bioihbjkbjnl/mcl2 huggingface dataset:
Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
Condition: Hypolipoproteinemia; Hypercholesterolemia; Dyslipidemia; Hyperlipidemia
MeSH terms: Hypolipoproteinemias; Hypercholesterolemia; Dyslipidemias; Hyperlipidemias
Study type: Observational

Summary: 
      Researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the
      blood. This study is designed to improve understanding of normal, as well as abnormal,
      lipoprotein metabolism and the role it plays in the development of hardening of the arteries
      (atherosclerosis).

      Patients participating in this study will receive injections of lipoproteins or
      apolipoproteins (the protein component of lipoproteins) that have been isolated and purified.
      These lipoproteins will be labeled with small amounts of radioactive material and sterilized
      before they are injected into the patient.

      Patients participating in the study will be required to have blood samples taken, and provide
      urine samples throughout the course of the study. In addition, patient will be required to
      follow a specially formulated diet. Patients will be weighed throughout the course of the
      study.
    

Detailed description: 
      We propose to investigate human in vivo lipoprotein metabolism using radiolabeled
      apolipoproteins on plasma lipoproteins. Paired kinetic studies using dual-labeled iodinated
      lipoproteins and apolipoproteins are performed in healthy volunteer controls with normal
      lipids and subjects with dyslipidemia under controlled metabolic conditions. Studies are
      designed to formulate metabolic pathways in patients with undefined genetic disorders of
      lipid metabolism as well as in healthy volunteers to provide original insights into normal
      and pathologic metabolic pathways. All kinetic data is computer analyzed to provide
      quantitative data and facilitate direct comparison of multiple studies.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Dsylipidemia
      
Keywords: Metabolism; HDL; Cholesterol; LDL; Hypoalphalipoproteinemia; Natural History
Treatment of Chronic Itch in Atopic Dermatitis (Eczema): Nerve Function
Condition: Cutaneous Nerves CNS Itch
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and efficacy of oral clonidine in subjects
      with symptomatic atopic dermatitis and to assess the safety and efficacy of oral naltrexone
      in subjects with symptomatic atopic dermatitis.
    

Detailed description: 
      This study will serve as a pilot study to determine the efficacy and safety of two novel oral
      agents (clonidine, naltrexone) in the treatment of chronic, non-experimentally induced itch
      in atopic dermatitis. In this study, eight subjects with symptomatic atopic dermatitis will
      be recruited and treated with either oral clonidine (four subjects) or oral naltrexone (four
      subjects) . Disease burden will be evaluated before and after 4 weeks of treatment through
      reporting of subjective symptomatology via surveys/questionnaire, neurometer study, and
      clinical assessment.
    

Intervention name(s): Clonidine; Naltrexone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clonidine; Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: itch atopic dermatitis
GW572016 In Patients With Advanced Or Metastatic Breast Cancer
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the efficacy and safety of GW572016 in patients with
      refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must
      have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2
      overexpressing tumors. Patients eligible for this study must have advanced metastatic breast
      cancer who have previously received treatment with anthracycline and taxane.
    


Intervention name(s): Tykerb
Intervention type(s): Drug
Intervention description(s): lapatinib 1500mg daily
Intervention MeSH terms: Lapatinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lapatinib; metastatic breast cancer; trastuzumab (Herceptin); Stage IV breast cancer; ErbB2; ErbB1
Seroquel on Glucose Metabolism
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether six months treatment with the antipsychotic
      medicine Seroquel (quetiapine) may affect the schizophrenic patient's glucose metabolism
    


Intervention name(s): Seroquel (quetiapine)
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia
The Detection of Circulating Tumor Cells (CTCs) in Patients With Breast Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment
Condition: Neoplastic Cells, Circulating
MeSH terms: Neoplastic Cells, Circulating
Study type: Observational

Summary: 
      Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time
      biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in
      breast cancer could play an important role in diagnosis, predicting the risk for tumor
      recurrence, and providing novel target therapy biomarkers. In view of these facts, the
      investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting
      human tumor cells of breast cancer in normal peripheral blood after cryosurgery with or
      without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators
      also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)
      method.
    

