bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Polyphenols From Milk and Dark Chocolate
Condition: No Disease
Study type: Interventional

Summary: 
      Dark chocolate is one of the richest sources of polyphenols though it has been hypothesised
      that the bioavailability and therefore probably the bioefficacy of epicatechin from milk
      chocolate was reduced compared to dark. This study is designed to compare milk and dark
      chocolate as a source of polyphenols with a control "chocolate" for improving a risk
      biomarker for vascular disease.
    

Detailed description: 
      Dark chocolate is one of the richest sources of polyphenols, for example, a standard 40g
      portion of dark chocolate contains 400-800 mg of polyphenols, compared to red wine (170 mg
      /100ml) or an apple (200 mg/piece). Cocoa polyphenols, most notably the catechins, can exist
      in both lipid and water-based environments (amphipathic), meaning they can spare both
      lipophilic and hydrophilic vitamins. There have been a number of human trials conducted using
      chocolate or cocoa and measuring various endpoints. Most have been conducted with dark
      chocolate. An article in Nature found that the bioavailability of epicatechin from milk
      chocolate was substantially reduced compared to dark, and even dark taken with a glass of
      milk (Serafini et al 2003). The hypothesis was that the milk proteins bind to polyphenols,
      making them unavailable. Subsequent studies have not been able to reproduce this, but none
      have been conducted using solid chocolate as the first study, all have been done using a
      drink matrix, which may completely alter the binding interactions of the polyphenols and
      protein. To this end, this study is designed to compare solid chocolates as a source of
      polyphenols for improving a risk biomarker for vascular disease.

      This study is designed as a blinded, three arm crossover trial. The primary outcome measure
      is to compare endothelial function after consumption of 3 chocolates (1 milk, 1 dark, 1
      polyphenol-free control) with a secondary outcome of arterial stiffness. All volunteers will
      take all chocolate types in a crossover design. Subjects will undergo medical screening,
      anthropometry, physical activity and dietary assessments before randomization for the order
      of consumption.
    

Intervention name(s): Dark Chocolate; Milk Chocolate; Control (polyphenol-free) "Chocolate"
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1 portion; 1 portion; one portion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Endothelial function; Arterial stiffness; Dark chocolate; Milk chocolate; Polyphenols
The Maraviroc Central Nervous System (CNS) Study
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to describe the Central Nervous System exposure of maraviroc in
      HIV-1 infected subjects receiving a stable antiretroviral regimen, including maraviroc, at
      steady state.
    

Detailed description: 
      15 HIV-1 infected subjects currently receiving stable antiretroviral therapy will be
      recruited. At study entry, within 14 days of screening procedures, subjects will commence
      maraviroc dosed at 150 mg twice daily. For the rest of study period antiretroviral therapy
      will comprise:

        -  Truvada™ one tablet once daily at 0900

        -  Kaletra™ two tablets twice daily 0900 and 2100

        -  maraviroc 150 mg twice daily at 0900 and 2100

      Subjects will attend for regular clinic visits during study treatment phase.

      On day 15, subjects will attend the unit in the morning prior to usual dosing time. Blood
      with be drawn to assess plasma maraviroc concentration pre dose and pre lumbar puncture. A
      lumbar puncture will be performed under standard aseptic techniques to asses CSF maraviroc
      concentration and routine CSF parameters.

      On completion of this study visit, subjects will cease maraviroc, continue on their usual
      antiretroviral regimen and attend for a follow up visit 10 days later.
    

Intervention name(s): Maraviroc
Intervention type(s): Drug
Intervention description(s): 150mg twice daily
Intervention MeSH terms: Maraviroc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treatment experienced
Evaluation of an Asthma Treatment Strategy Based on Exhaled Nitric Oxide Measurements in Adolescents
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of ICAC-01 is to determine whether an asthma treatment strategy that measures
      exhaled nitric oxide (eNO) to indicate disease progression is more effective in treating
      asthma symptoms when combined with existing asthma treatment guidelines than treatment using
      the guidelines alone.
    

Detailed description: 
      Over the past two decades, the prevalence of asthma has dramatically increased in many parts
      of the world. The current National Asthma Education and Prevention Program (NAEPP) identifies
      inhaled corticosteroids (ICS) as the preferred long-term control therapy for all forms of
      persistent asthma. However, there is still a significant proportion of patients with
      persistent asthma who are not receiving ICS therapy or do not follow their treatment plan.
      Individualized asthma treatment plans are needed. The use of biomarkers, in addition to NAEPP
      guidelines, may help enhance the level of asthma assessment, guide medication regimens, and
      improve overall asthma control. This study will determine whether NAEPP-recommended
      treatment, combined with eNO measurement, is more effective in reducing asthma symptoms than
      NAEPP-recommended treatment alone. ICAC-01 will last 46 weeks and will comprise 8 study
      visits.

