bioihbjkbjnl/mcl2 huggingface dataset:
A Five-Treatment-Period Study to Evaluate the Single-Dose Pharmacokinetics and Pharmacodynamics of Avatrombopag in Healthy Japanese and White Subjects
Condition: Thrombocytopenia
MeSH terms: Thrombocytopenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, open-label, 5-treatment-period study to evaluate the PK and PD of
      avatrombopag following a single administration of avatrombopag in the fed and fasted
      condition, or the fed condition, to healthy Japanese and white subjects. A standard high-fat,
      high calorie breakfast will be used to assess the fed condition.
    

Detailed description: 
      The study will comprise a Prerandomization Phase and a Randomization Phase. The
      Prerandomization Phase will include 2 periods, Screening and Baseline 1. The Screening Period
      will be up to 3 weeks (21 days) in duration. The Randomization Phase will consist of 5
      single-dose treatment periods, of which 3 will include administration of avatrombopag in the
      fed condition and 2 will include administration of avatrombopag in the fasted condition. Each
      treatment period will be separated by a wash out interval of at least 28 days. Before each
      treatment period, subjects will complete a baseline period (Baseline Periods 2, 3, 4, and 5),
      during which baseline assessments will be collected. A Final Visit will occur 28 days (+/- 1
      day) after dosing in Treatment Period 5.
    

Intervention name(s): avatrombopag
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy
Von Willebrand Factor to Predict Postoperative Outcome
Condition: Liver Dysfunction; Morbidity; Mortality; Hospitalisation
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      vWF is stored in weibel-palade-bodies of endothelial cells as well as alpha-granula of
      platelets and is released upon their activation. Endothelial cell dysfunction as well as
      platelet activation often occur in liver disease and portal hypertension, which may lead to
      an increase in circulating vWF levels. Indeed, multiple studies have reported that liver
      disease is associated with increased circulating vWF- antigen (vWF-Ag). Furthermore,
      increased circulating vWF -Ag Levels have been shown to be associated with increased
      mortality rates in patients with chronic liver disease. Within a prospective evaluation
      cohort, the investigators were able to document that patients with increased vWF-Ag levels
      prior to liver resection suffered from an increased incidence of postoperative liver
      dysfunction and morbidity. Within this prospective multicenter validation study, the
      investigators now aim to prospectively validate that circulating vWF-Ag prior to liver
      resection is a valuable marker to predict postoperative clinical outcome.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing liver resections for either hepatocellular carcinoma, cholangiocellular
        carcinoma or colorectal cancer liver metastasis. vWF-Ag will be evaluated prior to liver
        resection
      
Keywords: vWF; Liver Resection; Liver Dysfunction; Liver Regeneration; Postoperative Outcome
Pharmacokinetics and Metabolism Study in Healthy Male Participants
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 Phamacokinetic and metabolism study of BMS-986205 in healthy males
    


Intervention name(s): BMS-986205
Intervention type(s): Drug
Intervention description(s): Carbon 14 tagged BMS-986205
Intervention MeSH terms: Linrodostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study in Healthy Japanese and Caucasian Subjects to Assess the Pharmacokinetics, Safety and Tolerability of Risankizumab
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to assess the pharmacokinetics, safety, tolerability and
      immunogenicity following a single intravenous (IV) infusion of risankizumab in healthy
      Japanese and Caucasian participants.
    


Intervention name(s): Risankizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV) Infusion; Intravenous (IV) Infusion
Other intervention name(s): SKYRIZI; ABBV-066
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; Risankizumab; Skyrizi
Pre-Exposure Prophylaxis in YMSM
Condition: HIV
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an exploratory mixed-methods research study that compares an efficacious behavioral
      HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention
      combined with a biomedical intervention (PrEP). After completing the 3MV behavioral
      intervention, participants will be randomly assigned to one of three study arms: 1) daily
      FTC/TDF as PrEP, 2) placebo pill control, or 3) "no pill" control. Behavioral and biomedical
      data will be collected at baseline and every 4 weeks thereafter for 24 weeks. Youth who
      decline to participate will be asked to complete a brief survey about their opinions on PrEP.
      Qualitative interviews will be completed with six study participants and the study
      coordinators at the end of the trial to explore further the issues of trial acceptability and
      feasibility. Finally, focus groups will be conducted to explore feasibility and acceptability
      issues with YMSM who meet all eligibility requirements of the study except for not being age
      18 or older, but are at least 16 years of age.
    