Detailed description: 
      1 day before and 2 days after cryosurgery with or without DC-CIK treatment，approximately
      17-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients
      with breast cancer and healthy volunteers. The blood of the healthy volunteers will be used
      to evaluate the sensitivity and specificity and as negative control cells. To avoid
      contamination with skin cells, 2 mL blood will be discarded before the study samples will be
      taken.Briefly, the mononucleate cells will be separated from the blood over Ficoll- Paque for
      20 min with 1800g at 4℃. The interface cells will be removed and washed, and the red blood
      cells(RBCs) will be removed using a lysis buffer followed by a repeated wash. The mononuclear
      cells will be counted and aliquot for RT-PCR and multiparameter flow cytometry on the basis
      of at least 2-3×106 cells for each methodology. The cell pellet will be resuspended in
      phosphate-buffered saline for multiparameter flow cytometry and in Trizol reagent for RT-PCR.
      Aim : Identification of CTCs may lead to better diagnosis and prognosis and could help to
      choose an adequate therapy.
    

Intervention name(s): Flow cytometry (FCM); RT-PCR
Intervention type(s): Other; Other
Intervention description(s): Use FCM to test PBMCs/CTCs from volunteers/patients.; Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Ⅱ,Ⅲ,Ⅳ stage breast cancer come to Fuda Hospital for treatment.
      
Keywords: Breast Neoplasms; Circulating Tumor Cells
A Phase II Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia
Condition: Community Acquired Pneumonia
MeSH terms: Pneumonia; Pneumonia, Bacterial
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and Efficacy of Faropenem in
      community-acquired pneumonia (CAP) subjects，and explore its therapeutic dose.
    


Intervention name(s): Faropenem（high dose group）; Faropenem（low-dose group); Ertapenem
Intervention type(s): Drug; Drug; Drug
Intervention description(s): dosage form: Injection dosage:2400 mg frequency: Three times a day; dosage form: Injection dosage:2400 mg frequency: twice a day; dosage form: Injection dosage:1000 mg frequency: once a day
Intervention MeSH terms: Ertapenem; beta-Lactams
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Plasma Ropivacaine Concentrations After Sciatic Nerve Block in Patients With Chronic Kidney Disease
Condition: Regional Anesthesia Morbidity; Local Anesthetic Drug Adverse Reaction
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Observational

Summary: 
      This prospective observational study aimed to examine the pharmacokinetics of ropivacaine in
      patients with chronic kidney disease after sciatic nerve block.

      Sciatic nerve block for foot and ankle surgery will be performed using ropivacaine under
      ultrasound-guidance, and arterial blood test will be taken for total plasma ropivacaine
      concentration at 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after sciatic nerve block.
    


Intervention name(s): Sciatic nerve block
Intervention type(s): Procedure
Intervention description(s): Sciatic nerve block will be performed using ropivacaine (2.5mg/kg) under ultrasound-guidance with nerve stimulator.
Other intervention name(s): Popliteal block
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for foot and ankle surgery under sciatic nerve block and who had chronic
        kidney disease
      
Biospecimen description: 
      Arterial blood sampling will be taken at 2.5, 5, 15, 30, 60 minutes and 2, 6, 24 hours after
      sciatic nerve block.
Evaluation of the Effect of the Dietary Supplement X34 on Skin Radiance of Healthy Volunteers With Dull Complexion
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The main objective of this trial is to evaluate the effect of the daily dose of X34 dietary
      supplement on skin radiance (clinical assessment) for 8 weeks.
    


Intervention name(s): X34
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary supplement named X34
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: antioxidant; skin radiance; skin elasticity; skin firmness; skin hydration
Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S)
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of
      subjects to receive seasonal trivalent inactivated split virion influenza vaccine (A/H1N1;
      A/H3N2 and B strains) or placebo (phosphate buffered saline). A total of 60 healthy male and
      female adults 18 through 45 years of age will be randomized to receive vaccine (30) or
      placebo (30).
    

Detailed description: 
      This is a phase 1, single center, double blinded, randomized, placebo-controlled study. Sixty
      (60) healthy male and female adults, 18 to 45 years of age, will be enrolled into the trial.
      Subjects will be randomized 1:1 to one of two treatment allocations: 30 to vaccine, 30 to
      placebo. The study will utilize a "randomized block design" to assure a balance of 1:1
      vaccine and placebo when all subjects are enrolled. The study will be double blinded, meaning
      the study subjects, investigators, and the sponsor will be unaware of the treatment allocated
      to each subject until the clinical trial database is declared final and locked. The study
      should take about 5 months to complete, with each subject involved for 3 months from the day
      of injection. The justification for the 3 month follow up, rather than 6 month follow up is
      that this is an inactivated vaccine that follows very standard manufacturing practices with
      standard antigens. The safety of inactivated influenza vaccines is well-established. Adding
      length to the follow up results in delays in future testing of the vaccine for licensure.
    

Intervention name(s): Trivalent Seasonal Influenza Vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 0.5 mL of phosphate buffered saline
Other intervention name(s): IVACFLU-S
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Seasonal Influenza; Trivalent Vaccine; Inactivated Vaccine
A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and tolerability of E5555 in Japanese
      subjects with coronary artery disease.
    


