bioihbjkbjnl/mcl2 huggingface dataset:
Combination With Gemcitabine in Advanced Pancreatic Cancer
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus
      gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.

      Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine
      (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.

      Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints:
      response duration, disease control rate, time to progression, progression-free survival,
      overall survival, safety and tolerability.

      Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and
      weekly throughout the study; Safety follow-up visit 30 days after the last dose of study
      treatment; Survival follow up monthly for up to 8 month after LPFV.
    


Intervention name(s): BAY86-9766+Gemcitabine
Intervention type(s): Drug
Intervention description(s): Phase I: 40 mg/day (20 mg twice daily), 60 mg/day (30 mg twice daily, 100 mg/day (50 mg bid) dependent on safety/tolerability Phase II: Recommended Phase II dose (RP2D) dependent on the results of the Phase I part of this study Route of administration: Oral, twice daily (bid) in combination with gemcitabine 1000 mg/m2 Intravenous infusion over 30 minutes weekly for seven out of eight weeks (Cycle 1); followed by 1000 mg/m2 Intravenous infusion over 30 minutes weekly for three out of four weeks (Cycle 2 and subsequent)
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreatic cancer,; MEK-inhibitor
The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne
Condition: Post - Adolescence Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      To study efficacy (total numbers of acne reduction) and safety of 2% Ketoconazole cream in
      Thai females with Mild degree Post-Adolescence acne comparing with placebo for a period of 12
      weeks.
    


Intervention name(s): 2% ketoconazole cream; Hydrophilic Cream
Intervention type(s): Drug; Drug
Intervention description(s): 2% ketoconazole cream applies twice daily; Hydrophilic cream (in-house preparation) applies twice daily
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post - adolescence acne; Topical 2% ketoconazole cream
Bananas as an Energy Source During Exercise: a Metabolomics Approach
Condition: Intense Exercise
Study type: Interventional

Summary: 
      This study compared the acute effect of ingesting bananas (BAN) versus a 6% carbohydrate
      drink (CHO) on 75-km cycling performance and post-exercise inflammation, oxidative stress,
      and innate immune function using traditional and metabolomics-based profiling.
    

Detailed description: 
      Trained cyclists (N=14) completed two 75-km cycling time trials (randomized, crossover) while
      ingesting BAN or CHO (0.2 g/kg carbohydrate every 15 min). Pre-, post-, and 1-h-post-exercise
      blood samples were analyzed for glucose, granulocyte (GR) and monocyte (MO) phagocytosis
      (PHAG) and oxidative burst activity, nine cytokines, F2-isoprostanes, ferric reducing ability
      of plasma (FRAP), and metabolic profiles using gas chromatography-mass spectrometry.
    

Intervention name(s): Bananas versus 6% carbohydrate beverage
Intervention type(s): Dietary Supplement
Intervention description(s): Trained cyclists (N=14) completed two 75-km cycling time trials (randomized, crossover) while ingesting BAN or CHO (0.2 g/kg carbohydrate every 15 min).
Other intervention name(s): Gatorade
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bananas; Exercise; Metabolomics; Oxidative stress; Inflammation; Immune function
SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have
      recurrent or metastatic colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of SarCNU in patients with recurrent or metastatic colorectal
           cancer.

        -  Determine the qualitative and quantitative toxicity of this drug in these patients.

        -  Determine the time to progression and survival of patients treated with this drug.

      OUTLINE: This is a multicenter study.

      Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4
      courses in the absence of disease progression or unacceptable toxicity. Patients who achieve
      complete response (CR) receive 2 additional courses beyond documentation of CR. Patients who
      achieve partial response (PR) receive 4 additional courses beyond documentation of PR.

      Patients are followed at 4 weeks and then every 3 months thereafter.

      PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 6-8
      months.
    

