bioihbjkbjnl/mcl2 huggingface dataset:
Crossover Study to Compare Pharmacokinetic Property of SYP-1512 Tab and Revlimid Cap in Healthy Male Volunteers
Condition: Healthy, Male
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by
      comparing pharmacokinetics characteristics between the SYP-1512 Tab and Revlimid cap (25mg)
      when administered a single-dose to healthy male volunteers.
    

Detailed description: 
      Healthy volunteers are administrated single-dose over the period I and II (crossover) of
      SYP-1512 Tab and Revlimid cap (25mg) as of lenalidomide 25mg.

      Every time before and after each medication, pharmacokinetic (PK) parameters and safety of
      SYP-1512 Tab and Revlimid cap (25mg) is performed using a blood sample and conducting some
      tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively
    

Intervention name(s): SYP-1512; Revlimid cap
Intervention type(s): Drug; Drug
Intervention description(s): Lenalidomide 25mg/tablet, PO, 1 tablet once daily for I&II D1(crossover); Lenalidomide 25mg/capsule, po, 1 capsule once daily for period I&II D1(crossover)
Other intervention name(s): Lenalidomide 25mg; Lenalidomide 25mg
Intervention MeSH terms: Lenalidomide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Evaluation of the pharmacokinetics equivalence; Healthy volunteers; Single dose over the period I and II(crossover); Healthy male volunteers
The Effects of Acute Total Sleep Deprivation Versus Normal Sleep on Metabolism
Condition: Sleep Deprivation; Sleep
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      The study proposes to investigate whether acute total deprivation affects metabolism as
      measured through blood and peripheral tissues. Its aim is also to investigate how acute total
      sleep deprivation affects neurodegenerative markers, as well as hormones, memory performance
      and aspects of appetite regulation.
    

Detailed description: 
      It is predicted that acute total sleep deprivation will affect gene expression and DNA
      methylation. It is also predicted that sleep deprivation will up-regulate ghrelin, and affect
      other neuroendocrine markers and hormones in a negative manner. It is further predicted that
      sleep deprivation will decrease participants' memory performance.
    

Intervention name(s): Inhibitory task; Blood samples; Tissue samples; Oral glucose tolerance test; Portion Size Task
Intervention type(s): Behavioral; Procedure; Procedure; Procedure; Behavioral
Intervention description(s): Participants perform a binary decision on each presented stimuli. Of the two possible outcomes, participants are instructed to make a motor response (go) for one type, and are to withhold a response (no-go) for the other type. Reaction time and accuracy are measured for each event; Hormone levels, neuromolecular levels and gene expression profiles will be analyzed from repeated blood samples obtained before and after the nighttime intervention; Expression profiles will be analyzed from samples obtained from tissues involved in metabolism; 75 g of glucose will be dissolved in 300 ml of water and given to participants, followed by blood sampling at 0, 15, 30, 60, 90, 120 and 150 minutes following the ingestion of the glucose solution.; Participants are given a computer program that gives them the opportunity to choose the portions of a variety of food items that they would ideally like to consume
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Influence of Beetroot Juice on Racial Disparities in Vascular Health
Condition: Blood Pressure; Racial Disparities; Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      Black adults are 30% more likely to die from cardiovascular disease (CVD) compared to White
      adults, and more than half of this racial disparity in cardiovascular mortality may be
      attributed to the substantially greater prevalence of high blood pressure and vascular
      dysfunction in Black adults. Nitric oxide (NO) is a potent signaling molecule and key regular
      of vascular function that is suspected to be reduced in black individuals, but can be
      enriched by dietary nitrate (e.g., arugula, spinach, beets). The purpose of this study is to
      test the hypothesis that increasing NO bioavailability via nitrate-rich beetroot juice (BRJ)
      will lower blood pressure and improve vascular health in Black adults.
    

Detailed description: 
      The investigators long-term research goal is to investigate mechanisms accounting for the
      higher prevalence of CVD and high blood pressure in Black individuals, and identify effective
      preventive strategies. Nitric oxide (NO) is a gaseous molecule that plays an essential role
      in the regulation of vascular tone and blood pressure regulation. Some, but not all, studies
      have observed reduced NO bioavailability in Black individuals, which may contribute to racial
      disparities in vascular health. Dietary nitrate supplementation using beetroot juice (BRJ) is
      demonstrated to increase circulating NO, lower blood pressure and arterial stiffness, and
      improve blood pressure regulation in clinical populations and health individuals. The central
      hypothesis is that increasing NO bioavailability by nitrate-rich BRJ supplementation will
      lower blood pressure and improve vascular health in Black adults. The investigators
      acknowledge that racial differences are not entirely driven by ancestry, and thus will assess
      and account for sociocultural factors and health behaviors (i.e., sleep, physical activity,
      and nutrition) that may contribute to racial health disparities.
    