Intervention name(s): coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP; Placebo; Many Men, Many Voices (3MV)
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.; Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.; Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
Intervention MeSH terms: Tenofovir; Emtricitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Pre-exposure prophylaxis; HIV Prevention; Truvada; Many Men, Many Voices; Emtricitabine; Tenofovir disoproxil fumarate; Young men who have sex with men; HIV Seronegativity
A Prospective Study of Natural History of Pancreatitis
Condition: Chronic Pancreatitis
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Study type: Observational

Summary: 
      To prospectively define the natural history and the clinical, laboratory and
      histomorphometric features of chronic pancreatitis (CP) of varying etiology. To identify
      clinical and laboratory parameters that correlate with the pathophysiologic state in patients
      with CP. To quantify the behavioral abnormalities associated with CP. To determine
      psychological and behavioral correlates of CP disease progression and outcomes.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects presenting to the Pancreatitis clinic with diagnosis of pancreatitis
      
Keywords: To define the natural history and the clinical, laboratory and histomorphometric features of chronic pancreatitis (CP).; To identify clinical and laboratory parameters that correlate with the pathophysiologic state in patients with CP.; To quantify the behavioral abnormalities associated with CP.; To determine psychological and behavioral correlates of CP disease progression and outcomes.
Coordinating Teams in Primary Health Care.
Condition: Musculoskeletal Diseases
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      Patients who suffer from musculoskeletal pain often have more than one diagnosis. These
      patients mostly have to wait a long time for the doctor's examination and treatment, and they
      also often have a sick leave for a long period of time. The investigators expect that
      treatment and follow-up by an coordinating interdisciplinary team can improve these patients
      opportunity to function, increase their quality of life, and decrease their pain. The purpose
      of this study is to investigate if use of a coordinating interdisciplinary team in primary
      health care will result in reduced sick leave compared with practice as usual, and give fewer
      referrals to specialized health services and private rehabilitation centers. Research data
      will be obtained from the patients journals, questionnaires, and clinical examinations..
    


Intervention name(s): coordinating primary health care; usual primary health care
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: primary health care; Physical Therapy Specialty; General Practitioners; General Practice
Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy
Condition: IGA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Interventional

Summary: 
      A single-center random parallel study to compare the efficacy and safety of Mycophenolate
      mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA
      nephropathy
    

Detailed description: 
      IgA nephropathy is an immune-complex glomerulopathy that can result in capillary necrosis or
      extracapillary proliferation (crescents). Several studies have documented a higher incidence
      of hypertension and nephritic-range proteinuria in patients with the crescentic form of IgA
      nephropathy, suggesting that patients with this variant of the disease may have a worse
      prognosis. Some studies have shown that treatment with steroids and cyclophosphamide had
      efficacy on reducing proteinuria and preserving renal function by healing vasculitic lesions,
      therefore preventing the progression of glomerular sclerosis. Recent studies have also shown
      that mycophenolate mofetil is effective in the treatment of lupus nephritis with vasculitic
      lesion and small vasculitis with renal involvement. We will conduct a single-center
      prospective open-labeled clinical trial of 40 patients with crescentic IgA nephropathy and
      treat them randomly with pulse intravenous cyclophosphamide or oral mycophenolate mofetil.
      After 12 months of treatment, we will assess the efficacy, safety, tolerability and relapse
      of mycophenolate mofetil compared with cyclophosphamide in the treatment of crescentic IgA
      nephropathy.
    