Intervention name(s): SarCNU
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer
Human Placental-Derived Stem Cell Transplantation
Condition: Mucopolysaccharidosis I; Mucopolysaccharidosis VI; Adrenoleukodystrophy; Niemann-Pick Disease; Metachromatic Leukodystrophy; Wolman Disease; Krabbe's Disease; Gaucher's Disease; Fucosidosis; Batten Disease; Severe Aplastic Anemia; Diamond-Blackfan Anemia; Amegakaryocytic Thrombocytopenia; Myelodysplastic Syndrome; Acute Myelogenous Leukemia; Acute Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Gaucher Disease; Adrenoleukodystrophy; Pick Disease of the Brain; Leukodystrophy, Metachromatic; Niemann-Pick Diseases; Niemann-Pick Disease, Type A; Niemann-Pick Disease, Type C; Neuronal Ceroid-Lipofuscinoses; Leukodystrophy, Globoid Cell; Fucosidosis; Anemia; Myelodysplastic Syndromes; Thrombocytopenia; Anemia, Aplastic; Anemia, Diamond-Blackfan; Mucopolysaccharidoses; Mucopolysaccharidosis I; Wolman Disease; Mucopolysaccharidosis VI
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to investigate the safety of human placental-derived
      stem cells (HPDSC) given in conjunction with umbilical cord blood (UCB) stem cells in
      patients with various malignant or nonmalignant disorders who require a stem cell transplant.
      Patients will get either full dose (high-intensity) or lower dose (low intensity) chemo- and
      immunotherapy followed by a stem cell transplantation with UCB and HPDSC.
    


Intervention name(s): Human Placental Derived Stem Cell
Intervention type(s): Drug
Intervention description(s): Infusions of thawed HPDSC to be given following UCB infusion.
Other intervention name(s): HPDSC
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: umbilical cord blood; stem cell transplantation; placental stem cell; inborn errors of metabolism; marrow failure; Severe Combined Immunodeficiency Disease; AML; ALL; MDS
(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis:

      Low dose intracoronary unfractionated heparin is as effective and safe as standard dose
      intravenous unfractionated heparin on patients with elective percutaneous coronary
      intervention.
    

Detailed description: 
      Aim:

      Primary objective:To evaluate the efficiency and safety of low dose intracoronary
      unfractioned heparin (UFH) on elective percutaneous coronary intervention (PCI).

      Secondary objective:

        -  To evaluate the effect of low dose intracoronary UFH on myocardial ischemia after PCI.

        -  To evaluate the effect of low dose intracoronary UFH on bleeding complications after
           PCI.

        -  To evaluate the cost-effectivity of low dose intracoronary UFH on elective PCI

      Study central:

        -  Bursa Postgraduate Hospital, Cardiology Clinic

      Study population:

        -  we planned to enrol 200 patients.

        -  Patients will randomise in two groups (control group:100 patients, study group:100
           patients)

      Study works:-Write case report form for all patients

        -  Control for inclusion criteria

        -  Demographic data (age, gender)

        -  Height, weight, BMI and glomerular filtration rate (GFR)

        -  Risk factors

        -  laboratory data (biochemical and hematologic)

        -  Medication history

        -  Echocardiographic data

        -  Angiographic data

        -  Procedure time

        -  PCI data(vessel diameter, stent diameter, lesion and stent length, performed
           percutaneous transluminal coronary angioplasty (PTCA) or not, etc)

        -  Before and after procedure (activated clotting time) ACT value

        -  Before and after procedure troponin I (TnI) and Creatine kinase MB (CKMB) levels

        -  Note complication (MACE, bleeding, hematoma etc)

        -  Note femoral compression time.

           4 weeks later note the first control data.

      Six months later note the second control data.
    

Intervention name(s): coronary intervention
Intervention type(s): Other
Intervention description(s): elective coronary intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: percutaneous coronary intervention; low dose intracoronary heparin
Impact of Purple Wheat Consumption on Markers of Inflammation and Oxidative Stress in Adults.
Condition: Healthy
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The main purpose of this study is to determine the effect of consumption of purple wheat
      anthocyanin-rich products for eight weeks by human participants with an elevated level of
      chronic inflammation, on oxidative stress and inflammatory responses as measured by select
      plasma biomarkers.
    

Detailed description: 
      This study will investigate the effect of daily consumption of purple wheat bran-enriched
      wholegrain convenience bars, for 8 weeks on inflammation and oxidative stress biomarkers and
      plasma antioxidant capacity. This study is a randomized, parallel arm study with 20 men and
      20 women who will adhere to a low anthocyanin and low phenolic aid diet for the duration of
      the study. The participants will be randomly divided into two groups, using stratification
      for matching sex and screening hs-CRP level to be equally distributed in each group, and
      assigned to either the treatment group or control group. Both group will have a 10 day diet
      run-in period where consumption of foods rich in anthocyanins and phenolic acids will be
      limited. Both groups will consume 4 servings of wheat products per day for 8 weeks and will
      replace 4 grain servings from their typical daily intake with the study treatment products.
      Fasting blood samples will be collected during three study visits, including baseline, for
      the analysis of inflammatory and oxidative stress biomarkers and plasma antioxidant capacity.
      The plasma metabolites of anthocyanins and phenolic acids will also be determined.
    

Intervention name(s): Purple Wheat Convenience Bars; Control Wheat Convenience Bars
Intervention type(s): Other; Other
Intervention description(s): Whole grain convenience bars manufactured with purple wheat; Whole grain convenience bars manufactured with ordinary wheat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Chronic inflammation; Adults; overweight; obese
Adalimumab in Axial Spondyloarthritis (ASIM) - MRI and Biomarkers in Patients With Spondyloarthritis
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigation of wholebody MRI and circulating biomarkers of inflammation, cartilage and bone
      metabolism in patients with spondyloarthritis treated with adalimumab. Furthermore to compare
      ultrasound examination with wholebody MRI etc.
    


Intervention name(s): Adalimumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sc. inj. adalimumab 40 mg every other week for 42 to 48 weeks. At week 24, clinical non-responders (not fulfilling primary outcome measure) were allowed treatment with other drugs, following local treatment guidelines.; sc. inj. placebo every other week, week 0, 2, and 4. Sc. inj. adalimumab 40 mg every other week from week 6.
At week 24, clinical non-responders (not fulfilling primary outcome measure) were allowed treatment with other drugs, following local treatment guidelines.
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Patients with axial spondyloarthritis
Urine Biomarkers for Renal Function Monitoring in Preterm Infants
Condition: Premature Infant
Study type: Observational

Summary: 
      The true renal function of preterm infants is difficult to evaluate. Serum creatinine (Cr)
      levels in infants are unreliable as a detector of renal function in the first few days of
      life because they may continue to reflect maternal levels. Although few candidates appear to
      be a useful biomarker for kidney injury, scant reference data on these biomarker in preterm
      infants exist, and studies have yielded conflicting results. Therefore, we aimed to determine
      the reliable urinary biomarkers to detect kidney injuries in preterm infants.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        below gestational age 37 weeks
      
Biospecimen description: 
      urine
GSK Drug Single Dose Escalation And Their Effect On Resting Motor Threshold In Healthy Volunteers
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a First Time in Human Study to assess the safety, tolerability, pharmacokinetics and
      resting motor threshold (rMT) of single doses of GSK drug in healthy volunteers.This will be
      a 2 part and 2 centre study.Part 1 will be a double-blind, randomized, placebo-controlled,
      single oral dose, dose-rising, cross-over study in healthy male and female (of non-child
      bearing potential) volunteers.Subjects will be randomized into cohorts of 10 subjects and
      cohorts will be recruited until the pre-defined safety or PK stopping limits are reached.Each
      subject will receive placebo and no more than 4 ascending doses of GSK drug in a randomized
      sequence on 5 separate study occasions.Each dosing session will take place over 2 days and
      there will be at least one subject on placebo on each day. There will be only one subject on
      any new active dose during the first day.Part 2 will be a randomised, double-blind,
      double-dummy, placebo-controlled, cross-over study to investigate the effect of single doses
      of GSK drug and lamotrigine on resting motor threshold in healthy male subjects. Subjects
      will attend the unit a maximum of 4 separate occasions.During each session subjects will
      receive up to 4 TMS measurements and single doses of either GSK drug, lamotrigine or placebo,
      in a randomised manner.Up to two doses of GSK drug will be investigated.
    

Detailed description: 
      This study, previously posted by GlaxoSmithKline (GSK), was transitioned to Convergence
      Pharmaceuticals, Ltd., which spun off from GSK. Convergence Pharmaceuticals, Ltd., has now
      been acquired by Biogen.
    

Intervention name(s): GSK drug; Placebo; Lamictal
Intervention type(s): Drug; Other; Other
Intervention description(s): GSK drug; Placebo; Positive control
Other intervention name(s): BIIB074 and CNV1014802
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: bipolar disorder,; single doses,; resting motor threshold; TMS,
The Effects of Replacing Red and Processed Meat With Quorn on Biomarkers of Gut Health
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This study will evaluate the effects of substituting red and processed meat in the diet with
      Quorn; a meat replacement product, on biomarkers of gut health. This will be a crossover
      design where participants will take part in 2 study periods where they will consume a diet
      containing red and processed meat during one of the study periods, whereas in the other study
      period, they will consume a diet containing Quorn.
    

