bioihbjkbjnl/mcl2 huggingface dataset:
Phase II Study of Pemetrexed in Advanced or Recurrent Gastric Cancer After Chemotherapy
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial aimed to assess the efficacy and safety of pemetrexed in patients with
      pretreated metastatic gastric cancer.
    

Detailed description: 
      Patients enrolled in this study received pemetrexed 500mg/m2, once every 21 days, until the
      presence of progressive disease or unacceptable toxicity. All patients took dexamethasone
      3.75 mg twice daily, starting from the day before and continuing to the day after the drug
      administration. Patients were instructed to take oral folic acid 400 mg daily beginning 5
      days before the first therapy and until the final therapy.Patients received Vitamin B12 very
      3 cycle of chemoherapy. Granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage
      colony-stimulating factor (GM-CSF) or Erythropoietin (EPO) was not allowed, but they could be
      used when the patients suffered from bone marrow depression.
    

Intervention name(s): Pemetrexed disodium
Intervention type(s): Drug
Intervention description(s): Patients received Pemetrexed disodium 500mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.Patients were instructed to take oral folic acid 400 mg daily beginning 5 days before the first therapy and until the final therapy. Patients received vitamin B12 before the first cycle of Pemetrexed and every three cycles of chemotherapy.
Other intervention name(s): LY-231514; brand name: Alimta
Intervention MeSH terms: Pemetrexed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Evaluation of the Accuracy of Vitastiq Device for Tracking Vitamin and Mineral Trend in Human Body
Condition: No Conditions
Study type: Interventional

Summary: 
      This is a single site evaluation study of Vitastiq device accuracy in healthy men and women
      in ratio 1:1 (approximately) aged between 18 and 64 years. A total of 45 Vitastiq personal
      devices will be used by volunteers for two months. The Vitastiq device will be evaluated
      during three site visits: on day 1, 29 ± 4 days and 57 ± 4 days. During site visit days,
      blood sampling will be collected and analysed and readings using Vitastiq device will be
      performed. Data will be analysed retrospectively to evaluate Vitastiq performance compared to
      blood tests results.
    


Intervention name(s): Vitasitiq device
Intervention type(s): Device
Intervention description(s): Participant uses Vitastiq device for about 2 months to perform Vitastiq readings every day, preferably in the morning. On day 1, 29 and 57 participants' blood sampling is collected and analysed, and measurements using Vitastiq device are performed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Volunteers
Condition: Healthy
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the potential efficacy of JNJ-42165279 in treating
      anxiety disorders through evaluation of brain activation patterns using imaging technology in
      healthy volunteers.
    

Detailed description: 
      This is a single site, double-blind (neither investigator nor the participant knows the
      treatment that the participant receives) study. The study will consist of a screening phase
      (1-2 visits), a treatment phase (4 visits), and a post treatment phase (follow-up safety
      visit, 7 to 14 days after the last dose of the study drug). During the screening phase,
      participants will be evaluated to determine if they meet the study eligibility criteria,
      which will include collection of blood and urine samples. During the treatment phase,
      eligible participants will be assigned by chance (like a toss of a coin) to receive either
      JNJ-42165279 100 mg or placebo once daily during 4 consecutive visits to the clinic. Placebo
      is an inactive substance that is compared with a drug to test whether the drug has a real
      effect. The potential of the drug to treat anxiety will be assessed on Day 4 of the treatment
      phase. The primary assessment, Blood Oxygen Level Dependent Functional Magnetic Resonance
      Imaging (BOLD-fMRI), will measure brain activity patterns while participants complete 3
      emotionally-provoking tasks. Additionally, participants' startle responses (eye blinks) will
      be evaluated in two emotionally-provoking behavioral tasks outside of the scanner.
      Questionnaires will be completed to evaluate participants' mood, and blood samples will be
      collected to measure concentrations of JNJ-42165279 and biomarkers of drug activity.

      Safety will be monitored throughout the study, including adverse events, vital signs (blood
      pressure and heart rate), 12-lead ECGs, physical examinations, clinical safety laboratories,
      evaluation of suicidal risk, and a Walk and Turn test. The total study duration will be
      approximately 46 days.
    