      ICAC-01 also includes a mechanistic sub-study (ICAC-02). Its primary objective is to
      determine whether "highly sensitized", compared to "weakly sensitized" asthmatic subjects
      have more severe asthma, as defined by the levels at randomization to the completion of
      ICAC-01. To address the primary objective of ICAC-02, the study will include all the
      participants enrolled in ICAC-01 with dust mite-, cockroach- and/or alternaria-specific IgE
      levels within certain parameters.
    

Intervention name(s): Inhaled corticosteroids; eNO measurement
Intervention type(s): Drug; Procedure
Intervention description(s): Used for both regular asthma control and as a rescue inhaler; measured by Aerocrine® NIOX device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exhaled Nitric Oxide; Lung; Urban Health; Child; Adolescent
Effects of Dehydroepiandrosterone Supplementation on Cumulus Cells Gene Expression Under Controlled Ovarian Hyper-stimulation in Patients With Diminished Ovarian Reserve
Condition: Dehydroepiandrosterone; DHEAS; Gene Expression of Cumulus Cells.; Ovarian Hyper-stimulation Protocol.; Artificial Reproduction Technology.
MeSH terms: Ovarian Hyperstimulation Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Diminished ovarian reserve (DOR) is one the challenge in the field of artificial reproductive
      technology (ART) while there is still no effective resolution of this disorder. In patents
      with DOR, the pregnancy rate is about only 2-4%. Eventually, patients with DOR turn to adapt
      children instead. In recent studies, dehydroepiandrosterone (DHEAS) supplement might play a
      role in reverse diminished ovarian reserve and improve the prognosis of ART. Cumulus cells,
      formed cumulus-oocyte complex (COC) with oocyte, play a important role in folliculogenesis,
      oocyte maturation, oocyte meiosis and ovulation. Growing evidences disclose there are
      crosstalks between oocyte and cumulus cells as paracrine regulations. Aberration the
      crosswalks between oocytes and cumulus cells would be associated with poor prognosis of
      folliculogenesis and further pregnancy outcomes. In patients under ovarian hyper-stimulation
      protocol, the assessment of cumulus cells might be reliable indicators of folliculogenesis,
      embryo development, pregnancy rate and pregnancy outcomes. These genes (indicators), such as
      Hyaluronan synthase（HAS2), Versican (VCAN), Thrombospondin 1 (THBS1), Runt-related
      transcription factor 2 (RUNX2), Chromobox homolog 3 (CBX3),Tripartite motif-containing 28
      (TRIM28), B-cell lymphoma 2 (BCL2)，BCL2-associated X protein (BAX). This study was assess the
      gene expressions of cumulus cells after the DHEAS supplement in patients with DOR under
      ovarian hyper stimulation protocol.
    

Detailed description: 
      This study was designed as a prospective case-control study to assess the gene expression of
      cumulus cells after DHEAS supplement. Patients with diminished ovarian reserve under ovarian
      hyper-stimulation protocol were evaluated at Kaoshiung Veteran General Hospital from January
      1, 2013 through October 31, 2013. Approval for the study was obtained from the hospital's
      ethic committee, and informed consent was obtained from all patients (VGHKS13-CT11-17)
    

Intervention name(s): Dehydroepiandrosterone (DHEAS)
Intervention type(s): Drug
Other intervention name(s): DHEAS
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dehydroepiandrosterone; DHEAS; Gene expression of cumulus cells.; Folliculogenesis.; Oocyte maturation.; Ovarian hyper-stimulation protocol.; Artificial reproduction technology.
Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery
Condition: Lung Tumor
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      We will study the efficacy of FDA approved intravenous (IV) acetaminophen ("Ofirmev", © 2011
      Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive
      thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to
      reduce the need for patient controlled analgesia and the total dose of opioids, which have
      serious side effects in thoracic surgery patients. We will compare the use of IV
      patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain.
      We will determine if IV acetaminophen reduces post-operative morphine requirements (primary
      end point). We will also assess subject pain scores and post-operative complications
      associated with pain management as secondary end points. Our hypothesis is that the study arm
      receiving intravenous acetaminophen will have lower total morphine consumptions compared to
      the placebo group.
    

