental tyrosine increases BP and HR in people with PD during
      daily activities such as standing up from a chair and walking can lead to new therapies to
      improve Parkinsonian orthostatic hypotension.

      Hypothesis We will test the hypothesis that symptomatic individuals with PD on dopamine
      therapy who suffer from orthostatic hypotension and blunted HR and BP responses will improve
      after tyrosine supplementation.
    


Intervention name(s): Tyrosine; Placebo Comparator:Sugar Pill
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Tyrosine supplementation (500 mg 2 x daily) for 7 days; Placebo sugar pills (2x daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's Disease (PD); Orthostatic hypotension (OH)
A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis
Condition: Pouchitis
MeSH terms: Pouchitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy of vedolizumab intravenous (IV) and
      placebo in terms of the percentage of participants with chronic or recurrent pouchitis
      achieving clinically relevant remission.
    

Detailed description: 
      Vedolizumab is being tested to treat people who have chronic pouchitis. This study will look
      at the healing of inflammation of ileal pouch in people who take vedolizumab as compared to
      those receiving a matching placebo. The study will enroll approximately 110 patients.
      Participants will be randomly assigned to one of the two treatment groups-which will remain
      undisclosed to the patient and study doctor during the study (unless there is an urgent
      medical need):

        -  Vedolizumab 300 mg IV

        -  Placebo IV

      All participants will receive an intravenous infusion at Day 1, Weeks 2, 6, 14, 22, and 30
      along with concomitant antibiotic treatment with ciprofloxacin 500 mg twice daily through
      Week 4.

      This multicenter trial will be conducted in North America and Europe. The overall time to
      participate in treatment and efficacy assessment of this study is 34 weeks. Participants will
      make multiple visits to the clinic, plus a final visit 18 weeks after the last dose of study
      drug for a safety follow-up assessment (up to Week 48). Participants will also participate in
      a long-term follow-up, by phone after the last dose of study drug up to Week 56.
    

Intervention name(s): Vedolizumab Placebo; Ciprofloxacin; Vedolizumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vedolizumab placebo-matching IV infusion; Ciprofloxacin tablets; Vedolizumab IV infusion
Other intervention name(s): Entyvio; MLN0002 IV; Kynteles
Intervention MeSH terms: Ciprofloxacin; Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy