bioihbjkbjnl/mcl2 huggingface dataset:
Study of Irinotecan on a Weekly Schedule in Children
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The medicine being offered in this study is called Irinotecan. Irinotecan has been effective
      against many animal cancers. It has been given to both adults and children. We are now
      attempting to determine how much of the drug can be given to children when Irinotecan is
      given weekly for four weeks in a row every 6 weeks and the toxicities (bad side effects) that
      occur when irinotecan is administered on this schedule.

      The purposes of this study are to:

        1. To determine the highest dose of Irinotecan that can safely be given to children whose
           cancer no longer responds to standard treatment.

        2. To determine the toxicities of Irinotecan.

        3. To determine what studies (laboratory or x-rays) need to be done to evaluate the
           toxicities of this drug.

        4. To determine if irinotecan is beneficial to the patient.

        5. To understand how the drug Irinotecan works in the body.
    

Detailed description: 
      Irinotecan will be given intravenously (into the vein) over 90 minutes for four weeks in a
      row. This cycle may be repeated in six weeks as long as the cancer is not getting worse and
      there are no serious side effects.

      After one cycle patients will be evaluated to decide if the treatments should continue. If
      the disease is no worse or better additional courses may be given. If treatment continues,
      evaluations will be done after the second cycle and then every 2 cycles.

      If patients choose to participate in this study we would request that they remain in the
      study for one full cycle. During the first cycle of treatment we would like to draw special
      blood samples to help us learn how much drug is in the blood. These special studies are
      called pharmacokinetics. On the first day the drug is given, fourteen blood samples will be
      drawn. Each blood sample will be about 1/2 teaspoon, for a total of about 3 tablespoons.
      These samples will only be drawn during the first cycle of therapy. The total amount of blood
      drawn will be less than 5% of the total blood volume, an amount safe even for small children.

      Examinations and other blood tests will be done twice a week initially, then weekly to look
      for side effects of the drug. Patients will have an additional one teaspoon of blood drawn at
      each of these visits.
    

Intervention name(s): Irinotecan
Intervention type(s): Drug
Other intervention name(s): Onivyde,
Intervention MeSH terms: Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Genetic Basis for Variation in the Renal Elimination of Metformin
Condition: Other Conditions That May Be A Focus of Clinical Attention
Study type: Interventional
Phase: Phase 4

Summary: 
      The current study is part of a large multi-investigator grant to look at the pharmacogenetics
      of a number of membrane transporters. We will study individuals with particular genotypes of
      the human organic cation transporter, (hOCT2), to test the hypothesis that genetic variation
      in hOCT2 is associated with variation in the renal clearance of the antidiabetic agent,
      metformin.
    

Detailed description: 
      The drug, which is used in the treatment of Type II diabetes, has a narrow therapeutic range.
      Its net renal clearance by secretion (i.e., renal clearance minus filtration clearance)
      ranges from approximately 100 ml/min to 800ml/min in normal, healthy subjects. Although many
      factors may contribute to inter-individual variation in renal secretory clearance, initial
      estimates of heritability (greater than 0.6) suggest that genetic factors play an important
      role in the renal secretion of metformin. Available evidence supports the idea that hOCT2 is
      the primary transporter involved in the first-step of renal secretion of metformin, i.e.,
      uptake from the blood to the tubule cell across the basolateral membrane. In particular, (a)
      hOCT2 is the primary organic cation transporter on the basolateral membrane of the human
      kidney; and (b) metformin interacts with and is translocated by hOCT2 in heterologous
      expression systems.

      In recent studies, we identified four variants (M165I, A270S, R400C, and K432Q) with
      ethnic-specific allele frequencies ≥1% [6] that have altered function in studies in
      heterologous expression systems. In addition, we identified a common haplotype of hOCT2 and
      one haplotype that contain the non-synonymous cSNP, A270S. We will determine whether
      variability in the renal secretory clearance of the model organic cation, metformin, in
      healthy individuals is associated with genetic variation in hOCT2. In particular, we will
      determine whether the renal clearance of metformin differs in individuals who are homozygous
      for the common haplotype of OCT2 (OCT2*1) and those who are heterozygous for the less common
      haplotype OCT2*3D, which we have identified in a comprehensive screen of ethnically
      identified DNA samples. We will also determine whether individuals who are heterozygous for
      the less common OCT2 variants, M165I, R400C and K432Q, have reduced renal clearances of
      metformin.
    

Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Subjects will be given a single oral dose of 850 mg of metformin
Other intervention name(s): GLUCOPHAGE
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Healthy Control
Decision Aid - Extreme Prematurity
Condition: Prematurity; Decision Support
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study is to assess in a pilot randomized controlled trial the following
      PICOT question: In parents facing extreme premature delivery, does the use of an existing
      validated visual decision aid as compared to standard counseling, reduce the primary outcome
      of parental decisional conflict? Furthermore, is such a decision aid understood and
      applicable across differing populations of different ethnic backgrounds and social classes?
    


Intervention name(s): Decision Aid; Standard
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Counseling; Limits of viability
A Safety And Pharmacokinetic Study of Setrobuvir Alone and In Combination With Ritonavir-Boosted Danoprevir in Subjects With Mild Hepatic Impairment Compared to Healthy Controls
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate
      the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with
      ritonavir-boosted danoprevir in subjects with mild hepatic impairment compared to healthy
      controls. All subjects will receive multiple doses of setrobuvir orally for 10 days in Period
      1 and multiple doses of setrobuvir plus ritonavir-boosted danoprevir orally for 10 days in
      Period 2, with a washout phase of at least 9 days between treatments.
    


Intervention name(s): danoprevir; ritonavir; setrobuvir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 mg orally every 12 hours; 100 mg orally every 12 hours; 200 mg orally every 12 hours
Intervention MeSH terms: Ritonavir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Efficacy of Anti-CFA/I and CfaE Bovine Milk Immunoglobulin Against Challenge With H10407 ETEC Expressing CFA/I
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess anti-CFA/I and anti-CfaE BIgG safety and to determine
      protective efficacy of anti-CFA/I and anti-CfaE BIgG against diarrhea after challenge with
      H10407, a CFA/I-expressing ETEC strain.
    

Detailed description: 
      This is a Randomized, double-blinded, placebo-controlled trial involving up to 33 subjects.
      Subjects will be randomized into one of the following three groups.

      Group N Product

        1. 10 BIgG anti-CFA/I

        2. 10 BIgG anti-CfaE

        3. 10 LactoFree® Lipil®

      Volunteers will receive the test article three times daily following meals beginning 2 days
      prior to oral ETEC challenge (strain H10407). Test article will be administered for a total
      of 7 days. Monitoring procedures will assess volunteer safety, the primary endpoint
      (diarrhea), stool microbiology (H10407 excretion), and ETEC-specific immunology. All
      volunteers will receive antibiotic treatment (ciprofloxacin, trimethoprim-sulfamethoxazole or
      amoxicillin) starting 5 days after ETEC challenge or sooner based on pre-defined clinical
      criteria. Follow-up visits for 2 weeks post-discharge will monitor safety and immunological
      parameters.
    

Intervention name(s): anti-CFA/I bovine IgG, and anti-CfaE bovine IgG
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: traveler's diarrhea; ETEC diarrhea; passive immunization; bovine milk prophylaxis
Curcumin Supplement in Nonalcoholic Fatty Liver Patients
Condition: Type 2 Diabetes; Nonalcoholic Fatty Liver
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to investigate the effects of curcumin supplement on metabolic
      factors and hepatic fibrosis in nonalcoholic fatty liver patients with type 2 diabetes.
      Subjects will participate in 3 month, two group, randomized intervention, where one group
      (n=25) will take 1.5g/d curcumin and the other group (n=25) will take a placebo to compare
      differences in outcomes between the two groups.
    


Intervention name(s): curcumin; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1500 mg
1 capsule / day for 12 weeks; 1500 mg
1 capsule / day for 12 weeks
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study in a Human Laboratory Model of Smoking Behavior
Condition: Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human
      Laboratory Model of Smoking Behavior.
    

Detailed description: 
      The study will be performed in subjects who are heavy cigarette smokers currently not seeking
      treatment for tobacco use disorder.

      The study is a crossover design study (within-subject analysis), which allows for subjects to
      be their own control.

