bioihbjkbjnl/mcl2 huggingface dataset:
Soy, Selenium and Breast Cancer Risk
Condition: Breast Cancer Risk
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      There is evidence to suggest that some dietary components can reduce the risk of breast
      cancer. In this pilot study two such components, isoflavones (compounds found in soy
      products) and selenium, will be given to women classed as at moderate to high risk of the
      disease. The aim is to determine some novel biomarkers of risk and to see the effect of
      supplementation on them.
    

Detailed description: 
      The high incidence of breast cancer, its relatively long development phase and the financial
      burden to the NHS in relation to treatment makes it a prime target for dietary preventative
      strategies. Epidemiological and experimental investigations suggest several key dietary
      components that may reduce breast cancer, in particular isoflavones and selenium. Few dietary
      intervention studies have been conducted to investigate putative protective effects, but with
      our growing understanding of cancer biology and the application of new -omics technologies it
      is now possible to use early biomarkers of risk to assess the potential efficacy of
      intervention studies.

      In this pilot project, we will employ a combination of disciplines to examine the effect of
      dietary intervention in a group of women defined by NICE guidelines as being at increased
      risk (moderate-high) of developing breast cancer, using metabolomics to assess the
      tractability of biomarkers in response to the dietary intervention. Such trials are urgently
      needed to examine the protective effects of diet in women classified at increased risk and
      who are still in the 'zone of reversibility'. The results of this study will be used to
      justify and optimise larger scale intervention trials and ultimately to develop appropriate
      dietary recommendations for the prevention of breast cancer.

      A dietary intervention study based on a randomised double-blind parallel design will be
      conducted in 30 pre-menopausal women (age 35-50) at moderate to high risk of developing
      breast cancer. The metabolomic profiles of urine and serum samples (collected at baseline and
      after dietary intervention) will be assessed. Participants will be randomised into two
      groups; the placebo group (consuming 6g of non-supplemented chocolate per day) and the
      supplemented group (consuming 6g of chocolate containing both soy and selenium per day). The
      intervention will last for the duration of one menstrual cycle.
    

Intervention name(s): Soy and Selenium
Intervention type(s): Dietary Supplement
Intervention description(s): 6g of chocolate per day Control group with no supplementation Active group 50mg of soy protein isolate + 200µg selenium in the form of MSC
Intervention MeSH terms: Selenium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Selenium; Soy; Breast Cancer Risk
A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United
      Kingdom. The first part is a randomized, placebo-controlled study comparing the safety
      profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an
      open-label extension where all subjects will receive an additional 2 intratympanic injections
      of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1
      year.
    


Intervention name(s): OTO-104; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Longitudinal Measurement of Caloric Compensation and Eating in the Absence of Hunger in French Preschool Children
Condition: Healthy
Study type: Observational

Summary: 
      Objectives: The aims were to measure one year change in caloric compensation (CC) and eating
      in the absence of hunger (EAH) in 3 to 6 year-old French children in their regular eating
      context and to link these change with individual characteristics (adiposity, age, gender) and
      maternal feeding practices.

      Three series of measurements of caloric compensation (CC) and eating in the absence of hunger
      (EAH) were conducted: at baseline, and 3 (FU3M) and 15 (FU15M) months later. Each serie of
      measurement was composed of three consecutive weeks an identical lunch was served in four
      preschool canteens reaching 236 children. The first lunch was a control session. For the CC
      situation (week 2), thirty minutes before the lunch children were offered a preload (137
      kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to
      palatable foods (430 kcal). Food intake was measured at the individual level. Maternal eating
      behaviour and feeding practices were measured by questionnaires. Child's height and weight
      were measured by a medical doctor.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population was composed of 236 children at inclusion. Among them, 98 participated in
        the three time of measurements of caloric compensation or eating in the absence of hunger.
      
Keywords: Caloric compensation; Eating in the absence of hunger; Preschool children; Maternal feeding practices; Maternal eating behavior; one year; children
Phase Ib, Administration the IOP Injection for MRI Contrast Agent in Healthy Subjects
Condition: Magnetic Resonance Imaging
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to assess the dose dependent changes in MRI signal intensity
      (SI) in liver after IOP Injection intravenous administration in healthy volunteers.
    

