bioihbjkbjnl/mcl2 huggingface dataset:
Multi-Centre, Open-Label, Two Segment, Study Comparing Plasma Pharmacokinetics of Ketoprofen in Diractin® Alone to Diractin® Applied Concomitant With Heat or Moderate Exercise
Condition: Pharmacokinetic
Study type: Interventional
Phase: Phase 1

Summary: 
      -  Comparison of the plasma PK after single use of 100 mg ketoprofen from Diractin®. 50 mg
           applied on 2 major joints to

        -  400 mg ketoprofen from Diractin® (100 mg applied to 4 joints - overexposure)

        -  100 mg and 400 mg ketoprofen from Diractin® used concomitant with heat application

        -  100 mg and 400 mg ketoprofen from Diractin® used concomitant with moderate exercise
    


Intervention name(s): Diractin; Diractin; Diractin; Diractin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100 mg Ketoprofen to 2 joints; 400 mg ketoprofen to 4 joints; 100 and 400 mg Ketoprofen used concomittant with heat; 100 and 400 mg Ketoprofen concomittant with moderate exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: heat; exercise
Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and tolerability of ziprasidone during
      long-term open-label administration in children and adolescents (ages 10-17) with bipolar I
      disorder (manic or mixed)
    


Intervention name(s): Ziprasidone oral capsules
Intervention type(s): Drug
Intervention description(s): Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .
Intervention MeSH terms: Ziprasidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Leukapheresis to Obtain Lymphocytes for Studies on Antiretroviral Naive HIV-infected Patients
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Observational

Summary: 
      To further investigate differences in the immunologic function of various lymphocyte subsets
      in HIV-infected patients who are treated early in their infection and during the chronic
      phase of the infection. Studies will also be done to further delineate the various
      antigen-specific and innate immune responses including characterization of soluble factors
      associated with primary HIV infection.
    

Detailed description: 
      Primary HIV-1 infected and chronically infected individuals will be recruited and
      leukapheresis will be performed. This one year study requires that patients be apheresed once
      before initiating therapy and on two other occasions (at month 6 and month 12) after
      suppression of plasma viremia. Peripheral blood mononuclear cells will be isolated by sodium
      diatrizoate density centrifugation and subjected to immunologic and virologic studies.
    

Intervention name(s): leukapheresis
Intervention type(s): Procedure
Intervention description(s): pack of cells as per protocol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HIV-infected adults who have a positive ELISA and a confirmatory western blot HIV test.
      
Biospecimen description: 
      Obtain lymphocytes for research studies on anti-retroviral naive HIV-infected patients.
    
Keywords: primary HIV infection; chronic HIV infection
Monitoring Living Donor Liver Functions by Thromboelastometry
Condition: THROMBELASTOGRAPHY and Liver Graft Functions
Study type: Observational

Summary: 
      A prospective Observational study including 50 living donor liver transplant recipients to
      monitor the graft functions through thromboelastometry
    

Detailed description: 
      This is a prospective observational study Includes 50 living donor liver transplant
      recipients performed in gastroenterology surgical center - Mansoura University liver
      transplantation program.

      Study period: from June 2014 to May 2015 The early post-operative graft functions will be
      correlated with concomitant monitored thromboelastometric (TEM) parameters derived from a
      ROTEM Delt device

      TEM Samples will be collected at the following times:

      Pre-transplant 10 minutes post portal declamping at ICU admission Morning of Days from 1 to 7
      Laboratory data relevant to graft functional status will be collected at the same times.
    

Intervention name(s): living donor liver transplantation
Intervention type(s): Procedure
Intervention description(s): living donor liver transplantation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Living donor liver transplant recipients operated upon in mansoura university liver
        transplantion project
      
Keywords: living donor liver transplantation; graft function; thromboelastometry
The Effect of Lifestyle-induced Hepatic Steatosis on Glucagon-stimulated Amino Acid Turnover
Condition: Non-Alcoholic Fatty Liver Disease; Glucagon Resistance
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Many patients with type 2 diabetes exhibit elevated plasma concentrations of the
      glucose-mobilising pancreatic hormone glucagon; i.e. hyperglucagonaemia. This contributes to
      the hyperglycaemic state of the patients and is considered an important component in the
      pathophysiology of type 2 diabetes; but the mechanisms underlying this phenomenon remain
      unclear. The liver constitutes the main target organ of glucagon, and studies have shown that
      hyperglucagonaemia goes hand in hand with hyperaminoacidaemia and that both are associated
      with non-alcoholic fatty liver disease (NAFLD), independently of the presence of type 2
      diabetes. In line with this, several recent studies support the existence of a feedback-cycle
      between the liver and the pancreatic alpha cells, governed by circulating glucagon and amino
      acids. The investigators hypothesise that the presence of hepatic steatosis results in
      hepatic glucagon resistance at the level of amino acid turnover, i.e. impaired
      glucagon-induced suppression of circulating amino acid concentrations. If this hypothesis
      proves correct, it would establish build-up of fat in the liver as a core mechanism
      underlying hyperglucagonaemia and, since the hyperglucagonemia is at least partly responsible
      for the fasting hyperglycaemia, as an important contributor to the hyperglycaemia of type 2
      diabetes.
    