Intervention name(s): Mycophenolate mofetil
Intervention type(s): Drug
Intervention description(s): MMF,1.0g/d
Other intervention name(s): MMF,cellcept
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crescentic IgA nephropathy; Mycophenolate mofetil; Cyclophosphamide; treatment
Clinical Neurobiology of Serotonin and Addiction
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to examine the relationship between 5-HT2R function, impulsivity
      and cue reactivity in cocaine dependent subjects and healthy controls and examine specific
      effects of escitalopram and mirtazapine on impulsivity and cue reactivity in human cocaine
      users.
    

Detailed description: 
      Specific Aim 1: We will test the hypothesis that cocaine-dependent subjects will exhibit
      greater impulsivity than controls as determined by a battery of impulsivity measures and that
      impulsivity will be associated with specific profiles of 5-HT2AR and/or 5-HT2CR expression in
      platelets. We predict that treatment of cocaine-dependent subjects with escitalopram and/or
      mirtazapine will reduce impulsivity and cocaine-positive urines, in concert with a normalized
      balance of platelet 5-HT2AR and/or 5-HT2CR expression.

      Specific Aim 2: We will test the hypothesis that cocaine-dependent subjects will exhibit
      greater cue reactivity than controls as determined by a modified Stroop task, and that cue
      reactivity will be associated with specific profiles of 5-HT2AR and/or 5-HT2CR expression in
      platelets. We predict that treatment of cocaine-dependent subjects with escitalopram and/or
      mirtazapine will reduce cue reactivity and cocaine-positive urines, in concert with a
      normalized balance of platelet 5-HT2AR and/or 5-HT2CR expression.

      Specific Aim 3: We will test the hypothesis that specific polymorphisms in the 5-HT2AR and/or
      5-HT2CR will predict baseline impulsivity and/or cue reactivity as well as treatment response
      to serotonergic medications in cocaine-dependent subjects.
    

Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28; Once daily days 1-28
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: substance abuse; cocaine; impulsivity; serotonin; Remeron; Mirtzapine; Lexapro; Escatilopram
Explore the Efficiency of Fiberscope-guided Nasogastric Tube Insertion
Condition: Nasogastric Tube Esophagitis
MeSH terms: Esophagitis
Study type: Interventional

Summary: 
      For Head and neck cancer and uncooperative patients, blind nasogastric tube (NGT) insertion
      may sometimes be very difficult because of the anatomical obstructions in the pharynx and
      uncoordinated swallowing motion. To solve the problem, flexible endoscope has been used
      widely to assist the NGT insertion via direct visual assistance, working channels/guide
      wires, or suture fixation. Unfortunately, these tools are not easily assessed in the
      outpatient department. Here, we try to use a simpler method for the flexible endoscope to
      guide the NGT insertion.
    

Detailed description: 
      NGT and fiberscope was combined to facilitate NG tube insertion
    

Intervention name(s): Fiberscope-Guided Nasogastric tube insertion
Intervention type(s): Device
Intervention description(s): Fiberscope-Guided Nasogastric tube insertion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cancer patients, Nutritional status
A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140)
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to determine the efficacy and safety of an investigational drug
      in patients with benign prostatic hyperplasia.
    


Intervention name(s): MK0906, finasteride / Duration of Treatment: 48 weeks; Comparator: placebo / Duration of Treatment: 48 weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Finasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Phase II Multi-Strata Study of PM01183 as a Single Agent or in Combination With Conventional Chemotherapy in Metastatic and/or Unresectable Sarcomas
Condition: Metastatic Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study is investigating a drug called PM01183 alone and in combination with
      chemotherapy drugs called gemcitabine or doxorubicin as a possible treatment for metastatic
      or unresectable Sarcoma.
    

Detailed description: 
      This research study is a Phase II clinical trial. Phase II clinical trials test the safety
      and effectiveness of an investigational intervention to learn whether the intervention works
      in treating a specific disease. "Investigational" means that the intervention is being
      studied.

      PM01183 is a new drug that is believed to bind DNA cause double strands of DNA to break. This
      drug has been studied in previous research studies, and these suggest that it may slow or
      stop the growth of cancers. The FDA (the U.S. Food and Drug Administration) has not approved
      PM01183 as a treatment for any disease.