Detailed description: 
      Find the max. signal change after IOP administration
    

Intervention name(s): IOP Injection
Intervention type(s): Drug
Intervention description(s): T1 and T2
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Intraoperative Lidocaine Infusion as a Sole Analgesic Versus Morphine in Laparoscopic Gastric Bypass Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Postoperative opioid-centric pain management strategies in obese patients are accompanied by
      the possible development of; opioid-induced ventilatory impairment (OIVI) and hypoxemia. This
      presents as sedation and respiratory depression, combined with upper airway obstruction and
      hypercapnia. If it remains undetected and untreated, it can result in increased perioperative
      morbidity and mortality.Thus, an increased interest in the use of non-opioid analgesic
      adjuncts has been prompted.

      Intra-operative intravenous lidocaine infusion has analgesic, anti-inflammatory,
      anti-hyperalgesic, opioid-sparing effects with an enhanced recovery after surgery (ERAS)
      profile. Its postoperative analgesia may last after reduction of its plasma concentration.
      So, lidocaine could be a good alternative in bariatric surgery.

      Lidocaine has been studied as part of an opioid-free multimodal analgesia in morbidly obese
      patients. Also, its use in bariatric surgery showed a decrease in postoperative opioid use
      and improvement in the quality of recovery.
    

Detailed description: 
      compare the postoperative analgesic effect of intraoperative lidocaine infusion (Study group)
      used as a sole analgesic agent, to the intraoperative intravenous morphine (Control group) in
      laparoscopic gastric bypass surgery.
    

Intervention name(s): Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE]; morphine sulphate (10mg/ ml ampoule)
Intervention type(s): Drug; Drug
Intervention description(s): At induction of anesthesia, patients will receive a loading dose of 1.5mg/kg lidocaine hydrochloride 2% slowly over 3 min followed by IV infusion of 2mg/kg/hr lidocaine hydrochloride 2% till the end of surgery; At induction of anesthesia, patients will receive a loading dose of IV 0.1mg/kg morphine sulphate slowly over 3 minutes followed by IV infusion of normal saline via infusion pump. The infusion will be continued till the end of surgery
Other intervention name(s): Xylocaine 2%
Intervention MeSH terms: Lidocaine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lidocaine; morphine; analgesia
Compare the Effect on Cognitive Functioning of Two Formulations of Seroquel, Seroquel XR and IR in Patients With Stable Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a phase IV 20 -32 day prospective, double blind, double-dummy, randomised
      crossover study that will evaluate the effect of quetiapine XR and quetiapine IR on cognitive
      performance in patients with schizophrenia stabilized on a single antipsychotic medication.
    


Intervention name(s): Seroquel XR- quetiapine fumarate extended release; Seroquel IR - quetiapine fumarate; Placebo matching Seroquel XR; Placebo matching Seroquel IR
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Seroquel XR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken once a day for 10-16 days.; Seroquel IR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken twice a day for 10-16 days.; Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days.; Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stable schizophrenia; cognitive functioning
GDC-0449 in Treating Young Patients With Medulloblastoma That is Recurrent or Did Not Respond to Previous Treatment
Condition: Recurrent Childhood Medulloblastoma
MeSH terms: Medulloblastoma; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial is studying the side effects and best dose of GDC-0449 in treating young
      patients with medulloblastoma that is recurrent or did not respond to previous treatment.
      GDC-0449 may be effective in treating young patients with medulloblastoma.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To investigate the safety and pharmacokinetics of a daily dose of hedgehog antagonist
      GDC-0449 using the available formulation in pediatric patients with recurrent or refractory
      medulloblastoma.

      SECONDARY OBJECTIVES:

      I. To document and describe toxicities associated with this drug in these patients.

      II. To characterize the pharmacokinetics of this drug in these patients. III. To document
      preliminary antitumor activity of this drug in these patients. IV. To document pathologic and
      genomic methods to identify CNS tumors with activation of the PTCH/SHH pathway.