Intervention name(s): Glucagon
Intervention type(s): Drug
Intervention description(s): Pancreatic clamp
Other intervention name(s): Insulin; Somatostatin; 6,6 H2-glucose
Intervention MeSH terms: Glucagon; Somatostatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Multiple Dose Escalation Study (14 Days) to Investigate Safety, Tolerability, PK and PD of Vardenafil and BAY60-4552
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this
      multiple dose escalation study. In three treatments groups different dosages of BAY 60-4552
      and vardenafil will be given with patients with erectile dysfunction.
    


Intervention name(s): BAY60-4552 + Vardenafil; BAY60-4552 + Vardenafil; BAY60-4552 + Vardenafil; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil; Total dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil; Total dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil; Placebo
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Erectile Dysfunction
Ventilation Using a Bag Valve Mask With Supplemental External Handle
Condition: Apnea
Study type: Interventional

Summary: 
      Investigators compared tidal volumes for single rescuer ventilation using a modified bag
      valve mask with a supplemental external handle versus a conventional bag valve mask in a
      manikin model.
    

Detailed description: 
      This was a prospective, randomized, crossover study to assess the tidal volume delivered
      using a standard and modified bag valve mask (BVM) device in a manikin airway model. The
      modified device comprised a standard bag valve mask with supplemental external bar. Data was
      collected during May 2016 at the San Antonio Military Medical Center. Emergency medicine
      providers (physicians, physician assistants, residents, nurses, medics) were randomized to
      device order. Prior to participation each participant filled out a survey indicating their
      job status, gender, years of medical experience, and experience level with BVM ventilation.
      Hand grip strength and size (length, width, span) were measured. Each participant was then
      asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per
      minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was
      recorded in milliliters. After a 3 minute rest period, testing was repeated with the second
      device. After ventilation with each device, participants completed an anonymous questionnaire
      that used a Likert scale to assess perceived qualities of the modified device including ease
      of use, ability to provide a superior mask seal, willingness to use in an emergency
      situation, and overall preference between the two devices. Each participant served as his/her
      own control.
    

Intervention name(s): Modified Ambu Spur II bag valve mask; Conventional Ambu Spur II bag valve mask
Intervention type(s): Device; Device
Intervention description(s): Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle; Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol as
      add-on medication to methotrexate over the long term in Japanese RA patients transferred from
      Study 275-08-001 (NCT00791999), and to evaluate the effects of different dosing regimens on
      the safety and efficacy of certolizumab pegol in American College of Rheumatology 20% (ACR20)
      responders who completed Study 275-08-001.
    

Detailed description: 
      This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on
      12/04/2012.
    

Intervention name(s): Certolizumab pegol; Methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous (SC) injection; Methotrexate dose between 6 to 8 mg/week.
Other intervention name(s): CDP870; Cimzia
Intervention MeSH terms: Certolizumab Pegol; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Certolizumab Pegol; Cimzia
School-based Oral Health Education Program Using Experiential Learning
Condition: Caries; Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The aim of this project was to compare the effectiveness of experiential learning (EL) and
      traditional lecturing (TL) school-based oral health education on the oral health knowledge,
      attitude, habits, oral hygiene, gingival health and caries incidence of 10 and 13-year-old
      Greek children. Thee hundred and fifty children were selected from three areas of Greece.
      Information on oral health knowledge, attitude and behaviour were obtained using a
      questionnaire. Dental plaque was recorded using a modified hygiene index, gingivitis was
      assessed using the simplified gingival index and dental caries was measured by recording the
      number of Decayed, Missing and Filled teeth (DMFT) using the British Association for the
      Study of Community Dentistry (BASCD) criteria. All children were examined by two calibrated
      dentists, using a World Health Organisation (WHO) periodontal probe and artificial light.
      Questionnaires were delivered and clinical examinations were performed at baseline and at 6
      and 18 months post-intervention. The EL oral health educational program was implemented by
      teachers using the program's manual.
    


Intervention name(s): Experiential learning oral health education
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Perspective on Thoughts and Feelings as a Predictor of Psychological Well-being in Daily Life, in a Community Sample
Condition: Mental Health; Mindfulness
Study type: Observational

Summary: 
      This project examines the psychological construct of decentering - a mindfulness-related
      construct marked by an observer perspective on one's ongoing mental processes. Specifically,
      this project seeks to explore the extent to which decentering modulates the relationship
      between people's affective states and their momentary mental health and well-being, and to
      test the psychological processes by which decentering might exert these effects. This study
      includes a baseline assessment followed by a 7-day study completed from home where
      participants respond to brief surveys about their current experiences six times per day
      (i.e., an Ecological Momentary Assessment [EMA] design).

      The investigators hypothesize that decentering moderates the association of extreme affect
      with related symptoms (i.e., elevated negative affect with depression and anxiety; elevated
      positive affect with mania, narcissism, and histrionic traits) and well-being, such that the
      association is attenuated at high levels of decentering. This will be examined using the EMA
      data, analyzing between-person levels (i.e., trait) as well as momentary within-person
      processes (i.e., concurrent and prospective states).