      Each period of the crossover consists of a 7-day out-patient treatment period followed by a
      single in-patient testing day on Day 8. Subjects will participate in a laboratory session
      following the McKee Smoking Lapse Test and be discharged from the clinic to undergo a 7 day
      washout period followed by the second period of the crossover design and a 7-day follow-up
      visit.
    

Intervention name(s): CERC-501; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CERC-501; Placebo
Intervention MeSH terms: Aticaprant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cardiovascular Effects of Chronic Snus Use
Condition: Vascular Complications; Vascular Stiffness; Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Observational

Summary: 
      The current study proposes to investigate the effects of chronic snus use on the blood
      vessels. Several cardiovascular endpoints are measured using various methods in healthy daily
      snus users as well as in healthy matched controls.
    

Detailed description: 
      The Swedish moist oral snuff known as "snus" has previously been found primarily in
      Scandinavia. In Sweden approximately 1 in 5 men are habitual users of snus. It is estimated
      that 3-4% of the female population are regular users. However, the last few years has seen a
      shift in the global tobacco industry towards finding novel ways of entering the smokeless
      tobacco (ST) markets. In the United States both Camel and Marlboro brands, among others, have
      launched an array of ST products similar to Swedish snus. Since its launch in 2007, the US
      snus market has continued to grow at an exponential rate and now sells approximately 50
      million cans a year.

      Smoking has been studied extensively and been undoubtedly linked to a range of detrimental
      health effects, including cardiovascular disease. As snus has until recently been available
      in a limited Scandinavian market, few experimental and epidemiological studies have been
      performed.

      A recent meta-analysis found snus to be associated with heart failure and higher risk of
      fatal myocardial infarctions and stroke. Following myocardial infarction, discontinuation of
      snus use was associated with a 50% decreased risk of mortality.

      With new emerging markets worldwide publicizing the product as a discrete and healthier
      alternative to cigarettes, it has become all the more imperative to study the health effects
      of this smokeless tobacco. Using well validated methods the investigators intend to study the
      possible effects of chronic snus use on vascular endothelial function, thrombosis,
      circulating microparticles in blood and arterial stiffness.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        25 healthy non-smoking males with regular snus consumption and 25 healthy non-smoking and
        non-snus using. Healthy volunteers were recruited in Umeå and surrounding communities.
      
Biospecimen description: 
      Blood samples, Urine samples
    
Keywords: microvesicles, microparticles; Plethysmography; Snus; Arterial Stiffness; EPC
A First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD2373 After Single Dose Administration in Healthy Male Subjects of African Ancestry.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to assess the the safety, tolerability and pharmacokinetics (PK) of
      AZD2373, following subcutaneous (SC) administration of single ascending doses (SAD) of
      AZD2373 in healthy male subjects of African ancestry.
    

Detailed description: 
      This study will be conducted as a single-centre, randomised, placebo-controlled, single-blind
      study to assess the effect of AZD2373 following ascending dose sequential group design
      administrations to healthy male subjects of African ancestry. The study will include 6 single
      dose cohorts with the option to include 2 additional cohorts based on emerging data from
      preceding cohorts in the study.

      Approximately 48 male subjects aged 18 to 55 years at the time of informed consent
      (inclusive) will be randomized with the aim to have 8 subjects participate in each cohort.
      Within each cohort, 6 subjects will receive AZD2373 and 2 subjects will receive placebo.

      Sentinel dosing will be applied for each cohort and will be divided into 2 groups:

        -  Group 1 (sentinel group): 1 active, 1 placebo;

        -  Group 2 (the rest of the cohort): 5 active, 1 placebo. The safety data of up to 72 hours
           post-dose in Group 1 will be reviewed by the Principal Investigator (PI) before the
           subjects in Group 2 are dosed.

      The study will comprise:

        -  A Screening Period of maximum 35 days;

        -  A Treatment Period during which subjects will be resident at the Clinical Unit from the
           day before investigational medicinal product (IMP) administration (Day -1) until at
           least 72 hours after IMP administration; discharged from the Clinical Unit on Day 4;

        -  Follow-up Visits on 1, 1.5, 2, 3, 4, 5, 6, and 8 weeks (Visits 3 to 10); and

        -  A Final Follow up Visit 10 weeks after the last IMP dose.