      In this research study, the investigators are trying to assess the effects, good or bad, that
      PM01183, administered either alone or in combination with gemcitabine or doxorubicin has on
      metastatic or unresectable sarcoma.
    

Intervention name(s): PM01183; Doxorubicin; Gemcitabine
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): lurbinectedin; Hydroxydaunomycin Hydrochloride; Adriamycin; Hydroxydoxorubicin Hydrochloride; Gemzar
Intervention MeSH terms: Gemcitabine; Doxorubicin; Liposomal doxorubicin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic Sarcoma; Unresectable Sarcoma; PM01183
Tysabri Observational Program
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The primary objective of this study is to assess the long-term safety and impact on disease
      activity and progression of Tysabri in participants with relapsing remitting multiple
      sclerosis (RRMS) in a clinical practice setting.
    

Detailed description: 
      TOP is an epidemiological observational study of participants receiving natalizumab, with
      each participant to be followed for up to 15 years. This study is designed to address the
      long-term safety profile and the long-term impact on disease activity and progression of
      Tysabri with marketed use, and the impact of treatment on disability in particular by
      comparing the results with prospectively determined controls from established databases.
    

Intervention name(s): Tysabri
Intervention type(s): Drug
Intervention description(s): According to the local prescribing information
Other intervention name(s): BG00002; natalizumab
Intervention MeSH terms: Natalizumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with RRMS who are therapy-naïve to Tysabri and who meet the criteria defined
        in the indication statement for prescription in the respective country.
      
Keywords: disease progression; Multiple Sclerosis; disease activity; Tysabri; natalizumab; long-term safety
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 3

Summary: 
      This open-label, multicenter study is designed to evaluate the safety, tolerability and
      immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than
      15 months up to less than 18 years.
    


Intervention name(s): 13 valent pneumococcal conjugate vaccine
Intervention type(s): Biological
Intervention description(s): Intramuscular injection of 0.5mL at visit 1 and visit 2 for group 1 and and visit 1 for groups 2, 3, and 4.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
Condition: ARDS
Study type: Interventional
Phase: Phase 4

Summary: 
      The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively
      investigated. The aim of the study is to show a reduction of the mortality rate of ARDS
      patients.
    

Detailed description: 
      The use of neuromuscular blocking agents (NMBA) in ARDS patients has not been extensively
      investigated. It has been recently demonstrated that a systematic 48-h infusion of NMBA is
      associated with a significant improvement in oxygenation as compared with a control group
      (Gainnier et al., Crit Care Med 2004). Moreover, a trend towards a reduction in the mortality
      rate has been observed. The aim of the study is to show a reduction of the mortality rate of
      ARDS patients.
    

Intervention name(s): cisatracurium; Placebo; Cisatracurium besilate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): physiological serum infusion; Cisatracurium besilate infusion (900mg/day)
Intervention MeSH terms: Cisatracurium; Atracurium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ARDS; mortality; mechanical ventilation; pneumonia; muscle relaxants
Immunogenicity and Safety of Trivalent Influenza Vaccine in Pregnant and Nonpregnant HIV Uninfected Women
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in
      HIV-uninfected pregnant women compared with HIV-uninfected non-pregnant women in 2013. Safety
      data will also be collected.THe Pregnancy outcomes and the transplacental transfer of
      antibodies will also be assessed.
    


Intervention name(s): Trivalent Influenza Vaccine
Intervention type(s): Biological
Intervention description(s): The formulation based on the WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains:
an A/California/7/2009 (H1N1)pdm09-like virus;
an A/Victoria/361/2011 (H3N2)-like virus; - a B/Wisconsin/1/2010-like virus.
The vaccine to be used in the study in 2013 is Vaxigrip (Sanofi Pasteur), or other equivalent licensed vaccine should the latter not be available, which will be procured commercially in pre-filled syringes. Using aseptic technique, participants will be injected with 0.5 mL of TIV from pre-filled syringe.
Other intervention name(s): Vaxigrip
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Influenza; Vaccination