      Further, the investigators predict that broadened attentional focus and improved
      self-regulation are mechanisms that contribute to the beneficial effects of decentering in
      daily life. This hypothesis will be examined in two ways:

        1. as individual differences, wherein greater self-regulatory abilities (e.g., higher heart
           rate variability) and less attentional biases towards emotional stimuli mediate the
           association between trait decentering and subsequent daily well-being/symptoms, and

        2. as within-person momentary levels, wherein broader attentional processes and greater
           self-regulation in daily life mediate the concurrent and prospective association between
           momentary decentering and well-being/symptoms.

      Note that the study uses a multimodal assessment of each of the proposed processes. For
      attentional processes, a variety of parameters extracted from an emotional eye tracking
      paradigm will be examined. For self-regulatory abilities, assessments will include
      self-report, physiological (heart rate variability), and behavioral ("go / no-go" task)
      measures of such abilities.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population from which the sample will be recruited will be residents of the greater
        Buffalo, NY metropolitan area.
      
Keywords: Self-control; Ecological Momentary Assessment; Attentional bias; Respiratory Sinus Arrhythmia; Affect; Emotion Regulation; Well-being; Decentering; Affective disorders
Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study,
      designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the
      marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.
    


Intervention name(s): Clindamycin 1% Gel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Topical gel; Topical Placebo gel
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who
      have previously untreated or relapsed mantle cell lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Assess the efficacy of flavopiridol in terms of response rate in patients with
           previously untreated or relapsed mantle cell lymphoma.

        -  Assess the toxicity of this regimen in this patient population.

        -  Determine the time to progression and, if responses are observed, response duration in
           these patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive flavopiridol IV over 1 hour daily for 3 days. Treatment continues every 3
      weeks in the absence of unacceptable toxicity or disease progression. Patients with a
      complete response (CR) receive 2 additional courses after documented CR. Patients with a
      partial response receive 2 additional courses after documented maximal tumor shrinkage.
      Patients with stable disease receive a maximum of 4 courses.

      Patients are followed at 4 weeks and then every 3 months until relapse or death.

      PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 18-24
      months.
    

Intervention name(s): alvocidib
Intervention type(s): Drug
Intervention MeSH terms: Alvocidib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I mantle cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; recurrent mantle cell lymphoma; stage II mantle cell lymphoma
Effect of Imatinib on Suppression of Malaria Parasites in Patients With Uncomplicated Plasmodium Falciparum Malaria
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the efficacy and safety of imatinib in combination
      with dihydroartemisinin plus piperaquine in the treatment uncomplicated P. falciparum malaria
      in adult male patients.
    

Detailed description: 
      An exploratory study to examine the efficacy and safety of imatinib mesylate in combination
      with dihydroartemisinin plus piperaquine on suppression of parasitemia in patients with
      uncomplicated Plasmodium falciparum malaria. In vitro studies of P. falciparum parasitized
      erythrocytes demonstrate that inhibitors of the protein tyrosine kinase SYK prevent malaria
      parasite egress from infected red blood cells and thereby terminate the parasite's life
      cycle. Although no potent syk kinase inhibitors were approved for human use at the time of
      initiation of this study, a bcr-abl tyrosine kinase inhibitor (imatinib mesylate (Gleevec®))
      that also exhibits off-target inhibition of syk tyrosine kinase, has been FDA-approved for
      treatment of a number of human malignancies including chronic myelogenous leukemia and GIST.
      Because imatinib can be taken daily for many years without significant toxicity, it can be
      used to obtain a preliminary indication of whether inhibition of erythrocyte syk kinase can
      suppress parasitemia in patients with P. falciparum malaria. In a phase 1 clinical trial on
      the same patient population, anti-malaria activity was observed with imatinib, with little or
      no accompanying toxicity. Because dihydroartemisinin plus piperaquine constitute the
      currently used standard-of-care therapy for malaria in Southeast Asia, the above trial will
      test the safety and efficacy of the combination of imatinib plus dihydroartemisinin and
      piperaquine in treatment of uncomplicated malaria. In this pilot study, the rate of decrease
      in peripheral blood parasitemia in 30 adult male patients with uncomplicated malaria will be
      compared to the same rate of decrease in parasitemia in 30 adult male patients treated solely
      with dihydroartemisinin plus piperaquine.
    

Intervention name(s): Imatinib combination therapy; Dihydroartemisinin-piperaquine
Intervention type(s): Drug; Drug
Intervention description(s): Imatinib plus dihydroartemisinin plus piperaquine; Standard of care
Other intervention name(s): Gleevec; Glivec; Artekin; Eurartesim; Diphos; Timequin; Duocotecxin; Malacur; Ridmal
Intervention MeSH terms: Piperaquine; Artenimol; Imatinib Mesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plasmodium falciparum; Uncomplicated malarial; imatinib mesylate; antimalarials