Intervention name(s): Acute Beetroot Juice
Intervention type(s): Other
Intervention description(s): Participants will ingest a beetroot juice supplement with and without inorganic nitrate to determine the effects of acute dietary nitrate ingestion on blood pressure and arterial stiffness
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The intervention is to provide participants with either nitrate-rich (~12.8 mmol nitrate; 140 mL) beetroot juice or an indistinguishable equal volume placebo with nitrate removed, the order of which will be randomized.
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: blood pressure; arterial stiffness; cardiovascular health; nitric oxide
Genes Involved in Lipid Disorders
Condition: Lipid Disorders
MeSH terms: Lipid Metabolism Disorders
Study type: Observational

Summary: 
      Background:

      - Genes are the instructions our body uses to function. Researchers can look for changes, or
      variants, in the genes. The goal of this study is to find new gene changes that lead to lipid
      disorders. Older research methods looked at one or a few genes at a time. Genomic sequencing
      looks at most of the genes at once. Genomic sequencing may find the cause researchers haven t
      been able to find from past methods.

      Objectives:

      - To better understand genetic causes of lipid disorders through genomic sequencing.

      Eligibility:

      - People age 2 and older with unusual lipid disorders, and their relatives.

      Design:

        -  Participants will be screened with a physical exam and medical history. They will have
           blood taken. They may give a saliva sample.

        -  Based on the screening test, researchers will chose 3-5 family members to perform the
           genomic sequencing. The sequencing will be done on a sample of DNA collected during the
           blood draw and saliva sample.

        -  Participants may be invited to take part in other protocols that may involve imaging of
           their heart or blood vessels. They do not have to participate. If they do, they will
           sign a separate consent for those tests.

        -  If a participant s family member cannot travel to the NIH, the NIH documents and consent
           will be reviewed during a teleconference. A blood or sputum kit will be mailed to them.
    

Detailed description: 
      The primary purpose of this discovery protocol is to identify new lipid genes from subjects
      with rare genetic lipids disorders. We will take advantage of the new technology of whole
      exome sequencing to find the cause of dyslipidemia that we haven t been able to find using
      past methods. We will work with geneticists to review the sequence data for unexpected gene
      changes (incidental findings) that do not explain the lipid disorder but gene changes that
      can cause medical disorders such as rare forms of cancer or heart disease. The opportunity to
      participate in the Clinical Center Genomics Opportunity (CCGO) program will enable us to take
      advantage of our expertise in other rare lipid disorders and translate this knowledge into
      new diagnostics and therapies, which is a key mission of the NIH.
    

Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Entire population.
      
Keywords: Hypertriglyceridemia; Atherosclerosis; Genectic Variants; Hyperalphalipoproteinemia; Dyslipidemia; Natural History
Effectiveness of Amantadine and Propranolol for Treating Cocaine Dependence - 2
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Cocaine addiction is a serious health problem with no available medical treatment for
      preventing relapse. Amantadine, a medication that improves muscle control, and propranolol, a
      medication that lowers blood pressure, may be useful in treating cocaine addiction in
      individuals with severe cocaine withdrawal symptoms. This study will evaluate the
      effectiveness of amantadine and propranolol in preventing drug relapse among cocaine addicts.
    

Detailed description: 
      Cocaine withdrawal symptoms are a major contributing factor for why outpatient cocaine
      dependence treatment programs often fail. Individuals with severe cocaine withdrawal symptoms
      often experience anxiety, shaking, and muscle pain. Amantadine is a medication currently used
      to improve muscle control, reduce shaking, and lessen stiffness. Therefore, it may help
      reduce the muscle pain that some cocaine addicts experience. By enhancing activity of the
      brain chemical dopamine, amantadine may also reduce other symptoms associated with cocaine
      withdrawal. Propranolol is a medication currently used to treat high blood pressure and
      irregular heart rhythms. It may reduce anxiety and lessen cocaine cravings in individuals
      addicted to cocaine. The purpose of this study is to evaluate the effectiveness of amantadine
      and propranolol, alone and in combination, for treating cocaine addicts with severe cocaine
      withdrawal symptoms.