Detailed description: 
      There is a strong association between a diet which is high in red and processed meat, while
      low in fibre, and the incidence of colorectal cancer. This study aims to evaluate the effects
      of replacing red and processed meat in the diet with an alternative meat product such as
      Quorn, on biomarkers of gut health that may be associated with colorectal cancer.

      Quorn is a product which has a considerable fibre component; thus, the replacement of red and
      processed meat with Quorn, will not only reduce the amount of compounds implicated to have
      deleterious effects in the gastrointestinal tract (E.G. haem, nitroso compounds, heterocyclic
      amines), but will also increase the delivery of fibre into the gastrointestinal system, that
      may well have an overall positive impact on gut health.

      In this study, the participants will consume 240 grams (raw weight) of either red and
      processed meat, or Quorn each day for a 2 week period, this will be followed by a 4 week
      period where they will return to their usual dietary habits; before swapping to consume the
      alternative food (red/processed meat or Quorn) for another 2 week period.
    

Intervention name(s): Red and Processed Meat; Quorn
Intervention type(s): Other; Other
Intervention description(s): Integration of 240 grams (raw weight) of red and processed meat into daily diet for 2 week period.; Integration of 240 grams (uncooked weight) of Quorn into daily diet for 2 week period.
Other intervention name(s): Quorn Food
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Genotoxicity; DNA damage; Gut Microbiota; Metabolites
Studying the Analgesic Mechanism of the "Cough-Trick"
Condition: Pain; Acute Pain; Venipuncture
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the trial is to study the possible mechanism of the pain reducing effect of CT at
      peripheral venipuncture
    


Intervention name(s): Venipuncture with "cough-trick"
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Acute pain; pain on venipuncture; "cough-trick"; distraction
Investigation of the Metabolism and Pharmacokinetics of Ambroxol in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the basic pharmacokinetics of ambroxol and [14C]-radioactivity including
      mass balance, excretion pathways and complete metabolism in healthy male volunteers following
      administration of a lozenge of 20 mg ambroxol together with an oral solution of 0.4 mg
      [14C]-ambroxol labelled in two different positions
    


Intervention name(s): [14C]-cyclohexane ambroxol oral solution; [14C]-benzyl ambroxol oral solution; Ambroxol lozenge
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Pharmaceutical Solutions; Ambroxol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Galantamine Effects on Cognitive Function in Abstinent Cocaine Users
Condition: Cocaine Abuse
MeSH terms: Cocaine-Related Disorders
Study type: Interventional

Summary: 
      To evaluate galantamine's effects on cognitive performance in abstinent cocaine users.
      Galantamine, a medication approved for treatment of Alzheimer's disease, is an acetylcholine
      esterase inhibitor. Galantamine also directly potentiates nicotine receptors. Both of these
      effects may result in improved cognitive performance in a group of subjects known to have
      impaired performance in various cognitive tasks.
    

Detailed description: 
      Galantamine, compared to placebo, will improve cognitive performance in abstinent cocaine
      users. The cognitive performance will be measured with the Stroop test and 3 Cambridge
      Neuropsychological Test Automated Battery (CANTAB) tests: Paired Associate Learning (PAL),
      Delayed Pattern Recognition Memory (PRM),and Rapid Visual Information Processing (RVIP).
      Performance on these tests has been shown to be impaired in abstinent cocaine users, compared
      to healthy controls.

      Galantamine, compared to placebo, will not be associated with any significant changes in
      mood. Monitoring of mood will be achieved with 3 mood scales: 1) Center for Epidemiologic
      Studies Depression (CES-D) scale, Positive and Negative Affect Schedule (PANAS) and the
      Profile of Mood States (POMS).

      Currently this study is completed, Patients are no longer being enrolled. There were 28
      completers. This study has been published.
    

Intervention name(s): Galantamine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Galantamine 8 mg/day; sugar pill
Other intervention name(s): Nivalin,; Razadyne,; Razadyne ER,; Reminyl,; Lycoremine; Sugar Pill
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cognitive enhancers; Nootropic Agents