      OUTLINE: This is a multicenter study.

      Patients receive oral hedgehog antagonist GDC-0449 once daily on days 1 and 4-28 in course 1
      and on days 1-28 in all subsequent courses. Treatment repeats every 28 days for up to 26
      courses in the absence of disease progression or unacceptable toxicity.

      Blood samples are collected periodically for pharmacokinetic studies. Archival tumor tissue
      samples are collected and analyzed for the expression of genes that activate the SHH (e.g.,
      Gli1, Gli2, SFRP1, ATOH1, and PTCH2) or WNT (e.g., DKK2 and DKK4) cell signal pathways by in
      situ hybridization and reverse transcriptase real time-PCR.

      After completion of study therapy, patients are followed for 90 days.
    

Intervention name(s): vismodegib; laboratory biomarker analysis; pharmacological study
Intervention type(s): Drug; Other; Other
Intervention description(s): Given orally
Other intervention name(s): Erivedge; GDC-0449; Hedgehog antagonist GDC-0449; pharmacological studies
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients as Monotherapy or in Combination With Atorvastatin
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this placebo-controlled study is to evaluate the low-density
      lipoprotein cholesterol (LDL-C) efficacy and dose-response of gemcabene 300, 600 and 900
      mg/day administered as monotherapy or in combination with atorvastatin 10, 40, and 80 mg/day
      to hypercholesterolemic patients.

      Secondary purposes include evaluating the effects of high-sensitivity C-reactive protein
      (hsCRP), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG) and apolipoprotein
      B (ApoB), and safety and efficacy of gemcabene monotherapy and gemcabene/atorvastatin
      combination.
    


Intervention name(s): Gemcabene; Atorvastatin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Gemcabene; Atorvastatin
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LDL-C; Lipid Regulator
Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI
Condition: Non ST Segment Elevation Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      It is designed to test the hypothesis that high loading dose(360mg) ticagrelor versus
      conventional loading dose(180mg) will result in a higher inhibition of platelet
      aggregation(IPA) without increasing the bleeding events.
    

Detailed description: 
      After providing written informed consent, all patients will be randomized to receive
      ticagrelor 360mg or 180mg loading dose(LD),then 90mg bid maintenance dose starting 12 hours
      after LD.PCI will performed in 2h-72h after they are given the loading dose.All patients
      should receive acetylsalicylic acid (ASA) 75 to 100 mg daily unless intolerant.IPA at 0, 0.5,
      1, 2, 8, 24h after the loading dose of ticagrelor will be measured. CK-MB, troponin I,
      myoglobin, CRP will be detected at 0h, before PCI, 8h after PCI, 24h after PCI. ECG will be
      conducted at 0h and within 24h after PCI. Patients returned 28 days for follow-up visits
      after the loading dose of ticagrelor, documented any adverse events.
    

Intervention name(s): ticagrelor
Intervention type(s): Drug
Intervention description(s): Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
Other intervention name(s): Brilinta
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ticagrelor; loading dose; non-ST-segment elevation acute coronary syndromes; percutaneous coronary intervention; the antiplatelet effects; bleeding events; major adverse cardiac events
Closed Intravenous Catheter System on Catheter Success, Length of Stay and Complications
Condition: Catheter Complications; Catheter Leakage
Study type: Interventional

Summary: 
      Peripheral intravenous catheters (PIVCs) can be used frequently in pediatric hematology
      oncology patients. There are different types of PIVCs as open and closed. There are studies
      on adults using the closed IV catheter system, which is a type of PICK. However, no study was
      found in the literature in which the closed IV catheter system was used in the pediatric
      population.
    

Detailed description: 
      The primary purpose of this research is; to evaluate the effect of two different catheter
      systems (closed IV catheter system: BD Nexiva™/ peripheral open IV catheter: BD Insyte™
      Autoguard™) on catheter stay in pediatric hematology and oncology patients aged 1-12 years.

      The secondary aim of the research is; to evaluate the effect of two different catheter
      systems on the success of catheter placement and the development of complications in the
      first attempt in pediatric hematology and oncology patients.
    