      A 2-week baseline evaluation period will be followed by an 8-week treatment phase. During the
      baseline evaluation, cocaine use will be measured with urine tests, three times each week.
      Only participants who are experiencing severe withdrawal symptoms and who use cocaine at
      least twice during the first 2 weeks will continue in the study. Eligible individuals will
      then be randomly assigned to receive amantadine alone, propranolol alone, a combination of
      amantadine and propranolol, or placebo. Treatments will begin at Week 3 and study visits will
      occur three times each week. Cocaine levels will be monitored throughout the study with urine
      tests.
    

Intervention name(s): Propranolol; Amantadine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Propranolol 100mg/day in 3 divided doses; Amantadine 100mg three times daily; Placebo pills
Intervention MeSH terms: Amantadine; Propranolol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine
Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare repeated intermittent IV dosing of diclofenac in patient with
      moderate to severe post-surgical pain from elective orthopedic surgery.
    

Detailed description: 
      The primary objective is to evaluate the analgesic efficacy and safety of three dosage levels
      of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac
      tromethamine.
    

Intervention name(s): IV Diclofenac; IV ketorolac; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV Diclofenac q6h; IV ketorolac q6h; Placebo q6h
Intervention MeSH terms: Diclofenac; Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Mizone vs Water for Bowel Preparation.
Condition: Bowel Preparation
Study type: Interventional

Summary: 
      In order to analyze the effectiveness and patient tolerance of the two bowel preparation
      regimens, we will compare Polyethylene Glycol Electrolytes Powder (PEG-4000) and Mizone with
      PEG-ELS. The aim was to demonstrate that polyethylene glycol electrolyte powder (PEG-4000)
      and Mizone is not inferior in overall quality of intestinal preparation to PEG-ELS in
      subjects undergoing colonoscopy.
    


Intervention name(s): PEG-Mizone; PEG-ELS
Intervention type(s): Drug; Drug
Intervention description(s): The evening before the colonoscopy:60gPEG-4000 was mixed with 0.6LMizone and 0.4L water.
On the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 1.2LMizone and 0.8L water.; The evening before the colonoscopy:60gPEG-4000 was mixed with 1L water. On the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 2L water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: bowel preparation quality
Survey of Adolescent Living in Vestmanland
Condition: Alcohol Abuse; Criminalism; Depression
MeSH terms: Alcoholism
Study type: Observational

Summary: 
      The interaction of MAO-A genotype and psychosocial risk, in relation to male adolescent
      criminality The interaction of 5-HTTLPR genotype and psychosocial risk in relation to
      excessive adolescent alcohol consumption The interaction of 5-HTTLPR genotype and
      psychosocial risk in relation to depressive symptoms among adolescents The interaction of
      MAO-A genotype and psychosocial risk, in relation to female adolescent criminality
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        16 and 19-year-olds school students in county of Vestmanland.
      
Keywords: Adolescent; Alcohol; Criminology; Genes; Environment; Mono amine Oxidase; Serotonin; Social Support
Hodgkin Lymphoma Treatment With Adcetris and Levact in the Old Patient
Condition: Clinical Efficacy; Safety
MeSH terms: Hodgkin Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Treatment outcome with ABVD in elderly patients remains inferior to adults. Moreover,
      Bleomycin-induced lung toxicity in the elderly has been reported as high as 46%. For these
      reasons, questions arise whether ABVD could be still considered the standard treatment in HL
      patients aged > than 60. Regimens containing other alkylators such as CHOP proved even
      superior to ABVD, with a 3-y PFS of 67%. Frontline treatment of advanced-stage HL with
      Brentuximab Vedotin (BV) in association with AVD (Doxorubicin, Vinblastine, Dacarbazine)
      proved very active in a pioneer study, reporting the preliminary results of a phase 1
      multicentre trial, in which the percentage of patients achieving CR was as high as 92%. For
      all these reason the investigators decided to test the association of an alkylator with an
      innovative mechanism of action and a very safe toxicity profile in the elderly such as
      Bendamustine (Be) with BV in untreated elderly HL patients.