Intervention name(s): JNJ-42165279 (100 mg); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-42165279 (100 mg/day) will be orally administered once daily for 4 consecutive days.; Matching placebo to JNJ-42165279 will be orally administered once daily for 4 consecutive days.
Intervention MeSH terms: JNJ-42165279
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy; Anxiety Disorders; Anxiety Modulation; Male
Behavioral CVD Prevention Using Informatics
Condition: Health Behavior
Study type: Interventional

Summary: 
      Overweight/obesity is strongly linked to mortality from multiple chronic diseases, including
      cardiovascular disease, diabetes, and obesity-related cancers.The successful management of
      overweight/obesity requires management of nutrition and physical activity over time. For
      racial/ethnic minority and low-income populations, who face both higher prevalence of obesity
      and chronic diseases compared to others, interventions promoting behavioral change are a
      national health priority. From the available range of behavioral change intervention
      strategies, there is a growing knowledge base that documents the efficacy of peer support
      interventions for improving self-care, quality of life, and behavioral change. In this study,
      the investigators will examine the following research question: What is the preliminary
      efficacy and degree of implementation and acceptability of an intervention approach in which
      peer counselors provide evidenced-based counseling about nutrition and physical activity
      behaviors for weight management to public housing residents using a computer-assisted program
      called CuesWeight?
    


Intervention name(s): Counseling; feedback report
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Up to 12 sessions of behavioral counseling using motivational interviewing techniques focused on diet and physical activity behaviors over a 12 week period. Counselors will be guided in their sessions by a computer program called CuesWeight. Participants also receive text messages to enable participants to track their behaviors; this information is relayed to the counselors to inform the counseling sessions.; All participants receive a brief printed feedback report displaying their current levels of nutrition and physical activity behaviors and tips for meeting recommended guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Weight Loss; Health Status Disparities
Pilot Study Using a PET Gamma Probe to Evaluate Lymph Nodes in Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional

Summary: 
      The surgical management of high-risk endometrial cancer often involves an extensive operation
      to remove lymph nodes as sites of possible cancer spread.

      18F-FDG PET/CT imaging is increasingly being used to identify sites of cancer spread and
      recently groups have used an intra-operative gamma probe to better localize metastatic
      disease. In this pilot study, patients with newly diagnosed early stage, high-risk
      endometrial cancer undergoing primary surgery will have a pre-operative PET scan and
      intra-operative localization of metastatic lymph nodes with the use of a gamma probe. A
      complete lymphadenectomy will follow and ability to detect positive lymph nodes of both PET
      scan and the intra-operative probe will be calculated.

      This study addresses the feasibility of an FDG detection gamma probe in addition to a
      pre-operative PET/CT for lymphatic mapping in women with clinical early stage high risk
      endometrial cancer. The study will also evaluate the role of identifying metastatic lymph
      nodes intraoperatively that would otherwise be clinically negative.
    


Intervention name(s): lymphadenectomy; therapeutic conventional therapy; Positron Emission Tomography/ Computed Tomography; fludeoxyglucose F 18
Intervention type(s): Procedure; Procedure; Procedure; Radiation
Intervention description(s): bilateral pelvic and para-aortic lymph node dissection; hysterectomy, bilateral salpingo-oophorectomy,bilateral pelvic and para-aortic lymph node dissection +/- omentectomy via laparotomy, laparoscopy or robotic-assisted; Pre-operative PET/CT scan; 5 MBq/kg body weight of FDG (up to 550 MBq)
Intervention MeSH terms: Fluorodeoxyglucose F18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: early; high risk
Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy
Condition: Breast Cancer; Precancerous Condition
MeSH terms: Carcinoma in Situ; Precancerous Conditions
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Broccoli sprout extract supplements may slow the growth of tumor cells or abnormal
      cells and may be an effective treatment for ductal carcinoma in situ and/or atypical ductal
      hyperplasia.

      PURPOSE: This randomized phase II trial is studying how well broccoli sprout extract works in
      treating women with a diagnosis of breast cancer, ductal carcinoma in situ and/or atypical
      ductal hyperplasia.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the correlation between supplemental sulforaphane (broccoli sprout extract)
           dose and concentrations of sulforaphane and its metabolites in blood and urine samples
           from women positive for cancer, ductal carcinoma in situ and/or atypical ductal
           hyperplasia.

        -  To determine the effect of this supplement on biomarkers of prognosis in these patients.

        -  To determine the effect of this supplement on HDAC inhibition in peripheral blood cell
           and normal and cancerous breast tissue samples from these patients.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

        -  Sulforaphane Supplement: Patients receive oral broccoli sprout extract supplementation
           three times daily for 2-8 weeks in the absence of unacceptable toxicity.