Intervention name(s): E5555 50 mg; E5555 100 mg; E5555 200 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): E5555 50 mg (tablet) taken orally, once a day.; E5555 100 mg (tablet) taken orally, once a day.; E5555 200 mg (tablet) taken orally, once a day.; Placebo (tablet) taken orally, once a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Coronary artery disease
Renal Transplantation and Raltegravir in HIV-Infected Patients
Condition: HIV-1 Infection; Chronic Renal Insufficiency
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the incidence of acute renal graft rejection 6 months
      after transplantation in HIV-infected patients under three antiretroviral drugs regimen
      including Raltegravir.
    

Detailed description: 
      Antiretroviral treatment of HIV-1 Infection might interact with immunosuppressive treatments
      which increase rejection of renal graft incidence.

      In addition HIV infection may be modified together with cardiovascular risk. Patients
      participating to this study will receive after transplantation antiretroviral regimen
      including Raltegravir.

      Raltegravir treatment does not interact with immunosuppressive drugs and thus seems to be the
      treatment of choice to be associated with immunosuppressive drugs.
    

Intervention name(s): Raltegravir
Intervention type(s): Drug
Intervention description(s): Introduction of Raltegravir 2 days after renal transplantation within an antiretroviral regimen without ritonavir boosted antiprotease
Other intervention name(s): Isentress
Intervention MeSH terms: Raltegravir Potassium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Raltegravir; Renal transplantation; HIV-1; Acute renal graft rejection
Safety and Efficacy of Alteplase When Administered in Chinese Patients With Acute Ischemic Hemispheric Stroke Where Thrombolysis is Initiated Between 3 and 4.5 Hours After Stroke Onset
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and efficacy of alteplase when administered between 3 and 4.5 hours
      after onset of stroke symptoms in Chinese patients with acute ischemic stroke
    


Intervention name(s): alteplase
Intervention type(s): Drug
Intervention MeSH terms: Tissue Plasminogen Activator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I Clinical Study of Hemay808
Condition: Safety Issues
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study in health volunteers. The purpose is the local tolerability
      and systemic safety of Hemay808, which is an ointment made of a novel small molecule
      Hemay028. The safety and systemic pharmacokinetics (PK) of Hemay028 will be evaluated
      following topical application of Hemay808 to healthy volunteers.
    

Detailed description: 
      There are two pre-test groups. Group1 use Hemay808 and placebo on sensitive areas. Group2
      will only topical use Hemay808 on 5%BSA.

      After 2 pre-test group, 4 formal testing groups will start. 1% Hemay808 apply to 25%BSA; 3%
      Hemay808 apply to 25%BSA; 3% Hemay808 apply to 55%BSA; 7% Hemay808 apply to 25%BSA. First a
      single doses then wash-out for three days, after that subjects will applicant twice daily for
      7 days to assess the local skin tolerability, and systemic PK of these treatments.

      Approximately 42 healthy adult volunteers will be enrolled in this study with 8- 10
      volunteers each cohort.
    

Intervention name(s): Hemay808; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): topical apply; topical apply
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: first in human; atopic dermatitis
Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when
      given together with vinorelbine in treating patients with recurrent lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose of topotecan when combined with vinorelbine
           ditartrate in patients with recurrent lung cancer.

      Secondary

        -  Assess the response and stable disease rates and the time to disease progression among
           treated patients.

      OUTLINE: This is a dose-escalation study of topotecan.

      Patents receive vinorelbine ditartrate IV over 8-10 minutes and topotecan IV over 30 minutes
      on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of
      disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which ≥ 2 of 6
      patients experience dose-limiting toxicity.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
    

Intervention name(s): topotecan hydrochloride; vinorelbine tartrate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Topotecan; Vinorelbine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the lung; adenosquamous cell lung cancer; bronchoalveolar cell lung cancer; combined type small cell lung cancer; intermediate type small cell lung cancer; large cell lung cancer; lymphocyte-like type small cell lung cancer; recurrent non-small cell lung cancer; recurrent small cell lung cancer; squamous cell lung cancer
A Study of LY900014 in Participants With Type 2 Diabetes on Insulin Injection Therapy
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be conducted in participants with type 2 diabetes on insulin injection therapy
      to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar
      levels. Side effects and tolerability will be documented. The study will be conducted in two
      parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in
      both parts.
    


Intervention name(s): LY900014; Insulin Lispro
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (SC); Administered SC
Other intervention name(s): Ultra-Rapid Lispro; LY275585
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science