Intervention name(s): closed IV catheter system (BD Nexiva™); open IV catheter (BD Insyte™ Autoguard™)
Intervention type(s): Device; Device
Intervention description(s): There is a high-pressure extension set and a Q-syte split septum needle-free intervention device at the tip of the catheter. It creates a closed integrated system with this apparatus, reducing the risk of catheter-related bloodstream infection.; BD Instaflash™ needle technology improves initial entry success by confirming vascular access through the needle noch. It has flexible wings for secure cannula fixation.
Other intervention name(s): BD Nexiva™; BD Insyte™ Autoguard™
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this study, the intervention group was given a closed IV catheter system called BD Nexiva™; the control group received an open IV catheter called BD Insyte™ Autoguard™. Within the scope of the study, "Peripheral IV Catheter Care Bundle Approach" was applied to all patients.
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: closed IV catheter system; pediatric hematology oncology; first IV attempt
BOTOX® in the Treatment of Crow's Feet Lines in Japan
Condition: Lateral Canthus Rhytides; Crow's Feet Lines
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared
      to placebo for the treatment of Crow's Feet Lines (Lateral Canthus Rhytides).
    


Intervention name(s): botulinum toxin Type A (24 U); botulinum toxin Type A (12 U); Normal Saline
Intervention type(s): Biological; Biological; Other
Intervention description(s): 24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.; 12 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.; Normal saline (placebo) injected into bilateral Crow's Feet Line areas per treatment.
Other intervention name(s): BOTOX®; BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Generation of Biological Samples Positive to Somatropin for Anti-doping Control
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      Somatropin, also known as recombinant growth hormone (rhGH), is one of the World Anti-Doping
      Agency (WADA) prohibited substances. Its consumption in athletes has been banned since 1990,
      as it is known to improve physical performance.

      Hypothesis:

      The subcutaneous administration of recombinant somatropin (rhGH) in healthy subjects allows
      obtaining positive doping samples.

      The concentrations of hGH variants (isoforms) and biomarkers can be measured in serum.

      Objectives:

      Primary objective: To generate enough serum samples positive to recombinant somatropin in
      order to be analyzed as control samples by anti-doping laboratories.

      Secondary objective: To determine the analytical parameters necessary to detect the
      administration of recombinant somatropin in healthy volunteers by direct and/or indirect
      methods.

      Methods:

      Phase I, open, randomized clinical trial, with a treatment condition (recombinant somatropin
      or rhGH) administered subcutaneously to 4 subjects (2:1 ratio). Control samples of the study
      correspond to basal samples of 2 subjects who do not receive any treatment.
    

Detailed description: 
      A blood sample volume of 450 mL is obtained from each subject receiving the treatment
      condition to perform the proposed tests.

      In order to validate the determination methodology of hGH variants and biomarkers, blood
      samples from treatment group subjects are compared to reference blood samples of 450 mL from
      a control group (not receiving treatment) as it is not possible to obtain a basal sample of
      such volume from the subjects receiving treatment.
    

Intervention name(s): Somatropin injection
Intervention type(s): Drug
Intervention description(s): Subjects receive a daily subcutaneous dose of 0.2 IU/kg (0.067 mg/kg) of recombinant somatropin (rhGH) during 14 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Samples from treatment group are compared to samples from control group (not receiving treatment). It is not possible to use a basal sample of the subjects receiving treatment as a comparator since a minimum period of 2 months' time is required between a 450 mL extraction and another.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Somatropin; Growth hormone; Anti-doping control; Athletic performance
Alcohol Interaction Study
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is understand the effects of GSK114814 and alcohol in healthy
      volunteers when taken together.
    

Detailed description: 
      The primary objective of this study is to investigate the CNS effects of co-administration of
      GSK1144814 with alcohol. Healthy volunteers who meet the eligibility criteria will be
      randomized to receive GSK1144814 or placebo with alcohol.
    

Intervention name(s): single dose
Intervention type(s): Drug
Intervention description(s): Subjects will receive a single dose of GSK1144814 or placebo.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: alcohol; drug interaction; pharmacodynamic