        -  Placebo: Patients receive oral placebo supplementation three times daily for 2-8 weeks
           in the absence of unacceptable toxicity.

      Blood and urine samples are collected at baseline and after completion of study treatment for
      laboratory biomarker studies. Patients scheduled to undergo surgery (mastectomy or
      lumpectomy) also undergo breast tissue sample collection at baseline and at the time of
      surgery. Samples are analyzed for sulforaphane metabolism (isothiocyanate levels), HDAC
      activity (acetylated histone expression), cell proliferation (Ki-67 index by IHC), and
      apoptosis (TUNEL assay).

      Patients complete questionnaires at baseline and periodically during study about their
      dietary history, family history, cruciferous vegetable intake, adverse events, and dietary
      and medication changes.

      After completion of study therapy, patients are followed at/around 30 days.
    

Intervention name(s): broccoli sprout extract; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Given orally; Given orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mammography; biopsy; ductal breast carcinoma in situ; atypical ductal breast hyperplasia
Performance Evaluation of Blood Glucose Monitoring Systems
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this single-center, comparative, open label, in-vitro diagnostic device
      performance evaluation was to investigate the performance of two sanofi-aventis BGMSs
      (BGStar® and iBGStar®) with regard to system accuracy (Polaris), precision and Hct influence
      (Helios).
    

Detailed description: 
      The main study (Polaris) investigated blood glucose measuring accuracy and intra-assay
      precision while the substudy (Helios) investigated potential haematocrit interference of
      sanofi-aventis BGMSs BGStar® and iBGStar® and partly of competitor BGMSs according to ISO
      15197 [1] and TNO 2001 Quality Guideline [2], respectively.

      The primary objective of the system accuracy evaluation is to identify the number of blood
      glucose readings of both sanofi-aventis devices within the ISO 15197 area of acceptable
      accuracy of ± 20% [DEV%] for blood samples with glucose concentration > 75 mg/dL (4.2 mmol/L)
      and within the ISO 15197 area of acceptable accuracy of ± 15 mg/dL (± 0.83 mmol/L) for blood
      samples with glucose concentration < 75 mg/dL (4.2 mmol/L) as compared to the StatStrip®
      Connectivity reference method. The primary objective of the haematocrit interference
      evaluation is to demonstrate that the BGStar® and iBGStar® devices meet the Hct interference
      requirements according to TNO 2001 Quality Guideline when used to measure BG of venous whole
      blood as compared to a venous plasma reference method (YSI 2300 STAT Plus™) at Hct levels
      between 35 - 55% in terms of:(1) a mean deviation not exceeding ± 10% [DEV%] for
      hyperglycaemic glucose concentrations (150 - 180, 250 - 280, 320 - 350 mg/dL) and (2)a mean
      deviation not exceeding ± 18 mg/dL (1.0 mmol/L) [DEVtotal] for hypo- and normoglycaemic
      glucose values (50 - 60, 100 - 120 mg/dL) compared to the reference method at Hct levels
      between 35 - 55%.
    

Intervention name(s): Sugar infusion; insulin infusion
Intervention type(s): Other; Drug
Intervention description(s): Infusion of glucose to achieve high blood glucose levels; i.v. infusion of insulin
Other intervention name(s): 5 % glucose solution; insuman rapid
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: diabetes mellitus; blood glucose self-assessment; Accuracy; Intra-Assay precision; Hematocrit interference
Stress-induced Vascular Dysfunction: Evaluation of Endothelial Function in a Cohort of Patients With Takotsubo Syndrome
Condition: Takotsubo Syndrome
MeSH terms: Takotsubo Cardiomyopathy; Syndrome
Study type: Observational

Summary: 
      The aim of this prospective single-center study is to evaluate endothelial function, arterial
      compliance, sympathetic nervous activity at rest and after mental and physical stress,
      carotid atherosclerosis, oxidative stress parameters, quality of life and platelet adhesion
      in patients with apical ballooning syndrome and age-matched controls.
    

Detailed description: 
      The aim of this prospective single-center study is to evaluate endothelial function, arterial
      compliance, sympathetic nervous activity at rest and after mental and physical stress,
      carotid atherosclerosis, oxidative stress parameters, quality of life and platelet adhesion
      in patients with Takotsubo Syndrome (apical ballooning syndrome/broken heart syndrome) and
      age-matched controls.
    