      The combination of BV and Be, investigated in this study, might represent an innovative
      treatment alternative for HL patients older than 60 years of age, especially for those of
      them in whom ABVD chemotherapy, the current standard front-line treatment, is not suitable.
      However, even when ABVD is given as upfront treatment for elderly HL patients, it is
      associated with substantial dose reduction, treatment delay, toxicity, and treatment-related
      mortality, with treatment outcomes remaining much inferior to those obtained in younger
      patients. This drug association is expected to be safe, well-tolerated and to demonstrate
      higher efficiency compared with ABVD. In this setting, it is expected that this therapy could
      be offered to the large majority of elderly patients with a full treatment completion reached
      in up to 80% of these patients.

      Thus, the aim of this study will be to assess safety and efficacy of the above association.
    


Intervention name(s): Adcetris-Levact
Intervention type(s): Drug
Intervention description(s): Association of Adcetris (1.2 mg/kg intravenously every 3 weeks) with Levact (90 mg/m2/day intravenously for 2 days every 3 weeks) during at least 6 cycles.
Other intervention name(s): Bendamustine; Brentuximab Vedotin
Intervention MeSH terms: Bendamustine Hydrochloride; Brentuximab Vedotin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SCCOR Minorities Observational Study
Condition: Pulmonary Disease, Chronic Obstructive; Emphysema
MeSH terms: Pulmonary Disease, Chronic Obstructive; Emphysema
Study type: Observational

Summary: 
      The SCCOR Minorities study will recruit minority participants from the COPDGene cohort, in
      whom the University of Pittsburgh has already obtained baseline and five year data, in order
      to enhance bone mineral density and vascular function data collection from minority smokers.
      Dual X-ray absorptiometry (DXA) scans will be obtained to measure bone mineral density.
      Non-invasive vascular studies will be performed to measure endothelial function.
      Questionnaires regarding symptoms and activity levels will be administered and a blood sample
      will be obtained in participants in which blood samples are not already available from the
      COPDGene study visits.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        - African American male and female subjects participating in COPDGene study
      
Biospecimen description: 
      blood specimens will be obtained and stored for later analysis, which may include measurement
      of proteins, RNA expression, DNA.
HMPL-523 CYP3A/P-gp Inhibitor and CYP Inducer Study
Condition: Relapsed or Refractory Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Open-label, 2-Part, 2-Period Fixed-Sequence Crossover Study to Assess the Effect
      of Itraconazole, a CYP3A and P-glycoprotein Inhibitor, and the Effect of Rifampin, a CYP
      Enzyme Inducer, on the Pharmacokinetics of HMPL-523 in Healthy Volunteers
    

Detailed description: 
      This study will be a single-center, open-label, 2-part, 2-period fixed-sequence crossover
      study to be conducted with 28 healthy male and female volunteers. The study will consist of a
      Screening Phase (Screening and Day -1), a Treatment Phase (Period 1 and Period 2), and an End
      of Study (EOS) Phase.
    

Intervention name(s): HMPL-523; Itraconazole; Rifampin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HMPL-523 is a selective small-molecule SYK inhibitor.; Itraconazole is an FDA approved synthetic triazole antifungal agent; Rifampin is an FDA approved semisynthetic antiobiotic derivative indicated in the treatment of both tuberculosis and meningococcal carrier state
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Intervention Study for Smoking Cessation in Spanish College Students
Condition: Smoking; Smoking Cessation
Study type: Interventional

Summary: 
      This study evaluate the effectiveness of a nurse multi-component intervention aimed at
      helping Spanish college student smokers to quit smoking.
    

Detailed description: 
      This study hipotetize that a multicomponent intervention, tailored to college student and
      conducted by a nurse is more effective than brief advise.

      The intervention was a multi-component intervention based on the Theory of Triadic Influence
      and on previous recommendations made in the Surgeon General's report . The strategies of this
      program consisted of a 50-minute motivational interview conducted by a nurse and online
      self-help material. The follow-up included a reinforcing e-mail and group therapy. The
      smoking-related Self-efficacy, Belief and Intention scale was used to assess outcomes.
    

Intervention name(s): Multicomponent intervention; Brief advice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Motivational interview (50 minutes), on-line self-help material, support e-mail, group therapy, and second motivational interview (20 minutes); Brief advice (5-10minutes) and a self-help pamphlet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cessation; College student; Motivational Interview; Self-efficacy; Intention; Beliefs; Young adult