Detailed description: 
      We will study the efficacy of FDA approved intravenous (IV) acetaminophen ("Ofirmev", © 2011
      Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive
      thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to
      reduce the need for patient controlled analgesia and the total dose of opioids, which have
      serious side effects in thoracic surgery patients. We will compare the use of IV
      patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain.
      One group of subjects will receive IV acetaminophen every six hours beginning within 30
      minutes before surgical end time and continuing for 24 hours plus IV morphine PCA, and the
      other group will receive IV placebo every six hours plus IV morphine PCA, a standard
      treatment for postoperative pain. We will determine if IV acetaminophen reduces
      post-operative morphine requirements (primary end point). We will also assess subject pain
      scores and post-operative complications associated with pain management as secondary end
      points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have
      lower total morphine consumptions compared to the placebo group.
    

Intervention name(s): IV Acetaminophen; Saline Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1000mg IV Ofirmev given every six hours for a total of four doses.; Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.
Other intervention name(s): Ofirmev; Paracetamol; Normal saline solution
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: VATS; thoracic surgery; acetaminophen; ofirmev; lung surgery; thoracoscopic; intravenous acetaminophen
Functional Organization of Somatosensory Responses in the Secondary Somatosensitive Area and Insula
Condition: Healthy
Study type: Interventional

Summary: 
      The implication of the second somatosensory area (SII) and the insular cortex in the
      processing of somatosensory inputs is now well established. However the functional anatomy of
      these areas hidden in the depth of the sylvian scissure remain mostly unknown.

      The aim of this fMRI study is to determine the functional cartography of SII and insula. The
      localization of responses to different somatosensory stimuli (slight touch, warm, cold, heat
      pain and arthrokinesia) applied on the left hand of 25 healthy volunteers, will be compared.
    

Detailed description: 
      Aims : Demonstrate that localization of the several types of somatosensory stimuli is
      different into SII and into insula. If possible, we'll determine a functional cartography of
      these areas.
    

Intervention name(s): localization
Intervention type(s): Other
Intervention description(s): localization of the several types of somatosensory stimuli
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy volunteers; Somatosensory stimuli; fMRI; second somatosensory area; insular cortex; functional anatomy
Efficacy of Treatment for Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      The purpose of these questionnaires is to give us an overview of how GAD has affected your
      life, and perhaps also to give us some clues about things that may have set you up to
      experience GAD.
    

Detailed description: 
      For us to evaluate the efficacy of our treatment programs, we are interested in your
      responses before and after treatment. We use two methods to evaluate the efficacy of our
      treatments: questionnaires and interviews with a member of the Anxiety Disorders Clinic. As
      part of standard clinic procedure, each person in the program completes an in-person
      interview with a staff member who will determine your suitability for treatment. If you have
      received this questionnaire packet, it is likely that your concerns will be appropriately
      addressed in the Anxiety Disorders Clinic. The purpose of the questionnaire packet is to
      assess the severity of your generalized anxiety disorder; its impact on your functioning, and
      factors that may contribute to the onset or maintenance of your GAD (e.g., depression,
      intolerance of uncertainty). We will ask you to complete this questionnaire again when you
      have completed your treatment along with a brief telephone interview with a staff member of
      the Anxiety Disorders Clinic.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in the study will be recruited from individuals receiving treatment for
        generalized anxiety disorder (GAD) at the Anxiety Disorders Clinic of UBC Hospital
      
Keywords: Generalized Anxiety Disorder; Anxiety; Treatment efficacy
Intraocular Steroid After Cataract Surgery Study
Condition: Cataract
MeSH terms: Cataract; Capsule Opacification
Study type: Interventional

Summary: 
      The use of one dose of an antibiotic and steroid injected into the eye at the end of cataract
      surgery is as safe and effective as the post operative use of eyedrops after cataract
      surgery.
    

Detailed description: 
      This prospective randomized controlled trial included 80 eyes of 40 patients having routine
      phacoemulsification of cataract. Patients between 40 and 80 years of age who met enrollment
      criteria, required cataract surgery in both eyes, and agreed to participate, were enrolled in
      the study over a nine month period in 2006 at the office of one cataract surgeon. Eyes were
      randomly assigned to receive either the eye drop or injection protocol on the initial
      consultative visit. All surgery was preformed by one surgeon (JGS) using topical anesthesia,
      the Infiniti phacoemulsification system (Alcon) and an Acrysof SN60WF (Alcon) intraocular
      lens. The fellow eye was operated upon using the same technique and instrumentation two weeks
      later and was assigned to the group opposite the first eye. All eyes were examined by the
      operating surgeon at days 1, 8, 15, 30 and 90 postoperatively with uncorrected visual acuity,
      best corrected visual acuity, intraocular pressure, corneal edema, anterior chamber cell and
      flare recorded.
    