Intervention name(s): blood sample analysis
Intervention type(s): Procedure
Intervention description(s): The aim of this prospective single-center study is to evaluate endothelial function, vascular compliance, oxidative stress parameters, quality of life and platelet adhesion in patients with apical ballooning syndrome and age-matched controls.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        male or female subjects, age 18-80 with a diagnosis of Takotsubo Syndrome according to
        standard clinical criteria [Strony, J., et al., Analysis of shear stress and hemodynamic
        factors in a model of coronary artery stenosis and thrombosis. Am J Physiol, 1993. 265 (5
        Pt 2): p. H1787-96.] in the last 10 years.
      
Keywords: Takotsubo Syndrome; apical balooning syndrome; stress-cardiomyopathy; endothelial function; sympathetic nervous activity; platelet adhesion; arterial compliance
An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of 2 different doses of
      canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are
      receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have
      inadequate glycemic (blood sugar) control.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), double-blind (neither the patient nor
      the study doctor will know the identity of assigned study drug), placebo-controlled,
      parallel-group,3-arm (3 treatment groups) multicenter study to determine the efficacy,
      safety, and tolerability of canagliflozin compared to placebo (a capsule that is identical in
      appearance to canagliflozin but does not contain active drug) in patients with type 2
      diabetes mellitus (T2DM) who are not achieving an adequate response from current
      antihyperglycemic therapy with metformin to control their diabetes. Canagliflozin (a
      Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar
      levels in patients with T2DM. Patients will take single-blind placebo capsules orally (by
      mouth) for 2 weeks before randomization. Patients will be randomly assigned canagliflozin or
      matching placebo, orally, twice daily, with 1 capsule taken with the morning meal and 1
      capsule taken with the evening meal (2 capsules per day) and concurrent with metformin, if
      applicable, for up to 18 weeks. The dosing time of metformin should remain the same
      throughout the study.
    

Intervention name(s): Canagliflozin 50 mg; Placebo; Canagliflozin 150 mg; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One canagliflozin 50-mg capsule taken orally twice daily with a meal for 18 weeks; 1 placebo capsule taken orally twice daily with a meal for 18 weeks; 1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks; The patient's stable daily dose of Metformin background therapy should be continued throughout the study.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Canagliflozin; Placebo; Metformin; Hemoglobin A1c; Type 2 diabetes mellitus
Exploratory Efficacy Study of Guaifenesin in Upper Back Pain
Condition: Upper Back Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      Explore the clinical efficacy of 7-day treatment regimens of guaifenesin in order to
      investigate the evidence that guaifenesin is an effective treatment for upper
      back/neck/shoulder muscle spasm/stiffness and pain.
    


Intervention name(s): Guaifenesin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): high and low dose of Guaifenesin each given twice daily over a 4-day treatment period; no active ingredient
Intervention MeSH terms: Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: upper back/neck/shoulder muscle spasm
The Acute Effect of Boxing on Balance, Neuropsychological, and Visual Functions
Condition: Craniocerebral Trauma
MeSH terms: Craniocerebral Trauma
Study type: Observational

Summary: 
      Prior research has investigated the effect of repetitive head trauma as it relates to
      physiological and psychological function. Boxing is one particular sport which predisposes
      athletes to a large amount of head impacts. We plan to assess the effects of a boxing
      tournament on balance, neuropsychological, and visual functions.
    

Detailed description: 
      This is a prospective, repeated measures cohort study, which is able to make within-subject
      (pre and post boxing tournament) comparisons on measures of physiologic and behavioral
      function.

      We plan to enroll boxing athletes who are participating in a boxing tournament. Each
      individual will be assessed on the following tests: balance (dynamic and static balance),
      vestibular-ocular motor function, neuropsychological function, and symptoms. Additionally,
      each boxing match will be video recorded and the total number of head impacts they sustain
      will be documented.

        -  In order to prospectively assess how a boxing tournament affects balance,
           neuropsychological, and visual functions from pre-tournament assessments to
           post-tournament assessments (Specific Aim 1), we plan to test all athletes before
           competition at the Pan-American games begins (pre-test) and after they have been
           eliminated from the tournament (post-test).

        -  In order to measure the associations between the number of head blows sustained during a
           boxing tournament with balance, neuropsychological, visual, and symptom deficits, we
           will also use a video camera to record each match and count the total number of hits to
           the head.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from those who are participating at a boxing tournament.
      
Keywords: Brain Concussion; Balance; Locomotion; Mild Traumatic Brain Injury