      The visit occurring at 5 weeks post dose (Visit 5) is optional. The expected duration for any
      subject participating in the study is approximately 10 weeks (excluding an up to 28-day
      Screening Period).
    

Intervention name(s): AZD2373 subcutaneous injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Randomised subjects will receive a single ascending dose of AZD2373 by SC injection (dose 1, dose 2, dose 3, dose 4, dose 5 and dose 6).; Randomised subjects will receive a single ascending dose of placebo (saline solution) by SC injection.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: First-in-Human; Randomized; Single-blind; Placebo controlled; AZD2373; Single Ascending Dose; Sentinel Dosing
Effects of Subanesthetic Concentrations of Nitrous Oxide - 1
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to conduct experiments to examine subjective and reinforcing
      effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug
      abusers and preference procedures will be used to assess reinforcing effects. To examine
      effects of subanesthetic concentrations of nitrous oxide on cold-pressor pain in humans.
    


Intervention name(s): 20% N2O; 30% N2O; 40% N2O
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20% inhaled N2O; 30% inhaled N2O; 40% inhaled N2O
Intervention MeSH terms: Nitrous Oxide
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nitrous oxide; subjective effects; healthy volunteer
Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce
      fatigue in prostate cancer patients receiving LHRH agonist therapy.
    


Intervention name(s): Red Bull™ Sugar-Free Drink
Intervention type(s): Other
Intervention description(s): Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Pain Severity in Fibromyalgia Syndrome
Condition: Fibromyalgia; Pain, Chronic
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Chronic Pain; Pain
Study type: Observational [Patient Registry]

Summary: 
      Fibromyalgia Syndrome (FMS) is a complex syndrome that mainly includes the musculoskeletal
      system and is characterized by many symptoms such as chronic widespread pain, fatigue and
      sleep disorders, cognitive dysfunctions, regional pain syndrome, psychiatric disorders. The
      existence and importance of the multidimensional nature of chronic pain in FMS has been
      demonstrated. Factors such as pain intensity, persistence of pain, pain-related disability,
      and novelty of onset are all important characteristics of a chronic pain condition.
      Therefore, there was a need for a global measure of chronic pain severity that summarized
      different measures of pain and a graded classification of chronic pain was proposed. Patients
      with chronic pain such as FMS are known to have a greater negative impact than many chronic
      medical conditions. Chronic pain severity in FMS has been found to be associated with various
      conditions such as function and health status, and it has been shown that reduction in pain
      severity provides broadly beneficial results on these conditions. However; there are no
      studies in which chronic pain severity in FMS is classified by grading and investigating the
      relationship of different pain severity degrees with disease severity and other symptoms.

      The aim of this study is to evaluate whether the severity of the disease, kinesiophobia, and
      concerns about pain differ in individuals with different pain severity by grading the
      severity of pain in individuals with fibromyalgia syndrome.
    


Intervention name(s): No Interventions
Intervention type(s): Other
Intervention description(s): There is no interventions in this study
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Participants who directly presented to the Physical Therapy Department of Kutahya Health
        Sciences University Hospital during the study period (between 15 August and 15 Nowember)
        with persistent and diffuse pain, will be screened for eligibility by an independent
        physician (M.A.L.)
      
Keywords: fibromyalgia; pain; patient reported outcome measurement
Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the CYP2C8 inhibition by BIA 9-1067.
    

Detailed description: 
      Single-centre, open-label, randomised, two-way crossover study in healthy young male and
      female volunteers
    

Intervention name(s): BIA 9-1067; Repaglinide
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg BIA 9-1067 (single-dose); 0.5 mg repaglinide (single-dose)
Other intervention name(s): OPC, Opicapone; Novonorm®
Intervention MeSH terms: Repaglinide; Opicapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson Disease; BIA 9-1067
Diagnosis of Depression Among Adolescents
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      The objective of the study is to improve general practitioners' diagnoses of adolescent
      depression. Major depression is ranked fourth in the worldwide disability impact. The
      proportion of adolescents suffering from depressive disorders also seems to be increasing
      worldwide. Early interventions are known to reduce this illness. Therefore, the earlier
      depression can be identified in adolescents, the greater the advantage.
    


Intervention name(s): Validation
Intervention type(s): Procedure
Keywords: Depression; Validation; Adolescent; Validation of three key questions and questionnaire