Intervention name(s): intraocular triamcinolone and gatifloxicin
Intervention type(s): Drug
Intervention MeSH terms: Triamcinolone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intraocular; triamcinolone; gatifloxicin; inflammation; visual acuity
The Optimization of Iron Bioavailability of Supplements Using Hepcidin Levels in Humans
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      Background: Oral iron supplementation (OIS) is a widely-used strategy to treat iron
      deficiency anemia. However, absorption of OIS is often low and response is variable. To
      overcome this, large doses are given but this may reduce compliance due to gastric
      irritation. Thus, OIS doses should be low, while maximizing absorption. The prevailing serum
      hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte
      iron utilization. Based on limited data in humans, SHep can be increased by a single OIS dose
      but the duration of the increase is uncertain: In a recent study conducted in our laboratory
      it has been found to last approx. 24 h. Also, there are few data on how the increase in SHep
      determines the absorption of further doses of oral iron. Is there a threshold SHep at which
      subsequent iron absorption is sharply reduced? Better understanding of this relationship
      would be valuable to design more effective and safer OIS regimens.

      Objectives: 1) Determine whether two consecutive dosages of 60 mg Fe differently affect
      hepcidin response and iron bioavailability (Study 1) 2) Compare the bioavailability of iron
      supplement dosages given at different times of the day (Study 2).

      Methods/Subjects: Healthy female subjects will be screened for low iron status. Anemic
      subjects will be excluded from the study. Thirty two subjects will be included with serum
      ferritin <20 µg/L, C-reactive protein <5 mg/L and Hemoglobin >117 g/L. Subjects will be
      randomized in two groups and their Hepcidin (sHep) and iron status markers monitored at day 1
      (baseline). Subjects will receive iron supplement dosages of 60 mg with stable iron isotopes
      54Fe, 57Fe, 58Fe in form of 4 mg of FeSO4. Prior administration blood samples will be
      collected to monitor sHep and iron status markers.

      Outcome: The combined use of stable iron isotopes and a sensitive SHep assay will allow for
      better understanding of the iron-hepcidin relationship and this may enable design of more
      effective OIS regimens.
    


Intervention name(s): 60 mg Fe as FeSO4 with stable isotopic labels
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will receive FeSo4 supplements labeled with stable isotopic labels (54Fe, 57Fe, 58Fe) and iron absorption will be measured for each administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hepcidin; iron bioavailability; iron supplementation
A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2; Hypoglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about how tirzepatide affects the body's
      response to low blood sugar (hypoglycemia). The study is open to participants with type 2
      diabetes. It will last about 42 weeks for each participant.
    


Intervention name(s): Tirzepatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY3298176
Intervention MeSH terms: Tirzepatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Compare the Efficacy and Tolerability of the Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitors (SSRIs) Used in Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      FDA has accepted atypical antipsychotics of olanzapine and aripiprazole as the adjuvant
      medications for refractory major depression. But there is still no trial about atypical
      antipsychotics combined with antidepressant of SSRI used in fresh major depressive patients.
      This project aims to compare the efficacy and tolerability of sertraline with or without
      low-dosed aripiprazole added in fresh major depression.
    

Detailed description: 
      This double-blind, placebo-control, fixed dose, randomized study will be conducted at a
      tertiary clinical setting. Patients over 18 y/o fulfilled DSM-IV criteria for major
      depression, having a baseline HAM-D score ≧ 14 and a HAM-D item 3 score < 3 will be recruited
      into the groups. The study group of patients will receive ten weeks of treatment with a
      combination of fix-dosed sertraline and aripiprazole. The control group will received
      sertraline only. The score reduction in HAM-D17, CGI, SF-36 and Brief Symptom Rating Scale
      (BSRS-50) will be periodically estimated as an efficacy following the use of a SSRIs or and
      aripiprazole.
    

Intervention name(s): aripiprazole , sertraline
Intervention type(s): Drug
Intervention description(s): In this ten weeks,double-blind,placebo-control,randomized,fixed dose study, study,subjects were randomly assigned to treatment with aripiprazole 2.5mg/day plus sertraline 50mg/day or sertraline 50mg/day plus placebo.
Intervention MeSH terms: Aripiprazole; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: efficacy; tolerability; combination of aripiprazole and SSRI(sertraline)